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Sample records for device-assisted implantable cardioverter-defibrillator

  1. Optimal Implantable Cardioverter Defibrillator Programming.

    PubMed

    Shah, Bindi K

    2016-11-17

    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, as well as the consensus statement on ICD programming. In so doing, we found that prolonged ICD detection times, higher rate cutoffs, and antitachycardia pacing 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.

  2. 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.

  3. 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

  4. Implantable cardioverter defibrillator during laser transurethral resection of the prostate.

    PubMed

    Deroee, A F; Cohen, B J; O'Hara, J F

    2014-01-01

      Implantable cardioverter defibrillators have been instrumental in the health and safety of patients who are at increased risk of sudden death by ventricular tachycardia or fibrillation. Consensus on the perioperative management of cardiovascular implantable electronic devices has suggested that certain surgical interventions (including transurethral resection of the prostate) may interfere with the sensing capability of the device, thereby resulting in unforeseen adverse outcomes. However, improvements in the implantable cardioverter defibrillators have made it less susceptible to surgical interference. In addition, current guidelines recommend deactivation of the implantable cardioverter defibrillators to an asynchronous mode prior to most surgical interventions. We present the first two case reports in which implantable cardioverter defibrillators were not deactivated prior to GreenLight 180-W XPS laser-guided transurethral resection of the prostate. We left the implantable cardioverter defibrillators activated to allow them to detect and treat lethal arrhythmias by direct rather than extrinsic cardioversion. There was no cardiac arrhythmia incident in these two cases. Laser technology is not a documented source of electromagnetic interference in patients with implantable cardioverter defibrillators. There is no current evidence that links lasers to implantable cardioverter defibrillators malfunction. With increasing numbers of patients with implantable cardioverter defibrillators undergoing many different laser surgical procedures, further studies are warranted to analyze in depth the effects of laser therapy on implantable cardioverter defibrillators function and update in current guidelines.

  5. 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

  6. What Are the Risks of Having an Implantable Cardioverter Defibrillator?

    MedlinePlus

    ... from the NHLBI on Twitter. What Are the Risks of Having an Implantable Cardioverter Defibrillator? Unnecessary Electrical ... prescribe medicine so unnecessary pulses occur less often. Risks Related to Surgery Although rare, some ICD risks ...

  7. 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

    2017-06-01

    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

  8. Chagas' disease and the use of implantable cardioverter-defibrillators in Brazil.

    PubMed

    Rosa, Ronaldo F; Neto, Argemiro S; Franken, Roberto A

    2006-01-01

    The authors discuss the epidemiology and pathogenesis of Chagas' disease in Brazil, including the use of treatment with a cardioverter-defibrillator in patients with low ejection fraction. Select patients may benefit from resynchronization therapy associated with cardioverter-defibrillator treatment. Electrophysiologic study is indicated in the assessment of the potential utility of an implantable cardioverter-defibrillator.

  9. Implantable cardioverter defibrillator pocket infection caused by Klebsiella pneumonia.

    PubMed

    Ertas, F; Acet, H; Kaya, H; Kayan, F; Soydinc, S

    2012-09-01

    Like any other foreign bodies, implanted cardiac devices can become infected. Staphylococcus aureus and coagulase-negative Staphilococci are the most common causes of infections of pacemaker and defibrillator systems. In this case an implantable cardioverter defibrillator pocket infection caused by an extremely rare microorganism, Klebsiella pneumonia, is presented.

  10. Safety of Outpatient Implantation of the Implantable Cardioverter-defibrillator.

    PubMed

    Datino, Tomás; Miracle Blanco, Ángel; Núñez García, Alberto; González-Torrecilla, Esteban; Atienza Fernández, Felipe; Arenal Maíz, Ángel; Hernández-Hernández, Jesús; Ávila Alonso, Pablo; Eidelman, Gabriel; Fernández-Avilés, Francisco

    2015-07-01

    Strategies are needed to reduce health care costs and improve patient care. The objective of our study was to analyze the safety of outpatient implantation of cardioverter-defibrillators. A retrospective study was conducted in 401 consecutive patients who received an implantable cardioverter-defibrillator between 2007 and 2012. The rate of intervention-related complications was compared between 232 patients (58%) whose implantation was performed in the outpatient setting and 169 patients (42%) whose intervention was performed in the inpatient setting. The mean age (standard deviation) of the patients was 62 (14) years; 336 (84%) were male. Outpatients had lower left ventricular ejection fraction and a higher percentage had an indication for primary prevention of sudden death, compared to inpatients. Only 21 outpatients (9%) required subsequent hospitalization. The rate of complications until the third month postimplantation was similar for outpatients (6.0%) and inpatients (5.3%); P = .763. In multivariate analysis, only previous anticoagulant therapy was related to the presence of complications (odds ratio = 3.2; 95% confidence interval, 1.4-7.4; P < .01), mainly due to an increased rate of pocket hematomas. Each outpatient implantation saved approximately €735. Outpatient implantation of implantable cardioverter-defibrillators is safe and reduces costs. Close observation is recommended for patients receiving chronic anticoagulation therapy due to an increased risk of complications. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. 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.

  12. Role of antiarrhythmic drugs in patients with implantable cardioverter defibrillators.

    PubMed

    Van Herendael, Hugo; Pinter, Arnold; Ahmad, Kamran; Korley, Victoria; Mangat, Iqwal; Dorian, Paul

    2010-05-01

    The transvenous implantable cardioverter defibrillator (ICD) has emerged as the primary therapy for patients at high risk of life-threatening ventricular arrhythmias. A high number of ICD recipients will require subsequent adjunctive treatment with antiarrhythmic drugs (AADs). This review provides an overview of potential reasons for AAD initiation, candidates for treatment, current medical options, and possible drug-device interactions.

  13. Prevalence of appropriate cardioverter-defibrillator shocks in 1038 consecutive patients with implantable cardioverter-defibrillators.

    PubMed

    Kruger, Adam; Aronow, Wilbert S; Lai, Hoang; Desai, Harit; Singla, Atul; Frishman, William H; Cohen, Martin; Sorbera, Carmine

    2009-01-01

    During a 33-month follow-up of 1038 consecutive patients who had implantable cardioverter-defibrillators, appropriate shocks occurred in 329 of 1038 patients (32%). Appropriate shocks occurred in 101 of 380 patients (27%) treated with beta-adrenergic blockers alone; in 31 of 95 patients (33%) treated with amiodarone alone; in 39 of 149 patients (26%) treated with beta-blockers plus amiodarone; in 11 of 28 patients (39%) treated with sotalol alone; and in 147 of 386 patients (38%) treated with no beta-blockers, amiodarone, or sotalol (P < 0.001 comparing patients treated with beta-adrenergic blockers alone with patients treated with no beta-blockers, amiodarone, or sotalol; and P < 0.01 comparing patients treated with beta-blockers plus amiodarone with patients treated with no beta-blockers, amiodarone, or sotalol). In conclusion, patients having implantable cardioverter-defibrillators should also be treated with beta-adrenergic blockers to reduce the frequency of appropriate shocks.

  14. [The implantable automatic cardioverter-defibrillator].

    PubMed

    Klein, H; Tröster, J; Trappe, H J; Becht, I; Siclari, F

    1990-04-01

    In addition to medical treatment for ventricular tachyarrhythmias which has not proven to be sufficient, nonmedical modes of treatment are available such as electrophysiologically-guided surgical measures and catheter ablation, both of which are restricted to only a relatively small patient population and require further technical refinement. In 1980, Mirowski introduced the automatic implantable defibrillator and, to date, world-wide, this device has been implanted in 8000 patients. CHARACTERISTICS AND IMPLANTATION OF THE AUTOMATIC IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR (AICD): The AICD continuously monitors the electrical activity of the heart, recognizes the onset of threatening ventricular tachycardias and terminates these according to the respectively programmed mode by delivering direct current shocks or stimuli. The currently used defibrillators consist of an impulse generator with lithium batteries and an electrode system. The batteries can charge a capacitor with about 700 volts in five to eight seconds which produces a current with an energy up to 30 Joules on discharge. The current is delivered either by two plate electrodes on the right and left ventricles or a plate electrode on the left ventricle and a spiral electrode inserted in the superior vena cava. The electrodes also serve the purpose of tachycardia detection by means of an electrical signal, the probability density function (PDF), that is, a significant decrease in the potentials to isoelectric. With this, it is only possible to terminate ventricular fibrillation. Additional electrical detection criteria are obtained and analyzed by two adjacently positioned epicardial screw electrodes or a bipolar endocardial electrode, enable identification of ventricular tachycardia as well. If the tachycardia detection criteria are fulfilled, the capacitor is discharged according to its programmed shock energy. In 1988, programmable defibrillators were introduced. Current defibrillator treatment also

  15. Organisation of care for Swedish patients with an implantable cardioverter defibrillator, a national survey.

    PubMed

    Bolse, Kärstin; Johansson, Ingela; Strömberg, Anna

    2011-09-01

    To describe the clinical aspects of implantable cardioverter defibrillators care in Sweden with focus on organisation, the role and education of nurses, patient information and education and areas in need of improvement. Implantable cardioverter defibrillators implantations have developed rapidly in recent years and are now an established arrhythmia treatment. The expanding indication for implantable cardioverter defibrillators implantation demands new competencies and resources in the implantable cardioverter defibrillators team members. Participants were recruited among physicians and nurses in all of the hospitals implanting implantable cardioverter defibrillators (n = 16). Data were collected by a questionnaire. Additionally, all written educational materials provided to patients pre- and postimplant were collected from all 16 hospitals. Deductive content analysis using Sarvimäki and Stenbock-Hult's five holistic dimensions was employed to ascertain how information was provided in brochures and information materials. Half of the hospitals (n=8) had nurse-based outpatient clinics and several others planned to introduce them. Three hospitals carried out distance follow-ups by means of tele-monitoring. The nurses had received specific implantable cardioverter defibrillators education from implantable cardioverter defibrillators companies and/or various university courses. The biophysical dimension dominated in the information material, while the emotional, intellectual and socio-cultural dimensions were scarcely described, and the spiritual-existential was not referred to at all. Holistic care of implantable cardioverter defibrillators patients can be achieved by means of a multidisciplinary implantable cardioverter defibrillators team and more patient-centred educational strategies. In Sweden, the organisation of implantable cardioverter defibrillators care and follow-up is developing towards more nurse-based clinics. Development and implementation of structured

  16. 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

  17. 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.

  18. 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

  19. Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators.

    PubMed

    Lee, Douglas S; 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

    2015-09-01

    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. 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). 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. © 2015 The Authors.

  20. Implantable cardioverter-defibrillator infection caused by Tsukamurella.

    PubMed

    Almehmi, Ammar; Pfister, Alfred K; McCowan, Ronald; Matulis, Susie

    2004-01-01

    Human infections with Tsukamurella are very rare with only 13 reported cases in the literature. Certain conditions, such as immunosuppression, an indwelling foreign body, and postoperative wounds predispose humans to Tsukamurella infections. The rarity of Tsukamurella infection in humans makes its diagnosis and treatment very difficult. This article describes the first case of implantable cardioverter-defibrillator (ICD) infection related to Tsukamurella in the literature.

  1. Normativity under change: Older persons with implantable cardioverter defibrillator.

    PubMed

    Svanholm, Jette Rolf; Nielsen, Jens Cosedis; Mortensen, Peter Thomas; Christensen, Charlotte Fuglesang; Birkelund, Regner

    2016-05-01

    In modern society, death has become 'forbidden' fed by the medical technology to conquer death. The technological paradigm is challenged by a social-liberal political ideology in postmodern Western societies. The question raised in this study was as follows: Which arguments, attitudes, values and paradoxes between modern and postmodern tendencies concerning treatment and care of older persons with an implantable cardioverter defibrillator appear in the literature? The aim of this study was to describe and interpret how the field of tension concerning older persons with an implantable cardioverter defibrillator - especially end-of-life issues - has been expressed in the literature throughout the last decade. Paul Ricoeur's reflexive interpretive approach was used to extract the meaningful content of the literature involving qualitative, quantitative and normative literature. Analysis and interpretation involved naive reading, structural analysis and critical interpretation. The investigation complied with the principles outlined in the Declaration of Helsinki. The unifying theme was 'Normativity under change'. The sub-themes were 'Death has become legitimate', 'The technological imperative is challenged' and 'Patients and healthcare professionals need to talk about end-of-life issues'. There seems to be a considerable distance between the normative approach of how practice ought to be and findings in empirical studies. Modern as well as postmodern attitudes and perceptions illustrate contradictory tendencies regarding deactivation of the implantable cardioverter defibrillator and replacement of the implantable cardioverter defibrillator in older persons nearing the end of life. The tendencies challenge each other in a struggle to gain position. On the other hand, they can also complement each other because professionalism and health professional expertise cannot stand alone when the patient's life is at stake but must be unfolded in an alliance with the patient who

  2. Beyond the implantable cardioverter-defibrillator: are we making progress?

    PubMed

    Weiss, James N

    2008-06-01

    Sudden cardiac death due to ventricular fibrillation occurs when a dynamic interaction between triggers and substrate leads to the development of reentry, initiation of ventricular tachycardia, and its degeneration to fibrillation. To move beyond the implantable cardioverter-defibrillator as the only effective therapy for aborting sudden cardiac death, an improved understanding of trigger-substrate interaction is essential. This brief review summarizes some of the recent progress in this direction.

  3. Lingular pneumonia obscured by implanted cardioverter-defibrillator: Lateral thinking.

    PubMed

    Sewell, Laura; Harries, Ivan; Chandrasekaran, Barinathan

    2015-01-01

    A 56-year-old female with an implanted cardioverter-defibrillator was admitted with a short history suggestive of a diagnosis of pneumonia. An AP radiograph did not identify an area of consolidation. A subsequent lateral radiograph highlighted an extensive left-lingular-lobe consolidation that had been obscured by the cardiac device. This case highlights the fact that large devices can obscure significant pathology, and that lateral or cross-sectional imaging may be helpful in reaching a diagnosis.

  4. 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

  5. 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.

  6. Patient perceptions of implantable cardioverter-defibrillator deactivation discussions: A qualitative study.

    PubMed

    MacIver, Jane; Tibbles, Alana; Billia, Filio; Ross, Heather

    2016-01-01

    There is a class I recommendation for implantable cardioverter-defibrillator deactivation discussions to occur between physicians and heart failure patients. Few studies have reported the patient's perspective on the timing of implantable cardioverter-defibrillator deactivation discussions. To determine patient awareness, preferences and timing of implantable cardioverter-defibrillator deactivation discussions. Grounded theory was used to collect and analyze interview data from 25 heart failure patients with an implantable cardioverter-defibrillator. Patients with an implantable cardioverter-defibrillator, from the Heart Function Clinic at University Health Network (Toronto, Canada). The sample (n = 25) was predominately male (76%) with an average age of 62 years. Patients identified three stages where they felt implantable cardioverter-defibrillator deactivation should be discussed: (1) prior to implantation, (2) with any significant deterioration but while they were of sound mind to engage in and communicate their preferences and (3) at end of life, where patients wished further review of their previously established preferences and decisions about implantable cardioverter-defibrillator deactivation. Most patients (n = 17, 68%) said they would consider deactivation, six (24%) were undecided and two (8%) were adamant they would never turn it off. The patient preferences identified in this study support the need to include information on implantable cardioverter-defibrillator deactivation at implant, with change in clinical status and within broader discussions about end-of-life treatment preferences. Using this process to help patients determine and communicate their implantable cardioverter-defibrillator deactivation preferences may reduce the number of patients experiencing distressing implantable cardioverter-defibrillator shocks at end of life.

  7. Patient perceptions of implantable cardioverter-defibrillator deactivation discussions: A qualitative study

    PubMed Central

    MacIver, Jane; Tibbles, Alana; Billia, Filio; Ross, Heather

    2016-01-01

    Background: There is a class I recommendation for implantable cardioverter-defibrillator deactivation discussions to occur between physicians and heart failure patients. Few studies have reported the patient’s perspective on the timing of implantable cardioverter-defibrillator deactivation discussions. Aim: To determine patient awareness, preferences and timing of implantable cardioverter-defibrillator deactivation discussions. Design: Grounded theory was used to collect and analyze interview data from 25 heart failure patients with an implantable cardioverter-defibrillator. Setting and participants: Patients with an implantable cardioverter-defibrillator, from the Heart Function Clinic at University Health Network (Toronto, Canada). Results: The sample (n = 25) was predominately male (76%) with an average age of 62 years. Patients identified three stages where they felt implantable cardioverter-defibrillator deactivation should be discussed: (1) prior to implantation, (2) with any significant deterioration but while they were of sound mind to engage in and communicate their preferences and (3) at end of life, where patients wished further review of their previously established preferences and decisions about implantable cardioverter-defibrillator deactivation. Most patients (n = 17, 68%) said they would consider deactivation, six (24%) were undecided and two (8%) were adamant they would never turn it off. Conclusion: The patient preferences identified in this study support the need to include information on implantable cardioverter-defibrillator deactivation at implant, with change in clinical status and within broader discussions about end-of-life treatment preferences. Using this process to help patients determine and communicate their implantable cardioverter-defibrillator deactivation preferences may reduce the number of patients experiencing distressing implantable cardioverter-defibrillator shocks at end of life. PMID:27110361

  8. [Spanish implantable cardioverter-defibrillator registry. Seventh official report of the spanish society of cardiology working group on implantable cardioverter-defibrillators (2010)].

    PubMed

    Alzueta, Javier; Fernández, José Maria

    2011-11-01

    The authors summarize the findings of the Spanish Implantable Cardioverter-Defibrillator Registry for 2010 compiled by the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators. Members of the Spanish Society of Cardiology were prospectively surveyed; data were recorded voluntarily by each implantation team on one-page questionnaires. In total, 4627 device implantations were reported, comprising 85.6% of the overall estimated number of implantations. The reported implantation rate was 100.61 per million population and the estimated total implantation rate was 117.50 per million. The proportion of first implantations was 73.87%. We collected data from 143 hospitals (9 more than in 2009). The majority of the implantable cardioverter-defibrillator implantations were performed in men (81%). The mean age was 62.5 ± 13 years. Most of the patients had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. Ischemic heart disease was the most frequent underlying cardiac condition, followed by dilated cardiomyopathy. The number of implantable cardioverter-defibrillator implantations indicated for primary prevention increased over the previous year and now accounts for 65.6% of first implantations. In all, 76.1% of the implantable cardioverter-defibrillator implantations were performed by cardiac electrophysiologists. The 2010 Spanish Implantable Cardioverter-Defibrillator Registry includes data on almost 86% of all the implantable cardioverter-defibrillator implantations performed in Spain. Although the number has continued to increase, it still remains far lower than the European average. There has been a significant increase in the number of implantations indicated for primary prevention. Copyright © 2011 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  9. Magnets and implantable cardioverter defibrillators: what's the problem?

    PubMed

    Rodriguez-Blanco, Yiliam F; Souki, Fouad; Tamayo, Evelyn; Candiotti, Keith

    2013-01-01

    A growing number of surgical patients present to the operating room with implantable cardioverter defibrillators (ICD). Peri-operative care of these patients dictates that ICD function be suspended for many surgical procedures to avoid inappropriate, and possibly harmful, ICD therapy triggered by electromagnetic interference (EMI). An alternative to reprogramming the ICD is the use of a magnet to temporarily suspend its function. However, this approach is not without complications. We report a case where magnet use failed to inhibit ICD sensing of EMI, and a shock was delivered to the patient. Measures to decrease EMI, controversies regarding magnet use, and expert recommendations are discussed.

  10. Sports participation in patients with implantable cardioverter-defibrillators.

    PubMed

    Lampert, R; Olshansky, B

    2012-06-01

    The safety of sports participation for patients with implantable cardioverter-defibrillators (ICDs) is not yet defined, and current recommendations in both Europe and the US restrict these patients from competative sports more vigorous than golf or bowling. Postulated risks include increased frequency of arrhythmias, inability of the ICD to terminate ventricular arrhythmias during the metabolic changes accompanying extreme exercise, injury to the patient, or damage to the ICD system. However, survey data suggest that many ICD patients do participate in sports, and risks may be fewer than postulated. Ongoing research will better delineate the risks of sports for patients with ICDs.

  11. An unusual presentation of implantable cardioverter-defibrillator lead perforation.

    PubMed

    Crusio, Robbert H J; Greenberg, Yisachar J

    2009-01-01

    Recently, there have been increased reports of implantable cardioverter-defibrillator (ICD) lead perforation. Controversy exists about the safety of certain leads. A 37-year-old man with an ischemic cardiomyopathy presented four days postimplantation of an ICD lead with localized nonpleuritic chest wall pain. Imaging demonstrated proximity of the lead to the rib, suggestive of irritation of the periosteum. The lead was repositioned to the right ventricular septum without adverse effect on defibrillation. Lead perforation presenting with focal chest pain due to rib irritation is unusual. Placement of ICD leads on the right ventricular septum should be considered to improve safety.

  12. Ethnic differences among implantable cardioverter defibrillators recipients in Israel.

    PubMed

    Sabbag, Avi; Suleiman, Mahmoud; Glick, Aharon; Medina, Aharon; Golovchiner, Gregory; Steiner, Hillel; Arad, Michael; Goldenberg, Ilan; Glikson, Michael; Beinart, Roy

    2015-04-15

    Heart failure is an increasingly common condition arising from a variety of different pathophysiological processes. Little is known about the unique features of Israeli Arabs who present with heart failure and who undergo cardiac device implantation. The study population comprised of 4,671 patients who were enrolled in the national Israeli Implantable Cardioverter Defibrillator registry. We compared demographic, clinical, and echocardiographic characteristics; device-related indications; and outcomes between Israeli Arabs (n = 733) and Jews (n = 3,938), who were enrolled in the registry from July 2010 through December 2013. Israeli Arabs constituted 15.7% of the study population. They were younger at presentation compared with Jews (57 ± 15 vs 66 ± 12 years, respectively; p <0.001), with a greater burden of co-morbidities, including diabetes mellitus and chronic obstructive lung disease and smoking. In addition, Arab patients had a greater frequency of non-ischemic cardiomyopathy (40.2% vs 24.6%, respectively; p <0.001), which was associated with a greater frequency of familial history of sudden cardiac death. During 15 ± 9 month follow-up, the mortality rates and appropriate device therapy were similar in both ethnic groups. In conclusion, Israeli Arab patients implanted with implantable cardioverter defibrillators display unique clinical features with greater prevalence of non-ischemic cardiomyopathy characterized by an early-onset and rapid deterioration. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Predictors of implantable cardioverter defibrillator shocks during the first year.

    PubMed

    Dougherty, Cynthia M; Hunziker, Jim

    2009-01-01

    The purpose of this study was to predict implantable cardioverter defibrillator (ICD) shocks using demographic and clinical characteristics in the first year after implantation for secondary prevention of cardiac arrest. A prospective design was used to follow 168 first-time ICD recipients over 12 months. Demographic and clinical data were obtained from medical records at the time of ICD insertion. Implantable cardioverter defibrillator shock data were obtained from ICD interrogation reports at hospital discharge, 3, 6, and 12 months. Logistic regression was used to predict ever receiving an ICD shock using background characteristics. Patients received an ICD for secondary prevention of sudden cardiac arrest, they were 64.1 years old, 89% were white, 77% were male, with a mean (SD) ejection fraction of 33.7% (14.1%). The cumulative percentage of ever receiving an ICD shock was 33.3% over 1 year. Three variables predicted shocks in the first year: history of chronic obstructive pulmonary disease (COPD) (odds ratio [OR], 4.42; 95% confidence interval [CI], 1.2-16.4; P = .03), history of congestive heart failure (OR, 3.55; 95% CI, 1.4-9.3; P = .01), and documented ventricular tachycardia (VT) at the time of ICD implant (OR, 10.05; 95% Cl, 1.8-55.4; P = .01). High levels of anxiety approached significance (OR = 2.82; P = .09). The presence of COPD, congestive heart failure, or VT at ICD implant was a significant predictor of receiving an ICD shock in the first year after ICD implantation. Because ICD shocks are distressing, painful, and associated with greater mortality, healthcare providers should focus attention on prevention of shocks by controlling VT, careful management of HF symptoms, reduction of the use of short acting beta agonist medications in COPD, and perhaps recognizing and treating high levels of anxiety.

  14. Deactivation of Pacemakers and Implantable Cardioverter-Defibrillators

    PubMed Central

    Kramer, Daniel B.; Mitchell, Susan L.; Brock, Dan W.

    2013-01-01

    Cardiac implantable electrical devices (CIEDs), including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs), are the most effective treatment for life-threatening arrhythmias. Patients or their surrogates may request device deactivation to avoid prolongation of the dying process or in other settings, such as after device-related complications or with changes in their health care goals. Despite published guidelines outlining theoretical and practical aspects of this common clinical scenario, significant uncertainty remains for both patients and health care providers regarding the ethical and legal status of CIED deactivation. This review outlines the ethical and legal principles supporting CIED deactivation at patients’ request, centered upon patient autonomy and authority over their own medical treatment. The empirical literature describing stakeholder views and experiences surrounding CIED deactivation is described, along with lessons for future research and practice guidance surrounding the care of patients with CIEDs. PMID:23217433

  15. Coping with Trauma and Stressful Events As a Patient with an Implantable Cardioverter-Defibrillator

    MedlinePlus

    ... Patient Page Coping With Trauma and Stressful Events as a Patient With an Implantable Cardioverter-Defibrillator Jessica Ford , ... plan for developing effective coping responses. Is There a Difference Between a Stressful Event and a Traumatic ...

  16. Cost effectiveness of the implantable cardioverter defibrillator: a preliminary analysis

    PubMed Central

    O'Brien, Bernie J; Buxton, Martin J; Rushby, Julia A

    1992-01-01

    Background—An implantable cardioverter defibrillator (ICD) may be effective in reducing the risk of sudden cardiac death. The high cost of ICD treatment, however, compared with alternatives raises the question of whether this new technology is an efficient use of scarce health care resources. Objective—To estimate the incremental cost effectiveness of the implantable cardioverter defibrillator compared with drug treatment with amiodarone in the management of patients at high risk of sudden cardiac death. Design—A cost effectiveness model was constructed from data already published and other secondary sources. Differences in patient survival were calculated from life tables for comparable ICD and amiodarone patient series. Costs were based on typical patient management protocols derived from current United Kingdom practice and interviews with physicians. Main outcome measures—Cost effectiveness of ICD treatment was computed over 20 years; all future costs and effects were discounted at 6% per year. Results—Estimated life expectancy was 11·1 and 6·7 years with ICD and amiodarone respectively; the discounted 20 year difference lies in the range 1·7 to 3·7 years. Discounted 20 year treatment costs were £28 400 for the ICD and £2300 for amiodarone. Cost effectiveness of ICD treatment lies in the range of £15 400 to £8200 per life-year gained. Conclusions—Cost effectiveness of ICD treatment is similar to some existing cardiac programmes funded under the NHS but uncertainty exists due to limitations of the data. Costs of ICD treatment may fall in the future as the life of the device increases and less invasive implantation methods are needed. The effectivess of ICD compared with amiodarone is currently being studied by a randomised controlled trial. PMID:1389748

  17. 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

  18. The Challenges of Living With an Implantable Cardioverter Defibrillator: A Qualitative Study

    PubMed Central

    Abbasi, Mohammad; Negarandeh, Reza; Norouzadeh, Reza; Shojae Mogadam, Amir Reza

    2016-01-01

    Background Dysrhythmia is one of the most common causes of sudden cardiac death worldwide. An implantable cardioverter defibrillator is the most effective method of treatment for dysrhythmias causing cardiac arrest. However, living with an implantable cardioverter defibrillator is associated with challenges such as fear, anxiety, and depression. Objectives The purpose of this study was to identify the challenges of living with an implantable cardioverter defibrillator. Patients and Methods In this qualitative study, an interpretive phenomenological approach was used, with thirteen participants (seven men and six women) between the ages of 21 and 70 years old (mean = 58.15, SD = 14.4). The duration of having an implantable cardioverter defibrillator was 1 - 120 months (mean = 23.15, SD = 33.31). Maximum variation sampling was used to purposefully select the participants from the governmental Imam Khomeini hospital in Tehran, Iran, between May and October of 2013. Semi-structured interviews were conducted for 30 to 45 minutes, and Van Manen’s six-step method was used in this study. Results The challenges of living with an implantable cardioverter defibrillator include: living with fear, concerns about the future, concerns about device malfunction, fearing death during the shock, pain due to the shock, loss of control, the cost of the device, and the lifestyle limitations. Conclusions Patients who live with implantable cardioverter defibrillators face many concerns and challenges. Therefore, the role of nurses in teaching patients before and after implementation is very important. PMID:28180011

  19. The Challenges of Living With an Implantable Cardioverter Defibrillator: A Qualitative Study.

    PubMed

    Abbasi, Mohammad; Negarandeh, Reza; Norouzadeh, Reza; Shojae Mogadam, Amir Reza

    2016-10-01

    Dysrhythmia is one of the most common causes of sudden cardiac death worldwide. An implantable cardioverter defibrillator is the most effective method of treatment for dysrhythmias causing cardiac arrest. However, living with an implantable cardioverter defibrillator is associated with challenges such as fear, anxiety, and depression. The purpose of this study was to identify the challenges of living with an implantable cardioverter defibrillator. In this qualitative study, an interpretive phenomenological approach was used, with thirteen participants (seven men and six women) between the ages of 21 and 70 years old (mean = 58.15, SD = 14.4). The duration of having an implantable cardioverter defibrillator was 1 - 120 months (mean = 23.15, SD = 33.31). Maximum variation sampling was used to purposefully select the participants from the governmental Imam Khomeini hospital in Tehran, Iran, between May and October of 2013. Semi-structured interviews were conducted for 30 to 45 minutes, and Van Manen's six-step method was used in this study. The challenges of living with an implantable cardioverter defibrillator include: living with fear, concerns about the future, concerns about device malfunction, fearing death during the shock, pain due to the shock, loss of control, the cost of the device, and the lifestyle limitations. Patients who live with implantable cardioverter defibrillators face many concerns and challenges. Therefore, the role of nurses in teaching patients before and after implementation is very important.

  20. Economic evaluations of implantable cardioverter defibrillators: a systematic review.

    PubMed

    García-Pérez, Lidia; Pinilla-Domínguez, Pilar; García-Quintana, Antonio; Caballero-Dorta, Eduardo; García-García, F Javier; Linertová, Renata; Imaz-Iglesia, Iñaki

    2015-11-01

    The aim of this paper was to review the cost-effectiveness studies of implantable cardioverter defibrillators (ICD) for primary or secondary prevention of sudden cardiac death (SCD). A systematic review of the literature published in English or Spanish was performed by electronically searching MEDLINE and MEDLINE in process, EMBASE, NHS-EED, and EconLit. Some keywords were implantable cardioverter defibrillator, heart failure, heart arrest, myocardial infarction, arrhythmias, syncope, sudden death. Selection criteria were the following: (1) full economic evaluations published after 1995, model-based studies or alongside clinical trials (2) that explored the cost-effectiveness of ICD with or without associated treatment compared with placebo or best medical treatment, (3) in adult patients for primary or secondary prevention of SCD because of ventricular arrhythmias. Studies that fulfilled these criteria were reviewed and data were extracted by two reviewers. The methodological quality of the studies was assessed and a narrative synthesis was prepared. In total, 24 studies were included: seven studies on secondary prevention and 18 studies on primary prevention. Seven studies were performed in Europe. For secondary prevention, the results showed that the ICD is considered cost-effective in patients with more risk. For primary prevention, the cost-effectiveness of ICD has been widely studied, but uncertainty about its cost-effectiveness remains. The cost-effectiveness ratios vary between studies depending on the patient characteristics, methodology, perspective, and national settings. Among the European studies, the conclusions are varied, where the ICD is considered cost-effective or not dependent on the study.

  1. 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.

  2. 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.

  3. Patients, intimate partners and family experiences of implantable cardioverter defibrillators: qualitative systematic review.

    PubMed

    Palacios-Ceña, Domingo; Losa-Iglesias, Marta E; Alvarez-López, Cristina; Cachón-Pérez, Miguel; Reyes, Rosalie Ann R; Salvadores-Fuentes, Paloma; Fernández-de-Las-Peñas, César

    2011-12-01

    This paper is a report of an interpretive review of qualitative research on how an implantable cardioverter defibrillator affects adult recipients and their significant others. An implantable cardioverter defibrillator detects pathological cardiac rhythms and automatically converts the rhythm with electrical counter shocks. A systematic literature search was conducted for qualitative research papers published between January 1999 and January 2009. PubMed, Medline, ISI Web of Knowledge and CINAHL databases were searched with the following key words: internal defibrillator, implantable defibrillator and qualitative research. Twenty-two papers were included. The critical appraisal skills programme and prompts were used to appraise studies. Thematic analysis and synthesis approaches were used to interpret evidence. People with an implantable cardioverter defibrillator were found to experience physical, psychological and social changes. Shocks produce fear and anxiety, affecting relationships and sexual relations. The use of support groups and the use of the Internet are important in helping adjustment to an implantable cardioverter defibrillator. Women's responses to an implantable cardioverter defibrillator appear different than men's responses and include concerns about physical appearance and relationship issues. Postdischarge follow-up and educational programmes are still underdeveloped. Patients need additional education, support and follow-up care after hospital discharge. Patients and significant others benefit from collaboration between patient associations and healthcare professional societies. Future research is needed to identify the specific challenges that women recipients face. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  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. [Implantable Cardioverter Defibrillator and Perioperative Magnet Application: A Case Report].

    PubMed

    Inoue, Miho; Tokuhira, Natsuko; Sawa, Teiji; Ibuki, Takae

    2015-02-01

    An implantable cardioverter defibrillator (ICD) can falsely recognize noise by monopolar electrocautery as tachyarrhythmia and deliver inappropriate antitachycardia therapy. Application of a clinical magnet on an ICD suspends antitachycardia therapy, but it has not been widely used for this purpose. A 67-year-old male underwent laryngopharyngectomy, cervical esophagectomy, right neck dissection, tracheostomy and reconstruction with free jejunal transplant for recurrent hypopharyngeal cancer. He had an ICD (PARADYM DR8550, Sorin) implanted below the left clavicle for ventricular tachycardia and prolonged QT syndrome. During the operation, a clinical magnet was left on the ICD to disable antitachycardia therapy. The magnet mode of the ICD provided asynchronous AAI pacing at 96 beats x min(-1). The surgery proceeded uneventfully. No episode of ventricular tachyarrythmia or pacing inhibition by electromagnetic interference was observed on electrocardiogram. This case illustrated the potential role of a clinical magnet as an alternative to reprogramming of an ICD by a programmer in the perioperative management of a patient with an ICD when a technical expert to operate a programmer is not available.

  6. 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.

  7. Relationship of Extreme Cold Weather and Implantable Cardioverter Defibrillator Shocks.

    PubMed

    Cloutier, Justin M; Liu, Shuangbo; Hiebert, Brett; Tam, James W; Seifer, Colette M

    2017-09-15

    Cold weather to 0°C has been implicated as a risk factor for ventricular arrhythmias and implantable cardioverter defibrillator (ICD) shocks. The effect of more extreme cold weather on the risk of ventricular arrhythmias and ICD shocks is unknown. We sought to describe the relationship between extreme cold weather and the risk of ICD shocks. We retrospectively identified patients seen at the Pacemaker and Defibrillator Clinic at St. Boniface Hospital in Winnipeg, Manitoba, Canada between 2010 and 2015 with an ICD shock. We excluded multiple shocks occurring on the same day in a single patient. We collected weather data, and evaluated the relationship between ICD shocks and weather on the same day as the shock using Negative Binomial regression. Three hundred and sixty patients experienced a total of 1,355 shocks. When excluding multiple shocks occurring in a single patient on the same day, there were 756 unique shocks. The daily high (DH) was the strongest predictor of receiving an ICD shock. Compared with the warmest days (DH above 10°C), shocks were 25% more common on the coldest days (DH below -10°C), and 8% more common on cold days (DH between -10°C and 10°C). This linear trend was statistically significant, with a p-value of 0.04. In conclusion, we found an association between extreme cold weather and ICD shocks. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Sensing and detection in Medtronic implantable cardioverter defibrillators.

    PubMed

    Brown, Mark L; Swerdlow, Charles D

    2016-09-01

    Ensuring sensing and detection of ventricular tachycardia (VT) and ventricular fibrillation (VF) was a prerequisite for the clinical trials that established the survival benefit of implantable cardioverter defibrillators (ICDs). However, for decades, a high incidence of unnecessary shocks limited patients' and physicians' acceptance of ICD therapy. Oversensing, misclassification of supraventricular tachycardia (SVT) as VT, and self-terminating VT accounted for the vast majority of unnecessary shocks. Medtronic ICDs utilize sensitive baseline settings with minimal blanking periods to ensure accurate sensing of VF, VT, and SVT electrograms. Programmable algorithms reject oversensing caused by far-field R waves, T waves, and non-physiologic signals caused by lead failure. A robust hierarchy of SVT-VT discriminators minimize misclassification of SVT as VT. These features, combined with evidence-based programming, have reduced the 1‑year inappropriate shock rate to 1.5 % for dual-/triple-chamber ICDs and to 2.5 % for single-chamber ICDs.

  9. The federal audit of implantable cardioverter-defibrillator implants: lessons learned.

    PubMed

    Steinberg, Jonathan S; Mittal, Suneet

    2012-04-03

    The federal government has investigated a large number of institutions regarding concerns that implantable cardioverter-defibrillator procedures were performed in violation of the criteria set forth in a National Coverage Determination. We describe our experience and responses to such an audit, as well as the to complexities and nuances of practicing evidence-based medicine in the setting of heavy regulatory oversight.

  10. Spanish implantable cardioverter-defibrillator registry. Eighth official report of the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators (2011).

    PubMed

    Alzueta, Javier; Fernández, José María

    2012-11-01

    To summarize the findings of the Spanish Implantable Cardioverter-Defibrillator Registry for 2011 compiled by the Electrophysiology and Arrhythmia Section of the Spanish Society of Cardiology. Each implantation team voluntarily and prospectively recorded data on a data collection form, which was then sent to the Spanish Society of Cardiology. Overall, 4481 device implantations were notified, representing 83.6% of the estimated total number of implantations. The notified implantation rate was 97 per million population and the estimated total implantation rate was 116.2 per million. First implantations accounted for 70.2% of the total notified. Data were collected from 167 hospitals (22 more than in 2010). Most implantable cardioverter-defibrillator implantations took place in men (82.1%). The mean age was 62.4 (14.1) years. Most patients had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most frequent underlying cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. The number of indications for primary prevention increased over the previous year and accounted for 70.6% of first implantations. Overall, 78.4% of implantable cardioverter-defibrillators were implanted by cardiac electrophysiologists. The 2011 Spanish Implantable Cardioverter-Defibrillator Registry includes data on almost 84% of all implantations of these devices performed in Spain. This was the first year in which the number of implants decreased slightly from the previous year, as also occurred in the rest of Europe. The percentage of implants for primary prevention continued to increase. Full English text available from:www.revespcardiol.org. Copyright © 2012 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  11. 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.

  12. 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

  13. [Spanish Implantable Cardioverter-Defibrillator Registry. Fourth Official Report of the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators (2007)].

    PubMed

    Peinado Peinado, Rafael; Torrecilla, Esteban G; Ormaetxe, José; Alvarez, Miguel

    2008-11-01

    This article presents the 2007 findings of the Spanish Implantable Cardioverter-Defibrillator (ICD) Registry, established by the Working Group on Implantable Cardioverter-Defibrillators, Electrophysiology and Arrhythmia Section, Spanish Society of Cardiology. The Spanish Society of Cardiology received prospective data recorded on a single-page questionnaire on 96.6% of device implantations. Overall, 3,291 implantations were reported (90.1% of the estimated total). The reported implantation rate was 72.8 per million inhabitants, and 77.1% were first implantations. The majority of ICDs were implanted in males (mean age, 61 [12] years) in functional class II with severe or moderate-to-severe left ventricular dysfunction. The most frequent form of heart disease was ischemic heart disease, followed by dilated cardiomyopathy. Indications for primary prevention remained unchanged relative to the previous year and now account for half of all first implantations, with an increasing number of patients with dilated cardiomyopathy. The number of ICDs incorporating cardiac resynchronization therapy has increased slightly and now comprises 30.1% of the total. Around 70% of ICD implantations were performed in an electrophysiology laboratory by a cardiac electrophysiologist. The incidence of complications was very low. The 2007 Spanish Implantable Cardioverter-Defibrillator Registry contains data on more than 90% of all ICD implantations performed in Spain, thereby confirming that it has become increasingly representative in recent years. The number of implantations has continued to grow, though the proportion carried out for primary prevention has stabilized at around 50%.

  14. 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.

  15. 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

  16. 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.

  17. Automatic implantable cardioverter/defibrillator discharges and acute myocardial injury

    SciTech Connect

    Avitall, B.; Port, S.; Gal, R.; McKinnie, J.; Tchou, P.; Jazayeri, M.; Troup, P.; Akhtar, M. )

    1990-05-01

    Multiple defibrillations by the automatic implantable cardioverter/defibrillator (AICD) have been reported to result in localized epicardial damage. No data exist, however, regarding whether this damage can be detected in the clinical setting or whether it interferes with the detection of true myocardial infarction. Forty-nine patients who received defibrillations by patch electrodes were studied prospectively. We attempted to document the presence of myocardial injury with the following three commonly used modalities for the detection of myocardial infarction: serial electrocardiographic changes, serial creatine phosphokinase (CPK) and CPK-MB release, and technetium 99m pyrophosphate scanning. Fifteen patients received defibrillations by AICD patches at the time of AICD generator replacement. Nine patients received defibrillations at the time of new AICD lead placement. The average total energy delivered was 85 +/- 29 J. None of these patients had detectable myocardial injury. Ten patients had defibrillations by the AICD patches at the time of bypass operation. One patient in this group developed acute myocardial infarction in the inferior wall after posterior descending coronary bypass operation, as detected by electrocardiogram, 99mTc pyrophosphate scanning, and CPK-MB analysis. Fifteen patients were evaluated for spontaneous AICD discharges. Thirteen had a maximum of five consecutive shocks, and cumulative energy delivered was not greater than 330 J. None of these patients had detectable injury. Two patients had CPK-MB release of 15.3% and 7.5%, respectively. One of these patients had a positive 99mTc pyrophosphate scan. These two patients received 12 and 17 rapid and consecutive AICD discharges, respectively, with cumulative delivered energy of 360 and 510 J, respectively.

  18. Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.

    PubMed

    Schoenfeld, Mark H; Compton, Steven J; Mead, R Hardwin; Weiss, Daniel N; Sherfesee, Lou; Englund, Jennifer; Mongeon, Luc R

    2004-06-01

    A prospective study evaluating the functionality and ease of use of the Medtronic CareLink Network, "CareLink," was conducted at ten investigational sites. This internet-based remote monitoring service allows clinicians to remotely manage their patients' implantable cardioverter defibrillators (ICDs) and chronic diseases. The network is comprised of a patient monitor, a secure server, and clinician and patient websites. Under clinician direction, patients interrogated their ICDs at home, and transmitted data to secure servers via a standard telephone line. Comprehensive device data and a 10-second presenting rhythm electrogram were captured by the monitor and available for access and review on the clinician website. The information could also be printed using a standard desktop computer with internet access. During this study, patients were asked to transmit device data twice, at least 7 days apart, as scheduled by the clinic. Monitor functionality was assessed, and ease of using the system components was evaluated via questionnaires completed by patients and clinicians following each data transmission and review. Fifty-nine patients (64 +/- 14 years, range 22-85 years) completed 119 transmissions with only 14 calls to the study support center. Clinician review of data transmissions revealed several clinically significant findings, including silent AF discovery, assessment of antiarrhythmic drug efficacy in a previously diagnosed AF patient, previously unobserved atrial undersensing, and ventricular tachycardia. ICD patients found the monitor easy to use. Clinicians were pleased with the performance of the network and the quality of the web-accessed data, and found it comparable to an in-office device interrogation. CareLink is a practical tool for routine device management and may allow timely identification of clinically important issues.

  19. Mycobacterium fortuitum causing infection of a biventricular pacemaker/implantable cardioverter defibrillator.

    PubMed

    Hu, Yuhning L; Bridge, Bronwyn; Wang, Jeffrey; Jovin, Ion S

    2012-12-01

    Increased utilization of cardiovascular implantable electronic devices (CIED) has seen a corresponding rise in related infections. Non-tuberculosis mycobacteria (NTM) are rarely the cause. Treatment involves susceptibilities, antimicrobials, and device removal. This study presents a patient who underwent a biventricular implantable cardioverter defibrillator upgrade with a multi-drug resistant Mycobacterium fortuitum located at the pocket site and a lead infection.

  20. [The automatic implantable cardioverter-defibrillator for prevention of sudden heart death in children and adolescents].

    PubMed

    Paul, T; Luhmer, I; Trappe, H J; Klein, H; Fieguth, H G; Brauer, C; Scharpwinkel, U; Kallfelz, H C

    1993-08-01

    Little experience exists with the automatic implantable cardioverter-defibrillator in the pediatric population. Since 1990, an automatic implantable cardioverter defibrillator was implanted in four young patients (mean age 15.8 years, mean body weight 53.3 kg) with life-threatening ventricular tachyarrhythmias at our institution. In three patients, a cardiac anomaly was evident (dilated cardiomyopathy, status post Rastelli operation for complex transposition of the great arteries, status post atrial switch for transposition of the great arteries), the last patient had a normal cardiac anatomy. Indications for implantation were resuscitation from documented hypotensive ventricular tachycardia in one patient and recurrent syncope of suspected cardiac origin in the remaining three patients. At preimplantation electrophysiological study, all four patients had inducible ventricular tachycardia and/or ventricular fibrillation. At implantation of the cardioverter defibrillator in the operating theatre, the ventricular tachyarrhythmias were again induced and terminated reliably by the device. After a mean follow-up of 13 months, three of the four patients had appropriate discharges without syncope or resuscitation. The automatic implantable cardioverter-defibrillator appears to be a feasible and effective therapy also in pediatric patients for prevention of sudden cardiac death due to ventricular tachyarrhythmias.

  1. Implantation of the Subcutaneous Implantable Cardioverter-Defibrillator: An Evaluation of 4 Implantation Techniques.

    PubMed

    Brouwer, Tom F; Miller, Marc A; Quast, Anne-Floor B E; Palaniswamy, Chandrasekar; Dukkipati, Srinivas R; Reddy, Vivek; Wilde, Arthur A; Willner, Jonathan M; Knops, Reinoud E

    2017-01-01

    Alternative techniques to the traditional 3-incision subcutaneous implantation of the subcutaneous implantable cardioverter-defibrillator may offer procedural and cosmetic advantages. We evaluate 4 different implant techniques of the subcutaneous implantable cardioverter-defibrillator. Patients implanted with subcutaneous implantable cardioverter-defibrillators from 2 hospitals between 2009 and 2016 were included. Four implantation techniques were used depending on physician preference and patient characteristics. The 2- and 3-incision techniques both place the pulse generator subcutaneously, but the 2-incision technique omits the superior parasternal incision for lead positioning. Submuscular implantation places the pulse generator underneath the serratus anterior muscle and subfascial implantation underneath the fascial layer on the anterior side of the serratus anterior muscle. Reported outcomes include perioperative parameters, defibrillation testing, and clinical follow-up. A total of 246 patients were included with a median age of 47 years and 37% female. Fifty-four patients were implanted with the 3-incision technique, 118 with the 2-incision technique, 38 with submuscular, and 37 with subfascial. Defibrillation test efficacy and shock lead impedance during testing did not differ among the groups; respectively, P=0.46 and P=0.18. The 2-incision technique resulted in the shortest procedure duration and time-to-hospital discharge compared with the other techniques (P<0.001). A total of 18 complications occurred, but there were no significant differences between the groups (P=0.21). All infections occurred in subcutaneous implants (3-incision, n=3; 2-incision, n=4). In the 2-incision group, there were no lead displacements. The presented implantation techniques are feasible alternatives to the standard 3-incision subcutaneous implantation, and the 2-incision technique resulted in shortest procedure duration. © 2017 American Heart Association, Inc.

  2. Transvenous implantable cardioverter-defibrillator lead reliability: implications for postmarket surveillance.

    PubMed

    Kramer, Daniel B; Hatfield, Laura A; McGriff, Deepa; Ellis, Christopher R; Gura, Melanie T; Samuel, Michelle; Retel, Linda Kallinen; Hauser, Robert G

    2015-05-29

    As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers. We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up. Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  3. Transvenous Implantable Cardioverter-Defibrillator Lead Reliability: Implications for Postmarket Surveillance

    PubMed Central

    Kramer, Daniel B; Hatfield, Laura A; McGriff, Deepa; Ellis, Christopher R; Gura, Melanie T; Samuel, Michelle; Retel, Linda Kallinen; Hauser, Robert G

    2015-01-01

    Background As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up. Conclusions Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death. PMID:26025935

  4. Inappropriate shock delivery due to interference between a washing machine and an implantable cardioverter defibrillator.

    PubMed

    Kolb, Christof; Schmieder, Sebastian; Schmitt, Claus

    2002-12-01

    Electromagnetic interference with implantable cardioverter defibrillators (ICD) can cause inappropriate delivery of therapies or temporary inhibition of ICD functions. The presented case describes electromagnetic interference between a washing machine and an ICD resulting in an inappropriate discharge of the device due to false detection of ventricular fibrillation.

  5. 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.

  6. 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,…

  7. 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,…

  8. Intermittent, erratic behaviour of an implantable cardioverter defibrillator secondary to a hidden magnetic source of interference

    PubMed Central

    Beinart, Roy; Guy, Mary L.; Ellinor, Patrick T.

    2011-01-01

    Interference between pacemakers or implantable cardioverter-defibrillators (ICDs) and electromagnetic fields are of great concern due to the potential harmful influence on the function of the device. We report a case of intermittent, erratic behaviour of an ICD secondary to electromagnetic interference (EMI) caused by small magnets that were incorporated into the patient's clothing. PMID:21576126

  9. [Spanish Implantable Cardioverter-Defibrillator Registry. Third Official Report of the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators (2006)].

    PubMed

    Peinado, Rafael; Torrecilla, Esteban G; Ormaetxe, José; Alvarez, Miguel

    2007-12-01

    To report the 2006 findings of the Spanish Implantable Cardioverter-Defibrillator (ICD) Registry, established by the Working Group on Implantable Cardioverter-Defibrillators, Electrophysiology and Arrhythmia Section, Spanish Society of Cardiology. Each ICD team voluntarily reported data to the Spanish Society of Cardiology by completing a single-page questionnaire. Prospective data were collected on 91.8% of implantations. In total, 2679 implantations were reported to the registry (86.6% of the estimated total). The reported implantation rate was 60 per million inhabitants, and the estimated rate was 69 per million. The proportion of first implantations was 80%. The majority of ICDs were implanted in males (mean age 61.5 [14] years) with severe or moderate-to-severe left ventricular dysfunction who were in functional class II or I. Ischemic heart disease was the most frequent etiology, followed by dilated cardiomyopathy. This is the first year that half of first device implantations were carried out for primary prevention, with substantial increases among patients with ischemic heart disease and dilated cardiomyopathy. The number of ICDs incorporating cardiac resynchronization therapy has continued to grow, and now comprises 28.6% of all devices implanted. As in the previous year, around 70% of ICD implantations were performed in an electrophysiology laboratory by a cardiac electrophysiologist. The incidence of complications during device implantation was very low. The 2006 Spanish Implantable Cardioverter-Defibrillator Registry contains data on more than 86% of all ICD implantations performed in Spain. Half of first device implantations were carried out for the purposes of primary prevention.

  10. 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

  11. 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.

  12. Spanish implantable cardioverter-defibrillator registry. 5th official report of the spanish society of cardiology working group on implantable cardioverter-defibrillators (2008).

    PubMed

    Peinado, Rafael; Torrecilla, Esteban G; Ormaetxe, José; Alvarez, Miguel; Cózar, Rocío; Alzueta, Javier

    2009-12-01

    To summarize the findings of the Spanish Implantable Cardioverter-Defibrillator (ICD) Registry for 2008 compiled by the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators. Prospective data recorded voluntarily on single-page questionnaires were sent to the Spanish Society of Cardiology by each implantation team. Overall, 3486 device implantations were reported, which is 84.7% of the estimated total number of implantations. The reported implantation rate was 76 per million population and the estimated total implantation rate was 90 per million. The proportion of first implantations was 78.1%. There continued to be substantial regional variations within Spain. The majority of ICD implantations took place in men (mean age 62+/-12 years) who had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. Ischemic heart disease was the most frequent underlying cardiac condition, followed by dilated cardiomyopathy. The number of indications for primary prevention increased relative to the previous year, especially in patients with ischemic cardiomyopathy, and now account for 57% of first implantations. The types of ICD implanted were unchanged from 2007. Overall, 73.6% of ICDs were implanted by cardiac electrophysiologists. The 2008 Spanish ICD Registry includes data on almost 85% of all ICD implantations performed in Spain. Although the number has continued to increase, it still remains far from the European average. There was a significant increase in indications for primary prevention. Substantial regional variations continue to exist within Spain.

  13. Silicone Breast Implant and Automatic Implantable Cardioverter Defibrillator: Can They Coexist? A Case Report.

    PubMed

    Or, Friedman; Arik, Zaretski

    2016-08-01

    We present a case of a silicone breast implant rupture after insertion of an automatic implantable cardioverter defibrillator (AICD). A 51-year-old woman presented to our plastic surgery clinic to exchange her silicone breast implants. The patient underwent cosmetic mastopexy and breast augmentation in 2008. Because of recurrent myocardial infarctions and chronic heart failure, she underwent an insertion of an AICD in 2014 in which the left breast implant was hit. In this report, we discuss the first case of an AICD insertion, disrupting a breast implant. This case report illustrates the rare but real possibility of breast implant rupture after even minor surgical manipulation of the breast area.

  14. [Spanish implantable cardioverter-defibrillator registry. First official report of the spanish society of cardiology working group on implantable cardioverter-defibrillators (2002-2004)].

    PubMed

    Peinado, Rafael; Arenal, Angel; Arribas, Fernando; Torrecilla, Esteban; Alvarez, Miguel; Ormaetxe, José M; Pérez-Castellano, Nicasio

    2005-12-01

    To report the 2002-2004 findings of the Spanish National Implantable Cardioverter-Defibrillator (ICD) Registry, established by the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators. Data were collected prospectively after implantation using a single-page questionnaire returned to the Spanish Society of Cardiology. Participation was voluntary. The registry received reports on 925, 1,046 and 1414 implants, respectively, in the years 2002, 2003 and 2004. These figures represent 63%, 59% and 67.5%, respectively, of the total number of ICDs implanted. The reported implantation rates were 22, 24 and 33 per million, respectively, and the estimated total implantation rates were 35, 41 and 49, per million, respectively. The number of device replacements increased from 20% to 30% between 2002 and 2004. The majority of patients were male, their median age was 66 years, they had severe or moderate left ventricular dysfunction, and they were in functional class I or II. The most common underlying heart disease was ischemic heart disease. The main indications for an ICD were sustained monomorphic ventricular tachycardia and aborted sudden cardiac death, though the number of prophylactic indications has increased. Most ICDs were implanted in an electrophysiology laboratory by a cardiac electrophysiologist. The implantation rates of dual-chamber ICDs and ICDs with cardiac resynchronization therapy were approximately 30% and 15%, respectively. Very few complications occurred during implantation. The Spanish National ICD Registry contains a representative sample of ICD implantations performed in the country. The registry is one of the largest reported.

