Sample records for automatic defibrillator implantation

  1. Patient ECG recording control for an automatic implantable defibrillator

    NASA Technical Reports Server (NTRS)

    Fountain, Glen H. (Inventor); Lee, Jr., David G. (Inventor); Kitchin, David A. (Inventor)

    1986-01-01

    An implantable automatic defibrillator includes sensors which are placed on or near the patient's heart to detect electrical signals indicative of the physiology of the heart. The signals are digitally converted and stored into a FIFO region of a RAM by operation of a direct memory access (DMA) controller. The DMA controller operates transparently with respect to the microprocessor which is part of the defibrillator. The implantable defibrillator includes a telemetry communications circuit for sending data outbound from the defibrillator to an external device (either a patient controller or a physician's console or other) and a receiver for sensing at least an externally generated patient ECG recording command signal. The patient recording command signal is generated by the hand held patient controller. Upon detection of the patient ECG recording command, DMA copies the contents of the FIFO into a specific region of the RAM.

  2. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

    PubMed

    Murgatroyd, Francis D; Helmling, Erhard; Lemke, Bernd; Eber, Bernd; Mewis, Christian; van der Meer-Hensgens, Judith; Chang, Yanping; Khalameizer, Vladimir; Katz, Amos

    2010-06-01

    The Secura ICD and Consulta CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population. Two prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 +/- 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were automatic CM measurements were available within 1 week prior to the 3-month visit in 90% (RA), 99% (RV), and 97% (LV) of the patients. Results indicated increased output (threshold >2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate. Complete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity. The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162.

  3. Driving safety among patients with automatic implantable cardioverter defibrillators.

    PubMed

    Finch, N J; Leman, R B; Kratz, J M; Gillette, P C

    1993-10-06

    To determine the driving behavior of patients following the placement of automatic implantable cardioverter defibrillators (AICDs). Forty patients with AICDs (33 men, seven women; mean age, 62.7 years) responded to a questionnaire designed to ascertain driving behavior after hospital discharge. Despite medical advice never to drive again, 28 patients (70%) resumed driving, with the majority doing so by 8 months after AICD implantation. Of these, 11 (40%) identified themselves as the primary driver in their household. Fourteen (50%) drove daily. Two (7%) were driving and continued to drive during discharge of their AICDs. Twenty-five (91%) reported that they felt comfortable and safe while driving. A majority of patients with AICDs continue to drive after a proscription of this activity by health care workers.

  4. Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol.

    PubMed

    Kutyifa, Valentina; Beck, Christopher; Brown, Mary W; Cannom, David; Daubert, James; Estes, Mark; Greenberg, Henry; Goldenberg, Ilan; Hammes, Stephen; Huang, David; Klein, Helmut; Knops, Reinoud; Kosiborod, Mikhail; Poole, Jeanne; Schuger, Claudio; Singh, Jagmeet P; Solomon, Scott; Wilber, David; Zareba, Wojciech; Moss, Arthur J

    2017-07-01

    Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post-myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  5. [Wearable Automatic External Defibrillators].

    PubMed

    Luo, Huajie; Luo, Zhangyuan; Jin, Xun; Zhang, Leilei; Wang, Changjin; Zhang, Wenzan; Tu, Quan

    2015-11-01

    Defibrillation is the most effective method of treating ventricular fibrillation(VF), this paper introduces wearable automatic external defibrillators based on embedded system which includes EGG measurements, bioelectrical impedance measurement, discharge defibrillation module, which can automatic identify VF signal, biphasic exponential waveform defibrillation discharge. After verified by animal tests, the device can realize EGG acquisition and automatic identification. After identifying the ventricular fibrillation signal, it can automatic defibrillate to abort ventricular fibrillation and to realize the cardiac electrical cardioversion.

  6. [Clinical development of the automatic implantable defibrillator over 35 years: A success story].

    PubMed

    Steinbeck, G

    2015-06-01

    After 12 years of development and experimental evaluation, the first automatic implantable cardioverter-defibrillator (ICD) was implanted in man on February 4, 1980. This overview describes the technical and functional developments over 35 years from a simple shock-box, weighing 292 g, to the sophisticated 80 g device of today, delivering graded therapy to sustained ventricular arrhythmias and biventricular stimulation to treat heart failure. Finally, a special tribute is given to Michel Mirowski, one of the inventors of the ICD, as scientist and physician dedicated to patient care.

  7. How implantable cardioverter-defibrillators work and simple programming.

    PubMed

    Bryant, Randall M

    2017-01-01

    Following the sudden death of a friend in 1966, Dr Michel Mirowski began pioneering work on the first implantable cardioverter-defibrillator. By 1969 he had developed an experimental model and performed the first transvenous defibrillation. In 1970 he reported on the use of a "standby automatic defibrillator" that was tested successfully in dogs. He postulated that such a device "when adapted for clinical use, might be implanted temporarily or permanently in selected patients particularly prone to develop ventricular fibrillation and thus provide them with some degree of protection from sudden coronary death". In 1980 he reported on the first human implants of an "electronic device designed to monitor cardiac electrical activity, to recognise ventricular fibrillation and ventricular tachyarrhythmias … and then to deliver corrective defibrillatory discharges". Through innovations in circuitry, battery, and capacitor technologies, the current implantable cardioverter-defibrillator is 10 times smaller and exponentially more sophisticated than that first iteration. This article will review the inner workings of the implantable cardioverter-defibrillator and outline several features that make it the wonder in technology that it has become.

  8. Specific considerations with the automatic implantable atrial defibrillator.

    PubMed

    Jung, W; Wolpert, C; Esmailzadeh, B; Spehl, S; Herwig, S; Schumacher, B; Lewalter, T; Omran, H; Kirchhoff, P G; Lüderitz, B

    1998-08-01

    Internal atrial defibrillation has been evaluated as an alternative approach to the external technique for more than two decades. Previous studies in animals and humans have shown that internal atrial defibrillation is feasible with relatively low energies. The promising results achieved with internal atrial defibrillation have facilitated the development of an implantable atrial defibrillator (IAD). For any new therapy, it is imperative to demonstrate safety, efficacy, tolerability with improvement in quality of life, and cost-effectiveness compared with therapeutic options already available. Maintenance of sinus rhythm or prolonged duration in arrhythmia-free intervals should be demonstrated clearly with an IAD. Initial clinical experience with the Metrix system indicates stable atrial defibrillation thresholds, appropriate R wave synchronization markers, no shock-induced ventricular proarrhythmia, and excellent detection of atrial fibrillation (AF) with a specificity of 100%. Ventricular proarrhythmia has not been reported for correctly R wave synchronized low-energy shocks when closely coupled to RR intervals, and long-short cycles are avoided. Preliminary experience with the Metrix system suggests that the IAD may offer a therapeutic alternative for a subgroup of patients with drug-refractory, symptomatic, long-lasting, and infrequent episodes of AF. Further efforts must be undertaken to reduce the patient discomfort associated with internal atrial defibrillation in an attempt to make this new therapy acceptable to a larger patient population with AF.

  9. Automatic external defibrillator, life vest defibrillator, or both?

    PubMed

    Richard Conti, C

    2010-12-01

    The standard of practice for out-of-hospital defibrillation is the implantable cardioverter-defibrillator. However, much has been written and discussed about the use of automated external defibrillators. Not as much has been written about life vest wearable defibrillators. Copyright © 2010 Wiley Periodicals, Inc.

  10. Relationship between age and inappropriate implantable cardioverter-defibrillator therapy in MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy).

    PubMed

    Biton, Yitschak; Huang, David T; Goldenberg, Ilan; Rosero, Spencer; Moss, Arthur J; Kutyifa, Valentina; McNitt, Scott; Strasberg, Boris; Zareba, Wojciech; Barsheshet, Alon

    2016-04-01

    There is limited data regarding the relationship between age and inappropriate therapy among patients with an implantable cardioverter-defibrillator (ICD) and resynchronization therapy. We aimed to investigate this relationship and the effect of ICD programming on inappropriate therapy by age. In the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) 1500 patients were randomized to 3 ICD programming arms: (A) conventional with ventricular tachycardia (VT) therapy ≥170; (B) high-rate cutoff with VT therapy ≥200, and (C) prolonged 60-second delay for VT therapy ≥170. We investigated the relationship between age, the risk of inappropriate ICD therapy (including antitachycardia pacing [ATP] or shock), and ICD programming. Cumulative incidence function Kaplan-Meier graphs showed an inverse relationship between increasing quartiles of age (Q1: ≤55, Q2: 56-64, Q3: 65-71, and Q4: ≥72 years) and the risk for inappropriate therapy. Multivariate analyses showed that each increasing decade of life was associated with 34% (P < .001), 27% (P < .001), and 26% (P < .001) reduction in the risk of inappropriate shock, inappropriate ATP, and any inappropriate therapy, respectively. Treatment arms B and C as compared with arm A were associated with a significant reduction in the risk of inappropriate therapies across all age quartiles (P < .001 for all). Among patients with a primary prevention indication for an ICD, there is an inverse relationship between age and inappropriate ICD therapy. Innovative ICD programming of high-rate cutoff or prolonged delay for VT therapy is associated with significant reductions in inappropriate therapy among all age groups. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  11. Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT).

    PubMed

    Ruwald, Anne-Christine; Schuger, Claudio; Moss, Arthur J; Kutyifa, Valentina; Olshansky, Brian; Greenberg, Henry; Cannom, David S; Estes, N A Mark; Ruwald, Martin H; Huang, David T; Klein, Helmut; McNitt, Scott; Beck, Christopher A; Goldstein, Robert; Brown, Mary W; Kautzner, Josef; Shoda, Morio; Wilber, David; Zareba, Wojciech; Daubert, James P

    2014-10-01

    The benefit of novel implantable cardioverter defibrillator (ICD) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). However, the cause of mortality reduction remains incompletely evaluated. We aimed to identify factors associated with mortality, with focus on ICD therapy and programming in the MADIT-RIT population. In MADIT-RIT, 1500 patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to 1 of 3 different ICD programming arms: conventional programming (ventricular tachycardia zone ≥170 beats per minute), high-rate programming (ventricular tachycardia zone ≥200 beats per minute), and delayed programming (60-second delay before therapy ≥170 beats per minute). Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy (shock and antitachycardia pacing) and randomized programming arm on all-cause mortality. During an average follow-up of 1.4±0.6 years, 71 of 1500 (5%) patients died: cardiac in 40 patients (56.3%), noncardiac in 23 patients (32.4%), and unknown in 8 patients (11.3%). Appropriate shocks (hazard ratio, 6.32; 95% confidence interval, 3.13-12.75; P<0.001) and inappropriate therapy (hazard ratio, 2.61; 95% confidence interval, 1.28-5.31; P=0.01) were significantly associated with an increased mortality risk. There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only (hazard ratio, 1.02; 95% confidence interval, 0.36-2.88; P=0.98). Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming (hazard ratio, 2.0; 95% confidence interval, 1.06-3.71; P=0.03). In MADIT-RIT, appropriate shocks, inappropriate ICD therapy, and randomization to

  12. [Research on automatic external defibrillator based on DSP].

    PubMed

    Jing, Jun; Ding, Jingyan; Zhang, Wei; Hong, Wenxue

    2012-10-01

    Electrical defibrillation is the most effective way to treat the ventricular tachycardia (VT) and ventricular fibrillation (VF). An automatic external defibrillator based on DSP is introduced in this paper. The whole design consists of the signal collection module, the microprocessor controlingl module, the display module, the defibrillation module and the automatic recognition algorithm for VF and non VF, etc. This automatic external defibrillator has achieved goals such as ECG signal real-time acquisition, ECG wave synchronous display, data delivering to U disk and automatic defibrillate when shockable rhythm appears, etc.

  13. Implantable cardioverter defibrillator - discharge

    MedlinePlus

    ... defibrillation. This device can also work as a pacemaker. What to Expect at Home When you leave ... pubmed/23265327 . Swerdlow CD, Wang PL, Zipes DP. Pacemakers and implantable cardioverter-defibrillators. In: Mann DL, Zipes ...

  14. Risk stratification for implantable cardioverter defibrillator therapy: the role of the wearable cardioverter-defibrillator.

    PubMed

    Klein, Helmut U; Goldenberg, Ilan; Moss, Arthur J

    2013-08-01

    The benefit of implantable cardioverter-defibrillator (ICD) therapy depends upon appropriate evaluation of a persisting risk of sudden death and estimation of the patient's overall survival. Assessment of a stable and unchangeable arrhythmogenic substrate is often difficult. Structural abnormality and ventricular dysfunction, the two major risk parameters, may recover, and heart failure symptoms can improve so that ICD therapy may not be indicated. Risk stratification can take time while the patient continues to be at high risk of arrhythmic death, and patients may need temporary bridging by a defibrillator in cases of interrupted ICD therapy. The wearable cardioverter-defibrillator (WCD) combines a long-term electrocardiogram (ECG)-monitoring system with an external automatic defibrillator. The LIfeVest® (ZOLL, Pittsburgh, PA, USA) is composed of a garment, containing two defibrillation patch electrodes on the back, and an elastic belt with a front-defibrillation patch electrode and four non-adhesive ECG electrodes, connected to a monitoring and defibrillation unit. The WCD is a safe and effective tool to terminate ventricular tachycardia/ventricular fibrillation events, unless a conscious patient withholds shock delivery. It may be used in patients in the early phase after acute myocardial infarction with poor left ventricular function, after acute coronary revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting) and reduced left ventricular ejection fraction (≤35%), in patients with acute heart failure in non-ischaemic cardiomyopathy of uncertain aetiology and prognosis. The WCD may be helpful in subjects with syncope of assumed tachyarrhythmia origin or in patients with inherited arrhythmia syndromes. The WCD may replace ICD implantation in patients waiting for heart transplantation or who need a ventricular-assist device. This review describes the technical details and characteristics of the WCD, discusses its

  15. Pacemakers and Implantable Defibrillators - Multiple Languages

    MedlinePlus

    ... Multiple Languages → All Health Topics → Pacemakers and Implantable Defibrillators URL of this page: https://medlineplus.gov/languages/ ... List of All Topics All Pacemakers and Implantable Defibrillators - Multiple Languages To use the sharing features on ...

  16. Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial.

    PubMed

    Varma, Niraj; Love, Charles J; Schweikert, Robert; Moll, Philip; Michalski, Justin; Epstein, Andrew E

    2018-04-01

    Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial. Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to Conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months. Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance. ClinicalTrials.gov; NCT00336284.

  17. Evaluation of an education and follow-up programme for implantable cardioverter defibrillator-implanted patients.

    PubMed

    Cinar, Fatma I; Tosun, Nuran; Kose, Sedat

    2013-09-01

    To determine the experiences, problems and the need for care and education of implantable cardioverter defibrillator-implanted patients and to assess the effects of an education and nurse follow-up programme on their quality of life, anxiety, depression and knowledge level. Although implantable cardioverter defibrillator has become a well-established therapy for people experiencing potentially lethal dysrhythmias, implantable cardioverter defibrillator patients may have physical and psychosocial problems due to the implantation. Applying a planning education and follow-up programme to implantable cardioverter defibrillator-implanted patients may prevent the need for more intensive treatment during the postimplantation period. A mixed methods design that used both qualitative and quantitative data collections and analysis was used for this study. The study was performed in the cardiology department in Turkey between 2009-2010. The data were collected using the 'Semi-Structured Interview Form', 'Form for Assessment of Patients' Knowledge Level about implantable cardioverter defibrillator', 'Spielberger's State-Trait Anxiety Inventory', 'Beck Depression Inventory II' and 'The Short-Form 36 Health Survey'. All forms were completed at the beginning of the study and at six months. The study included 27 patients in the experimental group and 27 patients in the control group. The results showed that the patients were living with various physical and psychosocial problems and insufficient knowledge regarding the implantable cardioverter defibrillator. Education and follow-up programme increased knowledge levels, decreased anxiety and depression scores and improved several subscales of quality of life in the experimental group patients. It was recommended that education and follow-up programme be used for patients scheduled to undergo implantable cardioverter defibrillator implantation, starting before implantation and continuing thereafter, to help patients adapt to a life

  18. Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations).

    PubMed

    Day, John D; Doshi, Rahul N; Belott, Peter; Birgersdotter-Green, Ulrika; Behboodikhah, Mahnaz; Ott, Peter; Glatter, Kathryn A; Tobias, Serge; Frumin, Howard; Lee, Byron K; Merillat, John; Wiener, Isaac; Wang, Samuel; Grogin, Harlan; Chun, Sung; Patrawalla, Rob; Crandall, Brian; Osborn, Jeffrey S; Weiss, J Peter; Lappe, Donald L; Neuman, Stacey

    2007-05-08

    Implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators have relied on multiple ventricular fibrillation (VF) induction/defibrillation tests at implantation to ensure that the device can reliably sense, detect, and convert VF. The ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations) is the first large, multicenter, prospective trial comparing vulnerability safety margin testing versus defibrillation safety margin testing with a single VF induction/defibrillation. A total of 426 patients receiving an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator underwent vulnerability safety margin or defibrillation safety margin screening at 14 J in a randomized order. After this, patients underwent confirmatory testing, which required 2 VF conversions without failure at < or = 21 J. Patients who passed their first 14-J and confirmatory tests, irrespective of the results of their second 14-J test, had their devices programmed to a 21-J shock for ventricular tachycardia (VT) or VF > or = 200 bpm and were followed up for 1 year. Of 420 patients who underwent 14-J vulnerability safety margin screening, 322 (76.7%) passed. Of these, 317 (98.4%) also passed 21-J confirmatory tests. Of 416 patients who underwent 14-J defibrillation safety margin screening, 343 (82.5%) passed, and 338 (98.5%) also passed 21-J confirmatory tests. Most clinical VT/VF episodes (32 of 37, or 86%) were terminated by the first shock, with no difference in first shock success. In all observed cases in which the first shock was unsuccessful, subsequent shocks terminated VT/VF without complication. Although spontaneous episodes of fast VT/VF were limited, there was no difference in the odds of first shock efficacy between groups. Screening with vulnerability safety margin or defibrillation safety

  19. Clinical impact of defibrillation testing at the time of implantable cardioverter-defibrillator insertion.

    PubMed

    Hadid, Claudio; Atienza, Felipe; Strasberg, Boris; Arenal, Ángel; Codner, Pablo; González-Torrecilla, Esteban; Datino, Tomás; Percal, Tamara; Almendral, Jesús; Ortiz, Mercedes; Martins, Raphael; Martinez-Alzamora, Nieves; Fernandez Aviles, Francisco

    2015-01-01

    Ventricular fibrillation is routinely induced during implantable cardioverter-defibrillator insertion to assess defibrillator performance, but this strategy is experiencing a progressive decline. We aimed to assess the efficacy of defibrillator therapies and long-term outcome in a cohort of patients that underwent defibrillator implantation with and without defibrillation testing. Retrospective observational series of consecutive patients undergoing initial defibrillator insertion or generator replacement. We registered spontaneous ventricular arrhythmias incidence and therapy efficacy, and mortality. A total of 545 patients underwent defibrillator implantation (111 with and 434 without defibrillation testing). After 19 (range 9-31) months of follow-up, the death rate per observation year (4% vs. 4%; p = 0.91) and the rate of patients with defibrillator-treated ventricular arrhythmic events per observation year (with test: 10% vs. without test: 12%; p = 0.46) were similar. The generalized estimating equations-adjusted first shock probability of success in patients with test (95%; CI 88-100%) vs. without test (98%; CI 96-100%; p = 0.42) and the proportion of successful antitachycardia therapies (with test: 87% vs. without test: 80%; p = 0.35) were similar between groups. There was no difference in the annualized rate of failed first shock per patient and per shocked patient between groups (5% vs. 4%; p = 0.94). In this observational study, that included an unselected population of patients with a defibrillator, no difference was found in overall mortality, first shock efficacy and rate of failed shocks regardless of whether defibrillation testing was performed or not.

  20. Dual- versus single-coil implantable defibrillator leads: review of the literature.

    PubMed

    Neuzner, Jörg; Carlsson, Jörg

    2012-04-01

    The preferred use of dual-coil implantable defibrillator lead systems in current implantable defibrillator therapy is likely based on data showing statistically lower defibrillation thresholds with dual-coil defibrillator lead systems. The following review will summarize the clinical data for dual- versus single-coil defibrillator leads in the left and right pectoral implant locations, and will then discuss the clinical implications of single- versus dual-coil usage for atrial defibrillation, venous complications, and the risks associated with lead extraction. It will be noted that there are no comparative clinical studies on the use and outcomes of single- versus dual-coil lead systems in implantable defibrillator therapy over a long-term follow-up. The limited long-term reliability of defibrillator leads is a major concern in implantable defibrillator and cardiac resynchronization therapy. A simpler single-coil defibrillator lead system may improve the long-term performance of implanted leads. Furthermore, the superior vena cava coil is suspected to increase interventional risk in transvenous lead extraction. Therefore, the need for objective data on extractions and complications will be emphasized.

  1. Implantable cardioverter defibrillator knowledge and end-of-life device deactivation: A cross-sectional survey.

    PubMed

    McEvedy, Samantha M; Cameron, Jan; Lugg, Eugene; Miller, Jennifer; Haedtke, Chris; Hammash, Muna; Biddle, Martha J; Lee, Kyoung Suk; Mariani, Justin A; Ski, Chantal F; Thompson, David R; Chung, Misook Lee; Moser, Debra K

    2018-01-01

    End-of-life implantable cardioverter defibrillator deactivation discussions should commence before device implantation and be ongoing, yet many implantable cardioverter defibrillators remain active in patients' last days. To examine associations among implantable cardioverter defibrillator knowledge, patient characteristics and attitudes to implantable cardioverter defibrillator deactivation. Cross-sectional survey using the Experiences, Attitudes and Knowledge of End-of-Life Issues in Implantable Cardioverter Defibrillator Patients Questionnaire. Participants were classified as insufficient or sufficient implantable cardioverter defibrillator knowledge and the two groups were compared. Implantable cardioverter defibrillator recipients ( n = 270, mean age 61 ± 14 years; 73% male) were recruited from cardiology and implantable cardioverter defibrillator clinics attached to two tertiary hospitals in Melbourne, Australia, and two in Kentucky, the United States. Participants with insufficient implantable cardioverter defibrillator knowledge ( n = 77, 29%) were significantly older (mean age 66 vs 60 years, p = 0.001), less likely to be Caucasian (77% vs 87%, p  = 0.047), less likely to have received implantable cardioverter defibrillator shocks (26% vs 40%, p = 0.031), and more likely to have indications of mild cognitive impairment (Montreal Cognitive Assessment score <24: 44% vs 16%, p < 0.001). Insufficient implantable cardioverter defibrillator knowledge was associated with attitudes suggesting unwillingness to discuss implantable cardioverter defibrillator deactivation, even during the last days towards end of life ( p < 0.05). Implantable cardioverter defibrillator recipients, especially those who are older or have mild cognitive impairment, often have limited knowledge about implantable cardioverter defibrillator deactivation. This study identified several potential teachable moments throughout the patients' treatment trajectory

  2. Gender-Related and Age-Related Differences in Implantable Defibrillator Recipients: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

    PubMed

    Feldman, Alyssa M; Kersten, Daniel J; Chung, Jessica A; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Cohen, Todd J

    2015-12-01

    The purpose of this study was to investigate the influences of gender and age on defibrillator lead failure and patient mortality. The specific influences of gender and age on defibrillator lead failure have not previously been investigated. This study analyzed the differences in gender and age in relation to defibrillator lead failure and mortality of patients in the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS"). PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Male and female patients were compared within each age decile, beginning at 15 years old, to analyze lead failure and patient mortality. Statistical analyses were performed using Wilcoxon rank-sum test, Fisher's exact test, Kaplan-Meier analysis, and multivariable Cox regression models. P<.05 was considered statistically significant. No correction for multiple comparisons was performed for the subgroup analyses. A total of 3802 patients (2812 men and 990 women) were included in the analysis. The mean age was 70 ± 13 years (range, 15-94 years). Kaplan-Meier analysis found that between 45 and 54 years of age, leads implanted in women failed significantly faster than in men (P=.03). Multivariable Cox regression models were built to validate this finding, and they confirmed that male gender was an independent protective factor of lead failure in the 45 to 54 years group (for male gender: HR, 0.37; 95% confidence interval, 0.14-0.96; P=.04). Lead survival time for women in this age group was 13.4 years (standard error, 0.6), while leads implanted in men of this age group survived 14.7 years (standard error, 0.3). Although there were significant differences in lead failure, no differences in mortality between the genders were found for any ages or within each decile. This study is the first to compare defibrillator lead failure and patient mortality in relation to gender and age

  3. Risk Stratification in Arrhythmic Right Ventricular Cardiomyopathy Without Implantable Cardioverter-Defibrillators

    PubMed Central

    Brun, Francesca; Groeneweg, Judith A.; Gear, Kathleen; Sinagra, Gianfranco; van der Heijden, Jeroen; Mestroni, Luisa; Hauer, Richard N.; Borgstrom, Mark; Marcus, Frank I.; Hughes, Trina

    2016-01-01

    Objectives The primary objective of this study is risk stratification of patients with arrhythmic right ventricular cardiomyopathy (ARVC). Background There is a need to identify those who need an automatic implantable defibrillator (ICD) to prevent sudden death. Methods This is an analysis of 88 patients with ARVC from three centers who were not treated with an ICD. Results Risk factors for subsequent arrhythmic deaths were pre-enrollment sustained or nonsustained ventricular tachycardia (VT) and decreased left ventricular function. Conclusion These factors serve as proposed guidelines for implantation of an ICD in patients with ARVC to prevent sudden death. PMID:27790640

  4. Epicardial implantable cardioverter-defibrillator system placed in a 4.9-kg infant.

    PubMed

    Bryant, Roosevelt; Aboutalebi, Amir; Kim, Jeffrey J; Kertesz, Naomi; Morales, David L S

    2011-01-01

    Implantable cardioverter-defibrillators have aided the prevention of sudden cardiac death in adults. The hope is to provide similar benefits to the pediatric population as the devices become smaller. Herein, we present the case of a 4.9-kg, 5-week-old infant boy who presented with cardiopulmonary arrest. After emergency defibrillation, conventional treatment options included long-term hospitalization for later cardioverter-defibrillator implantation, or installation of an external defibrillator with subsequent home telemetry. On the basis of the infant's body dimensions, we decided that an epicardial implantable cardioverter-defibrillator was feasible and the best option. We performed a median sternotomy and placed a Vitality® implantable cardioverter-defibrillator with a 25-cm defibrillator coil and a 35-cm bipolar ventricular lead. The patient experienced no postoperative morbidity or rhythm disturbances and was discharged from the hospital on postoperative day 5. He was placed on β-blocker therapy and has remained well for 3 years.Although external devices can be placed in a small patient, we believe that they are too susceptible to lead damage and lead migration, and that the defibrillator thresholds are less reliable. We think that dysrhythmias even in very small children can be treated effectively and safely with use of an epicardial implantable cardioverter-defibrillator. To our knowledge, this 4.9-kg infant is the smallest patient to have undergone a successful implantation of this kind.

  5. Pacemakers and implantable cardioverter defibrillators--general and anesthetic considerations.

    PubMed

    Rapsang, Amy G; Bhattacharyya, Prithwis

    2014-01-01

    A pacemaking system consists of an impulse generator and lead or leads to carry the electrical impulse to the patient's heart. Pacemaker and implantable cardioverter defibrillator codes were made to describe the type of pacemaker or implantable cardioverter defibrillator implanted. Indications for pacing and implantable cardioverter defibrillator implantation were given by the American College of Cardiologists. Certain pacemakers have magnet-operated reed switches incorporated; however, magnet application can have serious adverse effects; hence, devices should be considered programmable unless known otherwise. When a device patient undergoes any procedure (with or without anesthesia), special precautions have to be observed including a focused history/physical examination, interrogation of pacemaker before and after the procedure, emergency drugs/temporary pacing and defibrillation, reprogramming of pacemaker and disabling certain pacemaker functions if required, monitoring of electrolyte and metabolic disturbance and avoiding certain drugs and equipments that can interfere with pacemaker function. If unanticipated device interactions are found, consider discontinuation of the procedure until the source of interference can be eliminated or managed and all corrective measures should be taken to ensure proper pacemaker function should be done. Post procedure, the cardiac rate and rhythm should be monitored continuously and emergency drugs and equipments should be kept ready and consultation with a cardiologist or a pacemaker-implantable cardioverter defibrillator service may be necessary. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  6. Time-Dependent Changes in Psychosocial Distress in Japanese Patients with Implantable Cardioverter Defibrillators.

    PubMed

    Saito, Nao; Taru, Chiemi; Miyawaki, Ikuko

    2016-12-02

    This prospective study clarified changes in the mood states of Japanese patients with implantable cardioverter defibrillators as well as factors related to the mood states. Using a longitudinal repeated-measure design, 29 patients with implantable cardioverter defibrillators completed the Profile of Mood States-Short Form Japanese Version questionnaire before discharge and 1, 4, 7, and 13 months after implantation. One month after discharge, the mood states of the patients with implantable cardioverter defibrillators improved. From 7 to 13 months after discharge, moods deteriorated; 13 months after discharge, moods were equivalent to those at the time of discharge. No relationship with defibrillation experience was detected in this study, but employment, age, sex, and lack of experience of syncopal attack were factors related to poor mood states for patients with implantable cardioverter defibrillators. Therefore, Japanese patients with implantable cardioverter defibrillators with any factor deteriorating their mood state should be monitored so that their mood state does not deteriorate again between six months and one year after implantation.

  7. Classic conditioning and dysfunctional cognitions in patients with panic disorder and agoraphobia treated with an implantable cardioverter/defibrillator.

    PubMed

    Godemann, F; Ahrens, B; Behrens, S; Berthold, R; Gandor, C; Lampe, F; Linden, M

    2001-01-01

    A model for the development of anxiety disorders (panic disorder with or without agoraphobia) is needed. Patients with an implantable cardioverter/defibrillator (ICD) are exposed to repeated electric shocks. If the theory of anxiety development by aversive classic conditioning processes is valid, these repeated shocks should lead to an increased risk of anxiety disorders. To study this hypothesis, we retrospectively studied 72 patients after implantation of an automatic ICD. Patients were assessed with the semistructured Diagnostic Interview of Psychiatric Disease 1 to 6 years after implantation of an automatic ICD. Panic disorder and/or agoraphobia was diagnosed in patients who fulfilled all DSM-III-R criteria for those conditions. Anxiety disorder developed in 15.9% of patients after ICD implantation. This was significantly related to the frequency of repeated defibrillation (shocks) to stop malignant ventricular arrhythmias. Dysfunctional cognitions are an additional vulnerability factor. The data support both the conditioning hypothesis and the cognitive model of anxiety development. These findings suggest that ICD patients are an appropriate risk population for a prospective study of the development of anxiety disorders.

  8. Should an implanted defibrillator be considered in patients with vasospastic angina?

    PubMed

    Eschalier, Romain; Souteyrand, Géraud; Jean, Frédéric; Roux, Antoine; Combaret, Nicolas; Saludas, Yannick; Clerfond, Guillaume; Barber-Chamoux, Nicolas; Citron, Bernard; Lusson, Jean-René; Brugada, Pedro; Motreff, Pascal

    2014-01-01

    Vasospastic angina is a frequent and well-recognized pathology with a high risk of life-threatening ventricular arrhythmias and sudden cardiac death. The diagnosis of vasospastic angina requires the combination of clinical and electrocardiographic variables and the results of provocation tests, such as ergonovine administration. Smoking cessation is the first step in the management of vasospastic angina. Optimal medical treatment using calcium-channel blockers and/or nitrate derivatives can provide protection, but life-threatening ventricular arrhythmias may occur despite optimal medical treatment and several years after the start of treatment. In this review, we evaluate the role of implantable defibrillators as a complement to optimal medical management in patients with life-threatening ventricular arrhythmias due to vasospastic angina; this role is not well characterized in the literature or guidelines. We discuss the role of implantable defibrillators in secondary prevention in light of three recent cases managed in our departments and a review of the literature. An implantable defibrillator was implanted in two of the three cases of vasospastic angina with ventricular arrhythmias that we managed. We considered secondary prevention by implantable defibrillator to be justified even in the absence of any obvious risk factor. Ventricular arrhythmias recurred during implantable defibrillator follow-up in the two patients implanted. In patients with life-threatening ventricular arrhythmias due to vasospastic angina, an implantable defibrillator should be considered because of the risk of recurrence despite optimal medical management. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  9. Beam Profile Disturbances from Implantable Pacemakers or Implantable Cardioverter-Defibrillator Interactions

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gossman, Michael S., E-mail: mgossman@tsrcc.com; Comprehensive Heart and Vascular Associates, Heart and Vascular Center, Ashland, KY; Medtronic, Inc., External Research Program, Mounds View, MN

    2011-01-01

    The medical community is advocating for progressive improvement in the design of implantable cardioverter-defibrillators and implantable pacemakers to accommodate elevations in dose limitation criteria. With advancement already made for magnetic resonance imaging compatibility in some, a greater need is present to inform the radiation oncologist and medical physicist regarding treatment planning beam profile changes when such devices are in the field of a therapeutic radiation beam. Treatment plan modeling was conducted to simulate effects induced by Medtronic, Inc.-manufactured devices on therapeutic radiation beams. As a continuation of grant-supported research, we show that radial and transverse open beam profiles of amore » medical accelerator were altered when compared with profiles resulting when implantable pacemakers and cardioverter-defibrillators are placed directly in the beam. Results are markedly different between the 2 devices in the axial plane and the sagittal planes. Vast differences are also presented for the therapeutic beams at 6-MV and 18-MV x-ray energies. Maximum changes in percentage depth dose are observed for the implantable cardioverter-defibrillator as 9.3% at 6 MV and 10.1% at 18 MV, with worst distance to agreement of isodose lines at 2.3 cm and 1.3 cm, respectively. For the implantable pacemaker, the maximum changes in percentage depth dose were observed as 10.7% at 6 MV and 6.9% at 18 MV, with worst distance to agreement of isodose lines at 2.5 cm and 1.9 cm, respectively. No differences were discernible for the defibrillation leads and the pacing lead.« less

  10. Reliability systems for implantable cardiac defibrillator batteries

    NASA Astrophysics Data System (ADS)

    Takeuchi, Esther S.

    The reliability of the power sources used in implantable cardiac defibrillators is critical due to the life-saving nature of the device. Achieving a high reliability power source depends on several systems functioning together. Appropriate cell design is the first step in assuring a reliable product. Qualification of critical components and of the cells using those components is done prior to their designation as implantable grade. Product consistency is assured by control of manufacturing practices and verified by sampling plans using both accelerated and real-time testing. Results to date show that lithium/silver vanadium oxide cells used for implantable cardiac defibrillators have a calculated maximum random failure rate of 0.005% per test month.

  11. Living with life-saving technology - coping strategies in implantable cardioverter defibrillators recipients.

    PubMed

    Flemme, Inger; Johansson, Ingela; Strömberg, Anna

    2012-02-01

    To describe coping strategies and coping effectiveness in recipients with an implantable cardioverter defibrillator and to explore factors influencing coping. Implantable cardioverter defibrillators are documented as saving lives and are used to treat ventricular tachycardia and ventricular fibrillation. Despite the implantable cardioverter defibrillator not evidently interfering with everyday life, there is conflicting evidence regarding the psychosocial impact of an implantable cardioverter defibrillator implantation such as anxiety, depression, perceived control and quality of life and how these concerns may relate to coping. Cross-sectional multicentre design. Individuals (n = 147, mean age 63 years, 121 men) who had lived with an implantable cardioverter defibrillator between 6-24 months completed the Jalowiec Coping Scale-60, Hospital Anxiety and Depression Scale, Control Attitude Scale and Quality of Life Index-Cardiac version. Implantable cardioverter defibrillators recipients seldom used coping strategies, and the coping strategies used were perceived as fairly helpful. Optimism was found to be the most frequently used (1·8 SD 0·68) and most effective (2·1 SD 0·48) coping strategy, and recipients perceived moderate control in life. Anxiety (β = 3·5, p ≤ 0·001) and gender (β = 12·3, p = 0·046) accounted for 26% of the variance in the total use of coping strategies, suggesting that the more symptoms of anxiety and being women the greater use of coping strategies. Most recipients with an implantable cardioverter defibrillator did not appraise daily concerns as stressors in need of coping and seem to have made a successful transition in getting on with their lives 6-24 months after implantation. Relevance to clinical practice.  Nurses working with recipients with an implantable cardioverter defibrillator should have a supportive communication so that positive outcomes such as decreased anxiety and increased perceived control and quality of life

  12. Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

    PubMed Central

    Hardy, Judy; Yee, Raymond; Healey, Jeffrey S.; Birnie, David; Simpson, Christopher S.; Crystal, Eugene; Mangat, Iqwal; Nanthakumar, Kumaraswamy; Wang, Xuesong; Krahn, Andrew D.; Dorian, Paul; Austin, Peter C.; Tu, Jack V.

    2015-01-01

    Background— A conceptualized model may be useful for understanding risk stratification of primary prevention implantable cardioverter defibrillators considering the competing risks of appropriate implantable cardioverter defibrillator shock versus mortality. Methods and Results— In a prospective, multicenter, population-based cohort with left ventricular ejection fraction ≤35% referred for primary prevention implantable cardioverter defibrillator, we developed dual risk stratification models to determine the competing risks of appropriate defibrillator shock versus mortality using a Fine-Gray subdistribution hazard model. Among 7020 patients referred, 3445 underwent defibrillator implant (79.7% men, median, 66 years [25th, 75th: 58–73]). During 5918 person-years of follow-up, appropriate shock occurred in 204 patients (3.6 shocks/100 person-years) and 292 died (4.9 deaths/100 person-years). Competing risk predictors of appropriate shock included nonsustained ventricular tachycardia, atrial fibrillation, serum creatinine concentration, digoxin or amiodarone use, and QRS duration near 130-ms peak. One-year cumulative incidence of appropriate shock was 0.9% in the lowest risk category, and 1.7%, 2.5%, 4.9%, and 9.3% in low, intermediate, high, and highest risk groups, respectively. Hazard ratios for appropriate shock ranged from 4.04 to 7.79 in the highest 3 deciles (all P≤0.001 versus lowest risk). Cumulative incidence of 1-year death was 0.6%, 1.9%, 3.3%, 6.2%, and 17.7% in lowest, low, intermediate, high, and highest risk groups, respectively. Mortality hazard ratios ranged from 11.48 to 36.22 in the highest 3 deciles (all P<0.001 versus lowest risk). Conclusions— Simultaneous estimation of risks of appropriate shock and mortality can be performed using clinical variables, providing a potential framework for identification of patients who are unlikely to benefit from prophylactic implantable cardioverter defibrillator. PMID:26224792

  13. Intraoperative Defibrillation Testing of Subcutaneous Implantable Cardioverter-Defibrillator Systems-A Simple Issue?

    PubMed

    Frommeyer, Gerrit; Zumhagen, Sven; Dechering, Dirk G; Larbig, Robert; Bettin, Markus; Löher, Andreas; Köbe, Julia; Reinke, Florian; Eckardt, Lars

    2016-03-15

    The results of the recently published randomized SIMPLE trial question the role of routine intraoperative defibrillation testing. However, testing is still recommended during implantation of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) system. To address the question of whether defibrillation testing in S-ICD systems is still necessary, we analyzed the data of a large, standard-of-care prospective single-center S-ICD registry. In the present study, 102 consecutive patients received an S-ICD for primary (n=50) or secondary prevention (n=52). Defibrillation testing was performed in all except 4 patients. In 74 (75%; 95% CI 0.66-0.83) of 98 patients, ventricular fibrillation was effectively terminated by the first programmed internal shock. In 24 (25%; 95% CI 0.22-0.44) of 98 patients, the first internal shock was ineffective and further internal or external shock deliveries were required. In these patients, programming to reversed shock polarity (n=14) or repositioning of the sensing lead (n=1) or the pulse generator (n=5) led to successful defibrillation. In 4 patients, a safety margin of <10 J was not attained. Nevertheless, in these 4 patients, ventricular arrhythmias were effectively terminated with an internal 80-J shock. Although it has been shown that defibrillation testing is not necessary in transvenous ICD systems, it seems particular important for S-ICD systems, because in nearly 25% of the cases the primary intraoperative test was not successful. In most cases, a successful defibrillation could be achieved by changing shock polarity or by optimizing the shock vector caused by the pulse generator or lead repositioning. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  14. Defibrillation testing in everyday medical practice during implantable cardioverter defibrillator implantation in France: analysis from the LEADER registry.

    PubMed

    Sadoul, Nicolas; Defaye, Pascal; Mouton, Elisabeth; Bizeau, Olivier; Dupuis, Jean-Marc; Blangy, Hugues; Delarche, Nicolas; Blanc, Jean-Jacques; Lazarus, Arnaud

    2013-11-01

    Defibrillation testing (DT) is usually performed during implantable cardioverter defibrillator (ICD) implantation. We conducted a multicentre prospective study to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DT, and to compare severe adverse events in these two populations during implantation and follow-up. The LEADER registry enrolled 904 patients included for primo-implantation of a single (n=261), dual (n=230) or triple (n=429) defibrillation system in 42 French centres. Baseline characteristics of patients (62.0 ± 13.5 years; 88% men; primary indication 62%) who underwent ventricular fibrillation (VF) induction (VF induction group, n=810) and those who did not (untested group, n=94, representing 10.4% of the entire study population) revealed that the untested group were older (P<0.01), had a lower left ventricular ejection fraction, a wider QRS complex and a higher New York Heart Association class and were more often implanted for primary prevention (P<0.001 for all). The main reason given for not performing ICD testing was poor haemodynamic condition (59/94). At 1 year, the cumulative survival rate was 95% in tested patients and 85% in untested patients (P<0.001), mainly because of heart failure deaths. There was one sudden cardiac death in the VF induction group and none in the untested group (P=1.000). In this study, more than 10% of ICD patients were implanted without VF induction. Untested patients appeared to be sicker than tested patients, with a more severe long-term outcome, but without any difference in mortality due to arrhythmic events. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  15. The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation.

    PubMed

    Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan; Bode, Frank; Svendsen, Jesper Hastrup; Felk, Angelika; Hauser, Tino; Wegscheider, Karl

    2015-01-01

    Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing. Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance. The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation. NCT01282918. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email

  16. The rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation.

    PubMed

    Healey, Jeff S; Hohnloser, Stefan H; Glikson, Michael; Neuzner, Joerg; Viñolas, Xavier; Mabo, Philippe; Kautzner, Josef; O'Hara, Gilles; Van Erven, Liselot; Gadler, Frederick; Appl, Ursula; Connolly, Stuart J

    2012-08-01

    Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed. The SIMPLE trial will determine if ICD implantation without any DT is noninferior to implantation with DT. Patients will be eligible if they are receiving their first ICD using a Boston Scientific device (Boston Scientific, Natick, MA). Patients will be randomized to DT or no DT at the time of ICD implantation. In the DT arm, physicians will make all reasonable efforts to ensure 1 successful intraoperative defibrillation at 17 J or 2 at 21 J. The first clinical shock in all tachycardia zones will be set to 31 J for all patients. The primary outcome of SIMPLE will be the composite of ineffective appropriate shock or arrhythmic death. The safety outcome of SIMPLE will include a composite of potentially DT-related procedural complications within 30 days of ICD implantation. Several secondary outcomes will be evaluated, including all-cause mortality and heart failure hospitalization. Enrollment of 2,500 patients with 3.5-year mean follow-up will provide sufficient statistical power to demonstrate noninferiority. The study is being performed at approximately 90 centers in Canada, Europe, Israel, and Asia Pacific with final results expected in 2013. Copyright © 2012 Mosby, Inc. All rights reserved.

  17. Defibrillation threshold testing fails to show clinical benefit during long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation.

    PubMed

    Michowitz, Yoav; Lellouche, Nicolas; Contractor, Tahmeed; Bourke, Tara; Wiener, Isaac; Buch, Eric; Boyle, Noel; Bersohn, Malcolm; Shivkumar, Kalyanam

    2011-05-01

    The utility of defibrillation threshold testing in patients undergoing implantable cardioverter-defibrillator (ICD) implantation is controversial. Higher defibrillation thresholds have been noted in patients undergoing implantation of cardiac resynchronization therapy defibrillators (CRT-D). Since the risks and potential benefits of testing may be higher in this population, we sought to assess the impact of defibrillation safety margin or vulnerability safety margin testing in CRT-D recipients. A total of 256 consecutive subjects who underwent CRT-D implantation between January 2003 and December 2007 were retrospectively reviewed. Subjects were divided into two groups based on whether (n= 204) or not (n= 52) safety margin testing was performed. Patient characteristics, tachyarrhythmia therapies, procedural results, and clinical outcomes were recorded. Baseline characteristics, including heart failure (HF) severity, were comparable between the groups. Four cases of HF exacerbation (2%), including one leading to one death, were recorded in the tested group immediately post-implantation. No complications were observed in the untested group. After a mean follow-up of 32 ± 20 months, the proportion of appropriate shocks in the two groups was similar (31 vs. 25%, P = 0.49). There were three cases of failed appropriate shocks in the tested group, despite adequate safety margins at implantation, whereas no failed shocks were noted in the untested group. Survival was similar in the two groups. Defibrillation efficacy testing during implant of CRT-D was associated with increased morbidity and did not predict the success of future device therapy or improve survival during long-term follow-up.

  18. Double valve replacement in a patient with implantable cardioverter defibrillator with severe left ventricular dysfunction.

    PubMed

    Manjunath, Girish; Rao, Prakash; Prakash, Nagendra; Shivaram, B K

    2016-01-01

    Recent data from landmark trials suggest that the indications for cardiac pacing and implantable cardioverter defibrillators (ICDs) are set to expand to include heart failure, sleep-disordered breathing, and possibly routine implantation in patients with myocardial infarction and poor ventricular function.[1] This will inevitably result in more patients with cardiac devices undergoing surgeries. Perioperative electromagnetic interference and their potential effects on ICDs pose considerable challenges to the anesthesiologists.[2] We present a case of a patient with automatic ICD with severe left ventricular dysfunction posted for double valve replacement.

  19. Patients' perception of implantable cardioverter defibrillator deactivation at the end of life.

    PubMed

    Hill, Loreena; McIlfatrick, Sonja; Taylor, Brian; Dixon, Lana; Harbinson, Mark; Fitzsimons, Donna

    2015-04-01

    Individualised care at the end of life requires professional understanding of the patient's perception of implantable cardioverter defibrillator deactivation. The aim was to evaluate the evidence on patients' perception of implantable cardioverter defibrillator deactivation at end of life. Systematic narrative review of empirical studies was published during 2008-2014. Data were collected from six databases, citations from relevant articles and expert recommendations. In all, 18 studies included with collective population of n = 5810. Concept mapping highlighted three themes: (1) Diverse preferences regarding discussion and deactivation. Deactivation was rarely discussed pre-implantation, with some studies demonstrating patients' reluctance to discuss implantable cardioverter defibrillator deactivation at any stage. Two studies found the majority of patients valued such discussions. Diversity was reflected in patients' willingness to deactivate, ranging from 12% (n = 9) in Irish cohort to 79% (n = 195) in Dutch study. (2) Ethical and legal considerations were predominant in Canadian and American literature as patients wanted to contribute but felt the decision should be a doctor's responsibility. Advance directives were uncommon in Europe, and where they existed the implantable cardioverter defibrillator was not mentioned. (3) 'Living in the now' was evident as despite deteriorating symptoms many patients maintained a positive outlook and anticipated surviving more than 10 years. Several studies asserted living longer was more important than quality of life. Patients regard the implantable cardioverter defibrillator as a complex and solely beneficial device, with little insight regarding its potential impact on a peaceful death. This review confirms the need for professionals to discuss with patients and families implantable cardioverter defibrillator functionality and deactivation at appropriate opportunities. © The Author(s) 2014.

  20. [LifeVest - a novel treatment option prior to implantable cardioverter defibrillator].

    PubMed

    Mustafić, Hazrije; Karimzadeh, Soran; Park, Chan-Il

    2017-03-01

    Implantable cardioverter defibrillation has taken a predominant place in secondary and primary preventions of sudden rhythmic cardiac death in high-risk patients. However, in certain clinical situations, the implantation of definitive system should be postponed. The LifeVest, a portable external cardiac defibrillator system, has emerged as a novel therapeutic option before a final decision.

  1. The subcutaneous implantable cardioverter-defibrillator.

    PubMed

    Grace, Andrew

    2014-01-01

    To consider the case of need that underpinned the development of the subcutaneous implantable cardioverter-defibrillator (SICD), the preclinical and clinical data obtained so far, its current role and likely future. The data from prospective clinical evaluation of the device demonstrated safety and efficacy leading to Food and Drug Administration approval. This superseded earlier reports from Europe that raised some clinical concerns, previously anticipated through the introduction of new technology. Recent estimates indicate maybe 55% of patients in routine clinical practice needing an ICD are potentially suitable for a subcutaneous device. The SICD provides a useful alternative for high-energy (ICD) therapy in those deemed at risk and who need defibrillation and in whom there are no indications for cardiac resynchronization, bradycardia support or antitachycardia pacing. There is the possibility of both higher specificity and the avoidance of myo-cellular damage with shock delivery, and if these two aspects play out subcutaneous defibrillation could become an option of choice in many settings.

  2. Implantable Cardioverter Defibrillators. Prophylactic Use

    PubMed Central

    2005-01-01

    of evidence for each outcome. The balance between benefits and harms, quality of evidence, applicability, and the certainty of the baseline risks are considered in judgments about the strength of recommendations. Summary of Findings Overall, ICDs are effective for the primary prevention of SCD. Three studies – the Multicentre Automatic Defibrillator Implantation Trial I (MADIT I), the Multicentre Automatic Defibrillator Implantation Trial II (MADIT II), and SCD-HeFT – showed there was a statistically significant decrease in total mortality for patients who prophylactically received an ICD compared with those who received conventional therapy (Table 1). Table 1: Results of Key Studies on the Use of Implantable Cardioverter Defibrillators for the Primary Prevention of Sudden Cardiac Death – All-Cause Mortality Study, * Year Population N Follow-up, Months Mortality, ICD† Group, % Mortality, Control Group, % Hazard Ratio (95% CI) P NNT† MADIT, 1996 (2) Ischemic 196 27 15.8 38.6 0.46 (0.26–0.82) .009 4 Priormyocardialinfarction Conventional therapy 54% relative reduction Ejection fraction ≤ 0.35NSVT†EP† + MADIT II, 2002 (3) Ischemic 1232 20 14.2 19.8 0.69(0.51–0.93) .016 18 Priormyocardialinfarction Conventional therapy 31% relative reduction Ejection fraction ≤ 0.30 SCD-HeFT, 2005 (4) Ischemic & Nonischemic 2521 60 22 29 0.77 (0.62–0.96) .007 13 Optimal therapy Ejection fraction < 0.35 23% relative reduction * MADIT I: Multicentre Automatic Defibrillator Implantation Trial I; MADIT II: Multicentre Automatic Defibrillator Implantation Trial II; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial. † EP indicates electrophysiology; ICD, implantable cardioverter defibrillator; NNT, number needed to treat; NSVT, nonsustained ventricular tachycardia. The NNT will appear higher if follow-up is short. For ICDs, the absolute benefit increases over time for at least a 5-year period; the NNT declines, often substantially, in studies with a longer follow

  3. Public knowledge of how to use an automatic external defibrillator in out-of-hospital cardiac arrest in Hong Kong.

    PubMed

    Fan, K L; Leung, L P; Poon, H T; Chiu, H Y; Liu, H L; Tang, W Y

    2016-12-01

    The survival rate of out-of-hospital cardiac arrest in Hong Kong is low. A long delay between collapse and defibrillation is a contributing factor. Public access to defibrillation may shorten this delay. It is unknown, however, whether Hong Kong's public is willing or able to use an automatic external defibrillator. This study aimed to evaluate public knowledge of how to use an automatic external defibrillator in out-of-hospital cardiac arrest. A face-to-face semi-structured questionnaire survey of the public was conducted in six locations with a high pedestrian flow in Hong Kong. In this study, 401 members of the public were interviewed. Most had no training in first aid (65.8%) or in use of an automatic external defibrillator (85.3%). Nearly all (96.5%) would call for help for a victim of out-of-hospital cardiac arrest but only 18.0% would use an automatic external defibrillator. Public knowledge of automatic external defibrillator use was low: 77.6% did not know the location of an automatic external defibrillator in the vicinity of their home or workplace. People who had ever been trained in both first aid and use of an automatic external defibrillator were more likely to respond to and help a victim of cardiac arrest, and to use an automatic external defibrillator. Public knowledge of automatic external defibrillator use is low in Hong Kong. A combination of training in first aid and in the use of an automatic external defibrillator is better than either one alone.

  4. Inverse Relationship of Blood Pressure to Long-Term Outcomes and Benefit of Cardiac Resynchronization Therapy in Patients With Mild Heart Failure: A Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Long-Term Follow-Up Substudy.

    PubMed

    Biton, Yitschak; Moss, Arthur J; Kutyifa, Valentina; Mathias, Andrew; Sherazi, Saadia; Zareba, Wojciech; McNitt, Scott; Polonsky, Bronislava; Barsheshet, Alon; Brown, Mary W; Goldenberg, Ilan

    2015-09-01

    Previous studies have shown that low blood pressure is associated with increased mortality and heart failure (HF) in patients with left ventricular dysfunction. Cardiac resynchronization therapy (CRT) was shown to increase systolic blood pressure (SBP). Therefore, we hypothesized that treatment with CRT would provide incremental benefit in patients with lower SBP values. The independent contribution of SBP to outcome was analyzed in 1267 patients with left bundle brunch block enrolled in Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT). SBP was assessed as continuous measures and further categorized into approximate quintiles. The risk of long-term HF or death and CRT with defibrillator versus implantable cardioverter defibrillator benefit was assessed in multivariate Cox proportional hazards regression models. Multivariate analysis showed that in the implantable cardioverter defibrillator arm, each 10-mm Hg decrement of SBP was independently associated with a significant 21% (P<0.001) increased risk for HF or death, and patients with lower quintile SBP (<110 mm Hg) experienced a corresponding >2-fold risk-increase. CRT with defibrillator provided the greatest HF or mortality risk reduction in patients with SBP<110 mm Hg hazard ratio of 0.34, P<0.001, when compared with hazard ratio of 0.52, P<0.001, in those with 110>SBP≥136 mm Hg and hazard ratio of 0.94, P=0.808, with SBP>136 mm Hg (P for trend=0.001). In patients with mild HF, prolonged QRS, and left bundle brunch block, low SBP is related to higher risk of mortality or HF with implantable cardioverter defibrillator therapy alone. Treatment with CRT is associated with incremental clinical benefits in patients with lower baseline SBP values. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271. © 2015 American Heart Association, Inc.

  5. Wearable cardioverter defibrillator: Bridge or alternative to implantation?

    PubMed Central

    Barraud, Jeremie; Cautela, Jennifer; Orabona, Morgane; Pinto, Johan; Missenard, Olivier; Laine, Marc; Thuny, Franck; Paganelli, Franck; Bonello, Laurent; Peyrol, Michael

    2017-01-01

    The implantable cardioverter-defibrillator (ICD) is effective to prevent sudden cardiac death (SCD) in selected patients with heart disease known to be at high risk for ventricular arrhythmia. Nevertheless, this invasive and definitive therapy is not indicated in patients with potentially transient or reversible causes of sudden death, or in patients with temporary contra-indication for ICD placement. The wearable cardioverter defibrillator (WCD) is increasingly used for SCD prevention both in patients awaiting ICD implantation or with an estimated high risk of ventricular arrhythmia though to be transient. We conducted a review of current clinical uses and benefits of the WCD, and described its technical aspects, limitations and perspectives. PMID:28706588

  6. A Comparative Study of Defibrillator Leads at a Large-Volume Implanting Hospital: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

    PubMed

    Cohen, Todd J; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Patel, Dhimesh

    2015-06-01

    The purpose of the study was to examine survival in the implantable defibrillator subset of implanted leads at a large-volume implanting hospital. Implantable lead survival has been the subject of many multicenter studies over the past decade. Fewer large implanting volume single-hospital studies have examined defibrillator lead failure as it relates to patient survival and lead construction. This investigator-initiated retrospective study examined defibrillator lead failure in those who underwent implantation of a defibrillator between February 1, 1996 and December 31, 2011. Lead failure was defined as: failure to capture/sense, abnormal pacing and/or defibrillator impedance, visual insulation defect or lead fracture, extracardiac stimulation, cardiac perforation, tricuspid valve entrapment, lead tip fracture and/or lead dislodgment. Patient characteristics, implant approach, lead manufacturers, lead models, recalled status, patient mortality, and core lead design elements were compared using methods that include Kaplan Meier analysis, univariate and multivariable Cox regression models. A total of 4078 defibrillator leads were implanted in 3802 patients (74% male; n = 2812) with a mean age of 70 ± 13 years at Winthrop University Hospital. Lead manufacturers included: Medtronic: [n = 1834; 801 recalled]; St. Jude Medical: [n = 1707; 703 recalled]; Boston Scientific: [n = 537; 0 recalled]. Kaplan-Meier analysis adjusted for multiple comparisons revealed that both Boston Scientific's and St. Jude Medical's leads had better survival than Medtronic's leads (P<.001 and P=.01, respectively). Lead survival was comparable between Boston Scientific and St. Jude Medical (P=.80). A total of 153 leads failed (3.5% of all leads) during the study. There were 99 lead failures from Medtronic (5.4% failure rate); 56 were recalled Sprint Fidelis leads. There were 36 lead failures from St. Jude (2.1% failure rate); 20 were recalled Riata or Riata ST leads. There were 18 lead

  7. Implantable cardioverter-defibrillator implantation for primary and secondary prevention: indications and outcomes.

    PubMed

    Pick, Justin M; Batra, Anjan S

    2017-01-01

    Implantable cardioverter-defibrillators effectively reduce the rate of sudden cardiac death in children. Significant efforts have been made to better characterise the indications for their placement, and over the past two decades there has been a shift in their use from secondary to primary prevention. Primary prevention includes placement in patients thought to be at high risk of sudden cardiac death before the patient experiences any event. Secondary prevention includes placement after a high-risk event including sustained ventricular tachycardia or resuscitated cardiac arrest. Although liberal device implantation may be appealing even in patients having marginal indications, studies have shown high rates of adverse effects including inappropriate device discharges and the need for re-intervention because of hardware malfunction. The indications for placement of an implantable cardioverter-defibrillator, whether for primary or secondary prevention of sudden cardiac death, vary based on cardiac pathology. This review will assist the provider in understanding the risks and benefits of device implantation in order to enhance the shared decision-making capacity of patients, families, and providers.

  8. Spinal cord stimulation for refractory angina in a patient implanted with a cardioverter defibrillator.

    PubMed

    Ferrero, Paolo; Grimaldi, Roberto; Massa, Riccardo; Chiribiri, Amedeo; De Luca, Anna; Castellano, Maddalena; Cardano, Paola; Trevi, Gian Paolo

    2007-01-01

    Spinal cord stimulation is currently used to treat refractory angina. Some concerns may arise about the possible interaction concerning the spinal cord stimulator in patients already implanted with a pacemaker or a cardioverter defibrillator. We are going to describe the successful implantation of a spinal cord stimulator in a patient previously implanted with a cardioverter defibrillator.

  9. Routine implantation of cardioverter/defibrillator devices in patients aged 75 years and older with prior myocardial infarction and left ventricular ejection fraction < 30: antagonist viewpoint.

    PubMed

    Basta, Lofty L

    2003-01-01

    The Multicenter Automatic Defibrillator Implantation Trial (MADIT II) investigators assert that their results justify the placement of artificial implantable defibrillator cardioverter devices in patients aged 75 years and older with prior myocardial infarction and left ventricular dysfunction (ejection fraction of 30 or less). The authors claim that the results of the trial do not justify this conclusion. The majority of patients were male (84%) and aged 64+/-10 years. Also, 2.8% of patients assigned to the defibrillator group and 1.5% had their device removed. Of the latter subgroup, nine patients (1.3%) received a heart transplant. Twelve had their artificial implantable defibrillator cardioverter device deactivated mostly because of terminal illness. Although the study results show a significant reduction in mortality over the control group (absolute reduction=5.6%), almost the same percentage required hospitalization because of manifestation of congestive heart failure (absolute value 5%; p=0.09). Also, 1.8% had lead problems, 0.7% had infections, and the benefits were only seen after the first year. Caution is needed before the results of this study are applied to a much older cohort comprised mainly of women in whom heart transplant is contraindicated and who have multiple health problems, including cognitive impairment. Artificial implantable cardioverter/defibrillator devices are expensive and this study's results need to be duplicated in other comparable cohorts.

  10. A rare, late complication after automated implantable cardioverter-defibrillator placement.

    PubMed

    Shapiro, Michael; Hanon, Sam; Schweitzer, Paul

    2004-10-01

    This article describes an interesting case of automated implantable cardioverter defibrillator (AICD) extrusion fifteen months after implantation. The case report is followed by a discussion of the causes and treatment of skin erosion following pacemaker/AICD insertion.

  11. Electromagnetic interference caused by common surgical energy-based devices on an implanted cardiac defibrillator.

    PubMed

    Paniccia, Alessandro; Rozner, Marc; Jones, Edward L; Townsend, Nicole T; Varosy, Paul D; Dunning, James E; Girard, Guillaume; Weyer, Christopher; Stiegmann, Gregory V; Robinson, Thomas N

    2014-12-01

    Surgical energy-based devices emit energy, which can interfere with other electronic devices (eg, implanted cardiac pacemakers and/or defibrillators). The purpose of this study was to quantify the amount of unintentional energy (electromagnetic interference [EMI]) transferred to an implanted cardiac defibrillator by common surgical energy-based devices. A transvenous cardiac defibrillator was implanted in an anesthetized pig. The primary outcome measure was the average maximum EMI occurring on the implanted cardiac device during activations of multiple different surgical energy-based devices. The EMI transferred to the implanted cardiac device is as follows: traditional bipolar 30 W .01 ± .004 mV, advanced bipolar .004 ± .003 mV, ultrasonic shears .01 ± .004 mV, monopolar Bovie 30 W coagulation .50 ± .20 mV, monopolar Bovie 30 W blend .92 ± .63 mV, monopolar instrument without dispersive electrode .21 ± .07 mV, plasma energy 3.48 ± .78 mV, and argon beam coagulator 2.58 ± .34 mV. Surgeons can minimize EMI on implanted cardiac defibrillators by preferentially utilizing bipolar and ultrasonic devices. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Shock whilst gardening--implantable defibrillators & lawn mowers.

    PubMed

    Von Olshausen, G; Lennerz, C; Grebmer, C; Pavaci, H; Kolb, C

    2014-02-01

    Electromagnetic interference with implantable cardioverter defibrillators (ICDs) can cause inappropriate shock delivery or temporary inhibition of ICD functions. We present a case of electromagnetic interference between a lawn mower and an ICD resulting in an inappropriate discharge of the device due to erroneous detection of ventricular fibrillation.

  13. Recent advances in pacemaker and implantable defibrillator therapy for young patients.

    PubMed

    Walsh, Edward P; Cecchin, Frank

    2004-03-01

    This review is intended to highlight major clinical advances over the past year related to (1). biventricular pacing as a treatment for dilated myopathy, (2). growing clinical experience with implantable cardioverter defibrillators in pediatrics, (3). technical advances in standard antibradycardia pacing, and (4). an appraisal of the newly updated ACC/AHA/NASPE guidelines for device implant in children and adolescents. Complex rhythm devices are being used more frequently in children. Biventricular pacing to improve ventricular contractility is a rapidly evolving technology that has now been applied to children and young adults with intraventricular conduction delay, such as bundle branch block after cardiac surgery. Implantable defibrillators are also being used for an expanding list of conditions, although lead dysfunction is seen as a fairly common complication in active young patients. Guidelines for device implantation have been developed, but the weight of evidence remains somewhat limited by the paucity of pediatric data in this field. Thanks to refinements in lead design and generator technology, coupled with rapidly expanding clinical indications, pacemakers and implantable defibrillators have become increasingly important components of cardiac therapy for young patients. Expanded multicenter clinical studies will be needed to develop more objective guidelines for use of this advanced technology.

  14. Impact of programming strategies aimed at reducing nonessential implantable cardioverter defibrillator therapies on mortality: a systematic review and meta-analysis.

    PubMed

    Tan, Vern Hsen; Wilton, Stephen B; Kuriachan, Vikas; Sumner, Glen L; Exner, Derek V

    2014-02-01

    Patients who receive implantable cardioverter defibrillator therapies are at higher risk of death versus those who do not. Programmed settings to reduce nonessential implantable cardioverter defibrillator therapies (therapy reduction programming) have been developed but may have adverse effects. This systematic review and meta-analysis assessed the relationship between therapy reduction programming with the risks of death from any cause, implantable cardioverter defibrillator shocks, and syncope. MEDLINE, EMBASE, and clinicaltrials.gov databases were searched to identify relevant studies. Those that followed patients for ≥6 months and reported mortality were included. Six met the inclusion criteria; 4 randomized (Comparison of Empiric to Physician-Tailored Programming of ICDs [EMPIRIC], Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy [MADIT-RIT], Avoid Delivering Therapies for Non-sustained Arrhythmias in ICD Patients III [ADVANCE III], and Programming Implantable Cardioverter-Defibrillators in Patients with Primary Prevention Indication to Prolong Time to First Shock [PROVIDE]) and 2 prospective studies (Role of Long Detection Window Programming in Patients With Left Ventricular Dysfunction, Non-ischemic Etiology in Primary Prevention Treated with a Biventricular ICD [RELEVANT] and Primary Prevention Parameters Evaluation [PREPARE]). These 6 studies included 7687 (3598 conventional and 4089 therapy reduction programming) patients. Most (77%) participants were men, had a history of ischemic heart disease (56%), and were prescribed β-blockers (84%). Therapy reduction programming was associated with a 30% relative reduction in mortality (95% confidence interval, 16%-41%; P<0.001). No significant heterogeneity among studies was observed (P=0.6). A similar 26% reduction in mortality was observed when only the 4 randomized trials were included (95% confidence interval, 11%-40%; P=0.002). These results were not significantly altered

  15. Comparison of outcomes in patients undergoing defibrillation threshold testing at the time of implantable cardioverter-defibrillator implantation versus no defibrillation threshold testing.

    PubMed

    Hall, Burr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Hall, Freburr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Hall, Fred Morady And Frank Pelosiburr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Morady, Fred Morady And Frank Pelosid; Pelosi, Frank

    2007-01-01

    Inability to perform defibrillation threshold (DFT) testing during implantable cardioverter defibrillator (ICD) implantation due to co-morbidities may influence long-term survival. Retrospective review at The University of Michigan (1999-2004) identified 55 patients undergoing ICD implantation without DFT testing ("No-DFT group"). A randomly selected sample of patients (n = 57) undergoing standard DFT testing ("DFT group") was compared in terms of appropriate shocks, clinical shock efficacy and all-cause mortality. DFT testing was withheld due to hypotension, atrial fibrillation with inability to exclude left atrial thrombus, left ventricular thrombus, CHF and/or ischemia. The No-DFT group had a similar appropriate shock rate, but lower total survival (69.1% vs. 91.2%, p = 0.004) than the DFT group. The No-DFT group had a higher incidence of ventricular fibrillation (VF) episodes (9.1% vs. 3.1%, p = 0.037), and deaths attributable to VF (3 of 17 deaths vs. 0 of 5 deaths) compared to the DFT group. Multivariate analysis found a trend toward increased risk of death in the No-DFT group (HR 3.18, 95% CI 0.82-12.41, p = 0.095) after adjusting for baseline differences in gender distribution, NYHA class and prior CABG. In summary, overall mortality was higher in the No-DFT group. More deaths attributable to VF occurred in the No-DFT group. Thus, DFT testing should therefore remain the standard of care. Nevertheless, ICD therapy should not be withheld in patients who meet appropriate implant criteria simply on the basis of clinical scenarios that preclude routine DFT testing. (Cardiol J 2007; 14: 463-469).

  16. Subcutaneous chronic implantable defibrillation systems in humans.

    PubMed

    Cappato, Riccardo; Smith, Warren M; Hood, Margaret A; Crozier, Ian G; Jordaens, Luc; Spitzer, Stefan G; Ardashev, Andrey V; Boersma, Lucas; Lupo, Pierpaolo; Grace, Andrew A; Bardy, Gust H

    2012-09-01

    The recent introduction of subcutaneous implantable cardioverter defibrillator (S-ICD) has raised attention about the potential of this technology for clinical use in daily clinical practice. We review the methods and results of the four studies conducted in humans for approval of this innovative technology for daily practice. Two studies using a temporary S-ICD system (acute human studies) were conducted to search for an appropriate lead configuration and energy requirements. For this purpose, 4 S-ICD configurations were tested in 78 patients at the time of transvenous (TV)-ICD implantation. The optimal configuration was tested in 49 more patients to comparatively assess the subcutaneous defibrillation threshold (S-DFT) versus the standard TV-ICD. Long-term implants were evaluated in 55 patients using an implanted system (chronic human study). The acute humans studies led to an optimal S-ICD configuration comprising a parasternal electrode and left anterolateral thoracic pulse generator. Both configurations successfully terminated 98% of induced ventricular fibrillation (VF), but significantly higher energy levels were required with S-ICD than with TV-ICD systems (36.6 ± 19.8 J vs. 11.1 ± 8.5 J). In the chronic study, all 137 VF episodes induced at time of implant were detected with a 98% conversion rate. Two pocket infections and four lead revisions were required during 10 ± 1 months of follow-up. During this period, survival was 98%, and 12 spontaneous ventricular tachyarrhythmias were detected and treated by the device. These data show that the S-ICD systems here consistently detected and converted VF induced at time of implant as well as sustained ventricular tachyarrhythmias occurring during follow-up (248).

  17. Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time.

    PubMed

    von Gunten, Simon; Schaer, Beat A; Yap, Sing-Chien; Szili-Torok, Tamas; Kühne, Michael; Sticherling, Christian; Osswald, Stefan; Theuns, Dominic A M J

    2016-05-01

    Longevity of implantable cardioverter defibrillators (ICDs) is crucial for patients and healthcare systems as replacements impact on infection rates and cost-effectiveness. Aim was to determine longevity using very large databases of two teaching hospitals with a high number of replacements and a rather homogeneous distribution among manufacturers. The study population consists of all patients in whom an ICD was inserted in. All ICD manufacturers operating in Switzerland and the Netherlands and all implanted ICDs were included. Implantable cardioverter defibrillator replacements due to normal battery depletion were considered events, and other replacements were censored. Longevity was assessed depending on manufacturers, pacing mode, implant before/after 2006, and all parameters combined. We analysed data from 3436 patients in whom 4881 ICDs [44.2% VVI-ICDs, 27.4% DDD-ICDs, 26.3% cardiac resynchronization therapy (CRT)-ICDs, 2.0% subcutaneous ICDs] were implanted. The four major manufacturers had implant shares between 18.4 and 31.5%. Replacement due to battery depletion (27.4%) was performed for 1339 ICDs. Patient survival at 5 years was 80.1%. Longevity at 5 years improved in contemporary compared with elderly ICDs [63.9-80.6% across all ICDs, of 73.7-92.1% in VVIs, 58.2-76.1% in DDDs, and of 47.1-66.3% in CRT defibrillators, all P value < 0.05]. Remarkable differences were seen among manufacturers, and those with better performance in elderly ICDs were not those with better performance in contemporary ones. Implantable cardioverter defibrillator longevity increased in contemporary models independent of manufacturer and pacing mode. Still, significant differences exist among manufacturers. These results might impact on device selection. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

  18. Current state of knowledge and experts' perspective on the subcutaneous implantable cardioverter-defibrillator.

    PubMed

    Santini, Massimo; Cappato, Riccardo; Andresen, Dietrich; Brachmann, Johannes; Davies, D Wyn; Cleland, John; Filippi, Alessandro; Gronda, Edoardo; Hauer, Richard; Steinbeck, Gerhard; Steinhaus, David

    2009-06-01

    ICD implantation is today a well-recognized therapy to prevent sudden cardiac death. The available implantable devices at present need the use of permanent endocavitary leads which may cause, in some instances, serious troubles to the patients (lead dislodgement, ventricular perforation, lead infections, etc.). A new implantable defibrillator provided by only a subcutaneous lead is at present under evaluation. Its potential indications, usefulness benefits, and problems represent an interesting field of investigation and discussion. This paper describes the conclusions recently reached by a panel of experts, with regard to the potential role of an implantable subcutaneous defibrillator in the prevention of sudden cardiac death.

  19. Acute and Long-term Results After Contemporary Subcutaneous Implantable Cardioverter-defibrillator Implantation: A Single-center Experience.

    PubMed

    Arias, Miguel A; Pachón, Marta; Akerström, Finn; Puchol, Alberto; Martín-Sierra, Cristina; Rodríguez-Padial, Luis

    2017-12-05

    The subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as an alternative to the transvenous defibrillator. The incidence of complications is similar, with inappropriate shocks (IS) being more frequent than those occurring with contemporary programming of transvenous defibrillators. Several improvements have been implemented after the S-ICD was approved for use in Europe in 2009. This study reports the results of S-ICD use in a single center, whose experience began late, at the end of 2013. Prospective observational study including consecutive patients with defibrillator indication and no indication for either permanent pacing or cardiac resynchronization who underwent S-ICD implantation. Implant data and long-term follow-up were analyzed. An S-ICD was implanted in 50 patients who were deemed suitable after electrocardiographic screening. The mean age was 46.9±15 (range, 15-78) years and 72% were male. Thirty eight percent had left ventricular ejection fraction ≤ 35%. The most frequent heart disease was ischemic heart disease (34%), followed by hypertrophic cardiomyopathy (18%). The intermuscular technique was used, with 3 incisions in 10% and 2 incisions in the remaining 90%. Ventricular fibrillation was induced in 49 patients, with 100% effectiveness in their conversion. After a mean follow-up of 18.1 (range, 2.3-44.8) months, there were no late complications requiring surgical revision, the rate of IS was 0%, and 1 patient (2%) experienced appropriate shocks. Improvements in technology, implant technique and device programming, along with appropriate patient selection, have led to outstanding acute and long-term results, especially regarding the absence of both IS and complications requiring surgical revision. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  20. Marked attenuation of shock burden by the use of antitachycardia pacing therapy in a patient with an implanted cardioverter-defibrillator.

    PubMed

    Ganjehei, Leila; Nazeri, Alireza; Massumi, Ali; Razavi, Mehdi

    2012-01-01

    A 76-year-old man was admitted to our institution for elective exchange of his implanted cardioverter-defibrillator generator. Nine years earlier, he had been diagnosed with nonischemic cardiomyopathy and nonsustainable ventricular tachycardia. At that time, he had received a single-chamber implanted cardioverter-defibrillator, which was upgraded to a dual-chamber implanted cardioverter-defibrillator 3 years later. In the course of the current admission, routine device interrogation during exchange of the patient's implanted cardioverter-defibrillator generator revealed 150 episodes of ventricular tachycardia in the preceding 7 months, 137 of which had been successfully treated by antitachycardia pacing therapy without shock. These findings show the remarkable effectiveness of antitachycardia pacing in terminating ventricular tachycardia while preventing the delivery of shocks, minimizing patient discomfort, and avoiding implanted cardioverter-defibrillator battery depletion.

  1. Cardioverter-defibrillator implantation in myeloma-associated cardiac amyloidosis

    PubMed Central

    Campanile, Alfonso; Sozzi, Fabiola B; Canetta, Ciro; Danzi, Gian Battista

    2013-01-01

    A 62-year-old woman with multiple myeloma and light-chain amyloidosis with significant heart involvement developed an in-hospital cardiac arrest. After cardiopulmonary resuscitation, a stable sinus rhythm without any cerebral damage was restored, and the patient was admitted to the coronary care unit. A cardioverter-defibrillator was implanted, and it successfully intervened in two sustained ventricular tachycardia episodes and one ventricular fibrillation episode, which were recorded during hospitalization. After achieving discrete cardiac compensation, the patient was transferred to the emergency medicine department where she underwent chemotherapy for multiple myeloma. The patient died 40 days after admission from refractory heart failure. In the literature, there are studies that describe the use of cardioverter-defibrillator implantation in cardiac amyloidosis; however, at present, there is no evidence of a beneficial effect on survival with the use of this intervention. A high index of suspicion for amyloid heart disease and early diagnosis are critical to improving outcomes. PMID:24294034

  2. Cardioverter-defibrillator implantation in myeloma-associated cardiac amyloidosis.

    PubMed

    Campanile, Alfonso; Sozzi, Fabiola B; Canetta, Ciro; Danzi, Gian Battista

    2013-01-01

    A 62-year-old woman with multiple myeloma and light-chain amyloidosis with significant heart involvement developed an in-hospital cardiac arrest. After cardiopulmonary resuscitation, a stable sinus rhythm without any cerebral damage was restored, and the patient was admitted to the coronary care unit. A cardioverter-defibrillator was implanted, and it successfully intervened in two sustained ventricular tachycardia episodes and one ventricular fibrillation episode, which were recorded during hospitalization. After achieving discrete cardiac compensation, the patient was transferred to the emergency medicine department where she underwent chemotherapy for multiple myeloma. The patient died 40 days after admission from refractory heart failure. In the literature, there are studies that describe the use of cardioverter-defibrillator implantation in cardiac amyloidosis; however, at present, there is no evidence of a beneficial effect on survival with the use of this intervention. A high index of suspicion for amyloid heart disease and early diagnosis are critical to improving outcomes.

  3. Implantable Cardioverter-defibrillator Therapy for Hypertrophic Cardiomyopathy: Usefulness in Primary and Secondary Prevention.

    PubMed

    Sarrias, Axel; Galve, Enrique; Sabaté, Xavier; Moya, Àngel; Anguera, Ignacio; Núñez, Elaine; Villuendas, Roger; Alcalde, Óscar; García-Dorado, David

    2015-06-01

    Hypertrophic cardiomyopathy is a frequent cause of sudden death. Clinical practice guidelines indicate defibrillator implantation for primary prevention in patients with 1 or more risk factors and for secondary prevention in patients with a history of aborted sudden death or sustained ventricular arrhythmias. The aim of the present study was to analyze the follow-up of patients who received an implantable defibrillator following the current guidelines in nonreferral centers for this disease. This retrospective observational study included all patients who underwent defibrillator implantation between January 1996 and December 2012 in 3 centers in the province of Barcelona. The study included 69 patients (mean age [standard deviation], 44.8 [17] years; 79.3% men), 48 in primary prevention and 21 in secondary prevention. The mean number of risk factors per patient was 1.8 in the primary prevention group and 0.5 in the secondary prevention group (P=.029). The median follow-up duration was 40.5 months. The appropriate therapy rate was 32.7/100 patient-years in secondary prevention and 1.7/100 patient-years in primary prevention (P<.001). Overall mortality was 10.1%. Implant-related complications were experienced by 8.7% of patients, and 13% had inappropriate defibrillator discharges. In patients with a defibrillator for primary prevention, the appropriate therapy rate is extremely low, indicating the low predictive power of the current risk stratification criteria. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  4. Initial experience of subcutaneous implantable cardioverter defibrillators in Singapore: a case series and review of the literature

    PubMed Central

    Lim, Tien Siang Eric; Tan, Boon Yew; Ho, Kah Leng; Lim, Chuh Yih Paul; Teo, Wee Siong; Ching, Chi-Keong

    2015-01-01

    Transvenous implantable cardioverter defibrillators are a type of implantable cardiac device. They are effective at reducing total and arrhythmic mortality in patients at risk of sudden cardiac death. Subcutaneous implantable cardioverter defibrillators (S-ICDs) are a new alternative that avoids the disadvantages of transvenous lead placement. In this case series, we report on the initial feasibility and safety of S-ICD implantation in Singapore. PMID:26512151

  5. Initial experience of subcutaneous implantable cardioverter defibrillators in Singapore: a case series and review of the literature.

    PubMed

    Lim, Tien Siang Eric; Tan, Boon Yew; Ho, Kah Leng; Lim, Chuh Yih Paul; Teo, Wee Siong; Ching, Chi-Keong

    2015-10-01

    Transvenous implantable cardioverter defibrillators are a type of implantable cardiac device. They are effective at reducing total and arrhythmic mortality in patients at risk of sudden cardiac death. Subcutaneous implantable cardioverter defibrillators (S-ICDs) are a new alternative that avoids the disadvantages of transvenous lead placement. In this case series, we report on the initial feasibility and safety of S-ICD implantation in Singapore.

  6. Three-year outcome of a nonthoracotomy approach to cardioverter-defibrillator implantation in 189 consecutive patients.

    PubMed

    Brooks, R; Garan, H; Torchiana, D; Vlahakes, G J; Dziuban, S; Newell, J; McGovern, B A; Ruskin, J N

    1994-11-15

    To date, no long-term clinical data have been published in patients undergoing a nonthoracotomy approach to cardioverter-defibrillator system implantation. In the present report, 189 consecutive patients prospectively underwent a standardized approach to cardioverter-defibrillator system implantation in which the nonthoracotomy configurations were tested first. If satisfactory defibrillation thresholds were not obtained, thoracotomy was performed during the same intraoperative session. A nonthoracotomy system was successfully implanted in 149 of 189 patients (79%), with a higher success rate (90%) observed in patients who had more recent implantations. The overall rate of complications associated with these systems was low (11%). Over a mean follow-up of 12.5 +/- 9.3 months, 17 patients (9%) died. Three-year total, cardiac, and sudden death-free actuarial survival for all patients was 83 +/- 11%, 88 +/- 7%, and 94 +/- 2%, respectively. Three-year sudden death-free actuarial survival was higher in the nonthoracotomy than in the thoracotomy patients (97 +/- 2% vs 87 +/- 6%, p = 0.047), although total survival was similar (77 +/- 11% vs 83 +/- 7%, p = 0.77). These data suggest that a majority of patients (> 80%) requiring a cardioverter-defibrillator system can undergo implantation using a nonthoracotomy approach. Patients receiving nonthoracotomy systems have 3-year outcomes comparable to those implanted via thoracotomy. If these results are maintained, a nonthoracotomy approach will supplant thoracotomy-implanted systems as the preferred method because of the simpler implant procedure and lower overall cost involved.

  7. Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks.

    PubMed

    Turakhia, Mintu P; Zweibel, Steven; Swain, Andrea L; Mollenkopf, Sarah A; Reynolds, Matthew R

    2017-02-01

    In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified. We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different. After implantable cardioverter-defibrillator shock, related HCU was common, with 1 in 3 shock events followed by outpatient HCU and 1 in 7 followed by hospitalization. Use of invasive cardiovascular procedures was substantial, even after inappropriate shocks, which comprised 38% of all shocks. Implantable cardioverter-defibrillator shocks seem to trigger a cascade of health care. Strategies to reduce shocks could result in cost savings. © 2017 American Heart Association, Inc.

  8. Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

    PubMed

    Gadler, Fredrik; Valzania, Cinzia; Linde, Cecilia

    2015-01-01

    The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  9. Spouses' reflections on implantable cardioverter defibrillator treatment with focus on the future and the end-of-life: a qualitative content analysis.

    PubMed

    Fluur, Christina; Bolse, Kärstin; Strömberg, Anna; Thylén, Ingela

    2014-08-01

    To explore future reflections of spouses living with an implantable cardioverter defibrillator recipient with focus on the end-of-life phase in an anticipated palliative phase. A history of or risk for life-threatening arrhythmias may require an implantable cardioverter defibrillator. Despite the life-saving capacity of the device, eventually life will come to an end. As discussion about preferences of shock therapy at end-of-life phase seldom takes place in advance, the implantable cardioverter defibrillator recipients may face defibrillating shocks in the final weeks of their lives, adding to stress and anxiety in patients and their families. Qualitative study with in-depth interviews analysed with a content analysis. Interviews were performed with 18 spouses of medically stable implantable cardioverter defibrillator recipients during 2011-2012. The spouses described how they dealt with changes in life and an uncertain future following the implantable cardioverter defibrillator implantation. Six subcategories conceptualized the spouses' concerns: Aspiring for involvement; Managing an altered relationship; Being attentive to warning signs; Worries for deterioration in the partner's health; Waiting for the defibrillating shock; and Death is veiled in silence. Despite the partner's serious state of health; terminal illness or death and the role of the device was seldom discussed with healthcare professionals or the implantable cardioverter defibrillator recipient. Open and honest communication was requested as important to support coping with an unpredictable life situation and to reduce worries and uncertainty about the future and end-of-life. © 2013 John Wiley & Sons Ltd.

  10. Pacemakers and implantable cardioverter-defibrillators in pediatric patients.

    PubMed

    Silka, Michael J; Bar-Cohen, Yaniv

    2006-11-01

    The use of pacemakers and implantable cardioverter-defibrillators (ICDs) in infants, children, and patients with congenital heart disease presents unique challenges and considerations. They include uncommon indications for device implantation, innovative approaches to lead implantation and configuration, and age-dependent and disease-specific aspects of device programming. In this review, the current indications for pacemaker and ICD implantation in young patients are discussed, followed by consideration of the approaches to lead and device placement in very small patients and those with complex congenital heart disease, in whom unique problems may be encountered. The limitations of programmability of current pacemakers and ICDs when used in young patients are discussed, followed by an analysis of long-term device follow-up and potential late complications.

  11. Position of Subcutaneous Implantable Cardioverter-Defibrillators and Possible Interference on Myocardial Perfusion Imaging.

    PubMed

    Kahaly, Omar Ray; Shafiei, Fereidoon; Hardebeck, Charles; Houmsse, Mahmoud

    2017-06-01

    Implanted cardioverter-defibrillators can prevent sudden cardiac death in at-risk patients. In comparison with conventional transvenous systems, entirely subcutaneous implantable cardioverter-defibrillators have produced similar reductions in the rate of sudden cardiac death but with fewer sequelae. An infrequently reported drawback of subcutaneous devices, however, is the potential for generating attenuation artifact during nuclear myocardial perfusion imaging. We had concerns about potential attenuation artifact in a 65-year-old man with coronary artery disease but found that having positioned the pulse generator in the midaxillary zone avoided problems.

  12. Living with life insurance: a qualitative analysis of the experience of male implantable defibrillator recipients in Spain.

    PubMed

    Palacios-Ceña, Domingo; Losa Iglesias, Marta E; Losa, Marta E; Fernández-de-Las-Peñas, César; Salvadores-Fuentes, Paloma

    2011-07-01

    The implantation of defibrillators should not be studied simply on the basis of clinical improvement or quality of life: it is also important to understand the significance, which the recipients attach to the defibrillator and their experiences with it. The aim of this work was, therefore, to determine the experience of Spanish implantable defibrillator recipients. A qualitative phenomenological study. Purposeful sampling of male implantable defibrillator recipients older than 18 years of age attended at the defibrillator consultancy at the Hospital Fuenlabrada or belonging to the Heart Patients' Association (Asociación de Pacientes Coronarios, APACOR). A secondary, theoretical sampling was also carried out to gain a more in-depth understanding of certain aspects identified in the first sampling, such as living with the discharges and difficulties during sexual activity. Data were collected using unstructured and semi-structured questionnaires and applying a question guide, field notes and the recipients' personal diaries/letters. Data collection was terminated once theoretical saturation was reached. Data were analysed using the Giorgi method. Finally, the seven themes, which showed what it means to be an implantable cardioverter-defibrillator recipient, were described. The defibrillator is perceived positively and is considered to be a form of life insurance, whereas the discharges are a limiting factor. The recipient's outlook on life changes. Acceptance of the changes resulting from the implant leads to the development of strategies to facilitate everyday life. An understanding of the significance attached by recipients to their disease, diagnosis and treatment allows their behaviour and expectations to be understood. Provide the basis for nursing assessment after discharge, understand the effects of the device in the recipient and track the process of adapting the recipient to daily life. © 2011 Blackwell Publishing Ltd.

