[Atrial fibrillation before and after pacemaker implantation (WI and DDD) in patients with complete atrioventricular block].

PubMed

Matusik, Paweł; Woznica, Natalia; Lelakowsk, Jacek

2010-05-01

Atrial fibrillation (AF) is a frequent problem of patients with pacemakers, and depends not only on disease but also on stimulation method. The aim of the study was to estimate the prevalence of AF before and after pacemaker implantation as well as to assess the influence of VVI and DDD cardiac pacing on onset of AF in patients with complete atrioventricularblock (AVB). We included 155 patients controlled between 2000 and 2008 in Pacemaker Clinic because of AVB III degree, treated with VVI or DDD pacemaker implantation. Information about the health status of the patients was gathered from medical documentation and analysis of clinical ambulatory electrocardiograms. The study group comprised of 68 women and 87 men, mean age 68.7 +/- 13.9 years during implantation. 69% of patients had VVI pacemaker. There were 72.3% of patients with sinus rhythm before pacemaker implantation. During follow-up 4 +/- 2.8 years in 19.6% cases onset of atrial fibrillation de novo was diagnosed (in 31.3% in VVI mode vs. 2.2% in DDD mode; p = 0.00014). Mean time to AF since implantation was approximately 2.5 years. In VVI group (21 persons) amounted 32.1 months, while in 1 patient with DDD pacemaker 18 months. Between group with AF after implantation and with sinus rhythm preserved there was no statistically significant difference in age or gender (p = 0.89512 and p = 0.1253, respectively). Prevalence of atrial fibrillation after pacemaker implantation increased to 40%. Atrial fibrillation is frequent in patients before and after pacemaker implantation, especially in patients stimulated in VVI mode. Major possibility of atrial fibrillation onset after pacemaker implantation should result in more attention during routine ECG examination.

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... pacemaker pulse generator. (a) Identification. An implantable pacemaker pulse generator is a device that has...

Low pacemaker incidence with continuous-sutured valves: a retrospective analysis.

PubMed

Niclauss, Lars; Delay, Dominique; Pfister, Raymond; Colombier, Sebastien; Kirsch, Matthias; Prêtre, René

2017-06-01

Background Permanent pacemaker implantation after surgical aortic valve replacement depends on patient selection and risk factors for conduction disorders. We aimed to identify risk criteria and obtain a selected group comparable to patients assigned to transcatheter aortic valve implantation. Methods Isolated sutured aortic valve replacements in 994 patients treated from 2007 to 2015 were reviewed. Demographics, hospital stay, preexisting conduction disorders, surgical technique, and etiology in patients with and without permanent pacemaker implantation were compared. Reported outcomes after transcatheter aortic valve implantation were compared with those of a subgroup including only degenerative valve disease and first redo. Results The incidence of permanent pacemaker implantation was 2.9%. Longer hospital stay ( p = 0.01), preexisting rhythm disorders ( p < 0.001), complex prosthetic endocarditis ( p = 0.01), and complex redo ( p < 0.001) were associated with permanent pacemaker implantation. Although prostheses were sutured with continuous monofilament in the majority of cases (86%), interrupted pledgetted sutures were used more often in the pacemaker group ( p = 0.002). In the subgroup analysis, the incidence of permanent pacemaker implantation was 2%; preexisting rhythm disorders and the suture technique were still major risk factors. Conclusion Permanent pacemaker implantation depends on etiology, preexisting rhythm disorders, and suture technique, and the 2% incidence compares favorably with the reported 5- to 10-fold higher incidence after transcatheter aortic valve implantation. Cost analysis should take this into account. Often dismissed as minor complication, permanent pacemaker implantation increases the risks of endocarditis, impaired myocardial recovery, and higher mortality if associated with prosthesis regurgitation.

Pacemakers and Implantable Defibrillators - Multiple Languages

MedlinePlus

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

Redo surgery after permanent pacemaker implantation: performance indicator of surgical techniques and pacing technology.

PubMed

Bharat, Vijaya

2004-01-01

The incidence of permanent pacemaker-related complications is reducing due to advancement of technology and increasing operator experience. There are only few series from India reporting the annual complication rates from a single center over the years. This is a series of 782 pacemakers implanted over 20 years in a secondary healthcare set-up. Eighty-two patients underwent redo surgery, either for a procedure-related complication (n=34) or for replacement of a malfunctioning/end-of-life pacemaker (n=48). Through critical analysis and corrective measures, all the procedural complications were reduced to less than 4% of the annual implantations. The introduction of a pacemaker follow-up clinic contributed to reducing the rate of elective replacement for battery depletion from 19.17% of the implanted VVI pacemakers to 0.63%. Despite being a low-volume center, with less than 100 pacemakers implanted annually, the performance of our pacing practice has shown continuous improvement.

Transvenous permanent pacemaker implantation in dextrocardia: technique, challenges, outcome, and a brief review of literature.

PubMed

Shenthar, Jayaprakash; Rai, Maneesh K; Walia, Rohit; Ghanta, Somasekhar; Sreekumar, Praveen; Reddy, Satish S

2014-09-01

Dextrocardia is a rare congenital anomaly. Pacemaker implantation in dextrocardia can be challenging because of the distorted anatomy and associated anomalies. The literature regarding implantation of pacemaker in dextrocardia is scarce. The study involved retrospective analysis of records of patients with dextrocardia who had undergone pacemaker implantation between January 2006 and July 2013 from a single centre. Six patients with dextrocardia (five males and one female) underwent permanent pacemaker implantation (PPI) between January 2006 and July 2013. Of them, three had situs solitus dextrocardia and three situs inversus dextrocardia. All three patients with situs solitus dextrocardia had associated corrected transposition of great arteries. The indication for pacemaker implantation was symptomatic complete atrioventricular (AV) block in four, high-grade AV block in one, and sinus node dysfunction in one patient. A favourable outcome was noted during a mean follow-up of 3.9 years (4 months to 7 years) with one patient needing a pulse generator replacement. Permanent pacemaker implantation in dextrocardia can be challenging because of the distorted anatomy. Use of a technique employing angiography to delineate chamber anatomy and relationship can assist the operator during such difficult PPIs. The medium- and long-term survival after a successful pacemaker implantation in dextrocardia is favourable. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Survival time with pacemaker implantation for dogs diagnosed with persistent atrial standstill.

PubMed

Cervenec, R M; Stauthammer, C D; Fine, D M; Kellihan, H B; Scansen, B A

2017-06-01

To evaluate survival time in dogs with persistent atrial standstill after pacemaker implantation and to compare the survival times for cardiac-related vs. non-cardiac deaths. Secondary objectives were to evaluate the effects of breed and the presence of congestive heart failure (CHF) at the time of diagnosis on survival time. Twenty dogs with persistent atrial standstill and pacemaker implantation. Medical records were searched to identify dogs diagnosed with persistent atrial standstill based on electrocardiogram that underwent pacemaker implantation. Survival after pacemaker implantation was analyzed using the Kaplan-Meier method. The median survival time after pacemaker implantation for all-cause mortality was 866 days. There was no significant difference (p=0.573) in median survival time for cardiac (506 days) vs. non-cardiac deaths (400 days). The presence of CHF at the time of diagnosis did not affect the survival time (P=0.854). No difference in median survival time was noted between breeds (P=0.126). Dogs with persistent atrial standstill have a median survival time of 866 days with pacemaker implantation, though a wide range of survival times was observed. There was no difference in the median survival time for dogs with cardiac-related deaths and those without. Patient breed and the presence of CHF before pacemaker implantation did not affect median survival time. Copyright © 2017 Elsevier B.V. All rights reserved.

Pacemaker lead perforation of the right ventricle associated with Moraxella phenylpyruvica infection in a dog.

PubMed

Ciavarella, A; Nimmo, J; Hambrook, L

2016-04-01

A 13-year-old neutered male Border Collie was presented with acute onset syncope, weakness and anorexia 10 months after transvenous pacemaker implantation. The patient was laterally recumbent, bradycardic (36 beats/min) and febrile (40.7°C) on presentation. An electrocardiogram (ECG) revealed recurrence of third-degree atrioventricular block with a ventricular escape rhythm. Fluoroscopy identified migration of the pacemaker tip through the apex of the right ventricle. Echocardiography failed to reveal any evidence of pericardial effusion or cardiac tamponade. Full postmortem was performed after euthanasia. The pacemaker lead had perforated the apex of the right ventricle and lodged in the right pleural space. Culture of blood (taken antemortem), pericardial sac, right ventricular wall (surrounding pacemaker lead), pacemaker lead tip and pericardial fluid revealed a pure growth of Moraxella phenylpyruvica. Bacteraemia associated with M. phenylpyruvica has never been reported in the dog, but sporadic cases are reported in humans. Infection could have resulted from either pre-existing myocarditis or opportunistic infection and bacteraemia post pacemaker implantation. Evaluation of the pacemaker function at regular intervals would allow early detection of poor pacemaker-to-myocardium contact, which would prompt further investigation of pacemaker lead abnormalities such as perforation. © 2016 Australian Veterinary Association.

Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience.

PubMed

Reddy, Vivek Y; Miller, Marc A; Knops, Reinoud E; Neuzil, Petr; Defaye, Pascal; Jung, Werner; Doshi, Rahul; Castellani, Mark; Strickberger, Adam; Mead, R Hardwin; Doppalapudi, Harish; Lakkireddy, Dhanunjaya; Bennett, Matthew; Sperzel, Johannes

2016-12-01

Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans. This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure. This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker. URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244. © 2016 American Heart Association, Inc.

The effect of different atrioventricular delays on left atrium and left atrial appendage function in patients with DDD pacemaker.

PubMed

Kanadaşı, Mehmet; Caylı, Murat; Sahin, Durmuş Yıldıray; Sen, Ömer; Koç, Mevlüt; Usal, Ayhan; Batur, Mustafa Kemal; Demirtaş, Mustafa

2011-07-01

Although it has been known that optimization of atrioventricular delay (AVD) has favorable effect on the left ventricular functions in patients with DDD pacemaker, the effect of different AVDs on left atrium (LA) and left atrial appendage (LAA) functions has not been exactly evaluated. The aim of the present study was to assess the effect of different AVDs on LA and LAA functions in DDD pacemaker implanted patients with atrioventricular block. Forty-eight patients with DDD pacemaker were enrolled into the study. Patients were divided into two groups according to the echocardiographic diastolic function: Group I (normal diastolic function) and Group II (diastolic dysfunction). LAA emptying velocity on pulsed wave Doppler and LAA late systolic wave velocity by using tissue Doppler were recorded. Patients were paced for five successive continuous pacing periods of 10 minutes duration using five selective AVDs (80-250 ms). Significant effect on LA and LAA functions has not been observed by the setting of AVD in Group I. However, when the AVD was gradually shortened form 150 ms to 80 ms, LA and LAA functions gradually decreased in Group II patients. When AVD increased to 200 ms, LA and LAA functions were improved. Further increase in AVD resulted in decreased LA and LAA functions. Setting of AVD has not significant effect on the LA and LAA functions in patients with normal diastolic function, but moderate prolongation of AVD in physiological limits improved LA and LAA functions in DDD pacemaker implanted patients with diastolic dysfunction. © 2011, Wiley Periodicals, Inc.

Case report: use caution when applying magnets to pacemakers or defibrillators for surgery.

PubMed

Schulman, Peter M; Rozner, Marc A

2013-08-01

The application of a magnet to a pacemaker (intended to cause asynchronous pacing) or implanted cardioverter defibrillator (intended to prevent shocks) during surgery without a clear understanding of actual magnet function(s) or precautions can have unexpected, untoward, or harmful consequences. In this report, we present 3 cases in which inadequate assessment of cardiac implanted electronic device (CIED) function, coupled with magnet application, contributed to or resulted in inappropriate antitachycardia pacing or shocks, CIED damage, or patient injury. Although these cases might be rare, they reinforce the need for a timely, detailed preoperative review of CIED function and programming as recommended by the American Society of Anesthesiologists and the Heart Rhythm Society.

Reducing RF-related heating of cardiac pacemaker leads in MRI: implementation and experimental verification of practical design changes.

PubMed

Nordbeck, Peter; Fidler, Florian; Friedrich, Michael T; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Herold, Volker; Geistert, Wolfgang; Jakob, Peter M; Ertl, Georg; Ritter, Oliver; Ladd, Mark E; Bauer, Wolfgang R; Quick, Harald H

2012-12-01

There are serious concerns regarding safety when performing magnetic resonance imaging in patients with implanted conductive medical devices, such as cardiac pacemakers, and associated leads, as severe incidents have occurred in the past. In this study, several approaches for altering an implant's lead design were systematically developed and evaluated to enhance the safety of implanted medical devices in a magnetic resonance imaging environment. The individual impact of each design change on radiofrequency heating was then systematically investigated in functional lead prototypes at 1.5 T. Radiofrequency-induced heating could be successfully reduced by three basic changes in conventional pacemaker lead design: (1) increasing the lead tip area, (2) increasing the lead conductor resistance, and (3) increasing outer lead insulation conductivity. The findings show that radiofrequency energy pickup in magnetic resonance imaging can be reduced and, therefore, patient safety can be improved with dedicated construction changes according to a "safe by design" strategy. Incorporation of the described alterations into implantable medical devices such as pacemaker leads can be used to help achieve favorable risk-benefit-ratios when performing magnetic resonance imaging in the respective patient group. Copyright © 2012 Wiley Periodicals, Inc.

Intermittent pacemaker dysfunction caused by digital mobile telephones.

PubMed

Naegeli, B; Osswald, S; Deola, M; Burkart, F

1996-05-01

This study was designed to evaluate possible interactions between digital mobile telephones and implanted pacemakers. Electromagnetic fields may interfere with normal pacemaker function. Development of bipolar sensing leads and modern noise filtering techniques have lessened this problem. However, it remains unclear whether these features also protect from high frequency noise arising from digital cellular phones. In 39 patients with an implanted pacemaker (14 dual-chamber [DDD], 8 atrial-synchronized ventricular-inhibited [VDD(R)] and 17 ventricular-inhibited [VVI(R)] pacemakers), four mobile phones with different levels of power output (2 and 8 W) were tested in the standby, dialing and operating mode. During continuous electrocardiographic monitoring, 672 tests were performed in each mode with the phones positioned over the pulse generator, the atrial and the ventricular electrode tip. The tests were carried out at different sensitivity settings and, where possible, in the unipolar and bipolar pacing modes as well. In 7 (18%) of 39 patients, a reproducible interference was induced during 26 (3.9%) of 672 tests with the operating phones in close proximity (<10 cm) to the pacemaker. In 22 dual-chamber (14 DDD, 8 VDD) pacemakers, atrial triggering occurred in 7 (2.8%) of 248 and ventricular inhibition in 5 (2.8%) of 176 tests. In 17 VVI(R) systems, pacemaker inhibition was induced in 14 (5.6%) of 248 tests. Interference was more likely to occur at higher power output of the phone and at maximal sensitivity of the pacemakers (maximal vs. nominal sensitivity, 6% vs. 1.8% positive test results, p = 0.009). When the bipolar and unipolar pacing modes were compared in the same patients, ventricular inhibition was induced only in the unipolar mode (12.5% positive test results, p = 0.0003). Digital mobile phones in close proximity to implanted pacemakers may cause intermittent pacemaker dysfunction with inappropriate ventricular tracking and potentially dangerous pacemaker inhibition.

Sacral neuromodulation and cardiac pacemakers.

PubMed

Roth, Ted M

2010-08-01

Potential for cross-talk between cardiac pacemakers and sacral neuromodulation remains speculative. We present a case series of patients with cardiac pacemakers who underwent staged Interstim (Medtronic, Minneapolis, MN) implantation and patients who had pulse generator implantation who later required cardiac pacemakers. No cross-talk was demonstrated in either group. Sacral neuromodulation appears to be safe in the setting of cardiac pacemakers without cardioversion/defibrillation technology.

Safety of implantable pacemakers and cardioverter defibrillators in the magnetic field of a novel remote magnetic navigation system.

PubMed

Jilek, Clemens; Tzeis, Stylianos; Reents, Tilko; Estner, Heidi-Luise; Fichtner, Stephanie; Ammar, Sonia; Wu, Jinjin; Hessling, Gabriele; Deisenhofer, Isabel; Kolb, Christof

2010-10-01

Electromagnetic interference with pacemaker and implantable cardioverter defibrillator (ICD) systems may cause temporary or permanent system malfunction of implanted devices. The aim of this study was to evaluate potential interference of a novel magnetic navigation system with implantable rhythm devices. A total of 121 devices (77 pacemakers, 44 ICDs) were exposed to an activated NIOBE II® Magnetic Navigation System (Stereotaxis, St. Louis, MO, USA) at the maximal magnetic field strength of 0.1 Tesla and evaluated in vitro with respect to changes in parameter settings of the device, changes of the battery status/detection of elective replacement indication, or alterations of data stored in the device. A total of 115 out of 121 (95%) devices were free of changes in parameter settings, battery status, and internally stored data after repeated exposition to the electromagnetic field of the remote magnetic navigation system. Interference with the magnetic navigation field was observed in 6 pacemakers, resulting in reprogramming to a power-on-reset mode with or without detection of the elective replacement indication in 5 devices and abnormal variance of battery status in one device. All pacemakers could be reprogrammed to the initial modes and the battery status proved to be normal some minutes after the pacemakers had been removed from the magnetic field. Interference of a remote magnetic navigation system (at maximal field strength) with pacemakers and ICDs not connected to leads with antitachycardic detection and therapies turned off is rare. Occurring functional abnormalities could be reprogrammed in our sample. An in vitro study will give information about interference of devices connected to leads. © 2010 Wiley Periodicals, Inc.

A Single Center Study of 1,179 Heart Transplant Patients-Factors Affecting Pacemaker Implantation.

PubMed

Wellmann, Petra; Herrmann, Florian Ernst Martin; Hagl, Christian; Juchem, Gerd

2017-03-01

After around 10% of heart transplant patients require pacemaker implantation. The bradyarrhythmias causing pacemaker requirement include sinus node dysfunction (SND) and atrioventricular block (AVB). This study sought to define clinical predictors for pacemaker requirement as well as identify differences in the patient groups developing SND and AVB. Our operative database was used to collect retrospective recipient, donor, and operative data of all patients receiving orthotopic heart transplants between 1981 and 2016. In the 35-year period 1,179 transplants were performed (mean recipient age 45.5 ± 0.5 years, 20.4% female, 90.6% biatrial technique) with bradyarrhythmias requiring pacemaker implantation developing in 135 patients (11.5%). Independent risk factors were prolonged operative time 340 minutes versus 313 minutes (P = 0.027) and a biatrial anastomosis (P = 0.036). Ischemia time, cardiopulmonary bypass time, aortic cross clamp time, and reperfusion time all had no significant effect on pacemaker implantation rates. Similarly, whether the transplant was a reoperation, a retransplant, or performed after primary assist implantation had no effects on pacemaker implantation rates. There was no survival difference between the paced and nonpaced groups. The donor age was higher in the patients who developed AVB as the indication for pacemaker implantation (43 vs 34 years, P = 0.031). Patients with AVB had longer aortic cross clamp times and developed the arrhythmia later than those who developed SND. Use of the bicaval instead of the biatrial technique and shortened operative times should reduce pacemaker requirement after heart transplantation. Survival is not affected by this complication. © 2017 Wiley Periodicals, Inc.

Is pacemaker therapy the right key to patients with vasovagal syncope?

PubMed

Radovanović, Nikola N; Kirćanski, Bratislav; Raspopović, Srdjan; Pavlović, Siniša U; Jovanović, Velibor; Milašinović, Goran

2016-01-01

Vasovagal syncope is the most common type of reflex syncope. Efficacy of cardiac pacing in this indication has not been the subject of many studies and pacemaker therapy in patients with vasovagal syncope is still controversial. This study aimed to assess the efficacy and safety of pacing therapy in treatment of patients with vasovagal syncope, to determine contribution of new therapeutic models in increasing its success, and to identify risk factors associated with a higher rate of symptoms after pacemaker implantation. A retrospective study included 30 patients with pacemaker implanted due to vasovagal syncope in the Pacemaker Center, Clinical Center of Serbia, between November 2003 and June 2014. Head-up tilt test was performed to diagnose vasovagal syncope. Patients with cardioinhibitory and mixed type of disease were enrolled in the study. Mean age was 48.1 ± 11.1 years and 18 (60%) patients were men. Mean follow-up period was 5.9 ± 3.0 years. Primarily, implantable loop recorder was implanted in 10 (33.3%) patients. Twenty (66.7%) patients presented cardioinhibitory and 10 (33.3%) mixed type of vasovagal syncope. After pacemaker implantation, 11 (36.7%) patients had syncope. In multiple logistic regression analysis we showed that syncope is statistically more likely to occur after pacemaker implantation in patients with mixed type of vasovagal syncope (p = 0.018). There were two (6.7%) perioperative surgical complications. Pacemaker therapy is a safe treatment for patients with vasovagal syncope, whose efficacy can be improved by strict selection of patients. We showed that symptoms occur statistically more often in patients with mixed type of disease after pacemaker implantation.

Retrospective analysis of reasons for failure of DDD pacemaker implantation in patients operated on between 1993 and 2005.

PubMed

Lelakowski, Jacek; Majewski, Jacek; Małecka, Barbara; Bednarek, Jacek; Stypuła, Paweł; Szeglowski, Marcin

2007-01-01

During implantation of a DDD pacemaker the following difficulties may be encountered: venous anomalies (the absence of vessels of adequate calibre or difficulty in subclavian vein puncture), arrhythmias during implantation (episodes of atrial flutter/fibrillation while the atrial leads are being positioned), lack of mechanical stability of the electrode in the heart chamber and inability to achieve an acceptable pacing and sensing threshold during implantation. The purpose of the study was to analyse retrospectively the reasons for DDD pacemaker failure in patients operated on between 1993 and 2005. We reviewed retrospectively all implantation data from 1988 to 2005 to identify patients with primary failure of DDD pacemaker implantation. Further analysis included patients who had received a DDD pacemaker between 1993 and 2005, when this type of pacemaker made up between 9 and 40% of all pacemaker implantations. We implanted 7469 pacemakers, including 1958 (26.2%) dual-chamber pacemakers, in 783 patients with atrioventricular block (AVB), 392 with sick sinus syndrome (SSS), 450 with AVB +/- SSS and 333 with tachy-brady syndrome (TBS). The mean age of the patients was 65.5 +/- 17.3 years. DDD pacing was unsuccessful in 108 (1.4%) patients, including 32 with AVB, 22 with SSS, 16 with SSS +/- AVB and 38 with TBS. The mean age of these patients was 78.5 +/- 19.4 years. The reasons for failed implantation were venous anomalies in 12%, an arrhythmia episode in 27.8%, a high pacing threshold in the atrium in 17.6%, low atrial potential amplitude in 25.9% and lack of mechanical stability of the electrode in 16.7% of patients. The difficulties were encountered in elderly patients (p < 0.01), most frequently in patients with SSS and TBS (71). Between 2004 and 2005 venous anomalies and a high pacing threshold were the main causes of failure. Currently the main difficulties encountered during pacemaker implantation are venous anomalies and a high pacing threshold. Arrhythmia episodes, low atrial potential amplitude and lack of mechanical stability are of minor importance. Elderly patients with sick sinus syndrome and tachy-brady syndrome have the highest failure rate. (Cardiol J 2007; 14: 155-159).

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

PubMed

Krackhardt, Florian; Kherad, Behrouz; Krisper, Maximilian; Pieske, Burkert; Laule, Michael; Tschöpe, Carsten

2017-01-01

Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria. A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation. The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days. The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

Electrical interference in non-competitive pacemakers

PubMed Central

Sowton, E.; Gray, K.; Preston, T.

1970-01-01

Patients with 41 implanted non-competitive pacemakers were investigated. A variety of domestic electrical equipment, a motor-car, and a physiotherapy diathermy apparatus were each operated in turn at various ranges from the patient. Interference effects on pacemaker function were assessed on the electrocardiograph. Medtronic demand 5841 pacemakers were stopped by diathermy while Cordis Ectocor pacemakers developed a fast discharge rate. Cordis triggered pacemakers (both Atricor and Ectocor) were sensitive to interference from many items of domestic equipment and the motor car. The Elema EM153 ran at an increased rate when an electric razor was running close to the pacemaker. The Devices demand 2980 and the Medtronic demand 5841 were not affected by the domestic equipment tested. The significance of interference effects is discussed in relation to pacemaker design. Images PMID:5470044

Risk of pacemaker implantation after uneventful successful cavotricuspid isthmus radiofrequency ablation in patients with common atrial flutter.

PubMed

Rodríguez-Mañero, Moisés; González-Melchor, Layla; Ballesteros, Gabriel; Raposeiras-Roubín, Sergio; García-Seara, Javier; López, Xesús Alberte Fernández; Cambeiro, Cristina González; Alcalde, Oscar; García-Bolao, Ignacio; Martínez-Sande, Luis; González-Juanatey, José Ramón

2016-01-01

Little is known about the risk of pacemaker implantation after common atrial flutter ablation in the long-term. We retrospectively reviewed the electrophysiology laboratory database at two Spanish University Hospitals from 1998 to 2012 to identify patients who had undergone successful ablation for cavotricuspid dependent atrial flutter. Cox regression analysis was used to examine the risk of pacemaker implantation. A total of 298 patients were considered eligible for inclusion. The mean age of the enrolled patients was 65.7±11. During 57.7±42.8 months, 30 patients (10.1%) underwent pacemaker implantation. In the stepwise multivariate models only heart rate at the time of the ablation (OR: 0.96; 95% CI: 0.93-0.98; p<0.0001) and intraventricular conduction disturbances in the baseline ECG (OR: 3.87; 95% CI: 1.54-9.70; p=0.004) were independents predictors of the need of pacemaker implantation. A heart rate of ≤65 bpm was identified as the optimal cut-off value to predict the need of pacemaker implantation in the follow-up (sensitivity: 79%, specificity: 74%) by ROC curve analyses. This is the first study of an association between the slow conducting common atrial flutter and subsequent risk of pacemaker implantation. In light of these findings, assessing it prior to ablation can be helpful for the risk stratification of sinus node disease or atrioventricular conduction disease requiring a pacemaker implantation in patients with persistent atrial flutter. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Late Outcome and Predictors of Adverse Events Related to the Implantation of a Permanent Pacemaker in Patients with Isolated Congenital Atrioventricular Block.

PubMed

de Oliveira, Grasiele Bess; de Oliveira, Fábio Silveira; Osório, Ana Paula Susin; Medeiros, Alexandre Kreling; Sant'anna, João Ricardo Michielin; Leiria, Tiago Luiz Luz

2016-10-01

Isolated congenital atrioventricular block (ICAVB) is a rare, and pacemaker implantation is the only effective treatment. We sought to identify the predictive factors of adverse events related to pacemaker implantation in ICAVB. This is a cohort study of patients diagnosed with ICAVB who underwent pacemaker implantation from 1980 to 2014 in a single center. During the studied period, a total of 647 patients underwent implantation of their first permanent cardiac pacemaker before 30 years of age. Of these, only 62 (9.5 %) were diagnosed with ICAVB. This condition was diagnosed in utero in 15 (24.2 %) cases, 5 (8.1 %) in the neonatal period, 32 (51.6 %) during childhood, and 10 (16.1 %) during adolescence and young adulthood. The presence of autoantibodies (anti-Ro/SSA) was observed in 41 % of mothers who underwent serological evaluation. Age at the time of the initial pacemaker implant was 9.8 ± 9 years. During a mean follow-up time of 15 years, 1 (1.7 %) death occurred due to infectious endocarditis. Complications related to pacemaker implant were reported in 24 patients (38.7 %). The number of complications was significantly higher in the group with an epimyocardial implantation site (HR 6; CI 2.45-14.95). Ventricular dysfunction occurred in 6 (11.7 %) patients; however, we were not able to identify any predictors of it. Our results showed a low mortality rate after permanent therapy. However, these patients exhibited high morbidity related to the pacemaker system, and the epimyocardial implant site was an independent predictor of complications. Predictors of left ventricular dysfunction were not found in the present study.

Case study thoracic radiotherapy in an elderly patient with pacemaker: The issue of pacing leads

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

Kirova, Youlia M., E-mail: youlia.kirova@curie.net; Menard, Jean; Chargari, Cyrus

2012-07-01

To assess clinical outcome of patients with pacemaker treated with thoracic radiation therapy for T8-T9 paravertebral chloroma. A 92-year-old male patient with chloroma presenting as paravertebral painful and compressive (T8-T9) mass was referred for radiotherapy in the Department of Radiation Oncology, Institut Curie. The patient presented with cardiac dysfunction and a permanent pacemaker that had been implanted prior. The decision of Multidisciplinary Meeting was to deliver 30 Gy in 10 fractions for reducing the symptoms and controlling the tumor growth. The patient received a total dose of 30 Gy in 10 fractions using 4-field conformal radiotherapy with 20-MV photons. Themore » dose to pacemaker was 0.1 Gy but a part of the pacing leads was in the irradiation fields. The patient was treated the first time in the presence of his radiation oncologist and an intensive care unit doctor. Moreover, the function of his pacemaker was monitored during the entire radiotherapy course. No change in pacemaker function was observed during any of the radiotherapy fractions. The radiotherapy was very well tolerated without any side effects. The function of the pacemaker was checked before and after the radiotherapy treatment by the cardiologist and no pacemaker dysfunction was observed. Although updated guidelines are needed with acceptable dose criteria for implantable cardiac devices, it is possible to treat patients with these devices and parts encroaching on the radiation field. This case report shows we were able to safely treat our patient through a multidisciplinary approach, monitoring the patient during each step of the treatment.« less

Troponin T elevation after permanent pacemaker implantation.

PubMed

Chen, Xueying; Yu, Ziqing; Bai, Jin; Hu, Shulan; Wang, Wei; Qin, Shengmei; Wang, Jingfeng; Sun, Zhe; Su, Yangang; Ge, Junbo

2017-08-01

The objective of the study is to study the incidence, significance, and factors associated with cardiac troponin T (CTNT) elevation after pacemaker implantation. Three hundred seventy-four patients (104 single-chamber pacemakers or ICD, 243 dual-chamber pacemakers, and 27 cardiac resynchronization therapy/cardiac resynchronization therapy defibrillator) who had normal levels of CTNT at baseline and underwent implantation of a permanent pacemaker system were included in this study. Serum levels of CTNT were measured at baseline, 6 and 24 h after the implantation procedure. The median of CTNT levels increased from 0.012 ng/mL at baseline to 0.032 and 0.019 ng/mL at 6 and 24 h after the procedure, respectively (all p < 0.0001). Elevated CTNT levels were noted in 208 patients (55.6%) at 6 h after the implantation, among which 29 patients (7.8%) had CTNT levels exceeding the range of minimal myocardial damage (>0.09 ng/mL). After 1-year follow-up, the incidence of complications including dislodgement of the lead, pocket infection, pneumothorax, hemothorax, and vein thrombus and cardiac outcomes including hospitalization of heart failure, coronary artery disease, arrhythmia, and cardiovascular mortality was not significantly different between the normal and elevated CTNT groups at 6 h after the procedure. By logistic regression analysis, gender, N-terminal pro-B type natriuretic peptide (NT-pro-BNP) at baseline, left ventricular ejection fractions (LVEF), estimated glomerular filtration rate (eGFR), and fluoroscopy time were independently associated with CTNT elevation after adjusted for age, pacemaker types, right ventricle lead location (RVA or RVOT), heart function, and left ventricular end systolic dimension. Pacemaker implantation was found to be accompanied with CTNT elevation in 55.6% of the patients at 6 h after the procedure, and its kinetics were fast, which might not be related to the complications and adverse cardiac outcomes within 1 year of follow-up. Moreover, gender, NT-pro-BNP at baseline, LVEF, eGFR, and fluoroscopy time were found to be independent predictors of CTNT elevation.

Advanced Pacemaker

NASA Technical Reports Server (NTRS)

1990-01-01

Synchrony, developed by St. Jude Medical's Cardiac Rhythm Management Division (formerly known as Pacesetter Systems, Inc.) is an advanced state-of-the-art implantable pacemaker that closely matches the natural rhythm of the heart. The companion element of the Synchrony Pacemaker System is the Programmer Analyzer APS-II which allows a doctor to reprogram and fine tune the pacemaker to each user's special requirements without surgery. The two-way communications capability that allows the physician to instruct and query the pacemaker is accomplished by bidirectional telemetry. APS-II features 28 pacing functions and thousands of programming combinations to accommodate diverse lifestyles. Microprocessor unit also records and stores pertinent patient data up to a year.

Pacemaker implantation after catheter ablation for atrial fibrillation.

PubMed

Deshmukh, Abhishek J; Yao, Xiaoxi; Schilz, Stephanie; Van Houten, Holly; Sangaralingham, Lindsey R; Asirvatham, Samuel J; Friedman, Paul A; Packer, Douglas L; Noseworthy, Peter A

2016-01-01

Sinus node dysfunction requiring pacemaker implantation is commonly associated with atrial fibrillation (AF), but may not be clinically apparent until restoration of sinus rhythm with ablation or cardioversion. We sought to determine frequency, time course, and predictors for pacemaker implantation after catheter ablation, and to compare the overall rates to a matched cardioversion cohort. We conducted a retrospective analysis using a large US commercial insurance database and identified 12,158 AF patients who underwent catheter ablation between January 1, 2005 and December 31, 2012. Over an average of 2.4 years of follow-up, 5.6 % of the patients underwent pacemaker implantation. Using the Cox proportional hazards models, we found that risk of risks of pacemaker implantation was associated with older age (50-64 and ≥65 versus <50 years), female gender, higher CHADS2 score (≥2 and 1 versus 0), higher Charlson index (≥2 versus 0-1), certain baseline comorbidities (conduction disorder, coronary atherosclerosis, and congestive heart failure), and the year of ablation. There was no significant difference in the risk of pacemaker implantation between ablation patients and propensity score (PS)-matched cardioversion groups (3.5 versus. 4.1 % at 1 year and 8.8 versus 8.3 % at 5 years). Overall, pacemaker implantation occurs in about 1/28 patients within 1 year of catheter ablation. The overall implantation rate decreased between 2005 and 2012. Furthermore, the risk after ablation is similar to cardioversion, suggesting that patients require pacing due to a common underlying electrophysiologic substrate, rather than the ablation itself.

The interference of electronic implants in low frequency electromagnetic fields.

PubMed

Silny, J

2003-04-01

Electronic implants such as cardiac pacemakers or nerve stimulators can be impaired in different ways by amplitude-modulated and even continuous electric or magnetic fields of strong field intensities. For the implant bearer, possible consequences of a temporary electromagnetic interference may range from a harmless impairment of his well-being to a perilous predicament. Electromagnetic interferences in all types of implants cannot be covered here due to their various locations in the body and their different sensing systems. Therefore, this presentation focuses exemplarily on the most frequently used implant, the cardiac pacemaker. In case of an electromagnetic interference the cardiac pacemaker reacts by switching to inhibition mode or to fast asynchronous pacing. At a higher disturbance voltage on the input of the pacemaker, a regular asynchronous pacing is likely to arise. In particular, the first-named interference could be highly dangerous for the pacemaker patient. The interference threshold of cardiac pacemakers depends in a complex way on a number of different factors such as: electromagnetic immunity and adjustment of the pacemaker, the composition of the applied low-frequency fields (only electric or magnetic fields or combinations of both), their frequencies and modulations, the type of pacemaker system (bipolar, unipolar) and its location in the body, as well as the body size and orientation in the field, and last but not least, certain physiological conditions of the patient (e.g. inhalation, exhalation). In extensive laboratory studies we have investigated the interference mechanisms in more than 100 cardiac pacemakers (older types as well as current models) and the resulting worst-case conditions for pacemaker patients in low-frequency electric and magnetic fields. The verification of these results in different practical everyday-life situations, e.g. in the fields of high-voltage overhead lines or those of electronic article surveillance systems is currently in progress. In case of the vertically-oriented electric 50 Hz fields preliminary results show that per 1 kV/m unimpaired electrical field strength (rms) an interference voltage of about 400 microVpp as worst-case could occur at the input of a unipolar ventricularly controlled, left-pectorally implanted cardiac pacemaker. Thus, already a field strength above ca. 5 kV/m could cause an interference with an implanted pacemaker. The magnetic fields induces an electric disturbance voltage at the input of the pacemaker. The body and the pacemaker system compose several induction loops, whose induced voltages rates add or subtract. The effective area of one representing inductive loop ranges from 100 to 221 cm2. For the unfavourable left-pectorally implantated and atrially-controlled pacemaker with a low interference threshold, the interference threshold ranges between 552 and 16 microT (rms) for magnetic fields at frequencies between 10 and 250 Hz. On this basis the occurrence of interferences with implanted pacemakers is possible in everyday-life situations. But experiments demonstrate a low probability of interference of cardiac pacemakers in practical situations. This apparent contradiction can be explained by a very small band of inhibition in most pacemakers and, in comparison with the worst-case, deviating conditions.