  15. Implantable cardioverter defibrillator specific rehabilitation improves health cost outcomes: Findings from the COPE-ICD randomized controlled trial.

    PubMed

    Berg, Selina Kikkenborg; Zwisler, Ann-Dorthe; Koch, Mette Bjerrum; Svendsen, Jesper Hastrup; Christensen, Anne Vinggaard; Pedersen, Preben U; Thygesen, Lau Caspar

    2015-03-01

    The Copenhagen Outpatient ProgrammE - implantable cardioverter defibrillator (COPE-ICD) trial included patients with implantable cardioverter defibrillators in a randomized controlled trial of rehabilitation. After 6-12 months significant differences were found in favour of the rehabilitation group for exercise capacity, general and mental health. The aim of this paper is to explore the long-term health effects and cost implications associated with the rehabilitation programme; more specifically, (i) to compare implantable cardioverter defibrillator therapy history and mortality between rehabilitation and usual care groups; (ii) to examine the difference between rehabilitation and usual care groups in terms of time to first admission; and (iii) to determine attributable direct costs. Patients with first-time implantable cardioverter defibrillator implantation (n = 196) were randomized (1:1) to comprehensive cardiac rehabilitation or usual care. Outcomes were measured by implantable cardioverter defibrillator therapy history from patient records and national register follow-up on mortality, hospital admissions and costs. No significant differences were found after 3 years for implantable cardioverter defibrillator therapy or mortality between rehabilitation and usual care. Time to first admission did not differ. The cost of rehabilitation was 335 USD/276 Euro per patient enrolled in rehabilitation. The total attributable cost of rehabilitation after 3 years was -6,789 USD/-5,593 Euro in favour of rehabilitation. No long-term health outcome benefits were found for the rehabilitation programme. However, the rehabilitation programme resulted in a reduction in total attributable direct costs.

  16. Fuzzy logic-based diagnostic algorithm for implantable cardioverter defibrillators.

    PubMed

    Bárdossy, András; Blinowska, Aleksandra; Kuzmicz, Wieslaw; Ollitrault, Jacky; Lewandowski, Michał; Przybylski, Andrzej; Jaworski, Zbigniew

    2014-02-01

    The paper presents a diagnostic algorithm for classifying cardiac tachyarrhythmias for implantable cardioverter defibrillators (ICDs). The main aim was to develop an algorithm that could reduce the rate of occurrence of inappropriate therapies, which are often observed in existing ICDs. To achieve low energy consumption, which is a critical factor for implantable medical devices, very low computational complexity of the algorithm was crucial. The study describes and validates such an algorithm and estimates its clinical value. The algorithm was based on the heart rate variability (HRV) analysis. The input data for our algorithm were: RR-interval (I), as extracted from raw intracardiac electrogram (EGM), and in addition two other features of HRV called here onset (ONS) and instability (INST). 6 diagnostic categories were considered: ventricular fibrillation (VF), ventricular tachycardia (VT), sinus tachycardia (ST), detection artifacts and irregularities (including extrasystoles) (DAI), atrial tachyarrhythmias (ATF) and no tachycardia (i.e. normal sinus rhythm) (NT). The initial set of fuzzy rules based on the distributions of I, ONS and INST in the 6 categories was optimized by means of a software tool for automatic rule assessment using simulated annealing. A training data set with 74 EGM recordings was used during optimization, and the algorithm was validated with a validation data set with 58 EGM recordings. Real life recordings stored in defibrillator memories were used. Additionally the algorithm was tested on 2 sets of recordings from the PhysioBank databases: MIT-BIH Arrhythmia Database and MIT-BIH Supraventricular Arrhythmia Database. A custom CMOS integrated circuit implementing the diagnostic algorithm was designed in order to estimate the power consumption. A dedicated Web site, which provides public online access to the algorithm, has been created and is available for testing it. The total number of events in our training and validation sets was 132. In

  17. Epicardial Implantable Cardioverter-Defibrillator in a 2-Month-Old Infant.

    PubMed

    Sughimoto, Koichi; Tsuchida, Yuta; Hayashi, Hidenori; Torii, Shinzo; Kitamura, Tadashi; Horai, Tetsuya; Miyaji, Kagami

    2017-03-01

    We describe the implantation of an implantable cardioverter defibrillator (ICD) in a 2-month-old infant with frequent sustained ventricular tachycardia (VT) refractory to antiarrhythmic agents. An epicardial ICD shock coil lead and pacing leads were placed, as was a cumbersome device console that was stored in a pocket between the left external and internal oblique muscles. These methods were safe and feasible even for such a small infant, and possible adverse events were avoided.

  18. Performance of Lead Integrity Alert to assist in the clinical diagnosis of implantable cardioverter defibrillator lead failures: analysis of different implantable cardioverter defibrillator leads.

    PubMed

    Ellenbogen, Kenneth A; Gunderson, Bruce D; Stromberg, Kurt D; Swerdlow, Charles D

    2013-12-01

    The Lead Integrity Alert (LIA) was developed for Medtronic implantable cardioverter defibrillators to reduce inappropriate shocks for rapid oversensing caused by conductor fractures and reported for Medtronic Fidelis conductor fractures. The goal of this study was to compare the performance of LIA with conventional impedance monitoring for identifying lead system events (LSEs) and lead failures (LFs) in lead families that differ from Fidelis. We analyzed data from 12 793 LIA enabled implantable cardioverter-defibrillator and lead combinations including 6123 St. Jude Riata or Durata, 5114 Boston Scientific Endotak, and 1556 Fidelis combinations followed in the CareLink remote monitoring network for LSEs and LFs. Each alert was adjudicated based on implantable cardioverter-defibrillator stored electrograms/diagnostics and clinical data as an LSE or non-lead system event by 2 physicians after reviewing the electrograms and clinical data. During 13 562 patient-years of LIA follow-up, there were 179 adjudicated alerts, of which 84 were LSEs (including 65 LFs) and 95 were non-lead system events. LIA identified >66% more LSE and >67% more LF compared with conventional impedance monitoring and did not differ by lead family for LSE (P=0.573) or LF (P=0.332). Isolated spikes on electrogram were associated more often with LF in St. Jude leads (71%) compared with Endotak (9%; P<0.001) and Fidelis leads (11%; P<0.001). The non-lead system event detection rate was different among lead families (P<0.001) ranging from 1 in every 78.5 years (Endotak), 228.9 years (St. Jude leads), and 627.6 years (Fidelis). LIA markedly increased the detection rate of LSE compared with conventional impedance monitoring.

  19. Successful intermuscular implantation of subcutaneous implantable cardioverter defibrillator in a Japanese patient with pectus excavatum.

    PubMed

    Kondo, Yusuke; Ueda, Marehiko; Winter, Joachim; Nakano, Miyo; Nakano, Masahiro; Ishimura, Masayuki; Miyazawa, Kazuo; Tateno, Kaoru; Kobayashi, Yoshio

    2017-02-01

    The entirely subcutaneous implantable cardioverter-defibrillator (ICD) system was developed to provide a life-saving defibrillation therapy that does not affect the heart and vasculature. The subcutaneous ICD is preferred over the transvenous ICD for patients with a history of recurrent infection presenting major life-threatening rhythms. In this case report, we describe the first successful intermuscular implantation of a completely subcutaneous ICD in a Japanese patient with pectus excavatum. There were no associated complications with the device implantation or lead positioning. Further, the defibrillation threshold testing did not pose any problem with the abnormal anatomy of the patient.

  20. Intraoperative defibrillation threshold testing and postoperative long-term efficacy of cardioverter-defibrillator implantation

    PubMed Central

    GAN, TIANYI; CAO, XIAOZHI; YU, ZHANG; TANG, BAOPENG; LI, JINXIN; XU, GUOJUN; ZHOU, XIANHUI; ZHANG, YANYI; LI, YAODONG; ZHANG, JIANGHUA

    2013-01-01

    The aim of this study was to determine the defibrillation threshold (DFT) of implantable cardioverter-defibrillators (ICDs) and outcomes of treatment. Sixty-four patients received cardioverter-defibrillator implantation. During implantation, the DFT was determined by the defibrillation safety margin (DSM). All patients were followed up for 12–48 months after the implantation. The overall DFT was 14.27±2.56 J and the DSM was 18.40±1.89 J. Malignant ventricular arrhythmias occurred in 42 patients following cardioverter-defibrillator implantation including 500 episodes of non-sustained ventricular tachycardia (VT) and 289 episodes of persistent VT. VT was treated using antitachycardia pacing (ATP); 265 episodes were treated successfully by a single ATP treatment (91.69%) and 12 episodes were treated successfully by two ATP treatments (4.15%). Twelve episodes were converted by low-energy electrical cardioversion (4.15%). A total of 175 ventricular fibrillation (VF) episodes were identified, of which 18 episodes automatically terminated prior to treatment. In total, 146 episodes were converted by a single cardioversion with a defibrillation energy of 13.21±2.58 J and 11 episodes were converted by two cardioversions with a defibrillation energy of 16.19±2.48 J. It is safe and feasible to determine the DFT by DSM measurement during cardioverterdefibrillator implantation. PMID:23251292

  1. Upper limit of vulnerability determination during implantable cardioverter-defibrillator placement to minimize ventricular fibrillation inductions.

    PubMed

    Glikson, Michael; Gurevitz, Osnat T; Trusty, Jane M; Sharma, Vinod; Luria, David M; Eldar, Michael; Shen, Win-Kuang; Rea, Robert F; Hammill, Stephen C; Friedman, Paul A

    2004-12-01

    The defibrillation threshold (DFT) and upper limit of vulnerability (ULV) were determined using step-down protocols in 50 patients who underwent implantable cardioverter-defibrillator placement or testing. The sensitivity and specificity of each ULV energy level was assessed for detecting an increased DFT, correlation of the DFT and ULV, and optimal shock timing for ULV determination. A ULV <10 or 11 J (failure to induce ventricular fibrillation with 10- to 11-J shocks) was 100% predictive of an acceptable DFT and may be sufficient to exclude unacceptable DFTs in 60% of implantable cardioverter-defibrillator recipients. All 4 shocks used to scan the peak of the T wave during ULV testing were necessary for accurate ULV determination.

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

    SciTech Connect

    Gossman, Michael S.; Nagra, Bipinpreet; Graves-Calhoun, Alison; Wilkinson, Jeffrey

    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 a 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.

  3. Dental management of a patient fitted with subcutaneous Implantable Cardioverter Defibrillator device and concomitant warfarin treatment.

    PubMed

    Shah, Altaf Hussain; Khalil, Hesham Saleh; Kola, Mohammed Zaheer

    2015-07-01

    Automated Implantable Cardioverter Defibrillators (AICD), simply known as an Implantable Cardioverter Defibrillator (ICD), has been used in patients for more than 30 years. An Implantable Cardioverter Defibrillator (ICD) is a small battery-powered electrical impulse generator that is implanted in patients who are at a risk of sudden cardiac death due to ventricular fibrillation, ventricular tachycardia or any such related event. Typically, patients with these types of occurrences are on anticoagulant therapy. The desired International Normalized Ratio (INR) for these patients is in the range of 2-3 to prevent any subsequent cardiac event. These patients possess a challenge to the dentist in many ways, especially during oral surgical procedures, and these challenges include risk of sudden death, control of post-operative bleeding and pain. This article presents the dental management of a 60 year-old person with an ICD and concomitant anticoagulant therapy. The patient was on multiple medications and was treated for a grossly neglected mouth with multiple carious root stumps. This case report outlines the important issues in managing patients fitted with an ICD device and at a risk of sudden cardiac death.

  4. Dental management of a patient fitted with subcutaneous Implantable Cardioverter Defibrillator device and concomitant warfarin treatment

    PubMed Central

    Shah, Altaf Hussain; Khalil, Hesham Saleh; Kola, Mohammed Zaheer

    2015-01-01

    Automated Implantable Cardioverter Defibrillators (AICD), simply known as an Implantable Cardioverter Defibrillator (ICD), has been used in patients for more than 30 years. An Implantable Cardioverter Defibrillator (ICD) is a small battery-powered electrical impulse generator that is implanted in patients who are at a risk of sudden cardiac death due to ventricular fibrillation, ventricular tachycardia or any such related event. Typically, patients with these types of occurrences are on anticoagulant therapy. The desired International Normalized Ratio (INR) for these patients is in the range of 2–3 to prevent any subsequent cardiac event. These patients possess a challenge to the dentist in many ways, especially during oral surgical procedures, and these challenges include risk of sudden death, control of post-operative bleeding and pain. This article presents the dental management of a 60 year-old person with an ICD and concomitant anticoagulant therapy. The patient was on multiple medications and was treated for a grossly neglected mouth with multiple carious root stumps. This case report outlines the important issues in managing patients fitted with an ICD device and at a risk of sudden cardiac death. PMID:26236132

  5. Inappropriate implantable cardioverter defibrillator shock from a transcutaneous muscle stimulation device therapy.

    PubMed

    Siu, Chung-Wah; Tse, Hung-Fat; Lau, Chu-Pak

    2005-06-01

    Inappropriate shock from implantable cardioverter defibrillator (ICD) may result from external electromagnetic interference (EMI), especially for unipolar ventricle sensing. Previous case reports and small in-vitro safety study suggested that endocardial bipolar lead system may be immune from EMI resulting from transcutaneous electrical neuromuscle stimulation (TENS) therapy. This report presents an unusual case of inappropriate discharge in a patient with ICD of endocardial bipolar lead system, receiving TENS from a commercially available device.

  6. Psychiatric Disorders and Quality of Life in Patients With Implantable Cardioverter Defibrillators: A Systematic Review

    PubMed Central

    Soares-Filho, Gastão; Pereira, Valeska; Nardi, Antonio Egidio; Silva, Adriana Cardoso

    2013-01-01

    Objective: To systematically review the literature with regard to psychiatric disorders and quality of life in patients with an implantable cardioverter defibrillator. Data Sources: Research was conducted in 3 databases (ISI Web of Science, PubMed, and PsycINFO) using the terms implantable, cardioverter, defibrillator, quality of life, psych*, anxiety, and depression. Study Selection: The search yielded 1,399 references. Non-English and repeated references were excluded. After abstract analysis, 42 references were recovered for full-text reading, and 25 articles were selected for this review. Data Extraction: Research took place in April 2012, and no time restriction was placed on any of the database searches. Review or theoretical articles were excluded, and only clinical trials and epidemiologic studies were selected for this review. Results: A systematic review of the literature revealed mostly observational prospective cohort studies followed by cross-sectional observational studies and randomized clinical trials. Few studies included in the review were observational retrospective cohort or case-control studies. There are prominent signs and symptoms of anxiety and depression in patients with an implantable cardioverter defibrillator. Disorders include phobic anxiety, posttraumatic stress disorder, panic disorder, somatoform disorder, agoraphobia, and depression. Quality of life in the physical, social, and psychological domains is affected and is related to the intensity and the frequency of the device’s electrical discharge. Conclusions: Work regarding psychiatric comorbidity in patients with an implantable cardioverter defibrillator has shown that anxiety and depression are common. The patients and their families should be informed by their doctors that the presence of the device minimizes risk of sudden death and allows them to have a normal life. PMID:23930235

  7. 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

  8. Athletic participation in the young patient with an implantable cardioverter-defibrillator.

    PubMed

    Lampert, Rachel; Law, Ian

    2017-01-01

    The decision of whether to allow a young patient with an implantable cardioverter-defibrillator to continue to participate in sports is complex and multi-factorial. The positive physical and psychosocial impact of sports participation must be weighed against the potential adverse events associated with implantable cardioverter-defibrillators. Arrhythmias appear to be more prevalent in athletes and occur more frequently during physical activity or competition/practice, but there is growing evidence that device therapy is effective in athletes across a wide range of competitive sports. Failure of a device to convert a life-threatening arrhythmia, major injury from a shock, and increased lead failure have thus far not been reported in the prospective Implantable Cardioverter-Defibrillator Sports Registry, but follow-up remains relatively short. Thoughtful consideration of disease state, arrhythmia risk, and the potential dangers of device therapy during the desired sports is imperative before allowing participation. Frank discussion with children and families regarding the possibility of shocks during sports, as well as at other times, is imperative. Ongoing and future studies will help guide these decisions.

  9. Critical analysis of ineffective post implantation implantable cardioverter-defibrillator-testing

    PubMed Central

    Roos, Markus; Geller, J Christoph; Ohlow, Marc-Alexander

    2017-01-01

    AIM To test of the implantable-cardioverter-defibrillator is done at the time of implantation. We investigate if any testing should be performed. METHODS All consecutive patients between January 2006 and December 2008 undergoing implantable cardioverter-defibrillator (ICD) implantation/replacement (a total of 634 patients) were included in the retrospective study. RESULTS Sixteen patients (2.5%) were not tested (9 with LA/LV-thrombus, 7 due to operator’s decision). Analyzed were 618 patients [76% men, 66.4 + 11 years, 24% secondary prevention (SP), 46% with left ventricular ejection fraction (LVEF) < 20%, 56% had coronary artery disease (CAD)] undergoing defibrillation safety testing (SMT) with an energy of 21 + 2.3 J. In 22/618 patients (3.6%) induced ventricular fibrillation (VF) could not be terminated with maximum energy of the ICD. Six of those (27%) had successful SMT after system modification or shock lead repositioning, 14 patients (64%) received a subcutaneous electrode array. Younger age (P = 0.0003), non-CAD (P = 0.007) and VF as index event for SP (P = 0.05) were associated with a higher incidence of ineffective SMT. LVEF < 20% and incomplete revascularisation in patients with CAD had no impact on SMT. CONCLUSION Defibrillation testing is well-tolerated. An ineffective SMT occurred in 4% and two third of those needed implantation of a subcutaneous electrode array to pass a SMT > 10 J. PMID:28289531

  10. Spanish Implantable Cardioverter-Defibrillator Registry. Sixth official report of the Spanish Society Of Cardiology Working Group on Implantable Cardioverter-defibrillators (2009).

    PubMed

    Alzueta, Javier; Linde, Antonio; Barrera, Alberto; Peña, Jose; Peinado, Rafael

    2010-12-01

    This article describes the findings of the 2009 Spanish Implantable Cardioverter-Defibrillator (ICD) Registry compiled by the Working Group on Implantable Cardioverter-Defibrillators of the Spanish Society of Cardiology's Electrophysiology and Arrhythmias Section. Each implantation team voluntarily sent prospective data recorded on a single-page document to the Spanish Society of Cardiology. In total, 4108 device implantations were reported, which comprised 88.6% of the estimated total number of implantations carried out. The number of implants reported corresponded to 89 per million population and the estimated total number was 100.2 per million. The proportion of first implantations among those reported was 71.3%. Data were received from 134 centers, 17 more than in 2008. There continued to be significant regional variations between the various Spanish autonomous regions. The highest implantation rate (81%) was in men (mean age 62 years) who had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most common heart condition was ischemic heart disease, followed by dilated cardiomyopathy. Indications for primary prevention accounted for 55.9% of first implantations; this figure was lower than the previous year's for the first time since 2003. The most significant increase observed was in patients with ischemic heart disease. The 2009 Spanish ICD registry included data on almost 89% of all ICD implantations performed in the country. Although the number of implantations has continued to increase, it still remains far from the European average. The percentage of implantations performed for primary prevention was observed to have stabilized.

  11. 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.

  12. [Implantation of an automatic cardioverter-defibrillator in small children--two case reports].

    PubMed

    Przybylski, Andrzej; Kucińska, Beata; Grabowski, Krzysztof; Sterliński, Maciej; Wróblewska-Kałuzewska, Maria; Szwed, Hanna

    2004-07-01

    Implantation of an automatic cardioverter-defibrillator (ICD) in children may be challenging due to the increased risk of periprocedural and long-term complications. ICD was implanted in two boys with hypertrophic cardiomyopathy, aged 6 and 9 years, with of a body weight of 20 and 25 kg, respectively. In one patient an ICD was implanted due to a history of ventricular fibrillation whereas the second patient underwent prophylactic ICD implantation due to a family history of sudden cardiac death. No short- or mid-term complications were recorded. Difficulties and risks of ICD implantation in children are discussed.

  13. Who should receive an implantable cardioverter-defibrillator after myocardial infarction?

    PubMed

    Mountantonakis, Stavros; Hutchinson, Mathew D

    2009-12-01

    Despite a decline in overall cardiovascular mortality, the incidence of sudden cardiac death (SCD) continues to rise. Patients who survive a myocardial infarction (MI) with depressed ejection fraction are at particularly high risk for SCD. The development of implantable cardioverter-defibrillators (ICDs) has revolutionized SCD prevention; however, despite the current fervor for device implantation, many unresolved questions remain about risk stratification in post-MI patients. This review presents the current indications and timing of ICD implantation for primary and secondary prevention of SCD after MI. Several conventional and investigational methods of risk stratification after MI, as well as current controversies regarding device implantation in specific patient populations, are also reviewed.

  14. Silicone Breast Implant and Automatic Implantable Cardioverter Defibrillator: Can They Coexist? A Case Report

    PubMed Central

    Arik, Zaretski

    2016-01-01

    Summary: We present a case of a silicone breast implant rupture after insertion of an automatic implantable cardioverter defibrillator (AICD). A 51-year-old woman presented to our plastic surgery clinic to exchange her silicone breast implants. The patient underwent cosmetic mastopexy and breast augmentation in 2008. Because of recurrent myocardial infarctions and chronic heart failure, she underwent an insertion of an AICD in 2014 in which the left breast implant was hit. In this report, we discuss the first case of an AICD insertion, disrupting a breast implant. This case report illustrates the rare but real possibility of breast implant rupture after even minor surgical manipulation of the breast area. PMID:27622117

  15. National Trends in the Use of Cardiac Resynchronization Therapy With or Without Implantable Cardioverter-Defibrillator.

    PubMed

    Lindvall, Charlotta; Chatterjee, Neal A; Chang, Yuchiao; Chernack, Betty; Jackson, Vicki A; Singh, Jagmeet P; Metlay, Joshua P

    2016-01-19

    Candidates for cardiac resynchronization therapy (CRT) receive either a biventricular pacemaker or a biventricular pacemaker with an implantable cardioverter-defibrillator (CRT-D). Optimal device selection remains challenging because the benefit of implantable cardioverter-defibrillator therapy may not be uniform, particularly in patients at competing risk of nonsudden death. In this serial cross-sectional study using the National Inpatient Sample database, we identified 311,086 admissions associated with CRT implant between 2006 to 2012. CRT-D was the most common device type (86.1%), including in patients ≥ 75 years of age with ≥ 5 Elixhauser comorbidities (75.5%). Multivariate predictors of CRT-D implant included demographic, clinical, and geographic factors: prior ventricular arrhythmia (rate ratio [RR], 1.14; 95% CI, 1.13-1.14), ischemic heart disease (RR, 1.11; 95% CI, 1.10-1.11), male sex (RR, 1.10; 95% CI, 1.09-1.10), black race (RR, 1.06; 95% CI: 1.04-1.07), and Northeast geographic region (RR, 1.06; 95% CI, 1.04-1.09). There was significant interhospital variation in the use of CRT-D (10-90 percentile range, 72.9%-98.0% CRT-D). The majority of patients in this contemporary US cohort underwent implantation of CRT-D. Predictors of CRT-D implant included demographic, clinical, and geographic factors. In patient subgroups predicted to have an attenuated benefit from implantable cardioverter-defibrillator therapy (older adults with multiple comorbidities), CRT-D remained the dominant device type. An improved understanding of the determinants of device selection may aid in decision making and ultimately better align patient risk with device benefit at the time of CRT implantation. © 2015 American Heart Association, Inc.

  16. 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.

  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. 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.

  19. Fish-oil supplementation in patients with implantable cardioverter defibrillators: a meta-analysis

    PubMed Central

    Jenkins MD, David J.A.; Josse, Andrea R.; Beyene, Joseph; Dorian, Paul; Burr, Michael L.; LaBelle, Roxanne; Kendall, Cyril W.C.; Cunnane, Stephen C.

    2008-01-01

    Background A recent Cochrane meta-analysis did not confirm the benefits of fish and fish oil in the secondary prevention of cardiac death and myocardial infarction. We performed a meta-analysis of randomized controlled trials that examined the effect of fish-oil supplementation on ventricular fibrillation and ventricular tachycardia to determine the overall effect and to assess whether heterogeneity exists between trials. Methods We searched electronic databases (MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, CINAHL) from inception to May 2007. We included randomized controlled trials of fish-oil supplementation on ventricular fibrillation or ventricular tachycardia in patients with implantable cardioverter defibrillators. The primary outcome was implantable cardioverter defibrillator discharge. We calculated relative risk [RR] for outcomes at 1-year follow-up for each study. We used the DerSimonian and Laird random-effects methods when there was significant heterogeneity between trials and the Mantel-Hanzel fixed-effects method when heterogeneity was negligible. Results We identified 3 trials of 1–2 years' duration. These trials included a total of 573 patients who received fish oil and 575 patients who received a control. Meta-analysis of data collected at 1 year showed no overall effect of fish oil on the relative risk of implantable cardioverter defibrillator discharge. There was significant heterogeneity between trials. The second largest study showed a significant benefit of fish oil (relative risk [RR] 0.74, 95% confidence interval [CI] 0.56–0.98). The smallest showed an adverse tendency at 1 year (RR 1.23, 95% CI 0.92–1.65) and significantly worse outcome at 2 years among patients with ventricular tachycardia at study entry (log rank p = 0.007). Conclusion These data indicate that there is heterogeneity in the response of patients to fish-oil supplementation. Caution should be used when prescribing fish-oil supplementation for

  20. Safety and feasibility of dobutamine stress echocardiography in patients with implantable cardioverter defibrillators.

    PubMed

    Elhendy, Abdou; Windle, John; Porter, Thomas R

    2003-08-15

    Coronary artery disease is the underlying etiology of left ventricular dysfunction and arrhythmias in most patients who receive implantable cardioverter defibrillators (ICDs). The aim of this study was to assess the safety and feasibility of dobutamine stress echocardiography (DSE) in patients with an ICD. DSE (dobutamine up to 50 microg/kg/min, atropine up to 2 mg) was performed in 87 patients with an ICD and known or suspected coronary artery disease. The ICD was inactivated before the stress test and reactivated after the study; no serious complications occurred. DSE is a safe and feasible method for evaluating myocardial ischemia in patients with an ICD.

  1. 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

  2. Promoting health-related quality of life in patients with an implantable cardioverter defibrillator.

    PubMed

    Wong, Florence

    2017-03-01

    Implantable cardioverter defibrillators (ICDs) are an effective treatment to reduce mortality rates in patients who are at risk of sudden cardiac death. However, ICDs have been shown to reduce the patient's mental and physical health-related quality of life. It is essential for nurses to have an understanding of the factors associated with health-related quality of life in patients with ICDs, to develop appropriate strategies to improve patient care and optimise quality of life. A case study is included in this article to enhance understanding of the effects these devices can have on a patient's quality of life.

  3. Inappropriate implantable cardioverter-defibrillator magnet-mode switch induced by a laptop computer.

    PubMed

    Tiikkaja, Maria; Aro, Aapo; Alanko, Tommi; Lindholm, Harri; Hietanen, Maila

    2012-06-01

    An implantable cardioverter-defibrillator (ICD) experienced electromagnetic interference from a laptop computer's hard disk. The patient with the ICD was using his laptop computer at home while lying on his bed. The laptop was positioned on his chest, when he heard a beeping sound from the ICD, indicating magnet mode conversion. This situation was replicated in a controlled environment, and the conversion was found to be due to the static magnetic field produced by the laptop's hard disk. The ICD's conversion to magnet mode can be dangerous because it ends all tachyarrhythmia detections and therapies.

  4. Subglandular placement of an implantable cardioverter-defibrillator for an improved cosmetic outcome.

    PubMed

    Wright, Cassidy D; Roehl, Kendall R; Stephen Huang, Shoei K; Mahabir, Raman C

    2013-11-01

    Implantable cardioverter-defibrillator (ICD) technology has progressed through the years decreasing the size of the device, and its effectiveness in preventing sudden cardiac death has made it a mainstay of treatment for many patients. As the use of ICDs in younger patients has increased, issues with placement of an ICD in the usual prepectoral, infraclavicular region have arisen. Subglandular placement through an inframammary incision provides a unique approach and an aesthetically pleasing outcome for ICD placement. We present a review of the current literature and 3 cases of young female patients who had placement of an ICD using this approach.

  5. Cosmetic approach for placement of the automatic implantable cardioverter-defibrillator in young women.

    PubMed

    Curiale, S; Rosenfeld, L E; Elefteriades, J A

    1991-12-01

    A surgical approach is described for a more cosmetically acceptable placement of the automatic implantable cardioverter-defibrillator in young women. The transvenous sensing lead and the vena caval spring electrode are placed through a small subclavicular incision. The left ventricular patch electrode is placed through an anterior minithoracotomy in the crease under the left breast. A small transverse incision in the left lower quadrant is used to place the generator under the external oblique fascia in the low abdominal wall. Minimal cosmetic impairment from incisions and hardware results.

  6. 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

  7. Spanish Implantable Cardioverter-defibrillator Registry. Ninth official report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2012).

    PubMed

    Alzueta, Javier; Fernández, José María

    2013-11-01

    To summarize the findings of the Spanish Implantable Cardioverter-defibrillator Registry for 2012 compiled by the Electrophysiology and Arrhythmias Section of the Spanish Society of Cardiology. Prospective data recorded voluntarily on single-page questionnaires were sent to the Spanish Society of Cardiology by each implantation team. Overall, 4216 device implantations were reported, representing 80.8% of the estimated total number of implantations. The reported implantation rate was 91.2 per million population and the estimated total implantation rate was 113 per million. The proportion of first implantations was 69.4%. We collected data from 161 hospitals (6 fewer than in 2011). The majority of implantable cardioverter-defibrillator recipients were men (83.4%). Mean age was 61.8 (13.4) years. Most patients had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. Ischemic heart disease was the most frequent underlying cardiac condition, followed by dilated cardiomyopathy. The number of indications for primary prevention decreased over the previous year and now account for 58.1% of first implantations. Overall, 81% of the implantable cardioverter-defibrillator were implanted by cardiac electrophysiologists. The 2012 Spanish Implantable Cardioverter-defibrillator Registry includes data on 80.8% of all implantable cardioverter-defibrillators implantations performed in Spain. This is the second consecutive year in which the number of implantations has slightly decreased compared to the previous year. This year, the percentage of implantations for primary prevention indications also decreased. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  8. Magnetic resonance imaging in patients with a subcutaneous implantable cardioverter-defibrillator.

    PubMed

    Keller, Jirí; Neužil, Petr; Vymazal, Josef; Janotka, Marek; Brada, Jirí; Žáček, Radovan; Vopálka, Roman; Weichet, Jirí; Reddy, Vivek Y

    2015-05-01

    Our aim was to evaluate the potential for safely imaging patients with a new type of implantable cardioverter-defibrillator called the subcutaneous implantable cardioverter-defibrillator (S-ICD) in a 1.5 T magnetic resonance imaging (MRI) scanner. With the increasing number of patients with cardiac implantable devices who are indicated for MRI, there is a growing need for establishing MRI compatibility of cardiac implantable devices. Patients with implanted S-ICD systems underwent one or more types of anatomical MRI scans. The S-ICD was programmed off and patients were monitored throughout the imaging procedure. Device function was evaluated pre- and post-scan. Patients were asked to report immediately any pain, torqueing movement, or heating sensation in the area of the pocket or electrode. Fifteen patients underwent a total of 22 examinations at 1.5 T. Scans included brain, spine, knee, and heart. Two patients were re-scanned due to complaints of heating over the can during lumbar scans, which was caused by a thermistor probe placed on the skin to measure skin temperature. All the remaining scans occurred without incident. No evidence of device malfunction was observed. This study is the first to domonstrate the feasibility of exposing S-ICD patients to MRI using the scanning and monitoring protocol described. More data are required to support S-ICD as a MRI conditional device. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

  9. Capsule endoscopy in patients with cardiac pacemakers, implantable cardioverter defibrillators and left heart assist devices

    PubMed Central

    Bandorski, Dirk; Höltgen, Reinhard; Stunder, Dominik; Keuchel, Martin

    2014-01-01

    According to the recommendations of the US Food and Drug Administration and manufacturers, capsule endoscopy should not be used in patients carrying implanted cardiac devices. For this review we considered studies indexed (until 30.06.2013) in Medline [keywords: capsule endoscopy, small bowel endoscopy, cardiac pacemaker, implantable cardioverter defibrillator, interference, left heart assist device], technical information from Given Imaging and one own publication (not listed in Medline). Several in vitro and in vivo studies included patients with implanted cardiac devices who underwent capsule endoscopy. No clinically relevant interference was noticed. Initial reports on interference with a simulating device were not reproduced. Furthermore technical data of PillCam (Given Imaging) demonstrate that the maximum transmission power is below the permitted limits for cardiac devices. Hence, impairment of cardiac pacemaker, defibrillator or left ventricular heart assist device function by capsule endoscopy is not expected. However, wireless telemetry can cause dysfunction of capsule endoscopy recording. Application of capsule endoscopy is feasible and safe in patients with implanted cardiac devices such as pacemakers, cardioverter defibrillators, and left heart assist devices. Development of new technologies warrants future re-evaluation. PMID:24714370

  10. [Implantable cardioverter-defibrillator deactivation at the end of life: ethical, clinical and communication issues].

    PubMed

    Romanò, Massimo; Piga, Maria Antonella; Bertona, Roberta; Negro, Roberto; Ruggeri, Chiara; Zorzoli, Federica; Villani, Rosvaldo

    2017-02-01

    The number of cardioverter-defibrillator implants is increasing worldwide, with the main indication being primary prevention of sudden cardiac death. During the follow-up, patients may die from progression of their underlying heart disease or from nonarrhythmic causes, such as malignancies, dementia and lung disease, without receiving appropriate shocks until the last few days or weeks of their life. These events occur roughly in 30% of patients, mainly in the last 24 hours before death. In this case, inappropriate and even appropriate shock deliveries can no longer prolong life and may simply lead to pain and reduced quality of life. Therefore, it appears important to discuss early with the patients and their relatives about deactivation of the implantable cardioverter-defibrillator (ICD) at the end of life.The goal of this review is to provide an overview of the ethical, clinical and communication issues of ICD deactivation, with a special focus on patients' wishes. It is outlined that patients are not adequately informed about risks and benefits of ICD and the option of ICD deactivation; the doctors are not used to discuss with the patients the topics of end-of-life decisions. Complete information must be part of current informed consent before ICD implantation and should be updated during the follow-up, with special attention to patients with heart failure in relation to their prognosis and advance directives, as suggested by international guidelines.

  11. Evolution of left ventricular ejection fraction after acute myocardial infarction: implications for implantable cardioverter-defibrillator eligibility.

    PubMed

    Sjöblom, Johanna; Muhrbeck, Josephine; Witt, Nils; Alam, Mahbubul; Frykman-Kull, Viveka

    2014-08-26

    Implantable cardioverter-defibrillator therapy improves survival in patients with reduced left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI). Although the risk of sudden cardiac death is highest in the first month after AMI, there is no survival benefit of early implantable cardioverter-defibrillator implantation, and the optimal time frame has yet to be established. Thus, the aim of this study was to investigate what proportion of post-AMI patients had improved LV function to such an extent that the indication for implantable cardioverter-defibrillator was no longer present. Patients admitted for AMI with reduced LVEF (≤40%) were eligible for inclusion. Repeat echocardiographic examinations were performed 5 days, 1 month, and 3 months after the AMI. We prospectively included 100 patients with LVEF of 31±5.8% after AMI. At the 1-month follow-up, 55% had an LVEF >35%. The main improvement in LVEF had occurred by 1 month. The mean difference in LVEF over the next 2 months was small, 1.9 percentage units. During the first 9 weeks, 10% of the patients suffered from life-threatening arrhythmias. Most patients have improved LVEF after AMI, and in the majority, the improvement can be confirmed after 1 month, implying that further delay of implantable cardioverter-defibrillator implantation may not be warranted. Life-threatening arrhythmias occurred in 10% of the patients, illustrating the high risk for sudden cardiac death in this population. © 2014 American Heart Association, Inc.

  12. Weather and triggering of ventricular arrhythmias in patients with implantable cardioverter-defibrillators

    PubMed Central

    Nguyen, Jennifer L.; Laden, Francine; Link, Mark S.; Schwartz, Joel; Luttmann-Gibson, Heike; Dockery, Douglas W.

    2015-01-01

    Outdoor ambient weather has been hypothesized to be responsible for the seasonal distribution of cardiac arrhythmias. Because people spend most of their time indoors, we hypothesized that weather-related arrhythmia risk would be better estimated using an indoor measure or an outdoor measure that correlates well with indoor conditions, such as absolute humidity. The clinical records of 203 patients in eastern Massachusetts, USA, with an implantable cardioverter-defibrillator were abstracted for arrhythmias between 1995 and 2002. We used case-crossover methods to examine the association between weather and ventricular arrhythmia (VA). Among 84 patients who experienced 787 VAs, lower estimated indoor temperature (odds ratio (OR) = 1.16, 95% confidence interval (CI) 1.05–1.27 for a 1 °C decrease in the 24-h average) and lower absolute humidity (OR = 1.06, 95% CI 1.03–1.08 for a 0.5 g/m3 decrease in the 96-h average) were associated with increased risk. Lower outdoor temperature increased risk only in warmer months, likely attributable to the poor correlation between outdoor and indoor temperature during cooler months. These results suggest that lower temperature and drier air are associated with increased risk of VA onset among implantable cardioverter-defibrillator patients. PMID:24169878

  13. Postoperative infection with the automatic implantable cardioverter defibrillator: clinical presentation and use of the gallium scan in diagnosis

    SciTech Connect

    Kelly, P.A.; Wallace, S.; Tucker, B.; Hurvitz, R.J.; Ilvento, J.; Mirabel, G.S.; Cannom, D.S.

    1988-08-01

    This report describes three patients with infection involving an automatic implantable cardioverter defibrillator. All three patients presented with fever, fluid in the pulse generator pocket, leukocytosis and an elevated erythrocyte sedimentation rate. A gallium scan, together with aspiration and culture of the fluid from the pocket, confirmed the diagnosis in each case.

  14. Economical aspect of PET/CT-guided diagnosis of suspected infective endocarditis in a patient with implantable cardioverter-defibrillator.

    PubMed

    Farkowski, Michal M; Milkowski, Maciej; Dziuk, Mirosław; Pytkowski, Mariusz; Marciniak, Marta; Kraska, Alicja; Szwed, Hanna; Sterlinski, Maciej

    2014-01-01

    We present a case report of potential reduction of hospitalization costs due to utilization of PET/CT in a diagnostic work-up of a patient with an implantable cardioverter-defibrillator and suspicion of infective endocarditis. The PET/CT scan would have shorten hospital stay, prevented clinical complications and reduced the cost of hospitalization by 45%.

  15. 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

  16. Epileptic seizure in a patient with an implantable cardioverter-defibrillator: Quo vadis right ventricular lead?

    PubMed

    Wedekind, Horst; Rozhnev, Andrey; Kleine-Katthöfer, Peter; Kranig, Wolfgang

    2016-03-01

    The case of a 77-year-old man admitted for suspected epileptic seizure is reported. Patient history showed implantation of a single-chamber implantable cardioverter-defibrillator (ICD) after cardiac arrest in 2007 with replacement in 2012 due to battery depletion; the patient reported no previous syncope, unconsciousness or seizures. Interrogation records of the ICD showed five ventricular tachyarrhythmia episodes that corresponded to the "seizure". Further examination revealed incorrect position of the RV-lead. Diagnosis was a provoked epileptic seizure due to undersensing of ventricular tachycardia because of improper ICD lead implantation in the coronary sinus. Treatment consisted of implantation of a new device with an additional ICD lead into the right ventricle.

  17. Wearable cardioverter-defibrillator for prevention of sudden cardiac death after infected implantable cardioverter-defibrillator removal: A cost-effectiveness evaluation.

    PubMed

    Healy, Christopher A; Carrillo, Roger G

    2015-07-01

    Prevention of sudden cardiac arrest (SCA) after removal of an infected implantable cardioverter-defibrillator (ICD) is a challenging clinical dilemma. The cost-effectiveness of the wearable cardioverter-defibrillator (WCD) in this setting remains uncertain. The purpose of this study was to compare the cost-effectiveness of the WCD with discharge home, discharge to a skilled nursing facility, or inpatient monitoring for the prevention of SCA after infected ICD removal. A decision model was developed to compare the cost-effectiveness of use of the WCD to several different strategies for patients who undergo ICD removal. One-way and 2-way sensitivity analyses were performed to account for uncertainties. In the base-case analysis, the incremental cost-effectiveness of the WCD strategy was $20,300 per life-year (LY) or $26,436 per quality-adjusted life-year (QALY) compared to discharge home without a WCD. Discharge to a skilled nursing facility and in-hospital monitoring resulted in higher costs and worse clinical outcomes. The incremental cost-effectiveness ratio was as low as $15,392/QALY if the WCD successfully terminated 95% of SCA events and exceeded the $50,000/QALY willingness-to-pay threshold if the efficacy was <69%.The WCD strategy remained cost-effective, assuming 5.6% 2-month SCA risk, as long as the time to reimplantation was at least 2 weeks. The WCD likely is cost-effective in protecting patients against SCA after infected ICD removal while waiting for ICD reimplantation compared to keeping patients in the hospital or discharging them home or to a skilled nursing facility. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  18. The 6 volt battery for implantable cardioverter/defibrillators.

    PubMed

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

    1998-01-01

    The usage of a 6 V lithium manganese dioxide battery results in a significant reduction of capacitor loading time within implantable defibrillators/cardioverters. In order to provide ERI indication a new cathode formulation has been developed. The battery shows no voltage delays, a low self-discharge and fulfilled all requirements to an energy source for an implantable device.

  19. Bilateral Subclavian Vein Occlusion in a SAPHO Syndrome Patient Who Needed an Implantable Cardioverter Defibrillator.

    PubMed

    Ishizuka, Masato; Yamamoto, Yuko; Yamada, Shintaro; Maemura, Sonoko; Nakata, Ryo; Motozawa, Yoshihiro; Yamamoto, Keisuke; Takizawa, Masataka; Uozumi, Hiroki; Ikenouchi, Hiroshi

    2016-05-25

    A 79-year-old Asian man was hospitalized because of progressive exertional dyspnea with decreasing left ventricular ejection fraction and frequent non-sustained ventricular tachycardia. Pre-procedure venography for implantable cardioverter defibrillator (ICD) implantation showed occlusion of the bilateral subclavian veins. In consideration of subcutaneous humps in the sterno-clavicular area and palmoplantar pustulosis, we diagnosed him as having synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) syndrome and speculated that it induced peri-osteal chronic inflammation in the sterno-clavicular area, resulting in occlusion of the adjacent bilateral subclavian veins. An automatic external defibrillator (AED) was installed in the patient's house and total subcutaneous ICD was considered. Venous thrombosis in SAPHO syndrome is not frequent but has been reported. To the best of our knowledge, this is the first case of bilateral subclavian vein occlusion in a SAPHO syndrome patient who needs ICD implantation.

  20. Implantable cardioverter defibrillator and survival after out-of-hospital cardiac arrest due to acute myocardial infarction in Denmark in the years 2001-2012, a nationwide study.

    PubMed

    Winther-Jensen, Matilde; Kjaergaard, Jesper; Lassen, Jens F; Køber, Lars; Torp-Pedersen, Christian; Hansen, Steen M; Lippert, Freddy; Kragholm, Kristian; Christensen, Erika F; Hassager, Christian

    2017-03-01

    The purpose of this study was to describe the implantation of implantable cardioverter defibrillator after out-of-hospital cardiac arrest caused by myocardial infarction in Denmark 2001-2012 and subsequent survival. The Danish Cardiac Arrest Registry was used to identify patients ⩾18 years surviving to discharge without prior implantable cardioverter defibrillator. Information on cardioverter defibrillator implantation was obtained from the National Patient Registry. We identified 974 myocardial infarction-out-of-hospital cardiac arrest patients surviving to hospital discharge, 130 of these patients (13%) had a cardioverter defibrillator implanted early (⩽40 days post-out-of-hospital cardiac arrest), 58 patients (6%) had late implantable cardioverter defibrillator (41-365 days post-out-of-hospital cardiac arrest). Odds of implantable cardioverter defibrillator implantation within one year were higher in patients receiving cardiopulmonary resuscitation (odds ratio (OR)CPR: 1.99, confidence interval (CI): 1.23-3.22, p=0.01), and Charlson Comorbidity Index level 1, (ORCCI1: 2.10, CI:1.25-3.49, p<0.01). Odds of a late implantable cardioverter defibrillator was higher in patients undergoing percutaneous coronary intervention (PCI) (ORPCI: 3.67, CI: 1.35-9.97, p=0. 01). An early, but not late implantable cardioverter defibrillator was associated with increased survival (event time ratioEarly ICD: 1.45, CI: 1.11-1.90, p=0.01). Chronic heart failure, higher age groups, Charlson Comorbidity Index levels 1 to ⩾3 and male sex were associated with lower survival. Highest income was associated with higher survival. Cardioverter defibrillator implantation rates in patients surviving an myocardial infarction-out-of-hospital cardiac arrest increased from 14% to 19% over the period. Of the total patient population, 13% had implantation earlier than recommended by guidelines, presumably as primary prevention of sudden cardiac death. Acute PCI and arrest later in the study

  1. Selective left ventricular sensing lead implantation to overcome undersensing of ventricular fibrillation during implantable cardioverter defibrillator implantation.

    PubMed

    Steinberg, Christian; Philippon, François; O'Hara, Gilles; Molin, Franck

    2013-06-01

    Accurate sensing of malignant arrhythmia is critical for the appropriate delivery of therapy from implantable cardioverter defibrillators, and undersensing of ventricular tachyarrhythmias can have catastrophic consequences. Here, we present an unusual case of ventricular fibrillation undersensing from the right ventricular lead at multiple different implantation sites because of very low amplitude voltage signals during induced ventricular fibrillation. A left ventricular sensing electrode was implanted to allow correct sensing and therapy delivery. Copyright © 2013 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  2. Spanish Implantable Cardioverter-defibrillator Registry. Tenth Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2013).

    PubMed

    Alzueta, Javier; Pedrote, Alonso; Fernández Lozano, Ignacio

    2014-11-01

    To present the findings of the Spanish Implantable Cardioverter-defibrillator Registry for 2013 compiled by the Electrophysiology and Arrhythmias Section of the Spanish Society of Cardiology. Prospective data were voluntarily recorded on a data collection form and sent to the Spanish Society of Cardiology by each implantation team. Overall, 4772 device implantations were reported, representing 85% of the estimated total number of implantations. The reported implantation rate was 102 per million population and the estimated total implantation rate was 120 per million. The proportion of first implantations was 68.8%. Data were received from 154 hospitals (4 fewer than in 2012). Most implantable cardioverter-defibrillator recipients were men (83.3%). The mean age was 62.5 (13.4) years. Most patients had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most frequent underlying cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Indications for primary prevention accounted for 53.0% of first implantations, consolidating the decrease first observed in 2012. Overall, 79.8% of devices were implanted by cardiac electrophysiologists. The 2013 Spanish Implantable Cardioverter-defibrillator Registry includes information on 85% of the devices implanted in Spain. The total number of implantations increased compared with the previous 2 years. The percentage of implantations for primary prevention indications decreased compared with the previous year. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  3. Questions to Ask Your Doctor--Implantable Cardioverter Defibrillator (ICD)

    MedlinePlus

    ... better chance for survival or better quality of life? Can you explain the ICD my child is receiving in understandable terms? Is there anything I need to know about an ICD regarding end-stage heart failure or death? After Implantation, Early Recovery, Adjustment How do I take ...

  4. 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

  5. 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.

  6. [Full dental rehabilitation of a patient with implantable cardioverter defibrillator].

    PubMed

    Imre, Ildikó; Tóth, Zsuzsanna

    2012-06-01

    During dental rehabilitation of a patient with ICD, an upper telescope retained overdenture with acrylic baseplate and lower cantilever bridges were constructed. In the consultation following the anamnesis and the clinical examination, the cardiologist did not believe antibiotic profilaxis to be necessary, adding that it is advisable to avoid the use of ultrasonic depurator and electrocauter. Nowadays after saving the life the improving of patient's better quality of life is an important aspect. The risk of ICD-implantation is minimal however, not negligible, the patient can pursue a way of life free of limitation. According to the latest trends, the number of ICD-implantations will increase exponentially in the near future, due to the aging of the population, the simplification and safeness of implantation and the increase of patients who can be treated with the device. In case of arritmia or putative dysfunction, the latest ICD-s are able to send emergency alert to the arritmia centre with the help of an outer transmitter. Probably the system will completely change the follow-up of patients with ICD within the next few years, clinical researches of its efficiency are going on at present.

  7. Florid psychopathology in patients receiving shocks from implanted cardioverter-defibrillators

    PubMed Central

    Bourke, J.; Turkington, D.; Thomas, G.; McComb, J.; Tynan, M.

    1997-01-01

    Objectives—To increase awareness of the potential for disabling anxiety and depression in patients receiving shocks from implanted cardioverter-defibrillators (ICDs).
Patients and methods—ICDs are implanted in patients at this hospital for control of serious ventricular tachyarrhythmias inadequately controlled by drug treatment, who are unsuitable for map guided antiarrhythmic surgery. All are reviewed regularly at a dedicated ICD clinic and are advised to make contact between visits if they experience shocks. Symptoms of anxiety or depression were not actively sought, nor was a patient support group operating at the time of this data collection. When overt psychopathology was identified, patients were referred to a designated psychiatrist for management.
Results—Over a six year period, six (17%) of 35 patients with ICDs developed florid psychiatric problems after experiencing shocks. None had premorbid psychiatric predisposition. Of the six patients suffering severe psychiatric problems, four were men, their age range was 30-63 years, and left ventricular ejection fraction was 18-40%. All shocks were appropriate for clinical arrhythmias and ranged in frequency from two in six months to 111 in 24 hours. All six patients manifested severe anxiety, focused on fear of future shocks. Depression was also evident in three patients and two had become housebound. All responded within weeks to anxiolytic or antidepressant drugs, combined with relaxation and cognitive therapies. Ongoing psychiatric therapy was refused by one patient, and was required for between three and 18 months in the remainder. One patient died and one received a cardiac transplant during the follow up period (median 27.5 months, range 8-43).
Conclusions—Because ICD implantation occurs against a complex medical background with inevitable psychological stress, all such patients should be considered at high risk for developing psychopathology.

 Keywords: implantable cardioverter-defibrillators

  8. Complications Associated With Implantable Cardioverter Defibrillators in Adults With Congenital Heart Disease or Left Ventricular Noncompaction Cardiomyopathy (From the NCDR(®) Implantable Cardioverter-Defibrillator Registry).

    PubMed

    Gleva, Marye J; Wang, Yongfei; Curtis, Jeptha P; Berul, Charles I; Huddleston, Charles B; Poole, Jeanne E

    2017-08-08

    Patients with childhood heart disease are living longer and entering adulthood, and may undergo implantable cardioverter-defibrillator (ICD) implantation to reduce the risk of sudden death. We evaluated the characteristics of adult patients with congenital heart disease or left ventricular noncompaction cardiomyopathy (LVNC) in the National Cardiovascular Disease Registry ICD Registry and determined ICD-related in-hospital complications. Patients with LVNC or transposition of the great arteries, tetralogy of Fallot, Ebstein's anomaly, atrial septal defect, ventricular septal defect, or common ventricle were identified in the registry. In-hospital complications were compared among different diagnoses using the chi-square test for categorical variables and the F-test in analyses of variance for continuous variables. A total of 3,077 patients were identified. The mean age was 48.0 ± 16.0 years, and 39.9% were female. Single-chamber ICDs were implanted in 25.2%, dual chamber in 41.9%, and cardiac resynchronization in 30.8%. Intraprocedural or postprocedural complications occurred in 70 patients (2.3%); there were 6 in-hospital deaths (0.2%). The most frequent complications were acute lead dislodgments, pneumothorax, and hematomas. Patients with Ebstein's anomaly had the greatest complication rate (8.3%, p = 0.03). The complication rate was 1.55% in single-chamber devices, 1.86% in dual chamber, and 3.5% in cardiac resynchronization (p < 0.001). For initial implants, the complication rate was 2.55%, 1.62% in generator replacements, and 8.77% in lead revisions (p = 0.001). In conclusion, in this large contemporary adult cohort of congenital heart disease and LVNC patients who underwent ICD implant procedures, periprocedural complication rates were low. Lead-related risks predominated. Copyright © 2017 Elsevier Inc. All rights reserved.

  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. 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.

  11. Psychological vulnerability, ventricular tachyarrhythmias and mortality in implantable cardioverter defibrillator patients: is there a link?

    PubMed

    Pedersen, Susanne S; Brouwers, Corline; Versteeg, Henneke

    2012-07-01

    Implantable cardioverter defibrillator (ICD) therapy is the first-line treatment for the prevention of sudden cardiac death. Despite the demonstrated survival benefits of the ICD, predicting which patients will die from a ventricular tachyarrhythmia remains a major challenge. So far, psychological factors have not been considered as potential risk markers that might enhance the prediction of sudden cardiac death. This article evaluates the evidence for a link between psychological vulnerability, ventricular tachyarrhythmias and mortality and the pathways that might explain such a link. This review demonstrates that there is cumulative evidence supporting a link between psychological vulnerability and risk of ventricular tachyarrhythmias and mortality in ICD patients independent of disease severity and other biomedical risk factors. It may be premature to include psychological factors in risk algorithms, but information on the psychological profile of the patient may help to optimize the management and care of these patients in clinical practice.

  12. Do ultrasonic dental scalers interfere with implantable cardioverter defibrillators? An in vivo investigation.

    PubMed

    Maiorana, Carlo; Grossi, Giovanni B; Garramone, Rocco A; Manfredini, Ruggero; Santoro, Franco

    2013-11-01

    To test the in vivo effects of an ultrasonic dental scaler on various implanted cardioverter defibrillator (ICD) models. 12 consecutive patients with ICDs had continuous both electrocardiogram monitoring and device interrogation to detect interferences during the use of an ultrasonic dental scaler. No interferences were detected by any ICD. Evaluation of the electrocardiograms for each patient failed to show any abnormalities in pacing during testing. The results of this study suggest that the routinary clinic use of piezoelectric dental scalers do not interfere with the functioning of any of the tested ICDs. Ultrasonic dental scalers have been suspected of electromagnetic interference (EMI) with the normal functioning of ICDs and the use of this type of equipment for patients with these devices has been controversial. This is the first in vivo study to investigate EMI of ICD activity during the operation with ultrasonic dental scaler. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. A rare cause of cyanosis and hypoxia that should not be forgotten after implantable cardioverter defibrillator implantation.