  13. Evolution of power sources for implantable cardioverter defibrillators

    NASA Astrophysics Data System (ADS)

    Crespi, Ann M.; Somdahl, Sonja K.; Schmidt, Craig L.; Skarstad, Paul M.

    The evolution of seven generations of power sources for implantable cardioverter defibrillators (ICD) is presented. The packaging efficiency of the power sources has steadily increased, resulting in smaller, lighter batteries while maintaining the required electrical characteristics. The main areas for improvement were reduction of headspace volume, reduction of separator volume, and a change from a two-cell battery to a single cell.

  14. [Automated external defibrillators, life vest defibrillator, or both?].

    PubMed

    Conti, C Richard

    2012-03-01

    As most understand, survival of cardiac arrest victims falls significantly if cardioversion is not performed promptly. The standard of practice for out-of-hospital defibrillation is the implantable cardiac defibrillator; however, much has been written and discussed about the use of automated external defibrillators. Not as much has been written about life vest wearable defibrillators. How to use these devices will be reviewed in this article.

  15. Subcutaneous Implantable Cardioverter Defibrillator in Patients With Hypertrophic Cardiomyopathy: An Initial Experience.

    PubMed

    Weinstock, Jonathan; Bader, Yousef H; Maron, Martin S; Rowin, Ethan J; Link, Mark S

    2016-02-12

    The subcutaneous implantable cardioverter defibrillator (S-ICD) has been developed to avert risks associated with transvenous defibrillator leads. The technology is attractive for younger patients, such as those with hypertrophic cardiomyopathy (HCM). However, there are limited data on S-ICD use in HCM. HCM patients identified at risk for sudden death were considered for S-ICD implantation. Patients were screened for potential oversensing by surface electrocardiography (ECG). At implant, defibrillation threshold (DFT) testing was performed at 65, 50, and 35 joules (J). Twenty-seven patients were considered for S-ICD implantation, and after screening, 23 (85%) remained eligible. The presence of a bundle branch block was associated with screening failure, whereas elevated body mass index (BMI) showed a trend toward association. One patient passed screening at rest, but failed with an ECG obtained after exercise. At implant, the S-ICD terminated ventricular fibrillation (VF) with a 65J shock in all 15 implanted patients and a 50J shock was successful in 12 of 15. A 35J shock terminated VF in 10 of 12 patients. DFT failure at 50 J was associated with a higher BMI. There were no appropriate shocks after a median follow-up of 17.5 (3-35) months, and 1 patient received an inappropriate shock attributable to a temporary reduction in QRS amplitude while bending forward, resulting in oversensing, despite successful screening. In a high-risk HCM cohort without a pacing indication referred for consideration of an ICD, the majority were eligible for S-ICD. The S-ICD is effective at recognizing and terminating VF at implant with a wide safety margin. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  16. Implantable Heart Aid

    NASA Technical Reports Server (NTRS)

    1984-01-01

    CPI's human-implantable automatic implantable defibrillator (AID) is a heart assist system, derived from NASA's space circuitry technology, that can prevent erratic heart action known as arrhythmias. Implanted AID, consisting of microcomputer power source and two electrodes for sensing heart activity, recognizes onset of ventricular fibrillation (VF) and delivers corrective electrical countershock to restore rhythmic heartbeat.

  17. Predictors of Severe Tricuspid Regurgitation in Patients with Permanent Pacemaker or Automatic Implantable Cardioverter-Defibrillator Leads

    PubMed Central

    Najib, Mohammad Q.; Vittala, Satya S.; Challa, Suresh; Raizada, Amol; Tondato, Fernando J.; Lee, Howard R.; Chaliki, Hari P.

    2013-01-01

    Patients with permanent pacemaker or automatic implantable cardioverter-defibrillator (AICD) leads have an increased prevalence of tricuspid regurgitation. However, the roles of cardiac rhythm and lead-placement duration in the development of severe tricuspid regurgitation are unclear. We reviewed echocardiographic data on 26 consecutive patients who had severe tricuspid regurgitation after permanent pacemaker or AICD placement; before treatment, they had no organic tricuspid valve disease, pulmonary hypertension, left ventricular dysfunction, or severe tricuspid regurgitation. We compared the results to those of 26 control subjects who had these same devices but no more than mild tricuspid regurgitation. The patients and control subjects were similar in age (mean, 81 ±6 vs 81 ±8 yr; P = 0.83), sex (male, 42% vs 46%; P = 0.78), and left ventricular ejection fraction (0.60 ±0.06 vs 0.58 ± 0.05; P = 0.4). The patients had a higher prevalence of atrial fibrillation (92% vs 65%; P=0.01) and longer median duration of pacemaker or AICD lead placement (49.5 vs 5 mo; P < 0.001). After adjusting for age, sex, and right ventricular systolic pressure by multivariate logistic regression analysis, we found that atrial fibrillation (odds ratio=6.4; P = 0.03) and duration of lead placement (odds ratio=1.5/yr; P = 0.001) were independently associated with severe tricuspid regurgitation. Out study shows that atrial fibrillation and longer durations of lead placement might increase the risk of severe tricuspid regurgitation in patients with permanent pacemakers or AICDs. PMID:24391312

  18. Remote monitoring to Improve long-term prognosis in heart failure patients with implantable cardioverter-defibrillators.

    PubMed

    Ono, Maki; Varma, Niraj

    2017-05-01

    Strong evidence exists for the utility of remote monitoring in cardiac implantable electronic devices for early detection of arrhythmias and evaluation of system performance. The application of remote monitoring for the management of chronic disease such as heart failure has been an active area of research. Areas covered: This review aims to cover the latest evidence of remote monitoring of implantable cardiac defibrillators in terms of heart failure prognosis. This article also updates the current technology relating to the method and discusses key factors to be addressed in order to better use the approach. PubMed and internet searches were conducted to acquire most recent data and technology information. Expert commentary: Multiparameter monitoring with automatic transmission is useful for heart failure management. Improved adherence to remote monitoring and an optimal algorithm for transmitted alerts and their management are warranted in the management of heart failure.

  19. Optimal Implantable Cardioverter Defibrillator Programming.

    PubMed

    Shah, Bindi K

    Optimal programming of implantable cardioverter defibrillators (ICDs) is essential to appropriately treat ventricular tachyarrhythmias and to avoid unnecessary and inappropriate shocks. There have been a series of large clinical trials evaluating tailored programming of ICDs. We reviewed the clinical trials evaluating ICD therapies and detection, and the consensus statement on ICD programming. In doing so, we found that prolonged ICD detection times, higher rate cutoffs, and antitachycardia pacing (ATP) programming decreases inappropriate and painful therapies in a primary prevention population. The use of supraventricular tachyarrhythmia discriminators can also decrease inappropriate shocks. Tailored ICD programming using the knowledge gained from recent ICD trials can decrease inappropriate and unnecessary ICD therapies and decrease mortality.

  20. [Electrical storm in patients with prophylactic defibrillator implantation].

    PubMed

    Rodríguez-Mañero, Moisés; González-Cambeiro, Cristina; Moreno-Arribas, Jose; Expósito-García, Víctor; Sánchez-Gómez, Juan Miguel; González-Torres, Luis; Arce-León, Álvaro; Arguedas-Jiménez, Hugo; Gaztañaga, Larraitz; Salvador-Montañés, Oscar; Iglesias-Bravo, Jose Antonio; Huerta, Ana Andrés La; Fernández-Armenta, Juan; Arias, Miguel Ángel; Martínez-Sande, Luis

    2016-01-01

    Little is known about the prevalence of electrical storm, baseline characteristics and mortality implications of patients with implantable cardioverter defibrillator in primary prevention versus those patients without electrical storm. We sought to assess the prevalence, baseline risk profile and survival significance of electrical storm in patients with implantable defibrillator for primary prevention. Retrospective multicenter study performed in 15 Spanish hospitals. Consecutives patients referred for desfibrillator implantation, with or without left ventricular lead (at least those performed in 2010 and 2011), were included. Over all 1,174 patients, 34 (2,9%) presented an electrical storm, mainly due to ventricular tachycardia (82.4%). There were no significant baseline differences between groups, with similar punctuation in the mortality risk scores (SHOCKED, MADIT and FADES). A clear trigger was identified in 47% of the events. During the study period (38±21 months), long-term total mortality (58.8% versus 14.4%, p<0.001) and cardiac mortality (52.9% versus 8.6%, p<0.001) were both increased among electrical storm patients. Rate of inappropriate desfibrillator intervention was also higher (14.7 versus 8.6%, p<0.001). In the present study of patients with desfibrillator implantation for primary prevention, prevalence of electrical storm was 2.9%. There were no baseline differences in the cardiovascular risk profile versus those without electrical storm. However, all cause mortality and cardiovascular mortality was increased in these patients versus control desfibrillator patients without electrical storm, as was the rate of inappropriate desfibrillator intervention. Copyright © 2015 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  1. iPad2(R) use in patients with implantable cardioverter defibrillators causes electromagnetic interference: the EMIT Study.

    PubMed

    Kozik, Teri M; Chien, Gianna; Connolly, Therese F; Grewal, Gurinder S; Liang, David; Chien, Walter

    2014-04-10

    Over 140 million iPads(®) have been sold worldwide. The iPad2(®), with magnets embedded in its frame and Smart Cover and 3G cellular data capability, can potentially cause electromagnetic interference in implantable cardioverter defibrillators. This can lead to potentially life-threatening situations in patients. The goal of this study was to determine whether the iPad2(®) can cause electromagnetic interference in patients with implantable cardioverter defibrillators. Twenty-seven patients with implantable cardioverter defibrillators were studied. The iPad2(®) was held at reading distance and placed directly over the device with cellular data capability activated and deactivated. The manufacturers/models of devices and the patients' body mass index were noted. The presence of electromagnetic interference was detected by using a programmer supplied by each manufacturer. Magnet mode with suspension of anti-tachycardia therapy was triggered in 9 (33%) patients. All occurred when the iPad2(®) was placed directly over the device. The cellular data status did not cause interference and no noise or oversensing was noted. There was no significant difference between the mean body mass index of the groups with or without interference. The iPad2(®) can trigger magnet mode in implantable cardioverter defibrillators when laid directly over the device. This is potentially dangerous if patients should develop life-threatening arrhythmias at the same time. As new electronic products that use magnets are produced, the potential risk to patients with implantable defibrillators needs to be addressed.

  2. [The subcutaneous cardioverter-defibrillator: When less is more].

    PubMed

    Kuschyk, J; Rudic, B; Akin, I; Borggrefe, M; Röger, S

    2015-06-01

    In the last few decades, defibrillator therapy has revolutionized treatment of patients at risk for sudden cardiac death. Multiple clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICD) for primary and secondary prevention of sudden cardiac death. Being an entirely subcutaneous system, the S-ICD® avoids important periprocedural and long-term complications associated with transvenous implantable cardioverter-defibrillator (TV-ICD) systems as well as the need for fluoroscopy during implant surgery. In patients with challenging anatomic conditions or after infection, the S-ICD® might be reasonable. In multicenter studies and registries efficacy and safety of the S-ICD® was equal or better to transvenous implantable defibrillators. The cardiac rhythm is detected by the use of 1 of the 3 potential vectors. The S-ICD® automatically selects the most suitable vector for rhythm detection. If ventricular tachyarrhythmia is detected, the device is able to deliver up to five shocks of 80 J, while postshock pacing is available at 50 bpm for 30 s. The implantation technique is different from that of conventional ICDs, but easily learnable by experienced cardiologists. Initially observed hurdles (e.g., inappropriate shocks or infections) have been overcome by standardized implantation techniques, operator learning curves, and modification of algorithms. The S-ICD® predominately might be suitable in all patients with ICD indication except patients with pacing or cardiac resynchronization therapy (CRT) indication, ventricular tachycardia < 170 bpm, negative screening, or in the occasional patient whose arrhythmia might be suppressed by overdrive pacing. The system received CE certification in 2009 and was approved by the FDA in 2012. Currently, in Germany the S-ICD® has been integrated into the DRG system and can be reimbursed as a single chamber ICD.

  3. Evaluation of outpatients experiencing implantable cardioverter defibrillator shocks associated with minimal symptoms.

    PubMed

    Hamer, M E; Clair, W K; Wilkinson, W E; Greenfield, R A; Pritchett, E L; Page, R L

    1994-05-01

    Patients receiving minimally symptomatic shocks from their implantable cardioverter defibrillators were studied prospectively using transtelephonic ECG loop monitoring. The time course to the first subsequent shock was evaluated. Twenty-nine consecutive patients who received a shock preceded by mild palpitations or no symptoms were given a transtelephonic ECG loop monitor and instructed to activate the monitor if a subsequent shock occurred. Kaplan-Meier analysis was used to quantitate the time to first shock during the study period. The point estimate +/- standard error of patients receiving a shock during the study period was 31% +/- 9% at 30 days, 41% +/- 9% at 60 days, and 60% +/- 9% at 120 days. The ECG was successfully transmitted in 7 of 13 patients who had shocks in the 60-day monitoring period, and demonstrated inappropriate shocks in 6 of 7. Determination of the cause of shock led to a change in subsequent management in all 7 patients. We conclude that the incidence of inappropriate shocks may be higher than estimated previously in patients with minimal symptoms prior to the shock. There are thousands of patients with implantable cardioverter defibrillators that have no storage function for treated tachycardias; transtelephonic ECG loop monitoring can determine the cause of implantable cardioverter defibrillator discharge in these patients, and the diagnosis is invaluable in their management.

  4. Association between patient activity and long-term cardiac death in patients with implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.

    PubMed

    Zhao, Shuang; Chen, Keping; Su, Yangang; Hua, Wei; Chen, Silin; Liang, Zhaoguang; Xu, Wei; Dai, Yan; Liu, Zhimin; Fan, Xiaohan; Hou, Cuihong; Zhang, Shu

    2017-05-01

    Background Patient activity (PA) has been demonstrated to predict all-cause mortality. However, the association between PA and cardiac death is unclear. Aims The aims of this study were to determine whether PA can predict cardiac death and what is the cut-off of PA to discriminate cardiac death, as well as the mechanism underlying the relationship between PA and survival in patients with home monitoring. Methods This study retrospectively analysed clinical and implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator device data in 845 patients. Data regarding PA and PP variability during the first 30-60 days of home monitoring were collected, and mean values were calculated. The primary endpoint was cardiac death, and the secondary endpoint was all-cause mortality. Results The mean PA percentage was 11 ± 5.8%. Based on receiver operating characteristic curve analysis, we determined that a PA cut-off value of 7.84% (113 min) can predict cardiac death. During a mean follow-up period of 31.1 ± 12.9 months (ranging from three to 60 months), PA ≤ 7.84% was associated with increased risks of cardiac death in an unadjusted analysis; after adjusting in a multivariate Cox model, the relationship remained significant between PA≤7.84% and cardiac death (hazard ratio = 3.644, 95% confidence interval = 2.424-5.477, p < 0.001). Moreover, a significant correlation was observed between PA and PP variability ( r = 0.601, p < 0.001). Conclusions A baseline PA ≤ 7.84% was associated with a higher risk of cardiac death in patients who have survived more than three months after implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator implantation. PA had a sizable effect on heart rate variability, reflecting autonomic function.

  5. Utilization of implantable defibrillators in Africa.

    PubMed

    Millar, R N Scott; Mayosi, B M

    2003-01-01

    Sub-Saharan Africa is dominated by diseases of poverty. HIV/AIDS affects 28.5 out of a total of 600 million in the region. South Africa is the only country in sub-Saharan Africa in which implantable cardiovertor defibrillators (ICDs) are implanted (0.8/million in 2001). Only 3 of the 35 new ICDs were implanted in state-funded public hospitals. The pacemaker implantation rate for South Africa was 41/million in 2001. Approximately 20% of the population consume 56% of the health care expenditure, mainly funded by Medical Insurance. A tax-funded state health care system serves the rest of the population, but is concentrated on improving sanitation and primary health care. Diversion of funds from academic tertiary hospitals has reduced specialised services, particularly cardiology and cardiac surgery, and has resulted in an exodus of skilled personnel to the private sector. In the rest of sub-Saharan Africa, tertiary health care is mainly privately funded. Cardiology and cardiac surgery is not widely available. Many countries are crippled by debt and chronic local conflicts. Only one state hospital (Groote Schuur, Cape Town) provides an electrophysiology (EP) service including catheter ablation and ICD implantation, and training in EP, by two electrophysiologists. EP services are available privately in 3 centres. No EP service exists in the rest of sub-Saharan Africa.

  6. Factors associated with anxiety and depression among patients with implantable cardioverter defibrillator.

    PubMed

    Wong, Mei Fung Florence

    2017-05-01

    To identify factors associated with anxiety and depression of patients with implantable cardioverter defibrillators. Implantable cardioverter defibrillator is effective to increase survival from life-threatening arrhythmias, but it lowers health-related quality of life. Anxiety and depression had significant negative association with health-related quality of life. However, knowledge about factors associated with these two negative emotions in this specific population is inadequate. A cross-sectional descriptive design was conducted. Secondary analysis was performed to address the aim. A convenience sampling of patients with implantable cardioverter defibrillators was performed. Anxiety and depression were measured by the Hospital Anxiety and Depression Scale through face-to-face interview. Stepwise multivariable regression results showed that older age (aged 60-69 and ≥70: B = 2·08 and 3·31, p = 0·039 and <0·001), self-care dependence (B = 3·47, p < 0·001), being married (B = -2·21, p = 0·004) and having ischaemic heart disease (B = -1·80, p = 0·008) were significantly associated with depression. However, there was no significant factor associated with anxiety. Factors associated with depression among patients with implantable cardioverter defibrillator are identified. Older age (aged ≥60) and more self-care dependence have positive, but being married and having ischaemic heart disease have negative association with depression. Strategies to reduce psychological distress are highlighted. The study findings direct the care to improve health-related quality of life by reducing and controlling vulnerabilities arising from depression. Patients who are older people (≥aged 60) and more self-care dependent perceive higher depression. Nursing strategies are suggested to reduce depression especially for those who are older people and more self-care dependent. Early screening is essential to provide immediate care for reducing vulnerabilities

  7. The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival.

    PubMed

    Bhatia, Atul; Cooley, Ryan; Berger, Marcie; Blanck, Zalmen; Dhala, Anwer; Sra, Jasbir; Axtell-Mcbride, Kathleen; Vandervort, Cheryl; Akhtar, Masood

    2004-06-01

    Since the introduction of the implantable cardioverter defibrillator (ICD) for the management of patients with high risk of arrhythmic SCD, there has been increasing use of this device. Its basic promise to effectively terminate ventricular tachycardia (VT)-ventricular fibrillation (VF) has been repeatedly met. In several randomized trials, the ICD has been shown to be superior to conventional anti-arrhythmic therapy, both in patients with documented VT-VF (secondary prevention) and those with high risk such as left ventricular ejection fraction and no prior sustained VT-VF (primary prevention). In both groups, the ICD showed overall and cardiac mortality reduction. The device now can more accurately detect VT-VF and differentiate these from other arrhythmias through a series of algorithms and direct-chamber sensing. Therapy options include painless antitachycardia pacing, low-energy cardioversion, and high-energy defibrillation. The technique implant is now simple as a pacemaker with one lead attached to an active (hot) can functioning as the other electrode. Among other improvements is its weight, volume, multiprogrammability, and storage of information,dual-chamber pacing and sensing, dual-chamber defibrillation, and addition of biventricular pacing for cardiac synchronization. It is anticipated that further improvement in ICD technology will take place and the list of indications will grow.

  8. Psychometric properties of HeartQoL, a core heart disease-specific health-related quality of life questionnaire, in Danish implantable cardioverter defibrillator recipients.

    PubMed

    Zangger, Graziella; Zwisler, Ann-Dorthe; Kikkenborg Berg, Selina; Kristensen, Marie S; Grønset, Charlotte N; Uddin, Jamal; Pedersen, Susanne S; Oldridge, Neil B; Thygesen, Lau C

    2018-01-01

    Background Patient-reported health-related quality of life is increasingly used as an outcome measure in clinical trials and as a performance measure to evaluate quality of care. The objective of this study was to assess the psychometric properties of the Danish HeartQoL questionnaire, a core heart disease-specific health-related quality of life questionnaire, in implantable cardioverter defibrillator recipients. Design This study involved cross-sectional and test-retest study designs. Method Implantable cardioverter defibrillator recipients in the cross-sectional study completed the HeartQoL, the Short-Form 36 Health Survey, and the Hospital Anxiety and Depression Scale. The HeartQoL structure, construct-related validity (convergent and discriminative) and reliability (internal consistency) were assessed. HeartQoL reproducibility (test-retest) was assessed in an independent sample of implantable cardioverter defibrillator recipients. Results Mokken scale analysis supported the bi-dimensional structure of HeartQoL among 358 implantable cardioverter defibrillator recipients. Convergent ( r > 0.72) and discriminative validity were confirmed. The HeartQoL scales demonstrated satisfactory internal consistency (Cronbach's alpha > 0.90). Test-retest reliability (two weeks interval) was assessed in 89 implantable cardioverter defibrillator recipients and found to be acceptable for each scale (intra-class correlation > 0.90). Conclusion The Danish HeartQoL questionnaire demonstrated satisfactory key psychometric attributes of validity and reliability in this implantable cardioverter defibrillator population. This study adds support for the HeartQoL as a core heart-specific health-related quality of life questionnaire in a broad group of patients with heart disease including implantable cardioverter defibrillator recipients.

  9. Utilization trends and clinical outcomes in patients implanted with a single- vs a dual-coil implantable cardioverter-defibrillator lead: Insights from the ALTITUDE Study.

    PubMed

    Hsu, Jonathan C; Saxon, Leslie A; Jones, Paul W; Wehrenberg, Scott; Marcus, Gregory M

    2015-08-01

    Historically, the most commonly implanted implantable cardioverter-defibrillator (ICD) lead is dual coil. Conventional wisdom holds that single-coil leads may be less effective than dual-coil leads, but easier to extract. No contemporary large-scale studies have evaluated the relative epidemiology of these 2 leads or compared their respective clinical outcomes. We sought to evaluate trends in single- vs dual-coil ICD lead implantation and differences in clinical outcomes. We evaluated 129,520 ICD recipients enrolled in the LATITUDE remote monitoring system between 2004 and 2014. Kaplan-Meier analyses and Cox proportional hazards regression analyses were used for univariate and multivariate survival analysis, respectively. The majority of ICD recipients received a dual-coil lead (n = 110,330 [85.2%]). Single-coil lead implantation increased from 1.9% to 55.2% between 2004 and 2014. After adjusting for age, sex, device type, and year of implant, single-coil lead implantation was associated with a greater odds of induction for defibrillation testing (odds ratio 1.05; 95% confidence interval [CI] 1.01-1.09; P = .0274), a higher rate of lead being taken out of service (hazard ratio 1.19; 95% CI 1.06-1.33; P = .0032), and a decreased mortality rate (hazard ratio 0.91; 95% CI 0.87-0.96; P = .0004). In a 795 patient subset with adjudicated shock outcomes, first shock success was no different (87.0% in single coil vs 86.1% in dual coil; P = .8473). In a large real-world US population, single-coil lead implantation rates increased substantially between 2004 and 2014. Single-coil lead implantation was associated with more frequent defibrillation testing and the lead being taken out of service, but was not associated with increased mortality or more frequent defibrillation failure. Copyright © 2015 Heart Rhythm Society. All rights reserved.

  10. Emotions and health: findings from a randomized clinical trial on psychoeducational nursing to patients with implantable cardioverter defibrillator.

    PubMed

    Kikkenborg Berg, Selina; Støier, Louise; Moons, Philip; Zwisler, Ann-Dorthe; Winkel, Per; Ulrich Pedersen, Preben

    2015-01-01

    Serious illness will inevitably lead to a fundamental emotional reaction. Traditionally, in interventional treatment or rehabilitation trials, the psychological status of patients with implantable cardioverter defibrillators has been evaluated with anxiety and depression as outcome measures. In caring for these patients, the aim of nursing is to help patients manage life with complex heart disease. The early detection and management of negative emotional response might prevent the development of pathological conditions such as depression. The aims of this study were to (a) describe the trajectory of primary emotions over time in patients with implantable cardioverter defibrillators and (b) examine the potential effects of psychoeducational nursing on primary emotions. During the inclusion period (October 2007 to November 2009), 196 patients with implantable cardioverter defibrillator were randomized (1:1) to rehabilitation versus usual care. Rehabilitation consisted of a psychoeducational nursing component and an exercise training component. This article concerns phase 1, psychoeducational nursing, guided by a theory of nursing, Rosemary Rizzo Parses Human Becoming Practice Methodologies. The outcome measure is the Emotions and Health Scale. The scale consists of 8 primary emotions: joy, agreeableness, surprise, fear, sadness, disgust, anger, and anticipation. Mean (SD) age was 58 (13) years, and 79% of the participants were men. Significant improvements were found in primary emotional responses over time (P < .05) when combining groups. However, no difference in emotional intensity was found between the groups after 3 months of psychoeducational nursing intervention (P > .05). Primary emotions are affected after implantable cardioverter defibrillator implantation. Improvements over time were found. However, it was not possible to detect any effect of a short-term psychoeducational nursing intervention. Evaluating the primary emotions might be a good way for nurses

  11. Inadvertent defibrillator lead placement into the left ventricle after MitraClip implantation: A case report.

    PubMed

    Santarpia, Giuseppe; Passafaro, Francesco; Pasceri, Eugenia; Mongiardo, Annalisa; Curcio, Antonio; Indolfi, Ciro

    2018-05-01

    Inadvertent pacemaker/defibrillator lead placement into the left ventricle is an unusual cardiac device-related complication and its diagnosis is not always easy and often misunderstood. Thromboembolic events are frequently associated with this procedural complication. Percutaneous lead extraction should be performed when diagnosis is made early after device implantation while long-life oral anticoagulation is a wise option when the diagnosis is delayed and the lead is not removed. A 65-year-old man affected by dilated cardiomyopathy, previously treated with a percutaneous mitral valve repair, with 2 MitraClip devices, and later with dual chamber cardioverter/defibrillator implantation, returned in outpatient clinics 2 months after discharge for deterioration of dyspnea; transthoracic echocardiography revealed that the shock lead had been accidentally placed in the apex of the left ventricle. The unintentional lead malposition through the iatrogenic atrial septal defect and its presence into the mitral valve orifice, together with the 2 clip devices implanted, generated an acceleration of transvalvular diastolic flow, determining a moderate stenosis of the mitral valve, as well as promoting a worsening of the degree of valvular regurgitation. Oral anticoagulation therapy was started and a mechanical lead extraction was percutaneously performed. A new defibrillator lead was later appropriately positioned in the apex of the right ventricle. The patient was discharged 3 days after intervention and the follow-up, performed 1 month after discharge, was uneventful. Complex interventional procedures and implantation of multiple devices can increase procedural troubles and the risk of mechanical complications related to pacemaker/defibrillator implantation. Careful observation of the QRS complex morphology on the electrocardiogram (ECG), during paced rhythm, and the achievement of the echocardiographic examination, in the postprocedural phase, allow an early diagnosis of

  12. Survival in Women Versus Men Following Implantation of Pacemakers, Defibrillators, and Cardiac Resynchronization Therapy Devices in a Large, Nationwide Cohort.

    PubMed

    Varma, Niraj; Mittal, Suneet; Prillinger, Julie B; Snell, Jeff; Dalal, Nirav; Piccini, Jonathan P

    2017-05-10

    Whether outcomes differ between sexes following treatment with pacemakers (PM), implantable cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices is unclear. Consecutive US patients with newly implanted PM, implantable cardioverter defibrillators, and CRT devices from a large remote monitoring database between 2008 and 2011 were included in this observational cohort study. Sex-specific all-cause survival postimplant was compared within each device type using a multivariable Cox proportional hazards model, stratified on age and adjusted for remote monitoring utilization and ZIP-based socioeconomic variables. A total of 269 471 patients were assessed over a median 2.9 [interquartile range, 2.2, 3.6] years. Unadjusted mortality rates (MR; deaths/100 000 patient-years) were similar between women versus men receiving PMs (n=115 076, 55% male; MR 4193 versus MR 4256, respectively; adjusted hazard ratio, 0.87; 95% CI, 0.84-0.90; P <0.001) and implantable cardioverter defibrillators (n=85 014, 74% male; MR 4417 versus MR 4479, respectively; adjusted hazard ratio, 0.98; 95% CI, 0.93-1.02; P =0.244). In contrast, survival was superior in women receiving CRT defibrillators (n=61 475, 72% male; MR 5270 versus male MR 7175; adjusted hazard ratio, 0.73; 95% CI, 0.70-0.76; P <0.001) and also CRT pacemakers (n=7906, 57% male; MR 5383 versus male MR 7625, adjusted hazard ratio, 0.69; 95% CI, 0.61-0.78; P <0.001). This relative difference increased with time. These results were unaffected by age or remote monitoring utilization. Women accounted for less than 30% of high-voltage implants and fewer than half of low-voltage implants in a large, nation-wide cohort. Survival for women and men receiving implantable cardioverter defibrillators and PMs was similar, but dramatically greater for women receiving both defibrillator- and PM-based CRT. © 2017 The Authors and St. Jude Medical. Published on behalf of the American Heart Association, Inc., by Wiley.

  13. Safety of Electromagnetic Articulography in Patients with Pacemakers and Implantable Cardioverter-Defibrillators

    ERIC Educational Resources Information Center

    Joglar, Jose A.; Nguyen, Carol; Garst, Diane M.; Katz, William F.

    2009-01-01

    Purpose: "Electromagnetic articulography (EMA)" uses a helmet to create alternating magnetic fields for tracking speech articulator movement. An important safety consideration is whether EMA magnetic fields interfere with the operation of speakers' pacemakers or implantable cardioverter-defibrillators (ICDs). In this investigation,…

  14. How, why, and when may atrial defibrillation find a specific role in implantable devices? A clinical viewpoint.

    PubMed

    Boriani, Giuseppe; Diemberger, Igor; Biffi, Mauro; Martignani, Cristian; Ziacchi, Matteo; Bertini, Matteo; Valzania, Cinzia; Bronzetti, Gabriele; Rapezzi, Claudio; Branzi, Angelo

    2007-03-01

    This viewpoint article discusses the potential for incorporation of atrial defibrillation capabilities in modern multi-chamber devices. In the late 1990s, the possibility of using shock-only therapy to treat selected patients with recurrent atrial fibrillation (AF) was explored in the context of the stand-alone atrial defibrillator. The failure of this strategy can be attributed to the technical limitations of the stand-alone device, low tolerance of atrial shocks, difficulties in patient selection, a lack of predictive knowledge about the evolution of AF, and, last but not least, commercial considerations. An open question is how atrial defibrillation capability may now assume a specific new role in devices implanted for sudden death prevention or cardiac resynchronization. For patients who already have indications for implantable devices, device-based atrial defibrillation appears attractive as a "backup" option for managing AF when preventive pharmacological/electrical measures fail. This and several other personalized hybrid therapeutic approaches await exploration, though assessment of their efficacy is methodologically challenging. Achievement of acceptance by patients is an essential premise for any updated atrial defibrillation strategy. Strategies that are being investigated to improve patient tolerance include waveform shaping, pharmacologic modulation of pain, and patient-activated defibrillation (patients might also perceive the problem of discomfort somewhat differently in the context of a backup therapy). The economic impact of implementing atrial defibrillation features in available devices is progressively decreasing, and financial feasibility need not be a major issue. Future studies should examine clinically relevant outcomes and not be limited (as occurred with stand-alone defibrillators) to technical or other soft endpoints.

  15. Early Implantation of Primary Prevention Implantable Cardioverter Defibrillators for Patients with Newly Diagnosed Severe Nonischemic Cardiomyopathy.

    PubMed

    Voskoboinik, Aleksandr; Bloom, Jason; Taylor, Andrew; Mariani, Justin

    2016-09-01

    Primary prevention implantable cardioverter defibrillators (ICDs) reduce mortality in selected patients with severe systolic dysfunction. Current guidelines suggest a 3- to 6-month waiting period before implantation. We retrospectively studied 29 consecutive patients with newly diagnosed nonischemic cardiomyopathy (NICM) who underwent primary prevention ICD implantation within 6 months of diagnosis between January 2008 and April 2014. Cardiac MRI (CMR) evaluated left ventricular ejection fraction (LVEF) and regional fibrosis preimplant. The primary end point was "failure to qualify for an ICD at 12 months postimplant," either due to LVEF ≥ 35% or deterioration necessitating mechanical support or transplantation, without appropriate ICD therapy. Secondary end points were appropriate and inappropriate ICD therapy. Baseline mean age was 44.2 ± 14.8 years and median LVEF 16.4%. Median time from diagnosis to implant was 32 days. At 12 months, 17 patients (58.6%) no longer qualified for an ICD, mainly due to LVEF improvement. At follow-up (mean 32.0 ± 20.6 months), three patients received appropriate therapy (one for ventricular fibrillation). All three had CMR late gadolinium enhancement (LGE) and nonsustained ventricular tachycardia (NSVT) preimplant. Cardiac resynchronization at implant predicted LVEF improvement. Early appropriate therapy, particularly for ventricular fibrillation, is infrequent for patients with very severe NICM who have ICDs implanted within 6 months of diagnosis. The majority of these patients would not qualify for an ICD at 12 months postinsertion. In the absence of a multimodality risk score, early ICD insertion should only be considered in selected cases (presence of LGE and NSVT). Wearable cardioverter defibrillators may have a role as a bridge to ICD decision. © 2016 Wiley Periodicals, Inc.

  16. Development of a hybrid battery system for an implantable biomedical device, especially a defibrillator/cardioverter (ICD)

    NASA Astrophysics Data System (ADS)

    Drews, Jürgen; Wolf, R.; Fehrmann, G.; Staub, R.

    An implantable defibrillator battery has to provide pulse power capabilities as well as high energy density. Low self-discharge rates are mandatory and a way to check the remaining available capacity is necessary. These requirements are accomplished by a system consisting of a lithium/manganese dioxide 6 V battery, plus a lithium/iodine-cell. The use of a high rate 6 V double-cell design in combination with a high energy density cell reduces the total volume required by the power source within an implantable defibrillator. The design features and performance data of the hybrid system are described.

  17. Quality of Life Effects of Automatic External Defibrillators in the Home: Results from the Home Automatic External Defibrillator Trial (HAT)

    PubMed Central

    Mark, Daniel B.; Anstrom, Kevin J.; McNulty, Steven E.; Flaker, Greg C.; Tonkin, Andrew M.; Smith, Warren M.; Toff, William D.; Dorian, Paul; Clapp-Channing, Nancy E.; Anderson, Jill; Johnson, George; Schron, Eleanor B.; Poole, Jeanne E.; Lee, Kerry L.; Bardy, Gust H.

    2010-01-01

    Background Public access automatic external defibrillators (AEDs) can save lives, but most deaths from out-of-hospital sudden cardiac arrest occur at home. The Home Automatic External Defibrillator Trial (HAT) found no survival advantage for adding a home AED to cardiopulmonary resuscitation (CPR) training for 7001 patients with a prior anterior wall myocardial infarction. Quality of life (QOL) outcomes for both the patient and spouse/companion were secondary endpoints. Methods A subset of 1007 study patients and their spouse/companions was randomly selected for ascertainment of QOL by structured interview at baseline and 12 and 24 months following enrollment. The primary QOL measures were the Medical Outcomes Study 36-Item Short-Form (SF-36) psychological well-being (reflecting anxiety and depression) and vitality (reflecting energy and fatigue) subscales. Results For patients and spouse/companions, the psychological well-being and vitality scales did not differ significantly between those randomly assigned an AED plus CPR training and controls who received CPR training only. None of the other QOL measures collected showed a clinically and statistically significant difference between treatment groups. Patients in the AED group were more likely to report being extremely or quite a bit reassured by their treatment assignment. Spouse/companions in the AED group reported being less often nervous about the possibility of using AED/CPR treatment than those in the CPR group. Conclusions Adding access to a home AED to CPR training did not affect quality of life either for patients with a prior anterior myocardial infarction or their spouse/companion but did provide more reassurance to the patients without increasing anxiety for spouse/companions. PMID:20362722

  18. Effect of defibrillation threshold testing on effectiveness of the subcutaneous implantable cardioverter defibrillator.

    PubMed

    Peddareddy, Lakshmi; Merchant, Faisal M; Leon, Angel R; Smith, Paige; Patel, Akshar; El-Chami, Mikhael F

    2018-06-12

    Defibrillation threshold (DFT) testing is recommended with the subcutaneous ICD (SICD). To describe first shock efficacy for appropriate SICD therapies stratified by the presence of implant DFT testing. We reviewed all patients receiving SICDs at our institution and stratified them based on whether implant DFT testing was performed. Appropriate shocks were reviewed to see if ventricular tachycardia/ventricular fibrillation (VT/VF) terminated with a single shock. First shock efficacy was stratified by implant DFT status. 178 patients implanted with SICDs and followed in our center were included in this study. Of these, 135 (76 %) underwent DFT testing (DFT (+) group). In the DFT (+) 80 appropriate shocks were needed to treat 69 episodes of VT/VF. The first shock was effective in 61 out of 69 episodes (88.4 %), whereas multiple shocks were required to terminate VT/VF in the remaining 8 episodes. Among 43 patients without implant DFT testing (DFT (-) group), 20 appropriate shocks to treat 17 episodes of VT/VF occurred in 7 patients. VT/VF was successfully terminated with the first shock in 16 out of 17 episodes (first shock efficacy 94.1 %). There was no significant difference in first shock effectiveness between those with and without implant DFT testing (p = 0.97). A strategy that omits DFT testing at implant did not appear to compromise the effictiveness of the SICD. These data suggest that routine DFT testing at SICD implant might not be necessary. Randomized trials are needed to confirm this finding. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  19. Primary batteries for implantable pacemakers and defibrillators

    NASA Astrophysics Data System (ADS)

    Drews, J.; Fehrmann, G.; Staub, R.; Wolf, R.

    The lithium-iodine battery is established as the standard system for low-rate implantable applications, namely pacemakers because of its excellent volumetric energy density. Within defibrillators/cardioverters lithium-silver-oxovanadium (SVO) and lithium-manganese-dioxide (MDX) high-rate batteries are in use. The concept of a hybrid system which makes use of a high-rate battery and a low-rate battery within one application is described. Experimental results obtained from a MDX battery and a lithium-iodine battery, both with the same dimensions, are showing that MDX batteries of that size are able to combine excellent volumetric energy density and medium power ratings. Energy densities of 650 mWh/cm 3 for the MDX battery with a lode of 30 kΩ to an end voltage of 2.5 V have been confirmed. These results show the potential of lithium-manganese-dioxide batteries to be used as low-rate and medium-rate sources within implantable applications.

  20. Implant and clinical characteristics for pediatric and congenital heart patients in the national cardiovascular data registry implantable cardioverter defibrillator registry.

    PubMed

    Jordan, Christopher P; Freedenberg, Vicki; Wang, Yongfei; Curtis, Jeptha P; Gleva, Marye J; Berul, Charles I

    2014-12-01

    In 2010, the National Cardiovascular Data Registry enhanced pediatric, nonatherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter defibrillator implantation. In this article, we report implantable cardioverter defibrillator procedures (April 2010 to December 2012) in the registry for 2 cohorts: (1) all patients with CHD (atrial septal defect, ventricular septal defect, tetralogy of Fallot, Ebstein anomaly, transposition of the great vessels, and common ventricle) and (2) patients <21 years. We evaluated indications and characteristics to include transvenous and nontransvenous lead implants, CHD type, and New York Heart Association class. There were 3139 CHD procedures, 1601 for patients <21 years and 126 for CHD <21 years. Implantable cardioverter defibrillator indications for patients with CHD were primary prevention in 1943 (61.9%) and secondary prevention in 1107 (35.2%). Pediatric patients had 935 (58.4%) primary prevention and 588 (36.7%) secondary prevention devices. Primary prevention had higher New York Heart Association class. Nontransvenous age (35.9 ± 23.2 versus 40.1 ± 24.6 years; P=0.05) and nontransvenous height (167.1 ± 18.9 cm; range, 53-193 cm versus 170.4 ± 13.1 cm; range, 61-203 cm; P<0.01) were lower than for transvenous patients. CHD and pediatrics had similar rates of transvenous (97%) and nontransvenous (3%) leads and did not differ from the overall registry. Transposition of the great vessels and common ventricle had higher rates of nontransvenous leads. Primary prevention exceeds secondary prevention for CHD and pediatrics. Nontransvenous lead patients were younger, with higher rates of transposition of the great vessels and common ventricle patients compared with transvenous lead patients. © 2014 American Heart Association, Inc.

  1. [Tachycardia detection in implantable cardioverter-defibrillators by Sorin/LivaNova : Algorithms, pearls and pitfalls].

    PubMed

    Kolb, Christof; Ocklenburg, Rolf

    2016-09-01

    For physicians involved in the treatment of patients with implantable cardioverter-defibrillators (ICDs) the knowledge of tachycardia detection algorithms is of paramount importance. This knowledge is essential for adequate device selection during de-novo implantation, ICD replacement, and for troubleshooting during follow-up. This review describes tachycardia detection algorithms incorporated in ICDs by Sorin/LivaNova and analyses their strengths and weaknesses.

  2. Malfunction of subpectorally implanted cardiac resynchronization therapy defibrillators due to weakened header bond.

    PubMed

    Hayat, Sajad A; Kojodjojo, Pipin; Mason, Anthony; Benfield, Ann; Wright, Ian; Whinnett, Zachary; Lim, Phang Boon; Davies, D Wyn; Lefroy, David; Peters, Nicholas S; Kanagaratnam, Prapa

    2013-03-01

    Implantable cardioverter defibrillator (ICD) implantation has increased significantly over the last 10 years. Concerns about the safety and reliability of ICD systems have been raised, with premature lead failure and battery malfunctions accounting for the majority of reported adverse events. We describe the unique mode of presentation, diagnosis, and management of cardiac resynchronization therapy defibrillators (CRT-D) malfunctions that were caused by weakened bonding between the generator and header. Between June 2008 and December 2009, 22 Teligen™ ICDs and 24 Cognis™ CRT-Ds were implanted subpectorally at our institution, until a product advisory was issued. Of 24 Cognis™ CRT-D implants, 3 patients presented with CRT-D malfunctions. All our cases presented with initially intermittent and then persisting increases in shock lead impedance, associated with nonphysiological noise in the shock electrogram channels. These issues were rectified by generator change. Postexplant laboratory analysis confirmed inadequate bonding between device header and titanium casing in all cases, resulting in loosening and rocking of the header followed by fatigue-induced fracture of the shock circuitry. Weakened bonding between the header and generator casing of subpectorally implanted CRT-Ds can result in fractures and malfunction of the HV circuit. Physicians monitoring patients with devices affected by the product advisory should remain vigilant in order to diagnose and manage similar device malfunction expediently. © 2012 Wiley Periodicals, Inc.

  3. Factors associated with health-related quality of life among patients with implantable cardioverter defibrillator: identification of foci for nursing intervention.

    PubMed

    Wong, Florence Mei Fung; Sit, Janet Wing Hung; Wong, Eliza Mi Ling; Choi, Kai Chow

    2014-12-01

    To explore factors associated with health-related quality of life of patients with implantable cardioverter defibrillators. Substantial evidence indicates that implantable cardioverter defibrillator is proven to increase survival rate by terminating life-threatening arrhythmia. However, this device can negatively affect health-related quality of life. Little is known about factors associated with health-related quality of life of patients with implantable cardioverter defibrillators, particularly in Asian population. A transversal descriptive design was used. Data were collected from a convenience sample of 139 adult patients with implantable cardioverter defibrillators from 4 January-30 April 2012 using the structured questionnaires administered by the researcher and medical record reviews. The Short Form-36 Health Survey version 2 was used to measure health-related quality of life. A total of 139 Chinese patients, including 107 (77·0%) males with a mean age of 63·0 (14·6) years, were selected. The physical component summary was relatively lower, whereas the mental component summary was relatively higher than that of the general Hong Kong Chinese population. Multivariable regression analysis revealed gender, self-care dependence, educational level, atrial fibrillation, diabetes mellitus, anxiety and depression significantly associated with physical or mental quality of life. Depression was a common factor affecting physical and mental quality of life. Self-care dependence, atrial fibrillation, diabetes mellitus, depression and anxiety could be improved. Our findings expand existing knowledge on identifying at-risk patients for having lower quality of life, thus allowing development of appropriate interventions targeting risk factors for improving health-related quality of life of patients with implantable cardioverter defibrillator. © 2014 John Wiley & Sons Ltd.

  4. Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry.

    PubMed

    Kaiser, Daniel W; Tsai, Vivian; Heidenreich, Paul A; Goldstein, Mary K; Wang, Yongfei; Curtis, Jeptha; Turakhia, Mintu P

    2015-10-01

    Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria. We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs. Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT). Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4). Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance. Published by Elsevier Inc.

  5. Disparities in the use of primary prevention and defibrillator therapy among blacks and women.

    PubMed

    Gauri, Andre J; Davis, Andrew; Hong, Thomas; Burke, Martin C; Knight, Bradley P

    2006-02-01

    This study determines whether there are racial or gender disparities in the use of implantable cardioverter-defibrillator therapy for primary prevention of sudden cardiac death. Primary prevention of sudden death with implantable cardioverter-defibrillator therapy has been shown to improve survival for high-risk patients with coronary artery disease and left ventricular dysfunction. The Center for Medicare and Medicaid Services Medicare database from the year 2002 was used to identify patients who were potential candidates for implantable cardioverter-defibrillator therapy on the basis of a combination of International Classification of Diseases, Ninth Revision, Clinical Modification codes that reflected the presence of an ischemic cardiomyopathy. This cohort was analyzed to determine which patients received implantable cardioverter-defibrillator therapy during the same year. The clinical characteristics of the potential implantable cardioverter-defibrillator candidates were compared with those who actually received an implantable cardioverter-defibrillator. A total 132565 Medicare patients hospitalized during 2002 were identified as having an ischemic cardiomyopathy; 10370 (8%) of these patients underwent implantable cardioverter-defibrillator implantation during the same year. The percentage of patients who underwent implantable cardioverter-defibrillator implantation was higher for men compared with women (10.2% vs 3.5%; P<.001) and whites compared with blacks (8.1 vs 5.4; P<.001). After multivariate analysis, age, gender, and race remained independent predictors of implantable cardioverter-defibrillator implantation. Women with an ischemic cardiomyopathy were 65% less likely to receive implantable cardioverter-defibrillator therapy compared with men (P<.001), and black patients were 31% less likely to receive implantable cardioverter-defibrillator therapy compared with patients of other races (P < .001). Use of implantable cardioverter-defibrillator therapy for

  6. Life-saving implantable cardioverter defibrillator therapy in cardiac AL amyloidosis

    PubMed Central

    Patel, Ketna S; Hawkins, Philip N; Whelan, Carol J; Gillmore, Julian D

    2014-01-01

    Cardiac involvement is the main determinant of prognosis in systemic monoclonal immunoglobulin light chain (AL) amyloidosis. Ventricular arrhythmias and sudden cardiac death are not uncommon. The electrical events that precede sudden death, and their potential to be treated effectively, remain undefined. There are no European guidelines for the use of implantable cardioverter defibrillator (ICD) in amyloidosis. ICDs in general are not usually offered to patients with a life expectancy of less than 1 year. We describe a patient who presented with cardiac AL amyloidosis who underwent prophylactic ICD implantation for the prevention of sudden cardiac death during treatment with chemotherapy, in whom life-threatening ventricular arrhythmia was successfully terminated over a 3-year period. PMID:25535224

  7. Inappropriate shock delivery by implantable cardioverter defibrillator due to electrical interference with washing machine.

    PubMed

    Chongtham, Dhanaraj Singh; Bahl, Ajay; Kumar, Rohit Manoj; Talwar, K K

    2007-05-31

    We report a patient with hypertrophic cardiomyopathy who received an inappropriate implantable cardioverter defibrillator shock due to electrical interference from a washing machine. This electrical interference was detected as an episode of ventricular fibrillation with delivery of shock without warning symptoms.

  8. [The daily experience of the patient with an implantable cardioverter defibrillator].

    PubMed

    Palacios-Ceña, Domingo; Alonso-Blanco, Cristina; Cachón-Pérez, José Miguel; Alvarez-López, Cristina

    2010-01-01

    To describe the daily experience of patients with an automatic defibrillator (AD) implant and the adaptive changes of the patient. Qualitative and phenomenological research. Collection of data through; initially unstructured interview with half of the informants, semi-structured interviews through an open questions guide after the initial unstructured interviews and use of personal narratives of the informants. Analysis of the data using the Van Manen proposal. We analysed the interviews of 10 participants. We collected socio-demographic variables and identified the following themes, which respond to the question "How is life with an AD": It is life "with the two sides of the coin," living in constant wait and uncertainty, accepting change, developing adaptation strategies, renegotiating relationships and sexuality and it is to live transformed. The results of this study can be integrated into nurse clinical practice in areas such as valuation after discharge, changes in habits, control of treatment, notification of shocks, masking detection of symptoms and strategies that can jeopardise the bearer. Research needs to be developed that looks closer into the influence of other technological devices in people. Copyright 2009 Elsevier España, S.L. All rights reserved.

  9. Initial clinical experience with ambulatory use of an implantable atrial defibrillator for conversion of atrial fibrillation. Metrix Investigators.

    PubMed

    Daoud, E G; Timmermans, C; Fellows, C; Hoyt, R; Lemery, R; Dawson, K; Ayers, G M

    2000-09-19

    A recent study has shown that the implantable atrial defibrillator can restore sinus rhythm in patients with recurrent atrial fibrillation when therapy was delivered under physician observation. The objective of this study was to evaluate the safety and efficacy of ambulatory use of the implantable atrial defibrillator. An atrial defibrillator was implanted in 105 patients (75 men; mean age, 59+/-12 years) with recurrent, symptomatic, drug-refractory atrial fibrillation. After successful 3-month testing, patients could transition to ambulatory delivery of shock therapy. Patients completed questionnaires regarding shock therapy discomfort and therapy satisfaction using a 10-point visual-analog scale (1 represented "not at all," 10 represented "extremely") after each treated episode of atrial fibrillation. During a mean follow-up of 11.7 months, 48 of 105 patients satisfied criteria for transition and received therapy for 275 episodes of atrial fibrillation. Overall shock therapy efficacy was 90% with 1.6+/-1.2 shocks delivered per episode (median, 1). Patients rated shock discomfort as 5.2+/-2.4 for successful therapy and 4.2+/-2.2 for unsuccessful therapy (P:>0.05). The satisfaction score was higher for successful versus unsuccessful therapy (3.4+/-3. 3 versus 8.7+/-1.3, P:<0.05). There was no ventricular proarrhythmia observed throughout the course of this study. Ambulatory use of an implantable atrial defibrillator can safely and successfully convert most episodes of atrial fibrillation, often requiring only a single shock. Successful therapy is associated with high satisfaction and only moderate discomfort.

  10. No Electromagnetic Interference Occurred in a Patient with a HeartMate II Left Ventricular Assist System and a Subcutaneous Implantable Cardioverter-Defibrillator.

    PubMed

    Raman, Ajay Sundara; Shabari, Farshad Raissi; Kar, Biswajit; Loyalka, Pranav; Hariharan, Ramesh

    2016-04-01

    The use of subcutaneous implantable cardioverter-defibrillators is a novel option for preventing arrhythmia-mediated cardiac death in patients who are at risk of endovascular-device infection or in whom venous access is difficult. However, the potential for electromagnetic interference between subcutaneous defibrillators and left ventricular assist devices is largely unknown. We report the case of a 24-year-old man in whom we observed no electromagnetic interference between a subcutaneous implanted cardioverter-defibrillator and a HeartMate II Left Ventricular Assist System, at 3 different pump speeds. To our knowledge, this is the first report of such findings in this circumstance.

  11. Tricuspid Valve Dysfunction Following Pacemaker or Cardioverter-Defibrillator Implantation.

    PubMed

    Chang, James D; Manning, Warren J; Ebrille, Elisa; Zimetbaum, Peter J

    2017-05-09

    The potential for cardiac implantable electronic device leads to interfere with tricuspid valve (TV) function has gained increasing recognition as having hemodynamic and clinical consequences associated with incremental morbidity and death. The diagnosis and treatment of lead-related (as distinct from functional) tricuspid regurgitation pose unique challenges. Because of pitfalls in routine diagnostic imaging, a high level of clinical suspicion must be maintained to avoid overlooking the possibility that worsening heart failure is a consequence of mechanical interference with TV leaflet mobility or coaptation and is amenable to lead extraction or valve repair or replacement. The future of cardiac implantable electronic devices includes pacing and perhaps defibrillation without a lead traversing the TV. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  12. Clinical performance of different DF-4 implantable cardioverter defibrillator leads.

    PubMed

    Sarrazin, Jean-François; Philippon, François; Sellier, Romain; André, Philippe; O'Hara, Gilles; Molin, Franck; Nault, Isabelle; Blier, Louis; Champagne, Jean

    2018-06-01

    Implantable cardioverter-defibrillator (ICD) DF-4 connectors have been introduced to facilitate defibrillator lead connection and to reduce the size of device header. There are limited data regarding the overall performance of those leads and no comparison between different ICD DF-4 leads. This is a cohort study of consecutive patients implanted with ICD DF-4 lead system at one University Centre between October 2010 and February 2015. A historical control group of patients with ICD DF-1 lead implantation was used for comparison. The following ICD DF-4 leads were evaluated: St. Jude Medical Durata 7122Q (St. Jude Medical, St. Paul, MN, USA), Medtronic Sprint Quattro Secure 6935 M (Medtronic Inc., Minneapolis, MN, USA), Boston Scientific Endotak Reliance 4-Site 0293 (Boston Scientific, Marlborough, MA, USA), and Boston Scientific Reliance 4-Front 0693. This study evaluated the acute and mid-term performances of those leads as well as complications. A total of 812 patients (age 63 ± 12 years, 80% male, left ventricular ejection fraction 31 ± 12%) underwent implantation of an ICD DF-4 lead. Acute and follow-up R-wave sensing and threshold were excellent. Compared to implantation, intrinsic R waves were higher at follow-up for Boston Scientific and Medtronic leads, and pacing lead impedances were lower for all leads at first follow-up (P < 0.001). The number of lead dislodgement or failure was similar between all leads. The estimated lead survival rates at 3 years were 95.6% for Boston Scientific Endotak 4-Site, 97.1% for Boston Scientific 4-Front, 97.7% for Medtronic Sprint Quattro, and 97.5% for St. Jude Durata (P  =  0.553). All ICD DF-4 leads had excellent acute and mid-term electrical performances. Longer follow-up will be necessary to confirm their sustained performance. © 2018 Wiley Periodicals, Inc.

  13. [Sudden cardiac death in the youth. Is the new subcutaneous implantable cardioverter defibrillator S-ICD an alternative solution?].

    PubMed

    Roche, N-C; Stefuriac, M; Dumitrescu, N; Charbonnel, A; Godreuil, C; Bonnevie, L

    2015-02-01

    Implantable cardioverter defibrillator (ICD) is well-recognized therapy to prevent sudden cardiac death. Classic ICD need the use of permanent endocavitary leads, which may cause serious troubles (lead dislodgement, ventricular perforation, lead infections, etc.). The subcutaneous implantable cardioverter defibrillator (S-ICD) is a new device provided by only a subcutaneous lead. It has been developed for the last five years and it is becoming at present a real alternative to classic ICD. We report a clinical case of a 34 y.o. woman who presented a sudden cardiac death and who benefited the implantation of this new technology. This paper deals with the potential indications, usefulness benefits, and problems of the S-ICD. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  14. Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads.

    PubMed

    Koneru, Jayanthi N; Jones, Paul W; Hammill, Eric F; Wold, Nicholas; Ellenbogen, Kenneth A

    2018-05-10

    The transvenous implantable cardioverter-defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database. Data from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5-year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications. Incidence of mechanical and infectious complications of transvenous ICD leads over long-term follow-up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  15. Living with hypertrophic cardiomyopathy and an implantable defibrillator.

    PubMed

    Magnusson, Peter; Jonsson, Jessica; Mörner, Stellan; Fredriksson, Lennart

    2017-05-10

    ICDs efficiently terminate life-threatening arrhythmias, but complications occur during long-term follow-up. Patients' own perspective is largely unknown. The aim of the study was to describe experiences of hypertrophic cardiomyopathy (HCM) patients with implantable defibrillators (ICDs). We analyzed 26 Swedish patient interviews using hermeneutics and latent content analysis. Patients (aged 27-76 years) were limited by HCM especially if it deteriorates into heart failure. The ICD implies safety, gratitude, and is accepted as a part of the body even when inappropriate ICD shocks are encountered. Nobody regretted the implant. Both the disease and the ICD affected professional life and leisure time activities, especially at younger ages. Family support was usually strong, but sometimes resulted in overprotection, whereas health care focused on medical issues. Despite limitations, patients adapted, accepted, and managed challenges. HCM patients with ICDs reported good spirit and hope even though they had to adapt and accept limitations over time.

  16. Frozen shoulder syndrome associated with subpectoral defibrillator implantation.

    PubMed

    Burke, M C; Drinan, K; Kopp, D E; Kall, J G; Verdino, R J; Paydak, H; Wilber, D J

    1999-10-01

    Pectoral implantation of transvenous non-thoracotomy internal cardioverter defibrillators (ICD) has resulted in very few complications whether placed subpectorally or subcutaneously. We report the case of a 68 year old man with a subpectorally implanted MINI-plus (Cardiac Pacemakers, Incorporated, St. Paul, Mn.) transvenous ICD who developed nearly instantaneous severe ipsilateral shoulder pain and immobilization. The symptoms progressed despite aggressive physical therapy. We elected to remove the device from the pectoral site and place it in a traditional abdominal position due to the severity, duration and refractoriness of his symptoms. This procedure utilized the chronic Endotak DSP (Model 0125, Cardiac Pacemakers, Incorporated) transvenous lead, a compatible Endotak DSP lead extender (Model 6952, Cardiac Pacemakers, Incorporated) and the above described ICD. Immediate relief of symptoms was accomplished by relocation of the device to an abdominal site. This intervention should be reserved for patients with severely debilitating symptoms. Prospective comparison of subpectoral and subcutaneous surgical approaches with respect to patient comfort and acceptance and complications may be warranted.

  17. No Electromagnetic Interference Occurred in a Patient with a HeartMate II Left Ventricular Assist System and a Subcutaneous Implantable Cardioverter-Defibrillator

    PubMed Central

    Raman, Ajay Sundara; Kar, Biswajit; Loyalka, Pranav; Hariharan, Ramesh

    2016-01-01

    The use of subcutaneous implantable cardioverter-defibrillators is a novel option for preventing arrhythmia-mediated cardiac death in patients who are at risk of endovascular-device infection or in whom venous access is difficult. However, the potential for electromagnetic interference between subcutaneous defibrillators and left ventricular assist devices is largely unknown. We report the case of a 24-year-old man in whom we observed no electromagnetic interference between a subcutaneous implanted cardioverter-defibrillator and a HeartMate II Left Ventricular Assist System, at 3 different pump speeds. To our knowledge, this is the first report of such findings in this circumstance. PMID:27127441

  18. Protein biomarkers identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillators: findings from the Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSE-ICD).

    PubMed

    Cheng, Alan; Zhang, Yiyi; Blasco-Colmenares, Elena; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Eldadah, Zayd; Ellenbogen, Kenneth A; Dickfeld, Timm; Spragg, David D; Marine, Joseph E; Guallar, Eliseo; Tomaselli, Gordon F

    2014-12-01

    Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality, but the benefits are heterogeneous. Current risk stratification based on left ventricular ejection fraction has limited discrimination power. We hypothesize that biomarkers for inflammation, neurohumoral activation, and cardiac injury can predict appropriate shocks and all-cause mortality in patients with primary prevention ICDs. The Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSe-ICD) enrolled 1189 patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end point was an ICD shock for adjudicated ventricular tachyarrhythmia. The secondary end point was all-cause mortality. After a median follow-up of 4.0 years, 137 subjects experienced an appropriate ICD shock and 343 participants died (incidence rates of 3.2 and 5.8 per 100 person-years, respectively). In multivariable-adjusted models, higher interleukin-6 levels increased the risk of appropriate ICD shocks. In contrast, C-reactive protein, interleukin-6, tumor necrosis factor-α receptor II, pro-brain natriuretic peptide (pro-BNP), and cardiac troponin T showed significant linear trends for increased risk of all-cause mortality across quartiles. A score combining these 5 biomarkers identified patients who were much more likely to die than to receive an appropriate shock from the ICD. An increase in serum biomarkers of inflammation, neurohumoral activation, and myocardial injury increased the risk for death but poorly predicted the likelihood of an ICD shock. These findings highlight the potential importance of serum-based biomarkers in identifying patients who are unlikely to benefit from primary prevention ICDs. clinicaltrials.gov; Unique Identifier: NCT00733590. © 2014 American Heart Association, Inc.

  19. Contemporary rates and outcomes of single- vs. dual-coil implantable cardioverter defibrillator lead implantation: data from the Israeli ICD Registry.

    PubMed

    Leshem, Eran; Suleiman, Mahmoud; Laish-Farkash, Avishag; Konstantino, Yuval; Glikson, Michael; Barsheshet, Alon; Goldenberg, Ilan; Michowitz, Yoav

    2017-09-01

    Dual-coil leads were traditionally considered standard of care due to lower defibrillation thresholds (DFT). Higher complication rates during extraction with parallel progression in implantable cardioverter defibrillator (ICD) technology raised questions on dual coil necessity. Prior substudies found no significant outcome difference between dual and single coils, although using higher rates of DFT testing then currently practiced. We evaluated the temporal trends in implantation rates of single- vs. dual-coil leads and determined the associated adverse clinical outcomes, using a contemporary nation-wide ICD registry. Between July 2010 and March 2015, 6343 consecutive ICD (n = 3998) or CRT-D (n = 2345) implantation patients were prospectively enrolled in the Israeli ICD Registry. A follow-up of at least 1 year of 2285 patients was available for outcome analysis. The primary endpoint was all-cause mortality. Single-coil leads were implanted in 32% of our cohort, 36% among ICD recipients, and 26% among CRT-D recipients. Secondary prevention indication was associated with an increased rate of dual-coil implantation. A significant decline in dual-coil leads with reciprocal incline of single coils was observed, despite low rates of DFT testing (11.6%) during implantation, which also declined from 31 to 2%. In the multivariate Cox model analysis, dual- vs. single-coil lead implantation was not associated with an increased risk of mortality [hazard ratio (HR) = 1.23; P= 0.33], heart failure hospitalization (HR = 1.34; P=0.13), appropriate (HR = 1.25; P= 0.33), or inappropriate ICD therapy (HR = 2.07; P= 0.12). Real-life rates of single-coil lead implantation are rising while adding no additional risk. These results of single-coil safety are reassuring and obtained, despite low and contemporary rates of DFT testing. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  20. Cost-Utility Analysis of the EVOLVO Study on Remote Monitoring for Heart Failure Patients With Implantable Defibrillators: Randomized Controlled Trial

    PubMed Central

    Landolina, Maurizio; Marzegalli, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Guenzati, Giuseppe; Curnis, Antonio; Valsecchi, Sergio; Borghetti, Francesca; Borghi, Gabriella; Masella, Cristina

    2013-01-01

    Background Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. Objective We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Methods Two hundred patients implanted with a wireless transmission–enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Results Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Conclusions Remote management of heart

  1. Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial.

    PubMed

    Zanaboni, Paolo; Landolina, Maurizio; Marzegalli, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Guenzati, Giuseppe; Curnis, Antonio; Valsecchi, Sergio; Borghetti, Francesca; Borghi, Gabriella; Masella, Cristina

    2013-05-30

    Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Remote management of heart failure patients with implantable defibrillators

  2. Electromagnetic interference from welding and motors on implantable cardioverter-defibrillators as tested in the electrically hostile work site.

    PubMed

    Fetter, J G; Benditt, D G; Stanton, M S

    1996-08-01

    This study was designed to determine the susceptibility of an implanted cardioverter-defibrillator to electromagnetic interference in an electrically hostile work site environment, with the ultimate goal of allowing the patient to return to work. Normal operation of an implanted cardioverter-defibrillator depends on reliable sensing of the heart's electrical activity. Consequently, there is concern that external electromagnetic interference from external sources in the work place, especially welding equipment or motor-generator systems, may be sensed and produce inappropriate shocks or abnormal reed switch operation, temporarily suspending detection of ventricular tachycardia or ventricular fibrillation. The effects of electromagnetic interference on the operation of one type of implantable cardioverter-defibrillator (Medtronic models 7217 and 7219) was measured by using internal event counter monitoring in 10 patients operating arc welders at up to 900 A or working near 200-hp motors and 1 patient close to a locomotive starter drawing up to 400 A. The electromagnetic interference produced two sources of potential interference on the sensing circuit or reed switch operation, respectively: 1) electrical fields with measured frequencies up to 50 MHz produced by the high currents during welding electrode activation, and 2) magnetic fields produced by the current in the welding electrode and cable. The defibrillator sensitivity was programmed to the highest (most sensitive) value: 0.15 mV (model 7219) or 0.3 mV (model 7217). The ventricular tachycardia and ventricular fibrillation therapies were temporarily turned off but the detection circuits left on. None of the implanted defibrillators tested were affected by oversensing of the electric field as verified by telemetry from the detection circuits. The magnetic field from 225-A welding current produced a flux density of 1.2 G; this density was not adequate to close the reed switch, which requires approximately 10 G

  3. Perceptions of healthcare professionals' support, shock anxiety and device acceptance among implantable cardioverter defibrillator recipients.

    PubMed

    Morken, Ingvild M; Norekvål, Tone M; Bru, Edvin; Larsen, Alf I; Karlsen, Bjørg

    2014-09-01

    To investigate the extent to which perceived support from healthcare professionals and shock anxiety is related to device acceptance among implantable cardioverter defibrillator recipients. Device acceptance can be influenced by several factors, one of which is shock anxiety associated with poor device acceptance. Reduced shock anxiety, as well as increased device acceptance, has been reported after psycho-educational programmes. As healthcare professionals appear to play a significant role in providing support and education during regular follow-up visits, they may constitute an important social support system that could be another factor influencing device acceptance. However, little is known about the relationship between perceived support from healthcare professionals and device acceptance among recipients. A cross-sectional survey design. A sample comprising implantable cardioverter defibrillator recipients completed questionnaires assessing perceived support from healthcare professionals, shock anxiety and device acceptance. Demographic and clinical data were collected by self-report and from medical records in September-October 2010. The descriptive results indicated that approximately 85% of the recipients experienced high device acceptance. Regression analysis demonstrated that constructive support from healthcare professionals was positively associated with device acceptance and moderated the negative relationship between shock anxiety and device acceptance. Non-constructive support and shock anxiety had a negative statistical association with device acceptance. Healthcare professionals may represent a valuable constructive support system that can enhance device acceptance among implantable cardioverter defibrillator recipients, partly by preventing shock anxiety from leading to poor device acceptance. Non-constructive communication on the part of healthcare professionals could hinder device acceptance. © 2014 John Wiley & Sons Ltd.

  4. Insulation defects in Riata implantable cardioverter-defibrillator leads.

    PubMed

    Sato, Akinori; Chinushi, Masaomi; Iijima, Kenichi; Izumi, Daisuke; Furushima, Hiroshi

    2012-01-01

    The structures composing implantable cardioverter-defibrillator (ICD) leads have become more complicated and thinner with technological advances. Silicon insulation defects with and without clinically manifested electrical abnormalities have been reported in Riata leads (St. Jude Medical). The aim of this study was to assess the incidence and clinical implications of insulation defects in Riata leads implanted at our hospital. The subjects included 10 consecutive patients who received 8-French Riata ICD leads with dual-coil conductors (model 1580 or 1581) between 2006 and 2010 at our hospital. Operative records, chest X-rays and interrogation data were reviewed. In all cases, Atlas+ (St. Jude Medical) was used as an ICD generator and the Riata leads were implanted transvenously and fixed to the right ventricular apex. During a mean follow-up period of 52±9 (36-70) months, chest X-rays revealed insulation defects in Riata leads and conductor wires projecting from the bodies of the Riata leads in two of 10 (20%) patients. One of the patients received inappropriate ICD therapies due to T-wave oversensing based on attenuation of R waves and augmentation of T waves 41 months after implantation. In the other patient, an insulation defect without any clinically manifested electrical troubles was detected 50 months after implantation. Riata leads have a high incidence of insulation defects, which may be occasionally accompanied by inappropriate ICD discharges. For patients with Riata leads, careful observation of any changes in the lead-electrical measurements and a routine chest X-ray follow-up are necessary.

  5. Physicians’ Knowledge and Attitudes Regarding Implantable Cardioverter- Defibrillators

    PubMed Central

    Sherazi, Saadia; Zareba, Wojciech; Daubert, James P.; McNitt, Scott; Shah, Abrar H.; Aktas, Mehmet K.; Block, Robert C.

    2012-01-01

    Background Information is limited regarding the knowledge and attitudes of physicians typically involved in the referral of patients for implantable cardioverter defibrillator (ICD) implantation. Methods We conducted a survey of primary care physicians and cardiologists at the University of Rochester Medical Center and the Unity Health System Rochester, NY from December 2008 to February 2009. The survey collected information regarding knowledge and attitudes of physicians towards ICD therapy. Results Of the 332 surveys distributed, 110 (33%) were returned. Over-all 94 (87%) physicians reported referring patients for ICD implantation. Eighteen (17%) physicians reported unawareness of guidelines for ICD use. Sixty-four (59%) physicians recommended ICD in patients with ischemic cardiomyopathy and left ventricular ejection fraction (LVEF) ≤ 35%. Sixty-five (62%) physicians use ≤ 35% as LVEF criteria for ICD referral in patients with non-ischemic cardiomyopathy. Cardiologists were more familiar than primary care physicians with LVEF criteria for implantation of ICD in patients with ischemic and non-ischemic cardiomyopathy (p value 0.005 and 0.002 respectively). Twenty-nine (27%) participants were unsure regarding benefits of ICDs in eligible women and Blacks. Eighty two (76%) physicians believed that an ICD could benefit patients ≥70 years whereas only 53 (49%) indicated that an ICD would benefit patients ≥ 80 years of age. A lack of familiarity with current clinical guidelines regarding ICD implantation exists. Primary care physicians are less aware of clinical guidelines than are cardiologists. This finding highlights the need to improve the dissemination of guidelines to primary care physicians in an effort to improve ICD utilization. PMID:20535717

  6. Feasibility of early discharge after implantable cardioverter-defibrillator procedures.

    PubMed

    Choudhuri, Indrajit; Desai, Dipan; Walburg, Jon; August, Phyllis; Keller, Seth I; Suri, Ranjit

    2012-10-01

    Registry data demonstrate considerably low complication rates after implantable cardioverter-defibrillator (ICD) procedures for primary prevention of sudden death. Yet standard of care includes postimplant overnight in-hospital observation that may levy substantial unnecessary financial burden on health care systems. In appropriate patients, discharge soon after implant could translate into significant cost savings, if such practice does not result in complications. We applied a simple clinical algorithm to assess feasibility of discharge on the same day of ICD implantation in patients at low risk for procedural complications. We prospectively randomized primary prevention ICD candidates at low risk for complications (not pacing-dependent or requiring bridging heparin anticoagulation) to next-day discharge with overnight in-hospital observation, or same-day discharge with remote monitoring for 24 hours after ICD implant. Implants were performed via cephalic vein access, and randomization occurred after 4-hours clinical observation and device interrogation. All patients were followed for a minimum of 6 weeks to assess acute procedural complications. 71 patients comprised the study cohort (mean age 62, 79% male) after 3 were excluded. The most common indication for ICD implant was ischemic cardiomyopathy with ejection fraction ≤35%. Device data obtained through 24-hour remote monitoring was comparable to 4-hour postimplant parameters in same-day discharge patients. No acute complications occurred in same-day discharge patients; 1 next-day discharge patient developed pneumothorax. ICD implantation with same-day discharge is reasonable in patients at low risk for complications. Remote monitoring can be useful in indicating lead-parameter stability during the immediate postoperative period. © 2012 Wiley Periodicals, Inc.

  7. Athletes with Implantable Cardioverter Defibrillators

    PubMed Central

    Ponamgi, Shiva P.; DeSimone, Christopher V.; Ackerman, Michael J.

    2015-01-01

    Summary Athletes with an implantable cardioverter defibrillator (ICD) represent a diverse group of individuals who may be at an increased risk of sudden cardiac death (SCD) when engaging in vigorous physical activity. Therefore, they are excluded by the current guidelines from participating in most competitive sports except those classified as low intensity, such as bowling and golf. The lack of substantial data on the natural history of the cardiac diseases affecting these athletes, as well as the unknown efficacy of implanted ICDs in terminating life-threatening arrhythmias occurring during intense exercise, have resulted in the restrictive nature of these now decade old guidelines. Recently, there is emerging data, derived from a few retrospective studies and a large prospective registry that demonstrates the relative safety of high-risk athletes participating in competitive sports and challenges the prohibitive nature of these guidelines. Nevertheless, the safe participation of all athletes with an ICD in competitive sports continues to be contemplated. The increased number of inappropriate shocks, damage to the ICD/pacemaker system, and the questionable efficacy of the delivered shock in the setting of vigorous physical activity are some of the main challenges faced by these athletes who choose to continue participation in competitive sports. The fear of SCD and ICD shocks faced by these athletes is also associated with a negative psychological burden and affects their quality of life, as does restricting them from all competitive sports. Therefore, shared decision making is necessary between the clinician and athlete after carefully analyzing the risks and benefits associated with competitive sports participation. PMID:26100423

  8. Battery and capacitor technology for uniform charge time in implantable cardioverter-defibrillators

    NASA Astrophysics Data System (ADS)

    Skarstad, Paul M.

    Implantable cardioverter-defibrillators (ICDs) are implantable medical devices designed to treat ventricular fibrillation by administering a high-voltage shock directly to the heart. Minimizing the time a patient remains in fibrillation is an important goal of this therapy. Both batteries and high-voltage capacitors used in these devices can display time-dependency in performance, resulting in significant extension of charge time. Altering the electrode balance in lithium/silver vanadium oxide batteries used to power these devices has minimized time-dependent changes in battery resistance. Charge-interval dependent changes in capacitor cycling efficiency have been minimized for stacked-plate aluminum electrolytic capacitors by a combination of material and processing factors.

  9. Legal aspects of the application of the lay rescuer automatic external defibrillator (AED) program in South Korea.

    PubMed

    Bae, Hyuna

    2008-04-01

    The American Heart Association has stated that the automatic external defibrillator (AED) is a promising method for achieving rapid defibrillation, and emphasized that AED training and use should be available in every community. The demonstrated safety and effectiveness of the AED make it ideally suited for the delivery of early defibrillation by trained laypersons, and the placement of AEDs in selected locations for immediate use by trained laypersons may enable critical intervention that can significantly increase survival from out-of-hospital cardiac arrest. The American Heart Association recommends the installation of AEDs in public locations such as airports, thus allowing laypersons to conduct defibrillation and cardiopulmonary resuscitation on the occasion of adverse cardiopulmonary events. In Korea, the Ministry of Health and Welfare officially prohibits the installation of AEDs in public locations on the grounds that cardiopulmonary resuscitation and defibrillation are understood as medical practices that can be conducted only by licensed medical practitioners. The purpose of this article is to discuss the necessity for AEDs and the appropriate process for their implementation in Korea, by examining the current pre-AED status of Korea and the relevant legal aspects.

  10. T-wave alternans negative coronary patients with low ejection and benefit from defibrillator implantation

    NASA Technical Reports Server (NTRS)

    Hohnloser, S. H.; Ikeda, T.; Bloomfield, D. M.; Dabbous, O. H.; Cohen, R. J.

    2003-01-01

    In a trial of prophylactic implantation of a defibrillator, a mortality benefit was seen among patients with previous myocardial infarction and a left-ventricular ejection fraction of 0.30 or less. We identified 129 similar patients from two previously published clinical trials in which microvolt T-wave alternans testing was prospectively assessed. At 24 months of follow-up, no sudden cardiac death or cardiac arrest was seen among patients who tested T-wave alternans negative, compared with an event rate of 15.6% among the remaining patients. Testing of T-wave alternans seems to identify patients who are at low risk of ventricular tachyarrhythmic event and who may not benefit from defibrillator therapy.

  11. Electromagnetic interference of dental equipment with implantable cardioverter defibrillators.

    PubMed

    Dadalti, Manoela Teixeira de Sant'Anna; da Cunha, Antônio José Ledo Alves; Araújo, Marcos César Pimenta de; Moraes, Luis Gustavo Belo de; Risso, Patrícia de Andrade

    2017-11-01

    Implantable cardioverter defibrillators (ICDs) are subject to electromagnetic interference (EMI). The aim of this study was to assess both the EMI of dental equipments with ICDs and related factors. High- and low-speed handpieces, an electric toothbrush, an implant motor and two types of ultrasonic devices were tested next to an ICD with different sensitivity settings. The ICD was immersed in a saline solution with electrical resistance of 400-800 ohms to simulate the resistance of the human body. The dental equipments were tested in both horizontal (0°) and vertical (90°) positions in relation to the components of the ICD. The tests were performed with a container containing saline solution, which was placed on a dental chair in order to assess the cumulative effect of electromagnetic fields. The dental chair, high- and low-speed handpieces, electric toothbrush, implant motor and ultrasonic devices caused no EMI with the ICD, irrespective of the program set-up or positioning. No cumulative effect of electromagnetic fields was verified. The results of this study suggest that the devices tested are safe for use in patients with an ICD.

  12. Sudden cardiac death: a critical appraisal of the implantable cardioverter defibrillator.

    PubMed

    Rajabali, A; Heist, E K

    2014-04-01

    Approximately 350,000 Americans still die of sudden cardiac death each year. This exceeds the number of patients who die annually from stroke, lung cancer, breast cancer and AIDS combined. This review aims to trace the history of implantable cardioverter defibrillators (ICD) with reference to landmark trials and their influence on the formulation of Medicare guidelines for ICD implantation criteria. This paper will also discuss the cost-effectiveness of ICDs and the quality of life after implantation. The reasons for the disparity between guidelines for implantation and actual clinical practice will be elucidated, with suggestions for improving overall clinical performance. The ICD has been shown to be cost-effective in reducing sudden cardiac death and all-cause mortality. However, the existing recommendations for ICD implantation have yet to translate completely into clinical practice. Barriers to implementation of existing guidelines include knowledge gaps in the referring physician practices, lack of validated screening tools to assess patient candidacy for the device and patient understanding of the need for the device. Future strategies to increase compliance with the existing guidelines and improve clinical performance are areas of potential research focus. © 2013 John Wiley & Sons Ltd.

  13. Perceived support from healthcare professionals, shock anxiety and post-traumatic stress in implantable cardioverter defibrillator recipients.

    PubMed

    Morken, Ingvild M; Bru, Edvin; Norekvål, Tone M; Larsen, Alf I; Idsoe, Thormod; Karlsen, Bjørg

    2014-02-01

    To investigate (1) the extent to which shock anxiety and perceived support from healthcare professionals are related to post-traumatic stress disease (PTSD) symptoms and (2) the extent to which perceived support from healthcare professionals moderates the relationship between shock anxiety and PTSD symptoms in implantable cardioverter defibrillator recipients. An additional aim was to describe the level of PTSD symptoms and perceptions of support from healthcare professionals. Studies examining PTSD symptoms among implantable cardioverter defibrillator recipients are still sparse. In addition, little is known about how perceived support from healthcare professionals is related to PTSD symptoms. Cross-sectional survey design. Recipients (n = 167) with implantable cardioverter defibrillator attending an outpatient device clinic completed questionnaires assessing shock anxiety, PTSD symptoms and perceived support from healthcare professionals. The results indicated that between ten and 15% of the recipients experienced moderate to severe symptoms of PTSD. Although a majority perceived constructive support from healthcare professionals, 12% perceived nonconstructive support. Regression analysis demonstrated that shock anxiety and perceived nonconstructive support from healthcare professionals had a statistically significant (p < 0·01) association with PTSD symptoms. Moreover, the results suggest that associations between shock anxiety and PTSD symptoms were significantly (p < 0·01) moderated by perceived nonconstructive support from healthcare professionals. Young age, short time since implantation and secondary prevention indication were also significantly associated with PTSD symptoms. The results indicate that nonconstructive support from healthcare professionals can increase the tendency to develop PTSD symptoms, particularly in those who experience shock anxiety. Healthcare professionals should pay more attention to the way in which they communicate information

  14. Long-Term Survival With Implantable Cardioverter-Defibrillator in Different Symptomatic Functional Classes of Heart Failure.

    PubMed

    Biton, Yitschak; Rosero, Spencer; Moss, Arthur; Zareba, Wojciech; Kutyifa, Valentina; Baman, Jayson; Barsheshet, Alon; McNitt, Scott; Polonsky, Bronislava; Goldenberg, Ilan

    2018-03-01

    The ACC/AHA/HRS (American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society) guidelines recommend implantable cardioverter-defibrillator (ICD) therapy primary prevention in all patients with severely reduced left ventricular ejection fraction (≤30%) regardless of New York Heart Association (NYHA) functional class, whereas recent European guidelines limit the indication to those with symptomatic heart failure (NYHA ≥ II). We therefore aimed to evaluate the long-term survival benefit of primary ICD therapy among postmyocardial infarction patients with and without heart failure (HF) symptoms who were enrolled in MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II). We classified 1,164 MADIT-II patient groups according to the baseline NYHA class (NYHA I [n = 442], NYHA II [n = 425], and NYHA III [n = 297]); patients with NYHA IV were excluded. Multivariate Cox proportional hazards regression modeling was performed to compare the mortality reduction with ICD versus non-ICD therapy during 8 years of follow-up between the 3 NYHA groups. The median (interquartile range) follow-up time was 7.6 (3.5 to 9) years. At 8 years of follow-up, the cumulative probability of mortality in the non-ICD treatment arm was 57% for NYHA I, 57% for NYHA II, and 76% for NYHA III (p <0.001). Multivariate models demonstrated similar long-term mortality risk reduction with ICD compared with the non-ICD treatment arm regardless of HF symptoms: NYHA I (HR = 0.63, 0.46 to 0.85, p = 0.003), NYHA II (HR = 0.68, 0.50 to 0.93, p = 0.017), and NYHA III (HR = 0.68, 0.50 to 0.94, p = 0.018); p for NYHA class by treatment arm interaction >0.10. In conclusion, primary ICD therapy provides consistent long-term survival benefit among patients with previous myocardial infarction and severe left ventricular dysfunction, regardless of HF symptoms. Copyright © 2017 Elsevier Inc

  15. Infrequent physician use of implantable cardioverter-defibrillators risks patient safety.

    PubMed

    Lyman, Stephen; Sedrakyan, Art; Do, Huong; Razzano, Renee; Mushlin, Alvin I

    2011-10-01

    Implantable cardioverter-defibrillators (ICDs) have diffused rapidly into clinical practice with little evaluation of their real-world effectiveness. To determine the effect of the adoption of ICD on patient safety, particularly with respect to physician volume and early outcomes. Retrospective cohort of all ICD implantations in New York state from 1997 to 2006, with follow-up at 90 days and 1 year. Setting New York state non-federal hospital discharges in which an ICD was implanted during the admission. Patients were followed forward for 1 year for subsequent admissions. Patients New York state residents undergoing ICD implantation. Effects of annual and career ICD implantation volume on 90-day complication, readmission, reprogramming, mortality and revision of the ICD within 1 year. This cohort (N = 38,992) represents a period of rapid adoption and implementation of this new technology, with frequency more than tripling between 1997 and 2006. We identified 6439 (16.5%) post-implantation complications and 1093 (2.8%) deaths within 90 days of implantation. The majority (73.4%) of physicians implanted one or fewer ICDs per year, and 11.0% of all implantations were performed by these very-low-volume operators. Patients treated by very-low-volume operators were more likely to die (RR = 1.8, 95% CI 1.3 to 2.4) or experience cardiac complications (RR = 4.7, 95% CI 3.3 to 6.8) even after the adjustment for case mix compared to operators who frequently performed ICD implantation. These findings suggest a need for safe and effective implementation strategies for new medical technologies, which minimize patient risk due to rapid diffusion among inexperienced providers and assure that the intended benefit can be maximised rapidly.

  16. Diabetes Mellitus and Outcomes of Cardiac Resynchronization With Implantable Cardioverter-Defibrillator Therapy in Older Patients With Heart Failure.

    PubMed

    Echouffo-Tcheugui, Justin B; Masoudi, Frederick A; Bao, Haikun; Spatz, Erica S; Fonarow, Gregg C

    2016-08-01

    Large-scale data on outcomes with cardiac resynchronization therapy with defibrillator in patients with diabetes mellitus are limited. We compared outcomes after cardiac resynchronization therapy with defibrillator implantation among patients with heart failure who have diabetes mellitus versus those without diabetes mellitus. Survival curves and covariate adjusted hazard ratio (HR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by diabetes mellitus status among 18 428 patients at least 65 years old receiving cardiac resynchronization therapy with defibrillator from the National Cardiovascular Data Registry, implantable cardioverter-defibrillator registry between 2006 and 2009, with up to 3 years of follow-up. Accounting for differences between groups, compared with those without diabetes mellitus (n=11 345), patients with diabetes mellitus (n=7083) had a higher risk of death both at 1 year (HR, 1.16 [95% confidence interval (CI), 1.05-1.29]; P=0.0037) and 3 years (HR, 1.21 [1.14-1.29]; P<0.001) after device implantation and higher risks of all-cause readmission (sub-HR, 1.16 [1.11-1.21] at 1 year; P<0.0001; sub-HR, 1.15 [1.11-1.19] at 3 years; P<0.0001) and heart failure-related readmission (sub-HR, 1.18 [1.09-1.28] at 1 year; P<0.0001; and sub-HR, 1.22 [1.15-1.30] at 3 years; P<0.0001). Device-related complications within 90 days did not differ between those with and without diabetes mellitus (odds ratio: 0.90 [0.77-1.06]; P=0.37). Interactions of age, sex, ischemic cardiomyopathy, renal failure, or QRS duration were not significant. In older patients with heart failure receiving cardiac resynchronization therapy with defibrillator, diabetes mellitus was independently associated with greater risks of death and rehospitalization, but similar risks of procedural complications. © 2016 American Heart Association, Inc.

  17. Providers issue brief: automated external defibrillators.

    PubMed

    Rothouse, M

    1999-06-25

    With expanded access to automatic external defibrillators, hundreds of lives could be saved on a daily basis. By training nonphysician providers, such as emergency medical service personnel or first responders, this life-saving medical equipment could help improve the survival rates for people suffering from cardiac arrest. During the last two years, state lawmakers have begun to enact legislation that develops training standards and provides immunity from civil liability for automatic external defibrillator users.