Long-Term Mortality Effect of Early Pacemaker Implantation After Surgical Aortic Valve Replacement.

PubMed

Greason, Kevin L; Lahr, Brian D; Stulak, John M; Cha, Yong-Mei; Rea, Robert F; Schaff, Hartzell V; Dearani, Joseph A

2017-10-01

The need for pacemaker implantation is a well-described complication of aortic valve replacement. Not so well described is the effect such an event has on long-term outcome. This study reviewed a 21-year experience at the Mayo Clinic (Rochester, Minnesota) with aortic valve replacement to understand the influence of early postoperative pacemaker implantation on long-term mortality rates more clearly. This study retrospectively reviewed the records of 5,842 patients without previous pacemaker implantation who underwent surgical aortic valve replacement from January 1993 through June 2014. The median age of these patients was 73 years (range, 65 to 79 years), the median ejection fraction was 62% (range, 53% to 68%), 3,853 patients were male (66%), and coronary artery bypass graft operation was performed in 2,553 (44%) of the patients studied. Early pacemaker implantation occurred in 146 patients (2.5%) within 30 days of surgical aortic valve replacement. The median follow-up of patients was 11.1 years (range, 5.8 to 16.5 years), and all-cause mortality rates were 2.4% at 30 days, 6.4% at 1 year, 23.1% at 5 years, 48.3% at 10 years, and 67.9% at 15 years postoperatively. Early pacemaker implantation was associated with an increased risk of death after multivariable adjustment for baseline patients' characteristics (hazard ratio, 1.49; 95% confidence interval, 1.20, 1.84; p < 0.001). Early pacemaker implantation as a complication of surgical aortic valve replacement is associated with an increased risk of long-term death. Valve replacement-related pacemaker implantation rates should be important considerations with respect to new valve replacement paradigms, especially in younger and lower-risk patients. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Leadless Cardiac Pacemaker Implantation After Lead Extraction in Patients With Severe Device Infection.

PubMed

Kypta, Alexander; Blessberger, Hermann; Kammler, Juergen; Lambert, Thomas; Lichtenauer, Michael; Brandstaetter, Walter; Gabriel, Michael; Steinwender, Clemens

2016-09-01

Conventional pacemaker therapy is limited by short- and long-term complications, most notably device infection. Transcatheter pacing systems (TPS) may be beneficial in this kind of patients as they eliminate the need for a device pocket and leads and thus may reduce the risk of re-infection. We assessed a novel procedure in 6 patients with severe device infection who were pacemaker dependent. After lead extraction a single chamber TPS was implanted into the right ventricle. Of the 6 patients who underwent lead extraction due to severe device infection at our institution, 3 were diagnosed with a pocket infection only, whereas the other 3 showed symptoms of both pocket and lead infection. Successful lead extraction and TPS implantation was accomplished in all patients. Four patients were bridged with a temporary pacemaker between 2 hours and 2 days after lead extraction, whereas 2 patients had the TPS implanted during the same procedure just before traditional pacemaker system removal. All patients stayed free of infection during the follow-up period of 12 weeks. An additional positron emission tomography scan was performed in each patient and indicated no signs of an infection around the TPS. Transcather pacemaker implantation was safe and feasible in 6 patients and did not result in re-infection even if implanted before removal of the infected pacemaker system within the same procedure. Therefore, implantation of a TPS may be an option for patients with severe device infection, especially in those with blocked venous access or who are pacemaker dependent. © 2016 Wiley Periodicals, Inc.

Effect of electric and magnetic fields near an HVDC converter terminal on implanted cardiac pacemakers. Final report

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

Frazier, M.J.

1980-08-01

The electromagnetic fields associated with HVDC converters and transmission lines constitute a unique environment for persons with implanted cardiac pacemakers. A measurement program has been conducted to assess the potential interfering effects of these harmonically rich fields on implanted pacemakers. The experimental procedures that were employed take into account the combined effects of the electric and magnetic fields. The effect of the resulting body current on the response of six pacemakers was assessed in the laboratory, using a previously developed model to relate body current to pacemaker pickup voltage. The results show that R-wave pacemaker reversion can be expected atmore » some locations within the converter facility, but that a large safety margin for unperturbed pacemaker operation exists beneath the transmission lines.« less

Pacemaker therapy in low-birth-weight infants.

PubMed

Fuchigami, Tai; Nishioka, Masahiko; Akashige, Toru; Shimabukuro, Atsuya; Nagata, Nobuhiro

2018-02-01

Infants born with complete atrioventricular block (CAVB) and fetal bradycardia are frequently born with low birth weight. Three low-birth-weight CAVB infants underwent temporary pacemaker implantation, followed by permanent single-chamber pacemaker implantation at median body weights of 1.7 and 3.2 kg, respectively. All infants caught up with their growth curves and had >3 years of estimated residual battery life. This two-stage strategy was successful in facilitating permanent pacemaker implantation in low-birth-weight babies. Placement of single-chamber pacemaker on the apex of the left ventricle appears to be associated with longer battery lifespan. © 2018 Wiley Periodicals, Inc.

Management and outcome of topical beta-blockerinduced atrioventricular block

PubMed Central

Özcan, Kazım Serhan; Güngör, Barış; Tekkeşin, Ahmet İlker; Altay, Servet; Ekmekçi, Ahmet; Toprak, Ercan; Yıldırım, Ersin; Çalık, Nazmi; Alper, Ahmet Taha; Gürkan, Kadir; Erdinler, İzzet; Osmonov, Damirbek

2015-01-01

Summary Background Topical beta-blockers have a well-established role in the treatment of glaucoma. We aimed to investigate the outcome of patients who developed symptomatic atrioventricular (AV) block induced by topical beta-blockers. Methods All patients admitted or discharged from our institution, the Siyami Ersek Training and Research Hospital, between January 2009 and January 2013 with a diagnosis of AV block were included in the study. Subjects using ophthalmic beta-blockers were recruited and followed for permanent pacemaker requirement during hospitalisation and for three months after discontinuation of the drug. A permanent pacemaker was implanted in patients in whom AV block persisted beyond 72 hours or recurred during the follow-up period. Results A total of 1 122 patients were hospitalised with a diagnosis of AV block and a permanent pacemaker was implanted in 946 cases (84.3%) during the study period. Thirteen patients using ophthalmic beta-blockers for the treatment of glaucoma and no other rate-limiting drugs were included in the study. On electrocardiography, eight patients had complete AV block and five had high-degree AV block. The ophthalmic beta-blockers used were timolol in seven patients (55%), betaxolol in four (30%), and cartelol in two cases (15%). The mean duration of ophthalmic beta-blocker treatment was 30.1 ± 15.9 months. After drug discontinuation, in 10 patients the block persisted and a permanent pacemaker was implanted. During follow up, one more patient required pacemaker implantation. Therefore in total, pacemakers were implanted in 11 out of 13 patients (84.6%). The pacemaker implantation rate did not differ according to the type of topical beta-blocker used (p = 0.37). The presence of infra-nodal block on electrocardiography was associated with higher rates of pacemaker implantation. Conclusion Our results indicate that topical beta-blockers for the treatment of glaucoma may cause severe conduction abnormalities and when AV block occurs, pacemaker implantation is required in a high percentage of the patients. PMID:26659434

Comparison of DDD versus VVIR pacing modes in elderly patients with atrioventricular block.

PubMed

Kılıçaslan, Barış; Vatansever Ağca, Fahriye; Kılıçaslan, Esin Evren; Kınay, Ozan; Tigen, Kürşat; Cakır, Cayan; Nazlı, Cem; Ergene, Oktay

2012-06-01

Dual-chamber pacing is believed to have an advantage over single-chamber ventricular pacing. The aim of this study was to determine whether elderly patients who have implanted pacemakers for complete atrioventricular block gain significant benefits from dual-chamber (DDD) pacemakers compared with single chamber ventricular (VVIR) pacemakers. This study was designed as a randomized, two-period crossover study-each pacing mode was maintained for 1 month. Thirty patients (16 men, mean age 68.87 ± 6.89 years) with implanted DDD pacemakers were submitted to a standard protocol, which included an interview, pacemaker syndrome assessment, health related quality of life (HRQoL) questionnaires assessed by an SF-36 test, 6-minute walk test (6MWT), and transthoracic echocardiographic examinations. All of these parameters were obtained on both DDD and VVIR mode pacing. Paired data were compared. HRQoL scores were similar, and 6MWT results did not differ between the two groups. VVIR pacing elicited significant enlargement of the left atrium and impaired left ventricular diastolic functions as compared with DDD pacing. Two patients reported subclinical pacemaker syndrome, but this was not statistically significant. Our study revealed that in active elderly patients with complete heart block, DDD pacing and VVIR pacing yielded similar improvements in QoL and exercise performance. However, after a short follow-up period, we noted that VVIR pacing caused significant left atrial enlargement and impaired left ventricular diastolic functions.

Pacemakers and implantable cardioverter-defibrillators in pediatric patients.

PubMed

Silka, Michael J; Bar-Cohen, Yaniv

2006-11-01

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

[Temporary Pacemakers - Step by Step].

PubMed

Graf, Matthias; Stiller, Patrick; Karch, Martin

2018-06-01

Symptomatic bradycardia is usually caused by abnormalities of atrioventricular conduction or sinus node dysfunction. Reversible and irreversible causes must be considered.Temporary pacemakers are used in the emergency treatment in case of severe bradyarrhythmia.They help to bridge the acute phase until spontaneous restoration of atrioventricular or sinus node function or -if spontaneous restoration fails- until a permanent pacemaker system was implanted.In the following article we discuss the commonly used temporary pacemaker systems. We demonstrate their use and correct programming by an illustrated step by step explanation. For troubleshooting a flow chart was added. © Georg Thieme Verlag KG Stuttgart · New York.

Short- and long-term need for permanent pacemaker after transcatheter implantation of the Edwards Sapien aortic valve prosthesis.

PubMed

Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Angel; Galeote, Guillermo; Jiménez-Valero, Santiago; López, Teresa; Plaza, Ignacio; González-Davia, Rosa; Ramírez, Ulises; Mesa, Jose Maria; Moreno-Gomez, Isidro; López-Sendón, José-Luis

2015-11-01

A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system. To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors. We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients. A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013). The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

Zero-fluoroscopy permanent pacemaker implantation using Ensite NavX system: Clinical viability or fanciful technique?

PubMed

Guo, Ping; Qiu, Jie; Wang, Yan; Chen, Guangzhi; Proietti, Riccardo; Fadhle, Al-Selmi; Zhao, Chunxia; Wen Wang, Dao

2018-02-01

Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures. Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Their applicability in cardiac device implantation has been rarely reported. Our aim is to evaluate the feasibility and safety of permanent pacemaker implantation without fluoroscopy. From January 2012 to June 2016, six patients (50 ± 15 years, four of six were female, one of who was at the 25th week of gestation) who underwent permanent pacemaker implantation were included (zero-fluoroscopy group). Data from 20 consecutive cases of implantation performed under fluoroscopy guidance were chosen as a control group (fluoroscopy group). Total implantation procedure time for single-chamber pacemaker was 51.3 ± 13.1 minutes in the zero-fluoroscopy group and 42.6 ± 7.4 minutes in the fluoroscopy group (P  =  0.155). The implantation procedural time for a dual-chamber pacemaker was 88.3 ± 19.6 minutes and 67.3 ± 7.6 minutes in the zero-fluoroscopy and fluoroscopy groups (P  =  0.013), respectively. No complications were observed during the procedure and the follow-up in the two groups, and all pacemakers worked with satisfactory parameters. Ensite NavX system can be used as a reliable and safe zero-fluoroscopy approach for the implantation of single- or dual-chamber permanent pacemakers in specific patients, such as pregnant women or in extreme situations when the x-ray machine is not available. © 2017 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

Pacemaker Implants in Children and Adolescents with Chagas Disease in Brazil: 18-Year Incidence.

PubMed

Mizzaci, Carolina Christianini; Souza, Thiago Gonçalves Schroder E; Targueta, Gabriel Pelegrineti; Tótora, Ana Paula Frederico; Mateos, Juan Carlos Pachón; Mateos, José Carlos Pachon

2017-06-01

Chagas disease continues to be a serious public health problem, and accounts for 25-30% of the indications for cardiac stimulation in Brazil. To assess clinical and epidemiological characteristics of patients with Chagas disease, younger than 18 years, who had undergone pacemaker implantation in Brazil between 1994 and 2011, and its temporal trend. This was a cross-sectional analysis of data from the Brazilian Pacemaker Registry database. The following variables were analyzed: year when pacemaker was implanted, location, age, sex, ethnic group, functional class and the main electrocardiographic findings at baseline. In a total of 183,123 implants performed between 1994 and 2011, 214 implants of cardiac stimulation device in Chagas disease patients aged younger than 18 years were identified. Mean age at implantation was 5.6 ± 6.2 years. Second- and third-degree atrioventricular blocks corresponded to 71% of indications for pacemaker implantation. Fifty-six percent of the procedures were performed in the southeast region. Regarding the total number of pacemaker implants per year, there was a remarkable increase in the implants for all causes. However, time series analysis of the implants in Chagas disease patients younger than 18 years revealed a significant reduction in the annual number of implants. There has been an important reduction in the number of pacemaker implantations among children and adolescents with Chagas disease, suggesting a reduction in the vertical transmission of the parasite. A doença de Chagas mantém-se como sério problema de saúde pública e tem sido responsável por aproximadamente 25% a 30% das indicações de estimulação cardíaca no Brasil. Estudar as características clínicas e epidemiológicas dos pacientes menores de 18 anos portadores de doença de Chagas submetidos a implante de marca-passo no território brasileiro entre 1994 e 2011, e sua tendência temporal. Trata-se de um estudo retrospectivo que utilizou informações coletadas pelo Registro Brasileiro de Marca-passo. As variáveis analisadas foram: ano do implante, localidade, idade, sexo, grupo étnico dos pacientes; classificação funcional e os principais achados eletrocardiográficos de base. Em um total de 183 123 implantes realizados entre 1994 e 2011, foram identificados 214 implantes de dispositivos de estimulação cardíaca em portadores de doença de Chagas com idade inferior a 18 anos. A média de idade no momento do implante foi de 5,6 ± 6,2 anos. Bloqueios atrioventriculares de 2º e 3º graus foram responsáveis por 71% das indicações. Dos procedimentos, 55,6% foram realizados na região sudeste. Em relação ao total de implantes de marca-passo por ano, observamos um aumento importante e significante de implante por todas as causas. Entretanto, quando avaliamos a série temporal de implantes em pacientes com doença de Chagas menores que 18 anos, observamos uma redução expressiva e significativa no número anual de implantes. Observa-se uma redução importante do número de implantes de marca-passo em crianças e adolescente chagásicos, o que sugere uma redução da transmissão vertical do parasita.

Analysis of a five year experience of permanent pacemaker implantation at a Nigerian Teaching Hospital: need for a national database

PubMed Central

Falase, Bode; Sanusi, Michael; Johnson, Adeyemi; Akinrinlola, Fola; Ajayi, Reina; Oke, David

2013-01-01

Introduction Permanent pacemaker implantation is available in Nigeria. There is however no national registry or framework for pacemaker data collection. A pacemaker database has been developed in our institution and the results are analyzed in this study. Methods The study period was between January 2008 and December 2012. Patient data was extracted from a prospectively maintained database which was designed to include the fields of the European pacemaker patient identification code. Results Of the 51 pacemaker implants done, there were 29 males (56.9%) and 22 females (43.1%). Mean age was 68.2±12.7 years. Clinical indications were syncopal attacks in 25 patients (49%), dizzy spells in 15 patients (29.4%), bradycardia with no symptoms in 10 patients (17.7%) and dyspnoea in 2 patients (3.9%). The ECG diagnosis was complete heart block in 27 patients (53%), second degree heart block in 19 patients (37.2%) and sick sinus syndrome with bradycardia in 5 patients (9.8%). Pacemaker modes used were ventricular pacing in 29 patients (56.9%) and dual chamber pacing in 22 patients (43.1%). Files have been closed in 20 patients (39.2%) and 31 patients (60.8%) are still being followed up with median follow up of 26 months, median of 5 visits and 282 pacemaker checks done. Complications seen during follow up were 3 lead displacements (5.9%), 3 pacemaker infections (5.9%), 2 pacemaker pocket erosions (3.9%), and 1 pacemaker related death (2%). There were 5 non-pacemaker related deaths (9.8%). Conclusion Pacemaker data has been maintained for 5 years. We urge other implanting institutions in Nigeria to maintain similar databases and work towards establishment of a national pacemaker registry. PMID:24498465

Remodeling of sinus node function after catheter ablation of right atrial flutter.

PubMed

Daoud, Emile G; Weiss, Raul; Augostini, Ralph S; Kalbfleisch, Steven J; Schroeder, Jason; Polsinelli, Georgia; Hummel, John D

2002-01-01

The purpose of this study was to investigate the effect of ablation of right atrial flutter upon sinus node function in humans. This study enrolled 35 patients. Twenty-four patients (16 men and 8 women; age 68 +/- 11 years) were referred for ablation of persistent atrial flutter (duration 8 +/- 11 months). After ablation, there was abnormal sinus node function defined as a corrected sinus node recovery time (CSNRT) > or = 550 msec. The control group consisted of 11 patients who were undergoing pacemaker implantation for sinus node disease but did not have a history of atrial dysrhythmias or ablation. Within 24 hours of ablation or pacemaker implantation, baseline maximal CSNRT was measured through a permanent pacemaker by AAI pacing at six cycle lengths: 600, 550, 500, 450, 400, and 350 msec. CSNRT then was measured in the same manner at 48 hours, 14 days, and 3 months after ablation/pacemaker implantation. P wave amplitude and duration, and percent atrial sensing also were assessed at the same intervals. For patients undergoing atrial flutter ablation, there was progressive temporal recovery of CSNRT (1,204 +/- 671 msec at baseline vs 834 +/- 380 msec at 3 months; P < 0.001) and a significant increase in the percent atrial sensing and P wave amplitude at 3 months compared with baseline (P < 0.001). In control subjects, there was no change in the CSNRT, percent atrial pacing, or P wave amplitude. After ablation of persistent atrial flutter, there is temporal recovery of CSNRT and increase in spontaneous atrial activity. These findings suggest that atrial flutter induces reversible changes in sinus node function.

Complete removal of infected devices and simultaneous implantation of new devices for infective endocarditis after pacemaker implantation.

PubMed

Miura, Takuya; Inoue, Kazushige; Yokota, Takenori; Iwata, Takashi; Yoshitatsu, Masao

2017-02-01

Two cases of infective endocarditis after pacemaker implantation were reported. Complete removal of infected devices was performed under cardiopulmonary bypass, and simultaneous implantation of new devices was performed using epicardial leads and generator on the abdominal wall. The postoperative course was uneventful and recurrence was not recognized. These procedures may be suitable for the patients who depend on the pacemaker or who have repeat bacteremia with other infectious disease or conditions.

The usefulness of a stretch-polyester pouch to encase implanted pacemakers and defibrillators.

PubMed

Parsonnet, V; Bernstein, A D; Neglia, D; Omar, A

1994-12-01

This study was undertaken to assess the effects of enclosing permanent pacemaker and ICD pulse generators in a stretch-polyester pouch prior to implantation. Follow-up of 223 patients with oversized pacemakers and with ICDs and 344 with standard-sized pacemaker pulse generators showed that the pouch was effective in decreasing the frequency of pulse generator migration and extrusion.

Programmable Pacemaker

NASA Technical Reports Server (NTRS)

1980-01-01

St. Jude Medical's Cardiac Rhythm Management Division, formerly known as Pacesetter Systems, Inc., incorporated Apollo technology into the development of the programmable pacemaker system. This consists of the implantable pacemaker together with a physician's console containing the programmer and a data printer. Physician can communicate with patient's pacemaker by means of wireless telemetry signals transmitted through the communicating head held over the patient's chest. Where earlier pacemakers deliver a fixed type of stimulus once implanted, Programalith enables surgery free "fine tuning" of device to best suit the patient's changing needs.

Permanent Leadless Cardiac Pacemaker Therapy: A Comprehensive Review.

PubMed

Tjong, Fleur V Y; Reddy, Vivek Y

2017-04-11

A new technology, leadless pacemaker therapy, was recently introduced clinically to address lead- and pocket-related complications in conventional transvenous pacemaker therapy. These leadless devices are self-contained right ventricular single-chamber pacemakers implanted by using a femoral percutaneous approach. In this review of available clinical data on leadless pacemakers, early results with leadless devices are compared with historical results with conventional single-chamber pacing. Both presently manufactured leadless pacemakers show similar complications, which are mostly related to the implant procedure: cardiac perforation, device dislocation, and femoral vascular access site complications. In comparison with conventional transvenous single-chamber pacemakers, slightly higher short-term complication rates have been observed: 4.8% for leadless pacemakers versus 4.1% for conventional pacemakers. The complication rate of the leadless pacemakers is influenced by the implanter learning curve for this new procedure. No long-term outcome data are yet available for the leadless pacemakers. Larger leadless pacing trials, with long-term follow-up and direct randomized comparison with conventional pacing systems, will be required to define the proper clinical role of these leadless systems. Although current leadless pacemakers are limited to right ventricular pacing, future advanced, communicating, multicomponent systems are expected to expand the potential benefits of leadless therapy to a larger patient population. © 2017 American Heart Association, Inc.

Impact of pacemaker mode in patients with atrioventricular conduction disturbance after trans-catheter aortic valve implantation.

PubMed

Takahashi, Masao; Badenco, Nicolas; Monteau, Jacques; Gandjbakhch, Estelle; Extramiana, Fabrice; Urena, Marina; Karam, Nicole; Marijon, Eloi; Algalarrondo, Vincent; Teiger, Emmanuel; Lellouche, Nicolas

2018-03-14

This study aimed to assess the impact of pacemaker mode programming on clinical outcomes in patients with high-degree atrioventricular conduction disturbance (AVCD) after transcatheter aortic valve implantation (TAVI). Although high-degree AVCD after TAVI can receive pacemaker, recovery of the AVCD is often observed. Specific pacemaker algorithms (AAI-DDD mode switch) are available which favor spontaneous atrioventricular conduction. Of 1,621 consecutive multi-center TAVI patients, 269 (16.4%) received pacemaker. We retrospectively included 91 patients with persistent high-degree AVCD at hospital discharge. Pacemaker dependency was defined as absence, inadequate intrinsic ventricular rhythm, or ventricular pacing time > 95% on pacemaker interrogation during follow-up. Comparison of heart failure hospitalization and death between conventional DDD (cDDD) and other modes was examined (AAI-DDD and VVI). During a mean follow-up duration of 13 months, the pacemaker dependency rate was 52.8%. Patients with cDDD mode (N = 36: 40.0%) had significantly more pacemaker dependency. Multivariate analysis showed that cDDD mode was independently associated with pacemaker dependency (odds ratio = 3.63, P = 0.03). Moreover, cDDD patients had a significant higher incidence of heart failure hospitalization (Hospitalization: cDDD vs. others = 45.4% vs. 18.2%, P = 0.03) and had a higher incidence of mortality (Death: cDDD vs. the others = 27.0% vs. 4.4%, P = 0.06). Up to half of patients implanted for high-degree AVCD after TAVI had conduction recovery. Patients with cDDD programming at hospital discharge had more pacemaker dependency and a worse cardiac prognosis. Thus, pacemaker mode should be systematically set to promote spontaneous atrioventricular conduction in patients with pacemaker implantation after TAVI. © 2018 Wiley Periodicals, Inc.

Pacemaker Use in New Zealand - Data From the New Zealand Implanted Cardiac Device Registry (ANZACS-QI 15).

PubMed

Larsen, P D; Kerr, A J; Hood, M; Harding, S A; Hooks, D; Heaven, D; Lever, N A; Sinclair, S; Boddington, D; Tang, E W; Swampillai, J; Stiles, M K

2017-03-01

The New Zealand Cardiac Implanted Device Registry (Device) has recently been developed under the auspices of the New Zealand Branch of the Cardiac Society of Australia and New Zealand. This study describes the initial Device registry cohort of patients receiving a new pacemaker, their indications for pacing and their perioperative complications. The Device Registry was used to audit patients receiving a first pacemaker between 1 st January 2014 and 1 st June 2015. We examined 1611 patients undergoing first pacemaker implantation. Patients were predominantly male (59%), and had a median age of 70 years. The most common symptom for pacemaker implantation was syncope (39%), followed by dizziness (30%) and dyspnoea (12%). The most common aetiology for a pacemaker was a conduction tissue disorder (35%), followed by sinus node dysfunction (22%). Atrioventricular (AV) block was the most common ECG abnormality, present in 44%. Dual chamber pacemakers were most common (62%), followed by single chamber ventricular pacemakers (34%), and cardiac resynchronisation therapy - pacemakers (CRT-P) (2%). Complications within 24hours of the implant procedure were reported in 64 patients (3.9%), none of which were fatal. The most common complication was the need for reoperation to manipulate a lead, occurring in 23 patients (1.4%). This is the first description of data entered into the Device registry. Patients receiving a pacemaker were younger than in European registries, and there was a low use of CRT-P devices compared to international rates. Complications rates were low and compare favourably to available international data. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

An approach to ablate and pace:AV junction ablation and pacemaker implantation performed concurrently from the same venous access site.

PubMed

Issa, Ziad F

2007-09-01

Atrioventricular junction (AVJ) ablation combined with permanent pacemaker implantation (the "ablate and pace" approach) remains an acceptable alternative treatment strategy for symptomatic, drug-refractory atrial fibrillation (AF) with rapid ventricular response. This case series describes the feasibility and safety of catheter ablation of the AVJ via a superior vena caval approach performed during concurrent dual-chamber pacemaker implantation. A total of 17 consecutive patients with symptomatic, drug-refractory, paroxysmal AF underwent combined AVJ ablation and dual-chamber pacemaker implantation procedure using a left axillary venous approach. Two separate introducer sheaths were placed into the axillary vein. The first sheath was used for implantation of the pacemaker ventricular lead, which was then connected to the pulse generator. Subsequently, a standard ablation catheter was introduced through the second axillary venous sheath and used for radiofrequency (RF) ablation of the AVJ. After successful ablation, the catheter was withdrawn and the pacemaker atrial lead was advanced through that same sheath and implanted in the right atrium. Catheter ablation of the AVJ was successfully achieved in all patients. The median number of RF applications required to achieve complete AV block was three (range 1-10). In one patient, AV conduction recovered within the first hour after completion of the procedure, and AVJ ablation was then performed using the conventional femoral venous approach. There were no procedural complications. Catheter ablation of the AVJ can be performed successfully and safely via a superior vena caval approach in patients undergoing concurrent dual-chamber pacemaker implantation.

Acute pericarditis with cardiac tamponade induced by pacemaker implantation.

PubMed

Shingaki, Masami; Kobayashi, Yutaka; Suzuki, Haruo

2015-11-01

An 87-year-old woman was diagnosed with third-degree atrioventricular block and underwent pacemaker implantation. On postoperative day 12, she experienced cardiac tamponade that was suspected on computed tomography to be caused by lead perforation; therefore, we performed open-heart surgery. However, we could not identify a perforation site on the heart, and drained a 400-mL exudative pericardial effusion. Subsequently, we diagnosed the pericardial effusion as due to pericarditis induced by pacemaker implantation. It is sometimes difficult to distinguish pericarditis from pacemaker lead perforation, so both should be included in the differential diagnosis. © The Author(s) 2014.

Pacemaker Dependency after Cardiac Surgery: A Systematic Review of Current Evidence.

PubMed

Steyers, Curtis M; Khera, Rohan; Bhave, Prashant

2015-01-01

Severe postoperative conduction disturbances requiring permanent pacemaker implantation frequently occur following cardiac surgery. Little is known about the long-term pacing requirements and risk factors for pacemaker dependency in this population. We performed a systematic review of the literature addressing rates and predictors of pacemaker dependency in patients requiring permanent pacemaker implantation after cardiac surgery. Using a comprehensive search of the Medline, Web of Science and EMBASE databases, studies were selected for review based on predetermined inclusion and exclusion criteria. A total of 8 studies addressing the endpoint of pacemaker-dependency were identified, while 3 studies were found that addressed the recovery of atrioventricular (AV) conduction endpoint. There were 10 unique studies with a total of 780 patients. Mean follow-up ranged from 6-72 months. Pacemaker dependency rates ranged from 32%-91% and recovery of AV conduction ranged from 16%-42%. There was significant heterogeneity with respect to the definition of pacemaker dependency. Several patient and procedure-specific variables were found to be independently associated with pacemaker dependency, but these were not consistent between studies. Pacemaker dependency following cardiac surgery occurs with variable frequency. While individual studies have identified various perioperative risk factors for pacemaker dependency and non-resolution of AV conduction disease, results have been inconsistent. Well-conducted studies using a uniform definition of pacemaker dependency might identify patients who will benefit most from early permanent pacemaker implantation after cardiac surgery.

Third-generation mobile phones (UMTS) do not interfere with permanent implanted pacemakers.

PubMed

Ismail, Mohamed M; Badreldin, Akmal M A; Heldwein, Matthias; Hekmat, Khosro

2010-07-01

Third-generation mobile phones, UMTS (Universal Mobile Telecommunication System), were recently introduced in Europe. The safety of these devices with regard to their interference with implanted pacemakers is as yet unknown and is the point of interest in this study. The study comprised 100 patients with permanent pacemaker implantation between November 2004 and June 2005. Two UMTS cellular phones (T-Mobile, Vodafone) were tested in the standby, dialing, and operating mode with 23 single-chamber and 77 dual-chamber pacemakers. Continuous surface electrocardiograms (ECGs), intracardiac electrograms, and marker channels were recorded when calls were made by a stationary phone to cellular phone. All pacemakers were tested under a "worst-case scenario," which includes a programming of the pacemaker to unipolar sensing and pacing modes and inducing of a maximum sensitivity setting during continuous pacing of the patient. Patients had pacemaker implantation between June 1990 and April 2005. The mean age was 68.4 +/- 15.1 years. Regardless of atrial and ventricular sensitivity settings, both UMTS mobile phones (Nokia 6650 and Motorola A835) did not show any interference with all tested pacemakers. In addition, both cellular phones did not interfere with the marker channels and the intracardiac ECGs of the pacemakers. Third-generation mobile phones are safe for patients with permanent pacemakers. This is due to the high-frequency band for this system (1,800-2,200 MHz) and the low power output between 0.01 W and 0.25 W.

Transfemoral access when superior venous approach is not feasible equals overall success of permanent pacemaker implantation. Ten-year series.

PubMed

García Guerrero, Juan J; Fernández de la Concha Castañeda, Joaquín; Doblado Calatrava, Manuel; Redondo Méndez, Ángel; Lázaro Medrano, Manuel; Merchán Herrera, Antonio

2017-06-01

When permanent pacemaker implantation is not possible or advisable via superior venous access (i.e., axillary or subclavian veins), safe and feasible surgical alternatives are required. The femoral approach is relatively unknown and seldom studied. This single-center study analyzed 10-year outcomes of a femoral implantation approach. Data about the implantation procedure (indication, approach, lead and pacemaker models, complications), patient characteristics (age, sex, medications, comorbidities), and follow-up were analyzed for all permanent pacemaker implantations using the femoral approach between June 2001 and June 2011. A permanent pacemaker was implanted with the femoral approach in 50 patients (mean age, 76 years [range: 45-96], 31 [61%] men). The most frequent indication was atrioventricular block, associated with sinus rhythm in 30 patients and with atrial fibrillation in eight patients. Overall, 20 patients (40%) were treated with oral anticoagulants postimplantation. Mean implantation time was 64 minutes (range: 20-210) and mean fluoroscopy time was 6.7 minutes (range: 0.2-50). Minimum follow-up window was 1 year (June 2012), with a mean of 50 months [range: 1-113]). No deaths, septic episodes, or severe complications were associated with the procedure, acute or long-term. Follow-up data were available for 46 patients, of who 21 (46%) died during follow-up (mean age, 87 years [range: 73-101]). No cause of death was associated with the femoral technique. Permanent pacemaker implantation through femoral access is not difficult for an experienced implant surgeon. Outcomes were comparable to systems implanted by superior venous approach, and no severe complications were observed at 10-year follow-up. © 2017 Wiley Periodicals, Inc.

The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

PubMed

Ritter, Philippe; Duray, Gabor Z; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight

2015-05-01

Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Cardiac MRI in patients with complex CHD following primary or secondary implantation of MRI-conditional pacemaker system.

PubMed

Al-Wakeel, Nadya; O h-Ici, Darach; Schmitt, Katharina R; Messroghli, Daniel R; Riesenkampff, Eugénie; Berger, Felix; Kuehne, Titus; Peters, Bjoern

2016-02-01

In patients with CHD, cardiac MRI is often indicated for functional and anatomical assessment. With the recent introduction of MRI-conditional pacemaker systems, cardiac MRI has become accessible for patients with pacemakers. The present clinical study aims to evaluate safety, susceptibility artefacts, and image reading of cardiac MRI in patients with CHD and MRI-conditional pacemaker systems. Material and methods CHD patients with MRI-conditional pacemaker systems and a clinical need for cardiac MRI were examined with a 1.5-T MRI system. Lead function was tested before and after MRI. Artefacts and image readings were evaluated using a four-point grading scale. A total of nine patients with CHD (mean age 34.0 years, range 19.5-53.6 years) received a total of 11 cardiac MRI examinations. Owing to clinical indications, seven patients had previously been converted from conventional to MRI-conditional pacemaker systems. All MRI examinations were completed without adverse effects. Device testing immediately after MRI and at follow-up showed no alteration of pacemaker device and lead function. Clinical questions could be addressed and answered in all patients. Cardiac MRI can be performed safely with high certainty of diagnosis in CHD patients with MRI-conditional pacemaker systems. In case of clinically indicated lead and box changing, CHD patients with non-MRI-conditional pacemaker systems should be considered for complete conversion to MRI-conditional systems.

Minimally Invasive Epicardial Pacemaker Implantation in Neonates with Congenital Heart Block.