    PubMed

    Canpolat, Uğur; Bahadır, Nihan; Şahiner, Levent; Aytemir, Kudret

    2017-09-01

    Transvenous pacemaker or implantable cardioverter defibrillator (ICD) implantation procedures are usually performed under local anesthetic, and prilocaine is the most common agent to be used. The data regarding methemoglobinemia after cardiac device implantation are scarce. Thus, presently described is the case of a 47-year-old female patient with arrhythmogenic right ventricular cardiomyopathy/dysplasia who underwent ICD implantation for secondary prophylaxis and developed cyanosis as a result of prilocaine-associated methemoglobinemia. Prilocaine was administered during the procedure. To our knowledge, this is the second case in the literature presenting methemoglobinemia due to local anesthetic after transvenous cardiac device implantation.

  14. MR Imaging in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators.

    PubMed

    Sommer, Torsten; Bauer, Wolfgang; Fischbach, Katharina; Kolb, Christof; Luechinger, Roger; Wiegand, Uwe; Lotz, Joachim; Eitel, Ingo; Gutberlet, Matthias; Thiele, Holger; Schild, Hans H; Kelm, Malte; Quick, Harald H; Schulz-Menger, Jeanette; Barkhausen, Jörg; Bänsch, Dietmar

    2017-02-15

    This joint consensus paper of the German Roentgen Society and the German Cardiac Society provides physical and electrophysiological background information and specific recommendations for the procedural management of patients with cardiac pacemakers (PM) and implantable cardioverter defibrillators (ICD) undergoing magnetic resonance (MR) imaging. The paper outlines the responsibilities of radiologists and cardiologists regarding patient education, indications, and monitoring with modification of MR sequences and PM/ICD reprogramming strategies being discussed in particular. The aim is to optimize patient safety and to improve legal clarity in order to facilitate the access of SM/ICD patients to MR imaging. Key Points:  · Conventional PM and ICD systems are no longer an absolute but rather a relative contraindication for performing an MR examination. Procedural management includes the assessment of the individual risk/benefit ratio, comprehensive patient informed consent about specific risks and "off label" use, extensive PM/ICD-related and MR-related safety precautions to reduce these risks to the greatest extent possible, as well as adequate monitoring techniques.. · MR conditional pacemaker and ICD systems have been tested and approved for MR examination under specific conditions ("in-label" use). Precise understanding of and compliance with the terms of use for the specific pacemaker system are essential for patient safety.. · The risk for an ICD patient during MR examinations is to be considered significantly higher compared to PM patients due to the higher vulnerability of the structurally damaged myocardium and the higher risk of irreversible damage to conventional ICD systems. The indication for a MR examination of an ICD patient should therefore be determined on a stricter basis and the expected risk/benefit ratio should be critically reviewed.. · This complex subject requires close collaboration between radiology and cardiology.. Citation Format

  15. Concerns about implantable cardioverter-defibrillator shocks mediate the relationship between actual shocks and psychological distress.

    PubMed

    Thylén, Ingela; Moser, Debra K; Strömberg, Anna; Dekker, Rebecca A; Chung, Misook L

    2016-06-01

    Although most implantable cardioverter-defibrillator (ICD) patients cope well, fears about receiving ICD shocks have been identified as a major determinant of psychological distress. The relationships among ICD-related concerns, receipt of defibrillating shocks, and symptoms of anxiety and depression have not yet been investigated. Our objective was to examine whether the relationship between receipt of defibrillating shocks and psychological distress was mediated by patients' concerns related to their ICD. All Swedish ICD-recipients were invited to this cross-sectional correlational study; 3067 completing the survey (55% response rate). Their mean age was 66 ± 11 years, and 80% were male. One-third (35%) had received defibrillating shocks, and 26% had high ICD-related concerns. Regression analyses demonstrated that having received at least one shock significantly predicted symptoms of anxiety and depression [odds ratio (OR) 1.58 and OR 3.04, respectively]. The association between receipt of shocks and psychologically distress was mediated by high ICD-related concerns which explained 68% of the relationship between shocks and symptoms of anxiety, and 54% of the relationship between shocks and symptoms of depression. Implantable cardioverter-defibrillator-related concerns have a bigger impact on psychological distress than receipt of an actual shock. Assessing ICD-related concerns in clinical practice can identify patients at risk for psychological distress. Further research on assessment of, and interventions targeting, ICD-related concerns is warranted. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  16. Experience of elderly Spanish men with an implantable cardioverter-defibrillator.

    PubMed

    Palacios-Ceña, Domingo; Losa-Iglesias, Marta Elena; Salvadores-Fuentes, Paloma; Alonso-Blanco, Cristina; Fernández-de-Las-Peñas, Cesar

    2011-07-01

    An implantable cardioverter-defibrillator is the treatment of choice for ventricular arrhythmias and sudden death. Clinical trials and qualitative studies normally exclude elderly patients. The aim of this study was to describe the experience of elderly Spanish men with an implantable cardioverter-defibrillator. This was a qualitative phenomenological study. Sampling was purposeful and used the snowball technique. Unstructured interviews and recipients' personal accounts were collected. Data collection finished with information saturation. Analysis was performed using the Giorgi proposal with triangulation between research-team members. Data were audited by an external researcher. The change and the need to adapt to the new situation can be perceived as a loss of independence by the elderly. The significance of the partner in the Spanish context is particularly relevant during the narration. Also, their view of the world is transformed, they experience an internal change. Additionally, the elderly patient may become confined to their home and shut off from their surroundings, accompanied by a sensation of being "stuck" and "imprisoned" by their own process. Elderly recipients can end up "clinging on" to customs as they are felt to define the recipient's identity and utility within their social and personal context. Their partner is of huge significance for elderly recipients. The geriatric health personnel must contribute to promote and maintain activities of daily living in elderly. Future qualitative studies taking an in-depth look at the experience and readjustment process of elderly recipients and the relationship among older people and technological equipment should be further conducted. © 2011 Japan Geriatrics Society.

  17. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator.

    PubMed

    Knops, Reinoud E; Olde Nordkamp, Louise R A; de Groot, Joris R; Wilde, Arthur A M

    2013-08-01

    Three incisions in the chest are necessary for implantation of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD). The superior parasternal incision is a possible risk for infection and a potential source of discomfort. A less invasive alternative technique of implanting the S-ICD electrode--the two-incision technique--avoids the superior parasternal incision. The purpose of this prospective cohort study was to evaluate the safety and efficacy of the two-incision technique for implantation of the S-ICD. Consecutive patients who received an S-ICD between October 2010 and December 2011 were implanted using the two-incision technique, which positions the parasternal part of the S-ICD electrode using a standard 11Fr peel-away sheath. All patients were routinely evaluated for at least 1 year for complications and device interrogation at the outpatient clinic. Thirty-nine patients (46% male, mean age 44 ± 15 years) were implanted with a S-ICD using the two-incision technique. During mean follow-up of 18 months (range 14-27 months) no dislocations were observed, and there was no need for repositioning of either the ICD or the electrode. No serious infections occurred during follow-up except for 2 superficial wound infections of the pocket incision site. Device function was normal in all patients, and no inappropriate sensing occurred related to the implantation technique. The two-incision technique is a safe and efficacious alternative for S-ICD implantations and may help to reduce complications. The two-incision technique offers physicians a less invasive and simplified implantation procedure of the S-ICD. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  18. Longitudinal study of implantable cardioverter-defibrillators: methods and clinical characteristics of patients receiving implantable cardioverter-defibrillators for primary prevention in contemporary practice.

    PubMed

    Masoudi, Frederick A; Go, Alan S; Magid, David J; Cassidy-Bushrow, Andrea E; Doris, Jonathan M; Fiocchi, Frances; Garcia-Montilla, Romel; Glenn, Karen A; Goldberg, Robert J; Gupta, Nigel; Gurwitz, Jerry H; Hammill, Stephen C; Hayes, John J; Jackson, Nathaniel; Kadish, Alan; Lauer, Michael; Miller, Aaron W; Multerer, Deborah; Peterson, Pamela N; Reifler, Liza M; Reynolds, Kristi; Saczynski, Jane S; Schuger, Claudio; Sharma, Param P; Smith, David H; Suits, Mary; Sung, Sue Hee; Varosy, Paul D; Vidaillet, Humberto J; Greenlee, Robert T

    2012-11-01

    Implantable cardioverter-defibrillators (ICDs) are increasingly used for primary prevention after randomized, controlled trials demonstrating that they reduce the risk of death in patients with left ventricular systolic dysfunction. The extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with left ventricular systolic dysfunction undergoing primary prevention ICD implantation in a real-world setting compare with those enrolled in the randomized, controlled trials is not well characterized. This study is being conducted to address these questions. The study cohort includes consecutive patients undergoing primary prevention ICD placement between January 1, 2006 and December 31, 2009 in 7 health plans. Baseline clinical characteristics were acquired from the National Cardiovascular Data Registry ICD Registry. Longitudinal data collection is underway, and will include hospitalization, mortality, and resource use from standardized health plan data archives. Data regarding ICD therapies will be obtained through chart abstraction and adjudicated by a panel of experts in device therapy. Compared with the populations of primary prevention ICD therapy randomized, controlled trials, the cohort (n=2621) is on average significantly older (by 2.5-6.5 years), more often female, more often from racial and ethnic minority groups, and has a higher burden of coexisting conditions. The cohort is similar, however, to a national population undergoing primary prevention ICD placement. Patients undergoing primary prevention ICD implantation in this study differ from those enrolled in the randomized, controlled trials that established the efficacy of ICDs. Understanding a broad range of health outcomes, including ICD therapies, will provide patients, clinicians, and policy makers with contemporary data to inform decision-making.

  19. [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.

  20. Intermuscular Two-Incision Technique for Subcutaneous Implantable Cardioverter Defibrillator Implantation: Results from a Multicenter Registry.

    PubMed

    Migliore, Federico; Allocca, Giuseppe; Calzolari, Vittorio; Crosato, Martino; Facchin, Domenico; Daleffe, Elisabetta; Zecchin, Massimo; Fantinel, Mauro; Cannas, Sergio; Arancio, Rocco; Marchese, Procolo; Zanon, Francesco; Zorzi, Alessandro; Iliceto, Sabino; Bertaglia, Emanuele

    2017-03-01

    The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, which involves three incisions and a subcutaneous pocket, is associated with possible complications, including inappropriate interventions. The aim of this prospective multicenter study was to evaluate the efficacy and safety of an alternative intermuscular two-incision technique for S-ICD implantation. The study population included 36 consecutive patients (75% male, mean age 44 ± 12 years [range 20-69]) who underwent S-ICD implantation using the intermuscular two-incision technique. This technique avoids the superior parasternal incision for the lead placement and consists of creating an intermuscular pocket between the anterior surface of the serratus anterior and the posterior surface of the latissimus dorsi muscles instead of a subcutaneous pocket. All patients were successfully implanted in the absence of any procedure-related complications with a successful 65-J standard polarity defibrillation threshold testing, except in one, who received a second successful shock after pocket revision. During a mean follow-up of 10 months (range 3-30), no complications requiring surgical revision were observed. At device interrogation, stable sensing without interferences was observed in all patients. Two patients (5.5%) experienced appropriate and successful shock on ventricular fibrillation and in four patients (11%), a total of seven nonsustained self-terminated ventricular tachycardias were correctly detected. No inappropriate interventions were observed. Our experience suggests that the two-incision intermuscular technique is a safe and efficacious alternative to the current technique for S-ICD implantation that may help reducing complications including inappropriate interventions and offer a better cosmetic outcome, especially in thin individuals. © 2016 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

  1. 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.

  2. Subcutaneous implantable cardioverter-defibrillator: First single-center experience with other cardiac implantable electronic devices.

    PubMed

    Kuschyk, Jürgen; Stach, Ksenija; Tülümen, Erol; Rudic, Boris; Liebe, Volker; Schimpf, Rainer; Borggrefe, Martin; Röger, Susanne

    2015-11-01

    The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an implantable device for antiarrhythmic therapy with no intravascular leads. The purpose of this study was to describe the technical feasibility of combining the S-ICD with other cardiac implantable electronic devices (CIEDs), including pacemakers with transvenous or epicardial electrodes. We also provide the first experience of combining an S-ICD with catheter-based therapies, including cardiac contractility modulation (CCM) and vagus nerve stimulation. Between July 2011 and November 2014, 6 patients received a CCM device and S-ICD, 3 patients with a single-chamber pacemaker using either transvenous or epicardial pacing electrodes received and S-ICD, and 1 patient with an implanted S-ICD received vagus nerve stimulation. In all patients, intraoperative S-ICD testing, crosstalk tests, and postoperative ergometric testing were performed. In all 10 patients, device implantations were successfully performed without complications. S-ICD therapy was shown to be technically feasible with concomitant CIED. Mean follow-up was nearly 17 months. S-ICD testing and crosstalk testing before and during exercise enabled device programming across a broad range of test conditions and was associated with no subsequent evidence of adverse device interaction. None of the devices required permanent inactivation or removal, and no patient received an inappropriate shock. In suitable patients, combining an S-ICD with CCM or pacemaker may provide an acceptable means to reduce the number of transvascular leads. S-ICD appeared safe with CCM over an intermediate follow-up period. Additional prospective randomized controlled trials examining S-ICD in conjunction with CIEDs are warranted. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  3. Single lead catheter of implantable cardioverter-defibrillator with floating atrial sensing dipole implanted via persistent left superior vena cava.

    PubMed

    Malagù, Michele; Toselli, Tiziano; Bertini, Matteo

    2016-04-26

    Persistent left superior vena cava (LSVC) is a congenital anomaly with 0.3%-1% prevalence in the general population. It is usually asymptomatic but in case of transvenous lead positioning, i.e., for pacemaker or implantable cardioverter defibrillator (ICD), may be a cause for significant complications or unsuccessful implantation. Single lead ICD with atrial sensing dipole (ICD DX) is a safe and functional technology in patients without congenital abnormalities. We provide a review of the literature and a case report of successful implantation of an ICD DX in a patient with LSVC and its efficacy in treating ventricular arrhythmias.

  4. Single lead catheter of implantable cardioverter-defibrillator with floating atrial sensing dipole implanted via persistent left superior vena cava

    PubMed Central

    Malagù, Michele; Toselli, Tiziano; Bertini, Matteo

    2016-01-01

    Persistent left superior vena cava (LSVC) is a congenital anomaly with 0.3%-1% prevalence in the general population. It is usually asymptomatic but in case of transvenous lead positioning, i.e., for pacemaker or implantable cardioverter defibrillator (ICD), may be a cause for significant complications or unsuccessful implantation. Single lead ICD with atrial sensing dipole (ICD DX) is a safe and functional technology in patients without congenital abnormalities. We provide a review of the literature and a case report of successful implantation of an ICD DX in a patient with LSVC and its efficacy in treating ventricular arrhythmias. PMID:27152145

  5. Incidence of appropriate cardioverter-defibrillator shocks and mortality in patients with implantable cardioverter-defibrillators with ischemic cardiomyopathy versus nonischemic cardiomyopathy at 33-month follow-up

    PubMed Central

    Gandhi, Kaushang; Aronow, Wilbert S.; Desai, Harit; Amin, Harshad; Lai, Hoang M.; Frishman, William H.; Cohen, Martin; Sorbera, Carmen

    2010-01-01

    Introduction The aim of the study was to investigate at long-term follow-up the incidence of appropriate implantable cardioverter-defibrillator (ICD) shocks and of all-cause mortality in patients with ICDs with ischemic cardiomyopathy versus nonischemic cardiomyopathy. Material and methods ICDs were implanted in 485 patients with ischemic cardiomyopathy and in 299 patients with nonischemic cardiomyopathy, all of whom had coronary angiography. Baseline characteristics were not significantly different between the 2 groups. Follow-up was 965 days in patients with ischemic cardiomyopathy versus 1039 days in patients with nonischemic cardiomyopathy (p not significant). The ICDs were interrogated every 3 months to see if shocks occurred. Results Appropriate ICD shocks occurred in 179 of 485 patients (37%) with ischemic cardiomyopathy and in 93 of 299 patients (31%) with nonischemic cardiomyopathy (p not significant). All-cause mortality occurred in 162 of 485 patients (33%) with ischemic cardiomyopathy and in 70 of 299 patients (23%) with nonischemic cardiomyopathy (p = 0.002). Conclusions The incidence of appropriate ICD shocks was not significantly different at 33-month follow-up in patients with ischemic cardiomyopathy versus nonischemic cardiomyopathy. However, patients with ischemic cardiomyopathy had a significantly higher incidence of all-cause mortality than patients with nonischemic cardiomyopathy (p = 0.002). PMID:22427764

  6. 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.

  7. Driving restrictions after implantable cardioverter defibrillator implantation: an evidence-based approach

    PubMed Central

    Thijssen, Joep; Borleffs, C. Jan Willem; van Rees, Johannes B.; de Bie, Mihály K.; van der Velde, Enno T.; van Erven, Lieselot; Bax, Jeroen J.; Cannegieter, Suzanne C.; Schalij, Martin J.

    2011-01-01

    Aims Little evidence is available regarding restrictions from driving following implantable cardioverter defibrillator (ICD) implantation or following first appropriate or inappropriate shock. The purpose of the current analysis was to provide evidence for driving restrictions based on real-world incidences of shocks (appropriate and inappropriate). Methods and results A total of 2786 primary and secondary prevention ICD patients were included. The occurrence of shocks was noted during a median follow-up of 996 days (inter-quartile range, 428–1833 days). With the risk of harm (RH) formula, using the incidence of sudden cardiac incapacitation, the annual RH to others posed by a driver with an ICD was calculated. Based on Canadian data, the annual RH to others of 5 in 100 000 (0.005%) was used as a cut-off value. In both primary and secondary prevention ICD patients with private driving habits, no restrictions to drive directly following implantation, or an inappropriate shock are warranted. However, following an appropriate shock, these patients are at an increased risk to cause harm to other road users and therefore should be restricted to drive for a period of 2 and 4 months, respectively. In addition, all ICD patients with professional driving habits have a substantial elevated risk to cause harm to other road users during the complete follow-up after both implantation and shock and should therefore be restricted to drive permanently. Conclusion The current analysis provides a clinically applicable tool for guideline committees to establish evidence-based driving restrictions. PMID:21646229

  8. Obstetric hemorrhage in a case of hypertrophic obstructive cardiomyopathy with automatic implantable cardioverter defibrillator: Anaesthesia and intensive care management.

    PubMed

    Mishra, Sandeep Kumar; Bhat, Ravindra R; Kavitha, Jayaram; Kundra, Pankaj; Parida, Satyen

    2016-01-01

    The physiological changes occurring during pregnancy and labor may reveal or exacerbate the symptoms of hypertrophic obstructive cardiomyopathy (HOCM). The addition of obstetric hemorrhage to this presents a unique challenge to the anesthesiologists and intensivists managing these patients in the operation theatres and the Intensive Care Units. Here we present a case of HOCM with automatic implantable cardioverter defibrillator in situ and postpartum hemorrhagic shock.

  9. Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients

    PubMed Central

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

    2016-01-01

    Background— Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown. Methods and Results— Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry – ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%–4.8%) within 1 year and 21.3% (95% CI, 20.7%–21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73–1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66–1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48–1.67), and greater hospice use among decedents in the patients’ health referral region. Conclusions— More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus. PMID:27016104

  10. 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.

  11. Sex differences in outcome after implantable cardioverter defibrillator implantation in nonischemic cardiomyopathy.

    PubMed

    Albert, Christine M; Quigg, Rebecca; Saba, Samir; Estes, N A Mark; Shaechter, Andi; Subacius, Haris; Howard, Adam; Levine, Joseph; Kadish, Alan

    2008-08-01

    Women have been underrepresented in randomized trials of implantable cardioverter defibrillator (ICD) therapy, and limited data suggest that women may not benefit from prophylactic ICD implantation to the same extent as men. In the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, a reduction in all-cause mortality was seen in men (P = .018) but not for women (P = .76). Sex-specific cumulative probabilities of event-free survival from total, arrhythmic, and noncardiac mortality as well as appropriate shocks were calculated, and log-rank tests were performed. Interaction terms in multivariable Cox proportional hazards models were used to test the hypothesis that the effectiveness of the ICD differed between men and women. Among 458 patients (326 men and 132 women) with nonischemic cardiomyopathy enrolled in the DEFINITE trial, the test for an interaction between sex and ICD treatment on total mortality was not significant in unadjusted (P = .11) or in multivariable adjusted (P = .18) analyses. When we examined cause-specific mortality, we found no sex difference in the incidence of arrhythmic death. Instead, we documented a relative excess of noncardiac death among women randomized to the ICD (P = .02) as compared with women randomized to standard medical therapy. With respect to device use, there was a trend for women to have fewer appropriate ICD shocks after multivariable adjustment (P = .06). Among patients with nonischemic cardiomyopathy enrolled in DEFINITE, we found no conclusive evidence for a sex difference in the effectiveness of the ICD; however, the trial was not adequately powered to detect such interaction effects. Larger studies are required to definitively address whether the benefit of ICD therapy differs between men and women.

  12. Utilization and outcomes of the implantable cardioverter defibrillator, 1987 to 1995.

    PubMed

    Hlatky, Mark A; Saynina, Olga; McDonald, Kathryn M; Garber, Alan M; McClellan, Mark B

    2002-09-01

    The patterns of adoption of the implantable cardioverter defibrillator (ICD) and the outcomes of its use have not been well documented in general, unselected populations. The purpose of this study was to document the impact of the ICD in widespread clinical practice. We identified ICD recipients by use of the hospital discharge databases of Medicare beneficiaries for 1987 through 1995 and of California residents for 1991 through 1995. The index admission for each patient was linked to previous and subsequent admissions and to mortality files to create a longitudinal patient profile. The rate of ICD implantations increased >10-fold between 1987 and 1995, as both the number of hospitals performing the procedure and the volume of ICD implantations per hospital rose. Mortality rates within 30 days of ICD implantation decreased from 6.0% to 1.9%, and mortality rates within 1 year fell from 19.3% to 11.4%. Surgical interventions to revise or replace the ICD within the first year remained about 5%, however, and cumulative expenditures at 1 year ($46,000-$51,000) changed very little. ICD implantation rates varied >3-fold among different regions of the United States. ICD use has expanded markedly during the study period, with improved mortality rates, but medical expenditures and rates of surgical revision remain high for ICD recipients.

  13. 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

    2017-01-01

    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.

  14. Patient-tailored implantable cardioverter defibrillator testing using the upper limit of vulnerability: the TULIP protocol.

    PubMed

    Lemke, Bernd; Lawo, Thomas; Zarse, Markus; Lubinski, Andrzej; Kreutzer, Ulrich; Mueller, Johannes; Schuchert, Andreas; Mitzenheim, Sabine; Danilovic, Dejan; Deneke, Thomas

    2008-08-01

    We evaluated the feasibility of the TULIP (Threshold test using Upper Limit during ImPlantation) protocol, which was designed to provide a confirmed, low defibrillation energy value during implantable cardioverter defibrillator (ICD) implantation with only two induced ventricular fibrillation (VF) episodes. Ninety-eight patients (62 +/- 12 years, 86 male) from 13 clinical centres underwent an active can ICD implantation. A single coupling interval derived from electrocardiogram lead II during ventricular pacing was used for VF induction shocks at 13, 11, 9, and 6 J in a step-down manner until the upper limit of VF induction (ULVI) was determined. If ULVI >or=9 J, a defibrillation energy of ULVI + 4 J was tested. For ULVI <9 J, the defibrillation test energy was 9 J. In 79/98 patients (80.6%), two induced VF episodes were sufficient to obtain confirmed defibrillation energy of 11.1 +/- 3.3 J. The mean strength of the successful VF induction shock was 6.8 +/- 4.3 J, the coupling interval was 303 +/- 35 ms, and the number of delivered induction shocks until the first VF induction was 3.9 +/- 1.6. TULIP is a safe and simple device testing procedure allowing the determination of confirmed, low defibrillation energy in most patients with two VF episodes induced at a single coupling interval.

  15. Concomitant Use of the Subcutaneous Implantable Cardioverter Defibrillator and a Permanent Pacemaker.

    PubMed

    Huang, Jason; Patton, Kristen K; Prutkin, Jordan M

    2016-11-01

    The subcutaneous implantable cardioverter defibrillator (S-ICD) is a novel implanted defibrillator for the prevention of sudden cardiac death that avoids intravascular access. Use of this device is limited by its inability to provide backup pacing. Combined use of the S-ICD with a permanent pacemaker may be the optimal choice in certain situations though experience with the use of both devices together remains limited. We reviewed our single-center experience with the S-ICD from March 2011 to November 2015. Four patients with concomitant use of the S-ICD and a permanent pacemaker were identified. Clinical indication for device therapy, operative details, and subsequent follow-up was reviewed. During implantation, S-ICD sensing of paced morphologies was evaluated at maximal voltage output. After S-ICD implant, if feasible, the upper rate was adjusted to ≤50% of the S-ICD tachycardia zone to minimize risk of inappropriate shocks. After a mean follow-up of over 1 year, no adverse events occurred, including no inappropriate shock, lead malfunction, or device infection. One patient had a total of eight appropriate shocks, while another individual had no inappropriate shocks despite having a unipolar pacing lead. In unique situations, combined use of the S-ICD and a permanent pacemaker may be preferable to alternative options. In our experience, this approach was successful in varying conditions including complex congenital heart disease, recurrent device infection, and limited vascular access. © 2016 Wiley Periodicals, Inc.

  16. The innominate vein as alternative venous access for complicated implantable cardioverter defibrillator revisions.

    PubMed

    Aleksic, Ivan; Kottenberg-Assenmacher, Eva; Kienbaum, Peter; Szabo, Andras K; Sommer, Sebastian-Patrick; Wieneke, Heiner; Yildirim, Cagatay; Leyh, Rainer G

    2007-08-01

    Venous complications of implantable cardioverter defibrillator (ICD) systems may cause significant problems when the need for system revision or upgrades arises. Such revisions require venous access close to the site of the previous ICD implantation. The internal and external jugular vein have disadvantages due to a long subcutaneous course crossing the clavicle and problems with lead extraction if infection occurs. In seven patients with ICD revisions due to lead dysfunction (n = 4) and upgrade to a biventricular device (n = 2) and status after system removal due to infection with new device implantation (n = 1) conventional venous access could not be obtained. Intraoperative contrast venography demonstrated an occluded left subclavian and/or left innominate vein in all patients. In all patients, we gained venous access through puncture of the right innominate vein and tunneled the new lead subcutaneously to the ICD pocket on the left. No intraoperative complications were observed. All patients are followed in our ICD clinic. Mean follow-up is 16 +/- 4 months now. So far, no clinical or lead complications with this access have been observed. We have demonstrated that ICD lead placement through puncture of the right innominate vein is feasible. We propose the innominate vein as an alternative route for establishing venous access in patients requiring ICD revisions or upgrades who suffer from venous obstruction. ICD implanting physicians should acquaint themselves with the technique of right innominate vein puncture to use this vein as a bail-out strategy in patients with complicated venous access.

  17. Do implantable cardioverter defibrillators contribute to new depression or anxiety symptoms? A retrospective study.

    PubMed

    Amiaz, Revital; Asher, Elad; Rozen, Guy; Czerniak, Efrat; Glikson, Michael; Weiser, Mark

    2016-01-01

    In this retrospective cross-sectional study, we evaluated the existence of psychiatric symptoms which appeared after implantation of an implantable cardioverter defibrillator (ICD). Patients with ICDs were diagnosed using the Mini International Neuropsychiatric Interview (MINI) and were excluded if they had any psychiatric diagnosis prior to ICD implantation. Depression and anxiety were evaluated using the HAM-D and HAM-A rating scales and their attitude towards the ICD using a visual analog scale (VAS). Ninety five ICD patients with mean age of 66 years (±11.5) were recruited, 80 (84%) were men. Four (4%) patients were diagnosed with new-onset MDD and one patient (1%) with anxiety. Twenty seven (28%) were found to have significant depressive symptoms (HAM-D >8), without MDD diagnosis; half of them attributing these symptoms to the device. Seven (8%) patients experienced phantom shocks and had relatively higher depressive scores (HAM-D 10.3 vs. 5.8; F = 3.696; p = 0.058). The MDD rates in our study were rather consistent with those reported for cardiac patients. We suggest that ICD contributed little, if any, additional depressive or anxiety symptoms after implantation. We found that the overall attitude towards the device was positive and that shocks and phantom shocks were related to depressive symptoms.

  18. Clinical Course After Cardioverter-Defibrillator Implantation: Chagasic Versus Ischemic Patients

    PubMed Central

    Pereira, Francisca Tatiana Moreira; Rocha, Eduardo Arrais; Monteiro, Marcelo de Paula Martins; Lima, Neiberg de Alcantara; Rodrigues Sobrinho, Carlos Roberto Martins; Pires Neto, Roberto da Justa

    2016-01-01

    Background: The outcome of Chagas disease patients after receiving implantable cardioverter defibrillator (ICD) is still controversial. Objective: To compare clinical outcomes after ICD implantation in patients with chronic Chagas cardiomyopathy (CCC) and ischemic heart disease (IHD). Methods: Prospective study of a population of 153 patients receiving ICD (65 with CCC and 88 with IHD). The devices were implanted between 2003 and 2011. Survival rates and event-free survival were compared. Results: The groups were similar regarding sex, functional class and ejection fraction. Ischemic patients were, on average, 10 years older than CCC patients (p < 0.05). Patients with CCC had lower schooling and monthly income than IHD patients (p < 0.05). The number of appropriate therapies was 2.07 higher in CCC patients, who had a greater incidence of appropriate shock (p < 0.05). Annual mortality rate and electrical storm incidence were similar in both groups. There was no sudden death in CCC patients, and only one in IHD patients. Neither survival time (p = 0.720) nor event-free survival (p = 0.143) significantly differed between the groups. Conclusion: CCC doubles the risk of receiving appropriate therapies as compared to IHD, showing the greater complexity of arrhythmias in Chagas patients. PMID:27411097

  19. 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.

  20. Implantable cardioverter defibrillators and Chagas' disease: results of the ICD Registry Latin America.

    PubMed

    Muratore, Claudio A; Batista Sa, Luiz A; Chiale, Pablo A; Eloy, Ricardo; Tentori, Maria Cristina; Escudero, Jaime; Lima, Antonio Malan Cavalcanti; Medina, Luis E; Garillo, Raúl; Maloney, Jennifer

    2009-02-01

    Chagas' disease is an endemic parasitic affliction in Latin America. It is frequently associated with ventricular tachyarrhythmia and sudden death. The aim of this study is to assess the evolution of patients with Chagas' disease treated with an implantable cardioverter defibrillator (ICD). Eighty-nine chagasic patients with ICD were included for analysis from the Medtronic ICD Registry Latin America. At implant, mean age was 59 +/- 10 years, and 72% were male. Eighty-one patients (91%) had secondary prevention indications. Mean left ventricular ejection fraction was 40 +/- 11%, and mean follow-up was 12 +/- 7 months. During follow-up, six patients died (6.7%); three due to congestive heart failure, one due to sudden death, and two due to non-cardiac cause. Hospitalization occurred in seven patients. Thirty-eight patients (42%) received appropriate ICD therapies. A total of 737 episodes were detected by the ICD. The mean period between ICD implantation and the first appropriate therapy was 104 days. Electrical storms were observed in 14 of the 89 patients (15.7%). Inappropriate therapies were observed in seven patients. This registry confirms that ICD therapy provides protection by effectively terminating life-threatening arrhythmias in patients with Chagas' disease. This is especially so when patients receive the device for secondary prevention.

  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. Third- and fourth-generation implantable cardioverter defibrillators: current status and future development.

    PubMed

    Saksena, S; Diaz, M L; Varanasi, S; Mathew, P; Berg, J; Krol, R B; Kaushik, R R

    1994-10-01

    Implantable cardioverter defibrillator (ICD) therapy has become the mainstay of therapy for patients with a history of sudden cardiac death or life-threatening ventricular arrhythmias. The current generation of ICDs used for secondary prevention combines features for tachycardia reversion with demand ventricular pacing, antitachycardia pacing, programmable shock therapy, and tachycardia events memory. Although demand pacing and defibrillation is indicated for primary prevention usage of ICDs, the application of antitachycardia pacing modes is more controversial. High energy cardioversion and defibrillation shocks remaining the mainstay of sudden death prevention will be redefined as more effective defibrillation shock modes and lead systems are developed. Fourth-generation ICD systems accomplished a significant reduction of device size and almost universal success using an endocardial lead configuration and pectoral implant. A variety of new directions of ICD therapy in clinical practice such as primary prevention applications and the adjunctive role of antiarrhythmic drug therapy are currently being examined in clinical trials. The concepts underlying initiation of tachyarrhythmias are being studied to develop new approaches to tachycardia prevention. These include rate support, subthreshold stimulation, and multiple site pacing. The current developments of ICD therapy promise continued growth of this technology.

  3. Cost-effectiveness of Implantable Cardioverter-Defibrillators in Children with Dilated Cardiomyopathy

    PubMed Central

    Feingold, Brian; Arora, Gaurav; Webber, Steven A.; Smith, Kenneth J.

    2010-01-01

    Background Implantable cardioverter-defibrillators (ICDs) improve survival and are cost-effective in adults with poor left ventricular function. Because of differences in heart failure etiology, sudden death rates, and ICD complication rates, these findings may not be applicable to children. Methods and Results We developed a Markov model to compare typical management of childhood dilated cardiomyopathy with symptomatic heart failure to prophylactic ICD implantation plus typical management. Model costs included costs of outpatient care, medications, complications, and transplantation. Time horizon was up to 20 years from model entry. Total costs were $433,000 (ICD strategy) and $355,000 (typical management). Although quality adjusted survival was greater in the ICD group (6.78 vs. 6.43 quality adjusted life-years, QALYs), the incremental cost-utility ratio was $281,622/QALY saved with the ICD strategy. In sensitivity analyses, the ICD strategy cost less than the $100,000/QALY benchmark for cost-effectiveness only when the annual probability of sudden death exceeded 13% or when strong, sustained benefits in QOL due to the ICD were assumed. Conclusions Prophylactic ICD use in children with dilated cardiomyopathy, poor ventricular function, and symptomatic heart failure does not appear to be cost-effective. This is likely due to lower sudden death rates in this population. PMID:20797597

  4. Benefit of implantable cardioverter-defibrillator therapy after generator replacement in patients with Brugada syndrome.

    PubMed

    Kim, Ju Youn; Kim, Sung-Hwan; Kim, Sung Su; Lee, Ki Hong; Park, Hyung-Wook; Cho, Jeong-Gwan; Uhm, Jae-Sun; Joung, Boyoung; Pak, Hui-Nam; Lee, Moon-Hyoung; Park, Seung-Jung; On, Young Keun; Kim, June Soo; Lim, Hong Euy; Shim, Jaemin; Choi, Jong-Il; Park, Sang Weon; Kim, Young-Hoon; Lee, Woo Seok; Kim, Jun; Nam, Gi-Byoung; Choi, Kee-Joon; Kim, You-Ho; Oh, Yong-Seog; Lee, Man-Young; Rho, Tai-Ho

    2015-01-01

    An implantable cardioverter-defibrillator (ICD) is the only proven effective therapeutic strategy for patients with Brugada syndrome (BS). However, it is controversial whether the device should be replaced even in patients who had never experienced appropriate ICD therapy until the time of generator replacement. This was a nationwide, multicenter retrospective study that enrolled patients who were diagnosed with BS and had an ICD implantation between January 1998 and April 2014. Appropriate ICD therapies administered for ventricular tachyarrhythmia were evaluated during follow-up. A total of 117 patients (age 43 ± 12 years, male 115 [98.3%]) were enrolled, and the mean follow-up duration was 6.0 ± 4.1 years. Thirty-seven (31.6%) patients had experienced appropriate ICD therapy during follow-up. Of all patients, 46 underwent replacement of the device. After the first generator replacement, the incidence of appropriate ICD therapy remained as high as 65.2% in patients who previously experienced appropriate ICD therapy before generator replacement. In 30 patients who did not experience any cardiac events until the first generator change, two (8.7%) had an episode of appropriate ICD therapy afterwards. No episode of ICD therapy before generator replacement could not guarantee a safe clinical course. ICD generator replacement should be considered even in patients without ICD therapy before. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. Radiotherapy in patients with pacemakers and implantable cardioverter defibrillators: a literature review.

    PubMed

    Zaremba, Tomas; Jakobsen, Annette Ross; Søgaard, Mette; Thøgersen, Anna Margrethe; Riahi, Sam

    2016-04-01

    An increasing number of patients with implantable cardiac rhythm devices undergo radiotherapy (RT) for cancer and are thereby exposed to the risk of device failure. Current safety recommendations seem to have limitations by not accounting for the risk of pacemakers and implantable cardioverter defibrillators malfunctioning at low radiation doses. Besides scant knowledge about optimal safety measures, only little is known about the exact prevalence of patients with devices undergoing RT. In this review, we provide a short overview of the principles of RT and present the current evidence on the predictors and mechanisms of device malfunctions during RT. We also summarize practical recommendations from recent publications and from the industry. Strongly associated with beam energy of photon RT, device malfunctions occur at ∼3% of RT courses, posing a substantial issue in clinical practice. Malfunctions described in the literature typically consist of transient software disturbances and only seldom manifest as a permanent damage of the device. Through close cooperation between cardiologists and oncologists, a tailored individualized approach might be necessary in this patient group in waiting time for updated international guidelines in the field. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  6. Treatment of patients with cardiac pacemakers and implantable cardioverter-defibrillators during radiotherapy.

    PubMed

    Solan, Amy N; Solan, Merrill J; Bednarz, Greg; Goodkin, Michael B

    2004-07-01

    To define the practical clinical guidelines that can be implemented by busy radiation oncology departments to minimize the risk of harm to patients with implanted cardiac pacemaker (ICP) and implantable cardioverter-defibrillator (ICD) devices during radiotherapy. A literature review was conducted to identify the mechanism of potential damage to ICPs and ICDs from exposure to electromagnetic interference and/or ionizing radiation and to assess the published evidence of such device malfunction or failure. Recommendations for patient management were obtained from three major manufacturers. Eighty-seven radiation oncology facilities across the United States and Canada were contacted to determine current practice patterns; 75 centers responded. The published documentation of potential life-threatening malfunction of ICP and ICD devices exposed to electromagnetic interference and ionizing radiation is considerable. However, major discrepancies exist among manufacturer recommendations and wide variations are present among radiation oncology facilities regarding patient management precautions. Precautions are necessary to minimize the risk to patients with ICP and ICD devices during radiotherapy. Practical management guidelines are presented that can be readily adopted by any busy clinical radiation oncology practice.

  7. A prospective 1-year study of changes in neuropsychological functioning after implantable cardioverter-defibrillator surgery.

    PubMed

    Hallas, Claire N; Burke, Julie L; White, David G; Connelly, Derek T

    2010-04-01

    The testing of the implantable cardioverter-defibrillator (ICD), through the induction of repeated episodes of ventricular fibrillation, has been associated with disturbances in cerebral activity and increased levels of cytoplasmic enzymes. However, the neuropsychological outcomes of cerebral changes and their quality-of-life implications are unknown. Fifty-two ICD recipients completed standardized validated neuropsychological tests 1 to 3 days before ICD surgery and then 6 weeks, 6 months, and 12 months after surgery. They also completed psychometric tests measuring anxiety, depression, and quality of life. Between 31% and 39% of patients showed a significant neuropsychological impairment from their baseline function 6 weeks, 6 months, and 12 months after surgery. Ten percent of patients had late-onset deficits at 12 months only. Frequent areas of impairment were auditory and visual memory and attention. Neuropsychological impairment was not related to mood or quality of life at follow-up, although anxiety and depression predicted reduced quality of life. ICD implantation is associated with neuropsychological impairment that dissipates for the majority of recipients after 12 months. Short-term memory function and attention are particularly vulnerable to changes in oxygen during ICD testing. Although anxiety and depression are prevalent, there is little evidence for the direct impact of mood on cognition, and deficits appear not to be associated with reduced quality of life. These results provide evidence for longitudinal outcomes of ICD surgery and have implications for patient rehabilitation and adjustment.

  8. Frequency and clinical impact of retained implantable cardioverter defibrillator lead materials in heart transplant recipients.

    PubMed

    Kim, Jun; Hwang, Jongmin; Choi, Jin Hee; Choi, Hyo-In; Kim, Min-Seok; Jung, Sung-Ho; Nam, Gi-Byoung; Choi, Kee-Joon; Lee, Jae Won; Kim, You-Ho; Kim, Jae-Joong

    2017-01-01

    End-stage heart failure patients with implantable cardioverter-defibrillator (ICD) with/without cardiac resynchronization therapy (CRT-D) often require heart transplantation (HTPL) as a last-resort treatment. We aimed to assess the frequency and clinical impact of retained ICD lead materials in HTPL patients. In this retrospective single center study, we examined the clinical records and chest radiographs of patients with ICD and CRT-D who underwent HTPL between January 1992 and July 2014. Of 40 patients with ICD and CRT-D at HTPL, 19 (47.5%) patients had retained ICD lead materials within the central venous system. Retained ICD lead materials following HTPL were more frequently noted in patients with longer implantation durations until HTPL. None of the patients underwent extraction procedures after HTPL. All patients were asymptomatic and did not exhibit significant complications or death related to the retained ICD lead materials. Seven (7/40, 17.5%) patients without any retained ICD lead materials underwent magnetic resonance imaging (MRI) during the follow-up period (median, 29.5 months); none of the patients with retained lead materials were given MRI. Considering the common use of MRI in HTPL patients, further studies on the prophylactic extraction of retained ICD lead materials and safety of MRI in these patients are needed.

  9. Indications for implantable cardioverter-defibrillators based on evidence and judgment.

    PubMed

    Myerburg, Robert J; Reddy, Vivek; Castellanos, Agustin

    2009-08-25

    Implantable cardioverter-defibrillators (ICDs) are generally reliable medical devices that have the potential to add quality years of life for appropriate candidates. Indications for ICDs have emerged from a series of randomized clinical trials, observational data from cohorts of high-risk patients with less common diseases, and expert opinion based on limited data in uncommon disorders. The randomized trials are limited by inadequate stratification designs that resulted from insufficient funding availability. The result was outcomes that led to uneven applications, based in part on post-implant experience of device utilization. In this document, we explore the basis for the features of the evidence available to support ICD use, the role of clinical judgment in circumstances in which data are limited or lacking, and the need for additional research to improve the specificity of indications. Directions for new research initiatives are considered. In addition, a general overview of a clinical research paradigm is presented, in which the research and health care delivery arms of the health care enterprise combine in research design and funding, as the latter bears the impact of the outcomes of the former. Impact estimates during the design of trials, considering reasonable contingencies for outcomes, are suggested as a means of justifying the size, scope, and appropriate costs of studies. If we who are involved in clinical research and health care delivery do not resolve this problem, for both ICDs and other new therapies that appear in the future, society will do it for us.

  10. Underutilization of Implantable Cardioverter Defibrillator in Primary Prevention of Sudden Cardiac Arrest

    PubMed Central

    Lakshmanadoss, Umashankar; Sherazi, Saadia; Aggarwal, Ashim; Hsi, David; Aktas, Mehmet K.; Daubert, James P.; Shah, Abrar H

    2011-01-01

    Background The aim of this study was to evaluate the overall use of implantable cardioverter defibrillators (ICD) for primary prevention of sudden cardiac arrest (SCA), among eligible patients from an outpatient cardiology clinic and to determine what factors might contribute to underutilization of ICDs. Methods This report was a retrospective chart review of patients with ischemic or non-ischemic cardiomyopathy and left ventricular ejection fraction ≤ 35% from an outpatient cardiology practice from January 2005 to May 2008. These patients met the eligibility criteria for ICD implantation for primary prevention of SCA. A detailed review of medical records captured distribution of ICD implantation including future plans for ICD implant, patient preference against ICD use, presence of severe co-morbidities, and any other documented reasons/contraindications regarding ICD implantation. Results Of the 275 patients who were eligible for ICD for primary prevention of SCA, 119 (43%) had an ICD implantation. ICDs were used in 84 (48%) eligible men and 35 (35%) eligible women (P 0.02). Among 156 (57%) patients who did not receive ICD, 79 (28%) had severe co-morbidities precluding them from having ICD. Twenty-six patients (10%) refused to have ICD implanted. The remaining 51 (19%) patient charts did not include any documentation regarding ICD use (future plan or contraindication). Conclusions ICDs are underutilized for primary prevention of SCA, with rates of use being lowest among eligible women. This underutilization exists even after accounting for patient preferences and presence of severe co-morbid conditions that might make an otherwise eligible patient not a suitable candidate for ICD implantation.

  11. [Chronic transvenous pacemaker/implantable cardioverter defibrillator leads implantation induced pathological changes].

    PubMed

    Li, Yanhui; Dykoski, Richard; Li, Jianming

    2015-05-01

    Widely pacemaker/implantable cardioverter defibrillator (ICD) implantation is also related to an increasing need for transvenous lead extraction. Understanding the location and extent of pathological changes, including adhesions and fibrous tissue formation along the course of chronic pacemaker/ICD leads, are essential for operators performing lead extraction operations in order to reduce the potential life threatening complications. Three parts are included in the research, pathological examination on 83 extracted pacemaker/ICD leads using excimer laser technique from March 2008 to March 2011, autopsy examination of one died patient during lead extraction for lead-related infective endocarditis, and anatomical analysis on pacemaker/ICD leads from 10 patients died of other non-cardiac causes. Extensive encapsulated fibrous tissue around the leads and extensive adhesion/fibrosis along the course of the leads from venous entry site to the lead/myocardial interface could be detected on transvenous pacemaker/ICD leads. Since the tissue at the junction between superior vena cava (SVC) and right atrium (RA) is very thin, free of pericardium, thus, this is a common place for extensive adhesion/fibrosis and myocardial perforation/tear during lead extraction, which accounted for one death during extraction in our cohort. Extensive adhesion and fibrosis were also observed at the tricuspid valve and subvalvular structures. Leads implanted to the right ventricular apex were close to the epicardial surface and prone to perforation through myocardium. It is common to observe thrombus on the leads or at the interface between leads and myocardial tissue, especially at right atrial appendage (RAA) at the site of lead insertion. Extensive adhesions and fibrosis can be commonly seen along the course of pacemaker/ICD leads, and at SVC to RA junction, the tricuspid valve/subvalvular structures, and RA/RV lead interface. The tissue at SVC to RA junction is very thin, making it

  12. Spanish Implantable Cardioverter-defibrillator Registry. Twelfth Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2015).

    PubMed

    Alzueta, Javier; Fernández-Lozano, Ignacio; Barrera, Alberto

    2016-12-01

    We present the results of the Spanish Implantable Cardioverter-defibrillator Registry for 2015, as compiled by the Electrophysiology and Arrhythmia Section of the Spanish Society of Cardiology. Data collection sheets were voluntarily completed by each implantation team and prospectively sent to the Spanish Society of Cardiology. The number of reported implantations was 5465 (85% of the estimated total number of implantations). The implantation rate was 118 per million population while the estimated rate was 138. First implantations comprised 71.8%. Data were obtained from 169 hospitals (7 more than in 2014). Most implantations (82.7%) were performed in men. The mean patient age was 62.8±13.3 years. Most patients showed severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association function class II. The most frequent cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Implantations for primary prevention indications comprised 58.2%. Electrophysiologists performed 79.6% of the implantations. The 2015 Spanish Implantable Cardioverter-defibrillator Registry received information on 85% of the implantations performed in Spain. The number of implantations has grown from previous years. The percentage of implantations for primary prevention indications has slightly decreased from the previous registry. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  13. Spanish Implantable Cardioverter-defibrillator Registry. Eleventh Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2014).

    PubMed

    Alzueta, Javier; Asso, Antonio; Quesada, Aurelio

    2015-11-01

    We present the results of the Spanish Implantable Cardioverter-defibrillator Registry for 2014, as compiled by the Electrophysiology and Arrhythmia Section of the Spanish Society of Cardiology. Data collection sheets were voluntarily completed by each implantation team and prospectively sent to the Spanish Society of Cardiology. The number of reported implantations was 4911 (82% of the estimated total number of implantations). The implantation rate was 106 per million population while the estimated rate was 128. First implantations comprised 72.2%. Data were obtained from 162 hospitals (8 more than in 2013). Most implantations (82%) were performed in men. The mean patient age was 61.8±13.7 years. Most patients showed severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most frequent cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Implantations for primary prevention indications comprised 58.5%. Electrophysiologists performed 85.6% of the implantations. The 2014 Spanish Implantable Cardioverter-defibrillator Registry received information on 82% of the implantations performed in Spain. The number of implantations has increased from previous years and the percentage of implantations for primary prevention indications has increased from the previous year. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  14. Changes in Daily Life of Iranian Patients with implantable Cardioverter Defibrillator: A Qualitative Study

    PubMed Central

    Pasyar, Nilofar; Sharif, Farkhondeh; Rakhshan, Mahnaz; Nikoo, Mohammad Hossein; Navab, Elham

    2017-01-01

    ABSTRACT Background: Although Implantable Cardioverter Defibrillator (ICD) saves the life of patients with life-threatening ventricular dysrhythmias, it causes various challenges in their life span. Considering the increase in the number of ICD users, more knowledge is required regarding changes in the patients’ life after device implantation. The aim of this study was description of changes in daily life of patients after ICD implantation Methods: This qualitative study was conducted through content analysis method. The participants were selected through purposive sampling. They included 3 women and 9 men whose ages ranged from 24 to 74 years, with the mean age of 42.58+1.55 years. They had implanted ICDs in order to treat life-threatening dysrhythmias. The study data were collected through interview and field notes from November 2013 to October 2014. The data were simultaneously analyzed using constant comparative analysis. Results: Through analysis of the study data, 2 categories were emerged representing dimensions of changes in daily life of the patients with ICD. These categories were changes in the social role and familial challenges after implantation. Change in social role included the following subcategories: “Change in manifestation of routines”, “Shift in leisure time”, “Change in job and education status”, and “Change in interaction between the patient and society members”. In addition, familial challenges after implantation consisted of 2 subcategories, namely “Difficulty in marriage” and “ICD implantation and a range of familial changes”. Conclusion: The study findings can be of great importance in nurses’ clinical practice for providing the patients with holistic care, education, support, and follow-up. They can also be used as a guide assisting clinical treatment of the patients with ICD. PMID:28409167

  15. 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

    2016-12-23

    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.

  16. Tachycardia detection in modern implantable cardioverter-defibrillators.

    PubMed

    Brüggemann, Thomas; Dahlke, Daniel; Chebbo, Amin; Neumann, Ilka

    2016-09-01

    Implantable cardioverter-defibrillators (ICD) have to reliably sense, detect, and treat malignant ventricular tachyarrhythmias. Inappropriate treatment of non life-threatening tachyarrhythmias should be avoided. This article outlines the functionality of ICDs developed and manufactured by BIOTRONIK. Proper sensing is achieved by an automatic sensitivity control which can be individually tailored to solve special under- and oversensing situations. The programming of detection zones for ventricular fibrillation (VF), ventricular tachycardia (VT), and zones to monitor other tachyarrhythmias is outlined. Dedicated single-chamber detection algorithms based on average heart rate, cycle length variability, sudden rate onset, and changes in QRS morphology as used in ICDs by BIOTRONIK are described in detail. Preconditions and confirmation algorithms for therapy deliveries as antitachycardia pacing (ATP) and high energy shocks are explained. Finally, a detailed description of the dual-chamber detection algorithm SMART is given. It comprises additional detection criteria as stability of atrial intervals, 1:1 conduction, atrial-ventricular (AV) multiplicity, AV trend, and AV regularity to differentiate between ventricular and supraventricular tachyarrhythmias.

  17. Potential interference of small neodymium magnets with cardiac pacemakers and implantable cardioverter-defibrillators.

    PubMed

    Wolber, Thomas; Ryf, Salome; Binggeli, Christian; Holzmeister, Johannes; Brunckhorst, Corinna; Luechinger, Roger; Duru, Firat

    2007-01-01

    Magnetic fields may interfere with the function of cardiac pacemakers and implantable cardioverter-defibrillators (ICDs). Neodymium-iron-boron (NdFeB) magnets, which are small in size but produce strong magnetic fields, have become widely available in recent years. Therefore, NdFeB magnets may be associated with an emerging risk of device interference. We conducted a clinical study to evaluate the potential of small NdFeB magnets to interfere with cardiac pacemakers and ICDs. The effect of four NdFeB magnets (two spherical magnets 8 and 10 mm in diameter, a necklace made of 45 spherical magnets, and a magnetic name tag) was tested in forty-one ambulatory patients with a pacemaker and 29 patients with an ICD. The maximum distance at which the magnetic switch of a device was influenced was observed. Magnetic interference was observed in all patients. The maximum distance resulting in device interference was 3 cm. No significant differences were found with respect to device manufacturer and device types. Small NdFeB magnets may cause interference with cardiac pacemakers and ICDs. Patients should be cautioned about the interference risk associated with NdFeB magnets during daily life.

  18. Interference of cardiac pacemaker and implantable cardioverter-defibrillator activity during electronic dental device use.

    PubMed

    Roedig, Jason J; Shah, Jignesh; Elayi, Claude Samy; Miller, Craig S

    2010-05-01

    The authors conducted a study to determine if electromagnetic interference of cardiac pacemaker and implantable cardioverter-defibrillator (ICD) activity occurs during the operation of electronic dental devices. The authors tested nine electronic dental devices in vitro to assess their ability to interfere with the function of two pacemakers and two ICDs as determined by electrocardiographic telemetry. The pacing activity of both pacemakers and the dual-chamber ICD were inhibited during operation of the battery-operated composite curing light at between 2 and 10 centimeters from the generator or leads. The use of the ultrasonic scaler interfered with the pacing activity of the dual-chamber pacemaker at between 17 and 23 cm from the generator or leads, the single-chamber pacemaker at 15 cm from the generator or leads and both ICDs at 7 cm from the leads. The operation of the ultrasonic cleaning system interfered with the activity of the dual-chamber pacemaker at between 15 and 23 cm from the generator or leads, and of the single-chamber pacemaker at 12 cm. Operation of the electric toothbrush, electrosurgical unit, electric pulp tester, high- and low-speed handpieces, and an amalgamator did not alter pacing function. Select electronic dental devices interfere with pacemakers' and ICDs' sensing and pacing activity in vitro. Use of the ultrasonic scaler, ultrasonic cleaning system and battery-operated composite curing light may produce deleterious effects in patients who have pacemakers or ICDs.

  19. Interference of neodymium magnets with cardiac pacemakers and implantable cardioverter-defibrillators: an in vitro study.