  18. Examination of the Effect of Implantable Cardioverter-Defibrillators on Health-Related Quality of Life

    PubMed Central

    Noyes, Katia; Corona, Ethan; Veazie, Peter; Dick, Andrew W.; Zhao, Hongwei; Moss, Arthur J.

    2015-01-01

    Background While implantable cardioverter-defibrillators (ICDs) improve survival, their benefit in terms of health-related quality of life (HRQOL) is negligible. Objective To examine how shocks and congestive heart failure (CHF) mediate the effect of ICDs on HRQOL. Methods The US patients from the MADIT-II (Multicenter Automatic Defibrillator Trial-II) trial (n = 983) were randomized to receive an ICD or medical treatment only. HRQOL was assessed using the Health Utility Index 3 at baseline and 3, 12, 24, and 36 months following randomization. Logistic regressions were used to test for the effect of ICDs on the CHF indicator, and linear regressions were used to examine the effect of ICD shocks and CHF on HRQOL in living patients. We used a Monte Carlo simulation and a parametric Weibull distribution survival model to test for the effect of selective attrition. Observations were clustered by patients and robust standard errors (RSEs) were used to control for the non-independence of multiple observations provided by the same patient. Results Patients in the ICD arm had 41% higher odds of experiencing CHF since their last assessment compared with those in the control arm (RSE = 0.19, p = 0.01). Developing CHF reduced HRQOL at the subsequent visit by 0.07 (p < 0.01). Having ICD shocks reduced overall HRQOL by 0.04 (p = 0.04) at the subsequent assessment. The negative effect of ICD firing on HRQOL was an order of magnitude greater than the effect of CHF. Conclusions A higher prevalence of CHF and shocks among patients with ICDs and their negative effect on HRQOL may partially explain the lack of HRQOL benefit of ICD therapy. PMID:19929037

  19. Electromagnetic Interference in Implantable Defibrillators in Single-Engine Fixed-Wing Aircraft.

    PubMed

    de Rotte, Alexandra A J; van der Kemp, Peter; Mundy, Peter A; Rienks, Rienk; de Rotte, August A

    2017-01-01

    Little is known about the possible electromagnetic interferences (EMI) in the single-engine fixed-wing aircraft environment with implantable cardio-defibrillators (ICDs). Our hypothesis is that EMI in the cockpit of a single-engine fixed-wing aircraft does not result in erroneous detection of arrhythmias and the subsequent delivery of an inappropriate device therapy. ICD devices of four different manufacturers, incorporated in a thorax phantom, were transported in a Piper Dakota Aircraft with ICAO type designator P28B during several flights. The devices under test were programmed to the most sensitive settings for detection of electromagnetic signals from their environment. After the final flight the devices under test were interrogated with the dedicated programmers in order to analyze the number of tachycardias detected. Cumulative registration time of the devices under test was 11,392 min, with a mean of 2848 min per device. The registration from each one of the devices did not show any detectable "tachycardia" or subsequent inappropriate device therapy. This indicates that no external signals, which could be originating from electromagnetic fields from the aircraft's avionics, were detected by the devices under test. During transport in the cockpit of a single-engine fixed-wing aircraft, the tested ICDs did not show any signs of being affected by electromagnetic fields originating from the avionics of the aircraft. This current study indicates that EMI is not a potential safety issue for transportation of passengers with an ICD implanted in a single-engine fixed-wing aircraft.de Rotte AAJ, van der Kemp P, Mundy PA, Rienks R, de Rotte AA. Electromagnetic interference in implantable defibrillators in single-engine fixed-wing aircraft. Aerosp Med Hum Perform. 2017; 88(1):52-55.

  20. Changes in Implantation Patterns and Therapy Rates of Implantable Cardioverter Defibrillators over Time in Ischemic and Dilated Cardiomyopathy Patients.

    PubMed

    Vandenberk, Bert; Garweg, Christophe; Voros, Gabor; Floré, Vincent; Marynissen, Thomas; Sticherling, Christian; Zabel, Markus; Ector, Joris; Willems, Rik

    2016-08-01

    Clinical guidelines on implantable cardioverter defibrillator (ICD) therapy changed significantly in the last decades with potential inherent effects on therapy efficacy. We aimed to study therapy rates in time and the association between therapies and mortality. All patients receiving an ICD, primary and secondary prevention, were included in a single-center retrospective registry. Information on first appropriate and inappropriate therapies was documented. Dates of implant were divided in P1: 1996-2001, P2: 2002-2008, and P3: 2009-2014. A total of 727 patients, 84.9% male-66.4% ischemic cardiomyopathy (ICM)-56% primary prevention-mean follow-up 5.2 ± 4.1 years, were included. There was a shift from secondary to primary prevention indications, from ischemic to non-ICM, and from single chamber to cardiac resynchronization therapy defibrillator devices. The annual 1- and 3-year appropriate shock (AS) rate declined from 29.4% and 15.1% in P1, over 13.3% and 9.2% in P2 to 7.8% and 5.7% in P3 (log-rank P < 0.001), while inappropriate shock (IAS) rates remained unchanged (log-rank P = 0.635). After multivariate regression analysis a higher age at implant, lower left ventricular ejection fraction, history of stroke, diabetes mellitus, intake of loop diuretics or digitalis, higher creatinine, and longer QTc were independent predictors of mortality. These changes in clinical practice with a shift to primary prevention and rise in non-ICM implants caused a significant decrease in AS incidence, while IAS remained stable. Receiving AS or IAS was not an independent predictor of mortality in our real-life cohort. © 2016 Wiley Periodicals, Inc.

  1. Deactivation of implantable cardioverter defibrillators in terminal illness and end of life care.

    PubMed

    Kirkpatrick, James N; Gottlieb, Maia; Sehgal, Priya; Patel, Rutuke; Verdino, Ralph J

    2012-01-01

    Cardiology professional societies have recommended that patients with cardiovascular implantable electronic devices complete advance directives (ADs). However, physicians rarely discuss end of life handling of implantable cardioverter defibrillators (ICDs), and standard AD forms do not address the presence of ICDs. We conducted a telephone survey of 278 patients with an ICD from a large, academic hospital. The average period since implantation was 5.15 years. More than 1/3 (38%) had been shocked, with a mean of 4.69 shocks. More than 1/2 had executed an AD, but only 3 had included a plan for their ICD. Most subjects (86%) had never considered what to do with their ICD if they had a serious illness and were unlikely to survive. When asked about ICD deactivation in an end of life situation, 42% said it would depend, 28% favored deactivation, and 11% would not deactivate. One quarter (26%) thought ICD deactivation was a form of assisted suicide, 22% thought a do not resuscitate order did not mean that the ICD should be deactivated, and 46% responded that the ICD should not be automatically deactivated in hospice. The answers did not correlate with any demographic factors. Almost all (95%) agreed that patients should have the opportunity to execute an AD that directs handing of an ICD. When asked who should be responsible for discussing this device for an AD, 31% said electrophysiologists, 45% said general cardiologists, and 14% said primary care physicians. In conclusion, the results of the present study highlight the lack of consensus among patients with an ICD on the issue of deactivation at the end of a patient's life. These findings suggest cardiologists should discuss end of life care and device deactivation with their patients with an ICD. Copyright © 2012 Elsevier Inc. All rights reserved.

  2. Using left-ventricular-only pacing to eliminate T-wave oversensing in a biventricular implantable cardiac defibrillator.

    PubMed

    Khoo, Clarence; Bennett, Matthew; Chakrabarti, Santabhanu; LeMaitre, John; Tung, Stanley K K

    2013-02-01

    A man aged 75 years and with nonischemic cardiomyopathy had implantation of a biventricular implantable cardiac defibrillator (ICD). Consistent biventricular pacing was limited by intermittent T-wave oversensing (TWOS). A strategy of left-ventricular-only pacing was used to eliminate TWOS. This strategy obviates the need to reduce ventricular sensitivity and thus may be an effective alternative to biventricular pacing complicated by TWOS. Copyright © 2013 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  3. [Fitness to drive in patients with implanted cardioverter-defibrillator].

    PubMed

    Klein, H H

    2012-09-01

    A physician who takes care for patients with implanted cardioverter-defibrillator (ICD) must inform them about their fitness to drive since these patients carry a higher risk for the occurrence of syncope or sudden cardiac death at the wheel. The driver's license law in Germany does not mention patients with ICD. The fitness to drive of patients with ICD is covered by the Advisory Board for Traffic Medicine in Germany (Bundesanstalt für Straßenwesen). These guidelines, however, are outdated and cannot be used to inform patients. Actually, these guidelines are under revision. Currently, the position paper of the German Society of Cardiology on "Fitness to drive and cardiovascular diseases" together with a recently published Dutch paper on this topic forms the basis of these recommendations. One week after ICD implantation for primary or one month after implantation for secondary prevention the patient may resume to drive. After adequate shocks the fitness to drive can be expected 2-4 months (3 months) later. The assessment of the fitness to drive has to be performed individually, taking into account also possible other influencing factors. In individual cases it appears to be justified that patients with ICD work as professional drivers. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Implantable Cardiac Defibrillator Lead Failure and Management.

    PubMed

    Swerdlow, Charles D; Kalahasty, Gautham; Ellenbogen, Kenneth A

    2016-03-22

    The implantable-cardioverter defibrillator (ICD) lead is the most vulnerable component of the ICD system. Despite advanced engineering design, sophisticated manufacturing techniques, and extensive bench, pre-clinical, and clinical testing, lead failure (LF) remains the Achilles' heel of the ICD system. ICD LF has a broad range of adverse outcomes, ranging from intermittent inappropriate pacing to proarrhythmia leading to patient mortality. ICD LF is often considered in the context of design or construction defects, but is more appropriately considered in the context of the finite service life of a mechanical component placed in chemically stressful environment and subjected to continuous mechanical stresses. This clinical review summarizes LF mechanisms, assessment, and differential diagnosis of LF, including lead diagnostics, recent prominent lead recalls, and management of LF and functioning, but recalled leads. Despite recent advances in lead technology, physicians will likely continue to need to understand how to manage patients with transvenous ICD leads. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Overview of implantable cardioverter defibrillator and cardiac resynchronisation therapy in heart failure management

    PubMed Central

    Chia, Pow-Li; Foo, David

    2016-01-01

    Clinical trials have established the benefits of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) in the treatment of heart failure patients. As adjuncts to guideline-directed medical therapy, ICDs confer mortality benefits from sudden cardiac arrest, while CRT reduces mortality, hospitalisation rates and improves functional capacity. This review discusses the use of ICDs and CRT devices in heart failure management, outlining the evidence supporting their use, indications and contraindications. PMID:27440409

  6. Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool.

    PubMed

    Zeb, Mehmood; Curzen, Nick; Allavatam, Venugopal; Wilson, David; Yue, Arthur; Roberts, Paul; Morgan, John

    2015-09-15

    The sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator (S-ICD) pre-implant screening tool required clinical evaluation. Bipolar vectors were derived from electrodes positioned at locations similar to those employed for S-ICD sensing and pre-implant screening electrodes, and recordings collected through 80-electrode PRIME®-ECGs, in six different postures, from 40 subjects (10 healthy controls, and 30 patients with complex congenital heart disease (CCHD); 10 with Tetralogy of Fallot (TOF), 10 with single ventricle physiology (SVP), and 10 with transposition of great arteries (TGA)). The resulting vectors were analysed using the S-ICD pre-implant screening tool (Boston Scientific) and processed through the sensing algorithm of S-ICD (Boston Scientific). The data were then evaluated using 2 × 2 contingency tables. Fisher exact and McNemar tests were used for a comparison of the different categories of CCHD, and p < 0.05 vs. controls considered to be statistically significant. 57% of patients were male, mean age of 36.3 years. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the S-ICD screening tool were 95%, 79%, 59% and 98%, respectively, for controls, and 84%, 79%, 76% and 86%, respectively, in patients with CCHD (p = 0.0001). The S-ICD screening tool was comparatively more sensitive in normal controls but less specific in both CCHD patients and controls; a possible explanation for the reported high incidence of inappropriate S-ICD shocks. Thus, we propose a pre-implant screening device using the S-ICD sensing algorithm to minimise false exclusion and selection, and hence minimise potentially inappropriate shocks. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Implantable Heart Aid

    NASA Technical Reports Server (NTRS)

    1980-01-01

    Medrad utilized NASA's Apollo technology to develop a new device called the AID implantable automatic pulse generator which monitors the heart continuously, recognizes the onset of ventricular fibrillation and delivers a corrective electrical shock. AID pulse generator is, in effect, a miniaturized version of the defibrillator used by emergency squads and hospitals to restore rhythmic heartbeat after fibrillation, but has the unique advantage of being permanently available to the patient at risk. Once implanted, it needs no specially trained personnel or additional equipment. AID system consists of a microcomputer, a power source and two electrodes which sense heart activity.

  8. The Significance of Shocks in Implantable Cardioverter Defibrillator Recipients

    PubMed Central

    Li, Anthony; Kaura, Amit; Sunderland, Nicholas; Dhillon, Paramdeep S

    2016-01-01

    Large-scale implantable cardioverter defibrillator (ICD) trials have unequivocally shown a reduction in mortality in appropriately selected patients with heart failure and depressed left ventricular function. However, there is a strong association between shocks and increased mortality in ICD recipients. It is unclear if shocks are merely a marker of a more severe cardiovascular disease or directly contribute to the increase in mortality. The aim of this review is to examine the relationship between ICD shocks and mortality, and explore possible mechanisms. Data examining the effect of shocks in the absence of spontaneous arrhythmias as well as studies of non-shock therapy and strategies to reduce shocks are analysed to try and disentangle the shocks versus substrate debate. PMID:27617089

  9. Tricuspid regurgitation in patients with pacemakers and implantable cardiac defibrillators: a comprehensive review.

    PubMed

    Al-Bawardy, Rasha; Krishnaswamy, Amar; Bhargava, Mandeep; Dunn, Justin; Wazni, Oussama; Tuzcu, E Murat; Stewart, William; Kapadia, Samir R

    2013-05-01

    Implantable cardiac devices, including defibrillators and pacemakers, may be the cause of tricuspid regurgitation (TR) or may worsen existing TR. This review of the literature suggests that TR usually occurs over time after lead implantation. Diagnosis by clinical exam and 2-dimensional echocardiography may be augmented by 3-dimensional echocardiography and/or computed tomography. The mechanism may be mechanical perforation or laceration of leaflets, scarring and restriction of leaflets, or asynchronized activation of the right ventricle. Pacemaker-related TR might cause severe right-sided heart failure, but data regarding associated mortality are lacking. This comprehensive review summarizes the data regarding incidence, mechanism, and treatment of lead-related TR. © 2013 Wiley Periodicals, Inc.

  10. The role of the wearable cardioverter defibrillator in clinical practice.

    PubMed

    Chung, Mina K

    2014-05-01

    The wearable cardioverter defibrillator (WCD) is an option for external monitoring and defibrillation in patients at risk for sudden cardiac arrest caused by ventricular tachycardia or ventricular fibrillation and who are not candidates for or who refuse an implantable cardioverter defibrillator (ICD). WCDs provide monitoring with backup defibrillation protection. WCDs have been used when a patient's condition delays or prohibits ICD implantation, or as a bridge when an indicated ICD must be explanted. WCDs are used for primary prevention of sudden cardiac death during high-risk gap periods early after myocardial infarction, coronary revascularization, or new diagnosis of heart failure. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.

    PubMed

    Zabel, Markus; Müller-Riemenschneider, Falk; Geller, J Christoph; Brachmann, Johannes; Kühlkamp, Volker; Dissmann, Rüdiger; Reinhold, Thomas; Roll, Stephanie; Lüthje, Lars; Bode, Frank; Eckardt, Lars; Willich, Stefan N

    2014-10-01

    Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM. Copyright © 2014 Mosby, Inc. All rights reserved.

  12. Expenditure and value for money: the challenge of implantable cardioverter defibrillators.

    PubMed

    Boriani, G; Biffi, M; Martignani, C; Diemberger, I; Valzania, C; Bertini, M; Branzi, A

    2009-05-01

    Many technology-driven interventions entail considerable financial cost, raising affordability issues. The implantable cardioverter defibrillator (ICD) is a case of an effective primary prevention intervention with high initial costs that is capable of delivering long-term population benefits. At first glance, such interventions may provoke diffidence, if not active resistance, due to the financial burdens which inevitably accompany their widespread adoption. In this article, we review the available economic tools that can help address the ICD cost issue. We think awareness of such knowledge may facilitate dialogues between physicians, administrators and policymakers, and help foster rational decision-making.

  13. Effects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy.

    PubMed

    Perini, Alessandro Paoletti; Kutyifa, Valentina; Veazie, Peter; Daubert, James P; Schuger, Claudio; Zareba, Wojciech; McNitt, Scott; Rosero, Spencer; Tompkins, Christine; Padeletti, Luigi; Moss, Arthur J

    2017-07-01

    Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood. We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) (n=1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0-1 vs ≥2) and adjusted for covariates. In MADIT-RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock-related anxiety than those with ≤1 appropriate shock (P<.01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P=.005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P=.028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P=.997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05). In MADIT-RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by the EQ-5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Inappropriate Implantable Cardioverter-Defibrillator Shocks Attributed to Alternating-Current Leak in a Swimming Pool

    PubMed Central

    Makaryus, John N.; Angert-Gilman, Julia; Yacoub, Mena; Patel, Apoor

    2014-01-01

    Implantable cardioverter-defibrillators (ICDs) are the standard of care for preventing sudden cardiac death in patients who are predisposed to malignant ventricular arrhythmias. Causes of inappropriate ICD shock include equipment malfunction, improper arrhythmia evaluation, misinterpretation of myopotentials, and electromagnetic interference. As the number of implanted ICDs has increased, other contributors to inappropriate therapy have become known, such as minimal electrical current leaks that mimic ventricular fibrillation. We present the case of a 63-year-old man with a biventricular ICD who received 2 inappropriate shocks, probably attributable to alternating-current leaks in a swimming pool. In addition, we discuss ICD sensitivity and offer recommendations to avoid similar occurrences. PMID:24512403

  15. Epicardial cardioverter-defibrillator implantation in a 4-month-old infant bridged to heart transplantation.

    PubMed

    Carro, Cristina; Cereda, Alberto Francesco; Annoni, Giuseppe; Marianeschi, Stefano Maria

    2017-11-01

    Implantable cardioverter-defibrillator (ICD) is the gold standard therapy for the prevention of sudden cardiac death. Nevertheless, ICD placement in the paediatric population is still limited because of several technical difficulties. Several implantation techniques have been proposed but experience in infants with very low weight and less than 6 months is very limited. We herein describe a case of a minimally invasive ICD epicardial implantation in a 4-month-old infant weighing 5 kg. A diagnosis of arrhythmic cardiomyopathy with left ventricular non-compaction disease with ventricular tachycardia storms, QT prolongation and Wolff-Parkinson-White pattern was made. Antiarrhythmic drugs, radiofrequency ablation and sympathetic denervation were not effective. ICD implantation was successful allowing the infant to survive and bridging to heart transplantation. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  16. Decision-Making Experiences of Patients with Implantable Cardioverter Defibrillators.

    PubMed

    Green, Ariel R; Jenkins, Amy; Masoudi, Frederick A; Magid, David J; Kutner, Jean S; Leff, Bruce; Matlock, Daniel D

    2016-10-01

    When patients are not adequately engaged in decision making, they may be at risk of decision regret. Our objective was to explore patients' perceptions of their decision-making experiences related to implantable cardioverter defibrillators (ICDs). Cross-sectional, mailed survey of 412 patients who received an ICD without cardiac resynchronization therapy for any indication between 2006 and 2009. Patients were asked about decision participation and decision regret. A total of 295 patients with ICDs responded (72% response rate). Overall, 79% reported that they were as involved in the decision as they wanted. However, 28% reported that they were not told of the option of not getting an ICD and 37% did not remember being asked if they wanted an ICD. In total, 19% reported not wanting their ICD at the time of implantation. Those who did not want the ICD were younger (<65 years; 74% vs 43%, P < 0.001), had higher decision regret (31/100 vs 11/100, P < 0.001), and reported less participation in decision making (the doctor "totally" made the decision, 9% vs 3%; P < 0.001). A considerable number of ICD recipients recalled not wanting their ICD at the time of implantation. While these findings may be prone to recall bias, they likely identify opportunities to improve ICD decision making. © 2016 Wiley Periodicals, Inc.

  17. The oral cavity is not a primary source for implantable pacemaker or cardioverter defibrillator infections

    PubMed Central

    2013-01-01

    Background To test the hypothesis that the oral cavity is a potential source for implantable pacemaker and cardioverter defibrillators infections, the bacterial diversity on explanted rhythm heart management devices was investigated and compared to the oral microbiome. Methods A metagenomic approach was used to analyze the bacterial diversity on the surfaces of non-infected and infected pacemakers. The DNA from surfaces swaps of 24 non-infected and 23 infected pacemaker were isolated and subjected to bacterial-specific DNA amplification, single strand conformation polymorphism- (SSCP) and sequencing analysis. Species-specific primer sets were used to analyze for any correlation between bacterial diversity on pacemakers and in the oral cavity. Results DNA of bacterial origin was detected in 21 cases on infected pacemakers and assigned to the bacterial phylotypes Staphylococcus epidermidis, Propionibacterium acnes, Staphylococcus aureus, Staphylococcus schleiferi and Stapyhlococcus. In 17 cases bacterial DNA was found on pacemakers with no clinical signs of infections. On the basis of the obtained sequence data, the phylotypes Propionibacterium acnes, Staphylococcus and an uncultured bacterium were identified. Propionibacterium acnes and Staphylococcus epidermidis were the only bacteria detected in pacemeaker (n = 25) and oral samples (n = 11). Conclusions The frequency of the coincidental detection of bacteria on infected devices and in the oral cavity is low and the detected bacteria are highly abundant colonizers of non-oral human niches. The transmission of oral bacteria to the lead or device of implantable pacemaker or cardioverter defibrillators is unlikely relevant for the pathogenesis of pacemaker or cardioverter defibrillators infections. PMID:23575037

  18. Anesthesia for subcutaneous implantable cardioverter-defibrillator implantation: Perspectives from the clinical experience of a US panel of physicians.

    PubMed

    Essandoh, Michael K; Mark, George E; Aasbo, Johan D; Joyner, Charles A; Sharma, Saumya; Decena, Beningo F; Bolin, Eric D; Weiss, Raul; Burke, Martin C; McClernon, Timothy R; Daoud, Emile G; Gold, Michael R

    2018-05-13

    Worldwide adoption of the subcutaneous implantable cardioverter-defibrillator (S-ICD) for preventing sudden cardiac death continues to increase, as longer-term evidence demonstrating the safety and efficacy of the S-ICD expands. As a relatively new technology, comprehensive anesthesia guidance for the management of patients undergoing S-ICD placement is lacking. This article presents advantages and disadvantages of different peri-procedural sedation and anesthesia options for S-ICD implants including general anesthesia, monitored anesthesia care, regional anesthesia, and nonanesthesia personnel administered sedation and analgesia. Guidance, for approaches to anesthesia care during S-ICD implantation, are presented based upon literature review and consensus of a panel of high volume S-ICD implanters, a regional anesthesiologist, and a cardiothoracic anesthesiologist with significant S-ICD experience. The panel developed suggested actions for perioperative sedation, anesthesia, surgical practices and a decision algorithm for S-ICD implantation. While S-ICD implantation currently requires higher sedation than transvenous ICD systems, the panel consensus is that general anesthesia is not required or is obligatory for the majority of patients for the experienced S-ICD implanter. The focus of the implanting physician and the anesthesia services should be to maximize patient comfort and take into consideration patient specific co-morbidities, with a low threshold to consult the anesthesiology team. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  19. Incidence and management of prolonged charge times in the Medtronic model 7219 implantable cardioverter defibrillator.

    PubMed

    Mann, D E; Gleason, S A; Kelly, P A; Easley, A R; Reiter, M J

    2001-06-01

    The Medtronic Jewel PCD model 7219, introduced in 1994, was the first downsized, pectoral implantable cardioverter defibrillator (ICD), and many of these units are approaching or have reached the elective replacement indicator (ERI). Unlike later Medtronic ICDs and most other ICDs, in which ERI is defined by battery voltage, the ERI in the model 7219 series is defined when either the capacitor charge time to full output is repeatedly> or =14.5 s or when battery voltage is< or =4.91 V. In this study we examined which of the two ERI criteria was met first in patients with this device model. We also assessed the effects of manual dumping and recharging and of increasing the automatic capacitor reformation frequency on prolonged charge times. In 16 patients with follow-up <2 years, 15 reached the charge time ERI before battery voltage ERI. Manual dumping and recharging led to spuriously low charge times due to residual charge at the start of recharging, and increasing the automatic capacitor reformation frequency to once a month did not decrease prolonged charge times. Because of persistently prolonged charge times, 15 patients had generator changes. None of these patients had reached battery voltage ERI (battery voltage at time of explantation 5.06+/-0.06 V). Thus in this early pectoral device, prolonged charge times occur commonly before battery voltage ERI is reached. Whether prolonged charge times will have an impact on device longevity in later model ICDs is unknown.

  20. Implantable cardioverter-defibrillators in adults with congenital heart disease: a systematic review and meta-analysis

    PubMed Central

    Vehmeijer, Jim T.; Brouwer, Tom F.; Limpens, Jacqueline; Knops, Reinoud E.; Bouma, Berto J.; Mulder, Barbara J.M.; de Groot, Joris R.

    2016-01-01

    Aims Sudden cardiac death is a major cause of mortality in adult congenital heart disease (ACHD) patients. The indications for implantable cardioverter-defibrillator (ICD) implantation in ACHD patients are still not well established. We aim to systematically review the literature on indications and outcome of ICD implantation in ACHD patients. Methods and results We performed a comprehensive search in EMBASE, MEDLINE, and Google Scholar to identify all studies on ICD implantation in ACHD patients. We used random effects models to calculate proportions and 95% confidence intervals. Of 1356 articles, 24 studies with 2162 patients were included, with a mean follow-up of 3.6 ± 0.9 years. Half of patients had tetralogy of Fallot. Mean age at implantation was 36.5 ± 5.5 years old and 66% was male. Implantable cardioverter-defibrillators were implanted for primary prevention in 53% (43.5–62.7). Overall, 24% (18.6–31.3) of patients received one or more appropriate ICD interventions (anti-tachycardia pacing or shocks) during 3.7 ± 0.9 years: 22% (16.9–28.8) of patients with primary prevention in 3.3 ± 0.3 years and 35% (26.6–45.2) of patients with secondary prevention in 4.3 ± 1.2 years. Inappropriate shocks occurred in 25% (20.1–31.0) in 3.7 ± 0.8 years and other, particularly lead-related complications in 26% (18.9–33.6) of patients in 3.8 ± 0.8 years. All-cause mortality was 10% during 3.7 ± 0.9 years. Conclusions In ACHD, remarkably high rates of appropriate ICD therapy were reported, both in primary and secondary prevention. Because of the young age and lower death rates, the cumulative beneficial effects are likely greater in ACHD patients than in acquired heart disease patients. However, considering the high rates of inappropriate shocks and complications, case-by-case weighing of costs and benefits, remains essential. PMID:26873095

  1. Performance of dedicated versus integrated bipolar defibrillator leads with CRT-defibrillators: results from a Prospective Multicenter Study.

    PubMed

    Freedman, Roger A; Petrakian, Alex; Boyce, Ker; Haffajee, Charles; Val-Mejias, Jesus E; Oza, Ashish L

    2009-02-01

    Right ventricular (RV) anodal stimulation may occur in cardiac resynchronization therapy defibrillators (CRT-D) when left ventricular (LV) pacing is configured between the LV lead and an electrode on the RV defibrillator lead. RV defibrillator leads can have a dedicated proximal pacing ring electrode (dedicated bipolar) or utilize the distal shocking coil as the proximal pacing electrode (integrated bipolar). This study compares the performance of integrated versus dedicated leads with respect to anodal stimulation incidence, sensing, and inappropriate ventricular tachyarrhythmia detection in patients implanted with CRT-D. Two hundred ninety-two patients were randomly assigned to receive dedicated or integrated bipolar RV leads at the time of CRT-D implantation. Patients were followed for 6 months. Patients with dedicated bipolar RV leads exhibited markedly higher rates of anodal stimulation than did patients with integrated leads. The incidence of anodal stimulation was 64% at implant for dedicated bipolar RV leads compared to 1% for integrated bipolar RV leads. The likelihood of anodal stimulation in patients with dedicated leads fell progressively during the 6-month follow-up (51.5%), but always exceeded the incidence of anodal stimulation in patients with integrated leads (5%). Clinically detectable undersensing and oversensing were very unusual and did not differ significantly between lead designs. There were no inappropriate ventricular tachyarrhythmia detections for either lead type. Integrated bipolar RV defibrillator leads had a significantly lower incidence of RV anodal stimulation when compared to dedicated bipolar RV defibrillation leads, with no clinically detectable oversensing or undersensing, and with no inappropriate ventricular tachyarrhythmia detections for either lead type.

  2. Prophylactic Catheter Ablation for the Prevention of Defibrillator Therapy

    PubMed Central

    Reddy, Vivek Y.; Reynolds, Matthew R.; Neuzil, Petr; Richardson, Allison W.; Taborsky, Milos; Jongnarangsin, Krit; Kralovec, Stepan; Sediva, Lucie; Ruskin, Jeremy N.; Josephson, Mark E.

    2008-01-01

    BACKGROUND For patients who have a ventricular tachyarrhythmic event, implantable cardioverter–defibrillators (ICDs) are a mainstay of therapy to prevent sudden death. However, ICD shocks are painful, can result in clinical depression, and do not offer complete protection against death from arrhythmia. We designed this randomized trial to examine whether prophylactic radiofrequency catheter ablation of arrhythmogenic ventricular tissue would reduce the incidence of ICD therapy. METHODS Eligible patients with a history of a myocardial infarction underwent defibrillator implantation for spontaneous ventricular tachycardia or fibrillation. The patients did not receive antiarrhythmic drugs. Patients were randomly assigned to defibrillator implantation alone or defibrillator implantation with adjunctive catheter ablation (64 patients in each group). Ablation was performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point was survival free from any appropriate ICD therapy. RESULTS The mortality rate 30 days after ablation was zero, and there were no significant changes in ventricular function or functional class during the mean (±SD) follow-up period of 22.5±5.5 months. Twenty-one patients assigned to defibrillator implantation alone (33%) and eight patients assigned to defibrillator implantation plus ablation (12%) received appropriate ICD therapy (antitachycardia pacing or shocks) (hazard ratio in the ablation group, 0.35; 95% confidence interval, 0.15 to 0.78, P = 0.007). Among these patients, 20 in the control group (31%) and 6 in the ablation group (9%) received shocks (P = 0.003). Mortality was not increased in the group assigned to ablation as compared with the control group (9% vs. 17%, P = 0.29). CONCLUSIONS In this randomized trial, prophylactic substrate-based catheter ablation reduced the incidence of ICD therapy in patients with a

  3. Pre-discharge defibrillation testing: Is it still justified?

    PubMed

    Kempa, Maciej; Królak, Tomasz; Drelich, Łukasz; Budrejko, Szymon; Daniłowicz-Szymanowicz, Ludmiła; Lewicka, Ewa; Kozłowski, Dariusz; Raczak, Grzegorz

    2016-01-01

    An implantable cardioverter-defibrillator (ICD) is routinely used to prevent sudden cardiac death. Since the introduction of that device into clinical practice, a defibrillation test (the so-called pre-discharge test [PDT]) has been an inseparable part of the ICD implantation procedure. Recently, the usefulness of PDT has been called into question. The aim of this research was to analyze ICD tests performed within two time periods: in years 1995-2001 (period I) and 2007-2010 (period II), in order to compare the results of tests and solutions to all the problems with ICD systems revealed by means of PDT. During period I, 193 tests were performed, among which the ICD system malfunction was observed in 16 cases. Those included: sensing issues, specifically R-wave undersensing during ventricular fibrillation (VF) (7 patients) and T-wave oversensing (4 patients), as well as high defibrillation threshold (DFT) (2 patients) and ICD-pacemaker interaction (3 patients). During period II, among 561 tests, system malfunction was observed in 15 cases. In 1 patient it was VF undersensing, and in the remaining 14 it was high DFT. All the above problems were solved by means of appropriate ICD reprogramming, repositioning of the endocardial defibrillation lead or implantation of an additional subcutaneous defibrillation lead. Contemporary ICD technical solutions, compared to older systems, in most cases allow to avoid sensing problems. The key rationale behind ICD testing is the ability to confirm the efficacy of high-voltage therapy. Despite the increasing maximal defibrillation out-put of devices, and all possible adjustments to the characteristics of the impulse, there is still a group of patients that require additional procedures to ensure the appropriate defibrillation efficacy.

  4. Posttraumatic stress symptoms and predicted mortality in patients with implantable cardioverter-defibrillators: results from the prospective living with an implanted cardioverter-defibrillator study.

    PubMed

    Ladwig, Karl-Heinz; Baumert, Jens; Marten-Mittag, Birgitt; Kolb, Christof; Zrenner, Bernhard; Schmitt, Claus

    2008-11-01

    Cardiac disease and treatment with an implantable cardioverter-defibrillator (ICD) may be psychologically traumatic. Posttraumatic stress disorder (PTSD) is generally overlooked in cardiac patients, and no study to date (to our knowledge) has evaluated the effect of PTSD symptoms on the prognosis in patients with ICDs. To test whether PTSD symptoms at baseline predict long-term mortality risk in patients with ICDs. Prospective cohort study with a mean follow-up period of 5.1 years, accounting for 743 person-years observed. Data were derived from the Living With an Implanted Cardioverter-Defibrillator-Study, which initially included 211 patients with ICDs routinely attending the German Heart Center Munich outpatient clinic. The Impact of Event Scale-Revised was used in 147 patients (125 men and 22 women) who qualified for the "A" criterion of PTSD (survival of a life-threatening event). Thirty-eight patients scoring in the upper quartile of the scale constituted the PTSD index group. Mortality risk per 1000 person-years as assessed by Cox proportional hazards regression analysis based on an appropriate model fit (area under the curve, >0.80). Index patients experienced more anxiety and depression, had more cardiac symptoms, but showed no differences in left ventricular ejection fraction status or extent of ICD discharges compared with non-index patients. Forty-five patients (30.6%) died during the follow-up period. The relative mortality risk (multivariate adjusted for age, sex, diabetes mellitus, left ventricular ejection fraction, beta-blocker prescription, prior resuscitation, ICD shocks received, depression, and anxiety) hazard ratio was 3.45 (95% confidence interval, 1.57-7.60; P = .002) for the PTSD group. Compared with 55 fatal events per 1000 person-years in patients without PTSD, the long-term absolute mortality risk accounted for 80 fatal events per 1000 person-years in patients with PTSD. The adverse effect of PTSD symptoms on the long-term mortality risk

  5. Internal defibrillation: where we have been and where we should be going?

    PubMed

    Lévy, Samuel

    2005-08-01

    Internal cardioversion has been developed as an alternative technique for patients who are resistant to external DC cardioversion of atrial fibrillation (AF) and was found to be associated with higher success rates. It used initially high energies (200-300 J) delivered between an intracardiac catheter and a backplate. Subsequent studies have shown that it is possible to terminate with energies of 1 to 6 Joules, paroxysmal or induced AF in 90 percent of patients and persistent AF in 75 percent of patients, using biphasic shocks delivered between a right atrium-coronary sinus vectors. Consequently, internal atrial defibrillation can be performed under sedation only without the need for general anesthesia. Recently developed external defibrillators, capable of delivering biphasic shocks, have increased the success rates of external cardioversion and reduced the need for internal cardioversion. However, internal defibrillation is still useful in overweight or obese patients, in patients with chronic obstructive pulmonary disease or asthma who are more difficult to defibrillate, and in patients with implanted devices which may be injured by high energy shocks. Low energy internal defibrillation has also proven to be safe and this has prompted the development of implantable devices for terminating AF. The first device used was the Metrix system, a stand-alone atrial defibrillator (without ventricular defibrillation) which was found to be safe and effective in selected groups of patients. Unfortunately, this device is no longer being marketed. Only double chamber defibrillators with pacing capabilities are presently available: the Medtronic GEM III AT, an updated version of the Jewel AF and the Guidant PRIZM AVT. These devices can be patient-activated or programmed to deliver automatically ounce atrial tachyarrhythmias are detected, therapies including pacing or/and shocks. Attempts to define the group of patients who might benefit from these devices are described but the

  6. "Pseudo" Faraday cage: a solution for telemetry link interaction between a left ventricular assist device and an implantable cardioverter defibrillator.

    PubMed

    Jacob, Sony; Cherian, Prasad K; Ghumman, Waqas S; Das, Mithilesh K

    2010-09-01

    Patients implanted with left ventricular assist devices (LVAD) may have implantable cardioverter defibrillators (ICD) implanted for sudden cardiac death prevention. This opens the possibility of device-device communication interactions and thus interferences. We present a case of such interaction that led to ICD communication failure following the activation of an LVAD. In this paper, we describe a practical solution to circumvent the communication interference and review the communication links of ICDs and possible mechanisms of ICD-LVAD interactions.

  7. Phone-Delivered Mindfulness Training for Patients with Implantable Cardioverter Defibrillators: Results of a Pilot Randomized Controlled Trial

    PubMed Central

    Salmoirago-Blotcher, Elena; Crawford, Sybil L.; Carmody, James; Rosenthal, Lawrence; Yeh, Gloria; Stanley, Mary; Rose, Karen; Browning, Clifford; Ockene, Ira S.

    2013-01-01

    Background The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. Purpose To determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. Methods Clinically stable outpatients were randomized to a mindfulness intervention (8 weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness; and multivariate linear regression to estimate the intervention effect on pre-post intervention changes in these variables. Results We enrolled 45 patients (23 mindfulness, 22 control; age 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = .04) and anxiety (beta = − 1.15; p = .059) improved in the mindfulness group. Conclusions Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients. PMID:23605175

  8. The learning curve associated with the introduction of the subcutaneous implantable defibrillator.

    PubMed

    Knops, Reinoud E; Brouwer, Tom F; Barr, Craig S; Theuns, Dominic A; Boersma, Lucas; Weiss, Raul; Neuzil, Petr; Scholten, Marcoen; Lambiase, Pier D; Leon, Angel R; Hood, Margaret; Jones, Paul W; Wold, Nicholas; Grace, Andrew A; Olde Nordkamp, Louise R A; Burke, Martin C

    2016-07-01

    The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

  9. Extended charge banking model of dual path shocks for implantable cardioverter defibrillators

    PubMed Central

    Dosdall, Derek J; Sweeney, James D

    2008-01-01

    Background Single path defibrillation shock methods have been improved through the use of the Charge Banking Model of defibrillation, which predicts the response of the heart to shocks as a simple resistor-capacitor (RC) circuit. While dual path defibrillation configurations have significantly reduced defibrillation thresholds, improvements to dual path defibrillation techniques have been limited to experimental observations without a practical model to aid in improving dual path defibrillation techniques. Methods The Charge Banking Model has been extended into a new Extended Charge Banking Model of defibrillation that represents small sections of the heart as separate RC circuits, uses a weighting factor based on published defibrillation shock field gradient measures, and implements a critical mass criteria to predict the relative efficacy of single and dual path defibrillation shocks. Results The new model reproduced the results from several published experimental protocols that demonstrated the relative efficacy of dual path defibrillation shocks. The model predicts that time between phases or pulses of dual path defibrillation shock configurations should be minimized to maximize shock efficacy. Discussion Through this approach the Extended Charge Banking Model predictions may be used to improve dual path and multi-pulse defibrillation techniques, which have been shown experimentally to lower defibrillation thresholds substantially. The new model may be a useful tool to help in further improving dual path and multiple pulse defibrillation techniques by predicting optimal pulse durations and shock timing parameters. PMID:18673561

  10. Implanted Cardiac Defibrillator Care in Radiation Oncology Patient Population

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gelblum, Daphna Y.; Amols, Howard

    2009-04-01

    Purpose: To review the experience of a large cancer center with radiotherapy (RT) patients bearing implantable cardiac defibrillators (ICDs) to propose some preliminary care guidelines as we learn more about the devices and their interaction with the therapeutic radiation environment. Methods and Materials: We collected data on patients with implanted ICDs treated with RT during a 2.5-year period at any of the five Memorial Sloan-Kettering clinical campuses. Information regarding the model, location, and dose detected from the device, as well as the treatment fields, fraction size, and treatment energy was collected. During this time, a new management policy for thesemore » patients had been implemented requiring treatment with low-energy beams (6 MV) and close surveillance of the patients in partnership with their electrophysiologist, as they received RT. Results: During the study period, 33 patients were treated with an ICD in place. One patient experienced a default of the device to its initial factory setting that was detected by the patient hearing an auditory signal from the device. This patient had initially been treated with a 15-MV beam. After this episode, his treatment was replanned to be completed with 6-MV photons, and he experienced no further events. Conclusion: Patients with ICDs and other implanted computer-controlled devices will be encountered more frequently in the RT department, and proper management is important. We present a policy for the safe treatment of these patients in the radiation oncology environment.« less

  11. Inappropriate Implantable Cardioverter-Defibrillator Shock from QRS Double Counting in the Setting of Hyperkalemia.

    PubMed

    Dadlani, Akash; Dukes, Jonathan W; Badhwar, Nitish

    2016-03-01

    This case shows the complexity of arrhythmia management in patients with implantable cardioverter-defibrillators (ICDs) who present with hyperkalemia. In order to prevent inappropriate ICD shock, consideration should be given to the suspension of ICD therapies while intensive care treatment of extreme electrolyte derangements is being pursued. Patients in these setting should be closely monitored until their electrocardiograms have normalized, after which the device can safely be reactivated. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Effectiveness of automated external defibrillators in high schools in greater Boston.

    PubMed

    England, Hannah; Hoffman, Caitlin; Hodgman, Thomas; Singh, Sushil; Homoud, Munther; Weinstock, Jonathan; Link, Mark; Estes, N A Mark

    2005-06-15

    A program using a strategy of donating a single automatic external defibrillator to 35 schools in the Boston area resulted in compliance with American Heart Association guidelines on automatic external defibrillator placement and training and 2 successful resuscitations from sudden cardiac arrest. Participating schools indicated a high degree of satisfaction with the program.

  13. The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not?

    PubMed

    Botto, Giovanni Luca; Forleo, Giovanni B; Capucci, Alessandro; Solimene, Francesco; Vado, Antonello; Bertero, Giovanni; Palmisano, Pietro; Pisanò, Ennio; Rapacciuolo, Antonio; Infusino, Tommaso; Vicentini, Alessandro; Viscusi, Miguel; Ferrari, Paola; Talarico, Antonello; Russo, Giovanni; Boriani, Giuseppe; Padeletti, Luigi; Lovecchio, Mariolina; Valsecchi, Sergio; D'Onofrio, Antonio

    2017-11-01

    A recommendation for a subcutaneous-implantable cardioverter-defibrillator (S-ICD) has been added to recent European Society of Cardiology Guidelines. However, the S-ICD is not ideally suitable for patients who need pacing. The aim of this survey was to analyse the current practice of ICD implantation and to evaluate the actual suitability of S-ICD. The survey 'S-ICD Why Not?' was an independent initiative taken by the Italian Heart Rhythm Society (AIAC). Clinical characteristics, selection criteria, and factors guiding the choice of ICD type were collected in consecutive patients who underwent ICD implantation in 33 Italian centres from September to December 2015. A cardiac resynchronization therapy (CRT) device was implanted in 39% (369 of 947) of patients undergoing de novo ICD implantation. An S-ICD was implanted in 12% of patients with no CRT indication (62 of 510 with available data). S-ICD patients were younger than patients who received transvenous ICD, more often had channelopathies, and more frequently received their device for secondary prevention of sudden death. More frequently, the clinical reason for preferring a transvenous ICD over an S-ICD was the need for pacing (45%) or for antitachycardia pacing (36%). Nonetheless, only 7% of patients fulfilled conditions for recommending permanent pacing, and 4% of patients had a history of monomorphic ventricular tachycardia that might have been treatable with antitachycardia pacing. The vast majority of patients needing ICD therapy are suitable candidates for S-ICD implantation. Nevertheless, it currently seems to be preferentially adopted for secondary prevention of sudden death in young patients with channelopathies. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  14. Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing.

    PubMed

    Healey, Jeff S; Dorian, Paul; Mitchell, L Brent; Talajic, Mario; Philippon, Francois; Simpson, Chris; Yee, Raymond; Morillo, Carlos A; Lamy, Andre; Basta, Magdy; Birnie, David H; Wang, Xiaoyin; Nair, Girish M; Crystal, Eugene; Kerr, Charles R; Connolly, Stuart J

    2010-02-01

    There is uncertainty about the proper role of defibrillation testing (DT) at the time of implantable cardioverter defibrillator (ICD) insertion. A prospective registry was conducted at 13 sites in Canada between January 2006 and October 2007. To document the details of DT, the reasons for not conducting DT, and the costs and complications associated with DT. DT was conducted at implantation in 230 of 361 patients (64%). DT was more likely to be conducted for new implants compared with impulse generator replacements (71% vs 32%, P = 0.0001), but was similar for primary and secondary prevention indications (64% vs 63%, P = NS). Among patients not having DT, the reason(s) given were: considered unnecessary (44%); considered unsafe, mainly due to persistent atrial fibrillation (37%); lack of an anesthetist (20%); and, patient or physician preference (6%). When performed, DT consisted of a single successful shock > or = 10J below maximum device output in 65% of cases. A 10J safety-margin was met by 97% of patients, requiring system modification in 2.3%. Major perioperative complications occurred in 4.4% of patients having DT versus 6.6% of patients not having DT (P = NS). ICD insertion was $844 more expensive for patients having DT (P = 0.16), largely due to increased costs ($28,017 vs $24,545) among patients having impulse generator replacement (P = 0.02). DT was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.

  15. The potential role for automatic external defibrillators in palliative care units.

    PubMed

    Thorns, Andrew; Gannon, Craig

    2003-07-01

    Cardiopulmonary resuscitation (CPR) has received frequent attention by professionals and the public in recent times. Concerns regarding the potential harms for little chance of success have caused palliative care units (PCUs) doubts about initiating CPR. However, there appears to be a moral responsibility to offer CPR to some, carefully selected, patients. Automatic external defibrillators (AEDs) have been shown to significantly increase chances of survival following CPR and are simple to use, even for non-professionals. It is argued that AEDs may increase the moral imperative on PCUs to offer CPR to certain patients and provide the basis for a necessary debate on where the border between appropriate active treatment and a disturbance to the aim of a peaceful death rests.

  16. Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators in Medicare Patients.

    PubMed

    Zusterzeel, Robbert; Caños, Daniel A; Sanders, William E; Silverman, Henry; MaCurdy, Thomas E; Worrall, Christopher M; Kelman, Jeffrey; Marinac-Dabic, Danica; Strauss, David G

    2015-07-01

    Previous analyses have shown that there is lower mortality with cardiac resynchronization therapy defibrillators (CRT-D) in patients with left bundle branch block (LBBB) but demonstrated mixed results in patients without LBBB. We evaluated the comparative effectiveness of CRT-D versus standard implantable defibrillators (ICDs) separately in patients with LBBB and right bundle branch block (RBBB) using Medicare claims data. Medicare records from CRT-D and ICD recipients from 2002 to 2009 that were followed up for up to 48 months were analyzed. We used propensity scores to match patients with ICD to those with CRT-D. In LBBB, 1:1 matching with replacement resulted in 54,218 patients with CRT-D and 20,763 with ICD, and in RBBB, 1:1 matching resulted in 7,298 patients with CRT-D and 7,298 with ICD. In LBBB, CRT-D had a 12% lower risk of heart failure hospitalization or death (hazard ratio [HR] 0.88, 95% confidence interval 0.86 to 0.90) and 5% lower death risk (HR 0.95, 0.92 to 0.97) compared with ICD. In RBBB, CRT-D had a 15% higher risk of heart failure hospitalization or death (HR 1.15, 1.10 to 1.20) and 13% higher death risk (HR 1.13, 1.07 to 1.18). Sensitivity analysis revealed that accounting for covariates not captured in the Medicare database may lead to increased benefit with CRT-D in LBBB and no difference in RBBB. In conclusion, in a large Medicare population, CRT-D was associated with lower mortality in LBBB but higher mortality in RBBB. The absence of certain covariates, in particular those that determine treatment selection, may affect the results of comparative effectiveness studies using claims data. Published by Elsevier Inc.

  17. Accelerated Implantable Defibrillator Battery Depletion Secondary to Lithium Cluster Formation: A Case Series.

    PubMed

    Aggarwal, Ashim; Sarmiento, Joseph J; Charles, David R; Parr, Alan R; Baman, Timir S

    2016-04-01

    Device failure from unanticipated and precipitous battery depletion is uncommon but can be life-threatening. Multiple mechanisms of battery failure have been previously described in the medical literature. However, in this current case series, we describe the largest cohort of patients (n = 4) with St. Jude (St. Paul, MN, USA) early implantable defibrillator battery depletion attributable to lithium cluster formation causing short circuit and high current drain. Clinicians must be aware of this occult cause of device failure and more studies are needed to determine its true prevalence. © 2015 Wiley Periodicals, Inc.

  18. Comparative Evaluation of Four Risk Scores for Predicting Mortality in Patients With Implantable Cardioverter-defibrillator for Primary Prevention.

    PubMed

    Rodríguez-Mañero, Moisés; Abu Assi, Emad; Sánchez-Gómez, Juan Miguel; Fernández-Armenta, Juan; Díaz-Infante, Ernesto; García-Bolao, Ignacio; Benezet-Mazuecos, Juan; Andrés Lahuerta, Ana; Expósito-García, Víctor; Bertomeu-González, Vicente; Arce-León, Álvaro; Barrio-López, María Teresa; Peinado, Rafael; Martínez-Sande, Luis; Arias, Miguel A

    2016-11-01

    Several clinical risk scores have been developed to identify patients at high risk of all-cause mortality despite implantation of an implantable cardioverter-defibrillator. We aimed to examine and compare the predictive capacity of 4 simple scoring systems (MADIT-II, FADES, PACE and SHOCKED) for predicting mortality after defibrillator implantation for primary prevention of sudden cardiac death in a Mediterranean country. A multicenter retrospective study was performed in 15 Spanish hospitals. Consecutive patients referred for defibrillator implantation between January 2010 and December 2011 were included. A total of 916 patients with ischemic and nonischemic heart disease were included (mean age, 62 ± 11 years, 81.4% male). Over 33.4 ± 12.9 months, 113 (12.3%) patients died (cardiovascular origin in 86 [9.4%] patients). At 12, 24, 36, and 48 months, mortality rates were 4.5%, 7.6%, 10.8%, and 12.3% respectively. All the risk scores showed a stepwise increase in the risk of death throughout the scoring system of each of the scores and all 4 scores identified patients at greater risk of mortality. The scores were significantly associated with all-cause mortality throughout the follow-up period. PACE displayed the lowest c-index value regardless of whether the population had heart disease of ischemic (c-statistic = 0.61) or nonischemic origin (c-statistic = 0.61), whereas MADIT-II (c-statistic = 0.67 and 0.65 in ischemic and nonischemic cardiomyopathy, respectively), SHOCKED (c-statistic = 0.68 and 0.66, respectively), and FADES (c-statistic = 0.66 and 0.60) provided similar c-statistic values (P ≥ .09). In this nontrial-based cohort of Mediterranean patients, the 4 evaluated risk scores showed a significant stepwise increase in the risk of death. Among the currently available risk scores, MADIT-II, FADES, and SHOCKED provide slightly better performance than PACE. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All

  19. Impact of new X-ray technology on patient dose in pacemaker and implantable cardioverter defibrillator (ICD) implantations.

    PubMed

    van Dijk, Joris D; Ottervanger, Jan Paul; Delnoy, Peter Paul H M; Lagerweij, Martine C M; Knollema, Siert; Slump, Cornelis H; Jager, Pieter L

    2017-01-01

    New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm 2 for the non-CRT implantations (p < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm 2 for the CRT implantations (p < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology (p = 0.09 and p = 0.20, respectively). Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected.

  20. Advances in sudden death prevention: the emerging role of a fully subcutaneous defibrillator.

    PubMed

    Majithia, Arjun; Estes, N A Mark; Weinstock, Jonathan

    2014-03-01

    Randomized clinical trials support the use of implantable defibrillators for mortality reduction in specific populations at high risk for sudden cardiac death. Conventional transvenous defibrillator systems are limited by implantation-associated complications, infection, and lead failure, which may lead to delivery of inappropriate shocks and diminish survival. The development of a fully subcutaneous defibrillator may represent a valuable addition to therapies targeted at sudden death prevention. The PubMed database was searched to identify all clinical reports of the subcutaneous defibrillator from 2000 to the present. We reviewed all case series, cohort analyses, and randomized trials evaluating the safety and efficacy of subcutaneous defibrillators. The subcutaneous defibrillator is a feasible development in sudden cardiac death therapy and may be useful particularly to extend defibrillator therapy to patients with complicated anatomy, limited vascular access, and congenital disease. The subcutaneous defibrillator should not be considered in patients with an indication for cardiac pacing or who have ventricular tachycardia responsive to antitachycardia pacing. Further investigation is needed to compare long-term, head-to-head performance of subcutaneous defibrillators and conventional transvenous defibrillator systems. Published by Elsevier Inc.

  1. Initial dynamics of the EKG during an electrical defibrillation of the heart

    NASA Technical Reports Server (NTRS)

    Bikov, I. I.; Chebotarov, Y. P.; Nikolaev, V. G.

    1980-01-01

    In tests on 11 mature dogs, immobilized by means of an automatic blocking and synchronization system, artefact free EKG were obtained, beginning 0.04-0.06 sec after passage of a defibrillating current. Different versions of the start of fibrillation were noted, in application of the defibrillating stimulus in the early phase of the cardiac cycle. A swinging phenomenon, increasing amplitude, of fibrillation was noted for 0.4-1.5 sec after delivery of a subthreshold stimulus. Conditions for a positive outcome of repeated defibrillation were found, and a relationship was noted between the configuration of the exciting process with respect to the lines of force of the defibrillating current and the defibrillation threshold. It was shown that the initial EKG dynamics after defibrillation is based on a gradual shift of the pacemaker from the myocardium of the ventricles to the sinus node, through phases of atrioventricular and atrial automatism.

  2. Implantable or external defibrillators for individuals at increased risk of cardiac arrest: where cost-effectiveness hits fiscal reality.

    PubMed

    Cram, Peter; Katz, David; Vijan, Sandeep; Kent, David M; Langa, Kenneth M; Fendrick, A Mark

    2006-01-01

    Implantable cardioverter defibrillators (ICDs) are highly effective at preventing cardiac arrest, but their availability is limited by high cost. Automated external defibrillators (AEDs) are likely to be less effective, but also less expensive. We used decision analysis to evaluate the clinical and economic trade-offs of AEDs, ICDs, and emergency medical services equipped with defibrillators (EMS-D) for reducing cardiac arrest mortality. A Markov model was developed to compare the cost-effectiveness of three strategies in adults meeting entry criteria for the MADIT II Trial: strategy 1, individuals experiencing cardiac arrest are treated by EMS-D; strategy 2, individuals experiencing cardiac arrest are treated with an in-home AED; and strategy 3, individuals receive a prophylactic ICD. The model was then used to quantify the aggregate societal benefit of these three strategies under the conditions of a constrained federal budget. Compared with EMS-D, in-home AEDs produced a gain of 0.05 quality-adjusted life-years (QALYs) at an incremental cost of $5225 ($104,500 per QALY), while ICDs produced a gain of 0.90 QALYs at a cost of $114,660 ($127,400 per QALY). For every $1 million spent on defibrillators, 1.7 additional QALYs are produced by purchasing AEDs (9.6 QALYs/$million) instead of ICDs (7.9 QALYs/$million). Results were most sensitive to defibrillator complication rates and effectiveness, defibrillator cost, and adults' risk of cardiac arrest. Both AEDs and ICDs reduce cardiac arrest mortality, but AEDs are significantly less expensive and less effective. If financial constraints were to lead to rationing of defibrillators, it might be preferable to provide more people with a less effective and less expensive intervention (in-home AEDs) instead of providing fewer people with a more effective and more costly intervention (ICDs).

  3. [Sudden cardiac death out of the hospital and early defibrillation].

    PubMed

    Marín-Huerta, E; Peinado, R; Asso, A; Loma, A; Villacastín, J P; Muñiz, J; Brugada, J

    2000-06-01

    Since most sudden cardiac death victims show neither symptoms before the event nor other signs or risk factors that would have identified them as a high risk population before their cardiac arrest, emergency out-of-hospital medical services must be improved in order to obtain a higher survival in these patients. Early defibrillation is an essential part of the chain of survival that also includes the early identification of the victim, activation of the emergency medical system, immediate arrival of trained personnel who can perform basic cardiopulmonary resuscitation and early initiation of advanced cardiac life support that would raise the survival rate for sudden cardiac arrest victims. Many studies have demonstrated the enormous importance of early defibrillation in patients with a cardiac arrest due to ventricular fibrillation. The most important predictor of survival in these individuals is the time that elapses until electric defibrillation, the longer the time to defbrillation the lower the number of patients who are eventually discharged. Multiple studies have demonstrated that automatic external defibrillation will reduce the time elapsed to defibrillation and thus improve survival. For these reason, public access defibrillation to allow the use of automatic external defibrillators by minimally trained members of the lay public, has received increasing interest on the part of a groving number of companies, cities or countries. The automatic external defibrillaton, as performed by a lay person is being investigated. The liberalization of its application, if is demonstrated to be effective, will need to be accompanied by legal measures to endorse it and appropriate health education, probably during secondary education.

  4. Single-Coil Defibrillator Leads Yield Satisfactory Defibrillation Safety Margin in Hypertrophic Cardiomyopathy.

    PubMed

    Okamura, Hideo; Friedman, Paul A; Inoue, Yuko; Noda, Takashi; Aiba, Takeshi; Yasuda, Satoshi; Ogawa, Hisao; Kamakura, Shiro; Kusano, Kengo; Espinosa, Raul E

    2016-09-23

    Single-coil defibrillator leads have gained favor because of their potential ease of extraction. However, a high defibrillation threshold remains a concern in patients with hypertrophic cardiomyopathy (HCM), and in many cases, dual-coil leads have been used for this patient group. There is little data on using single-coil leads for HCM patients. We evaluated 20 patients with HCM who received an implantable cardioverter-defibrillator (ICD) on the left side in combination with a dual-coil lead. Two sets of defibrillation tests were performed in each patient, one with the superior vena cava (SVC) coil "on" and one with the SVC coil "off". ICDs were programmed to deliver 25 joules (J) for the first attempt followed by maximum energy (35 J or 40 J). Shock impedance and shock pulse width at 25 J in each setting as well as the results of the shock were analyzed. All 25-J shocks in both settings successfully terminated ventricular fibrillation. However, shock impedance and pulse width increased substantially with the SVC coil programmed "off" compared with "on" (66.4±6.1 ohm and 14.0±1.3 ms "off" vs. 41.9±5.0 ohm and 9.3±0.8 ms "on", P<0.0001 respectively). Biphasic 25-J shocks with the SVC coil 'off' successfully terminated ventricular fibrillation in HCM patients, indicating a satisfactory safety margin for 35-J devices. Single-coil leads appear appropriate for left-sided implantation in this patient group. (Circ J 2016; 80: 2199-2203).

  5. The Use of Advance Directives Among Patients With Implantable Cardioverter Defibrillators

    PubMed Central

    Tajouri, Tanya H.; Ottenberg, Abigale L.; Hayes, David L.; Mueller, Paul S.

    2013-01-01

    Background We aimed to determine the prevalence of advance directives (ADs) among patients with implantable cardioverter defibrillators (ICDs) and of ADs that addressed ICD management at the end of life. Methods The medical records of all patients who underwent ICD implantation during 2007 at a single institution were reviewed retrospectively to determine the number of patients with an AD and the number of ADs mentioning the ICD specifically (ie, ICD management at end of life). Results During 2007, 420 patients (males, 71%) underwent ICD implantation at our institution (mean age [range] at implantation, 63 [1–90] years). Primary prevention was the most common indication for device therapy (254 patients [61%]). Overall, 127 patients (30%) had an AD, with 83 ADs (65%) completed more than 12 months before ICD implantation and 10 (8%) completed after it. Several life-sustaining treatments were mentioned in the ADs: tube feeding, 46 (37%); cardiopulmonary resuscitation, 25 (20%); mechanical ventilation, 22 (17%); and hemodialysis, 9 (7%). Pain control was mentioned in 58 ADs (46%) and comfort measures in 38 (30%). However, only 2 ADs (2%) mentioned the ICD or its deactivation at end of life. Conclusions About one-third of patients with ICDs had an AD, but only a couple ADs mentioned the ICD. These results suggest that clinicians should not only encourage patients with ICDs to complete an AD, but also encourage them to address ICD management specifically. Not addressing ICD management in an AD may result in ethical dilemmas during end-of- life care. PMID:22432897

  6. Efficacy and safety of nitroglycerin for preventing venous spasm during contrast-guided axillary vein puncture for pacemaker or defibrillator leads implantation.

    PubMed

    Duan, Xu; Ling, Feng; Shen, Yun; Yang, Jun; Xu, Hai-ying; Tong, Xiao-shan

    2013-04-01

    We investigated the efficacy and safety of nitroglycerin for preventing venous spasm during contrast-guided axillary vein puncture for pacemaker or defibrillator leads implantation. A total of 40 consecutive patients referred for contrast-guided axillary vein puncture for pacemaker or defibrillator implantations were included in the study. Patients were randomly assigned to control group and nitroglycerin group. Patients in the nitroglycerin group were given 200 µg (2 mL) nitroglycerin via ipsilateral peripheral vein about 3 min before puncture. The degree of venous spasm was evaluated by the reduction in lumen calibre of the axillary vein after puncture. Mild venous spasm and severe venous spasm were defined as a reduction in lumen calibre of 50-90% and ≥ 90%, respectively. The mean degree of venous spasm of axillary vein was lower in the nitroglycerin group than in the control group (23.0 ± 22.3 vs. 45.5 ± 33.6%, P = 0.018). The incidence of mild or severe venous spasm was lower in the nitroglycerin group than in the control group (3/20 vs. 11/20, P = 0.019). In the nitroglycerin group, the systolic blood pressure had a significant decrease after puncture (129.5 ± 23.7 vs. 143.0 ± 24.1 mmHg, P = 0.003). There was no hypotension and other adverse reaction of nitroglycerin in the nitroglycerin group. Intravenous nitroglycerin is effective and safe for preventing venous spasm during contrast-guided axillary vein puncture for pacemaker or defibrillator leads implantation.

  7. Battery longevity in cardiac resynchronization therapy implantable cardioverter defibrillators.

    PubMed

    Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rohit; Flanigan, Susan; Adelstein, Evan; Jain, Sandeep; Saba, Samir

    2014-02-01

    Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) deliver high burden ventricular pacing to heart failure patients, which has a significant effect on battery longevity. The aim of this study was to investigate whether battery longevity is comparable for CRT-ICDs from different manufacturers in a contemporary cohort of patients. All the CRT-ICDs implanted at our institution from 1 January 2008 to 31 December 2010 were included in this analysis. Baseline demographic and clinical data were collected on all patients using the electronic medical record. Detailed device information was collected on all patients from scanned device printouts obtained during routine follow-up. The primary endpoint was device replacement for battery reaching the elective replacement indicator (ERI). A total of 646 patients (age 69 ± 13 years), implanted with CRT-ICDs (Boston Scientific 173, Medtronic 416, and St Jude Medical 57) were included in this analysis. During 2.7 ± 1.5 years follow-up, 113 (17%) devices had reached ERI (Boston scientific 4%, Medtronic 25%, and St Jude Medical 7%, P < 0.001). The 4-year survival rate of device battery was significantly worse for Medtronic devices compared with devices from other manufacturers (94% for Boston scientific, 67% for Medtronic, and 92% for St Jude Medical, P < 0.001). The difference in battery longevity by manufacturer was independent of pacing burden, lead parameters, and burden of ICD therapy. There are significant discrepancies in CRT-ICD battery longevity by manufacturer. These data have important implications on clinical practice and patient outcomes.

  8. [Magnets, pacemaker and defibrillator: fatal attraction?].

    PubMed

    Bergamin, C; Graf, D

    2015-05-27

    This article aims at clarifying the effects of a clinical magnet on pacemakers and Implantable Cardioverter Defibrillators. The effects of electromagnetic interferences on such devices, including interferences linked to electrosurgery and magnetic resonance imaging are also discussed. In general, a magnet provokes a distinctive effect on a pacemaker by converting it into an asynchronous mode of pacing, and on an Implantable Cardioverter Defibrillator by suspending its own antitachyarythmia therapies without affecting the pacing. In the operating room, the magnet has to be used cautiously with precisely defined protocols which respect the type of the device used, the type of intervention planned, the presence or absence of EMI and the pacing-dependency of the patient.

  9. Effect of a Reminder Statement on Echocardiography Reports on Referrals for Implantable Cardioverter-Defibrillators for Primary Prevention.

    PubMed

    Chokshi, Moulin; McNamara, Robert L; Rajeswaran, Yasotha; Lampert, Rachel

    2017-02-01

    Numerous trials show the benefit of implantable cardioverter-defibrillators (ICDs) for primary prevention in patients with low ejection fraction (EF), a class I indication. However, underutilization is well documented. We retrospectively reviewed charts to see whether placing a reminder statement into echocardiogram reports for appropriate patients increased adherence to guidelines. From January through June 2013, a brief reminder of the ICD guidelines was automatically inserted into echocardiogram reports with EF ≤ 35% (reminder period). Charts were reviewed to determine if these patients (1) were referred to Electrophysiology (EP) within 6 months of the index echo and (2) received an ICD within 6 months of EP referral. Chart review of all patients who had an echocardiogram performed between March and August 2012 with an EF ≤ 35% provided a control period. More patients were referred to EP in the reminder period compared with control period, 68% (54 of 80) versus 51% (53 of 104), p = 0.03. There was also a higher rate of discussions in the reminder period between patients and physicians about ICD therapy (71% vs 54%, p = 0.02). Among patients appropriate for ICD, 52% of patients during the reminder period received an ICD versus 38% of patients during the control period (p = 0.11). A simple reminder statement on echocardiography reports led to a significant improvement in appropriate EP referrals and a trend toward increased ICD implantation in appropriate patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Implantation of subcutaneous implantable cardioverter defibrillators in Europe: results of the European Heart Rhythm Association survey.

    PubMed

    Boveda, Serge; Lenarczyk, Radoslaw; Haugaa, Kristina; Fumagalli, Stefano; Madrid, Antonio Hernandez; Defaye, Pascal; Broadhurst, Paul; Dagres, Nikolaos

    2016-09-01

    The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of subcutaneous cardioverter defibrillators (S-ICDs) across a broad range of European centres. A questionnaire was sent via the internet to centres participating in the EHRA electrophysiology research network. Questions included standards of care and policies used for patient management, indications, and techniques of implantation of the S-ICDs. In total, 52 centres replied to the questionnaire. More than one-fourth of the responding centres does not implant the S-ICD (n = 14, 27%). The majority reported to have implanted <10 (50%) or 10-29 (23%) S-ICDs during the last 12 months. Lack of reimbursement (25%), non-availability (19%), and cost of the device (25%) seem to limit the use of the S-ICD. The most commonly reported indications for S-ICD implantation are a difficult vascular access (82%), a history of previous complicated transvenous ICD (8O%), young age (69%), or an anticipated higher risk of infection (63%). Inappropriate therapies were the most frequently reported major problems (38%), but the majority of respondents (51%) never encountered any issue after an S-ICD implantation. Most of the respondents (83%) anticipate significant increase of S-ICD use within the next 2 years. This survey provides a contemporary insight into S-ICD implantation and management in the European electrophysiology centres, showing different approaches, depending on local policies. Cost issues or lack of reimbursement strongly influence the dissemination of the device. However, most respondents retain that S-ICD use will significantly increase in a very short time. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  11. [Resuscitation - Basic Life Support in adults and application of automatic external defibrillators].

    PubMed

    Bohn, Andreas; Seewald, Stephan; Wnent, Jan

    2016-03-01

    Witnesses of a sudden cardiac arrest play a key-role in resuscitation. Lay-persons should therefore be trained to recognize that a collapsed person who is not breathing at all or breathing normally might suffer from cardiac arrest. Information of professional emergency medical staff by lay-persons and their initiation of cardio-pulmonary-resuscitation-measures are of great importance for cardiac-arrest victims. Ambulance-dispatchers have to support lay-rescuers via telephone. This support includes the localisation of the nearest Automatic External Defibrillator (AED). Presentation of agonal breathing or convulsions due to brain-hypoxia need to be recognized as potential early signs of cardiac arrest. In any case of cardiac arrest chest-compressions need to be started. There is insufficiant data to recommend "chest-compression-only"-CPR as being equally sufficient as cardio-pulmonary-resuscitation including ventilation. Rescuers trained in ventilation should therefore combine compressions and ventilations at a 30:2-ratio. Movement of the chest is being used as a sign of sufficient ventilation. High-quality chest-compressions of at least 5 cm of depth, not exceeding 6 cm, are recommended at a ratio of 100-120 chest conpressions/min. Interruption of chest-compression should be avoided. At busy public places AED should be available to enable lay-rescuers to apply early defibrillation. © Georg Thieme Verlag Stuttgart · New York.

  12. An abdominal active can defibrillator may facilitate a successful generator change when a lead failure is present.

    PubMed

    Solomon, A J; Moubarak, J B; Drood, J M; Tracy, C M; Karasik, P E

    1999-10-01

    Defibrillator generator changes are frequently performed on patients with an implantable cardioverter defibrillator in an abdominal pocket. These patients usually have epicardial patches or older endocardial lead systems. At the time of a defibrillator generator change defibrillation may be unsuccessful as a result of lead failure. We tested the hypothesis that an active can defibrillator implanted in the abdominal pocket could replace a non-functioning endocardial lead or epicardial patch. An abdominal defibrillator generator change was performed in 10 patients, (mean age = 67 +/- 13 years, nine men). Initially, a defibrillation threshold (DFT) was obtained using a passive defibrillator and the chronic endocardial or epicardial lead system. DFTs were then performed using an active can emulator and one chronic lead to simulate endocardial or epicardial lead failure. We tested 30 lead configurations (nine endocardial and 21 epicardial). Although a DFT of 7.3 +/- 4.2 joules was obtained with the intact chronic lead system, the active can emulator and one endocardial or epicardial lead still yielded an acceptable DFT of 19.9 +/- 6.1 joules. In addition, a successful implant (DFT < or = 24 joules) could have been accomplished in 28 of 30 (93%) lead configurations. An active can defibrillator in an abdominal pocket may allow for a successful generator change in patients with defibrillator lead malfunction. This would be simpler than abandoning the abdominal implant and moving to a new pectoral device and lead or tunnelling a new endocardial electrode. However, loss of defibrillation capability with a particular complex lead may be a warning of impending loss of other functions (eg. sensing and/or pacing).

  13. Genome-wide association of implantable cardioverter-defibrillator activation with life-threatening arrhythmias.

    PubMed

    Murray, Sarah S; Smith, Erin N; Villarasa, Nikki; Nahey, Tara; Lande, Jeff; Goldberg, Harold; Shaw, Marian; Rosenthal, Lawrence; Ramza, Brian; Alaeddini, Jamshid; Han, Xinqiang; Damani, Samir; Soykan, Orhan; Kowal, Robert C; Topol, Eric J

    2012-01-01

    To identify genetic factors that would be predictive of individuals who require an implantable cardioverter-defibrillator (ICD), we conducted a genome-wide association study among individuals with an ICD who experienced a life-threatening arrhythmia (LTA; cases) vs. those who did not over at least a 3-year period (controls). Most individuals that receive implantable cardioverter-defibrillators never experience a life-threatening arrhythmia. Genetic factors may help identify who is most at risk. Patients with an ICD and extended follow-up were recruited from 34 clinical sites with the goal of oversampling those who had experienced LTA, with a cumulative 607 cases and 297 controls included in the analysis. A total of 1,006 Caucasian patients were enrolled during a time period of 13 months. Arrhythmia status of 904 patients could be confirmed and their genomic data were included in the analysis. In this cohort, there were 704 males, 200 females, and the average age was 73.3 years. We genotyped DNA samples using the Illumina Human660 W Genotyping BeadChip and tested for association between genotype at common variants and the phenotype of having an LTA. We did not find any associations reaching genome-wide significance, with the strongest association at chromosome 13, rs11856574 at P = 5×10⁻⁶. Loci previously implicated in phenotypes such as QT interval (measure of the time between the start of the Q wave and the end of the T wave as measured by electrocardiogram) were not found to be significantly associated with having an LTA. Although powered to detect such associations, we did not find common genetic variants of large effect associated with having a LTA in those of European descent. This indicates that common gene variants cannot be used at this time to guide ICD risk-stratification. ClinicalTrials.gov NCT00664807.

  14. [Experimental study of PVPP/silicone composite automatic expanded material as implants].

    PubMed

    Yin, Wei-min; Gao, Jian-hua; Yang, Qing-fang; Lu, Feng; Ye, Jia-jia

    2009-03-01

    To study the feasibility of Polyvinylpolypyrrolidone (PVPP)/silicone composite automatic expanded material as implants. The PVPP hydrogel was mixed with silicone through the location at the high temperature. Implants with different ratio of PVPP to silicone were placed under the back and nose skin in 24 New Zealand rabbits. The surrounding tissue reaction, material and skin expansion were observed and compared with those with pure silicone implants. The study lasted for 200 days. Compared with pure silicone implants, the composite material could expand automatically and stop expanding at about 2 weeks after implantation. Histological study showed similar inflectional and foreign body reaction around the composite material and the pure silicone. Compared with pure silicone, the PVPP/silicone composite implant has the advantage of automatic expansion, so as to expand the soft tissue.

  15. [Knowledge and attitudes of citizens in the Basque Country (Spain) towards cardiopulmonary resuscitation and automatic external defibrillators].

    PubMed

    Ballesteros-Peña, S; Fernández-Aedo, I; Pérez-Urdiales, I; García-Azpiazu, Z; Unanue-Arza, S

    2016-03-01

    To explore the training, ability and attitudes towards cardiopulmonary resuscitation and the use of automatic defibrillators among the population of the Basque Country (Spain). A face-to-face survey. Capital cities of the Basque Country. A total of 605 people between 15-64 years of age were randomly selected. Information about the knowledge, perceptions and self-perceived ability to identify and assist cardiopulmonary arrest was requested. A total of 56.4% of the responders were women, 61.8% were occupationally active, and 48.3% had higher education. Thirty-seven percent of the responders claimed to be trained in resuscitation techniques, but only 20.2% considered themselves able to apply such techniques. Public servants were almost 4 times more likely of being trained in defibrillation compared to the rest of workers (OR 3.7; P<.001), while people with elementary studies or no studies were almost 3 times more likely of not being trained in cardiopulmonary resuscitation, in comparison with the rest (OR 2.7; P=.001). A total of 94.7% of the responders considered it "quite or very important" for the general population to be able to apply resuscitation, though 55% considered themselves unable to identify an eye witnessed cardiac arrest, and 40.3% would not recognize a public-access defibrillator. Citizens of the Basque Country consider the early identification and treatment of cardiorespiratory arrest victims to be important, though their knowledge in cardiopulmonary resuscitation and defibrillation is limited. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  16. Implantation of a cardiac resynchronization therapy-defibrillator device in a patient with persistent left superior vena cava.

    PubMed

    Atar, İlyas; Karaçağlar, Emir; Özçalık, Emre; Özin, Bülent; Müderrisoğlu, Haldun

    2015-06-01

    Presence of a persistent left superior vena cava (PLSVC) is generally clinically asymptomatic and discovered incidentally during central venous catheterization. However, PLSVC may cause technical difficulties during cardiac device implantation. An 82-year-old man with heart failure symptoms and an ejection fraction (EF) of 20% was scheduled for resynchronization therapy-defibrillator device (CRT-D) implantation. A PLSVC draining via a dilated coronary sinus into an enlarged right atrium was diagnosed. First, an active-fixation right ventricular lead was inserted into the right atrium through the PLSVC. The stylet was preshaped to facilitate its passage to the right ventricular apex. An atrial lead was positioned on the right atrium free wall, and an over-the-wire coronary sinus lead deployed to a stable position. CRT-D implantation procedure was successfully completed.

  17. [Automatic external defibrillator--mode of operation and clinical use].

    PubMed

    Wieneke, H; Konorza, T; Breuckmann, F; Reinsch, N; Erbel, R

    2008-10-01

    Every year about 100,000 persons die from sudden cardiac death (SCD) in Germany. Although many efforts have been undertaken, mortality remains high. Only 2 - 10% of patients with out-off hospital SCD can finally be discharged from hospital after resuscitation. Observational studies show that ventricular fibrillation and ventricular tachycardia are the primary arrhythmias underlying SCD. For both arrhythmias the main determinant for survival is the time between onset and termination by defibrillation. The chance of survival declines by 10% for every minute of delay. These findings prompted the concept of early defibrillation by first responders. Many studies have shown that non-medical professionals, like police men, firemen or security officers, often arrive at the patient more early than emergency medical service. Thus, "smart" automated external defibrillators (AEDs), designed to identify VT/VF and prompt the user when to deliver a shock were introduced. These devices allow lay rescuers to terminate ventricular arrhythmias before the arrival of medical professionals. By this approach the time to defibrillation could be reduced and a significant reduction in mortality could be documented in selected situation. These encouraging results initialled the installation of AED at public places like aircrafts, airports, underground stations and shopping males. Due to the success of this approach doctors are more and more confronted with questions about technical details, reliability and cost effectiveness of these devices. The present review should give an overview about the current studies and guidelines.

  18. Downward delegation of implantable cardioverter defibrillator decision-making in a restricted-resource environment: the pitfalls of bedside rationing.

    PubMed

    Simpson, Christopher S; Hoffmaster, Barry; Dorian, Paul

    2005-05-15

    Implantable cardioverter defibrillators have been shown to reduce all-cause mortality in some patient populations at risk of sudden death. New Canadian guidelines recommend implantable cardioverter defibrillator therapy for these patients. However, the need for these devices exceeds the funded volumes in many Canadian jurisdictions. As a result, rationing of this resource has been necessary. While rationing at the macro (Ministry of Health) and meso (hospital) levels has achieved some level of acceptance by society, the responsibility for the decisions taken at the micro (individual) patient level actually rests with the physician at the bedside. This 'bedside rationing' creates a moral dilemma for physicians, who are torn between their traditional fiduciary role as 'patient advocate' and the competing role of 'gatekeeper'. This 'downward delegation' of rationing decision-making obscures the reality that rationing occurs, and encourages covert, opaque and inconsistent approaches. The remedy is the development of fair, legitimate procedures for making rationing decisions that include guidelines that structure and constrain those decisions. Macro- and meso-level stakeholders must also recognize and take responsibility for their part in restricting resources in a broadly inclusive and transparent process.

  19. Assessing access to MRI of patients with magnetic resonance-conditional pacemaker and implantable cardioverter defibrillator systems: the Really ProMRI study design.

    PubMed

    Maglia, Giampiero; Curnis, Antonio; Brieda, Marco; Anaclerio, Matteo; Caccavo, Vincenzo; Bonfanti, Paolo; Melissano, Donato; Caravati, Fabrizio; Giovene, Lisa; Gargaro, Alessio

    2015-10-01

    Despite the fact that magnetic resonance (MR)-conditional pacemaker and lead systems have been introduced more than 5 years ago, it is still not clear whether they have actually facilitated the access of pacemaker patients to this important diagnostic tool. Factors limiting MR scans in daily practice in patients with MR-conditional cardiac implantable electronic device (CIED) systems may be related to organizational, cultural and sometimes legal aspects. The Really ProMRI registry is an ongoing survey designed to assess the annual rate of MR examinations in patients with MR-conditional implants, with either pacemakers or implantable cardioverter defibrillators, and to detect the main factors limiting MRI. The primary endpoint of the Really ProMRI registry is to assess the current access to MRI of patients with MR-conditional pacemaker or implantable cardioverter defibrillator systems during normal practice. Data in the literature reported a 17% annual incidence of medical conditions requiring MRI in CIED patients. The Really ProMRI registry has been designed to detect 4.5% absolute difference with an 80% statistical power, by recruiting 600 patients already implanted with MR-conditional CIED implant. Patients will be followed up for 1 year, during which they will be asked to refer any prescription, execution or denial of an MR examination by patient questionnaires and original source documents. The ongoing Really ProMRI registry will assess the actual rate of and factors limiting the access to MRI for patients with MR-conditional CIEDs.

  20. An automated, web-enabled and searchable database system for archiving electrogram and related data from implantable cardioverter defibrillators.

    PubMed

    Zong, W; Wang, P; Leung, B; Moody, G B; Mark, R G

    2002-01-01

    The advent of implantable cardioverter defibrillators (ICDs) has resulted in significant reductions in mortality in patients at high risk for sudden cardiac death. Extensive related basic research and clinical investigation continue. ICDs typically record intracardiac electrograms and inter-beat intervals along with device settings during episodes of device delivery of therapy. Researchers wishing to study these data further have until now been limited to viewing paper plots. In support of multi-center clinical studies of patients with ICDs, we have developed a web based searchable ICD data archiving system, which allows users to use a web browser to upload ICD data from diskettes to a server where the data are automatically processed and archived. Users can view and download the archived ICD data directly via the web. The entire system is built from open source software. At present more than 500 patient ICD data sets have been uploaded to and archived in the system. This project will be of value not only to those who wish to conduct research using ICD data, but also to clinicians who need to archive and review ICD data collected from their patients.

  1. Shock Reduction With Antitachycardia Pacing Before and During Charging for Fast Ventricular Tachycardias in Patients With Implantable Defibrillators.

    PubMed

    Dallaglio, Paolo Domenico; Anguera, Ignasi; Martínez Ferrer, José B; Pérez, Luisa; Viñolas, Xavier; Porres, Jose Manuel; Fontenla, Adolfo; Alzueta, Javier; Martínez, Juan Gabriel; Rodríguez, Aníbal; Basterra, Nuria; Sabaté, Xavier

    2017-12-11

    Fast ventricular tachycardias in the ventricular fibrillation zone in patients with an implantable cardioverter-defibrillator are susceptible to antitachycardia pacing (ATP) termination. Some manufacturers allow programming 2 ATP bursts: before charging (BC) and during (DC) charging. The aim of this study was to describe the safety and effectiveness of ATP BC and DC for fast ventricular tachycardias in the ventricular fibrillation zone in patients with an implantable cardioverter-defibrillator in daily clinical practice. Data proceeded from the multicenter UMBRELLA trial, including implantable cardioverter-defibrillator patients followed up by the CareLink monitoring system. Fast ventricular tachycardias in the ventricular fibrillation zone until a cycle length of 200ms with ATP BC and/or ATP DC were included. We reviewed 542 episodes in 240 patients. Two ATP bursts (BC/DC) were programmed in 291 episodes (53.7%, 87 patients), while 251 episodes (46.3%, 153 patients) had 1 ATP burst only DC. The number of episodes terminated by 1 ATP DC was 139, representing 55.4% effectiveness (generalized estimating equation-adjusted 60.4%). There were 256 episodes terminated by 1 or 2 ATP (BC/DC), representing 88% effectiveness (generalized estimating equation-adjusted 79.3%); the OR for ATP effectiveness BC/DC vs DC was 2.5, 95%CI, 1.5-4.1; P <.001. Shocked episodes were 112 (45%) for ATP DC vs 35 (12%) for ATP BC/DC, representing an absolute reduction of 73%. The mean shocked episode duration was 16seconds for ATP DC vs 19seconds for ATP BC/DC (P=.07). The ATP DC in the ventricular fibrillation zone for fast ventricular tachycardia is moderately effective. Adding an ATP burst BC increases the overall effectiveness, reduces the need for shocks, and does not prolong episode duration. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  2. [The Wearable Cardioverter-Defibrillator (WCD)].

    PubMed

    Helms, Thomas M; Müller, A; Schwab, J O; Bänsch, D; Karle, C; Klingenheben, T; Zugck, C; Perings, C

    2015-06-01

    While the implantable cardioverter-defibrillator (ICD) has been proven to be the best choice for patients with long-term risk for sudden cardiac arrest/sudden cardiac death (SCA/SCD), the question is how to manage patients with only temporary risk, e.g., during the guidelines-recommended waiting period until the decision for an ICD can be made. These patient groups should be monitored around the clock to guarantee a lifesaving shock within a few minutes, if necessary.These conditions can be accomplished by the wearable cardioverter-defibrillator (WCD) in the outpatient sector. The WCD is worn on the skin and consists of four nonadhesive ECG electrodes as well as three defibrillation electrodes-two at the back and one at the front-embedded in a garment. The defibrillation unit is connected via a cord and can be worn over the shoulder or on a belt. Cardiac events can be recorded and retrospectively analyzed by the treating physician.The WCD is a safe and effective measure to terminate potentially lethal ventricular tachycardia and ventricular fibrillation. It may be used early after myocardial infarction with reduced left ventricular ejection fraction (LVEF), as well as for patients with acute heart failure in nonischemic cardiomyopathy with uncertain cause and prognosis. In addition, it may be used for patients waiting for heart transplantation, for patients who cannot be implanted an ICD due to comorbidities, and for patients after explantation of their ICD, e.g., because of infection until reimplantation.One may expect that risk stratification of patients with the WCD will lead to even better selection for ICD use.