PubMed

Costa, Roberto; Silva, Katia Regina da; Martinelli Filho, Martino; Carrillo, Roger

2017-10-01

Few studies have characterized the surgical outcomes following epicardial pacemaker implantation in neonates with congenital complete atrioventricular block (CCAVB). This study sought to assess the long-term outcomes of a minimally invasive epicardial approach using a subxiphoid access for pacemaker implantation in neonates. Between July 2002 and February 2015, 16 consecutive neonates underwent epicardial pacemaker implantation due to CCAVB. Among these, 12 (75.0%) had congenital heart defects associated with CCAVB. The patients had a mean age of 4.7 ± 5.3 days and nine (56.3%) were female. Bipolar steroid-eluting epicardial leads were implanted in all patients through a minimally invasive subxiphoid approach and fixed on the diaphragmatic ventricular surface. The pulse generator was placed in an epigastric submuscular position. All procedures were successful, with no perioperative complications or early deaths. Mean operating time was 90.2 ± 16.8 minutes. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 4.1 ± 3.9 years. Three children underwent pulse generator replacement due to normal battery depletion at 4.0, 7.2, and 9.0 years of age without the need of ventricular lead replacement. There were two deaths at 12 and 325 days after pacemaker implantation due to bleeding from thrombolytic use and progressive refractory heart failure, respectively. Epicardial pacemaker implantation through a subxiphoid approach in neonates with CCAVB is technically feasible and associated with excellent surgical outcomes and pacing lead longevity.

Successful pacing using a batteryless sunlight-powered pacemaker.

PubMed

Haeberlin, Andreas; Zurbuchen, Adrian; Schaerer, Jakob; Wagner, Joerg; Walpen, Sébastien; Huber, Christoph; Haeberlin, Heinrich; Fuhrer, Juerg; Vogel, Rolf

2014-10-01

Today's cardiac pacemakers are powered by batteries with limited energy capacity. As the battery's lifetime ends, the pacemaker needs to be replaced. This surgical re-intervention is costly and bears the risk of complications. Thus, a pacemaker without primary batteries is desirable. The goal of this study was to test whether transcutaneous solar light could power a pacemaker. We used a three-step approach to investigate the feasibility of sunlight-powered cardiac pacing. First, the harvestable power was estimated. Theoretically, a subcutaneously implanted 1 cm(2) solar module may harvest ∼2500 µW from sunlight (3 mm implantation depth). Secondly, ex vivo measurements were performed with solar cells placed under pig skin flaps exposed to a solar simulator and real sunlight. Ex vivo measurements under real sunlight resulted in a median output power of 4941 µW/cm(2) [interquartile range (IQR) 3767-5598 µW/cm(2), median skin flap thickness 3.0 mm (IQR 2.7-3.3 mm)]. The output power strongly depended on implantation depth (ρSpearman = -0.86, P < 0.001). Finally, a batteryless single-chamber pacemaker powered by a 3.24 cm(2) solar module was implanted in vivo in a pig to measure output power and to pace. In vivo measurements showed a median output power of >3500 µW/cm(2) (skin flap thickness 2.8-3.84 mm). Successful batteryless VVI pacing using a subcutaneously implanted solar module was performed. Based on our results, we estimate that a few minutes of direct sunlight (irradiating an implanted solar module) allow powering a pacemaker for 24 h using a suitable energy storage. Thus, powering a pacemaker by sunlight is feasible and may be an alternative energy supply for tomorrow's pacemakers. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Pacemaker Dependency after Cardiac Surgery: A Systematic Review of Current Evidence

PubMed Central

2015-01-01

Background Severe postoperative conduction disturbances requiring permanent pacemaker implantation frequently occur following cardiac surgery. Little is known about the long-term pacing requirements and risk factors for pacemaker dependency in this population. Methods We performed a systematic review of the literature addressing rates and predictors of pacemaker dependency in patients requiring permanent pacemaker implantation after cardiac surgery. Using a comprehensive search of the Medline, Web of Science and EMBASE databases, studies were selected for review based on predetermined inclusion and exclusion criteria. Results A total of 8 studies addressing the endpoint of pacemaker-dependency were identified, while 3 studies were found that addressed the recovery of atrioventricular (AV) conduction endpoint. There were 10 unique studies with a total of 780 patients. Mean follow-up ranged from 6–72 months. Pacemaker dependency rates ranged from 32%-91% and recovery of AV conduction ranged from 16%-42%. There was significant heterogeneity with respect to the definition of pacemaker dependency. Several patient and procedure-specific variables were found to be independently associated with pacemaker dependency, but these were not consistent between studies. Conclusions Pacemaker dependency following cardiac surgery occurs with variable frequency. While individual studies have identified various perioperative risk factors for pacemaker dependency and non-resolution of AV conduction disease, results have been inconsistent. Well-conducted studies using a uniform definition of pacemaker dependency might identify patients who will benefit most from early permanent pacemaker implantation after cardiac surgery. PMID:26470027

The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation.

PubMed

Esmaiel, Abdullah; Hassan, Jeremy; Blenkhorn, Fay; Mardigyan, Vartan

2016-05-01

The Agency for Healthcare Research and Quality in the United States recommends the use of ultrasound (US) for central venous access to improve patient outcomes. However, in a recent publication, US is still underutilized for axillary vein access during pacemaker implantation. We sought to describe a technique for US-guided axillary vein access during pacemaker implantation and to report complication rates and success rate. Retrospective data collection included success rate and complications on all pacemaker implants by one operator since implementing the systematic use of US at our institution, from November 2012 to January 2015. For the last 59 cases, data were collected prospectively to include time of venous access and number of attempts. A total of 403 consecutive patients were included in the analysis. Two leads were implanted in 255 cases and one lead was implanted in 148 cases. The rate of successful US-guided access was 99.25%. There were no access-related complications. The average number of venipuncture attempts was 1.18 per patient. The average time to obtain venous access was 2.24 minutes including the time to apply the sterile US sleeve. The described technique has the potential to improve the success rate of axillary vein access and minimize complications during pacemaker implantation. ©2016 Wiley Periodicals, Inc.

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

Implantable cardioverter defibrillator - discharge

MedlinePlus

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

Right bundle branch block without overt heart disease predicts higher risk of pacemaker implantation: the study of atomic-bomb survivors.

PubMed

Kusumoto, Saburo; Kawano, Hiroaki; Makita, Naomasa; Ichimaru, Shinichiro; Kaku, Takashi; Haruta, Daisuke; Hida, Ayumi; Sera, Nobuko; Imaizumi, Misa; Nakashima, Eiji; Maemura, Koji; Akahoshi, Masazumi

2014-06-01

We investigated the clinical course of complete right bundle branch block (RBBB) or RBBB with axis deviation (AD) in terms of subsequent pacemaker implantation for high-degree atrioventricular (AV) block or sick sinus syndrome (SSS). Among the 16,170 atomic-bomb survivors in our biennial health examination between July 1967 and December 2010, we detected 520 newly-acquired RBBB subjects with no organic heart disease, and selected 1038 age- (at RBBB diagnosis) and sex-matched subjects without RBBB to serve as comparison subjects. Multivariate Cox regression analysis was used to estimate the hazard ratios (HRs) for the risk of pacemaker implantation due to all causes, AV block or SSS between RBBB and comparison subjects and between RBBB subjects with and without AD. The risk of pacemaker implantation for RBBB was 4.79 (95% confidence interval [CI] 1.89-12.58; P=0.001), 3.77 (95% CI, 1.09-13.07; P=0.036), and 6.28 (95% CI, 1.24-31.73, P=0.026) when implantation was for all causes, AV block and SSS, respectively. RBBB subjects with AD had a higher risk for all-cause pacemaker implantation than subjects without AD (HR, 3.03; 95% CI, 1.00-9.13, P=0.049). RBBB subjects with AD were younger than subjects without AD at the time of RBBB diagnosis (59.4±7.6 vs 74.4±3.1 years old, P=0.019), and their progression from diagnosis to pacemaker implantation took longer (15.1±6.6 vs 6.4±3.0 years, P=0.032). RBBB, especially with AD, progresses to AV block and SSS that requires pacemaker implantation; the mechanisms by which the conduction defect progresses differ among patients with and without AD. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Implantable automatic scanning pacemaker for termination of supraventricular tachycardia.

PubMed

Spurrell, R A; Nathan, A W; Bexton, R S; Hellestrand, K J; Nappholz, T; Camm, A J

1982-03-01

Thirteen patients suffering from reentrant supraventricular tachycardia have undergone implantation of a scanning extrastimulus pacemaker. This pacemaker is fully implanted and automatic, and it requires no external control device to activate or control it. The pacemaker is activated when tachycardia occurs. After four cycles an extrastimulus is induced with a preset coupling time from a sensed intracardiac potential, and every four cycles thereafter a further extrastimulus occurs, but on each occasion there is a decrement in coupling cycle by 6 ms until 90 ms of the cardiac cycle has been scanned by extrastimuli. When necessary, two extrastimuli can be introduced with a fixed but preset coupling time between them. Every four beats two extrastimuli are induced but the coupling time between the spontaneous cardiac potential and the first stimulus is decreased by 6 ms until 90 ms of the cardiac cycle has been scanned. The coupling time between the two stimuli is fixed throughout the scan. When termination of tachycardia occurs the successful timing variables are retained in the pacemaker memory so that at the onset of the next episode of tachycardia these settings are used first. Pacemaker pulse width, sensitivity, tachycardia trigger rate, coupling intervals for both stimuli and the use of single or double extrastimuli are all programmable transcutaneously. Three patients required single, and seven patients double ventricular premature stimuli; three patients required double atrial premature stimuli for termination of tachycardia. Despite frequent attacks of tachycardia before implantation, only two patients had a sustained attack of tachycardia after pacemaker implantation.

Characteristics and Prognosis of Pacemaker-Identified New-Onset Atrial Fibrillation in Japanese People.

PubMed

Ogino, Yutaka; Ishikawa, Toshiyuki; Ishigami, Tomoaki; Matsumoto, Katsumi; Hosoda, Junya; Iguchi, Kouhei; Matsushita, Hirooki; Taguchi, Yuka; Horiguchi, Yoriko; Kimura, Kazuo

2017-05-25

The characteristics and prognosis of implanted pacemaker-identified new-onset atrial fibrillation (AF) in Japanese people has not been well evaluated.Methods and Results:A total of 395 consecutive patients with newly implanted pacemakers were retrospectively analyzed between January 2010 and December 2015 at Yokohama City University Hospital. Patients with a prior history of AF, VVI mode pacemaker, congenital heart disease, severe valvular heart disease, and cardiovascular surgery before pacemaker implantation were excluded. Among the remaining patients, 44 (21.3%) developed new AF during follow-up (mean follow-up, 1,115±651 days; range, 9-2,176 days). Patients with new-onset AF had a significantly higher CHADS 2 score (2.09±1.27 vs. 1.31±1.08, P<0.001) and CHA 2 DS 2 -VASc score (3.00±1.39 vs. 2.26±1.19, P<0.001) compared with those without new-onset AF. On Cox regression analysis only age at implantation was significantly correlated with new-onset AF. Interestingly, the incidence of hospitalization due to heart failure was significantly higher in the new-onset AF than in the without new-onset AF group. A total of 21.3% of pacemaker-implanted patients with high CHADS 2 and CHA 2 DS 2 -VASc scores developed new-onset AF during a mean follow-up of 3.1 years; and pacemaker-identified AF was associated with an increased risk of worsening heart failure.

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... asynchronous devices implanted in the human body. (b) Classification. Class III (premarket approval). (c) Date... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... asynchronous devices implanted in the human body. (b) Classification. Class III (premarket approval). (c) Date... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of aortic valve calcification was also associated with a higher pacing rate (OR: 0.55; p = 0.031). Multivariate regression analysis did not show an independent association between depth of implant, valve oversizing, balloon post-dilatation, and the need for pacing post-procedure. Following implantation of the repositionable LOTUS valve, 55% of patients developed LBBB and 32% of patients required a pacemaker during their index hospital admission. Patients with pre-procedural conduction disturbance and non-calcified aortic valves were more likely to need pacing. No other anatomic features were identified with increased pacing requirement with the LOTUS device. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Recovery of Ventriculo-Atrial Conduction after Adrenaline in Patients Implanted with Pacemakers.

PubMed

Cismaru, Gabriel; Gusetu, Gabriel; Muresan, Lucian; Rosu, Radu; Andronache, Marius; Matuz, Roxana; Puiu, Mihai; Mester, Petru; Miclaus, Maria; Pop, Dana; Mircea, Petru Adrian; Zdrenghea, Dumitru

2015-07-01

Ventriculo-atrial (VA) conduction can have negative consequences for patients with implanted pacemakers and defibrillators. There is concern whether impaired VA conduction could recover during stressful situations. Although the influence of isoproterenol and atropine are well established, the effect of adrenaline has not been studied systematically. The objective of this study was to determine if adrenaline can facilitate recovery of VA conduction in patients implanted with pacemakers. A prospective study was conducted on 61 consecutive patients during a 4-month period (April-July 2014). The presence of VA conduction was assessed during the pacemaker implantation procedure. In case of an impaired VA conduction, adrenaline infusio was used as a stress surrogate to test conduction recovery. The indications for pacemaker implantation were: sinus node dysfunction in 18 patients, atrioventricular (AV) block in 40 patients, binodal dysfunction (sinus node+ AV node) in two patients and other (carotid sinus syndrome) in one patient. In the basal state, 15/61 (24.6%) presented spontaneous VA conduction and 46/61 (75.4%) had no VA conduction. After administration of adrenaline, there was VA conduction recovery in 5/46 (10.9%) patients. Adrenaline infusion produced recovery of VA conduction in 10.9% of patients with absent VA conduction in a basal state. Recovery of VA conduction during physiological or pathological stresses could be responsible for the pacemaker syndrome, PMT episodes, or certain implantable cardiac defibrillator detection issues. © 2015 Wiley Periodicals, Inc.

Endocardial Energy Harvesting by Electromagnetic Induction.

PubMed

Zurbuchen, Adrian; Haeberlin, Andreas; Bereuter, Lukas; Pfenniger, Alois; Bosshard, Simon; Kernen, Micha; Philipp Heinisch, Paul; Fuhrer, Juerg; Vogel, Rolf

2018-02-01

cardiac pacemakers require regular medical follow-ups to ensure proper functioning. However, device replacements due to battery depletion are common and account for ∼25% of all implantation procedures. Furthermore, conventional pacemakers require pacemaker leads which are prone to fractures, dislocations or isolation defects. The ensuing surgical interventions increase risks for the patients and costs that need to be avoided. in this study, we present a method to harvest energy from endocardial heart motions. We developed a novel generator, which converts the heart's mechanical into electrical energy by electromagnetic induction. A mathematical model has been introduced to identify design parameters strongly related to the energy conversion efficiency of heart motions and fit the geometrical constraints for a miniaturized transcatheter deployable device. The implemented final design was tested on the bench and in vivo. the mathematical model proved an accurate method to estimate the harvested energy. For three previously recorded heart motions, the model predicted a mean output power of 14.5, 41.9, and 16.9 μW. During an animal experiment, the implanted device harvested a mean output power of 0.78 and 1.7 μW at a heart rate of 84 and 160 bpm, respectively. harvesting kinetic energy from endocardial motions seems feasible. Implanted at an energetically favorable location, such systems might become a welcome alternative to extend the lifetime of cardiac implantable electronic device. the presented endocardial energy harvesting concept has the potential to turn pacemakers into battery- and leadless systems and thereby eliminate two major drawbacks of contemporary systems.

Performance of re-used pacemakers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa

PubMed Central

Jama, Zimasa V; Chin, Ashley; Mayosi, Bongani M; Badri, Motasim

2015-01-01

Objectives Little is known about the performance of re-used pacemakers and implantable cardioverter defibrillators (ICDs) in Africa. We sought to compare the risk of infection and the rate of malfunction of re-used pacemakers and ICDs with new devices implanted at Groote Schuur Hospital in Cape Town, South Africa. Methods This was a retrospective case comparison study of the performance of re-used pacemakers and ICDs in comparison with new devices implanted at Groote Schuur Hospital over a 10-year period. The outcomes were incidence of device infection, device malfunction, early battery depletion, and device removal due to infection, malfunction, or early battery depletion. Results Data for 126 devices implanted in 126 patients between 2003 and 2013 were analysed, of which 102 (81%) were pacemakers (51 re-used and 51 new) and 24 (19%) were ICDs (12 re-used and 12 new). There was no device infection, malfunction, early battery depletion or device removal in either the re-used or new pacemaker groups over the median follow up of 15.1 months [interquartile range (IQR), 1.3–36.24 months] for the re-used pacemakers, and 55.8 months (IQR, 20.3–77.8 months) for the new pacemakers. In the ICD group, no device infection occurred over a median follow up of 35.9 months (IQR, 17.0–70.9 months) for the re-used ICDs and 45.7 months (IQR, 37.6–53.7 months) for the new ICDs. One device delivered inappropriate shocks, which resolved without intervention and with no harm to the patient. This re-used ICD subsequently needed generator replacement 14 months later. In both the pacemaker and ICD groups, there were no procedure-non-related infections documented for the respective follow-up periods. Conclusion No significant differences were found in performance between re-used and new pacemakers and ICDs with regard to infection rates, device malfunction, battery life and device removal for complications. Pacemaker and ICD re-use is feasible and safe and is a viable option for patients with bradyarrhythmias and tachyarrthythmias. PMID:26407220

Automatic management of atrial and ventricular stimulation in a contemporary unselected population of pacemaker recipients: the ESSENTIAL Registry.

PubMed

Biffi, Mauro; Bertini, Matteo; Saporito, Davide; Belotti, Giuseppina; Quartieri, Fabio; Piancastelli, Maurizio; Pucci, Angelo; Boggian, Giulio; Mazzocca, Gian Franco; Giorgi, Davide; Diotallevi, Paolo; Diemberger, Igor; Martignani, Cristian; Pancaldi, Stefano; Ziacchi, Matteo; Marcantoni, Lina; Toselli, Tiziano; Attala, Simone; Iori, Matteo; Bottoni, Nicola; Argnani, Selina; Tomasi, Corrado; Sassone, Biagio; Boriani, Giuseppe

2016-10-01

We investigated the applicability of the Ventricular Capture Control (VCC) and Atrial Capture Control (ACC) algorithms for automatic management of cardiac stimulation featured by Biotronik pacemakers in a broad, unselected population of pacemaker recipients. Ventricular Capture Control and Atrial Capture Control were programmed to work at a maximum adapted output voltage as 4.8 V in consecutive recipients of Biotronik pacemakers. Ambulatory threshold measurements were made 1 and 12 months after pacemaker implant/replacement in all possible pacing/sensing configurations, and were compared with manual measurements. Among 542 patients aged 80 (73-85) years, 382 had a pacemaker implant and 160 a pacemaker replacement. Ventricular Capture Control could work at long term in 97% of patients irrespectively of pacing indication, lead type, and lead service life, performance being superior with discordant pacing/sensing configurations. Atrial Capture Control could work in 93% of patients at 4.8 V maximum adapted voltage and at any pulse width, regardless of pacing indication, lead type, and service life. At 12-month follow-up, a ventricular threshold increase ≥1.5 V had occurred in 4.4% of patients uneventfully owing to VCC functioning. Projected pacemaker longevity at 1 month was strongly correlated with the 12-month estimate, and exceeded 13 years in >60% of patients. These algorithms for automatic management of pacing output ensure patient safety in the event of a huge increase of pacing threshold, while enabling maximization of battery longevity. Their applicability is quite broad in an unselected pacemaker population irrespectively of lead choice and service of life. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

How smart should pacemakers Be?

PubMed

Saoudi, N; Appl, U; Anselme, F; Voglimacci, M; Cribier, A

1999-03-11

The concept of the "smart" pacemaker has been continuously changing during 40 years of progress in technology. When we talk today about smart pacemakers, it means optimal treatment, diagnosis, and follow-up for patients fitting the current indications for pacemakers. So what is smart today becomes accepted as "state of the art" tomorrow. Originally, implantable pacemakers were developed to save lives from prolonged episodes of bradycardia and/or complete heart block. Now, in addition, they improve quality of life via numerous different functions acting under specific conditions, thanks to the introduction of microprocessors. The devices have become smaller, with the miniaturization of the electrical components, without compromising longevity. Nevertheless, there are still some unmatched objectives for these devices, for example, the optimization of cardiac output and the management of atrial arrhythmias in dual-chamber devices. Furthermore, indications continue to evolve, which in turn require new, additional functions. These functions are often very complex, necessitating computerized programming to simplify application. In addition, the follow-up of these devices is time-consuming, as appropriate system performance has to be regularly monitored. A great many of these functions could be automatically performed and documented, thus enabling physicians and paramedical staff to avoid losing time with routine control procedures. In addition, modern pacemakers offer extensive diagnostic functions to help diagnose patient symptoms and pacemaker system problems. Different types of data are available, and their presentation differs from one company to the other. This huge amount of data can only be managed with automatic diagnostic functions. Thus, the smart pacemaker of the near future should offer high flexibility to permit easy programming of available therapies and follow-up, and extensive, easily comprehensible diagnostic functions.

Space Derived Health Aids (Cardiac Pacemaker)

NASA Technical Reports Server (NTRS)

1981-01-01

St. Jude Medical's Cardiac Rhythm Management Division's (formerly known as Pacesetter Systems, Inc.) pacer is a rechargeable cardiac pacemaker that eliminates the recurring need for surgery to implant a new battery. The Programalith is an advanced cardiac pacing system which permits a physician to reprogram a patient's implanted pacemaker without surgery. System consists of a pacemaker, together with a physician's console containing the programmer and a data printer. Signals are transmitted by wireless telemetry. Two-way communications, originating from spacecraft electrical power systems technology, allows physician to interrogate the pacemaker as to the status of the heart, then to fine tune the device to best suit the patient's needs.

Development of Implantable Medical Devices: From an Engineering Perspective

PubMed Central

2013-01-01

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

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

PubMed

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

2012-12-01

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

A pacemaker powered by an implantable biofuel cell operating under conditions mimicking the human blood circulatory system--battery not included.

PubMed

Southcott, Mark; MacVittie, Kevin; Halámek, Jan; Halámková, Lenka; Jemison, William D; Lobel, Robert; Katz, Evgeny

2013-05-07

Biocatalytic electrodes made of buckypaper were modified with PQQ-dependent glucose dehydrogenase on the anode and with laccase on the cathode and were assembled in a flow biofuel cell filled with serum solution mimicking the human blood circulatory system. The biofuel cell generated an open circuitry voltage, Voc, of ca. 470 mV and a short circuitry current, Isc, of ca. 5 mA (a current density of 0.83 mA cm(-2)). The power generated by the implantable biofuel cell was used to activate a pacemaker connected to the cell via a charge pump and a DC-DC converter interface circuit to adjust the voltage produced by the biofuel cell to the value required by the pacemaker. The voltage-current dependencies were analyzed for the biofuel cell connected to an Ohmic load and to the electronic loads composed of the interface circuit, or the power converter, and the pacemaker to study their operation. The correct pacemaker operation was confirmed using a medical device - an implantable loop recorder. Sustainable operation of the pacemaker was achieved with the system closely mimicking human physiological conditions using a single biofuel cell. This first demonstration of the pacemaker activated by the physiologically produced electrical energy shows promise for future electronic implantable medical devices powered by electricity harvested from the human body.

Novel approach to epicardial pacemaker implantation in patients with limited venous access.

PubMed

Costa, Roberto; Scanavacca, Mauricio; da Silva, Kátia Regina; Martinelli Filho, Martino; Carrillo, Roger

2013-11-01

Limited venous access in certain patients increases the procedural risk and complexity of conventional transvenous pacemaker implantation. The purpose of this study was to determine a minimally invasive epicardial approach using pericardial reflections for dual-chamber pacemaker implantation in patients with limited venous access. Between June 2006 and November 2011, 15 patients underwent epicardial pacemaker implantation. Procedures were performed through a minimally invasive subxiphoid approach and pericardial window with subsequent fluoroscopy-assisted lead placement. Mean patient age was 46.4 ± 15.3 years (9 male [(60.0%], 6 female [40.0%]). The new surgical approach was used in patients determined to have limited venous access due to multiple abandoned leads in 5 (33.3%), venous occlusion in 3 (20.0%), intravascular retention of lead fragments from prior extraction in 3 (20.0%), tricuspid valve vegetation currently under treatment in 2 (13.3%), and unrepaired intracardiac defects in 2 (13.3%). All procedures were successful with no perioperative complications or early deaths. Mean operating time for isolated pacemaker implantation was 231.7 ± 33.5 minutes. Lead placement on the superior aspect of right atrium, through the transverse sinus, was possible in 12 patients. In the remaining 3 patients, the atrial lead was implanted on the left atrium through the oblique sinus, the postcaval recess, or the left pulmonary vein recess. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 36.8 ± 25.1 months. Epicardial pacemaker implantation through pericardial reflections is an effective alternative therapy for those patients requiring physiologic pacing in whom venous access is limited. © 2013 Heart Rhythm Society. All rights reserved.

Significant and safe reduction of propofol sedation dose for geriatric population undergoing pacemaker implantation: randomized clinical trial.

PubMed

Hernandez-Perez, Ana Luisa; Gallardo-Hernandez, Ana Gabriela; Ordoñez-Espinosa, German; Martinez-Carrillo, Beatriz; Bermudez-Ochoa, Manuel Gerardo; Revilla-Monsalve, Cristina; Sanchez-Lopez, Jose Antonio; Saturno-Chiu, Guillemo; Leder, Ronald

2018-02-21

A previous multidisciplinary pilot study based on computer simulations for the geriatric population showed that a dose of 0.5 mg/kg/h of propofol could sedate patients older than 65 for pacemaker implantation. The present study validates that the pacemaker implantation can be done in the elderly using 0.5-1 mg/kg/h of propofol with hemodynamic stability. 66 patients from 65 to 88 years old scheduled for pacemaker implantation were randomly assigned one of three doses of propofol. The first group received 2 mg/kg/h of propofol (P2) that is within normal range of the sedation dose. The second group received 1 mg/kg/h (P1) dose and the third group received the dose of 0.5 mg/kg/h (P0.5) according to the simulation-predicted dose for geriatric populations. All patients kept MAP between 76 and 85 mmHg, with no hypotension episodes in any of the groups; therefore, they were all hemodynamically stable during the procedure. BIS was between 80 and 65 during the pacemaker implantation for the three groups, BIS of group P2 was significantly lower than the other groups. BIS in groups P1 and P0.5 was within the appropriated range for moderate sedation. Brice was positive for auditory recalls only when there was arousing noise in the operating room. Moderate sedation, adequate for pacemaker implantation, can be achieved infusing 0.5-1 mg/kg/h of propofol in elderly patients when the patient has proper analgesia management at the device implantation site. The second important condition is to avoid unnecessary and alerting auditory and mechanical stimuli in the operating room, so that the patient will remain calm.

Conduction Abnormalities and Pacemaker Implantations After SAPIEN 3 Vs SAPIEN XT Prosthesis Aortic Valve Implantation.

PubMed

Husser, Oliver; Kessler, Thorsten; Burgdorf, Christof; Templin, Christian; Pellegrini, Costanza; Schneider, Simon; Kasel, Albert Markus; Kastrati, Adnan; Schunkert, Heribert; Hengstenberg, Christian

2016-02-01

Transcatheter aortic valve implantation is increasingly used in patients with aortic stenosis. Post-procedural intraventricular conduction abnormalities and permanent pacemaker implantations remain a serious concern. Recently, the Edwards SAPIEN 3 prosthesis has replaced the SAPIEN XT. We sought to determine the incidences of new-onset intraventricular conduction abnormalities and permanent pacemaker implantations by comparing the 2 devices. We analyzed the last consecutive 103 patients undergoing transcatheter aortic valve implantation with SAPIEN XT before SAPIEN 3 was used in the next 105 patients. To analyze permanent pacemaker implantations and new-onset intraventricular conduction abnormalities, patients with these conditions at baseline were excluded. Electrocardiograms were recorded at baseline, after the procedure, and before discharge. SAPIEN 3 was associated with higher device success (100% vs 92%; P=.005) and less paravalvular leakage (0% vs 7%; P<.001). The incidence of permanent pacemaker implantations was 12.6% (23 of 183) with no difference between the 2 groups (SAPIEN 3: 12.5% [12 of 96] vs SAPIEN XT: 12.6% [11 of 87]; P=.99). SAPIEN 3 was associated with a higher rate of new-onset intraventricular conduction abnormalities (49% vs 27%; P=.007) due to a higher rate of fascicular blocks (17% vs 5%; P=.021). There was no statistically significant difference in transient (29% [20 of 69] vs persistent 19% [12 of 64]; P=.168) left bundle branch blocks (28% [19 of 69] vs 17% [11 of 64]; P=.154) when SAPIEN 3 was compared with SAPIEN XT. We found a trend toward a higher rate of new-onset intraventricular conduction abnormalities with SAPIEN 3 compared with SAPIEN XT, although this did not result in a higher permanent pacemaker implantation rate. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Dosimetric perturbations due to an implanted cardiac pacemaker in MammoSite{sup Registered-Sign} treatment

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

Sung, Wonmo; Kim, Siyong; Kim, Jung-in

2012-10-15

Purpose: To investigate dose perturbations for pacemaker-implanted patients in partial breast irradiation using high dose rate (HDR) balloon brachytherapy. Methods: Monte Carlo (MC) simulations were performed to calculate dose distributions involving a pacemaker in Ir-192 HDR balloon brachytherapy. Dose perturbations by varying balloon-to-pacemaker distances (BPD = 50 or 100 mm) and concentrations of iodine contrast medium (2.5%, 5.0%, 7.5%, and 10.0% by volume) in the balloon were investigated for separate parts of the pacemaker (i.e., battery and substrate). Relative measurements using an ion-chamber were also performed to confirm MC results. Results: The MC and measured results in homogeneous media withoutmore » a pacemaker agreed with published data within 2% from the balloon surface to 100 mm BPD. Further their dose distributions with a pacemaker were in a comparable agreement. The MC results showed that doses over the battery were increased by a factor of 3, compared to doses without a pacemaker. However, there was no significant dose perturbation in the middle of substrate but up to 70% dose increase in the substrate interface with the titanium capsule. The attenuation by iodine contrast medium lessened doses delivered to the pacemaker by up to 9%. Conclusions: Due to inhomogeneity of pacemaker and contrast medium as well as low-energy photons in Ir-192 HDR balloon brachytherapy, the actual dose received in a pacemaker is different from the homogeneous medium-based dose and the external beam-based dose. Therefore, the dose perturbations should be considered for pacemaker-implanted patients when evaluating a safe clinical distance between the balloon and pacemaker.« less

Devices for Arrhythmia

MedlinePlus

... with recurrent arrhythmias, medical devices such as a pacemaker and implantable cardioverter defibrillator (ICD) can help by ... with an ICD Questions to ask your doctor Pacemakers Learn what an artificial pacemaker is, how it ...

Complications of pacemaker therapy in adults with congenital heart disease: a multicenter study.

PubMed

Opić, Petra; van Kranenburg, Matthijs; Yap, Sing-Chien; van Dijk, Arie P; Budts, Werner; Vliegen, Hubert W; van Erven, Lieselot; Can, Anil; Sahin, Gulhan; Theuns, Dominic A M J; Witsenburg, Maarten; Roos-Hesselink, Jolien W

2013-10-09

This study aims to investigate indications and complications of permanent cardiac pacing in adults with congenital heart disease (CHD). Two-hundred and seventy-four CHD patients were identified who underwent permanent pacemaker implantation between 1972 and 2009. The indication for pacing was acquired sinus node or AV node conduction disease (63%), sinus node or AV node conduction disease after cardiac surgery (28%), and drug/arrhythmia-related indications (9%). Patients with complex CHD received a pacemaker at younger age (23 versus 31 years, p<0.0001) and more often received an epicardial pacing system (51% versus 23%, p<0.0001) compared to those with simple or moderate CHD. Twenty-nine patients (10.6%) had a periprocedural complication during the primary pacemaker implantation (general population: 5.2%). The most common acute complications were lead dysfunction (4.0%), bleeding (2.6%), pocket infection (1.5%) and pneumothorax (1.5%). During a median follow-up of 12 years, pacemaker-related complications requiring intervention occurred in 95 patients (34.6%). The most common late pacemaker-related complications included lead failure (24.8%), pacemaker dysfunction/early battery depletion (5.1%), pacemaker migration (4.7%) and erosion (4.7%). Pacemaker implantation at younger age (<18 years) was an independent predictor of late pacemaker-related complication (adjusted hazard ratio 1.68, 95% confidence interval 1.07 to 2.63, p=0.023). The risk of periprocedural complications seems higher in the CHD population compared to the general population and more than one-third of CHD patients encountered a pacemaker-related complication during long-term follow-up. This risk increases for those who receive a pacemaker at younger age. Crown Copyright © 2013. Published by Elsevier Ireland Ltd. All rights reserved.

Ventricular fibrillation induced by coagulating mode bipolar electrocautery during pacemaker implantation in Myotonic Dystrophy type 1 patient.

PubMed

Russo, Vincenzo; Rago, Anna; DI Meo, Federica; Cioppa, Nadia Della; Papa, Andrea Antonio; Russo, Maria Giovanna; Nigro, Gerardo

2014-12-01

The occurrence of ventricular fibrillation, induced by bipolar electrocautery during elective dual chamber pacemaker implantation, is reported in a patient affected by Myotonic Distrophy type 1 with normal left ventricular ejection fraction.

Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

PubMed

Zaman, Sarah; McCormick, Liam; Gooley, Robert; Rashid, Hashrul; Ramkumar, Satish; Jackson, Damon; Hui, Samuel; Meredith, Ian T

2017-07-01

To determine the incidence and predictors of permanent pacemaker (PPM) requirement following transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus TM Valve System (Boston Scientific). Pacemaker implantation is the most common complication following TAVR. Predictors of pacing following TAVR with the Lotus valve have not been systematically assessed. Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited at a single-centre. Patients with a pre-existing PPM were excluded. Baseline ECG, echocardiographic and multiple detector computed tomography as well as procedural telemetry and depth of implantation were independently analyzed in a blinded manner. The primary endpoint was 30-day incidence of pacemaker requirement (PPM implantation or death while pacing-dependent). Multivariate analysis was performed to identify independent predictors of the primary endpoint. A total of 104 consecutive patients underwent TAVR with the Lotus valve with 9/104 (9%) with a pre-existing PPM excluded. New or worsened procedural LBBB occurred in 78%. Thirty-day incidence of the primary pacing endpoint was 28%. The most common indication for PPM implantation was complete heart block (CHB) (69%). Independent predictors of the primary endpoint included pre-existing RBBB (hazard ratio [HR] 2.8, 95% CI 1.1-7.0; P = 0.032) and depth of implantation below the noncoronary cusp (NCC) (HR 2.4, 95% CI 1.0-5.7; P = 0.045). Almost a third of Lotus valve recipients require pacemaker implantation within 30 days. The presence of pre-existing RBBB and the depth of prosthesis implantation below the NCC were significant pacing predictors. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Remote control improves quality of life in elderly pacemaker patients versus standard ambulatory-based follow-up.

PubMed

Comoretto, Rosanna Irene; Facchin, Domenico; Ghidina, Marco; Proclemer, Alessandro; Gregori, Dario

2017-08-01

Health-related quality of life (HRQoL) improves shortly after pacemaker (PM) implantation. No studies have investigated the HRQoL trend for elderly patients with a remote device monitoring follow-up system. Using EuroQol-5D Questionnaire and the PM-specific Assessment of Quality of Life and Related Events Questionnaire, HRQoL was measured at baseline and then repeatedly during the 6 months following PM implantation in a cohort of 42 consecutive patients. Twenty-five patients were followed-up with standard outpatient visits, while 17 used a remote monitoring system. Aquarel scores were significantly higher in patients with remote device monitoring system regarding chest discomfort and arrhythmia subscales the first month after PM implant and remained stable until 6 months. Remote monitoring affected the rate of HRQoL improvement in the first 3 months after pacemaker implantation more than ambulatory follow-up. Remote device monitoring has a significant impact on HRQoL in pacemaker patients, increasing its levels up to 6 months after implant. © 2017 John Wiley & Sons, Ltd.

Myopotential inhibition of a bipolar pacemaker caused by electrode insulation defect.