    PubMed

    Ryf, Salome; Wolber, Thomas; Duru, Firat; Luechinger, Roger

    2008-01-01

    Permanent magnets may interfere with the function of cardiac pacemakers and implantable cardioverter-defibrillators (ICDs). Neodymium-iron-boron (NdFeB) magnets have become widely available in recent years and are incorporated in various articles of daily life. We conducted an in-vitro study to evaluate the ability of NdFeB magnets for home and office use to cause interference with cardiac pacemakers and ICDs. The magnetic fields of ten NdFeB magnets of different size and shape were measured at increasing distances beginning from the surface until a field-strength (B-field) value of 0.5 mT was reached. Furthermore, for each magnet the distance was determined at which a sample pacemaker switched from magnet mode to normal mode. Depending on the size and remanence of individual magnets, a B-field value of 0.5 mT was found at distances ranging from 1.5 cm to 30 cm and a value of 1 mT at distances from 1 cm to 22 cm. The pacemaker behavior was influenced at distances from 1 cm to 24 cm. NdFeB magnets for home and office use may cause interference with cardiac pacemakers and ICDs at distances up to 24 centimeters. Patient education and product declarations should include information about the risk associated with these magnets.

  20. Catheter ablation for ventricular tachycardia in patients with an implantable cardioverter defibrillator (CALYPSO) pilot trial.

    PubMed

    Al-Khatib, Sana M; Daubert, James P; Anstrom, Kevin J; Daoud, Emile G; Gonzalez, Mario; Saba, Samir; Jackson, Kevin P; Reece, Tammy; Gu, Joan; Pokorney, Sean D; Granger, Christopher B; Hess, Paul L; Mark, Daniel B; Stevenson, William G

    2015-02-01

    We conducted this pilot randomized clinical trial to determine the feasibility of a large clinical trial aimed at testing whether early use of catheter ablation of ventricular tachycardia (VT) is superior to antiarrhythmic medications at reducing mortality. Patients were enrolled at 4 sites if they had ischemic heart disease, an implantable cardioverter defibrillator (ICD), and received ≥1 ICD shock or ≥3 antitachycardia pacing therapies for VT. Patients were randomized to 2 arms: (1) antiarrhythmic medication (n = 14) and (2) catheter ablation (n = 13); patients were followed at 3 and 6 months. Endpoints included recurrent VT, time to first ICD therapy for VT, and death. Of 243 screened patients, 27 were enrolled. Main reasons for screen failures were: (1) patient was already on an antiarrhythmic medication (88 [41%]), (2) VT due to a reversible cause (23 [11%]), and (3) incessant VT (20 [9%]). Fourteen patients had recurrent VT, 8 (62%) in the ablation arm and 6 (43%) in the antiarrhythmic medication arm. Median time to recurrent VT was 75 days (25th, 75th: 51, 89) in the ablation arm and 57 days (30, 145) in the antiarrhythmic arm. Four patients died, 2 in each arm. This clinical trial shows that most patients in clinical practice have already failed antiarrhythmic drug therapy before catheter ablation is considered, and the VT recurrence rates and death in these patients are high. For a large clinical trial to be feasible, factors limiting early consideration of catheter ablation need to be identified and addressed. © 2014 Wiley Periodicals, Inc.

  1. Adjunctive antiarrhythmic drug therapy in patients with implantable cardioverter defibrillators: a systematic review.

    PubMed

    Ferreira-González, Ignacio; Dos-Subirá, Laura; Guyatt, Gordon H

    2007-02-01

    To assess the efficacy and safety of adjunctive antiarrhythmic drug therapy for preventing implantable cardioverter defibrillator (ICD) therapies. We conducted a systematic literature search to identify all randomized, controlled trials assessing the efficacy of adjunctive antiarrhythmic drug therapy. Trial data were reviewed and extracted independently by two investigators in an unblinded, standardized manner. Eight trials including a total of 1889 patients were analysed. There was heterogeneity in the type of antiarrhythmic used in the treatment arm (amiodarone, sotalol, azimilide, and dofetilide) as well as in the control group (five trials compared with placebo and three trials compared with beta-blocker). The main outcome, risk of shock therapy, was reduced when comparing amiodarone plus beta-blocker with beta-blocker alone (HR 0.27; 95% CI 0.14-0.52) and when comparing sotalol with placebo (HR 0.55; 95% CI 0.4-0.78). The effect was not conclusive when comparing sotalol with other beta-blocker (HR 0.61; 95% CI 0.37-1) and azimilide or dofetilide with placebo (HR 0.78; 95% CI 0.58-1.04 and HR 0.67; 95% CI 0.43-1.04, respectively). Although there were some benefits for secondary outcomes in all antiarrhythmics, the magnitude of the benefit was higher with amiodarone. Amiodarone is the most effective treatment to reduce ICD shock therapies. The benefit of other antiarrhythmics is limited to secondary outcomes.

  2. The ethics of unilateral implantable cardioverter defibrillators and cardiac resynchronization therapy with defibrillator deactivation: patient perspectives.

    PubMed

    Daeschler, Margaret; Verdino, Ralph J; Kirkpatrick, James N

    2017-08-01

    Decisions about deactivation of implantable cardioverter defibrillators (ICDs) are complicated. Unilateral do-not-resuscitate (DNR) orders (against patient/family wishes) have been ethically justified in cases of medical futility. Unilateral deactivation of ICDs may be seen as a logical extension of a unilateral DNR order. However, the ethical implications of unilateral ICD deactivation have not been explored. Sixty patients who had an ICD or cardiac resynchronization therapy with defibrillator (CRT-D) were interviewed at a quaternary medical centre outpatient electrophysiology practice. Survey questions addressed whether deactivation of defibrillator function was included in advanced directives, whether deactivation constitutes physician-assisted suicide, and whether unilateral deactivation can be ethically justified. Responses were elicited to scenarios in which defibrillation function was deactivated in different contexts (including patient request to deactivate, existing DNR, and unilateral deactivation). Only 15% of respondents had thought about device deactivation if they were to develop a serious illness from which they were not expected to recover. A majority (53%) had advance directives, but only one mentioned what to do with the device. However, a majority (78%) did not consider deactivation of an ICD shocking function against patients' wishes to be ethical or moral. Management of ICDs and CRT-Ds as patients near the end of their lives creates ethical dilemmas. Few patients consider device deactivation at end-of-life, although a large majority believes that unilateral deactivation is not ethical/moral, even in the setting of medical futility. Advance care planning for these patients should address device deactivation.

  3. Psychological effects of implantable cardioverter defibrillator shocks. A review of study methods

    PubMed Central

    Manzoni, Gian Mauro; Castelnuovo, Gianluca; Compare, Angelo; Pagnini, Francesco; Essebag, Vidal; Proietti, Riccardo

    2015-01-01

    Background: The implantable cardioverter defibrillator (ICD) saves lives but clinical experience suggests that it may have detrimental effects on mental health. The ICD shock has been largely blamed as the main offender but empirical evidence is not consistent, perhaps because of methodological differences across studies. Objective: To appraise methodologies of studies that assessed the psychological effects of ICD shock and explore associations between methods and results. Data Sources: A comprehensive search of English articles that were published between 1980 and 30 June 2013 was applied to the following electronic databases: PubMed, EMBASE, NHS HTA database, PsycINFO, Sciencedirect and CINAHL. Review Methods: Only studies testing the effects of ICD shock on psychological and quality of life outcomes were included. Data were extracted according to a PICOS pre-defined sheet including methods and study quality indicators. Results: Fifty-four observational studies and six randomized controlled trials met the inclusion criteria. Multiple differences in methods that were used to test the psychological effects of ICD shock were found across them. No significant association with results was observed. Conclusions: Methodological heterogeneity of study methods is too wide and limits any quantitative attempt to account for the mixed findings. Well-built and standardized research is urgently needed. PMID:25698991

  4. 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

  5. Arrhythmia Management in the Elderly-Implanted Cardioverter Defibrillators and Prevention of Sudden Death.

    PubMed

    Manian, Usha; Gula, Lorne J

    2016-09-01

    We present an overview of arrhythmia management in elderly patients as it pertains to implantable cardioverter defibrillator (ICD) therapy and prevention of sudden death. Treatment of arrhythmia in elderly patients is fraught with challenges pertaining to goals of care and patient frailty. With an ever increasing amount of technology available, realistic expectations of therapy need to balance quality and quantity of life. The ICD is an important treatment option for selected patients at risk of ventricular arrhythmia and sudden cardiac death. However, the incidence of sudden death as a percentage of all-cause mortality decreases with age. Studies have reported that 20% of elderly patients might die within 1 year of an episode of life-threatening ventricular arrhythmia, but most because of nonarrhythmic causes. This illustrates the 'sudden cardiac death paradox,' with a great proportion of death in elderly patients, even those at risk for ventricular arrhythmias, attributable to medical conditions that cannot be addressed by an ICD. We discuss current practices in ICD therapy in elderly patients, existing evidence from registries and clinical trials, approaches to risk stratification, and important ethical considerations. Although the decision on whether ICD insertion is appropriate in the elderly population remains an area of uncertainty from an evidence-based and ethical perspective, we offer insight on potential clinical and research strategies for this growing population.

  6. [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.

  7. 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.

  8. Nontraditional implantable cardioverter defibrillator placement in adult patients with limited venous access: a case series.

    PubMed

    Bhakta, Mayurkumar; Obioha, Chedozie C; Sorajja, Dan; Srivathsan, Komadoor; Arabia, Francisco A; Devaleria, Patrick A; Jaroszewski, Dawn E; Scott, Luis R; Altemose, Gregory T

    2010-02-01

    Conventional transvenous approaches for implantable cardioverter defibrillator (ICD) lead placement are not possible in some patients with limited venous access or severe tricuspid valve dysfunction. We retrospectively identified six patients who underwent ICD placement or revision requiring nontraditional alternative surgical lead placement at our institution between November 2006 and August 2008. The baseline and operative patient characteristic data were accumulated and reviewed. All the patients (mean age 71 +/- 3.4 years) underwent nontraditional surgical placement of epicardial ICD leads and traditional placement of ventricular epicardial bipolar pacing/sensing leads. Five patients had the distal lead tip fixed to the anterior epicardium of the right ventricular outflow tract, which was then looped under and around the ventricles, forming a "sling," and tunneled to a left subclavicular pocket. One patient had a single unipolar subcutaneous array lead fashioned into a "loop" and placed under the inferior aspect of the ventricles. The average procedure time was 311 +/- 115 minutes with a mean defibrillatory threshold (DFT) of < or = 22 + 3 J. Post-procedure hospitalization was 9.3 +/- 4.4 days and no device-related complications were encountered. Mean device follow-up of 451 + 330 days showed normal function and two appropriate successful ICD discharges. Nontraditional alternative surgical methods for the placement of ICD systems in adult patients with limited venous access or TV dysfunction can achieve results similar to those of conventionally placed endovascular leads with limited complications and comparable DFTs in short-term follow-up.

  9. 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.

  10. 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

  11. Ironic technology: Old age and the implantable cardioverter defibrillator in US health care.

    PubMed

    Kaufman, Sharon R; Mueller, Paul S; Ottenberg, Abigale L; Koenig, Barbara A

    2011-01-01

    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. Copyright © 2010 Elsevier Ltd. All rights reserved.

  12. Implantable cardioverter defibrillators in electric and magnetic fields of 400 kV power lines.

    PubMed

    Korpinen, Leena; Kuisti, Harri; Elovaara, Jarmo; Virtanen, Vesa

    2014-03-01

    Implantable cardioverter defibrillator (ICD) therapy has increased in Western countries. The aim of the study was to investigate the function of ICDs using a human-shaped phantom in electric and magnetic fields of 400 kV power lines. The phantom was used in the following manner: isolated from the ground, earthed from a foot, or earthed from a hand. We performed 37 ICD tests using 10 different ICD devices. When the electric fields varied from 6.8 kV/m to 7.5 kV/m (humidity 70.5%) and the magnetic field was 2.0 μT, one of the ICDs tested recorded 258 ventricular beats/min when a simulated heart signal was applied to ICD electrodes. When the exposure was 5.1 kV/m, the same ICD had a similar disturbance; however, in a 0.9 kV/m field, it worked correctly. Consequently, no effect on ICDs functioning was observed up to 0.9 kV/m, while anomalous behavior in some conditions was observed when levels exceeded 5.1 kV/m; ICD malfunctioning seems possible within 11.5 m from 400 kV power lines or in conditions inducing exposures exceeding 5 kV/m. Further development of this research field is needed. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

  13. [Surgical and interventional use of radiofrequency current: is there interference with implantable cardioverter/defibrillators?].

    PubMed

    Fiek, M; Dorwarth, U; Durchlaub, I; Mayer, A; Steinbeck, G; Hoffmann, E

    2002-07-01

    During surgical and interventional procedures, interactions between implantable cardioverter defibrillators (ICD) and electrical cautery, respectively, application of radiofrequency (RF) energy may occur. Induction of inadequate shock therapies or device malfunction may result and represent a potential perioperative hazard for the patient. Hence, we analyzed the intraoperative interactions in 23 consecutive ICD patients with regard to different surgical and interventional procedures. Sixteen surgical operations (general surgery n = 7, urologic n = 5, abdominal n = 2, gynecological n = 1, thoracic n = 1) and 7 interventional therapies (RF catheter ablation n = 5, endoscopic papillotomy n = 2) were performed. The ICD devices were all located in the left pectoral position and consisted of 15 single and 8 dual chamber defibrillators. During the procedure tachyarrhythmia detection (VF 295 +/- 21 ms, VT 370 +/- 55 ms) of the devices was maintained active (monitoring mode); only ICD therapies were inactivated. The indifferent electrode of the electrical cauter/RF generator was placed in standard positions (right mid femoral position n = 18, thoracic spine area n = 5). After the procedure, the ICD memory was checked for detections, respectively, for changes of the programming. There was no misdetection or reprogramming of the ICD caused by electrical cautery or RF energy. Despite the lack of undesired interactions ICDs should be inactivated preoperatively to assure maximum patient safety. However, should inactivation be ineffective or not manageable, electromagnetic interference is highly unlikely.

  14. 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.

  15. The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation

    PubMed Central

    Alsheikh-Ali, Alawi A.; Hersi, Ahmad S.; Hamad, Adel K. S.; Al Fagih, Ahmed R.; Al-Samadi, Faisal M.; Almusaad, Abdulmohsen M.; Bokhari, Fayez A.; Al-Kandari, Fawzia; Al-Ghamdi, Bandar S.; Al Rawahi, Najib; Asaad, Nidal; Alkaabi, Salem; Daoulah, Amin; Zaky, Hosam A.; Elhag, Omer; Al Hebaishi, Yahya S.; Sweidan, Raed; Alanazi, Haitham; Chase, David; Sabbour, Hani; Al Meheiri, Mohammad; Al Abri, Ismail; Amin, Mohammad; Dagriri, Khaled; Ahmed, Adil O.; Shafquat, Azam; Khan, Shahul Hameed

    2015-01-01

    Background: The implantable cardioverter-defibrillator (ICD) is effective in the prevention of sudden cardiac death in high-risk patients. Little is known about ICD use in the Arabian Gulf. We designed a study to describe the characteristics and outcomes of patients receiving ICDs in the Arab Gulf region. Methods: Gulf ICD is a prospective, multi-center, multinational, and observational study. All adult patients 18 years or older, receiving a de novo ICD implant and willing to sign a consent form will be eligible. Data on baseline characteristics, ICD indication, procedure and programing, in-hospital, and 1-year outcomes will be collected. Target enrollment is 1500 patients, which will provide adequate precision across a wide range of expected event rates. Results: Fifteen centers in six countries are enrolling patients (Saudi Arabia, United Arab Emirates, Kuwait, Oman, Bahrain, and Qatar). Two-thirds of the centers have dedicated electrophysiology laboratories, and in almost all centers ICDs are implanted exclusively by electrophysiologists. Nearly three-quarters of the centers reported annual ICD implant volumes of ≤150 devices, and pulse generator replacements constitute <30% of implants in the majority of centers. Enrollment started in December 2013, and accrual rate increased as more centers entered the study reaching an average of 98 patients per month. Conclusions: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region. PMID:26900416

  16. The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation.

    PubMed

    Alsheikh-Ali, Alawi A; Hersi, Ahmad S; Hamad, Adel K S; Al Fagih, Ahmed R; Al-Samadi, Faisal M; Almusaad, Abdulmohsen M; Bokhari, Fayez A; Al-Kandari, Fawzia; Al-Ghamdi, Bandar S; Al Rawahi, Najib; Asaad, Nidal; Alkaabi, Salem; Daoulah, Amin; Zaky, Hosam A; Elhag, Omer; Al Hebaishi, Yahya S; Sweidan, Raed; Alanazi, Haitham; Chase, David; Sabbour, Hani; Al Meheiri, Mohammad; Al Abri, Ismail; Amin, Mohammad; Dagriri, Khaled; Ahmed, Adil O; Shafquat, Azam; Khan, Shahul Hameed

    2015-01-01

    The implantable cardioverter-defibrillator (ICD) is effective in the prevention of sudden cardiac death in high-risk patients. Little is known about ICD use in the Arabian Gulf. We designed a study to describe the characteristics and outcomes of patients receiving ICDs in the Arab Gulf region. Gulf ICD is a prospective, multi-center, multinational, and observational study. All adult patients 18 years or older, receiving a de novo ICD implant and willing to sign a consent form will be eligible. Data on baseline characteristics, ICD indication, procedure and programing, in-hospital, and 1-year outcomes will be collected. Target enrollment is 1500 patients, which will provide adequate precision across a wide range of expected event rates. Fifteen centers in six countries are enrolling patients (Saudi Arabia, United Arab Emirates, Kuwait, Oman, Bahrain, and Qatar). Two-thirds of the centers have dedicated electrophysiology laboratories, and in almost all centers ICDs are implanted exclusively by electrophysiologists. Nearly three-quarters of the centers reported annual ICD implant volumes of ≤150 devices, and pulse generator replacements constitute <30% of implants in the majority of centers. Enrollment started in December 2013, and accrual rate increased as more centers entered the study reaching an average of 98 patients per month. Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region.

  17. Prognosis after Implantation of Cardioverter-Defibrillators in Korean Patients with Brugada Syndrome

    PubMed Central

    Son, Myoung Kyun; Byeon, Kyeongmin; Park, Seung-Jung; Kim, June Soo; Nam, Gi-Byoung; Choi, Kee-Joon; Kim, You-Ho; Park, Sang Weon; Kim, Young-Hoon; Park, Hyung Wook; Cho, Jeong Gwan

    2014-01-01

    Purpose Our study aims to analyze prognosis after implantable cardioverter-defibrillator (ICD) implantation in Korean patients with Brugada syndrome (BrS). Materials and Methods This was a retrospective study of BrS patients implanted with an ICD at one of four centers in Korea between January 1998 and April 2012. Sixty-nine patients (68 males, 1 female) were implanted with an ICD based on aborted cardiac arrest (n=38, 55%), history of syncope (n=17, 25%), or induced ven tricular tachyarrhythmia on electrophysiologic study in asymptomatic patients (n=14, 20%). A family history of sudden cardiac death and a spontaneous type 1 electrocardiography (ECG) were noted in 13 patients (19%) and 44 patients (64%), respectively. Results During a mean follow-up of 59±46 months, 4.6±5.5 appropri ate shocks were delivered in 19 patients (28%). Fourteen patients (20%) experienced 5.2±8.0 inappropriate shocks caused by supraventricular arrhythmia, lead failure, or abnormal sensing. Six patients were admitted for cardiac causes during follow-up, but no cardiac deaths occurred. An episode of aborted cardiac arrest was a significant predictor of appropriate shock, and the composite of cardiac events in the Cox pro portional hazard model [hazard ratio (95% confidence interval) was 11.34 (1.31-97.94) and 4.78 (1.41-16.22), respectively]. However, a spontaneous type 1 ECG was not a predictor of cardiac events. Conclusion Appropriate shock (28%) and inappropriate shock (20%) were noted during a mean follow-up of 59±46 months in Korean BrS patients implanted with an ICD. An episode of aborted cardiac ar rest was the most powerful predictor of cardiac events. PMID:24339285

  18. Implantable cardioverter-defibrillators in lamin A/C mutation carriers with cardiac conduction disorders.

    PubMed

    Anselme, Frédéric; Moubarak, Ghassan; Savouré, Arnaud; Godin, Bénédicte; Borz, Bogdan; Drouin-Garraud, Valérie; Gay, Arnaud

    2013-10-01

    Sudden cardiac death is frequent in patients with lamin A/C gene (LMNA) mutations and may be related to ventricular arrhythmias (VA). To evaluate a strategy of prophylactic implantable cardioverter-defibrillator (ICD) implantation in LMNA mutation carriers with significant cardiac conduction disorders. Forty-seven consecutive patients (mean age 38 ± 11 years; 26 men) were prospectively enrolled between March 1999 and April 2009. Prophylactic ICD implantation was performed in patients with significant cardiac conduction disorders: patients requiring permanent pacing for bradycardia or already implanted with a pacemaker at the initial presentation, or patients with a PR interval of >0.24 seconds and either complete left bundle branch block or nonsustained ventricular tachycardia. Twenty-one (45%) patients had significant conduction disorders and received a prophylactic ICD. Among ICD recipients, no patient died suddenly and 11 (52%) patients required appropriate ICD therapy during a median follow-up of 62 months. Left ventricular ejection fraction was ≥45% in 9 patients at the time of the event. Among the 10 patients without malignant VA, device memory recorded nonsustained ventricular tachycardia in 8 (80%). The presence of significant conduction disorders was the only factor related to the occurrence of malignant VA (hazard ratio 5.20; 95% confidence interval 1.14-23.53; P = .03). Life-threatening VAs are common in patients with LMNA mutations and significant cardiac conduction disorders, even if left ventricular ejection fraction is preserved. ICD is an effective treatment and should be considered in this patient population. © 2013 Heart Rhythm Society. All rights reserved.

  19. [Sexual activity in implantable cardioverter defibrillator patients included in cardiac rehabilitation].

    PubMed

    Maroto-Montero, José María; Maroto-de Pablo, Marta; Starling-Duarte, Juan; Prados-Cabiedas, Carolina; Villahoz-Garcia, Carmen; Cabrero-Soblechero, Lara; Sánchez-Corbal, Marta; Valverde-Dos Anjos, Belén; Muñoz-Sanjuan, Yésica

    2017-08-25

    Analysis of the effects of a Cardiac Rehabilitation Program (CRP) on life quality and sexual activity levels, in patients with implantable cardioverter defibrillators (ICD). Twenty-five patients (22 men and 3 women) were included in the study consisting in the analysis of the existence of defibrillator discharges, its repercussion on the couple and the effects of CRP on physical and psychological aspects and on sexual activity (SA). Patient mean age was 55years (22 to 79). Initially, fear for device discharges was present in all patients. On arrival, 14 patients (56%) did not have SA: 2 with ages of 69 and 79years; a woman due to severe anxiety; an alcoholic man, and 10 because the ICD had been implanted less than 1month before. Nine men and two women had restarted SA: 5 of them 5-52months after the implantation and the other 6, 30days after implantation of the ICD while attending the CRP. At the end of the study, 21 patients had regain SA. Two men had clinical signs of depression and anxiety, one requiring specialized treatment. Functional capacity improved significantly, 6.5±3.0METs at the beginning of the program and 9.2±3.3MRTs at the end, with P<.005. There was only one inappropriate discharge. Discharges caused by newest devices have dropped significantly. This fact, together with the action of CRP at physical, psychological and informative levels, makes it possible to control the dysfunctions in life quality and sexuality in patients. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

  20. 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.

  1. Outcomes of single- or dual-chamber implantable cardioverter defibrillator systems in Japanese patients

    PubMed Central

    Ueda, Akiko; Oginosawa, Yasushi; Soejima, Kyoko; Abe, Haruhiko; Kohno, Ritsuko; Ohe, Hisaharu; Momose, Yuichi; Nagaoka, Mika; Matsushita, Noriko; Hoshida, Kyoko; Miwa, Yosuke; Miyakoshi, Mutsumi; Togashi, Ikuko; Maeda, Akiko; Sato, Toshiaki; Yoshino, Hideaki

    2015-01-01

    Background There are no criteria for selecting single- or dual-chamber implantable cardioverter defibrillators (ICDs) in patients without a pacing indication. Recent reports showed no benefit of the dual-chamber system despite its preference in the United States. As data on ICD selection and respective outcomes in Japanese patients are scarce, we investigated trends regarding single- and dual-chamber ICD usage in Japan. Methods Data from a total of 205 ICD recipients with structural heart disease (median age, 63 years) in two Japanese university hospitals were reviewed. Patients with bradycardia with a pacing indication and permanent atrial fibrillation at implantation were excluded. Results Single- and dual-chamber ICDs were implanted in 36 (18%) and 169 (82%) patients, respectively. Non-ischemic cardiomyopathy dominated both groups. Seventeen dual-chamber patients developed atrial pacing-dependency over 4.5 years, and it developed immediately after implantation in 14. Although preoperative testing showed no sign of bradycardia in these patients, their pacing rate was set higher than it was in patients who were pacing-independent (61 vs. 46 paces per min, p<0.01). Two single-chamber patients (5%) underwent atrial lead insertion. While inappropriate shock equally occurred in both groups (7 vs. 21 patients, single- vs. dual-chamber, P=0.285), device-related infection occurred only in dual-chamber patients (0 vs. 9 patients, P=0.155). No differences in death or heart failure hospitalization were observed between groups. Conclusions Dual-chamber ICDs were four-fold more common in Japanese patients without a pacing indication. No benefit over single-chamber ICD was observed. Newly developed atrial pacing-dependency seemed to be limited and could have been overestimated due to higher pacing rate settings in dual-chamber patients. PMID:27092188

  2. 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.

  3. Design and implementation of a population-based registry of Implantable Cardioverter Defibrillators (ICDs) in Ontario.

    PubMed

    Lee, Douglas S; Birnie, David; Cameron, Douglas; Crystal, Eugene; Dorian, Paul; Gula, Lorne J; Healey, Jeffrey S; Janmohammed, Amir; Khaykin, Yaariv; Krahn, Andrew D; LeFeuvre, Catherine; Simpson, Christopher S; Yee, Raymond; Hardy, Judy; Slaughter, Pamela M; Chen, Zhongliang; Alter, David A; Laupacis, Andreas; Tu, Jack V

    2008-09-01

    There are scarce population-based data on the use, complication rates, and outcomes of patients receiving implantable cardioverter defibrillators (ICDs). This study sought to describe the methodology of the Ontario ICD Database, a prospective study of all ICD recipients in Ontario, Canada. In this registry, web-based data collection will be performed in all patients referred to a cardiac electrophysiologist for consideration of an ICD. The variables included in the database were determined by consensus. Outcomes to be assessed will include defibrillator device therapies (e.g., shock or antitachycardia pacing), morbidity, and death. Preliminary statistics are reported after the first 6 months of data collection. Of 208 total variables selected by consensus, 111 (53.4%) were referral/patient characteristics, 12 (5.8%) were implant-related, and 85 (40.9%) were outcome variables. Among 990 referred patients, 902 were accepted, with the following ICD indications: primary prevention (63.3%), secondary prevention (21.6%), and generator replacement (15.1%). The mean (SD) age of patients with implants was 63.9 +/- 12.6 years, and 79% were men. Among accepted ICD patients, 66% had ischemic heart disease, 23% had nonischemic dilated cardiomyopathy, and 11% had other cardiac conditions. Left ventricular (LV) systolic dysfunction was highly prevalent, with 82% of primary and 44% of secondary prevention patients having LV ejection fraction implanted largely for primary prevention, and the majority of these conformed with LV ejection fraction guidelines.

  4. Statins, ventricular arrhythmias and heart rate variability in patients with implantable cardioverter defibrillators and coronary heart disease.

    PubMed

    Riahi, Sam; Schmidt, Erik Berg; Christensen, Jeppe Hagstrup; Heath, Finn; Pedersen, Anders Kirstein; Nielsen, Jens Cosedis; Mølgaard, Henning; Toft, Egon

    2005-01-01

    The aim of this study was to evaluate whether the incidence of ventricular arrhythmias and heart rate variability were influenced by statin treatment and lipid levels in patients treated with an implantable cardioverter defibrillator (ICD). Heart rate variability measurements were performed in 86 patients with coronary heart disease and an ICD implant. The number of events with ventricular fibrillation and ventricular tachycardia were recorded during a 12-month period. This study lends little support for an antiarrhythmic effect of statins or any relation between plasma lipids and lipoproteins and malignant ventricular arrhythmias in patients with an ICD. Copyright (c) 2005 S. Karger AG, Basel.

  5. 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.

  6. 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.

  7. Depression and outcome among veterans with implantable cardioverter defibrillators with or without cardiac resynchronization therapy capability.

    PubMed

    Shalaby, Alaa A; Brumberg, Genevieve E; Pointer, Lauren; Bekelman, David B; Rumsfeld, John S; Yang, Yanfei; Pellegrini, Cara N; Heidenreich, Paul A; Keung, Edmund; Massie, Barry M; Varosy, Paul D

    2014-08-01

    The impact of depression on outcome in implantable cardioverter defibrillator (ICD) recipients has not been fully appreciated. We assessed the prevalence of depression and its association with heart failure (HF) outcome among veterans with ICDs. Patients enrolled between January 2005 and January 2010 in the Outcomes among Veterans with Implantable Defibrillators Registry were studied. We examined the cross-sectional association of depression with severity of HF functional class as well as the association of depression with the composite outcome of mortality or HF hospitalization over a mean follow-up time of 2.7 years. There were 3,862 patients enrolled. Patients with depression (1,162, 43%) were younger (63.1 ± 9.4 years vs 66.6 ± 9.9 years, P < 0.001), more likely to have a history of tobacco or alcohol abuse (P < 0.0001) or atrial fibrillation (P = 0.05) while having a higher ejection fraction (28.3% vs 27.4%, P = 0.03). Depression was associated with advanced HF class at time of implant; odds ratio (OR; vs class I) for class III: 1.65 (confidence interval [CI] 1.17-2.33), class IV: 1.73 (95% CI 1.08-2.76). Death or HF hospitalization was more likely to occur in patients with depression (35.2% vs 32.0%, HR: 1.15 [95% CI 0.99-1.33]). The predictive value of depression was stronger after multivariable adjustment; HR: 1.25 (95% CI 1.05-1.49). Depression was prevalent among veterans with ICDs. Depression was associated with severity of HF. The predictive value of associated depression was significant after multivariable adjustment. ©2014 Wiley Periodicals, Inc.

  8. Outcomes of Implantable Cardioverter-Defibrillator Use in Patients With Comorbidities

    PubMed Central

    Steinberg, Benjamin A.; Al-Khatib, Sana M.; Edwards, Rex; Han, JooYoon; Bardy, Gust H.; Bigger, Thomas J.; Buxton, Alfred E.; Moss, Arthur J.; Lee, Kerry L.; Steinman, Richard; Dorian, Paul; Hallstrom, Alfred; Cappato, Riccardo; Kadish, Alan H.; Kudenchuk, Peter J.; Mark, Daniel B.; Inoue, Lurdes Y.T.; Sanders, Gillian D.

    2014-01-01

    Objectives The aim of this study was to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. Background Primary prevention ICDs improve survival in patients at risk for sudden cardiac death. Their benefit in patients with significant comorbid illness has not been demonstrated. Methods Original, patient-level datasets from MADIT I (Multicenter Automatic Defibrillator Implantation Trial I), MADIT II, DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation), and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were combined. Patients in the combined population (N = 3,348) were assessed with respect to the following comorbidities: smoking, pulmonary disease, diabetes, peripheral vascular disease, atrial fibrillation, ischemic heart disease, and chronic kidney disease. The primary outcome was overall mortality, using the hazard ratio (HR) of time to death for patients receiving an ICD versus no ICD by extent of medical comorbidity, and adjusted for age, sex, race, left ventricular ejection fraction, use of antiarrhythmic drugs, beta-blockers, and angiotensin-converting enzyme inhibitors. Results Overall, 25% of patients (n = 830) had <2 comorbid conditions versus 75% (n = 2,518) with significant comorbidity (≥2). The unadjusted hazard of death for patients with an ICD versus no ICD was significantly lower, but this effect was less for patients with ≥2 comorbidities (unadjusted HR: 0.71; 95% confidence interval: 0.61 to 0.84) compared with those with <2 comorbidities (unadjusted HR: 0.59; 95% confidence interval: 0.40 to 0.87). After adjustment, the benefit of an ICD decreased with increasing number of comorbidities (p = 0.004). Conclusions Patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity; implantation should be carefully considered in sick patients. Further study of ICDs in medically complex

  9. Performance of a radiation protection cabin during implantation of pacemakers or cardioverter defibrillators.

    PubMed

    Ploux, Sylvain; Ritter, Philippe; Haïssaguerre, Michel; Clementy, Jacques; Bordachar, Pierre

    2010-04-01

    Pacemaker implants are associated with a high cumulative exposure of the operators to radiation. Standard radiation protection with lead aprons is incomplete and the cause of spine disorders. A radiation protection cabin offers complete protection by surrounding the operator, without requiring a lead apron. We randomly and evenly assigned 60 patients undergoing implantations of permanent pacemakers or cardioverter defibrillators (ICD) with (a) a radiation protection cabin (cabin group, n = 30) versus (b) standard protection with a 0.5 mm lead-equivalent apron (control group, n = 30). Radiation exposure was measured using personal electronic dosimeters placed on the thorax, back, and head of the operator. The patient, procedural, and device characteristics of the 2 study groups were similar. All procedures in the cabin group were performed as planned without increase in duration or complication rate compared with the control group. The mean radiation dose to the head, normalized for fluoroscopy duration, was significantly lower in the cabin (0.040 +/- 0.032 microSv/min) than in the control (1.138 +/- 0.560 microSv/min) group (p < 0.0001). The radiation doses to the thorax (0.043 +/- 0.027 vs 0.041 +/- 0.040 microSv/min) and back (0.038 +/- 0.029 vs 0.033 +/- 0.018 microSv/min) in the cabin versus control group (under the apron) were similar. The use of a radiation protection cabin markedly decreased the exposure of the operator to radiation, and eliminated the need to wear a lead apron, without increasing the procedural time or complication rate during implantation of pacemaker and ICD.

  10. Experiences of Young Adults With Pacemakers and/or Implantable Cardioverter Defibrillators.

    PubMed

    Larimer, Karen; Durmus, Julie; Florez, Elizabeth

    The number of implanted devices (pacemakers [PMs] and implantable cardioverter defibrillators [ICDs]) is increasing. Because of technological advances, these devices are used in greater numbers in children and adolescents. Challenges of having these devices have been well studied in adults, but little is known about the lived experiences from the perspective of young adults. This study explored the lived experiences, coping behaviors, and challenges of young adults who had cardiac devices implanted during childhood. A descriptive qualitative study design was used. Purposive sampling was used to identify young adults aged 18 to 29 years, living with a PM and/or ICD. Participants were interviewed about their experiences and challenges related to living with a PM or ICD, with common themes identified and analyzed. A total of 6 participants were interviewed for this study. The challenges of living with a PM and/or ICD included insecurity about physical appearance, device compliance, physical sensations of the device, future uncertainty, and limited support. The identified coping behaviors utilized by the participants were confrontation, acceptance, educating others, spreading awareness, avoidance, and humor. The overall lived experiences described were appreciation for device benefits, fear of device malfunction, and attracting attention. The lived experiences of young recipients often mirror that of older adults; however, it is clear that there are challenges and coping behaviors unique to young adults living with a PM and/or ICD. It is important to educate healthcare providers about the unique challenges that young adults may face so they can provide the appropriate support to this population.

  11. Psychological correlates, allostatic overload and clinical course in patients with implantable cardioverter defibrillator (ICD).

    PubMed

    Gostoli, Sara; Bonomo, Matteo; Roncuzzi, Renzo; Biffi, Mauro; Boriani, Giuseppe; Rafanelli, Chiara

    2016-10-01

    Implantable cardioverter defibrillator (ICD) is a key treatment option for both primary and secondary prevention of sudden cardiac death. Despite this, there is a growing number of studies showing that ICD is often associated with post-implantation deleterious psychosocial effects, even in the absence of medical complications. Knowledge about the predictive role of pre-ICD psychological profile is scant. The present research aims to describe patients' pre-ICD psychological profile, focusing on acute and chronic distress, such as anxiety, depression, type D personality, psychosomatic syndromes and allostatic overload (AO), and to evaluate if these psychological variables could affect ICD outcomes and survival. 117 consecutive patients (74.4% males; mean age=63.1±13.7years) underwent psychological assessment prior to ICD implantation. Data on ICD-related complications and death were collected up to 26months after the intervention. At baseline, 36.8% of the sample had anxiety and 17.9% depression. Among psychosomatic syndromes, psychological factors affecting medical conditions were the most frequent (37.6%). 12.8% presented with type D personality, whereas 16.2% showed moderate AO and 4.3% severe AO. 25.6% of the patients had post-ICD complications and 6% died. Severe AO was the only predictor of survival. Our findings show that a reliable evaluation of stress and the inability to cope with it (allostatic overload) may help to identify patients at higher risk of post-ICD complications and death. Such sensitive index, more than traditional psychiatric diagnostic criteria, may help the physician to identify easily manifestations of distress and clinically relevant information, which could affect medical illness outcomes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. Association of Physician Certification and Outcomes Among Patients Receiving an Implantable Cardioverter-Defibrillator

    PubMed Central

    Curtis, Jeptha P.; Luebbert, Jeffrey J.; Wang, Yongfei; Rathore, Saif S.; Chen, Jersey; Heidenreich, Paul A.; Hammill, Stephen C.; Lampert, Rachel I.; Krumholz, Harlan M.

    2009-01-01

    Context Allowing nonelectrophysiologists to perform implantable cardioverter-defibrillator (ICD) procedures is controversial. However, it is not known whether outcomes of ICD implantation vary by physician specialty. Objective To determine the association of implanting physician certification with outcomes following ICD implantation. Design, Setting, and Patients Retrospective cohort study using cases submitted to the ICD Registry performed between January 2006 and June 2007. Patients were grouped by the certification status of the implanting physician into mutually exclusive categories: electrophysiologists, nonelectrophysiologist cardiologists, thoracic surgeons, and other specialists. Hierarchical logistic regression models were developed to determine the independent association of physician certification with outcomes. Main Outcome Measures In-hospital procedural complication rates and the proportion of patients meeting criteria for a defibrillator with cardiac resynchronization therapy (CRT-D) who received that device. Results Of 111 293 ICD implantations included in the analysis, 78 857 (70.9%) were performed by electrophysiologists, 24 399 (21.9%) by nonelectrophysiologist cardiologists, 1862 (1.7%) by thoracic surgeons, and 6175 (5.5%) by other specialists. Compared with patients whose ICD was implanted by electrophysiologists, patients whose ICD was implanted by either nonelectrophysiologist cardiologists or thoracic surgeons were at increased risk of complications in both unadjusted (electrophysiologists, 3.5% [2743/78 857]; nonelectrophysiologist cardiologists, 4.0% [970/24 399]; thoracic surgeons, 5.8% [108/1862]; P < .001) and adjusted analyses (relative risk [RR] for nonelectrophysiologist cardiologists, 1.11 [95% confidence interval {CI}, 1.01–1.21]; RR for thoracic surgeons, 1.44 [95% CI, 1.15–1.79]). Among 35 841 patients who met criteria for CRT-D, those whose ICD was implanted by physicians other than electrophysiologists were significantly

  13. 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

  14. 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.

  15. 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.

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

    SciTech Connect

    Hurkmans, Coen W. . E-mail: Coen.Hurkmans@cze.nl; Scheepers, Egon; Springorum, Bob G.F.; Uiterwaal, Hans

    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 have 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.

  17. Effect of Significant Weight Change on Inappropriate Implantable Cardioverter-Defibrillator Therapy.

    PubMed

    Daimee, Usama A; Biton, Yitschak; Aktas, Mehmet K; Zannad, Faiez; Klein, Helmut; Szepietowska, Barbara; McNitt, Scott; Polonsky, Bronislava; Wang, Paul J; Zareba, Wojciech; Moss, Arthur J; Kutyifa, Valentina

    2017-01-01

    Weight loss has been associated with adverse outcomes among heart failure (HF) patients, including those receiving cardiac resynchronization therapy with defibrillator (CRT-D). The effect of significant weight change on inappropriate implantable cardioverter-defibrillator (ICD) therapy among CRT-D patients is not well understood. We evaluated the impact of significant weight change at 1 year on subsequent inappropriate ICD therapy during follow-up among 993 CRT-D patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy. Patients were divided into three subgroups based on weight change at 1 year after enrollment: weight loss (weight loss ≥ 5%), weight gain (weight gain ≥ 5%), and stable weight (weight loss and weight gain < 5%). The primary end point was inappropriate ICD therapy. Secondary end point included inappropriate ICD therapy related to supraventricular arrhythmias (SVAs). There were 102 (10.3%) patients who experienced weight loss, 689 (69.4%) whose weight was stable, and 202 (20.3%) who gained weight at 1 year. Patients with weight loss had increased risk of subsequent inappropriate ICD therapy relative to patients with stable weight (hazard ratio [HR] = 2.35, 95% confidence interval [CI]: 1.39-3.98, P = 0.001) or weight gain (HR = 2.27, 95% CI: 1.18-4.38, P = 0.014). Furthermore, patients losing weight were at greater risk of subsequent inappropriate ICD therapy related to SVAs when compared to patients with stable weight (HR = 2.16, 95% CI: 1.18-3.95, P = 0.013) or weight gain (HR = 2.02, 95% CI: 0.95-4.29, P = 0.068). In mild HF patients receiving CRT-D, significant weight loss at 1 year is associated with increased risk of subsequent inappropriate ICD therapy, including risk related to SVAs. © 2016 Wiley Periodicals, Inc.

  18. Depression and anxiety status of patients with implantable cardioverter defibrillator and precipitating factors.

    PubMed

    Bilge, Ahmet Kaya; Ozben, Beste; Demircan, Sabri; Cinar, Mutlu; Yilmaz, Ercument; Adalet, Kamil

    2006-06-01

    Implantable cardioverter defibrillators (ICDs) are life-saving devices in treatment of life-threatening arrhythmia. We evaluate the emotional status of Turkish patients with ICD and try to explain factors that affect emotional status of the patients. Ninety-one patients with previously implanted ICD were included in the study. Follow-up periods, presence of ICD shock, shock frequency, time of the recent shock, age, and gender were noted. Depression and anxiety scores were evaluated according to Hospital Anxiety and Depression (HAD) chart. Mean anxiety and depression scores were found as 9.1 +/- 5.3 and 7.2 +/- 5.1, respectively. According to HAD charts, 42 patients (46%) had anxiety and 37 patients (41%) had depression. Depression scores indicated significant difference between subgroups divided on the basis of follow-up periods (P = 0.026) and on the basis of time of recent shock (P = 0.028). There was significant difference in anxiety scores (P = 0.016) between patients with ICD shocks and patients with no shocks. When the patients were divided into subgroups according to shock frequency, both depression (P = 0.024) and anxiety (P = 0.016) scores presented significant difference. In female patients, depression and anxiety scores were found significantly higher compared to male patients (P = 0.046 and P = 0.016, respectively). In multivariate analysis, gender and shock frequency were found as predictors for anxiety scores (P = 0.019 and P = 0.044, respectively). However same analysis revealed no predictive factor for depression score. Our study indicates presence of depression and anxiety in nearly half of the patients with ICD. Consultation with psychiatry should be a part of the treatment for patients with ICD, especially for those who constitute high-risk groups.

  19. 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.

  20. Induction ovens and electromagnetic interference: what is the risk for patients with implantable cardioverter defibrillators?

    PubMed

    Binggeli, Christian; Rickli, Hans; Ammann, Peter; Brunckhorst, Corinna; Hufschmid, Urs; Luechinger, Roger; Duru, Firat

    2005-04-01

    Electromagnetic fields may interfere with normal implantable cardioverter defibrillator (ICD) function. Although the devices are effectively shielded and use exclusively bipolar leads, electromagnetic interference (EMI) remains a concern when patients are exposed to several household appliances. The aim of this study was to evaluate potential EMI risk of induction ovens, which are increasingly common in private households. In vitro measurements of an induction oven for private households GK 43 TI (V-Zug, Inc., Zug, Switzerland) showed that heating is regulated by increasing operating time from level 1 (100 ms/sec) to 5 (continuous operation). From levels 5 to 9 the magnetic field increases. Nineteen patients with left-sided implants of single- and dual-chamber ICD systems (8 Medtronic, 7 Guidant, and 4 St. Jude Medical) (18 males, 1 female), age (mean +/- SEM) 58 +/- 3 years, were included in this study. All patients were examined in standing position, bent over the cooking pot (minimal distance to the induction coil 25 cm), and with the cooking pot put eccentrically over the induction field at three different cooking levels (level 2, 5, and 9). The tests were repeated touching the cooking pot with one hand. Ventricular sensitivity was left unchanged. Ventricular tachycardia therapies were turned off in Medtronic and Guidant devices and ventricular sensing was continuously monitored in St. Jude Medical devices during testing. Interrogation of the devices after exposure did not show any inappropriate tachycardia detection, oversensing, or reprogramming. In conclusion, ICD patients can be reassured that EMI is unlikely to affect their devices if induction ovens are used in their kitchens.

  1. Interference of programmed electromagnetic stimulation with pacemakers and automatic implantable cardioverter defibrillators.

    PubMed

    Gwechenberger, Marianne; Rauscha, Friedrich; Stix, Günter; Schmid, Gernot; Strametz-Juranek, Jeanette

    2006-07-01

    A commercially available magnetic therapy system, designed for clinical application as well as for private use without medical supervision, was examined with respect to its potential for causing electromagnetic interference with implantable pacemakers (PMs) and automatic implantable cardioverter defibrillators (AICDs). A sample of 15 PMs and 5 AICDs were experimentally investigated. Each of the implants was realistically positioned in a homogeneous, electrically passive torso phantom and exposed to the magnetic fields of the system's applicators (whole body mat, cushion, and bar applicator). The detection thresholds of the implants were programmed to maximum sensitivity and both unipolar as well as bipolar electrode configurations were considered. The evaluation of possible interferences was derived from the internal event storages and pacing statistics recorded by the implants during exposure. Any "heart activity" recorded by the implants during exposure was interpreted as a potential interference, because the implant obviously misinterpreted the external interference signal as a physiological signal. Only cases without any recorded "heart activity" and with nominal pacing rates (as expected from the program parameter settings) of the implants were rated as "interference-free." Exposure to the whole body mat (peak magnetic induction up to 265 microT) did not show an influence on PMs and AICD in any case. The cushion applicator at the highest field intensity (peak magnetic induction up to 360 microT) led to atrial sensing defects in four PM models with unipolar electrode configuration. Under bipolar electrode configuration no disturbances occurred. The bar applicator led to sensing problems and consecutively reduced pacing rates in all tested PM models under unipolar electrode configuration and maximum field intensity (peak magnetic induction up to 980 microT). Bipolar electrode configuration resolved the problem. The investigated AICDs did not show malfunctions

  2. 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

  3. Assessing Health Literacy in Urban Patients With Implantable Cardioverter Defibrillators and Pacemakers.

    PubMed

    Hickey, Kathleen T; Sciacca, Robert R; Gonzalez, Paul; Castillo, Carmen; Frulla, Ashton

    2015-01-01

    Functional health literacy (FHL) has become an increasingly prevalent topic of discussion in patient health and well-being. Although FHL has been studied in a variety of populations, it has not been investigated in patients with pacemakers and implantable cardioverter defibrillators (ICDs).The purpose of this study was to evaluate FHL in a primarily older, urban-dwelling ICD/pacemaker population. A secondary objective was to compare 2 commonly used instruments for assessing FHL.A convenience sample of 116 patients was recruited from an urban ICD/pacemaker clinic. Participants were asked to complete the Short Test of Functional Health Literacy in Adults (STOFHLA) followed by the Test of Functional Health Literacy in Adults to assess reading comprehension and numeracy. Logistic regression was used to assess the association between FHL and patient descriptors.The population was 68 ± 13 years of age, and 62.7% were men. The sample was ethnically diverse: 37.1% white, 39.7% Hispanic, and 22.4% African American; 77.4% of the population reported finishing high school. Of the 109 completing the Test of Functional Health Literacy in Adults, 60.6% had adequate FHL, 10.1% had marginal FHL, and 29.4% had inadequate FHL. The presence of coexisting chronic conditions such as diabetes mellitus, hyperlipidemia, and hypertension was associated with inadequate/marginal FHL (P = .007, P = .004, and P = .02, respectively). Of the 113 completing STOFHLA, 67.3% had adequate FHL, 7.1% had marginal FHL, and 25.7% had inadequate FHL. The presence of diabetes mellitus, hyperlipidemia, and hypertension was also associated with inadequate/marginal FHL as assessed by STOFHLA (P = .009, P = .02, and P = .004, respectively).In this older, urban, ICD/pacemaker population, approximately 40% had inadequate/marginal FHL. These results warrant further investigation of FHL in other cardiovascular populations.

  4. A Prospective Randomized Trial of Moderately Strenuous Aerobic Exercise After an Implantable Cardioverter Defibrillator (ICD)

    PubMed Central

    Dougherty, Cynthia M.; Glenny, Robb W.; Burr, Robert L.; Flo ARNP, Gayle L.; Kudenchuk, Peter J.

    2015-01-01

    Background Despite its salutary effects on health, aerobic exercise is often avoided after receipt of an implantable cardioverter-defibrillator (ICD) because of fears that exercise may provoke acute arrhythmias. We prospectively evaluated the effects of a home aerobic exercise training and maintenance program (EX) on aerobic performance, ICD shocks and hospitalizations exclusively in ICD recipients. Methods and Results One hundred sixty (124 men, 36 women) were randomized who had an ICD for primary (43%) or secondary (57%) prevention to EX or usual care (UC). The primary outcome was peak oxygen consumption (peakVO2), measured with cardiopulmonary exercise testing at baseline, 8 and 24 weeks. EX consisted of 8 weeks of home walking 1 hour/day, 5 days/week at 60-80% of heart rate reserve, followed by 16 weeks of maintenance home walking for 150 minutes/week. Adherence to EX was determined from exercise logs, ambulatory HR recordings of exercise, and weekly telephone contacts. UC received no exercise directives and were monitored by monthly telephone contact. Adverse events were identified by ICD interrogations, patient reports and medical records. ICD recipients averaged 55±12 years and mean ejection fraction of 40.6±15.7, all were taking beta blocker medications. EX significantly increased peakVO2 ml/kg/min (EX 26.7±7.0; UC 23.9±6.6, p=0.002) at 8 weeks, which persisted during maintenance exercise at 24 weeks (EX 26.9±7,7; UC 23.4±6.0, p<0.001). ICD shocks were infrequent (EX=4 vs UC=8), with no differences in hospitalizations or deaths between groups. Conclusions Prescribed home exercise is safe and significantly improves cardiovascular performance in ICD recipients without causing shocks or hospitalizations. PMID:25792557

  5. A review of implantable cardioverter defibrillator failures during radiation therapy in three Sydney hospitals.

    PubMed

    Hudson, Felicity J; Ryan, Elaine A

    2017-08-01

    In recent years, using radiation energies greater than 10 MV in patients with implantable cardioverter defibrillators (ICDs) has been contra-indicated due to the risk of a power on reset (POR) occurring. The ICD is often greater than 30 cm from the treatment field and subject to scatter radiation only. The aim of this study was to use recent patient cases to verify published failure rates and treatment recommendations. Five patients with ICDs who experienced a device malfunction during radiation therapy treatments were identified in three Sydney hospitals between 2008 and 2012. The types of treatments delivered during these events were assessed. Further assessment of all ICD patients at one Sydney hospital during this time was carried out to assess the rate of ICD failure during high energy treatments using 18 MV. All ICDs that suffered malfunctions were exposed to scatter radiation only. All were exposed to partial or exclusive irradiation using 18 MV photons. Accumulated doses to the ICDs were estimated to be well below accepted dose limits found in literature. One centre reported a 22.2% rate of POR during exposure to 18 MV radiation therapy during this time frame. Where possible, radiation therapy using energies greater than 10 MV should be avoided for ICD patients. While the use of these energies carries a risk of failure, it must be weighed against potential benefit to the patient requiring treatment if no alternatives are available. Stringent monitoring of these patients, including regular cardiac device checks and ECG monitoring is recommended if treatment is to proceed with energies greater than 10 MV. © 2017 The Royal Australian and New Zealand College of Radiologists.

  6. 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.

  7. Outcomes After Implantable Cardioverter-Defibrillator Generator Replacement for Primary Prevention of Sudden Cardiac Death.

    PubMed

    Madhavan, Malini; Waks, Jonathan W; Friedman, Paul A; Kramer, Daniel B; Buxton, Alfred E; Noseworthy, Peter A; Mehta, Ramila A; Hodge, David O; Higgins, Angela Y; Webster, Tracy L; Witt, Chance M; Cha, Yong-Mei; Gersh, Bernard J

    2016-03-01

    The effectiveness of implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden death in patients with an ejection fraction (EF) ≤ 35% and clinical heart failure is well established. However, outcomes after replacement of the ICD generator in patients with recovery of EF to >35% and no previous therapies are not well characterized. Between 2001 and 2011, generator replacement was performed at 2 tertiary medical centers in 253 patients (mean age, 68.3 ± 12.7 years; 82% men) who had previously undergone ICD placement for primary prevention but subsequently never received appropriate ICD therapy. EF had recovered to > 35% in 72 of 253 (28%) patients at generator replacement. During median (quartiles) follow-up of 3.3 (1.8-5.3) years after generator replacement, 68 of 253 (27%) experienced appropriate ICD therapy. Patients with EF ≤ 35% were more likely to experience ICD therapy compared with those with EF > 35% (12% versus 5% per year; hazard ratio, 3.57; P = 0.001). On multivariable analysis, low EF predicted appropriate ICD therapy after generator replacement (hazard ratio, 1.96 [1.35-2.87] per 10% decrement; P = 0.001). Death occurred in 25% of patients 5 years after generator replacement. Mortality was similar in patients with EF ≤ 35% and > 35% (7% versus 5% per year; hazard ratio, 1.10; P = 0.68). Atrial fibrillation (3.24 [1.63-6.43]; P < 0.001) and higher blood urea nitrogen (1.28 [1.14-1.45] per increase of 10 mg/dL; P < 0.001) were associated with mortality. Although approximately one fourth of patients with a primary prevention ICD and no previous therapy have EF >35% at the time of generator replacement, these patients continue to be at significant risk for appropriate ICD therapy (5% per year). These data may inform decisions on ICD replacement. © 2016 American Heart Association, Inc.