  3. Sex difference in appropriate shocks but not mortality during long-term follow-up in patients with implantable cardioverter-defibrillators

    PubMed Central

    Seegers, Joachim; Conen, David; Jung, Klaus; Bergau, Leonard; Dorenkamp, Marc; Lüthje, Lars; Sohns, Christian; Sossalla, Samuel T.; Fischer, Thomas H.; Hasenfuss, Gerd; Friede, Tim; Zabel, Markus

    2016-01-01

    Abstract Aims Implantable cardioverter-defibrillators (ICDs) have been shown to improve survival, although a considerable number of patients never receive therapy. Implantable cardioverter-defibrillators are routinely implanted regardless of sex. There is continuing controversy whether major outcomes differ between men and women. Methods and results In this retrospective single-centre study, 1151 consecutive patients (19% women) undergoing ICD implantation between 1998 and 2010 were followed for mortality and first appropriate ICD shock over 4.9 ± 2.7 years. Sex-related differences were investigated using multivariable Cox models adjusting for potential confounders. During follow-up, 318 patients died, a rate of 5.9% per year among men and 4.6% among women (uncorrected P = 0.08); 266 patients received a first appropriate ICD shock (6.3% per year among men vs. 3.6% among women, P = 0.002). After multivariate correction, independent predictors of all-cause mortality were age (hazard ratio, HR = 1.04 per year of age, 95% confidence interval (CI) [1.03–1.06], P < 0.001), left ventricular ejection fraction (HR = 0.98 per %, 95% CI [0.97–1.00], P = 0.025), renal function (HR = 0.99 per mL/min/1.73 m2, 95% CI [0.99–1.00], P = 0.009), use of diuretics (HR = 1.81, 95% CI [1.29–2.54], P = 0.0023), peripheral arterial disease (HR = 2.21, 95% CI [1.62–3.00], P < 0.001), and chronic obstructive pulmonary disease (HR = 1.48, 95% CI [1.13–1.94], P = 0.029), but not sex. Female sex (HR = 0.51, 95% CI [0.33–0.81], P = 0.013), older age (HR = 0.98, 95% CI [0.97–0.99], P < 0.001), and primary prophylactic ICD indication (HR = 0.69, 95% CI [0.52–0.93], P = 0.043) were independent predictors for less appropriate shocks. Conclusion Women receive 50% less appropriate shocks than men having similar mortality in this large single-centre population. These data may pertain to individually improved selection of defibrillator candidates using risk factors, e.g. sex as

  4. Placement of implantable cardioverter-defibrillators in paediatric and congenital heart defect patients: a pipeline for model generation and simulation prediction of optimal configurations

    PubMed Central

    Rantner, Lukas J; Vadakkumpadan, Fijoy; Spevak, Philip J; Crosson, Jane E; Trayanova, Natalia A

    2013-01-01

    There is currently no reliable way of predicting the optimal implantable cardioverter-defibrillator (ICD) placement in paediatric and congenital heart defect (CHD) patients. This study aimed to: (1) develop a new image processing pipeline for constructing patient-specific heart–torso models from clinical magnetic resonance images (MRIs); (2) use the pipeline to determine the optimal ICD configuration in a paediatric tricuspid valve atresia patient; (3) establish whether the widely used criterion of shock-induced extracellular potential (Φe) gradients ≥5 V cm−1 in ≥95% of ventricular volume predicts defibrillation success. A biophysically detailed heart–torso model was generated from patient MRIs. Because transvenous access was impossible, three subcutaneous and three epicardial lead placement sites were identified along with five ICD scan locations. Ventricular fibrillation was induced, and defibrillation shocks were applied from 11 ICD configurations to determine defibrillation thresholds (DFTs). Two configurations with epicardial leads resulted in the lowest DFTs overall and were thus considered optimal. Three configurations shared the lowest DFT among subcutaneous lead ICDs. The Φe gradient criterion was an inadequate predictor of defibrillation success, as defibrillation failed in numerous instances even when 100% of the myocardium experienced such gradients. In conclusion, we have developed a new image processing pipeline and applied it to a CHD patient to construct the first active heart–torso model from clinical MRIs. PMID:23798492

  5. Diaphragmatic Myopotential Oversensing Caused by Change in Implantable Cardioverter Defibrillator Sensing Bandpass Filter.

    PubMed

    Ploux, Sylvain; Swerdlow, Charles D; Eschalier, Romain; Monteil, Benjamin; Ouali, Sana; Haïssaguerre, Michel; Bordachar, Pierre

    2016-07-01

    Diaphragmatic myopotential oversensing (DMO) causes inhibition of pacing and inappropriate detection of ventricular fibrillation in implantable cardioverter defibrillators (ICDs). It occurs almost exclusively with integrated bipolar leads and is extremely rare with dedicated bipolar leads. If DMO cannot be corrected by reducing programmed sensitivity, ventricular lead revision is often required. The new Low Frequency Attenuation (LFA) filter in St. Jude Medical ICDs (St. Jude Medical, Sylmar, CA, USA) alters the sensing bandpass to reduce T-wave oversensing. This paper aims to present the LFA filter as a reversible cause of DMO. Unnecessary lead revision can be avoided by the simple programming solution of deactivating this LFA filter. ©2016 Wiley Periodicals, Inc.

  6. Survival after shock therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator recipients according to rhythm shocked. The ALTITUDE survival by rhythm study.

    PubMed

    Powell, Brian D; Saxon, Leslie A; Boehmer, John P; Day, John D; Gilliam, F Roosevelt; Heidenreich, Paul A; Jones, Paul W; Rousseau, Matthew J; Hayes, David L

    2013-10-29

    This study sought to determine if the risk of mortality associated with inappropriate implantable cardioverter-defibrillator (ICD) shocks is due to the underlying arrhythmia or the shock itself. Shocks delivered from ICDs are associated with an increased risk of mortality. It is unknown if all patients who experience inappropriate ICD shocks have an increased risk of death. We evaluated survival outcomes in patients with an ICD and a cardiac resynchronization therapy defibrillator enrolled in the LATITUDE remote monitoring system (Boston Scientific Corp., Natick, Massachusetts) through January 1, 2010. First shock episode rhythms from 3,809 patients who acutely survived the initial shock were adjudicated by 7 electrophysiologists. Patients with a shock were matched to patients without a shock (n = 3,630) by age at implant, implant year, sex, and device type. The mean age of the study group was 64 ± 13 years, and 78% were male. Compared with no shock, there was an increased rate of mortality in those who received their first shock for monomorphic ventricular tachycardia (hazard ratio [HR]: 1.65, p < 0.0001), ventricular fibrillation/polymorphic ventricular tachycardia (HR: 2.10, p < 0.0001), and atrial fibrillation/flutter (HR: 1.61, p = 0.003). In contrast, mortality after first shocks due to sinus tachycardia and supraventricular tachycardia (HR: 0.97, p = 0.86) and noise/artifact/oversensing (HR: 0.91, p = 0.76) was comparable to that in patients without a shock. Compared with no shock, those who received their first shock for ventricular rhythms and atrial fibrillation had an increased risk of death. There was no significant difference in survival after inappropriate shocks for sinus tachycardia or noise/artifact/oversensing. In this study, the adverse prognosis after first shock appears to be more related to the underlying arrhythmia than to an adverse effect from the shock itself. Copyright © 2013 American College of Cardiology Foundation. Published by

  7. Gender, Racial, and Health Insurance Differences in the Trend of Implantable Cardioverter-Defibrillator (ICD) Utilization: A United States Experience Over the Last Decade.

    PubMed

    Patel, Nileshkumar J; Edla, Sushruth; Deshmukh, Abhishek; Nalluri, Nikhil; Patel, Nilay; Agnihotri, Kanishk; Patel, Achint; Savani, Chirag; Patel, Nish; Bhimani, Ronak; Thakkar, Badal; Arora, Shilpkumar; Asti, Deepak; Badheka, Apurva O; Parikh, Valay; Mitrani, Raul D; Noseworthy, Peter; Paydak, Hakan; Viles-Gonzalez, Juan; Friedman, Paul A; Kowalski, Marcin

    2016-02-01

    Prior studies have highlighted disparities in cardiac lifesaving procedure utilization, particularly among women and in minorities. Although there has been a significant increase in implantable cardioverter-defibrillator (ICD) insertion, socioeconomic disparities still exist in the trend of ICD utilization. With the use of the Nationwide Inpatient Sample from 2003 through 2011, we identified subjects with ICD insertion (procedure code 37.94) and cardiac resynchronization defibrillator (procedure code 00.50, 00.51) as codified by the International Classification of Diseases, Ninth Revision, Clinical Modification. Overall, 1 020 076 ICDs were implanted in the United States from 2003 to 2011. We observed an initial increase in ICD utilization by 51%, from 95 062 in 2003 to 143 262 in 2006, followed by a more recent decline. The majority of ICDs were implanted in men age ≥65 years. Implantation of ICDs was 2.5× more common in men than in women (402 per million vs 163 per million). Approximately 95% of the ICDs were implanted in insured patients, and 5% were used in the uninsured population. There has been a significant increase in ICD implantation in blacks, from 162 per million in 2003 to 291 per million in 2011. We found a significant difference in the volume of ICD implants between the insured and the uninsured patient populations. Racial disparities have narrowed significantly in comparison with those noted in earlier studies and are now more reflective of the population demographics at large. On the other hand, significant gender disparities continue to exist. © 2016 Wiley Periodicals, Inc.

  8. Genome-Wide Association of Implantable Cardioverter-Defibrillator Activation With Life-Threatening Arrhythmias

    PubMed Central

    Murray, Sarah S.; Smith, Erin N.; Villarasa, Nikki; Nahey, Tara; Lande, Jeff; Goldberg, Harold; Shaw, Marian; Rosenthal, Lawrence; Ramza, Brian; Alaeddini, Jamshid; Han, Xinqiang; Damani, Samir; Soykan, Orhan; Kowal, Robert C.; Topol, Eric J.

    2012-01-01

    Objectives To identify genetic factors that would be predictive of individuals who require an implantable cardioverter-defibrillator (ICD), we conducted a genome-wide association study among individuals with an ICD who experienced a life-threatening arrhythmia (LTA; cases) vs. those who did not over at least a 3-year period (controls). Background Most individuals that receive implantable cardioverter-defibrillators never experience a life-threatening arrhythmia. Genetic factors may help identify who is most at risk. Methods Patients with an ICD and extended follow-up were recruited from 34 clinical sites with the goal of oversampling those who had experienced LTA, with a cumulative 607 cases and 297 controls included in the analysis. A total of 1,006 Caucasian patients were enrolled during a time period of 13 months. Arrhythmia status of 904 patients could be confirmed and their genomic data were included in the analysis. In this cohort, there were 704 males, 200 females, and the average age was 73.3 years. We genotyped DNA samples using the Illumina Human660 W Genotyping BeadChip and tested for association between genotype at common variants and the phenotype of having an LTA. Results and Conclusions We did not find any associations reaching genome-wide significance, with the strongest association at chromosome 13, rs11856574 at P = 5×10−6. Loci previously implicated in phenotypes such as QT interval (measure of the time between the start of the Q wave and the end of the T wave as measured by electrocardiogram) were not found to be significantly associated with having an LTA. Although powered to detect such associations, we did not find common genetic variants of large effect associated with having a LTA in those of European descent. This indicates that common gene variants cannot be used at this time to guide ICD risk-stratification. Trial Registration ClinicalTrials.gov NCT00664807 PMID:22247754

  9. Implantation techniques and chronic lead parameters of biventricular pacing dual-chamber defibrillators.

    PubMed

    Daoud, Emile G; Kalbfleisch, Steven J; Hummel, John D; Weiss, Raul; Augustini, Ralph S; Duff, Steven B; Polsinelli, Georgia; Castor, John; Meta, Tejas

    2002-10-01

    The aim of this study is to describe implantation techniques and lead performance for biventricular pacing, dual-chamber implantable cardioverter defibrillators (ICDs). A dual-chamber ICD with biventricular pacing was implanted in 87 patients with congestive heart failure (ejection fraction: 0.21 +/- 0.09), prolonged QRS duration (161 +/- 22 msec), and an indication for ICD therapy. Left ventricular pacing was achieved with a thoracotomy approach (n = 21) or a nonthoracotomy approach (n = 66). With a thoracotomy, biventricular devices were implanted successfully in all patients. During follow-up (17 +/- 11 months), 9 patients died (43%), 2 underwent transplantation, and 2 required left ventricular lead revision. At last follow-up, biventricular sensing and capture threshold were 11 +/- 5 mV and 1.5 +/- 0.8 V, respectively. For nonthoracotomy procedures, two types of coronary sinus (CS) leads were implanted: an over-the-wire lead (n = 45) and a shaped lead (n = 21). The rate of successful implantation (overall: 89%) (over-the-wire 93% vs shaped 81%; P = 0.1) and durations for CS lead placement (66 +/- 50 vs 58 +/- 34 min, P = 0.6) and the procedure (133 +/- 58 vs 129 +/- 33 min, P = 0.8) were not different between the two CS leads. During follow-up (11 +/- 9 months), 9 patients died (14%), and the shaped CS lead dislodged in 3 patients (3 shaped vs 0 over-the-wire, P = 0.01). At last follow-up, biventricular sensing and capture threshold were 10 +/- 4 mV and 1.8 +/- 0.7 V, respectively, and there was no difference between over-the-wire and shaped leads. By multivariate analysis, mortality was associated with absence of spironolactone therapy but not procedural features. Nonthoracotomy CS lead implantation is feasible, with a success rate of about 90% and few adverse events. For the remaining 10%, a thoracotomy approach can be completed safely in these ill patients without increased risk for death.

  10. Inadvertent transposition of defibrillator coil terminal pins causing inappropriate ICD therapies.

    PubMed

    Issa, Ziad F

    2008-06-01

    We report the case of a 65-year-old man with chronic atrial fibrillation (AF) and severe ischemic cardiomyopathy who underwent implantation of a prophylactic single-chamber implantable cardioverter-defibrillator (ICD). The patient experienced inappropriate ICD therapies due to oversensing of pectoral muscle myopotential secondary to reversal of the defibrillator coil terminal pins in the ICD header. Recognizing this possibility is important to avoid misinterpretation of spontaneous oversensing as hardware failure (e.g., lead fracture or insulation breech) and potentially unnecessary ICD system surgical intervention, including lead extraction.

  11. Electrical treatment of atrial arrhythmias in heart failure patients implanted with a dual defibrillator CRT device. Results from the TRADE-HF study.

    PubMed

    Botto, Giovanni Luca; Padeletti, Luigi; Covino, Gregorio; Pieragnoli, Paolo; Liccardo, Mattia; Mariconti, Barbara; Favale, Stefano; Molon, Giulio; De Filippo, Paolo; Bolognese, Leonardo; Landolina, Maurizio; Raciti, Giovanni; Boriani, Giuseppe

    2017-06-01

    Ventricular and atrial arrhythmias commonly occur in heart failure patients and are a significant source of symptoms, morbidity and mortality. Some specific generators referred to as dual defibrillators, Dual CRT-Ds, have the ability to treat atrial and ventricular arrhythmias. TRADE-HF is a prospective two-arm randomized study aimed at assessing the benefits of complete automatic management of atrial arrhythmias in patients implanted with a dual CRT-D. Primary objective of the TRADE-HF study was to document reduction of unplanned hospital admission for cardiac reasons or death for cardiovascular causes or progression to permanent AF, by comparing fully-automatic device driven therapy for atrial tachycardia or fibrillation (AT/AF) to an in-hospital approach for treatment of symptomatic AT/AF. Randomized Patients were followed every 6months for 3years to assess the primary objective. Four-hundred-twenty patients have been enrolled in the study. At the end of the study 30 subjects died for cardiovascular causes, 60 had at least one hospitalization for cardiovascular causes and 14 developed permanent AF. Eighty-seven patients experienced a composite event. Hazard Ratio for device-managed automatic therapy arm compared to traditional was 0.987 (95% CI: 0.684-1.503; p=0.951). The primary endpoint analysis resulted in no difference between the device managed and in-hospital treatment arm. The TRADE-HF study failed to demonstrate a reduction in the composite of unplanned hospitalizations for cardiovascular causes or death for cardiovascular causes or progression to permanent AF using automatic atrial therapy compared to a traditional approach including hospitalization for symptomatic episodes and/or in-hospital treatment of AT/AF. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Effectiveness of implantable cardioverter-defibrillators in survivors of inhospital cardiac arrest.

    PubMed

    Chan, Paul S; Krumholz, Harlan M; Spertus, John A; Curtis, Lesley H; Li, Yan; Hammill, Bradley G; Nallamothu, Brahmajee K

    2015-06-01

    Although implantable cardioverter-defibrillators (ICDs) reduce mortality in patients with out-of-hospital cardiac arrest, their effectiveness in survivors of "inhospital" cardiac arrest-a population with different arrest etiologies and higher illness acuity than out-of-hospital cardiac arrest-is unknown. We therefore sought to conduct a comparative effectiveness study of ICD therapy in survivors of inhospital cardiac arrest. We linked data from a national inpatient cardiac arrest registry with Medicare files and identified 1,200 adults from 267 hospitals between 2000 and 2008 who were discharged after surviving an inhospital cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia and who otherwise met traditional inclusion and exclusion criteria for secondary prevention ICD trials. The association between ICD treatment and long-term mortality was evaluated using an optimal match (≤4 controls for each ICD patient) propensity-score analysis. Of 1,200 survivors, 343 (28.6%) received an ICD during the index hospitalization. Overall, 3-year mortality was 44.2%, with higher unadjusted mortality in the non-ICD versus the ICD group (46.9% vs 37.3%; log-rank; P < .001). After successfully matching 343 patients treated with ICDs with 823 untreated patients by propensity score, ICD treatment was associated with a 24% lower mortality rate (adjusted hazard ratio [HR] 0.76; 95% CI 0.60-0.97; P = .025). This lower mortality was mediated by lower rates of out-of-hospital deaths among ICD-treated patients (22.1% vs 30.8%; adjusted HR 0.71 [0.52-0.96]; P = .019), whereas deaths occurring during a readmission were similar (15.2% vs 16.1%; adjusted HR 0.89 [95% CI 0.60-1.32]; P = .56). Implantable cardioverter-defibrillator therapy in survivors of inhospital cardiac arrest due to a pulseless ventricular rhythm is used uncommonly but associated with lower long-term mortality. Given that fewer than 3 in 10 eligible survivors are treated with ICDs after

  13. Impact of a hybrid decision support system to improve the adherence to implantable cardioverter defibrillator therapy guidelines for primary prevention of sudden cardiac death.

    PubMed

    Vecchio, Nicolás; Belardi, Diego; Benzadón, Mariano; Seoane, Leonardo; Daquarti, Gustavo; Scazzuso, Fernando

    2018-06-01

    Despite the well-documented benefit of implantable cardioverter defibrillator (ICD) in patients with severe left ventricular dysfunction, there is a large number of patients who had not been offered this therapy. The aim of this study is to evaluate the utility of a hybrid decision support system (hCDSS) to improve the adherence to indicate ICD therapy in our institution. We conducted a retrospective, observational and single-center study. An hCDSS focused on patients with severe deterioration of the left ventricular function was implemented, creating a mandatory field containing the value of left ejection fraction and three options to choose: >35%, ≤ 35% or unknown. When the option ≤ 35% is checked, an email is automatically sent to the electrophysiology section where the staff can contact the treating physician to discuss the indication of ICD therapy. We measured the number of ICDs implanted before the alert (month 1-21), immediate post and late post alert (month 22-27 and 28-48 months respectively) RESULTS: The rate of ICD implantation increased from 1.76% per month in the pre-intervention period to 4.48% after the intervention (p < 0.001). This increase in the rate of ICD implantation remained stable between the immediate and late post-intervention period (4.6 vs. 4.4; p = .8) CONCLUSION: The implementation of a hybrid decision support system was associated with improved adherence to clinical guidelines for prevention of sudden cardiac death, as evidenced by a rapid and sustained increase in the number of ICD implants in patients with severe left ventricular dysfunction. Copyright © 2018 Elsevier B.V. All rights reserved.

  14. Long-term follow-up study of uncertainty and psychosocial adjustment among implantable cardioverter defibrillator recipients.

    PubMed

    Mauro, Ann Marie P

    2010-09-01

    Sudden cardiac death is an international health issue. Implantable defibrillators have been effective in the secondary prevention of sudden cardiac death and are increasingly being utilized for primary prevention in individuals without a prior history of cardiac arrest or sustained ventricular tachycardia. Although it has been well documented that some recipients experience psychological distress and have difficulty in adjusting to the device, long-term data on psychological outcomes are limited. The aims of this study were to determine: (a) if there is a long-term relationship between uncertainty and psychosocial adjustment among implantable cardioverter defibrillator (ICD) recipients; and (b) if changes in uncertainty and/or adjustment occur over time. A longitudinal, descriptive, correlational design was used for this long-term follow-up study (M=9.4 years, SD=.23). Ninety-four patients from 4 major teaching hospitals in New England who had participated in an investigation of uncertainty and adjustment at 1 and 8 weeks following an initial ICD implant between 1996 and 1997 were solicited. From the original sample, 41 patients had expired (44%) and 5 had heart transplants (5%). Two individuals chose not to participate. Twenty-five persons (27%) were not found despite numerous attempts to locate them. The final sample included 21 subjects (22%). Following university institutional review board approval, a mail survey was administered using the Dillman method. Instruments included a demographic data questionnaire, the Psychosocial Adjustment to Illness Scale-Self-Report and the 2-factor version of the Mishel Uncertainty in Illness Scale. The final sample primarily included educated, married, white males. Uncertainty and adjustment levels did not change significantly over time. Early adjustment explained 40% of the variance in overall adjustment at long-term follow-up (P=.010). Men experienced significantly more uncertainty overall [t(19)=2.925, P=.009] and

  15. In vitro assessment of the immunity of implantable cardioverter-defibrillators to magnetic fields of 50/60 Hz.

    PubMed

    Katrib, J; Nadi, M; Kourtiche, D; Magne, I; Schmitt, P; Souques, M; Roth, P

    2013-10-01

    Public concern for the compatibility of electromagnetic (EM) sources with active implantable medical devices (AIMD) has prompted the development of new systems that can perform accurate exposure studies. EM field interference with active cardiac implants (e.g. implantable cardioverter-defibrillators (ICDs)) can be critical. This paper describes a magnetic field (MF) exposure system and the method developed for testing the immunity of ICD to continuous-wave MFs. The MFs were created by Helmholtz coils, housed in a Faraday cage. The coils were able to produce highly uniform MFs up to 4000 µT at 50 Hz and 3900 µT at 60 Hz, within the test space. Four ICDs were tested. No dysfunctions were found in the generated MFs. These results confirm that the tested ICDs were immune to low frequency MFs.

  16. Evaluation of a novel ventricular support device with defibrillation capabilities in canine and porcine animal models.

    PubMed

    Killingsworth, Cheryl R; Rippy, Marian K; Virmani, Renu; Rollins, Dennis L; McGiffin, David C; Ideker, Raymond E

    2008-08-01

    Sudden death is prevalent in heart failure patients. We tested an implantable ventricular support device consisting of a wireform harness with one or two pairs of integrated defibrillation electrode coils. The device was implanted into six pigs (36-44 kg) through a subxiphoid incision. Peak voltage (V) defibrillation thresholds (DFT) were determined for five test configurations compared with a control transvenous lead (RV to CanPect). Defibrillator can location (abdominal or pectoral) and common coil separation on the implant (0 degrees or 60 degrees ) were studied.(.) The DFT for RV60 to LV60 + CanPect was significantly less than control (348 +/- 57 vs 473 +/- 27 V, P < 0.05). The DFTs for other vectors were similar to control except for RV0 to LV0 + CanAbd (608 +/- 159 V). The device was implanted into 12 adult dogs for 42, 90, or 180 days with DFT and pathological examination performed at the terminal study. Cardiac pressures were determined at baseline, after implantation, and at the terminal study. The DFT was also determined in a separate group of four dogs at 42 days following implantation of the support device with one pair of defibrillation electrodes. The DFTs at implant and explant in dogs with one pair (8 +/- 1.5 Joules [J] and 6 +/- 1.9 J) or two pairs (8 +/- 3.4 J and 7 +/- 1.9 J) of defibrillation electrodes were not significantly different from each other but significantly less than control measured at the terminal study (18 +/- 3.4 J). Left-sided pressures were significantly decreased at explant but within expected normal ranges. Right-sided pressures were not different except for RV systolic. Histopathology indicated mild to moderate epicardial inflammation and fibrosis, consistent with a foreign body healing response. This defibrillation-enabled ventricular support system maintained mechanical functionality for up to 6 months while inducing typical chronic healing responses. The DFT was equal to or lower than a standard transvenous vector.

  17. Proportion of patients needing an implantable cardioverter defibrillator on the basis of current guidelines: impact on healthcare resources in Italy and the USA. Data from the ALPHA study registry.

    PubMed

    Pedretti, Roberto F E; Curnis, Antonio; Massa, Riccardo; Morandi, Fabrizio; Tritto, Massimo; Manca, Lorenzo; Occhetta, Eraldo; Molon, Giulio; De Ferrari, Gaetano M; Sarzi Braga, Simona; Raciti, Giovanni; Klersy, Catherine; Salerno-Uriarte, Jorge A

    2010-08-01

    Implantable cardioverter defibrillators (ICD) improve survival in selected patients with left ventricular dysfunction or heart failure (HF). The objective is to estimate the number of ICD candidates and to assess the potential impact on public health expenditure in Italy and the USA. Data from 3513 consecutive patients (ALPHA study registry) were screened. A model based on international guidelines inclusion criteria and epidemiological data was used to estimate the number of eligible patients. A comparison with current ICD implant rate was done to estimate the necessary incremental rate to treat eligible patients within 5 years. Up to 54% of HF patients are estimated to be eligible for ICD implantation. An implantation policy based on guidelines would significantly increase the ICD number to 2671 implants per million inhabitants in Italy and to 4261 in the USA. An annual increment of prophylactic ICD implants of 20% in the USA and 68% in Italy would be necessary to treat all indicated patients in a 5-year timeframe. Implantable cardioverter defibrillator implantation policy based on current evidence may have significant impact on public health expenditure. Effective risk stratification may be useful in order to maximize benefit of ICD therapy and its cost-effectiveness in primary prevention.

  18. "Real life" longevity of implantable cardioverter-defibrillator devices.

    PubMed

    Manolis, Antonis S; Maounis, Themistoklis; Koulouris, Spyridon; Vassilikos, Vassilios

    2017-09-01

    Manufacturers of implantable cardioverter-defibrillators (ICDs) promise a 5- to 9-year projected longevity; however, real-life data indicate otherwise. The aim of the present study was to assess ICD longevity among 685 consecutive patients over the last 20 years. Real-life longevity of ICDs may differ from that stated by the manufacturers. The study included 601 men and 84 women (mean age, 63.1 ± 13.3 years). The underlying disease was coronary (n = 396) or valvular (n = 15) disease, cardiomyopathy (n = 220), or electrical disease (n = 54). The mean ejection fraction was 35%. Devices were implanted for secondary (n = 562) or primary (n = 123) prevention. Single- (n = 292) or dual-chamber (n = 269) or cardiac resynchronization therapy (CRT) devices (n = 124) were implanted in the abdomen (n = 17) or chest (n = 668). Over 20 years, ICD pulse generator replacements were performed in 238 patients (209 men; age 63.7 ± 13.9 years; ejection fraction, 37.7% ± 14.0%) who had an ICD for secondary (n = 210) or primary (n = 28) prevention. The mean ICD longevity was 58.3 ± 18.7 months. In 20 (8.4%) patients, devices exhibited premature battery depletion within 36 months. Most (94%) patients had none, minor, or modest use of ICD therapy. Longevity was longest for single-chamber devices and shortest for CRT devices. Latest-generation devices replaced over the second decade lasted longer compared with devices replaced during the first decade. When analyzed by manufacturer, Medtronic devices appeared to have longer longevity by 13 to 18 months. ICDs continue to have limited longevity of 4.9 ± 1.6 years, and 8% demonstrate premature battery depletion by 3 years. CRT devices have the shortest longevity (mean, 3.8 years) by 13 to 17 months, compared with other ICD devices. These findings have important implications, particularly in view of the high expense involved with this type of electrical

  19. Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of ventricular fibrillation.

    PubMed

    Auricchio, A; Klein, H; Geller, C J; Reek, S; Heilman, M S; Szymkiewicz, S J

    1998-05-15

    The findings of our initial study demonstrate for the first time the ability to terminate induced VT/VF reliably (100% of all episodes) by a single, monophasic 230-J shock delivered by the Wearable Cardioverter-Defibrillator (WCD). Although limited by sample size, our data suggest the WCD could be used as a feasible bridge to definitive implantation of an implantable cardioverter-defibrillator in patients in whom risk stratification for sudden death is not completed.

  20. Wearable Cardioverter Defibrillators.

    PubMed

    Ferrick, Aileen M; Tian, David; Vudathaneni, Vijaya; Shevchuk, Olga L; Ferrick, Neal J; Frishman, William

    The use of implantable cardioverter defibrillators (ICD) has favorably impacted the prevention and treatment of sudden cardiac death (SCD) associated with ventricular arrhythmias. However, there are situations where an ICD cannot be immediately implanted, even though the patient is at high risk for SCD. The wearable cardioverter defibrillator (WCD) is a unique technology that can bridge this gap for patients. The WCD has been demonstrated to terminate ventricular tachycardia/fibrillation if worn and used correctly. With proper training, it is relatively easy to put on, maintain, and use. Most patients are compliant and are able to consistently wear the device. The WCD negates the infection risk or procedural complications associated with insertion and possible extraction of leads, as with an ICD. In terms of primary prevention of ventricular tachycardia/fibrillation in patients with a left ventricular ejection fraction ≤35%, prospective, randomized studies evaluating the survival of patients utilizing the WCD will need to be performed before evidenced-based criteria for its use can be established. On the basis of current data, WCD use for those awaiting heart transplant, for those with ICD indications status post-ICD explant, and for high-risk SCD patients with possible reversible cardiomyopathy appears to be a reasonable approach on the basis of current data.

  1. Posttraumatic stress 18 months following cardioverter defibrillator implantation: shocks, anxiety, and personality.

    PubMed

    Habibović, Mirela; van den Broek, Krista C; Alings, Marco; Van der Voort, Pepijn H; Denollet, Johan

    2012-03-01

    Posttraumatic stress disorder (PTSD) has been observed in cardiac patients, but little is known about PTSD in implantable cardioverter defibrillator (ICD) patients. We examined the prevalence and predictors (clinical variables, personality, and anxiety) of PTSD in ICD patients. Three hundred ninety-five ICD patients (20.1% female; mean age = 62.8 ± 10.3 years) from two Dutch referral hospitals completed the 14-item Type D scale (DS14) and the State-Trait Anxiety Inventory to assess Type D (distressed) personality (high negative affect with social inhibition) and anxiety (on the State Anxiety Inventory) at the time of implantation. Logistic regression analysis was performed to identify independent predictors of PTSD at 18 months postimplantation. At 18 months postimplantation, 30 patients (7.6%) qualified for a PTSD diagnosis. Of these patients, 55% (n = 16) had a Type D personality, 83% (n = 25) experienced anxiety at baseline, and 24% (n = 7) had experienced shocks during follow-up. Both Type D personality (odds ratio [OR] = 3.5) and baseline anxiety (OR = 4.3) were significant predictors of posttraumatic stress at 18 months postimplantation, independent of shocks and other clinical and demographic covariates. Shocks were not significantly associated with PTSD. A significant group of ICD patients is at risk of posttraumatic stress 18 months postimplantation, especially Type D patients and patients with increased levels of baseline anxiety. Identification of patients with Type D personality and anxiety at the time of implantation may be warranted to prevent PTSD in ICD patients.

  2. Interactions between pacing and arrhythmia detection algorithms in the dual chamber implantable cardioverter defibrillator.

    PubMed

    Dijkman, B; Wellens, H J

    2001-09-01

    Dual chamber implantable cardioverter defibrillator (ICD) combines the possibility to detect and treat ventricular and atrial arrhythmias with the possibility of modern heart stimulation techniques. Advanced pacing algorithms together with extended arrhythmia detection capabilities can give rise to new types of device-device interactions. Some of the possible interactions are illustrated by four cases documented in four models of dual chamber ICDs. Functioning of new features in dual chamber devices is influenced by the fact that the pacemaker is not a separate device but a part of the ICD system and that both are being used in a patient with arrhythmia. Programming measures are suggested to optimize use of new pacing algorithms while maintaining correct arrhythmia detection.

  3. [Semi-automatic defibrillators does not always interpret heart rhythms correctly. Five patients were defibrillated despite non-shockable rhythms].

    PubMed

    Wangenheim, Burkard; Israelsson, Johan; Lindstaedt, Michael; Carlsson, Jörg

    2015-08-04

    Automated external defibrillators (AED) have become an important part of the »the chain of survival« in case of sudden cardiac arrest (SCA), where early defibrillation is lifesaving. The American Heart Association demands that AEDs have a specificity of >99 % to recognize normal sinus rhythm and >95 % for the other non-shockable rhythms. Reports on their performance in the field are scarce. We present five cases in which AED recommended shock for apparently non-shockable rhythms. This indicates the necessity to systematically reevaluate AED performance.

  4. The wearable cardioverter-defibrillator: current technology and evolving indications.

    PubMed

    Reek, Sven; Burri, Haran; Roberts, Paul R; Perings, Christian; Epstein, Andrew E; Klein, Helmut U; Lip, Gregory; Gorenek, Bulent; Sticherling, Christian; Fauchier, Laurent; Goette, Andreas; Jung, Werner; Vos, Marc A; Brignole, Michele; Elsner, Christian; Dan, Gheorghe-Andrei; Marin, Francisco; Boriani, Giuseppe; Lane, Deirdre; Blomström-Lundqvist, Carina; Savelieva, Irina

    2017-03-01

    The wearable cardioverter-defibrillator has been available for over a decade and now is frequently prescribed for patients deemed at high arrhythmic risk in whom the underlying pathology is potentially reversible or who are awaiting an implantable cardioverter-defibrillator. The use of the wearable cardioverter-defibrillator is included in the new 2015 ESC guidelines for the management of ventricular arrhythmias and prevention of sudden cardiac death. The present review provides insight into the current technology and an overview of this approach. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  5. Diagnostic Value of MRI in Patients With Implanted Pacemakers and Implantable Cardioverter-Defibrillators Across a Cross Population: Does the Benefit Justify the Risk? A Proof of Concept Study.

    PubMed

    Samar, Huma; Yamrozik, June A; Williams, Ronald B; Doyle, Mark; Shah, Moneal; Bonnet, Christopher A; Biederman, Robert W W

    2017-09-01

    The objective of this study was to assess the diagnostic usefulness of thoracic and nonthoracic magnetic resonance imaging (MRI) imaging in patients with implantable cardiac devices (permanent pacemaker or implantable cardioverter-defibrillators [ICDs]) to determine if there was a substantial benefit to patients with regard to diagnosis and/or management. MRI is infrequently performed on patients with conventional pacemakers or ICDs. Multiple studies have documented the safety of MRI scans in patients with implanted devices, yet the diagnostic value of this approach has not been established. Evaluation data were acquired in 136 patients with implanted cardiac devices who underwent MRIs during a 10-year period at a single institution. Specific criteria were followed for all patients to objectively define if the diagnosis by MRI enhanced patient care; 4 questions were answered after scan interpretation by both MRI technologists and MRI physicians who performed the scan. 1) Did the primary diagnosis change? 2) Did the MRI provide additional information to the existing diagnosis? 3) Was the pre-MRI (tentative) diagnosis confirmed? 4) Did patient management change? If "Yes" was answered to any of the preceding questions, the MRI scan was considered to be of value to patient diagnosis and/or therapy. In 97% (n = 132) of patients, MR added value to patient diagnosis and management. In 49% (n = 67) of patients, MRI added additional valuable information to the primary diagnosis, and in 30% (n = 41) of patients, MRI changed the principle diagnosis and subsequent management of the patient. No safety issues were encountered, and no adverse effects of undergoing the MRI scan were noted in any patient. MRI in patients with implanted pacemakers and defibrillators added value to patient diagnosis and management, which justified the risk of the procedure. Published by Elsevier Inc.

  6. Results of ENHANCED Implantable Cardioverter Defibrillator Programming to Reduce Therapies and Improve Quality of Life (from the ENHANCED-ICD Study).

    PubMed

    Mastenbroek, Mirjam H; Pedersen, Susanne S; van der Tweel, Ingeborg; Doevendans, Pieter A; Meine, Mathias

    2016-02-15

    Novel implantable cardioverter defibrillator (ICD) discrimination algorithms and programming strategies have significantly reduced the incidence of inappropriate shocks, but there are still gains to be made with respect to reducing appropriate but unnecessary antitachycardia pacing (ATP) and shocks. We examined whether programming a number of intervals to detect (NID) of 60/80 for ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) detection was safe and the impact of this strategy on (1) adverse events related to ICD shocks and syncopal events; (2) ATPs/shocks; and (3) patient-reported outcomes. The "ENHANCED Implantable Cardioverter Defibrillator programming to reduce therapies and improve quality of life" study (ENHANCED-ICD study) was a prospective, safety-monitoring study enrolling 60 primary and secondary prevention patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technology and aged 18 to 80 years were eligible to participate. In all patients, a prolonged NID 60/80 was programmed. The cycle length for VT/fast VT/VF was 360/330/240 ms, respectively. Programming a NID 60/80 proved safe for ICD patients. Because of the new programming strategy, unnecessary ICD therapy was prevented in 10% of ENHANCED-ICD patients during a median follow-up period of 1.3 years. With respect to patient-reported outcomes, levels of distress were highest and perceived health status lowest at the time of implantation, which both gradually improved during follow-up. In conclusion, the ENHANCED-ICD study demonstrates that programming a NID 60/80 for VT/VF detection is safe for ICD patients and does not negatively impact their quality of life. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Performing magnetic resonance imaging in patients with implantable pacemakers and defibrillators: results of a European Heart Rhythm Association survey.

    PubMed

    Marinskis, Germanas; Bongiorni, Maria Grazia; Dagres, Nikolaos; Dobreanu, Dan; Lewalter, Thorsten; Blomström-Lundqvist, Carina

    2012-12-01

    The purpose of our survey was to evaluate the experience, current practice and attitudes of performing magnetic resonance imaging (MRI) studies in patients with cardiac implantable electronic devices. Fifty-one centre-members of European Heart Rhythm Association Research network have responded to the survey. According to the obtained data, 55.2% of responding centres do not perform MRI scans in patients with non-MRI-certified pacemakers and 65.8% in patients with such implantable cardioverter defibrillators (ICDs). Reported complication rate in patients with non-MRI-certified devices is low and conforms to the literature data. Experience with newer MRI-compatible pacemakers and ICDs is limited to single cases in most centres. This survey shows limited experience with performing MRI studies in patients with implanted pacemakers and ICDs. In concordance with available guidelines, most centres limit MRI scans in patients with non-MRI-certified devices. The implant numbers for MRI-certified devices and experience with performing MRI scans in these patients are still low.

  8. Prospective Observational Study of Implantable Cardioverter‐Defibrillators in Primary Prevention of Sudden Cardiac Death: Study Design and Cohort Description

    PubMed Central

    Cheng, Alan; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Zhang, Yiyi; Dickfeld, Timm; Eldadah, Zayd A.; Ellenbogen, Kenneth A.; Guallar, Eliseo; Tomaselli, Gordon F.

    2013-01-01

    Background Primary‐prevention implantable cardioverter‐defibrillators (ICDs) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter‐Defibrillators (PROSE‐ICD) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing ICD implantation for primary prevention of sudden death. Methods and Results This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is ICD shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal‐averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6 months and after every known ICD shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow‐up of 59 months. The PROSE‐ICD study represents a real‐world cohort of individuals with systolic heart failure receiving primary‐prevention ICDs. Conclusions Extensive electrophysiological and structural phenotyping as well as the availability of serial DNA and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death. Clinical Trial Registration URL: http://clinicaltrials.gov/ Unique Identifier: NCT00733590. PMID:23525420

  9. Evidence of Cognitive Bias in Decision Making Around Implantable-Cardioverter Defibrillators: A Qualitative Framework Analysis.

    PubMed

    Matlock, Daniel D; Jones, Jacqueline; Nowels, Carolyn T; Jenkins, Amy; Allen, Larry A; Kutner, Jean S

    2017-11-01

    Studies have demonstrated that patients with primary prevention implantable cardioverter-defibrillators (ICDs) often misunderstand the ICD. Advances in behavioral economics demonstrate that some misunderstandings may be due to cognitive biases. We aimed to explore the influence of cognitive bias on ICD decision making. We used a qualitative framework analysis including 9 cognitive biases: affect heuristic, affective forecasting, anchoring, availability, default effects, halo effects, optimism bias, framing effects, and state dependence. We interviewed 48 patients from 4 settings in Denver. The majority were male (n = 32). Overall median age was 61 years. We found frequent evidence for framing, default, and halo effects; some evidence of optimism bias, affect heuristic, state dependence, anchoring and availability bias; and little or no evidence of affective forecasting. Framing effects were apparent in overestimation of benefits and downplaying or omitting potential harms. We found evidence of cognitive bias in decision making for ICD implantation. The majority of these biases appeared to encourage ICD treatment. Published by Elsevier Inc.

  10. Automated implantable cardioverter defibrillator lead infection in a patient with previous superior vena cava thrombosis.

    PubMed

    Connelly, Tara; Siddiqui, Sadiq; Kolcow, Walenty; Veerasingam, Dave

    2015-11-04

    We present a case of a 44-year-old woman who presented with cough, pleuritic chest pain and fever leading to a diagnosis of pneumonia±pulmonary embolism. She had a history of familial hypertrophic obstructive cardiomyopathy (HOCM), for which an automated implantable cardioverter defibrillator (AICD) had been implanted, and a subsequent superior vena cava (SVC) thrombus, for which she was anticoagulated with warfarin. On admission, blood cultures grew a coagulase-negative Staphylococcus. CT pulmonary angiogram and transoesophageal echocardiography (TOE) were performed and revealed large vegetations adherent to the AICD leads with complete occlusion of the SVC. The infected leads were the source of sepsis. Open surgery was planned. For cardiopulmonary bypass, the venous cannula was inserted in the inferior vena cava (IVC) and a completely bloodless field was obtained in the right atrium allowing for the extraction of the AICD leads completely, along with the adherent vegetations from within. 2015 BMJ Publishing Group Ltd.

  11. Relation between total shock energy and mortality in patients with implantable cardioverter-defibrillator.

    PubMed

    Tenma, Taro; Yokoshiki, Hisashi; Mitsuyama, Hirofumi; Watanabe, Masaya; Mizukami, Kazuya; Kamada, Rui; Takahashi, Masayuki; Sasaki, Ryo; Maeno, Motoki; Okamoto, Kaori; Chiba, Yuki; Anzai, Toshihisa

    2018-05-15

    Implantable Cardioverter-Defibrillator (ICD) shocks have been associated with mortality. However, no study has examined the relation between total shock energy and mortality. The aim of this study is to assess the association of total shock energy with mortality, and to determine the patients who are at risk of this association. Data from 316 consecutive patients who underwent initial ICD implantation in our hospital between 2000 and 2011 were retrospectively studied. We collected shock energy for 3 years from the ICD implantation, and determined the relation of shock energy on mortality after adjusting confounding factors. Eighty-seven ICD recipients experienced shock(s) within 3 years from ICD implantation and 43 patients had died during the follow-up. The amount of shock energy was significantly associated with all-cause death [adjusted hazard ratio (HR) 1.26 (per 100 joule increase), p < 0.01] and tended to be associated with cardiac death (adjusted HR 1.30, p = 0.08). The survival rate of patients with high shock energy accumulation (≥182 joule) was lower (p < 0.05), as compared to low shock energy accumulation (<182 joule), likewise to no shock. Besides, the relation between high shock energy accumulation and all-cause death was remarkable in the patients with low left ventricular ejection fraction (LVEF ≤40%) or atrial fibrillation (AF). Increase of shock energy was related to mortality in ICD recipients. This relation was evident in patients with low LVEF or AF. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. Do women benefit equally as men from the primary prevention implantable cardioverter-defibrillator?

    PubMed

    Barra, Sérgio; Providência, Rui; Boveda, Serge; Narayanan, Kumar; Virdee, Munmohan; Marijon, Eloi; Agarwal, Sharad

    2018-06-01

    Women traditionally have been and are still underrepresented in research in many important areas of cardiology, and guideline recommendations which also encompass women are mostly based on research conducted predominantly in men. However, there is plausible cause to believe that sex may have a potential influence on the benefit derived from the implantable cardioverter-defibrillators (ICD), alone or in association with cardiac resynchronization therapy. We assessed the possible relationship between sex and outcome with ICD implantation in the setting of primary prevention, by pooling the results of MUSTT, MADIT-II, DEFINITE, COMPANION, SCD-HeFT and DANISH trials in a meta-analysis. We pooled results for female and male patients separately. The results suggest that women as a group do not seem to obtain a significant survival benefit from the primary prevention ICD, contrary to men. This in turn may also have contributed to a relative underestimation of the ICD benefit among males when looking at the results in total. It is time for the medical and research communities to actively question the presumed overarching benefit of ICDs irrespective of sex and engage in systematic scientific efforts to definitively evaluate the value of this intervention in women.

  13. Performance of the 2015 International Task Force Consensus Statement Risk Stratification Algorithm for Implantable Cardioverter-Defibrillator Placement in Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy.

    PubMed

    Orgeron, Gabriela M; Te Riele, Anneline; Tichnell, Crystal; Wang, Weijia; Murray, Brittney; Bhonsale, Aditya; Judge, Daniel P; Kamel, Ihab R; Zimmerman, Stephan L; Tandri, Harikrishna; Calkins, Hugh; James, Cynthia A

    2018-02-01

    Ventricular arrhythmias are a feared complication of arrhythmogenic right ventricular dysplasia/cardiomyopathy. In 2015, an International Task Force Consensus Statement proposed a risk stratification algorithm for implantable cardioverter-defibrillator placement in arrhythmogenic right ventricular dysplasia/cardiomyopathy. To evaluate performance of the algorithm, 365 arrhythmogenic right ventricular dysplasia/cardiomyopathy patients were classified as having a Class I, IIa, IIb, or III indication per the algorithm at baseline. Survival free from sustained ventricular arrhythmia (VT/VF) in follow-up was the primary outcome. Incidence of ventricular fibrillation/flutter cycle length <240 ms was also assessed. Two hundred twenty-four (61%) patients had a Class I implantable cardioverter-defibrillator indication; 80 (22%), Class IIa; 54 (15%), Class IIb; and 7 (2%), Class III. During a median 4.2 (interquartile range, 1.7-8.4)-year follow-up, 190 (52%) patients had VT/VF and 60 (16%) had ventricular fibrillation/flutter. Although the algorithm appropriately differentiated risk of VT/VF, incidence of VT/VF was underestimated (observed versus expected: 29.6 [95% confidence interval, 25.2-34.0] versus >10%/year Class I; 15.5 [confidence interval 11.1-21.6] versus 1% to 10%/year Class IIa). In addition, the algorithm did not differentiate survival free from ventricular fibrillation/flutter between Class I and IIa patients ( P =0.97) or for VT/VF in Class I and IIa primary prevention patients ( P =0.22). Adding Holter results (<1000 premature ventricular contractions/24 hours) to International Task Force Consensus classification differentiated risks. While the algorithm differentiates arrhythmic risk well overall, it did not distinguish ventricular fibrillation/flutter risks of patients with Class I and IIa implantable cardioverter-defibrillator indications. Limited differentiation was seen for primary prevention cases. As these are vital uncertainties in clinical decision

  14. ICD defibrillation failure solved in an unusual fashion.

    PubMed

    Oliveira, Ricardo Gil; Madeira, Francisco; Ferreira, Ana Rita; Antunes, Susana; Morais, Carlos; Gil, Victor

    2010-04-01

    An implantable cardioverter defibrillator (ICD) is designed to sense life-threatening ventricular arrhythmias and terminate them, either by rapid pacing or by delivering an electrical shock. Nowadays it is a proven therapy for both primary and secondary prevention of sudden cardiac death. The typical configuration of an ICD consists of a right ventricular sensing/defibrillator lead with two coils (one distal, located in the right ventricle, and one proximal, located at the superior vena cava-right atrium junction) and an active can, the so-called "ventricular triad". Although effective in the vast majority of patients, it could be argued that this is not the most rational arrangement in electrical terms, since the main shock vector is anteriorly displaced in relation to the greater portion of the left ventricular mass. We describe a case of an ICD defibrillation failure that was solved by placing an additional defibrillator lead in a tributary of the coronary sinus.

  15. [The wearable cardioverter/defibrillator : Temporary protection from sudden cardiac death].

    PubMed

    Duncker, D; Bauersachs, J; Veltmann, C

    2016-09-01

    In the majority of cases sudden cardiac death (SCD) is caused by ventricular tachyarrhythmia. Implantable cardioverter-defibrillators (ICD) represent an evidence-based and established method for prevention of SCD. For patients who do not fulfill the criteria for guideline-conform implantation of an ICD but still have an increased, e.g. transient risk for SCD, a wearable cardioverter-defibrillator (WCD) vest was developed to temporarily prevent SCD. Numerous studies have shown the safety and efficacy of the WCD, although there is still a gap in evidence concerning a reduction in overall mortality and improvement in prognosis. This article gives an overview on the currently available literature on WCD, the indications, potential risks and complications.

  16. Implantable intravascular defibrillator: defibrillation thresholds of an intravascular cardioverter-defibrillator compared with those of a conventional ICD in humans.

    PubMed

    Neuzil, Petr; Reddy, Vivek Y; Merkely, Bela; Geller, Laszlo; Molnar, Levente; Bednarek, Jacek; Bartus, Krzysztof; Richey, Mark; Bsee, T J Ransbury; Sanders, William E

    2014-02-01

    A percutaneous intravascular cardioverter-defibrillator (PICD) has been developed with a right ventricular (RV) single-coil lead and titanium electrodes in the superior vena cava (SVC)-brachiocephalic vein (BCV) region and the inferior vena cava (IVC). To compare defibrillation thresholds (DFTs) of the PICD with those of a conventional ICD in humans. Ten patients with ischemic cardiomyopathy and ejection fraction ≤35% were randomized to initial testing with either PICD or conventional ICD. A standard dual-coil lead was positioned in the RV apex. If randomized to PICD, the device was placed into the vasculature such that 1 titanium electrode was positioned in the SVC-BCV region and the second in the IVC. For PICD DFTs, the RV coil of the conventional ICD lead was connected to the PICD mandrel [shock vector: RV (+) to SVC-BCV (-) + IVC (-)]. When testing the conventional ICD, a subcutaneous pocket was formed in the left pectoralis region and the ICD was connected to the lead system and positioned in the pocket [shock vector: RV (+) to SVC (-) + active can (-)]. Each device was removed before testing with the other. A step-down binary search protocol determined the DFT, with the initial shock being 9 J. The mean PICD DFT was 7.6 ± 3.3 J, and the conventional ICD system demonstrated a mean DFT of 9.5 ± 4.7 J (N = 10; paired t test, P = .28). The intravascular defibrillator has DFTs similar to those of commercially available ICDs. Published by Heart Rhythm Society on behalf of Heart Rhythm Society.

  17. Gender disparities in quality of life and psychological disturbance in patients with implantable cardioverter-defibrillators.

    PubMed

    Rahmawati, Anita; Chishaki, Akiko; Sawatari, Hiroyuki; Tsuchihashi-Makaya, Miyuki; Ohtsuka, Yuko; Nakai, Mori; Miyazono, Mami; Hashiguchi, Nobuko; Sakurada, Harumizu; Takemoto, Masao; Mukai, Yasushi; Inoue, Shujiro; Sunagawa, Kenji; Chishaki, Hiroaki

    2013-01-01

    Implantable cardioverter-defibrillator (ICD) has improved prognosis in fatal arrhythmia and the number of ICD implantations has increased. ICD-related psychological problems and impaired quality of life (QOL), however, have been observed. This study examined whether gender differences exist in QOL and psychological disturbances in ICD patients. Consecutive outpatients (n=179; mean age, 60.5±15.9 years; 81% male) with ICD implantations completed questionnaires consisting of the Short Form-8 (SF-8), Beck Depression Inventory, Impact of Event Scale-Revised (IES-R), State-Trait Anxiety Inventory, and Worries about ICD. One-way multivariate analysis of variance (MANOVA) showed women to have impaired QOL on the role physical functioning (F15,157=4.57, P<0.05) and bodily pain (F15,157=5.26, P<0.05) subscales of the SF-8. More women reported depression (F15,157=5.37, P<0.05) and worry about ICD than men (F15,157=6.62, P<0.05). Moreover, women also had higher IES-R scores indicating post-traumatic stress disorder (PTSD) than men (F15,157=5.87, P<0.05). Women reported poorer QOL on 2 subscales: role physical functioning and bodily pain. There was a significant relationship between gender and depression, worry about ICD, and PTSD, but not for anxiety. Female patients need more psychological interventions following ICD implantation.  

  18. Safety of the Wearable Cardioverter Defibrillator (WCD) in Patients with Implanted Pacemakers.

    PubMed

    Schmitt, Joern; Abaci, Guezine; Johnson, Victoria; Erkapic, Damir; Gemein, Christopher; Chasan, Ritvan; Weipert, Kay; Hamm, Christian W; Klein, Helmut U

    2017-03-01

    The wearable cardioverter defibrillator (WCD) is an important approach for better risk stratification, applied to patients considered to be at high risk of sudden arrhythmic death. Patients with implanted pacemakers may also become candidates for use of the WCD. However, there is a potential risk that pacemaker signals may mislead the WCD detection algorithm and cause inappropriate WCD shock delivery. The aim of the study was to test the impact of different types of pacing, various right ventricular (RV) lead positions, and pacing modes for potential misleading of the WCD detection algorithm. Sixty patients with implanted pacemakers received the WCD for a short time and each pacing mode (AAI, VVI, and DDD) was tested for at least 30 seconds in unipolar and bipolar pacing configuration. In case of triggering the WCD detection algorithm and starting the sequence of arrhythmia alarms, shock delivery was prevented by pushing of the response buttons. In six of 60 patients (10%), continuous unipolar pacing in DDD mode triggered the WCD detection algorithm. In no patient, triggering occurred with bipolar DDD pacing, unipolar and bipolar AAI, and VVI pacing. Triggering was independent of pacing amplitude, RV pacing lead position, and pulse generator implantation site. Unipolar DDD pacing bears a high risk of false triggering of the WCD detection algorithm. Other types of unipolar pacing and all bipolar pacing modes do not seem to mislead the WCD detection algorithm. Therefore, patients with no reprogrammable unipolar DDD pacing should not become candidates for the WCD. © 2016 Wiley Periodicals, Inc.

  19. Feedback to providers improves evidence-based implantable cardioverter-defibrillator programming and reduces shocks.

    PubMed

    Silver, Marc T; Sterns, Laurence D; Piccini, Jonathan P; Joung, Boyoung; Ching, Chi-Keong; Pickett, Robert A; Rabinovich, Rafael; Liu, Shufeng; Peterson, Brett J; Lexcen, Daniel R

    2015-03-01

    Implantable cardioverter-defibrillator (ICD) shocks are associated with increased anxiety, health care utilization, and potentially mortality. The purpose of the Shock-Less Study was to determine if providing feedback reports to physicians on their adherence to evidence-based shock reduction programming could improve their programming behavior and reduce shocks. Shock-Less enrolled primary prevention (PP) and secondary prevention (SP) ICD patients between 2009 and 2012 at 118 study centers worldwide and followed patients longitudinally after their ICD implant. Center-specific therapy programming reports (TPRs) were delivered to each center 9 to 12 months after their first enrollment. The reports detailed adherence to evidence-based programming targets: number of intervals to detect ventricular fibrillation (VF NID), longest treatment interval (LTI), supraventricular tachycardia (SVT) discriminators (Wavelet, PR Logic), SVT limit, Lead Integrity Alert (LIA), and antitachycardia pacing (ATP). Clinicians programmed ICDs at their discretion. The primary outcome measure was the change in utilization of evidence-based shock reduction programming before (phase I, n = 2694 patients) and after initiation of the TPR (phase II, n = 1438 patients). Patients implanted after feedback reports (phase II) were up to 20% more likely to have their ICDs programmed in line with evidence-based shock reduction programming (eg, VF NID in PP patients 30/40 in 33.5% vs 18.6%, P < .0001). Patients implanted in phase II had a lower risk of all-cause shock (adjusted hazard ratio 0.72, 95% confidence interval 0.58-0.90, P = .003). Providing programming feedback reports improves adherence to evidence-based shock reduction programming and is associated with lower risk of ICD shocks. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  20. Beta-blocker therapy is not associated with symptoms of depression and anxiety in patients receiving an implantable cardioverter-defibrillator.

    PubMed

    Hoogwegt, Madelein T; Kupper, Nina; Theuns, Dominic A M J; Jordaens, Luc; Pedersen, Susanne S

    2012-01-01

    Beta-blockers are frequently prescribed to implantable cardioverter-defibrillator (ICD) patients. Beta-blocker therapy has been proposed to induce emotional distress such as depression and anxiety, but a paucity of studies has examined the relationship between beta-blockers and distress. We investigated the association between beta-blocker therapy, including type and dosage, and symptoms of anxiety and depression in a consecutive cohort of patients receiving an ICD. Between 2003 and 2010, 448 consecutively implanted ICD patients were enrolled in the prospective Mood and personality as precipitants of arrhythmia in patients with an Implantable cardioverter Defibrillator: A prospective Study (MIDAS), of which 429 completed the Hospital Anxiety and Depression Scale (HADS) and the ICD Patient Concerns questionnaire (ICDC) at baseline. Eighty per cent of all patients received beta-blocker therapy. In univariate analysis, beta-blocker therapy was not significantly associated with symptoms of anxiety, depression, and ICD concerns (β = -0.030, β = 0.007, and β = -0.045, respectively; all P's >0.36). Type of beta-blocker showed a trend towards significance for mean levels of ICD concerns (P = 0.09). No association was found between dosage and emotional distress (all P's >0.21). After adjustment for relevant clinical and demographic variables, the association of beta-blocker therapy and symptoms of anxiety, depression, and ICD concerns remained non-significant (β = 0.009, β = 0.037, and β = 0.019, respectively; all P's >0.47). In patients receiving an ICD, beta-blocker therapy was not associated with symptoms of anxiety, depression, and ICD concerns. Research is warranted that further elucidates the link between beta-blocker therapy and emotional distress in this vulnerable patient group.

  1. Trajectories of perceived emotional and physical distress in patients with an implantable cardioverter defibrillator.

    PubMed

    van den Broek, Krista C; Kupper, Nina; van der Voort, Pepijn H; Alings, Marco; Denollet, Johan; Nyklíček, Ivan

    2014-02-01

    Little is known about the course of emotional and physical distress in patients with an implantable cardioverter defibrillator (ICD). We examined (1) trajectories of emotional and physical distress in the first 18 months postimplantation and (2) predictors of these trajectories, including demographical, clinical, and personality factors. Dutch patients with an ICD (N = 645) completed measures on anxiety, depression, somatic symptoms, and perceived disability at the time of implantation, and 2, 12, and 18 months postimplantation. Measures on Type D personality (tendency to inhibit the expression of negative emotions) and anxiety sensitivity (tendency to fear anxiety-related sensations) were also completed at baseline. Latent class analysis (LatentGOLD) identified six to seven distinct trajectories, varying largely in overall levels of distress, and remaining relatively stable after a small initial decline. Multinomial regression showed that Type D personality and anxiety sensitivity were the most prominent predictors, particularly of trajectories that reflected higher distress levels. Cardiac resynchronization therapy and coronary artery disease also increased the risk for distress, whereas ICD indication and shocks did not. The course of emotional and physical distress may be relatively stable after ICD implantation. In clinical practice, identification of patients with high risk of higher levels of emotional and physical distress may be warranted; as such, patients with high levels of anxiety sensitivity or a Type D personality should be identified and offered behavioral support.

  2. An inappropriate pacing threshold increase after repeated electrical storm in a patient with implantable cardioverter defibrillator.

    PubMed

    Zhu, Ye; Gu, Xiang; Xu, Chao

    2017-10-16

    Implantable cardioverter defibrillators (ICD) are capable of effectively terminating malignant ventricular arrhythmia and are the most effective way to prevent sudden cardiac death. However, some evidences demonstrated that both anti-tachycardia pacing (ATP) and ICD shock can also bring adverse prognosis. A 66-year-old Han Chinese man with prior ICD implantation was admitted to our hospital because of frequent ICD shocks. Although intravenous amiodarone and esmolol succinate were administered daily, the patient suffered 155 episodes of VT/VF during 8 weeks after implantation. After repeated discharge of the device, the pacing threshold of the patient increased gradually. Considering the inappropriate increase of the pacing threshold, we decided to reposition the right ventricular (RV) lead with good sensing and threshold parameters confirmed. Subsequent 22 months interrogation follow-up revealed a stable lead position and electrical specifications. Furthermore, antiarrhythmic drugs were maximally increased, while ATP burst was remarkably decreased and the inappropriate ICD shock never occurred until now. An inappropriate pacing threshold was increased secondary to repeated ICD electrical storm. A timely active lead position adjustment reduced the pacing threshold and eliminated the risk of premature battery depletion.

  3. The benefits of remote monitoring in long-term care for patients with implantable cardioverter-defibrillators.

    PubMed

    Ošmera, Ondřej; Bulava, Alan

    2014-01-01

    The increasing number of patients with implantable cardiac devices raises the need for more efficient outpatient follow-up care. Due to technological progress in communication and transmission systems and in the implantable devices themselves, telemonitoring can be widely used as an important part of care for patients and devices. Our objective was to evaluate the benefits of continuous remote monitoring using the BIOTRONIK Home Monitoring® (HM) system compared to standard outpatient follow-ups. 198 patients with single- or dual-chamber implantable cardioverter-defibrillator (ICD) implanted for primary or secondary prevention of sudden cardiac death were randomized into a group of patients followed through standard outpatient visits ( HM-) and a group telemonitored by the HM system (HM+). Planned and emergency visits, ICD-related hospitalizations, and delivered shocks and their appropriateness were evaluated in the respective groups. A significant reduction was achieved in the number of planned (by 48%, p<0.001) and total visits (by 45%, p<0.001) during a three-year evaluation. A comparable number of patients experienced one or more shocks. Mortality rates were equivalent, as was the number of patients hospitalized in relation to their ICD. However, there was a significant reduction in the number and proportion of inappropriate shocks delivered in the HM+ patient group: by 80% (p=0.002) in outpatient follow-up care and by 90% (p<0.001) when multiple shocks requiring hospitalization were included. The HM system was an effective and safe method of follow-up in patients with an implanted ICD. Remote monitoring reduces the number of outpatient visits and inappropriate shocks.

  4. Antitachycardia pacing programming in implantable cardioverter defibrillator: A systematic review.

    PubMed

    De Maria, Elia; Giacopelli, Daniele; Borghi, Ambra; Modonesi, Letizia; Cappelli, Stefano

    2017-05-26

    Implantable cardioverter defibrillator (ICD) programming involves several parameters. In recent years antitachycardia pacing (ATP) has gained an increasing importance in the treatment of ventricular arrhythmias, whether slow or fast. It reduces the number of unnecessary and inappropriate shocks and improves both patient's quality of life and device longevity. There is no clear indication regarding the type of ATP to be used, except for the treatment of fast ventricular tachycardias (188 bpm-250 bpm) where it has been shown a greater efficacy and safety of burst compared to ramp; 8 impulses in each sequence of ATP appears to be the best programming option in this setting. Beyond ATP use, excellent clinical results were obtained with programming standardization following these principles: extended detection time in ventricular fibrillation (VF) zone; supraventricular discrimination criteria up to 200 bpm; first shock in VF zone at the maximum energy in order to reduce the risk of multiple shocks. The MADIT-RIT trial and some observational registries have also recently demonstrated that programming with a widespread use of ATP, higher cut-off rates or delayed intervention reduces the number of inappropriate and unnecessary therapies and improves the survival of patients during mid-term follow-up.

  5. Time dependence of risks and benefits in pediatric primary prevention implantable cardioverter-defibrillator therapy.

    PubMed

    DeWitt, Elizabeth S; Triedman, John K; Cecchin, Frank; Mah, Doug Y; Abrams, Dominic J; Walsh, Edward P; Gauvreau, Kimberlee; Alexander, Mark E

    2014-12-01

    Implantable cardioverter defibrillators (ICDs) used to prevent sudden cardiac arrest in children not only provide appropriate therapy in 25% of patients but also result in a significant incidence of inappropriate shocks and other device complications. ICDs placed for secondary prevention have higher rates of appropriate therapy than those placed for primary prevention. Pediatric patients with primary prevention ICDs were studied to determine time-dependent incidence of appropriate use and adverse events. A total of 140 patients aged <21 years (median age, 15 years) at first ICD implantation at Boston Children's Hospital (2000-2009) in whom devices were placed for primary prevention were retrospectively identified. Demographics and times to first appropriate shock; adverse events (including inappropriate shock, lead failure, reintervention, and complication); generator replacement and follow-up were noted. During mean follow-up of 4 years, appropriate shock occurred in 19% patients and first adverse event (excluding death/transplant) occurred in 36%. Risk of death or transplant was ≈1% per year and was not related to receiving appropriate therapy. Conditional survival analysis showed rates of appropriate therapy and adverse events decrease soon after implantation, but adverse events are more frequent than appropriate therapy throughout follow-up. Primary prevention ICDs were associated with appropriate therapy in 19% and adverse event in 36% in this cohort. The incidence of both first appropriate therapy and device-related adverse events decreased during longer periods of follow-up after implantation. This suggests that indications for continued device therapy in pediatric primary prevention ICD patients might be reconsidered after a period of nonuse. © 2014 American Heart Association, Inc.

  6. Lithium-manganese dioxide cells for implantable defibrillator devices-Discharge voltage models

    NASA Astrophysics Data System (ADS)

    Root, Michael J.

    The discharge potential behavior of lithium-manganese dioxide cells designed for implantable cardiac defibrillators was characterized as a function of extent of cell depletion for tests designed to discharge the cells for times between 1 and 7 years. The discharge potential curves may be separated into two segments from 0 ≤ x ≤ ∼0.51 and ∼0.51 ≤ x ≤ 1.00, where x is the dimensionless extent of discharge referenced to the rated cell capacity. The discharge potentials conform to Tafel kinetics in each segment. This behavior allows the discharge potential curves to be predicted for an arbitrary discharge load and long term discharge performance may be predicted from short term test results. The discharge potentials may subsequently be modeled by fitting the discharge curves to empirical functions like polynomials and Padé approximants. A function based on the Nernst equation that includes a term accounting for nonideal interactions between lithium ions and the cathode host material, such as the Redlich-Kister relationship, also may be used to predict discharge behavior.

  7. Ambient temperature and activation of implantable cardioverter defibrillators

    NASA Astrophysics Data System (ADS)

    McGuinn, L.; Hajat, S.; Wilkinson, P.; Armstrong, B.; Anderson, H. R.; Monk, V.; Harrison, R.

    2013-09-01

    The degree to which weather influences the occurrence of serious cardiac arrhythmias is not fully understood. To investigate, we studied the timing of activation of implanted cardiac defibrillators (ICDs) in relation to daily outdoor temperatures using a fixed stratum case-crossover approach. All patients attending ICD clinics in London between 1995 and 2003 were recruited onto the study. Temperature exposure for each ICD patient was determined by linking each patient's postcode of residence to their nearest temperature monitoring station in London and the South of England. There were 5,038 activations during the study period. Graphical inspection of ICD activation against temperature suggested increased risk at lower but not higher temperatures. For every 1 °C decrease in ambient temperature, risk of ventricular arrhythmias up to 7 days later increased by 1.2 % (95 % CI -0.6 %, 2.9 %). In threshold models, risk of ventricular arrhythmias increased by 11.2 % (0.5 %, 23.1 %) for every 1° decrease in temperature below 2 °C. Patients over the age of 65 exhibited the highest risk. This large study suggests an inverse relationship between ambient outdoor temperature and risk of ventricular arrhythmias. The highest risk was found for patients over the age of 65. This provides evidence about a mechanism for some cases of low-temperature cardiac death, and suggests a possible strategy for reducing risk among selected cardiac patients by encouraging behaviour modification to minimise cold exposure.

  8. The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients.

    PubMed

    Varma, Niraj; Piccini, Jonathan P; Snell, Jeffery; Fischer, Avi; Dalal, Nirav; Mittal, Suneet

    2015-06-23

    Remote monitoring (RM) technology embedded within cardiac rhythm devices permits continuous monitoring, which may result in improved patient outcomes. This study used "big data" to assess whether RM is associated with improved survival and whether this is influenced by the type of cardiac device and/or its degree of use. We studied 269,471 consecutive U.S. patients implanted between 2008 and 2011 with pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) with pacing capability (CRT-P)/defibrillation capability (CRT-D) with wireless RM. We analyzed weekly use and all-cause survival for each device type by the percentage of time in RM (%TRM) stratified by age. Socioeconomic influences on %TRM were assessed using 8 census variables from 2012. The group had implanted PMs (n = 115,076; 43%), ICDs (n = 85,014; 32%), CRT-D (n = 61,475; 23%), and CRT-P (n = 7,906; 3%). When considered together, 127,706 patients (47%) used RM, of whom 67,920 (53%) had ≥75%TRM (high %TRM) and 59,786 (47%) <75%TRM (low %TRM); 141,765 (53%) never used RM (RM None). RM use was not affected by age or sex, but demonstrated wide geographic and socioeconomic variability. Survival was better in high %TRM versus RM None (hazard ratio [HR]: 2.10; p < 0.001), in high %TRM versus low %TRM (HR: 1.32; p < 0.001), and also in low %TRM versus RM None (HR: 1.58; p < 0.001). The same relationship was observed when assessed by individual device type. RM is associated with improved survival, irrespective of device type (including PMs), but demonstrates a graded relationship with the level of adherence. The results support the increased application of RM to improve patient outcomes. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  9. High-intensity cardiac rehabilitation training of a firefighter after placement of an implantable cardioverter-defibrillator

    PubMed Central

    DeJong, Sandra; Arnett, Justin K.; Kennedy, Kathleen; Franklin, Jay O.; Berbarie, Rafic F.

    2014-01-01

    Firefighters who have received an implantable cardioverter-defibrillator (ICD) are asked to retire or are permanently placed on restricted duty because of concerns about their being incapacitated by an ICD shock during a fire emergency. We present the case of a 40-year-old firefighter who, after surviving sudden cardiac arrest and undergoing ICD implantation, sought to demonstrate his fitness for active duty by completing a high-intensity, occupation-specific cardiac rehabilitation training program. The report details the exercise training, ICD monitoring, and stress testing that he underwent. During the post-training treadmill stress test in firefighter turnout gear, the patient reached a functional capacity of 17 metabolic equivalents (METs), exceeding the 12-MET level required for his occupation. He had no ICD shock therapy or recurrent sustained arrhythmias during stress testing or at any time during his cardiac rehabilitation stay. By presenting this case, we hope to stimulate further discussion about firefighters who have an ICD, can meet the functional capacity requirements of their occupation, and want to return to work. PMID:24982569

  10. High-intensity cardiac rehabilitation training of a firefighter after placement of an implantable cardioverter-defibrillator.

    PubMed

    Adams, Jenny; DeJong, Sandra; Arnett, Justin K; Kennedy, Kathleen; Franklin, Jay O; Berbarie, Rafic F

    2014-07-01

    Firefighters who have received an implantable cardioverter-defibrillator (ICD) are asked to retire or are permanently placed on restricted duty because of concerns about their being incapacitated by an ICD shock during a fire emergency. We present the case of a 40-year-old firefighter who, after surviving sudden cardiac arrest and undergoing ICD implantation, sought to demonstrate his fitness for active duty by completing a high-intensity, occupation-specific cardiac rehabilitation training program. The report details the exercise training, ICD monitoring, and stress testing that he underwent. During the post-training treadmill stress test in firefighter turnout gear, the patient reached a functional capacity of 17 metabolic equivalents (METs), exceeding the 12-MET level required for his occupation. He had no ICD shock therapy or recurrent sustained arrhythmias during stress testing or at any time during his cardiac rehabilitation stay. By presenting this case, we hope to stimulate further discussion about firefighters who have an ICD, can meet the functional capacity requirements of their occupation, and want to return to work.

  11. [Subcutaneous implantable cardioverter-defibrillator in prevention of sudden cardiac death in Poland - opinion paper endorsed by the Polish Cardiac Society Working Group on Heart Rhythm].

    PubMed

    Ptaszyński, Paweł; Grabowski, Marcin; Kowalski, Oskar; Kempa, Maciej; Mitkowski, Przemysław; Przybylski, Andrzej; Sterliński, Maciej

    2017-01-01

    In the past years, cardiovascular mortality has decreased but despite these cardiovascular diseases are responsible for millions of deaths every year in the world and approximately 25% of which are sudden cardiac death (SCD). Implantable defibrillators (ICD) is proven therapy used in primary and secondary SCD prevention. Currently majority of devices use transvenous leads inserted predominantly into the right heart for both pacing and defibrillation. On the other hand, ICD may cause complica-tions, including inappropriate shocks, device-related infection and lead failure. Problems with transvenous leads prompted the development of a subcutaneous defibrillator (S-ICD) with an electrode system that is placed entirely subcutaneously, outside the thoracic cavity. The device may be useful when venous access is difficult, in young patients and in patients at particular risk of infection. S-ICD is not suitable for patients with indications for bradycardia pacing, cardiac resynchronisation therapy and in cases with tachyarrhythmia easily terminated by antitachycardia pacing.

  12. Low risk of electromagnetic interference between smartphones and contemporary implantable cardioverter defibrillators.

    PubMed

    Burri, Haran; Mondouagne Engkolo, Louis Paulin; Dayal, Nicolas; Etemadi, Abdul; Makhlouf, Anne-Marie; Stettler, Carine; Trentaz, Florence

    2016-05-01

    Manufacturers of implantable cardioverter defibrillators (ICDs) recommend that cell phones be maintained at a distance of ∼15 cm from the implanted device in order to avoid risk of dysfunction due to electromagnetic interference (EMI). Data relating to this issue are outdated and do not reflect modern technology. Our aim was to evaluate whether EMI is still an issue with contemporary ICDs and smartphones. Consecutive patients implanted with a wireless-enabled ICD were tested for potential interference with two models of recent 4G smartphones in conditions intended to maximize risk of EMI. A magnet effect (due to the phone speakers) was tested by placing the smartphones in the standby mode directly over the ICD generator. The presence of EMI artefacts on the real-time electrograms was evaluated by placing the smartphones in the standby, dialling, and operating modes directly over the generator casing and over the parasternal region in the vicinity of the ventricular lead. A total of 63 patients equipped with 29 different models of single, dual, or biventricular ICDs from five major manufacturers were included. None of the patients showed any evidence of interference with the smartphones during any of the 882 tests. The risk of EMI between modern smartphones and contemporary ICDs is low. This is probably due to the filters incorporated in the ICDs and low emission by the phones, as well as the small size of the magnets in the smartphones tested. NCT02330900 (http://www.clinicaltrials.gov). Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  13. Wearable Cardioverter-Defibrillators following Cardiac Surgery-A Single-Center Experience.

    PubMed

    Heimeshoff, Jan; Merz, Constanze; Ricklefs, Marcel; Kirchhoff, Felix; Haverich, Axel; Bara, Christoph; Kühn, Christian

    2018-06-20

     A wearable cardioverter-defibrillator (WCD) can terminate ventricular fibrillation and ventricular tachycardias via electrical shock and thus give transient protection from sudden cardiac death. We investigated its role after cardiac surgery.  We retrospectively analyzed all patients who were discharged with a WCD from cardiac surgery department. The WCD was prescribed for patients with a left ventricular ejection fraction (LVEF) of ≤35% or an explanted implantable cardioverter-defibrillator (ICD).  A total of 100 patients were included in this study, the majority ( n  = 59) had received coronary artery bypass graft surgery. The median wearing time of a WCD patient was 23.5 hours per day. LVEF was 28.9 ± 8% after surgery and improved in the follow-up to 36.7 ± 11% ( p  < 0.001). Three patients were successfully defibrillated. Ten patients experienced ventricular tachycardias. No inappropriate shocks were given. An ICD was implanted in 25 patients after the WCD wearing period.  Ventricular arrhythmias occurred in 13% of the investigated patients. LVEF improved significantly after 3 months, and thus a permanent ICD implantation was avoided in several cases. Sternotomy did not impair wearing time of the WCD. A WCD can effectively protect patients against ventricular tachyarrhythmias after cardiac surgery. Georg Thieme Verlag KG Stuttgart · New York.

  14. Does defibrillation testing influence outcomes after CRT-D implantation? A cause-of-death analysis from the DAI-PP study.

    PubMed

    Perrin, Tilman; Mechulan, Alexis; Boveda, Serge; Beganton, Frankie; Defaye, Pascal; Sadoul, Nicolas; Piot, Olivier; Klug, Didier; Gras, Daniel; Perier, Marie-Cécile; Algalarrondo, Vincent; Bordachar, Pierre; Babuty, Dominique; Fauchier, Laurent; Leclercq, Christophe; Marijon, Eloi; Deharo, Jean-Claude

    2016-10-15

    Little data address the usefulness of defibrillation testing in patients with prolonged QRS duration, known for more advanced myocardial disease. We aimed to compare baseline characteristics and outcomes between patients who underwent defibrillation testing (DT+) and those who did not (DT-), immediately after the implantation of a cardiac resynchronization therapy with defibrillator (CRT-D). Data from all patients with ischemic or non-ischemic cardiomyopathy implanted in primary prevention with a CRT-D in 12 French centers were considered for analysis (2002-2012). Out of the 1516 patients with DT information available, DT was performed in 958(63%) patients. Compared to DT- patients, DT+ patients presented no significant differences in terms of age (65.1±10.8 vs 64.7±10.3years, p=0.45), LVEF (25%[20.0-30.0] vs 25%[20.5-30.0], p=0.30), or etiologies of heart failure (ischemic: 49.6% vs 46.9%, p=0.32). By contrast, DT+ patients were less likely to present atrial fibrillation (25.3% vs 33.4%, p=0.001), renal insufficiency (eGFR<60ml/min in 45.3% vs 51.7%, p=0.04) and NYHA functional class≥III (68.9% vs 77.4%, p=0.0006). All of the three perioperative deaths occurred in the DT+ group and were related to DT itself. After a mean follow-up of 3.1±2.1years, the adjusted incidence of overall mortality was lower among DT+ patients (adjusted HR 0.6, 95%CI 0.4-0.7, p<0.0001). However, ICD-unresponsive sudden deaths remained very rare and no more frequently observed among DT- patients (p=0.41). In our cohort, the higher (up to 40%) mortality at midterm among DT- patients is mainly reflecting their more severe cardiac disease, rather than a higher rate of ICD-unresponsive sudden death. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Validation of a defibrillation lead ventricular volume measurement compared to three-dimensional echocardiography.

    PubMed

    Haines, David E; Wong, Wilson; Canby, Robert; Jewell, Coty; Houmsse, Mahmoud; Pederson, David; Sugeng, Lissa; Porterfield, John; Kottam, Anil; Pearce, John; Valvano, Jon; Michalek, Joel; Trevino, Aron; Sagar, Sandeep; Feldman, Marc D

    2017-10-01

    There is increasing evidence that using frequent invasive measures of pressure in patients with heart failure results in improved outcomes compared to traditional measures. Admittance, a measure of volume derived from preexisting defibrillation leads, is proposed as a new technique to monitor cardiac hemodynamics in patients with an implantable defibrillator. The purpose of this study was to evaluate the accuracy of a new ventricular volume sensor (VVS, CardioVol) compared with 3-dimenssional echocardiography (echo) in patients with an implantable defibrillator. Twenty-two patients referred for generator replacement had their defibrillation lead attached to VVS to determine the level of agreement to a volume measurement standard (echo). Two opposite hemodynamic challenges were sequentially applied to the heart (overdrive pacing and dobutamine administration) to determine whether real changes in hemodynamics could be reliably and repeatedly assessed with VVS. Equivalence of end-diastolic volume (EDV) and stroke volume (SV) determined by both methods was also assessed. EDV and SV were compared using VVS and echo. VVS tracked expected physiologic trends. EDV was modulated -10% by overdrive pacing (14 mL). SV was modulated -13.7% during overdrive pacing (-6 mL) and increased over baseline +14.6% (+8 mL) with dobutamine. VVS and echo mean EDVs were found statistically equivalent, with margin of equivalence 13.8 mL (P <.05). Likewise, mean SVs were found statistically equivalent with margin of equivalence 15.8 mL (P <.05). VVS provides an accurate method for ventricular volume assessment using chronically implanted defibrillator leads and is statistically equivalent to echo determination of mean EDV and SV. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  16. How does an implantable cardioverter defibrillator (ICD) affect the lives of patients and their families?

    PubMed

    Eckert, Marion; Jones, Tina

    2002-06-01

    This study aimed to identify the lived experience of patients with implantable cardioverter defibrillators (ICD) and their families. The methodology used was interpretative phenomenology. Unstructured interviews were conducted with three family members and three ICD recipients. Using a methodological approach outlined by van Manen, the participants transcribed texts were analysed looking for similar concepts and ideas that developed into themes that explicated the meaning of this phenomena. The themes that emerged were: dependence, which encompassed their perceptions about the life-saving device; the memory of their first defibrillation experience; lifestyle changes, which incorporated modification techniques; lack of control, which highlighted feelings such as fear, anxiety and powerlessness; mind game, which illustrated psychological challenges; and the issue of security, demonstrating how 'being there' and not 'being there' impacted on their everyday lives. The long-term outcomes of living with an ICD are important considerations for all health-care providers. This research highlights the everyday activities of recipients, the lifestyle changes they have made, the emotional significance of the device and the psychological coping strategies that the participants have adopted. The findings of this research will allow health-care professionals to be better prepared to provide education and support for ICD recipients and their families in regards to issues related to insertion of the device during the postinsertion recovery period and for long-term management after hospital discharge.

  17. Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study.

    PubMed

    Kowey, Peter R; Crijns, Harry J G M; Aliot, Etienne M; Capucci, Alessandro; Kulakowski, Piotr; Radzik, David; Roy, Denis; Connolly, Stuart J; Hohnloser, Stefan H

    2011-12-13

    Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death. Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction ≤40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation-triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile. Celivarone was not effective for the prevention of ICD interventions or sudden death. http://www.clinicaltrials.gov. Unique identifier: NCT00993382.

  18. Thirteen-year nationwide trends in use of implantable cardioverter-defibrillators and subsequent long-term survival.

    PubMed

    Schmidt, Morten; Pedersen, Susanne Bendesgaard; Farkas, Dóra Körmendiné; Hjortshøj, Søren Pihlkjær; Bøtker, Hans Erik; Nielsen, Jens Cosedis; Sørensen, Henrik Toft

    2015-09-01

    Long-term trends in use of implantable cardioverter-defibrillators (ICDs) and outcomes are rare. We examined 13-year nationwide trends in ICD implantation and survival rates in Denmark. Using medical databases, we identified all first time ICD recipients in Denmark during 2000-2012 (N = 8460) and ascertained all-cause mortality. We computed standardized annual implantation rates and mortality rate ratios according to age, sex, comorbidity level, indication, and device type. The standardized annual implantation rate increased from 42 per million persons in 2000 to 213 per million persons in 2012 (from 34 to 174 for men and from 8 to 39 for women). The increase was driven by secondary prophylactic ICDs until 2006 and primary prophylactic ICDs thereafter. The increase occurred particularly in older patients and those with a high level of comorbidity. Independent of indication, 76% of all patients with ICD were alive after 5 years. Men had a higher mortality rate compared with women (mortality rate ratio 1.28; 95% confidence interval 1.10-1.49). Compared with low comorbidity level, moderate, severe, and very severe comorbidity levels were associated with 1.6-, 2.5-, and 4.9-fold increased mortality rates, respectively. The most influential individual comorbidities were heart failure, diabetes, liver disease, and renal disease. The annual implantation rate of ICDs increased 5-fold in Denmark between 2000 and 2012. The rate increase occurred for both men and women, but particularly in the elderly and patients with severe comorbidity. Five-year survival probability was high, but severe comorbidity and male sex were associated with shorter survival. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  19. Inadvertent transarterial insertion of atrial and ventricular defibrillator leads.

    PubMed

    Issa, Ziad F; Rumman, Syeda S; Mullin, James C

    2009-01-01

    Inadvertent placement of pacemaker and implantable cardioverter-defibrillator (ICD) leads in the left ventricle (LV) is a rare but well-recognized complication of device implantation [1]. We report a case of inadvertent transarterial implantation of dual-chamber ICD leads; the ventricular lead positioned in the LV and the atrial lead positioned in the aortic root. The tip of the atrial lead migrated across the aortic wall and captured the epicardial surface of the left atrium. The diagnosis was made 5 years after the implantation procedure with no apparent adverse events directly related to left heart lead placement.

  20. Clinical Experience With the Subcutaneous Implantable Cardioverter-Defibrillator in Adults With Congenital Heart Disease.

    PubMed

    Moore, Jeremy P; Mondésert, Blandine; Lloyd, Michael S; Cook, Stephen C; Zaidi, Ali N; Pass, Robert H; John, Anitha S; Fish, Frank A; Shannon, Kevin M; Aboulhosn, Jamil A; Khairy, Paul

    2016-09-01

    Sudden cardiac death is a major contributor to mortality for adults with congenital heart disease. The subcutaneous implantable cardioverter-defibrillator (ICD) has emerged as a novel tool for prevention of sudden cardiac death, but clinical performance data for adults with congenital heart disease are limited. A retrospective study involving 7 centers over a 5-year period beginning in 2011 was performed. Twenty-one patients (median 33.9 years) were identified. The most common diagnosis was single ventricle physiology (52%), 9 palliated by Fontan operation and 2 by aortopulmonary shunts: d-transposition of the great arteries after Mustard/Senning (n=2), tetralogy of Fallot (n=2), aortic valve disease (n=2), and other biventricular surgery (n=4). A prior cardiac device had been implanted in 7 (33%). The ICD indication was primary prevention in 67% and secondary in 33% patients. The most common reason for subcutaneous ICD placement was limited transvenous access for ventricular lead placement (n=10) followed by intracardiac right-to-left shunt (n=5). Ventricular arrhythmia was induced in 17 (81%) and was converted with ≤80 Joules in all. There was one implant complication related to infection, not requiring device removal. Over a median follow-up of 14 months, 4 patients (21%) received inappropriate and 1 (5%) patient received appropriate shocks. There was one arrhythmic death related to asystole in a single ventricle patient. Subcutaneous ICD implantation is feasible for adults with congenital heart disease patients. Most candidates have single ventricle heart disease and limited transvenous options for ICD placement. Despite variable anatomy, this study demonstrates successful conversion of induced ventricular arrhythmia and reasonable rhythm discrimination during follow-up. © 2016 American Heart Association, Inc.

  1. The Number of Recalled Leads is Highly Predictive of Lead Failure: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS").

    PubMed

    Kersten, Daniel J; Yi, Jinju; Feldman, Alyssa M; Brahmbhatt, Kunal; Asheld, Wilbur J; Germano, Joseph; Islam, Shahidul; Cohen, Todd J

    2016-12-01

    The purpose of this study was to determine if implantation of multiple recalled defibrillator leads is associated with an increased risk of lead failure. The authors of the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS") have previously reported a relationship between recalled lead status, lead failure, and patient mortality. This substudy analyzes the relationship in a smaller subset of patients who received more than one recalled lead. The specific effects of having one or more recalled leads have not been previously examined. This study analyzed lead failure and mortality of 3802 patients in PAIDLESS and compared outcomes with respect to the number of recalled leads received. PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Patients with no recalled ICD leads, one recalled ICD lead, and two recalled ICD leads were compared using the Kaplan-Meier method and log-rank test. Sidak adjustment method was used to correct for multiple comparisons. All calculations were performed using SAS 9.4. P-values <.05 were considered statistically significant. This study included 4078 total ICD leads implanted during the trial period. There were 2400 leads (59%) in the no recalled leads category, 1620 leads (40%) in the one recalled lead category, and 58 leads (1%) in the two recalled leads category. No patient received more than two recalled leads. Of the leads categorized in the two recalled leads group, 12 experienced lead failures (21%), which was significantly higher (P<.001) than in the no recalled leads group (60 failures, 2.5%) and one recalled lead group (81 failures; 5%). Multivariable Cox's regression analysis found a total of six significant predictive variables for lead failure including the number of recalled leads (P<.001 for one and two recalled leads group). The number of recalled leads is highly predictive of lead failure. Lead

  2. Pacemakers and implantable cardioverter defibrillators: device longevity is more important than smaller size: the patient's viewpoint.