PubMed Central

Amikam, S; Peleg, H; Lemer, J; Riss, E

1977-01-01

A patient is described in whom myopotentials orginating from the anterior abdominal wall muscle suppressed the implanted demand pacemaker despite its bipolar mode of action. This phenomenon was shown by simultaneous recording of the electrocardiogram the electromyogram. At operation, a defect in the insulation of a previously repaired epicardial electrode was found lying in close proximity to these muscles. After repair of the insulation defect, normal pacemaker function was restored. It is suggested that the myopotentials leaked into the pacing system through the insulation defect, thereby suppressing the demand unit, which maintained its bipolar mode of pacing throughout. Images PMID:145229

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.

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.

Conduction disturbances after TAVR: Electrophysiological studies and pacemaker dependency.

PubMed

Makki, Nader; Dollery, Jenn; Jones, Danielle; Crestanello, Juan; Lilly, Scott

Permanent pacemaker (PPM) placement occurs in 5-20% of patients after transcatheter aortic valve replacement (TAVR). Although predictors of pacemaker implantation have been established, features that predispose patients to pacemaker utilization on follow up have not been widely reported. We performed a retrospective review of patients undergoing commercial TAVR between 2011 and 2016. We collated patients that underwent in-hospital PPM implantation and had a follow up of at least 3months. Data abstraction was performed for electrophysiological studies (EPS), pacemaker indication, timing, and device interrogation for pacemaker dependency on follow up. A total of 24 patients received in-hospital PPM post-TAVR (14% of total cohort), and mean follow up was 22months. Indications for PPM included resting complete heart block (CHB; 15/24, 63%), left bundle branch block and abnormal electrophysiological study (EPS; 7/24, 29%), alternating bundle branch block (1/24, 4%) and tachy-brady syndrome (1/24, 4%). Pacemaker dependency (underlying ventricular asystole, complete heart block, or >50% pacing) occurred in 8/24 patients (33%) during follow-up, 7 of whom had resting CHB, and one with CHB invoked during EPS. Pacemaker dependency after TAVR is common among those that exhibited CHB, but not among those with a prolonged HV delay during EPS. Although preliminary, these observations are relevant to management of rhythm disturbances after TAVR, and may inform the practice of EPS-based PPM implantation. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

Congestive heart failure caused by transvenous pacemaker lead prolapse and associated right ventricular outflow tract obstruction in a dog.

PubMed

Djani, D M; Coleman, A E; Rapoport, G S; Schmiedt, C W; Layher, J; Thomason, J D

2016-12-01

A 16-year-old dog was presented for cough as well as increased respiratory rate and effort three years after implantation of a single-lead transvenous artificial pacemaker system. Thoracic radiographs and echocardiography disclosed prolapse of the pacemaker lead into the main pulmonary artery, causing severe pulmonary insufficiency and right-sided volume overload. Repositioning of the pacemaker lead led to improvement of pulmonary insufficiency and resolution of the dog's clinical signs and cavitary effusions. This case describes a late complication of pacemaker implantation that may be avoided by appropriate use of the manufacturer-provided anchoring sleeve and avoidance of excessive lead redundancy. Copyright © 2016 Elsevier B.V. All rights reserved.

Transcatheter leadless pacemaker implantation in a patient with a transvenous dual-chamber pacemaker already in place.

PubMed

Karjalainen, Pasi P; Nammas, Wail; Paana, Tuomas

2016-01-01

An 83-year-old lady had a DDDR pacemaker inserted in 1997 for symptomatic atrioventricular block. She underwent battery replacement in 2008. In 2010, she developed atrial fibrillation; the pacemaker was switched to VVIR mode. During the last 2years, ventricular lead threshold increased progressively. In December 2015, she presented for elective battery replacement. After successful battery replacement, the ventricular lead threshold remained high; therefore, we implanted a leadless transcatheter pacemaker, via femoral vein access, using a dedicated catheter delivery system. Electrical measurements at this stage revealed a pacing threshold of 0.28V at 0.24msec, and an impedance of 650Ω. Copyright © 2016 Elsevier Inc. All rights reserved.

The pacemaker-twiddler's syndrome: an infrequent cause of pacemaker failure.

PubMed

Salahuddin, Mohammad; Cader, Fathima Aaysha; Nasrin, Sahela; Chowdhury, Mashhud Zia

2016-01-20

The pacemaker-twiddler's syndrome is an uncommon cause of pacemaker malfunction. It occurs due to unintentional or deliberate manipulation of the pacemaker pulse generator within its skin pocket by the patient. This causes coiling of the lead and its dislodgement, resulting in failure of ventricular pacing. More commonly reported among elderly females with impaired cognition, the phenomenon usually occurs in the first year following pacemaker implantation. Treatment involves repositioning of the dislodged leads and suture fixation of the lead and pulse generator within its pocket. An 87 year old Bangladeshi lady who underwent a single chamber ventricular pacemaker (VVI mode: i.e. ventricle paced, ventricle sensed, inhibitory mode) implantation with the indication of complete heart block, and presented to us again 7 weeks later, with syncopal attacks. She admitted to repeatedly manipulating the pacemaker generator in her left pectoral region. Physical examination revealed a heart rate of 42 beats/minute, blood pressure 140/80 mmHg and bilateral crackles on lung auscultation. She had no cognitive deficit. An immediate electrocardiogram showed complete heart block with pacemaker spikes and failure to capture. Chest X-ray showed coiled and retracted right ventricular lead and rotated pulse generator. An emergent temporary pace maker was set at a rate of 60 beats per minute. Subsequently, she underwent successful lead repositioning with strong counselling to avoid further twiddling. Twiddler's syndrome should be considered as a cause of pacemaker failure in elderly patients presenting with bradyarrythmias following pacemaker implantation. Chest X-ray and electrocardiograms are simple and easily-available first line investigations for its diagnosis. Lead repositioning is required, however proper patient education and counselling against further manipulation is paramount to long-term management.

A survey of cardiac implantable electronic device implantation in India: By Indian Society of Electrocardiology and Indian Heart Rhythm Society.

PubMed

Shenthar, Jayaprakash; Bohra, Shomu; Jetley, Vinay; Vora, Amit; Lokhandwala, Yash; Nabar, Ashish; Naik, Ajay; Calambur, Narsimhan; Gupta, S B

2016-01-01

There is limited data regarding the demographics and type of cardiac implantable electronic device (CIED) in India. The aim of this survey was to define trends in CIED implants, which included permanent pacemakers (PM), intracardiac defibrillators (ICD), and cardiac resynchronization therapy pacemakers and defibrillators (CRT-P/D) devices in India. The survey was the initiative of the Indian Society of Electrocardiology and the Indian Heart Rhythm Society. The type of CIED used, their indications, demographic characteristics, clinical status and co-morbidities were collected using a survey form over a period of 1 year. 2117 forms were analysed from 136 centers. PM for bradyarrhythmic indication constituted 80% of the devices implanted with ICD's and CRT-P/D forming approximately 10% each. The most common indication for PM implantation was complete atrio-ventricular block (76%). Single chamber (VVI) pacemakers formed 54% of implants, majority in males (64%). The indication for ICD implantation was almost equal for primary and secondary prevention. A single chamber ICD was most commonly implanted (65%). Coronary artery disease was the etiology in 58.5% of patients with ICD implants. CRT pacemakers were implanted mostly in patients with NYHA III/IV (82%), left ventricular ejection fraction <0.35 (88%) with CRT-P being most commonly used (57%). A large proportion of CIED implants in India are PM for bradyarrhythmic indications, predominantly AV block. ICD's are implanted almost equally for primary and secondary prophylaxis. Most CRT devices are implanted for NYHA Class III. There is a male predominance for implantation of CIED. Copyright © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

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

PubMed

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

2015-10-01

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

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

PubMed

Carrasco, Francisco; Anguita, Manuel; Ruiz, Martín; Castillo, Juan Carlos; Delgado, Mónica; Mesa, Dolores; Romo, Elias; Pan, Manuel; Suárez de Lezo, Jose

2016-06-01

Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

Tachycardia-bradycardia syndrome: Electrophysiological mechanisms and future therapeutic approaches (Review)

PubMed Central

Tse, Gary; Liu, Tong; Li, Ka Hou Christien; Laxton, Victoria; Wong, Andy On-Tik; Chan, Yin Wah Fiona; Keung, Wendy; Chan, Camie W.Y.; Li, Ronald A.

2017-01-01

Sick sinus syndrome (SSS) encompasses a group of disorders whereby the heart is unable to perform its pacemaker function, due to genetic and acquired causes. Tachycardia-bradycardia syndrome (TBS) is a complication of SSS characterized by alternating tachycardia and bradycardia. Techniques such as genetic screening and molecular diagnostics together with the use of pre-clinical models have elucidated the electrophysiological mechanisms of this condition. Dysfunction of ion channels responsible for initiation or conduction of cardiac action potentials may underlie both bradycardia and tachycardia; bradycardia can also increase the risk of tachycardia, and vice versa. The mainstay treatment option for SSS is pacemaker implantation, an effective approach, but has disadvantages such as infection, limited battery life, dislodgement of leads and catheters to be permanently implanted in situ. Alternatives to electronic pacemakers are gene-based bio-artificial sinoatrial node and cell-based bio-artificial pacemakers, which are promising techniques whose long-term safety and efficacy need to be established. The aim of this article is to review the different ion channels involved in TBS, examine the three-way relationship between ion channel dysfunction, tachycardia and bradycardia in TBS and to consider its current and future therapies. PMID:28204831

Tachycardia-bradycardia syndrome: Electrophysiological mechanisms and future therapeutic approaches (Review).

PubMed

Tse, Gary; Liu, Tong; Li, Ka Hou Christien; Laxton, Victoria; Wong, Andy On-Tik; Chan, Yin Wah Fiona; Keung, Wendy; Chan, Camie W Y; Li, Ronald A

2017-03-01

Sick sinus syndrome (SSS) encompasses a group of disorders whereby the heart is unable to perform its pacemaker function, due to genetic and acquired causes. Tachycardia‑bradycardia syndrome (TBS) is a complication of SSS characterized by alternating tachycardia and bradycardia. Techniques such as genetic screening and molecular diagnostics together with the use of pre-clinical models have elucidated the electrophysiological mechanisms of this condition. Dysfunction of ion channels responsible for initiation or conduction of cardiac action potentials may underlie both bradycardia and tachycardia; bradycardia can also increase the risk of tachycardia, and vice versa. The mainstay treatment option for SSS is pacemaker implantation, an effective approach, but has disadvantages such as infection, limited battery life, dislodgement of leads and catheters to be permanently implanted in situ. Alternatives to electronic pacemakers are gene‑based bio‑artificial sinoatrial node and cell‑based bio‑artificial pacemakers, which are promising techniques whose long-term safety and efficacy need to be established. The aim of this article is to review the different ion channels involved in TBS, examine the three‑way relationship between ion channel dysfunction, tachycardia and bradycardia in TBS and to consider its current and future therapies.

Surgical outcome of Fontan conversion and arrhythmia surgery: Need a pacemaker?

PubMed

Terada, Takafumi; Sakurai, Hajime; Nonaka, Toshimichi; Sakurai, Takahisa; Sugiura, Junya; Taneichi, Tetsuyoshi; Ohtsuka, Ryohei

2014-07-01

Atrial tachyarrhythmias are frequent complications in the late period after the Fontan procedure, and important risk factors for a poor prognosis. The impact of Fontan conversion and arrhythmia surgery in failed Fontan patients has been described in many reports. We evaluated our experience with Fontan conversion procedures, concomitant arrhythmia surgery, and pacemaker implantation. We reviewed the hospital records of 25 consecutive patients who underwent a Fontan conversion procedure from January 2004 to March 2012. Twenty-four patients had arrhythmia surgery using cryoablation and radiofrequency ablation at the time of conversion. A bilateral atrial maze procedure was performed in 6 patients, right-side maze in 15, and isthmus block in 3. Three patients with a diagnosis of corrected transposition of the great arteries underwent simultaneous pacemaker implantation electively. There was no early death and one late death during a mean follow-up period of 21.2 months. Three tachyarrhythmia recurrences developed, and there were 4 occurrences of sinus bradycardia. Five of these patients required postoperative pacemaker implantation. The mid-term results of Fontan conversion and arrhythmia surgery in our institute were satisfactory. The occurrence of unexpected postoperative pacemaker requirement was high in the patients who underwent a right atrial or bilateral atrial maze procedure. Pacemaker or lead implantation is recommended for patients planned to undergo a right-side or full maze procedure. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

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,…

Management of congenital complete heart block in a low-birth-weight infant.

PubMed

Nakanishi, Keisuke; Takahashi, Ken; Kawasaki, Shiori; Fukunaga, Hideo; Amano, Atsushi

2016-10-01

Pacemaker implantation in infants during the early postnatal period is difficult because of their small body size and susceptibility to infection. We describe the successful pacemaker implantation for complete heart block in an infant weighing 803 g. © 2016 Wiley Periodicals, Inc.

Clinical use of isotope cardiac pacemakers (in German)

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

Wagner, J.; Kreutzberg, B.

1973-01-01

Plutoninm-235 having a half-life of 86.4 yrs has proved suitable as a long-life energy source for a cardiac pacemaker. The radiation dose of this pacemaker is below the I. C. R. P.-recommended values. As the isotope pacemaker costs three times as much as a conventional pacemaker, the merits of implanting an isotope pacemaker vs. the conventional kind are discussed. A survey is given of the cases in which an isotope pacemaker has been used. (GE)

Gene- and cell-based bio-artificial pacemaker: what basic and translational lessons have we learned?

PubMed Central

Li, RA

2012-01-01

Normal rhythms originate in the sino-atrial node, a specialized cardiac tissue consisting of only a few thousands of pacemaker cells. Malfunction of pacemaker cells due to diseases or aging leads to rhythm generation disorders (for example, bradycardias and sick-sinus syndrome (SSS)), which often necessitate the implantation of electronic pacemakers. Although effective, electronic devices are associated with such shortcomings as limited battery life, permanent implantation of leads, lead dislodging, the lack of autonomic responses and so on. Here, various gene- and cell-based approaches, with a particular emphasis placed on the use of pluripotent stem cells and the hyperpolarization-activated cyclic nucleotide-gated-encoded pacemaker gene family, that have been pursued in the past decade to reconstruct bio-artificial pacemakers as alternatives will be discussed in relation to the basic biological insights and translational regenerative potential. PMID:22673497

Gene- and cell-based bio-artificial pacemaker: what basic and translational lessons have we learned?

PubMed

Li, R A

2012-06-01

Normal rhythms originate in the sino-atrial node, a specialized cardiac tissue consisting of only a few thousands of nodal pacemaker cells. Malfunction of pacemaker cells due to diseases or aging leads to rhythm generation disorders (for example, bradycardias and sick-sinus syndrome (SSS)), which often necessitate the implantation of electronic pacemakers. Although effective, electronic devices are associated with such shortcomings as limited battery life, permanent implantation of leads, lead dislodging, the lack of autonomic responses and so on. Here, various gene- and cell-based approaches, with a particular emphasis placed on the use of pluripotent stem cells and the hyperpolarization-activated cyclic nucleotide-gated-encoded pacemaker gene family, that have been pursued in the past decade to reconstruct bio-artificial pacemakers as alternatives will be discussed in relation to the basic biological insights and translational regenerative potential.

Wireless power transfer for a pacemaker application.

PubMed

Vulfin, Vladimir; Sayfan-Altman, Shai; Ianconescu, Reuven

2017-05-01

An artificial pacemaker is a small medical device that uses electrical impulses, delivered by electrodes contracting the heart muscles, to regulate the beating of the heart. The pacemaker is implanted under the skin, and uses for many years regular non-rechargeable batteries. However, the demand for rechargeable batteries in pacemakers increased, and the aim of this work is to design an efficient charging system for pacemakers.

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

Lanciego, Carlos; Rodriguez, Mario; Rodriguez, Adela

The use of metallic stents in the management of benign and malignant superior vena cava syndrome (SVCS) is well documented. Symptomatic stenosis or occlusion of the SVC is a rare complication of a transvenous permanent pacemaker implant. Suggested treatments have included anticoagulation therapy, thrombolysis, balloon angioplasty and surgery. More recently, endovascular stenting has evolved as an attractive alternative but the data available in the literature are limited. We describe a case in which venous stenting with a Wallstent endoprosthesis was used successfully. The patient remains symptom free and with normal pacemaker function 36 months later.

The challenge of staphylococcal pacemaker endocarditis in a patient with transposition of the great arteries endocarditis in congenital heart disease

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

Ch'ng, Julie; Chan, William; Lee, Paul

2003-06-01

Staphylococcus aureus is a leading cause of septicaemia and infective endocarditis. The overall incidence of staphylococcal bacteraemia is increasing, contributing to 16% of all hospital-acquired bacteraemias. The use of cardiac pacemakers has revolutionized the management of rhythm disturbances, yet this has also resulted in a group of patients at risk of pacemaker lead endocarditis and seeding in the range of 1% to 7%. We describe a 26-year-old man with transposition of the great arteries who had a pacemaker implanted and presented with S. aureus septicaemia 2 years postpacemaker implantation and went on to develop pacemaker lead endocarditis. This report illustratesmore » the risk of endocarditis in the population with congenital heart disease and an intracardiac device.« less

Risk Factors For Bradycardia Requiring Pacemaker Implantation In Patients With Atrial Fibrillation

PubMed Central

Barrett, Tyler W.; Abraham, Robert L.; Jenkins, Cathy A.; Russ, Stephan; Storrow, Alan B.; Darbar, Dawood

2012-01-01

Symptomatic bradycardia may complicate atrial fibrillation (AF) and necessitate a permanent pacemaker. Identifying patients at increased risk for symptomatic bradycardia may reduce associated morbidities and healthcare costs. We investigated predictors for developing bradycardia requiring a permanent pacemaker among AF patients. We reviewed records of all patients treated for AF/flutter in an academic hospital’s emergency department from 8/1/2005 to 8/30/2008. We determined survival and presence of a pacemaker as of 11/1/2011. Cases were defined as patients with pacemakers placed for bradycardia after their AF diagnoses. Patients without a pacemaker who were followed at our hospital comprised the controls. We identified a priori variables for the logistic regression analysis. We fit a post-hoc model adjusting for AF type and atrioventricular nodal blocker (AVN) use. Of the 362 patients in our cohort, 119 cases had permanent pacemakers implanted for bradycardia subsequent to AF diagnosis and 243 controls were alive without a pacemaker. Median and interquartile range follow-up time was 4.5 (3.8 – 5.4) years. Odds ratios and 95% confidence intervals were determined for age at time of AF diagnosis (1.02 [1, 1.04]), female (1.58 [0.95, 2.63]), prior heart failure (2.72 [1.47, 5.01]), and African-American (0.33 [0.12, 0.94]). Post-hoc model identified permanent AF (2.99 [1.61, 5.57]) and AVN use (1.43 [0.85, 2.4]). In conclusion, among AF patients, heart failure and permanent AF each nearly triple the odds of developing bradycardia requiring a permanent pacemaker; while not statistically significant, our results suggest that women are more likely and African-Americans less likely to develop bradycardia requiring pacemaker implantation. PMID:22840846

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

Magnetic Resonance Imaging in Nondependent Pacemaker Patients with Pacemakers and Defibrillators with a Nearly Depleted Battery.

PubMed

Okamura, Hideo; Padmanabhan, Deepak; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Jondal, Mary; Romme, Abby L; Cha, Yong-Mei; Asirvatham, Samuel J; Felmlee, Joel P; Friedman, Paul A

2017-05-01

Magnetic resonance imaging (MRI) in patients with non-MRI-conditional cardiac implantable electronic devices (CIEDs) has been shown to be safe when performed under closely monitored protocols. However, the safety of MRI in patients with devices with a nearly depleted battery has not been reported. Prospective data were collected between January 2008 and May 2015 in patients with non-MRI-conditional CIEDs undergoing clinically indicated MRI under institutional protocol. Patients who were pacemaker dependent were excluded. Patients whose devices were at elective replacement indicator (ERI) at the time of MRI or close to ERI (ERI or replacement for battery depletion within 3 months of scan) were identified through database review and analyzed for clinical events. MRI scans (n = 569) were performed in 442 patients. Of these, we identified 13 scans performed with a nearly depleted battery in nine patients. All scans with implantable cardioverter defibrillators (ICDs, n = 9) were uneventful. However, two scans with pacemakers close to ERI resulted in a power-on-reset (PoR) event. One scan with a pacemaker close to ERI that was programmed to DOO mode reached ERI during MRI and automatically changed to VVI mode. Additionally, one scan with a pacemaker at ERI did not allow programming. All pacemakers with events were implanted before 2005. Patients with pacemakers and ICDs with a nearly depleted battery can safely undergo MRI when patients are not pacemaker dependent. Attention should be paid because old devices can result in PoR or ERI during MRI, which may lead to oversensing and inhibition of pacing. © 2017 Wiley Periodicals, Inc.

Outcome and management of pacemaker-induced superior vena cava syndrome.

PubMed

Fu, Hai-Xia; Huang, Xin-Miao; Zhong, Li; Osborn, Michael J; Bjarnason, Haraldur; Mulpuru, Siva; Zhao, Xian-Xian; Friedman, Paul A; Cha, Yong-Mei

2014-11-01

We aimed to determine the long-term outcomes of percutaneous lead extraction and stent placement in patients with pacemaker-induced superior vena cava (SVC) syndrome. The study retrospectively screened patients who underwent lead extraction followed by central vein stent implantation at Mayo Clinic (Rochester, MN, USA), from January 2005 to December 2012, to identify the patients with pacemaker-induced SVC syndrome. Demographic, clinical, and follow-up characteristics of those patients were collected from electronic medical records. Six cases were identified. The mean (standard deviation) age was 56 (15) years (male, 67%). All patients had permanent dual-chamber pacemakers, with a mean 11-year history of pacemaker placement. The entire device system was explanted in five patients; one patient had a 21-year-old pacemaker lead that could not be removed. Eight stents were implanted in six patients: five patients had one stent, one patient had three. A new pacemaker system was reimplanted through the stented vein in five patients. Technical success was achieved in all patients, without any complication. Symptoms rapidly resolved in all patients after stent deployment. The mean follow-up duration was 48 months (range, 10-100 months). Three patients remained symptom free. Reintervention with percutaneous balloon venoplasty was successful in three patients with symptom recurrence. Percutaneous stent implantation after lead removal followed by reimplantation of leads is a feasible alternative therapy for pacemaker-induced SVC syndrome, although some cases may require repeat intervention. ©2014 Wiley Periodicals, Inc.

Comparative Study of Electrical Stimulation of the Heart with VDD and DDD Pacemakers as to the Evolution to Atrial Fibrillation

PubMed Central

de Campos, Nelson Leonardo Kerdahi Leite; de Andrade, Rubens Ramos; Fellicio, Marcello Laneza; Martins, Antônio Sergio; Garzesi, André Monti; Garcia, Leonardo Rufino; Takeda, Tassya Bueno

2017-01-01

Introduction The pacemaker implantation VDD is considered simpler, faster, less expensive and causes fewer complications compared to DDD. However, the VDD pacemaker has not been widely used in many centers, perhaps for fear of dysfunction of the sinus node and the reduction of atrial sensitivity by the pacemaker during follow-up after implantation. Objective To compare patients with DDD and VDD pacemakers regarding the evolution of chronic atrial fibrillation (AF) and length of stay outside this postoperative arrhythmia. Methods It was included 158 patients with dual chamber pacemakers, 48 DDD and 110 VDD. Follow-up period: between January 1, 1999 and December 31, 2015. The mean follow-up of patients with DDD was 5.35 years and the VDD, 4.74 years. The percentage of each group (DDD and VDD) which evolved to AF during follow-up was assessed. Also, it was made an actuarial study with the respective curves indicating the time free from AF for each group. Patients were classified according to the diagnosis that led to pacemaker implantation and the degree of heart failure. Results The percentage of patients who developed AF was higher in DDD group (10.42%) than in VDD group (6.36%), but without statistical significance. Patients with DDD and VDD remained free of AF for similar period. Conclusion Considering the results, the VDD pacemaker continues to be a good option to the DDD for routine use in cases properly indicated. PMID:29211212

Comparative Study of Electrical Stimulation of the Heart with VDD and DDD Pacemakers as to the Evolution to Atrial Fibrillation.

PubMed

Campos, Nelson Leonardo Kerdahi Leite de; Andrade, Rubens Ramos de; Fellicio, Marcello Laneza; Martins, Antônio Sergio; Garzesi, André Monti; Garcia, Leonardo Rufino; Takeda, Tassya Bueno

2017-01-01

The pacemaker implantation VDD is considered simpler, faster, less expensive and causes fewer complications compared to DDD. However, the VDD pacemaker has not been widely used in many centers, perhaps for fear of dysfunction of the sinus node and the reduction of atrial sensitivity by the pacemaker during follow-up after implantation. To compare patients with DDD and VDD pacemakers regarding the evolution of chronic atrial fibrillation (AF) and length of stay outside this postoperative arrhythmia. It was included 158 patients with dual chamber pacemakers, 48 DDD and 110 VDD. Follow-up period: between January 1, 1999 and December 31, 2015. The mean follow-up of patients with DDD was 5.35 years and the VDD, 4.74 years. The percentage of each group (DDD and VDD) which evolved to AF during follow-up was assessed. Also, it was made an actuarial study with the respective curves indicating the time free from AF for each group. Patients were classified according to the diagnosis that led to pacemaker implantation and the degree of heart failure. The percentage of patients who developed AF was higher in DDD group (10.42%) than in VDD group (6.36%), but without statistical significance. Patients with DDD and VDD remained free of AF for similar period. Considering the results, the VDD pacemaker continues to be a good option to the DDD for routine use in cases properly indicated.

Evaluation of Death among the Patients Undergoing Permanent Pacemaker Implantation: A Competing Risks Analysis.

PubMed

Ghaem, Haleh; Ghorbani, Mohammad; Zare Dorniani, Samira

2017-06-01

Permanent artificial pacemaker is one of the important therapies for treatment of cardiac conduction system problems. The present study aimed to determine the association between some predictive variables and all-cause and cause-specific mortality in the patients who had undergone pacemaker implantation. This study was conducted on 1207 patients who had undergone permanent pacemaker implantation in the hospitals affiliated with Shiraz University of Medical Sciences, Iran, from Mar 2002 to Mar 2012. The variables that existed in the patients' medical records included sex, diabetes mellitus, obesity, cerebrovascular accident, cardiomegaly, smoking, hypertension, ischemic heart disease, congenital heart disease, sick sinus syndrome, and atrial fibrillation. Competing risks model was used to assess the association between the predictive variables and cause-specific (i.e., cardiac and vascular) mortality. The patients' mean age was 66.32±17.92 yr (70.62±14.45 yr in the patients with single-chamber pacemakers vs. 61.91±17.69 yr in those with two-chamber pacemakers) ( P <0.001). Sick sinus syndrome and age increased the risk of all-cause mortality, while two-chamber pacemaker decreased this risk. Obesity increased the risk of cardiac death, and diabetes mellitus and heart valve disease increased the risk of vascular death. The variables predicting mortality in all-cause model were completely different from those in cause-specific model. Moreover, death in such patients may occur due to reasons other than pacemaker. Therefore, future studies, particularly prospective ones, are recommended to use competing risks models.

The influence of anatomical and physiological parameters on the interference voltage at the input of unipolar cardiac pacemakers in low frequency electric fields.

PubMed

Joosten, S; Pammler, K; Silny, J

2009-02-07

The problem of electromagnetic interference of electronic implants such as cardiac pacemakers has been well known for many years. An increasing number of field sources in everyday life and occupational environment leads unavoidably to an increased risk for patients with electronic implants. However, no obligatory national or international safety regulations exist for the protection of this patient group. The aim of this study is to find out the anatomical and physiological worst-case conditions for patients with an implanted pacemaker adjusted to unipolar sensing in external time-varying electric fields. The results of this study with 15 volunteers show that, in electric fields, variation of the interference voltage at the input of a cardiac pacemaker adds up to 200% only because of individual factors. These factors should be considered in human studies and in the setting of safety regulations.

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

PubMed

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

2013-05-01

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

Percutaneously injectable fetal pacemaker: electrodes, mechanical design and implantation.

PubMed

Zhou, Li; Chmait, Ramen; Bar-Cohen, Yaniv; Peck, Raymond A; Loeb, Gerald E

2012-01-01

We are developing a self-contained cardiac pacemaker with a small, cylindrical shape (~3 × 20 mm) that permits it to be implanted percutaneously into a fetus to treat complete heart block and consequent hydrops fetalis, which is otherwise fatal. The device uses off-the-shelf components including a rechargeable lithium cell and a highly efficient relaxation oscillator encapsulated in epoxy and glass. A corkscrew electrode made from activated iridium can be screwed into the myocardium, followed by release of the pacemaker and a short, flexible lead entirely within the chest of the fetus to avoid dislodgement from fetal movement. The feasibility of implanting the device percutaneously under ultrasonic imaging guidance was demonstrated in acute adult rabbit experiments.

Complications with the MICRA TPS Pacemaker System: Persistent Complete Heart Block and Late Capture Failure.

PubMed

Holm, Niels; Müller, Andreas; Zbinden, Rainer

2017-04-01

A Medtronic MICRA transcatheter pacing system (Medtronic, Minneapolis, MN, USA) was implanted in an 86-year-old patient with sick sinus syndrome and left bundle branch block after transfemoral aortic valve implantation. During implantation she developed a persistent complete heart block due to manipulation with the large-bore delivery catheter. Two weeks later, acute pacemaker dysfunction occurred due to massive increase of pacing threshold and impedance without obvious pacemaker dislocation or myocardial perforation. Recurrent capture failure was seen with pacing output set at 5 V/1.0 ms. Hence, microdislocation or fixation of the tines in the right ventricular trabeculae has to be assumed. © 2016 Wiley Periodicals, Inc.

Clinical Profile and Early Complications after Single and Dual Chamber Permanent Pacemaker Implantation at Manmohan Cardiothoracic Vascular and Transplant Centre, Kathmandu, Nepal.

PubMed

Khanal, J; Poudyal, R R; Devkota, S; Thapa, S; Dhungana, R R

2015-01-01

Permanent pacemaker implantation is a minimally invasive surgical procedure in the management of patients with cardiac problems. However, complications during and after implantation are not uncommon. There is lack of evidences in rate of complications with the selection of pacemakers in Nepal. Therefore, this study was performed to compare the frequency of implantation and complication rate between single chamber and dual chamber pacemaker. The present study is based on all consecutive pacemaker implantations in a single centre between April 2014 and May 2015. A total of 116 patients were categorized into two cohorts according to the type of pacemaker implanted- single chamber or dual chamber. All patients had regular 2-weeks follow-up intervals with standardized documentation of all relevant patient data till 6-week after implantation. Data were presented as means ± standard deviation (SD) for continuous variables and as proportions for categorical variables. Comparison of continuous variables between the groups was made with independent Student's t-test. For discrete variables distribution between groups were compared with Chi-square test. The mean age (±SD) of total population at implant was 64.08 (± 15.09) years. Dual chamber units were implanted in 44 (37.93%) of patients, single chamber in 72 (62.06%). Only 14 women (31.81%) received dual chamber compared with 42 women (58.33%) who received single chamber (Chi-square=18, DF=1, P = 0.0084). Complete atrioventricular block was the commonest (56.03%) indication for permanent pacemaker insertion followed by sick sinus syndrome (33.62%), symptomatic high-grade AV block (11.20%). Hypertension (dual chamber 21.55%, single chamber 40.51%) was the most common comorbidity in both cohorts. Complications occurred in 11 (9.48%) patients. More proportion of complication occurred in single chamber group (9 patients, 12.50%) than in dual chamber (2 patients, 4.54%). Complications occurring in dual chamber group include pocket hematoma 1 patient (2.27%) and arrhythmia in 1 patient (2.27%). Similarly, complications occurring in single chamber include RV perforation in two patients (2.77%) and one each (1.38%) had pocket hematoma, pneumothorax, infection, swelling at pocket site, arrhythmia in the form of NSVT, leads displacement, DVT and mortality. Women were more likely to receive single chamber systems than men. More proportion of complication occurred in single chamber group than in dual chamber. Future prospective studies on larger number of patients are needed to confirm and support our findings.

Twenty-Seven Years Experience With Transvenous Pacemaker Implantation in Children Weighing <10 kg.

PubMed

Konta, Laura; Chubb, Mark Henry; Bostock, Julian; Rogers, Jan; Rosenthal, Eric

2016-02-01

Epicardial pacemaker implantation is the favored approach in children weighing <10 kg in many units. The high incidence of premature failure and fractures with earlier epicardial leads led our unit to undertake transvenous pacemaker implantation in neonates and infants from 1987. To date there have been no long-term follow-up reports of what is for many a controversial strategy. Between 1987 and 2003, 37 neonates and infants-median age 6.7 months (1 day to 3 years) and median weight 4.6 kg (2.7-10 kg)-had a permanent transvenous pacing system implanted. Pacing leads were placed into the right ventricular apex/outflow tract through a subclavian vein puncture with a redundant loop in the atrium. Three patients were lost to follow-up, 4 patients died from complications of cardiac surgery, and 2 patients had their system removed. At long-term follow-up in 28 patients at a median of 17.2 (range, 11.2-27.4) years, 10 patients have a single chamber ventricular pacemaker, 14 a dual chamber pacemaker, 3 a biventricular pacemaker, and 1 has a single chamber implantable cardioverter defibrillator. Subclavian vein patency was assessed in 26 patients. The overall subclavian vein occlusion rate was 10 of 13 (77%) <5 kg and 2 of 13 (15%) >5 kg during long-term follow-up. After a median of 14.3 (range, 13.4-17.6) years of pacing, 7 patients continue with their original lead. Transvenous pacing in infants <10 kg results in encouraging short- and long-term clinical outcomes. Subclavian vein occlusion remains an important complication, occurring predominantly in those weighing <5 kg. © 2016 American Heart Association, Inc.

Permanent epicardial pacing in pediatric patients: 12-year experience at a single center.

PubMed

Kwak, Jae Gun; Kim, Soo-Jin; Song, Jin Young; Choi, Eun Young; Lee, Sang Yoon; Shim, Woo Sup; Lee, Chang-Ha; Lee, Cheul; Park, Chun Soo

2012-02-01

Permanent cardiac pacing is not often done in children, and when done is usually accomplished through epicardial pacing. We reviewed a 12-year experience with the implantation of epicardial pacemakers by our clinical group. Fifty-three patients who underwent their first implantation of an epicardial pacemaker before the age of 18 years and between 1997 and 2009 were included in our study. The mean age of the patients at the time of first pacemaker implantation was 5.7±4.8 years. Indications for pacemaker implantation included postoperative or congenital atrioventricular block and sinus node dysfunction. The patients underwent 105 operations for the replacement of pacemaker pulse generators and 75 operations for the replacement of pacemaker leads. The most commonly used generator mode was the rate-responsive accelerometer-based (DDDR) mode, which was used in 40.9% of the patients. We used more non-steroid-eluting leads (70.1%) than steroid-eluting leads (29.1%). The overall duration of follow-up in the study was 8.0±4.5 years (range, 2.1 months to approximately 17.0 years). Freedom from the need for generator replacement was 98.0%, 60.7%, and 11.1% at 1, 5, and 8 years, respectively. A tendency toward early generator exhaustion was observed among younger patients (p=0.058). The generator mode used for pacing did not significantly affect generator longevity. Freedom from the need for lead replacement was 98.3%, 83.8%, and 63.6% at 1, 5, and 10 years, respectively. The mean longevity of the leads used in the study was 10.8±0.8 years. Neither patient age at the time of lead implantation nor type of lead significantly affected lead longevity. Lead longevity was sufficiently long and did not vary significantly according to type of lead. Generator longevity was not affected by lead type, generator mode, or patient age at the time of pacemaker implantation. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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

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

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

2005-09-01

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

Permanent Pacemaker Implantation after TAVR – Predictors and Impact on Outcomes

PubMed Central

Sinning, Jan-Malte; Hammerstingl, Christoph; Werner, Nikos; Grube, Eberhard; Nickenig, Georg

2015-01-01

The number of patients undergoing transcatheter aortic valve replacement (TAVR) worldwide is increasing steadily. Atrioventricular conduction disturbances, with or without the need for permanent pacemaker (PPM) implantation, are one of the most common adverse events after TAVR. Among transcatheter heart valves (THV), rates of conduction abnormalities vary from less than 10 % to more than 50 %. Depending on the reported data referred to, historical data showed that up to one-third of the patients required implantation of a PPM following TAVR. Although generally considered as a minor complication, PPM may have a profound impact on prognosis and quality of life after TAVR. Current data support the hypothesis that conduction abnormalities leading to pacemaker dependency result from mechanical compression of the conduction system by the prosthesis stent frame and individual predisposing conduction defects such as right bundle-branch block (RBBB). With several large randomised trials and registry studies having been published recently and second generation THV having been introduced, the debate about predictors for pacemaker implantation and their impact on outcome after TAVR is still ongoing. PMID:29588683

Spanish Pacemaker Registry. Twelfth Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2014).