  8. 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

  9. Neuromuscular electrical stimulation of the thighs in cardiac patients with implantable cardioverter defibrillators.

    PubMed

    Cenik, Fadime; Schoberwalter, Dieter; Keilani, Mohammad; Maehr, Bruno; Wolzt, Michael; Marhold, Maximilian; Crevenna, Richard

    2016-11-01

    The aim of this systematic review was to update scientific knowledge concerning the safety of neuromuscular electrical stimulation (NMES) to increase exercise capacity and prevent cardiac cachexia in patients with implantable cardioverter defibrillators (ICDs). A systematic review including the electronic databases PubMed, MEDLINE, and SCOPUS was conducted for the time period from 1966 to March 31, 2016. Only four articles fulfilled the inclusion criteria (three original articles/safety studies and one case report). The three (safety) studies used NMES to increase muscle strength and/or endurance capacity of the thighs. NMES did not show electromagnetic interference (EMI) with ICD function. EMI was described in a case report of 2 patients with subpectoral ICDs and application of NMES on abdominal muscles. This review indicates that NMES may be applied in cardiac ICD patients if 1) individual risks (e. g., pacing dependency, acute heart failure, unstable angina, ventricular arrhythmic episode in the last 3 months) are excluded by performing a safety check before starting NMES treatment and 2) "passive" exercise using NMES is performed only for thighs and gluteal muscles in 3) compliant ICD patients (especially for home-based NMES) and 4) the treatment is regularly supervised by a physician and the device is examined after the first use of NMES to exclude EMI. Nevertheless, further studies including larger sample sizes are necessary to exclude any risk when NMES is used in this patient group.

  10. In vitro tests of electromagnetic interference of electromagnetic navigational bronchoscopy to implantable cardioverter defibrillators.

    PubMed

    Magnani, Andrea; Matheoud, Roberta; Brambilla, Marco; Valzano, Serena; Occhetta, Eraldo; Marino, Paolo; Balbo, Piero

    2012-07-01

    To characterize the electromagnetic field emitted by the electromagnetic navigational bronchoscopy (ENB) superDimension(®) Bronchus system (SDBS) and to determine whether current implantable cardioverter defibrillator (ICD) systems are suitable for use in conjunction with SDBS. The electromagnetic emission of the SDBS location board were measured using a field strength meter connected to a low-frequency (5 Hz-100 kHz) electric and magnetic field analyser; the static magnetic field was measured using a three-axis Tesla meter. A human torso simulator was used in the in vitro experiment: a polyethylene plastic box (61 cm length × 43 cm depth × 16.5 cm height) was filled with a semisolid gel and a 0.45% saline solution to provide electric conductance similar to tissue. The ICDs were immersed 1 cm into the gel and connected with a dual-coil integrated bipolar pacing/sensing/shock lead. Tip and right ventricular coil of the lead were connected to an arrhythmia simulator using low-impedance cables. The system transmits electromagnetic waves of 2.5, 3.0, and 3.5 kHz frequency. The maximum magnetic fields measured were B = 53 and 12 µT at location board plane and at ICD plane, respectively. Corresponding figures for the electric field were E = 16.6 and 4.4 V/m. None of the tested ICDs recorded any noise signal during the period in which the location board was switched-on. Stored electrogram analysis confirmed the correct detection of simulated tachyarrhythmia and therapy delivery by every tested ICD. The results of this study demonstrated that tested ICDs are compatible with ENB performed with SDBS. They also suggest that these results may be extended to all ICDs manufactured in compliance with current EN regulations.

  11. 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.

  12. 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

  13. Validation of an Organizational Management Model of Remote Implantable Cardioverter-Defibrillator Monitoring Alerts.

    PubMed

    Guédon-Moreau, Laurence; Finat, Loïc; Boulé, Stéphane; Wissocque, Ludivine; Marquié, Christelle; Brigadeau, François; Kouakam, Claude; Mondésert, Blandine; Kacet, Salem; Klug, Didier; Lacroix, Dominique

    2015-07-01

    Implantable cardioverter-defibrillators (ICDs) are a standard means of sudden cardiac death prevention. Compared with ambulatory visits, remote monitoring (RM) of ICD recipients has improved the quality of health care and spared its resources. Few studies have addressed the organization of RM. We optimized and validated our institutional model of RM organization for ICD recipients. This observational study of 562 ICD recipients compared 2 RM periods consisting of iterative, qualitative, and quantitative (1) device diagnostic evaluations by nurses and cardiologists; and (2) selected decisional trees. The main study end points were the professional interventions prompted by, and times allocated to, RM alerts. During the first period, 1134 alerts occurred in 427 patients (286 patient-year), of which 376 (33%) were submitted to cardiologists' reviews, compared with, 1522 alerts in 562 patients (458 patient-year), of which 273 (18%) were submitted to cardiologists' reviews during the second period (P<0.001). An intervention was prompted by 73 of 376 (19.4%) alerts in the first versus 77 of 273 (28.2%) in the second period (P=0.009). The mean time to manage an alert was 4 minutes 31 s in the first versus 2 minutes 10 s in the second period (P<0.001). The annual numbers of alert-related hospitalizations were 10.8 versus 8.1 per 100-patient-year (P=0.230), and annual numbers of alert-related visits were 9.8 and 6.1 per 100-patient-year (P=0.081), respectively. An optimized RM organization based on automated alerts and decisional trees enabled a focus on clinically relevant events and a decrease in the consumption of resources without compromising the quality of ICD recipients' care. © 2015 American Heart Association, Inc.

  14. Investigation of the Utility of the Audible Alert in Recent Generation Medtronic Implantable Cardioverter Defibrillators.

    PubMed

    Manandhar, Meryna; Nemirovsky, Dmitry; Feigenblum, David Y; Simons, Grant R

    2016-12-01

    Medtronic implantable cardioverter defibrillators (ICDs; Medtronic Inc., Mounds View, MN, USA) are equipped with Patient Alert™, a feature in which the ICD generator emits a series of audible tones to notify patients of possible system malfunction. A prior study of this issue revealed that only 50% of patients with older Medtronic devices were able to hear alerts. More recently, Medtronic has incorporated modifications to the alert. Therefore, we studied how frequently alert tones emitted by the current generation of Medtronic ICDs are audible by patients. A series of patients were evaluated in an outpatient ICD clinic. Alert tones were demonstrated using a device programmer in a quiet room and in the presence of low-level background noise. Patients reported whether they heard the tones, and they completed questionnaires regarding the tones. The total sample size was 100 patients, 81 male, who ranged from 29 years to 94 years of age (mean age 72.1 ± 11.8). Among the study subjects, 46% were older than 75 years, 41% were between 55 years and 75 years, and 13% were younger than 55 years. In the absence of background noise, 94% of patients were able to hear both alerts, 1% heard only one alert, and 5% heard neither. In the presence of background noise, 88% of patients heard both the alerts, 7% heard only one alert, and 5% heard neither alerts. Our results demonstrate that alert tones in recent generation Medtronic ICDs have improved audibility, compared to prior published data, among a large outpatient ICD population. © 2016 Wiley Periodicals, Inc.

  15. Readability and content of patient education material related to implantable cardioverter defibrillators.

    PubMed

    Strachan, Patricia H; de Laat, Sonya; Carroll, Sandra L; Schwartz, Lisa; Vaandering, Katie; Toor, Gurjit K; Arthur, Heather M

    2012-01-01

    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. 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. 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 "simple measurement of gobbledygook" and Fry methods. The material was evaluated according to selected plain-language criteria, thematic content analysis, and rhetoric analysis. 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. 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 multicultural and debilitated population who may require ICDs. The

  16. Analysis of willingness to pay for implantable cardioverter-defibrillator therapy.

    PubMed

    Nowakowska, Dominika; Guertin, Jason R; Liu, Aihua; Abrahamowicz, Michal; Lelorier, Jacques; Lespérance, François; Brophy, James M; Rinfret, Stéphane

    2011-02-01

    Despite being effective in the primary and secondary prevention of sudden cardiac arrest, the cost-effectiveness of implantable cardioverter-defibrillator (ICD) therapy remains debated. We attempted to estimate the value ICD recipients place on their ICD device. We used the contingent valuation method to evaluate the willingness to pay (WTP) and the cost benefit of ICD therapy in an unselected population of 237 recipients. A hypothetical scenario was presented to patients in which at the end of their current ICD no public reimbursement for the replacement would occur. Patients were asked to indicate their out-of-pocket WTP for a replacement ICD using a close-ended question format. Seven different "take-it-or-leave-it" bids were randomly varied and assigned to patients. Median WTP was calculated with nonparametric methods, and multiple logistic regression models were generated to identify factors associated with WTP. Only cost of the device was considered. Median WTP was estimated at CAN $4,125, which corresponds to 21% of the cost of the device (CAN $20,000). In multiple logistic regression analysis, a higher bid (odds ratio [OR] 0.95, 95% confidence interval [CI] 0.91 to 0.99, per CAN $1,000 increase) was associated with a lower WTP, whereas a higher gross family income (OR 2.3, 95% CI 0.9 to 9.0) and higher education (OR 2.2, 95% CI 0.9 to 5.1) were associated with a trend for higher WTP. In conclusion, ICD recipients would be willing to pay a substantial amount for a replacement ICD. Considering the expensive price of the device, ICD recipients value favorably the benefits provided by the ICD.

  17. 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.

  18. 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.

  19. Survival after primary prevention implantable cardioverter-defibrillator placement among patients with chronic kidney disease.

    PubMed

    Hess, Paul L; Hellkamp, Anne S; Peterson, Eric D; Sanders, Gillian D; Al-Khalidi, Hussein R; Curtis, Lesley H; Hammill, Bradley G; Pun, Patrick H; Curtis, Jeptha P; Anstrom, Kevin J; Hammill, Stephen C; Al-Khatib, Sana M

    2014-10-01

    Guidelines recommend that implantable cardioverter-defibrillator (ICD) candidates have an estimated longevity of ≥1 year. Longevity can be affected by chronic kidney disease (CKD). Using the National Cardiovascular Data Registry ICD registry linked with the Social Security Death Master File, we assessed the rate of death after primary prevention ICD placement between January 1, 2006, and December 31, 2007, according to CKD stage. Using Cox models, we identified factors associated with death among patients with CKD. Compared with patients without CKD (n=26,056), those with CKD (n=21,226) were older, less commonly men, more often white, and more frequently had comorbid illness. Compared with patients without CKD, patients with a glomerular filtration rate 30 to 60, glomerular filtration rate <30, and end-stage renal disease on dialysis had a higher risk of death after ICD placement (hazard ratio, 2.08; 95% confidence interval, 1.99-2.18; P<0.0001; hazard ratio, 4.20; 95% confidence interval, 3.92-4.50; P<0.0001; and hazard ratio, 4.80; 95% confidence interval, 4.46-5.17; P<0.0001, respectively). Corresponding 1-year death rates were 4.4%, 9.1%, 20.2%, and 22.4%. Among patients with CKD, factors associated with increased risk of death included CKD severity, age >65 years, heart failure symptoms, diabetes mellitus, lung disease, serum sodium <140 mEq/L, atrial fibrillation or flutter, and a lower ejection fraction. The risk of death after primary prevention ICD placement is proportional to CKD severity. Among patients with CKD, several factors are prognostically significant and could inform clinical decision making on primary prevention ICD candidacy. © 2014 American Heart Association, Inc.

  20. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients?

    PubMed

    Glikson, Michael; Suleiman, Mahmoud; Luria, David M; Martin, Marjorie L; Hodge, David O; Shen, Win-Kuang; Bradley, David J; Munger, Thomas M; Rea, Robert F; Hayes, David L; Hammill, Stephen C; Friedman, Paul A

    2009-01-01

    With the increased number of implantable cardioverter-defibrillator (ICD) recipients and the frequent need for device upgrading, lead malfunction is a concern, but the optimal approach to managing nonfunctioning leads is unknown. The purpose of this study was to determine the rate and characteristics of complications related to abandoned ICD leads. Patients with abandoned leads were identified by retrospective review of the Mayo Clinic ICD database from August 1993 to May 2002. We reviewed the medical records to assess long-term follow-up for venous thromboembolic complications, device sensing malfunction, appropriateness of delivered shocks, defibrillation threshold (DFT) values before and after lead abandonment, and subsequent surgical procedures related to devices or leads. We identified 78 ICD patients (81% males; mean age 63 +/- 14 years) with 101 abandoned leads (69 in the right ventricle, 31 in the right atrium or superior vena cava, 1 in the coronary sinus). During a mean follow-up of 3.1 +/- 2.0 years, neither sensing malfunction nor venous thromboembolic complications were detected. DFT values were high in 13 patients (17%), but there was no significant increase in mean DFT values before and after lead abandonment in 43 patients for whom both values were available (16.2 +/- 9.2 J before abandonment vs 14.1 +/- 5.5 J after; P = .24). Fourteen patients (18%) required further ICD-related surgery; none of these operations were attributed to abandoned leads. Five-year rates of appropriate and inappropriate shocks were 25.9% and 20.5%, respectively. Abandoning a nonfunctioning lead appears to be safe and does not pose a clinically significant additional risk of future complications.

  1. Long-term outcome of patients who received implantable cardioverter defibrillators for stable ventricular tachycardia.

    PubMed

    Glikson, Michael; Lipchenca, Igor; Viskin, Sami; Ballman, Karla V; Trusty, Jane M; Gurevitz, Osnat T; Luria, David M; Eldar, Michael; Hammill, Stephen C; Friedman, Paul A

    2004-06-01

    Evidence is inconclusive concerning the role of implantable cardioverter defibrillators (ICDs) to treat patients with hemodynamically stable ventricular tachycardia (VT). The goal of this study was to estimate future risk of unstable ventricular arrhythmias in patients who received ICDs for stable VT. We reviewed complete ICD follow-up data from 82 patients (age 66.1 +/- 11.3 years; left ventricular ejection fraction 32.3%+/- 11.2%; mean +/- SD) who received ICDs for stable VT. During the follow-up period of 23.6 +/- 21.5 months (mean +/- SD), 15 patients (18%) died, and 10 (12%) developed unstable ventricular arrhythmia, 8 of whom had the unstable arrhythmia as the first arrhythmia after ICD placement. Estimated 2- and 4-year survival in the whole group was 80% and 74%, respectively. Estimated 2- and 4-year probability of any VT and unstable VT was 67% and 77% and 11% and 25%, respectively. There were no differences in age, ejection fraction, sex, underlying heart disease, cycle length, symptoms, baseline electrophysiologic study results, or QRS characteristics of qualifying VT between patients who developed unstable ventricular arrhythmia and patients who did not. Twenty-nine patients (35%) had at least one inappropriate shock, and 11 (13%) underwent further surgery for ICD-related complications. Patients who present with hemodynamically stable VT are at risk for subsequent unstable VT. ICD treatment offers potential salvage of patients with stable VT who subsequently develop unstable VT/ventricular fibrillation, although complications and inappropriate shocks are considerable. No predictors could be found for high and low risk for unstable arrhythmias. These findings support ICD treatment for stable VT survivors.

  2. 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

  3. 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.

  4. Anesthesia care for subcutaneous implantable cardioverter/defibrillator placement: a single-center experience.

    PubMed

    Essandoh, Michael K; Portillo, Juan G; Weiss, Raul; Otey, Andrew J; Zuleta-Alarcon, Alix N; Humeidan, Michelle L; Torres, Jose L; Flores, Antolin S; Castellon-Larios, Karina; Abdel-Rasoul, Mahmoud; Andritsos, Michael J; Perez, William J; Stein, Erica J; Turner, Katja R; Dimitrova, Galina T; Awad, Hamdy; Bhandary, Sujatha P; Tripathi, Ravi S; Joseph, Nicholas C; Hummel, John D; Augostini, Ralph S; Kalbfleisch, Steven J; Tyler, Jaret D; Houmsse, Mahmoud; Daoud, Emile G

    2016-06-01

    The recently approved subcutaneous implantable cardioverter/defibrillator (S-ICD) uses a single extrathoracic subcutaneous lead to treat life-threatening ventricular arrhythmias, such as ventricular tachycardia and ventricular fibrillation. This is different from conventional transvenous ICDs, which are typically implanted under sedation. Currently, there are no reports regarding the anesthetic management of patients undergoing S-ICD implantation. This study describes the anesthetic management and outcomes in patients undergoing S-ICD implantation and defibrillation threshold (DFT) testing. The study population consists of 73 patients who underwent S-ICD implantation. General anesthesia (n = 69, 95%) or conscious/deep sedation (n = 4, 5%) was used for device implantation. Systolic blood pressure (SBP) and heart rate were recorded periprocedurally for S-ICD implantation and DFTs. Major adverse events were SBP <90 mm Hg refractory to vasopressor agents, significant bradycardia (heart rate <45 beats per minute) requiring pharmacologic intervention and, "severe" pain at the lead tunneling site and the S-ICD generator insertion site based on patient perception. Of the 73 patients, 39 had SBP <90 mm Hg (53%), and intermittent boluses of vasopressors and inotropes were administered with recovery of SBP. In 2 patients, SBP did not respond, and the patients required vasopressor infusion in the intensive care unit. Although the S-ICD procedure involved extensive tunneling and a mean of 2.5 ± 1.7 DFTs per patient, refractory hypotension was a major adverse event in only 2 patients. The mean baseline SBP was 132.5 ± 22.0 mm Hg, and the mean minimum SBP during the procedure was 97.3 ± 9.2 mm Hg (P < .01). There was also a mean 13-beats per minute decrease in heart rate (P < .01), but no pharmacologic intervention was required. Eight patients developed "severe" pain at the lead tunneling and generator insertion sites and were adequately managed with intravenous morphine

  5. Pre-clinical detection of amiodarone-induced acute fibrosing alveolitis by intra-thoracic impedance monitor of an implantable cardioverter-defibrillator.

    PubMed

    Hsieh, Yu-Cheng; Huang, Jin-Long; Chin, Chun-Shih; Lin, Tung-Chao; Liao, Ying-Chieh; Ting, Chih-Tai; Wu, Tsu-Juey

    2011-01-01

    A 66-year-old male received an implant of a dual-chamber implantable cardioverter-defibrillator (ICD) and was prescribed amiodarone (400 mg/day). The intra-thoracic impedance monitor in the ICD antecedently detected amiodarone-induced acute fibrosing alveolitis >3 months prior to clinical symptoms.

  6. Efficacy and safety of early comprehensive cardiac rehabilitation following the implantation of cardioverter-defibrillator.

    PubMed

    Śmiałek, Jacek; Lelakowski, Jacek; Majewski, Jacek

    2013-01-01

    Implantable cardioverter-defibrillator (ICD) therapy is current the main approach to prevent sudden cardiac death. It was demonstrated that patients with ICD are characterised by worse quality of life (QOL) and exercise capacity and are prone to depressive symptoms. Thus, comprehensive rehabilitation is indicated in ICD recipients. To evaluate safety and benefits of comprehensive cardiac rehabilitation early after ICD implantation. The study group consisted of 45 patients (28 males, mean age 62.2 years) in whom a program of comprehensive cardiac rehabilitation was initiated at 6 weeks after ICD implantation. Rehabilitation consisted of two phases: 2-week inpatient Phase I and 12-week outpatient Phase II. Before and after the rehabilitation program, all patients were evaluated with transthoracic echocardiography, treadmill spiroergometric exercise test according to the modified Naughton protocol, a Polish version of the SF-36 questionnaire to assess QOL, and the Beck Depression Inventory (BDI) for depressive symptoms. No deaths during the study and no complications or adverse events during rehabilitation or exercise testing were noted. Following comprehensive cardiac rehabilitation, we found an increase in left ventricular ejection fraction (30.09 ± 12.75 vs. 35.43 ± 13.4%; p = 0.002), peak oxygen uptake (VO₂) (21.3 ± 9.2 vs. 24.2 ± 10.3 mL/kg/min; p = 0.007) and duration of exercise (9.14 ± 3.7 vs. 9.53 ± 3.8 min; p < 0.05). An improvement was also noted in terms of depressive symptoms, as BDI score decreased (14.81 ± 9.27 vs. 12.83 ± 10.75; p = 0.020). QOL improved (p < 0.05), particularly the physical index (p = 0.02), as was the New York Heart Association class (p < 0.001). Improvement in peak VO₂ was associated with better QOL (SF-total, r = -0.34; and physical index, r = -0.36). We also found a correlation between alleviation of depressive symptoms (BDI score) and improvement of QOL (SF-total, r = 0.52). An improvement in left ventricular systolic

  7. The wearable cardioverter defibrillator as a bridge to implantable defibrillator post myocardial infarction: what do we know?

    PubMed

    Barsheshet, Alon; Vamvouris, Theodora; Goldenberg, Ilan

    2016-07-01

    Ventricular tachyarrhythmias (ventricular tachycardia and ventricular fibrillation) can lead to aborted cardiac arrest or sudden cardiac death in patients with poor left ventricular function early after acute myocardial infarction (AMI). Although it has been shown that the implantable cardioverter defibrillator (ICD) can treat ventricular tachyarrhythmias and save lives in patients with ischemic cardiomyopathy, it's use during the early phase post AMI has not been shown to reduce mortality. Current device guidelines require a waiting period of 40 days post AMI and 3 months post revascularization. Thus, there is a time gap where high-risk patients may not be protected. This review summarizes the characteristics of the wearable cardioverter-defibrillator (WCD) and its role in bridging the gap between an AMI and time of ICD eligibility. In addition, we focus on the efficacy of the WCD in treating ventricular tachyarrhythmias events, compliance and safety of the WCD use. Expert commentary: The WCD use during the early post AMI period can add crucial information to the process of risk stratification and decision-making whether an individual needs an implantation of an ICD or not. The WCD can serve as a safe and effective bridge during the interval preceding ICD placement.

  8. Implantable cardioverter defibrillator therapy in young patients with cardiomyopathies and channelopathies: a single Italian centre experience.

    PubMed

    Migliore, Federico; Silvano, Maria; Zorzi, Alessandro; Bertaglia, Emanuele; Siciliano, Mariachiara; Leoni, Loira; De Franceschi, Pietro; Iliceto, Sabino; Corrado, Domenico

    2016-07-01

    This study was designed to prospectively evaluate the risk-benefit ratio of implantable cardioverter defibrillator (ICD) therapy in young patients with cardiomyopathies and channelopathies. The study population included 96 consecutive patients [68 men, median age 27 (22-32) years] with cardiomyopathies, such as arrhythmogenic right ventricular cardiomyopathy (n = 35), dilated cardiomyopathy (n = 17), hypertrophic cardiomyopathy (n = 15), Brugada syndrome (n = 14), idiopathic ventricular fibrillation (n = 5), left ventricular noncompaction (n = 4), long-QT syndrome (n = 4) and short-QT syndrome (n = 2), who were 18-35 years old at the time of ICD implantation. During a mean follow-up of 72.6 ± 53.3 months, one patient with end-stage hypertrophic cardiomyopathy died because of acute heart failure, and 11 patients underwent orthotopic heart transplantation. Twenty patients (20.8%) had a total of 38 appropriate ICD interventions (4%/year), and 26 patients (27.1%) experienced a total of 49 adverse ICD-related events (5.4%/year), including 23 inappropriate ICD interventions occurring in nine patients (9.4%) and 26 device-related complications requiring surgical revision occurring in 20 patients (20.8%). Lead failure/fracture requiring lead extraction was the most common complication (n = 9). A threshold for ICD therapy less than 300 ms was associated with a borderline significant lower probability of inappropriate ICD interventions (hazard ratio = 0.2; 95% confidence interval 0.02-1.2; P = 0.07), whereas underweight status was an independent predictor of device-related complications (hazard ratio = 5.4; 95% confidence interval 1.5-19.4; P = 0.01). In young patients with cardiomyopathies and channelopathies, ICD therapy provided life-saving protection by effectively terminating life-threatening ventricular arrhythmias. However, because ICD-related adverse events are common, the risk/benefit ratio should be

  9. How to truly value implantable cardioverter-defibrillators technology: up-front cost or daily cost?

    PubMed

    Biffi, Mauro; Ziacchi, Matteo; Bertini, Matteo; Gardini, Beatrice; Mazzotti, Andrea; Massaro, Giulia; Martignani, Cristian; Diemberger, Igor; Boriani, Giuseppe; Corsini, Daniela

    2011-07-01

    We calculated the daily cost of implantable cardioverter-defibrillators (ICDs) based on their actual longevity to prove whether the up-front cost is a reliable parameter for the ICD purchasing-process. METHODS. Longevity of single chamber (SC), double chamber (DC), and biventricular (BiV) ICDs from Medtronic (MDT), Guidant (GDT), and St. Jude Medical (SJM) was measured in all the patients implanted in years 2000, 2001, 2002 who reached device replacement within December 31, 2009. The cost of each ICD (device + lead/s) was normalized for its own longevity. Data are expressed as median (25th-75th percentile). A total of 123/153 patients completed the study, 70 percent being alive 8 years after implantation. MDT devices had a superior longevity compared with GDT and SJM (p < .001). Fifty-eight percent of replaced ICDs had a service life at least 1 year shorter than the manufacturers' prediction. Longer-lasting devices had a significantly lower daily cost: €4.8 (4.6-5.7) versus €6.8 (6.2-9.2) and €6.9 (6.2-7.6) for SC (p < .001); €6.9 (6.8-7.7) versus €12.6 (11.8-13.3) and €13.4 (10.3-16.1) for DC; €8.5 (8.3-10.3) versus €15.4 (15.1-15.8) and €14.6 (14.1-14.9) for BiV (p < .005). The true cost of ICD treatment is strictly dependent on device longevity, whereas device up-front cost is unreliable. This aspect should be valued in the technology purchasing process, and could set the basis for an outcome-based reimbursement system. Our observations may be the benchmark respectively for ICD longevity and daily ICD cost in future comparisons. Independent observations in the real-life scenario are needed to properly value newer technologic improvements.

  10. Usefulness of Left Atrial Emptying Fraction to Predict Ventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillators.

    PubMed

    Rijnierse, Mischa T; Kamali Sadeghian, Mehran; Schuurmans Stekhoven, Sophie; Biesbroek, P Stefan; van der Lingen, Anne-Lotte C; van de Ven, Peter M; van Rossum, Albert C; Nijveldt, Robin; Allaart, Cornelis P

    2017-07-15

    Impaired left atrial emptying fraction (LAEF) is an important predictor of mortality in patients with heart failure. As it may reflect increased LV wall stress, it might predict ventricular arrhythmia (VA) specifically. This study evaluated the predictive value of LAEF assessed with cardiovascular magnetic resonance (CMR) imaging with respect to appropriate device therapy (ADT) for VA and compared its role with CMR assessed scar size and other risk factors. In total, 229 patients (68% male, 63 ± 10 years, 61% ischemic cardiomyopathy) with LV ejection fraction ≤35% who underwent CMR and implantable cardioverter defibrillator (ICD) implantation for primary prevention in 2005 to 2012 were included. CMR was used to quantify LV volumes and function. LV scar size was quantified when late gadolinium enhancement was available (n = 166). Maximum and minimum left atrial volumes and LAEF were calculated using the biplane area-length method. The occurrence of ADT and mortality was assessed during a median follow-up of 3.9 years. Sixty-two patients (27%) received ADT. Univariable Cox analysis showed that male gender, creatinine level, minimum left atrial volume, LAEF, and total scar size were significant predictors of ADT. In multivariable Cox analysis, LAEF (hazard ratio 0.75 per 10%, p <0.01), and scar size (hazard ratio 1.03 per g, p = 0.03) remained the only independent predictors of ADT. Patients with both LAEF > median and scar size < median were at low risk (13% ADT at 5 years), whereas those with LAEF < median and scar size > median experienced 40% ADT at 5 years (log-rank p = 0.01). In conclusion, LAEF independently predicts ADT in patients with primary prevention ICDs. Combined assessment of LAEF and scar size identifies a group with low risk of ADT. Therefore, LAEF assessment could assist in risk stratification for VA to select patients with the highest benefit from ICD implantation. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Failure of implantable cardioverter-defibrillator leads: a matter of lead size?

    PubMed

    Rordorf, Roberto; Poggio, Luca; Savastano, Simone; Vicentini, Alessandro; Petracci, Barbara; Chieffo, Enrico; Klersy, Catherine; Landolina, Maurizio

    2013-02-01

    Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. To compare the incidence of failure of small-diameter (≤8 F) and standard-diameter (>8 F) ICD leads implanted in a single center. From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata), and 419 standard-diameter leads were implanted in our center. During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata, and standard-diameter leads but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads than in both standard-diameter (4.8%/year vs 0.8%/year; P<.001) and Riata/Riata ST (4.8%/year vs 2.6%/year; P = .03) leads. The incidence of lead failure in Riata/Riata ST leads proved significantly higher than in standard-diameter leads (2.6%/year vs 0.8%/year; P = .001). No cases of lead failure were recorded in the Optim group. On multivariable analyses, small-diameter (hazard ratio [HR] 5.03, 2.53-10.01, P<.001), Sprint Fidelis (HR 6.3, 3.1-13.3, P<.001), or Riata/Riata ST (HR 4.5, 1.9-10.5, P = .001) leads and age<60 years (HR 2.3, 1.3-4.3, P = .005) were found to independently increase the risk of lead failure. Compared with standard-diameter leads, both Sprint Fidelis and Riata/Riata ST small-diameter ICD leads are at an increased risk of failure, although the incidence of events is significantly lower in the Riata than in the Sprint Fidelis group. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  12. Longitudinal changes in intracardiac repolarization lability in patients with implantable cardioverter-defibrillator

    PubMed Central

    Guduru, Abhilash; Lansdown, Jason; Chernichenko, Daniil; Berger, Ronald D.; Tereshchenko, Larisa G.

    2013-01-01

    Background: While it is known that elevated baseline intracardiac repolarization lability is associated with the risk of fast ventricular tachycardia (FVT)/ventricular fibrillation (VF), the effect of its longitudinal changes on the risk of FVT/VF is unknown. Methods and Results: Near-field (NF) right ventricular (RV) intracardiac electrograms (EGMs) were recorded every 3–6 months at rest in 248 patients with structural heart disease [mean age 61.2 ± 13.3; 185(75%) male; 162(65.3%) ischemic cardiomyopathy] and implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) [201 (81%) primary prevention]. Intracardiac beat-to-beat QT variability index (QTVINF) was measured on NF RV EGM. During the first study phase (median 18 months), participants made on average 2.4 visits. Then remote follow-up was continued for an additional median period of 3 years. Average QTVINF did not change during the first year after ICD implantation (−0.342 ± 0.603 at baseline vs. −0.262 ± 0.552 at 6 months vs. −0.334 ± 0.603 at 12 months); however, it decreased thereafter (−0.510 ± 0.603 at 18 months; P = 0.042). Adjusted population-averaged GEE model showed that the odds of developing FVT/VF increased by 75% for each 1 unit increase in QTVINF. (OR 1.75 [95%CI 1.05–2.92]; P = 0.031). However, individual patient–specific QTVINF trends (increasing, decreasing, flat) varied from patient to patient. For a given patient, the odds of developing FVT/VF were not associated with increasing or decreasing QTVINF over time [OR 1.27; (95%CI 0.05–30.10); P = 0.881]. Conclusion: While on average the odds of FVT/VF increased with an increase in QTVINF, patient-specific longitudinal trends in QTVINF did not affect the odds of FVT/VF. PMID:23964242

  13. Evaluation of shock waveform configuration on the defibrillation capacity of implantable cardioverter defibrillators in dogs.

    PubMed

    Pariaut, Romain; Saelinger, Carley; Vila, Jorge; Deforge, William; Queiroz-Williams, Patricia; Beaufrère, Hugues; Zimmerman, Michael; Saile, Katrin; Reynolds, Caryn A

    2012-09-01

    Implantable cardioverter defibrillators (ICD) are programmed to detect ventricular arrhythmias and terminate them by delivering an electrical shock. A defibrillation threshold (DFT) at least 10 J below the maximum device output is recommended for successful therapy. Shock waveform configuration is a programmable parameter used to achieve a low DFT. It is hypothesized that a fixed-pulse configuration results in lower defibrillation energy requirements than a fixed-tilt configuration. 10 mongrel dogs. ICD generator and transvenous lead were surgically implanted. Defibrillation threshold was determined using a protocol guided by the upper limit of vulnerability. Fixed-pulse and fixed-tilt (50%/50%) waveform configurations were tested in a random order. Plasma cardiac troponin I (cTnI) was measured for signs of myocardial injury. The experiment was completed in 9 dogs. Overall mean DFT value was 424 ± 88 V (9.2 ± 3.9 J). Mean differences among voltage, energy and impedance at the DFT for fixed-pulse (422 ± 97 V, 9.1 ± 4.2 J, 62.6 ± 13.8 Ω) and fixed-tilt (426 ± 83 V, 9.3 ± 3.8 J, 62.8 ± 18.5 Ω) configurations were not statistically significant (All P > 0.21). Cardiac TnI concentration changed from 0.03 ng/mL (95% CI: 0.02-0.04) at baseline to 0.11 ng/mL (95 CI: 0.08-0.16) after DFT was obtained with the first waveform configuration and 0.19 ng/mL (95% CI: 0.13-0.28) at the end of the study period. There were no significant changes in heart rate, end-tidal CO2 and blood pressure over time (all P > 0.09). The tested ICD device and lead placement reliably produced acceptable DFT values, based on a 10-J safety margin below the maximum device output. A benefit of fixed-pulse configuration could not be demonstrated over the standard fixed-tilt waveform. Signs of acute myocardial damage from repeated high-voltage shocks and episodes of ventricular fibrillation seemed of limited clinical significance. Copyright © 2012 Elsevier B.V. All rights reserved.

  14. Clinical application of the fibrillation number in patients with an implantable cardioverter defibrillator.

    PubMed

    Hwang, Minki; Lee, Hancheol; Lee, Young-Seon; Chung, Soonwon; Choi, Sung Hwan; Shim, Eun Bo; Pak, Hui-Nam

    2014-09-01

    Although ventricular tachycardia/fibrillation (VT/VF) develops suddenly with catastrophic results, its prediction is limited. We tested the fibrillation number (FibN) for potential predictor of VT/VF using clinical data of implantable cardioverter-defibrillator (ICD) patients after validating the number by computational modeling. For clinical application of FibN, we used electrocardiography and echocardiography data: QRS width, QTc, and left ventricular (LV) end-systolic dimension (FibNVT/VF1) or LV end-diastolic dimension (FibNVT/VF2). We compared the maintenance duration of VT/VF for various FibN values using computational modeling, and tested FibNVT/VF in 142 patients with ICD for secondary prevention and 426 patients in age-sex matched control group (81.9% male, 56.1 ± 12.3 years old). 1. Computational results showed a positive correlation between VT/VF maintenance duration and FibN (R = 0.82, p < 0.001). 2. FibNVT/VFs were significantly higher in patients with ICD than in control (both FibNVT/VF1 and FibNVT/VF2, p < 0.001). 3. Within ICD group, FibNVT/VF values were higher in patients with cardiomyopathy than those without (both FibNVT/VF1 and FibNVT/VF2, p < 0.001). 4. During 50 ± 39 months follow-up period, the frequency of appropriate ICD therapy was higher in the high FibNVT/VF group (FibNVT/VF1, p = 0.001; FibNVT/VF2, p = 0.002). Both FibNVT/VF1 (HR 2.51, 95%CI 1.48-4.24, p = 0.001) and FibNVT/VF2 (HR 2.11, 95%CI 1.25-3.55, p = 0.005) were independently associated with appropriate ICD therapy in multi-variate analyses. FibNVT/VF, a parameter based on wavelength and heart size, correlates well with maintenance of VT/VF in computational modeling, and may have predictive value for VT/VF events in patients with ICD for secondary prevention. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Impact of implantable cardioverter-defibrillator recalls on patients' anxiety, depression, and quality of life.

    PubMed

    Undavia, Manish; Goldstein, Nathan E; Cohen, Pilar; Sinthawanarong, Kamoltip; Singson, Magdalena; Bhutani, Divaya; Munson, Tracey; Gomes, Joseph Anthony; Fischer, Avi; Mehta, Davendra

    2008-11-01

    In the past 2 years, multiple implantable cardioverter-defibrillator (ICD) manufacturers have issued recalls on ICD models due to the potential for serious malfunction and even patient death. Previous studies examining the relationship between these recalls and patients' psychological well-being have been limited by small sample size and conflicting results. The purpose of this study is to examine the association between ICD recalls and patients' anxiety, depression, and quality of life. Patients were drawn from an outpatient electrophysiology clinic at a tertiary care hospital in New York City. Patients who had devices subject to a recall (cases) were identified from lists provided by device manufacturer and controls (patients with ICDs not subjected to a recall) were drawn from a convenience sample of outpatients. The survey instrument consisted of two validated questionnaires--Hospital Anxiety and Depression Score (HADS) and MacNew heart disease health-related quality of life (QOL) instrument. In addition, a series of Likert-type scales were designed to elucidate patients' concerns related to the following domains: anger, trust, hope, concerns regarding ICD shock, fear of death (FOD), and physicians' ability to reduce their concern about the ICD recall. Data were analyzed using simple descriptive statistics and bivariate analyses (chi(2) and t-test) as appropriate. Sixty-one cases and 43 control patients were enrolled. Thirty-two patients (52%) with devices subject to a recall opted for a generator replacement. There were no significant differences in the mean scores on the HADS scale, or the MacNew QOL scale between these two groups of patients (cases and controls). Subgroup analysis within the group of patients whose ICDs were recalled (cases) revealed a reduced QOL among patients with a class I recall (reasonable probability that the product will cause serious adverse health consequences or death) as compared to those with a class II recall (product may cause

  16. [New algorithms for discrimination between supraventricular and ventricular tachyarrhythmias in patients with implantable cardioverter/defibrillator].

    PubMed

    Neuzner, J; Schlepper, M

    1997-03-01

    The current therapy with implantable cardioverter/defibrillators (ICD) is lacking specificity. The technical concept of arrhythmia detection, as a single channel ventricular rate threshold does not provide a clear differentiation between supraventricular and ventricular rhythms. Nearly 25% of all ICD-therapies are related to a false positive detection of supraventricular arrhythmias.The use of alternative, non rate based detection algorithms is limited due to the reduced long-term stability of the sensors and due to a high battery drain. Based on the current concept of arrhythmia detection, the use of additional timing algorithms as the variability of consecutive RR-cycle length ("Rate-Stability") and the detection of a sudden acceleration in the ventricular rate ("Rate-Onset") provide a clinical relevant increase in specificity in ICD-therapy. A further class of detection algorithms uses the morphologic assessment of intracardiac electrograms. Despite the fact that these morphology based algorithms have shown a high sensitivity and specificity in the discrimination between ventricular and non-ventricular rhythms, only one algorithm was implemented in ICD-generators and the clinical importance in ICD-therapy was very small. In 1995 a new morphology based detection algorithm was introduced in ICD-therapy. The "width criterion" is based on the measurment of the duration of the intracardiac signal. In 1995 and 1996 the first two series of a dual chamber ICD system were introduced in clinical ICD-therapy. These devices provide a two-channel atrio-ventricular arrhythmia detection in connection with a DDD antibradycardia pacing therapy. The use of DDD-ICD systems is expected to be a great step forward to enhance diagnostic specificty. A number of rate and timing detection algorithms and algorithms comparing the assoziation of atrial and ventricular signals may improve the discrimination between supraventricular and ventricular tachyarrhythmias. The future implementation

  17. Riata implantable cardioverter-defibrillator lead failure: analysis of explanted leads with a unique insulation defect.

    PubMed

    Hauser, Robert G; McGriff, Deepa; Retel, Linda Kallinen

    2012-05-01

    The Riata family of implantable cardioverter-defibrillator leads (St Jude Medical, Sylmar, CA) appears prone to a unique failure mechanism whereby the conductor cables wear through the silicone insulation from inside-out and are seen outside the lead body (externalized conductors). To assess the extent of Riata lead damage associated with inside-out insulation defects and their clinical consequences. In September 2011, we searched the U.S. Food and Drug Administration's Manufacturers and User Defined Experience medical device database for reports describing Riata lead failures that had been analyzed by the manufacturer. The Manufacturers and User Defined Experience search identified 105 leads that had inside-out insulation defects. Eight-French single-coil Riata leads accounted for a higher-than-expected proportion (25.7%) of the leads with this defect. A total of 226 insulation defects were found in the 105 leads (2.2 defects per lead), including 143 inside-out defects (1.4 defects per lead). The most common location of insulation defects was distal to the proximal coil (n = 108). Twenty-eight leads (26.7%) had inside-out insulation defects underneath the shocking coils. Of 43 leads whose cables were assessed for the integrity of the ethylene-tetrafluoroethylene cable coating, 22 (51.2%) were found to be abraded, exposing the conductor surfaces. On X-ray radiography or fluoroscopy, 7 leads were found to have externalized cables; 2 of these leads had no electrical abnormalities, while 4 exhibited noise or increased impedance. Inappropriate shocks were experienced by 31 of the 105 patients (29.5%). Riata leads that have inside-out insulation defects often have multiple defects, including additional inside-out abrasions along the body of the lead and beneath the shocking coils. Eight-French single-coil Riata models may be more prone to externalized cables than are dual-coil and 7-F designs. Externalized cables are but one manifestation of interior insulation damage

  18. Outcomes After Implantable Cardioverter-Defibrillator Generator Replacement for Primary Prevention of Sudden Cardiac Death

    PubMed Central

    Madhavan, Malini; Waks, Jonathan W.; Friedman, Paul A.; Kramer, Daniel B.; Buxton, Alfred E.; Noseworthy, Peter A.; Mehta, Ramila A.; Hodge, David O.; Higgins, Angela Y.; Webster, Tracy L.; Witt, Chance M.; Cha, Yong-Mei; Gersh, Bernard J.

    2016-01-01

    Background The effectiveness of implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden death in patients with an ejection fraction (EF) ≤35% and clinical heart failure is well established. However, outcomes after replacement of the ICD generator in patients with recovery of EF to >35% and no previous therapies are not well characterized. Methods and Results Between 2001 and 2011, generator replacement was performed at 2 tertiary medical centers in 253 patients (mean age, 68.3±12.7 years; 82% men) who had previously undergone ICD placement for primary prevention but subsequently never received appropriate ICD therapy. EF had recovered to >35% in 72 of 253 (28%) patients at generator replacement. During median (quartiles) follow-up of 3.3 (1.8–5.3) years after generator replacement, 68 of 253 (27%) experienced appropriate ICD therapy. Patients with EF ≤35% were more likely to experience ICD therapy compared with those with EF >35% (12% versus 5% per year; hazard ratio, 3.57; P=0.001). On multivariable analysis, low EF predicted appropriate ICD therapy after generator replacement (hazard ratio, 1.96 [1.35–2.87] per 10% decrement; P=0.001). Death occurred in 25% of patients 5 years after generator replacement. Mortality was similar in patients with EF ≤35% and >35% (7% versus 5% per year; hazard ratio, 1.10; P=0.68). Atrial fibrillation (3.24 [1.63–6.43]; P<0.001) and higher blood urea nitrogen (1.28 [1.14–1.45] per increase of 10 mg/dL; P<0.001) were associated with mortality. Conclusions Although approximately one fourth of patients with a primary prevention ICD and no previous therapy have EF >35% at the time of generator replacement, these patients continue to be at significant risk for appropriate ICD therapy (5% per year). These data may inform decisions on ICD replacement. PMID:26921377

  19. Correlation of Geomagnetic Activity with Implantable Cardioverter Defibrillator Shocks and Antitachycardia Pacing

    PubMed Central

    Ebrille, Elisa; Konecny, Tomas; Konecny, Dana; Spacek, Radim; Jones, Paul; Ambroz, Pavel; DeSimone, Christopher V; Powell, Brian D; Hayes, David L; Friedman, Paul A; Asirvatham, Samuel J

    2016-01-01

    Objective Small-scale observational studies have suggested that geomagnetic activity (GMA) may negatively correlate with the frequency of life-threatening arrhythmias. We investigated a potential relationship between implantable cardioverter defibrillator (ICD) therapies and daily GMA recorded in a large database. Patients and Methods The ALTITUDE database, derived from the Boston Scientific LATITUDE remote monitoring system, was retrospectively analyzed for the frequency of ICD therapies. Daily GMA was expressed as the planetary K-index and the integrated A-index and graded as Levels I – quiet, II – unsettled, III – active, and IV – storm. Results A daily mean of 59,468 ± 11,397 patients were monitored between 2009 and 2012. The distribution of days according to GMA was: Level I 75%, Level II 18%, Level III 5%, Level IV 2%. The daily number of ICD shocks received per 1000 active patients in the database was 1.29 ± 0.47, 1.17 ± 0.46, 1.03 ± 0.37, and 0.94 ± 0.29 on Level I, Level II, Level III, and Level IV days respectively; the daily sum of shocks and antitachycardia pacing (ATP) therapies was 9.29 ± 2.86, 8.46 ± 2.45, 7.92 ± 1.80, and 7.83 ± 2.28 on quiet, unsettled, active and storm days respectively. A statistically significant inverse relationship between GMA and the frequency of ICD therapies was identified, with the most pronounced difference between Level I and Level IV days (p < .001 for shocks, p = .008 for shocks + ATP). Conclusion In a large scale cohort analysis, ICD therapies were delivered less frequently on days of higher GMA, confirming the previous pilot data and suggesting that higher GMA does not pose an increased risk of arrhythmias using ICD therapies as a surrogate marker. Further studies are needed to gain an in-depth understanding of the underlying mechanisms. PMID:25659238

  20. Implantable Cardioverter-Defibrillators in Patients with CKD: A Propensity-Matched Mortality Analysis

    PubMed Central

    Nakhoul, Georges N.; Schold, Jesse D.; Arrigain, Susana; Harb, Serge C.; Jolly, Stacey; Wilkoff, Bruce L.; Nally, Joseph V.

    2015-01-01

    Background and objectives Benefits of transvenous implantable cardioverter-defibrillators (ICDs) in prevention of sudden cardiac death among the general population are proven. However, the benefit of ICDs remains unclear in CKD. A propensity-matched analysis was conducted to examine the survival benefits of ICDs placed for primary prevention in those with CKD not on dialysis (eGFR<60 ml/min per 1.73 m2). Design, setting, participants, & measurements The Cleveland Clinic CKD registry was utilized to identify individuals who had an echocardiogram at the institution (between 2001 and October 2011). A propensity score of the likelihood of receiving an ICD was developed with the following variables: demographics, comorbid conditions, use of cardioprotective medications, eGFR, left ventricular ejection fraction, and ventricular arrhythmia. One-to-one greedy matching was used with 0.1 caliper width to match patients with and without an ICD. A Cox proportional hazards model was used to examine survival of matched patients with and without an ICD. Results This study included 1053 ICD patients and 9435 potential controls. Of 1053 ICD patients (60%), 631 were matched to the control group. During a median follow-up of 2.9 years (25th and 75th percentiles, 1.5, 4.7), 578 patients died. After adjusting for covariates, the hazard of mortality among propensity-matched patients was 0.69 (95% confidence interval [95% CI], 0.59 to 0.82) for the ICD group compared with the non-ICD group. A significant interaction was found between ICDs and eGFR (P=0.04). Presence of an ICD was associated with a lower risk of death among those with eGFRs of 45–59 ml/min per 1.73 m2 (hazard ratio [HR], 0.58; 95% CI, 0.44 to 0.77) and 30–44 ml/min per 1.73 m2 (HR, 0.65; 95% CI, 0.50 to 0.85), but not among those with eGFRs<30 ml/min per 1.73 m2 (HR, 0.98; 95% CI, 0.71 to 1.35). Conclusions Transvenous ICDs placed for primary prevention are associated with a survival benefit in those with stage 3 CKD

  1. Safety threshold of R-wave amplitudes in patients with implantable cardioverter defibrillator.

    PubMed

    Lillo-Castellano, J M; Marina-Breysse, Manuel; Gómez-Gallanti, Alfonso; Martínez-Ferrer, J B; Alzueta, Javier; Pérez-Álvarez, Luisa; Alberola, Arcadi; Fernández-Lozano, Ignacio; Rodríguez, Anibal; Porro, Rosa; Anguera, Ignacio; Fontenla, Adolfo; González-Ferrer, J J; Cañadas-Godoy, Victoria; Pérez-Castellano, Nicasio; Garófalo, Daniel; Salvador-Montañés, Óscar; Calvo, Conrado J; Quintanilla, Jorge G; Peinado, Rafael; Mora-Jiménez, Inmaculada; Pérez-Villacastín, Julián; Rojo-Álvarez, J L; Filgueiras-Rama, David

    2016-10-15

    A safety threshold for baseline rhythm R-wave amplitudes during follow-up of implantable cardioverter defibrillators (ICD) has not been established. We aimed to analyse the amplitude distribution and undersensing rate during spontaneous episodes of ventricular fibrillation (VF), and define a safety amplitude threshold for baseline R-waves. Data were obtained from an observational multicentre registry conducted at 48 centres in Spain. Baseline R-wave amplitudes and VF events were prospectively registered by remote monitoring. Signal processing algorithms were used to compare amplitudes of baseline R-waves with VF R-waves. All undersensed R-waves after the blanking period (120 ms) were manually marked. We studied 2507 patients from August 2011 to September 2014, which yielded 229 VF episodes (cycle length 189.6±29.1 ms) from 83 patients that were suitable for R-wave comparisons (follow-up 2.7±2.6 years). The majority (77.6%) of VF R-waves (n=13953) showed lower amplitudes than the reference baseline R-wave. The decrease in VF amplitude was progressively attenuated among subgroups of baseline R-wave amplitude (≥17; ≥12 to <17; ≥7 to <12; ≥2.2 to <7 mV) from the highest to the lowest: median deviations -51.2% to +22.4%, respectively (p=0.027). There were no significant differences in undersensing rates of VF R-waves among subgroups. Both the normalised histogram distribution and the undersensing risk function obtained from the ≥2.2 to <7 mV subgroup enabled the prediction that baseline R-wave amplitudes ≤2.5 mV (interquartile range: 2.3-2.8 mV) may lead to ≥25% of undersensed VF R-waves. Baseline R-wave amplitudes ≤2.5 mV during follow-up of patients with ICDs may lead to high risk of delayed detection of VF. NCT01561144; results. 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/

  2. Implantable cardioverter-defibrillator elective generator replacement: a procedure for all?

    PubMed

    Barra, Sergio; Goonewardene, Manoj; Heck, Patrick; Begley, David; Virdee, Munmohan; Fynn, Simon; Grace, Andrew; Agarwal, Sharad

    2016-03-01

    Six risk stratification scores have been developed to estimate mortality risk in patients receiving an implantable cardioverter-defibrillator (ICD). This study aims at validating and comparing these risk scores in patients having elective ICD generator replacement (GR) and assessing the outcome of patients submitted to this procedure. Two hundred twenty three consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy submitted to elective ICD GR and followed-up for 44 ± 19 months were included. We evaluated which of six previously developed risk scores could predict post-discharge all-cause mortality risk in this context with the highest efficacy. Comparisons between these scores were made using receiver-operating characteristic curves and the integrated discrimination improvement (IDI) index. We further assessed risk of appropriate ICD therapies and all-cause mortality following ICD GR. The prognostic utility of the six scores was assessed by calculating the AUC for follow-up all-cause mortality prediction: Goldenberg - 0.758 ± 0.042, p < 0.001; Parkash - 0.754 ± 0.042, p < 0.001; Bilchick - 0.813 ± 0.038, p < 0.001; Kraaier - 0.721 ± 0.043, p < 0.001; REPLACE DARE - 0.746 ± 0.048, p < 0.001; Providencia - 0.739 ± 0.043, p < 0.001. Through measures of risk reclassification (IDI and relative IDI), the score by Bilchick et al. was shown to outperform all other scores. Binary logistic regression identified pre-GR-appropriate ICD therapy as an independent predictor of post-GR ICD therapy (OR 6.2, CI 95% 3.0-12.7, p < 0.001), along with male gender (OR 6.6, CI 95% 0.8-55, p = 0.082) and history of atrial fibrillation (OR 2.28, CI 95% 1.1-4.5, p = 0.019). Current prediction scores are useful in predicting mortality risk of patients considered for ICD generator replacement and can potentially help identify patients who may not benefit from continuous ICD treatment due to high

  3. Implantable cardioverter-defibrillators in patients with CKD: a propensity-matched mortality analysis.

    PubMed

    Nakhoul, Georges N; Schold, Jesse D; Arrigain, Susana; Harb, Serge C; Jolly, Stacey; Wilkoff, Bruce L; Nally, Joseph V; Navaneethan, Sankar D

    2015-07-07

    Benefits of transvenous implantable cardioverter-defibrillators (ICDs) in prevention of sudden cardiac death among the general population are proven. However, the benefit of ICDs remains unclear in CKD. A propensity-matched analysis was conducted to examine the survival benefits of ICDs placed for primary prevention in those with CKD not on dialysis (eGFR<60 ml/min per 1.73 m(2)). The Cleveland Clinic CKD registry was utilized to identify individuals who had an echocardiogram at the institution (between 2001 and October 2011). A propensity score of the likelihood of receiving an ICD was developed with the following variables: demographics, comorbid conditions, use of cardioprotective medications, eGFR, left ventricular ejection fraction, and ventricular arrhythmia. One-to-one greedy matching was used with 0.1 caliper width to match patients with and without an ICD. A Cox proportional hazards model was used to examine survival of matched patients with and without an ICD. This study included 1053 ICD patients and 9435 potential controls. Of 1053 ICD patients (60%), 631 were matched to the control group. During a median follow-up of 2.9 years (25th and 75th percentiles, 1.5, 4.7), 578 patients died. After adjusting for covariates, the hazard of mortality among propensity-matched patients was 0.69 (95% confidence interval [95% CI], 0.59 to 0.82) for the ICD group compared with the non-ICD group. A significant interaction was found between ICDs and eGFR (P=0.04). Presence of an ICD was associated with a lower risk of death among those with eGFRs of 45-59 ml/min per 1.73 m(2) (hazard ratio [HR], 0.58; 95% CI, 0.44 to 0.77) and 30-44 ml/min per 1.73 m(2) (HR, 0.65; 95% CI, 0.50 to 0.85), but not among those with eGFRs<30 ml/min per 1.73 m(2) (HR, 0.98; 95% CI, 0.71 to 1.35). Transvenous ICDs placed for primary prevention are associated with a survival benefit in those with stage 3 CKD, but not in those with stage 4 CKD. Copyright © 2015 by the American Society of

  4. Correlation of geomagnetic activity with implantable cardioverter defibrillator shocks and antitachycardia pacing.

    PubMed

    Ebrille, Elisa; Konecny, Tomas; Konecny, Dana; Spacek, Radim; Jones, Paul; Ambroz, Pavel; DeSimone, Christopher V; Powell, Brian D; Hayes, David L; Friedman, Paul A; Asirvatham, Samuel J

    2015-02-01

    To investigate a potential relationship between implantable cardioverter defibrillator (ICD) therapies and daily geomagnetic activity (GMA) recorded in a large database. The ALTITUDE database, derived from the Boston Scientific LATITUDE remote monitoring system, was retrospectively analyzed for the frequency of ICD therapies. Daily GMA was expressed as the planetary K-index and the integrated A-index and was graded as levels I (quiet), II (unsettled), III (active), and IV (storm). A daily mean ± SD of 59,468±11,397 patients were monitored between January 1, 2009, and May 15, 2012. The distribution of days according to GMA was as follows: level I, 924/1231 (75%); level II, 226/1231 (18%); level III, 60/1231 (5%); and level IV, 21/1231 (2%). The daily mean ± SD numbers of ICD shocks received per 1000 active patients in the database were 1.29±0.47, 1.17±0.46, 1.03±0.37, and 0.94±0.29 on level I, II, III, and IV days, respectively; the daily mean ± SD sums of shocks and antitachycardia pacing therapies were 9.29±2.86, 8.46±2.45, 7.92±1.80, and 7.83±2.28 on quiet, unsettled, active, and storm days, respectively. A significant inverse relationship between GMA and frequency of ICD therapies was identified, with the most pronounced difference between level I and level IV days (P<.001 for shocks; P=.008 for shocks + antitachycardia pacing). In a large-scale cohort analysis, ICD therapies were delivered less frequently on days of higher GMA, confirming the previous pilot data and suggesting that higher GMA does not pose an increased risk of arrhythmias using ICD therapies as a surrogate marker. Further studies are needed to gain an in-depth understanding of the underlying mechanisms. Copyright © 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  5. 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.