    PubMed

    Wild, David M; Fisher, John D; Kim, Soo G; Ferrick, Kevin J; Gross, Jay N; Palma, Eugen C

    2004-11-01

    The size of pacemakers and implantable cardioverter defibrillators (ICDs) has been diminishing progressively. If two devices are otherwise identical in components, features and technology, the one with a larger battery should have a longer service life. Therefore, patients who receive smaller devices may require more frequent surgery to replace the devices. It is uncertain whether this tradeoff for smaller size is desired by patients. We surveyed 156 patients to determine whether patients prefer a larger, longer-lasting device, or a smaller device that is less noticeable but requires more frequent surgery. The effects of subgroups were evaluated; these included body habitus, age, gender, and patients seen at time of pulse generator replacement (PGR), initial implant, or follow-up. Among 156 patients surveyed, 151 expressed a preference. Of these, 90.1% preferred the larger device and 9.9% the smaller device (P <0.0001). Among thin patients, 79.5% preferred a larger device. Ninety percent of males and 89.2% of females selected the larger device. Among younger patients (< or =72 years), 89.6% preferred the larger device, as did 90.5% of older patients (>72 years). Of patients undergoing PGR or initial implants, 95% favored the larger device, as did 86% of patients presenting for follow-up. The vast majority of patients prefer a larger device to reduce the number of potential replacement operations. This preference crosses the spectrum of those with a previously implanted device, those undergoing initial implants, those returning for routine follow-up, and patients of various ages, gender, and habitus.

  3. Prognostic role of post-infarction C-reactive protein in patients undergoing implantation of cardioverter-defibrillators: design of the C-reactive protein Assessment after Myocardial Infarction to GUide Implantation of DEfibrillator (CAMI GUIDE) study.

    PubMed

    Bellocci, Fulvio; Biasucci, Luigi M; Gensini, Gian Franco; Padeletti, Luigi; Raviele, Antonio; Santini, Massimo; Giubilato, Giovanna; Landolina, Maurizio; Biondi-Zoccai, Giuseppe; Raciti, Giovanni; Sassara, Massimo; Castro, Antonello; Kheir, Antoine; Crea, Filippo

    2007-04-01

    Patients at risk of sudden cardiac death (SCD) after myocardial infarction (MI) can currently be offered effective means of prevention, such as implantable cardioverter-defibrillators (ICD). However, predictors of SCD able to identify those patients who are at higher risk are still lacking. Whether C-reactive protein (CRP), a serum inflammatory marker with established prognostic accuracy after MI, can also be a predictor of SCD is unclear. The CAMI GUIDE study is designed to evaluate the prognostic role of CRP in patients undergoing ICD implantation after MI according to MADIT II criteria (i.e. left ventricular ejection fractionimplantation; clinical follow-up will last 24 months. The primary endpoint is the combined rate of SCD or fast ventricular tachycardia/ventricular fibrillation. Secondary endpoints will be total mortality, death due to acute coronary syndromes, death from pump failure, non-fatal MI, coronary revascularization, hospitalization for congestive heart failure or unstable angina and inappropriate ICD shocks. Twenty-four Italian centers will participate in enrollment of the 290 patients planned according to power analysis. The CAMI GUIDE study will assess the predictive role of CRP in SCD in patients with previous MI undergoing ICD implantation. Its results will improve risk stratification, thereby enabling better-tailored and more cost-effective therapies to be undertaken in those patients whose need is greatest.

  4. Automatic Frequency Controller for Power Amplifiers Used in Bio-Implanted Applications: Issues and Challenges

    PubMed Central

    Hannan, Mahammad A.; Hussein, Hussein A.; Mutashar, Saad; Samad, Salina A.; Hussain, Aini

    2014-01-01

    With the development of communication technologies, the use of wireless systems in biomedical implanted devices has become very useful. Bio-implantable devices are electronic devices which are used for treatment and monitoring brain implants, pacemakers, cochlear implants, retinal implants and so on. The inductive coupling link is used to transmit power and data between the primary and secondary sides of the biomedical implanted system, in which efficient power amplifier is very much needed to ensure the best data transmission rates and low power losses. However, the efficiency of the implanted devices depends on the circuit design, controller, load variation, changes of radio frequency coil's mutual displacement and coupling coefficients. This paper provides a comprehensive survey on various power amplifier classes and their characteristics, efficiency and controller techniques that have been used in bio-implants. The automatic frequency controller used in biomedical implants such as gate drive switching control, closed loop power control, voltage controlled oscillator, capacitor control and microcontroller frequency control have been explained. Most of these techniques keep the resonance frequency stable in transcutaneous power transfer between the external coil and the coil implanted inside the body. Detailed information including carrier frequency, power efficiency, coils displacement, power consumption, supplied voltage and CMOS chip for the controllers techniques are investigated and summarized in the provided tables. From the rigorous review, it is observed that the existing automatic frequency controller technologies are more or less can capable of performing well in the implant devices; however, the systems are still not up to the mark. Accordingly, current challenges and problems of the typical automatic frequency controller techniques for power amplifiers are illustrated, with a brief suggestions and discussion section concerning the progress of

  5. Antitachycardia pacing programming in implantable cardioverter defibrillator: A systematic review

    PubMed Central

    De Maria, Elia; Giacopelli, Daniele; Borghi, Ambra; Modonesi, Letizia; Cappelli, Stefano

    2017-01-01

    Implantable cardioverter defibrillator (ICD) programming involves several parameters. In recent years antitachycardia pacing (ATP) has gained an increasing importance in the treatment of ventricular arrhythmias, whether slow or fast. It reduces the number of unnecessary and inappropriate shocks and improves both patient’s quality of life and device longevity. There is no clear indication regarding the type of ATP to be used, except for the treatment of fast ventricular tachycardias (188 bpm-250 bpm) where it has been shown a greater efficacy and safety of burst compared to ramp; 8 impulses in each sequence of ATP appears to be the best programming option in this setting. Beyond ATP use, excellent clinical results were obtained with programming standardization following these principles: extended detection time in ventricular fibrillation (VF) zone; supraventricular discrimination criteria up to 200 bpm; first shock in VF zone at the maximum energy in order to reduce the risk of multiple shocks. The MADIT-RIT trial and some observational registries have also recently demonstrated that programming with a widespread use of ATP, higher cut-off rates or delayed intervention reduces the number of inappropriate and unnecessary therapies and improves the survival of patients during mid-term follow-up. PMID:28603590

  6. EMT-defibrillation: a recipe for saving lives.

    PubMed

    Paris, P M

    1988-05-01

    Sudden cardiac death is the number-one cause of death in this country. It has long been known that most of these deaths occur outside of the hospital, therefore necessitating an approach to the problem involving prehospital care. The development of advanced life support emergency medical systems has had a dramatic impact on improving survival in selected communities. Most of the country continues to see little result because of our inability to provide timely defibrillation. Automatic external defibrillators now provide a safe, reliable, proven method to increase the number of "saves" in rural, urban, and suburban communities. This new tool, if widely used, will allow us to save scores of "hearts too good to die."

  7. Increasing sex differences in the use of cardiac resynchronization therapy with or without implantable cardioverter-defibrillator

    PubMed Central

    Chatterjee, Neal A.; Borgquist, Rasmus; Chang, Yuchiao; Lewey, Jennifer; Jackson, Vicki A.; Singh, Jagmeet P.; Metlay, Joshua P.; Lindvall, Charlotta

    2017-01-01

    Aims Previous studies have identified sex disparities in the use of cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD), although the basis of underutilization in women remains poorly understood. The aim of this study was to assess sex differences in patterns of CRT use with our without ICD. Methods and results In this cross-sectional study using the National Inpatient Sample database we identified 311 009 patients undergoing CRT implantation in the United States between 2006 and 2012. Demographic and clinical characteristics were compared between men and women undergoing CRT implantation, with special attention to clinical predictors of left ventricular reverse remodelling (CRT response, score range: 0–4) and reduced ICD efficacy (score range: 0–7). When compared to men, women undergoing CRT implantation were significantly more likely to have ≥ 3 predictors of CRT response (47.3 vs. 33.2%, P < 0.001) and less likely to have ≥3 predictors of reduced ICD efficacy (27.0 vs. 37.3%, P < 0.001). Despite this, men were significantly more likely to undergo CRT with ICD (CRT-D) as the type of CRT (88.6 vs. 80.1% of all CRT implants). Compared to those with the greatest likelihood of CRT response (score ≥ 3), those with the least likelihood of CRT response had a significant decreased odds of CRT-D implant (adj odds ratio 0.27 [0.24–0.31], P < 0.001), with a greater decreased odds in women compared to men (P, for sex interaction <0.001). The difference in the % of CRT-D implant in men vs. women increased over the study period (P, sex Δ time trend = 0.012). Conclusion In this large, contemporary cohort, sex differences in CRT-D implantation were inversely related to predicted CRT efficacy and have increased over time. Future efforts to narrow the gap in CRT-D implantation in men and women may help better align device selection with those most likely to benefit. PMID:28065904

  8. Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry.

    PubMed

    Kramer, Daniel B; Reynolds, Matthew R; Normand, Sharon-Lise; Parzynski, Craig S; Spertus, John A; Mor, Vincent; Mitchell, Susan L

    2017-02-01

    To evaluate the incidence and characteristics of nursing home (NH) use after implantable cardioverter-defibrillator (ICD) implantation. Cohort study. Medicare beneficiaries in the National Cardiovascular Data Registry-ICD Registry. Individuals aged 65 and older receiving ICDs between January 1, 2006, and March 31, 2010 (N = 192,483). Proportion of ICD recipients discharged to NHs directly after device placement, cumulative incidence of long-term NH admission, and factors associated with immediate discharge to a NH and time to long-term NH admission. Over 4 years, 40.6% of the cohort died, and 35,939 (18.7%) experienced at least one NH admission, including 4.0% directly discharged to a NH after ICD implantation and 2.8% admitted to long-term NH care during follow-up. The cumulative incidence of long-term NH admission, accounting for the competing risk of death, was 1.7% at 1 year, 3.8% at 3 years, and 4.6% at 4 years; 20.1% of individuals admitted to a NH died there. Factors most strongly associated with direct NH discharge and time to long-term NH care were older age (adjusted odds ratio (AOR) = 2.09, 95% confidence interval (CI) = 2.01-2.17 per 10-year increment; adjusted hazard ratio (AHR) = 1.88, 95% CI = 1.80-1.97, respectively), dementia (AOR = 2.60, 95% CI = 2.25-3.01; AHR = 2.50, 95% CI = 2.14-2.93, respectively), and Medicare Part A claim for NH stay in prior 6 months (AOR = 3.96, 95% CI = 3.70-4.25; AHR = 2.88, 95% CI = 2.65-3.14, respectively). Nearly one in five individuals are admitted to NHs over a median of 1.6 years of follow-up after ICD implantation. Understanding these outcomes may help inform the clinical care of these individuals. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  9. Remote monitoring of implantable cardioverter-defibrillators. Problems and implications using a telemonitoring system.

    PubMed

    Siebermair, J; Clauss, S; Martens, E; Schuessler, F; Oversohl, N; Haserueck, N; Estner, H L; Kääb, S; Wakili, R

    2015-04-01

    The rising number of implantable devices has led to an increase in device-related workload, e.g., regular interrogation follow-up visits. Telemonitoring systems for implantable cardioverter-defibrillators (ICDs) seem to be a promising tool for reducing workload and costs, and they have the potential of optimizing patient care. However, issues such as practical functionality of ICD telemonitoring in daily routine may affect its broad implementation. The objective of this study was to evaluate potential problems during the implementation of a telemonitoring system, Medtronic CareLink™ (CL™) with respect to the installation and data transmission process. A total of 159 patients with ICDs who were equipped with the CL™ system were evaluated and followed up for 16 months regarding the success rate of the first data transmission via the telemonitoring system. In this cohort, a high rate of nontransmission of 23.9 % was observed after the 16-month follow-up. A detailed interview of these patients (no transmission) revealed that the main reasons for failed transmissions were due to the patients' loss of interest in the concept (approximately 50 %) as well as technical problems (approximately 25 %) with setting up the system. These results indicate that telemonitoring systems bear potential problems and that the evaluation of patient motivation and technical support options seems to play an important role in establishing the functionality of these systems.

  10. Diagnosis and therapy of atrial tachyarrhythmias in the dual chamber implantable cardioverter defibrillator.

    PubMed

    Dijkman, B; Wellens, H J

    2000-11-01

    Devices capable of monitoring and treating atrial tachyarrhythmias provide information about the natural history of the arrhythmias and potentially can influence their natural course by electrical therapy early after onset. Types of atrial arrhythmias and efficacy of device therapies were evaluated in 30 patients implanted with the Medtronic model 7250 Jewel AF implantable cardioverter defibrillator (ICD). All patients had structural heart disease and documented sustained ventricular and atrial arrhythmias (27 with atrial fibrillation [AF]) before implant. Twenty patients were taking amiodarone, and three were taking sotalol. During 20+/-10 months of follow-up, 600 atrial arrhythmia recurrences were documented in 50% of patients. AF was diagnosed in 19%, fast polymorphic atrial tachycardia (AT) in 20%, fast monomorphic AT in 57%, and slow AT in 4% of episodes. The two adaptive pacing therapies, burst and ramp, together with the 50-Hz burst, were successful in 57% of detected atrial arrhythmias. Burst and ramp were responsible for 49% and 50-Hz burst for 51% of successfully treated arrhythmias; 33% of the episodes terminated spontaneously. No ventricular proarrhythmia was observed due to atrial pacing therapies. In 30% of episodes, dual chamber pacing was required due to post termination bradycardia. Atrial arrhythmia recurrences in patients with dilated cardiomyopathy were not amenable to pacing therapies. Several aspects of atrial arrhythmia diagnosis, therapy, and documentation that are specific for functioning of the Jewel AF are discussed. Atrial arrhythmias in ICD patients with diseased hearts who are taking Class III antiarrhythmics frequently had longer cycle lengths than AF. Half of these arrhythmias could be terminated with pacing therapies; one third terminated spontaneously.

  11. Implantable cardioverter defibrillators for primary prevention in patients with nonischemic cardiomyopathy: A systematic review and meta-analysis.

    PubMed

    Akel, Tamer; Lafferty, James

    2017-06-01

    Implantable cardioverter defibrillators (ICDs) have proved their favorable outcomes on survival in selected patients with cardiomyopathy. Although previous meta-analyses have shown benefit for their use in primary prevention, the evidence remains less robust for patients with nonischemic cardiomyopathy (NICM) in comparison to patients with coronary artery disease (CAD). To evaluate the effect of ICD therapy on reducing all-cause mortality and sudden cardiac death (SCD) in patients with NICM. PubMed (1993-2016), the Cochrane Central Register of Controlled Trials (2000-2016), reference lists of relevant articles, and previous meta-analyses. Search terms included defibrillator, heart failure, cardiomyopathy, randomized controlled trials, and clinical trials. Eligible trials were randomized controlled trials with at least an arm of ICD, an arm of medical therapy and enrolled some patients with NICM. The primary endpoint in the trials should include all-cause mortality or mortality from SCD. Hazard ratios (HRs) for all-cause mortality and mortality from SCD were either extracted or calculated along with their standard errors. Of the 1047 abstracts retained by the initial screen, eight randomized controlled trials were identified. Five of these trials reported relevant data regarding patients with NICM and were subsequently included in this meta-analysis. Pooled analysis of HRs suggested a statistically significant reduction in all-cause mortality among a total of 2573 patients randomized to ICD vs medical therapy (HR 0.80; 95% CI, 0.67-0.96; P=.02). Pooled analysis of HRs for mortality from SCD was also statistically significant (n=1677) (HR 0.51; 95% CI, 0.34-0.76; P=.001). ICD implantation is beneficial in terms of all-cause mortality and mortality from SCD in certain subgroups of patients with NICM. © 2017 John Wiley & Sons Ltd.

  12. Decision-Making of Patients With Implantable Cardioverter-Defibrillators at End of Life: Family Members' Experiences.

    PubMed

    Lee, Mei Ching; Sulmasy, Daniel P; Gallo, Joseph; Kub, Joan; Hughes, Mark T; Russell, Stuart; Kellogg, Anela; Owens, Sharon G; Terry, Peter; Nolan, Marie T

    2017-07-01

    Many patients with advanced heart failure (HF) experience the life-extending benefits of implantable cardioverter-defibrillators (ICD), but at the end stage of HF, patients may experience shocks with increasing frequency and change the plan for end-of-life (EOL) care including the deactivation of the ICD. This report describes family members' experiences of patients with ICD making decisions at EOL. Understanding the decision-making of patients with ICD at EOL can promote informed decision-making and improve the quality of EOL care. This pilot study used a mixed methods approach to test the effects of a nurse-guided discussion in decision-making about ICD deactivation (turning off the defibrillation function) at the EOL. Interviews were conducted, audiotaped, and transcribed in 2012 to 2013 with 6 family members of patients with advanced HF and ICDs. Three researchers coded the data and identified themes in 2014. Three main themes described family members' experiences related to patients having HF with ICDs making health-care decision at EOL: decision-making preferences, patients' perception on ICD deactivation, and communication methods. Health-care providers need to have knowledge of patients' decision-making preferences. Preferences for decision-making include the allowing of appropriate people to involve and encourages direct conversation with family members even when advance directives is completed. Information of ICD function and the option of deactivation need to be clearly delivered to patients and family members. Education and guidelines will facilitate the communication of the preferences of EOL care.

  13. Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention.

    PubMed

    Ascoeta, Maria Soledad; Marijon, Eloi; Defaye, Pascal; Klug, Didier; Beganton, Frankie; Perier, Marie-Cécile; Gras, Daniel; Algalarrondo, Vincent; Deharo, Jean-Claude; Leclercq, Christophe; Fauchier, Laurent; Babuty, Dominique; Bordachar, Pierre; Sadoul, Nicolas; Boveda, Serge; Piot, Olivier

    2016-05-01

    The lifesaving benefit of implantable cardioverter-defibrillators (ICDs) has been demonstrated. Their use has increased considerably in the past decade, but related complications have become a major concern. The purpose of this study was to assess the incidence and effect on outcomes of early (≤30 days) complications after ICD implantation for primary prevention in a large French population. We analyzed data from 5539 patients from the multicenter French DAI-PP (Défibrillateur Automatique Implantable-Prévention Primaire) registry (2002-2012) who had coronary artery disease or dilated cardiomyopathy and were implanted with an ICD for primary prevention. Overall, early complications occurred in 707 patients (13.5%), mainly related to lead dislodgment or hematoma (57%). Independent factors associated with occurrence of early complications were severe renal impairment (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.17-2.37, P = .02), age ≥75 years (OR 1.01, 95% CI 1.00-1.02, P = .03), cardiac resynchronization therapy (OR 1.58, 95% CI 1.16-2.17, P = .01), and anticoagulant therapy (OR 1.28, 95% CI 1.02-1.61, P = .03). During a mean ± SD follow-up of 3.1 ± 2.3 years, 824 (15.8%) patients experienced ≥1 late complication (>30 days), and 782 (14.9%) patients died. After adjustment, early complications remained associated with occurrence of late complications (OR 2.15, 95% CI 1.73-2.66, P < .0001) and mortality (OR 1.70, 95% CI 1.34-2.17, P = .003). Early complications are common after ICD implantation for primary prevention, occurring in 1 in 7 patients, and are associated with an increased risk of late complications and overall mortality. Further studies are needed to investigate the underlying mechanisms of such associations. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  14. Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort.

    PubMed

    Larsen, Jacob M; Hjortshøj, Søren P; Nielsen, Jens C; Johansen, Jens B; Petersen, Helen H; Haarbo, Jens; Johansen, Martin B; Thøgersen, Anna Margrethe

    2016-03-01

    The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing. The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads. All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes. Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications. Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  15. Minimally invasive epicardial implantable cardioverter-defibrillator placement for infants and children: An effective alternative to the transvenous approach.

    PubMed

    Schneider, Andrew E; Burkhart, Harold M; Ackerman, Michael J; Dearani, Joseph A; Wackel, Philip; Cannon, Bryan C

    2016-09-01

    Young patients have high rates of implantable cardioverter-defibrillator (ICD) lead fractures and are at risk for venous occlusion or tricuspid regurgitation with transvenous lead placement. Epicardial ICDs have the potential to circumvent complications associated with transvenous ICDs, but the literature on young patients remains limited. The purpose of this study was to evaluate the results of a minimally invasive epicardial ICD lead placement approach in young patients. A retrospective, institutional review board-approved electronic medical record review of all patients undergoing epicardial ICD placement at our institution from January 2011 to December 2015 was performed. A total of 46 patients (20 female [43%]; mean age 10.3 years, range 0.7-18.2 years; mean weight 41 ± 21 kg) were identified; 24 (52%) were ≤10 years old. A minithoracotomy was used in 28 patients (61%). All had acceptable defibrillation, right ventricular sensing, and stimulation thresholds. Median follow-up was 2.0 ± 1.3 years (range 0.02-4.5 years). Eight surgical complications occurred in 7 patients (15%), and 8 device-related complications occurred in 6 patients (13%). Fifty-eight appropriate shocks were delivered in 7 patients (15%). Four patients received inappropriate shocks in relation to lead fractures/microfractures. One patient in this cohort who had long QT syndrome type 8 died of a hypoglycemic seizure. Minimally invasive epicardial ICD placement provides an effective, alternative method for implanting an ICD system, particularly in very young patients (<6 years of age) or patients who are concerned about cosmetic appearance. This technique is an acceptable alternative to traditional transvenous ICD placement. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  16. Significant impact of electrical storm on mortality in patients with structural heart disease and an implantable cardiac defibrillator.

    PubMed

    Noda, Takashi; Kurita, Takashi; Nitta, Takashi; Chiba, Yasutaka; Furushima, Hiroshi; Matsumoto, Naoki; Toyoshima, Takeshi; Shimizu, Akihiko; Mitamura, Hideo; Okumura, Ken; Ohe, Tohru; Aizawa, Yoshifusa

    2018-03-15

    Electrical storm (E-Storm), defined as multiple episodes of ventricular arrhythmias within a short period of time, is an important clinical problem in patients with an implantable cardiac defibrillator (ICD) including cardiac resynchronization therapy devices capable of defibrillation. The detailed clinical aspects of E-Storm in large populations especially for non-ischemic dilated cardiomyopathy (DCM), however, remain unclear. This study was performed to elucidate the detailed clinical aspects of E-Storm, such as its predictors and prevalence among patients with structural heart disease including DCM. We analyzed the data of the Nippon Storm Study, which was a prospective observational study involving 1570 patients enrolled from 48 ICD centers. For the purpose of this study, we evaluated 1274 patients with structural heart disease, including 482 (38%) patients with ischemic heart disease (IHD) and 342 (27%) patients with DCM. During a median follow-up of 28months (interquartile range: 23 to 33months), E-Storm occurred in 84 (6.6%) patients. The incidence of E-Storm was not significantly different between patients with IHD and patients with DCM (log-rank p=0.52). Proportional hazard regression analyses showed that ICD implantation for secondary prevention of sudden cardiac death (p=0.0001) and QRS width (p=0.015) were the independent risk factors for E-storm. In a comparison between patients with and without E-Storm, survival curves after adjustment for clinical characteristics showed a significant difference in mortality. E-Storm was associated with subsequent mortality in patients with structural heart disease including DCM. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  17. Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry.

    PubMed

    Russo, Robert J

    2013-03-01

    Until recently, the presence of a permanent pacemaker or an implantable cardioverter-defibrillator has been a relative contraindication for the performance of magnetic resonance imaging (MRI). A number of small studies have shown that MRI can be performed with minimal risk when patients are properly monitored and device programming is modified appropriately for the procedure. However, the risk of performing MRI for patients with implanted cardiac devices has not been sufficiently evaluated to advocate routine clinical use. The aim of the present protocol is to prospectively determine the rate of adverse clinical events and device parameter changes in patients with implanted non-MRI-conditional cardiac devices undergoing clinically indicated nonthoracic MRI at 1.5 T. The MagnaSafe Registry is a multicenter, prospective cohort study of up to 1500 MRI examinations in patients with pacemakers or implantable cardioverter-defibrillators implanted after 2001 who undergo clinically indicated nonthoracic MRI following a specific protocol to ensure that preventable potential adverse events are mitigated. Adverse events and changes in device parameter measurements that may be associated with the imaging procedure will be documented. Through August 2012, 701 MRI studies have been performed, representing 47% of the total target enrollment. The results of this registry will provide additional documentation of the risk of MRI and will further validate a clinical protocol for screening and the performance of clinically indicated MRI for patients with implanted cardiac devices. Copyright © 2013 Mosby, Inc. All rights reserved.

  18. Case-control study of surgical site infections associated with pacemakers and implantable cardioverter-defibrillators.

    PubMed

    Marschall, Jonas; Hopkins-Broyles, Diane; Jones, Marilyn; Fraser, Victoria J; Warren, David K

    2007-11-01

    In 2000, the rate of surgical site infections (SSIs) associated with pacemaker and implantable cardioverter-defibrillator (ICD) procedures performed in the cardiothoracic operating rooms of hospital A was 16% (19 of 116 procedures resulted in infections). This study investigates risks for SSI associated with these procedures in the cardiothoracic operating room. Unmatched 1 : 3 case-control study performed over a 12-month period among patients who had undergone implantation of a pacemaker and/or ICD. A standardized observation scrutinized infection control practices in the area where the procedures were performed. The cardiothoracic operating rooms of hospital A, which belongs to a hospital consortium in the midwestern United States. Patients with SSI were identified as case patients. Control patients were chosen from the group of uninfected patients who had procedures performed during the same period as case patients. A total of 19 SSIs associated with pacemaker and ICD procedures were retrospectively identified among the patients who underwent procedures in these cardiothoracic operating rooms. Culture samples were obtained from 7 patients; 2 yielded coagulase-negative Staphylococcus on culture, 2 yielded Staphylococcus aureus, 1 yielded Serratia marcescens, and 2 showed no growth. In the case-control study, age, race, sex, diabetes mellitus, smoking history, timing of antibiotic therapy, and hair removal did not differ significantly between case patients and control patients. Case patients were more likely to have an abdominal device in place (odds ratio [OR], 5.5 [95% confidence interval {CI}, 1.6-19.3]; P=.006) and less likely to have received a new implant (OR 0.3 [95% CI, 0.1-0.8]; P=.02) or to have had new leads placed (OR, 0.2 [95% CI, 0.1-0.6]; P=.003). Abdominal placement of implanted devices was associated with occurrence of an SSI after pacemaker and/or ICD procedures.

  19. Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators.

    PubMed

    Vijgen, Johan; Botto, Gianluca; Camm, John; Hoijer, Carl-Johan; Jung, Werner; Le Heuzey, Jean-Yves; Lubinski, Andrzej; Norekvål, Tone M; Santomauro, Maurizio; Schalij, Martin; Schmid, Jean-Paul; Vardas, Panos

    2010-03-01

    Patients with an implantable cardioverter defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions vary across different countries in Europe. The most recent recommendations for driving of ICD patients in Europe were published in 1997 and focused mainly on patients implanted for secondary prevention. In recent years there has been a vast increase in the number of patients with an ICD and in the percentage of patients implanted for primary prevention. The EHRA task force on ICD and driving was formed to reassess the risk of driving for ICD patients based on the literature available. The recommendations are summarized in the following table and are further explained in the document, (Table see text). Driving restrictions are perceived as difficult for patients and their families, and have an immediate consequence for their lifestyle. To increase the adherence to the driving restrictions, adequate discharge of education and follow-up of patients and family are pivotal. The task force members hope this document may serve as an instrument for European and national regulatory authorities to formulate uniform driving regulations. Copyright (c) 2010 Elsevier B.V. All rights reserved.

  20. Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators.

    PubMed

    Vijgen, Johan; Botto, Gianluca; Camm, John; Hoijer, Carl-Johan; Jung, Werner; Le Heuzey, Jean-Yves; Lubinski, Andrzej; Norekvål, Tone M; Santomauro, Maurizio; Schalij, Martin; Schmid, Jean-Paul; Vardas, Panos

    2009-08-01

    Patients with an implantable cardioverter defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions vary across different countries in Europe. The most recent recommendations for driving of ICD patients in Europe were published in 1997 and focused mainly on patients implanted for secondary prevention. In recent years there has been a vast increase in the number of patients with an ICD and in the percentage of patients implanted for primary prevention. The EHRA task force on ICD and driving was formed to reassess the risk of driving for ICD patients based on the literature available. The recommendations are summarized in the following table and are further explained in the document. [table: see text] Driving restrictions are perceived as difficult for patients and their families, and have an immediate consequence for their lifestyle. To increase the adherence to the driving restrictions, adequate discharge of education and follow-up of patients and family are pivotal. The task force members hope this document may serve as an instrument for European and national regulatory authorities to formulate uniform driving regulations.

  1. Outcomes in African Americans undergoing cardioverter-defibrillator implantation for primary prevention of sudden cardiac death: findings from the Prospective Observational Study of Implantable Cardioverter-Defibrillators (PROSE-ICD).

    PubMed

    Zhang, Yiyi; Kennedy, Robert; Blasco-Colmenares, Elena; Butcher, Barbara; Norgard, Sanaz; Eldadah, Zayd; Dickfeld, Timm; Ellenbogen, Kenneth A; Marine, Joseph E; Guallar, Eliseo; Tomaselli, Gordon F; Cheng, Alan

    2014-08-01

    Implantable cardioverter-defibrillators (ICDs) reduce the risk of death in patients with left ventricular dysfunction. Little is known regarding the benefit of this therapy in African Americans (AAs). The purpose of this study was to determine the association between AA race and outcomes in a cohort of primary prevention ICD patients. We conducted a prospective cohort study of patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end-point was appropriate ICD shock defined as a shock for rapid ventricular tachyarrhythmias. The secondary end-point was all-cause mortality. There were 1189 patients (447 AAs and 712 non-AAs) enrolled. Over a median follow-up of 5.1 years, a total of 137 patients experienced an appropriate ICD shock, and 343 died (294 of whom died without receiving an appropriate ICD shock). The multivariate adjusted hazard ratio (95% confidence interval) comparing AAs vs non-AAs were 1.24 (0.96-1.59) for all-cause mortality, 1.33 (1.02, 1.74) for all-cause mortality without receiving appropriate ICD shock, and 0.78 (0.51, 1.19) for appropriate ICD shock. Ejection fraction, diabetes, and hypertension appeared to explain 24.1% (10.1%-69.5%), 18.7% (5.3%-58.0%), and 13.6% (3.8%-53.6%) of the excess risk of mortality in AAs, with a large proportion of the mortality difference remaining unexplained. In patients with primary prevention ICDs, AAs had an increased risk of dying without receiving an appropriate ICD shock compared to non-AAs. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  2. Determinants of geographic variations in implantation of cardiac defibrillators in the European Society of Cardiology member countries--data from the European Heart Rhythm Association White Book.

    PubMed

    Lubinski, Andrzej; Bissinger, Andrzej; Boersma, Lucas; Leenhardt, Antoine; Merkely, Bela; Oto, Ali; Proclemer, Alessandro; Brugada, Josep; Vardas, Panos E; Wolpert, Christian

    2011-05-01

    Sudden cardiac death (SCD) is a major health concern in developed countries. Many studies have demonstrated the efficacy of implantable cardioverter defibrillator (ICD) therapy in the prevention of SCD and total mortality reduction. However, the high individual costs and the reimbursement policy may limit widespread ICD utilization. This study analyzed the temporal and the geographical trends of the ICD implantation rate. Data were gathered from two editions of the European Heart Rhythm Association (EHRA) White Books published in 2008 and 2009. The analysis revealed significant differences in the rates of ICD implantation per million capita between the countries, but the median implantations was constantly increasing. The number of ICD implantations correlated with gross domestic product (GDP), GDP per capita, expenditure on health, life expectancy, and the number of implanting centres. There are great number of differences in the ICD-implanting rates between EHRA member countries, consequent to the increase in the number of ICD implantations. The ICD implantation rates are related to national economic status and healthcare expenses.

  3. Current Indications for Implantable Cardioverter Defibrillators in Non-Ischemic Cardiomyopathies and Channelopathies.

    PubMed

    González-Torrecilla, Esteban; Arenal, Angel; Atienza, Felipe; Datino, Tomás; Bravo, Loreto; Ruiz, Pablo; Ávila, Pablo; Fernández-Avilés, Francisco

    2015-01-01

    Current indications for implantable cardioverter defibrillators (ICDs) in patients with channelopathies and cardiomyopathies of non-ischemic origin are mainly based on non-randomized evidence. In patients with nonischemic dilated cardiomyopathy (NIDCM), there is a tendency towards a beneficial effect on total mortality of ICD therapy in patients with significant left ventricular (LV) dysfunction. Although an important reduction in sudden cardiac death (SCD) seems to be clearly demonstrated in these patients, a net beneficial effect on total mortality is unclear mostly in cases with good functional status. Risk stratification has been changing over the last two decades in patients with hypertrophic cardiomyopathy (HCM). Its risk profile has been delineated in parallel with the beneficial effect of ICD in high risk patients. Observational results based on "appropriate" ICD interventions do support its usefulness both in primary and secondary SCD prevention in these patients. Novel risk models quantify the rate of sudden cardiac death in these patients on individual basis. Less clear risk stratification is available for cases of arrhythmogenic right ventricular cardiomyopathy (ARVC) and in other uncommon familiar cardiomyopathies. Main features of risk stratification vary among the different channelopathies (long QT syndrome -LQTS-, Brugada syndrome, etc) with great debate on the management of asymptomatic patients. For most familiar cardiomyopathies, ICD therapy is the only accepted strategy in the prevention of SCD. So far, genetic testing has a limited role in risk evaluation and management of the individual patient. This review aims to summarize these criticisms and to refine the current indications of ICD implantation in patients with cardiomyopathies and major channelopathies.

  4. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study.

    PubMed

    Landolina, Maurizio; Perego, Giovanni B; Lunati, Maurizio; Curnis, Antonio; Guenzati, Giuseppe; Vicentini, Alessandro; Parati, Gianfranco; Borghi, Gabriella; Zanaboni, Paolo; Valsecchi, Sergio; Marzegalli, Maurizio

    2012-06-19

    Heart failure patients with implantable cardioverter-defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits. This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; P=0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; P<0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (P<0.001). The patients' clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (P=0.026). Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00873899.

  5. Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer.

    PubMed

    Landolina, Maurizio; Curnis, Antonio; Morani, Giovanni; Vado, Antonello; Ammendola, Ernesto; D'onofrio, Antonio; Stabile, Giuseppe; Crosato, Martino; Petracci, Barbara; Ceriotti, Carlo; Bontempi, Luca; Morosato, Martina; Ballari, Gian Paolo; Gasparini, Maurizio

    2015-08-01

    Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices. We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion. The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

  6. Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection.

    PubMed

    Knops, Paul; Theuns, Dominic A M J; Res, Jan C J; Jordaens, Luc

    2009-10-01

    Information about implantable cardioverter-defibrillator (ICD) longevity is mostly calculated from measurements under ideal laboratory conditions. However, little information about longevity under clinical circumstances is available. This survey gives an overview on ICD service times and generator replacements in a cohort of consecutive ICD patients. Indications for replacement were classified as a normal end-of-service (EOS), premature EOS, system malfunction, infection and device advisory, or recall actions. From the premature and normal EOS group, longevity from single-chamber (SC), dual-chamber (DC), and cardiac resynchronization therapy defibrillator (CRT-D), rate-responsive (RR) settings, high output (HO) stimulation, and indication for ICD therapy was compared. Differences between brands were compared as well. In a total of 854 patients, 203 ICD replacements (165 patients) were recorded. Premature and normal EOS replacements consisted of 32 SC, 98 DC and 24 CRT-D systems. Longevity was significantly longer in SC systems compared to DC and CRT-D systems (54 +/- 19 vs. 40 +/- 17 and 42 +/- 15 months; P = 0.008). Longevity between non-RR (n = 143) and RR (n = 11) settings was not significantly different (43 +/- 18 vs. 45 +/- 13 months) as it also was not for HO versus non-HO stimulation (43 +/- 19 vs. 46 +/- 17 months). Longevity of ICDs was not significantly different between primary and secondary prevention (42 +/- 19 vs. 44 +/- 18 months). The average longevity on account of a device-based EOS message was 43 +/- 18 months. Average longevity for Biotronik (BIO, n = 72) was 33 +/- 10 months, for ELA Medical (ELA, n = 12) 44 +/- 17 months, for Guidant (GDT, n = 36) 49 +/- 12 months, for Medtronic (MDT, n = 29) 62 +/- 22 months, and for St. Jude Medical (SJM, n = 5) 31 +/- 9 months (P < 0.001). SC ICD generators had a longer service time compared to DC and CRT-D systems. No influence of indication for ICD therapy and HO stimulation on generator longevity was

  7. Influence of radiotherapy on the latest generation of implantable cardioverter-defibrillators

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hurkmans, Coen W.; Scheepers, Egon; Springorum, Bob G.F.

    2005-09-01

    Purpose: Radiotherapy can influence the functioning of pacemakers and implantable cardioverter-defibrillators (ICDs). ICDs offer the same functionality as pacemakers, but are also able to deliver a high-voltage shock to the heart if needed. Guidelines for radiotherapy treatment of patients with an implanted rhythm device have been published in 1994 by The American Association of Physicists in Medicine, and are based only on experience with pacemakers. Data on the influence of radiotherapy on ICDs are limited. The objective of our study is to determine the influence of radiotherapy on the latest generation of ICDs. Methods and Materials: Eleven modern ICDs havemore » been irradiated in our department. The irradiation was performed with a 6-MV photon beam. The given dose was fractionated up to a cumulative dose of 120 Gy. Two to 5 days passed between consecutive irradiations. Frequency, output, sensing, telemetry, and shock energy were monitored. Results: Sensing interference by ionizing radiation on all ICDs has been demonstrated. For four ICDs, this would have caused the inappropriate delivery of a shock because of interference. At the end of the irradiation sessions, all devices had reached their point of failure. Complete loss of function was observed for four ICDs at dose levels between 0.5 Gy and 1.5 Gy. Conclusions: The effect of radiation therapy on the newest generation of ICDs varies widely. If tachycardia monitoring and therapy are functional (programmed on) during irradiation, the ICD might inappropriately give antitachycardia therapy, often resulting in a shock. Although most ICDs did not fail below 80 Gy, some devices had already failed at doses below 1.5 Gy. Guidelines are formulated for the treatment of patients with an ICD.« less

  8. Psychosocial impact of implantable cardioverter defibrillators (ICD) in young adults with Tetralogy of Fallot.

    PubMed

    Opić, Petra; Utens, Elisabeth M W J; Moons, Philip; Theuns, Dominic A M J; van Dijk, Arie P J; Hoendermis, Elke S; Vliegen, Hubert W; de Groot, Natasja M S; Witsenburg, Maarten; Schalij, Martin; Roos-Hesselink, Jolien W

    2012-07-01

    To investigate the psychosocial impact of having an implantable cardioverter defibrillator (ICD) in adults with Tetralogy of Fallot (ToF). Included were 26 ToF-patients with an ICD (age 44 ± 12 years), and two control groups consisting of 28 ToF-patients without an ICD (age 40 ± 10 years) and a group of 35 ICD-patients of older age without ToF (age 72.0 ± 8 years). This last control group was chosen to represent the "older general ICD population" with acquired heart disease seen at the out-patient clinic. Psychosocial functioning encompassed daily functioning, subjective health status, quality of life, anxiety, depression, coping and social support. ToF-patients with ICD showed diminished psychosocial functioning in comparison to ToF-patients without ICD. This was reflected by diminished subjectively perceived physical functioning (p = 0.01), general health perception (p < 0.01) and a lower satisfaction with life (p = 0.02). In comparison to older ICD-patients, ToF-patients with ICD showed less satisfaction with life (p = 0.03), experienced more anxiety (p = 0.01) and showed less favourable coping styles, although physical functioning was better for ToF-patients with ICD than for older ICD-patients (p = 0.01). More inappropriate shocks were found in ToF-patients with ICD compared to the older ICD-patients. In patients with ToF, ICD implantation had a major impact on psychosocial functioning which should be taken into account when considering ICD implantation in these young patients. To help improve psychosocial functioning, psychological counselling attuned to the specific needs of these patients may be useful.

  9. Guidelines on the management of implantable cardioverter defibrillators at the end of life.

    PubMed

    Datino, T; Rexach, L; Vidán, M T; Alonso, A; Gándara, Á; Ruiz-García, J; Fontecha, B; Martínez-Sellés, M

    2014-01-01

    This article is a joint document of the Spanish Society of Geriatrics and Gerontology, the Spanish Society of Palliative Care and the Section of Geriatric Cardiology of the Spanish Society of Cardiology. Its aim is to address the huge gap that exists in Spain with regard to the management of implantable cardioverter defibrillators (ICDs) in the final stages of life. It is increasingly common to find patients carrying these devices that are in the terminal stage of an advanced disease. This occurs in patients with advanced heart disease and subsequent heart failure refractory to treatment but also in a patient with an ICD who develops cancer disease, organ failure or other neurodegenerative diseases with poor short-term prognosis. The vast majority of these patients are over 65, so the paper focuses particularly on the elderly who are in this situation, but the decision-making process is similar in younger patients with ICDs who are in the final phase of their life. Copyright © 2013 Elsevier España, S.L. All rights reserved.

  10. [Guidelines on the management of implantable cardioverter defibrillators at the end of life].

    PubMed

    Datino, T; Rexach, L; Vidán, M T; Alonso, A; Gándara, Á; Ruiz-García, J; Fontecha, B; Martínez-Sellés, M

    2014-01-01

    This article is a joint document of the Spanish Society of Geriatrics and Gerontology, the Spanish Society of Palliative Care and the Section of Geriatric Cardiology of the Spanish Society of Cardiology. Its aim is to address the huge gap that exists in Spain with regard to the management of implantable cardioverter defibrillators (ICDs) in the final stages of life. It is increasingly common to find patients carrying these devices that are in the terminal stage of an advanced disease. This occurs in patients with advanced heart disease and subsequent heart failure refractory to treatment but also in a patient with an ICD who develops cancer disease, organ failure or other neurodegenerative diseases with poor short-term prognosis. The vast majority of these patients are over 65, so the paper focuses particularly on the elderly who are in this situation, but the decision-making process is similar in younger patients with ICDs who are in the final phase of their life. Copyright © 2013 SEGG. Published by Elsevier Espana. All rights reserved.

  11. Impact of Shocks on Mortality in Patients with Ischemic or Dilated Cardiomyopathy and Defibrillators Implanted for Primary Prevention

    PubMed Central

    Streitner, Florian; Herrmann, Thomas; Kuschyk, Juergen; Lang, Siegfried; Doesch, Christina; Papavassiliu, Theano; Streitner, Ines; Veltmann, Christian; Haghi, Dariusch; Borggrefe, Martin

    2013-01-01

    Background Emerging interest is seen in the paradox of defibrillator shocks for ventricular tachyarrhythmia and increased mortality risk. Particularly in patients with dilated cardiomyopathy (DCM), the prognostic importance of shocks is unclear. The purpose of this study was to compare the outcome after shocks in patients with ischemic cardiomyopathy (ICM) or DCM and defibrillators (ICD) implanted for primary prevention. Methods and Results Data of 561 patients were analyzed (mean age 68.6±10.6 years, mean left ventricular ejection fraction 28.6±7.3%). During a median follow-up of 49.3 months, occurrence of device therapies and all-cause mortality were recorded. 74 out of 561 patients (13.2%) experienced ≥1 appropriate and 51 out of 561 patients (9.1%) ≥1 inappropriate shock. All-cause mortality was 24.2% (136 out of 561 subjects). Appropriate shock was associated with a trend to higher mortality in the overall patient population (HR 1.48, 95% CI 0.96–2.28, log rank p = 0.072). The effect was significant in ICM patients (HR 1.61, 95% CI 1.00–2.59, log rank p = 0.049) but not in DCM patients (HR 1.03, 95% CI 0.36–2.96, log rank p = 0.96). Appropriate shocks occurring before the median follow-up revealed a much stronger impact on mortality (HR for the overall patient population 2.12, 95% CI 1.24–3.63, p = 0.005). The effect was driven by ICM patients (HR 2.48, 95% CI 1.41–4.37, p = 0.001), as appropriate shocks again did not influence survival of DCM patients (HR 0.63, 95% CI 0.083–4.75, p = 0.65). Appropriate shocks occurring after the median follow-up and inappropriate shocks occurring at any time revealed no impact on survival in any of the groups (p = ns). Conclusion Appropriate shocks are associated with reduced survival in patients with ICM but not in patients with DCM and ICDs implanted for primary prevention. Furthermore, the negative effect of appropriate shocks on survival in ICM patients is only evident within

  12. Impact of shocks on mortality in patients with ischemic or dilated cardiomyopathy and defibrillators implanted for primary prevention.

    PubMed

    Streitner, Florian; Herrmann, Thomas; Kuschyk, Juergen; Lang, Siegfried; Doesch, Christina; Papavassiliu, Theano; Streitner, Ines; Veltmann, Christian; Haghi, Dariusch; Borggrefe, Martin

    2013-01-01

    Emerging interest is seen in the paradox of defibrillator shocks for ventricular tachyarrhythmia and increased mortality risk. Particularly in patients with dilated cardiomyopathy (DCM), the prognostic importance of shocks is unclear. The purpose of this study was to compare the outcome after shocks in patients with ischemic cardiomyopathy (ICM) or DCM and defibrillators (ICD) implanted for primary prevention. Data of 561 patients were analyzed (mean age 68.6±10.6 years, mean left ventricular ejection fraction 28.6±7.3%). During a median follow-up of 49.3 months, occurrence of device therapies and all-cause mortality were recorded. 74 out of 561 patients (13.2%) experienced ≥1 appropriate and 51 out of 561 patients (9.1%) ≥1 inappropriate shock. All-cause mortality was 24.2% (136 out of 561 subjects). Appropriate shock was associated with a trend to higher mortality in the overall patient population (HR 1.48, 95% CI 0.96-2.28, log rank p = 0.072). The effect was significant in ICM patients (HR 1.61, 95% CI 1.00-2.59, log rank p = 0.049) but not in DCM patients (HR 1.03, 95% CI 0.36-2.96, log rank p = 0.96). Appropriate shocks occurring before the median follow-up revealed a much stronger impact on mortality (HR for the overall patient population 2.12, 95% CI 1.24-3.63, p = 0.005). The effect was driven by ICM patients (HR 2.48, 95% CI 1.41-4.37, p = 0.001), as appropriate shocks again did not influence survival of DCM patients (HR 0.63, 95% CI 0.083-4.75, p = 0.65). Appropriate shocks occurring after the median follow-up and inappropriate shocks occurring at any time revealed no impact on survival in any of the groups (p = ns). Appropriate shocks are associated with reduced survival in patients with ICM but not in patients with DCM and ICDs implanted for primary prevention. Furthermore, the negative effect of appropriate shocks on survival in ICM patients is only evident within the first 4 years after device implantation.

  13. Effect of radiation therapy on permanent pacemaker and implantable cardioverter-defibrillator function.

    PubMed

    Makkar, Akash; Prisciandaro, Joann; Agarwal, Sunil; Lusk, Morgan; Horwood, Laura; Moran, Jean; Fox, Colleen; Hayman, James A; Ghanbari, Hamid; Roberts, Brett; Belardi, Diego; Latchamsetty, Rakesh; Crawford, Thomas; Good, Eric; Jongnarangsin, Krit; Bogun, Frank; Chugh, Aman; Oral, Hakan; Morady, Fred; Pelosi, Frank

    2012-12-01

    Radiation therapy's (RT's) effects on cardiac implantable electronic devices (CIEDs) such as implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs) are not well established, leading to device removal or relocation in preparation for RT. To determine the effect of scattered RT on CIED performance. We analyzed 69 patients--50 (72%) with PMs and 19 (28%) with ICDs--receiving RT at the University of Michigan. Collected data included device model, anatomic location, and treatment beam energies, treatment type, and estimated dose to the device. Patients were treated with either high-energy (16-MV) and/or low-energy (6 MV) photon beams with or without electron beams (6-16 MeV). The devices were interrogated with pre- and post-RT and/or weekly with either in-treatment or home interrogation, depending on the patient's dependence on the device and the estimated or measured delivered dose. Outcomes analyzed were inappropriate ICD therapies, device malfunctions, or device-related clinical events. The PMs were exposed to 84.4 ± 99.7 cGy of radiation, and the ICDs were exposed to 92.1 ± 72.6 cGy of radiation. Two patients with ICDs experienced a partial reset of the ICD with the loss of historic diagnostic data after receiving 123 and 4 cGy, respectively. No device malfunction or premature battery depletion was observed at 6-month follow-up from RT completion. CIED malfunction due to indirect RT exposure is uncommon. Regular in-treatment or home interrogation should be done to detect and treat these events and to ensure that diagnostic data are preserved. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. Association between Serum Uric Acid Level and Ventricular Tachyarrhythmia in Heart Failure Patients with Implantable Cardioverter-Defibrillator.

    PubMed

    Nodera, Minoru; Suzuki, Hitoshi; Matsumoto, Yoshiyuki; Kamioka, Masashi; Kaneshiro, Takashi; Yoshihisa, Akiomi; Ohira, Tetsuya; Takeishi, Yasuchika

    2018-05-25

    The uric acid (UA) level is related to cardiac events and mortality, but little is known about the clinical significance of serum UA with regard to the ventricular tachyarrhythmia (VT) risk in patients with heart failure. The present study enrolled 56 patients with ischemic and nonischemic cardiomyopathy (37 males, mean age 64.7 ± 11.1 years) who received prophylactic implantable cardioverter-defibrillator (ICD) implantation. Based on a median serum UA value, study subjects were divided into two groups: serum UA < 6.1 mg/dL (group L, n = 29) and ≥6.1 mg/dL (group H, n = 27). Echo- and electrocardiograms (QRS duration and QTc intervals) were examined in each group. During the follow-up period (30 ± 8 months), 22 (39%) patients had appropriate ICD therapies for sustained VT. There was no significant difference in the electro- and echocardiographic data between both groups. However, appropriate ICD therapies were significantly higher in group H than in group L (p  =  0.02). In multivariate analysis, UA was an independent predictor of appropriate ICD therapies (hazard ratio 1.826, 95% confidence interval 1.248-2.671, p = 0.002). Serum UA levels might be a predictor of VT, providing new aspects regarding the decision to adapt ICD implantation in patients with heart failure. © 2018 S. Karger AG, Basel.

  15. Wearable cardioverter defibrillator: a life vest till the life boat (ICD) arrives.

    PubMed

    Francis, Johnson; Reek, Sven

    2014-01-01

    It is well established that implantable cardioverter defibrillator (ICD) is a life saving device ensuring protection against life threatening ventricular arrhythmias. But there are certain situations like a recent myocardial infarction where the standard guidelines do not recommend the implantation of an ICD while the patient can still be at a risk of demise due to a life threatening ventricular arrhythmia. There could also be a temporary indication for protection while explanting an infected ICD system. The wearable cardioverter defibrillator (WCD) is a device which comes to the rescue in such situations. In this brief review, we discuss the historical aspects of the development of a WCD, technical aspects as well as the clinical trial data and real world scenario of its use. Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  16. Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator.

    PubMed

    van Barreveld, M; Dijkgraaf, M G W; Hulleman, M; Boersma, L V A; Delnoy, P P H M; Meine, M; Tuinenburg, A E; Theuns, D A M J; van der Voort, P H; Kimman, G P; Buskens, E; Tijssen, J P G; Bruinsma, N; Verstraelen, T E; Zwinderman, A H; van Dessel, P H F M; Wilde, A A M

    2017-10-01

    Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy. The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women. The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

  17. Help seeking in a support group for recipients of implantable cardioverter defibrillators and their support persons.

    PubMed

    Dickerson, S S; Posluszny, M; Kennedy, M C

    2000-01-01

    To understand shared meanings of help-seeking experiences in support groups of people with implantable cardioverter defibrillator (ICD) and their support persons. ICD support group at an urban medical center. Fifteen individuals with ICD and 9 support persons. Six related themes and 1 constitutive pattern emerged. Themes included hearing and telling stories, help seeking encouraged by triggers, seeking meaningful information, forming a therapeutic friendship through group camaraderie, gaining assistance from the facilitator, and the sharing of a similar view by support persons. The constitutive pattern is coping with the possibility of death. Health care providers may recommend storytelling as the central mechanism of interactions in support groups that assist in coping with daily anxieties of living with an ICD. Nurses would be appropriate facilitators to guide discussion, to provide technical information, and to promote anticipatory guidance in coping with potential firing events.

  18. Battery longevity of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators: technical, clinical and economic aspects. An expert review paper from EHRA.

    PubMed

    Boriani, Giuseppe; Merino, Josè; Wright, David J; Gadler, Fredrik; Schaer, Beat; Landolina, Maurizio

    2018-05-10

    In recent years an extension of devices longevity has been obtained for implantable cardioverter-defibrillators (ICDs), including ICDs for cardiac resynchronization therapy (CRT-D) through improved battery chemistry and device technology and this implies important clinical benefits (reduced need for device replacements and associated complications, particularly infections), as well as economic benefits, in line with patient preferences and needs. From a clinical point of view, the availability of this improvement in technology allows to better tune the choice of the device to be implanted, taking into account that the reasons supporting the value of an extended device longevity as a clinical priority may differ according to the clinical setting (purely electrical diseases or left ventricular dysfunction/heart failure, respectively). From an economic point of view, extension of device longevity may have an important impact in reducing long-term costs of device therapy, with substantial daily savings in favour of devices with extended longevity, up to 30%, depending on clinical scenarios. In studies based on projections, an extension of device longevity allowed to calculate that the cost per day of ICDs may be substantially reduced, and this allows to overcome the frequent perception of ICD and CRT-D devices as treatments with unaffordable costs and to overturn the misconception that up-front costs are the only metric with which to value device treatments. In view of its clinical and economic value, device longevity should be a determining factor in device choice by physicians and healthcare commissioners and should be appropriately considered and valued in comparative tenders.

  19. Subcutaneous Implantable Cardioverter-Defibrillator

    MedlinePlus

    ... the SICD. The SICD lacks remote monitoring capabilities. Battery Life Device battery replacement is necessary for all patients with implanted devices. The SICD battery life is not as long as that of ...

  20. Y2K: effects on pacemaker and implantable defibrillator programmers.

    PubMed

    Flynn, D P; Daubert, J P; Huang, D T; Ocampo, C M; O'Gorman, E

    1999-01-01

    All permanent pacemakers and implantable defibrillators (PPM/ICDs) will continue to function as programmed without regard to the date in the year 2000 (Y2K). All manufacturers contacted reassured us that some of these devices incorporate a day/year clock in the circuitry; however, these are not involved in sensing or delivering programmed therapy. Some manufacturers' device programmers will roll over to the year 2000 without any problems at all, whereas others may have difficulty with date and time stamping on printed reports. We tested 14 different types of PPM/ICD programmers for Y2K compliance using 8 tests. Five of the 14 models passed each test and were labeled at our institution with a green "Y2K" sticker to identify them as Y2K compatible and needing no special attention after December 31, 1999. The most common test failed was the ability to roll the date forward from December 31, 1999, with the programmer power off. Organizations should consider testing and replacing noncompliant device programmers or placing a red sticker with "Y2K" crossed out on noncompliant pieces. The red sticker alerts the advanced practice nurse or physician to the need to confirm the appropriate date and time in the programmer after startup in the year 2000 and before interrogating or programming any PPM/ICD, to avoid inappropriate date and time stamping on printed reports from that programmer.

  1. Psychological and clinical problems in young adults with implantable cardioverter-defibrillators.

    PubMed

    Wójcicka, Mariola; Lewandowski, Michał; Smolis-Bak, Edyta; Szwed, Hanna

    2008-10-01

    Implantable cardioverter-defibrillators (ICD) are the most effective treatment in patients with the risk of sudden cardiac death. ICD improves patients' safety but is also the source of numerous inconveniences. Especially young people consider such ICD-related inconveniences as most unwelcome. To assess the quality of life and main psychological problems encountered in young adults with an ICD. We studied 45 subjects aged 14-29 years (mean 21.2+/-4.3). ICDs were used in primary prevention in 22 patients, and in secondary prevention in 23 patients. Time elapsed from implantation ranged from 5 months to 11 years (4.3+/-2.7 years). Since the problems affecting this group were rather specific, the patients' quality of life was assessed with a special questionnaire addressing important issues and problems associated with living with an ICD. ICD discharges were observed in 67.4% of patients (primary prevention - 45.5%, secondary prevention - 82.6%), multiple shocks in 47.2%, and phantom shocks in 21.4%. Anxiety associated with an ICD discharge was reported by 84.4% of patients. In order to prevent ICD discharges, 53.3% of patients decreased their activity. Problems with memory were observed in 42.2% of patients, with concentration in 47.6%, and with sleep in 42.2%. Almost half of those over 18 years of age were active drivers. None of the subjects experienced an ICD discharge during sexual intercourse. None of the men reported any sexual problems, while seven (41.2%) women did. Almost a quarter of the patients claimed to have had complications after the implantation. Young adult patients generally were compliant to have their ICD checked and accepted their limitations and disease. Fewer people assessed their health status as bad. Some patients in the group studied found it extremely difficult to accept their disease and/or ICD and to adapt to the situation. As many as nine patients believed the ICD implantation had been unnecessary, seven did not accept the ICD, three

  2. Modern Pacemaker and Implantable Cardioverter/Defibrillator Systems Can Be Magnetic Resonance Imaging Safe

    PubMed Central

    Roguin, Ariel; Zviman, Menekhem M.; Meininger, Glenn R.; Rodrigues, E. Rene; Dickfeld, Timm M.; Bluemke, David A.; Lardo, Albert; Berger, Ronald D.; Calkins, Hugh; Halperin, Henry R.

    2011-01-01

    Background MRI has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter/defibrillators (ICDs), however, is historically considered a contraindication to MRI. These devices are now smaller, with less magnetic material and improved electromagnetic interference protection. Our aim was to determine whether these modern systems can be used in an MR environment. Methods and Results We tested in vitro and in vivo lead heating, device function, force acting on the device, and image distortion at 1.5 T. Clinical MR protocols and in vivo measurements yielded temperature changes <0.5°C. Older (manufactured before 2000) ICDs were damaged by the MR scans. Newer ICD systems and most pacemakers, however, were not. The maximal force acting on newer devices was <100 g. Modern (manufactured after 2000) ICD systems were implanted in dogs (n=18), and after 4 weeks, 3- to 4-hour MR scans were performed (n=15). No device dysfunction occurred. The images were of high quality with distortion dependent on the scan sequence and plane. Pacing threshold and intracardiac electrogram amplitude were unchanged over the 8 weeks, except in 1 animal that, after MRI, had a transient (<12 hours) capture failure. Pathological data of the scanned animals revealed very limited necrosis or fibrosis at the tip of the lead area, which was not different from controls (n=3) not subjected to MRI. Conclusions These data suggest that certain modern pacemaker and ICD systems may indeed be MRI safe. This may have major clinical implications for current imaging practices. PMID:15277324

  3. Long-term follow-up of implantable cardioverter-defibrillators in adult congenital heart disease patients: indications and outcomes.

    PubMed

    Santharam, Sandhya; Hudsmith, Lucy; Thorne, Sara; Clift, Paul; Marshall, Howard; De Bono, Joseph

    2017-03-01

    Ventricular arrhythmias are a major cause of mortality in adult congenital heart disease (ACHD) patients. The European Society of Cardiology guidelines state that implantable cardioverter-defibrillators (ICD) should be considered in patients with congenital heart disease following spontaneous sustained ventricular tachycardia (VT) or cardiac arrest and in patients at presumed high risk. This study sought to analyse the circumstances in which ACHD patients received ICD and to assess outcomes of ICD implantation, including therapies delivered and the rate of complications. A retrospective review was performed of all adult patients with congenital heart disease undergoing ICD implant between 2000 and 2014, in a large quaternary referral centre with over 4000 adults with congenital heart disease under active follow-up. Demographics: 42 patients with congenital heart disease had ICD implants: 55% male; age range 21-71 years and mean age 45 years. Mean age at implantation of ICD was 41 years. Mean follow-up was 5 years. Diagnosis: 50% of patients had repaired tetralogy of Fallot (TOF). Twelve per cent of patients had repaired transposition of the great arteries. Reason for ICD: 15 patients (35.7%) received ICD after sustained VT. Eleven patients (26.2%) received ICD after cardiac arrest. Sixteen (38%) had ICD implanted as primary prophylaxis. Outcome: Since implantation, six patients received an appropriate full-output shock for VT from ICD. Nineteen (45%) patients suffered significant complications (inappropriate shocks 11, inappropriate anti-tachycardia pacing resulting in VF 1, infection requiring extraction 3, lead abnormalities 3, and pneumothorax 1). Equal proportions of primary and secondary prevention patients received appropriate shocks. Most patients had ICD for secondary prevention (62%), and the majority had repaired TOF. There was a 2.9% annual appropriate shock rate. However, there was a high incidence of complications with more than a third suffering a

  4. Impaired left atrial function predicts inappropriate shocks in primary prevention implantable cardioverter-defibrillator candidates.

    PubMed

    Tao, Susumu; Ashikaga, Hiroshi; Ciuffo, Luisa A; Yoneyama, Kihei; Lima, Joao A C; Frank, Terry F; Weiss, Robert G; Tomaselli, Gordon F; Wu, Katherine C

    2017-07-01

    Inappropriate implantable cardioverter-defibrillator (ICD) shocks, commonly caused by atrial fibrillation (AF), are associated with an increased mortality. Because impaired left atrial (LA) function predicts development of AF, we hypothesized that impaired LA function predicts inappropriate shocks beyond a history of AF. We prospectively analyzed the association between LA function and incident inappropriate shocks in primary prevention ICD candidates. In the Prospective Observational Study of ICD (PROSE-ICD), we assessed LA function using tissue-tracking cardiac magnetic resonance (CMR) prior to ICD implantation. A total of 162 patients (113 males, age 56 ± 15 years) were included. During the mean follow-up of 4.0 ± 2.9 years, 26 patients (16%) experienced inappropriate shocks due to AF (n = 19; 73%), supraventricular tachycardia (n = 5; 19%), and abnormal sensing (n = 2; 8%). In univariable analyses, inappropriate shocks were associated with AF history prior to ICD implantation, age below 70 years, QRS duration less than 120 milliseconds, larger LA minimum volume, lower LA stroke volume, lower LA emptying fraction, impaired LA maximum and preatrial contraction strains (S max and S preA ), and impaired LA strain rate during left ventricular systole and atrial contraction (SR s and SR a ). In multivariable analysis, impaired S max (hazard ratio [HR]: 0.96, P = 0.044), S preA (HR: 0.94, P = 0.030), and SR a (HR: 0.25, P < 0.001) were independently associated with inappropriate shocks. The receiver-operating characteristics curve showed that SR a improved the predictive value beyond the patient demographics including AF history (P = 0.033). Impaired LA function assessed by tissue-tracking CMR is an independent predictor of inappropriate shocks in primary prevention ICD candidates beyond AF history. © 2017 Wiley Periodicals, Inc.

  5. Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED and Efficacy.

    PubMed

    1997-01-01

    These recommendations are presented to enhance the safety and efficacy of AEDs intended for public access. The task force recommends that manufacturers present developmental and validation data on their own devices, emphasizing high sensitivity for shockable rhythms and high specificity for nonshockable rhythms. Alternative defibrillation waveforms may reduce energy requirements, reducing the size and weight of the device. The highest levels of safety for public access defibrillation are needed. Safe and effective use of AEDs that are widely available and easily handled by non-medical personnel has the potential to dramatically increase survival from cardiac arrest.

  6. Survival After Application of Automatic External Defibrillators Before Arrival of the Emergency Medical System

    PubMed Central

    Weisfeldt, Myron L.; Sitlani, Colleen M.; Ornato, Joseph P.; Rea, Thomas; Aufderheide, Tom P.; Davis, Daniel; Dreyer, Jonathan; Hess, Erik P.; Jui, Jonathan; Maloney, Justin; Sopko, George; Powell, Judy; Nichol, Graham; Morrison, Laurie J.

    2010-01-01

    Objectives The purpose of this study was to assess the effectiveness of contemporary automatic external defibrillator (AED) use. Background In the PAD (Public Access Defibrillation) trial, survival was doubled by focused training of lay volunteers to use an AED in high-risk public settings. Methods We performed a population-based cohort study of persons with nontraumatic out-of-hospital cardiac arrest before emergency medical system (EMS) arrival at Resuscitation Outcomes Consortium (ROC) sites between December 2005 and May 2007. Multiple logistic regression was used to assess the independent association between AED application and survival to hospital discharge. Results Of 13,769 out-of-hospital cardiac arrests, 4,403 (32.0%) received bystander cardiopulmonary resuscitation but had no AED applied before EMS arrival, and 289 (2.1%) had an AED applied before EMS arrival. The AED was applied by health care workers (32%), lay volunteers (35%), police (26%), or unknown (7%). Overall survival to hospital discharge was 7%. Survival was 9% (382 of 4,403) with bystander cardiopulmonary resuscitation but no AED, 24% (69 of 289) with AED application, and 38% (64 of 170) with AED shock delivered. In multivariable analyses adjusting for: 1) age and sex; 2) bystander cardiopulmonary resuscitation performed; 3) location of arrest (public or private); 4) EMS response interval; 5) arrest witnessed; 6) initial shockable or not shockable rhythm; and 7) study site, AED application was associated with greater likelihood of survival (odds ratio: 1.75; 95% confidence interval: 1.23 to 2.50; p < 0.002). Extrapolating this greater survival from the ROC EMS population base (21 million) to the population of the U.S. and Canada (330 million), AED application by bystanders seems to save 474 lives/year. Conclusions Application of an AED in communities is associated with nearly a doubling of survival after out-of-hospital cardiac arrest. These results reinforce the importance of strategically

  7. Impact of remote monitoring on the management of arrhythmias in patients with implantable cardioverter-defibrillator.

    PubMed

    Marcantoni, Lina; Toselli, Tiziano; Urso, Giulia; Pratola, Claudio; Ceconi, Claudio; Bertini, Matteo

    2015-11-01

    In the last decade, there has been an exponential increase in cardioverter-defibrillator (ICD) implants. Remote monitoring systems, allow daily follow-ups of patients with ICD. To evaluate the impact of remote monitoring on the management of cardiovascular events associated with supraventricular and ventricular arrhythmias during long-term follow-up. A total of 207 patients undergoing ICD implantation/replacement were enrolled: 79 patients received remote monitoring systems and were followed up every 12 months, and 128 patients were followed up conventionally every 6 months. All patients were followed up and monitored for the occurrence of supraventricular and ventricular arrhythmia-related cardiovascular events (ICD shocks and/or hospitalizations). During a median follow-up of 842 days (interquartile range 476-1288 days), 32 (15.5%) patients experienced supraventricular arrhythmia-related events and 51 (24.6%) patients experienced ventricular arrhythmia-related events. Remote monitoring had a significant role in the reduction of supraventricular arrhythmia-related events, but it had no effect on ventricular arrhythmia-related events. In multivariable analysis, remote monitoring remained as an independent protective factor, reducing the risk of supraventricular arrhythmia-related events of 67% [hazard ratio, 0.33; 95% confidence interval (CI), 0.13-0.82; P = 0.017]. Remote monitoring systems improved outcomes in patients with supraventricular arrhythmias by reducing the risk of cardiovascular events, but no benefits were observed in patients with ventricular arrhythmias.

  8. Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review.

    PubMed

    Chue, Colin Dominic; Kwok, Chun Shing; Wong, Chun Wai; Patwala, Ashish; Barker, Diane; Zaidi, Amir; Mamas, Mamas A; Cunnington, Colin; Ahmed, Fozia Z

    2017-09-01

    Subcutaneous implantable cardioverter defibrillators (S-ICDs) are considered an alternative to conventional transvenous ICDs (TV-ICDs) in patients not requiring pacing. We searched MEDLINE and EMBASE for studies evaluating efficacy and safety outcomes in S-ICD patients. Outcomes were pooled across studies. Sixteen studies were included with 5380 participants (mean age range 33-56 years). Short-term follow-up data were available for 1670 subjects. The most common complication was pocket infection, affecting 2.7%. Other complications included delayed wound healing (0.6%) and wound discomfort (0.8%). 3.8% of S-ICDs were explanted, most commonly for pocket infection. Mortality rates in hospital (0.4%) and during follow-up (3.4% from 12 studies reporting) were low. Incidence of ventricular arrhythmia varied from 0% to 12%. Overall shock efficacy exceeded 96%. Inappropriate shocks affected 4.3% and was most commonly caused by T-wave oversensing. Although long-term randomised data are lacking, observational data suggest similar shock efficacy and short-term complication rates between the S-ICD and TV-ICD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. Eligibility and utilization of implantable cardioverter-defibrillators in a regional STEMI system.

    PubMed

    Johnson, Benjamin K; Garberich, Ross F; Henry, Timothy D; Katsiyiannis, William T; Sengupta, Jay; Kalra, Ankur; Hauser, Robert G; Lardy, Meghan E; Newell, Marc C

    2016-02-01

    Studies have shown mortality benefit for implantable cardioverter-defibrillators (ICDs) in ST-elevation myocardial infarction (STEMI) patients with reduced left ventricular ejection fraction (LVEF), but contemporary eligibility and appropriate utilization of ICDs is unknown. The purpose of this study was to determine the contemporary eligibility and appropriate utilization of ICDs post-STEMI. Using the prospective Minneapolis Heart Institute regional STEMI registry, LVEF before discharge and at follow-up were stratified into 3 groups: normal (LVEF ≥50%), mildly reduced (LVEF 35%-49%), and severely reduced (LVEF <35%). From March 2003 to June 2012, 3626 patients were treated. Patients with in-hospital death (n = 187), ICD in place (n = 21), negative cardiac biomarkers (n = 337), and undocumented in-hospital LVEF (n = 9) were excluded, leaving 3072 patients in the final analysis, including 1833 (59.7%) with LVEF ≥50%, 875 (28.5%) with LVEF between 35% and 49%, and 364 (11.8%) with LVEF <35% before hospital discharge. Overall, 1029 patients (33.5%) underwent follow-up echocardiography ≥40 days post-STEMI, including 140 of the 364 patients (38.5%) discharged with LVEF <35%. In total, 73 patients (7.1%) with follow-up echocardiography ≥40 days post-STEMI met criteria for an ICD (68 LVEF ≤30%, 5 LVEF 30%-35%, and New York Heart Association class II or greater). Only 26 of these patients (35.6%) underwent ICD placement within 1 year post-STEMI. Overall, only 10% to 15% of potentially eligible patients had an ICD implemented. Rates of ICD implantation in appropriate STEMI patients after 40 days are low. Strategies are needed to identify and expand access to these high-risk patients. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  10. [Primary prevention of sudden cardiac death through a wearable cardioverter-defibrillator].

    PubMed

    Gabrielli, Domenico; Benvenuto, Manuela; Baroni, Matteo; Oliva, Fabrizio; Capucci, Alessandro

    2015-01-01

    Nowadays, the implantable cardioverter-defibrillator is the gold standard for the prevention of sudden cardiac death due to tachyarrhythmias. However, its use is not free from short and long-term risks. In the last years, the wearable cardioverter-defibrillator (WCD) has become a widespread option for patients who need a safe and reversible protection against ventricular tachyarrhythmias. Notwithstanding this, its everyday application is restricted by several limitations, including the risk of inappropriate shocks, the device size and the need for strict compliance of both patients and caregivers. In this review, we report the most relevant literature data on WCD usage along with the main fields of applications and future perspectives.

  11. Neutrophil to lymphocyte ratio predicts appropriate therapy in idiopathic dilated cardiomyopathy patients with primary prevention implantable cardioverter defibrillator

    PubMed Central

    Uçar, Fatih M.; Açar, Burak

    2017-01-01

    Objectives: To investigate whether an inflammatory marker of neutrophil to lymphocyte ratio (NLR) predicts appropriate implantable cardioverter defibrillator (ICD) therapy (shock or anti tachycardia pacing) in idiopathic dilated cardiomyopathy (IDC) patients. Methods: We retrospectively examined IDC patients (mean age: 58.3 ± 11.8 years, 81.5% male) with ICD who admitted to outpatient clinic for pacemaker control at 2 tertiary care hospitals in Ankara and Edirne, Turkey from January 2013-2015. All ICDs were implanted for primary prevention. Hematological and biochemical parameters were measured prior procedure. Results: Over a median follow-up period of 43 months (Range 7-125), 68 (33.1%) patients experienced appropriate ICD therapy. The NLR was increased in patients that received appropriate therapy (4.39 ± 2.94 versus 2.96 ± 1.97, p<0.001). To identify independent risk factors for appropriate therapy, a multivariate linear regression model was conducted and age (β=0.163, p=0.013), fasting glucose (β=0.158, p=0.017), C-reactive protein (CRP) (β=0.289, p<0.001) and NLR (β=0.212, p<0.008) were found to be independent risk factors for appropriate ICD therapy. Conclusions: Before ICD implantation by using NLR and CRP, arrhythmic episodes may be predictable and better antiarrhythmic medical therapy optimization may protect these IDC patients from unwanted events. PMID:28133686

  12. Society position statement : Canadian Cardiovascular Society/Canadian Anesthesiologists' Society/Canadian Heart Rhythm Society joint position statement on the perioperative management of patients with implanted pacemakers, defibrillators, and neurostimulating devices.

    PubMed

    Healey, Jeff S; Merchant, Richard; Simpson, Chris; Tang, Timothy; Beardsall, Marianne; Tung, Stanley; Fraser, Jennifer A; Long, Laurene; van Vlymen, Janet M; Manninen, Pirjo; Ralley, Fiona; Venkatraghavan, Lashmi; Yee, Raymond; Prasloski, Bruce; Sanatani, Shubhayan; Philippon, François

    2012-04-01

    There are more than 200,000 Canadians living with permanent pacemakers or implantable defibrillators, many of whom will require surgery or invasive procedures each year. They face potential hazards when undergoing surgery; however, with appropriate planning and education of operating room personnel, adverse device-related outcomes should be rare. This joint position statement from the Canadian Cardiovascular Society (CCS) and the Canadian Anesthesiologists' Society (CAS) has been developed as an accessible reference for physicians and surgeons, providing an overview of the key issues for the preoperative, intraoperative, and postoperative care of these patients. The document summarizes the limited published literature in this field, but for most issues, relies heavily on the experience of the cardiologists and anesthesiologists who contributed to this work. This position statement outlines how to obtain information about an individual's type of pacemaker or implantable defibrillator and its programming. It also stresses the importance of determining if a patient is highly pacemaker-dependent and proposes a simple approach for nonelective evaluation of dependency. Although the document provides a comprehensive list of the intraoperative issues facing these patients, there is a focus on electromagnetic interference resulting from electrocautery and practical guidance is given regarding the characteristics of surgery, electrocautery, pacemakers, and defibrillators which are most likely to lead to interference. The document stresses the importance of preoperative consultation and planning to minimize complications. It reviews the relative merits of intraoperative magnet use vs reprogramming of devices and gives examples of situations where one or the other approach is preferable.

  13. Implantable Defibrillators for Secondary Prevention of Sudden Cardiac Death in Cardiac Surgery Patients With Perioperative Ventricular Arrhythmias

    PubMed Central

    Nageh, Maged F.; Kim, John J.; Chen, Lie‐Hong; Yao, Janis F.

    2014-01-01

    Background Randomized studies of implantable cardioverter defibrillators (ICD) have excluded sudden cardiac death survivors who had revascularization before or after an arrhythmic event. To evaluate the role of ICD and the effects of clinical variables including degree of revascularization, we studied cardiac surgery patients who had an ICD implanted for sustained perioperative ventricular arrhythmias. Methods and Results The electronic database for Southern California Kaiser Foundation hospitals was searched for patients who had cardiac surgery between 1999 and 2005 and an ICD implanted within 3 months of surgery. One hundred sixty‐four patients were identified; 93/164 had an ICD for sustained pre‐ or postoperative ventricular tachycardia or fibrillation requiring resuscitation. Records were reviewed for the following: presenting arrhythmia, ejection fraction, and degree of revascularization. The primary end point was total mortality (TM) and/or appropriate ICD therapy (ICD‐T), and secondary end points are TM and ICD‐T. During the mean follow up of 49 months, the primary endpoint of TM+ICD‐T and individual end points of TM and ICD‐T were observed in 52 (56%), 35 (38%), and 28 (30%) patients, respectively, with 55% of TM, and 23% of ICD‐T occurring within 2 years of implant. In multivariate risk analysis, none of the following was associated with any of the end points: incomplete revascularization, presenting ventricular arrhythmia, and timing of arrhythmias. Conclusion Our data supports the recent guidelines for ICD in this cohort of patients, as the presence of irreversible substrate and triggers of ventricular arrhythmias, cannot be reliably excluded even with complete revascularization. Further studies are needed to understand this complex group of patients. PMID:25146702

  14. Value of an automatic external defibrillator printout as a diagnostic tool after successful AED use on a child.

    PubMed

    van Sambeeck, S J; van Gent, R; Schroër, C; Halbertsma, F J J

    2013-04-22

    A 6-year-old girl without any medical history experienced a drowning incident for a duration of 2 min, according to witnesses. This was followed by cardiopulmonary resuscitation, during which the automatic external defibrillator (AED) detected a shockable rhythm and subsequently delivered a single electroshock. At the time of admission, her medical history was unclear, and as her chest had been wet, it was not clear if the AED had been capable of correctly analysing the rhythm. The AED printout, however, revealed ventricular fibrillation (VF), which proved to be a primary cardiac cause at the time of the incident. This case report confirms the assumption that the AED can adequately perform rhythm analysis on children and convert VF into sinus rhythm. Moreover, the AED printout can provide information about the rhythm that is necessary for the diagnosis of an underlying cardiac disease.

  15. Initial experience with a microprocessor controlled current based defibrillator.

    PubMed Central

    Dalzell, G W; Cunningham, S R; Anderson, J; Adgey, A A

    1989-01-01

    Intramyocardial current flow is a critical factor in successful ventricular defibrillation. The main determinants of intramyocardial current flow during transthoracic countershock are the selected energy and the transthoracic impedance of the patient. To optimise the success of the first shock and to titrate energy dosage according to each patient's transthoracic impedance, a microprocessor controlled current based defibrillator was developed. It was compared with a conventional energy based protocol of 200 J (delivered energy), 200 J, then 360 J if required in 42 consecutive episodes of ventricular fibrillation in 33 men and seven women. The mean (SD) predicted transthoracic impedance was 69.9 (14.0) omega. First shock success with the standard protocol was 80.9%, and first or second shock success was 95.2%. The microprocessor controlled current based defibrillator automatically measured transthoracic impedance and calculated the energy required to develop a selected current in each patient. A current protocol of 30 A, 30 A, then 40 A, if required, was used in 29 men and 12 women with 41 episodes of ventricular fibrillation. Transthoracic impedance (mean 65.1 (15.9) omega) was similar to that in the energy protocol group and success rates for first shock (82.9%) and first or second shocks (97.5%) were also similar. The mean delivered energy per shock with the current based defibrillator for first or second shock success was significantly less (144.8 J) with the energy protocol (200 J). The mean peak current of successful shocks was also significantly reduced (29.0 v 31.9 A). A current based defibrillator titrates energy according to transthoracic impedance; it has a success rate comparable to conventional defibrillators but it delivers significantly less energy and current per shock. Images Fig 1 PMID:2757862

  16. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices.

    PubMed

    Martin, David T; Bersohn, Malcolm M; Waldo, Albert L; Wathen, Mark S; Choucair, Wassim K; Lip, Gregory Y H; Ip, John; Holcomb, Richard; Akar, Joseph G; Halperin, Jonathan L

    2015-07-07

    Atrial tachyarrhythmias (ATs) detected by implanted devices are often atrial fibrillation or flutter (AF) associated with stroke. We hypothesized that introduction and termination of anticoagulation based upon AT monitoring would reduce both stroke and bleeding. We randomized 2718 patients with dual-chamber and biventricular defibrillators to start and stop anticoagulation based on remote rhythm monitoring vs. usual office-based follow-up with anticoagulation determined by standard clinical criteria. The primary analysis compared the composite endpoint of stroke, systemic embolism, and major bleeding with the two strategies. The trial was stopped after 2 years median follow-up based on futility of finding a difference in primary endpoints between groups. A total of 945 patients (34.8%) developed AT, 264 meeting study anticoagulation criteria. Adjudicated atrial electrograms confirmed AF in 91%; median time to initiate anticoagulation was 3 vs. 54 days in the intervention and control groups, respectively (P < 0.001). Primary events (2.4 vs. 2.3 per 100 patient-years) did not differ between groups (HR 1.06; 95% CI 0.75-1.51; P = 0.732). Major bleeding occurred at 1.6 vs. 1.2 per 100 patient-years (HR 1.39; 95% CI 0.89-2.17; P = 0.145). In patients with AT, thromboembolism rates were 1.0 vs. 1.6 per 100 patient-years (relative risk -35.3%; 95% CI -70.8 to 35.3%; P = 0.251). Although AT burden was associated with thromboembolism, there was no temporal relationship between AT and stroke. In patients with implanted defibrillators, the strategy of early initiation and interruption of anticoagulation based on remotely detected AT did not prevent thromboembolism and bleeding. IMPACT ClinicalTrials.gov identifier: NCT00559988 ( http://clinicaltrials.gov/ct2/show/NCT00559988?term=NCT00559988&rank=1 ). Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  17. Decreasing the time to defibrillation: a comparative study of defibrillator electrode designs.

    PubMed

    Adams, Bruce D; Easty, David M; Stuffel, Elaine; Hartman, Irma

    2005-08-01

    Time to defibrillation (T(defib)) is the most important modifiable factor affecting survival from cardiac arrest. Mortality increases by approximately 7--10% for each minute of defibrillation delay. The purpose of this study was to determine whether defibrillator electrode design complexity affects T(defib). This was a randomized sequential design study utilizing a standardized ventricular fibrillation cardiac arrest model for CPR mannequins. We evaluated two common types of defibrillator electrode models: a single connector design and a double connector design that requires an adaptor. We compared the time required by cardiac arrest team leaders to apply the two types of defibrillator electrodes to a manikin, connect them to a defibrillator, and then deliver a first defibrillatory shock. The primary outcome was time to defibrillation. The secondary outcome was difficulty of application as perceived by the physician participants on a 10 cm visual analog scale. Thirty-two residents performed a sequential assessment of both electrodes. The average T(defib) for the double connector model was 42.9s longer than that of the single connector model (87.5s versus 44.6s, p<0.001). As evaluated by the study participants, the single connector model was significantly easier to apply then the double connector model (1.3 cm versus 4.4 cm, p<0.001). The single connector defibrillator electrode design was associated with a significantly shorter T(defib) than the double connector design. It also was judged to be easier to apply in this model. Ergonomic design of defibrillator electrodes can significantly impact time to defibrillation.

  18. Influence of time between last myocardial infarction and prophylactic implantable defibrillator implant on device detections and therapies. “Routine Practice” data from the SEARCH MI registry

    PubMed Central

    2012-01-01

    Background A multicenter European Registry, SEARCH-MI, was instituted in the year 2002 in order to assess patients’ outcomes and ICD interventions in patients with a previous MI and depressed LV function, treated with an ICD according to MADIT II results. In this analysis, we evaluate the influence of the time elapsed between last myocardial infarction (MI) and prophylactic cardioverter defibrillator (ICD) implant on device activations. Methods 643 patients with left ventricular dysfunction (mean LVEF 26 ± 5%) and NYHA class I-III were prospectively followed for 1.8 ± 1.2 years in a multicenter registry. The population was divided into 3 groups according to the time between last MI and ICD implant: [1] from 40 days to less than 1.5 years; [2] from 1.5 to less than 7 years and [3] at least 7 years. Results The cumulative incidence of ventricular tachyarrhymias and appropriate device therapy (ATP or shock) were higher in patients implanted longer time from last MI (Gray’s Test p = 0.002 and p = 0.013 respectively). No significant differences were seen in all cause mortality (Gray’s Test p = 0.618) or sudden cardiac death across the MI stratification groups (Gray’s Test p = 0.663). Conclusions Patients implanted with an ICD longer after the MI have a higher chance of presenting ventricular tachyarrhythmias and appropriate ICD therapy, while no differences were seen in overall mortality. These observations may be important for improving patient targeting in sudden death prevention. PMID:22966862

  19. Defibrillator synchronization tester.

    PubMed

    Demirbilek, Fatma N; Krajnak, Mike; Stolarczyk, George

    2009-01-01

    A defibrillator sync output signal connector provides an ECG synchronization signal that can be used by some defibrillators for the purpose of performing synchronized cardioversion [1]. This process is used to stop an abnormally fast heart rate or cardiac arrhythmia by the delivery of a therapeutic dose of electric current to the heart during the R-wave of the cardiac cycle. Timing the shock to the R-wave prevents the delivery of the shock during the vulnerable period of the cardiac cycle, which could induce ventricular fibrillation [2]. GE patient monitors include a selectable analog output feature, which provides an analog ECG or arterial blood pressure signal. The blood pressure signal can be used to synchronize balloon pumps to provide cardiac assist to post-MI patients with poor injection fraction. Proper operation requires the defibrillator sync and analog output function to be checked. Checkouts are typically done during planned maintenance and after major part replacements such as patient monitor's main CPU board. Checking out defibrillator sync signals could be done using a GE defibrillator sync tester. The defibrillator sync tester provides a loop back path for the defibrillator sync signals to be displayed on the patient monitor screen and eliminates the need for an external oscilloscope.

  20. Dual chamber arrhythmia detection in the implantable cardioverter defibrillator.

    PubMed

    Dijkman, B; Wellens, H J

    2000-10-01

    Dual chamber implantable cardioverter defibrillator (ICD) technology extended ICD therapy to more than termination of hemodynamically unstable ventricular tachyarrhythmias. It created the basis for dual chamber arrhythmia management in which dependable detection is important for treatment and prevention of both ventricular and atrial arrhythmias. Dual chamber detection algorithms were investigated in two Medtronic dual chamber ICDs: the 7250 Jewel AF (33 patients) and the 7271 Gem DR (31 patients). Both ICDs use the same PR Logic algorithm to interpret tachycardia as ventricular tachycardia (VT), supraventricular tachycardia (SVT), or dual (VT+ SVT). The accuracy of dual chamber detection was studied in 310 of 1,367 spontaneously occurring tachycardias in which rate criterion only was not sufficient for arrhythmia diagnosis. In 78 episodes there was a double tachycardia, in 223 episodes SVT was detected in the VT or ventricular fibrillation zone, and in 9 episodes arrhythmia was detected outside the boundaries of the PR Logic functioning. In 100% of double tachycardias the VT was correctly diagnosed and received priority treatment. SVT was seen in 59 (19%) episodes diagnosed as VT. The causes of inappropriate detection were (1) algorithm failure (inability to fulfill the PR

  1. Implantable acoustic-beacon automatic fish-tracking system

    NASA Technical Reports Server (NTRS)

    Mayhue, R. J.; Lovelady, R. W.; Ferguson, R. L.; Richards, C. E.