PubMed

Cano Pérez, Óscar; Pombo Jiménez, Marta; Coma Samartín, Raúl

2015-12-01

This report describes the results of the analysis of pacemaker implant and replacement data submitted to the Spanish Pacemaker Registry in 2014, with special reference to pacing mode selection. The report is based on the processing of information provided by the European Pacemaker Patient Identification Card. Information was received from 117 hospitals, with a total of 12 358 cards, representing 34% of estimated activity. Use of conventional generators and resynchronization devices was 784 and 64.4 units per million population, respectively. The mean age of patients receiving an implant was 77.3 years. Men received 59% of implants and 56.4% of replacements. Most patients receiving generator implants and replacements were in the age range 80 to 89 years. Most endocardial leads used were bipolar, and 84.2% had an active fixation system. Pacing was in VVI/R mode despite being in sinus rhythm in 24.7% of patients with sick sinus syndrome and 24% of those with atrioventricular block. The use of pacemaker generators and resynchronization devices per million population continued to increase. Most implanted leads had active fixation and approximately 20% had magnetic resonance imaging protection. Age and sex directly influenced pacing mode selection, which could have been improved in more than 20% of cases. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Ambulatory Holter monitoring in asymptomatic patients with DDD pacemakers - do we need ACC/AHA Guidelines revision?

PubMed

Chudzik, Michal; Klimczak, Artur; Wranicz, Jerzy Krzysztof

2013-10-31

We sought to determine the usefulness of ambulatory 24-hour Holter monitoring in detecting asymptomatic pacemaker (PM) malfunction episodes in patients with dual-chamber pacemakers whose pacing and sensing parameters were proper, as seen in routine post-implantation follow-ups. Ambulatory 24-hour Holter recordings (HM) were performed in 100 patients with DDD pacemakers 1 day after the implantation. Only asymptomatic patients with proper pacing and sensing parameters (assessed on PM telemetry on the first day post-implantation) were enrolled in the study. The following parameters were assessed: failure to pace, failure to sense (both oversensing and undersensing episodes) as well as the percentage of all PM disturbances. Despite proper sensing and pacing parameters, HM revealed PM disturbances in 23 patients out of 100 (23%). Atrial undersensing episodes were found in 12 patients (p < 0.005) with totally 963 episodes and failure to capture in 1 patient (1%). T wave oversensing was the most common ventricular channel disorder (1316 episodes in 9 patients, p < 0.0005). Malfunction episodes occurred sporadically, leading to pauses of up to 1.6 s or temporary bradycardia, which were, nevertheless, not accompanied by clinical symptoms. No ventricular pacing disturbances were found. Asymptomatic pacemaker dysfunction may be observed in nearly 25% of patients with proper DDD parameters after implantation. Thus, ambulatory HM during the early post-implantation period may be a useful tool to detect the need to reprogram PM parameters.

Incidence and Time Course for Developing Heart Failure With High-Burden Right Ventricular Pacing.

PubMed

Merchant, Faisal M; Hoskins, Michael H; Musat, Dan L; Prillinger, Julie B; Roberts, Gregory J; Nabutovsky, Yelena; Mittal, Suneet

2017-06-01

Although right ventricular pacing can contribute to cardiomyopathy, the impact of complete atrioventricular block (cAVB) on heart failure (HF) development in pacemaker patients has not been well characterized. We evaluated the incidence and time course for developing HF after pacemaker implantation for cAVB. A MarketScan database identified patients undergoing dual-chamber pacemaker implantation from 2008 to 2014. Patients with cAVB were identified by an atrioventricular node ablation or diagnosis of third-degree AVB. Patients with ≥1 year of continuous MarketScan enrollment before and after implant and without a previous diagnosis of HF were dichotomized into those with cAVB and without AVB. The primary end point was new HF assessed over acute (0-6 months) and chronic (6 months to 4 years) phases post-pacemaker implantation. The cohort included 6994 cAVB patients and 14 208 patients without AVB, followed for 2.35 years (interquartile range, 1.62-3.39 years). After adjustment for baseline covariates, patients with cAVB experienced an increased risk of new-onset HF in the acute phase (hazard ratio, 1.62; 95% confidence interval, 1.48-1.79; P <0.001). Although the risk of HF remained elevated among those with cAVB in the chronic phase, the effect was attenuated (hazard ratio, 1.16; 95% confidence interval, 1.08-1.25; P <0.001). After pacemaker implantation, younger patients (≤55 years of age) and those with an antecedent history of atrial fibrillation experienced the highest risk of HF associated with cAVB. Patients with a diagnosis of cAVB, and thus presumed to have a higher burden of right ventricular pacing, experienced an increased risk of new-onset HF after pacemaker implantation compared with those without AVB. Better tools are needed to identify patients at high risk of developing HF in the setting of right ventricular pacing and to determine whether these patients benefit from upfront biventricular pacing. © 2017 American Heart Association, Inc.

Prediction of significant conduction disease through noninvasive assessment of cardiac calcification.

PubMed

Mainigi, Sumeet K; Chebrolu, Lakshmi Hima Bindu; Romero-Corral, Abel; Mehta, Vinay; Machado, Rodolfo Rozindo; Konecny, Tomas; Pressman, Gregg S

2012-10-01

Cardiac calcification is associated with coronary artery disease, arrhythmias, conduction disease, and adverse cardiac events. Recently, we have described an echocardiographic-based global cardiac calcification scoring system. The objective of this study was to evaluate the severity of cardiac calcification in patients with permanent pacemakers as based on this scoring system. Patients with a pacemaker implanted within the 2-year study period with a previous echocardiogram were identified and underwent blinded global cardiac calcium scoring. These patients were compared to matched control patients without a pacemaker who also underwent calcium scoring. The study group consisted of 49 patients with pacemaker implantation who were compared to 100 matched control patients. The mean calcium score in the pacemaker group was 3.3 ± 2.9 versus 1.8 ± 2.0 (P = 0.006) in the control group. Univariate and multivariate analysis revealed glomerular filtration rate and calcium scoring to be significant predictors of the presence of a pacemaker. Echocardiographic-based calcium scoring correlates with the presence of severe conduction disease requiring a pacemaker. © 2012, Wiley Periodicals, Inc.

Evaluation of Death among the Patients Undergoing Permanent Pacemaker Implantation: A Competing Risks Analysis

PubMed Central

GHAEM, Haleh; GHORBANI, Mohammad; ZARE DORNIANI, Samira

2017-01-01

Background: Permanent artificial pacemaker is one of the important therapies for treatment of cardiac conduction system problems. The present study aimed to determine the association between some predictive variables and all-cause and cause-specific mortality in the patients who had undergone pacemaker implantation. Methods: This study was conducted on 1207 patients who had undergone permanent pacemaker implantation in the hospitals affiliated with Shiraz University of Medical Sciences, Iran, from Mar 2002 to Mar 2012. The variables that existed in the patients’ medical records included sex, diabetes mellitus, obesity, cerebrovascular accident, cardiomegaly, smoking, hypertension, ischemic heart disease, congenital heart disease, sick sinus syndrome, and atrial fibrillation. Competing risks model was used to assess the association between the predictive variables and cause-specific (i.e., cardiac and vascular) mortality. Results: The patients’ mean age was 66.32±17.92 yr (70.62±14.45 yr in the patients with single-chamber pacemakers vs. 61.91±17.69 yr in those with two-chamber pacemakers) (P<0.001). Sick sinus syndrome and age increased the risk of all-cause mortality, while two-chamber pacemaker decreased this risk. Obesity increased the risk of cardiac death, and diabetes mellitus and heart valve disease increased the risk of vascular death. Conclusion: The variables predicting mortality in all-cause model were completely different from those in cause-specific model. Moreover, death in such patients may occur due to reasons other than pacemaker. Therefore, future studies, particularly prospective ones, are recommended to use competing risks models. PMID:28828325

Permanent transvenous pacemaker implantation in an Ibizan hound cross with persistent atrial standstill

PubMed Central

MacAulay, Kevin

2002-01-01

An Ibizan hound cross was referred with a 1-year history of syncope and exercise intolerance. An electrocardiogram showed bradycardia and no P waves; atrial standstill was diagnosed. A permanent artificial endocardial pacemaker was implanted. The lead dislodged and was reimplanted into the right ventricular apex. Capture was once again achieved. PMID:12395764

Percutaneously Inject able Fetal Pacemaker: Electrodes, Mechanical Design and Implantation*

PubMed Central

Zhou, Li; Chmait, Ramen; Bar-Cohen, Yaniv; Peck, Raymond A.; Loeb, Gerald E.

2015-01-01

We are developing a self-contained cardiac pacemaker with a small, cylindrical shape (~3×20mm) that permits it to be implanted percutaneously into a fetus to treat complete heart block and consequent hydrops fetalis, which is otherwise fatal. The device uses off-the-shelf components including a rechargeable lithium cell and a highly efficient relaxation oscillator encapsulated in epoxy and glass. A corkscrew electrode made from activated iridium can be screwed into the myocardium, followed by release of the pacemaker and a short, flexible lead entirely within the chest of the fetus to avoid dislodgement from fetal movement. The feasibility of implanting the device percutaneously under ultrasonic imaging guidance was demonstrated in acute adult rabbit experiments. PMID:23367442

Next-generation pacemakers: from small devices to biological pacemakers.

PubMed

Cingolani, Eugenio; Goldhaber, Joshua I; Marbán, Eduardo

2018-03-01

Electrogenesis in the heart begins in the sinoatrial node and proceeds down the conduction system to originate the heartbeat. Conduction system disorders lead to slow heart rates that are insufficient to support the circulation, necessitating implantation of electronic pacemakers. The typical electronic pacemaker consists of a subcutaneous generator and battery module attached to one or more endocardial leads. New leadless pacemakers can be implanted directly into the right ventricular apex, providing single-chamber pacing without a subcutaneous generator. Modern pacemakers are generally reliable, and their programmability provides options for different pacing modes tailored to specific clinical needs. Advances in device technology will probably include alternative energy sources and dual-chamber leadless pacing in the not-too-distant future. Although effective, current electronic devices have limitations related to lead or generator malfunction, lack of autonomic responsiveness, undesirable interactions with strong magnetic fields, and device-related infections. Biological pacemakers, generated by somatic gene transfer, cell fusion, or cell transplantation, provide an alternative to electronic devices. Somatic reprogramming strategies, which involve transfer of genes encoding transcription factors to transform working myocardium into a surrogate sinoatrial node, are furthest along in the translational pipeline. Even as electronic pacemakers become smaller and less invasive, biological pacemakers might expand the therapeutic armamentarium for conduction system disorders.

Fifty years of pacemaker advancements.

PubMed

Steinhaus, David

2008-12-01

A 1957 power blackout in Minnesota prompted C. Walton Lillehei, MD, a pioneer in open heart surgery, to ask Earl Bakken, the co-founder of Medtronic, Inc., to create a battery-operated pacemaker for pediatric patients. That conversation led to the development of the first external battery-operated pacemaker. That first bulky device is far removed from the tiny implantable computers available to heart patients today. Now, the size of two silver dollars stacked on top of one another, a pacemaker is prescribed for a person whose heart beats too slowly or pauses irregularly. Slightly larger devices have more recently evolved from pacing and regulating the heartbeat to being able to provide therapeutic high voltage shocks when needed to stop runaway fast heart rates, recording heart activity, and other physiologic functions, even resynchronizing the heart's chambers-all while providing information on the patient's condition and device performance to the doctor remotely or in the office.

Ten-year Survival and Its Associated Factors in the Patients Undergoing Pacemaker Implantation in Hospitals Affiliated to Shiraz University of Medical Sciences During 2002 - 2012

PubMed Central

Rajaeefard, Abdolreza; Ghorbani, Mohammad; Babaee Baigi, Mohammad Ali; Tabatabae, Hamidreza

2015-01-01

Background: Heart failure is a prevalent disease affecting about 4.9 million people in the U.S. and more than 22 million individuals worldwide. Using electric pacemaker is the most common treatment for the patients with heart conduction problems. The present study aimed to determine the factors affecting survival in the patients undergoing pacemaker implantation in the hospitals affiliated to Shiraz University of Medical Sciences. Objectives: The aim of the present study was to identify the factors affecting the survival of the patients suffering from arrhythmia. Patients and Methods: This retrospective survival analysis was conducted on all 1207 patients with heart failure who had undergone permanent pacemaker implantation in the hospitals affiliated to Shiraz University of Medical Sciences from 2002 to 2012. The data were analyzed using non-parametric methods such as Kaplan-Meier method, life table, and Cox regression model. The risk factors of mortality were determined using multivariate Cox proportional hazards method. Results: Survival data were available for 1030 (80%) patients (median age = 71 years [5th to 95th percentile range: 26 - 86 years]) and follow-up was completed for 84.28% of them. According to the results, 56% of the patients had received dual-chamber systems, while 44% had been implanted by single-chamber ventricular systems. Moreover, sick sinus syndrome and pacemaker mode were independent predictors of increased mortality. Conclusions: In this study, sick sinus syndrome and pacemaker mode followed by syncope were independently associated with increased mortality. PMID:26734484

Modern Pacemaker and Implantable Cardioverter/Defibrillator Systems Can Be Magnetic Resonance Imaging Safe

PubMed Central

Roguin, Ariel; Zviman, Menekhem M.; Meininger, Glenn R.; Rodrigues, E. Rene; Dickfeld, Timm M.; Bluemke, David A.; Lardo, Albert; Berger, Ronald D.; Calkins, Hugh; Halperin, Henry R.

2011-01-01

Background MRI has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter/defibrillators (ICDs), however, is historically considered a contraindication to MRI. These devices are now smaller, with less magnetic material and improved electromagnetic interference protection. Our aim was to determine whether these modern systems can be used in an MR environment. Methods and Results We tested in vitro and in vivo lead heating, device function, force acting on the device, and image distortion at 1.5 T. Clinical MR protocols and in vivo measurements yielded temperature changes <0.5°C. Older (manufactured before 2000) ICDs were damaged by the MR scans. Newer ICD systems and most pacemakers, however, were not. The maximal force acting on newer devices was <100 g. Modern (manufactured after 2000) ICD systems were implanted in dogs (n=18), and after 4 weeks, 3- to 4-hour MR scans were performed (n=15). No device dysfunction occurred. The images were of high quality with distortion dependent on the scan sequence and plane. Pacing threshold and intracardiac electrogram amplitude were unchanged over the 8 weeks, except in 1 animal that, after MRI, had a transient (<12 hours) capture failure. Pathological data of the scanned animals revealed very limited necrosis or fibrosis at the tip of the lead area, which was not different from controls (n=3) not subjected to MRI. Conclusions These data suggest that certain modern pacemaker and ICD systems may indeed be MRI safe. This may have major clinical implications for current imaging practices. PMID:15277324

Rate-dependent Loss of Capture during Ventricular Pacing.

PubMed

Wang, Jingfeng; Chen, Haiyan; Su, Yangang; Ge, Junbo

2015-01-01

A 63-year-old patient who had undergone atrial septal defect surgical repair received implantation of a single chamber VVI pacemaker for long RR intervals during atrial fibrillation. One week later, an intermittent loss of capture and sensing failure was detected at a pacing rate of 70 beats/min. However, a successful capture was observed during rapid pacing. Consequently, the pacing rate was temporarily adjusted to 90 beats/min. At the 3-month follow-up, the pacemaker was shown to be functioning properly independent of the pacing rate. An echocardiogram showed that the increased pacing rates were accompanied by a reduction in the right ventricular outflow tract dimension. The pacemaker was then permanently programmed at a lower rate of 60 beats/min.

Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads.

PubMed

Blažek, Patrick; Ferri-Certić, Jerko; Vražić, Hrvoje; Lennerz, Carsten; Grebmer, Christian; Kaitani, Kazuaki; Karch, Martin; Starčević, Boris; Semmler, Verena; Kolb, Christof

2018-03-20

Fixation of the pacemaker leads during pacemaker implantation leads to an increase of cardiac Troponin T (cTnT) that can be interpreted as a sign of minimal myocardial damage. This trial evaluates whether the mechanism type of lead fixation influences the magnitude of cTnT release. Patients having a de-novo cardiac pacemaker implantation or a lead revision were centrally randomized to receive either a ventricular lead with an active (screw) or passive (tine) fixation mechanism. High-sensitive Troponin T (hsTnT) was determined on the day of the procedure beforehand and on the following day. 326 Patients (median age (IQR) 75.0 (69.0-80.0) years, 64% male) from six international centers were randomized to receive ventricular leads with an active (n = 166) or passive (n = 160) fixation mechanism. Median (IQR) hsTnT levels increased by 0.009 (0.004-0.021) ng/ml in the group receiving screw-in ventricular leads and by 0.008 (0.003-0.030) ng/ml in the group receiving tined ventricular leads (n.s.). In conclusion pacemaker implantations are followed by a release of hsTnT. The choice between active or passive fixation ventricular leads does not have a significant influence on the extent of myocardial injury and the magnitude of hsTnT release.

Implantable cardiac arrhythmia devices--part I: pacemakers.

PubMed

Kusumoto, Fred M; Goldschlager, Nora

2006-05-01

Implantable cardiac devices have become firmly entrenched as important therapeutic tools for a variety of cardiac conditions. The first part of this two-part review will discuss the contemporary use and follow-up of pacemakers, while the second part will address the use of implantable cardioverter defibrillators and implantable loop recorders. Pacemakers are the only available treatment for symptomatic bradycardia not due to reversible causes. Large randomized studies have demonstrated a small but statistically significant reduction in atrial fibrillation associated with pacing modes that maintain atrioventricular synchrony. In contrast, pacing mode appears to have a less dramatic effect in patients with atrioventricular block. Cardiac resynchronization with specialized left ventricular leads has been shown to reduce symptoms and improve survival in patients with symptomatic heart failure, systolic dysfunction, and widened QRS complexes. For all patients, careful follow-up is necessary to ensure optimal therapeutic benefit of pacing systems.

The role of lithium batteries in modern health care

NASA Astrophysics Data System (ADS)

Holmes, Curtis F.

Since the implantation of the first lithium-powered pacemaker in 1972, biomedical devices powered by lithium batteries have played a significant role in saving lives and providing health-improving therapy. Today a wide variety of devices performing functions from managing cardiac rhythm to relieving pain and administering drugs is available to clinicians. Newer devices such as ventricular assist devices and implantable hearing devices are powered by lithium ion secondary batteries.

Capacity of dental equipment to interfere with cardiac implantable electrical devices.

PubMed

Lahor-Soler, Eduard; Miranda-Rius, Jaume; Brunet-Llobet, Lluís; Sabaté de la Cruz, Xavier

2015-06-01

Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer. © 2015 Eur J Oral Sci.

[Management of surgery patients with implanted cardiac pacemakers].

PubMed

Ugljen, R; Dadić, D; Ferek-Petrić, B; Jelić, I; Letica, D; Anić, D; Husar, J

1995-01-01

Patients having cardiac pacemaker implanted may be subjected to various general surgery procedures. Application of electrosurgery for the purpose of resection and coagulation, provides a high frequency electric field which produces electric voltage on the electrodes of the pacing system. This voltage may be detected within the pacing system, and various arrhythmias can be provoked in correlation with underlying rhythm and mode of pacing. Preoperative patient control and proper pacemaker programming can prevent the pacing malfunctions due to the electrosurgery application. Appropriate positioning of the neutral electrode in relation to the pacing system avoids the electric fields intersection and decreases their interference.

Reticulated telangiectatic erythema of the pacemaker.

PubMed

Martin, Lucy K; Wendschuh, Philip; Wendschuh, Peter

2008-05-01

Reticulated telangiectatic erythema is a rare entity; it has been reported to occur following the placement of implanted cardiac devices and drug delivery systems. Histologically, reticulated telangiectatic erythema of the pacemaker is characterized by slight spongiosis and increased dermal telangiectasias. We describe a patient that developed reticulated telangiectatic nonpruritic patches on the left chest after the placement of a pacemaker. The patient responded favorably to the removal of the pacemaker.

Rhabdomyosarcoma associated with the lead wire of a pacemaker generator implant.

PubMed

Thieman Mankin, Kelley M; Dunbar, Mark D; Toplon, David; Ginn, Pamela; Maisenbacher, Herbert W; Risselada, Marije

2014-06-01

An 11-year-old female spayed Labrador Retriever was presented for a draining, painful subcutaneous mass palpated over a previously implanted pacemaker generator. Infection was suspected and the mass was removed surgically. On cut surface, the mass was friable and mottled tan to brown with firm pale tan nodules, surrounding the pacemaker lead wire adjacent to the pacemaker generator. Cytologic interpretation of impression smears was consistent with a sarcoma, and suggestive of a rhabdomyosarcoma due to the presence of strap-like cells. On histopathologic examination, a highly invasive nodular mass surrounded the pacemaker lead, composed of pleomorphic round, spindle and strap cells, and multinucleated giant cells. The population exhibited microscopic invasion into the deep portion of the fibrous capsule surrounding the pacemaker generator. There were tumor emboli within small to medium subcutaneous veins adjacent to the mass. Immunohistochemically, the neoplastic cells stained positive for α-sarcomeric actin and vimentin, and negative for α-smooth muscle actin, consistent with a rhabdomyosarcoma arising at the site of the pacemaker generator. To our knowledge, this is the first report of a rhabdomyosarcoma associated with the lead wire of a pacemaker generator in a dog. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Ductal carcinoma of the breast in the pacemaker generator's pocket.

PubMed

Zonca, P; Herokova, J; Cambal, M; Jacobi, C A

2009-01-01

Authors present a case of a 78-year-old female patient with invasive ductal adenocarcinoma in the pacemaker, s pocket. A decubitus-like tumor had developed in this place, and has been missinterpretated as a benign lesion for 5 months. Diagnosis was done with a time delay. An excisional biopsy revealed annvasive ductal adenocarcinoma. The first step was the implantation of a new pacemaker generator performed on the opposite side. The second step was a modified radical mastectomy, according to Madden, and the removal of the originally implanted pacemaker generator. Radiotherapy and hormonal adjuvant therapy were applied after surgery. The patient was followed-up at an out-patient clinic, and died 25 months after diagnosis because of generalization of the disease (Fig. 2, Ref. 35). Full Text (Free, PDF) www.bmj.sk.

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

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

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

2011-01-01

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

Safety of capsule endoscopy using human body communication in patients with cardiac devices.

PubMed

Chung, Joo Won; Hwang, Hye Jin; Chung, Moon Jae; Park, Jeong Youp; Pak, Hui-Nam; Song, Si Young

2012-06-01

The MiroCam (IntroMedic, Ltd., Seoul, Korea) is a small-bowel capsule endoscope that uses human body communication to transmit data. The potential interactions between cardiac devices and the capsule endoscope are causes for concern, but no data are available for this matter. This clinical study was designed to evaluate the potential influence of the MiroCam capsules on cardiac devices. Patients with cardiac pacemakers or implantable cardiac defibrillators referred for evaluation of small bowel disease were prospectively enrolled in this study. Before capsule endoscopy, a cardiologist checked baseline electrocardiograms and functions of the cardiac devices. Cardiac rhythms were continuously monitored by 24-h telemetry during capsule endoscopy in the hospital. After completion of procedures, functions of the cardiac devices were checked again for interference. Images from the capsule endoscopy were reviewed and analyzed for technical problems. Six patients, three with pacemakers and three with implantable cardiac defibrillators, were included in the study. We identified no disturbances in the cardiac devices and no arrhythmias detected on telemetry monitoring during capsule endoscopy. No significant changes in the programmed parameters of the cardiac devices were noted after capsule endoscopy. There were no imaging disturbances from the cardiac devices on capsule endoscopy. Capsule endoscopy using human body communication to transmit data was safely performed in patients with cardiac pacemakers or implantable cardiac defibrillators. Images from the capsule endoscopy were not affected by cardiac devices. A further large-scale study is required to confirm the safety of capsule endoscopy with various types of cardiac devices.

Financial audit of antitachycardia pacing for the control of recurrent supraventricular tachycardia.

PubMed Central

Griffith, M J; Bexton, R S; McComb, J M

1993-01-01

OBJECTIVE--To assess the financial implications of antitachycardia pacing in patients with frequent supraventricular tachycardia. PATIENTS--Intertach pacemakers were implanted in 25 patients (mean age 47 years, five men): 22 had atrioventricular nodal reentry tachycardia. The patients had failed a mean of 4.9 (range zero to eight) drugs and had been admitted to hospital 3.7 (zero to 31) times over a symptomatic period of 13.9 years (two months to 54 years). RESULTS--The mean admission time for implantation was 2.8 (two to seven) days. One patient with Wolff-Parkinson-White syndrome subsequently underwent surgery. Infection occurred in two patients, and pain over the pacemaker required its resiting in two. Two patients have had one admission each for tachycardia. Six patients remain on anti-arrhythmic drugs. Costs were calculated including value added tax, capital charges, and allocated overheads. The cost a year before pacing was 1174 pounds including drug costs, clinic visits, and hospital admissions. The mean cost of pacemaker implantation was 3364.22 pounds, including the pacemaker and lead, admission and procedure, readmissions and first pacing check. Subsequent annual follow up cost was 73.72 pounds including annual clinic visits and drug costs. The cost of pacing is 4241 pounds whereas medical management costs 7044 pounds assuming pacemaker life of six years: with a 10 year life the cost is 4537 pounds compared with 11,740 pounds: with a 12 year life the cost is 4685 pounds compared with 14,088 pounds. CONCLUSION--The excess cost of implantation of an antitachycardia pacemaker is minimal in patients with frequent supraventricular tachycardia despite drug treatment and is justified by excellent control of symptoms and reduction of drug use and hospital admissions. PMID:8461232

Financial audit of antitachycardia pacing for the control of recurrent supraventricular tachycardia.

PubMed

Griffith, M J; Bexton, R S; McComb, J M

1993-03-01

To assess the financial implications of antitachycardia pacing in patients with frequent supraventricular tachycardia. Intertach pacemakers were implanted in 25 patients (mean age 47 years, five men): 22 had atrioventricular nodal reentry tachycardia. The patients had failed a mean of 4.9 (range zero to eight) drugs and had been admitted to hospital 3.7 (zero to 31) times over a symptomatic period of 13.9 years (two months to 54 years). The mean admission time for implantation was 2.8 (two to seven) days. One patient with Wolff-Parkinson-White syndrome subsequently underwent surgery. Infection occurred in two patients, and pain over the pacemaker required its resiting in two. Two patients have had one admission each for tachycardia. Six patients remain on anti-arrhythmic drugs. Costs were calculated including value added tax, capital charges, and allocated overheads. The cost a year before pacing was 1174 pounds including drug costs, clinic visits, and hospital admissions. The mean cost of pacemaker implantation was 3364.22 pounds, including the pacemaker and lead, admission and procedure, readmissions and first pacing check. Subsequent annual follow up cost was 73.72 pounds including annual clinic visits and drug costs. The cost of pacing is 4241 pounds whereas medical management costs 7044 pounds assuming pacemaker life of six years: with a 10 year life the cost is 4537 pounds compared with 11,740 pounds: with a 12 year life the cost is 4685 pounds compared with 14,088 pounds. The excess cost of implantation of an antitachycardia pacemaker is minimal in patients with frequent supraventricular tachycardia despite drug treatment and is justified by excellent control of symptoms and reduction of drug use and hospital admissions.

The nuclear pacemaker: Is renewed interest warranted

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

Parsonnet, V.; Berstein, A.D.; Perry, G.Y.

1990-10-01

From 1973 through 1987, 155 radioisotope-powered nuclear pacemakers were implanted in 132 patients at the Newark Beth Israel Medical Center. The longevity of the first 15 devices, all of which were fixed-rate (VOO) pacemakers, was significantly better than that of 15 lithium-chemistry demand (VVI) pacemakers used as control devices (p = 0.0002). Of the entire cohort of 155 nuclear pacemakers, 136 were VVI devices and 19 were VOO units. The patients with VOO pacemakers needed reoperations more often than did those with VVI pacemakers, chiefly for mode change (p less than 0.001). Power-source failure was observed in only 1 case,more » but 47 nuclear pacemakers were removed for other reasons, including component malfunction (15 units), mode change (12 units), high pacing thresholds (8 units) and lead or connector problems (5 units). The actuarial survival at 15 years was 99% for power sources and 82% for the entire pacing systems (pulse generators plus leads). The frequency of malignancy was similar to that of the population at large and primary tumor sites were randomly distributed. Deaths most commonly were due to cardiac causes (68%). Thus, nuclear pacemakers are safe and reliable and their greater initial cost appears to be offset by their longevity and the resulting decrease in the frequency of reoperations. It is reasonable to suggest that further use be made of long-lasting nuclear power sources for modern pacemakers and other implantable rhythm-management devices.« less

Implantable Medical Devices

MedlinePlus

... Also known as ICD ) - An ICD is a battery-powered device placed under the skin that keeps ... Pacemaker (Also known as Artificial Pacemaker) - A small battery-operated device that helps the heart beat in ...

Sick sinus syndrome

MedlinePlus

... the heart (atria). This area is the heart's pacemaker. It may be called the sinoatrial node, sinus ... do so. You may need a permanent implanted pacemaker if your symptoms are related to bradycardia (slow ...

Transarterial pacemaker lead implantation results in acute myocardial infarction.

PubMed

Issa, Ziad F; Gill, John B

2010-11-01

We report a case of inadvertent transarterial implantation of dual-chamber pacemaker leads; the ventricular lead positioned across the aortic valve into the left ventricle and the atrial lead curving in the aortic root with the tip positioned into the left circumflex artery, resulting in acute myocardial infarction. The diagnosis was made based on the finding on the chest X-ray, surface ECG, and coronary angiography.

Virtual Humans for Implantable Device Safety Assessment in MRI: Mitigating Magnetic Resonance Imaging Hazards for Implanted Medical Devices.

PubMed

Brown, James E; Qiang, Rui; Stadnik, Paul J; Stotts, Larry J; Von Arx, Jeffrey A

2017-01-01

Magnetic resonance imaging (MRI) is the preferred modality for soft tissue imaging because of its nonionizing radiation and lack of contrast agent. Due to interactions between the MR system and active implantable medical devices (AIMDs), patients with implants such as pacemakers are generally denied access to MRI, which presents a detriment to that population. It has been estimated that 50-75% of patients with a cardiac device were denied access to MRI scanning and, moreover, that 17% of pacemaker patients need an MRI within 12 months of implantation [1]. In recent years, AIMD manufacturers, such as Biotronik, have assessed the conditional safety of devices in MRI.

PubMed Central

RUSSO, VINCENZO; DI MEO, FEDERICA; PAPA, ANDREA ANTONIO; CIOPPA, NADIA DELLA; PROIETTI, RICCARDO; RUSSO, MARIA GIOVANNA; CALABRÒ, RAFFAELE; POLITANO, LUISA

2014-01-01

P-wave dispersion is a non invasive indicator of intra-atrial conduction heterogeneity producing substrate for reentry, which is a pathophysiological mechanism of atrial fibrillation. The relationship between P-wave dispersion (PD) and atrial fibrillation (AF) in Myotonic dystrophy type 1 (DM1) patients is still unclear. Atrial Preference Pacing (APP) is an efficient algorithm to prevent paroxysmal AF in patients implanted with dual-chamber pacemaker. Aim of our study was to evaluate the possible correlation between atrial preference pacing algorithm, P-wave dispersion and AF burden in DM1 patients with normal cardiac function underwent permanent dual-chamber pacemaker implantation. We enrolled 50 patients with DM1 (age 50.3 ± 7.3; 11 F) underwent dual-chamber pacemaker implantation for various degree of atrioventricula block. The study population was randomized following 1 months stabilization period to APP algorithm features programmed OFF or ON. Patients were assessed every 3 months for the first year, and every 6 months thereafter up to 3 years. At each follow-up visit, we counted: the number of premature atrial beats, the number and the mean duration of AF episodes, AF burden and the percentage of atrial and ventricular pacing. APP ON Group showed lower number of AF episodes (117 ± 25 vs. 143 ± 37; p = 0.03) and AF burden (3059 ± 275 vs. 9010 ± 630 min; p < 0.04) than APP OFF Group. Atrial premature beats count (44903 ± 30689 vs. 13720 ± 7717 beats; p = 0.005) and Pwave dispersion values (42,1 ± 11 ms vs. 29,1 ± 4,2 ms, p = 0,003) were decreased in APP ON Group. We found a significant positive correlation between PD and AF burden (R = 0,8, p = 0.007). Atrial preference pacing algorithm, decreasing the number of atrial premature beats and the P-wave dispersion, reduces the onset and perpetuator factors of AF episodes and decreases the AF burden in DM1 patients underwent dual chamber pacemaker implantation for various degree of atrioventricular blocks and documented atrial fibrillation. PMID:25873781

SU-E-T-802: Verification of Implanted Cardiac Pacemaker Doses in Intensity-Modulated Radiation Therapy: Dose Prediction Accuracy and Reduction Effect of a Lead Sheet

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

Lee, J; Chung, J

2015-06-15

Purpose: To verify delivered doses on the implanted cardiac pacemaker, predicted doses with and without dose reduction method were verified using the MOSFET detectors in terms of beam delivery and dose calculation techniques in intensity-modulated radiation therapy (IMRT). Methods: The pacemaker doses for a patient with a tongue cancer were predicted according to the beam delivery methods [step-and-shoot (SS) and sliding window (SW)], intensity levels for dose optimization, and dose calculation algorithms. Dosimetric effects on the pacemaker were calculated three dose engines: pencil-beam convolution (PBC), analytical anisotropic algorithm (AAA), and Acuros-XB. A lead shield of 2 mm thickness was designedmore » for minimizing irradiated doses to the pacemaker. Dose variations affected by the heterogeneous material properties of the pacemaker and effectiveness of the lead shield were predicted by the Acuros-XB. Dose prediction accuracy and the feasibility of the dose reduction strategy were verified based on the measured skin doses right above the pacemaker using mosfet detectors during the radiation treatment. Results: The Acuros-XB showed underestimated skin doses and overestimated doses by the lead-shield effect, even though the lower dose disagreement was observed. It led to improved dose prediction with higher intensity level of dose optimization in IMRT. The dedicated tertiary lead sheet effectively achieved reduction of pacemaker dose up to 60%. Conclusion: The current SS technique could deliver lower scattered doses than recommendation criteria, however, use of the lead sheet contributed to reduce scattered doses.Thin lead plate can be a useful tertiary shielder and it could not acuse malfunction or electrical damage of the implanted pacemaker in IMRT. It is required to estimate more accurate scattered doses of the patient with medical device to design proper dose reduction strategy.« less

Cardiac iodine-123-metaiodobenzylguanidine scintigraphy may be useful to identify pathologic from physiologic sinus bradycardia.