  6. 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

  7. Clinical Effects and Implications of Cardiac Rehabilitation for Implantable Cardioverter Defibrillator Patients: A Mixed-Methods Approach Embedding Data From the Copenhagen Outpatient ProgrammE-Implantable Cardioverter Defibrillator Randomized Clinical Trial With Qualitative Data.

    PubMed

    Berg, Selina Kikkenborg; Moons, Philip; Christensen, Anne Vingaard; Zwisler, Ann-Dorthe; Pedersen, Birthe D; Pedersen, Preben Ulrich

    2015-01-01

    The Copenhagen Outpatient ProgrammE-Implantable Cardioverter Defibrillator trial was a randomized clinical trial that compared a complex rehabilitation intervention including exercise training and psychoeducational interventions with usual care. A significant difference between rehabilitation and usual care was found in physical capacity and general and mental health. However, the clinical effect sizes of these findings were not investigated, and the findings from the quantitative and qualitative analyses were not triangulated to address the issue of whether the qualitative results could help explain the quantitative results and bring forward additional information. The objectives are to (a) determine the clinical effect sizes of the primary outcomes and (b) triangulate the quantitative and qualitative findings. A total of 196 patients with first-time implantable cardioverter defibrillator implantation were randomized (1:1) to comprehensive cardiac rehabilitation (12 weeks of exercise training and 1 year of psychoeducational follow-up) versus treatment as usual. Two primary outcomes, perceived health (Short Form-36) and peak oxygen uptake, were used. Cohen d was calculated. Qualitative interviews were conducted with 10 patients representing the rehabilitation group. Triangulation was carried out by integrating the findings from the quantitative and qualitative results in light of each other. Clinically meaningful effects were found between groups in peak oxygen uptake, general health, and mental health in favor of the rehabilitation group. Within groups, we found medium/high effect sizes on the mental component score in the rehabilitation group over time and only a small effect in the usual care group. The mechanisms of these effects were further explained by the qualitative findings. Patients with better physical health learned how to interpret body signals and adjust exercise behavior and experienced increased physical capacity. Those with better mental health

  8. Electrocardiographic Markers of Appropriate Implantable Cardioverter-Defibrillator Therapy in Young People with Congenital Heart Diseases.

    PubMed

    Benítez Ramos, Dunia Bárbara; Cabrera Ortega, Michel; Castro Hevia, Jesús; Dorantes Sánchez, Margarita; Alemán Fernández, Ailema Amelia; Castañeda Chirino, Osmin; Cruz Cardentey, Marlenis; Martínez López, Frank; Falcón Rodríguez, Roylan

    2017-09-04

    Implantable cardioverter-defibrillators (ICDs) are increasingly utilized in patients with congenital heart disease (CHD). Prediction of the occurrence of shocks is important if improved patient selection is desired. The electrocardiogram (ECG) has been the first-line tool predicting the risk of sudden death, but data in CHD patients are lacking. We aim to evaluate the predictive value of electrocardiographic markers of appropriate therapy of ICD in young people with CHD. We conducted a prospective, longitudinal study, in twenty-six CHD patients (mean age 24.7 ± 5.3 years) who underwent first ICD implantation. Forty-two age- and diagnosis-matched controls were recruited. Twelve-lead ECG and 24 h Holter analysis were performed during a mean follow-up of 38.9 months. Data included heart rate, heart rate variability, QRS duration (QRSd), QTc interval and its dispersion, Tpeak-Tend (Tp-Te) interval and its dispersion, presence of fragmented QRS (fQRS), T wave alternans, atrial arrhythmias, and non-sustained ventricular tachycardia. Implant indication was primary prevention in ten cases (38.5%) and secondary prevention in 16 (61.5%). Overall, 17 subjects (65.3%) received at least one appropriate and effective ICD discharge. fQRS was present in 64.7% of cases with ICD therapy compared with patients without events or controls (p < 0.0001). Tp-e and Tp-e dispersion were significantly prolonged in patients with recurrences (113.5 and 37.2 ms) versus patients without ICD discharge (89.6 and 24.1 ms) or controls (72.4 and 19.3 ms) (p < 0.0001 and p < 0.0001, respectively). On univariate Cox regression analysis QRSd (hazard ratio: 1.19 per ms, p = 0.003), QTc dispersion (hazard ratio: 1.57 per ms, p = 0.002), fQRS (hazard ratio: 3.58 p < 0.0001), Tp-e (hazard ratio: 2.27 per ms, p < 0.0001), and Tp-e dispersion (hazard ratio: 4.15 per ms, p < 0.0001), emerged as strong predictors of outcome. On multivariate Cox analysis fQRS, Tp-e and Tp-e dispersion

  9. Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort description.

    PubMed

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

    2013-02-22

    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. 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. 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. URL: http://clinicaltrials.gov/ Unique Identifier: NCT00733590.

  10. Capsule endoscopy in patients with cardiac pacemakers, implantable cardioverter defibrillators, and left heart devices: a review of the current literature.

    PubMed

    Bandorski, Dirk; Keuchel, Martin; Brück, Martin; Hoeltgen, Reinhard; Wieczorek, Marcus; Jakobs, Ralf

    2011-01-01

    Background and Study Aims. Capsule endoscopy is an established tool for investigation of the small intestine. Because of limited clinical experience in patients with cardiac devices, the Food and Drug Administration and the manufacturer recommended not to use capsule endoscopy in these patients. The vast majority of investigations did not reveal any interference between capsule endoscopy and cardiac devices. Methods. Studies investigating interference between CE and cardiac devices were analysed. For the review we considered studies published in English or German and indexed in Medline, as well as highly relevant abstracts. Results. In vitro and in vivo studies mainly revealed no interference between capsule endoscopy and cardiac devices. Technical data of capsule endoscopy (Given Imaging) reveal that interference with cardiac pacemakers and implantable cardioverter defibrillator is impossible. Telemetry can interfere with CE video. Conclusion. The clinical use of capsule endoscopy (Given Imaging) is unproblematic in patients with cardiac pacemakers.

  11. Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial

    PubMed Central

    Alings, Marco; van der Voort, Pepijn; Theuns, Dominic; Bouwels, Leon; Herrman, Jean-Paul; Valk, Suzanne

    2014-01-01

    Background WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence. Objective In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE. Methods Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group. Results The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support. Conclusions Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes. Trial Registration Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz). PMID:24583632

  12. Association between Symptoms of Depression and Anxiety with Heart Rate Variability in Patients with Implantable Cardioverter Defibrillators

    PubMed Central

    Francis, Jennifer L.; Weinstein, Ali A.; Krantz, David S.; Haigney, Mark C.; Stein, Phyllis K.; Stone, Peter H.; Gottdiener, John S.; Kop, Willem J.

    2009-01-01

    Objective Depression and anxiety are associated with autonomic nervous system dysfunction, which may promote the risk of malignant cardiac arrhythmias. This study investigates whether depression and anxiety symptoms are associated with measures of autonomic nervous system dysfunction in patients with implantable cardioverter defibrillators who are at high risk of cardiac rhythm disturbances. Methods Patients with an implantable cardioverter defibrillator (ICD) underwent ambulatory electrocardiographic monitoring (n=44, mean age 62.1 ± 9.3 yrs). Depression was assessed using the Beck Depression Inventory and anxiety using the Taylor Manifest Anxiety Scale. Heart rate variability (HRV) was assessed using time (RMSSD, pNN50 and SDNN) and frequency domain measures derived from 24 hour R-R intervals. Multivariate models were adjusted for age, sex, hypertension, diabetes and smoking status. Results Defibrillator patients with elevated depression symptoms (n=12) had significantly lower RMSSD (15.25 ± 1.66 ms, vs. 24.97 ± 2.44, p = 0.002) and pNN50 (1.83 ± 0.77 vs. 5.61 ± 1.04, p = 0.006) than defibrillator patients with low depression symptoms (n=32). These associations remained significant after multivariate adjustment for covariates. ICD patients with high anxiety levels (n=10) displayed lower RMSSD (p = 0.013), which became marginally significant when adjusting for covariates (p = 0.069). Conclusion Depression and anxiety in defibrillator patients are associated with autonomic nervous system dysfunction indices of reduced parasympathetic control. Autonomic nervous system dysfunction may partially explain the association between depression and anxiety with life-threatening cardiac outcomes in vulnerable patients. PMID:19661191

  13. 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.

  14. Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction (PROTECT-ICD): Trial Protocol, Background and Significance.

    PubMed

    Zaman, Sarah; Taylor, Andrew J; Stiles, Martin; Chow, Clara; Kovoor, Pramesh

    2016-11-01

    The 'Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction' (PROTECT-ICD) trial is an Australian-led multicentre randomised controlled trial targeting prevention of sudden cardiac death in patients who have at least moderately reduced cardiac function following a myocardial infarct (MI). The primary objective of the trial is to assess whether electrophysiological study to guide prophylactic implantation of an implantable cardioverter-defibrillator (ICD) early following MI (first 40 days) will lead to a significant reduction in sudden cardiac death and non-fatal arrhythmia. The secondary objective is to assess the utility of cardiac MRI (CMR) in assessing early myocardial characteristics, and its predictive value for both inducible ventricular tachycardia (VT) at EPS and SCD/ non-fatal arrhythmia at follow-up.

  15. Implantable Cardioverter Defibrillator Implantation Rates After Out of Hospital Cardiac Arrest: Are the Rates Guideline-Concordant?

    PubMed

    Ho, Edwin C; Cheskes, Sheldon; Angaran, Paul; Morrison, Laurie J; Aves, Theresa; Zhan, Cathy; Ko, Dennis T; Dorian, Paul

    2017-10-01

    Clinical practice guidelines recommend implantable cardioverter defibrillators (ICDs) for the secondary prevention of sudden death after a cardiac arrest not from a reversible cause, but "real world" implantation rates are not well described. Adults with out of hospital cardiac arrest attended by Emergency Medical Services are captured in the Toronto Regional RescuNET database. We analyzed those who survived to hospital discharge and collected data on age, sex, initial rhythm, ST-elevation myocardial infarction (STEMI) on presenting electrocardiogram (ECG), in-hospital revascularization, neurologic status (Modified Rankin Scale [MRS]) at discharge, and admission hospital type. To estimate 'indicated' ICD implantation rates, "likely ICD-eligible" patients were defined as having an initial shockable rhythm, no STEMI on presenting ECG, no revascularization, and good neurologic status (MRS 0-3). "Not likely ICD-eligible" patients were defined as having a STEMI on presenting ECG, revascularization, or poor neurologic status (MRS 4-5). In the 1238 adults (2011-2014) analyzed, the overall ICD implantation rate was 23.9%. Two hundred fifty-six patients were "likely ICD-eligible," of whom 146 (57.0%) received an ICD. The implantation rate for "not likely ICD-eligible" patients was 16.7% (112 of 670). ICD eligibility could not be determined for 312 patients, of whom 38 (12.2%) received an ICD. Admission to a hospital with ICD implantation facilities was associated with a higher probability of ICD implantation (odds ratio, 2.85; 95% confidence interval, 1.40-5.82). Postcardiac arrest ICD implantation rates in eligible patients are lower than expected. Implementation strategies to monitor guideline adherence after out of hospital cardiac arrest are warranted. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  16. 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.

  17. Sex differences in implantable cardioverter-defibrillator implantation indications and outcomes: lessons from the Nationwide Israeli-ICD Registry.

    PubMed

    Amit, Guy; Suleiman, Mahmoud; Konstantino, Yuval; Luria, David; Kazatsker, Mark; Chetboun, Israel; Haim, Moti; Gavrielov-Yusim, Natalie; Goldenberg, Ilan; Glikson, Michael

    2014-08-01

    Implantable cardioverter-defibrillators (ICDs) improve survival in certain high arrhythmic risk populations. However, there are sex differences regarding both the utilization and the benefit of these devices. Using a prospective national ICD registry, we aim to compare the indications for ICD implantation as well as outcomes in implanted women vs. men. All subjects implanted with an ICD or cardiac resynchronization therapy with a defibrillator (CRTD) in Israel between July 2010 and February 2013 were included. A total of 3544 subjects constructed the baseline cohort, of whom 615 (17%) were women. Women had the same age (64 years) and rate of secondary prevention indication (26%) as men. However, women were more likely than men to have significant heart failure symptoms (52 vs. 45%), QRS > 120 ms (41 vs. 36%), and a higher rate of non-ischaemic cardiomyopathy (54 vs. 21%, all P values <0.05). Using multivariate analysis, women were more likely to undergo CRTD implantation (odds ratio = 1.8, P < 0.01). Follow-up data were available for 1518 subjects with a mean follow-up of 12 months. During follow-up, there were no significant differences among genders in the rate of any single or the combined outcomes of appropriate device therapies, heart failure admissions, or death. First-year re-intervention rate was double among women (5.6 vs. 3.0%, P < 0.01). In real-world setting, women implanted with an ICD differ significantly from men in their baseline characteristics and in the use of CRTD devices. These, however, did not translate into outcome differences. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  18. Risk of pacemaker or implantable cardioverter defibrillator after radiotherapy for early-stage breast cancer in Denmark, 1982-2005.

    PubMed

    Rehammar, Jens Christian; Johansen, Jens Brock; Jensen, Maj-Britt; Videbæk, Lars; Jørgensen, Ole Dan; Lorenzen, Ebbe; Ewertz, Marianne

    2017-01-01

    To examine the risk of cardiac conduction abnormalities or severe ventricular arrhythmias requiring implantation of a cardiac implantable electronic device (CIED), either a pacemaker or an implantable cardioverter-defibrillator, subsequent to breast cancer (BC) radiotherapy (RT). All women treated for early-stage BC in Denmark from 1982 to 2005 were identified from the Danish Breast Cancer Cooperative Group. By record linkage to the Danish Pacemaker and ICD Registry information was retrieved on CIED implants subsequent to RT. Standardized incidence ratios (SIR) of CIED implantation were estimated for women receiving RT and compared to women not receiving RT for BC. Uni- and multivariate Poisson regression models were used to estimate incidence rate ratios (IRR) among irradiated women compared to non-irradiated. Of 44,423 BC patients, 179 had a CIED implanted among 18,251 women who received RT, and 401 had a CIED in 26,172 who did not receive RT. The unadjusted IRR was 1.09 (0.91-1.30 95% CI) for CIED implants among women receiving RT compared to non-irradiated women and the IRR was 1.13 (0.93-1.38 95% CI) when adjustments were made. BC RT as practiced in Denmark in 1982-2005 did not increase the risk of CIED implants. This indicates that RT for BC does not increase the risk of severe ventricular arrhythmias or cardiac conduction abnormalities. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  19. Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads.

    PubMed

    Forleo, Giovanni B; Di Biase, Luigi; Panattoni, Germana; Politano, Alessandro; Magliano, Giulia; Santini, Luca; Natale, Andrea; Romeo, Francesco

    2014-02-01

    Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients. Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant. This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.

  20. Successful Delivery by a Cesarean Section in a Parturient with Severe Dilated Cardiomyopathy, an Implantable Cardioverter Defibrillator, and a Repaired Tetralogy of Fallot

    PubMed Central

    Al-Aqeedi, Rafid Fayadh; Alnabti, Abdulrahman; Al-Ani, Fuad; Dabdoob, Wafer; Abdullatef, Waleed Khalid

    2011-01-01

    Repaired congenital heart disease has become more prevalent in women of childbearing age. We report an unusual case of a 24-year-old multigravida with a repaired tetralogy of Fallot, severe dilated cardiomyopathy, and implantable cardioverter defibrillator placement who was managed successfully by a cesarean section three times. This case underscores the impact of such events on maternal and fetal safety and the importance of a multidisciplinary approach in the management of pregnant patients with complex congenital and medical problems. PMID:21731806

  1. 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

  2. The Relevance of the Primary Prevention Criteria for Implantable Cardioverter Defibrillator Implantation in Korean Symptomatic Severe Heart Failure Patients

    PubMed Central

    Kim, JiYeong; Lee, Min-Ho; Kang, Do-Yoon; Sung, Young-Jun; Lee, Dong-Won; Oh, Ilyoung; Choi, Yun-Shik; Oh, Seil

    2012-01-01

    Background and Objectives Implantable cardioverter defibrillator (ICD) therapy is recommended as the primary tool for prevention of sudden cardiac death (SCD) in symptomatic patients with severe left ventricular dysfunction. There is a paucity of information on whether this recommendation is appropriate for the Korean population with severe heart failure. Subjects and Methods The study group consisted of 275 consecutive patients (mean age 65 years, 71% male) who met the ICD implantation criteria for primary prevention (left ventricular ejection fraction ≤30% and New York Heart Association functional class II or III). We analyzed the clinical characteristics and outcomes of an ischemic cardiomyopathy (ICMP) group (n=131) and a non-ischemic cardiomyopathy (NICMP) group (n=144). The outcomes of these 2 groups were compared with the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) conventional and Defibrillators in the Non-ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) standard therapy groups, respectively. Results Eighty patients (29%) died during a follow-up period of 40±17 months. The NICMP group had better all-cause mortality rates than the ICMP group (19% vs. 40%, p<0.001), however both groups had a similar incidence of SCD (7% vs. 10%, p=0.272). The 2-year all-cause mortality and SCD for the ICMP group were similar to those of the MADIT-II conventional therapy group (20% vs. 20%, 7% vs. 10%, respectively, all p>0.05). All-cause mortality and the incidence of SCD in the NICMP group were comparable to those of the DEFINITE standard therapy group (13% vs. 17%, 6% vs. 6%, respectively, all p>0.05). Conclusion Korean patients with severe heart failure in both the ICMP and NICMP groups had all-caused mortality and risk of SCD comparable to patients in the MADIT-II and DEFINITE standard therapy groups. Therefore, the primary prevention criteria for ICD implantation would be appropriate in both Korean ICMP and NICMP patients. PMID:22493612

  3. Role of exercise electrocardiogram to screen for T-wave oversensing after implantation of subcutaneous implantable cardioverter-defibrillator.

    PubMed

    Afzal, Muhammad R; Evenson, Christopher; Badin, Auroa; Patel, Dilesh; Godara, Hemant; Essandoh, Michael; Okabe, Toshimasa; Tyler, Jaret; Houmsse, Mahmoud; Augostini, Ralph; Hummel, John; Kalbfleisch, Steven; Daoud, Emile G; Weiss, Raul

    2017-06-15

    During early experience with subcutaneous implantable cardioverter-defibrillators (S-ICD), several patients had inappropriate shocks from T-wave oversensing (TWOS) during exercise. This prompted some operators to perform routine treadmill exercise tests after implantation of S-ICD to screen for TWOS. Meanwhile, improvements have been made in the detection algorithms by the manufacturer. To assess whether routine treadmill exercise post S-ICD implantation is warranted. Patients undergoing S-ICD implantation from October 2012 to December 2016 who were able to complete a treadmill exercise were included in the study. The amplitude of R and T waves as assessed by the device programmer at rest and peak exercise was calculated and incidence of TWOS recorded. Eighty-seven patients with complete treadmill exercise test data were included in the final analysis. The majority of the patients received S-ICD for primary prevention. Nine percent of the included patients had hypertrophic obstructive cardiomyopathy. During treadmill exercise, there was significant increase in the heart rate from rest (77 ± 14 beats per minute) to peak exercise (133 ± 14 beats per minute; P < .0001). There was no significant difference between R-wave amplitude at rest (2 ± 0.77 mV) and peak exercise (1.88 ± 0.94 mV; P = .36). Similarly, there was no significant difference between T-wave amplitude at rest (0.27 ± 0.19 mV) and peak exercise (0.33 ± 0.23 mV; P = .06). The incidence of TWOS during exercise was zero. With current screening and detection algorithms for S-ICD, routine treadmill exercise does not result in additional discrimination of patients susceptible to TWOS. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: 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

    2016-05-24

    Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown. Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry - ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%-4.8%) within 1 year and 21.3% (95% CI, 20.7%-21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73-1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66-1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48-1.67), and greater hospice use among decedents in the patients' health referral region. More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus. © 2016 The Authors.

  5. Implantation of a right ventricular implantable cardioverter-defibrillator lead in the right ventricular outflow tract in a patient with Ebstein anomaly and right ventricular lead dislocation.

    PubMed

    Pecha, Simon; Yildirim, Yalin; Hahnel, Fabian; Reichenspurner, Hermann; Aydin, Muhammed Ali

    2014-04-01

    An 80-year-old patient with Ebstein anomaly and prior implantable cardioverter-defibrillator (ICD) implantation was sent to our heart center because of right ventricular (RV)-ICD lead dislocation. Positioning of the new RV lead was difficult, no stable position could be found, and sensing and threshold measurements showed weak results in the RV basis, apex, and septum. So, we conducted positioning of the lead in the RV outflow tract where a stable position with good sensing and threshold parameters was found.

  6. Survival Benefit of Primary Prevention Implantable Cardioverter-Defibrillator Therapy After Myocardial Infarction: Does Time to Implant Matter?

    PubMed Central

    Hess, Paul L.; Laird, Amy; Edwards, Rex; Bardy, Gust H.; Bigger, J. Thomas; Buxton, Alfred E.; Moss, Arthur J.; Lee, Kerry L.; Hall, W.J.; Steinman, Richard; Dorian, Paul; Hallstrom, Al; Cappato, Riccardo; Kadish, Alan H.; Kudenchuk, Peter J.; Mark, Daniel B.; Al-Khatib, Sana M.; Piccini, Jonathan P.; Inoue, Lurdes Y.T.; Sanders, Gillian D.

    2013-01-01

    Background Whether there is an optimal time to place an implantable cardioverter-defibrillator (ICD) more than 40 days after myocardial infarction (MI) in guideline-eligible patients is unknown. Objective To evaluate the impact of time from MI to randomization on mortality, re-hospitalizations, and complications. Methods Individual data on patients enrolled in 9 primary and secondary prevention ICD trials were provided. Clinical trials were eligible for the current analysis if they enrolled patients with an MI more than 40 days prior to randomization to primary prevention ICD therapy versus usual care: MADIT-I, MUSTT, MADIT-II, and SCD-HeFT. Results ICD recipients died less frequently than non-recipients at 5 years across all subgroups of time from MI to randomization. In unadjusted Cox proportional hazards regression, a survival benefit was evident in most subgroups. Adjusted Bayesian Weibull survival modeling yielded hazard ratio (HR) 0.50, 95% posterior credible interval [PCI] 0.20–1.25 41–180 days after MI; HR 0.98, 95% PCI 0.37–2.37 181–365 days after MI; HR 0.22, 95% PCI 0.07–0.59 >1–2 years after MI; HR 0.42, 95% PCI 0.17–0.90 >2–5 years after MI; HR 0.55, 95% PCI 0.25–1.15 >5–10 years after MI; and HR 0.48, 95% PCI 0.20–1.02 > 10 years after MI. There was no evidence of an interaction between time from MI and all-cause mortality, re-hospitalizations, or complications. Conclusions In this meta-analysis, there was scant evidence that the efficacy of primary prevention ICD therapy and no evidence that the risks of re-hospitalizations or complications are dependent on time to implantation more than 40 days after MI. PMID:23416381

  7. Lower Body Mass Index and Atrial Fibrillation as Independent Predictors for Mortality in Patients with Implantable Cardioverter Defibrillator

    PubMed Central

    Schernthaner, Christiana; Pichler, Maximilian; Strohmer, Bernhard

    2007-01-01

    Aim To evaluate risk factors related to total mortality in an unselected population of patients implanted with a cardioverter defibrillator. Methods Survival analysis was performed retrospectively investigating the records of 77 consecutive patients implanted with defibrillators (median 67 years, range 38-83 years; 63 men). All patients were followed regularly in 3-month intervals. The cause of mortality was assessed clinically, including post-mortem examination of device to assess possible arrhythmogenic death. Predictors were evaluated by Kaplan-Meier analysis with log-rank tests and by Cox regression analysis (proportional hazards). Results Defibrillator recipients had a mean (±SD) ejection fraction of 34 ± 13%, left ventricular end-diastolic dimension (LVEDD) of 6.24 ± 0.8 cm, QRS duration of 129 ± 34 ms, and body mass index (BMI) of 26.4 ± 4.3 kg/m2. Atrial fibrillation was present in 32 patients, paroxysmal fibrillation in 23, and permanent fibrillation in 9 patients. The estimate of mean survival time for all patients was 51.5 (95% confidence interval 46.6-56.5) months. During the study period 11/77 (14%) patients died. Mean follow-up time was 24.5 months (range 0.2-60.7) for survivors and 7.6 months (range 1.5-42) for non-survivors. Independent predictors of mortality were the NYHA class (P = 0.004), BMI≤26 kg/m2 (P = 0.024), presence of paroxysmal or permanent atrial fibrillation (P = 0.014), and absence of arterial hypertension (P = 0.010). LVEDD showed a weak significant effect on survival (P = 0.049). Conclusion Patients with implantable cardioverter defibrillator and a normal to lower BMI or atrial fibrillation had a significantly higher overall mortality. These factors may be indicative of end stage heart failure or diseases associated with high sympathetic activation. PMID:17309140

  8. Serum amine-based metabolites and their association with outcomes in primary prevention implantable cardioverter-defibrillator patients.

    PubMed

    Zhang, Yiyi; Blasco-Colmenares, Elena; Harms, Amy C; London, Barry; Halder, Indrani; Singh, Madhurmeet; Dudley, Samuel C; Gutmann, Rebecca; Guallar, Eliseo; Hankemeier, Thomas; Tomaselli, Gordon F; Cheng, Alan

    2016-09-01

    Heart failure patients are at increased risk of ventricular arrhythmias and all-cause mortality. However, existing clinical and serum markers only modestly predict these adverse events. We sought to use metabolic profiling to identify novel biomarkers in two independent prospective cohorts of patients with implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (SCD). Baseline serum was quantitatively profiled for 42 known biologically relevant amine-based metabolites among 402 patients from the Prospective Observational Study of Implantable Cardioverter-Defibrillators (PROSE-ICD) Study (derivation group) and 240 patients from the Genetic Risk Assessment of Defibrillator Events (GRADE) Study (validation group) for ventricular arrhythmia-induced ICD shocks and all-cause mortality. Three amines, N-methyl-l-histidine, symmetric dimethylarginine (SDMA), and l-kynurenine, were derived and validated to be associated with all-cause mortality. The hazard ratios of mortality in PROSE-ICD and GRADE were 1.48 (95% confidence interval 1.14-1.92) and 1.67 (1.22-2.27) for N-methyl-l-histidine, 1.49 (1.17-1.91) and 1.77 (1.27-2.45) for SDMA, 1.31 (1.06-1.63) and 1.73 (1.32-2.27) for l-kynurenine, respectively. l-Histidine, SDMA, and l-kynurenine were associated with ventricular arrhythmia-induced ICD shocks in PROSE-ICD, but they did not reach statistical significance in the GRADE cohort. Utilizing metabolic profiling in two independent prospective cohorts of patients undergoing ICD implantation for primary prevention of SCD, we identified several novel amine markers that were associated with appropriate shock and mortality. These findings shed insight into the potential biologic pathways leading to adverse events in ICD patients. Further studies are needed to confirm the prognostic value of these findings. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email

  9. Prevalence and Outcomes of Patients Receiving Implantable Cardioverter-Defibrillators for Primary Prevention Not Based on Guidelines

    PubMed Central

    Levine, Yehoshua C.; Tuttle, Mark K.; Rosenberg, Michael A.; Goldberg, Randal; Matos, Jason; Samuel, Michelle; Kramer, Daniel B.; Buxton, Alfred E.

    2015-01-01

    Implantable cardioverter-defibrillator (ICD) implantation outside practice guidelines remains contentious, particularly during the mandated waiting periods in patients with recent cardiac events. We assessed the prevalence and outcomes of noneguideline-based (NGB) ICD implantations in a tertiary academic medical center, with a specific focus on adjudication of arrhythmia events. All patients who underwent initial primary prevention ICD implantation at our institution from 2004 to 2012 were categorized as having received guideline-based (GB) or NGB implants and were retrospectively assessed for first episode of appropriate ICD therapy and total mortality. Of 807 patients, 137 (17.0%) received NGB implants. During a median follow-up of 2.9 years, patients with NGB implants had similar times to first appropriate ICD therapy (median time to event 1.94 vs 2.17 years in patients with GB implants, p = 0.20). After multivariable analysis, patients with NGB implants remained at higher risk for death (hazard ratio 1.54, 95% confidence interval 1.1 to 2.2, p = 0.03) but not appropriate ICD therapy (hazard ratio 0.83, 95% confidence interval 0.5 to 1.3, p = 0.51). Furthermore, only 1 of 125 patients who underwent implant within the 40-day waiting period after myocardial infarction or 3-month waiting period after revascularization or cardiomyopathy diagnosis received an appropriate therapy within this period. In conclusion, few patients received NGB ICD implants in our academic medical center. Although these patients have similar long-term risk of receiving appropriate ICD therapy compared with patients with GB implants, this risk is very low during the waiting periods mandated by clinical practice guidelines. These results suggest that there is little need to rush into implanting ICDs during these waiting periods. PMID:25840578

  10. 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

  11. High Dose Radiotherapy to Automated Implantable Cardioverter-Defibrillator: A Case Report and Review of the Literature

    PubMed Central

    Jabbour, Salma K.

    2014-01-01

    We report a case of successful full-dose chemoradiotherapy to stage IIIB nonsmall cell lung cancer (NSCLC) in a 59-year-old man with extensive cardiac history and an automated implantable cardioverter-defibrillator (AICD) located within the radiotherapeutic field. In this case, the AICD was a St. Jude Medical Fortify Assura VR 1257-40Q ICD, and it was implanted prophylactically during bypass grafting. Although we do not recommend routine radiotherapy dose to exceed recommended current guidelines due to the potential risks to the patient, this is a situation where relocation of the device was not possible. Fortunately, our patient was not AICD-dependent; so following much discussion and deliberation, the decision was made to treat the patient with AICD in place. The patient completed definitive chemoradiotherapy with concurrent cisplatin and etoposide and thoracic irradiation to 69.6 Gy. The minimum, maximum, and mean doses to the AICD directly were 13.5 Gy, 52.4 Gy, and 29.3 Gy, respectively. The device withstood full thoracic radiation dose, and the patient denied cardiac symptoms during the time before, during, and after completion of therapy. We sought to offer this case for both teaching and guidance in practice and to contribute to the published literature currently available in this area. PMID:25276450

  12. Behavioral interventions in patients with an implantable cardioverter defibrillator: Lessons learned and where to go from here?

    PubMed Central

    Habibović, Mirela; Burg, Matthew M.; Pedersen, Susanne S.

    2013-01-01

    Background The implantable cardioverter defibrillator (ICD) is the first line treatment for primary and secondary prevention of sudden cardiac death. A subgroup of patients experiences psychological distress post implant, and no clear evidence base exists regarding how best to address patients’ needs. The aim of this critical review is to provide an overview of behavioral interventions in ICD patients to date, and to delineate directions for future research using lessons learned from the ongoing RISTA and WEBCARE trials. Methods We searched the PubMed and PsycInfo databases to identify reports of behavioral trials targeting distress and related factors in ICD patients published between 1980 and April 2012. Results We identified 17 trials for the review. Generally, compared to usual care, behavioral interventions were associated with reduced anxiety and depression, and improved physical functioning, with effect sizes ranging from small to moderate-large (0.10 – 1.79 for anxiety; 0.23 – 1.20 for depression). Important limitations were small sample sizes and potential selection bias, hampering generalizability of the results. In addition to a need for larger trials, experiences from the RISTA and WEBCARE trials suggest that intervention trials tailored to the individual patient may be the way forward.. Conclusions Behavioral interventions show promise with respect to reducing distress in ICD patients. Large-scale intervention trials targeted to the individual needs and preferences of patients are warranted, as a ‘one size fits all’ approach is unlikely to work for all ICD patients. PMID:23438053

  13. High dose radiotherapy to automated implantable cardioverter-defibrillator: a case report and review of the literature.

    PubMed

    Ahmed, Inaya; Zou, Wei; Jabbour, Salma K

    2014-01-01

    We report a case of successful full-dose chemoradiotherapy to stage IIIB nonsmall cell lung cancer (NSCLC) in a 59-year-old man with extensive cardiac history and an automated implantable cardioverter-defibrillator (AICD) located within the radiotherapeutic field. In this case, the AICD was a St. Jude Medical Fortify Assura VR 1257-40Q ICD, and it was implanted prophylactically during bypass grafting. Although we do not recommend routine radiotherapy dose to exceed recommended current guidelines due to the potential risks to the patient, this is a situation where relocation of the device was not possible. Fortunately, our patient was not AICD-dependent; so following much discussion and deliberation, the decision was made to treat the patient with AICD in place. The patient completed definitive chemoradiotherapy with concurrent cisplatin and etoposide and thoracic irradiation to 69.6 Gy. The minimum, maximum, and mean doses to the AICD directly were 13.5 Gy, 52.4 Gy, and 29.3 Gy, respectively. The device withstood full thoracic radiation dose, and the patient denied cardiac symptoms during the time before, during, and after completion of therapy. We sought to offer this case for both teaching and guidance in practice and to contribute to the published literature currently available in this area.

  14. Clinical course of arrhythmogenic right ventricular cardiomyopathy in the era of implantable cardioverter-defibrillators and radiofrequency catheter ablation.

    PubMed

    Komura, Masatoshi; Suzuki, Jun-Ichi; Adachi, Susumu; Takahashi, Atsushi; Otomo, Kenichiro; Nitta, Junichi; Nishizaki, Mitsuhiro; Obayashi, Tohru; Nogami, Akihiko; Satoh, Yasuhiro; Okishige, Kaoru; Hachiya, Hitoshi; Hirao, Kenzo; Isobe, Mitsuaki

    2010-01-01

    This study investigated the clinical course of arrhythmogenic right ventricular cardiomyopathy (ARVC) patients and in particular evaluated the contribution of radiofrequency catheter ablation (RFCA) and an implantable cardioverter-defibrillator (ICD) to the treatment of ARVC. ARVC is a myocardial disorder and a cause of sudden cardiac death due to ventricular tachycardia (VT). Little is known about its prognosis in Japanese ARVC patients. Thirty-five ARVC patients were studied. Mean age of patients whose onset of ARVC was congestive heart failure (CHF) (66.0 +/- 4.0 years) was significantly higher than those whose onset was VT (44.5 +/- 14.8 years, P < 0.05). ARVC patients with CHF onset showed significantly higher death rates compared to those with VT onset. ICD treatment significantly reduced episodes of hospitalization due to VT (0.1 +/- 0.4 episodes) in comparison to treatment by RFCA (1.7 +/- 2.2 episodes, P < 0.03). RFCA treatment did not reduce recurrence of VT in the follow-up period. ICD therapy showed comparable mortality to RFCA treatment. The prognosis of ARVC with CHF onset is poor. ICD therapy significantly reduced hospitalization due to VT compared with RFCA treatment. ICD implantation in combination with medication may be a better treatment for ARVC.

  15. Safety Profile of Liver FibroScan in Patients with Cardiac Pacemakers or Implantable Cardioverter-Defibrillators

    PubMed Central

    Pranke, Stephanie; Rashidi, Farid; Nosib, Shravan; Worobetz, Lawrence

    2017-01-01

    Background. Emerging evidence suggests that nonalcoholic fatty liver disease (NAFLD) is associated with coronary artery diseases and arrhythmias. The FibroScan (Echosens, France), a widely available, noninvasive device, is able to detect liver fibrosis and steatosis within this patient population. However, the FibroScan is currently contraindicated in patients with cardiac pacemakers (PM) or implantable cardioverter-defibrillators (ICD). Objective. To determine the safety profile of FibroScan testing in patients with PM or ICD. Methods. Consecutive outpatients undergoing routine device interrogations at a tertiary level teaching hospital underwent simultaneous liver stiffness measurements. PM or ICD performance data, device types, patient demographics, medical history, and previous laboratory and conventional liver imaging results were collected. Results. Analysis of 107 subjects with 33 different types of implanted cardiac devices, from 5 different companies (Medtronic, Sorin, ELA Medical, Boston Scientific, and St. Jude), did not demonstrate any adverse events as defined by abnormal device sensing/pacing or ICD firing. This population included high risk subjects undergoing active pacing (n = 53) and with right pectoral PM placement (n = 1). None of the subjects had any clinical signs of decompensated congestive heart failure or cirrhosis during the exam. Conclusion. TE with FibroScan can be safely performed in patients with PM or ICD. PMID:28349045

  16. 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.

  17. 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

  18. 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.

  19. Variation among hospitals in selection of higher-cost, "higher-tech," implantable cardioverter-defibrillators: data from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter/Defibrillator (ICD) Registry.

    PubMed

    Lampert, Rachel; Wang, Yongfei; Curtis, Jeptha P

    2013-06-01

    New implantable cardioverter/defibrillator (ICD) models are regularly introduced, incorporating technological advantages. The purpose of this study was to determine factors associated with use of a newer, higher-tech/higher-cost device, as opposed to a previously released device, among patients undergoing ICD implantation. We analyzed the 78,494 cases receiving new ICD implants submitted by 978 hospitals to the NCDR ICD Registry between January 2005 and June 2007. Devices were categorized as "previously released" 3 months after a new model from the same manufacturer was released. A nonparsimonious model including all demographic, clinical, provider, and hospital characteristics was created using logistic regression to predict use of a previously released device. Overall, 36% of implants involved previously released devices. However, no demographic (race, gender, payor status), clinical, or provider characteristics had a meaningful impact on use of previously released devices. The model C-statistic was 0.602, suggesting that measured characteristics had a limited ability to differentiate those receiving a previously released device. However, individual hospitals varied greatly in use of "previously released" devices, from 3% in the lowest decile to 91% in the top decile. Among physicians implanting at >1 hospital, there was minimal correlation between use of previously released devices between hospitals, suggesting hospital policies or culture, rather than physician preference, drives the large interhospital variation seen. The use of "previously released" devices is influenced minimally by measured patient or provider characteristics. Rather, the main determinant of whether patients receive the newest, versus a previously released device, appears to be practice patterns at individual hospitals. Copyright © 2013 Mosby, Inc. All rights reserved.

  20. 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

  1. 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.

  2. [Cost effectiveness of implantable cardioverter-defibrillators for patients who are at risk for sudden death in Argentina].

    PubMed

    Alcaraz, Andrea; González-Zuelgaray, Jorge; Augustovski, Federico

    2011-01-01

    To evaluate the cost-effectiveness and cost-utility of the cardioverter-defibrillator (ICD) among patients who are at risk for sudden death in Argentina, from three scenarios: public health, social security and private sector. We developed a Markov model to evaluate the survival, quality of life and cost of the prophylactic implantation of an ICD, as compared with pharmacological therapy, among three different target populations according to clinical trials selected using a systematic review, and choosing epidemiological, effectiveness, resource use and cost parameters. A healthcare system perspective was adopted. A 3% discount rate was used. The use of the ICD was more costly and more effective than control therapy. The cohort with greater benefits was represented by MADIT I study, showing an incremental cost effectiveness rate (ICER) of $8,539 (dollar 2009) for public, $9,371 for social security and $10,083 for private sector. ICERs for secondary prevention population were $21,016, $22,520 and $24,012, and for MADIT II population were $17,379, $18,574 and $19,799. The analysis was robust to different deterministic and probabilistic sensitivity analyses, except for the cost of ICD and for battery life. The results varied considerably depending on the cohort and discretely according to the health system. ICD could be cost-effective in Argentina, mainly in the MADIT I patients. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. Depression and anxiety symptoms are associated with reduced dietary adherence in heart failure patients treated with an implantable cardioverter defibrillator.

    PubMed

    Luyster, Faith S; Hughes, Joel W; Gunstad, John

    2009-01-01

    Heart failure (HF) patients treated with an implantable cardioverter defibrillator (ICD) are a growing patient population for whom the general treatment guidelines for HF still apply. Dietary recommendations, sodium and fluid restriction and daily weight monitoring, are a critical component of HF self-management. However, HF patients often report poor adherence to these recommendations. Studies that have investigated factors associated with poor diet adherence have focused on knowledge and beliefs. The current study extends previous research by examining the impact of psychosocial factors (depression, anxiety, and social support) on adherence to dietary recommendations in this growing subgroup of HF patients. Eighty-eight HF patients, with a mean age of 70 years, treated with an ICD (77% male) completed questionnaires assessing depression and anxiety symptoms, social support, and dietary adherence. Most patients reported following dietary recommendations in the past week most of the time (63%), whereas only 16% of patients reported following dietary recommendations all of the time. Greater depression and anxiety symptoms were associated with poorer dietary adherence, whereas social support did not predict reported dietary adherence. Findings suggest that many HF patients treated with an ICD do not comply with dietary recommendations. Depression and anxiety symptoms were found to be associated with worse dietary adherence, whereas social support was not related to adherence. Further research is needed to understand the role of social support in dietary adherence in HF patients.

  4. Current implantable cardioverter-defibrillator programming in Europe: the results of the European Heart Rhythm Association survey.

    PubMed

    Proclemer, Alessandro; Grazia Bongiorni, Maria; Etsner, Heidi; Todd, Derick; Sciaraffia, Elena; Blomström-Lundqvist, Carina

    2014-06-01

    The purpose of this European Heart Rhythm Association (EHRA) survey was to examine the current practice on the choice of implantable cardioverter-defibrillator (ICD) type, use of defibrillation testing, and ICD programming for detection and therapy of ventricular arrhythmias. In accordance with recent guidelines and the results of observational studies, the majority of EHRA research network centres reported a high utilization rate of dual-chamber ICDs in the presence of symptomatic and asymptomatic sinus node dysfunction, biventricular ICD in high-degree atrioventricular block and QRS duration <120 ms, and a limited use of defibrillation testing either in primary and secondary prevention settings. Activation of the long ventricular tachycardia (VT) detection window, slow VT zone, antitachycardia pacing before shock for slow and fast VT, and atrial tachyarrhythmia discrimination were considered useful in ICD programming for the majority of patients. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  5. Small bowel capsule endoscopy in patients with cardiac pacemakers and implantable cardioverter defibrillators: Outcome analysis using telemetry review

    PubMed Central

    Cuschieri, Justin R; Osman, Mohammed N; Wong, Richard CK; Chak, Amitabh; Isenberg, Gerard A

    2012-01-01

    AIM: To determine if there were any interactions between cardiac devices and small bowel capsules secondary to electromagnetic interference (EMI) in patients who have undergone small bowel capsule endoscopy (SBCE). METHODS: Authors conducted a chart review of 20 patients with a cardiac pacemaker (CP) or implantable cardioverter defibrillator (ICD) who underwent continuous electrocardiographic monitoring during their SBCE from 2003-2008. authors searched for unexplained electrocardiogram (ECG) findings, changes in CP and ICD set parameters, any abnormality in transmitted capsule data, and adverse clinical events. RESULTS: There were no adverse events or hemodynamically significant arrhythmias reported. CP and ICD set parameters were preserved. The majority of ECG abnormalities were also found in pre- or post- SBCE ECG tracings and the CP behavior during arrhythmias appeared appropriate. Two patients seemed to have episodes of undersensing by the CP. However, similar findings were documented in ECGs taken outside the time frame of the SBCE. One patient was observed to have a low signal encountered from the capsule resulting in lack of localization, but no images were lost. CONCLUSION: Capsule-induced EMI remains a possibility but is unlikely to be clinically important. CP-induced interference of SBCE is also possible, but is infrequent and does not result in loss of images transmitted by the capsule. PMID:22442746

  6. n-3 Fatty acids and ventricular arrhythmias in patients with ischaemic heart disease and implantable cardioverter defibrillators.

    PubMed

    Christensen, Jeppe Hagstrup; Riahi, Sam; Schmidt, Erik Berg; Mølgaard, Henning; Kirstein Pedersen, Anders; Heath, Finn; Cosedis Nielsen, Jens; Toft, Egon

    2005-07-01

    To investigate the relationship between serum content of n-3 polyunsaturated fatty acids (PUFA) and the incidence of ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD). We included 98 patients with ischaemic heart disease and an ICD. The numbers of ventricular fibrillation (VF) and ventricular tachycardia (VT) events were assessed during a 12-month period and related to the concentration of n-3 PUFA in serum phospholipids. Patients with more than one arrhythmic event had significantly lower n-3 PUFA levels compared with patients without arrhythmias (mean 7.1% vs 9.2%, P<0.01). Dividing the patients into quintiles according to their n-3 PUFA level those with the lowest content of n-3 PUFA had more ventricular arrhythmias than patients with the highest concentration of n-3 PUFA (mean 1.3 event vs 0.2 event, P<0.05). Patients with a low content of n-3 PUFA in serum had a higher incidence of ventricular arrhythmias compared with patients with high serum levels of n-3 PUFA. The data suggest that the protection offered by n-3 PUFA against sudden cardiac death observed in previous studies is mediated by a direct antiarrhythmic effect of n-3 PUFA.

  7. Gender and outcomes after primary prevention implantable cardioverter-defibrillator implantation: Findings from the National Cardiovascular Data Registry (NCDR)

    PubMed Central

    Russo, Andrea M.; Daugherty, Stacie L.; Masoudi, Frederick A.; Wang, Yongfei; Curtis, Jeptha; Lampert, Rachel

    2016-01-01

    Background Clinical trials have demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in selected high-risk individuals. Because of small numbers of women enrolled in these trials, outcomes for women after hospital discharge have not been well described. We compared procedure-related complications and outcomes after hospital discharge between men and women undergoing single- or dual-chamber ICD implantation for primary prevention. Methods In patients 65 years or older with Medicare fee-for-service coverage, we identified 38,912 initial implants (25% women) who received single- or dual-chamber ICDs for primary prevention between January 2006 and December 2009 in the NCDR and evaluated gender differences in outcomes. Results Women had greater comorbidity and more advanced heart failure (HF) at the time of ICD implantation than did men. Device-related complications, death at 6 months, all-cause readmissions, and HF readmissions at 6 months were significantly more common in women (7.2% vs 4.8%, 6.5% vs 5.6%, 37.2% vs 31.7%, and 14.0% vs 10.0% respectively; P < .001 for all). Women continued to have higher odds of procedural complications (odds ratio [OR] 1.39, 95% CI 1.26–1.53, P < .001), 6-month all-cause readmission (OR 1.22, 95% CI 1.16–1.28, P < .001), and 6-month HF readmission (OR 1.32, 95% CI 1.23–1.42, P < .001), with a trend toward higher 6-month mortality (OR 1.08, 95% CI 0.98–1.20, P = .123), compared with men, after adjusting for differences in baseline characteristics and device type (single vs dual chamber). Conclusions Among older patients receiving ICDs for primary prevention in clinical practice, women experience worse outcomes than do men. Reasons for gender differences in outcomes are poorly understood and require further investigation. PMID:26299231

  8. Shock or no shock - a question of philosophy or should intraoperative implantable cardioverter defibrillator testing be recommended?

    PubMed

    Keyser, Andreas; Hilker, Michael K; Schmidt, Sebastian; von Bary, Christian; Zink, Wolfgang; Ried, Michael; Schmid, Christof; Diez, Claudius

    2013-03-01

    Implantation of implantable cardioverter defibrillators (ICDs) in patients with a high risk for life-threatening ventricular arrhythmias is a standard therapy. The development of new ICD leads, shock algorithms, high-energy defibrillators and rapid energy supply has improved the devices. Nevertheless, the discussion regarding 'shock or no shock' to test the system intraoperatively has not silenced yet. In this study, all 718 patients (60.0 ± 14.2 years old, 570 male) who were treated with a first ICD at our institution since 2005 were analysed. The indication for implantation was primarily prophylactic in 511 patients (71.3%). Underlying diseases included ischaemic cardiomyopathy (358 patients, 50%), dilated cardiomyopathy (270 patients, 37.7%) and others (12.3%). Mean ejection fraction was 27.4 ± 11.8%. Intraoperative ventricular fibrillation was induced with a T-wave shock or burst stimulation. The primary end-point was failing the initial intraoperative testing. During the initial testing, 28 patients (3.9%) had a defibrillation threshold (DFT) >21 J. The mean age of these patients was 51 ± 14 years, ranging from 22 to 71 years, 20 were male, and the ejection fraction was 23.8 ± 11.8%. The indication for ICD implantation was prophylactic in 13 patients. Twenty-one of the 28 patients suffered from dilated cardiomyopathy, whereas seven patients had ischaemic cardiomyopathy. Twenty-four ICDs were implanted on the left side and four on the right side. None of the patients had been treated with amiodarone at the time of implantation. All patients achieved a sufficient DFT ≤ 21 J by changing the ICD leads, device repositioning and/or optimizing the shock configuration. The standard of care intraoperative ICD testing remains necessary.

  9. Survival Benefit of Implantable Cardioverter-Defibrillators in Left Ventricular Assist Device-Supported Heart Failure Patients

    PubMed Central

    Refaat, Marwan M.; Tanaka, Toshikazu; Kormos, Robert L; McNamara, Dennis; Teuteberg, Jeffrey; Winowich, Steve; London, Barry; Simon, Marc A

    2012-01-01

    Background Implantable Cardioverter-Defibrillators (ICDs) reduce mortality in heart failure (HF). In patients requiring ventricular assist device (VAD), the benefit from ICD therapy is not well established. The aim of the study is to define the impact of ICD on outcomes in VAD - supported patients. Methods and Results We reviewed data for consecutive adult HF patients receiving VAD as bridge-to-transplantation from 1996 to 2003. Primary outcome was survival to transplantation. A total of 144 VADs were implanted [85 left ventricular (LVAD), 59 biventricular (BIVAD), age 50±12 years, 77% male, LVEF 18±9%, 54% ischemic]. Mean length of support was 119 days (range 1–670); 103 (72%) patients survived to transplantation. Forty-five patients had an ICD (33 LVAD, 12 BIVAD). More LVAD patients had an appropriate ICD shock before implantation than afterwards (16 vs. 7, p=0.02). There was a trend towards higher shock frequency before LVAD implant than after (3.3±5.2 vs 1.1±3.8 shocks/year, p=0.06). Mean time to first shock after VAD implant was 129±109 days. LVAD-supported patients with an ICD were significantly more likely to survive to transplantation (LVAD: 1-year actuarial survival to transplantation 91% with ICD vs. 57% without ICD, log-rank p=0.01; BIVAD: 54% vs. 47%, log-rank p=NS). An ICD was associated with significantly increased survival in a multivariate model controlling for confounding variables (OR 2.54, 95% CI 1.04-6.21, p=0.04). Conclusions Shock frequency decreases after VAD implantation, likely due to ventricular unloading, but appropriate ICD shocks still occur in 21% of patients. An ICD is associated with improved survival in LVAD-supported HF patients. PMID:22300782

  10. 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.

  11. Failure of a novel silicone–polyurethane copolymer (Optim™) to prevent implantable cardioverter-defibrillator lead insulation abrasions

    PubMed Central

    Hauser, Robert G.; Abdelhadi, Raed H.; McGriff, Deepa M.; Kallinen Retel, Linda

    2013-01-01

    Aim The purpose of this study was to determine if Optim™, a unique copolymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads (SJM, St Jude Medical Inc., Sylmar, CA, USA) from abrasions that cause lead failure. Methods and results We searched the US Food and Drug Administration's (FDA's) Manufacturers and User Device Experience (MAUDE) database on 13 April 2012 using the simple search terms ‘Riata ST Optim™ abrasion analysis’ and ‘Durata abrasion analysis’. Lead implant time was estimated by subtracting 3 months from the reported lead age. The MAUDE search returned 15 reports for Riata ST Optim™ and 37 reports for Durata leads, which were submitted by SJM based on its analyses of returned leads for clinical events that occurred between December 2007 and January 2012. Riata ST Optim™ leads had been implanted 29.1 ± 11.7 months. Eight of 15 leads had can abrasions and three abrasions were caused by friction with another device, most likely another lead. Four of these abrasions resulted in high-voltage failures and one death. One failure was caused by an internal insulation defect. Durata leads had been implanted 22.2 ± 10.6 months. Twelve Durata leads had can abrasions, and six leads had abrasions caused by friction with another device. Of these 18 can and other device abrasions, 13 (72%) had electrical abnormalities. Low impedances identified three internal insulation abrasions. Conclusions Riata ST Optim™ and Durata ICD leads have failed due to insulation abrasions. Optim™ did not prevent these abrasions, which developed ≤4 years after implant. Studies are needed to determine the incidence of these failures and their clinical implications. PMID:22915789

  12. 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.

  13. Frequency and determinants of implantable cardioverter defibrillator deployment among primary prevention candidates with subsequent sudden cardiac arrest in the community.

    PubMed

    Narayanan, Kumar; Reinier, Kyndaron; Uy-Evanado, Audrey; Teodorescu, Carmen; Chugh, Harpriya; Marijon, Eloi; Gunson, Karen; Jui, Jonathan; Chugh, Sumeet S

    2013-10-15

    The prevalence rates and influencing factors for deployment of primary prevention implantable cardioverter defibrillators (ICDs) among subjects who eventually experience sudden cardiac arrest in the general population have not been evaluated. Cases of adult sudden cardiac arrest with echocardiographic evaluation before the event were identified from the ongoing Oregon Sudden Unexpected Death Study (population approximately 1 million). Eligibility for primary ICD implantation was determined from medical records based on established guidelines. The frequency of prior primary ICD implantation in eligible subjects was evaluated, and ICD nonrecipients were characterized. Of 2093 cases (2003-2012), 448 had appropriate pre- sudden cardiac arrest left ventricular ejection fraction information available. Of these, 92 (20.5%) were eligible for primary ICD implantation, 304 (67.9%) were ineligible because of left ventricular ejection fraction >35%, and the remainder (52, 11.6%) had left ventricular ejection fraction ≤35% but were ineligible on the basis of clinical guideline criteria. Among eligible subjects, only 12 (13.0%; 95% confidence interval, 6.1%-19.9%) received a primary ICD. Compared with recipients, primary ICD nonrecipients were older (age at ejection fraction assessment, 67.1±13.6 versus 58.5±14.8 years, P=0.05), with 20% aged ≥80 years (versus 0% among recipients, P=0.11). Additionally, a subgroup (26%) had either a clinical history of dementia or were undergoing chronic dialysis. Only one fifth of the sudden cardiac arrest cases in the community were eligible for a primary prevention ICD before the event, but among these, a small proportion (13%) were actually implanted. Although older age and comorbidity may explain nondeployment in a subgroup of these cases, other determinants such as socioeconomic factors, health insurance, patient preference, and clinical practice patterns warrant further detailed investigation.