    1977-01-01

    A portable automatic fish tracking system was developed for monitoring the two dimensional movements of small fish within fixed areas of estuarine waters and lakes. By using the miniature pinger previously developed for this application, prototype tests of the system were conducted in the York River near the Virginia Institute of Marine Science with two underwater listening stations. Results from these tests showed that the tracking system could position the miniature pinger signals to within + or - 2.5 deg and + or - 135 m at ranges up to 2.5 km. The pingers were implanted in small fish and were successfully tracked at comparable ranges. No changes in either fish behavior or pinger performance were observed as a result of the implantation. Based on results from these prototype tests, it is concluded that the now commercially available system provides an effective approach to underwater tracking of small fish within a fixed area of interest.

  2. Influence of primary and secondary prevention indications on anxiety about the implantable cardioverter-defibrillator.

    PubMed

    Rahmawati, Anita; Chishaki, Akiko; Ohkusa, Tomoko; Sawatari, Hiroyuki; Tsuchihashi-Makaya, Miyuki; Ohtsuka, Yuko; Nakai, Mori; Miyazono, Mami; Hashiguchi, Nobuko; Sakurada, Harumizu; Takemoto, Masao; Mukai, Yasushi; Inoue, Shujirou; Sunagawa, Kenji; Chishaki, Hiroaki

    2016-04-01

    Implantable cardioverter-defibrillators (ICDs) have been established for primary and secondary prevention of fatal arrhythmias. However, little is known about the influence of ICD indications on quality of life (QOL) and psychological disturbances. This study aimed to examine whether there were differences in QOL and psychological distress in patients that have an ICD for primary or secondary prevention of fatal arrhythmias. A multicenter survey of 179 consecutive outpatients (29.1% primary prevention) with ICD implantations completed the Short Form-8 (SF-8), Beck Depression Inventory (BDI), Impact of Event Scale-Revised (IES-R), State-Trait Anxiety Inventory (STAI), and Worries about ICD (WAICD). Patients with an ICD for primary prevention had a higher trait anxiety score and worries about ICD score than patients with an ICD for secondary prevention (41.7±12.4 vs. 34.7±12.3, p=0.001 and 39.6±18.0 vs. 30.0±18.9, p=0.002, respectively), even after adjusting for demographic and clinical characteristics. In multivariable analysis of variance, primary prevention ICD recipients reported a poorer QOL on the vitality subscale of the SF-8. In our study population, which mostly consisted of New York Heart Association (NYHA) class I and II subjects, primary prevention ICD recipients were more prone to experience worries about their ICD, anxiety, and a poorer QOL compared to secondary prevention ICD recipients. In clinical practice, primary prevention ICD patients should be closely monitored. If warranted, they should be offered psychological intervention, as anxiety and low QOL were predictors of mortality.

  3. Optimizing implantable cardioverter-defibrillator treatment of rapid ventricular tachycardia: antitachycardia pacing therapy during charging.

    PubMed

    Schoels, Wolfgang; Steinhaus, David; Johnson, W Ben; O'hara, Gilles; Schwab, Joerg O; Jenniskens, Inge; Degroot, Paul J; Tang, Feng; Helmling, Erhard

    2007-07-01

    Previous studies in implantable cardioverter-defibrillator (ICD) patients demonstrated the efficacy and safety of antitachycardia pacing (ATP) for rapid ventricular tachycardias (VT). To prevent shock delay in case of ATP failure, a new feature (ATP during charging) was developed to deliver ATP for rapid VT while charging for shock. The purpose of this study was to determine the efficacy and safety of this new feature. In a prospective, nonrandomized trial, patients with standard ICD indication received an EnTrust ICD. VT and ventricular fibrillation (VF) episodes were reviewed for appropriate detection, ATP success, rhythm acceleration, and related symptoms. In 421 implanted patients, 116 VF episodes occurred in 37 patients. Eighty-four (72%) episodes received ATP during or before charging. ATP prevented a shock in 58 (69%) of 84 episodes in 15 patients. ATP stopped significantly more monomorphic (77%) than polymorphic VTs (44%, P = .05). Five (6%) episodes accelerated after ATP but were terminated by the backup shock(s). No symptoms were related to ATP during charging. In four patients, 38 charges were saved by delivering ATP before charging. Of 98 induced VF episodes, 28% were successfully terminated by ATP versus 69% for spontaneous episodes (P <.01). Most VTs detected in the VF zone can be painlessly terminated by ATP delivered during charging, with a low risk of acceleration or symptoms. ATP before charging allows delivery of two ATP attempts before shock in the same time that would otherwise be required to deliver only one ATP plus a shock. It also offers potential battery energy savings.

  4. Ventricular tachyarrhythmias and mortality in patients with an implantable cardioverter defibrillator: impact of depression in the MIDAS cohort.

    PubMed

    Mastenbroek, Mirjam H; Versteeg, Henneke; Jordaens, Luc; Theuns, Dominic A M J; Pedersen, Susanne S

    2014-01-01

    We examined whether depression is independently associated with implantable cardioverter defibrillator (ICD) therapy for ventricular tachyarrhythmias and mortality. A cohort of 430 consecutive patients with a first-time ICD (79% men; mean [standard deviation] age = 57.8 [12.1] years) completed the Hospital Anxiety and Depression Scale 1 day before implantation. During follow-up, the ICD was interrogated at 3-month intervals. Cox proportional hazard regression analyses were used to examine the impact of depression on time to first appropriate ICD therapy and all-cause mortality during a median follow-up period of 3.8 years. Of all patients, 108 (25.1%) were depressed. Depression was not associated with time to first appropriate ICD therapy (unadjusted hazard ratio [HR] = 1.07, 95% confidence interval [CI] = 0.73-1.56). However, depression was associated with an increased risk for all-cause mortality (unadjusted HR = 2.18, 95% CI = 1.36-3.49). Depression remained independently associated with all-cause mortality (HR = 1.94, 95% CI = 1.06-3.54, p = .031), after adjusting for demographic and clinical characteristics. Patients who remained depressed during the first 3 months after implantation were at greatest risk for dying (HR = 2.88, 95% CI = 1.29-6.45, p = .010). The current study showed that depression at the time of implant is not associated with time to first appropriate ICD therapy but almost doubled the risk for all-cause mortality in patients with an ICD. Patients with persistent depression during the first 3 months after implantation face the greatest risk of dying. Current evidence indicates that multifactorial interventions are likely to be the most successful in terms of reducing distress. Whether this translates into enhanced survival has yet to be determined.

  5. Minimal instructions improve the performance of laypersons in the use of semiautomatic and automatic external defibrillators

    PubMed Central

    Beckers, Stefan; Fries, Michael; Bickenbach, Johannes; Derwall, Matthias; Kuhlen, Ralf; Rossaint, Rolf

    2005-01-01

    Introduction There is evidence that use of automated external defibrillators (AEDs) by laypersons improves rates of survival from cardiac arrest, but there is no consensus on the optimal content and duration of training for this purpose. In this study we examined the use of semiautomatic or automatic AEDs by laypersons who had received no training (intuitive use) and the effects of minimal general theoretical instructions on their performance. Methods In a mock cardiac arrest scenario, 236 first year medical students who had not previously attended any preclinical courses were evaluated in their first study week, before and after receiving prespecified instructions (15 min) once. The primary end-point was the time to first shock for each time point; secondary end-points were correct electrode pad positioning, safety of the procedure and the subjective feelings of the students. Results The mean time to shock for both AED types was 81.2 ± 19.2 s (range 45–178 s). Correct pad placement was observed in 85.6% and adequate safety in 94.1%. The time to shock after instruction decreased significantly to 56.8 ± 9.9 s (range 35–95 s; P ≤ 0.01), with correct electrode placement in 92.8% and adequate safety in 97%. The students were significantly quicker at both evaluations using the semiautomatic device than with the automatic AED (first evaluation: 77.5 ± 20.5 s versus 85.2 ± 17 s, P ≤ 0.01; second evaluation: 55 ± 10.3 s versus 59.6 ± 9.6 s, P ≤ 0.01). Conclusion Untrained laypersons can use semiautomatic and automatic AEDs sufficiently quickly and without instruction. After one use and minimal instructions, improvements in practical performance were significant. All tested laypersons were able to deliver the first shock in under 1 min. PMID:15774042

  6. Superior Rhythm Discrimination With the SmartShock Technology Algorithm - Results of the Implantable Defibrillator With Enhanced Features and Settings for Reduction of Inaccurate Detection (DEFENSE) Trial.

    PubMed

    Oginosawa, Yasushi; Kohno, Ritsuko; Honda, Toshihiro; Kikuchi, Kan; Nozoe, Masatsugu; Uchida, Takayuki; Minamiguchi, Hitoshi; Sonoda, Koichiro; Ogawa, Masahiro; Ideguchi, Takeshi; Kizaki, Yoshihisa; Nakamura, Toshihiro; Oba, Kageyuki; Higa, Satoshi; Yoshida, Keiki; Tsunoda, Soichi; Fujino, Yoshihisa; Abe, Haruhiko

    2017-08-25

    Shocks delivered by implanted anti-tachyarrhythmia devices, even when appropriate, lower the quality of life and survival. The new SmartShock Technology ® (SST) discrimination algorithm was developed to prevent the delivery of inappropriate shock. This prospective, multicenter, observational study compared the rate of inaccurate detection of ventricular tachyarrhythmia using the SST vs. a conventional discrimination algorithm.Methods and Results:Recipients of implantable cardioverter defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D) equipped with the SST algorithm were enrolled and followed up every 6 months. The tachycardia detection rate was set at ≥150 beats/min with the SST algorithm. The primary endpoint was the time to first inaccurate detection of ventricular tachycardia (VT) with conventional vs. the SST discrimination algorithm, up to 2 years of follow-up. Between March 2012 and September 2013, 185 patients (mean age, 64.0±14.9 years; men, 74%; secondary prevention indication, 49.5%) were enrolled at 14 Japanese medical centers. Inaccurate detection was observed in 32 patients (17.6%) with the conventional, vs. in 19 patients (10.4%) with the SST algorithm. SST significantly lowered the rate of inaccurate detection by dual chamber devices (HR, 0.50; 95% CI: 0.263-0.950; P=0.034). Compared with previous algorithms, the SST discrimination algorithm significantly lowered the rate of inaccurate detection of VT in recipients of dual-chamber ICD or CRT-D.

  7. The natural history of new-onset heart failure with a severely depressed left ventricular ejection fraction: implications for timing of implantable cardioverter-defibrillator implantation.

    PubMed

    Teeter, William A; Thibodeau, Jennifer T; Rao, Krishnasree; Brickner, M Elizabeth; Toto, Kathleen H; Nelson, Lauren L; Mishkin, Joseph D; Ayers, Colby R; Miller, Justin G; Mammen, Pradeep P A; Patel, Parag C; Markham, David W; Drazner, Mark H

    2012-09-01

    Guidelines recommend that patients with new-onset systolic heart failure (HF) receive a trial of medical therapy before an implantable cardiac defibrillator (ICD). This strategy allows for improvement of left ventricular ejection fraction (LVEF), thereby avoiding an ICD, but exposes patients to risk of potentially preventable sudden cardiac death during the trial of medical therapy. We reviewed a consecutive series of patients with HF of <6 months duration with a severely depressed LVEF (<30%) evaluated in a HF clinic (N = 224). The ICD implantation was delayed with plans to reassess LVEF approximately 6 months after optimization of β-blockers. Mortality was ascertained by the National Death Index. Follow-up echocardiograms were performed in 115 of the 224 subjects. Of these, 50 (43%) had mildly depressed or normal LVEF at follow-up ("LVEF recovery") such that an ICD was no longer indicated. In a conservative sensitivity analysis (using the entire study cohort, whether or not a follow-up echocardiogram was obtained, as the denominator), 22% of subjects had LVEF recovery. Mortality at 6, 12, and 18 months in the entire cohort was 2.3%, 4.5%, and 6.8%, respectively. Of 87 patients who tolerated target doses of β-blockers, only 1 (1.1%) died during the first 18 months. Patients with new-onset systolic HF have both a good chance of LVEF recovery and low 6-month mortality. Achievement of target β-blocker dose identifies a very low-risk population. These data support delaying ICD implantation for a trial of medical therapy. Copyright © 2012 Mosby, Inc. All rights reserved.

  8. Inappropriate implantable cardioverter defibrillator shocks in fractured Sprint Fidelis leads associated with 'appropriate' interrogation.

    PubMed

    Farwell, David; Redpath, Calum; Birnie, David; Gollob, Michael; Lemery, Robert; Posan, Emoke; Green, Martin

    2008-06-01

    We present two patients with fractures within the pace-sense circuit of their Medtronic Sprint Fidelis leads who received inappropriate shocks from their Medtronic defibrillators during device interrogation. This was not simply a coincidence, but due to electromagnetic interference induced within the Sprint Fidelis lead by the device programmer during two-way communication with the defibrillator. Our subsequent investigations have uncovered at least two other similar incidents in Canada. We have also discovered that the Medtronic 'Auto-resume' feature may leave future patients uniquely vulnerable to such inappropriate shocks in the future.

  9. Dual- vs. single-chamber defibrillators for primary prevention of sudden cardiac death: long-term follow-up of the Défibrillateur Automatique Implantable-Prévention Primaire registry.

    PubMed

    Defaye, Pascal; Boveda, Serge; Klug, Didier; Beganton, Frankie; Piot, Olivier; Narayanan, Kumar; Périer, Marie-Cécile; Gras, Daniel; Fauchier, Laurent; Bordachar, Pierre; Algalarrondo, Vincent; Babuty, Dominique; Deharo, Jean-Claude; Leclercq, Christophe; Marijon, Eloi; Sadoul, Nicolas

    2017-09-01

    Implantable cardioverter defibrillators (ICDs) are an effective primary prevention of sudden cardiac death. We examined whether dual-chamber (DC) ICDs confer a greater benefit than single-chamber (SC) ICDs, and compared the long-term outcomes of recipients of each type of device implanted for primary prevention. Between 2002 and 2012, the DAI-PP registry consecutively enrolled 1258 SC- and 1280 DC-ICD recipients at 12 French medical centres. The devices were interrogated at 4- to 6-month intervals during outpatient visits, with a focus on the therapies delivered. The study endpoints were incidence of appropriate therapies, ICD-related morbidity, and deaths from all and from specific causes. The mean age of the SC- and DC-ICD recipients was 59 ± 12 and 62 ± 11 years, respectively (P< 0.0001). The distribution of genders, New York Heart Association functional classes and glomerular filtration rates, and the rates of ischaemic vs. dilated cardiomyopathies and of defibrillation tests at implant, were similar in both study groups. The rates of periprocedural complications were 12.1% in the DC- vs. 8.8% in the SC-ICD groups (P= 0.008). Over a mean follow-up of 3.1 ± 2.2 years, pulse generators were replaced in 21.9% of the DC- vs. 13.6% of the SC-ICD group (P< 0.0001). The proportions of patients treated with ≥1 appropriate therapies (24.7 vs. 23.8%) and ≥1 inappropriate shocks (8.4 vs. 7.8%), and all-cause mortality (12.4 vs. 13.2%) were similar in both groups. In this large registry of ICD implanted for primary prevention, DC-ICDs were associated with higher rates of peri-implant complications and generator replacements, whereas the survival and rates of inappropriate shocks were similar in both groups. NCT#01992458. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions please email: journals.permissions@oup.com.

  10. Capacity of dental equipment to interfere with cardiac implantable electrical devices.

    PubMed

    Lahor-Soler, Eduard; Miranda-Rius, Jaume; Brunet-Llobet, Lluís; Sabaté de la Cruz, Xavier

    2015-06-01

    Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer. © 2015 Eur J Oral Sci.

  11. Sex is associated with differences in individual trajectories of change in social health after implantable cardioverter-defibrillator.

    PubMed

    Lauck, Sandra B; Sawatzky, Richard; Johnson, Joy L; Humphries, Karin; Bennett, Matthew T; Chakrabarti, Santabhanu; Kerr, Charles R; Tung, Stanley; Yeung-Lai-Wah, John A; Ratner, Pamela A

    2015-03-01

    Social health is a dimension of quality of life, and refers to people's involvement in, and satisfaction with social roles, responsibilities, and activities. The implantable cardioverter-defibrillator is associated with changes in overall quality of life, but little is known about sex differences in individual trajectories of change in social health. We prospectively measured changes in 3 subscales of the SF-36v2 generic health questionnaire (role physical, role emotional, and social functioning), 2 Patient-Reported Outcomes Measurement Information System short forms (satisfaction with participation in social roles and satisfaction with participation in discretionary social activities), and the Florida Patient Acceptance Survey before and at 1, 2, and 6 months after implantation. Individual growth models of temporal change were estimated. The scores of the 6 indicators improved with time. The unconditional model demonstrated significant (fixed effects: P<0.05; covariance parameters: P<0.10) residual variability in the individual trajectories. In the conditional model, men and women differed significantly in their rates of change in the scores of 3 of the 6 measures. Although men's mean scores exceeded women's mean scores on all indicators at baseline (range of relative mean difference: 11.0% to 17.8%), the rate of women's change resulted in a reversal in relative standing at 6 months after implantation, with the mean scores of women exceeding the men's by 4.5% to 5.6%. Men and women differed in their trajectories of change in social health, both in terms of their starting points (ie, baseline scores) and their rates of change. © 2015 American Heart Association, Inc.

  12. [Inappropriate analyses of automated external defibrillators used during out-of-hospital cardiac arrests].

    PubMed

    Ballesteros Peña, Sendoa

    2013-04-01

    To estimate the frequency of therapeutic errors and to evaluate the diagnostic accuracy in the recognition of shockable rhythms by automated external defibrillators. A retrospective descriptive study. Nine basic life support units from Biscay (Spain). Included 201 patients with cardiac arrest, since 2006 to 2011. The study was made of the suitability of treatment (shock or not) after each analysis and medical errors identified. The sensitivity, specificity and predictive values with 95% confidence intervals were then calculated. A total of 811 electrocardiographic rhythm analyses were obtained, of which 120 (14.1%), from 30 patients, corresponded to shockable rhythms. Sensitivity and specificity for appropriate automated external defibrillators management of a shockable rhythm were 85% (95% CI, 77.5% to 90.3%) and 100% (95% CI, 99.4% to 100%), respectively. Positive and negative predictive values were 100% (95% CI, 96.4% to 100%) and 97.5% (95% CI, 96% to 98.4%), respectively. There were 18 (2.2%; 95% CI, 1.3% to 3.5%) errors associated with defibrillator management, all relating to cases of shockable rhythms that were not shocked. One error was operator dependent, 6 were defibrillator dependent (caused by interaction of pacemakers), and 11 were unclassified. Automated external defibrillators have a very high specificity and moderately high sensitivity. There are few operator dependent errors. Implanted pacemakers interfere with defibrillator analyses. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  13. Shock anxiety among implantable cardioverter defibrillator recipients with recent tachyarrhythmia.

    PubMed

    Morken, Ingvild M; Isaksen, Kjetil; Karlsen, Bjørg; Norekvål, Tone M; Bru, Edvin; Larsen, Alf Inge

    2012-11-01

    Shock anxiety has been documented irrespective of shock exposure in implantable cardioverter defibrillator (ICD) recipients. The presence of tachyarrhythmia may lead to an anticipation of receiving a shock and thereby give rise to shock anxiety. The aims were to assess: (1) the level of shock anxiety in a sample of ICD recipients, (2) the relationship between such anxiety and shock exposure, and (3) the relationship between recent tachyarrhythmia and shock anxiety. ICD recipients (n = 167) completed the Florida Shock Anxiety Scale measure of shock anxiety. The recipients were divided into three groups: (1) Recipients with no documented tachyarrhythmia over the previous 12 months (n = 56), (2) recipients with documented tachyarrhythmia over the previous twelve months (n = 54), and (3) recipients with any history of shocks (n = 57). Of the recipients, 44% experienced some form of shock anxiety, whereas 15% reported general shock anxiety. Analyses of covariance revealed that recipients with recent tachyarrhythmia (F = 7.675 df = 9/100, P = 0.007) as well as recipients with a shock history (F = 9.976, df = 9/103, P = 0.002) reported higher levels of shock anxiety than recipients with no recent tachyarrhythmia. This study indicates that although a substantial proportion of the ICD recipients experienced some form of shock anxiety, only a relatively small proportion reported general shock anxiety. ICD recipients with recent tachyarrhythmia, in addition to recipients with shock history, appear to be at greater risk for development of shock anxiety. This implies that these recipients may profit from clinical-based strategies and interventions targeting shock anxiety. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

  14. Implantable cardioverter-defibrillator therapy in Brugada syndrome: a 20-year single-center experience.

    PubMed

    Conte, Giulio; Sieira, Juan; Ciconte, Giuseppe; de Asmundis, Carlo; Chierchia, Gian-Battista; Baltogiannis, Giannis; Di Giovanni, Giacomo; La Meir, Mark; Wellens, Francis; Czapla, Jens; Wauters, Kristel; Levinstein, Moises; Saitoh, Yukio; Irfan, Ghazala; Julià, Justo; Pappaert, Gudrun; Brugada, Pedro

    2015-03-10

    Patients with Brugada syndrome and aborted sudden cardiac death or syncope have higher risks for ventricular arrhythmias (VAs) and should undergo implantable cardioverter-defibrillator (ICD) placement. Device-based management of asymptomatic patients is controversial. ICD therapy is associated with high rates of inappropriate shocks and device-related complications. The objective of this study was to investigate clinical features, management, and long-term follow-up of ICD therapy in patients with Brugada syndrome. Patients presenting with spontaneous or drug-induced Brugada type 1 electrocardiographic findings, who underwent ICD implantation and continuous follow-up at a single institution, were eligible for this study. A total of 176 consecutive patients were included. During a mean follow-up period of 83.8 ± 57.3 months, spontaneous sustained VAs occurred in 30 patients (17%). Eight patients (4.5%) died. Appropriate ICD shocks occurred in 28 patients (15.9%), and 33 patients (18.7%) had inappropriate shocks. Electrical storm occurred in 4 subjects (2.3%). Twenty-eight patients (15.9%) experienced device-related complications. In multivariate Cox regression analysis, aborted sudden cardiac death and VA inducibility on electrophysiologic studies were independent predictors of appropriate shock occurrence. ICD therapy was an effective strategy in Brugada syndrome, treating potentially lethal arrhythmias in 17% of patients during long-term follow-up. Appropriate shocks were significantly associated with the presence of aborted sudden cardiac death but also occurred in 13% of asymptomatic patients. Risk stratification by electrophysiologic study may identify asymptomatic patients at risk for arrhythmic events and could be helpful in investigating syncope not related to VAs. ICD placement is frequently associated with device-related complications, and rates of inappropriate shocks remain high regardless of careful device programming. Copyright © 2015 American

  15. The Girona Territori Cardioprotegit Project: Performance Evaluation of Public Defibrillators.

    PubMed

    Loma-Osorio, Pablo; Nuñez, Maria; Aboal, Jaime; Bosch, Daniel; Batlle, Pau; Ruiz de Morales, Ester; Ramos, Rafael; Brugada, Josep; Onaga, Hisao; Morales, Alex; Olivet, Josep; Brugada, Ramon

    2018-02-01

    In recent years, public access defibrillation programs have exponentially increased the availability of automatic external defibrillators (AED) in public spaces but there are no data on their performance in our setting. We conducted a descriptive analysis of the performance of AED since the launch of a public defibrillation program in our region. A retrospective analysis was conducted of electrocardiographic tracings and the performance of AED in a public defibrillation program from June 2011 to June 2015 in the province of Girona, Spain. There were 231 AED activations. Full information was available on 188 activations, of which 82% corresponded to mobile devices and 18% to permanent devices. Asystole was the most prevalent rhythm (42%), while ventricular fibrillation accounted for 23%. The specificity of the device in identifying a shockable rhythm was 100%, but there were 8 false negatives (sensitivity 83%). There were 47 shockable rhythms, with a spontaneous circulation recovery rate of 49% (23 cases). There were no accidents related to the use of the device. Nearly half of the recorded rhythms were asystole. The AED analyzed showed excellent safety and specificity, with moderate sensitivity. Half the patients with a shockable rhythm were successfully treated by the AED. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  16. Automatic identification of cochlear implant electrode arrays for post-operative assessment

    NASA Astrophysics Data System (ADS)

    Noble, Jack H.; Schuman, Theodore A.; Wright, Charles G.; Labadie, Robert F.; Dawant, Benoit M.

    2011-03-01

    Cochlear implantation is a procedure performed to treat profound hearing loss. Accurately determining the postoperative position of the implant in vivo would permit studying the correlations between implant position and hearing restoration. To solve this problem, we present an approach based on parametric Gradient Vector Flow snakes to segment the electrode array in post-operative CT. By combining this with existing methods for localizing intra-cochlear anatomy, we have developed a system that permits accurate assessment of the implant position in vivo. The system is validated using a set of seven temporal bone specimens. The algorithms were run on pre- and post-operative CTs of the specimens, and the results were compared to histological images. It was found that the position of the arrays observed in the histological images is in excellent agreement with the position of their automatically generated 3D reconstructions in the CT scans.

  17. Influence of primary and secondary prevention indications on anxiety about the implantable cardioverter-defibrillator

    PubMed Central

    Rahmawati, Anita; Chishaki, Akiko; Ohkusa, Tomoko; Sawatari, Hiroyuki; Tsuchihashi-Makaya, Miyuki; Ohtsuka, Yuko; Nakai, Mori; Miyazono, Mami; Hashiguchi, Nobuko; Sakurada, Harumizu; Takemoto, Masao; Mukai, Yasushi; Inoue, Shujirou; Sunagawa, Kenji; Chishaki, Hiroaki

    2015-01-01

    Background Implantable cardioverter-defibrillators (ICDs) have been established for primary and secondary prevention of fatal arrhythmias. However, little is known about the influence of ICD indications on quality of life (QOL) and psychological disturbances. This study aimed to examine whether there were differences in QOL and psychological distress in patients that have an ICD for primary or secondary prevention of fatal arrhythmias. Methods A multicenter survey of 179 consecutive outpatients (29.1% primary prevention) with ICD implantations completed the Short Form-8 (SF-8), Beck Depression Inventory (BDI), Impact of Event Scale-Revised (IES-R), State-Trait Anxiety Inventory (STAI), and Worries about ICD (WAICD). Results Patients with an ICD for primary prevention had a higher trait anxiety score and worries about ICD score than patients with an ICD for secondary prevention (41.7±12.4 vs. 34.7±12.3, p=0.001 and 39.6±18.0 vs. 30.0±18.9, p=0.002, respectively), even after adjusting for demographic and clinical characteristics. In multivariable analysis of variance, primary prevention ICD recipients reported a poorer QOL on the vitality subscale of the SF-8. Conclusions In our study population, which mostly consisted of New York Heart Association (NYHA) class I and II subjects, primary prevention ICD recipients were more prone to experience worries about their ICD, anxiety, and a poorer QOL compared to secondary prevention ICD recipients. In clinical practice, primary prevention ICD patients should be closely monitored. If warranted, they should be offered psychological intervention, as anxiety and low QOL were predictors of mortality. PMID:27092190

  18. Cost-effectiveness of the implantable cardioverter defibrillator: a review of current evidence.

    PubMed

    Lynd, Larry D; O'Brien, Bernie J

    2003-09-01

    Implantable cardioverter defibrillator (ICD) therapy is indicated for patients at risk for sudden cardiac death (SCD) due to ventricular tachycardia (VT) or ventricular fibrillation (VF). The high relative cost of therapy with the ICD versus antiarrhythmic drugs has raised questions regarding its cost-effectiveness. To address these questions, we review the literature on ICD cost-effectiveness. MEDLINE and other databases were searched for articles published since 1980 reporting original data on the cost-effectiveness of ICD versus drug therapy for patients at risk for SCD. Data on costs and life-years were abstracted and studies grouped into decision analysis models and trial-based analyses. Cost-effectiveness ratios were inflated to 2002 US dollars. Thirteen economic studies were included in this review: 6 decision-analytic models, 4 economic analysis alongside randomized controlled trials, and 1 observational study. Two additional studies evaluated the cost-effectiveness of ICDs stratified by mortality risk. Studies varied in time horizon, and in all but one study ICD therapy was more costly than drug therapy. Early models assumed larger survival benefits than were observed in subsequent trials; therefore, ICDs appeared to be more cost-effective (i.e., US dollars 28000-US dollars 60000 per life-year gained). Three large clinical trial-based studies estimated that the cost per life-year gained was between US dollars 30181 and US dollars 185000. Stratified analyses show that patients at higher risk for mortality due to structural heart disease (e.g., left ventricular ejection fraction <35%) benefit more from ICD therapy, resulting in lower cost-effectiveness ratios. ICD therapy continues to evolve with changing methods of implantation and improving technology. Current evidence suggests that ICDs may be a cost-effective option in patients at high risk for VT/VF. The cost-effectiveness of ICD therapy for primary and secondary prevention of SCD depends upon patient

  19. Out-of-hospital defibrillation with automated external defibrillators: postshock analysis should be delayed.

    PubMed

    Blouin, D; Topping, C; Moore, S; Stiell, I; Afilalo, M

    2001-09-01

    The American Heart Association protocols for use of automated external defibrillators (AEDs) recommend that a rhythm analysis be done immediately after each defibrillation attempt. However, shock is often followed by electrical silence or marginally organized electrical activity before ventricular fibrillation (VF) or ventricular tachycardia (VT) recurs. The optimal timing of postshock analysis for identification of recurrent VF/VT is unknown. This study examines the time to recurrence of VF/VT after a defibrillation attempt with AED. Over an 18-month period, all tapes from patients with out-of-hospital cardiac arrest who received shocks at least once with an AED were screened for recurrent VF/VT. All cases come from a single emergency medical services system providing basic life support, defibrillation with AED, and intubation with an esophageal-tracheal twin-lumen airway device (Combitube) for a population of 633,511 individuals. Pediatric and traumatic cases were excluded. When VF/VT recurred within 3 minutes of the defibrillation attempt, rhythm strips were printed and included in the study. Two cardiology fellows, blinded to the study objectives, measured the time from defibrillation to recurrent VF/VT for each strip. Over the study period, 222 tapes from 96 patients met the inclusion criteria. Only 44 (20%) occurrences of VF/VT had recurred within 6 seconds of defibrillation, 162 (73%) at 60 seconds, and 200 (90%) at 90 seconds. Eighty percent of VF/VT recurred more than 6 seconds after defibrillation and were missed when using current American Heart Association AED protocols. Subsequent analysis should be postponed until at least 30 seconds after defibrillation. Performing 30 seconds of chest compressions after defibrillation before subsequent AED rhythm analysis would increase AED identification of VF/VT to 52%.

  20. Automatic localization of cochlear implant electrodes in CTs with a limited intensity range

    NASA Astrophysics Data System (ADS)

    Zhao, Yiyuan; Dawant, Benoit M.; Noble, Jack H.

    2017-02-01

    Cochlear implants (CIs) are neural prosthetics for treating severe-to-profound hearing loss. Our group has developed an image-guided cochlear implant programming (IGCIP) system that uses image analysis techniques to recommend patientspecific CI processor settings to improve hearing outcomes. One crucial step in IGCIP is the localization of CI electrodes in post-implantation CTs. Manual localization of electrodes requires time and expertise. To automate this process, our group has proposed automatic techniques that have been validated on CTs acquired with scanners that produce images with an extended range of intensity values. However, there are many clinical CTs acquired with a limited intensity range. This limitation complicates the electrode localization process. In this work, we present a pre-processing step for CTs with a limited intensity range and extend the methods we proposed for full intensity range CTs to localize CI electrodes in CTs with limited intensity range. We evaluate our method on CTs of 20 subjects implanted with CI arrays produced by different manufacturers. Our method achieves a mean localization error of 0.21mm. This indicates our method is robust for automatic localization of CI electrodes in different types of CTs, which represents a crucial step for translating IGCIP from research laboratory to clinical use.

  1. Percutaneous pacemaker or implantable cardioverter-defibrillator lead removal in an attempt to improve symptomatic tricuspid regurgitation.

    PubMed

    Nazmul, Mohammed N; Cha, Yong-Mei; Lin, Grace; Asirvatham, Samuel J; Powell, Brian D

    2013-03-01

    Pacemaker and implantable cardioverter-defibrillator (ICD) leads can cause tricuspid valve regurgitation (TR). Few data are available on the best management of significant TR that develops after pacemaker or ICD implantation and regarding any benefits of right ventricular (RV) lead extraction. We sought to determine the impact of RV lead removal on lead-induced TR. We reviewed all patients between 1 January 2000 and 31 December 2010 at the tertiary care hospital who had a preoperative indication of TR and underwent percutaneous extraction of an RV lead with the intent of trying to correct moderate or severe TR. Pre- and post-procedure echoes and clinical data were retrospectively reviewed. In the four patients identified, the RV lead was removed and placed in the coronary sinus to try to improve moderate or severe TR due to lead impingement. There was no significant improvement in the degree of TR except one patient where TR improved slightly from moderate to mild-moderate. All patients had a dilated tricuspid valve annulus by the time of lead extraction. Tricuspid annulus dilatation appeared to account for the persistent TR after RV lead removal. A greater degree of tricuspid valve annulus dilatation may be a marker and mechanism for irreversible lead-induced TR. Further studies are needed to determine whether surgical tricuspid valve repair or replacement combined with RV lead extraction would result in better outcomes than a percutaneous lead extraction approach.

  2. Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors.

    PubMed

    Abraham, William T

    2013-06-01

    Heart failure represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary heart failure management is reduction of hospital admission and readmission rates. While optimal medical therapy favourably impacts the natural history of the disease, devices such as cardiac resynchronization therapy devices and implantable cardioverter defibrillators have added incremental value in improving heart failure outcomes. These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intrathoracic impedance and heart rate variability, provide a means to assess risk of worsening heart failure and the possibility of future hospitalization. Beyond this capability, implantable haemodynamic monitors have the potential to direct day-to-day management of heart failure patients to significantly reduce hospitalization rates. The use of a pulmonary artery pressure measurement system has been shown to significantly reduce the risk of heart failure hospitalization in a large randomized controlled study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. Observations from a pilot study also support the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial. All these devices depend upon high-intensity remote monitoring for successful detection of parameter deviations and for directing and following therapy.

  3. Acute hemodynamic effects of right and left ventricular lead positions during the implantation of cardiac resynchronization therapy defibrillators.

    PubMed

    Stockinger, Jochem; Staier, Klaus; Schiebeling-Römer, Jochen; Keyl, Cornelius

    2011-11-01

    To evaluate the acute hemodynamic effects of different right (RV) and left ventricular (LV) pacing sites in patients undergoing the implantation of a cardiac resynchronization therapy defibrillator (CRT-D). Stroke volume index (SVI), assessed via pulse contour analysis, and dp/dt max, obtained in the abdominal aorta, were analyzed in 21 patients with New York Heart Association class III heart failure and left bundle branch block (mean ejection fraction of 24 ± 6%), scheduled for CRT-D implantation under general anesthesia. We compared the hemodynamic effects of RV apical (A), RV septal (B), and biventricular pacing using the worst (lowest SVI; C) and best (highest SVI; D) coronary sinus lead positions. Mean arterial pressure, SVI, and dp/dt max did not differ significantly between RV apical and septal pacing. Dp/dt max and SVI increased significantly during biventricular pacing (dp/dt max: B, 588 ± 160 mmHg/s; C, 651 ± 218 mmHg/s, P = 0.03 vs B; D, 690 ± 220 mmHg/s, P = 0.02 vs C; SVI: B, 33.6 ± 5.5 mL/m², C, 34.8 ± 6.1 mL/m², P = 0.08 vs B, D 36.0 ± 6.0 mL/m², P < 0.001 vs C). The best hemodynamic response was associated with lateral or inferior lead positions in 15 patients. Other LV lead positions were most effective in six patients. The optimal LV lead position varies significantly among patients and should be individually determined during CRT-D implantation. The impact of the RV stimulation site in patients with intraventricular conduction delay, undergoing CRT-D implantation, has to be investigated in further studies.

  4. Efficacy of implantable cardioverter defibrillators in young patients with catecholaminergic polymorphic ventricular tachycardia: success depends on substrate.

    PubMed

    Miyake, Christina Y; Webster, Gregory; Czosek, Richard J; Kantoch, Michal J; Dubin, Anne M; Avasarala, Kishor; Atallah, Joseph

    2013-06-01

    The effectiveness of implantable cardioverter-defibrillator (ICD) therapy for the management of catecholaminergic polymorphic ventricular tachycardia (VT) in young patients is not known. ICD discharges are not always effective and inappropriate discharges are common, both resulting in morbidity and mortality. This is a multicenter, retrospective review of young patients with catecholaminergic polymorphic VT and ICDs from 5 centers. ICD discharges were evaluated to determine arrhythmia mechanism, appropriateness, efficacy of therapy, and complications. A total of 24 patients were included. Median (interquartile range) ages at onset of catecholaminergic polymorphic VT symptoms and ICD implant were 10.6 (5.0-13.8) years and 13.7 (10.7-16.3) years, respectively. Fourteen patients received 140 shocks. Ten patients (42%) experienced 75 appropriate shocks and 11 patients (46%) received 65 inappropriate shocks. On actuarial analysis, freedom from appropriate shock at 1 year after ICD implant was 75%. Of appropriate shocks, only 43 (57%) demonstrated successful primary termination. All successful appropriate ICD discharges were for ventricular fibrillation. No episodes of polymorphic VT or bidirectional VT demonstrated successful primary termination. The adjusted mean (95% confidence interval) cycle length of successful discharges was significantly shorter than unsuccessful discharges (168 [152-184] ms versus 245 [229-262] ms; adjusted P=0.002). Electrical storm occurred in 29% (4/14) and induction of more malignant ventricular arrhythmias in 36% (5/14). There were no deaths. ICD efficacy in catecholaminergic polymorphic VT depends on arrhythmia mechanism. Episodes of ventricular fibrillation were uniformly successfully treated, whereas polymorphic and bidirectional VT did not demonstrate successful primary termination. Inappropriate shocks, electrical storm, and ICD complications were common.

  5. Acute effects of implantable cardioverter-defibrillator shocks on biomarkers of myocardial injury, apoptosis, heart failure, and systemic inflammation

    PubMed Central

    Brewster, Jordan; Sexton, Travis; Dhaliwal, Gary; Charnigo, Richard; Morales, Gustavo; Parrott, Kevin; Darrat, Yousef; Gurley, John; Smyth, Susan; Elayi, Claude S.

    2017-01-01

    Background ICD shocks are potentially associated with myocardial injury, altered hemodynamics, apoptosis and inflammatory signaling. Their precise cellular impact can be explored after defibrillation testing (DFT) via biomarkers. We evaluated changes in biomarkers after ICD shocks during DFT. Methods We prospectively enrolled outpatients presenting for first implantation of a cardiac device. Biomarkers indicative of myocardial injury, inflammation and apoptosis were measured before and after implantation, and compared between patients receiving DFT (DFT+) to those not (DFT−). Results Sixty-three patients were enrolled, 40 in the DFT+ group and 23 in the DFT− group. Average levels of troponin I, hsCRP, Calprotectin, NTproBNP, and sFas increased by >50% after cardiac device implantation compared to baseline. Increase in troponin never exceeded 50 fold upper limit of normal (2ng/mL). Troponin trended higher in the DFT+ group at 8 hours (median 0.18 ng/mL, IQR 0.11–0.48) versus the DFT− group (0.10 ng/mL, IQR 0.06–0.28, P=0.0501); NTproBNP had a similar trend (p=0.0581). sFas significantly increased in the DFT+ group from baseline (median 4663 pg/mL, IQR 2908–5679) to 24 hours (5039 pg/mL, IQR 3274–6261; p=0.0338) but not in the DFT− group (p=0.4705). Conclusion DFT testing is associated with acutely increased plasma levels of troponin and sFas, a biomarker of apoptosis, along with a trend towards higher NTproBNP. PMID:28156007

  6. Primary Prevention Implantable Cardioverter-Defibrillators and Survival in Older Women

    PubMed Central

    Zeitler, Emily P.; Hellkamp, Anne S.; Fonarow, Gregg C.; Hammill, Stephen C.; Curtis, Lesley H.; Hernandez, Adrian F.; Al-Khalidi, Hussein R.; Curtis, Jeptha P.; Heidenreich, Paul A.; Anstrom, Kevin J.; Peterson, Eric D.; Mark, Daniel B.; Hammill, Bradley G.; Sanders, Gillian D.; Al-Khatib, Sana M.

    2015-01-01

    OBJECTIVES The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women. BACKGROUND Clinical trials of primary prevention ICDs enrolled a limited number of women. METHODS Using a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men. RESULTS Median follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44). CONCLUSIONS Among older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex. PMID:25543969

  7. Electrical storm in patients with an implanted defibrillator: a matter of definition.

    PubMed

    Israel, Carsten W; Barold, S Serge

    2007-10-01

    The term "electrical storm" (ES) indicates a state of cardiac electrical instability manifested by several episodes of ventricular tachyarrhythmias (VTs) within a short time. In patients with an implantable cardioverter defibrillator (ICD), ES is best defined as 3 appropriate VT detections in 24 h, treated by antitachycardia pacing, shock or eventually untreated but sustained in a VT monitoring zone. The number of shocks and inappropriate detections are irrelevant for the definition. ES occurs in approximately 25% of ICD patients within 3 years, with typically 5-55 individual VTs within one storm. Potential triggers can be found in approximately 66% of patients and include new/worsened heart failure, changes in antiarrhythmic medication, context with other illness, psychological stress, diarrhea, and hypokalemia. In most patients, ES consists of monomorphic VT indicating the presence of reentry while ventricular fibrillation indicating acute ischemia is rare. ES seems to have a low immediate mortality (1%) but frequently (50-80%) leads to hospitalization. Long-term prognostic implications of ES are unclear. The key intervention in ES is reduction of the elevated sympathetic tone by beta blockers and frequently benzodiazepines. Amiodarone i.v. has also been successful and azimilide seems promising while class I antiarrhythmic drugs are usually unsuccessful. Substrate mapping and VT ablation may be useful in treatment and prevention of ES. Prevention of ES requires ICD programming systematically avoiding unnecessary shocks (long VT detection, antitachycardia pacing where ever possible) which otherwise can fuel the sympathetic tone and prolong ES.

  8. The healthcare utilization and cost of treating patients experiencing inappropriate implantable cardioverter defibrillator shocks: a propensity score study.

    PubMed

    Bhavnani, Sanjeev P; Giedrimiene, Dalia; Coleman, Craig I; Guertin, Danette; Azeem, Meena; Kluger, Jeffrey

    2014-10-01

    Inappropriate shocks (IASs) from implantable cardioverter defibrillators (ICDs) are associated with decreased quality of life, but whether they increase healthcare utilization and treatment costs is unknown. We sought to determine the impact of IASs on subsequent healthcare utilization and treatment costs. We conducted a case-control analysis of ICD patients at a single institution from 1997 to 2010 and who had ≥12 months of post-ICD implant follow-up. Cases included all patients experiencing an IAS during the first 12 months after implantation. Eligible control patients did not receive a shock of any kind during the 12 months after implantation. Propensity scores based on 36 covariates (area under curve = 0.78) were used to match cases to controls. We compared the rate (occurrences/person year [PY]) of healthcare utilization immediately following IAS to the end of the 12-month follow-up period to the rate in the no-shock group over 12 months of follow-up. We also compared 12-month postimplant treatment (outpatient clinic, emergency room, and hospitalization) costs in both groups. A total of 76 patients experiencing ≥1 IAS during the first 12 months after implant (contributing 48 PYs) were matched to 76 no-shock patients (contributing 76 PYs). Cardiovascular (CV)-related clinic visit and hospitalization rates were increased following an IAS compared to those not receiving a shock (4.0 vs 3.3 and 0.7 vs 0.5, respectively, P = 0.02 for both). CV-related emergency room visitation (0.15 vs 0.08) rates were also numerically higher following an IAS, but did not reach statistical significance (P = 0.26). Patients experiencing an IAS accrued greater treatment costs during the 12 months postimplant compared to no-shock patients ($13,973 ± $46,345 vs $6,790 ± $19,091, P = 0.001). Recipients of IAS utilize the healthcare system more frequently following an IAS than patients not experiencing a shock. This increased utilization results in higher costs of treating IAS

  9. Magnetic resonance imaging safety in pacemaker and implantable cardioverter defibrillator patients: how far have we come?

    PubMed Central

    Nordbeck, Peter; Ertl, Georg; Ritter, Oliver

    2015-01-01

    Magnetic resonance imaging (MRI) has long been regarded a general contraindication in patients with cardiovascular implanted electronic devices such as cardiac pacemakers or cardioverter defibrillators (ICDs) due to the risk of severe complications and even deaths caused by interactions of the magnetic resonance (MR) surrounding and the electric devices. Over the last decade, a better understanding of the underlying mechanisms responsible for such potentially life-threatening complications as well as technical advances have allowed an increasing number of pacemaker and ICD patients to safely undergo MRI. This review lists the key findings from basic research and clinical trials over the last 20 years, and discusses the impact on current day clinical practice. With ‘MR-conditional’ devices being the new standard of care, MRI in pacemaker and ICD patients has been adopted to clinical routine today. However, specific precautions and specifications of these devices should be carefully followed if possible, to avoid patient risks which might appear with new MR technology and further increasing indications and patient numbers. PMID:25796053

  10. Impact of remote monitoring on reducing the burden of inappropriate shocks related to implantable cardioverter-defibrillator lead fractures: insights from a French single-centre registry.

    PubMed

    Souissi, Zouheir; Guédon-Moreau, Laurence; Boulé, Stéphane; Kouakam, Claude; Finat, Loïc; Marquié, Christelle; Brigadeau, François; Wissocque, Ludivine; Mouton, Stéphanie; Montaigne, David; Klug, Didier; Kacet, Salem; Lacroix, Dominique

    2016-06-01

    Lead fractures in implantable cardioverter-defibrillator (ICD) patients may cause inappropriate shocks (ISs). An early diagnosis is essential to prevent adverse clinical events. Implantable cardioverter-defibrillator remote monitoring (RM) permits prompt detection of lead fracture. Limited data define the impact of RM on ISs specifically related to lead fracture. We sought to compare the number of ISs related to lead fracture in patients with vs. without RM follow-up. We checked the registry of our institution and collected, between July 2007 and June 2014, 115 cases of right ventricular lead fractures. All relevant data were documented from patients' files, device-interrogation printouts and electronic records, and remote transmissions databases when applicable. We assessed the ISs that were related to lead fracture. The first study endpoint was the number of ISs per shocked patient. Among the 82 patients with conventional follow-up (CFU) and the 33 patients with RM, a first IS occurred to 32.9% (n = 27) and 30.3% (n = 10, P = 0.83) of the patients, respectively. Shocked patients in the RM group underwent significantly fewer ISs with a mean of 6 ± 2 shocks per patient [median of 3.5 shocks (2-8)] than those in the CFU group with a mean of 18 ± 5 shocks per patient [median of 10 shocks (5-22), P = 0.03]. Remote monitoring helps to reduce the burden of ISs related to ICD lead fractures. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  11. Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden.

    PubMed

    Gadler, Fredrik; Ding, Yao; Verin, Nathalie; Bergius, Martin; Miller, Jeffrey D; Lenhart, Gregory M; Russell, Mason W

    2016-01-01

    The objective of this study was to quantify the impact that longer battery life of cardiac resynchronization therapy defibrillator (CRT-D) devices has on reducing the number of device replacements and associated costs of these replacements from a Swedish health care system perspective. An economic model based on real-world published data was developed to estimate cost savings and avoided device replacements for CRT-Ds with longer battery life compared with devices with industry-standard battery life expectancy. Base-case comparisons were performed among CRT-Ds of three manufacturers - Boston Scientific Corporation, St. Jude Medical, and Medtronic - over a 6-year time horizon, as per the available clinical data. As a sensitivity analysis, we evaluated CRT-Ds as well as single-chamber implantable cardioverter defibrillator (ICD-VR) and dual-chamber implantable cardioverter defibrillator (ICD-DR) devices over a longer 10-year period. All costs were in 2015 Swedish Krona (SEK) discounted at 3% per annum. Base-case analysis results show that up to 603 replacements and up to SEK 60.4 million cumulative-associated costs could be avoided over 6 years by using devices with extended battery life. The pattern of savings over time suggests that savings are modest initially but increase rapidly beginning in the third year of follow-up with each year's cumulative savings two to three times the previous year. Evaluating CRT-D, ICD-VR, and ICD-DR devices together over a longer 10-year period, the sensitivity analysis showed 2,820 fewer replacement procedures and associated cost savings of SEK 249.3 million for all defibrillators with extended battery life. Extended battery life is likely to reduce device replacements and associated complications and costs, which may result in important cost savings and a more efficient use of health care resources as well as a better quality of life for heart failure patients in Sweden.

  12. [Worldwide experience with automated external defibrillators: What have we achieved? What else can we expect?].

    PubMed

    Trappe, Hans-Joachim

    2016-03-01

    In Germany approximately 70,000-100,000 SCD patients die from sudden cardiac death (SCD). SCD is not caused by a single factor but is a multifactorial problem. In 50 % of SCD victims, sudden cardiac death is the first manifestation of heart disease. SCD is caused by ventricular tachyarrhythmias in approximately 90 % of patients, whereas SCD is caused by bradyarrhythmias in 5-10 % of the patients. Risk stratification is not possible in the majority of them prior to the fatal event. Early defibrillation is the method of choice to terminate ventricular fibrillation. Therefore, it is mandatory to install automatic external defibrillators (AED) in places with many people. There is general agreement that early defibrillation with automated external defibrillators (AED) is an effective tool to treat patients with ventricular fibrillation and will improve survival. It seems necessary to teach cardiocompression and AED use, also to children and adolescents. AED therapy "at home" did not improve survival in patients with cardiac arrest and can not be recommended.

  13. Evaluation of a Unique Defibrillation Unit with Dual-Vector Biphasic Waveform Capabilities: Towards a Miniaturized Defibrillator.

    PubMed

    Okamura, Hideo; Desimone, Christopher V; Killu, Ammar M; Gilles, Emily J; Tri, Jason; Asirvatham, Roshini; Ladewig, Dejae J; Suddendorf, Scott H; Powers, Joanne M; Wood-Wentz, Christina M; Gray, Peter D; Raymond, Douglas M; Savage, Shelley J; Savage, Walter T; Bruce, Charles J; Asirvatham, Samuel J; Friedman, Paul A

    2017-02-01

    Automated external defibrillators can provide life-saving therapies to treat ventricular fibrillation. We developed a prototype unit that can deliver a unique shock waveform produced by four independent capacitors that is delivered through two shock vectors, with the rationale of providing more robust shock pathways during emergent defibrillation. We describe the initial testing and feasibility of this unique defibrillation unit, features of which may enable downsizing of current defibrillator devices. We tested our defibrillation unit in four large animal models (two canine and two swine) under general anesthesia. Experimental defibrillation thresholds (DFT) were obtained by delivery of a unique waveform shock pulse via a dual-vector pathway with four defibrillation pads (placed across the chest). DFTs were measured and compared with those of a commercially available biphasic defibrillator (Zoll M series, Zoll Medical, Chelmsford, MA, USA) tested in two different vectors. Shocks were delivered after 10 seconds of stable ventricular fibrillation and the output characteristics and shock outcome recorded. Each defibrillation series used a step-down to failure protocol to define the defibrillation threshold. A total of 96 shocks were delivered during ventricular fibrillation in four large animals. In comparison to the Zoll M series, which delivered a single-vector, biphasic shock, the energy required for successful defibrillation using the unique dual-vector biphasic waveform did not differ significantly (P = 0.65). Our early findings support the feasibility of a unique external defibrillation unit using a dual-vector biphasic waveform approach. This warrants further study to leverage this unique concept and work toward a miniaturized, portable shock delivery system. © 2016 Wiley Periodicals, Inc.

  14. Ironic Technology: Old Age and the implantable cardioverter defibrillator in US health care

    PubMed Central

    Kaufman, Sharon R.; Mueller, Paul S.; Ottenberg, Abigale L.; Koenig, Barbara A.

    2010-01-01

    We take the example of cardiac devices, specifically the implantable cardioverter defibrillator, or ICD, to explore the complex cultural role of technology in medicine today. We focus on persons age 80 and above, for whom ICD use is growing in the U.S. We highlight an ironic feature of this device. While it postpones death and ‘saves’ life by thwarting a lethal heart rhythm, it also prolongs living in a state of dying from heart failure. In that regard the ICD is simultaneously a technology of life extension and dying. We explore that irony among the oldest age group -- those whose considerations of medical interventions are framed by changing societal assumptions of what constitutes premature death, the appropriate time for death and medicine’s goals in an aging society. Background to the rapidly growing use of this device among the elderly is the ‘technological imperative’ in medicine, bolstered today by the value given to evidence-based studies. We show how evidence contributes to standards of care and to the expansion of Medicare reimbursement criteria. Together, those factors shape the ethical necessity of physicians offering and patients accepting the ICD in late life. Two ethnographic examples document the ways in which those factors are lived in treatment discussions and in expectations about death and longevity. PMID:21126815

  15. [The early semiautomatic defibrillation: legislative Italian framing and medical-legal aspects].

    PubMed

    Fontana, Alessandro; Zancaner, Silvano

    2004-10-01

    Following Anglosaxon experience, automatic external defibrillators (AEDs), devices capable of automatically identifying a defibrillating rhythm and triggering a life-saving discharge, are now becoming widespread in Italy too. Their extremely simple functioning, and diagnostic sensitivity combined with diagnostic specificity all mean that AEDs can even be used by non-medical personnel (nurses) and, more extensively and after proper training, also by "first responders" who are not necessarily healthcare-related (red cross volunteers, members of the police force, firemen, etc.). In this sense Italian law no. 120/2001, enacted in the interests of the collectivity, and its later provisions approved at the conference of the Italian state and regional authorities in 2003, admits this type of application. AED safety assurance means that these devices can also be used by ordinary people who are not trained and have no specific obligations, but who suddenly find themselves in an emergency situation. However, medical personnel, paramedics and non-healthcare-related "first responders" trained in the use of AEDs, are required to apply them in suitable circumstances and, if they do not, may be accused of refusal to act in an official capacity, omission of first aid, and manslaughter.

  16. Safety of sports for athletes with implantable cardioverter-defibrillators: results of a prospective, multinational registry.

    PubMed

    Lampert, Rachel; Olshansky, Brian; Heidbuchel, Hein; Lawless, Christine; Saarel, Elizabeth; Ackerman, Michael; Calkins, Hugh; Estes, N A Mark; Link, Mark S; Maron, Barry J; Marcus, Frank; Scheinman, Melvin; Wilkoff, Bruce L; Zipes, Douglas P; Berul, Charles I; Cheng, Alan; Law, Ian; Loomis, Michele; Barth, Cheryl; Brandt, Cynthia; Dziura, James; Li, Fangyong; Cannom, David

    2013-05-21

    The risks of sports participation for implantable cardioverter-defibrillator (ICD) patients are unknown. Athletes with ICDs (age, 10-60 years) participating in organized (n=328) or high-risk (n=44) sports were recruited. Sports-related and clinical data were obtained by phone interview and medical records. Follow-up occurred every 6 months. ICD shock data and clinical outcomes were adjudicated by 2 electrophysiologists. Median age was 33 years (89 subjects <20 years of age); 33% were female. Sixty were competitive athletes (varsity/junior varsity/traveling team). A pre-ICD history of ventricular arrhythmia was present in 42%. Running, basketball, and soccer were the most common sports. Over a median 31-month (interquartile range, 21-46 months) follow-up, there were no occurrences of either primary end point-death or resuscitated arrest or arrhythmia- or shock-related injury-during sports. There were 49 shocks in 37 participants (10% of study population) during competition/practice, 39 shocks in 29 participants (8%) during other physical activity, and 33 shocks in 24 participants (6%) at rest. In 8 ventricular arrhythmia episodes (device defined), multiple shocks were received: 1 at rest, 4 during competition/practice, and 3 during other physical activity. Ultimately, the ICD terminated all episodes. Freedom from lead malfunction was 97% at 5 years (from implantation) and 90% at 10 years. Many athletes with ICDs can engage in vigorous and competitive sports without physical injury or failure to terminate the arrhythmia despite the occurrence of both inappropriate and appropriate shocks. These data provide a basis for more informed physician and patient decision making in terms of sports participation for athletes with ICDs.

  17. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator.

    PubMed

    Zishiri, Edwin T; Williams, Sarah; Cronin, Edmond M; Blackstone, Eugene H; Ellis, Stephen G; Roselli, Eric E; Smedira, Nicholas G; Gillinov, A Marc; Glad, Jo Ann; Tchou, Patrick J; Szymkiewicz, Steven J; Chung, Mina K

    2013-02-01

    Implantation of implantable cardioverter defibrillator for prevention of sudden cardiac death is deferred for 90 days after coronary revascularization, but mortality may be highest early after cardiac procedures in patients with ventricular dysfunction. We determined mortality risk in postrevascularization patients with left ventricular ejection fraction ≤35% and compared survival with those discharged with a wearable cardioverter defibrillator (WCD). Hospital survivors after surgical (coronary artery bypass graft surgery) or percutaneous (percutaneous coronary intervention [PCI]) revascularization with left ventricular ejection fraction ≤35% were included from Cleveland Clinic and national WCD registries. Kaplan-Meier, Cox proportional hazards, propensity score-matched survival, and hazard function analyses were performed. Early mortality hazard was higher among 4149 patients discharged without a defibrillator compared with 809 with WCDs (90-day mortality post-coronary artery bypass graft surgery 7% versus 3%, P=0.03; post-PCI 10% versus 2%, P<0.0001). WCD use was associated with adjusted lower risks of long-term mortality in the total cohort (39%, P<0.0001) and both post-coronary artery bypass graft surgery (38%, P=0.048) and post-PCI (57%, P<0.0001) cohorts (mean follow-up, 3.2 years). In propensity-matched analyses, WCD use remained associated with lower mortality (58% post-coronary artery bypass graft surgery, P=0.002; 67% post-PCI, P<0.0001). Mortality differences were not attributable solely to therapies for ventricular arrhythmia. Only 1.3% of the WCD group had a documented appropriate therapy. Patients with left ventricular ejection fraction ≤35% have higher early compared to late mortality after coronary revascularization, particularly after PCI. As early hazard seemed less marked in WCD users, prospective studies in this high-risk population are indicated to confirm whether WCD use as a bridge to left ventricular ejection fraction improvement or

  18. Age and Outcomes of Primary Prevention Implantable Cardioverter-Defibrillators in Patients With Nonischemic Systolic Heart Failure.

    PubMed

    Elming, Marie Bayer; Nielsen, Jens C; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Signorovitch, James; Olesen, Line Lisbeth; Hildebrandt, Per; Steffensen, Flemming H; Bruun, Niels E; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna M; Gustafsson, Finn; Egstrup, Kenneth; Videbæk, Regitze; Hassager, Christian; Svendsen, Jesper Hastrup; Høfsten, Dan E; Torp-Pedersen, Christian; Pehrson, Steen; Køber, Lars; Thune, Jens Jakob

    2017-11-07

    The DANISH study (Danish Study to Assess the Efficacy of ICDs [Implantable Cardioverter Defibrillators] in Patients With Non-Ischemic Systolic Heart Failure on Mortality) did not demonstrate an overall effect on all-cause mortality with ICD implantation. However, the prespecified subgroup analysis suggested a possible age-dependent association between ICD implantation and mortality with survival benefit seen only in the youngest patients. The nature of this relationship between age and outcome of a primary prevention ICD in patients with nonischemic systolic heart failure warrants further investigation. All 1116 patients from the DANISH study were included in this prespecified subgroup analysis. We assessed the relationship between ICD implantation and mortality by age, and an optimal age cutoff was estimated nonparametrically with selection impact curves. Modes of death were divided into sudden cardiac death and nonsudden death and compared between patients younger and older than this age cutoff with the use of χ 2 analysis. Median age of the study population was 63 years (range, 21-84 years). There was a linearly decreasing relationship between ICD and mortality with age (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.003-1.06; P =0.03). An optimal age cutoff for ICD implantation was present at ≤70 years. There was an association between reduced all-cause mortality and ICD in patients ≤70 years of age (HR, 0.70; 95% CI, 0.51-0.96; P =0.03) but not in patients >70 years of age (HR, 1.05; 95% CI, 0.68-1.62; P =0.84). For patients ≤70 years old, the sudden cardiac death rate was 1.8 (95% CI, 1.3-2.5) and nonsudden death rate was 2.7 (95% CI, 2.1-3.5) events per 100 patient-years, whereas for patients >70 years old, the sudden cardiac death rate was 1.6 (95% CI, 0.8-3.2) and nonsudden death rate was 5.4 (95% CI, 3.7-7.8) events per 100 patient-years. This difference in modes of death between the 2 age groups was statistically significant ( P =0

  19. Radiotherapy and risk of implantable cardioverter-defibrillator malfunctions: experimental data from direct exposure at increasing doses.

    PubMed

    Zecchin, Massimo; Artico, Jessica; Morea, Gaetano; Severgnini, Mara; Bianco, Elisabetta; De Luca, Antonio; Fantasia, Anna Zorzin; Salvatore, Luca; Milan, Vittorino; Lucarelli, Matteo; Dissegna, Roberta; Cannatà, Antonio; Sinagra, Gianfranco

    2018-04-01

    During radiotherapy, in patients with implantable cardioverter-defibrillators (ICDs) malfunctions are considered more likely if doses more than 2 Gy reach the ICD site; however, most malfunctions occur with high-energy (>10 MV) radiations, and the risk is less defined using 6-MV linear accelerators. The purpose of the study is to experimentally evaluate the occurrence of malfunctions in ICDs radiated with a 6-MV linear accelerator at increasing photon doses. Thirty-two ICDs from all manufacturers (31 explanted and one demo) were evaluated; all devices with a sufficient battery charge underwent multiple radiations with a 6-MV photon beam reaching a cumulative dose at ICD site of 0.5, 1, 2, 3, 5 and 10 Gy and interrogated after every session. All antitachycardia therapies were left enabled; two ICDs were connected to a rhythm simulator (one simulating a complete atrioventricular block without ventricular activity) and visually monitored by external ECG and the ICD programmer during radiation. Thirteen ICDs were excluded before radiation because of battery depletion; after radiation up to the cumulative dose at the cardiac implantable electronic device site of 10 Gy, in the remaining 19 devices, programmation and battery charge remained unchanged and no switch to safety mode was observed; oversensing, pacing inhibition or inappropriate antitachycardia therapy were neither recorded nor visually observed during radiation. With a low-energy accelerator, neither malfunctions nor electromagnetic interferences were detected radiating the ICDs at doses usually reaching the ICD pocket during radiotherapy sessions. In this context, magnet application to avoid oversensing and inappropriate therapy seems, therefore, useless.

  20. Implantable Cardioverter Defibrillator Programming Characteristics, Shocked Rhythms, and Survival Among Patients Under Thirty Years of Age.

    PubMed

    Chang, Philip M; Powell, Brian D; Jones, Paul W; Carter, Nathan; Hayes, David L; Saxon, Leslie A

    2016-10-01

    Indications for implantable cardioverter defibrillators (ICDs) in young patients have expanded and differ from those in older adults. We sought to provide descriptive characteristics and data regarding ICD therapy and outcomes among younger and older ICD recipients. Demographics, device type and programming, remotely transmitted data, shock events, and survival were compared among younger (≤30 years) and older (>30 years) cohorts with ICDs from a single manufacturer followed on a remote network. The younger cohort included 904 patients (1.6% of all implants). This group had more females (46% vs. 25%; P < 0.01), single-coil leads (21% vs. 4%; P < 0.01), and single-chamber devices (46% vs. 34%; P < 0.01). Shock incidence was higher (40% younger vs. 32% older at 4 years; P < 0.01) and survival was better over comparable follow-up (88% vs. 72%; P < 0.01). Remote monitoring was associated with improved survival in both groups (93% vs. 86% ≤ 30 years, P < 0.01; 73% vs. 66% > 30 years, P < 0.01). Shock for polymorphic ventricular tachycardia/fibrillation (VT/VF) was more frequent in younger patients (12% vs. 5%; P < 0.01); 39% of all shocks were inappropriate. A 10-fold increased risk of mortality was seen among young patients with shocks for atrial fibrillation/flutter (AF/AFL). Differences in survival, shock incidence, and prognostic significance of VT/VF and AF/AFL exist between younger and older ICD recipients. These suggest distinct differences in myocardial substrates and diseases that ultimately impact ICD management. © 2016 Wiley Periodicals, Inc.

  1. Electromagnetic interference with cardiac pacemakers and implantable cardioverter-defibrillators from low-frequency electromagnetic fields in vivo.

    PubMed

    Tiikkaja, Maria; Aro, Aapo L; Alanko, Tommi; Lindholm, Harri; Sistonen, Heli; Hartikainen, Juha E K; Toivonen, Lauri; Juutilainen, Jukka; Hietanen, Maila

    2013-03-01

    Electromagnetic interference (EMI) can pose a danger to workers with pacemakers and implantable cardioverter-defibrillators (ICDs). At some workplaces electromagnetic fields are high enough to potentially inflict EMI. The purpose of this in vivo study was to evaluate the susceptibility of pacemakers and ICDs to external electromagnetic fields. Eleven volunteers with a pacemaker and 13 with an ICD were exposed to sine, pulse, ramp, and square waveform magnetic fields with frequencies of 2-200 Hz using Helmholtz coil. The magnetic field flux densities varied to 300 µT. We also tested the occurrence of EMI from an electronic article surveillance (EAS) gate, an induction cooktop, and a metal inert gas (MIG) welding machine. All pacemakers were tested with bipolar settings and three of them also with unipolar sensing configurations. None of the bipolar pacemakers or ICDs tested experienced interference in any of the exposure situations. The three pacemakers with unipolar settings were affected by the highest fields of the Helmholtz coil, and one of them also by the EAS gate and the welding cable. The induction cooktop did not interfere with any of the unipolarly programmed pacemakers. Magnetic fields with intensities as high as those used in this study are rare even in industrial working environments. In most cases, employees can return to work after implantation of a bipolar pacemaker or an ICD, after an appropriate risk assessment. Pacemakers programmed to unipolar configurations can cause danger to their users in environments with high electromagnetic fields, and should be avoided, if possible.

  2. Initial Experience of an Anesthesiology-based Service for Perioperative Management of Pacemakers and Implantable Cardioverter Defibrillators.

    PubMed

    Rooke, G Alec; Lombaard, Stefan A; Van Norman, Gail A; Dziersk, Jörg; Natrajan, Krishna M; Larson, Lyle W; Poole, Jeanne E

    2015-11-01

    Management of cardiovascular implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter defibrillators, for surgical procedures is challenging due to the increasing number of patients with CIEDs and limited availability of trained providers. At the authors' institution, a small group of anesthesiologists were trained to interrogate CIEDs, devise a management plan, and perform preoperative and postoperative programming and device testing whenever necessary. Patients undergoing surgery between October 1, 2009 and June 30, 2013 at the University of Washington Medical Center were included in a retrospective chart review to determine the number of devices actively managed by the Electrophysiology/Cardiology Service (EPCS) versus the Anesthesiology Device Service (ADS), changes in workload over time, surgical case delays due to device management, and errors and problems encountered in device programming. The EPCS managed 254 CIEDs, the ADS managed 548, and 227 by neither service. Over time, the ADS providers managed an increasing percentage of devices with decreasing supervision from the EPCS. Only two CIEDs managed by the ADS required immediate assistance from the EPCS. Patients who were unstable postoperatively were referred to the EPCS. Although numerous issues in programming were encountered, primarily when restoring demand pacing after programming asynchronous pacing for surgery, no patient harm resulted from ADS or EPCS management of CIEDs. An ADS can provide safe CIED management for surgery, but it requires specialized provider training and strong support from the EPCS. Due to the complexity of CIED management, an ADS will likely only be feasible in high-volume settings.

  3. Effectiveness of prophylactic implantation of cardioverter-defibrillators without cardiac resynchronization therapy in patients with ischaemic or non-ischaemic heart disease: a systematic review and meta-analysis

    PubMed Central

    Theuns, Dominic A.M.J.; Smith, Tim; Hunink, Myriam G.M.; Bardy, Gust H.; Jordaens, Luc

    2010-01-01

    Aims Much controversy exists concerning the efficacy of primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with low ejection fraction due to coronary artery disease (CAD) or dilated cardiomyopathy (DCM). This is also related to the bias created by function improving interventions added to ICD therapy, e.g. resynchronization therapy. The aim was to investigate the efficacy of ICD-only therapy in primary prevention in patients with CAD or DCM. Methods and results Public domain databases, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials, were searched from 1980 to 2009 for randomized clinical trials of ICD vs. conventional therapy. Two investigators independently abstracted the data. Pooled estimates were calculated using both fixed-effects and random-effects models. Eight trials were included in the final analysis (5343 patients). Implantable cardioverter-defibrillators significantly reduced the arrhythmic mortality [relative risk (RR): 0.40; 95% confidence interval (CI): 0.27–0.67] and all-cause mortality (RR: 0.73; 95% CI: 0.64–0.82). Regardless of aetiology of heart disease, ICD benefit was similar for CAD (RR: 0.67; 95% CI: 0.51–0.88) vs. DCM (RR: 0.74; 95% CI: 0.59–0.93). Conclusions The results of this meta-analysis provide strong evidence for the beneficial effect of ICD-only therapy on the survival of patients with ischaemic or non-ischaemic heart disease, with a left ventricular ejection fraction ≤35%, if they are 40 days from myocardial infarction and ≥3 months from a coronary revascularization procedure. PMID:20974768

  4. Safety of implantable pacemakers and cardioverter defibrillators in the magnetic field of a novel remote magnetic navigation system.

    PubMed

    Jilek, Clemens; Tzeis, Stylianos; Reents, Tilko; Estner, Heidi-Luise; Fichtner, Stephanie; Ammar, Sonia; Wu, Jinjin; Hessling, Gabriele; Deisenhofer, Isabel; Kolb, Christof

    2010-10-01

    Electromagnetic interference with pacemaker and implantable cardioverter defibrillator (ICD) systems may cause temporary or permanent system malfunction of implanted devices. The aim of this study was to evaluate potential interference of a novel magnetic navigation system with implantable rhythm devices. A total of 121 devices (77 pacemakers, 44 ICDs) were exposed to an activated NIOBE II® Magnetic Navigation System (Stereotaxis, St. Louis, MO, USA) at the maximal magnetic field strength of 0.1 Tesla and evaluated in vitro with respect to changes in parameter settings of the device, changes of the battery status/detection of elective replacement indication, or alterations of data stored in the device. A total of 115 out of 121 (95%) devices were free of changes in parameter settings, battery status, and internally stored data after repeated exposition to the electromagnetic field of the remote magnetic navigation system. Interference with the magnetic navigation field was observed in 6 pacemakers, resulting in reprogramming to a power-on-reset mode with or without detection of the elective replacement indication in 5 devices and abnormal variance of battery status in one device. All pacemakers could be reprogrammed to the initial modes and the battery status proved to be normal some minutes after the pacemakers had been removed from the magnetic field. Interference of a remote magnetic navigation system (at maximal field strength) with pacemakers and ICDs not connected to leads with antitachycardic detection and therapies turned off is rare. Occurring functional abnormalities could be reprogrammed in our sample. An in vitro study will give information about interference of devices connected to leads. © 2010 Wiley Periodicals, Inc.

  5. Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death

    PubMed Central

    Carroll, Sandra L.; Strachan, Patricia H.; de Laat, Sonya; Schwartz, Lisa; Arthur, Heather M.

    2011-01-01

    Abstract Background  Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patients’ decision‐making process (DMP) of whether or not to accept an ICD has not been explored. We asked patients about their decision making when offered an ICD. Design/Setting  A grounded theory methodology was employed. Patients were recruited from three ICD centres. Those who received an ICD underwent interviews the first month after implant. Declining patients had interviews at their convenience. In‐depth analysis of transcripts was completed. Identified themes were placed along process pathways in a DMP model and tested. Findings  Forty‐four patients consented to participate (25% women). Thirty‐four accepted an ICD and 10 (23%) declined. Ages ranged from 26 to 87 (mean = 65; SD = 12.5). Participants were retired (65%), had ischaemic heart disease (64%) and some post‐secondary education (52%). The DMP was triggered when patient’s risk for SCD was communicated. The physician’s recommendation and a new awareness SCD risk were motivators to accept the ICD. Patient’s decision‐making approaches fell along a continuum, from active and engaged to passive and indifferent. Patient’s approaches were influenced most by the following: (i) trust; (ii) social influences and (iii) health state. Conclusions  Health‐care providers need to recognize the DMP pathways in which ICD candidacy and SCD risk are understood. The factors that influence a patient’s decision warrant discussion pre‐implant. It is imperative that patients comprehend the meaning of ICD candidacy to make an informed decision. Participants did not recall alternatives to receiving ICD therapy. PMID:21645190

  6. Ventricular antitachycardia pacing therapy in patients with heart failure implanted with a cardiac resynchronization therapy defibrillator device: Efficacy, safety, and impact on mortality.

    PubMed

    Landolina, Maurizio; Lunati, Maurizio; Boriani, Giuseppe; Pietro Ricci, Renato; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Morani, Giovanni; Maines, Massimiliano; Gasparini, Gianni; Molon, Giulio; Turrini, Pietro; Gasparini, Maurizio

    2016-02-01

    Cardiac resynchronization therapy defibrillator can terminate ventricular tachycardia (VT) and fast VT (FVT) via antitachycardia pacing (ATP). We evaluated efficacy and safety of ATP, whether ATP induces ventricular arrhythmias after inappropriate ATP or atrial fibrillation (AF) after appropriate ATP, and whether ATP is associated with mortality. A total of 1404 patients with a cardiac resynchronization therapy defibrillator were followed in a prospective multicenter observational research. All-cause mortality rates were estimated in patient subgroups in order to uncouple the trigger (VT/FVT or other rhythms causing inappropriate detections) from ATP therapy. Over a median follow-up of 31 months, 2938 VT/FVT episodes were treated with ATP in 360 patients. The adjusted ATP success rate was 63% (95% confidence interval [CI] 57%-69%) on FVTs and 68% (95% CI 62%-74%) on VTs. Acceleration occurred in 55 (1.87%) and syncope in 4 (0.14%) of all ATP-treated episodes. In 14 true VT/FVT episodes in 5 patients, AF followed ATP therapy. In 4 episodes in 2 patients, VT followed ATP inappropriately applied during AF. Death rate per 100 patient-years was 5.6 (95% CI 4.3-7.5) in patients with appropriate ATP and 1.5 (95% CI 0.4-6.1) in patients with inappropriate ATP (P = .045). ATP was effective in terminating VT/FVT episodes and displayed a good safety profile. ATP therapies by themselves did not increase death risk; prognosis was indeed better in patients without arrhythmic episodes, even if they received inappropriate ATP, than in patients with ATP on VT/FVT episodes. Adverse outcomes observed in patients receiving implantable cardioverter-defibrillator therapies are probably related to the arrhythmia itself, a marker of disease progression, rather than to adverse effects of ATP. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  7. The Selective Late Sodium Current Inhibitor Eleclazine, Unlike Amiodarone, Does Not Alter Defibrillation Threshold or Dominant Frequency of Ventricular Fibrillation.

    PubMed

    Silva, Ana F G; Bonatti, Rodolfo; Batatinha, Julio A P; Nearing, Bruce D; Zeng, Dewan; Belardinelli, Luiz; Verrier, Richard L

    2017-03-01

    We examined the effects of the selective late INa inhibitor eleclazine on the 50% probability of successful defibrillation (DFT50) before and after administration of amiodarone to determine its suitability for use in patients with implantable cardioverter defibrillators (ICDs). In 20 anesthetized pigs, transvenous active-fixation cardiac defibrillation leads were fluoroscopically positioned into right ventricular apex through jugular vein. ICDs were implanted subcutaneously. Dominant frequency of ventricular fibrillation was analyzed by fast Fourier transform. The measurements were made before drug administration (control), and at 40 minutes after vehicle, eleclazine (2 mg/kg, i.v., bolus over 15 minutes), or subsequent/single amiodarone administration (10 mg/kg, i.v., bolus over 10 minutes). Eleclazine did not alter DFT50, dominant frequency, heart rate, or mean arterial pressure (MAP). Subsequent amiodarone increased DFT50 (P = 0.006), decreased dominant frequency (P = 0.022), and reduced heart rate (P = 0.031) with no change in MAP. Amiodarone alone increased DFT50 (P = 0.005; NS compared to following eleclazine) and decreased dominant frequency (P = 0.003; NS compared to following eleclazine). Selective late INa inhibition with eleclazine does not alter DFT50 or dominant frequency of ventricular fibrillation when administered alone or in combination with amiodarone. Accordingly, eleclazine would not be anticipated to affect the margin of defibrillation safety in patients with ICDs.

  8. Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy.

    PubMed

    Sticherling, Christian; Müller, Dirk; Schaer, Beat A; Krüger, Silke; Kolb, Christof

    2018-03-27

    Many patients receiving cardiac resynchronization therapy (CRT) suffer from permanent atrial fibrillation (AF). Knowledge of the atrial rhythm is important to direct pharmacological or interventional treatment as well as maintaining AV-synchronous biventricular pacing if sinus rhythm can be restored. A single pass single-coil defibrillator lead with a floating atrial bipole has been shown to obtain reliable information about the atrial rhythm but has never been employed in a CRT-system. The purpose of this study was to assess the feasibility of implanting a single coil right ventricular ICD lead with a floating atrial bipole and the signal quality of atrial electrograms (AEGM) in CRT-defibrillator recipients with permanent AF. Seventeen patients (16 males, mean age 73 ± 6 years, mean EF 25 ± 5%) with permanent AF and an indication for CRT-defibrillator placement were implanted with a designated CRT-D system comprising a single pass defibrillator lead with a atrial floating bipole. They were followed-up for 103 ± 22 days using remote monitoring for AEGM transmission. All patients had at last one AEGM suitable for atrial rhythm diagnosis and of 100 AEGM 99% were suitable for visual atrial rhythm assessment. Four patients were discharged in sinus rhythm and one reverted to AF during follow-up. Atrial electrograms retrieved from a single-pass defibrillator lead with a floating atrial bipole can be reliably used for atrial rhythm diagnosis in CRT recipients with permanent AF. Hence, a single pass ventricular defibrillator lead with a floating bipole can be considered in this population. Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

  9. Primary Prevention of Sudden Cardiac Death in Adults with Transposition of the Great Arteries: A Review of Implantable Cardioverter-Defibrillator Placement

    PubMed Central

    Cedars, Ari M.

    2015-01-01

    Transposition of the great arteries encompasses a set of structural congenital cardiac lesions that has in common ventriculoarterial discordance. Primarily because of advances in medical and surgical care, an increasing number of children born with this anomaly are surviving into adulthood. Depending upon the subtype of lesion or the particular corrective surgery that the patient might have undergone, this group of adult congenital heart disease patients constitutes a relatively new population with unique medical sequelae. Among the more common and difficult to manage are cardiac arrhythmias and other sequelae that can lead to sudden cardiac death. To date, the question of whether implantable cardioverter-defibrillators should be placed in this cohort as a preventive measure to abort sudden death has largely gone unanswered. Therefore, we review the available literature surrounding this issue. PMID:26413012

  10. Failure to Treat Life-Threatening Ventricular Tachyarrhythmias in Contemporary Implantable Cardioverter–Defibrillators

    PubMed Central

    Thøgersen, Anna Margrethe; Larsen, Jacob Moesgaard; Johansen, Jens Brock; Abedin, Moeen

    2017-01-01

    Background: In clinical trials, manufacturer-specific, strategic programming of implantable cardioverter–defibrillators (ICDs), including faster detection rates, reduces unnecessary therapy but permits therapy for ventricular tachycardia/ventricular fibrillation (VF). Present consensus recommends a generic rate threshold between 185 and 200 beats per minute, which exceeds the rate tested in clinical trials for some manufacturers. In a case series, we sought to determine the relationship between programmed parameters and failure of modern ICDs to treat VF. Methods and Results: We reviewed cases in which normally functioning ICDs failed to deliver timely therapy for VF from April 2015 to January 2017 at 4 institutions. Of 10 ambulatory patients, 5 died from untreated VF, 4 had cardiac arrests requiring external shocks, and 1 was rescued by a delayed ICD shock. VF did not satisfy programmed detection criteria in 9 patients (90%). Seven of these patients had slowest detection rates that were consistent with generic recommendations but not tested in a peer-reviewed trial for their manufacturer’s ICDs. Manufacturer-specific factors interacted with fast detection rates to withhold therapy, including strict VF episode termination rules, enhancements to minimize T-wave oversensing, and features that restrict therapy to regular rhythms in ventricular tachycardia zones. Untreated VF despite recommended programming accounted for 56% of sudden deaths and 11% of all deaths during the study period. Conclusions: Complex and unanticipated interactions between manufacturer-specific features and generic programming can prevent therapy for VF. More data are needed to assess the risks and benefits of translating evidence-based detection parameters from one manufacturer to another. PMID:28916511

  11. Unique presentation of Twiddler’s syndrome

    PubMed Central

    Parikh, Valay; Barsoum, Emad A; Morcus, Rewais; Azab, Basem; Lafferty, James; Kohn, Jeffrey

    2013-01-01

    We present a rare case of Twiddler’s syndrome diagnosed in an asymptomatic patient on a routine follow up. This case reiterates the need for frequent monitoring of the implanted device. In addition, it was detected 4 years after implantation of an automatic implantable cardioverter defibrillator. This late representation is extremely uncommon. PMID:23802049

  12. Cardiac e-learning: Development of a web-based implantable cardioverter defibrillator educational system.

    PubMed

    Hickey, Kathleen T; Johnson, Mary P; Biviano, Angelo; Aboelela, Sally; Thomas, Tami; Bakken, Suzanne; Garan, Hasan; Zimmerman, John L; Whang, William

    2011-04-01

    The objective of this study was to design a Web-based implantable cardioverter defibrillator (ICD) module that would allow greater access to learning which could occur at an individual's convenience outside the fast-paced clinical environment. A Web-based ICD software educational program was developed to provide general knowledge of the function of the ICD and the interpretation of the stored electrocardiograms. This learning tool could be accessed at any time via the Columbia University Internet server, using a unique, password protected login. A series of basic and advanced ICD terms were presented using actual ICD screenshots and videos that simulated scenarios the practitioner would most commonly encounter in the fast-paced clinical setting. To determine the usefulness of the site and improve the module, practitioners were asked to complete a brief (less than 5 min) online survey at the end of the module. Twenty-six practitioners have logged into our Web site: 20 nurses/nurse practitioners, four cardiac fellows, and two other practitioners. The majority of respondents rated the program as easy to use and useful. The success of this module has led to it becoming part of the training for student nurse practitioners before a clinical electrophysiology rotation, and the module is accessed by our cardiac entry level fellows before a rotation in the intensive care unit or electrophysiology service. Remote electronic arrhythmia learning is a successful example of the melding of technology and education to enhance clinical learning.

  13. Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator.

    PubMed

    Al-Mohaissen, Maha A; Chan, Kwan Leung

    2012-03-01

    Endocardial lead-induced tricuspid regurgitation has not been well recognized, either clinically or echocardiographically, and yet it is likely a preventable iatrogenic disease. In severe cases, it can lead to right ventricular failure and require tricuspid valve surgery. This complication will become increasingly important, because the numbers of permanent pacemakers and implantable cardioverter-defibrillators are expected to increase because of the aging population and the expanding capabilities of these devices. Published studies are largely retrospective, and serial studies to assess the time course of the development of tricuspid regurgitation are lacking. The mechanisms and severity of tricuspid regurgitation may not be well evaluated by two-dimensional echocardiography. Real-time three-dimensional echocardiography appears to be a promising technique to evaluate the mechanism of tricuspid regurgitation and may allow the early detection of patients who will develop severe lead-induced tricuspid regurgitation. A better understanding of the mechanism of lead-induced tricuspid regurgitation will be essential to the development of preventive strategies, which can then be tested in future clinical trials. Copyright © 2012 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

  14. Pacing and Defibrillators in Complex Congenital Heart Disease

    PubMed Central

    Chubb, Henry; O’Neill, Mark; Rosenthal, Eric

    2016-01-01

    Device therapy in the complex congenital heart disease (CHD) population is a challenging field. There is a myriad of devices available, but none designed specifically for the CHD patient group, and a scarcity of prospective studies to guide best practice. Baseline cardiac anatomy, prior surgical and interventional procedures, existing tachyarrhythmias and the requirement for future intervention all play a substantial role in decision making. For both pacing systems and implantable cardioverter defibrillators, numerous factors impact on the merits of system location (endovascular versus non-endovascular), lead positioning, device selection and device programming. For those with Fontan circulation and following the atrial switch procedure there are also very specific considerations regarding access and potential complications. This review discusses the published guidelines, device indications and the best available evidence for guidance of device implantation in the complex CHD population. PMID:27403295

  15. Development and evaluation of the EOL-ICDQ as a measure of experiences, attitudes and knowledge in end-of-life in patients living with an implantable cardioverter defibrillator.

    PubMed

    Thylén, Ingela; Wenemark, Marika; Fluur, Christina; Strömberg, Anna; Bolse, Kärstin; Årestedt, Kristofer

    2014-04-01

    Due to extended indications and resynchronization therapy, many implantable cardioverter defibrillator (ICD) recipients will experience progressive co-morbid conditions and will be more likely to die of causes other than cardiac death. It is therefore important to elucidate the ICD patients' preferences when nearing end-of-life. Instead of avoiding the subject of end-of-life, a validated questionnaire may be helpful to explore patients' experiences and attitudes about end-of-life concerns and to assess knowledge of the function of the ICD in end-of-life. Validated instruments assessing patients' perspective concerning end-of-life issues are scarce. The purpose of this study was to develop and evaluate respondent satisfaction and measurement properties of the 'Experiences, Attitudes and Knowledge of End-of-Life Issues in Implantable Cardioverter Defibrillator Patients' Questionnaire' (EOL-ICDQ). The instrument was tested for validity, respondent satisfaction, and for homogeneity and stability in the Swedish language. An English version of the EOL-ICDQ was validated, but has not yet been pilot tested. The final instrument contained three domains, which were clustered into 39 items measuring: experiences (10 items), attitudes (18 items), and knowledge (11 items) of end-of-life concerns in ICD patients. In addition, the questionnaire also contained items on socio-demographic background (six items) and ICD-specific background (eight items). The validity and reliability properties were considered sufficient. The EOL-ICDQ has the potential to be used in clinical practice and future research. Further studies are needed using this instrument in an Anglo-Saxon context with a sample of English-speaking ICD recipients.