PubMed

Sunaga, Akihiro; Masuda, Masaharu; Fujita, Masashi; Iida, Osamu; Kanda, Takashi; Matsuda, Yasuhiro; Morozumi, Takakazu; Mano, Toshiaki; Uematsu, Masaaki

2017-06-01

Sinus bradycardia includes pathologic sick sinus syndrome (SSS) and physiologic bradycardia such as athletes' heart. Pacemaker implantation is indicated for patients with symptomatic SSS; however, the indication remains difficult to determine in those with mild and/or unspecific symptoms. The sympathetic tone is increased in response to reduced cardiac output in SSS, whereas excessive vagal tone has been seen in physiological bradycardia. We sought to determine if cardiac iodine-123-metaiodobenzylguanidine scintigraphy ( 123 I-MIBG) was useful in differentiating pathologic from physiologic sinus bradycardia. Twenty consecutive patients presenting with continuous sinus bradycardia (heart rate of <50 beats/min) in our outpatient clinic (male, eight patients; age, 70 ± 12 years old) were enrolled. The indication for a pacemaker implantation was determined by an experienced electrophysiologist in compliance with the international guidelines. The sympathetic nervous tone was assessed by cardiac 123 I-MIBG. Eight patients (40%) were clinically diagnosed as SSS (type I) including four suffering from obvious symptoms (syncope or dizziness) and four suffering from mild symptoms (fatigue), and had an indication for a pacemaker implantation. The patients with SSS indicated for a pacemaker implantation had a lower early heart-to-mediastinum ratio (2.0 ± 0.6 vs 2.5 ± 0.2, P = 0.043), lower delayed heart to mediastinum ratio (2.0 ± 0.8 vs 2.8 ± 0.3, P = 0.026), and higher washout rate (34 ± 6.0 vs 26 ± 6.0, P = 0.008) than those without. Excessive sympathetic tone detected by 123 I-MIBG may serve as an adjunct to determine the indication for a pacemaker implantation in sinus bradycardia. © 2017 Wiley Periodicals, Inc.

Long-Term Follow-Up of Children with Heart Block Born from Mothers with Systemic Lupus Erythematosus: A Retrospective Study from the Database Pediatric and Congenital Heart Disease in University Hospitals Leuven.

PubMed

DE Caluwé, Eva; VAN DE Bruaene, Alexander; Willems, Rik; Troost, Els; Gewillig, Marc; Rega, Filip; Budts, Werner

2016-09-01

Children from mothers with systemic lupus erythematosus are frequently born with congenital heart block. This study aimed at evaluating long-term outcome because long-term data are scarce. In the database of pediatric and congenital heart disease (University Hospitals Leuven), 19 children from systemic lupus erythematosus mothers and who were born with or developed atrioventricular block were identified. All records were reviewed for disease course and outcome. Median follow-up time was 7 years (interquartile ranges [IQR] 4.5-13 years). One child had no heart block at birth and developed only a first-degree block during follow-up. One had a second-degree heart block and developed a complete heart block. Seventeen patients (89%) were born with a complete heart block. Seventeen patients (89%) needed a definitive pacemaker. In all, epicardial leads were used at first implantation. Eighty-two percent received their pacemaker in the first year of life. The first battery had a median lifetime of 5 years (IQR 3.5-5 years), the second 6 years (IQR 4.5-6.3 years), and the third 5 years (IQR 5-6 years). Note that 47% of patients needed a lead replacement due to lead problems. Only one pericardial tamponade after pacemaker implantation. No device or lead infections occurred. The left ventricular systolic function at latest follow-up was normal for all. No patients died. In children with heart block born from systemic lupus erythematosus mothers, an early need for pacemaker implantation was documented. The overall battery life was acceptable, but there was a high need for lead replacement. Complication rate was low. Late outcome was good. © 2016 Wiley Periodicals, Inc.

Cardiac Resynchronization Therapy and phase resetting of the sinoatrial node: A conjecture

NASA Astrophysics Data System (ADS)

Cantini, Federico; Varanini, Maurizio; Macerata, Alberto; Piacenti, Marcello; Morales, Maria-Aurora; Balocchi, Rita

2007-03-01

Congestive heart failure is a severe chronic disease often associated with disorders that alter the mechanisms of excitation-contraction coupling that may result in an asynchronous left ventricular motion which may further impair the ability of the failing heart to eject blood. In recent years a therapeutic approach to resynchronize the ventricles (cardiac resynchronization therapy, CRT) has been performed through the use of a pacemaker device able to provide atrial-based biventricular stimulation. Atrial lead senses the spontaneous occurrence of cells depolarization and sends the information to the generator which, in turn, after a settled delay [atrioventricular (AV) delay], sends electrical impulses to both ventricles to stimulate their synchronous contraction. Recent studies performed on heart rate behavior of chronically implanted patients at different epochs after implantation have shown that CRT can lead to sustained overall improvement of heart function with a reduction in morbidity and mortality. At this moment, however, there are no studies about CRT effects on spontaneous heart activity of chronically implanted patients. We performed an experimental study in which the electrocardiographic signal of five subjects under chronic CRT was recorded during the activity of the pacemaker programmed at different AV delays and under spontaneous cardiac activity after pacemaker deactivation. The different behavior of heart rate variability during pacemaker activity and after pacemaker deactivation suggested the hypothesis of a phase resetting mechanism induced by the pacemaker stimulus on the sinoatrial (SA) node, a phenomenon already known in literature for aggregate of cardiac cells, but still unexplored in vivo. The constraints imposed by the nature of our study (in vivo tests) made it impossible to plan an experiment to prove our hypothesis directly. We therefore considered the best attainable result would be to prove the accordance of our data to the conjecture through the use of models and physical considerations. We first used the data of literature on far-field effects of cardiac defibrillators to prove that the pacemaker impulses delivered to the two ventricles were able to induce modifications in membrane voltage at the level of the SA node. To simulate a phase resetting mechanism of the SA node, we used a Van der Pol modified model to allow the possibility of changing the refractory period and the firing frequency of the cells separately. With appropriate parameters of the model we reproduced phase response curves that can account for our experimental data. Furthermore, the simulated curves closely resemble the functional form proposed in literature for perturbed aggregate of cardiac cells. Despite the small sample of subjects investigated and the limited number of ECG recordings at different AV delays, we think we have proved the plausibility of the proposed conjecture.

Medial subclavicular musculotendinous complex and insulation break: Rare cause of late pacemaker lead malfunction

PubMed Central

Bhattacharyya, Pranab Jyoti; Agrawal, Shweta; Barkataky, Jogesh Chandra; Bhattacharyya, Anjan Kumar

2015-01-01

Insulation break in a permanent pacemaker lead is a rare long-term complication. We describe an elderly male with a VVIR pacemaker, who presented with an episode of presyncope more than 3 years after the initial implantation procedure, attributed to insulation break possibly caused by lead entrapment in components of the medial subclavicular musculotendinous complex (MSMC) and repeated compressive damage over time during ipsilateral arm movement requiring lead replacement. The differential diagnosis of a clinical presentation when pacing stimuli are present with failure to capture and the role of the MSMC in causing lead damage late after implantation are discussed. PMID:26995445

Design and Testing of a Percutaneously Implantable Fetal Pacemaker

PubMed Central

Loeb, Gerald E.; Zhou, Li; Zheng, Kaihui; Nicholson, Adriana; Peck, Raymond A.; Krishnan, Anjana; Silka, Michael; Pruetz, Jay; Chmait, Ramen; Bar-Cohen, Yaniv

2012-01-01

We are developing a cardiac pacemaker with a small, cylindrical shape that permits percutaneous implantation into a fetus to treat complete heart block and consequent hydrops fetalis, which can otherwise be fatal. The device uses off-the-shelf components including a rechargeable lithium cell and a highly efficient relaxation oscillator encapsulated in epoxy and glass. A corkscrew electrode made from activated iridium can be screwed into the myocardium, followed by release of the pacemaker and a short, flexible lead entirely within the chest of the fetus to avoid dislodgement from fetal movement. Acute tests in adult rabbits demonstrated the range of electrical parameters required for successful pacing and the feasibility of successfully implanting the device percutaneously under ultrasonic imaging guidance. The lithium cell can be recharged inductively as needed, as indicated by a small decline in the pulsing rate. PMID:22855119

Prevention and Treatment of Arrhythmia

MedlinePlus

... your pulse – especially if you have an artificial pacemaker. Put the second and third fingers of one ... Ablation Devices for Arrhythmia - Implantable Cardioverter Defibrillator (ICD) - Pacemaker Treating Arrhythmias in Children • Arrhythmia Tools & Resources Watch, ...

Outcomes of cardiac pacing in adult patients after a Fontan operation.

PubMed

Egbe, Alexander C; Huntley, Geoffery D; Connolly, Heidi M; Ammash, Naser M; Deshmukh, Abhishek J; Khan, Arooj R; Said, Sameh M; Akintoye, Emmanuel; Warnes, Carole A; Kapa, Suraj

2017-12-01

Cardiac pacing can be challenging after a Fontan operation, and limited data exist regarding pacing in adult Fontan patients. The objectives of our study were to determine risk factors for pacing and occurrence of device-related complications (DRCs) and pacemaker reinterventions. We performed a retrospective review of Fontan patients from 1994 through 2014. We defined DRCs as lead failure, lead recall, cardiac perforation, lead thrombus/vegetation, or device-related infection, and cardiovascular adverse events (CAEs) as venous thrombosis, stroke, death, or heart transplant. Pacemaker reintervention was defined as lead failure or recall. Of 439 patients, 166 (38%) had pacemakers implanted (79 during childhood; 87, adulthood); 114 patients (69%) received epicardial leads initially, and 52 (31%), endocardial leads. Pacing was initially atrial in 52 patients (31%); ventricular, 30 (18%); or dual chamber, 84 (51%). There were 37 reinterventions (1.9% per year) and 48 DRCs (2.4% per year). Pacemaker implantation during childhood was a risk factor for DRCs (hazard ratio, 2.01 [CI, 1.22-5.63]; P = .03). There were 70 CAEs (venous thrombosis, 5; stroke, 11; transplant, 8; and death, 46), yielding a rate of 3.5% per year. DRCs, CAEs, and reintervention rates were comparable for patients with epicardial or endocardial leads. More than one-third of adult Fontan patients referred to Mayo Clinic had pacemaker implantation. Epicardial leads were associated with high rate of pacemaker reinterventions but similar DRC rates in comparison to endocardial leads. Copyright © 2017 Elsevier Inc. All rights reserved.

Runtime Verification of Pacemaker Functionality Using Hierarchical Fuzzy Colored Petri-nets.

PubMed

Majma, Negar; Babamir, Seyed Morteza; Monadjemi, Amirhassan

2017-02-01

Today, implanted medical devices are increasingly used for many patients and in case of diverse health problems. However, several runtime problems and errors are reported by the relevant organizations, even resulting in patient death. One of those devices is the pacemaker. The pacemaker is a device helping the patient to regulate the heartbeat by connecting to the cardiac vessels. This device is directed by its software, so any failure in this software causes a serious malfunction. Therefore, this study aims to a better way to monitor the device's software behavior to decrease the failure risk. Accordingly, we supervise the runtime function and status of the software. The software verification means examining limitations and needs of the system users by the system running software. In this paper, a method to verify the pacemaker software, based on the fuzzy function of the device, is presented. So, the function limitations of the device are identified and presented as fuzzy rules and then the device is verified based on the hierarchical Fuzzy Colored Petri-net (FCPN), which is formed considering the software limits. Regarding the experiences of using: 1) Fuzzy Petri-nets (FPN) to verify insulin pumps, 2) Colored Petri-nets (CPN) to verify the pacemaker and 3) To verify the pacemaker by a software agent with Petri-network based knowledge, which we gained during the previous studies, the runtime behavior of the pacemaker software is examined by HFCPN, in this paper. This is considered a developing step compared to the earlier work. HFCPN in this paper, compared to the FPN and CPN used in our previous studies reduces the complexity. By presenting the Petri-net (PN) in a hierarchical form, the verification runtime, decreased as 90.61% compared to the verification runtime in the earlier work. Since we need an inference engine in the runtime verification, we used the HFCPN to enhance the performance of the inference engine.

Leadless cardiac pacemakers: present and the future.

PubMed

Chew, Derek S; Kuriachan, Vikas

2018-01-01

Pacing technology for many decades has been composed of a generator attached to leads that are usually transvenous. Recently, leadless pacemakers have been studied in clinical settings and now available for use in many countries. This includes the single-component Nanostim Leadless Cardiac Pacemaker and Micra Transcatheter Pacing System, as well as the multicomponent Wireless Stimulation Endocardial system. Clinical studies in single-component leadless pacing technology has shown that they can be successfully implanted with minimal complications. The follow-up studies also seem to confirm the findings from the initial clinical trials. These systems offer some advantages over a traditional pacing system comprised of a subcutaneous generator and transvenous leads. In many ways, these leadless systems are disruptive technologies that are changing the traditional pacemaker concept and preferred for some patients. Ongoing research is needed to better assess their long-term function, safety, and end-of-life strategies. In the future, multichamber leadless pacing is expected to be developed and perhaps obviating the need for transvenous leads and their associated complications.

Neck Pain One Week after Pacemaker Generator Replacement.

PubMed

Graham, Ross F; Wightman, John M

2015-07-01

The incidence of cardiac pacemaker implantation has risen markedly in the past three decades, making awareness of possible postprocedural complications critical to the emergency physician. This case is the first documented instance of internal jugular (IJ) deep vein thrombosis (DVT) from an uncomplicated pacemaker generator replacement. A patient presented to an Emergency Department with a 2-day history of mild left temporal headache migrating to his left neck. The patient did not volunteer this information, but review of systems revealed a temporary transvenous pacemaker inserted through the right IJ vein 1 week previously during a routine exchange of a left-sided cardiac pacemaker generator. Manipulation of the existing pacemaker wires entering the left subclavian vein was minimal. Computed tomographic angiography of the neck demonstrated near-complete thrombotic occlusion of the entire length of his left IJ vein. This required hospital admission for observation and treatment with anticoagulation. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: DVT, with thrombotic extension into adjacent vessels anywhere along the course of pacemaker wires, should be considered by the emergency provider in the evaluation of head, neck, or upper extremity symptoms after recent or remote implantation or manipulation of a transvenous cardiac pacemaker, including generator replacement. Failure to identify and treat appropriately could result in significant morbidity and mortality from airway edema, septic thrombophlebitis, superior vena cava syndrome, superior sagittal sinus thrombosis, or pulmonary embolism. Published by Elsevier Inc.

The effect of right ventricle pacemaker lead position on diastolic function in patients with preserved left ventricle ejection fraction.

PubMed

Mitov, Vladimir; Perisić, Zoran; Jolić, Aleksandar; Adamović, Dragana; Zastranović, Lale; Aleksić, Aleksandar; Kostić, Tomislav; Božinović, Nenad; Aleksić, Zeljka; Soldatović, Ivan

2013-01-01

Our aim was to analyze any changes during diastole in patients with normal left ventricular ejection fraction (LVEF), after pacemaker stimulation from the right ventricular outflow tract (RVOT) and right ventricular apex (RVA) lead position. This was a prospective, randomized, follow up study, which lasted for 12 months. Our research included 132 consecutive patients who were implanted with a permanent antibradycardiac pacemaker. Regarding the right ventricle lead position the patients were divided into two groups: The RVOT group--71 patients, with right ventricle outflow tract lead position and the RVA group--61 patients, with right ventricle apex lead position. We measured LVEF and diastolic parameters: peak filling ratio and time to peak filling ratio obtained by radionuclide ventriculography (RNV). The LVEF and various diastolic parameters and left atrial diameter were obtained by echocardiography. Based on the values of deceleration time of early diastolic filling (DTE), and other diastolic parameters like left atrial diameter, all the patients were classified into three degrees of diastolic dysfunction. Our results showed that there was no group difference in distribution of gender, age, body mass index (BMI), VVI to DDD pacemakers implantation ratio, RNV parameters (LVEF, peak filling rate (PFR), time to PFR (TPFR)) and echocardiography parameters: LVEF and parameters of diastolic dysfunction. After 12 months of pacemaker stimulation, LVEF by RNV remained the same in the RVOT group 51.31±15.80% (P=0.75), and also in the RVA group 53.83±6.57%, (P=0.19). In the RVOT group the PFR was highly lower and this finding was significant (P=0.01), while TPFR was also significantly lower (P=0.03). By dividing the patients according to the degree of diastolic dysfunction we found that most patients in both groups at enrollment had a second degree diastolic dysfunction. In both groups diastolic dysfunction increased, the number of patients with third degree diastolic dysfunction increased, and the number of patients with second degree diastolic dysfunction decreased, however, the worsening of diastolic function was significant only in the RVOT group. In conclusion, pacemaker stimulation from RVOT, but not in RVA, leads to progression of diastolic dysfunction in patients with preserved LVEF. This negative effect of pacemaker stimulation from RVOT on diastolic parameters was confirmed by two independent methods, RNV and echocardiography.

Pacemakers and Implantable Defibrillators: MedlinePlus Health Topic

MedlinePlus

... pattern. Most arrhythmias result from problems in the electrical system of the heart. If your arrhythmia is ... pacemaker helps control abnormal heart rhythms. It uses electrical pulses to prompt the heart to beat at ...

Significant effects of atrioventricular node ablation and pacemaker implantation on left ventricular function and long-term survival in patients with atrial fibrillation and left ventricular dysfunction.

PubMed

Ozcan, Cevher; Jahangir, Arshad; Friedman, Paul A; Munger, Thomas M; Packer, Douglas L; Hodge, David O; Hayes, David L; Gersh, Bernard J; Hammill, Stephen C; Shen, Win-Kuang

2003-07-01

Control of ventricular rate by atrioventricular node ablation and pacemaker implantation in patients with drug-refractory atrial fibrillation (AF) is associated with improved left ventricular (LV) function. The objective of this study was to determine the effect of atrioventricular node ablation on long-term survival in patients with AF and LV dysfunction. Survival was determined by the Kaplan-Meier method for 56 study patients with LV ejection fraction (EF) < or =40% who underwent atrioventricular node ablation and pacemaker implantation and 56 age- and gender-matched control patients with AF and LVEF >40%, and age- and gender-matched control subjects from Minnesota. Groups were compared using the log-rank test. In study patients (age 69 +/- 10 years; 45 men), LVEF was 26% +/- 8% and 34% +/- 13% (p <0.001) before and after ablation, respectively. During follow-up (40 +/- 23 months), 23 patients died. Observed survival was worse than that of normal subjects (p <0.001) and control patients (p = 0.005). After ablation, LVEF nearly normalized (> or =45%) in 16 study patients (29%), in whom observed survival was comparable to that of normal subjects (p = 0.37). Coronary artery disease, hyperlipidemia, chronic renal failure, previous myocardial infarction, and coronary artery operation were independent predictors for mortality. Near normalization of LVEF occurred in 29% of study patients, suggesting that AF-induced EF reduction is reversible in many patients. Normal survival in patients with reversible LV dysfunction highlights potential survival benefits of rate control. Poor survival in patients with persistent LV dysfunction confirms the importance of optimal medical therapy.

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

PubMed

Bergamin, C; Graf, D

2015-05-27

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

Potential for Personal Digital Assistant interference with implantable cardiac devices.

PubMed

Tri, Jeffrey L; Trusty, Jane M; Hayes, David L

2004-12-01

To determine whether the wireless local area network (WLAN) technology, specifically the Personal Digital Assistant (PDA), interferes with implantable cardiac pacemakers and defibrillators. Various pacemakers and defibrillators were tested in vitro at the Mayo Clinic in Rochester, Minn, between March 6 and July 30, 2003. These cardiac devices were exposed to an HP Compaq IPAQ PDA fitted with a Cisco Aironet WLAN card. Initial testing was designed to show whether the Aironet card radiated energy in a consistent pattern from the antenna of the PDA to ensure that subsequent cardiac device testing would not be affected by the orientation of the PDA to the cardiac device. Testing involved placing individual cardiac devices in a simulator and uniformly exposing each device at its most sensitive programmable value to the WLAN card set to maximum power. During testing with the Cisco WLAN Aironet card, all devices programmed to the unipolar or bipolar configuration single- or dual-chamber mode had normal pacing and sensing functions and exhibited no effects of electromagnetic interference except for 1 implantable cardioverter-defibrillator (ICD). This aberration was determined to relate to the design of the investigators' testing apparatus and not to the output of the PDA. The ICD device appropriately identified and labeled the electromagnetic aberration as "noise." We documented no electromagnetic interference caused by the WLAN technology by using in vitro testing of pacemakers and ICDs; however, testing ideally should be completed in vivo to confirm the lack of any clinically important interactions.

Effect of 1. 5 tesla nuclear magnetic resonance imaging scanner on implanted permanent pacemakers

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

Hayes, D.L.; Holmes, D.R. Jr.; Gray, J.E.

1987-10-01

Patients with a permanent pacemaker are currently restricted from diagnostic nuclear magnetic resonance (NMR) imaging because of potential adverse effects on the pacemaker by the magnet. Previous work has shown that NMR imaging will result in asynchronous pacing of the pulse generator within a given distance of the magnet. The radiofrequency signal generated by the system may also result in rapid cardiac pacing, which may have deleterious effects. This study utilized a 1.5 tesla unit in an in vivo laboratory animal to evaluate the unit's effects on eight different pulse generators from two manufacturers. All pacemakers functioned in an asynchronousmore » mode when placed within a certain distance of the magnet. In addition, transient reed switch inhibition was observed. Seven of the eight pulse generators paced rapidly when exposed to the radiofrequency signal and there was a dramatic decrease in arterial blood pressure. Whether effective rapid cardiac pacing would occur could not be predicted before exposure to the magnetic resonance unit. Nuclear magnetic resonance imaging with high magnetic fields in patients with a pacemaker should continue to be avoided until the mechanism of the rapid cardiac pacing can be further delineated and either predicted or prevented.« less

[Kurschmann-Steinert myotonic dystrophia and Adams-Stoke attacks. Successful treatment of arrhythmia by means of pacemaker implantation].

PubMed

Bieler, M; Sefidpar, M; Engel, U R; Reutter, F W

1976-11-20

The case is reported of a 39-year-old male with Steinert's dystrophia myotonica complicated by cardiac arrhythmias manifested by high-degree a-v block with Stokes-Adams attacks. Implantation of a demand-type cardiac pacemaker brought prompt relief from cardiac symptoms and the patient was able to resume work. The pathologico-anatomical findings in dystrophia myotonica are discussed, together with their possible connection with the type of arrhythmias described.

[Sport for pacemaker patients].

PubMed

Israel, C W

2012-06-01

Sport activity is an important issue in many patients with a pacemaker either because they performed sport activities before pacemaker implantation to reduce the cardiovascular risk or to improve the course of an underlying cardiovascular disease (e.g. coronary artery disease, heart failure) by sports. Compared to patients with an implantable cardioverter defibrillator (ICD) the risks from underlying cardiovascular disease (e.g. ischemia, heart failure), arrhythmia, lead dysfunction or inappropriate therapy are less important or absent. Sport is contraindicated in dyspnea at rest, acute heart failure, new complex arrhythmia, acute myocarditis and acute myocardial infarction, valvular disease with indications for intervention and surgery and comorbidities which prevent physical activity. Patients with underlying cardiovascular disease (including hypertension) should preferably perform types and levels of physical activity that are aerobic (with dynamic exercise) such as running, swimming, cycling instead of sport with high anaerobic demands and high muscular workload. In heart failure, studies demonstrated advantages of isometric sport that increases the amount of muscle, thereby preventing cardiac cachexia. Sport with a risk of blows to the chest or physical contact (e.g. boxing, rugby, martial arts) should be avoided. Implantation, programming and follow-up should respect specific precautions to allow optimal physical activity with a pacemaker including implantation of bipolar leads on the side contralateral to the dominant hand, individual programming of the upper sensor and tracking rate and regular exercise testing.

Percutaneous tricuspid valvotomy for pacemaker lead-induced tricuspid stenosis

PubMed Central

Patil, Devendra V.; Nabar, Ashish A.; Sabnis, Girish R.; Phadke, Milind S.; Lanjewar, Charan P.; Kerkar, Prafulla G.

2015-01-01

Permanent pacemaker lead-induced tricuspid regurgitation is extremely uncommon. We report a patient with severe tricuspid stenosis detected 10 years after permanent single chamber pacemaker implantation in surgically corrected congenital heart disease. The loop at the level of the tricuspid valve may have caused endothelial injury and eventually led to stenosis. Percutaneous balloon valvotomy for such stenosis has not been reported from India. PMID:26995417

Unpredictable interference of new transcranial motor-evoked potential monitor against the implanted pacemaker.

PubMed

Hayashi, Kazuko

2016-12-01

Recently, NuVasive NV-M5 nerve monitoring system, a new transcranial motor-evoked potential (TcMEP) monitor, has been introduced with the spread of flank-approach spinal operations such as extreme lateral interbody fusion, to prevent nerve damage. Conventional TcMEP monitors use changes in MEP wave patterns, such as amplitude and/or latency, whereas the NV-M5 nerve monitor system first measures the MEP baseline waveform from the transcranial-evoked potential then measures the electric current necessary to obtain the standard of the previous baseline wave pattern at subsequent monitoring times. The NV-M5 monitor determines nerve damage according to the increase in necessary electric current threshold. The NV-M5 monitor also uses a local electrical stimulation mode to monitor the safety of setting screws into the lumbar vertebrae. In this way, various electrical stimulations with various durations and frequencies are used, and electrical noise may result in unpredictable interference with cardiac pacemakers. We performed anesthetic management of extreme lateral interbody fusion surgery using the NV-M5 in a patient with an implanted pacemaker, during which TcMEP stimulation caused interference with the implanted pacemaker. Copyright © 2016 Elsevier Inc. All rights reserved.

Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols.

PubMed

Horwood, Laura; Attili, Anil; Luba, Frank; Ibrahim, El-Sayed H; Parmar, Hemant; Stojanovska, Jadranka; Gadoth-Goodman, Sharon; Fette, Carey; Oral, Hakan; Bogun, Frank

2017-05-01

Magnetic resonance imaging (MRI) has been reported to be safe in patients with cardiac implantable electronic devices (CIED) provided a specific protocol is followed. The objective of this study was to assess whether this is also true for patients excluded from published protocols. A total of 160 MRIs were obtained in 142 consecutive patients with CIEDs [106 patients had an implantable cardioverter defibrillator (ICD) and 36 had a pacemaker implanted] using an adapted, pre-specified protocol. A cardiac MRI was performed in 95 patients, and a spinal/brain MRI was performed in 47 patients. Forty-six patients (32%) had either abandoned leads (n = 10), and/or were pacemaker dependent with an implanted ICD (n = 19), had recently implanted CIEDs (n = 1), and/or had a CIED device with battery depletion (n = 2), and/or a component of the CIED was recalled or on advisory (n = 32). No major complications occurred. Some device parameters changed slightly, but significantly, right after or at 1-week post-MRI without requiring any reprogramming. In one patient with an ICD on advisory, the pacing rate changed inexplicably during one of his two MRIs from 90 to 50 b.p.m. Using a pre-specified protocol, cardiac and non-cardiac MRIs were performed in CIED patients with pacemaker dependency, abandoned leads, or depleted batteries without occurrence of major adverse events. Patients with devices on advisory need to be monitored carefully during MRI, especially if they are pacemaker dependent. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Permanent cardiac pacing in patients with end-stage renal disease undergoing dialysis.

PubMed

Wang, I-Kuan; Lin, Kuo-Hung; Lin, Shih-Yi; Lin, Cheng-Li; Chang, Chiz-Tzung; Yen, Tzung-Hai; Sung, Fung-Chang

2016-12-01

Studies investigating the risk of cardiac dysrhythmia warranting permanent pacemaker therapy for end-stage renal disease (ESRD) patients are limited. This study investigated the incidence rate of permanent cardiac pacing in dialysis patients. Using the Taiwan National Health Insurance Database, we identified 28 471 newly diagnosed ESRD patients in 2000-2010 [9700 on peritoneal dialysis (PD) and 18 771 on hemodialysis (HD)] and 113 769 randomly selected controls without kidney disease, frequency-matched by sex, age and diagnosis date. We also established propensity score-matched HD and PD cohorts with 9700 patients each. Incidence rates and hazard ratios (HRs) of implantation were evaluated by the end of 2011. Complications were also evaluated among patients with implantation. The incidence rates of permanent pacemaker implantation were 5.93- and 3.50-fold greater in HD and PD patients than in controls (1.44 and 0.85 versus 0.24 per 1000 person-years, respectively). The adjusted HRs (aHRs) of implantation were 3.26 [95% confidence interval (CI) = 2.41-4.42] and 2.36 (95% CI = 1.56-3.58) for HD and PD patients, respectively, compared with controls. The pacemaker implantation rate was 0.33 per 1000 person-years greater in the propensity score-matched HD cohort than in the PD cohort, with an aHR of 1.30 (95% CI = 0.82-2.05) for the HD cohort compared with the PD cohort. Dialysis patients are at an increased risk of dysrhythmia requiring pacemaker implantation compared with the general population. The risks are not significantly different between HD and PD patients. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Pacemaker explosions in crematoria: problems and possible solutions

PubMed Central

Gale, Christopher P; Mulley, Graham P

2002-01-01

The number of artificial cardiac pacemakers is increasing, as is the number of bodies being cremated. Because of the explosive potential of pacemakers when heated, a statutory question on the cremation form asks whether the deceased has a pacemaker and if so whether it has been removed. We sent a questionnaire to all the crematoria in the UK enquiring about the frequency, consequences and prevention of pacemaker explosions. We found that about half of all crematoria in the UK experience pacemaker explosions, that pacemaker explosions may cause structural damage and injury and that most crematoria staff are unaware of the explosive potential of implantable cardiac defibrillators. Crematoria staff rely on the accurate completion of cremation forms, and doctors who sign cremation forms have a legal obligation to provide such information. PMID:12091510

Incidence of ventricular tachyarrhythmias during permanent pacemaker therapy in low-risk patients results from the German multicentre EVENTS study.

PubMed

Faber, Thomas S; Gradinger, Robert; Treusch, Sven; Morkel, Carsten; Brachmann, Johannes; Bode, Christoph; Zehender, Manfred

2007-09-01

Current studies found an incidence of 12-31% ventricular tachyarrhythmias and sudden cardiac death during cardiac pacing months or even years after pacemaker insertion. MADIT(12) and MUSTT(13) demonstrated that patients with poor LV function after Myocardial infarction (MI) showing non-sustained ventricular tachycardia (nsVT) and inducibility during electrophysiologic testing benefit from an ICD. The present study was dedicated to assess the global incidence of non-sustained ventricular arrhythmias in a general population of pacemaker patients. Special regard was on patients with a potential ICD indication, e.g. those matching the MADIT/MUSTT criteria. Two hundred and thirty-one patients (72 +/- 11 years; 134 men) with an indication for dual chamber pacing entered the study. In all patients pacemaker systems capable of automatic storing of intracardiac electrocardiograms were implanted (Pulsar, Discovery, Guidant). Follow-up time was 15 months after inclusion. In 54 (25.7%) of 210 patients with at least one follow-up, episodes of nsVT were documented by stored electrocardiograms (up to >30 beats, >200 b.p.m.). Multiple-up to nine-episodes of ventricular tachycardia were retrieved in 31 of these patients. Three out of 14 patients with an LVEF <40% after MI presented nsVT during the follow-up. One of these patients received an ICD. A significant number of pacemaker patients present with ventricular tachycardia. Intracardiac electrocardiograms and alert functions from pacemakers may enhance physicians' awareness of the patient's intrinsic arrhythmic profile and help uncover underlying mechanisms of arrhythmias by storing the initiation of the arrhythmia.

Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access.

PubMed

Squara, Fabien; Tomi, Julien; Scarlatti, Didier; Theodore, Guillaume; Moceri, Pamela; Ferrari, Emile

2017-12-01

Axillary vein access for pacemaker implantation is uncommon in many centres because of the lack of training in this technique. We assessed whether the introduction of the axillary vein technique was safe and efficient as compared with cephalic vein access, in a centre where no operators had any previous experience in axillary vein puncture. Patients undergoing pacemaker implantation were randomized to axillary or cephalic vein access. All three operators had no experience nor training in axillary vein puncture, and self-learned the technique by reading a published review. Axillary vein puncture was fluoroscopy-guided without contrast venography. Cephalic access was performed by dissection of delto-pectoral groove. Venous access success, venous access duration (from skin incision to guidewire or lead in superior vena cava), procedure duration, X-ray exposure, and peri-procedural (1 month) complications were recorded. results We randomized 74 consecutive patients to axillary (n = 37) or cephalic vein access (n = 37). Axillary vein was successfully accessed in 30/37 (81.1%) patients vs. 28/37 (75.7%) of cephalic veins (P = 0.57). Venous access time was shorter in axillary group than in cephalic group [5.7 (4.4-8.3) vs. 12.2 (10.5-14.8) min, P < 0.001], as well as procedure duration [34.8 (30.6-38.4) vs. 42.0 (39.1-46.6) min, P = 0.043]. X-ray exposure and peri-procedural overall complications were comparable in both groups. Axillary puncture was safe and faster than cephalic access even for the five first procedures performed by each operator. Self-taught axillary vein puncture for pacemaker implantation seems immediately safe and faster than cephalic vein access, when performed by electrophysiologists trained to pacemaker implantation but not to axillary vein puncture. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

SU-E-I-42: Normalized Embryo/fetus Doses for Fluoroscopically Guided Pacemaker Implantation Procedures Calculated Using a Monte Carlo Technique

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

Damilakis, J; Stratakis, J; Solomou, G

Purpose: It is well known that pacemaker implantation is sometimes needed in pregnant patients with symptomatic bradycardia. To our knowledge, there is no reported experience regarding radiation doses to the unborn child resulting from fluoroscopy during pacemaker implantation. The purpose of the current study was to develop a method for estimating embryo/fetus dose from fluoroscopically guided pacemaker implantation procedures performed on pregnant patients during all trimesters of gestation. Methods: The Monte Carlo N-Particle (MCNP) radiation transport code was employed in this study. Three mathematical anthropomorphic phantoms representing the average pregnant patient at the first, second and third trimesters of gestationmore » were generated using Bodybuilder software (White Rock science, White Rock, NM). The normalized embryo/fetus dose from the posteroanterior (PA), the 30° left-anterior oblique (LAO) and the 30° right-anterior oblique (RAO) projections were calculated for a wide range of kVp (50–120 kVp) and total filtration values (2.5–9.0 mm Al). Results: The results consist of radiation doses normalized to a) entrance skin dose (ESD) and b) dose area product (DAP) so that the dose to the unborn child from any fluoroscopic technique and x-ray device used can be calculated. ESD normalized doses ranged from 0.008 (PA, first trimester) to 2.519 μGy/mGy (RAO, third trimester). DAP normalized doses ranged from 0.051 (PA, first trimester) to 12.852 μGy/Gycm2 (RAO, third trimester). Conclusion: Embryo/fetus doses from fluoroscopically guided pacemaker implantation procedures performed on pregnant patients during all stages of gestation can be estimated using the method developed in this study. This study was supported by the Greek Ministry of Education and Religious Affairs, General Secretariat for Research and Technology, Operational Program ‘Education and Lifelong Learning’, ARISTIA (Research project: CONCERT)« less

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

PubMed

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

2007-11-01

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

Electrocardiographic Predictors of Long-Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation.