  14. Noninvasive pacing study via pacemakers and implantable cardioverter-defibrillators for differentiating right from left atrial flutter.

    PubMed

    Burri, Haran; Zimmermann, Marc; Sunthorn, Henri; Al-Jefairi, Nora; Trentaz, Florence; Stettler, Carine; Gentil-Baron, Pascale; Shah, Dipen

    2015-06-01

    Patients with atrial flutter who are implanted with a pacemaker (PM) or implantable cardioverter-defibrillator (ICD) present with the opportunity to perform a noninvasive pacing study (NIPS) using the right atrial pacing lead to differentiate right from left atrial flutter. The purpose of this study was to study the feasibility and accuracy of NIPS to distinguish right from left atrial flutter. We enrolled consecutive patients scheduled for an electrophysiological study or ablation procedure who were in atrial flutter and who were implanted with a PM or ICD with a functional atrial lead in the right atrial appendage. Flutter tachycardia cycle lengths (TCLs) and postpacing intervals (PPIs) were measured noninvasively via the device during the procedure. A total of 48 (67%) patients were studied. Right atrial flutter was present in 32 patients (of whom 29 had typical cavotricuspid isthmus-dependent flutter) and 16 (33%) patients had left atrial flutter. A PPI-TCL interval of >100 ms was 100% specific and 81% sensitive to identify left atrial flutter, with an overall accuracy of 94% and a c statistic of 0.94 (95% confidence interval 0.87-1.00). A PPI-TCL interval of ≤100 ms had a positive predictive value of 86% for diagnosing typical flutter. NIPS via PMs and ICDs with a PPI-TCL interval of >100 ms can reliably identify left atrial flutter (although we have only validated this cutoff for leads implanted in the right atrial appendage). This simple maneuver may allow planning for left-sided access and may avoid an unnecessary invasive electrophysiological study if left atrial flutter ablation is not to be considered. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  15. Acute Effects of Implantable Cardioverter-Defibrillator Shocks on Biomarkers of Myocardial Injury, Apoptosis, Heart Failure, and Systemic Inflammation.

    PubMed

    Brewster, Jordan; Sexton, Travis; Dhaliwal, Gary; Charnigo, Richard; Morales, Gustavo; Parrott, Kevin; Darrat, Yousef; Gurley, John; Smyth, Susan; Elayi, Claude S

    2017-04-01

    Implantable cardioverter-defibrillator (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. 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-). Sixty-three patients were enrolled, 40 in the DFT+ group and 23 in the DFT- group. Average levels of troponin I, hsCRP, Calprotectin, N-terminal pro B-type natriuretic peptide (NTproBNP), and sFas increased by >50% after cardiac device implantation compared to baseline. Increase in troponin never exceeded the 50-fold upper limit of normal (2 ng/mL). Troponin trended higher in the DFT+ group at 8 hours (median 0.18 ng/mL, interquartile range [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). DFT testing is associated with acutely increased plasma levels of troponin and sFas, a biomarker of apoptosis, along with a trend toward higher NTproBNP. © 2017 Wiley Periodicals, Inc.

  16. Effect of a psychoeducational intervention on depression, anxiety, and health resource use in implantable cardioverter defibrillator patients.

    PubMed

    Dunbar, Sandra B; Langberg, Jonathan J; Reilly, Carolyn M; Viswanathan, Bindu; McCarty, Frances; Culler, Steven D; O'Brien, Marian C; Weintraub, William S

    2009-10-01

    Psychological responses have been reported for some patients after the insertion of an implantable cardioverter defibrillator (ICD). This study tested the effects of a psychoeducational intervention on anxiety, depressive symptoms, functional status, and health resource use during the first year after ICD implantation. ICD patients (n = 246) were randomized to usual care (UC), group (GRP), or telephone counseling (TC) intervention that included education, symptom management, and coping skill training. Participants were 58 +/- 11 years, 73% men, and 23% minorities. Anxiety (State-Trait Anxiety Inventory [STAI]), depressive symptoms (Beck Depression Inventory II [BDI-II]), and functional status (Duke Activity Status Inventory [DASI]) were measured at baseline and after 1, 3, 6, and 12 months. Health resource use and disability days were tracked. Analyses were repeated-measures analysis of covariance to assess Group x Time effects,chi(2)for percentage with clinically significant anxiety and depression at each time point, and logistic regression. All groups experienced decreased anxiety and depressive symptoms over the 12 months; GRP intervention had lower STAI (P = 0.03) than UC at 3 months. Logistic regression revealed group differences for predicted probability of having depressive symptoms at 12 months (UC = 0.31, GRP = 0.17, TC = 0.13, P = 0.03). UC had greater calls to providers at 1 and 6 months (P < 0.05) and more sick/disability days at 12 months (P = 0.01) than intervention groups. A psychoeducational intervention reduced anxiety and depressive symptoms early after ICD implant, lowered probability of depressive symptoms at 1 year, and decreased disability days/calls to providers. These findings support further study and clinical use of both group and telephone interventions to yield better psychological outcomes after ICD implant.

  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. 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.

  19. "Two for the Price of One": A Single-Lead Implantable Cardioverter-Defibrillator System with a Floating Atrial Dipole.

    PubMed

    E Worden Md, Nicole; Alqasrawi Md, Musab; M Krothapalli Md, Siva; Mazur Md, Alexander

    2016-01-01

    In patients known to be a high risk for sudden cardiac arrest, implantable cardioverter defibrillators (ICD) are a proven therapy to reduce risk of death. However, in patients without conventional indications for pacing, the optimal strategy for type of device, dual- versus single-chamber, remains debatable. The benefit of prophylactic pacing in this category of patients has never been documented. Although available atrial electrograms in a dual chamber system improve interpretation of stored arrhythmia events, allow monitoring of atrial fibrillation and may potentially reduce the risk of inappropriate shocks by enhancing automated arrhythmia discrimination, the use of dual-chamber ICDs has a number of disadvantages. The addition of an atrial lead adds complexity to implantation and extraction procedures, increases procedural cost and is associated with a higher risk of periprocedural complications. The single lead pacing system with ability to sense atrial signals via floating atrial electrodes (VDD) clinically became available in early 1980's but did not gain much popularity due to inconsistent atrial sensing and concerns about the potential need for an atrial lead if sinus node fails. Most ICD patients do not have indications for pacing at implantation and subsequent risk of symptomatic bradycardia seems to be low. The concept of atrial sensing via floating electrodes has recently been revitalized in the Biotronik DX ICD system (Biotronik, SE & Co., Berlin, Germany) aiming to provide all of the potential advantages of available atrial electrograms without the risks and incremental cost of an additional atrial lead. Compared to a traditional VDD pacing system, the DX ICD system uses an optimized (15 mm) atrial dipole spacing and improved atrial signal processing to offer more reliable atrial sensing. The initial experience with the DX system indicates that the clinically useful atrial signal amplitude in sinus rhythm remains stable over time. Future studies are

  20. The role of implantable cardioverter-defibrillators in patients with continuous flow left ventricular assist devices - A meta-analysis.

    PubMed

    Agrawal, Sahil; Garg, Lohit; Nanda, Sudip; Sharma, Abhishek; Bhatia, Nirmanmoh; Manda, Yugandhar; Singh, Amitoj; Fegley, Mark; Shirani, Jamshid

    2016-11-01

    Left ventricular assist devices (LVADs) and implantable cardioverter defibrillators (ICD) are each known to improve mortality in patients with advanced congestive heart failure (CHF). If ICDs contribute to improved survival specifically in recipients of LVADs is currently unknown. To evaluate the impact of presence of ICD on mortality in continuous flow LVAD recipients. A meta- analysis of available literature was performed. PubMed, Embase and Google Scholar databases were searched for studies that compared mortality in continuous flow LVAD patients with ICDs (new implantation or no de-activation) and without ICDs (including de-activation of existing implant). Pooled analysis using a fixed effects model was used for outcomes of interest. We included 3 observational studies for a total of 292 patients (203 (69.5%) with ICD versus 89 (30.5%) without ICD). The presence of an active ICD was not associated with improved survival [OR 0.63, 95% CI 0.33-1.18; p=0.15]. In bridge to transplantation [BT] patients (224 patients, 149 with ICD versus 75 without ICD), an active ICD was not associated with a higher probability of survivzal [OR 1.47, 95% CI 0.78-2.76; p=0.23]. There was no difference in the occurrence of severe right ventricular dysfunction or failure between two groups [OR 0.78, 95% CI 0.42-1.47; p=0.45]. The risk of LVAD related complications were similar [OR 0.68, 95% CI 0.35-1.31; P=0.25]. This meta-analysis demonstrates that there is no survival benefit with ICD in heart failure patients supported with continuous flow LVAD. There is an urgent need of large-scale randomized trials to specifically address this issue. Copyright © 2016. Published by Elsevier Ireland Ltd.

  1. Impact of manufacturer advisories and FDA recalls of implantable cardioverter defibrillator generators in pediatric and congenital heart disease patients.

    PubMed

    Mahajan, Tarun; Dubin, Anne M; Atkins, Dianne L; Bradley, David J; Shannon, Kevin M; Erickson, Christopher C; Franklin, Wayne H; Cecchin, Frank; Berul, Charles I

    2008-12-01

    Recalls of implantable cardioverter defibrillator (ICD) generators have affected many patients. No information is available regarding the impact specifically on pediatric and congenital heart disease (CHD) patients. This study was undertaken to determine implications of ICD manufacturers' advisories and recalls on children and CHD patients. The first part of this study involved single-center review of patients who underwent ICD placement between 2000 and 2005. Patients with ICDs affected by the 2005 advisories/recalls were reviewed for incidence of explantation, malfunction and complications. Secondly, members of the Pediatric and Congenital Electrophysiology Society (PACES) were queried for patients with affected devices, incidences of explantation, malfunction, and explant-related complications. Data were pooled for aggregate summary. Among 233 patients who underwent ICD implantation at our institution during the study period, 58 (25%) patients had advisory/recalled devices and 13 of 58 (22%) underwent explantation following 3.1 +/- 1.3 years implant duration. No defects were identified by the manufacturer. No patients experienced complications requiring reintervention or rehospitalization. Questionnaire responses were received from 22 PACES institutions, included 177 patients with affected devices, of which 76 (43%) were removed. One patient died from complications following revision, and 1 patient had complications requiring reoperation. Two explanted devices had loose headers; no other defects were discovered. Taken together, 2 of 89 explanted devices were defective, and 2 complications occurred from explantation. Advisories and recalls affect substantial numbers of pediatric and CHD patients. A significant proportion underwent explantation. Although complications are infrequent, there are important medical, psychosocial, and financial impacts associated with ICD replacement.

  2. Psychological wellbeing and posttraumatic stress associated with implantable cardioverter defibrillator therapy in young adults with genetic heart disease.

    PubMed

    Ingles, Jodie; Sarina, Tanya; Kasparian, Nadine; Semsarian, Christopher

    2013-10-09

    Sudden cardiac death is a tragic complication of a number of genetic heart diseases. Implantable cardioverter defibrillator (ICD) therapy plays an important role in prevention of sudden death. The psychological consequences of ICD therapy in young people with genetic heart disease are poorly understood. This study sought to better understand psychological wellbeing and identify symptoms of posttraumatic stress in young people who had experienced an ICD shock. Eligible patients (ICD implanted over 12 months prior) with an inherited cardiomyopathy or primary arrhythmogenic disorder, enrolled in the Australian Genetic Heart Disease Registry were included. Ninety patients completed the Hospital Anxiety and Depression Scale (HADS). Those patients who had an ICD shock (n=31) also completed the Impact of Events Scale-Revised (IES-R). While the mean HADS-Anxiety and IES-R scores were within the normal range in the total group (n=90), a significant subgroup reported symptoms of anxiety (38%), depression (17%) and posttraumatic stress (31%) indicative of the potential need for referral to clinical care. Overall, greater psychological distress in ICD patients was associated with female gender, a history of syncope, other comorbid medical conditions, and reporting of other distressing events (i.e., ICD complications). In those with an ICD shock, higher posttraumatic stress scores were associated with female gender and longer time to first shock. Patients with genetic heart diseases can experience psychological difficulties, including anxiety, depression and posttraumatic stress, related to ICD implantation and subsequent shocks. This signals the importance of offering patients access to targeted interventions, including psychological care and support. © 2013.

  3. Role of defibrillation threshold testing during implantable cardioverter-defibrillator placement: data from the Israeli ICD Registry.

    PubMed

    Arnson, Yoav; Suleiman, Mahmoud; Glikson, Michael; Sela, Ron; Geist, Michael; Amit, Guy; Schliamser, Jorge E; Goldenberg, Ilan; Ben-Zvi, Shlomit; Orvin, Katia; Rosenheck, Shimon; Adam Freedberg, Nahum; Strasberg, Boris; Haim, Moti

    2014-05-01

    Defibrillation threshold (DFT) testing during placement of an implantable cardioverter-defibrillator (ICD) has been considered mandatory. Accumulating data suggest a more limited role for DFT. The purpose of this study was to compare the outcome of ICD recipients who underwent DFT testing compared with those who did not. In this prospective cohort analysis of patients who received an ICD between July 2010 and March 2013, we compared patients who underwent DFT testing and those who did not. Primary end-points were death and malignant ventricular arrhythmias. Secondary end-points included the composite end-points and inappropriate ICD discharges. Of the 3596 patients in the registry, 614 patients (17%) underwent DFT testing during ICD placement vs 2982 (83%) who did not. Variables associated with ICD testing were implantation for secondary prevention (relative risk [RR] 1.87), prior ventricular arrhythmias (RR 1.81), use of antiarrhythmic medication (RR 1.59), and sinus rhythm (RR 2.05). Factors predisposing against testing were cardiac resynchronization therapy defibrillator implantation (RR 0.56) and concomitant diuretic use (RR 0.71). ICD testing was not associated with 1-year mortality (5.3% vs 5.1%, P = .74), delivery of appropriate shocks (8.6% vs 5.6%, P = .16), combined outcomes of ventricular arrhythmias and death (12.9% vs 11.3%, P = .45), or inappropriate ICD discharges (3.9% vs 2.1%, P = .2) compared to no DFT testing. No significant differences in the incidence of mortality, malignant ventricular arrhythmias, or inappropriate ICD discharges were observed between patients who underwent DFT testing compared to those who did not. Our results may support avoiding DFT testing during ICD placement, but this requires confirmation by additional prospective studies. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. Potential clinical impact of cardiovascular magnetic resonance assessment of ejection fraction on eligibility for cardioverter defibrillator implantation

    PubMed Central

    2012-01-01

    Background For the primary prevention of sudden cardiac death, guidelines provide left ventricular ejection fraction (EF) criteria for implantable cardioverter defibrillator (ICD) placement without specifying the technique by which it should be measured. We sought to investigate the potential impact of performing cardiovascular magnetic resonance (CMR) for EF on ICD eligibility. Methods The study population consisted of patients being considered for ICD implantation who were referred for EF assessment by CMR. Patients who underwent CMR within 30 days of echocardiography were included. Echocardiographic EF was determined by Simpson’s biplane method and CMR EF was measured by Simpson’s summation of discs method. Results Fifty-two patients (age 62±15 years, 81% male) had a mean EF of 38 ± 14% by echocardiography and 35 ± 14% by CMR. CMR had greater reproducibility than echocardiography for both intra-observer (ICC, 0.98 vs 0.94) and inter-observer comparisons (ICC 0.99 vs 0.93). The limits of agreement comparing CMR and echocardiographic EF were – 16 to +10 percentage points. CMR resulted in 11 of 52 (21%) and 5 of 52 (10%) of patients being reclassified regarding ICD eligibility at the EF thresholds of 35 and 30% respectively. Among patients with an echocardiographic EF of between 25 and 40%, 9 of 22 (41%) were reclassified by CMR at either the 35 or 30% threshold. Echocardiography identified only 1 of the 6 patients with left ventricular thrombus noted incidentally on CMR. Conclusions CMR resulted in 21% of patients being reclassified regarding ICD eligibility when strict EF criteria were used. In addition, CMR detected unexpected left ventricular thrombus in almost 10% of patients. Our findings suggest that the use of CMR for EF assessment may have a substantial impact on management in patients being considered for ICD implantation. PMID:23043729

  5. Use of implantable cardioverter defibrillators after out-of-hospital cardiac arrest: a prospective follow-up study

    PubMed Central

    Parkash, Ratika; Tang, Anthony; Wells, George; Blackburn, Josée; Stiell, Ian; Simpson, Christopher; Dorian, Paul; Yee, Raymond; Cameron, Doug; Connolly, Stuart; Birnie, David; Nichol, Graham

    2004-01-01

    Background Survivors of out-of-hospital cardiac arrest are at high risk of recurrent arrests, many of which could be prevented with implantable cardioverter defibrillators (ICDs). We sought to determine the ICD insertion rate among survivors of out-of-hospital cardiac arrest and to determine factors associated with ICD implantation. Methods The Ontario Prehospital Advanced Life Support (OPALS) study is a prospective, multiphase, before–after study assessing the effectiveness of prehospital interventions for people experiencing cardiac arrest, trauma or respiratory arrest in 19 Ontario communities. We linked OPALS data describing survivors of cardiac arrest with data from all defibrillator implantation centres in Ontario. Results From January 1997 to April 2002, 454 patients in the OPALS study survived to hospital discharge after experiencing an out-of-hospital cardiac arrest. The mean age was 65 (standard deviation 14) years, 122 (26.9%) were women, 398 (87.7%) had a witnessed arrest, 372 (81.9%) had an initial rhythm of ventricular tachycardia or ventricular fibrillation (VT/VF), and 76 (16.7%) had asystole or another arrhythmia. The median cerebral performance category at discharge (range 1–5, 1 = normal) was 1. Only 58 (12.8%) of the 454 patients received an ICD. Patients with an initial rhythm of VT/VF were more likely than those with an initial rhythm of asystole or another rhythm to undergo device insertion (adjusted odds ratio [OR] 9.63, 95% confidence interval [CI] 1.31–71.50). Similarly, patients with a normal cerebral performance score were more likely than those with abnormal scores to undergo ICD insertion (adjusted OR 12.52, 95% CI 1.74–92.12). Interpretation A minority of patients who survived cardiac arrest underwent ICD insertion. It is unclear whether this low usage rate reflects referral bias, selection bias by electrophysiologists, supply constraint or patient preference. PMID:15505267

  6. Wrong detection of ventricular fibrillation in an implantable cardioverter defibrillator caused by the movement near the MRI scanner bore.

    PubMed

    Mattei, Eugenio; Censi, Federica; Triventi, Michele; Mancini, Matteo; Napolitano, Antonio; Genovese, Elisabetta; Cannata, Vittorio; Falsaperla, Rosaria; Calcagnini, Giovanni

    2015-01-01

    The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). For patients with an implanted cardiac stimulators, such as an implantable cardioverter/defibrillator (ICD), the movements inside the MRI environment may thus induce voltages on the loop formed by the leads of the device, with the potential to affect the behavior of the stimulator. In particular, the ICD's detection algorithms may be affected by the induced voltage and may cause inappropriate sensing, arrhythmia detections, and eventually inappropriate ICD therapy.We performed in-vitro measurements on a saline-filled humanshaped phantom (male, 170 cm height), equipped with an MRconditional ICD able to transmit in real-time the detected cardiac activity (electrograms). A biventricular implant was reproduced and the ICD was programmed in standard operating conditions, but with the shock delivery disabled. The electrograms recorded in the atrial, left and right ventricle channels were monitored during rotational movements along the vertical axis, in close proximity of the bore. The phantom was also equipped with an accelerometer and a magnetic field probe to measure the angular velocity and the magnetic field variation during the experiment. Pacing inhibition, inappropriate detection of tachyarrhythmias and of ventricular fibrillation were observed. Pacing inhibition began at an angular velocity of about 7 rad/s, (dB/dt of about 2 T/s). Inappropriate detection of ventricular fibrillation occurred at about 8 rad/s (dB/dt of about 3 T/s). These findings highlight the need for a specific risk assessment of workers with MR-conditional ICDs, which takes into account also effects that are generally not considered relevant for patients, such as the movement around the scanner bore.

  7. 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

  8. 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.

  9. Efficacy of cognitive behavioral therapy in reducing psychiatric symptoms in patients with implantable cardioverter defibrillator: an integrative review.

    PubMed

    Maia, A C C O; Braga, A A; Soares-Filho, G; Pereira, V; Nardi, A E; Silva, A C

    2014-04-01

    This article is a systematic review of the available literature on the benefits that cognitive behavioral therapy (CBT) offers patients with implanted cardioverter defibrillators (ICDs) and confirms its effectiveness. After receiving the device, some patients fear that it will malfunction, or they remain in a constant state of tension due to sudden electrical discharges and develop symptoms of anxiety and depression. A search with the key words "anxiety", "depression", "implantable cardioverter", "cognitive behavioral therapy" and "psychotherapy" was carried out. The search was conducted in early January 2013. Sources for the search were ISI Web of Knowledge, PubMed, and PsycINFO. A total of 224 articles were retrieved: 155 from PubMed, 69 from ISI Web of Knowledge. Of these, 16 were written in a foreign language and 47 were duplicates, leaving 161 references for analysis of the abstracts. A total of 19 articles were eliminated after analysis of the abstracts, 13 were eliminated after full-text reading, and 11 articles were selected for the review. The collection of articles for literature review covered studies conducted over a period of 13 years (1998-2011), and, according to methodological design, there were 1 cross-sectional study, 1 prospective observational study, 2 clinical trials, 4 case-control studies, and 3 case studies. The criterion used for selection of the 11 articles was the effectiveness of the intervention of CBT to decrease anxiety and depression in patients with ICD, expressed as a ratio. The research indicated that CBT has been effective in the treatment of ICD patients with depressive and anxiety symptoms. Research also showed that young women represented a risk group, for which further study is needed. Because the number of references on this theme was small, further studies should be carried out.

  10. Appropriateness of primary prevention implantable cardioverter-defibrillators at the time of generator replacement: are indications still met?

    PubMed

    Kini, Vinay; Soufi, Mohamad Khaled; Deo, Rajat; Epstein, Andrew E; Bala, Rupa; Riley, Michael; Groeneveld, Peter W; Shalaby, Alaa; Dixit, Sanjay

    2014-06-10

    This study sought to determine how often patients with primary prevention implantable cardioverter-defibrillators (ICDs) meet guideline-derived indications at the time of generator replacement. Professional societies have developed guideline criteria for the appropriate implantation of an ICD for the primary prevention of sudden cardiac death. It is unknown whether patients continue to meet criteria when their devices need replacement for battery depletion. We performed a retrospective chart review of patients undergoing replacement of primary prevention ICDs at 2 tertiary Veterans Affairs Medical Centers. Indications for continued ICD therapy at the time of generator replacement included a left ventricular ejection fraction (LVEF) ≤35% or receipt of appropriate device therapy. In our cohort of 231 patients, 59 (26%) no longer met guideline-driven indications for an ICD at the time of generator replacement. An additional 79 patients (34%) had not received any appropriate ICD therapies and had not undergone reassessment of their LVEF. Patients with an initial LVEF of 30% to 35% were less likely to meet indications for ICD therapy at the time of replacement (odds ratio: 0.52; 95% confidence interval: 0.30 to 0.88; p = 0.01). Patients without ICD indications subsequently received appropriate ICD therapies at a significantly lower rate than patients with indications (2.8% vs. 10.7% annually, p < 0.001). If ICD generator explantations were performed instead of replacements in the patients without ICD indications, the cost savings would be $1.6 million. Approximately 25% of patients who receive primary prevention ICDs may no longer meet guideline indications for ICD use at the time of generator replacement, and these patients receive subsequent ICD therapies at a significantly lower rate. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. 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.

  12. Characteristics associated with anxiety, depressive symptoms, and quality-of-life in a large cohort of implantable cardioverter defibrillator recipients.

    PubMed

    Thylén, Ingela; Dekker, Rebecca L; Jaarsma, Tiny; Strömberg, Anna; Moser, Debra K

    2014-08-01

    Although most patients with implantable cardioverter defibrillators (ICDs) adjust well, some have considerable psychological distress. Factors associated with psychological adjustment in ICD-recipients are still not well understood. Our purpose was to describe quality-of-life (QoL) and prevalence of self-reported symptoms of anxiety and depression in a large national cohort of ICD-recipients, and to determine socio-demographic, clinical, and ICD-related factors associated with these variables. A cross-sectional, correlational design was used. All eligible adult ICD-recipients in the Swedish ICD- and Pacemaker Registry were invited to participate. Symptoms of anxiety and depression were measured using the Hospital Anxiety and Depression Scale (HADS), and QoL with the EuroQol-5D. A total of 3067 ICD-recipients (66±11years, 80% male) were included. The mean HADS score was 3.84±3.70 for anxiety symptoms and 2.99±3.01 for symptoms of depression. The mean EQ-5D index score was 0.82±0.21. The probability of symptoms of anxiety and depression was associated with younger age, living alone, and a previous history of myocardial infarction or heart failure. Additionally, female ICD-recipients had a higher probability of symptoms of anxiety. A higher level of ICD-related concerns was most prominently related to symptoms of anxiety, depressive symptoms and poorer QoL, while number of shocks, ICD-indication and time since implantation were not independently related. In this large cohort of ICD-recipients, the association of ICD-related concerns with symptoms of anxiety, depressive symptoms, and poor QoL suggests that ICD specific factors should be addressed in order to improve outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Usefulness of microvolt T-wave alternans for predicting outcome in patients with Chagas disease with implantable cardioverter defibrillators.

    PubMed

    Barbosa, Marco Paulo Tomaz; da Costa Rocha, Manoel Otávio; Neto, Elson Santos; Brandão, Fernando Vieira; Lombardi, Federico; Ribeiro, Antonio Luiz Pinho

    2016-11-01

    Chagas disease (ChD) may lead to life-threatening heart disease, including malignant ventricular arrhythmias. The use of implantable cardioverter defibrillators (ICDs) has become the main therapeutic strategy for secondary prevention of SCD in Chagas disease (ChD). Microvolt T-wave alternans (MTWA) is a direct measure of ventricular repolarization instability and has emerged as a potentially useful way of determining arrhythmia vulnerability. However, this methodology has not been evaluated in patients with ChD. To evaluate the predictive value of MTWA testing for appropriate therapy or death in ChD patients with ICDs. This prospective study included consecutive patients who received ICD implantations in a Brazilian tertiary referral center. Seventy-two patients were followed for a median time of 422 (range 294-642) days. Thirty-three patients had ChD. The MTWA was non-negative (positive or indeterminate) in 27 (81.8%) of ChD patients. The combined primary outcome (appropriate ICD therapy or death) occurred in 29 patients (40.3%); 17 out 33 ChD patients presented the primary outcome. There was a statistically significant difference in event-free survival between ChD patients with negative and non-negative MTWA results (p=0.02). Non-negative MTWA tests nearly triple the risk of appropriate ICD therapy or death (HR=2.7, 95% CI: 1.7-4.4, p=0.01) in patients with ChD and was the only variable associated with outcomes. The sensitivity and the negative predictive value was 100% in ChD patients. MTWA may be useful in recognizing high-risk ICD patients who may require adjunctive therapies with antiarrhythmic drugs or catheter ablation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. Digital Music Players Cause Interference with Interrogation Telemetry for Pacemakers and Implantable Cardioverter-Defibrillators without Affecting Device Function

    PubMed Central

    Webster, Gregory; Jordao, Ligia; Martuscello, Maria; Mahajan, Tarun; Alexander, Mark E.; Cecchin, Frank; Triedman, John K.; Walsh, Edward P.; Berul, Charles I.

    2014-01-01

    Background 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. Objective Given the high prevalence of DMP use among young patients, we sought to define the nature of interference from iPods and evaluate other DMPs. Methods 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. Results 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 impedance exhibited no more than baseline variability. When the DMPs were removed six inches, there were no further programmer telemetry interactions. Conclusions 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. PMID:18362020

  15. 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.

  16. Development and testing of an intervention to improve outcomes for partners following receipt of an implantable cardioverter defibrillator in the patient.

    PubMed

    Dougherty, Cynthia M; Thompson, Elaine A; Kudenchuk, Peter J

    2012-01-01

    The purpose of this article is to describe 3 foundational studies and how their results were used to formulate, design, and test a novel partner intervention for implementation in the immediate post-ICD (implantable cardioverter defibrillator) period after returning home. Nursing's expanding role into chronic illness management in the creation of evidence-based practice is highlighted. A randomized clinical trial comparing 2 intervention programs is being conducted with patients who receive an ICD for the first time and their intimate partners. Primary outcomes are physical functioning, psychological adjustment, relationship impact, and health care utilization.

  17. Efficacy and Limitations of Tachycardia Detection Interval Guided Reprogramming for Reduction of Inappropriate Shock in Implantable Cardioverter-Defibrillator Patients.

    PubMed

    Fujiishi, Tamami; Niwano, Shinichi; Murakami, Masami; Nakamura, Hironori; Igarashi, Tazuru; Ishizue, Naruya; Oikawa, Jun; Kishihara, Jun; Fukaya, Hidehira; Niwano, Hiroe; Ako, Junya

    2016-05-25

    The avoidance of inappropriate shock therapy is an important clinical issue in implantable cardioverter-defibrillator (ICD) patients. We retrospectively analyzed therapeutic events in ICD patients, and the effect of tachycardia detection interval (TDI) and tachycardia cycle length (TCL) guided reprograming on the reduction of inappropriate ICD therapy. The clinical determinants of after reprogramming were also evaluated.A total of 254 consecutive ICD patients were included in the study, and the incidence of antitachycardia therapy was evaluated during the follow-up period of 27.3 ± 18.7 months. When inappropriate antitachycardia therapy appeared, TDI was reprogrammed not to exceed the detected TCL and the patients continued to be followed-up. Various clinical parameters were compared between patients with and without inappropriate ICD therapy. During the initial follow-up period of 18.6 ± 15.6 months, ICD therapy occurred in 127/254 patients (50%) including inappropriate antitachycardia pacing (ATP) (12.9%) and shock (44.35%). Determinants of initial inappropriate therapy were dilated cardiomyopathy (DCM), history of therapeutic hypothermia, and QRS duration. Of the 61 patients with inappropriate therapy, 24 received TCL guided reprogramming. During the additional observation period of 17.0 ± 16.8 months, inappropriate therapy recurred in 5/24 patients (2 ATP, 3 shocks). The determinant of these inappropriate therapy events after reprogramming was the presence of supraventricular tachycardia.By applying simple TCL and TDI guided reprogramming, inappropriate therapy was reduced by 79%. The determinant of inappropriate therapy after reprogramming was the presence of supraventricular tachycardia.

  18. A pilot study of a mindfulness based stress reduction program in adolescents with implantable cardioverter defibrillators or pacemakers.

    PubMed

    Freedenberg, Vicki A; Thomas, Sue A; Friedmann, Erika

    2015-04-01

    Adolescents with implantable cardioverter defibrillators (ICDs) or pacemakers (PMs) face unique challenges that can cause psychosocial distress. Psychosocial interventions are effective for adults with cardiac devices and could potentially impact adolescents' adjustment to these devices. Mindfulness Based Stress Reduction (MBSR) is a structured psycho-educational program that includes meditation, yoga, and group support and has been studied extensively among adults. This study examined the feasibility of the MBSR program for adolescents with ICDs/PMs, a population previously unexamined in the research literature. The participants completed measures of anxiety and depression (Hospital Anxiety and Depression Scale) and coping (Responses to Stress Questionnaire) at baseline and after the six-session MBSR intervention. Mean age of the cohort (n = 10) was 15 ± 3 years, 6 were male, 6 had a PM, and 4 had an ICD. Feasibility was demonstrated by successful recruitment of 10 participants, 100 % participation and completion. Anxiety decreased significantly following the intervention, with a large effect size, t[9] = 3.67, p < .01, ŋ (2) = .59. Anxiety frequency decreased from baseline to post-intervention (Fisher's exact test p = .024), and 90 % of participants reported decreased anxiety scores post-intervention. Coping skills related negatively to anxiety (r = -.65, p = .04) and depression (r = -.88, p = .001). Post-intervention, the group independently formed their own Facebook group and requested to continue meeting monthly. Although generalizability is limited due to the small sample size, this successful pilot study paves the way for larger studies to examine the efficacy of MBSR interventions in adolescents with high-risk cardiac diagnoses.

  19. Influence of Renal Function on Mortality and Ventricular Arrhythmias in Patients Undergoing First Implantable Cardioverter-Defibrillator Generator Replacement

    PubMed Central

    WAKS, JONATHAN W.; HIGGINS, ANGELA Y.; MITTLEMAN, MURRAY A.; BUXTON, ALFRED E.

    2016-01-01

    Background Impaired renal function is associated with increased mortality among patients with implantable cardioverter-defibrillators (ICDs). The relationship between renal function at time of ICD generator replacement and subsequent appropriate ICD therapies is not known. Methods and Results We identified 441 patients who underwent first ICD generator replacement between 2000 and 2011 and had serum creatinine measured within 30 days of their procedure. Patients were divided into tertiles based on estimated glomerular filtration rate (eGFR). Adjusted Cox proportional hazard and competing risk models were used to assess relationships between eGFR and subsequent mortality and appropriate ICD therapy. Median eGFR was 37.6, 59.3, and 84.8 mL/min/1.73 m2 for tertiles 1–3, respectively. Five-year Kaplan–Meier survival probability was 34.8%, 61.4%, and 84.5% for tertiles 1–3, respectively (P < 0.001). After multivariable adjustment, compared to tertile 3, worse eGFR tertile was associated with increased mortality (HR 2.84, 95% CI [1.36–5.94] for tertile 2; HR 3.84, 95% CI [1.81–8.12] for tertile 1). At 5 years, 57.0%, 58.1%, and 60.2% of patients remained free of appropriate ICD therapy in tertiles 1–3, respectively (P = 0.82). After adjustment, eGFR tertile was not associated with future appropriate ICD therapy. Results were unchanged in an adjusted competing risk model accounting for death. Conclusions At time of first ICD generator replacement, lower eGFR is associated with higher mortality, but not with appropriate ICD therapies. The poorer survival of ICD patients with reduced eGFR does not appear to be influenced by arrhythmia status, and there is no clear proarrhythmic effect of renal dysfunction, even after accounting for the competing risk of death. PMID:25431143

  20. Influence of renal function on mortality and ventricular arrhythmias in patients undergoing first implantable cardioverter-defibrillator generator replacement.

    PubMed

    Waks, Jonathan W; Higgins, Angela Y; Mittleman, Murray A; Buxton, Alfred E

    2015-03-01

    Impaired renal function is associated with increased mortality among patients with implantable cardioverter-defibrillators (ICDs). The relationship between renal function at time of ICD generator replacement and subsequent appropriate ICD therapies is not known. We identified 441 patients who underwent first ICD generator replacement between 2000 and 2011 and had serum creatinine measured within 30 days of their procedure. Patients were divided into tertiles based on estimated glomerular filtration rate (eGFR). Adjusted Cox proportional hazard and competing risk models were used to assess relationships between eGFR and subsequent mortality and appropriate ICD therapy. Median eGFR was 37.6, 59.3, and 84.8 mL/min/1.73 m(2) for tertiles 1-3, respectively. Five-year Kaplan-Meier survival probability was 34.8%, 61.4%, and 84.5% for tertiles 1-3, respectively (P < 0.001). After multivariable adjustment, compared to tertile 3, worse eGFR tertile was associated with increased mortality (HR 2.84, 95% CI [1.36-5.94] for tertile 2; HR 3.84, 95% CI [1.81-8.12] for tertile 1). At 5 years, 57.0%, 58.1%, and 60.2% of patients remained free of appropriate ICD therapy in tertiles 1-3, respectively (P = 0.82). After adjustment, eGFR tertile was not associated with future appropriate ICD therapy. Results were unchanged in an adjusted competing risk model accounting for death. At time of first ICD generator replacement, lower eGFR is associated with higher mortality, but not with appropriate ICD therapies. The poorer survival of ICD patients with reduced eGFR does not appear to be influenced by arrhythmia status, and there is no clear proarrhythmic effect of renal dysfunction, even after accounting for the competing risk of death. © 2014 Wiley Periodicals, Inc.

  1. The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

    PubMed

    Timmermans, Ivy; Meine, Matias; Zitron, Edgar; Widdershoven, Jos; Kimman, Geert; Prevot, Sébastien; Rauwolf, Thomas; Anselme, Frédéric; Szendey, Istvan; Romero Roldán, Javier; Mabo, Philippe; Schaer, Beat; Denollet, Johan; Versteeg, Henneke

    2017-07-01

    Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. © 2017 Wiley Periodicals, Inc.

  2. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study

    PubMed Central

    Guédon-Moreau, Laurence; Lacroix, Dominique; Sadoul, Nicolas; Clémenty, Jacques; Kouakam, Claude; Hermida, Jean-Sylvain; Aliot, Etienne; Kacet, Salem

    2014-01-01

    Aims The Effectiveness and Cost of ICD follow-up Schedule with Telecardiology (ECOST) trial evaluated prospectively the economic impact of long-term remote monitoring (RM) of implantable cardioverter defibrillators (ICDs). Methods and results The analysis included 310 patients randomly assigned to RM (active group) vs. ambulatory follow-ups (control group). Patients in the active group were seen once a year unless the system reported an event mandating an ambulatory visit, while patients in the control group were seen in the ambulatory department every 6 months. The costs of each follow-up strategy were compared, using the actual billing documents issued by the French health insurance system, including costs of (i) (a) ICD-related ambulatory visits and transportation, (b) other ambulatory visits, (c) cardiovascular treatments and procedures, and (ii) hospitalizations for the management of cardiovascular events. The ICD and RM system costs were calculated on the basis of the device remaining longevity at the end of the study. The characteristics of the study groups were similar. Over a follow-up of 27 months, the mean non-hospital costs per patient-year were €1695 ± 1131 in the active, vs. €1952 ± 1023 in the control group (P = 0.04), a €257 difference mainly due to device management. The hospitalization costs per patient-year were €2829 ± 6382 and €3549 ± 9714 in the active and control groups, respectively (P = 0.46). Adding the ICD to the non-hospital costs, the savings were €494 (P = 0.005) or, when the monitoring system was included, €315 (P = 0.05) per patient-year. Conclusion From the French health insurance perspective, the remote management of ICD patients is cost saving. Clinical trials registration NCT00989417, www.clinicaltrials.gov PMID:24614572

  3. Home monitoring of implantable cardioverter-defibrillators: interpretation reliability of the second-generation “IEGM Online” system

    PubMed Central

    Nägele, Herbert; Lipoldová, Jolana; Oswald, Hanno; Klein, Gunnar; Elvan, Arif; Vester, Ernst; Bauer, Wolfgang; Bondke, Hansjürgen; Reif, Sebastian; Daub, Claudia; Menzel, Frank; Schrader, Jürgen; Zach, Göran

    2015-01-01

    Aims Intracardiac electrograms (IEGMs) are essential for the assessment of implantable cardioverter-defibrillator (ICD) function. The Biotronik Home Monitoring systems transmit an ‘IEGM Online’ that is shorter than the full-length programmer IEGM due to technical constrains. The aim of this study was to evaluate the accuracy of the physician's classification of the underlying rhythm based on the second-generation IEGM Online. Methods and results In total, 1533 patients treated with single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators were enrolled at 67 investigational sites and followed for 15 months. The investigators classified the rhythm shown in IEGM Online as ventricular tachycardia, ventricular fibrillation, atrial fibrillation, other supraventricular tachyarrhythmia, oversensing due to lead failure, T-wave oversensing, or other rhythm. At the next in-office follow-up, the investigators classified independently the rhythm seen in the corresponding programmer IEGM. The two rhythm classifications were compared thereafter. Both IEGM Online and programmer IEGM were available in 2099 arrhythmic or oversensing events, of which 146 (7.0%) were classified as other rhythm or artefacts and were excluded as inconclusive or atypical. The remaining 1953 events, affecting 352 patients (23.0%), were classified correctly in 1803 cases (92.3%). The accuracy of rough rhythm classification as ventricular, supraventricular, or oversensing was 97.2%. Conclusion The Lumax and IEGM Online HD Evaluation study demonstrates that remote IEGM analysis is reasonably accurate in a remote monitoring system that transmits shorter IEGM than the full-length programmer IEGM for the sake of frequent, fully automatic data transmission. PMID:25567067

  4. Incidence and predictors of appropriate therapies delivered by the implantable cardioverter defibrillator in patients with ischemic cardiomyopathy: a systematic review.

    PubMed

    Gracieux, Junève; Sanders, Gillian D; Pokorney, Sean D; Lopes, Renato D; Thomas, Kevin; Al-Khatib, Sana M

    2014-12-20

    Although the implantable cardioverter defibrillator (ICD) improves the survival of patients at increased risk of sudden cardiac death due to systolic heart failure, ICD shocks have been associated with both worse survival and quality of life. We performed a systematic review of primary prevention ICD studies to evaluate the incidence and clinical predictors of appropriate ICD shocks or anti-tachycardia pacing (ATP) in patients with ischemic cardiomyopathy. We performed a literature search in MEDLINE. Eligible studies had to be full text, written in the English language, performed in adults aged ≥ 19, and published from 1999 through April 2014. Of 289 identified studies, 9 met all our inclusion criteria. The mean length of follow up ranged from 17 to 45.5 months. The incidence of appropriate ICD therapy varied from 17% to 31%. Among those studies, only 4 included data on the clinical characteristics of appropriate ICD therapy recipients. Characteristics associated with appropriate ICD therapy included male sex, advanced New York Heart Association class, non-sustained ventricular tachycardia, and lower serum creatinine. Patients who received appropriate therapy were also less likely to be on a beta-blocker. Left ventricular ejection fraction was not significantly different between patients who received appropriate ICD therapy and those who did not. The incidence of appropriate ICD therapy is not trivial in patients with ischemic cardiomyopathy and a primary prevention ICD. Predictors of appropriate ICD therapy have not been adequately assessed in large patient populations. As such, large prospective studies of predictors of appropriate ICD therapies are needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial

    PubMed Central

    Guédon-Moreau, Laurence; Lacroix, Dominique; Sadoul, Nicolas; Clémenty, Jacques; Kouakam, Claude; Hermida, Jean-Sylvain; Aliot, Etienne; Boursier, Michel; Bizeau, Olivier; Kacet, Salem

    2013-01-01

    Aims The ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD). Methods and results The trial's primary objective was to randomly compare the proportions of patients experiencing ≥1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081). Conclusion Our observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery. Clinical trials registration NCT00989417. PMID:23242192

  6. Association of air pollution with increased incidence of ventricular tachyarrhythmias recorded by implantable cardioverter defibrillators: Vulnerable patients to air pollution.

    PubMed

    Kim, In-Soo; Sohn, Jungwoo; Lee, Seung-Jun; Park, Jin-Kyu; Uhm, Jae-Sun; Pak, Hui-Nam; Lee, Moon-Hyoung; Kim, Changsoo; Joung, Boyoung

    2017-08-01

    This study investigated the acute effects of exposure to air pollution on ventricular tachyarrhythmias (VTAs) in an East Asian population. The association between air pollution and VTA has not yet been studied in an East Asian country affected by the Asian dust phenomenon, which worsens air quality. The study cohort consisted of 160patients with implantable cardioverter defibrillator (ICD) devices in the Seoul metropolitan area who were followed for 5.5±3.8years. We used ICD records of VTAs and matched these with hourly measurements of air pollutant concentrations and meteorological data. Fine particle mass and gaseous air pollution plus temperature and relative humidity were measured hourly during the study period. During the study period, 1064 VTA events including 204 instances of ventricular fibrillation (VF) were observed. We found a statistically significant association between overall VTA events and SO2 (lag 24h; OR 1.49, 95%CI 1.16-1.92, p=0.002), PM10 (lag 2h; OR 2.56, 95%CI 2.03-3.23, p<0.001), NO2 (lag 24h; OR 1.25, 95%CI 1.19-1.31, p<0.001) and CO (lag 24h; OR 1.05, 95%CI 1.02-1.08, p=0.003). Sustained ventricular tachycardia or VF was also independently associated with SO2, PM10, NO2 and CO (all p<0.01). Exposures to SO2, PM10, NO2, and CO (all p<0.01) were significantly related to overall VTAs, especially in patients with structural heart disease (SHD). Associations between air pollution and VTA were observed in a metropolitan area of an East Asian country. Exposures to SO2, PM10, NO2, and CO were significantly associated with VTAs in ICD patients with SHD. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Shock-related anxiety and sexual function in adults with congenital heart disease and implantable cardioverter-defibrillators.

    PubMed

    Cook, Stephen C; Valente, Anne Marie; Maul, Timothy M; Dew, Mary Amanda; Hickey, Jenne; Jennifer Burger, Psyd; Harmon, Amy; Clair, Mathieu; Webster, Gregory; Cecchin, Frank; Khairy, Paul

    2013-06-01

    An increasing number of adults with congenital heart disease (CHD) require implantable cardioverter-defibrillators (ICDs), yet little is known about their impact on psychological well-being and sexual function. To assess shock-related anxiety in adults with CHD and its association with depression and sexual function. A prospective, multicenter, cross-sectional study was conducted on adult patients with CHD with (ICD(+)) and without (ICD(-)) ICDs. The Florida Shock Anxiety Scale was administered to patients with ICD(+) and the Beck Depression Inventory-II to all patients. Men completed the Sexual Health Inventory for Men, and women completed the Female Sexual Function Index. A total of 180 adults with CHD (ICD(+): n = 70; ICD(-): n = 110; median age 32 years [interquartile range 27-40 years]; 44% women) were enrolled. The complexity of CHD was classified as mild in 32 (18%), moderate in 93 (52%), and severe in 54 (30%) subjects. In ICD recipients, a high level of shock-related anxiety was identified (Florida Shock Anxiety Scale score 16; interquartile range 12-23.5), which was slightly higher than the median score for ICD recipients in the general population (P = .057). A higher level of shock-related anxiety was associated with poorer sexual function scores in both men (Spearman's ρ =-.480; P<.001) and women (Spearman's ρ =-.512; P<.01). It was also associated with self-reported depressive symptomatology (Spearman's ρ = .536; P< .001). Adults with CHD and ICDs demonstrate a high level of shock-related anxiety, which is associated with lower sexual functioning scores in men and women. These results underscore the need for increased clinical attention related to ICD-related shock anxiety and impaired sexual function in this population. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  8. Use of Implantable Cardioverter Defibrillators in Heart Failure Patients and Risk of Mortality: A Meta-Analysis

    PubMed Central

    Zhang, Yucong; Li, Kang

    2015-01-01

    Background The purpose of this study was to evaluate the effect of implantable cardioverter defibrillators (ICD) in heart failure (HF) patients compared to pharmacologic/conventional management. Material/Methods We searched PubMed, Embase, and Springer Link Library databases up to February 10th, 2014. Pooled risk ratio (RR) and 95% confidence interval (CI) for the mortality of the patients with HF were collected and calculated in a fixed-effects model or a random-effects model, as appropriate. Summary effect estimates were also stratified by sex and follow-up time. Egger’s regression asymmetry tests were utilized for publication bias detection. Results A total of 7 separate studies including 15 520 patients (10 801 ICD cases and 4719 controls) with HF were considered in the meta-analysis. The overall estimates showed that ICD could statistically significantly reduce the mortality of male (RR=0.73, 95% CI: 0.66–0.80) and female (RR=0.75, 95% CI: 0.63–0.90) patients. In addition, the further stratification subgroup analysis indicated that ICD presented a significant reduction (male: RR=0.72, 95% CI: 0.64–0.81; female: RR=0.69, 95% CI: 0.56–0.85) of mortality after 2–3 years of ICD therapy. The RR (95% CI) effects of mortality after 4–5 years of ICD therapy for males and females were 0.76 (0.51–1.14) and 0.96 (0.68–1.37), respectively. Conclusions This meta-analysis suggests that ICD could reduce HF patient mortality despite the sex difference. PMID:26093516

  9. Differences Between Access to Follow-Up Care and Inappropriate Shocks Based on Insurance Status of Implantable Cardioverter Defibrillator Recipients.

    PubMed

    Sager, Solomon J; Healy, Chris; Ramireddy, Archana; Rivner, Harold; Viles Gonzalez, Juan F; Coffey, James O; Rossin, Natalia; Lo, Ka M; Goldberger, Jeffrey J; Myerburg, Robert J; Mitrani, Raul D

    2017-02-15

    Differences in implantable cardioverter defibrillator (ICD) utilization based on insurance status have been described, but little is known about postimplant follow-up patterns associated with insurance status and outcomes. We collected demographic, clinical, and device data from 119 consecutive patients presenting with ICD shocks. Insurance status was classified as uninsured/Medicaid (uninsured) or private/Health Maintenance Organization /Medicare (insured). Shock frequencies were analyzed before and after a uniform follow-up pattern was implemented regardless of insurance profile. Uninsured patients were more likely to present with an inappropriate shock (63% vs 40%, p = 0.01), and they were more likely to present with atrial fibrillation (AF) as the shock trigger (37% vs 19%, p = 0.04). Uninsured patients had a longer interval between previous physician contact and index ICD shock (147 ± 167 vs 83 ± 124 days, p = 0.04). Patients were followed for a mean of 521 ± 458 days after being enrolled in a uniform follow-up protocol, and there were no differences in the rate of recurrent shocks based on insurance status. In conclusion, among patients presenting with an ICD shock, underinsured/uninsured patients had significantly longer intervals since previous physician contact and were more likely to present with inappropriate shocks and AF, compared to those with private/Medicare coverage. After the index shock, both groups were followed uniformly, and the differences in rates of inappropriate shocks were mitigated. This observation confirms the importance of regular postimplant follow-up as part of the overall ICD management standard.

  10. First inappropriate implantable cardioverter defibrillator therapy is often due to inaccurate device programming: analysis of the French OPERA registry.

    PubMed

    Leenhardt, Antoine; Defaye, Pascal; Mouton, Elisabeth; Delay, Marc; Delarche, Nicolas; Dupuis, Jean-Marc; Bizeau, Olivier; Mabo, Philippe; Cheggour, Saida; Babuty, Dominique

    2012-10-01

    Inappropriate therapy delivered by implantable cardioverter defibrillators (ICDs) remains a challenge. The OPERA registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapies delivered by single-, dual- and triple-chamber [cardiac resynchronization therapy defibrillator (CRT-D)] ICD. We entered 636 patients (mean age = 62.0 ± 13.5 years; 88% men) in the registry, of whom 251 received single-, 238 dual-, and 147 triple-chamber ICD, for primary (30.5%) or secondary (69.5%) indications. We measured times to FAT and FIT as a function of multiple clinical characteristics, examined the effects of various algorithm components on the likelihood of FAT and FIT delivery, and searched for predictors of FAT and FIT. Over 22.8 ± 8.8 months of observation, 184 patients (28.9%) received FAT and 70 (11.0%) received FIT. Ventricular tachycardia (VT) was the trigger of 88% of FAT, and supraventricular tachycardia was the trigger of 91% of FIT. The median times to FIT (90 days; range 49-258) and FAT (171 days; 50-363) were similar. The rate of FAT was higher (P <0.001) in patients treated for secondary than primary indications, while that of FIT were similar in both groups. Out of 57 analysable FIT, 27 (47.4%) could have been prevented by fine tuning the device programming like the sustained rate duration or the VT discrimination algorithm. First inappropriate therapy occurred in 11% of 636 ICD recipients followed for ∼2 years. Nearly 50% of FIT could have been prevented by improving device programming.

  11. 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.

  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. Over 10 years with an implantable cardioverter-defibrillator - a long term follow-up of 60 patients.

    PubMed

    Sterliński, Maciej; Przybylski, Andrzej; Gepner, Katarzyna; Syska, Paweł; Maciag, Aleksander; Lewandowski, Michał; Kowalik, Ilona; Pytkowski, Mariusz; Sitkowska-Rysiak, Ewa; Lichomski, Jerzy; Szwed, Hanna; Sadowski, Zygmunt

    2010-09-01

    Transvenous implantable cardioverter-defibrillators (ICD) have been implanted in Poland since 1995. As the method spreads it is important to consider its long-term benefits and disadvantages. To assess survival, efficacy and complication rate in ICD patients, who received the device more than ten years earlier. Retrospective analysis of 60 ICD patients implanted between 1995-1999. There were 42 (70%) males, mean age 50.6 ± 16.4 years. In 59 patients ICD was implanted for sudden cardiac death (SCD) secondary prevention. Thirty eight patients (34 M, 63.3%) had coronary artery disease (CAD). The CAD was diagnosed in 89.5% of males and 10.5% of females (p〈 0.0001). Mean follow-up time was 75.4 ± 34.7 months. During this time 22 patients died (37%, 19 M, 3 F). Three deaths were SCD. Mean one-year mortality was 6.7%. Deaths were more frequent among males: 45.2% vs 16.7%, p〈 0.005. In CAD mortality was higher than in non-CAD patients (50% vs 13.6%, p〈 0.005). Appropriate ICD discharges in the ventricular fibrillation (VF) zone occurred in 35 (58%) patients, and in ventricular tachycardia (VT) zone - in 26 (43%) patients. Mean intervention rate per year was 3.7 for VF and 0.6 for VT. Complications occurred in 27 (45%) patients and 5 (8%) of them had no ICD intervention during follow-up. In 5 patients more than one complication was diagnosed. There were inappropriate discharges in 15 (25%) patients, 11 (18%) had electrical storm, and ICD-related infections were noted in 3 (5%) patients. During the perioperative period, lead revisions were done in 4 patients; in 3 with discharges induced by T-wave oversensing and in one with lead dislocation. Four cases of lead failure occurred during follow-up, requiring new lead implantation. In 4 patients, electrical storm (3 patients) and supraventricular tachycardia with ICD discharges (1 patient) were treated with radiofrequency ablation. Only 10 (17%) patients did not demonstrate any ICD interventions or ICD

  14. 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

  15. Left ventricle remodeling predicts the recurrence of ventricular tachyarrhythmias in implantable cardioverter defibrillator recipients for secondary prevention.