  16. Uncovering phantom shocks in cardiac patients with an implantable cardioverter defibrillator.

    PubMed

    Bilanovic, Ana; Irvine, Jane; Kovacs, Adrienne H; Hill, Ann; Cameron, Doug; Katz, Joel

    2013-06-01

    Implantable cardioverter defibrillator recipients sometimes report "phantom shocks" (PSs), defined as a reported shock lacking objective evidence. The aim of this study was to describe the subjective experience of PSs and their psychosocial correlates using a mixed methods approach. PS participants were matched on sex and age with individuals who received objective shocks only (OSO). Participants were interviewed and completed measures of posttraumatic stress disorder (PTSD Checklist-Civilian Version), depression and anxiety (Hospital Anxiety and Depression Scale), disease-specific distress (Cardiac Anxiety Questionnaire-CAQ), and social desirability (Socially Desirable Response Set-SDRS). Interviews were analyzed using interpretative phenomenological analysis (IPA). Seventeen male patients participated (PS: n = 9; OSO: n = 8). Three themes emerged from IPA: (1) PS as a somatic experience, (2) the emotional impact of PSs, and (3) searching for meaning. Quantitative analyses showed that both groups exhibited elevated trauma and anxiety levels. Effect size differences (ESD) suggested a medium ESD on depression (P = 0.176, ηp (2) = 0.118) and PTSD (avoidance: P = 0.383, ηp (2) = 0.055, numbing: P = 0.311, ηp (2) = 0.068), and a large ESD on SDRS (P = 0.081, ηp (2) = 0.189), where PS participants, comparatively, exhibited elevated levels. A medium ESD was detected on CAQ-fear (P = 0.237, ηp (2) = 0.092) where OSO participants exhibited greater heart-focused worry. The qualitative and quantitative findings of this mixed method study show convergence in terms of the emotional factors associated with the experience of PSs. PSs are often reported to be indistinguishable from objective shocks, evoking alarm, frustration, and confusion, forcing the individual to face the uncertainties of what to them is a novel and confusing experience. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

  17. BAYESIAN META-ANALYSIS ON MEDICAL DEVICES: APPLICATION TO IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

    PubMed Central

    Youn, Ji-Hee; Lord, Joanne; Hemming, Karla; Girling, Alan; Buxton, Martin

    2012-01-01

    Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device. Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference. Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs. Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies. PMID:22559753

  18. Comparative study of the failure rates among 3 implantable defibrillator leads.

    PubMed

    van Malderen, Sophie C H; Szili-Torok, Tamas; Yap, Sing C; Hoeks, Sanne E; Zijlstra, Felix; Theuns, Dominic A M J

    2016-12-01

    After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed. The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads. We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference. During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%). This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure. Copyright © 2016. Published by Elsevier Inc.

  19. Insulation Failure of the Linox Defibrillator Lead: A Case Report and Retrospective Review of a Single Center Experience.

    PubMed

    Howe, Andrew J; McKeag, Nicholas A; Wilson, Carol M; Ashfield, Kyle P; Roberts, Michael J

    2015-06-01

    Implantable cardioverter defibrillator (ICD) lead insulation failure and conductor externalization have been increasingly reported. The 7.8F silicon-insulated Linox SD and Linox S ICD leads (Biotronik, Berlin, Germany) were released in 2006 and 2007, respectively, with an estimated 85,000 implantations worldwide. A 39-year-old female suffered an out-of-hospital ventricular fibrillation (VF) arrest with successful resuscitation. An ICD was implanted utilizing a single coil active fixation Linox(Smart) S lead (Biotronik, Berlin, Germany). A device-triggered alert approximately 3 years after implantation confirmed nonphysiological high rate sensing leading to VF detection. A chest X-ray showed an abnormality of the ICD lead and fluoroscopic screening confirmed conductor externalization proximal to the defibrillator coil. In view of the combined electrical and fluoroscopic abnormalities, urgent lead extraction and replacement were performed. A review of Linox (Biotronik) and Vigila (Sorin Group, Milan, Italy) lead implantations within our center (n = 98) identified 3 additional patients presenting with premature lead failure, 2 associated with nonphysiological sensed events and one associated with a significant decrease in lead impedance. All leads were subsequently removed and replaced. This case provides a striking example of insulation failure affecting the Linox ICD lead and, we believe, is the first to demonstrate conductor externalization manifesting both electrical and fluoroscopic abnormalities. © 2015 Wiley Periodicals, Inc.

  20. Temporal trend analysis of nurses' knowledge about implantable cardioverter defibrillators.

    PubMed

    Norekvål, Tone M; Peersen, Lene R L; Seivaag, Kirsten; Fridlund, Bengt; Wentzel-Larsen, Tore

    2015-05-01

    Although crucial, research on nurses' knowledge on the use of implantable cardioverter defibrillators (ICDs) is scant. The aims of the study were to investigate (i) the level of nurses' knowledge on care of patients with ICDs, (ii) whether knowledge level is related to education and type of hospital where nurses practice and (iii) whether knowledge level changes among nurses over time. We developed a questionnaire comprising 27 items in four parts: (1) Sociodemographics, (2) Technical facts about ICDs, (3) Daily life challenges and (4) Self-evaluation of knowledge. After validation, surveys were conducted during 1-week cardiac educational courses in 2003-2010. In total, 463 nurses working in cardiology-related areas participated, yielding a response rate of 91%. Practical and technical knowledge about ICDs was lacking. Nurses were unaware or did not know that mobile phones can affect the device (80%), that patients are restricted from driving heavy vehicles (69%), and that ICDs can deliver unintended shock therapy (73%). However, they were aware that ICD patients can resume sexual (87%) and physical activity (85%). There were few significant differences with regard to education and type of hospital where nurses practiced, but significant time trends in correct answers regarding kitchen appliances, resumption of physical activity and shock delivery. Over an 8-year period, despite the increased usage of ICDs, overall nurses had a lack of knowledge in relation to specific key clinical issues on the care of ICD patients. As a consequence, these patients may fail to receive qualified care. Future research should assess knowledge of other health care professionals and focus on interventions that increase and maintain an appropriate knowledge level in care of ICD patients. Relevance to clinical practice The level of nurses' knowledge on care of patients with ICDs needs to be systematically raised in order to ensure appropriate counselling and nursing care. © 2014 British

  1. Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices.

    PubMed

    Duray, Gabor Z; Schmitt, Joern; Cicek-Hartvig, Sule; Hohnloser, Stefan H; Israel, Carsten W

    2009-03-01

    Implantable cardioverter defibrillator (ICD) technology has become more complex, particularly with respect to biventricular resynchronization devices. The incidence of hardware-related complications in single (SC)-, dual (DC)-, and triple (BiV)-chamber devices requiring surgical revision has not been investigated systematically. We analysed data from consecutive ICD recipients implanted between January 2000 and December 2007 with respect to the need of surgical re-intervention for device- or lead-related complications. Generator exchanges due to normal battery depletion were not considered. From 816 patients (81% male, 69% ischaemic cardiomyopathy, 48% secondary prevention ICDs) followed for 31 +/- 24 months (2118 cumulative patient-years), 98 patients underwent 110 revisions (5.2% per patient-year). Complications included lead-related revision procedures in 81 cases and generator-related problems in 29 cases. The annual incidence of surgical revision due to complications was 11.8% in BiV compared with 4.9% in SC and 4.1% in DC patients (P = 0.002). This higher revision rate was mainly caused by lead-related complications. Implantation of a BiV system was an independent risk factor of the need for surgical revision (relative risk 2.37, 95% confidence interval 1.38-4.04). Even with long-lasting operator experience, complications requiring surgical revision remain a clinically important problem of ICD therapy. The incidence of complications is significantly higher in BiV resynchronization devices than in SC and DC systems.

  2. Do implantable cardioverter defibrillators improve survival in patients with severe left ventricular systolic dysfunction after coronary artery bypass graft surgery?

    PubMed

    Fazal, Iftikhar A; Bates, Matthew G D; Matthews, Iain G; Turley, Andrew J

    2011-06-01

    A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether implantable cardioverter defibrillators (ICD) improve survival in patients with severe left ventricular systolic dysfunction (LVSD) after coronary artery bypass graft (CABG) surgery. ICDs are designed to terminate potentially fatal cardiac tachyarrhythmias. A right ventricular lead is mandatory for detection, pacing and defibrillation capabilities. Dual chamber ICDs have an additional right atrial lead and are used for patients with conventional atrioventricular pacing indications. More sophisticated, biventricular devices exist to provide cardiac resynchronisation therapy (CRT) in addition to defibrillation (CRT-D). ICDs have been extensively investigated in patients with LVSD post myocardial infarction and in patients with non-ischaemic cardiomyopathy for both secondary prevention (history of ventricular arrhythmias) and primary prevention (deemed high risk for ventricular arrhythmias). This best evidence topic aims to review the evidence and its applicability to patients post CABG. Nine hundred and sixteen papers were identified using the search method outlined. Eight randomised controlled trials, two meta-analyses, and one non-randomised trial, in addition to international guidelines presented the best evidence to answer the clinical question. The current evidence base and guidelines suggest that ICDs should be considered for all patients with LVSD [ejection fraction (EF) ≤30-40%] receiving optimal pharmacological management, who are ≥40 days post MI [four weeks for National Institute for Health and Clinical Excellence (NICE)] and in New York Heart Association (NYHA) class I-III. UK NICE guidelines require in addition; non-sustained ventricular tachycardia (NSVT) on a Holter monitor and inducible ventricular tachycardia at electrophysiological study for EF between 30 and 35%; or a QRS >120 ms if EF <30%. The North American guidelines

  3. Automatic segmentation of stereoelectroencephalography (SEEG) electrodes post-implantation considering bending.

    PubMed

    Granados, Alejandro; Vakharia, Vejay; Rodionov, Roman; Schweiger, Martin; Vos, Sjoerd B; O'Keeffe, Aidan G; Li, Kuo; Wu, Chengyuan; Miserocchi, Anna; McEvoy, Andrew W; Clarkson, Matthew J; Duncan, John S; Sparks, Rachel; Ourselin, Sébastien

    2018-06-01

    The accurate and automatic localisation of SEEG electrodes is crucial for determining the location of epileptic seizure onset. We propose an algorithm for the automatic segmentation of electrode bolts and contacts that accounts for electrode bending in relation to regional brain anatomy. Co-registered post-implantation CT, pre-implantation MRI, and brain parcellation images are used to create regions of interest to automatically segment bolts and contacts. Contact search strategy is based on the direction of the bolt with distance and angle constraints, in addition to post-processing steps that assign remaining contacts and predict contact position. We measured the accuracy of contact position, bolt angle, and anatomical region at the tip of the electrode in 23 post-SEEG cases comprising two different surgical approaches when placing a guiding stylet close to and far from target point. Local and global bending are computed when modelling electrodes as elastic rods. Our approach executed on average in 36.17 s with a sensitivity of 98.81% and a positive predictive value (PPV) of 95.01%. Compared to manual segmentation, the position of contacts had a mean absolute error of 0.38 mm and the mean bolt angle difference of [Formula: see text] resulted in a mean displacement error of 0.68 mm at the tip of the electrode. Anatomical regions at the tip of the electrode were in strong concordance with those selected manually by neurosurgeons, [Formula: see text], with average distance between regions of 0.82 mm when in disagreement. Our approach performed equally in two surgical approaches regardless of the amount of electrode bending. We present a method robust to electrode bending that can accurately segment contact positions and bolt orientation. The techniques presented in this paper will allow further characterisation of bending within different brain regions.

  4. What Is an Automated External Defibrillator?

    MedlinePlus

    ANSWERS by heart Treatments + Tests What Is an Automated External Defibrillator? An automated external defibrillator (AED) is a lightweight, portable device ... ANSWERS by heart Treatments + Tests What Is an Automated External Defibrillator? detect a rhythm that should be ...

  5. Implantable cardioverter-defibrillator lead failure in children and young adults: a matter of lead diameter or lead design?

    PubMed

    Janson, Christopher M; Patel, Akash R; Bonney, William J; Smoots, Karen; Shah, Maully J

    2014-01-21

    This study aimed to investigate the impact of lead diameter and design on implantable cardioverter-defibrillator (ICD) lead survival in children and young adults. Recent reports have called attention to high rates of lead failure in adults with small-diameter ICD leads, but data in the pediatric population is limited. We reviewed lead performance in consecutive subjects ≤30 years with transvenous right ventricular ICD leads implanted at our center between January 1995 and October 2011. Lead failure was defined as fracture, perforation, or sensing failure necessitating revision. A total of 120 ICD leads were implanted in 101 patients at a mean age of 15.5 ± 4.9 years. There were 47 small-diameter (≤8-F) and 73 standard-diameter (>8-F) leads. During a median follow-up of 28.7 months (interquartile range: 14.4 to 59.2 months), there were 25 lead failures (21% prevalence), with an incidence of 5.6%/year (95% confidence interval: 3.4 to 7.8). Sprint Fidelis (SF) (Medtronic, Inc., Minneapolis, Minnesota) leads had lower 3-year (69% vs. 92%, p < 0.01) and 5-year (44% vs. 86%, p < 0.01) survival probabilities than standard-diameter leads. In multivariate Cox regression, SF design conferred the greatest hazard ratio for lead failure (hazard ratio: 4.42, 95% confidence interval: 1.73 to 11.29, p < 0.01). Age and linear growth were not significantly associated with lead failure. In this single-center pediatric study that evaluated lead diameter, lead design, and patient factors, the SF design conferred the highest risk of lead failure, suggesting that design rather than diameter is the critical issue in ICD lead performance. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Evaluation of acute cardiac and chest wall damage after shocks with a subcutaneous implantable cardioverter-defibrillator in swine

    PubMed Central

    KILLINGSWORTH, CHERYL R.; MELNICK, SHARON B.; LITOVSKY, SILVIO H.; IDEKER, RAYMOND E.; WALCOTT, GREGORY P.

    2013-01-01

    Background A subcutaneous implantable cardioverter defibrillator (S-ICD) could ease placement and reduce complications of transvenous ICDs, but requires more energy than transvenous ICDs. Therefore we assessed cardiac and chest wall damage caused by the maximum energy shocks delivered by both types of clinical devices. Methods During sinus rhythm, anesthetized pigs (38±6 kg) received an S-ICD (n = 4) and five 80-Joule (J) shocks, or a transvenous ICD (control, n = 4) and five 35-J shocks. An inactive S-ICD electrode was implanted into the same control pigs to study implant trauma. All animals survived 24-hours. Troponin I and creatine kinase muscle isoenzyme (CK-MM) were measured as indicators of myocardial and skeletal muscle injury. Histopathological injury of heart, lungs, and chest wall was assessed using semi-quantitative scoring. Results Troponin I was significantly elevated at 4- and 24-hours (22.6±16.3 and 3.1±1.3 ng/ml; baseline 0.07±0.09 ng/ml) in control pigs but not in S-ICD pigs (0.12±0.11 and 0.13±0.13 ng/ml; baseline 0.06±0.03 ng/ml). CK-MM was significantly elevated in S-ICD pigs after shocks (6544±1496 and 9705±6240 U/L; baseline 704±398 U/L) but not in controls. ECG changes occurred post-shock in controls but not in S-ICD pigs. The myocardium and lungs were histologically normal in both groups. Subcutaneous injury was greater in S-ICD compared to controls. Conclusion Although CK-MM suggested more skeletal muscle injury in S-ICD pigs, significant cardiac, lung, and chest wall histopathological changes were not detected in either group. Troponin I data indicate significantly less cardiac injury from 80-J S-ICD shocks than 35-J transvenous shocks. PMID:23713608

  7. Mechanical dispersion and global longitudinal strain by speckle tracking echocardiography: Predictors of appropriate implantable cardioverter defibrillator therapy in hypertrophic cardiomyopathy.

    PubMed

    Candan, Ozkan; Gecmen, Cetin; Bayam, Emrah; Guner, Ahmet; Celik, Mehmet; Doğan, Cem

    2017-06-01

    In this study, we investigated whether mechanical dispersion which reflects electrical abnormality and other echocardiographic and clinic parameters predict appropriate ICD shock in patients undergone ICD implantation for hypertrophic cardiomyopathy. Sixty-three patients who received ICD implantation for primary or secondary prevention were included in the study. Patients' clinical, electrocardiographic, 2D classic, and speckle tracking echocardiographic data were collected. Mechanical dispersion was defined as the standard deviation of time to peak negative strain in 18 left ventricular segments. Appropriate ICD therapy was defined as cardioversion or defibrillation due to ventricular tachycardia or fibrillation. Patients were divided into two groups as occurrence or the absence of appropriate ICD therapy. A total of 17 (26.9%) patients were observed to have an appropriate ICD therapy during follow-up periods. In patients who performed appropriate ICD therapy, a larger left atrial volume index, higher sudden cardiac death (SCD)-Risk Score, longer mechanical dispersion, and decreased global longitudinal peak strain (GLPS) were observed. In multivariate logistic regression analysis, including (GLPS, mechanical dispersion, LAVi, and SCD-Risk Score) was used to determine independent predictors of occurrence of appropriate ICD therapy during the follow-up. Mechanical dispersion, GLPS, and SCD-Risk Score were found to be independent predictors of occurrence of appropriate ICD therapy. Mechanical dispersion, GLPS, and SCD-Risk Score were found to be predictive for appropriate ICD therapy in patients receiving ICD implantation. Readily measurable mechanical dispersion and GLPS could be helpful to distinguish patients at high risk who could optimally benefit from ICD therapy. © 2017, Wiley Periodicals, Inc.

  8. A survey of cardiac implantable electronic device implantation in India: By Indian Society of Electrocardiology and Indian Heart Rhythm Society.

    PubMed

    Shenthar, Jayaprakash; Bohra, Shomu; Jetley, Vinay; Vora, Amit; Lokhandwala, Yash; Nabar, Ashish; Naik, Ajay; Calambur, Narsimhan; Gupta, S B

    2016-01-01

    There is limited data regarding the demographics and type of cardiac implantable electronic device (CIED) in India. The aim of this survey was to define trends in CIED implants, which included permanent pacemakers (PM), intracardiac defibrillators (ICD), and cardiac resynchronization therapy pacemakers and defibrillators (CRT-P/D) devices in India. The survey was the initiative of the Indian Society of Electrocardiology and the Indian Heart Rhythm Society. The type of CIED used, their indications, demographic characteristics, clinical status and co-morbidities were collected using a survey form over a period of 1 year. 2117 forms were analysed from 136 centers. PM for bradyarrhythmic indication constituted 80% of the devices implanted with ICD's and CRT-P/D forming approximately 10% each. The most common indication for PM implantation was complete atrio-ventricular block (76%). Single chamber (VVI) pacemakers formed 54% of implants, majority in males (64%). The indication for ICD implantation was almost equal for primary and secondary prevention. A single chamber ICD was most commonly implanted (65%). Coronary artery disease was the etiology in 58.5% of patients with ICD implants. CRT pacemakers were implanted mostly in patients with NYHA III/IV (82%), left ventricular ejection fraction <0.35 (88%) with CRT-P being most commonly used (57%). A large proportion of CIED implants in India are PM for bradyarrhythmic indications, predominantly AV block. ICD's are implanted almost equally for primary and secondary prophylaxis. Most CRT devices are implanted for NYHA Class III. There is a male predominance for implantation of CIED. Copyright © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  9. Implantable cardioverter-defibrillator explantation for overdiagnosed or overtreated congenital long QT syndrome.

    PubMed

    Gaba, Prakriti; Bos, J Martijn; Cannon, Bryan C; Cha, Yong-Mei; Friedman, Paul A; Asirvatham, Samuel J; Ackerman, Michael J

    2016-04-01

    Primary treatment of long QT syndrome (LQTS) currently consists of beta-blocker therapy, although an implantable cardioverter-defibrillator (ICD) is considered for high-risk patients. However, both overdiagnosis and overtreatment must be avoided because their sequelae can be significant. The purpose of this study was to evaluate the prevalence and details of ICD explants in a cohort of patients from a tertiary genetic heart rhythm clinic for a previously rendered diagnosis of LQTS. Overall, 1227 consecutive patients were included in the study. All patients had been referred to the Mayo Clinic for evaluation of possible LQTS and subsequently were either diagnosed with LQTS or dismissed as normal. Further stratification of patients was conducted to assess how many patients had an ICD and how many had a subsequent ICD explant. In total, 170 patients (14%) had an ICD, including 157 of 670 patients (23%) with confirmed LQTS and 13 of 557 patients (2%) who did not have LQTS. Among these, 12 of 1227 (1%) had the ICD removed: 7 of 157 LQTS patients (4.5%) compared to 5 of 14 non-LQTS patients (36%). Before explant, 5 of 12 patients (42%) experienced inappropriate shocks, ranging from 2 to as many as 54 shocks. In addition, 4 had a device-related infection, and 9 had device malfunction (including lead dysfunction or fracture). None of these patients had a breakthrough cardiac event since removal of their ICD during 5.5 ± 3.5 years of follow-up. Implications of overdiagnosis and overtreatment are profound because unnecessary ICD placement can be associated with infection, malfunction, inappropriate shocks, and subsequent anxiety. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  10. Sustaining cyborgs: sensing and tuning agencies of pacemakers and implantable cardioverter defibrillators.

    PubMed

    Oudshoorn, Nelly

    2015-02-01

    Recently there has been a renewed interest in cyborgs, and particularly in new and emerging fusions of humans and technologies related to the development of human enhancement technologies. These studies reflect a trend to follow new and emerging technologies. In this article, I argue that it is important to study 'older' and more familiar cyborgs as well. Studying 'the old' is important because it enables us to recognize hybrids' embodied experiences. This article addresses two of these older hybrids: pacemakers and implantable cardioverter defibrillators inserted in the bodies of people suffering from heart-rhythm disturbances. My concern with hybrid bodies is that internal devices seem to present a complex and neglected case if we wish to understand human agency. Their 'users' seem to be passive because they cannot exert any direct control over the working of their devices. Technologies inside bodies challenge a longstanding tradition of theorizing human-technology relations only in terms of technologies external to the body. Cyborg theory is problematic as well because most studies tend to conceptualize the cyborg merely as a discursive entity and silence the voices of people living as cyborgs. Inspired by feminist research that foregrounds the materiality of the lived and intimate relations between bodies and technologies, I argue that creating these intimate relations requires patients' active involvement in sustaining their hybrid bodies. Based on observations of these monitoring practices in a Dutch hospital and interviews with patients and technicians, the article shows that heart cyborgs are far from passive. On the contrary, their unique experience in sensing the entangled agencies of technologies and their own heart plays a crucial role in sustaining their hybrid bodies.

  11. Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.

    PubMed

    Gold, Michael R; Kanal, Emanuel; Schwitter, Juerg; Sommer, Torsten; Yoon, Hyun; Ellingson, Michael; Landborg, Lynn; Bratten, Tara

    2015-03-01

    Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system. The purpose of this study was to use preclinical computer modeling, animal studies, and bench and scanner testing to demonstrate the safety of an ICD system developed for 1.5-T whole-body MRI. MRI hazards were assessed and mitigated using multiple approaches: design decisions to increase safety and reliability, modeling and simulation to quantify clinical MRI exposure levels, animal studies to quantify the physiologic effects of MRI exposure, and bench testing to evaluate safety margin. Modeling estimated the incidence of a chronic change in pacing capture threshold >0.5 V and 1.0 V to be less than 1 in 160,000 and less than 1 in 1,000,000 cases, respectively. Modeling also estimated the incidence of unintended cardiac stimulation to occur in less than 1 in 1,000,000 cases. Animal studies demonstrated no delay in ventricular fibrillation detection and no reduction in ventricular fibrillation amplitude at clinical MRI exposure levels, even with multiple exposures. Bench and scanner testing demonstrated performance and safety against all other MRI-induced hazards. A preclinical strategy that includes comprehensive computer modeling, animal studies, and bench and scanner testing predicts that an ICD system developed for the magnetic resonance environment is safe and poses very low risks when exposed to 1.5-T normal operating mode whole-body MRI. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  12. Implantable automatic scanning pacemaker for termination of supraventricular tachycardia.

    PubMed

    Spurrell, R A; Nathan, A W; Bexton, R S; Hellestrand, K J; Nappholz, T; Camm, A J

    1982-03-01

    Thirteen patients suffering from reentrant supraventricular tachycardia have undergone implantation of a scanning extrastimulus pacemaker. This pacemaker is fully implanted and automatic, and it requires no external control device to activate or control it. The pacemaker is activated when tachycardia occurs. After four cycles an extrastimulus is induced with a preset coupling time from a sensed intracardiac potential, and every four cycles thereafter a further extrastimulus occurs, but on each occasion there is a decrement in coupling cycle by 6 ms until 90 ms of the cardiac cycle has been scanned by extrastimuli. When necessary, two extrastimuli can be introduced with a fixed but preset coupling time between them. Every four beats two extrastimuli are induced but the coupling time between the spontaneous cardiac potential and the first stimulus is decreased by 6 ms until 90 ms of the cardiac cycle has been scanned. The coupling time between the two stimuli is fixed throughout the scan. When termination of tachycardia occurs the successful timing variables are retained in the pacemaker memory so that at the onset of the next episode of tachycardia these settings are used first. Pacemaker pulse width, sensitivity, tachycardia trigger rate, coupling intervals for both stimuli and the use of single or double extrastimuli are all programmable transcutaneously. Three patients required single, and seven patients double ventricular premature stimuli; three patients required double atrial premature stimuli for termination of tachycardia. Despite frequent attacks of tachycardia before implantation, only two patients had a sustained attack of tachycardia after pacemaker implantation.

  13. Scottish survey of public place defibrillators.

    PubMed

    Ashimi, A O; Cobbe, S M; Pell, J P

    2010-08-01

    Public place defibrillators can reduce delays to defibrillation but their cost-effectiveness has not been evaluated in randomised trials. In Scotland, unlike England, no health sector funding has been provided. Nonetheless, anecdotal evidence suggests they are increasing in number. A cross-sectional survey was conducted of all airports, shopping malls, leisure centres, and major train and bus stations to determine whether defibrillators had been purchased and by whom, the training and maintenance arrangements, and whether they had been discharged. Of the 183 eligible sites, 153 (84%) participated. 33 (22%) had at least one defibrillator. Those in airports and shopping malls were purchased privately. Those in leisure centres were bought by charities or local authorities. The majority (97%) provided training to existing staff, but 6 (18%) provided no training to new staff. Only 6 (18%) had a maintenance agreement and 8 (24%) a replacement policy. Only one site permitted public access. Defibrillators had been discharged in 10 (30%) sites. Of the 32 people shocked, 23 (72%) survived until the ambulance arrived. Despite absence of health sector funding, defibrillators are located in 22% of high footfall public places. Those purchasing defibrillators need to ensure adequate maintenance, replacement and training arrangements.

  14. 21 CFR 870.5325 - Defibrillator tester.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

  15. 21 CFR 870.5325 - Defibrillator tester.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

  16. 21 CFR 870.5325 - Defibrillator tester.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

  17. 21 CFR 870.5325 - Defibrillator tester.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

  18. 21 CFR 870.5325 - Defibrillator tester.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Defibrillator tester. 870.5325 Section 870.5325...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5325 Defibrillator tester. (a) Identification. A defibrillator tester is a device that is connected to the output of a...

  19. Magnetic Resonance Imaging in Nondependent Pacemaker Patients with Pacemakers and Defibrillators with a Nearly Depleted Battery.

    PubMed

    Okamura, Hideo; Padmanabhan, Deepak; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Jondal, Mary; Romme, Abby L; Cha, Yong-Mei; Asirvatham, Samuel J; Felmlee, Joel P; Friedman, Paul A

    2017-05-01

    Magnetic resonance imaging (MRI) in patients with non-MRI-conditional cardiac implantable electronic devices (CIEDs) has been shown to be safe when performed under closely monitored protocols. However, the safety of MRI in patients with devices with a nearly depleted battery has not been reported. Prospective data were collected between January 2008 and May 2015 in patients with non-MRI-conditional CIEDs undergoing clinically indicated MRI under institutional protocol. Patients who were pacemaker dependent were excluded. Patients whose devices were at elective replacement indicator (ERI) at the time of MRI or close to ERI (ERI or replacement for battery depletion within 3 months of scan) were identified through database review and analyzed for clinical events. MRI scans (n = 569) were performed in 442 patients. Of these, we identified 13 scans performed with a nearly depleted battery in nine patients. All scans with implantable cardioverter defibrillators (ICDs, n = 9) were uneventful. However, two scans with pacemakers close to ERI resulted in a power-on-reset (PoR) event. One scan with a pacemaker close to ERI that was programmed to DOO mode reached ERI during MRI and automatically changed to VVI mode. Additionally, one scan with a pacemaker at ERI did not allow programming. All pacemakers with events were implanted before 2005. Patients with pacemakers and ICDs with a nearly depleted battery can safely undergo MRI when patients are not pacemaker dependent. Attention should be paid because old devices can result in PoR or ERI during MRI, which may lead to oversensing and inhibition of pacing. © 2017 Wiley Periodicals, Inc.

  20. Inconsistent shock advisories for monomorphic VT and Torsade de Pointes--A prospective experimental study on AEDs and defibrillators.

    PubMed

    Fitzgerald, Abi; Johnson, Meshell; Hirsch, Jan; Rich, Mary-Ann; Fidler, Richard

    2015-07-01

    Cardiovascular disease and sudden cardiac arrest are the leading causes of death in the United States. Early defibrillation is key to successful resuscitation for patients who experience shockable rhythms during a cardiac arrest. It is therefore vital that the shock advisory of AEDs (automated external defibrillators) or defibrillators in AED mode be reliable and appropriate. The goal of this study was to better understand the performance of multiple lay-rescuer and hospital professional defibrillators in AED mode in their analysis of ventricular arrhythmias. The measurable objectives of this study sought to quantify: 1. No shock advisory for sinus rhythms at any rate. 2. Recognition and shock advisory for ventricular fibrillation (VF). 3. Recognition and shock advisory for monomorphic ventricular tachycardia (VT). 4. Recognition and shock advisory for Torsades de Pointes (TdP). This is a prospective evaluation of two AEDs and four semi-automatic, hospital professional defibrillators. This study represents post-marketing evaluation of FDA approved devices. Each defibrillator was connected to multiple rhythm simulators and presented with simulated ECG waveforms 20 consecutive times at various rates when possible. All four defibrillators and both AEDs tested consistently recognized normal sinus rhythm (NSR) from all rhythm sources, and did not recommend a shock for NSR at any rate (from 80 to 220 bpm). All four defibrillators and both AEDs recognized VF from all rhythm sources tested and recommended a shock 100% of the time. Variations were found in the shock advisory rates among defibrillators when testing simulated VT heart rates at or below 150 bpm. One AED tested did not consistently advise a shock for monomorphic VT or TdP at any tested rate. Lay-rescuer AEDs and professional hospital defibrillators tested in AED mode did not reliably recommend a shock for sustained monomorphic VT or TdP at certain rates, despite the fact that it is a critical component of the

  1. [Public access defibrillation].

    PubMed

    Katz, Eugène; Metzger, Jacques-Thierry; Sierro, Christophe; Deac, Monica; Fishman, Daniel; Girod, Grégoire; Potin, Mathieu; Niquille, Marc; Stauffer, Jean-Christoffe; Kehtari, Réza; Sénéchaud, Christophe; Garcia, Wenceslao; Rodriguez, Maria; Fromer, Martin

    2008-08-27

    Placement of automated external defibrillators (AED) in public facilities and training of the lay persons in basic life support-defibrillation (BLS-D) was recommended by the American Heart Association for the treatment of out-of-hospital cardiac arrest (OHCA). Immediate use of AED result in increase of survival to hospital discharge. Many observation and much less randomized trials describe clinical efficacy of this approach. However, "negative" trials have also been published and some recent data suggest that public access defibrillation (PAD) will have a minimal impact on population survival. In this article various PAD strategies were briefly reviewed. In our opinion installation of AED in public places should be based on the long-term study of local OHCA demography and preceded by widespread BLS training of lay population.

  2. Ventricular arrhythmias and changes in heart rate preceding ventricular tachycardia in patients with an implantable cardioverter defibrillator.

    PubMed

    Lerma, Claudia; Wessel, Niels; Schirdewan, Alexander; Kurths, Jürgen; Glass, Leon

    2008-07-01

    The objective was to determine the characteristics of heart rate variability and ventricular arrhythmias prior to the onset of ventricular tachycardia (VT) in patients with an implantable cardioverter defibrillator (ICD). Sixty-eight beat-to-beat time series from 13 patients with an ICD were analyzed to quantify heart rate variability and ventricular arrhythmias. The episodes of VT were classified in one of two groups depending on whether the sinus rate in the 1 min preceding the VT was greater or less than 90 beats per minute. In a subset of patients, increased heart rate and reduced heart rate variability was often observed up to 20 min prior to the VT. There was a non-significant trend to higher incidence of premature ventricular complexes (PVCs) before VT compared to control recordings. The patterns of the ventricular arrhythmias were highly heterogeneous among different patients and even within the same patient. Analysis of the changes of heart rate and heart rate variability may have predictive value about the onset of VT in selected patients. The patterns of ventricular arrhythmia could not be used to predict onset of VT in this group of patients.

  3. Wearable defibrillator use in heart failure (WIF): results of a prospective registry

    PubMed Central

    2012-01-01

    Background Heart failure (HF) patients have a high risk of death, and implantable cardioverter defibrillators (ICDs) are effective in preventing sudden cardiac death (SCD). However, a certain percentage of patients may not be immediate candidates for ICDs, particularly those having a short duration of risk or an uncertain amount of risk. This includes the newly diagnosed patients, as well as those on the cardiac transplant list or NYHA class IV heart failure patients who do not already have an ICD. In these patients, a wearable cardioverter defibrillator (WCD) may be used until long term risk of SCD is defined. The purpose of this study was to determine the incidence of SCD in this population, and the efficacy of early defibrillation by a WCD. Methods Ten enrolling centers identified 89 eligible HF patients who were either listed for cardiac transplantation, diagnosed with dilated cardiomyopathy, or receiving inotropic medications. Data collected included medical history, device records, and outcomes (including 90 day mortality). Results Out of 89 patients, final data on 82 patients has been collected. Patients wore the device for 75±58 days. Mean age was 56.8±13.2, and 72% were male. Most patients (98.8%) were diagnosed with dilated cardiomyopathy with a low ejection fraction (<40%) and twelve were listed for cardiac transplantation. Four patients were on inotropes. There were no sudden cardiac arrests or deaths during the study. Interestingly, 41.5% of patients were much improved after WCD use, while 34.1% went on to receive an ICD. Conclusions In conclusion, the WCD monitored HF patients until further assessment of risk. The leading reasons for end of WCD use were improvement in left ventricular ejection fraction (LVEF) or ICD implantation if there was no significant improvement in LVEF. PMID:23234574

  4. Echocardiography in patients with complications related to pacemakers and cardiac defibrillators.

    PubMed

    Almomani, Ahmed; Siddiqui, Khadija; Ahmad, Masood

    2014-03-01

    The evolving indications and uses for implantable cardiac devices have led to a significant increase in the number of implanted devices each year. Implantation of endocardial leads for permanent pacemakers and cardiac defibrillators can cause many delayed complications. Complications may be mechanical and related to the interaction of the device leads with the valves and endomyocardium, e.g., perforation, infection, and thrombosis, or due to the electrical pacing of the myocardium and conduction abnormalities, e.g., left ventricular dyssynchrony. Tricuspid regurgitation, another delayed complication in these patients, may be secondary to both mechanical and pacing effects of the device leads. Echocardiography plays an important role in the diagnosis of these device-related complications. Both two-dimensional transthoracic echocardiography and transesophageal echocardiography provide useful diagnostic information. Real time three-dimensional echocardiography is a novel technique that can further enhance the detection of lead-related complications. © 2013, Wiley Periodicals, Inc.

  5. Surface electromyography of myopotential oversensing provoked by simultaneous straining and leftward twisting in a patient with an implantable cardioverter defibrillator.

    PubMed

    Ajiro, Yoichi; Shiga, Tsuyoshi; Shoda, Morio; Hagiwara, Nobuhisa

    2017-03-01

    An important step in diagnosing myopotential oversensing is to confirm its reproducibility using specific provocation maneuvers. Although most maneuvers involve the co-contraction of many muscles, no attempt has been made to assess relevant muscle activities by electromyography. We describe a case with an implantable cardioverter defibrillator (ICD) whose myopotential oversensing was provoked by simultaneous straining and leftward twisting. Simultaneous recordings from real-time ICD telemetry and myopotentials of the rectus abdominis, oblique abdominis, and diaphragm on electromyography during the provocation maneuvers were conducted. It was shown that all three muscles contracted simultaneously during the provocation maneuvers; the diaphragm activity was the main source of noise oversensing, and the twist itself caused oversensing possibly due to the change in the position of the lead. In conclusion, the electromyographic assessment of relevant muscle activities may be useful in assessing each muscle's role and its contribution to myopotential oversensing, especially in a patient whose myopotential oversensing requires complex maneuvers to be provoked.

  6. Appropriate evaluation and treatment of heart failure patients after implantable cardioverter-defibrillator discharge: time to go beyond the initial shock.

    PubMed

    Mishkin, Joseph D; Saxonhouse, Sherry J; Woo, Gregory W; Burkart, Thomas A; Miles, William M; Conti, Jamie B; Schofield, Richard S; Sears, Samuel F; Aranda, Juan M

    2009-11-24

    Multiple clinical trials support the use of implantable cardioverter-defibrillators (ICDs) for prevention of sudden cardiac death in patients with heart failure (HF). Unfortunately, several complicating issues have arisen from the universal use of ICDs in HF patients. An estimated 20% to 35% of HF patients who receive an ICD for primary prevention will experience an appropriate shock within 1 to 3 years of implant, and one-third of patients will experience an inappropriate shock. An ICD shock is associated with a 2- to 5-fold increase in mortality, with the most common cause being progressive HF. The median time from initial ICD shock to death ranges from 168 to 294 days depending on HF etiology and the appropriateness of the ICD therapy. Despite this prognosis, current guidelines do not provide a clear stepwise approach to managing these high-risk patients. An ICD shock increases HF event risk and should trigger a thorough evaluation to determine the etiology of the shock and guide subsequent therapeutic interventions. Several combinations of pharmacologic and device-based interventions such as adding amiodarone to baseline beta-blocker therapy, adjusting ICD sensitivity, and employing antitachycardia pacing may reduce future appropriate and inappropriate shocks. Aggressive HF surveillance and management is required after an ICD shock, as the risk of sudden cardiac death is transformed to an increased HF event risk.

  7. Training lay-people to use automatic external defibrillators: are all of their needs being met?

    PubMed

    Harrison-Paul, Russell; Timmons, Stephen; van Schalkwyk, Wilna Dirkse

    2006-10-01

    We explored the experiences of lay people who have been trained to use automatic external defibrillators. The research questions were: (1) How can training courses help prepare people for dealing with real life situations? (2) Who is ultimately responsible for providing critical incident debriefing and how should this be organised? (3) What is the best process for providing feedback to those who have used an AED? Fifty-three semi-structured, qualitative interviews were conducted, some with those who had been trained and others with trainers. Locations included airports, railway stations, private companies and first responder schemes. Geographically, we covered Nottinghamshire, Lincolnshire, Yorkshire, Staffordshire, Essex and the West Midlands in the UK. Our analysis of the data indicates that most people believe scenarios based within their place of work were most useful in preparing for 'real life'. Many people had not received critical incident debriefing after using an AED. There were a variety of systems in place to provide support after an incident, many of which were informal. Training scenarios should be conducted outside the classroom. There should be more focus on critical incident debriefing during training and a clear identification of who should provide support after an incident. Other issues which were of interest included: (1) people's views on do not attempt resuscitation (DNAR); (2) perceived boundaries of responsibility when using an AED; (3) when is someone no longer 'qualified' to use an AED?

  8. Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole.

    PubMed

    Safak, Erdal; Schmitz, Dietmar; Konorza, Thomas; Wende, Christian; De Ros, Jose Olague; Schirdewan, Alexander

    2013-08-01

    The concept of a single-lead implantable cardioverter-defibrillator (ICD), with a floating dipole, has been proven safe and functional. The studied active-fixation, steroid-eluting lead (Linox(smart) S DX, BIOTRONIK SE & Co KG, Berlin, Germany) is one French thinner than its predecessor and coated with lubricious SilGlide to improve lead handling. A dedicated ICD device has a self-adaptive atrial input stage including a fourfold amplifier. The amplification, filtering, and adapted atrial input stage are located in the Lumax 540 VR-T DX (BIOTRONIK). The Linox(smart) S DX ICD lead delivers only the signal. The lead was evaluated during implantation; at predischarge; and 1-, 3-, and 6-month follow-up examinations. The primary endpoint (efficacy) was the rate of appropriate atrial sensing tests. The secondary endpoint (safety) was freedom from lead-related invasive reinterventions. Both safety and efficacy were expected to be significantly higher than 90%. The study enrolled 116 patients at 25 clinical sites. Skin-to-skin operation time was 52.4 ± 26.2 minutes. The investigators graded lead insertion as "easy" in 87% of patients. Mean P-wave amplitudes (preamplified) varied from 5.0 to 6.1 mV in different body positions. Both primary and secondary endpoints were met, as 93.8% (364/388; P = 0.005) of specific sensing tests indicated appropriate atrial sensing, and 94.8% (110/116; P = 0.048) of patients were free from reinterventions (lead dislodgement). Analysis of arrhythmia episodes stored in ICDs and elective 24-hour Holter electrocardiogram tests raised no concerns about lead functionality. The studied ICD lead with a floating atrial sensing dipole met the predefined safety expectation and demonstrated appropriate atrial sensing performance. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

  9. Right ventricular apical versus non-apical implantable cardioverter defibrillator lead: A systematic review and meta-analysis.

    PubMed

    Garg, Jalaj; Chaudhary, Rahul; Shah, Neeraj; Palaniswamy, Chandrasekar; Bozorgnia, Babak; Nazir, Talha; Natale, Andrea; Kutyifa, Valentina

    We aimed to study the effect of right ventricular implantable cardioverter defibrillator (ICD) lead positioning on clinical outcomes in patients undergoing ICD placement. A systematic literature search was performed using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to identify clinical trials comparing outcomes in patients with ICD leads in apical and non-apical positions. The primary outcome of our study was death at 1-year follow-up. Secondary outcomes studied were "death at 3years", "total number of shocks", "appropriate shocks", "inappropriate shocks" and "cut-to-suture time". We analyzed a total of 3731 patients (2852 in apical and 879 in non-apical ICD groups) enrolled in 4 clinical trials. No significant difference was observed between the apical and non-apical ICD groups in all-cause mortality at 1year (OR 0.88; 95% CI 0.51-1.49, p=0.63; I 2 =5.32%). Similarly, no differences were seen between the two groups in death at 3years (OR=0.76; 95% CI 0.56-1.04, p=0.08; I 2 =0%), total number of shocks (OR 0.99; 95% CI 0.81-1.22, p=0.95; I 2 =0%), appropriate shocks (OR 1.00; 95% CI 0.79-1.27, p=0.99; I 2 =0%), inappropriate shocks (OR 0.98; 95% CI 0.70-1.37, p=0.91; I 2 =0%) and cut-to-suture time (Standard mean difference=-0.03; 95% CI -0.20 to 0.14, p=0.73; I 2 =0%). No publication bias was seen. Non-apical RV ICD lead implantation is non-inferior to traditional RV apical position with no significant differences in mortality, total number of shocks, appropriate shocks, inappropriate shocks and procedural time. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.

    PubMed

    Richardson, Travis D; Hale, Leslie; Arteaga, Christopher; Xu, Meng; Keebler, Mary; Schlendorf, Kelly; Danter, Matthew; Shah, Ashish; Lindenfeld, JoAnn; Ellis, Christopher R

    2018-02-23

    Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks. Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group ( P =0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks ( P =0.08). An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  11. Could implantable cardioverter defibrillators provide a human model supporting the learned helplessness theory of depression?

    PubMed

    Goodman, M; Hess, B

    1999-01-01

    Affective symptoms were examined retrospectively in 25 patients following placement of implantable cardioverter defibrillators (ICD) which can produce intermittent shocks without warning in response to cardiac ventricular arrhythmias. The number of ICD random, uncontrollable discharge shocks and pre-ICD history of psychological distress (i.e., depression and/or anxiety) were documented in all patients using a demographics questionnaire and a standardized behavioral/psychological symptoms questionnaire (i.e., Symptom Checklist-90 Revised). ICD patients were dichotomized into two groups: those without a history of psychological distress prior to ICD (n = 18) and those with a history of psychological distress prior to ICD (n = 7). In ICD patients without a prior history, results indicated that quantity of ICD discharge shocks was significantly predictive of current reported depression (r = 0.45, p = 0.03) and current reported anxiety (r = 0.51, p = 0.02). Conversely, in patients with a reported history of psychological distress, there was no significant relationship found between quantity of discharge shocks and current reported depression or anxiety. This study may provide evidence in support of a human model of learned helplessness in that it supports the notion that exposure to an unavoidable and inescapable aversive stimulus was found to be related to patients' reported depression. Further studies may wish to prospectively consider a larger sample as well as a more comprehensive assessment of premorbid psychological symptoms.

  12. Prospective evaluation of defibrillation threshold and postshock rhythm in young ICD recipients.

    PubMed

    Radbill, Andrew E; Triedman, John K; Berul, Charles I; Walsh, Edward P; Alexander, Mark E; Webster, Gregory; Cecchin, Frank

    2012-12-01

    Adaptation of implantable cardioverter defibrillator (ICD) systems to the needs of pediatric and congenital heart patients is problematic due to constraints of vascular and thoracic anatomy. An improved understanding of the defibrillation energy and postshock pacing requirements in such patients may help direct more tailored ICD therapy. We describe the first prospective evaluation of defibrillation threshold (DFT) and postshock rhythm in this population. We prospectively studied patients ≤ 60 kg at time of ICD intervention. DFTs were obtained using a binary search protocol with three VF inductions. Postshock pacing was programmed using a stepwise protocol, lowering the rate prior to each VF induction. Twenty patients were enrolled: 11 had channelopathy, five congenital heart disease, and four cardiomyopathy. The median age was 16 years, median weight 48 kg. Twelve patients had a transvenous high-voltage coil; eight had pericardial +/- subcutaneous coil(s). Median DFT was 7 J (range 3-31 J); 19/20 patients had DFT ≤ 15 J and all patients <25 kg had DFT ≤ 9 J (n = 6). There was no difference in DFT between patients with transvenous versus pericardial +/- subcutaneous coils (median 7 J vs 6 J, P = 0.59). No patient with normal atrioventricular conduction prior to defibrillation required postshock pacing (n = 16). There were no adverse events. These data suggest that many pediatric ICD patients have low DFTs and adequate postshock escape rhythm. This may help determine appropriate parameters for future design of pediatric-specific ICDs. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

  13. Defibrillator/monitor/pacemakers.

    PubMed

    2002-02-01

    Defibrillator/monitors allow operators to assess and monitor a patient's ECG and, when necessary, deliver a defibrillating shock to the heart. When integral noninvasive pacing capability is added, the resulting device is referred to as a defibrillator/monitor/pacemaker. In this Update Evaluation, we present our findings for one newly evaluated model, the Philips Heartstream XL, and we summarize our findings for the seven previously evaluated models that are still on the market. (Our previous Evaluations were published in the May-June 1993, February 1998, and September 2000 issues of Health Devices.) Defibrillator/monitor/pacemakers are used for a variety of applications within the hospital, as well as by emergency medical services (EMS) personnel and others in the prehospital environment. To help both hospital-based and prehospital users select an appropriate model, we rate the models (1) for each of three in-hospital applications--general crash-cart use, in-hospital transport use, and in-hospital use by basic as well as advanced users--and (2) for prehospital (EMS) use. For in-hospital use, we recommend four of the evaluated models. These received either Preferred or Acceptable ratings for all the applications considered. For prehospital use, we found that five of the models will meet most organizations' needs.

  14. Attitudes of older adults with serious competing health risks toward their implantable cardioverter-defibrillators: a pilot study.

    PubMed

    Green, Ariel R; Boyd, Cynthia M; Rickard, John; Gomon, Robert; Leff, Bruce

    2015-12-23

    In elderly heart failure patients, the survival benefit of implantable cardioverter-defibrillators (ICDs) may be attenuated due to competing health risks, and the risk of adverse outcomes magnified. Our objective was to examine older adults' attitudes towards ICD implantation in the context of competing health risks, exploring the determinants of ICD decision-making among a group of patients who had faced the decision in the past. Telephone survey with a qualitative component. Patients were age ≥70 with single- or dual-chamber ICDs from a single academic cardiac device clinic. Health status was assessed with the Vulnerable Elders Survey (VES-13). Responses to open-ended questions were transcribed verbatim; an "editing analysis" approach was used to extract themes. Forty-four ICD recipients participated (mean age 77.5 years). Nineteen participants (43%) had VES-13 scores ≥3, indicating a 50% likelihood of death or functional decline within 2 years. Twenty-one participants (48%) had received prior ICD shocks. Forty participants (91%) said they would "definitely" choose to get an ICD again in their current health. By and large, patients revealed a strong desire to extend life, expressed complete confidence in the lifesaving capabilities of their ICDs, and did not describe consideration of competing health risks. In this pilot telephone survey with a qualitative component, nearly all older adults with ICDs would still choose to get an ICD despite high short-term risk of death or health deterioration. These findings suggest the need to partner more effectively with patients and families to decide how best to use medical technologies, particularly for older adults with competing risks.

  15. Digital music players cause interference with interrogation telemetry for pacemakers and implantable cardioverter-defibrillators without affecting device function.

    PubMed

    Webster, Gregory; Jordao, Ligia; Martuscello, Maria; Mahajan, Tarun; Alexander, Mark E; Cecchin, Frank; Triedman, John K; Walsh, Edward P; Berul, Charles I

    2008-04-01

    Concern exists regarding the potential electromagnetic interaction between pacemakers, implantable cardioverter-defibrillators (ICDs) and digital music players (DMPs). A preliminary study reported interference in 50% of patients whose devices were interrogated near Apple iPods. Given the high prevalence of DMP use among young patients, we sought to define the nature of interference from iPods and evaluate other DMPs. Four DMPs (Apple Nano, Apple Video, SanDisk Sansa and Microsoft Zune) were evaluated against pacemakers and ICDs (PM/ICD). Along with continuous monitoring, we recorded a baseline ECG strip, sensing parameters and lead impedance at baseline and for each device. Among 51 patients evaluated (age 6 to 60 years, median 22), there was no interference with intrinsic device function. Interference with the programmer occurred in 41% of the patients. All four DMPs caused programmer interference, including disabled communication between the PM/ICD and programmer, noise in the ECG channel, and lost marker channel indicators. Sensing parameters and lead impedances exhibited no more than baseline variability. When the DMPs were removed six inches, there were no further programmer telemetry interactions. Contrary to a prior report, we did not identify any evidence for electromagnetic interference between a selection of DMPs and intrinsic function of PM/ICDs. The DMPs did sometimes interfere with device-programmer communication, but not in a way that compromised device function. Therefore, we recommend that DMPs not be used during device interrogation, but suggest that there is reassuring counterevidence to mitigate the current high level of concern for interactions between DMPs and implantable cardiac rhythm devices.

  16. Refusing Implantable Cardioverter Defibrillator (ICD) Replacement in Elderly Persons-The Same as Giving Up Life: A Qualitative Study.

    PubMed

    Svanholm, Jette Rolf; Nielsen, Jens Cosedis; Mortensen, Peter; Christensen, Charlotte Fuglesang; Birkelund, Regner

    2015-11-01

    More than 20% of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices are implanted in the elderly population aged 80 years or older. In recent scientific literature it is suggested to consider termination of ICD therapy, rather than ICD replacement, in this patient group. The aim of this study was to explore the experiences of persons above 80 years of age concerning replacement of the ICD battery, and the shared communication and decision making with healthcare professionals. We performed a qualitative, explorative study, inspired by Ricoeur's narrative, with a phenomenological-hermeneutic approach, involving 11 ICD patients older than 80 years. The study period was 2011-2012. The meaning of the patients' experiences of living with an ICD was formulated into two themes: (1) "Feeling safe with the ICD" with the subthemes: "The ICD-a life keeper," "The battery level is important," "ICD shock-no problem." (2) "The physician is an authority" with the subthemes: "Being trustful," "Feeling fine knowing nothing," "Criminal act to deactivate the ICD." The elderly ICD recipients tended not to be aware of the option of declining replacement of their ICD. They tended to expect to have their ICD replaced and not to be involved actively in decision making concerning this. Healthcare professionals have an obligation to discuss options and ensure that every patient understands these. More research is needed to change practices and create more realistic, person-centered, ethically acceptable, and constructive healthcare for elderly persons with an ICD. © 2015 Wiley Periodicals, Inc.

  17. Electrical Heart Defibrillation with Ion Channel Blockers

    NASA Astrophysics Data System (ADS)

    Feeney, Erin; Clark, Courtney; Puwal, Steffan

    Heart disease is the leading cause of mortality in the United States. Rotary electrical waves within heart muscle underlie electrical disorders of the heart termed fibrillation; their propagation and breakup leads to a complex distribution of electrical activation of the tissue (and of the ensuing mechanical contraction that comes from electrical activation). Successful heart defibrillation has, thus far, been limited to delivering large electrical shocks to activate the entire heart and reset its electrical activity. In theory, defibrillation of a system this nonlinear should be possible with small electrical perturbations (stimulations). A successful algorithm for such a low-energy defibrillator continues to elude researchers. We propose to examine in silica whether low-energy electrical stimulations can be combined with antiarrhythmic, ion channel-blocking drugs to achieve a higher rate of defibrillation and whether the antiarrhythmic drugs should be delivered before or after electrical stimulation has commenced. Progress toward a more successful, low-energy defibrillator will greatly minimize the adverse effects noted in defibrillation and will assist in the development of pediatric defibrillators.

  18. The wearable cardioverter-defibrillator in a real-world clinical setting: experience in 102 consecutive patients.

    PubMed

    Erath, Julia W; Vamos, Mate; Sirat, Abdul Sami; Hohnloser, Stefan H

    2017-04-01

    The wearable cardioverter-defibrillator (WCD) is used for temporary protection of patients deemed to be at high risk for sudden death (SCD) not yet meeting indications for the implantable defibrillator (ICD). To evaluate the efficacy, safety, and compliance of/to WCD use and subsequent medium-term outcome of patients in a single-center observational study. A total of 102 consecutive patients were fitted with the WCD from 2012 to 2015 and followed for a mean of 11 months (±8 months). The most common clinical indication for WCD-prescription (63%) was a new diagnosis of severely impaired LV function (LVEF ≤35%). The median wear time of the WCD was 54 days with a daily use of 23 h. Appropriate WCD therapy occurred in four patients (seven shocks for VF, one shock for VT). An ICD was finally implanted in 56 patients (55%). Improvement in LV function was the most common reason not to implant an ICD (HR 0.37; 95% CI 0.19-0.73; p = 0.004). Two patients had inappropriate shocks from their WCD due to atrial fibrillation/flutter. Five patients fitted with an ICD after the end of WCD therapy suffered VT/VF episodes. After wearing the WCD, six patients died (five ICD recipients and one non-ICD recipient). WCD therapy was well accepted by patients and provided temporary protection against ventricular tachyarrhythmias in patients at risk for SCD. The WCD may help to avoid unnecessary ICD implantations in a significant proportion of patients.

  19. Performance of 2014 NICE defibrillator implantation guidelines in heart failure risk stratification.

    PubMed

    Cubbon, Richard M; Witte, Klaus K; Kearney, Lorraine C; Gierula, John; Byrom, Rowenna; Paton, Maria; Sengupta, Anshuman; Patel, Peysh A; Mn Walker, Andrew; Cairns, David A; Rajwani, Adil; Hall, Alistair S; Sapsford, Robert J; Kearney, Mark T

    2016-05-15

    Define the real-world performance of recently updated National Institute for Health and Care Excellence guidelines (TA314) on implantable cardioverter-defibrillator (ICD) use in people with chronic heart failure. Multicentre prospective cohort study of 1026 patients with stable chronic heart failure, associated with left ventricular ejection fraction (LVEF) ≤45% recruited in cardiology outpatient departments of four UK hospitals. We assessed the capacity of TA314 to identify patients at increased risk of sudden cardiac death (SCD) or appropriate ICD shock. The overall risk of SCD or appropriate ICD shock was 2.1 events per 100 patient-years (95% CI 1.7 to 2.6). Patients meeting TA314 ICD criteria (31.1%) were 2.5-fold (95% CI 1.6 to 3.9) more likely to suffer SCD or appropriate ICD shock; they were also 1.5-fold (95% CI 1.1 to 2.2) more likely to die from non-cardiovascular causes and 1.6-fold (95% CI 1.1 to 2.3) more likely to die from progressive heart failure. Patients with diabetes not meeting TA314 criteria experienced comparable absolute risk of SCD or appropriate ICD shock to patients without diabetes who met TA314 criteria. Patients with ischaemic cardiomyopathy not meeting TA314 criteria experienced comparable absolute risk of SCD or appropriate ICD shock to patients with non-ischaemic cardiomyopathy who met TA314 criteria. TA314 can identify patients with reduced LVEF who are at increased relative risk of sudden death. Clinicians should also consider clinical context and the absolute risk of SCD when advising patients about the potential risks and benefits of ICD therapy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Readability and Content of Patient Education Material Related to Implantable Cardioverter Defibrillators

    PubMed Central

    Strachan, Patricia H.; de Laat, Sonya; Carroll, Sandra L.; Schwartz, Lisa; Vaandering, Katie; Toor, Gurjit K.; Arthur, Heather M.

    2012-01-01

    Background Implantable cardioverter defibrillators (ICDs) are increasingly offered to patients for primary prevention of sudden cardiac death. Candidates for ICD receive ICD-related patient education material when they make decisions to consent or decline a primary prevention ICD. Printed patient education material directed at ICD candidates has not been the focus of direct appraisal. Objective We evaluated the readability and content of ICD-related print education materials made available to patients who were enrolled in a study involving patient decision making for ICD from 3 ICD sites in southern Ontario, Canada. Methods All ICD print materials referred to during interviews and/or that were available in ICD site waiting rooms were collected for analysis. Readability testing was conducted using the SMOG (“simple measurement of gobbledygook”) and Fry methods. The material was evaluated according to selected plain-language criteria, thematic content analysis, and rhetoric analysis. Results Twenty-one print materials were identified and analyzed. Documents were authored by device manufacturers, tertiary care hospitals, and cardiac support organizations. Although many documents adhered to plain-language recommendations, text-reading levels were higher than recommended. Twelve major content themes were identified. Content focused heavily on the positive aspects of living with the device to the exclusion of other possible information that could be relevant to the decisions that patients made. Conclusions Print-based patient education materials for ICD candidates are geared to a highly literate population. The focus on positive information to the exclusion of potentially negative aspects of the ICD, or alternatives to accepting 1, could influence and/or confuse patients about the purpose and implications of this medical device. Development of print materials is indicated that includes information about possible problems and that would be relevant for the

  1. TED-Time and life saving External Defibrillator for home-use.

    PubMed

    Weiss, Teddy A; Rosenheck, Shimon; Gorni, Shraga; Katz, Ioni; Mendelbaum, Mendel; Gilon, Dan

    2014-06-01

    Sudden Cardiac Death--SCD --is a major unmet health problem that needs urgent and prompt solution. AICDs are very expensive, risky and indicated for a small group of patients, at the highest risk. AEDs--Automatic External Defibrillators--are designed for public places and although safe, cannot enter the home-market due to their cost and need for constant, high-cost maintenance. We developed TED, a low-cost AED that derives its energy off the mains, designed for home-use, to save SCD victims' lives. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Correlation-based pattern recognition for implantable defibrillators.

    PubMed Central

    Wilkins, J.

    1996-01-01

    An estimated 300,000 Americans die each year from cardiac arrhythmias. Historically, drug therapy or surgery were the only treatment options available for patients suffering from arrhythmias. Recently, implantable arrhythmia management devices have been developed. These devices allow abnormal cardiac rhythms to be sensed and corrected in vivo. Proper arrhythmia classification is critical to selecting the appropriate therapeutic intervention. The classification problem is made more challenging by the power/computation constraints imposed by the short battery life of implantable devices. Current devices utilize heart rate-based classification algorithms. Although easy to implement, rate-based approaches have unacceptably high error rates in distinguishing supraventricular tachycardia (SVT) from ventricular tachycardia (VT). Conventional morphology assessment techniques used in ECG analysis often require too much computation to be practical for implantable devices. In this paper, a computationally-efficient, arrhythmia classification architecture using correlation-based morphology assessment is presented. The architecture classifies individuals heart beats by assessing similarity between an incoming cardiac signal vector and a series of prestored class templates. A series of these beat classifications are used to make an overall rhythm assessment. The system makes use of several new results in the field of pattern recognition. The resulting system achieved excellent accuracy in discriminating SVT and VT. PMID:8947674

  3. Safety and interaction of patients with implantable cardiac defibrillators driving a hybrid vehicle.

    PubMed

    Tondato, Fernando; Bazzell, Jane; Schwartz, Linda; Mc Donald, Bruce W; Fisher, Robert; Anderson, S Shawn; Galindo, Arcenio; Dueck, Amylou C; Scott, Luis R

    2017-01-15

    Electromagnetic interference (EMI) can affect the function of implantable cardioverter defibrillators (ICD). Hybrid electric vehicles (HEV) have increased popularity and are a potential source of EMI. Little is known about the in vivo effects of EMI generated by HEV on ICD. This study evaluated the in vivo interaction between EMI generated by HEV with ICD. Thirty patients (73±9 y/o; 80% male) with stable ICD function were exposed to EMI generated by a Toyota Prius Hybrid®. The vehicle was lifted above the ground, allowing safe changes in engine rotation and consequent variations in electromagnetic emission. EMI was measured (NARDA STS® model EHP-50C) and expressed in A/m (magnetic), Volts/m (electrical), and Hertz (frequency). Six positions were evaluated: driver, front passenger, right and left back seats, outside, at the back and front of the car. Each position was evaluated at idle, 30 mph, 60 mph and variable speeds (acceleration-deceleration-brake). All ICD devices were continuously monitored during the study. The levels of EMI generated were low (highest mean levels: 2.09A/m at right back seat at 30 mph; and 3.5V/m at driver seat at variable speeds). No episode of oversensing or inadvertent change in ICD programming was observed. It is safe for patients with ICD to interact with HEV. This is the first study to address this issue using an in vivo model. Further studies are necessary to evaluate the interaction of different models of HEV or electric engine with ICD or unipolar pacemakers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Electrical storms and their prognostic implications.

    PubMed

    Awan, Zahid Aslam; ul Hassan, Mahmood; Bangash, Kamran; Shah, Bakhtawar; Noor, Lubna

    2009-01-01

    Prevention of sudden cardiac death has always been a challenge for electrophysiologists and to date, automatic implantable cardiovertor defibrillator (AICD) is found to be the only remedy. This device delivers an intracardiac shock whenever it senses a fatal ventricular arrhythmia in order to achieve sinus rhythm. If the delivery of these intracardiac shocks becomes frequent, the situation is declared as an electrical storm. This article deals with the frequency, precipitating factors and prevention of electrical storms. One hundred and ten episodes of electrical storms (a total of 668 shocks) were retrospectively analysed in 25 recipients of automatic implantable cardioverter defibrillators. ECG, echocardiography, serum electrolytes, urea and creatinine were done for all the patients, and they were hospitalized for a minimum of 24 hours. During the 3 year study period, all the 25 patients with an implantable cardiovertor defibrillator, on an average, received one shock per two years. However, 12 out of these 25 patients (50%) had more than two shocks within 24 hours. Most of these patients with electrical storms were having active ischemia, electrolytes imbalances or renal failure. Electrical storms are common in patients with coronary artery disease with impaired left ventricular functions. Ischemia, electrolytes imbalances and renal failure predispose to the electrical storms. Electrical Storms are predictors of poor prognosis.

  5. Evaluation of acute cardiac and chest wall damage after shocks with a subcutaneous implantable cardioverter defibrillator in Swine.

    PubMed

    Killingsworth, Cheryl R; Melnick, Sharon B; Litovsky, Silvio H; Ideker, Raymond E; Walcott, Gregory P

    2013-10-01

    A subcutaneous implantable cardioverter defibrillator (S-ICD) could ease placement and reduce complications of transvenous ICDs, but requires more energy than transvenous ICDs. Therefore we assessed cardiac and chest wall damage caused by the maximum energy shocks delivered by both types of clinical devices. During sinus rhythm, anesthetized pigs (38 ± 6 kg) received an S-ICD (n = 4) and five 80-Joule (J) shocks, or a transvenous ICD (control, n = 4) and five 35-J shocks. An inactive S-ICD electrode was implanted into the same control pigs to study implant trauma. All animals survived 24 hours. Troponin I and creatine kinase muscle isoenzyme (CK-MM) were measured as indicators of myocardial and skeletal muscle injury. Histopathological injury of heart, lungs, and chest wall was assessed using semiquantitative scoring. Troponin I was significantly elevated at 4 hours and 24 hours (22.6 ± 16.3 ng/mL and 3.1 ± 1.3 ng/mL; baseline 0.07 ± 0.09 ng/mL) in control pigs but not in S-ICD pigs (0.12 ± 0.11 ng/mL and 0.13 ± 0.13 ng/mL; baseline 0.06 ± 0.03 ng/mL). CK-MM was significantly elevated in S-ICD pigs after shocks (6,544 ± 1,496 U/L and 9,705 ± 6,240 U/L; baseline 704 ± 398 U/L) but not in controls. Electrocardiogram changes occurred postshock in controls but not in S-ICD pigs. The myocardium and lungs were histologically normal in both groups. Subcutaneous injury was greater in S-ICD compared to controls. Although CK-MM suggested more skeletal muscle injury in S-ICD pigs, significant cardiac, lung, and chest wall histopathological changes were not detected in either group. Troponin I data indicate significantly less cardiac injury from 80-J S-ICD shocks than 35-J transvenous shocks. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

  6. Case report: use caution when applying magnets to pacemakers or defibrillators for surgery.

    PubMed

    Schulman, Peter M; Rozner, Marc A

    2013-08-01

    The application of a magnet to a pacemaker (intended to cause asynchronous pacing) or implanted cardioverter defibrillator (intended to prevent shocks) during surgery without a clear understanding of actual magnet function(s) or precautions can have unexpected, untoward, or harmful consequences. In this report, we present 3 cases in which inadequate assessment of cardiac implanted electronic device (CIED) function, coupled with magnet application, contributed to or resulted in inappropriate antitachycardia pacing or shocks, CIED damage, or patient injury. Although these cases might be rare, they reinforce the need for a timely, detailed preoperative review of CIED function and programming as recommended by the American Society of Anesthesiologists and the Heart Rhythm Society.

  7. Scar extent as a predictive factor of ventricular tachycardia cycle length after myocardial infarction: implications for implantable cardioverter-defibrillator programming optimization.

    PubMed

    Alexandre, Joachim; Saloux, Eric; Lebon, Alain; Dugué, Audrey Emmanuelle; Lemaitre, Adrien; Roule, Vincent; Labombarda, Fabien; Champ-Rigot, Laure; Gomes, Sophie; Pellissier, Arnaud; Scanu, Patrice; Milliez, Paul

    2014-02-01

    After an old myocardial infarction (MI), patients are at risk for reentrant ventricular tachycardia (VT) due to scar tissue that can be accurately identified by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR). Although the ability of LGE-CMR to predict sustained VT in implantable cardioverter-defibrillator (ICD) recipients has been well established, its use to predict monomorphic VT (sustained or not) cycle length (CL) and so, optimize ICD programming has never been investigated. We included retrospectively 49 consecutive patients with an old MI who had undergone LGE-CMR before ICD implantation over a 4-year period (2006-09). Patients with amiodarone used were excluded. Scar extent was assessed by measuring scar mass, percent scar, and transmural scar extent. The endpoint was the occurrence of monomorphic VT, requiring an ICD therapy or not. The endpoint occurred in 26 patients. The median follow-up duration was 31 months. Scar extent parameters were significantly correlated with the study endpoint. With univariate regression analysis, the scar mass had the highest correlation with the VT CL (R = 0.671, P = 0.0002). Receiver-operating characteristic curve showed that scar mass can predict VT CL (area under the curve = 0.977, P < 0.0001). For a cut-off value of scar mass at 17.6 g, there is 100% specificity and 94.4% sensitivity. In this observational and retrospective study, scar mass studied by LGE-CMR was specific and sensitive to predict VT CL and so could be a promising option to improve ICD post-implantation programming and decrease appropriate and inappropriate shocks. These conclusions must now be confirmed in a large and prospective study.

  8. Estimating the Risks and Benefits of Implantable Cardioverter Defibrillator Generator Replacement: A Systematic Review.

    PubMed

    Lewis, Krystina B; Stacey, Dawn; Carroll, Sandra L; Boland, Laura; Sikora, Lindsey; Birnie, David

    2016-07-01

    Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk versus benefit ratio may be against replacement. We aimed to synthesize the evidence on risks, benefits, and costs related to ICD replacement. A systematic review was conducted using electronic databases from 2000 onward. Literature screening, quality appraisal, and data extraction were independently conducted by two reviewers. Outcomes included major and minor complications, ICD therapies, and costs, which were synthesized descriptively. Of 1,483 citations, 17 nonrandomized studies met criteria. Median rate of major complications was 4.05% (range 0.55-7.37%) and minor complications was 3.50% (range 0.36-7.37%). Without non-ICD control groups, the true risk reduction provided by the ICD following replacement is unknown. Following ICD replacement, annualized rate of appropriate ICD therapy was 10.52% (range 2.42-75.00%). Of these, patients without therapies during their first generator life and those no longer meeting ICD criteria received appropriate therapies at nontrivial rates. Rates of complications associated with ICD replacement are substantial. No study had nonreplacement groups, hence the true risk reduction provided by the ICD following replacement is unknown. Our analysis did not identify a subgroup at low risk of therapies following replacement. Shared discussions should occur with patients about the evidence, healthcare goals, risk tolerances, and feelings about life and death trade-offs to enable high-quality decisions about ICD replacement. ©2016 Wiley Periodicals, Inc.

  9. Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

    PubMed

    Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

    2017-01-01

    Machine learning methods may complement traditional analytic methods for medical device surveillance. Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%-20.9%; nonfatal ICD-related adverse events, 19.3%-26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%-37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k =0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k =-0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k =-0.042). Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.

  10. Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter–defibrillators

    PubMed Central

    Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

    2017-01-01

    Background Machine learning methods may complement traditional analytic methods for medical device surveillance. Methods and results Using data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%–20.9%; nonfatal ICD-related adverse events, 19.3%–26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%–37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=−0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=−0.042). Conclusion Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance. PMID:28860874

  11. Association of Air Pollution with Increased Incidence of Ventricular Tachyarrhythmias Recorded by Implanted Cardioverter Defibrillators

    PubMed Central

    Dockery, Douglas W.; Luttmann-Gibson, Heike; Rich, David Q.; Link, Mark S.; Mittleman, Murray A.; Gold, Diane R.; Koutrakis, Petros; Schwartz, Joel D.; Verrier, Richard L.

    2005-01-01

    Epidemiologic studies have demonstrated a consistent link between sudden cardiac deaths and particulate air pollution. We used implanted cardioverter defibrillator (ICD) records of ventricular tachyarrhythmias to assess the role of air pollution as a trigger of these potentially life-threatening events. The study cohort consisted of 203 cardiac patients with ICD devices in the Boston metropolitan area who were followed for an average of 3.1 years between 1995 and 2002. Fine particle mass and gaseous air pollution plus temperature and relative humidity were measured on almost all days, and black carbon, sulfate, and particle number on a subset of days. Date, time, and intracardiac electrograms of ICD-detected arrhythmias were downloaded at the patients’ regular follow-up visits (about every 3 months). Ventricular tachyarrhythmias were identified by electrophysiologist review. Risk of ventricular arrhythmias associated with air pollution was estimated with logistic regression, adjusting for season, temperature, relative humidity, day of the week, patient, and a recent prior arrhythmia. We found increased risks of ventricular arrhythmias associated with 2-day mean exposure for all air pollutants considered, although these associations were not statistically significant. We found statistically significant associations between air pollution and ventricular arrhythmias for episodes within 3 days of a previous arrhythmia. The associations of ventricular tachyarrhythmias with fine particle mass, carbon monoxide, nitrogen dioxide, and black carbon suggest a link with motor vehicle pollutants. The associations with sulfate suggest a link with stationary fossil fuel combustion sources. PMID:15929887

  12. Effect of Sleep-Disordered Breathing on Appropriate Implantable Cardioverter-defibrillator Therapy in Patients With Heart Failure

    PubMed Central

    Kwon, Younghoon; Koene, Ryan J.; Kwon, Osung; Kealhofer, Jessica V.; Adabag, Selcuk; Duval, Sue

    2017-01-01

    Background Patients with heart failure and reduced ejection fraction are at increased risk of malignant ventricular arrhythmias. Implantable cardioverter-defibrillator (ICD) is recommended to prevent sudden cardiac death in some of these patients. Sleep-disordered breathing (SDB) is highly prevalent in this population and may impact arrhythmogenicity. We performed a systematic review and meta-analysis of prospective studies that assessed the impact of SDB on ICD therapy. Methods and Results Relevant prospective studies were identified in the Ovid MEDLINE, EMBASE, and Google Scholar databases. Weighted risk ratios of the association between SDB and appropriate ICD therapies were estimated using random effects meta-analysis. Nine prospective cohort studies (n=1274) were included in this analysis. SDB was present in 52% of the participants. SDB was associated with a 55% higher risk of appropriate ICD therapies (45% versus 28%; risk ratio, 1.55; 95% confidence interval, 1.32–1.83). In a subgroup analysis based on the subtypes of SDB, the risk was higher in both central (risk ratio, 1.50; 95% confidence interval, 1.11–2.02) and obstructive (risk ratio, 1.43; 95% confidence interval, 1.01–2.03) sleep apnea. Conclusions SDB is associated with an increased risk of appropriate ICD therapy in patients with heart failure and reduced ejection fraction. PMID:28213507

  13. Cardiac implantable electronic device infection due to Mycobacterium species: a case report and review of the literature.

    PubMed

    Al-Ghamdi, Bandar; Widaa, Hassan El; Shahid, Maie Al; Aladmawi, Mohammed; Alotaibi, Jawaher; Sanei, Aly Al; Halim, Magid

    2016-08-24

    Infection of cardiac implantable electronic devices is a serious cardiovascular disease and it is associated with a high mortality. Mycobacterium species may rarely cause cardiac implantable electronic devices infection. We are reporting a case of miliary tuberculosis in an Arab patient with dilated cardiomyopathy and a cardiac resynchronization therapy-defibrillator device that was complicated with infection of his cardiac resynchronization therapy-defibrillator device. To our knowledge, this is the third case in the literature with such a presentation and all patients died during the course of treatment. This underscores the importance of early diagnosis and management. We also performed a literature review of reported cases of cardiac implantable electronic devices infection related to Mycobacterium species. Cardiac implantable electronic devices infection due to Mycobacterium species is an uncommon but a well-known entity. Early diagnosis and prompt management may result in a better outcome.

  14. In-flight automated external defibrillator use and consultation patterns

    PubMed Central

    Brown, AM; Rittenberger, JC; Ammon, CM; Harrington, S; Guyette, FX

    2010-01-01

    Background Limited information exists about the in-flight use and outcomes associated with automatic external defibrillators (AED) on commercial airlines. Methods We collected self-reported cases of AED use to an airline consultation service from three US airlines between May 2004 and March 2009. We reviewed all available data files, related consult forms, and recordings. For each case, demographics, initial rhythm, shock delivery/success, survival to admission, and ground medical consultation use were obtained. Success was defined as the return of a perfusing rhythm. Initial rhythms were classified as: sinus, heart block, SVT, atrial fibrillation/flutter, asystole, PEA and VF/VT. Results There were a total of 169 AED applications with 40 cardiac arrests. The mean ages were 58 years (SD 15) and 63 years (SD 12) respectively; both populations were 64% male. AEDs were applied for monitoring in 129 (76%) cases with initial rhythms of: sinus 114 (88%); atrial fibrillation/flutter 7 (5%); complete heart block 4 (3%); and SVT 4 (3%). Presenting rhythms among the cardiac arrest population were: asystole 16 (40%); ventricular fibrillation/ventricular tachycardia 10 (25%); and PEA 14 (35%). Fourteen patients were defibrillated including nine of the 10 patients with initial VF/VT and five for the presence of VF/VT after resuscitation for initial PEA/asystole. Defibrillation was advised but not performed in the remaining case of initial VF/VT and no medical consult was obtained. All five successful defibrillations occurred in patients with initial VF/VT. There were 6 (15%; 95% CI 3–27%) survivors with 5 occurring after successful defibrillation for initial VF/VT and one with return of a perfusing rhythm after CPR for a junctional rhythm. Survival in those with VF/VT was 5/10 (50%; 95% CI 14–86%). Medications were delivered twice. The median time to first shock was 19 (IQR 12–24) seconds from AED application. Medical consultation was obtained in 56 (33%) of the 169 AED

  15. The clinical benefit of cardiac resynchronization therapy optimization using a device-based hemodynamic sensor in a patient with dilated cardiomyopathy: a case report.

    PubMed

    Volpicelli, Mario; Covino, Gregorio; Capogrosso, Paolo

    2015-12-19

    Results on the evolution of the clinical status of patients undergoing cardiac resynchronization therapy with a defibrillator after automatic optimization of their cardiac resynchronization therapy are scarce. We observed a rapid and important change in the clinical status of our non-responding patient following activation of a sensor capable of weekly atrioventricular and interventricular delays' optimization. A 78-year-old Caucasian man presented with dilated cardiomyopathy, left bundle branch block, a left ventricular ejection fraction of 35 %, New York Heart Association class III/IV heart failure, and paroxysmal atrial fibrillation. Our patient was implanted with a cardiac resynchronization device with a defibrillator and the SonRtip atrial lead. Right ventricular and left ventricular leads were also implanted. Because of the recurrence of atrial fibrillation, the automatic optimization was set off at discharge. Consequently, the device did not optimize atrioventricular and interventricular delays (programming at discharge: 125 ms for the atrioventricular delay and 0 ms for the interventriculardelay). Our patient was treated with an anti-arrhythmic drug. Five months after implantation, his clinical status remained impaired (left ventricular ejection fraction = 30 %). The SonR signal amplitude had also decreased from 0.52 g to 0.29 g. Nevertheless, because our patient was no longer presenting with atrial fibrillation, the anti-arrhythmic treatment was stopped and the SonR optimization system was activated. After 2 months of automatic cardiac resynchronization therapy with defibrillator optimization, our patient's clinical status had significantly improved (left ventricular ejection fraction = 60 %, New York Heart Association class II) and the SonR signal amplitude had doubled shortly after the first weekly automatic optimization. In this non-responding patient, device-based automatic cardiac resynchronization therapy optimization was shown to significantly

  16. Semiautomated external defibrillators for in-hospital early defibrillation: a comparative study.

    PubMed

    Nocchi, Federico; Derrico, Pietro; Masucci, Gerardina; Capussotto, Carlo; Cecchetti, Corrado; Ritrovato, Matteo

    2014-01-01

    Semiautomated external defibrillators (AEDs) should be considered as a means to facilitate in-hospital early defibrillation (IHED) in areas where advanced life support rescuers are not readily available. In this study, we aimed to develop a checklist and a measurement protocol to evaluate and compare AEDs by assessing factors that may affect IHED. A clinical and technical comparison of six AEDs was performed. Technical specifications were analyzed, while an emergency team evaluated ergonomics and appropriateness for IHED at Bambino Gesù Children's Hospital. A measurement protocol was implemented, which aimed to assess the ability of defibrillators to recognize shockable and nonshockable rhythms, accuracy of delivered energy, and charging time. Designs of AEDs differed in several features which influence their appropriateness for IHED. Some units showed poor ergonomics and instructions/feedback for cardiopulmonary resuscitation. Differences between defibrillators in recognizing shockable and nonshockable rhythms emerged for polymorphic ventricular tachycardia waveforms and when the frequency and amplitude of input signals varied. Tests for accuracy revealed poor performances at low and high impedance levels for most AEDs. Notably, differences greater than 20 seconds were found in the time from power-on to "ready for discharge." The approach we used to assess AEDs allowed us to evaluate their appropriateness with respect to the organizational context, to measure their parameters, and to compare models. Results showed that ergonomics and/or performances (timing and accuracy) could be improved in each device.

  17. Risk of Sprint Fidelis defibrillator lead failure is highly dependent on age.

    PubMed

    Girerd, Nicolas; Nonin, Emilie; Pinot, Julien; Morel, Elodie; Flys, Carine; Scridon, Alina; Chevalier, Philippe

    2011-01-01

    In 2007, Medtronic Sprint Fidelis defibrillator leads were taken off the market due to a high rate of lead failure. Current data do not allow for risk stratification of patients with regard to lead failure. We sought to determine predictors of Sprint Fidelis lead failure. Between 2004 and 2007, 269 Sprint Fidelis leads were implanted in 258 patients in our centre. Variables associated with lead failure were assessed by the Kaplan-Meier method and a Cox survival model. During a median follow-up of 2.80 years (maximum 5.32), we observed 33 (12.3%) Sprint Fidelis lead failures (5-year survival, 65.6% ± 7.5%). In univariate analysis, age was the only predictor of lead failure (hazard ratio [HR] for 1-year increase 0.97; 95% confidence interval [CI] 0.95-0.99; p=0.009). Patients aged<62.5 years (median) had a significantly increased risk of lead failure compared with patients aged>62.5 years (HR 2.80; CI 1.30-6.02; p=0.009). Survival without Sprint Fidelis lead failure was 55.6% ± 10.4%) in patients aged<62.5 years (24/134 leads) vs 78.6% ± 8.8% in patients aged>62.5 years (9/135 leads). The annual incidence of lead failure in patients aged<62.5 years was 11.6% ± 4.9% during the fourth year after implantation and 22.9% ± 13.2% during the fifth year. Overall, we found a higher rate of Sprint Fidelis lead dysfunction than previously described. Lead failure was much more frequent in younger patients. Our results emphasize the need for close follow-up of younger patients with Sprint Fidelis leads and suggest that, in these patients, the implantation of a new implantable cardioverter defibrillator lead at the time of generator replacement might be reasonable. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  18. Public knowledge of automatic external defibrillators in a large U.S. urban community.

    PubMed

    Gonzalez, Mariana; Leary, Marion; Blewer, Audrey L; Cinousis, Marisa; Sheak, Kelsey; Ward, Michael; Merchant, Raina M; Becker, Lance B; Abella, Benjamin S

    2015-07-01

    Sudden cardiac arrest (SCA) strikes over 40,000 people in the public environment annually in the U.S., but despite evidence-based interventions such as prompt CPR and defibrillation, less than 25% of patients survive public SCA events. Effective use of automated external defibrillators (AEDs), especially by lay bystanders, represents an important strategy to improve survival rates. Previous investigations in Europe and Asia have demonstrated variable public awareness of AEDs; layperson knowledge of AEDs in the U.S. is poorly characterized. To measure understanding of AEDs among the general public, at multiple sites within a busy urban transportation system. Surveys were administered at two high-volume train stations in Philadelphia, Pennsylvania between April and June, 2013. A total of 514 surveys were completed. Two thirds (66%) of respondents were able to correctly identify an AED and its purpose, and just over half (58%) of respondents reported willingness to use an AED in an emergency situation. Less than 10% of respondents presented with a hypothetical SCA scenario spontaneously mentioned using an AED when asked what actions they would take. In this cross-sectional survey, public knowledge about AEDs and their use was high; however, a smaller number of respondents expressed thoughts of using the device in an emergency situation and demonstrated willingness to serve as a responder. Increased education and training efforts, as well as potential interventions such as 911 dispatcher-assisted AED use may help improve bystander response in SCA events. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Comparison of five different defibrillators using recommended energy protocols.

    PubMed

    Zelinka, M; Buić, D; Zelinka, I

    2007-09-01

    Biphasic defibrillators represent a great step ahead in defibrillation. The manufacturers claim that biphasic defibrillators are able to compensate for differences in transthoracic impedance. That should mean that all patients should be defibrillated with approximately the same amount of current, regardless of their transthoracic impedance. We assessed one monophasic and four biphasic defibrillators. The defibrillators were discharged into resistive loads of 50, 90 and 130 Omega, simulating transthoracic impedance. For each waveform we used energy protocols recommended by the manufacturers and guidelines 2005. Waveforms were observed with on a digitising oscilloscope on a current sensing resistor. We compared the electrical properties of different waveforms and two defibrillators with the same type of waveform. The influence of different impedance on shape, duration and amplitude of current flow were also observed for each waveform. Measurements showed a significant difference in current flow at different impedance loads. At low impedance the mean current is well above expectations for all the defibrillators studied and at high impedance load we observed a big reduction of current amplitude. We can conclude that the compensating mechanisms of biphasic defibrillators are, from electrical point of view, negligible. From the laws of physics it is practically impossible to keep same level of current at given time with same energy at higher impedance. That is why we should reconsider the use of different energy equivalents between patients with different transthoracic impedance and not between different defibrillation impulses.

  20. Implant healing in experimental animal models of diabetes.

    PubMed

    Le, Nga N; Rose, Michael B; Levinson, Howard; Klitzman, Bruce

    2011-05-01

    Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that

  1. Implant Healing in Experimental Animal Models of Diabetes

    PubMed Central

    Le, Nga N; Rose, Michael B; Levinson, Howard; Klitzman, Bruce

    2011-01-01

    Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that

  2. Utilization Rates of Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death: A 2012 Calculation for a Midwestern Health Referral Region

    PubMed Central

    Hoang, Allen; Shen, Changyu; Zheng, James; Taylor, Stanley; Groh, William J; Rosenman, Marc; Buxton, Alfred E.; Chen, Peng-Sheng

    2014-01-01

    Background Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. Objective To establish the ICD UR in central Indiana. Methods A query run on two hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD-eligibility and utilization were determined from chart review. Results We identified 1,863 patients with at least one low-EF study. Two cohorts were analyzed: 1,672 patients without, and 191 patients with, ICD-9-CM procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% CI 28–49%). URs were 48% for males (95% CI 34–61%), 21% for females (95% CI 16–26%, p=0.0002 vs males), 40% for whites (95% CI 27–53%), and 37% for blacks (95% CI 28–46%, p=0.66 vs whites). Conclusions The ICD UR is 38% among patients meeting Class I indications, suggesting further opportunities to improve guideline compliance. Furthermore, this study illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. PMID:24566233

  3. Impact of city police layperson education and equipment with automatic external defibrillators on patient outcome after out of hospital cardiac arrest.