PubMed

Naveh, Sivan; Perlman, Gidon Y; Elitsur, Yair; Planer, David; Gilon, Dan; Leibowitz, David; Lotan, Chaim; Danenberg, Haim; Alcalai, Ronny

2017-02-01

Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of transcatheter aortic valve implantation (TAVI). Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long-term pacing dependency. Consecutive patients who underwent TAVI were included in this prospective observational study. The conduction system was investigated by reviewing 12-lead ECGs during hospitalization and up to 1-year follow-up and by analyzing pacemaker interrogation data. Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency. Of 110 patients included in the analysis, 38 (34.5%) underwent PPM implantation. Of those, 26 (68.4%) had a long-term pacing dependency (required PPM), while 12 (31.6%) did not (not-required PPM). Logistic regression revealed that baseline RBBB (P = 0.01, OR = 18.0), baseline PR interval (P = 0.019, OR = 1.14), post-TAVI PR interval and the change in PR interval from baseline (P < 0.001 for both, OR = 1.17 for each 10 milliseconds increment) were independent predictors for long-term pacing dependency. A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency. Increased pre- and postprocedural PR intervals and pre-existing RBBB are reliable predictors for long-term PPM dependency, while left bundle branch block or QRS width are misleading factors. Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval. © 2016 Wiley Periodicals, Inc.

Effect on pacemakers of airport weapons detectors

PubMed Central

Johnson, David L.

1974-01-01

An investigation was carried out using a variety of pacemakers and all the types of weapons detectors in common use in Canada, to determine whether or not such detectors present a hazard to pacemaker bearers. The results indicate that only left-side implants of unipolar sensing pacemakers are likely to be affected, that ventricular fibrillation initiated by interference-induced competitive pacing is the only conceivable hazard, but that the probability of 10−9 for the occurrence of this event is so low that it may be completely disregarded. Physicians may therefore reassure pacemaker bearers of their safety in and around airport weapons detectors. ImagesFIG. 1 PMID:4825148

Electromagnetic interference with pacemakers caused by portable media players.

PubMed

Thaker, Jay P; Patel, Mehul B; Jongnarangsin, Krit; Liepa, Valdis V; Thakur, Ranjan K

2008-04-01

Electromagnetic fields generated by electrical devices may cause interference with permanent pacemakers. Media players are becoming a common mode of portable entertainment. The most common media players used worldwide are iPods. These devices are often carried in a shirt chest pocket, which may place the devices close to an implanted pacemaker. The purpose of this study was to determine if iPods cause interference with pacemakers. In this prospective, single-blinded study, 100 patients who had cardiac pacemakers were tested with four types of iPods to assess for interference. Patients were monitored by a single-channel ECG monitor as well as the respective pacemaker programmer via the telemetry wand. iPods were tested by placing them 2 inches anterior to the pacemaker and wand for up to 10 seconds. To simulate actual use, standard-issue headphones were plugged into the iPods. To maintain consistency, the volume was turned up maximally, and the equalizer was turned off. A subset of 25 patients underwent testing on 2 separate days to assess for reproducibility of interference. Pacemaker interference was categorized as type I or type II telemetry interference. Type I interference was associated with atrial and/or ventricular high rates on rate histograms. Type II interference did not affect pacemaker rate counters. Electromagnetic emissions from the four iPods also were evaluated in a Faraday cage to determine the mechanism of the observed interference. One hundred patients (63 men and 37 women; mean age 77.1 +/- 7.6 years) with 11 single-chamber pacemakers and 89 dual-chamber pacemakers underwent 800 tests. The incidence of any type of interference was 51% of patients and 20% of tests. Type I interference was seen in 19% of patients and type II in 32% of patients. Reproducibility testing confirmed that interference occurred regardless of pacing configuration (unipolar or bipolar), pacing mode (AAI, VVI, or DDD), and from one day to the next. Electromagnetic emissions testing from the iPods demonstrated maximum emissions in the pacemaker carrier frequency range when the iPod was turned "on" with the headphones attached. iPods placed within 2 inches of implanted pacemakers monitored via the telemetry wand can cause interference with pacemakers.

A Percutaneously Implantable Fetal Pacemaker

PubMed Central

Zhou, Li; Vest, Adriana N.; Chmait, Ramen H.; Bar-Cohen, Yaniv; Pruetz, Jay; Silka, Michael; Zheng, Kaihui; Peck, Ray; Loeb, Gerald E.

2015-01-01

A miniaturized, self-contained pacemaker that could be implanted with a minimally invasive technique would dramatically improve the survival rate for fetuses that develop hydrops fetalis as a result of congenital heart block. We are currently validating a device that we developed to address this bradyarrhythmia. Preclinical studies in a fetal sheep model are underway to demonstrate that the device can be implanted via a minimally invasive approach, can mechanically withstand the harsh bodily environment, can induce effective contractions of the heart muscle with an adequate safety factor, and can successfully operate for the required device lifetime of three months using the previously-developed closed loop transcutaneous recharging system. PMID:25570982

A new multiprogrammable isotopic powered cardiac pacemaker

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

Smyth, N.P.; Purdy, D.L.; Sager, D.

1982-09-01

A new multiprogrammable, isotopic-powered cardiac pacemaker was implanted in six patients as a custom device. Five were initial implants and one was a replacement. The patients were studied for up to two years. In five of the six cases it was found advantageous to change one of the programmable parameters. Multiprogrammability is obviously as important in an isotopic pulse generator as in a lithium unit, if not more so, because of the unit's greater longevity. Further studies are continuing in an FDA approved clinical trial.

Safety of Laser Interstitial Thermal Therapy in Patients With Pacemakers.

PubMed

Grewal, Sanjeet S; Gorny, Krzysztof R; Favazza, Christopher P; Watson, Robert E; Kaufmann, Timothy J; Van Gompel, Jamie J

2018-02-10

Laser interstitial thermal therapy (LiTT) has increasingly been used as a treatment option for medically refractory epilepsy, tumors, and radiation necrosis. The use of LiTT requires intraoperative magnetic resonance (MR) thermography. This can become an issue in patients with other implanted therapeutic devices such as pacemakers and vagal nerve stimulators due to concerns regarding increases in the specific absorption rate (SAR). This is a technical case report demonstrating a successfully and safely performed LiTT in a 1.5-T magnetic resonance imaging (MRI) in a patient with a pacemaker for mesial temporal sclerosis. An 83-yr-old gentleman who had an implanted cardiac pacemaker presented with medically intractable epilepsy and was confirmed to have mesial temporal sclerosis on imaging. Video electroencephalography demonstrated concordant ipsilateral seizures and semiology. He underwent LiTT for ablation of the mesial temporal lobe. This was performed with the below described protocol with a cardiology nurse monitoring the patient's cardiac condition and a physicist monitoring SAR, and MR imaging quality without any adverse events. This study reports on a protocol of cardiac and MR SAR to safely perform MR-guided LiTT in the setting of traditional pacemakers in patients who are not pacemaker dependent. Copyright © 2018 by the Congress of Neurological Surgeons

Hybrid bodies and the materiality of everyday life: how people living with pacemakers and defibrillators reinvent everyday routines and intimate relations.

PubMed

Oudshoorn, Nelly

2018-01-01

Technologies inside bodies pose new challenges in a technological culture. For people with pacemakers and defibrillators, activities such as passing security controls at airports, using electromagnetic machines, electrical domestic appliances and electronic devices, and even intimate contacts with their loved ones can turn into events where the proper functioning of their device may be at risk. Anticipation of potentially harmful events and situations thus becomes an important part of the choreography of everyday life. Technologies inside bodies not only pose a challenge for patients living with these devices but also to theorising body-technology relations. Whereas researchers usually address the merging of bodies and technologies, implants ask us to do the opposite as well. How are we to understand human-technology relations in which technologies should not entangle with bodies because they serve other purposes? Based on a study of the daily life practices of people with pacemakers and defibrillators in the Netherlands and the US, I argue that disentanglement work, i.e. work involved to prevent entanglements with objects and people that may inflict harm upon implanted devices, is key to understanding how hybrid bodies can survive in today's densely populated technological landscape. © 2017 Foundation for the Sociology of Health & Illness.

Early Performance and Safety of the Micra Transcatheter Pacemaker in Pigs.

PubMed

Bonner, Matthew; Eggen, Michael; Haddad, Tarek; Sheldon, Todd; Williams, Eric

2015-11-01

The Micra® Transcatheter Pacing System (TPS; Medtronic Inc., Minneapolis, MN, USA) is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. In this study, the electrical performance was compared between the TPS and a traditional leaded pacemaker. In addition, the safety profile of the two systems was compared by thorough monitoring for a number of adverse events. The TPS was implanted in the right ventricular apex of 10 Yucatan mini pigs and a Medtronic single-lead pacemaker (SLP) was implanted in the right ventricular apex of another 10 pigs and connected to a traditional pacemaker. The electrical performance of all devices was monitored for 12 weeks. The safety profile of each system was characterized using x-ray, computed tomography, ultrasound, blood work, and necropsy to monitor for a variety of adverse events. At implant the mean pacing thresholds were 0.58 ± 0.17 V @0.24 ms and 0.75 ± 0.29 V @0.21 ms for the TPS and the SLP respectively. After 12 weeks, mean thresholds were 0.94 ± 0.46 V and 1.85 ± 0.75 V (P < 0.0001). There were two pulmonary emboli that were small and past the tertiary branch, and one occurred in each arm. There were also two infections with one in each arm. There were no dislodgements (macro or micro), tissue injury, tamponade, or valve injury. Overall, despite the 10-fold size reduction of the Micra TPS, it appears to perform similarly and have a similar safety profile to a traditional pacemaker system. © 2015 Medtronic PLC. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

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

PubMed

Shapiro, Michael; Hanon, Sam; Schweitzer, Paul

2004-10-01

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

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

PubMed

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

2017-09-01

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

Frozen shoulder syndrome associated with subpectoral defibrillator implantation.

PubMed

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

1999-10-01

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

Re-use of explanted DDD pacemakers as VDD- clinical utility and cost effectiveness.

PubMed

Namboodiri, K K N; Sharma, Y P; Bali, H K; Grover, A

2004-01-01

Re-use of DDD pulse generators explanted from patients died of unrelated causes is associated with an additional cost of two transvenous leads if implanted as DDD itself, and high rate of infection according to some studies. We studied the clinical and economical aspects of reutilization of explanted DDD pacemakers programmed to VDD mode. Out of 28 patients who received VDD pacemaker during the period, October 2000- September 2001 in the Department of Cardiology, PGIMER, Chandigarh, 5 poor patients were implanted with explanted DDD pulse generators programmed to VDD mode. Each implantation was planned and carried out according to a standard protocol. The age ranged from 45 to 75 (mean-61) years. The indications for pacing were complete heart block (4) and second degree AV block (1). The clinical profile, costs and complications, if any were noted and followed up at regular intervals. The results were compared with patients who received new DDD pulse generators during this period. The additional cost for the atrial lead was not required in these patients. None of these patients had any local site infection. Compared to the two-lead system, the single lead system provided more rapid implantation and minimized complications associated with placement of an atrial lead. The explanted DDD pacemaker can be safely reused as VDD mode with same efficacy in selected patient population. This is associated with lower cost and complications compared to reimplantation as DDD itself.

Radioisotope-powered cardiac pacemaker program. Clinical studies of the nuclear pacemaker model NU-5. Final report

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

Not Available

1980-06-01

Beginning in February, 1970, the Nuclear Materials and Equipment Corporation (NUMEC) undertook a program to design, develop and manufacture a radioisotope powered cardiac pacemaker system. The scope of technical work was specified to be: establish system, component, and process cost reduction goals using the prototype Radioisotope Powered Cardiac Pacemaker (RCP) design and develop production techniques to achieve these cost reduction objectives; fabricate radioisotope powered fueled prototype cardiac pacemakers (RCP's) on a pilot production basis; conduct liaison with a Government-designated fueling facility for purposes of defining fueling requirements, fabrication and encapsulation procedures, safety design criteria and quality control and inspection requirements;more » develop and implement Quality Assurance and Reliability Programs; conduct performance, acceptance, lifetime and reliability tests of fueled RCP's in the laboratory; conduct liaison with the National Institutes of Health and with Government specified medical research institutions selected for the purpose of undertaking clinical evaluation of the RCP in humans; monitor and evaluate, on a continuing basis, all test data; and perform necessary safety analyses and tests. Pacemaker designs were developed and quality assurance and manufacturing procedures established. Prototype pacemakers were fabricated. A total of 126 radioisotope powered units were implanted and have been followed clinically for approximately seven years. Four (4) of these units have failed. Eighty-three (83) units remain implanted and satisfactorily operational. An overall failure rate of less than the target 0.15% per month has been achieved.« less

Retrospective analysis of mode survival, reliability of atrial sensing and incidence of atrial tachyarrhythmias in 307 single-lead VDD pacemaker patients.

PubMed

Zupan, Igor; Lipar, Luka; Zizek, David; Boute, Wim; Vidmar, Masa; Gabrijelcic, Tone; Rakovec, Peter; Brecelj, Ales

2006-10-01

The aim of this retrospective analysis was to investigate VDD mode survival, development of atrial tachyarrhythmias (AT), and long-term atrial sensing performance of VDD pacing systems. We implanted single-lead VDD pacemakers in patients with isolated atrioventricular block and performed a retrospective analysis of 307 patients who had their devices implanted between May 1994 and September 2001. In 39 patients (12.7%), the pacing mode had to be reprogrammed to a single-chamber ventricular pacing mode, mostly due to permanent AT. In 16 of these patients, the atrial sensing safety margin was less than 150%. The atrial sensing safety margin was insufficient, i.e. less than 100% in only seven patients. Although only 12 (3.9%) of the patients had a history of paroxysmal AT at the time of pacemaker implantation, 200 (65%) patients presented with AT during follow-up. The mean AT burden at the last follow-up was 2.5%. These data illustrate that single-lead VDD pacemakers can be applied without serious complications in a highly selected group of patients. Our main concern is the development of AT in a large part of our population. Over a 10-year period, two thirds of our patients presented with AT.

Tricuspid Valve Dysfunction Following Pacemaker or Cardioverter-Defibrillator Implantation.

PubMed

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

2017-05-09

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

Inadvertent positioning of pacemaker leads in the pericardium.

PubMed

Berenji, Kambeez; Nerheim, Pamela; Olshansky, Brian

2003-10-01

A patient had a dual chamber pacemaker with endocardial leads implanted chronically. The lead position on chest X ray and the ECG pattern indicated lead malposition, but a CT scan and transesophageal echocardiography were nondiagnostic. Venography indicated that both leads were in the mediastinal and pericardial space.

Spanish Pacemaker Registry. Thirteenth Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2015).

PubMed

Pombo Jiménez, Marta; Cano Pérez, Óscar; Fidalgo Andrés, María Luisa; Lorente Carreño, Diego; Coma Samartín, Raúl

2016-12-01

We describe the results of the analysis of the devices implanted and conveyed to the Spanish Pacemaker Registry in 2015. The report is based on the processing of information provided by the European Pacemaker Patient Identification Card. We received information from 111 hospitals, with a total of 12 555 cards, representing 32.1% of all the estimated activity. The use of conventional generators and resynchronization devices was 820 and 73 units per million population, respectively. The mean age of the patients receiving an implantation was 77.7 years, and more than 50% of the devices were implanted in patients over 80 years of age. Overall, 58.6% of the implants and 58.8% of the replacements were performed in men. All of the endocardial leads employed were bipolar, 81.5% had an active fixation system, and 16.5% were compatible with magnetic resonance. Although dual chamber sequential pacing continues to be more widespread, pacing with VVI/R mode is used because up to 23.8% of the patients with sinus node disease are in sinus rhythm, as are 24.1% of those with atrioventricular block. The total use of pacemaker generators in Spain has increased by about 5% with respect to 2014. The majority of the leads implanted are of active fixation, and less than 20% are protected from magnetic resonance. The factors directly related to the selection of pacing mode are age and sex. In around 20% of patients, the choice of the pacing mode could be improved. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Late deterioration of left ventricular function after right ventricular pacemaker implantation.

PubMed

Bellmann, Barbara; Muntean, Bogdan G; Lin, Tina; Gemein, Christopher; Schmitz, Kathrin; Schauerte, Patrick

2016-09-01

Right ventricular (RV) pacing induces a left bundle branch block pattern on ECG and may promote heart failure. Patients with dual chamber pacemakers (DCPs) who present with progressive reduction in left ventricular ejection fraction (LVEF) secondary to RV pacing are candidates for cardiac resynchronization therapy (CRT). This study analyzes whether upgrading DCP to CRT with the additional implantation of a left ventricular (LV) lead improves LV function in patients with reduced LVEF following DCP implantation. Twenty-two patients (13 males) implanted with DCPs and a high RV pacing percentage (>90%) were evaluated in term of new-onset heart failure symptoms. The patients were enrolled in this retrospective single-center study after obvious causes for a reduced LVEF were excluded with echocardiography and coronary angiography. In all patients, DCPs were then upgraded to biventricular devices. LVEF was analyzed with a two-sided t-test. QRS duration and brain natriuretic peptide (BNP) levels were analyzed with the unpaired t-test. LVEF declined after DCP implantation from 54±10% to 31±7%, and the mean QRS duration was 161±20 ms during RV pacing. NT-pro BNP levels were elevated (3365±11436 pmol/L). After upgrading to a biventricular device, a biventricular pacing percentage of 98.1±2% was achieved. QRS duration decreased to 108±16 ms and 106±20 ms after 1 and 6 months, respectively. There was a significant increase in LVEF to 38±8% and 41±11% and a decrease in NT-pro BNP levels to 3088±2326 pmol/L and 1860±1838 pmol/L at 1 and 6 months, respectively. Upgrading to CRT may be beneficial in patients with DCPs and heart failure induced by a high RV pacing percentage.

Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients

PubMed Central

Johansen, Jens Brock; Jørgensen, Ole Dan; Møller, Mogens; Arnsbo, Per; Mortensen, Peter Thomas; Nielsen, Jens Cosedis

2011-01-01

Aims Infection is a serious complication of pacemaker (PM) systems. Although the rate of infection has been debated, the figures are largely unknown. We therefore studied the incidence of PM infection and its associated risk factors in the Danish population. Methods and results Since 1982, all PM implantation and removal procedures performed in Denmark have been prospectively recorded in the Danish Pacemaker Register. All patients (n = 46299) who underwent implantation between 1982 and 2007 were included. The total length of surveillance was 236 888 PM-years. The incidence of infection was calculated according to the total number of PM-years. The incidence of surgical site infection (≤365 days after PM implantation) was compared with later infection in first implant and replacement procedures. Multiple-record and multiple-event-per-subject proportional hazards analyses were used to identify the independent risk factors of PM infection. Surgical site infection occurred in 192 cases after first implantation (incidence rate 4.82/1000 PM-years), and in 133 cases after replacement (12.12/1000 PM-years). Infections occurring more than 365 days after the first implantation occurred in 153 cases (1.02/1000 PM-years), and in 118 cases after replacement (3.26/1000 PM-years). Independent factors associated with an increased risk of PM infection were a greater number of PM operations (including replacements), male sex, younger age, implantation during the earliest part of the study period, and absence of antibiotics (P< 0.001). Conclusion The overall risk of infection after PM implantation was low. A greater number of operations augmented the risk of infection. This should be taken into account when considering revisions of PM systems. PMID:21252172

Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.

PubMed

Crossley, George H; Chen, Jane; Choucair, Wassim; Cohen, Todd J; Gohn, Douglas C; Johnson, W Ben; Kennedy, Eleanor E; Mongeon, Luc R; Serwer, Gerald A; Qiao, Hongyan; Wilkoff, Bruce L

2009-11-24

The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation. Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function. More recently developed remote monitoring technology leverages expanded device capabilities, augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation. The time to first diagnosis of a clinically actionable event was compared in patients who were followed by remote interrogation (Remote) and those who were followed per standard of care with office visits augmented by transtelephonic monitoring (Control). Patients were randomized 2:1. Remote arm patients transmitted pacemaker information at 3-month intervals. Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals. Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months. All patients were seen in office at 12 months. The mean time to first diagnosis of clinically actionable events was earlier in the Remote arm (5.7 months) than in the Control arm (7.7 months). Three (2%) of the 190 events in the Control arm and 446 (66%) of 676 events in the Remote arm were identified remotely. The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings. The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations. (PREFER [Pacemaker Remote Follow-up Evaluation and Review]; NCT00294645).

Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

PubMed

van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, Ramón; Molina-Martin de Nicolas, Javier; Stella, Pieter R; Carrié, Didier; De Jaegere, Peter P; Van Mieghem, Nicolas M

2017-03-03

Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Predictors of Need for Permanent Pacemaker Implantation and Conduction Abnormalities With a Novel Self-expanding Transcatheter Heart Valve.

PubMed

Pellegrini, Costanza; Husser, Oliver; Kim, Won-Keun; Holzamer, Andreas; Walther, Thomas; Rheude, Tobias; Mayr, Nicola Patrick; Trenkwalder, Teresa; Joner, Michael; Michel, Jonathan; Chaustre, Fabian; Kastrati, Adnan; Schunkert, Heribert; Burgdorf, Christof; Hilker, Michael; Möllmann, Helge; Hengstenberg, Christian

2018-03-15

The incidence of permanent pacemaker implantation (PPI) and new conduction abnormalities (CA) with the ACURATE neo (Symetis S.A., Eclubens, Switzerland) has not been studied in detail. We aimed to analyze their predictors, evaluating patient- and device-related factors, including implantation depth and device-to-annulus ratio (DAR). Two analyses of a multicenter population were performed: new PPI in pacemaker-naive patients (n = 283), and PPI/new-CA in patients without prior CA or pacemaker (n = 232). A new PPI was required in 9.9% of patients, who had a higher body mass index, higher rate of right bundle branch block and bradycardia. Neither implantation depth nor DAR differed in patients with PPI compared with those without. In the multivariable analysis neither DAR (OR, 1.010; 95%CI, 0.967-1.055; P = .7) nor implantation depth (OR, 0.972; 95%CI, 0.743-1.272; P = .8) predicted PPI. Only high body mass index, bradycardia and right bundle branch block persisted as independent predictors. PPI/new-onset CA occurred in 22.8% of patients and was associated with a higher logistic EuroSCORE. Neither implantation depth nor DAR differed in patients with PPI/new-CA vs those without (7.3 ± 1.9 vs 7.1 ± 1.5mm; P = .6 and 41.0 ± 7.9 vs 42.2 ± 10.1%; P = .4). The only predictor of PPI/new-CA was a higher logistic EuroSCORE (OR, 1.039; 95%CI, [1.008-1.071]; P = .013). New PPI and new-onset CA rates were low with the ACURATE neo. These were mainly influenced by patient characteristics and not by device-depending factors. Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Induced Pluripotent Stem Cell–Derived Cardiomyocytes Provide In Vivo Biological Pacemaker Function

PubMed Central

Chauveau, Samuel; Anyukhovsky, Evgeny P.; Ben-Ari, Meital; Naor, Shulamit; Jiang, Ya-Ping; Danilo, Peter; Rahim, Tania; Burke, Stephanie; Qiu, Xiaoliang; Potapova, Irina A.; Doronin, Sergey V.; Brink, Peter R.; Binah, Ofer

2017-01-01

Background— Although multiple approaches have been used to create biological pacemakers in animal models, induced pluripotent stem cell–derived cardiomyocytes (iPSC-CMs) have not been investigated for this purpose. We now report pacemaker function of iPSC-CMs in a canine model. Methods and Results— Embryoid bodies were derived from human keratinocytes, their action potential characteristics determined, and their gene expression profiles and markers of differentiation identified. Atrioventricular blocked dogs were immunosuppressed, instrumented with VVI pacemakers, and injected subepicardially into the anterobasal left ventricle with 40 to 75 rhythmically contracting embryoid bodies (totaling 1.3–2×106 cells). ECG and 24-hour Holter monitoring were performed biweekly. After 4 to 13 weeks, epinephrine (1 μg kg−1 min−1) was infused, and the heart removed for histological or electrophysiological study. iPSC-CMs largely lost the markers of pluripotency, became positive for cardiac-specific markers. and manifested If-dependent automaticity. Epicardial pacing of the injection site identified matching beats arising from that site by week 1 after implantation. By week 4, 20% of beats were electronically paced, 60% to 80% of beats were matching, and mean and maximal biological pacemaker rates were 45 and 75 beats per minute. Maximum night and day rates of matching beats were 53±6.9 and 69±10.4 beats per minute, respectively, at 4 weeks. Epinephrine increased rate of matching beats from 35±4.3 to 65±4.0 beats per minute. Incubation of embryoid bodies with the vital dye, Dil, revealed the persistence of injected cells at the site of administration. Conclusions— iPSC-CMs can integrate into host myocardium and create a biological pacemaker. Although this is a promising development, rate and rhythm of the iPSC-CMs pacemakers remain to be optimized. PMID:28500172

Study of electrochemical properties of thin film materials obtained using plasma technologies for production of electrodes for pacemakers

NASA Astrophysics Data System (ADS)

Obrezkov, O. I.; Vinogradov, V. P.; Krauz, V. I.; Mozgrin, D. V.; Guseva, I. A.; Andreev, E. S.; Zverev, A. A.; Starostin, A. L.

2016-09-01

Studies of thin film materials (TFM) as coatings of tips of pacemaker electrodes implanted into the human heart have been performed. TFM coatings were deposited in vacuum by arc magnetron discharge plasma, by pulsed discharge of “Plasma Focus”, and by electron beam evaporation. Simulation of electric charge transfer to the heart in physiological blood- imitator solution and determination of electrochemical properties of the coatings were carried out. TFM of highly developed surface of contact with tissue was produced by argon plasma spraying of titanium powder with subsequent coating by titanium nitride in vacuum arc assisted by Ti ion implantation. The TFM coatings of pacemaker electrode have passed necessary clinical tests and were used in medical practice. They provide low voltage myocardium stimulation thresholds within the required operating time.

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

PubMed

Russo, Robert J

2013-03-01

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

Isolated Complete Heart Block in the Fetus.

PubMed

Ho, Andrew; Gordon, Patrick; Rosenthal, Eric; Simpson, John; Miller, Owen; Sharland, Gurleen

2015-07-01

Isolated congenital complete heart block (CCHB) is a rare disease with significant associated morbidity and mortality. A diagnosis is often made in fetal life, but data regarding long-term outcomes are limited, and fetal therapy to improve prognosis is controversial. In our institution, 85 fetuses were diagnosed with CCHB from 1981 to 2013 in 80 mothers. There were 37 anti-Ro-positive pregnancies, 36 both anti-Ro and anti-La positive, 10 antibody negative, and 2 of unknown antibody status. Antenatal treatments were given in 14 fetuses, with 8 given fluorinated steroids, 4 beta sympathomimetics, and both in 2. Of the original 85, 74 babies survived to delivery. Fetal hydrops was the only risk factor found to be significantly associated with intrauterine death (p <0.001). Four babies died before pacemaker implantation, 56 have had pacemakers implanted, and 14 are pacemaker free. The Kaplan-Meier estimate for median time to pacemaker implantation was 2.6 years, with 15 implanted in the neonatal period. There have been 14 postnatal deaths, with a Kaplan-Meier estimate of survival at 30 years of 76.8% (95% confidence interval 65% to 90%). Dilated cardiomyopathy was uncommon, occurring in 6 patients. Prematurity and hydrops were associated with increased postnatal mortality (p = 0.02 and 0.005, respectively). In conclusion, we present the largest single-unit experience of prenatally diagnosed CCHB in the published literature. Our cohort was conservatively managed, with survival similar to those previously published. These data offer insight into the long-term natural history of CCHB. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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

PubMed

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

2013-04-01

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

Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.

PubMed Central

Mounsey, J P; Griffith, M J; Tynan, M; Gould, F K; MacDermott, A F; Gold, R G; Bexton, R S

1994-01-01

BACKGROUND--Pacemaker pocket infection is a potentially serious problem after permanent pacemaker implantation. Antibiotic prophylaxis is commonly prescribed to reduce the incidence of this complication, but current trial evidence of its efficacy is conflicting. A large prospective randomised trial was therefore performed of antibiotic prophylaxis in permanent pacemaker implantation. The intention was firstly to determine whether antibiotic prophylaxis is efficacious in these patients and secondly to identify which patients are at the highest risk of infection. METHODS--A prospective randomised open trial of flucloxacillin (clindamycin if the patient was allergic to penicillin) v no antibiotic was performed in a cohort of patients undergoing first implantation of a permanent pacing system over a 17 month period. Intravenous antibiotics were started at the time of implantation and continued for 48 hours. The trial endpoint was a repeat operation for an infective complication. RESULTS--473 patients were entered into a randomised trial. 224 received antibiotic prophylaxis and 249 received no antibiotics. A further 183 patients were not randomised but were treated according to the operator's preference (64 antibiotics, 119 no antibiotics); these patients are included only in the analysis of predictors of infection. Patients were followed up for a mean (SD) of 19(5) months. Among the patients in the randomised group there were nine infections requiring a repeat operation, all in the group not receiving antibiotic (P = 0.003). In the total patient cohort there were 13 infections, all but one in the non-antibiotic group (P = 0.006). Nine of the infections presented as erosion of the pulse generator or electrode, three as septicaemia secondary to Staphylococcus aureus, and one as a pocket abscess secondary to Staphylococcus epidermidis. Infections were significantly more common when the operator was inexperienced (< or = 100 previous patients), the operation was prolonged, or after a repeat operation for non-infective complications (principally lead displacement). Infection was not significantly more common in patients identified preoperatively as being at high risk (for example patients with diabetes mellitus, patients receiving long term steroid treatment), although there was a trend in this direction. CONCLUSIONS--Antibiotic prophylaxis significantly reduced the incidence of infective complications requiring a repeat operation after permanent pacemaker implantation. It is suggested that antibiotics should be used routinely. PMID:7833191

Hemodynamic instability after pulmonary veins isolation in a patient with dual chamber pacemaker

PubMed Central

Kiuchi, Márcio Galindo; Lobato, Guilherme Miglioli; Chen, Shaojie

2017-01-01

Abstract Introduction: The standard treatment of sinus node dysfunction (SND) is the pacemaker implantation, and the ideal methodology for the management of atrial fibrillation (AF) is rhythm control, but this is sometimes very hard to accomplish. For such actions, complete isolation of all pulmonary veins (PVI) is currently widely accepted as the best endpoint. Case Presentation: In this case, we report a female patient, 81 years old, with controlled hypertension, without coronary artery disease, bearer of bilateral knee replacement, and dual chamber pacemaker implanted 1.5 years ago owing to sinus node disease, presenting the following symptoms: presyncope episodes associated with sustained irregular palpitation tachycardia. The evaluation of the pacemaker-recorded episodes of atrial fibrillation, the echocardiogram-presented normal systolic function and measurements, as well as the resting myocardial scintigraphy and with drug use did not demonstrate ischemia and/or fibrosis. The patient was in use of valsartan 320 mg daily, amlodipine 10 mg daily, sotalol hydrochloride 120 mg 2 times daily, and dabigatran 110 mg 2 times daily. At the end of the PVI, the patient presented hemodynamic instability, with a decrease in heart rate to 30 bpm and invasive arterial blood pressure to 60/30 mmHg. The pericardial puncture was quickly carried out with the possibility of cardiac tamponade as the first hypothesis, but no pericardial effusion was found. Next, we detected acute capture loss from the ventricular pacemaker lead, unvarying with high voltage and pulse width, even with stable impedance, sense and keeping the same position visualized by fluoroscopy. And there was soon afterwards induction of sustained ventricular tachycardia degenerating to spontaneous ventricular fibrillation. Electrical cardioversion-defibrillation was performed with 200J, and the sinus rhythm was reestablished, but there was a dead short, and the pacemaker generator was burned and disabled. Conclusions: So, we can speculate that application of atrial radiofrequency for PVI diffused through the tissues, affecting in some way the tip of the ventricular electrode, causing a microlesion in this structure and making it impossible to capture the right ventricle by the pacemaker. As we cannot see it, we can call it of phantom injury of the ventricular lead. PMID:28562571

Hemodynamic instability after pulmonary veins isolation in a patient with dual chamber pacemaker: The phantom injury of the ventricular lead.

PubMed

Kiuchi, Márcio Galindo; Lobato, Guilherme Miglioli; Chen, Shaojie

2017-06-01

The standard treatment of sinus node dysfunction (SND) is the pacemaker implantation, and the ideal methodology for the management of atrial fibrillation (AF) is rhythm control, but this is sometimes very hard to accomplish. For such actions, complete isolation of all pulmonary veins (PVI) is currently widely accepted as the best endpoint. In this case, we report a female patient, 81 years old, with controlled hypertension, without coronary artery disease, bearer of bilateral knee replacement, and dual chamber pacemaker implanted 1.5 years ago owing to sinus node disease, presenting the following symptoms: presyncope episodes associated with sustained irregular palpitation tachycardia. The evaluation of the pacemaker-recorded episodes of atrial fibrillation, the echocardiogram-presented normal systolic function and measurements, as well as the resting myocardial scintigraphy and with drug use did not demonstrate ischemia and/or fibrosis. The patient was in use of valsartan 320 mg daily, amlodipine 10 mg daily, sotalol hydrochloride 120 mg 2 times daily, and dabigatran 110 mg 2 times daily. At the end of the PVI, the patient presented hemodynamic instability, with a decrease in heart rate to 30 bpm and invasive arterial blood pressure to 60/30 mmHg. The pericardial puncture was quickly carried out with the possibility of cardiac tamponade as the first hypothesis, but no pericardial effusion was found. Next, we detected acute capture loss from the ventricular pacemaker lead, unvarying with high voltage and pulse width, even with stable impedance, sense and keeping the same position visualized by fluoroscopy. And there was soon afterwards induction of sustained ventricular tachycardia degenerating to spontaneous ventricular fibrillation. Electrical cardioversion-defibrillation was performed with 200J, and the sinus rhythm was reestablished, but there was a dead short, and the pacemaker generator was burned and disabled. So, we can speculate that application of atrial radiofrequency for PVI diffused through the tissues, affecting in some way the tip of the ventricular electrode, causing a microlesion in this structure and making it impossible to capture the right ventricle by the pacemaker. As we cannot see it, we can call it of phantom injury of the ventricular lead.

The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients.

PubMed

Wiegand, Uwe; Nuernberg, Michael; Maier, Sebastian K G; Weiss, Christian; Sancho-Tello, María-José; Hartmann, Andreas; Schuchert, Andreas; Maier, Petra; Chan, Ngai-Yin

2008-06-01

Several studies showed the beneficial effect of pacemaker implantation on cognitive performance in patients with bradycardia. But it has never been investigated if patients with chronotropic incompetence may improve their cognitive performance if treated by a rate-adaptive system reacting to mental stress in comparison to the most frequently used accelerometer-driven pacing. The randomized, single-blind, multicenter COGNITION study evaluates if closed loop stimulation (CLS) offers incremental benefit in the speed of cognitive performance and the overall well-being of elderly patients with bradycardia compared with accelerometer-based pacing. Four hundred chronotropically incompetent patients older than 55 years will be randomized 3-6 weeks after implantation to CLS or accelerometer sensor. Follow-up visits are performed after 12 and 24 months. The speed of cognitive performance, which is the underlying function influencing all other aspects of cognitive performance, will be assessed by the number connection test, a standardized psychometric test for the elderly. Secondary endpoints include patient self-assessment of different aspects of health (by visual analogue scales), quality of life (by SF-8 health survey), the incidence of atrial fibrillation (episodes lasting for longer than 24 hours), and the frequency of serious adverse events. In the ongoing COGNITION study, we aim at long-term comparison of two rate-adaptive systems, focusing on the cognitive performance of the patients, which was neglected in the past evaluation of pacemaker sensors.