    PubMed

    Lee, Wei-Chieh; Chen, Huang-Chung; Chen, Yung-Lung; Tsai, Tzu-Hsien; Pan, Kuo-Li; Lin, Yu-Sheng; Chen, Mien-Cheng

    2016-11-21

    Implantable cardioverter defibrillator (ICD) is an effective treatment for secondary prevention of ventricular tachycardia/ventricular fibrillation (VT/VF). Left ventricular (LV) remodeling may develop before ICD implant and over time. However, it remains unclear how LV remodeling affects subsequent risk for recurrence VT/VF in ICD recipients under optimal medical therapy. From May of 2004 to June of 2015, 144 patients received ICD implantation for secondary prevention were enrolled in this study. All information interrogated from ICD devices during follow-up or ICD therapy history (anti-tachycardia pacing and shock therapy) were reviewed and validated the occurrences of VT/VF. At a mean follow-up of 1110.5 ± 860.6 days, 53 patients (36.8%) had recurrence of VT/VF episodes and 91 patients had no recurrence of VT/VF episode after ICD implant. Left ventricular end-diastolic volume (LVEDV) > 163.5 mL had significant predictive value for VT/VF recurrence (area under the curve: 0.602, p = 0.041). Moreover, the percentage of patients with LVEDV >163.5 mL was significantly higher in patients with recurrent VT/VF than patients without recurrent VT/VF (62.3 vs 40.0%, p = 0.010). Left ventricular ejection fraction ≤ 30% (p = 0.031), LVEDV > 163.5 mL (p = 0.012) and QRS width > 125 msec (p = 0.049) were significant predictors for VT/VF recurrence by univariate Cox regression analysis. However, only LVEDV > 163.5 mL (hazard ratio: 2.549, 95% confidence interval: 1.249 ~ 5.201, p = 0.010) and QRS width > 125 msec (hazard ratio: 2.173, 95% confidence interval: 1.030 ~ 4.586, p = 0.042) were independent predictors for recurrence of VT/VF after multivariable adjustment. LV remodeling and QRS width > 125 msec were independent predictors for VT/VF recurrence in secondary prevention ICD recipients under optimal medical therapy, independent of LV ejection fraction.

  16. 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

  17. Predictors of long-term mortality in Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) patients with implantable cardioverter-defibrillators.

    PubMed

    Cygankiewicz, Iwona; Gillespie, John; Zareba, Wojciech; Brown, Mary W; Goldenberg, Ilan; Klein, Helmut; McNitt, Scott; Polonsky, Slava; Andrews, Mark; Dwyer, Edward M; Hall, W Jackson; Moss, Arthur J

    2009-04-01

    Data on long-term follow-up and factors influencing mortality in implantable cardioverter-defibrillator (ICD) recipients are limited. The aim of this study was to evaluate mortality during long-term follow-up and the predictive value of several risk markers in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) patients with implanted cardioverter-defibrillators (ICDs). The study involved U.S. patients from the MADIT II trial randomized to and receiving ICD treatment. Data regarding long-term mortality were retrieved from the National Death Registry. Several clinical, biochemical, and electrocardiogram variables were tested in a multivariate Cox model for predicting long-term mortality, and a score identifying high-, medium-, and lower risk patients was developed. The study population consisted of 655 patients, mean age 64 +/- 10 years. During a follow-up of up to 9 years, averaging 63 months, 294 deaths occurred. The 6-year cumulative probability of death was 40%, with evidence of a constant risk of about 8.5% per year among survivors. Median survival was estimated at 8 years. Multivariate analysis identified age >65 years, New York Heart Association class 3-4, diabetes, non-sinus rhythm, and increased levels of blood urea nitrogen as independent risk predictors of mortality. Patients with three or more of these risk factors were characterized by a 6-year mortality rate of 68%, compared with 43% in those with one to two risk factors and 19% in patients with no risk factors. A combination of a few readily available clinical variables indicating advanced disease and comorbid conditions identifies ICD patients at high risk of mortality during long-term follow-up.

  18. 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.

  19. Technical and practical aspects of remote monitoring of implantable cardioverter-defibrillator patients in Poland - preliminary results.

    PubMed

    Przybylski, Andrzej; Zakrzewska-Koperska, Joanna; Maciag, Aleksander; Derejko, Paweł; Orczykowski, Michał; Szumowski, Lukasz; Walczak, Franciszek

    2009-05-01

    The aim of remote monitoring of implantable cardioverter-defibrillators (ICD) is to increase the patient's safety by early detection of technical or medical malfunctions and decrease the number of follow-up visits. To evaluate the feasibility and reliability of internet-based home monitoring of ICD recipients in Poland. Twenty-seven patients with ICD with remote monitoring options were evaluated; 20 (74%) patients had a single chamber ICD, 6 (22%) patients had a dual chamber ICD and one had an ICD with a resynchronisation therapy option. Medical and technical events reported by the remote monitoring system as well as interruptions in monitoring longer than 14 days were analysed. The patients were followed for 12.7 +/- 10.5 months. Two of them died because of heart failure (6 and 13 months after ICD implantation, respectively). The remote monitoring system reported medical events in 13 (48%) patients. In total, we received 32 event reports (from 1 to 19 per patient, mean 2.6) which were generated due to the detection of ventricular tachycardia (VT) (17 events in 9 patients), ventricular fibrillation (VF) (9 episodes in 6 patients), ineffective defibrillation with the maximal energy (5 reports in 3 patients) and supraventricular tachycardia in the VT detection window (1). Two patients had more than 3 VT/VF episodes during 24 h. There were no reports on technical abnormalities of the ICD system. Interruptions in home monitoring longer than 14 days occurred in 5 (18.5%) patients and lasted 2 to 14 weeks (mean 2.8 +/- 7.1). The longest break was caused by the patient's stay abroad. The remaining interruptions were caused by: journeys (5 episodes), hospitalisations (4), and a temporary stay in a place without sufficient GSM coverage (3). During the follow-up period there were no interruptions in monitoring caused by transmitter or ICD failure. All data received by the home monitoring system were confirmed during the follow-up visits. Remote monitoring of ICD recipients

  20. Differences in predictors of implantable cardioverter-defibrillator therapies in patients with ischaemic and non-ischaemic cardiomyopathies.

    PubMed

    Darma, Angeliki; Nedios, Sotirios; Kosiuk, Jedrzej; Richter, Sergio; Doering, Michael; Arya, Arash; Rolf, Sascha; Sommer, Philipp; Hindricks, Gerhard; Bollmann, Andreas

    2016-03-01

    Implantable cardioverter-defibrillators (ICDs) have been shown to reduce mortality in patients with both ischaemic and non-ischaemic cardiomyopathy by terminating life-threatening arrhythmias. However, such arrhythmic events are unequally distributed among different patient subgroups. We aimed to evaluate predictors of appropriate ICD therapies as a step towards risk stratification in a real-world cohort. The prevalence and predictors of appropriate ICD therapies were analysed in 330 consecutive patients (mean age 65 ± 11, 81% male) with implanted ICDs due to ischaemic (n = 204) or dilated (n = 126) cardiomyopathy. During a mean follow-up of 19 ± 9 months, 1545 appropriate ICD therapies (antitachycardia pacing and shocks) were detected in 94 patients (29%). In multivariate analysis applied on the whole cohort, the presence of atrial fibrillation [AF: odds ratio (OR) = 1.906, confidence interval (CI) = 1.143-3.177, P = 0.013] and secondary prevention indication (OR = 1.963, CI = 1.123-3.432, P = 0.018) was associated with ICD therapy. The presence of cardiac resynchronization therapy (CRT) had a protective value (OR = 0.563, CI = 0.327-0.968, P = 0.038). Moreover, the predictors were different depending on the aetiology of the cardiomyopathy: in the ischaemic group, only secondary prevention indication (OR = 2.0, CI = 1.029-3.891, P = 0.041) and the presence of a biventricular system (OR = 0.359, CI = 0.163-0.794, P = 0.011) remained significant, while in the non-ischaemic group, an association with AF was observed (OR = 4.281, CI = 1.632-11.231, P = 0.003). The aetiology of cardiomyopathy should be taken into consideration for the therapy of ICD patients. The protective role of CRT devices should be pointed out in ischaemic cardiomyopathy (ICM) and a more rigorous antiarrhythmic treatment should be considered for ICM patients with secondary prevention or for dilated cardiomyopathy patients with AF. Published on behalf of the European Society of Cardiology. All

  1. Impact of Substrate-Based Ablation of Ventricular Tachycardia on Cardiac Mortality in Patients with Implantable Cardioverter-Defibrillators.

    PubMed

    Komatsu, Yuki; Maury, Philippe; Sacher, Frédéric; Khairy, Paul; Daly, Matthew; Lim, Han S; Zellerhoff, Stephan; Jesel, Laurence; Rollin, Anne; Duparc, Alexandre; Mondoly, Pierre; Aurillac-Lavignolle, Valerie; Shah, Ashok; Denis, Arnaud; Cochet, Hubert; Derval, Nicolas; Hocini, Mélèze; Haïssaguerre, Michel; Jaïs, Pierre

    2015-09-01

    This study sought to determine if the acute procedural outcome of ventricular tachycardia (VT) substrate ablation is associated with a mortality benefit in patients with implantable cardioverter-defibrillators (ICD). A total of 195 ICD recipients (65±11years) with ischemic or non-ischemic dilated cardiomyopathy underwent substrate-based ablation targeting elimination of local abnormal ventricular activities (LAVA). Acute procedural success, which was defined as elimination of all identified LAVA in addition to the lack of VT inducibility, was achieved in 95 (49%) patients. During a median follow-up of 23 months, patients with acute procedure success had a significantly lower incidence of ICD shocks compared to those with ablation failure (8% vs. 30%, p<0.001). In multivariate analysis, acute procedural success was associated with a lower risk of VT recurrence (hazard ratio [HR] 0.30, 95% confidence interval [CI] 0.18-0.49, P<0.001) and all-cause mortality (HR 0.32, 95%CI 0.17-0.60, P<0.001). While the impact of ablation success on mortality was not statistically significant in patients with LVEF>35% (HR 0.45, 95%CI 0.15-1.34, P = 0.15) and those with NYHA class I/II (HR 0.63, 95%CI 0.29-1.40, P = 0.26), it was marked in patients with LVEF≤35% (HR 0.30, 95%CI 0.14-0.62, P = 0.001) and NYHA class III/IV (HR 0.17, 95%CI 0.05-0.57, P = 0.004). LAVA elimination in addition to VT non-inducibility as a procedural outcome for substrate-based ablation is associated with reduced mortality and better VT-free survival during follow-up. This prognostic benefit may be most pronounced in patients with severe heart failure as indicated by severely depressed LV function and NYHA class III/IV symptoms. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  2. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials.

    PubMed

    Al-Khatib, Sana M; Hellkamp, Anne; Bardy, Gust H; Hammill, Stephen; Hall, W Jackson; Mark, Daniel B; Anstrom, Kevin J; Curtis, Jeptha; Al-Khalidi, Hussein; Curtis, Lesley H; Heidenreich, Paul; Peterson, Eric D; Sanders, Gillian; Clapp-Channing, Nancy; Lee, Kerry L; Moss, Arthur J

    2013-01-02

    Randomized clinical trials have shown that implantable cardioverter-defibrillator (ICD) therapy saves lives. Whether the survival of patients who received an ICD in primary prevention clinical trials differs from that of trial-eligible patients receiving a primary prevention ICD in clinical practice is unknown. To determine whether trial-eligible patients who received a primary prevention ICD as documented in a large national registry have a survival rate that differs from the survival rate of similar patients who received an ICD in the 2 largest primary prevention clinical trials, MADIT-II (n = 742) and SCD-HeFT (n = 829). Retrospective analysis of data for patients enrolled in the National Cardiovascular Data Registry ICD Registry between January 1, 2006, and December 31, 2007, meeting the MADIT-II criteria (2464 propensity score-matched patients) or the SCD-HeFT criteria (3352 propensity score-matched patients). Mortality data for the registry patients were collected through December 31, 2009. Cox proportional hazards models were used to compare mortality from any cause. The median follow-up time in MADIT-II, SCD-HeFT, and the ICD Registry was 19.5, 46.1, and 35.2 months, respectively. Compared with patients enrolled in the clinical trials, patients in the ICD Registry were significantly older and had a higher burden of comorbidities. In the matched cohorts, there was no significant difference in survival between MADIT-II-like patients in the registry and MADIT-II patients randomized to receive an ICD (2-year mortality rates: 13.9% and 15.6%, respectively; adjusted ICD Registry vs trial hazard ratio, 1.06; 95% CI, 0.85-1.31; P = .62). Likewise, the survival among SCD-HeFT-like patients in the registry was not significantly different from survival among patients randomized to receive ICD therapy in SCD-HeFT (3-year mortality rates: 17.3% and 17.4%, respectively; adjusted registry vs trial hazard ratio, 1.16; 95% CI, 0.97-1.38; P = .11). There was no significant

  3. Nurse- and peer-led self-management programme for patients with an implantable cardioverter defibrillator; a feasibility study

    PubMed Central

    Smeulders, Esther STF; van Haastregt, Jolanda CM; Dijkman-Domanska, Barbara K; van Hoef, Elisabeth FM; van Eijk, Jacques ThM; Kempen, Gertrudis IJM

    2007-01-01

    Background The prevalence of cardiovascular disease is increasing. Improved treatment options increase survival after an acute myocardial infarction or sudden cardiac arrest, although patients often have difficulty adjusting and regaining control in daily life. In particular, patients who received an implantable cardioverter defibrillator (ICD) experience physical and psychological problems. Interventions to enhance perceived control and acceptance of the device are therefore necessary. This paper describes a small-scale study to explore the feasibility and the possible benefits of a structured nurse- and peer-led self-management programme ('Chronic Disease Self-Management Program' – CDSMP) among ICD patients. Methods Ten male ICD patients (mean age = 65.5 years) participated in a group programme, consisting of six sessions, led by a team consisting of a nurse specialist and a patient with cardiovascular disease. Programme feasibility was evaluated among patients and leaders by measuring performance of the intervention according to protocol, attendance and adherence of the participating ICD patients, and patients' and leaders' opinions about the programme. In addition, before and directly after attending the intervention, programme benefits (e.g. perceived control, symptoms of anxiety and depression, and quality of life) were assessed. Results The programme was conducted largely according to protocol. Eight patients attended at least four sessions, and adherence ranged from good to very good. On average, the patients reported to have benefited very much from the programme, which they gave an overall report mark of 8.4. The leaders considered the programme feasible as well. Furthermore, improvements were identified for general self-efficacy expectancies, symptoms of anxiety, physical functioning, social functioning, role limitations due to physical problems, and pain. Conclusion This study suggests that a self-management programme led by a team consisting of a

  4. Echocardiographic parameters to predict inadequate defibrillation safety margin in patients receiving implantable cardioverter defibrillators for primary prevention.

    PubMed

    Jain, Sachin Kumar Amruthlal; Ghanbari, Hamid; Hourani, Rayan; Larsen, Timothy R; Daccarett, Marcos; Machado, Christian

    2013-06-01

    Implantable cardioverter defibrillators (ICDs) have become an important part of the management of patients with congestive heart failure. At the time of ICD implantation, ventricular fibrillation (VF) is induced to assess adequate energy required for defibrillation. There are multiple parameters which influence the defibrillation safety margin (DSM); however, these factors are not well-established when ICDs are implanted for the primary prevention of sudden cardiac death (SCD) in patients with severe systolic dysfunction. We evaluated multiple clinical and echocardiographic parameters as predictors of adequate DSM in patients referred for ICD implantation for the primary prevention of SCD. We prospectively enrolled 41 patients for ICD implantation with clinical indications for the primary prevention of SCD. Two blinded independent readers evaluated the prespecified echocardiographic parameters. These included left ventricular (LV) mass, indices of right ventricular and LV systolic and diastolic functions, and LV geometric dimensions. Basic clinical demographics, including age, gender, comorbidities, and etiology of cardiomyopathy, were also evaluated. DSM was established using our standard protocol for defibrillation testing which includes VF with successful first shock terminating VF at a value at least 10 J below the maximum output of the implanted device. High defibrillation thresholds (DFT) were defined as >21 J. The mean age is 61.8 ± 14.7 years, with men comprising the majority of the patients (73 %). The only clinical variables which predicted the high DFT were age (in years) (54.5 ± 17.5 vs. 65.7 ± 11.3, p = 0.044), QRS duration (in milliseconds) (116.0 ± 29.5 vs. 110.5 ± 21.8, p = 0.03), LV mass (in grams) (241.0 ± 77.9 vs. 181.9 ± 52.3, p = 0.006), and LV mass index (in grams per square meter) (111.1 ± 38.2 vs. 86.4 ± 21.1, p = 0.02). On multivariate logistic regression analysis, LV mass was

  5. Patient barriers to implantable cardioverter defibrillator implantation for the primary prevention of sudden cardiac death in patients with heart failure and reduced ejection fraction

    PubMed Central

    Chan, Laura Lihua; Lim, Choon Pin; Aung, Soe Tin; Quetua, Paul; Ho, Kah Leng; Chong, Daniel; Teo, Wee Siong; Sim, David; Ching, Chi Keong

    2016-01-01

    INTRODUCTION Device therapy is efficacious in preventing sudden cardiac death (SCD) in patients with reduced ejection fraction. However, few who need the device eventually opt to undergo implantation and even fewer reconsider their decisions after deliberation. This is due to many factors, including unresolved patient barriers. This study identified the factors that influenced patients’ decision to decline implantable cardioverter defibrillator (ICD) implantation, and those that influenced patients who initially declined an implant to reconsider having one. METHODS A single-centre survey was conducted among 240 patients who had heart failure with reduced ejection fraction and met the ICD implantation criteria, but had declined ICD implantation. RESULTS Participants who refused ICD implantation were mostly male (84%), Chinese (71%), married (72%), currently employed (54%), and had up to primary or secondary education (78%) and monthly income of < SGD 3,000 (51%). Those who were more likely to reconsider their decision were aware that SCD was a consequence of heart failure with reduced ejection fraction, knowledgeable of the preventive role of ICDs, currently employed and aware that their doctor strongly recommended the implant. Based on multivariate analysis, knowledge of the role of ICDs for primary prophylaxis was the most important factor influencing patient decision. CONCLUSION This study identified the demographic and social factors of patients who refused ICD therapy. Knowledge of the role of ICDs in preventing SCD was found to be the strongest marker for reconsidering ICD implantation. Measures to address this information gap may lead to higher rates of ICD implantation. PMID:27075476

  6. Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States

    PubMed Central

    Friedman, Daniel J.; Parzynski, Craig S.; Varosy, Paul D.; Prutkin, Jordan M.; Patton, Kristen K.; Mithani, Ali; Russo, Andrea M.; Curtis, Jeptha P.; Al-Khatib, Sana M.

    2016-01-01

    IMPORTANCE Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described. OBJECTIVES To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation. DESIGN, SETTING, AND PARTICIPANTS A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)–ICD and dual-chamber (DC)–ICD. MAIN OUTCOMES AND MEASURES Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients. RESULTS Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2%during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD

  7. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE).

    PubMed

    Healey, Jeff S; Hohnloser, Stefan H; Glikson, Michael; Neuzner, Jorg; Mabo, Phillipe; Vinolas, Xavier; Kautzner, Josef; O'Hara, Gilles; VanErven, Lieselot; Gadler, Fredrik; Pogue, Janice; Appl, Ursula; Gilkerson, Jim; Pochet, Thierry; Stein, Kenneth M; Merkely, Bela; Chrolavicius, Susan; Meeks, Brandi; Foldesi, Csaba; Thibault, Bernard; Connolly, Stuart J

    2015-02-28

    Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly

  8. Implantable cardioverter defibrillator lead-related methicillin resistant Staphylococcus aureus endocarditis: Importance of heightened awareness

    PubMed Central

    Anusionwu, Obiora F; Smith, Cheri; Cheng, Alan

    2012-01-01

    Methicillin resistant Staphylococcus aureus (MRSA) septicemia is associated with high morbidity and mortality especially in patients with immunosuppression, diabetes, renal disease and endocarditis. There has been an increase in implantation of cardiac implantable electronic devices (CIED) with more cases of device-lead associated endocarditis been seen. A high index of suspicion is required to ensure patient outcomes are optimized. The excimer laser has been very efficient in helping to ensure successful lead extractions in patients with CIED infections. We present an unusual case report and literature review of MRSA septicemia from device-lead endocarditis and the importance of early recognition and prompt treatment. PMID:22905295

  9. The effect of duration of follow-up and presence of competing risk on lifespan-gain from implantable cardioverter defibrillator therapy: who benefits the most?

    PubMed

    Raphael, Claire E; Finegold, Judith A; Barron, Anthony J; Whinnett, Zachary I; Mayet, Jamil; Linde, Cecilia; Cleland, John G F; Levy, Wayne C; Francis, Darrel P

    2015-07-07

    In at-risk patients with left ventricular dysfunction, implantable cardioverter defibrillators (ICDs) prolong life. Implantable cardioverter defibrillators are increasingly implanted for primary prevention and therefore into lower risk patients. Trial data have demonstrated the benefit of these devices but does not provide an estimate of potential lifespan-gain over longer time periods, e.g. a patient's lifespan. Using data from landmark ICD trials, lifespan-gain was plotted against baseline annual mortality in the individual trials. Lifespan-gain was then extrapolated to a time-horizon of >20 years while adjusting for increasing 'competing' risk from ageing and non-sudden cardiac death (pump failure). At 3 years, directly observed lifespan-gain was strongly dependent on baseline event rate (r = 0.94, P < 0.001). However, projecting beyond the duration of the trial, lifespan-gain increases rapidly and non-linearly with time. At 3 years, it averages 1.7 months, but by 10 years up to 9-fold more. Lifespan-gain over time horizons >20 years were greatest in lower risk patients (∼5 life-years for 5% baseline mortality, ∼2 life-years for 15% baseline mortality). Increased competing risks significantly reduce lifespan-gain from ICD implantation. While high-risk patients may show the greatest short-term gain, the dramatic growth of lifespan-gain over time means that it is the lower risk patients, e.g. primary prevention ICD implantation, who gain the most life-years over their lifetime. Benefit is underestimated when only trial data are assessed as trials can only maintain randomization over limited periods. Lifespan-gain may be further increased through advances in ICD device programming. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  10. Age and sex differences in long-term outcomes following implantable cardioverter-defibrillator placement in contemporary clinical practice: findings from the Cardiovascular Research Network.

    PubMed

    Masoudi, Frederick A; Go, Alan S; Magid, David J; Cassidy-Bushrow, Andrea E; Gurwitz, Jerry H; Liu, Taylor I; Reynolds, Kristi; Smith, David H; Reifler, Liza M; Glenn, Karen A; Fiocchi, Frances; Goldberg, Robert; Gupta, Nigel; Peterson, Pamela N; Schuger, Claudio; Vidaillet, Humberto; Hammill, Stephen C; Greenlee, Robert T

    2015-06-02

    Patient sex and age may influence rates of death after receiving an implantable cardioverter-defibrillator for primary prevention. Differences in outcomes other than mortality and whether these differences vary by heart failure symptoms, etiology, and left ventricular ejection fraction are not well characterized. We studied 2954 patients with left ventricular ejection fraction ≤0.35 undergoing first-time implantable cardioverter-defibrillator for primary prevention within the Cardiovascular Research Network; 769 patients (26%) were women, and 2827 (62%) were aged >65 years. In a median follow-up of 2.4 years, outcome rates per 1000 patient-years were 109 for death, 438 for hospitalization, and 111 for heart failure hospitalizations. Procedure-related complications occurred in 8.36%. In multivariable models, women had significantly lower risks of death (hazard ratio 0.67, 95% CI 0.56 to 0.80) and heart failure hospitalization (hazard ratio 0.82, 95% CI 0.68 to 0.98) and higher risks for complications (hazard ratio 1.38, 95% CI 1.01 to 1.90) than men; patients aged >65 years had higher risks of death (hazard ratio 1.55, 95% CI 1.30 to 1.86) and heart failure hospitalization (hazard ratio 1.25, 95% CI 1.05 to 1.49) than younger patients. Age and sex differences were generally consistent in strata according to symptoms, etiology, and severity of left ventricular systolic dysfunction, except the higher risk of complications in women, which differed by New York Heart Association classification (P=0.03 for sex-New York Heart Association interaction), and the risk of heart failure hospitalization in older patients, which differed by etiology of heart failure (P=0.05 for age-etiology interaction). The burden of adverse outcomes after receipt of an implantable cardioverter-defibrillator for primary prevention is substantial and varies according to patient age and sex. These differences in outcome generally do not vary according to baseline heart failure characteristics.

  11. Implantable Cardioverter Defibrillators in Octogenarians: Clinical Outcomes From a Single Center

    PubMed Central

    Wilson, D.G.; Ahmed, N.; Nolan, R.; Frontera, A.; Thomas, G.; Duncan, E.R.

    2016-01-01

    Aims Limited data exist on outcomes in very elderly ICD recipients. We describe outcomes in new ICD and Cardiac Resynchronisation Therapy with Defibrillator (CRT-D) implants in octogenarians at our institution. Methods Patients aged 80 years and above who underwent de novo ICD or CRT-D implantation from January 2006 to July 2012 were identified. Clinical data were collected from the procedural record, medical and ICD notes. Baseline characteristics were compared using independent sample t test for continuous variables and Fisher’s exact test for categorical variables. Kaplan-Meier curves were constructed. Results Ten per cent of all new ICD/CRT-D implants were aged 80 years and over. Median age was 83.0 years. Median follow-up was 29 months. Death occurred in 17 (34%). Median time to death was 23 months. Three deaths (6%) occurred within 12 months of ICD implantation. Appropriate therapy (ATP or shock) occurred in 19 (38%). Inappropriate therapy occurred in 6 (12%). Rates of appropriate shocks and inappropriate therapy (shocks and ATP) and significant valvular incompetence were higher amongst deceased patients (P=0.03 OR 5.9 95% CI 1.3-27) and (P=0.02 OR 12 95% CI 1.3-112). Univariate analysis identified diuretic use (P=0.008 95% C.I. 0.05 to 0.63) and appropriate shock (P= 0.025 95% C.I. 1.25 to 26.3) as predictors of mortality. Conclusion Octogenarians make up a small but increasing number of ICD recipients. This study highlights high survival rates at one year with acceptable rates of appropriate and inappropriate device therapy. Ongoing debate regarding the appropriateness of ICD in very elderly patients is warranted. PMID:25852237

  12. 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.

  13. [Therapy with implantable cardioverter-defibrillators (ICD) in the early of third millenium].

    PubMed

    Kozák, M

    2010-08-01

    The patients without ventricular arrhythmias with markers of high risk of sudden cardiac death are indicated for ICD implantation today. Last generation of ICD systems are equipped with high capacity batteries, with many automatic functions, capabilities of data sending and possibilities of prediction of worsening of heart failure. Nowadays ICD systems offers not only elimination of the risk of sudden cardiac death but reduction of symptoms of chronic heart failure through the resynchronization therapy, too.

  14. 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.

  15. Programming implantable cardioverter-defibrillators in primary prevention: higher or later.

    PubMed

    Clementy, Nicolas; Pierre, Bertrand; Simeon, Edouard; Lallemand, Bénédicte; Fauchier, Laurent; Babuty, Dominique

    2014-05-01

    Defibrillator shocks, appropriate or not, are associated with significant morbidity, as they decrease quality of life, can be involved in depression and anxiety, and are known to be proarrhythmic. Most recent data have even shown an association between shocks and overall mortality. As opposed to other defibrillator-related complications, the rate of inappropriate and unnecessary shocks can (and should) be decreased with adequate programming. This review focuses on the different programming strategies and tips available to reduce the rate of shocks in primary prevention patients with left ventricular dysfunction implanted with a defibrillator, as well as some of the manufacturers' device specificities. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  16. Proton dose perturbations caused by high-voltage leads from implanted cardioverter defibrillators

    PubMed Central

    Wootton, Landon S.; Polf, Jerimy C.; Peterson, Stephen; Wilkinson, Jeff; Rozner, Marc A.; Balter, Peter A.; Beddar, Sam

    2013-01-01

    An increasing number of patients undergoing proton radiotherapy have cardiac implantable electrical devices (CIEDs). We recently encountered a situation in which a high-voltage coil on a lead from an implanted cardiac defibrillator was located within the clinical treatment volume for a patient receiving proton radiotherapy for esophageal cancer. To study the effects of the lead on the dose delivery we placed a high-Z CIED lead at both the center and the distal edge of a clinical spread-out Bragg peak (SOBP) in a water phantom, in both a stationary position and with the lead moving in a periodic pattern to simulate cardiorespiratory movement. We then calculated planned doses using a commercial proton treatment planning system (TPS) and compared them with the doses delivered in the phantom, measured using radiographic film. Dose profiles from TPS-calculated and measured dose distributions showed large pertubrations in the delivered proton dose in the vicinity of the CIED lead when it was not moving. The TPS predicted perturbations up to 20% and measurements revealed perturbations up to 35%. However, the perturbations were less than 3% when the lead was moving. Greater dose perturbations were seen when the lead was placed at the distal edge of the SOBP than when it was placed in the center of the SOBP. We conclude that although cardiorespiratory motion of the lead mitigates some of the perturbations, the effects of the leads should be considered and steps taken to reduce these effects during the treatment planning process. PMID:22766952

  17. Sleeping with the fishes: electromagnetic interference causing an inappropriate implantable cardioverter defibrillator shock.

    PubMed

    Knight, Hui Min; Cakebread, Holly Elizabeth; Gajendragadkar, Parag Ravindra; Duehmke, Rudolf Martin

    2014-05-30

    A 60-year-old man with a cardiac defibrillator implanted due to previous ventricular fibrillation arrest and ischaemic cardiomyopathy received a shock while cleaning his fish pond. At the time, his immersed arm was close to a submersed water pump, but the patient was asymptomatic. As a result of the shock he lost consciousness, but collapsed backwards, away from the pond. Interrogation of the device revealed a high-frequency artefact that was sensed by the device and triggered a shock. Device parameters were otherwise normal. Subsequently, the submersed water pump was found to be the source of an external alternating current leak and was identified as the likely cause of the inappropriate shock due to electromagnetic interference (EMI). Awareness of potential sources of EMI along with evaluation of data with a detailed clinical history is warranted in all cases. 2014 BMJ Publishing Group Ltd.

  18. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators

    PubMed Central

    Burri, Haran; Senouf, David

    2009-01-01

    In the era of communication technology, new options are now available for following-up patients implanted with pacemakers (PMs) and defibrillators (ICDs). Most major companies offer devices with wireless capabilities that communicate automatically with home transmitters, which then relay data to the physician, thereby allowing remote patient follow-up and monitoring. These systems are being widely used in the USA for remote follow-up, and have been more recently introduced in Europe, where their adoption is increasing. In this article, we describe the currently existing systems, review the available evidence in the literature regarding remote follow-up and monitoring of PMs and ICDs, and finally discuss some unresolved issues. PMID:19470595

  19. 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.

  20. Impact of carvedilol and metoprolol on inappropriate implantable cardioverter-defibrillator therapy: the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy).

    PubMed

    Ruwald, Martin H; Abu-Zeitone, Abeer; Jons, Christian; Ruwald, Anne-Christine; McNitt, Scott; Kutyifa, Valentina; Zareba, Wojciech; Moss, Arthur J

    2013-10-08

    The goal of this study was to evaluate the effects of carvedilol and metoprolol on the endpoint of inappropriate implantable cardioverter-defibrillator therapy in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy) study. The impact of carvedilol and metoprolol on inappropriate therapy in heart failure patients with devices has not yet been investigated. All patients in the MADIT-CRT study who received a device (N = 1,790) were identified. Using time-dependent Cox regression analysis, we compared patients treated with different types of beta-blockers or no beta-blockers on the primary endpoint of inappropriate therapy, delivered as antitachycardia pacing (ATP) or shock therapy. Secondary endpoints were inappropriate therapy due to atrial fibrillation and atrial tachyarrhythmias, also evaluated as ATP or shock therapy. Inappropriate therapy occurred in 253 (14%) of 1,790 patients during a follow-up period of 3.4 ± 1.1 years. Treatment with carvedilol was associated with a significantly decreased risk of inappropriate therapy compared with metoprolol (hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.48 to 0.85]; p = 0.002). The reduction in risk was consistent for inappropriate ATP (HR: 0.66 [95% CI: 0.48 to 0.90]; p = 0.009) and inappropriate shock therapy (HR: 0.54 [95% CI: 0.36 to 0.80]; p = 0.002). The risk of inappropriate therapy caused by atrial fibrillation was also reduced in patients receiving carvedilol compared with metoprolol (HR: 0.50 [95% CI: 0.32 to 0.81]; p = 0.004). General use of beta-blockers (93%) and adherence in this study was high. In heart failure patients undergoing either cardiac resynchronization therapy with a defibrillator or with an implantable cardioverter-defibrillator device, carvedilol was associated with a 36% lower rate of inappropriate ATP and shock therapy compared with metoprolol. Inappropriate therapy due to atrial fibrillation was associated with a 50% lower rate in

  1. CARDIAC MRI SCAR PATTERNS DIFFER BY GENDER IN AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION COHORT

    PubMed Central

    Loring, Zak; Strauss, David G.; Gerstenblith, Gary; Tomaselli, Gordon F.; Weiss, Robert G.; Wu, Katherine C.

    2013-01-01

    Background Recent meta-analyses suggest that the effectiveness of cardiac devices may differ between genders. Compared to men, women may not benefit as much from implantable defibrillators (ICDs), yet benefit more from cardiac resynchronization therapy (CRT). Myocardial scar burden is associated with increased incidence of appropriate ICD shocks but decreased response to CRT and may explain gender differences in device benefit. Objective To test the hypothesis that the extent of myocardial scar is less in women than men. Methods In 235 patients referred for primary prevention ICDs who underwent cardiac magnetic resonance imaging, we compared scar size by gender. Analyses were performed for all patients (ICD cohort) and those receiving biventricular pacemakers (CRT subgroup). Results In the ICD cohort, women (vs. men) had a higher prevalence of non-ischemic cardiomyopathy (NICM, 64% vs. 39%, p<0.001) which accounted for a smaller overall scar burden (0.5% vs 13%, p<0.01). Likewise, in the CRT subgroup, the higher prevalence of NICM in women (83% vs. 46%, p=0.01) also contributed to a smaller scar size (0 vs 13%, p<0.01). Women also had significantly less scarring of the inferolateral LV wall. Conclusions In a cohort of patients undergoing clinically indicated ICD and CRT, women had less myocardial scar than men. This difference was primarily driven by a higher prevalence of NICM in women. These findings may have important implications for the future study of gender disparities in ICD and CRT outcomes. PMID:23313802

  2. A Young Man Presenting with Pleuritic Chest Pain and Fever after Electrophysiological Study and Implantable Cardioverter-Defibrillator Placement: Diagnostic Difficulties and Value of Bedside Thoracic Sonography.

    PubMed

    Faraone, Antonio; Fortini, Alberto

    2015-01-01

    We describe the case of a 23-year-old man presenting with recurrent pleuritic chest pain and prolonged fever after electrophysiology testing and placement of an implantable cardioverter-defibrillator because of a suspected arrhythmogenic right ventricular dysplasia. The clinical suspicion was initially directed toward pneumonia with pleural effusion and later toward an infection of the cardiac device complicated by septic pulmonary embolism. The definitive diagnosis of pulmonary embolism and infarction was suggested by a point-of-care thoracic sonography, performed at the bedside by a clinician caring for the patient, and then confirmed by contrast enhanced computed tomography, which also showed thrombosis of the left iliofemoral vein, site of percutaneous puncture for cardiac catheterization. Prolonged fever was attributable to a concomitant Epstein-Barr virus primary infection that acted as confounding factor. The present report confirms the value of bedside thoracic sonography in the diagnostic evaluation of patients with nonspecific respiratory symptoms.

  3. 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

  4. A Young Man Presenting with Pleuritic Chest Pain and Fever after Electrophysiological Study and Implantable Cardioverter-Defibrillator Placement: Diagnostic Difficulties and Value of Bedside Thoracic Sonography

    PubMed Central

    Faraone, Antonio; Fortini, Alberto

    2015-01-01

    We describe the case of a 23-year-old man presenting with recurrent pleuritic chest pain and prolonged fever after electrophysiology testing and placement of an implantable cardioverter-defibrillator because of a suspected arrhythmogenic right ventricular dysplasia. The clinical suspicion was initially directed toward pneumonia with pleural effusion and later toward an infection of the cardiac device complicated by septic pulmonary embolism. The definitive diagnosis of pulmonary embolism and infarction was suggested by a point-of-care thoracic sonography, performed at the bedside by a clinician caring for the patient, and then confirmed by contrast enhanced computed tomography, which also showed thrombosis of the left iliofemoral vein, site of percutaneous puncture for cardiac catheterization. Prolonged fever was attributable to a concomitant Epstein-Barr virus primary infection that acted as confounding factor. The present report confirms the value of bedside thoracic sonography in the diagnostic evaluation of patients with nonspecific respiratory symptoms. PMID:26576159

  5. Primary Prevention of Sudden Cardiac Death in Adults with Transposition of the Great Arteries: A Review of Implantable Cardioverter-Defibrillator Placement.

    PubMed

    Sodhi, Sandeep S; Cedars, Ari M

    2015-08-01

    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.

  6. ST-segment deviation following implantable cardioverter defibrillator shocks: incidence, timing, and clinical significance.

    PubMed

    Gurevitz, Osnat; Lipchenca, Igor; Yaacoby, Elad; Segal, Eran; Perel, Azriel; Eldar, Michael; Glikson, Michael

    2002-10-01

    ST-segment analysis is frequently used during surgical procedures, while ST deviation is considered a sign of myocardial injury. ST deviations were reported following transthoracic and epicardial electrical shocks. The prevalence, timing, and clinical significance of ST-segment deviation following endocardial ICD shocks are discussed in this article. Twenty-eight patients undergoing 125 shock episodes during ICD implantation or testing were included. A 12-lead ECG was recorded at baseline, continuously during the first 3-10 seconds, 1 minute after test shocks, 3-10 seconds and 1 and 5 minutes after each shock given to terminate VF. ST deviation was diagnosed when the ST-segment was displaced > or = 1 mm in at least one lead compared to baseline. ST-segment deviations were observed after 49 (39%) of all shock episodes in 17 (61%) of patients. ST elevation was observed after 30 (24%) of all shock episodes, and ST depression after 31 (25%). Following 13 shock episodes in seven patients, ST-elevation and depression were observed. ST depressions occurred more frequently after shocks given to terminate VF than after lower energy test shocks (28% vs 18% respectively, P = 0.045). However, there was no significant difference in the prevalence of ST elevations between the lower or higher energy shocks. No adverse clinical events were observed in patients with or without postshock ST-segment deviation. ST-segment deviation following endocardial ICD shocks is a frequent phenomenon, occurring acutely and resolving during the first few minutes postshock. It mayhave no prognostic implications.

  7. 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.

  8. Disease-specific quality of life-patient acceptance: racial and gender differences in patients with implantable cardioverter defibrillators.

    PubMed

    Wilson, Mary H; Engelke, Martha K; Sears, Samuel F; Swanson, Melvin; Neil, Janice A

    2013-01-01

    Despite its established effectiveness, living with an implantable cardioverter defibrillator (ICD) is associated with ongoing physical and psychosocial distress. Little is known about which factors impact the patients' adjustment to living with the device and whether there are racial or gender differences related to these factors. The purpose of this study was to investigate factors (demographic, clinical, psychosocial, and religiosity) related to patients' ICD acceptance and to examine racial and gender differences in ICD acceptance. A total of 101 ICD patients (mean age, 65 ± 12.8 years, 34% female, 42% African American [AA]) seen in a cardiology clinic between January and August 2010 completed the Florida Patient Acceptance Survey (FPAS), Florida shock anxiety scale, ENRICHD social support instrument, hospital anxiety and depression scale, Hoge Religiosity Scale, and a demographic sheet during their clinic visit. All multiple-item scales demonstrated good internal consistency reliability, with Cronbach α values ranging from .77 to .89. Overall patient acceptance of the ICD was high, with an average FPAS acceptance score of 80.9 on the 0-to-100 point scale. The FPAS subscale scores indicated that the group was very positive about the benefits of having the device (mean, 90.3) and had few body image concerns (mean, 10.6), low device-related distress (mean, 15.6), and moderate return to function scores (mean, 63.0). White ICD participants were more accepting of their device than AA ICD patients were, scoring statistically significantly higher than AA patients on total patient acceptance and return to function and significantly lower than AA patients on device-related distress and shock anxiety. Controlling for ethnicity (β = .10, P = .15), age (β = .01, P = .90), and number of comorbidities (β = .19, P = .003) in a hierarchical multiple regression, shock anxiety (β = .31, P < .001), knowledge of the device (β = .23, P = .001), social support (β = .13, P

  9. Implantable cardioverter defibrillator - discharge

    MedlinePlus

    ... includes your refrigerator, washer, dryer, toaster, blender, personal computer and fax machine, hair dryer, stove, CD player, ... urac.org). URAC's accreditation program is an independent audit to verify that A.D.A.M. follows ...

  10. Implantable cardioverter-defibrillator

    MedlinePlus

    ... Angina - discharge Angina - when you have chest pain Antiplatelet drugs - P2Y12 inhibitors Aspirin and heart disease Butter, ... ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the ...

  11. Implantable Cardioverter Defibrillator

    MedlinePlus

    ... under the skin. Like pacemakers , ICDs contain a generator containing a computer, battery, and wires called “leads” ... while the other end is connected to the generator. The battery in the generator lasts 5-8 ...

  12. Implantable Cardioverter Defibrillator

    MedlinePlus

    ... a special device called a cardiac resynchronization therapy (CRT) device. The CRT device is able to pace both ventricles at ... better job pumping blood out of the heart. CRT devices that have a defibrillator are called CRT- ...

  13. 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.

  14. 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.

  15. 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.

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

    PubMed

    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

    2016-08-01

    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. 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 m(2), 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. 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 demonstrated in this study. © The Author 2015. Published by Oxford

  17. 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

    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 demonstrated in

  18. 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.

  19. Role of implantable cardioverter defibrillator in non-ischemic cardiomyopathy: a systematic review and meta-analysis of prospective randomized clinical trials.

    PubMed

    Romero, Jorge; Chaudhary, Rahul; Garg, Jalaj; Lupercio, Florentino; Shah, Neeraj; Gupta, Rahul; Nazir, Talha; Bozorgnia, Babak; Natale, Andrea; Di Biase, Luigi

    2017-09-01

    A mortality benefit in patients with implantable cardioverter defibrillator (ICD) in ischemic cardiomyopathy is well established. However, the benefit of ICD implantation in non-ischemic cardiomyopathy (NICM) on total mortality remains uncertain. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the role of primary prevention ICD in NICM patients. We performed a systematic review on PubMed, The Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from the inception through February 2017 to identify RCT evaluating the role of ICD in NICM patients. Mantel-Haenszel risk ratio (RR) fixed effects model was used to summarize data across treatment arms. If heterogeneity (I (2)) ≥25, random effects model was used instead. We analyzed a total of 2573 patients from five RCTs comparing ICD with medical therapy in patients with NICM. The mean follow up for the trials was 48 ± 22 months. There was a significant reduction in (a) all-cause mortality (RR 0.84, 95% CI 0.71-0.99, p = 0.03) and (b) sudden cardiac death (RR 0.47, 95% CI 0.30-0.73, p < 0.001) in ICD group versus medical therapy. Our analysis demonstrates that the use of ICD for primary prevention is associated with a reduction in all-cause mortality and SCD in patients with NICM.

  20. Prophylactic catheter ablation of ventricular tachycardia before cardioverter-defibrillator implantation in patients with non-ischemic cardiomyopathy: Clinical outcomes after a single endocardial ablation.

    PubMed

    Suzuki, Atsushi; Yoshida, Akihiro; Takei, Asumi; Fukuzawa, Koji; Kiuchi, Kunihiko; Takami, Kaoru; Itoh, Mitsuaki; Imamura, Kimitake; Fujiwara, Ryudo; Nakanishi, Tomoyuki; Yamashita, Soichiro; Matsumoto, Akinori; Shimane, Akira; Okajima, Katsunori; Hirata, Ken-Ichi

    2015-06-01

    Outcomes related to prophylactic catheter ablation (PCA) for ventricular tachycardia (VT) before implantable cardioverter-defibrillator (ICD) implantation in non-ischemic cardiomyopathy (NICM) are not well characterized. We assessed the efficacy of single endocardial PCA in NICM patients. We retrospectively analyzed 101 consecutive NICM patients with sustained VT. We compared clinical outcomes of patients who underwent PCA (ABL group) with those who did not (No ABL group). Successful PCA was defined as no inducible clinical VT. We also compared the clinical outcomes of patients with successful PCA (PCA success group) with those of the No ABL group. Endpoints were appropriate ICD therapy (shock and anti-tachycardia pacing) and the occurrence of electrical storm (ES). PCA was performed in 42 patients, and it succeeded in 20. The time to ES occurrence was significantly longer in the ABL group than in the No ABL group (p=0.04). The time to first appropriate ICD therapy and ES occurrence were significantly longer in the PCA success group than in the No ABL group (p=0.02 and p<0.01, respectively). Single endocardial PCA can decrease ES occurrence in NICM patients. However, high rates of VT recurrence and low success rates are issues to be resolved; therefore, the efficacy of single endocardial PCA is currently limited.

  1. Prophylactic catheter ablation of ventricular tachycardia before cardioverter-defibrillator implantation in patients with non-ischemic cardiomyopathy: Clinical outcomes after a single endocardial ablation

    PubMed Central

    Suzuki, Atsushi; Yoshida, Akihiro; Takei, Asumi; Fukuzawa, Koji; Kiuchi, Kunihiko; Takami, Kaoru; Itoh, Mitsuaki; Imamura, Kimitake; Fujiwara, Ryudo; Nakanishi, Tomoyuki; Yamashita, Soichiro; Matsumoto, Akinori; Shimane, Akira; Okajima, Katsunori; Hirata, Ken-ichi

    2015-01-01

    Background Outcomes related to prophylactic catheter ablation (PCA) for ventricular tachycardia (VT) before implantable cardioverter-defibrillator (ICD) implantation in non-ischemic cardiomyopathy (NICM) are not well characterized. We assessed the efficacy of single endocardial PCA in NICM patients. Methods We retrospectively analyzed 101 consecutive NICM patients with sustained VT. We compared clinical outcomes of patients who underwent PCA (ABL group) with those who did not (No ABL group). Successful PCA was defined as no inducible clinical VT. We also compared the clinical outcomes of patients with successful PCA (PCA success group) with those of the No ABL group. Endpoints were appropriate ICD therapy (shock and anti-tachycardia pacing) and the occurrence of electrical storm (ES). Results PCA was performed in 42 patients, and it succeeded in 20. The time to ES occurrence was significantly longer in the ABL group than in the No ABL group (p=0.04). The time to first appropriate ICD therapy and ES occurrence were significantly longer in the PCA success group than in the No ABL group (p=0.02 and p<0.01, respectively). Conclusion Single endocardial PCA can decrease ES occurrence in NICM patients. However, high rates of VT recurrence and low success rates are issues to be resolved; therefore, the efficacy of single endocardial PCA is currently limited. PMID:26336545

  2. 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.

  3. Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up

    PubMed Central

    Raatikainen, M.J. Pekka; Uusimaa, Paavo; van Ginneken, Mireille M.E.; Janssen, Jacques P.G.; Linnaluoto, Markku

    2008-01-01

    Aims The purpose of this prospective study was to investigate whether internet-based remote monitoring offers a safe, practical, and cost-effective alternative to the in-office follow-up visits of patients with an implantable cardioverter defibrillator (ICD). Methods and results Forty-one patients (62 ± 10 years, range 41–76, 83% male) with previously implanted ICD were followed for 9 months. One-hundred and nineteen scheduled and 18 unscheduled data transmissions were performed. There were no device-related adverse events. Over 90% of the patients found the system easy to use. Physicians reported the system as being ‘very easy’ or ‘easy’ to use and found the data comparable to traditional device interrogation in 99% of the cases. They were able to address all unscheduled data transmissions remotely. Compared with the in-office visits, remote monitoring required less time from patients (6.9 ± 5.0 vs. 182 ± 148 min, P < 0.001) and physicians (8.4 ± 4.5 vs. 25.8 ± 17.0 min, P < 0.001) to complete the follow-up. Substitution of two routine in-office visits during the study by remote monitoring reduced the overall cost of routine ICD follow-up by 524€ per patient (41%). Conclusion Remote monitoring offers a safe, feasible, time-saving, and cost-effective solution to ICD follow-up. PMID:18703585

  4. Lack of current implantable cardioverter defibrillator guidelines application for primary prevention of sudden cardiac death in Latin American patients with heart failure: a cross-sectional study.

    PubMed

    Gonzalez-Zuelgaray, Jorge; Pellizon, Oscar; Muratore, Claudio A; Oropeza, Elsa Silva; Rabinovich, Rafael; Ramos, José Luis; Tentori, Maria Cristina; Reyes, Nicolás; Aguayo, Rubén; Marin, Jorge; Peterson, Brett J

    2013-02-01

    This cross-sectional study evaluated the application of accepted international implantable cardioverter defibrillator (ICD) guidelines for primary prevention of sudden cardiac death in patients with heart failure. The PLASMA (Probabilidad de Sufrir Muerte Arritmica) study was designed to characterize management of cardiac patients in Latin America. Twelve centres included 1958 consecutively admitted patients in cardiology units in 2008 and 2009. Discharged patients were evaluated for primary prevention, ICD indication and prescription by general cardiologists. Of 1711 discharged patients, 1525 (89%) had data available for evaluating indication status. Class I indications for ICD therapy were met for 153 (10%) patients based on collected data. Only 20 (13%, 95% confidence interval: 7.7-18.4%) patients with indication were prescribed an ICD. Patients prescribed an ICD were younger than patients who were not prescribed an ICD (62 vs. 68 years, P < 0.01). The reasons given by cardiologists for not prescribing an ICD for 133 patients with an indication were: indication criteria not met (75%), life expectancy <1 year (9.7%), rejection by the patient (5.2%), no medical coverage paying for the device (3.7%), psychiatric patient (2.2%), and other reasons (4.2%). In Latin America, international guidelines for primary prevention ICD implantation are not well followed. The main reason is that cardiologists believe that patients do not meet indication criteria, even though study data confirm that criteria are met. This poses a significant challenge and underlines the importance of continuous and improved medical education.

  5. The use of guideline recommended beta-blocker therapy in primary prevention implantable cardioverter defibrillator patients: insight from Danish nationwide registers.

    PubMed

    Ruwald, Anne-Christine; Gislason, Gunnar Hilmar; Vinther, Michael; Johansen, Jens Brock; Nielsen, Jens Cosedis; Petersen, Helen Høgh; Torp-Pedersen, Christian; Riahi, Sam; Jøns, Christian

    2017-02-20

    We aimed to examine the use of guideline recommended beta-blocker therapy prior to and after primary prevention implantable cardioverter defibrillator (ICD) implantation in a 'real-life' setting. From the Danish Pacemaker and ICD Registry we identified all 1st-time primary prevention ICD and cardiac resynchronization therapy defibrillator (CRT-D) implantations in Denmark from 2007-12 (n = 2935). Use of beta-blocker, type and dose was acquired through the Danish Prescription Registry. According to guideline recommendations, we defined target daily doses as ≥50 mg carvedilol and ≥200 mg metoprolol. Prior to implantation 2427 of 2935 (83%) patients received beta-blocker therapy, with 2166 patients (89%) having initiated treatment 3 months or more prior to implantation. The majority of patients was prescribed carvedilol (52%) or metoprolol (41%). Patients on carvedilol reached target dosages more frequently than patients on metoprolol, with 39% of patients on carvedilol and 26% of patients on metoprolol at the time of implantation (P < 0.001 for all time-points). Increase in proportion of patients reaching target daily doses was observed for both carvedilol and metoprolol after ICD implantation. Carvedilol treatment was a strong predictor for being on target dose of BB at time of implant, as was treatment with angiotensin-converting enzyme inhibitors and/or spironolactone, no history of myocardial infarction, younger age and less pronounced heart failure symptoms. In a real-life setting of primary prevention ICD patients, 39% and 26% of patients were titrated to optimal target dose of carvedilol or metoprolol prior to implantation. A higher proportion of patients on carvedilol reached target dose, as compared with metoprolol.

  6. Outcomes in heart failure patients referred for consideration of implantable cardioverter defibrillator for primary prophylaxis of sudden cardiac death: what are the risks of waiting?

    PubMed

    Ghosh, Nina; Mangat, Iqwal; O'Donnell, Suzan S; Pinter, Arnold; Korley, Victoria; Lane, Chris; Dorian, Paul

    2009-10-01

    Clinical trials have confirmed that implantable cardioverter defibrillators (ICDs) reduce mortality in patients with a left ventricular ejection fraction below 30%. The 'real-world' prognosis before ICD implantation in such patients is not known. The estimated risk of death is 0.8% per month, and this forms the basis for wait-time recommendations. To determine the consequences of waiting for ICD implantation among heart failure patients eligible for primary prophylactic ICD. The present retrospective study evaluated consecutive patients who were deemed eligible for primary prophylactic ICD implantation. Survival outcomes were tracked for patients who declined an ICD, those who accepted and received an ICD, and patients who accepted an ICD but died while waiting. Of 470 patients referred for evaluation, 218 were deemed eligible for an ICD. A total of 174 of 218 patients (79.8%) accepted an ICD; 39 (17.9%) declined, and five (2.3%) were deemed to be at too great a risk for the procedure. The mortality rate at two years among patients who accepted an ICD was 18.8% before ICD implantation and 12.2% after ICD implantation. Among patients who declined ICD implantation, the two year mortality rate was 5.3%. Among patients waiting for an ICD, five of 19 deaths were out-of- hospital sudden deaths. Of 12 patients who died after ICD implantation, there were no documented out-of-hospital sudden deaths. Consistent with current estimates, the mortality rate at two years among patients who accepted and were waiting for an ICD implant was 18.8%. After receiving an ICD, the mortality rate was 12.2% at two years.

  7. Outcomes in heart failure patients referred for consideration of implantable cardioverter defibrillator for primary prophylaxis of sudden cardiac death: What are the risks of waiting?

    PubMed Central

    Ghosh, Nina; Mangat, Iqwal; O’Donnell, Suzan S; Pinter, Arnold; Korley, Victoria; Lane, Chris; Dorian, Paul

    2009-01-01

    BACKGROUND: Clinical trials have confirmed that implantable cardioverter defibrillators (ICDs) reduce mortality in patients with a left ventricular ejection fraction below 30%. The ‘real-world’ prognosis before ICD implantation in such patients is not known. The estimated risk of death is 0.8% per month, and this forms the basis for wait-time recommendations. OBJECTIVES: To determine the consequences of waiting for ICD implantation among heart failure patients eligible for primary prophylactic ICD. METHODS: The present retrospective study evaluated consecutive patients who were deemed eligible for primary prophylactic ICD implantation. Survival outcomes were tracked for patients who declined an ICD, those who accepted and received an ICD, and patients who accepted an ICD but died while waiting. RESULTS: Of 470 patients referred for evaluation, 218 were deemed eligible for an ICD. A total of 174 of 218 patients (79.8%) accepted an ICD; 39 (17.9%) declined, and five (2.3%) were deemed to be at too great a risk for the procedure. The mortality rate at two years among patients who accepted an ICD was 18.8% before ICD implantation and 12.2% after ICD implantation. Among patients who declined ICD implantation, the two-year mortality rate was 5.3%. Among patients waiting for an ICD, five of 19 deaths were out-of-hospital sudden deaths. Of 12 patients who died after ICD implantation, there were no documented out-of-hospital sudden deaths. CONCLUSION: Consistent with current estimates, the mortality rate at two years among patients who accepted and were waiting for an ICD implant was 18.8%. After receiving an ICD, the mortality rate was 12.2% at two years. PMID:19812807

  8. 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; Bart