    PubMed

    Stein, Philipp; Spahn, Gabriela H; Müller, Stefan; Zollinger, Andreas; Baulig, Werner; Brüesch, Martin; Seifert, Burkhardt; Spahn, Donat R

    2017-09-01

    Out of hospital cardiac arrest (OHCA) occurs frequently and the outcome is often dismal. Early defibrillation saves lives and brain function in OHCA. The Zurich city police (STAPO) forces were instructed and equipped to provide basic life support (BLS) and to use an AED in 2009. Retrospective observational study comparing period 1 (P1) 2004-2009 before equipping and training of the STAPO and period 2 (P2) 2010-2015 after the implementation. Patients suffering from OHCA of cardiac or presumed cardiac origin in the city of Zurich undergoing CPR by EMS in P1 (n=709) and P2 (n=684) were included. Intervention periods and outcome were compared between the periods. Outcome variables were adjusted for patient age and gender, witnessed status, and defibrillation by the EMS, STAPO, layperson or no defibrillation. In P2, CPR was started by the STAPO in a median of 8 (IQR 6-9) minutes after the arrest and thus significantly earlier (median 3min) than by the EMS (p<0.001). STAPO performed the first defibrillation in a median of 9 (IQR 8-10) minutes and thus significantly earlier (median 6min) than the EMS (p<0.001). Outcome improved significantly in P2: proportion of patients with return of spontaneous circulation (ROSC, P2 35.8%, P1 24.0%, OR 1.8, 95% CI 1.4-2.2, p<0.001), hospital admission (P2 32.2%, P1 21.4%, OR 1.7, 95% CI 1.4-2.2, p<0.001) and survival to hospital discharge (P2 13.6%, P1 6.9%, OR 2.1 95% CI 1.5-3.0, p<0.001). If the patient was firstly defibrillated by the STAPO, ROSC (STAPO 74.4%, adj. OR 2.6, 95% CI 1.3-5.4, p=0.010) and hospital admission (STAPO 72.1%, adj. OR 2.8, 95% CI 1.4-5.6, p=0.005) was higher compared to patients firstly defibrillated by the EMS. Survival to hospital discharge (STAPO 30.2%, adj. OR 1.4, 95% CI 0.7-2.9, p=0.38) was unchanged. Dispatching BLS trained and AED equipped police forces results in earlier and more successful resuscitation of OHCA victims, leading to higher proportions of patients with ROSC, hospital admission and

  4. Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter-Defibrillators.

    PubMed

    Doppalapudi, Harish; Barrios, James; Cuellar, Jose; Gannon, Melanie; Yamada, Takumi; Kumar, Vineet; Maddox, William R; Plumb, Vance J; Brown, Todd M; McElderry, H Tom

    2017-05-01

    Real-time estimated longevity has been reported in pacemakers for several years, and was recently introduced in implantable cardioverter-defibrillators (ICDs). We sought to evaluate the accuracy of this longevity estimate in St. Jude Medical (SJM) ICDs, especially as the device battery approaches depletion. Among patients with SJM ICDs who underwent generator replacements due to reaching elective replacement indicator (ERI) at our institution, we identified those with devices that provided longevity estimates and reviewed their device interrogations in the 18 months prior to ERI. Significant discrepancy was defined as a difference of more than 12 months between estimated and actual longevity at any point during this period. Forty-six patients with Current/Promote devices formed the study group (40 cardiac resynchronization therapy [CRT] and 6 single/dual chamber). Of these, 34 (74%) had significant discrepancy between estimated and actual longevity (28 CRT and all single/dual). Longevity was significantly overestimated by the device algorithm (mean maximum discrepancy of 18.8 months), more in single/dual than CRT devices (30.5 vs. 17.1 months). Marked discrepancy was seen at voltages ≥2.57 volts, with maximum discrepancy at 2.57 volts (23 months). The overall longevity was higher in the discrepant group of CRT devices than in the nondiscrepant group (67 vs. 61 months, log-rank P = 0.03). There was significant overestimation of longevity in nearly three-fourths of Current/Promote SJM ICDs in the last 18 months prior to ERI. Longevity estimates of SJM ICDs may not be reliable for making clinical decisions on frequency of follow-up, as the battery approaches depletion. © 2017 Wiley Periodicals, Inc.

  5. Critical analysis of dual-chamber implantable cardioverter-defibrillator arrhythmia detection : results and technical considerations.

    PubMed

    Wilkoff, B L; Kühlkamp, V; Volosin, K; Ellenbogen, K; Waldecker, B; Kacet, S; Gillberg, J M; DeSouza, C M

    2001-01-23

    One of the perceived benefits of dual-chamber implantable cardioverter-defibrillators (ICDs) is the reduction in inappropriate therapy due to new detection algorithms. It was the purpose of the present investigation to propose methods to minimize bias during such comparisons and to report the arrhythmia detection clinical results of the PR Logic dual-chamber detection algorithm in the GEM DR ICD in the context of these methods. Between November 1997 and October 1998, 933 patients received the GEM DR ICD in this prospective multicenter study. A total of 4856 sustained arrhythmia episodes (n=311) with stored electrogram and marker channel were classified by the investigators; 3488 episodes (n=232) were ventricular tachycardia (VT)/ventricular fibrillation (VF), and 1368 episodes (n=149) were supraventricular tachycardia (SVT). The overall detection results were corrected for multiple episodes within a patient with the generalized estimating equations (GEE) method with an exchangeable correlation structure between episodes. The relative sensitivity for detection of sustained VT and/or VF was 100.0% (3488 of 3488, n=232; 95% CI 98.3% to 100%), the VT/VF positive predictivity was 88.4% uncorrected (3488 of 3945, n=278) and 78.1% corrected (95% CI 73.3% to 82.3%) with the GEE method, and the SVT positive predictivity was 100.0% (911 of 911, n=101; 95% CI 96% to 100%). A structured approach to analysis limits the bias inherent in the evaluation of tachycardia discrimination algorithms through the use of relative VT/VF sensitivity, VT/VF positive predictivity, and SVT positive predictivity along with corrections for multiple tachycardia episodes in a single patient.

  6. Is optimal paddle force applied during paediatric external defibrillation?

    PubMed

    Bennetts, Sarah H; Deakin, Charles D; Petley, Graham W; Clewlow, Frank

    2004-01-01

    Optimal paddle force minimises transthoracic impedance; a factor associated with increased defibrillation success. Optimal force for the defibrillation of children < or =10 kg using paediatric paddles has previously been shown to be 2.9 kgf, and for children >10 kg using adult paddles is 5.1 kgf. We compared defibrillation paddle force applied during simulated paediatric defibrillation with these optimal values. 72 medical and nursing staff who would be expected to perform paediatric defibrillation were recruited from a University teaching hospital. Participants, blinded to the nature of the study, were asked to simulate defibrillation of an infant manikin (9 months of age) and a child manikin (6 years of age) using paediatric or adult paddles, respectively, according to guidelines. Paddle force (kgf) was measured at the time of simulated shock and compared with known optimal values. Median paddle force applied to the infant manikin was 2.8 kgf (max 9.6, min 0.6), with only 47% operators attaining optimal force. Median paddle force applied to the child manikin was 3.8 kgf (max 10.2, min 1.0), with only 24% of operators attaining optimal force. Defibrillation paddle force applied during paediatric defibrillation often falls below optimal values.

  7. Relationship between right and left ventricular function in candidates for implantable cardioverter defibrillator with low left ventricular ejection fraction.

    PubMed

    Jimenez-Juan, Laura; Karur, Gauri R; Connelly, Kim A; Deva, Djeven; Yan, Raymond T; Wald, Rachel M; Singh, Sheldon; Leung, General; Oikonomou, Anastasia; Dorian, Paul; Angaran, Paul; Yan, Andrew T

    2017-04-01

    Indications for the primary prevention of sudden death using an implantable cardioverter defibrillator (ICD) are based predominantly on left ventricular ejection fraction (LVEF). However, right ventricular ejection fraction (RVEF) is also a known prognostic factor in a variety of structural heart diseases that predispose to sudden cardiac death. We sought to investigate the relationship between right and left ventricular parameters (function and volume) measured by cardiovascular magnetic resonance (CMR) among a broad spectrum of patients considered for an ICD. In this retrospective, single tertiary-care center study, consecutive patients considered for ICD implantation who were referred for LVEF assessment by CMR were included. Right and left ventricular function and volumes were measured. In total, 102 patients (age 62±14 years; 23% women) had a mean LVEF of 28±11% and RVEF of 44±12%. The left ventricular and right ventricular end diastolic volume index was 140±42 mL/m 2 and 81±27 mL/m 2 , respectively. Eighty-six (84%) patients had a LVEF <35%, and 63 (62%) patients had right ventricular systolic dysfunction. Although there was a significant and moderate correlation between LVEF and RVEF ( r =0.40, p <0.001), 32 of 86 patients (37%) with LVEF <35% had preserved RVEF, while 9 of 16 patients (56%) with LVEF ≥35% had right ventricular systolic dysfunction (Kappa=0.041). Among patients being considered for an ICD, there is a positive but moderate correlation between LVEF and RVEF. A considerable proportion of patients who qualify for an ICD based on low LVEF have preserved RVEF, and vice versa.

  8. Implantable cardiac defibrillators and sudden death in recent onset nonischemic cardiomyopathy: results from IMAC2.

    PubMed

    Sheppard, Richard; Mather, Paul J; Alexis, Jeffrey D; Starling, Randall C; Boehmer, John P; Thohan, Vinay; Pauly, Daniel F; Markham, David W; Zucker, Mark; Kip, Kevin E; McNamara, Dennis M

    2012-09-01

    Given the potential for recovery in recent onset nonischemic cardiomyopathy (ROCM), the timing and need for implantable cardioverter-defibrillator (ICDs) remains controversial. We examined the utilization of ICDs and the impact on survival for subjects with ROCM. An National Heart, Lung, and Blood Institute sponsored registry enrolled 373 subjects with ROCM, all with a left ventricular ejection fraction (LVEF) ≤0.40 and ≤6 months of symptoms. The mean age was 45 ± 14 years, 38% were female, 21% black, 75% New York Heart Association II/III, and the mean LVEF was 0.24 ± 0.08. Survival was comparable for subjects with an ICD within 1 month of entry (n = 43, 1/2/3 year % survival = 97/97/92) and those with no ICD at 1 month (n = 330, % survival = 98/97/95, P = .30) and between those with and without an ICD at 6 months (ICD, n = 73, 1/2/3 year % survival = 98/98/95; no ICD, n = 300, % survival = 98/96/95, P = .95). There were only 6 sudden cardiac deaths (SCD) noted (% survival free from SCD = 99/98/97) and these occurred in 1.9% of subjects without ICD and 0.9% of those with a device (P = .50). In a multicenter cohort of ROCM the risk of SCD was low at 1% per year. Early ICD placement did not impact survival and can be deferred while assessing potential for myocardial recovery. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. Do physicians' attitudes toward implantable cardioverter defibrillator therapy vary by patient age, gender, or race?

    PubMed

    Al-Khatib, Sana M; Sanders, Gillian D; O'Brien, Sean M; Matlock, Daniel; Zimmer, Louise O; Masoudi, Frederick A; Peterson, Eric

    2011-01-01

    Implantable cardioverter defibrillator (ICD) therapy improves survival of patients with systolic heart failure. We assessed whether physicians' recommendation for ICD therapy varies as a function of patient age, gender, race, and physician's specialty. We surveyed a random sample (n = 9969) of U.S. physicians who are active members of the American College of Cardiology (ACC). We asked participants about their likelihood to recommend ICD therapy in 4 clinical scenarios that randomly varied patient age, gender, race, and ICD indication (guideline Class I, Class IIa, Class III, and Class I in a noncompliant patient). Responses were received from 1210 physicians (response rate 12%), of whom 1127 met the study inclusion criteria. Responders and nonresponders had similar demographics. In responding to hypothetical clinical scenarios, physicians were less likely to recommend an ICD to older patients (≥80 vs 50 years) (P < 0.01) but were unaffected by gender or race for all class indications. Compared with non-electrophysiologists (EPs), EPs were significantly more likely to recommend an ICD for a Class I indication (92.4% vs 81.4%; P < 0.01), but they were not more likely to offer an ICD for a Class III indication (0.4% vs 0.6%; P = 0.95). Based on survey responses, physicians were equally willing to offer an ICD to men and women and to whites and blacks, but were less likely to offer an ICD to an older patient even when indicated by practice guidelines. Electrophysiologists (EPs) more often adhered to practice guideline recommendations on ICD therapy compared with non-EPs. ©2011, Wiley Periodicals, Inc.

  10. Use of Automated External Defibrillators

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gregory K Christensen

    In an effort to improve survival from cardiac arrest, the American Heart Association (AHA) has promoted the Chain of Survival concept, describing a sequence of prehospital steps that result in improved survival after sudden cardiac arrest. These interventions include immediate deployment of emergency medical services, prompt cardiopulmonary resuscitation, early defibrillation when indicated, and early initiation of advanced medical care. Early defibrillation has emerged as the most important intervention with survival decreasing by 10% with each minute of delay in defibrillation. Ventricular Fibrillation (VF) is a condition in which there is uncoordinated contraction of the heart cardiac muscle of the ventriclesmore » in the heart, making them tremble rather than contract properly. VF is a medical emergency and if the arrhythmia continues for more than a few seconds, blood circulation will cease, and death can occur in a matter of minutes. During VF, contractions of the heart are not synchronized, blood flow ceases, organs begin to fail from oxygen deprivation and within 10 minutes, death will occur. When VF occurs, the victim must be defibrillated in order to establish the heart’s normal rhythm. On average, the wait for an ambulance in populated areas of the United States is about 11 minutes. In view of these facts, the EFCOG Electrical Safety Task Group initiated this review to evaluate the potential value of deployment and use of automated external defibrillators (AEDs) for treatment of SCA victims. This evaluation indicates the long term survival benefit to victims of SCA is high if treated with CPR plus defibrillation within the first 3-5 minutes after collapse. According to the American Heart Association (AHA), survival rates as high as 74% are possible if treatment and defibrillation is performed in the first 3 minutes. In contrast survival rates are only 5% where no AED programs have been established to provide prompt CPR and defibrillation. ["CPR

  11. The challenges and possibilities of public access defibrillation.

    PubMed

    Ringh, M; Hollenberg, J; Palsgaard-Moeller, T; Svensson, L; Rosenqvist, M; Lippert, F K; Wissenberg, M; Malta Hansen, C; Claesson, A; Viereck, S; Zijlstra, J A; Koster, R W; Herlitz, J; Blom, M T; Kramer-Johansen, J; Tan, H L; Beesems, S G; Hulleman, M; Olasveengen, T M; Folke, F

    2018-03-01

    Out-of-hospital cardiac arrest (OHCA) is a major health problem that affects approximately four hundred and thousand patients annually in the United States alone. It is a major challenge for the emergency medical system as decreased survival rates are directly proportional to the time delay from collapse to defibrillation. Historically, defibrillation has only been performed by physicians and in-hospital. With the development of automated external defibrillators (AEDs), rapid defibrillation by nonmedical professionals and subsequently by trained or untrained lay bystanders has become possible. Much hope has been put to the concept of Public Access Defibrillation with a massive dissemination of public available AEDs throughout most Western countries. Accordingly, current guidelines recommend that AEDs should be deployed in places with a high likelihood of OHCA. Despite these efforts, AED use is in most settings anecdotal with little effect on overall OHCA survival. The major reasons for low use of public AEDs are that most OHCAs take place outside high incidence sites of cardiac arrest and that most OHCAs take place in residential settings, currently defined as not suitable for Public Access Defibrillation. However, the use of new technology for identification and recruitment of lay bystanders and nearby AEDs to the scene of the cardiac arrest as well as new methods for strategic AED placement redefines and challenges the current concept and definitions of Public Access Defibrillation. Existing evidence of Public Access Defibrillation and knowledge gaps and future directions to improve outcomes for OHCA are discussed. In addition, a new definition of the different levels of Public Access Defibrillation is offered as well as new strategies for increasing AED use in the society. © 2018 The Association for the Publication of the Journal of Internal Medicine.

  12. Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients--results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study.

    PubMed

    Kolb, Christof; Solzbach, Ulrich; Biermann, Jürgen; Semmler, Verena; Kloppe, Axel; Klein, Norbert; Lennerz, Carsten; Szendey, Istvan; Andrikopoulos, George; Tzeis, Stylianos; Asbach, Stefan

    2014-07-01

    Detrimental effects of right ventricular (RV) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum. As safety data are scarce for implantable cardioverter defibrillator (ICD) recipients the study aims to evaluate ICD lead performance in the mid-septal position. A total of 299 ICD recipients (79% male, aged 65.2 ± 12.1 years, 83% primary prevention of sudden cardiac death) were randomized to receive the RV ICD electrode either in a mid-septal (n=145) or apical (n=154) location. Event-free survival was evaluated at 3 (primary endpoint) and 12 months (secondary endpoint). Events included a composite of lead revision, suboptimal right ventricular electrode performance (including defibrillation thresholds (DFT)>25 J) or lead position not in accordance with randomized location. Event-free survival at 3 (12) months was observed in 80.6% (72.3%) of patients randomized to a mid-septal and in 82.2% (72.1%) of patients randomized to an apical lead position, p=0.726 (p=0.969). Pre-defined margins for non-inferiority were not reached at 3 or 12 months. High DFT was found in 7 patients (5.0%) of the mid-septal and in 3 (2.2%) patients of the apical group (p=0.209). In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision, suboptimal right ventricular electrode performance or non-randomized lead position. Non-inferiority of the mid-septal lead location cannot be concluded. This should be taken into consideration when a mid-septal lead position is pursued. ClinicalTrials.gov identifier NCT00745745. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment.

    PubMed

    Schwitter, Juerg; Gold, Michael R; Al Fagih, Ahmed; Lee, Sung; Peterson, Michael; Ciuffo, Allen; Zhang, Yan; Kristiansen, Nina; Kanal, Emanuel; Sommer, Torsten

    2016-05-01

    Recently, magnetic resonance (MR)-conditional implantable cardioverter defibrillator (ICD) systems have become available. However, associated cardiac MR image (MRI) quality is unknown. The goal was to evaluate the image quality performance of various cardiac MR sequences in a multicenter trial of patients implanted with an MR-conditional ICD system. The Evera-MRI trial enrolled 275 patients in 42 centers worldwide. There were 263 patients implanted with an Evera-MRI single- or dual-chamber ICD and randomized to controls (n=88) and MRI (n=175), 156 of whom underwent a protocol-required MRI (9-12 weeks post implant). Steady-state-free-precession (SSFP) and fast-gradient-echo (FGE) sequences were acquired in short-axis and horizontal long-axis orientations. Qualitative and quantitative assessment of image quality was performed by using a 7-point scale (grades 1-3: good quality, grades 6-7: nondiagnostic) and measuring ICD- and lead-related artifact size. Good to moderate image quality (grades 1-5) was obtained in 53% and 74% of SSFP and FGE acquisitions, respectively, covering the left ventricle, and in 69% and 84%, respectively, covering the right ventricle. Odds for better image quality were greater for right ventricle versus left ventricle (odds ratio, 1.8; 95% confidence interval, 1.5-2.2; P<0.0001) and greater for FGE versus SSFP (odds ratio, 3.5; 95% confidence interval, 2.5-4.8; P<0.0001). Compared with SSFP, ICD-related artifacts on FGE were smaller (141±65 versus 75±57 mm, respectively; P<0.0001). Lead artifacts were much smaller than ICD artifacts (P<0.0001). FGE yields good to moderate quality in 74% of left ventricle and 84% of right ventricle acquisitions and performs better than SSFP in patients with an MRI-conditional ICD system. In these patients, cardiac MRI can offer diagnostic information in most cases. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02117414. © 2016 American Heart Association, Inc.

  14. Automated external defibrillators and simulated in-hospital cardiac arrests.

    PubMed

    Rossano, Joseph W; Jefferson, Larry S; Smith, E O'Brian; Ward, Mark A; Mott, Antonio R

    2009-05-01

    To test the hypothesis that pediatric residents would have shorter time to attempted defibrillation using automated external defibrillators (AEDs) compared with manual defibrillators (MDs). A prospective, randomized, controlled trial of AEDs versus MDs was performed. Pediatric residents responded to a simulated in-hospital ventricular fibrillation cardiac arrest and were randomized to using either an AED or MD. The primary end point was time to attempted defibrillation. Sixty residents, 21 (35%) interns, were randomized to 2 groups (AED = 30, MD = 30). Residents randomized to the AED group had a significantly shorter time to attempted defibrillation [median, 60 seconds (interquartile range, 53 to 71 seconds)] compared with those randomized to the MD group [median, 103 seconds (interquartile range, 68 to 288 seconds)] (P < .001). All residents in the AED group attempted defibrillation at <5 minutes compared with 23 (77%) in the MD group (P = .01). AEDs improve the time to attempted defibrillation by pediatric residents in simulated cardiac arrests. Further studies are needed to help determine the role of AEDs in pediatric in-hospital cardiac arrests.

  15. Should the implantable cardiac defibrillator be used for primary prevention of sudden death? A review of the issues relevant to hospital decision making.

    PubMed

    McGregor, Maurice; Chen, Jun

    2004-10-01

    New evidence suggests that the implantable cardiac defibrillator (ICD) may be effective for primary prevention of sudden death. High instrumental cost and the potentially large number of candidates will significantly impact hospital budgets. To review the information relevant to hospital policy decisions on the use of ICDs for primary prevention. Modelling based on an evaluation of reported studies and Canadian costs, detailed in a comprehensive review available at . Health outcomes: Two high-quality primary prevention trials suggest a reduction in annual mortality of 2.9% with bounds of probability (PB) of 2.0% to 3.8%, in early years. To undertake 100 implants per year may result in an increasing annual saving of life-years of acceptable quality, stabilizing by 15 years at 110 (PB 72 to 154) each year. Economic impact: The annual costs would stabilize at 15 years at approximately 4.3 million dollars. Cost-effectiveness: The incremental cost-effectiveness from the point of view of the health care system would be approximately 47,000 dollars (PB 35,000 dollars to 70,000 dollars), discounted at 3%. Ethical and legal issues: The decision should not be individual but institutional, using a process that is transparent, consistent and fair. The ICD can prolong life, with acceptable quality. Restriction of its use would be solely on grounds of expense.

  16. Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification

    PubMed Central

    2013-01-01

    Background The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Methods Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125–134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. Results For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Conclusion Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to

  17. Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification.

    PubMed

    Seidman, Seth J; Guag, Joshua W

    2013-07-11

    The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125-134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior

  18. Changes in transthoracic impedance during sequential biphasic defibrillation.

    PubMed

    Deakin, Charles D; Ambler, Jonathan J S; Shaw, Steven

    2008-08-01

    Sequential monophasic defibrillation reduces transthoracic impedance (TTI) and progressively increases current flow for any given energy level. The effect of sequential biphasic shocks on TTI is unknown. We therefore studied patients undergoing elective cardioversion using a biphasic waveform to establish whether this is a phenomenon seen in the clinical setting. Adults undergoing elective DC cardioversion for atrial flutter or fibrillation received sequential transthoracic shocks using an escalating protocol (70J, 100J, 150J, 200J, and 300J) with a truncated exponential biphasic waveform. TTI was calculated through the defibrillator circuit and recorded electronically. Successful cardioversion terminated further defibrillation shocks. A total of 58 patients underwent elective cardioversion. Cardioversion was successful in 93.1% patients. First shock TTI was 92.2 [52.0-126.0]Omega (n=58) and decreased significantly with each sequential shock. Mean TTI in patients receiving five shocks (n=5) was 85.0Omega. Sequential biphasic defibrillation decreases TTI in a similar manner to that seen with monophasic waveforms. The effect is likely during defibrillation during cardiac arrest by the quick succession in which shocks are delivered and the lack of cutaneous blood flow which limits the inflammatory response. The ability of biphasic defibrillators to adjust their waveform according to TTI is likely to minimise any effect of these findings on defibrillation efficacy.

  19. Utilization rates of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death: a 2012 calculation for a midwestern health referral region.

    PubMed

    Hoang, Allen; Shen, Changyu; Zheng, James; Taylor, Stanley; Groh, William J; Rosenman, Marc; Buxton, Alfred E; Chen, Peng-Sheng

    2014-05-01

    Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. The purpose of this study was to establish the ICD UR in central Indiana. A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) ≤0.35. ICD eligibility and utilization were determined from chart review. We identified 1863 patients with at least 1 low EF study. Two cohorts were analyzed: 1672 patients without and 191 patients with International Classification of Diseases, Ninth Revision, Clinical Modification procedure code 37.94 for ICD placement. We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16%) had no ICD but had class I indications for ICD. Eight of 300 (2.7%) actually had ICD implantation for PPSCD. Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38% overall (95% confidence interval [CI] 28%-49%). URs were 48% for males (95% CI 34%-61%), 21% for females (95% CI 16%-26%, P = .0002 vs males), 40% for whites (95% CI 27%-53%), and 37% for blacks (95% CI 28%-46%, P = .66 vs whites). ICD UR is 38% among patients meeting class I indications, suggesting further opportunities for improving guideline compliance. This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  20. Double simultaneous defibrillators for refractory ventricular fibrillation.

    PubMed

    Leacock, Benjamin W

    2014-04-01

    Out-of-hospital cardiac arrest is a leading cause of death in the United States. Ventricular fibrillation (VF) is the most common initial rhythm after cardiac arrest. To describe a novel approach to the patient with intractable VF after cardiac arrest. A 51-year old man presented in cardiac arrest after a ST-elevation myocardial infarction. He remained in VF despite receiving typical therapy including cardiopulmonary resuscitation, amiodarone, lidocaine, epinephrine, and five attempts at defibrillation with 200 J using a biphasic defibrillator. VF was eventually terminated with 400 J by the simultaneous use of two biphasic defibrillators. The patient had a full recovery. We present a case and supportive literature for a novel treatment of high-energy defibrillation in a patient with refractory VF. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Wide variation in cardiopulmonary resuscitation interruption intervals among commercially available automated external defibrillators may affect survival despite high defibrillation efficacy.

    PubMed

    Snyder, David; Morgan, Carl

    2004-09-01

    Recent studies have associated interruptions of cardiopulmonary resuscitation imposed by automated external defibrillators (AEDs) with poor resuscitation outcome. In particular, the "hands-off" interval between precordial compressions and subsequent defibrillation shock has been implicated. We sought to determine the range of variation among current-generation AEDs with respect to this characteristic. Seven AEDs from six manufacturers were characterized via stopwatch and arrhythmia simulator with respect to the imposed hands-off interval. All AEDs were equipped with new batteries, and measurements were repeated five times for each AED. A wide variation in the hands-off interval between precordial compressions and shock delivery was observed, ranging from 5.2 to 28.4 secs, with only one AED achieving an interruption of <10 secs. Laboratory and clinical data suggest that this range of variation could be responsible for a more than two-fold variation in patient resuscitation success, an effect that far exceeds any defibrillation efficacy differences that may hypothetically exist. In addition to defibrillation waveform and dose, researchers should consider the hands-off cardiopulmonary resuscitation interruption interval between cardiopulmonary resuscitation and subsequent defibrillation shock to be an important covariate of outcome in resuscitation studies. Defibrillator design should minimize this interval to avoid potential adverse consequences on patient survival.

  2. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up?

    PubMed

    Brugada, P

    2006-01-01

    Due to the increasing number of patients with an implantable cardioverter defibrillator (ICD), new options for ICD patient follow-up management are required. Patients with ICD indication according to the guidelines received an ICD with Home Monitoring technology. The devices enabled the transmission of the relevant episode, therapy, and system integrity data. Patients were followed for 12 months with routine controls every 3 months. The physician analyzed the Home Monitoring data before the routine follow-up visit (FU) and gave a forecast on the necessity of the pending FU, which was compared with the evaluation after the FU. Based on the derived forecast reliability, a patient management scheme was developed and its impact on patient safety was assessed retrospectively. A total of 271 patients were enrolled (40 f, mean age 62+/-12 years, mean LVEF 39+/-15%, 65% ischemic heart disease, 20% cardiomyopathy) and followed for 339+/-109 days. Of 908 pairs of Home Monitoring data and FU data evaluation, 129 there were false negative results for 92 patients. Safety concerns from false negative forecasts can be minimized with a patient management scheme containing the following elements: 1) never skip the first routine FU; 2) never skip a routine FU for a patient having already shown pacing threshold problems; 3) perform FU following hospitalizations; 4) perform FU following episode detection by the ICD; and 5) perform a routine FU if the patient reports symptoms. The retrospective analysis showed, that if the patients had been managed using this scheme, 503 of 1079 routine FU could have been skipped with only one safety concern, a three month delay in the detection of silent paroxysmal atrial fibrillation in one patient. Home Monitoring in ICD therapy over 12 months is feasible. The data transmitted relevantly contribute to a remarkable reduction of follow-up burden and enable the individualization of routine follow-up.

  3. Determinants and trajectory of phobic anxiety in patients living with an implantable cardioverter defibrillator.

    PubMed

    Cho, En-Young Nicole; von Känel, Roland; Marten-Mittag, Birgit; Ronel, Joram; Kolb, Christof; Baumert, Jens; Ladwig, Karl-Heinz

    2012-05-01

    The implantable cardioverter defibrillator (ICD) is the gold standard therapy to prevent life-threatening arrhythmias. Phobic anxiety predicts ventricular arrhythmia in coronary heart disease patients, but little is known about phobic anxiety in ICD patients. This study aimed to identify determinants and the course of phobic anxiety in ICD patients. 140 outpatients living with an ICD (mean age 56±14 years, 66% men). Phobic anxiety was assessed with the Symptom Checklist-90 Revised at a mean of 27±21 months (range 3-109) post-ICD placement (baseline) and after an average follow-up of 41±18 months (range 10-82). Multivariate linear regression models considered sociodemographic factors, clinical variables and psychological scales as potential determinants of phobic anxiety scores. ICD patients reported more than 10-fold higher levels of phobic anxiety than a previous representative population survey (2.6±3.4 vs 0.2±0.4). Greater age (p=0.003), previous shock experience (p=0.007), depressed mood (p<0.001) and hypochondriasis (p=0.005) were associated with higher phobic anxiety scores at baseline. Multimorbidity (p=0.030) and higher baseline phobic anxiety (p<0.001) determined greater phobic anxiety at follow-up. Younger age (p=0.029) and an elevated number of non-cardiac diseases (p=0.019) were both associated with an increase in phobic anxiety scores from baseline to follow-up. More patients had high phobic anxiety levels (score >4) at follow-up compared with baseline (31% vs 24%; p=0.048). Phobic anxiety was comparably high and persisted over time in ICD patients. Modifiable determinants of phobic anxiety were identified, which may inform tailored interventions to improve ICD patients' distress and perhaps also prognosis.

  4. The economic impact of battery longevity in implantable cardioverter-defibrillators for cardiac resynchronization therapy: the hospital and healthcare system perspectives.

    PubMed

    Landolina, Maurizio; Morani, Giovanni; Curnis, Antonio; Vado, Antonello; D'Onofrio, Antonio; Bianchi, Valter; Stabile, Giuseppe; Crosato, Martino; Petracci, Barbara; Ceriotti, Carlo; Bontempi, Luca; Morosato, Martina; Ballari, Gian Paolo; Gasparini, Maurizio

    2017-08-01

    Patients receiving cardiac resynchronization therapy defibrillators (CRT-Ds) are likely to undergo one or more device replacements, mainly for battery depletion. We assessed the economic impact of battery depletion on the overall cost of CRT-D treatment from the perspectives of the healthcare system and the hospital. We also compared devices of different generations and from different manufacturers in terms of therapy cost. We analysed data on 1792 CRT-Ds implanted in 1399 patients in 9 Italian centres. We calculated the replacement probability and the total therapy cost over 6 years, stratified by device generation and manufacturer. Public tariffs from diagnosis-related groups were used together with device prices and hospitalization costs. Generators were from 3 manufacturers: Boston Scientific (667, 37%), Medtronic (973, 54%), and St Jude Medical (152, 9%). The replacement probability at 6 years was 83 and 68% for earlier- and recent-generation devices, respectively. The need for replacement increased total therapy costs by more than 50% over the initial implantation cost for hospitals and by more than 30% for healthcare system. The improved longevity of recent-generation CRT-Ds reduced the therapy cost by ∼6% in both perspectives. Among recent-generation CRT-Ds, the replacement probability of devices from different manufacturers ranged from 12 to 70%. Consequently, the maximum difference in therapy cost between manufacturers was 40% for hospitals and 19% for the healthcare system. Differences in CRT-D longevity strongly affect the overall therapy cost. While the use of recent-generation devices has reduced the cost, significant differences exist among currently available systems. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  5. A miniature transformer/dc-dc converter for implantable medical devices

    NASA Astrophysics Data System (ADS)

    Mohammed, Osama A.; Jones, W. Kinzy

    1988-11-01

    This paper presents a new technique for the design of a miniature dc-dc converter used in energy producing implantable devices such as defibrillators and advanced pacemakers. This converter is inserted in such a device and is used to boost the voltage from a low voltage implanted battery to high voltage energy storage capacitors in a short period of time. The stored energy is then delivered, when needed, through an energy delivery circuit in order to stimulate or defibrillate the heart. The converter takes the form of a flyback topology which includes a miniature transformer and a specialized control circuit. The transformer was designed using a new numerical synthesis method which utilizes finite elements and dynamic programming for predicting the geometries of the transformer's magnetic circuit. The final transformer design satisfied the performance criteria and provided means for selecting the converter components. The obtained performance results for the transformer and the dc-dc converter were in excellent agreement with laboratory performance tests.

  6. Novel mechanism of premature battery failure due to lithium cluster formation in implantable cardioverter-defibrillators.

    PubMed

    Pokorney, Sean D; Greenfield, Ruth Ann; Atwater, Brett D; Daubert, James P; Piccini, Jonathan P

    2014-12-01

    Battery failure is an uncommon complication of implantable cardioverter-defibrillators (ICDs), but unanticipated battery depletion can have life-threatening consequences. The purpose of this study was to describe the prevalence of a novel mechanism of battery failure in St. Jude Medical Fortify and Unify ICDs. Cases of premature Fortify battery failure from a single center are reported. A search (January 1, 2010 through November 30, 2013) for Fortify and Unify premature batter failure was conducted of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database (MAUDE). These findings were supplemented with information provided by St. Jude Medical. Premature battery failure for 2 Fortify ICDs in our practice were attributed to the presence of lithium clusters near the cathode, causing a short circuit and high current drain. The prevalence of this mechanism of premature battery failure was 0.6% in our practice. A MAUDE search identified 39 cases of Fortify (30) and Unify (9) premature battery depletion confirmed by the manufacturer, representing a 0.03% prevalence. Four additional Fortify and 2 Unify cases were identified in MAUDE as suspected premature battery depletion, but in these cases the pulse generator was not returned to the manufacturer for evaluation. St. Jude Medical identified 10 cases of premature battery failure due to lithium clusters in Fortify devices (9) and Unify devices (1), representing a 0.004% prevalence. The deposition of lithium clusters near the cathode is a novel mechanism of premature battery failure. The prevalence of this problem is unknown. Providers should be aware of this mechanism for patient management. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  7. Work burden with remote monitoring of implantable cardioverter defibrillator: is it time for reimbursement policies?

    PubMed

    Papavasileiou, Lida P; Forleo, Giovanni B; Panattoni, Germana; Schirripa, Valentina; Minni, Valentina; Magliano, Giulia; Bellos, Kyriakos; Santini, Luca; Romeo, Francesco

    2013-02-01

    The efficacy and accuracy, as well as patients' satisfaction, of device remote monitoring are well demonstrated. However, the workload of remote monitoring management has not been estimated and reimbursement schemes are currently unavailable in most European countries. This study evaluates the workload associated with remote monitoring systems. A total of 154 consecutive implantable cardioverter defibrillator patients (age 66±12 years; 86.5% men) with a remote monitoring system were enrolled. Data on the clinician's workload required for the management of the patients were analyzed. A total of 1744 transmissions were received during a mean follow-up of 15.3±12.4 months. Median number of transmissions per patient was 11.3. There were 993 event-free transmissions, whereas 638 transmissions regarded one or more events (113 missed transmissions, 141 atrial events, 132 ventricular episodes, 299 heart failure-related transmissions, 14 transmissions regarding lead malfunction and 164 transmissions related to other events). In 402 cases telephonic contact was necessary, whereas in 68 cases an in-clinic visit was necessary and in 23 of them an in-clinic visit was prompted by the manufacturer due to technical issues of the transmitter. During follow-up, 316 work hours were required to manage the enrolled patients. Each month, a total of 14.9 h were spent on the remote monitoring of 154 patients (9.7 h for 100 patients monthly) with approximately 1.1±0.15 h per year for each patient. The clinician's work burden is high in patients with remote monitoring. In order to expand remote monitoring in all patients, reimbursement policies should be considered.

  8. Real-world geographic variations in the use of cardiac implantable electronic devices - The PANORAMA 2 observational cohort study.

    PubMed

    Bastian, Dirk; Ebrahim, Iftikhar O; Chen, Ju-Yi; Chen, Mien-Cheng; Huang, Dejia; Huang, Jin-Long; Kuznetsov, Vadim A; Maus, Bärbel; Naik, Ajay M; Verhees, Koen J P; Fagih, Ahmed R Al

    2018-06-13

    Currently, several geographies around the world remain underrepresented in medical device trials. The PANORAMA 2 study was designed to assess contemporary region-specific differences in clinical practice patterns of patients with cardiac implantable electronic devices (CIEDs). In this prospective, multicenter, observational, multi-national study, baseline and implant data of 4,706 patients receiving Medtronic CIEDs (either de novo device implants, replacements, or upgrades) were analyzed, consisting of: 54% implantable pulse generators (IPGs), 20.3% implantable cardiac defibrillators (ICDs), 15% cardiac resynchronization therapy defibrillators (CRT-Ds), 5.1% cardiac resynchronization therapy pacemakers (CRT-Ps), from 117 hospitals in 23 countries across 4 geographical regions between 2012 and 2016. For all device types, in all regions, there were less females than males enrolled, and women were less likely to have ischemic cardiomyopathy. Implant procedure duration differed significantly across the geographies for all device types. Subjects from emerging countries, women and older patients were less likely to receive a magnetic resonance imaging (MRI)-compatible device. Defibrillation testing differed significantly between the regions. European patients had the highest rates of atrial fibrillation (AF), and the lowest number of implanted single-chamber IPGs. Evaluation of stroke history suggested that the general embolic risk is more strongly associated with stroke than AF. We provide comprehensive descriptive data on patients receiving Medtronic CIEDs from several geographies, some of which are understudied in randomized controlled trials (RCTs). We found significant variations in patient characteristics. Several medical decisions appear to be affected by socioeconomic factors. Long-term follow-up data will help evaluate if these variations require adjustments to outcome expectations. This article is protected by copyright. All rights reserved. This article is

  9. Development and testing of an algorithm to detect implantable cardioverter-defibrillator lead failure.

    PubMed

    Gunderson, Bruce D; Gillberg, Jeffrey M; Wood, Mark A; Vijayaraman, Pugazhendhi; Shepard, Richard K; Ellenbogen, Kenneth A

    2006-02-01

    Implantable cardioverter-defibrillator (ICD) lead failures often present as inappropriate shock therapy. An algorithm that can reliably discriminate between ventricular tachyarrhythmias and noise due to lead failure may prevent patient discomfort and anxiety and avoid device-induced proarrhythmia by preventing inappropriate ICD shocks. The goal of this analysis was to test an ICD tachycardia detection algorithm that differentiates noise due to lead failure from ventricular tachyarrhythmias. We tested an algorithm that uses a measure of the ventricular intracardiac electrogram baseline to discriminate the sinus rhythm isoelectric line from the right ventricular coil-can (i.e., far-field) electrogram during oversensing of noise caused by a lead failure. The baseline measure was defined as the product of the sum (mV) and standard deviation (mV) of the voltage samples for a 188-ms window centered on each sensed electrogram. If the minimum baseline measure of the last 12 beats was <0.35 mV-mV, then the detected rhythm was considered noise due to a lead failure. The first ICD-detected episode of lead failure and inappropriate detection from 24 ICD patients with a pace/sense lead failure and all ventricular arrhythmias from 56 ICD patients without a lead failure were selected. The stored data were analyzed to determine the sensitivity and specificity of the algorithm to detect lead failures. The minimum baseline measure for the 24 lead failure episodes (0.28 +/- 0.34 mV-mV) was smaller than the 135 ventricular tachycardia (40.8 +/- 43.0 mV-mV, P <.0001) and 55 ventricular fibrillation episodes (19.1 +/- 22.8 mV-mV, P <.05). A minimum baseline <0.35 mV-mV threshold had a sensitivity of 83% (20/24) with a 100% (190/190) specificity. A baseline measure of the far-field electrogram had a high sensitivity and specificity to detect lead failure noise compared with ventricular tachycardia or fibrillation.

  10. Time until diagnosis of clinical events with different remote monitoring systems in Implantable Cardioverter-Defibrillator patients.

    PubMed

    Söth-Hansen, Malene; Witt, Christoffer Tobias; Rasmussen, Mathis; Kristensen, Jens; Gerdes, Christian; Nielsen, Jens Cosedis

    2018-05-24

    Remote monitoring (RM) is an established technology integrated into routine follow-up of patients with implantable cardioverter-defibrillator (ICD). Current RM systems differ according to transmission frequency and alert definition. We aimed to compare time difference between detection and acknowledgement of clinically relevant events between four RM systems. We analyzed time delay between detection of ventricular arrhythmic and technical events by the ICD and acknowledgement by hospital staff in 1.802 consecutive patients followed with RM during September 2014 - August 2016. Devices from Biotronik (BIO, n=374), Boston Scientific (BSC, n=196), Medtronic (MDT, n=468) and St Jude Medical (SJM, n=764) were included. We identified all events from RM webpages and their acknowledgement with RM or at in-clinic follow-up. Events occurring during weekends were excluded. We included 3.472 events. Proportion of events acknowledged within 24 hours was 72%, 23%, 18% and 65% with BIO, BSC, MDT and SJM, respectively, with median times of 13, 222, 163 and 18 hours from detection to acknowledgement (p<0.001 for both comparisons between manufacturers). Including only events transmitted as alerts by RM, 72%, 68%, 61% and 65% for BIO, BSC, MDT and SJM, respectively were acknowledged within 24 hours. Variation in time to acknowledgement of ventricular tachyarrhythmia episodes not treated with shock therapy was the primary cause for the difference between manufacturers. Significant and clinically relevant differences in time delay from event detection to acknowledgement exist between RM systems. Varying definitions of which events RM transmits as alerts are important for the differences observed. Copyright © 2018. Published by Elsevier Inc.

  11. Digoxin Is Associated With Increased Shock Events and Electrical Storms in Patients With Implantable Cardioverter Defibrillators.

    PubMed

    Mina, George S; Acharya, Madan; Shepherd, Taylor; Gobrial, George; Tekeste, Michael; Watti, Hussam; Bhandari, Ruchi; Saini, Aditya; Reddy, Pratap; Dominic, Paari

    2018-03-01

    Recently, digoxin use has been found to associate with higher mortality. Yet, potential mechanisms by which digoxin use increases mortality remain unclear. Increased arrhythmogenicity from digoxin use is one possibility. Thus, we aimed to evaluate the relation between digoxin and shock events in patients with implantable cardioverter defibrillators (ICDs). We performed a retrospective chart review of all patients with ICDs and at least 1 device interrogation at our institution between January 1, 2012, and January 1, 2015. We aimed to cover 1 year of interrogation period. Patients with heart failure, atrial fibrillation, or both were included in the analysis. Patients were divided into 2 groups based on digoxin use, defined as use of digoxin for any period of time during ICD interrogation period. Incidence of ICD shock events and electrical storms and hospitalizations were compared between the 2 groups. The study included 202 patients. Of those, 55 patients were on digoxin and 147 were not on digoxin. Patients on digoxin were more likely to receive ICD shocks (odds ratio [OR] = 2.5, 95% confidence interval [95% CI] = 1.01-6.18, P = .04) and have increased risk of electrical storms ( P = .02). Moreover, total hospitalizations were higher in digoxin users ( P = .02). Multivariate logistic regression analysis also showed that digoxin use was an independent predictor of shock events (OR = 4.07, 95% CI = 1.43-11.58, P = .009). Digoxin is associated with increased shock events and electrical storms in patients with ICDs; however, large randomized controlled studies are needed to confirm our findings.

  12. Safety of sports participation in patients with implantable cardioverter defibrillators: a survey of heart rhythm society members.

    PubMed

    Lampert, Rachel; Cannom, David; Olshansky, Brian

    2006-01-01

    Safety of Sports for ICD Patients. The safety of sports participation for patients with implantable cardioverter defibrillators (ICDs) is unknown, and recommendations among physicians may vary widely. The purposes of this study were to determine current practice among patients with ICDs and their physicians regarding sports participation, and to determine how many physicians have cared for patients who have sustained adverse events during sports participation. A survey was mailed to all 1,687 U.S. physician members of the Heart Rhythm Society. Among 614 respondent physicians, recommendations varied widely. Only 10% recommended avoidance of all sports more vigorous than golf. Seventy-six percent recommended avoidance of contact, and 45% recommend avoidance of competitive sports. Most (71%) based restrictions on patients' underlying heart disease. Regardless of recommendations, most physicians (71%) reported caring for patients who participated in sports, including many citing vigorous, competitive sports, most commonly cited were basketball, running, and skiing. ICD shocks during sports were common, cited by 40% of physicians. However, few adverse consequences were reported. One percent of physicians reported known injury to patient (all but 3 minor); 5%, injury to the ICD system, and <1%, failure of shocks to terminate arrhythmia. The most common adverse event reported was lead damage attributed to repetitive-motion activities, most commonly weightlifting and golf. Physician recommendations for sports participation for patients with ICDs varies widely. Many patients with ICDs do participate in vigorous and even competitive sports. While shocks were common, significant adverse events were rare.

  13. Computational studies of transthoracic and transvenous defibrillation in a detailed 3-D human thorax model.

    PubMed

    Jorgenson, D B; Haynor, D R; Bardy, G H; Kim, Y

    1995-02-01

    A method for constructing and solving detailed patient-specific 3-D finite element models of the human thorax is presented for use in defibrillation studies. The method utilizes the patient's own X-ray CT scan and a simplified meshing scheme to quickly and efficiently generate a model typically composed of approximately 400,000 elements. A parameter sensitivity study on one human thorax model to examine the effects of variation in assigned tissue resistivity values, level of anatomical detail included in the model, and number of CT slices used to produce the model is presented. Of the seven tissue types examined, the average left ventricular (LV) myocardial voltage gradient was most sensitive to the values of myocardial and blood resistivity. Incorrectly simplifying the model, for example modeling the heart as a homogeneous structure by ignoring the blood in the chambers, caused the average LV myocardial voltage gradient to increase by 12%. The sensitivity of the model to variations in electrode size and position was also examined. Small changes (< 2.0 cm) in electrode position caused average LV myocardial voltage gradient values to increase by up to 12%. We conclude that patient-specific 3-D finite element modeling of human thoracic electric fields is feasible and may reduce the empiric approach to insertion of implantable defibrillators and improve transthoracic defibrillation techniques.

  14. Very high rate programming in primary prevention patients with reduced ejection fraction implanted with a defibrillator: Results from a large multicenter controlled study.

    PubMed

    Clementy, Nicolas; Challal, Farid; Marijon, Eloi; Boveda, Serge; Defaye, Pascal; Leclercq, Christophe; Deharo, Jean-Claude; Sadoul, Nicolas; Klug, Didier; Piot, Olivier; Gras, Daniel; Bordachar, Pierre; Algalarrondo, Vincent; Fauchier, Laurent; Babuty, Dominique

    2017-02-01

    Programming implantable cardioverter-defibrillators (ICDs) with a high-rate therapy strategy has proven to be effective in reducing shocks and is associated with a reduced mortality. We sought to determine the impact of a very high rate cutoff programming strategy on outcomes in patients with a primary indication for an ICD due to reduced left ventricular ejection fraction. Using data from the multicenter French DAI-PP registry, this cohort-controlled study compared outcomes in 500 patients programmed with a very high rate cutoff (VH-RATE group: monitor zone 170-219 beats/min; ventricular fibrillation zone ≥220 beats/min with 13 ± 4 detection intervals) with 1500 matched control patients programmed with 1 or 2 therapy zone. All ICDs were implanted for primary prevention in patients with systolic dysfunction. Risks of events were compared after propensity score matching of sex, age, ejection fraction, New York Heart Association class, cardiomyopathy, atrial fibrillation, and type of device. After a mean follow-up of 3.6 ± 2.3 years, VH-RATE programming was associated with a reduction of appropriate therapy risk (hazard ratio [HR] 0.40; 95% confidence interval [CI] 0.31-0.51; P < .0001) and inappropriate shock (HR 0.42; 95% CI 0.27-0.63; P < .0001). It was also associated with a decreased risk of sudden cardiac death (HR 0.43; 95% CI 0.17-0.99; P = .04) as compared with patients programmed with 2 therapy zones. There was no significant difference in overall survival between the groups. In patients implanted with an ICD in primary prevention with left ventricular dysfunction, very high rate cutoff programming (single therapy zone ≥220 beats/min) was associated with a 60% reduction of appropriate therapies as well as inappropriate shocks, without affecting mortality. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  15. Survival After Rate-Responsive Programming in Patients With Cardiac Resynchronization Therapy-Defibrillator Implants Is Associated With a Novel Parameter: The Heart Rate Score.

    PubMed

    Olshansky, Brian; Richards, Mark; Sharma, Arjun; Wold, Nicholas; Jones, Paul; Perschbacher, David; Wilkoff, Bruce L

    2016-08-01

    Rate-responsive pacing (DDDR) versus nonrate-responsive pacing (DDD) has shown no survival benefit for patients undergoing cardiac resynchronization therapy defibrillator (CRT-D) implants. The heart rate score (HRSc), an indicator of heart rate variation, may predict survival. We hypothesized that high-risk HRSc CRT-D patients will have improved survival with DDDR versus DDD alone. All CRT-D patients in LATITUDE remote monitoring (2006-2011), programmed DDD, had HRSc calculated at first data upload after implant (median 1.4 months). Patients subsequently reprogrammed to DDDR 7.6 median months later were compared with a propensity-matched DDD group and followed for 21.4 median months by remote monitoring. Data were adjusted for age, sex, lower rate limit, percent atrial pacing, percent biventricular pacing, and implant year. The social security death index was used to identify deaths. Remote monitoring provided programming and histogram data. DDDR programming in CRT-D patients was associated with improved survival (adjusted hazard ratio =0.77; P<0.001). However, only those with baseline HRSc ≥70% (2308/6164) had improved HRSc with DDDR (from 88±9% to 78±15%; P<0.001) and improved survival (hazard ratio =0.74; P<0.001). Patients with a high baseline HRSc and significant improvement over time were more likely to survive (hazard ratio =0.63; P=0.006). For patients with HRSc <70%, DDDR reprogramming increased the HRSc from 46±11% to 50±15% (P<0.001); survival did not change. The HRSc did not change with DDD pacing over time. In CRT-D patients with HRSc ≥70%, DDDR reprogramming improved the HRSc and was associated with survival. Patients with lower HRSc had no change in survival with DDDR programming. © 2016 American Heart Association, Inc.

  16. Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study.

    PubMed

    Capucci, Alessandro; De Simone, Antonio; Luzi, Mario; Calvi, Valeria; Stabile, Giuseppe; D'Onofrio, Antonio; Maffei, Simone; Leoni, Loira; Morani, Giovanni; Sangiuolo, Raffaele; Amellone, Claudia; Checchinato, Catia; Ammendola, Ernesto; Buja, Gianfranco

    2017-09-01

    Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. http://clinicaltrials.gov/Identifier, NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

  17. Safety and Efficacy of Subcutaneous Cardioverter Defibrillator in Patients at High Risk of Sudden Cardiac Death - Primary Japanese Experience.

    PubMed

    Sasaki, Shingo; Tomita, Hirofumi; Tsurugi, Takuo; Ishida, Yuji; Shoji, Yoshihiro; Nishizaki, Kimitaka; Kinjo, Takahiko; Endo, Tomohide; Nishizaki, Fumie; Hanada, Kenji; Sasaki, Kenichi; Horiuchi, Daisuke; Kimura, Masaomi; Higuma, Takumi; Okamatsu, Hideharu; Tanaka, Yasuaki; Koyama, Junjiroh; Okumura, Ken

    2018-04-11

    The entirely subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced as a new alternative to conventional transvenous ICD (TV-ICD) in Japan in February 2016, but its safety and efficacy are unclear.Methods and Results:A total of 60 patients (48 men, median age, 60 years; IQR, 44-67 years; primary prevention, n=24) underwent S-ICD implantation between February 2016 and August 2017. The device pocket was formed in the intermuscular space between the serratus anterior muscle and the latissimus dorsi muscle, and the parasternal S-ICD lead was placed according to pre-implant screening. Defibrillation test was performed in 56 patients (93%). Ventricular fibrillation (VF) was induced in 55 patients and terminated by a single 65-J shock in all patients. The median time to shock therapy was 13.4 s (IQR, 12.1-14.9 s) and the median post-shock impedance of the S-ICD lead was 64 Ω (IQR, 58-77 Ω). There were no operation-related complications or subsequent infectious complications. During follow-up (median, 275 days; IQR, 107-421 days), 1 patient (1.7%) had appropriate shock for VF with successful termination, whereas 5 patients (8.3%) had inappropriate shock due to oversensing of myopotential (n=3) or T-wave (n=1), and detection of supraventricular tachycardia (n=1). S-ICD is a safe and effective alternative to conventional TV-ICD. The long-term safety and efficacy of the S-ICD need further investigation.

  18. Improved extraction of ePTFE and medical adhesive modified defibrillation leads from the coronary sinus and great cardiac vein.

    PubMed

    Wilkoff, Bruce L; Belott, Peter H; Love, Charles J; Scheiner, Avram; Westlund, Randy; Rippy, Marian; Krishnan, Mohan; Norlander, Barry E; Steinhaus, Bruce; Emmanuel, Janson; Zeller, Peter J

    2005-03-01

    Permanent leads with shocking coils for defibrillation therapy are sometimes implanted in the coronary sinus (CS) and great cardiac vein (GCV). These shocking coils, as documented by pathologic examination of animal investigations, often become tightly encapsulated by fibrosis and can be very difficult to remove. One of three configurations of the Guidant model 7109 Perimeter coronary sinus shocking lead was implanted into the distal portion of the GCV of 24 sheep for up to 14 months. Group 1 had unmodified coils (control), group 2 had coils backfilled with medical adhesive (MA), and Group 3 had coils coated with expanded polytetrafluoroethylene (ePTFE). Eighteen leads, three from each group at 6 and 14 months were transvenously extracted from the left jugular vein. The remaining six animals were not subject to extraction. All animals were euthanized for pathological and microscopic examination. All six of the control, three of the MA, and one of the ePTFE leads required the use of an electrosurgical dissection sheath (EDS) for extraction. Five control, two MA, and none of the ePTFE leads had significant fibrotic attachments to the shocking coils. Significant trauma was observed at necropsy for those leads requiring the use of the EDS for extraction. Tissue ingrowth is a major impediment to the removal of defibrillation leads implanted in the CS and GCV of sheep. Reduction of tissue ingrowth by coating the shocking coils with ePTFE or by backfilling with MA facilitates transvenous lead removal with reduced tissue trauma.

  19. Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era: results of the European Heart Rhythm Association survey.

    PubMed

    Haugaa, Kristina H; Tilz, Roland; Boveda, Serge; Dobreanu, Dan; Sciaraffia, Elena; Mansourati, Jacques; Papiashvili, Giorgi; Dagres, Nikolaos

    2017-04-01

    Implantable cardioverter-defibrillator (ICD) is the standard of care for prevention of sudden cardiac death (SCD) in high-risk patients. For primary prevention of SCD, in patients with ischaemic heart disease, there is more robust data on the effect of ICD therapy compared with patients with non-ischaemic heart disease, but current real-life practice may differ substantially. The aim of this European Heart Rhythm Association survey was to evaluate the clinical practice regarding implantation of ICD for primary prevention among European countries in patients with non-ischaemic and ischaemic heart disease. Furthermore, we wanted to investigate the impact of the results of the recently published DANISH trial on clinical practice among European countries. In total, 48 centres from 17 different countries responded to the questionnaire. The majority did not implant ICD for primary prevention on a regular basis in patients with non-ischaemic heart disease despite current guidelines. Also, centres have changed their indications after the recent report on the efficacy of ICD in these patients. In patients with ischaemic heart disease, the guidelines for primary prevention ICD were followed on a regular basis, and no relevant change in indications were reported. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  20. Atrial therapies reduce atrial arrhythmia burden in defibrillator patients.

    PubMed

    Friedman, P A; Dijkman, B; Warman, E N; Xia, H A; Mehra, R; Stanton, M S; Hammill, S C

    2001-08-28

    Approximately 25% of patients who receive an implantable cardioverter-defibrillator (ICD) to treat ventricular tachyarrhythmias have documented atrial tachyarrhythmias before implantation. This study assessed the ability of device-based prevention and termination therapies to reduce the burden of spontaneous atrial tachyarrhythmias. Patients with a standard indication for the implantation of an ICD and 2 episodes of atrial tachyarrhythmias in the preceding year received a dual-chamber ICD (Medtronic 7250 Jewel AF) that uses pacing and shock therapies for prevention and/or termination of atrial tachyarrhythmias. In a multicenter trial, patients were randomized to 3-month periods with atrial therapies "on" or "off" and subsequently crossed over. Analysis was performed on the 52 of 269 patients who had episodes of atrial tachyarrhythmia and had >/=30 days of follow-up with atrial therapies on and off. The atrial therapies resulted in a reduction of atrial tachyarrhythmia burden from a mean of 58.5 to 7.8 h/mo. A paired analysis (Wilcoxon signed-rank test) showed that the median difference in burden (1.1 h/mo) was highly significant (P=0.007). When the subgroup of 41 patients treated only with atrial pacing therapies was analyzed, the reduction in burden persisted (P=0.01). In this study, patients with a standard ICD indication and atrial tachyarrhythmias had a significant reduction in atrial tachyarrhythmia burden with use of atrial pacing and shock therapies.

  1. Automatic tracking of arbitrarily shaped implanted markers in kilovoltage projection images: A feasibility study

    PubMed Central

    Regmi, Rajesh; Lovelock, D. Michael; Hunt, Margie; Zhang, Pengpeng; Pham, Hai; Xiong, Jianping; Yorke, Ellen D.; Goodman, Karyn A.; Rimner, Andreas; Mostafavi, Hassan; Mageras, Gig S.

    2014-01-01

    Purpose: Certain types of commonly used fiducial markers take on irregular shapes upon implantation in soft tissue. This poses a challenge for methods that assume a predefined shape of markers when automatically tracking such markers in kilovoltage (kV) radiographs. The authors have developed a method of automatically tracking regularly and irregularly shaped markers using kV projection images and assessed its potential for detecting intrafractional target motion during rotational treatment. Methods: Template-based matching used a normalized cross-correlation with simplex minimization. Templates were created from computed tomography (CT) images for phantom studies and from end-expiration breath-hold planning CT for patient studies. The kV images were processed using a Sobel filter to enhance marker visibility. To correct for changes in intermarker relative positions between simulation and treatment that can introduce errors in automatic matching, marker offsets in three dimensions were manually determined from an approximately orthogonal pair of kV images. Two studies in anthropomorphic phantom were carried out, one using a gold cylindrical marker representing regular shape, another using a Visicoil marker representing irregular shape. Automatic matching of templates to cone beam CT (CBCT) projection images was performed to known marker positions in phantom. In patient data, automatic matching was compared to manual matching as an approximate ground truth. Positional discrepancy between automatic and manual matching of less than 2 mm was assumed as the criterion for successful tracking. Tracking success rates were examined in kV projection images from 22 CBCT scans of four pancreas, six gastroesophageal junction, and one lung cancer patients. Each patient had at least one irregularly shaped radiopaque marker implanted in or near the tumor. In addition, automatic tracking was tested in intrafraction kV images of three lung cancer patients with irregularly shaped

  2. Automatic tracking of arbitrarily shaped implanted markers in kilovoltage projection images: A feasibility study

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Regmi, Rajesh; Lovelock, D. Michael; Hunt, Margie

    Purpose: Certain types of commonly used fiducial markers take on irregular shapes upon implantation in soft tissue. This poses a challenge for methods that assume a predefined shape of markers when automatically tracking such markers in kilovoltage (kV) radiographs. The authors have developed a method of automatically tracking regularly and irregularly shaped markers using kV projection images and assessed its potential for detecting intrafractional target motion during rotational treatment. Methods: Template-based matching used a normalized cross-correlation with simplex minimization. Templates were created from computed tomography (CT) images for phantom studies and from end-expiration breath-hold planning CT for patient studies. Themore » kV images were processed using a Sobel filter to enhance marker visibility. To correct for changes in intermarker relative positions between simulation and treatment that can introduce errors in automatic matching, marker offsets in three dimensions were manually determined from an approximately orthogonal pair of kV images. Two studies in anthropomorphic phantom were carried out, one using a gold cylindrical marker representing regular shape, another using a Visicoil marker representing irregular shape. Automatic matching of templates to cone beam CT (CBCT) projection images was performed to known marker positions in phantom. In patient data, automatic matching was compared to manual matching as an approximate ground truth. Positional discrepancy between automatic and manual matching of less than 2 mm was assumed as the criterion for successful tracking. Tracking success rates were examined in kV projection images from 22 CBCT scans of four pancreas, six gastroesophageal junction, and one lung cancer patients. Each patient had at least one irregularly shaped radiopaque marker implanted in or near the tumor. In addition, automatic tracking was tested in intrafraction kV images of three lung cancer patients with irregularly

  3. Disease Severity and Exercise Testing Reduce Subcutaneous Implantable Cardioverter-Defibrillator Left Sternal ECG Screening Success in Hypertrophic Cardiomyopathy.

    PubMed

    Srinivasan, Neil T; Patel, Kiran H; Qamar, Kashif; Taylor, Amy; Bacà, Marco; Providência, Rui; Tome-Esteban, Maria; Elliott, Perry M; Lambiase, Pier D

    2017-04-01

    The features of the hypertrophic cardiomyopathy (HCM) ECG make it a challenge for subcutaneous implantable cardioverter-defibrillator (S-ICD) screening. We aimed to investigate the causes of screening failure at rest and on exercise to inform optimal S-ICD ECG vector development. One hundred and thirty-one HCM patients (age, 50±16 years; 92 males and 39 females) with ≥1 HCM risk factor for sudden death underwent S-ICD ECG screening at rest and on exercise. Fifty patients (38%) were ineligible for S-ICD because of screening failure in every lead vector: 33 (66%) failed in the supine position, 12 (24%) failed in the standing position, and 5 (10%) failed on exercise. In patients who could exercise and passed screening at rest, 31 (44%) had 1 vector safety, 16 (23%) had 2 vector safety, and 24 (33%) had 3 vector safety. Increased R:T wave ratio in the S-ICD screening ECG (odds ratio, 4.0; confidence interval, 3.0-5.3; P <0.001) was associated with screening failure, while R/T ratio <3 in aVF (odds ratio, 0.3; confidence interval, 0.12-0.69; P =0.006) and increasing age (odds ratio, 0.97; confidence interval, 0.95-0.99; P =0.03) was associated with reduced screening failure. European Society of Cardiology risk score was higher in those failing screening (risk score 5.5% [interquartile range, 3.2-8.7] in failed versus 4.5% [interquartile range, 2.9-7.4] in passed; P =0.04). HCM patients have a significant incidence of screening failure, which is determined primarily by the increased R:T ratio on the screening ECG and lead aVF. High-risk patients have an increased screening failure rate. Optimization of sensing algorithms is required to ensure that the highest risk HCM patients can benefit from S-ICD implantation. © 2017 American Heart Association, Inc.

  4. Performance of re-used pacemakers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa

    PubMed Central

    Jama, Zimasa V; Chin, Ashley; Mayosi, Bongani M; Badri, Motasim

    2015-01-01

    Objectives Little is known about the performance of re-used pacemakers and implantable cardioverter defibrillators (ICDs) in Africa. We sought to compare the risk of infection and the rate of malfunction of re-used pacemakers and ICDs with new devices implanted at Groote Schuur Hospital in Cape Town, South Africa. Methods This was a retrospective case comparison study of the performance of re-used pacemakers and ICDs in comparison with new devices implanted at Groote Schuur Hospital over a 10-year period. The outcomes were incidence of device infection, device malfunction, early battery depletion, and device removal due to infection, malfunction, or early battery depletion. Results Data for 126 devices implanted in 126 patients between 2003 and 2013 were analysed, of which 102 (81%) were pacemakers (51 re-used and 51 new) and 24 (19%) were ICDs (12 re-used and 12 new). There was no device infection, malfunction, early battery depletion or device removal in either the re-used or new pacemaker groups over the median follow up of 15.1 months [interquartile range (IQR), 1.3–36.24 months] for the re-used pacemakers, and 55.8 months (IQR, 20.3–77.8 months) for the new pacemakers. In the ICD group, no device infection occurred over a median follow up of 35.9 months (IQR, 17.0–70.9 months) for the re-used ICDs and 45.7 months (IQR, 37.6–53.7 months) for the new ICDs. One device delivered inappropriate shocks, which resolved without intervention and with no harm to the patient. This re-used ICD subsequently needed generator replacement 14 months later. In both the pacemaker and ICD groups, there were no procedure-non-related infections documented for the respective follow-up periods. Conclusion No significant differences were found in performance between re-used and new pacemakers and ICDs with regard to infection rates, device malfunction, battery life and device removal for complications. Pacemaker and ICD re-use is feasible and safe and is a viable option for

  5. Utilization of YouTube as a Tool to Assess Patient Perception Regarding Implanted Cardiac Devices.

    PubMed

    Hayes, Kevin; Mainali, Prajeena; Deshmukh, Abhishek; Pant, Sadip; Badheka, Apurva O; Paydak, Hakan

    2014-07-01

    The outreach of YouTube may have a dramatic role in the widespread dissemination of knowledge on implantable cardioverter devices (ICD). This study was designed to review and analyze the information available on YouTube pertaining to implantable cardiac devices such as implantable cardioverter defibrillators (ICDs) and pacemakers. YouTube was queried for the terms "ICD", "Implantable Cardioverter Defibrillator", and "Pacemaker". The videos were reviewed and categorized as according to content; number of views and "likes" or "dislikes" was recorded by two separate observers. Of the 55 videos reviewed, 18 of the videos were categorized as patient education, 12 were advertisements, 8 were intraoperative videos documenting the device implantation procedures, 7 of the videos were produced to document personal patient experiences, and 4 were categorized as documentation of a public event. 3 were intended to educate health care workers. The remaining 3 were intended to raise public awareness about sudden cardiac death. The videos portraying intraoperative procedures generated the most "likes" or "dislikes" per view. While YouTube provides a logical platform for delivery of health information, the information on this platform is not regulated. Initiative by reputed authorities and posting accurate information in such platform can be a great aid in public education regarding device therapy.

  6. Gender Differences in Appropriate Shocks and Mortality among Patients with Primary Prophylactic Implantable Cardioverter-Defibrillators: Systematic Review and Meta-Analysis.

    PubMed

    Conen, David; Arendacká, Barbora; Röver, Christian; Bergau, Leonard; Munoz, Pascal; Wijers, Sofieke; Sticherling, Christian; Zabel, Markus; Friede, Tim

    2016-01-01

    Some but not all prior studies have shown that women receiving a primary prophylactic implantable cardioverter defibrillator (ICD) have a lower risk of death and appropriate shocks than men. To evaluate the effect of gender on the risk of appropriate shock, all-cause mortality and inappropriate shock in contemporary studies of patients receiving a primary prophylactic ICD. PubMed, LIVIVO, Cochrane CENTRAL between 2010 and 2016. Studies providing at least 1 gender-specific risk estimate for the outcomes of interest. Abstracts were screened independently for potentially eligible studies for inclusion. Thereby each abstract was reviewed by at least two authors. Out of 680 abstracts retained by our search strategy, 20 studies including 46'657 patients had gender-specific information on at least one of the relevant endpoints. Mean age across the individual studies varied between 58 and 69 years. The proportion of women enrolled ranged from 10% to 30%. Across 6 available studies, women had a significantly lower risk of first appropriate shock compared with men (pooled multivariable adjusted hazard ratio 0.62 (95% CI [0.44; 0.88]). Across 14 studies reporting multivariable adjusted gender-specific hazard ratio estimates for all-cause mortality, women had a lower risk of death than men (pooled hazard ratio 0.75 (95% CI [0.66; 0.86]). There was no statistically significant difference for the incidence of first inappropriate shocks (3 studies, pooled hazard ratio 0.99 (95% CI [0.56; 1.73]). Individual patient data were not available for most studies. In this large contemporary meta-analysis, women had a significantly lower risk of appropriate shocks and death than men, but a similar risk of inappropriate shocks. These data may help to select patients who benefit from primary prophylactic ICD implantation.

  7. Adverse design of defibrillators: turning off the machine when trying to shock.

    PubMed

    Høyer, Christian S; Christensen, Erika F; Eika, Berit

    2008-11-01

    A recent publication demonstrated the possibility of erroneous operation of 2 widely used monitor-defibrillators and observed that the design of user interfaces might contribute to error during operation. During an ambulance simulation training exercise for 72 junior internal medicine physicians that called for defibrillation in the management of cardiac arrest, we observed that in 5 of 192 defibrillation attempts by the physicians, the monitor-defibrillator was inadvertently powered off. When the device is inadvertently powered off, recognition and subsequent steps to defibrillate delayed defibrillation an average of 24 seconds (range 14 to 32 seconds). Our analysis of the controls of this monitor-defibrillator found that the device could be powered off even if fully charged and ready to shock. Redesign of the equipment might prevent this inadvertent event.

  8. Influence of secondary neutrons induced by proton radiotherapy for cancer patients with implantable cardioverter defibrillators

    PubMed Central

    2012-01-01

    Background Although proton radiotherapy is a promising new approach for cancer patients, functional interference is a concern for patients with implantable cardioverter defibrillators (ICDs). The purpose of this study was to clarify the influence of secondary neutrons induced by proton radiotherapy on ICDs. Methods The experimental set-up simulated proton radiotherapy for a patient with an ICD. Four new ICDs were placed 0.3 cm laterally and 3 cm distally outside the radiation field in order to evaluate the influence of secondary neutrons. The cumulative in-field radiation dose was 107 Gy over 10 sessions of irradiation with a dose rate of 2 Gy/min and a field size of 10 × 10 cm2. After each radiation fraction, interference with the ICD by the therapy was analyzed by an ICD programmer. The dose distributions of secondary neutrons were estimated by Monte-Carlo simulation. Results The frequency of the power-on reset, the most serious soft error where the programmed pacing mode changes temporarily to a safety back-up mode, was 1 per approximately 50 Gy. The total number of soft errors logged in all devices was 29, which was a rate of 1 soft error per approximately 15 Gy. No permanent device malfunctions were detected. The calculated dose of secondary neutrons per 1 Gy proton dose in the phantom was approximately 1.3-8.9 mSv/Gy. Conclusions With the present experimental settings, the probability was approximately 1 power-on reset per 50 Gy, which was below the dose level (60-80 Gy) generally used in proton radiotherapy. Further quantitative analysis in various settings is needed to establish guidelines regarding proton radiotherapy for cancer patients with ICDs. PMID:22284700

  9. Cardiopulmonary resuscitation and automatic external defibrillator training in schools: "is anyone learning how to save a life?".

    PubMed

    Hart, Devin; Flores-Medrano, Oscar; Brooks, Steve; Buick, Jason E; Morrison, Laurie J

    2013-09-01

    Bystander resuscitation efforts, such as cardiopulmonary resuscitation (CPR) and use of an automatic external defibrillator (AED), save lives in cardiac arrest cases. School training in CPR and AED use may increase the currently low community rates of bystander resuscitation. The study objective was to determine the rates of CPR and AED training in Toronto secondary schools and to identify barriers to training and training techniques. This prospective study consisted of telephone interviews conducted with key school staff knowledgeable about CPR and AED teaching. An encrypted Web-based tool with prespecified variables and built-in logic was employed to standardize data collection. Of 268 schools contacted, 93% were available for interview and 83% consented to participate. Students and staff were trained in CPR in 51% and 80% of schools, respectively. Private schools had the lowest training rate (39%). Six percent of schools provided AED training to students and 47% provided AED training to staff. Forty-eight percent of schools had at least one AED installed, but 25% were unaware if their AED was registered with emergency services dispatch. Cost (17%), perceived need (11%), and school population size (10%) were common barriers to student training. Frequently employed training techniques were interactive (32%), didactic instruction (30%) and printed material (16%). CPR training rates for staff and students were moderate overall and lowest in private schools, whereas training rates in AED use were poor in all schools. Identified barriers to training include cost and student population size (perceived to be too small to be cost-effective or too large to be implemented). Future studies should assess the application of convenient and cost-effective teaching alternatives not presently in use.

  10. Female-specific education, management, and lifestyle enhancement for implantable cardioverter defibrillator patients: the FEMALE-ICD study.

    PubMed

    Vazquez, Lauren D; Conti, Jamie B; Sears, Samuel F

    2010-09-01

    Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are particularly at risk for developing distress and warrant psychosocial attention. The major objectives were to implement and test the effectiveness of a female-specific psychosocial group intervention on disease-specific quality of life outcomes in outpatient female ICD recipients versus a wait-list control group. Twenty-nine women were recruited for the study. Fourteen women were randomized to the intervention group and participated in a psychosocial intervention focused on female-specific issues; 15 were randomized to the wait-list control group. All women completed individual psychological batteries at baseline and at 1-month follow-up measuring shock anxiety and device acceptance. Pre-post measures of shock anxiety demonstrated a significant time by group interaction effect with the intervention group having a significantly greater decrease (Pillai's trace = 5.58, P = 0.026). A significant interaction effect (Pillai's trace = 5.05, P = 0.046) was found, such that women under the age of 50 experienced greater reduction in shock anxiety than their middle-aged cohorts. Pre-post measures of device acceptance revealed a significant time by group interaction effect with the intervention group having significantly greater increases (Pillai's trace = 5.80, P = 0.023). Structured interventions for female ICD patients involving ICD-specific education, cognitive behavioral therapy strategies, and group social support provide improvements in shock anxiety and device acceptance at 1-month re-assessment. Young women appear to be an at-risk subgroup of this population and may experience more benefit from psychosocial treatment targeting device-specific concerns. ©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.

  11. Importance of the atrial channel for ventricular arrhythmia therapy in the dual chamber implantable cardioverter defibrillator.

    PubMed

    Dijkman, B; Wellens, H J

    2000-12-01

    Performance of dual chamber implantable cardioverter defibrillator (ICD) systems has been judged based on functioning of the ventricular tachycardia:supraventricular tachycardia (VT:SVT) discrimination criteria and DDD pacing. The purpose of this study was to evaluate the use of dual chamber diagnostics to improve the electrical and antiarrhythmic therapy of ventricular arrhythmias. Information about atrial and ventricular rhythm in relation to ventricular arrhythmia occurrence and therapy was evaluated in 724 spontaneous arrhythmia episodes detected and treated by three types of dual chamber ICDs in 41 patients with structural heart disease. Device programming was based on clinically documented and induced ventricular arrhythmias. In ambulatory patients, sinus tachycardia preceded ventricular arrhythmias more often than in the hospital during exercise testing. The incidence of these VTs could be reduced by increasing the dose of a beta-blocking agent in only two patients. In five patients in whom sinus tachycardia developed after onset of hemodynamic stable VT, propranolol was more effective than Class III antiarrhythmics combined with another beta-blocking agent with regard to the incidence of VT and pace termination. In all but three cases, atrial arrhythmias were present for a longer time before the onset of ventricular arrhythmias. During atrial arrhythmias, fast ventricular rates before the onset of ventricular rate were observed more often than RR irregularities and short-long RR sequences. Dual chamber diagnostics allowed proper interpretation of detection and therapy outcome in patients with different types of ventricular arrhythmia. The advantages of the dual chamber ICD system go further than avoiding the shortcomings of the single chamber system. Information from the atrial chamber allows better device programming and individualization of drug therapy for ventricular arrhythmia.

  12. Statins reduce appropriate implantable cardioverter-defibrillator shocks in ischemic cardiomyopathy with no benefit in nonischemic cardiomyopathy.

    PubMed

    Contractor, Tahmeed; Beri, Abhimanyu; Gardiner, Joseph; Ardhanari, Sivakumar; Thakur, Ranjan

    2012-11-01

    Statins have been hypothesized to decrease ventricular arrhythmias through a direct antiarrhythmic effect. Clinical studies have demonstrated a clear reduction only in populations with underlying ischemic heart disease. This study was designed to compare the effect of statins on appropriate shocks between ischemic and nonischemic cardiomyopathy. Patients with an ejection fraction 35% or less who received an implantable cardioverter-defibrillator and had follow-up for at least 1 month were included. The ischemic and nonischemic groups were divided into statin treatment and control subgroups and the occurrence of appropriate shocks was compared. The frequency of shocks was analyzed using negative binomial models to account for overdispersion of the "count" data (number of appropriate shocks) and an adjusted intensity rate ratio was calculated for statin use. A total of 676 patients were included, of which statins were used by 65% (329 of 506) of the ischemic and 42% (72 of 170) of the nonischemic groups. Occurrence of appropriate shocks was significantly reduced with statins in ischemic (13.4% vs 20.9%; relative risk 0.64, P = 0.028), but not in the patients with nonischemic cardiomyopathy. Similarly, although use of statins lowered the intensity rate of appropriate shocks in ischemic patients (intensity rate ratio, 0.23; 95% confidence interval, 0.12-0.47), no such benefit was noted in the nonischemic group (intensity rate ratio, 1.27; 95% confidence interval, 0.37-4.40). In conclusion, statins reduced the occurrence and frequency of appropriate shocks for ventricular arrhythmias in ischemic but not in nonischemic cardiomyopathy. Larger, randomized controlled trials are needed to confirm these findings.

  13. Realistic expectations for public access defibrillation programs.

    PubMed

    Atkins, Dianne L

    2010-06-01

    Public access defibrillation programs have increased dramatically over the past 15 years. This review will focus on their effectiveness and operational characteristics and discuss the characteristics of successful programs, which can improve outcomes. Automated external defibrillators increase survival from cardiac arrest when used by a bystander. Recent studies show that the best outcomes are achieved when devices are placed in areas with a high frequency of cardiac arrest and there is ongoing supervision with emergency plans and cardiopulmonary resuscitation training. Programs are cost-effective under these circumstances, but become very inefficient when placed in areas of low risk. There are few adverse events related to the public access defibrillation programs and volunteers are not harmed. Unguided placement results in devices not being used and a decline in organizational structure of the program. As most cardiac arrests occur in the home, the impact on overall survival remains low. Automated external defibrillators are highly effective at reducing death from ventricular fibrillation and easy access in public areas is most effective. Placement must be prioritized based on public health impact and characteristics of the community.

  14. Entropy of cardiac repolarization predicts ventricular arrhythmias and mortality in patients receiving an implantable cardioverter-defibrillator for primary prevention of sudden death.

    PubMed

    DeMazumder, Deeptankar; Limpitikul, Worawan B; Dorante, Miguel; Dey, Swati; Mukhopadhyay, Bhasha; Zhang, Yiyi; Moorman, J Randall; Cheng, Alan; Berger, Ronald D; Guallar, Eliseo; Jones, Steven R; Tomaselli, Gordon F

    2016-12-01

    The need for a readily available, inexpensive, non-invasive method for improved risk stratification of heart failure (HF) patients is paramount. Prior studies have proposed that distinct fluctuation patterns underlying the variability of physiological signals have unique prognostic value. We tested this hypothesis in an extensively phenotyped cohort of HF patients using EntropyX QT , a novel non-linear measure of cardiac repolarization dynamics. In a prospective, multicentre, observational study of 852 patients in sinus rhythm undergoing clinically indicated primary prevention implantable cardioverter-defibrillator (ICD) implantation (2003-10), exposures included demographics, history, physical examination, medications, laboratory results, serum biomarkers, ejection fraction, conventional electrocardiographic (ECG) analyses of heart rate and QT variability, and EntropyX QT . The primary outcome was first 'appropriate' ICD shock for ventricular arrhythmias. The secondary outcome was composite events (appropriate ICD shock and all-cause mortality). After exclusions, the cohort (n = 816) had a mean age of 60 ± 13 years, 28% women, 36% African Americans, 56% ischaemic cardiomyopathy, and 29 ± 16% Seattle HF risk score (SHFS) 5-year predicted mortality. Over 45 ± 24 months, there were 134 appropriate shocks and 166 deaths. After adjusting for 30 exposures, the hazard ratios (comparing the 5th to 1st quintile of EntropyX QT ) for primary and secondary outcomes were 3.29 (95% CI 1.74-6.21) and 2.28 (1.53-3.41), respectively. Addition of EntropyX QT to a model comprised of the exposures or SHFS significantly increased net reclassification and the ROC curve area. EntropyX QT measured during ICD implantation strongly and independently predicts appropriate shock and all-cause mortality over follow-up. EntropyX QT complements conventional risk predictors and has the potential for broad clinical application. Published on behalf of the European Society of Cardiology. All

  15. Defibrillation and resuscitation in a piglet model of pediatric ventricular fibrillation following AHA 2005 guidelines.

    PubMed

    Zhou, Zhengyu; Wang, Yubin; Zhou, Huiying; Huang, Meng; Liu, Huiting; Hsieh, Chengtai; Xue, Zhimou

    2010-08-01

    dose defibrillation combined with effective CPR, successfully terminated VF without adverse effects on myocardial function and survival in a piglet defibrillation model for young children 1 to 8 yr of age. The new guidelines recommendation that one shock immediately followed by CPR is reasonable. Adults AED combined with pediatric electrodes is feasible to the diagnosis and treatment of pediatric VF model. But the user should not rely too much on AED's "automatic" function, but should accumulate and integrate his experience with AED technology.

  16. Interaction between shock coils increased the incidence of inappropriate therapies and lead failure in implantable cardioverter defibrillator.

    PubMed

    El Garhy, Mohammad; Ohlow, Marc-Alexander; Lauer, Bernward

    Shock coil interaction in patients with multiple implantable cardioverter defibrillator (ICD) leads is occasionally observed. We aimed to evaluate the incidence of shock coil interaction and its clinical relevance. All ICD patients (646 patients) who came to follow up control in our ICD ambulance between January 1, 2011, and December 31, 2011 in the department of cardiology in Bad Berka hospital were retrospectively evaluated in this study. All baseline demographic, clinical, and procedural characteristics and postoperative chest x ray in postero-anterior and lateral view as well as clinical and ICD follow up data were evaluated. Among 646 patients 42 had multiple ICD leads (6.5%) of whom 36 patients (5.5% of total cohort patients and 85.7% of patients with multiple ICD leads) had shock coil interaction and presented the study group (Group I). The control group (Group II) consisted of 610 patients without coil-coil interaction including patients with single shock lead (604 patients) or patients with multiple leads but without interaction between shock coils (6 patients). Inappropriate anti-tachycardia therapies and RV lead revisions were more frequent in patients with interaction between shock coils (Group I vs Group II: 27.7% and 5.7%; p = 0.049 and 30.6% vs 6.4; p = 0.0001, respectively). Interaction between shock coils may be one of possible causes of lead failure and resulted in inappropriate therapies and subsequent lead revision. Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

  17. Recovery of Ventriculo-Atrial Conduction after Adrenaline in Patients Implanted with Pacemakers.

    PubMed

    Cismaru, Gabriel; Gusetu, Gabriel; Muresan, Lucian; Rosu, Radu; Andronache, Marius; Matuz, Roxana; Puiu, Mihai; Mester, Petru; Miclaus, Maria; Pop, Dana; Mircea, Petru Adrian; Zdrenghea, Dumitru

    2015-07-01

    Ventriculo-atrial (VA) conduction can have negative consequences for patients with implanted pacemakers and defibrillators. There is concern whether impaired VA conduction could recover during stressful situations. Although the influence of isoproterenol and atropine are well established, the effect of adrenaline has not been studied systematically. The objective of this study was to determine if adrenaline can facilitate recovery of VA conduction in patients implanted with pacemakers. A prospective study was conducted on 61 consecutive patients during a 4-month period (April-July 2014). The presence of VA conduction was assessed during the pacemaker implantation procedure. In case of an impaired VA conduction, adrenaline infusio was used as a stress surrogate to test conduction recovery. The indications for pacemaker implantation were: sinus node dysfunction in 18 patients, atrioventricular (AV) block in 40 patients, binodal dysfunction (sinus node+ AV node) in two patients and other (carotid sinus syndrome) in one patient. In the basal state, 15/61 (24.6%) presented spontaneous VA conduction and 46/61 (75.4%) had no VA conduction. After administration of adrenaline, there was VA conduction recovery in 5/46 (10.9%) patients. Adrenaline infusion produced recovery of VA conduction in 10.9% of patients with absent VA conduction in a basal state. Recovery of VA conduction during physiological or pathological stresses could be responsible for the pacemaker syndrome, PMT episodes, or certain implantable cardiac defibrillator detection issues. © 2015 Wiley Periodicals, Inc.

  18. An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

    PubMed

    Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita

    2015-05-01

    The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

  19. Human Factors Approach to Comparative Usability of Hospital Manual Defibrillators.

    PubMed

    Fidler, Richard; Johnson, Meshell

    2016-04-01

    Equipment-related issues have recently been cited as a significant contributor to the suboptimal outcomes of resuscitation management. A systematic evaluation of the human-device interface was undertaken to evaluate the intuitive nature of three different defibrillators. Devices tested were the Physio-Control LifePak 15, the Zoll R Series Plus, and the Philips MRx. A convenience sample of 73 multidisciplinary health care providers from 5 different hospitals participated in this study. All subjects' performances were evaluated without any training on the devices being studied to assess the intuitiveness of the user interface to perform the functions of delivering an Automated External Defibrillator (AED) shock, a manual defibrillation, pacing to achieve 100% capture, and synchronized cardioversion on a rhythm simulator. Times to deliver an AED shock were fastest with the Zoll, whereas the Philips had the fastest times to deliver a manual defibrillation. Subjects took the least time to attain 100% capture for pacing with the Physio-Control device. No differences in performance times were seen with synchronized cardioversion among the devices. Human factors issues uncovered during this study included a preference for knobs over soft keys and a desire for clarity in control panel design. This study demonstrated no clearly superior defibrillator, as each of the models exhibited strengths in different areas. When asked their defibrillator preference, 67% of subjects chose the Philips. This comparison of user interfaces of defibrillators in simulated situations allows the assessment of usability that can provide manufacturers and educators with feedback about defibrillator implementation for these critical care devices. Published by Elsevier Ireland Ltd.

  20. Potential for Personal Digital Assistant interference with implantable cardiac devices.

    PubMed

    Tri, Jeffrey L; Trusty, Jane M; Hayes, David L

    2004-12-01

    To determine whether the wireless local area network (WLAN) technology, specifically the Personal Digital Assistant (PDA), interferes with implantable cardiac pacemakers and defibrillators. Various pacemakers and defibrillators were tested in vitro at the Mayo Clinic in Rochester, Minn, between March 6 and July 30, 2003. These cardiac devices were exposed to an HP Compaq IPAQ PDA fitted with a Cisco Aironet WLAN card. Initial testing was designed to show whether the Aironet card radiated energy in a consistent pattern from the antenna of the PDA to ensure that subsequent cardiac device testing would not be affected by the orientation of the PDA to the cardiac device. Testing involved placing individual cardiac devices in a simulator and uniformly exposing each device at its most sensitive programmable value to the WLAN card set to maximum power. During testing with the Cisco WLAN Aironet card, all devices programmed to the unipolar or bipolar configuration single- or dual-chamber mode had normal pacing and sensing functions and exhibited no effects of electromagnetic interference except for 1 implantable cardioverter-defibrillator (ICD). This aberration was determined to relate to the design of the investigators' testing apparatus and not to the output of the PDA. The ICD device appropriately identified and labeled the electromagnetic aberration as "noise." We documented no electromagnetic interference caused by the WLAN technology by using in vitro testing of pacemakers and ICDs; however, testing ideally should be completed in vivo to confirm the lack of any clinically important interactions.