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2010 CFR

2010-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2013 CFR

2013-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2011 CFR

2011-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2012 CFR

2012-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

21 CFR 870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Code of Federal Regulations, 2014 CFR

2014-04-01

... applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2... end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The...

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

The Brady Bunch? New evidence for nominative determinism in patients' health: retrospective, population based cohort study.

PubMed

Keaney, John J; Groarke, John D; Galvin, Zita; McGorrian, Catherine; McCann, Hugh A; Sugrue, Declan; Keelan, Edward; Galvin, Joseph; Blake, Gavin; Mahon, Niall G; O'Neill, James

2013-12-12

To ascertain whether a name can influence a person's health, by assessing whether people with the surname "Brady" have an increased prevalence of bradycardia. Retrospective, population based cohort study. One university teaching hospital in Dublin, Ireland. People with the surname "Brady" in Dublin, determined through use of an online telephone directory. Prevalence of participants who had pacemakers inserted for bradycardia between 1 January 2007 and 28 February 2013. 579 (0.36%) of 161,967 people who were listed on the Dublin telephone listings had the surname "Brady." The proportion of pacemaker recipients was significantly higher among Bradys (n=8, 1.38%) than among non-Bradys (n=991, 0.61%; P=0.03). The unadjusted odds ratio (95% confidence interval) for pacemaker implantation among individuals with the surname Brady compared with individuals with other surnames was 2.27 (1.13 to 4.57). Patients named Brady are at increased risk of needing pacemaker implantation compared with the general population. This finding shows a potential role for nominative determinism in health.

Implant experience with an implantable hemodynamic monitor for the management of symptomatic heart failure.

PubMed

Steinhaus, David; Reynolds, Dwight W; Gadler, Fredrik; Kay, G Neal; Hess, Mike F; Bennett, Tom

2005-08-01

Management of congestive heart failure is a serious public health problem. The use of implantable hemodynamic monitors (IHMs) may assist in this management by providing continuous ambulatory filling pressure status for optimal volume management. The Chronicle system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The tip of the lead is placed near the right ventricular outflow tract to minimize risk of sensor tissue encapsulation. Implant technique and lead placement is similar to that of a permanent pacemaker. After the system had been successfully implanted in 148 patients, the type and frequency of implant-related adverse events were similar to a single-chamber pacemaker implant. R-wave amplitude was 15.2 +/- 6.7 mV and the pressure waveform signal was acceptable in all but two patients in whom presence of artifacts required lead repositioning. Implant procedure time was not influenced by experience, remaining constant throughout the study. Based on this evaluation, permanent placement of an IHM in symptomatic heart failure patients is technically feasible. Further investigation is warranted to evaluate the use of the continuous hemodynamic data in management of heart failure patients.

MST development for medical applications: results of the German Research Programme on MST over ten years.

PubMed

Weiss, Christine

2007-01-01

Today microsystems are important for the prevention, diagnosis and therapy of diseases. Physicians use small endoscopes for minimally invasive surgery. Patients regain their mobility by high-tech prostheses equipped with several sensors and actuators. Intelligent implants such as pacemakers support existential functions. Cochlea-implants enable deaf persons to hear. Safe convalescence at home is possible by tele-monitoring devices. Point-of-care such as biochips supply quick diagnostic results. A number of these remarkable developments have been successfully supported by the German Federal Ministry of Education and Research (BMBF) since 1990.

Permanent pacemaker implantation in octogenarians with unexplained syncope and positive electrophysiologic testing.

PubMed

Giannopoulos, Georgios; Kossyvakis, Charalampos; Panagopoulou, Vasiliki; Tsiachris, Dimitrios; Doudoumis, Konstantinos; Mavri, Maria; Vrachatis, Dimitrios; Letsas, Konstantinos; Efremidis, Michael; Katsivas, Apostolos; Lekakis, John; Deftereos, Spyridon

2017-05-01

Syncope is a common problem in the elderly, and a permanent pacemaker is a therapeutic option when a bradycardic etiology is revealed. However, the benefit of pacing when no association of symptoms to bradycardia has been shown is not clear, especially in the elderly. The aim of this study was to evaluate the effect of pacing on syncope-free mortality in patients aged 80 years or older with unexplained syncope and "positive" invasive electrophysiologic testing (EPT). This was an observational study. A positive EPT for the purposes of this study was defined by at least 1 of the following: a corrected sinus node recovery time of >525 ms, a basic HV interval of >55 ms, detection of infra-Hisian block, or appearance of second-degree atrioventricular block on atrial decremental pacing at a paced cycle length of >400 ms. Among the 2435 screened patients, 228 eligible patients were identified, 145 of whom were implanted with a pacemaker. Kaplan-Meier analysis determined that time to event (syncope or death) was 50.1 months (95% confidence interval 45.4-54.8 months) with a pacemaker vs 37.8 months (95% confidence interval 31.3-44.4 months) without a pacemaker (log-rank test, P = .001). The 4-year time-dependent estimate of the rate of syncope was 12% vs 44% (P < .001) and that of any-cause death was 41% vs 56% (P = .023), respectively. The multivariable odds ratio was 0.25 (95% confidence interval 0.15-0.40) after adjustment for potential confounders. In patients with unexplained syncope and signs of sinus node dysfunction or impaired atrioventricular conduction on invasive EPT, pacemaker implantation was independently associated with longer syncope-free survival. Significant differences were also shown in the individual components of the primary outcome measure (syncope and death from any cause). Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Ultrasound-guided venous access for pacemakers and defibrillators.

PubMed

Seto, Arnold H; Jolly, Aaron; Salcedo, Jonathan

2013-03-01

Ultrasound guidance is widely recommended to reduce the risk of complications during central venous catheter placement. However, ultrasound guidance is not commonly utilized for implanting leads for cardiac rhythm management devices. We describe our technique of ultrasound-guided pacemaker implantation, including a novel pull-through technique that allows percutaneous guidewire insertion prior to the first incision. We review the literature and recent advances in ultrasound imaging technology that may facilitate the adoption of ultrasound guidance. Ultrasound guidance provides a safe and rapid technique for extrathoracic subclavian or axillary venous lead placement. © 2012 Wiley Periodicals, Inc.

Biofilm on artificial pacemaker: fiction or reality?

PubMed

Santos, Ana Paula Azevedo; Watanabe, Evandro; Andrade, Denise de

2011-11-01

Cardiac pacing through cardiac pacemaker is one of the most promising alternatives in the treatment of arrhythmias, but it can cause reactions natural or complex reactions, either early or late. This study aimed to describe the scientific evidence on the risk of infection and biofilm formation associated with cardiac pacemaker. This is a study of integrative literature review. It included 14 publications classified into three thematic categories: diagnosis (microbiological and/or clinical), complications and therapy of infections. Staphylococcus epidermidis and Staphylococcus aureus were the microorganisms most frequently isolated. It was not possible to determine the incidence of infection associated with pacemakers, since the studies were generally of prevalence. In terms of therapy, the complete removal of pacemakers stood out, especially in cases of suspected biofilm. Still controversial is the use of systemic antibiotic prophylaxis in reducing the incidence of infection associated with implantation of a pacemaker.

Case of pacemaker pocket infection caused by Finegoldia magna.

PubMed

Hosseini Dehkordi, Seyed Hamed; Osorio, Georgina

2017-10-01

Finegoldia magna (formerly called Peptostreptococcus magnus) is a Gram-positive anaerobic coccus which is increasingly recognized as an opportunistic pathogen. We present a case of F. magna associated non-valvular cardiovascular device-related infection in an 83 year-old male who received a permanent pacemaker for sick sinus syndrome seven weeks prior to his presentation. Five weeks after the implantation, the pacemaker and leads were explanted because of clinical evidence of pacemaker pocket infection. He was initially treated with sulfamethoxazole-trimethoprim based on the Gram stain results from the removed pacemaker. However, two weeks later, he was readmitted with sepsis and was successfully treated with ampicillin-sulbactam. Culture results from the pacemaker and pocket as well as blood cultures grew F. magna. Clinicians should be aware of the possibility of F. magna infection when initial gram stain results show "gram positive cocci". Copyright © 2017 Elsevier Ltd. All rights reserved.

Value of Combining Left Atrial Diameter and Amino-terminal Pro-brain Natriuretic Peptide to the CHA2DS2-VASc Score for Predicting Stroke and Death in Patients with Sick Sinus Syndrome after Pacemaker Implantation.

PubMed

Mo, Bin-Feng; Lu, Qiu-Fen; Lu, Shang-Biao; Xie, Yu-Quan; Feng, Xiang-Fei; Li, Yi-Gang

2017-08-20

The CHA2DS2-VASc score is used clinically for stroke risk stratification in patients with atrial fibrillation (AF). We sought to investigate whether the CHA2DS2-VASc score predicts stroke and death in Chinese patients with sick sinus syndrome (SSS) after pacemaker implantation and to evaluate whether the predictive power of the CHA2DS2-VASc score could be improved by combining it with left atrial diameter (LAD) and amino-terminal pro-brain natriuretic peptide (NT-proBNP). A total of 481 consecutive patients with SSS who underwent pacemaker implantation from January 2004 to December 2014 in our department were included. The CHA2DS2-VASc scores were retrospectively calculated according to the hospital medical records before pacemaker implantation. The outcome data (stroke and death) were collected by pacemaker follow-up visits and telephonic follow-up until December 31, 2015. During 2151 person-years of follow-up, 46 patients (9.6%) suffered stroke and 52 (10.8%) died. The CHA2DS2-VASc score showed a significant association with the development of stroke (hazard ratio [HR] 1.45, 95% confidence interval [CI] 1.20-1.75, P< 0.001) and death (HR 1.45, 95% CI 1.22-1.71, P< 0.001). The combination of increased LAD and the CHA2DS2-VASc score improved the predictive power for stroke (C-stat 0.69, 95% CI 0.61-0.77 vs. C-stat 0.66, 95% CI 0.57-0.74, P= 0.013), and the combination of increased NT-proBNP and the CHA2DS2-VASc score improved the predictive power for death (C-stat 0.70, 95% CI 0.64-0.77 vs. C-stat 0.67, 95% CI 0.60--0.75, P= 0.023). CHA2DS2-VASc score is valuable for predicting stroke and death risk in patients with SSS after pacemaker implantation. The addition of LAD and NT-proBNP to the CHA2DS2-VASc score improved its predictive power for stroke and death, respectively, in this patient cohort. Future prospective studies are warranted to validate the benefit of adding LAD and NT-proBNP to the CHA2DS2-VASc score for predicting stroke and death risk in non-AF populations.

Sick sinus syndrome in HCN1-deficient mice.

PubMed

Fenske, Stefanie; Krause, Stefanie C; Hassan, Sami I H; Becirovic, Elvir; Auer, Franziska; Bernard, Rebekka; Kupatt, Christian; Lange, Philipp; Ziegler, Tilman; Wotjak, Carsten T; Zhang, Henggui; Hammelmann, Verena; Paparizos, Christos; Biel, Martin; Wahl-Schott, Christian A

2013-12-17

Sinus node dysfunction (SND) is a major clinically relevant disease that is associated with sudden cardiac death and requires surgical implantation of electric pacemaker devices. Frequently, SND occurs in heart failure and hypertension, conditions that lead to electric instability of the heart. Although the pathologies of acquired SND have been studied extensively, little is known about the molecular and cellular mechanisms that cause congenital SND. Here, we show that the HCN1 protein is highly expressed in the sinoatrial node and is colocalized with HCN4, the main sinoatrial pacemaker channel isoform. To characterize the cardiac phenotype of HCN1-deficient mice, a detailed functional characterization of pacemaker mechanisms in single isolated sinoatrial node cells, explanted beating sinoatrial node preparation, telemetric in vivo electrocardiography, echocardiography, and in vivo electrophysiology was performed. On the basis of these experiments we demonstrate that mice lacking the pacemaker channel HCN1 display congenital SND characterized by bradycardia, sinus dysrhythmia, prolonged sinoatrial node recovery time, increased sinoatrial conduction time, and recurrent sinus pauses. As a consequence of SND, HCN1-deficient mice display a severely reduced cardiac output. We propose that HCN1 stabilizes the leading pacemaker region within the sinoatrial node and hence is crucial for stable heart rate and regular beat-to-beat variation. Furthermore, we suggest that HCN1-deficient mice may be a valuable genetic disease model for human SND.

Society position statement : Canadian Cardiovascular Society/Canadian Anesthesiologists' Society/Canadian Heart Rhythm Society joint position statement on the perioperative management of patients with implanted pacemakers, defibrillators, and neurostimulating devices.

PubMed

Healey, Jeff S; Merchant, Richard; Simpson, Chris; Tang, Timothy; Beardsall, Marianne; Tung, Stanley; Fraser, Jennifer A; Long, Laurene; van Vlymen, Janet M; Manninen, Pirjo; Ralley, Fiona; Venkatraghavan, Lashmi; Yee, Raymond; Prasloski, Bruce; Sanatani, Shubhayan; Philippon, François

2012-04-01

There are more than 200,000 Canadians living with permanent pacemakers or implantable defibrillators, many of whom will require surgery or invasive procedures each year. They face potential hazards when undergoing surgery; however, with appropriate planning and education of operating room personnel, adverse device-related outcomes should be rare. This joint position statement from the Canadian Cardiovascular Society (CCS) and the Canadian Anesthesiologists' Society (CAS) has been developed as an accessible reference for physicians and surgeons, providing an overview of the key issues for the preoperative, intraoperative, and postoperative care of these patients. The document summarizes the limited published literature in this field, but for most issues, relies heavily on the experience of the cardiologists and anesthesiologists who contributed to this work. This position statement outlines how to obtain information about an individual's type of pacemaker or implantable defibrillator and its programming. It also stresses the importance of determining if a patient is highly pacemaker-dependent and proposes a simple approach for nonelective evaluation of dependency. Although the document provides a comprehensive list of the intraoperative issues facing these patients, there is a focus on electromagnetic interference resulting from electrocautery and practical guidance is given regarding the characteristics of surgery, electrocautery, pacemakers, and defibrillators which are most likely to lead to interference. The document stresses the importance of preoperative consultation and planning to minimize complications. It reviews the relative merits of intraoperative magnet use vs reprogramming of devices and gives examples of situations where one or the other approach is preferable.

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.

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Indirect pacemaker generator function analyzer... Indirect pacemaker generator function analyzer. (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or...

New-Onset Left Bundle Branch Block Induced by Transcutaneous Aortic Valve Implantation.

PubMed

Massoullié, Grégoire; Bordachar, Pierre; Ellenbogen, Kenneth A; Souteyrand, Géraud; Jean, Frédéric; Combaret, Nicolas; Vorilhon, Charles; Clerfond, Guillaume; Farhat, Mehdi; Ritter, Philippe; Citron, Bernard; Lusson, Jean-R; Motreff, Pascal; Ploux, Sylvain; Eschalier, Romain

2016-03-01

New-onset left bundle branch block (LBBB) is a specific concern of transcutaneous aortic valve implantation (TAVI) given its estimated incidence ranging from 5% to 65%. This high rate of occurrence is dependent on the type of device used (size and shape), implantation methods, and patient co-morbidities. The appearance of an LBBB after TAVI reflects a very proximal lesion of the left bundle branch as it exits the bundle of His. At times transient, its persistence can lead to permanent pacemaker implantation in 15% to 20% of cases, most often for high-degree atrioventricular block. The management of LBBB after TAVI is currently not defined by international societies resulting in individual centers developing their own management strategy. The potential consequences of LBBB are dysrhythmias (atrioventricular block, syncope, and sudden death) and functional (heart failure) complications. Prompt postprocedural recognition and management (permanent pacemaker implantation) of patients prevents the occurrence of potential complications and may constitute the preferred approach in this frail and elderly population despite additional costs and complications of cardiac pacing. Moreover, the expansion of future indications for TAVI necessitates better identification of the predictive factors for the development of LBBB. Indeed, long-term right ventricular pacing may potentially increase the risk of developing heart failure in this population. In conclusion, it is thus imperative to not only develop new aortic prostheses with a less-deleterious impact on the conduction system but also to prescribe appropriate pacing modes in this frail population. Copyright © 2016 Elsevier Inc. All rights reserved.

[Permanent cardiac pacing for chronic symptomatic atrioventricular block in uremic hemodialysed patients. A prospective study].

PubMed

Arsenescu, Cătălina; Georgescu, G I M; Covic, A; Briotă, Laura

2002-01-01

Though sudden cardiac death accounts for as much as 15% of all cause mortality in uremia, reports concerning advanced A-V block, requiring permanent cardiac pacing in end-stage renal disease (ESRD) hemodialysed (HD) patients are very few. This is the first long term prospective study reporting on systematic permanent pacemaker implantation, in a cohort of ESRD patients from a single HD unit. Between 01/06/1997 and 30/12/2001, 396 pacemakers were inserted for advanced, symptomatic A-V block in our institution, including 5 in ESRD, HD patients (M/F--4/1, age 47-73, M +/- SD--61 +/- 12 years) from a single dialysis center, treating 137 patients during the study period. Thus, the incidence and prevalence of A-V defects treated by permanent pacing in uremic patients was 0.81% and 3.65% respectively. Conversely, the incidence and prevalence of ESRD treated by hemodialysis, among patients with advanced A-V conduction disturbances, requiring permanent pacing were 0.28% and 1.26%. Mitral valve calcifications were present in all patients; 3 subjects also had extensive aortic valve calcifications. Left ventricular hypertrophy (echocardiographic Framingham criteria) was present in 4 patients, but the systolic function (ejection fraction and fractional shortening index) was normal in all cases, although a clinical picture of chronic heart failure was seen in 3 subjects preoperatively. A-V conduction defects were attributed to extensive metastatic calcifications, involving the cardiac squeleton, consecutive to severe hyperparathyroidism and inadvertent use of calcitriol and calcium carbonate as phosphate binders. No technical difficulties, short or long-term complications related to pacemaker implantation (4 VVI and 1 VVD devices) were encountered. Acute threshold and sensing values were similar with those of non-uremic patients. During follow-up, one patients died from a non cardiac death. If optimal hemodialysis is provided, benefits of permanent pacing are equal in uremic or non uremic patients and pacemaker implantation should be instituted as a prompt life-saving method in all dialysis patients with chronic symptomatic advanced A-V blocks.

THE EFFECT OF RIGHT VENTRICULAR PACEMAKER LEAD POSITION ON FUNCTIONAL STATUS IN PATIENTS WITH PRESERVED LEFT VENTRICULAR EJECTION FRACTION.

PubMed

Mitov, Vladimir M; Perisic, Zoran; Jolic, Aleksandar; Kostic, Tomislav; Aleksic, Aleksandar; Aleksic, Zeljka

2016-07-01

The study was aimed at assessing the difference between the right ventricle apex versus the right ventricular outflow tract lead position in functional capacity in the patients with the preserved left ventricular ejection fraction after 12 months of pacemaker stimulation. This was a prospective, randomized, follow-up study, which lasted for 12 months. The study sample included 132 consecutive patients who were implanted with permanent anti-bradicardiac pacemaker. Regarding the right ventricular lead position the patients were divided into two groups: the right ventricle apex group consisting of 61 patients with right ventricular apex lead position. The right ventricular outflow tract group included 71 patients with right ventricular outflow tract lead position. Functional capacity was assessed by Minnesota Living With Heart Failure score, New York Heart Association class and Six Minute Walk Test. Left ventricular ejection fraction was assessed by echocardiography. Minnesota Living With Heart Failure score and New York Heart Association class had a statistically significant improvement in both study groups. The patients from right ventricle apex group walked 20.95% (p=O.03) more in comparison to starting values. The patients from right ventricular outflow tract group walked only 13.63% (p=0.09) longer distance than the startingoneConclusion. Analysis of tests of functional status New York Heart Association class and Minnesota Living With Heart Failure questionnaire showed an even improvement in the right ventricle apex and right ventricular outflow tract groups. Analysis of 6 minute walk test showed that only the patients with the preserved left ventricular ejection fraction from the right ventricle apex group had a significant improvement after 12 months of pacemaker stimulation..

Association between hospital procedure volume and early complications after pacemaker implantation: results from a large, unselected, contemporary cohort of the German nationwide obligatory external quality assurance programme.

PubMed

Nowak, Bernd; Tasche, Karl; Barnewold, Linda; Heller, Günther; Schmidt, Boris; Bordignon, Stefano; Chun, K R Julian; Fürnkranz, Alexander; Mehta, Rajendra H

2015-05-01

Several studies demonstrated an inverse relationship between cardioverter-defibrillator implantation volume and complication rates, suggesting better outcomes for higher volume centres. However, the association of institutional procedural volume with patient outcomes for permanent pacemaker (PPM) implantation remains less known, especially in decentralized implantation systems. We performed retrospective examination of data on patients undergoing PPM from the German obligatory quality assurance programme (2007-12) to evaluate the relationship of hospital PPM volume (categorized into quintiles of their mean annual volume) with risk-adjusted in-hospital surgical complications (composite of pneumothorax, haemothorax, pericardial effusion, or pocket haematoma, all requiring intervention, or device infection) and pacemaker lead dislocation. Overall 430 416 PPM implantations were documented in 1226 hospitals. Systems included dual (72.8%) and single (25.8%) chamber PPM and cardiac resynchronization therapy (CRT) devices (1.1%). Complications included surgical (0.92%), and ventricular (0.99%), and atrial (1.22%) lead dislocation. Despite an increase in relatively complex procedures (dual chamber, CRT), there was a significant decrease in the procedural and fluoroscopy times and complications from lowest to highest implantation volume quintiles (P for trend <0.0001). The greatest difference was observed between the lowest (1-50 implantations/year-reference group) and the second-lowest (51-90 implantations/year) quintile: surgical complications [odds ratio (OR) 0.69; confidence interval (CI) 0.60-0.78], atrial lead dislocations (OR 0.69; CI 0.59-0.80), and ventricular lead dislocations (OR 0.73; CI 0.63-0.84). Hospital annual PPM volume was directly related to indication-based implantation of relatively more complex PPM and yet inversely with procedural times and rates of early surgical complications and lead dislocations. Thus, our data suggest better performance and lower complications with increasing procedural volume. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Pacemaker remote monitoring in the pediatric population: is it a real solution?

PubMed

Leoni, Loira; Padalino, Massimo; Biffanti, Roberta; Ferretto, Sonia; Vettor, Giulia; Corrado, Domenico; Stellin, Giovanni; Milanesi, Ornella; Iliceto, Sabino

2015-05-01

Clinical utility of remote monitoring of implantable cardiac devices has been previously demonstrated in several trials in the adult population. The aim of this study was to assess the clinical utility of remote monitoring in a pediatric population undergoing pacemakers implantation. The study population included 73 consecutive pediatric patients who received an implantable pacemaker. The remote device check was programmed for every 3 months and all patients had a yearly out-patient visit. Data on device-related events, hospitalization, and other clinical information were collected during remote checks and out-patient visits. During a mean follow-up of 18 ± 10 months, 470 remote transmissions were collected and analyzed. Two deaths were reported. Eight transmissions (1.7%) triggered an urgent out-patient visit. Twenty percent of transmissions reported evidence of significant clinical or technical events. All young patients and their families were very satisfied when using remote monitoring to replace out-patient visits. The ease in use, together with satisfaction and acceptance of remote monitoring in pediatric patients, brought very good results. The remote management of our pediatric population was safe and remote monitoring adequately replaced the periodic out-patient device checks without compromising patient safety. ©2015 Wiley Periodicals, Inc.

Effects of gravity on the circadian period in rats

NASA Technical Reports Server (NTRS)

Murakami, Dean M.; Demaria, Victor H.; Fuller, Charles A.

1991-01-01

The effect of increased gravity force on the circadian period of body temperature and activity of rats was investigated using rats implanted with a small radio telemetry device and, after a 2-week recovery and a 3-week control period at 1G, rotated at for 4 weeks at a constant 2G field in a 18-ft-diam centrifuge. Measurements of the mean freerunning period of the temperature and activity rhythms after 10 days showed that the exposure to 2G led to a functional separation of the pacemakers that regulate the activity and the temperature in the animals. Each pacemaker reacted differently: the activity period increased and the temperature period decreased. By the third or the fourth week, the activity and the temperature periods have returned to 1G control levels.

The Brady Bunch? New evidence for nominative determinism in patients’ health: retrospective, population based cohort study

PubMed Central

Groarke, John D; Galvin, Zita; McGorrian, Catherine; McCann, Hugh A; Sugrue, Declan; Keelan, Edward; Galvin, Joseph; Blake, Gavin; Mahon, Niall G; O’Neill, James

2013-01-01

Objective To ascertain whether a name can influence a person’s health, by assessing whether people with the surname “Brady” have an increased prevalence of bradycardia. Design Retrospective, population based cohort study. Setting One university teaching hospital in Dublin, Ireland. Participants People with the surname “Brady” in Dublin, determined through use of an online telephone directory. Main outcome measure Prevalence of participants who had pacemakers inserted for bradycardia between 1 January 2007 and 28 February 2013. Results 579 (0.36%) of 161 967 people who were listed on the Dublin telephone listings had the surname “Brady.” The proportion of pacemaker recipients was significantly higher among Bradys (n=8, 1.38%) than among non-Bradys (n=991, 0.61%; P=0.03). The unadjusted odds ratio (95% confidence interval) for pacemaker implantation among individuals with the surname Brady compared with individuals with other surnames was 2.27 (1.13 to 4.57). Conclusions Patients named Brady are at increased risk of needing pacemaker implantation compared with the general population. This finding shows a potential role for nominative determinism in health. PMID:24336304

Pacemaker recycling: A notion whose time has come.

PubMed

Runge, Mason W; Baman, Timir S; Davis, Sheldon; Weatherwax, Kevin; Goldman, Ed; Eagle, Kim A; Crawford, Thomas C

2017-04-26

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

Powering a leadless pacemaker using a PiezoMEMS energy harvester

NASA Astrophysics Data System (ADS)

Jackson, Nathan; Olszewski, Oskar; O'Murchu, Cian; Mathewson, Alan

2017-06-01

MEMS based vibrational energy harvesting devices have been a highly researched topic over the past decade. The application targeted in this paper focuses on a leadless pacemaker that will be implanted in the right ventricle of the heart. A leadless pacemaker requires the same functionality as a normal pacemaker, but with significantly reduced volume. The reduced volume limits the space for a battery; therefore an energy harvesting device is required. This paper compares varying the dimensions of a linear MEMS based piezoelectric energy harvester that can harvest energy from the mechanical vibrations of the heart due to shock induced vibration. Typical MEMS linear energy harvesting devices operate at high frequency (<50 Hz) with low acceleration (< 1g). The force generated from the heart acts as a series of impulses as opposed to traditional sinusoidal vibration force with high acceleration (1-4 g). Therefore the design of a MEMS harvester that is based on shock-induced vibration is necessary. PiezoMEMS energy harvesting devices consisting of a silicon substrate and mass with aluminium nitride piezoelectric material were developed and characterized using acceleration forces that mimic the heartbeat. Peak powers of up to 25μW were obtained at 1 g acceleration with a powder density of approximately 1.5 mW cm-3.

HCN4-Overexpressing Mouse Embryonic Stem Cell-Derived Cardiomyocytes Generate a New Rapid Rhythm in Rats with Bradycardia.

PubMed

Saito, Yukihiro; Nakamura, Kazufumi; Yoshida, Masashi; Sugiyama, Hiroki; Takano, Makoto; Nagase, Satoshi; Morita, Hiroshi; Kusano, Kengo F; Ito, Hiroshi

2018-05-30

A biological pacemaker is expected to solve the persisting problems of an artificial cardiac pacemaker including short battery life, lead breaks, infection, and electromagnetic interference. We previously reported HCN4 overexpression enhances pacemaking ability of mouse embryonic stem cell-derived cardiomyocytes (mESC-CMs) in vitro. However, the effect of these cells on bradycardia in vivo has remained unclear. Therefore, we transplanted HCN4-overexpressing mESC-CMs into bradycardia model animals and investigated whether they could function as a biological pacemaker. The rabbit Hcn4 gene was transfected into mouse embryonic stem cells and induced HCN4-overexpressing mESC-CMs. Non-cardiomyocytes were removed under serum/glucose-free and lactate-supplemented conditions. Cardiac balls containing 5 × 10 3 mESC-CMs were made by using the hanging drop method. One hundred cardiac balls were injected into the left ventricular free wall of complete atrioventricular block (CAVB) model rats. Heart beats were evaluated using an implantable telemetry system 7 to 30 days after cell transplantation. The result showed that ectopic ventricular beats that were faster than the intrinsic escape rhythm were often observed in CAVB model rats transplanted with HCN4-overexpressing mESC-CMs. On the other hand, the rats transplanted with non-overexpressing mESC-CMs showed sporadic single premature ventricular contraction but not sustained ectopic ventricular rhythms. These results indicated that HCN4-overexpressing mESC-CMs produce rapid ectopic ventricular rhythms as a biological pacemaker.

Runaway pacemaker: a forgotten phenomenon?

PubMed

Ortega, Daniel F; Sammartino, M Victoria; Pellegrino, Graciela M M; Barja, Luis D; Albina, Gaston; Segura, Eliseo V; Balado, Roberto; Laiño, Ruben; Giniger, Alberto G

2005-11-01

Runaway is an uncommon pacemaker dysfunction, characterized by fast and erratic spikes at non-physiological rates. This infrequent but potentially lethal failure mode may be related to low battery voltage. Four single chamber pacemaker patients were analyzed (Medtronic Minix ST 8330, Minneapolis, MN, had been implanted in two patients and two CPI Triumph VR 1124, St Paul, MN, in the other two). They had been admitted because of presyncopal episodes. Typical high rate stimuli at 2000 ppm alternating with pacing at 60-65 ppm were recorded in all ECGs. Lead system tests were normal. The pulse generators had to be replaced.

Impact of imaging landmark on the risk of MRI-related heating near implanted medical devices like cardiac pacemaker leads.

PubMed

Nordbeck, Peter; Ritter, Oliver; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Burkard, Natalie; Herold, Volker; Jakob, Peter M; Ertl, Georg; Ladd, Mark E; Quick, Harald H; Bauer, Wolfgang R

2011-01-01

Implanted medical devices such as cardiac pacemakers pose a potential hazard in magnetic resonance imaging. Electromagnetic fields have been shown to cause severe radio frequency-induced tissue heating in some cases. Imaging exclusion zones have been proposed as an instrument to reduce patient risk. The purpose of this study was to further assess the impact of the imaging landmark on the risk for unintended implant heating by measuring the radio frequency-induced electric fields in a body phantom under several imaging conditions at 1.5T. The results show that global radio frequency-induced coupling is highest with the torso centered along the superior-inferior direction of the transmit coil. The induced E-fields inside the body shift when changing body positioning, reducing both global and local radio frequency coupling if body and/or conductive implant are moved out from the transmit coil center along the z-direction. Adequate selection of magnetic resonance imaging landmark can significantly reduce potential hazards in patients with implanted medical devices. © 2010 Wiley-Liss, Inc.

Increased base rate of atrial pacing for prevention of atrial fibrillation after implantation of a dual-chamber pacemaker: insights from the Atrial Overdrive Pacing Study.

PubMed

Kantharia, Bharat K; Freedman, Roger A; Hoekenga, David; Tomassoni, Gery; Worley, Seth; Sorrentino, Robert; Steinhaus, David; Wolkowicz, Joel M; Syed, Zaffer A

2007-11-01

Different pacing sites and various algorithms have been utilized to prevent atrial fibrillation (AF) in pacemaker recipients. However, the optimal pacing rate settings have not yet been established. In this randomized, prospective, multicentre, single-blinded, cross over study, rate-adaptive pacing at a high base rate (BR) in patients, age 60 years or above, or a history of paroxysmal AF, who underwent dual-chamber (DDD) pacemaker implantation for standard pacing indications, was evaluated for prevention of AF. In the study cohort of 145 patients implanted with DDD pacemakers with a programmable rest rate (RR) feature, the BR/RR settings were sequentially but randomly adjusted as follows: 60 bpm/Off for the baseline quarter (initial 3 months) and then to either 'A-B-C' or 'C-B-A' settings (A = 70/65 bpm, B = 70/Off, C = 80/65 bpm) for the subsequent quarters each of 3 months duration. Data on automatic mode switch episodes, device diagnostics, and a questionnaire evaluating pacemaker awareness and palpitations were collected. Ninety-nine patients, mean age 77 +/- 10 years, who completed the study protocol and followed for 12 months did not show significant differences in the number of mode switch episodes between any settings used. The percentage of atrial pacing was lower during baseline pacing compared to settings A, B, and C (P < 0.0001). Setting C produced a higher percentage of atrial pacing than A and B (P < 0.01). Although a higher percentage of atrial pacing correlated with a lower incidence of mode switch episodes, there was no statistically significant difference in the number of mode switch episodes between settings A, B, and C. There were no significant differences in the questionnaire scores relating to pacemaker awareness or palpitation. Overdrive single-site pacing in the right atrium achieved by programming analysed settings in the present study did not reduce AF as assessed by mode switch episodes. Additionally, no change in the symptoms of arrhythmia or awareness of pacing was seen.

Optimal pacing for right ventricular and biventricular devices: minimizing, maximizing, and right ventricular/left ventricular site considerations.

PubMed

Gillis, Anne M

2014-10-01

The results from numerous clinical studies provide guidance for optimizing outcomes related to RV or biventricular pacing in the pacemaker and ICD populations. (1) Programming algorithms to minimize RV pacing is imperative in patients with dual-chamber pacemakers who have intrinsic AV conduction or intermittent AV conduction block. (2) Dual-chamber ICDs should be avoided in candidates without an indication for bradycardia pacing. (3) Alternate RV septal pacing sites may be considered at the time of pacemaker implantation. (4) Biventricular pacing may be beneficial in some patients with mild LV dysfunction. (5) LV lead placement at the site of latest LV activation is desirable. (6) Programming CRT systems to achieve biventricular/LV pacing >98.5% is important. (7) Protocols for AV and VV optimization in patients with CRT are not recommended after device implantation but may be considered for CRT nonresponders. (8) Novel algorithms to maximize the benefit of CRT are in evolution further.

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

PubMed

Walsh, Edward P; Cecchin, Frank

2004-03-01

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

Beneficial effects of losartan for prevention of paroxysmal atrial fibrillation in patients with sick sinus syndrome: analysis with memory function of pacemaker.

PubMed

Takii, Eiichi; Inage, Tomohito; Yoshida, Teruhisa; Ohe, Masatsugu; Gondo, Takeki; Haraguchi, Go; Ito, Shogo; Kumanomido, Jun; Imaizumi, Tsutomu; Fukuomoto, Yoshihiro

2016-03-01

Renin-angiotensin system (RAS) inhibitors may be useful in preventing the occurrence of paroxysmal atrial fibrillation (PAF). However, evaluation of such effect is difficult because many PAF episodes are asymptomatic and not all episodes are detected by intermittent electrocardiographic monitoring. A pacemaker has been developed with dedicated functions for AF detection and electrocardiogram storage. Accordingly, we examined the effect of losartan, an angiotensin receptor blocker on PAF occurrence using this new modality. We enrolled 70 consecutive patients who had undergone dual-chamber pacemaker implantation for sick sinus syndrome. Finally, 62 patients participated in the study. Thirty patients were randomized to the losartan group (mean 43 ± 12 mg/day) and 32 patients to the control group. They were followed up for 3 months. The frequency, the maximum duration and the total duration of PAF recorded by the stored electrocardiograms for the last 1 month during the observation period and study period were compared between the two groups. The change in the frequency of PAF from the observation period in the losartan and control groups was similar (-35 ± 25 vs. -67 ± 62 times; NS). However, the change in the maximum duration and the total duration of PAF was significantly shorter in the losartan group than in the control group (-493 ± 158 vs. -10 ± 69 min; p < 0.05, and -4007 ± 2334 vs. 1119 ± 714 min; p < 0.05, respectively). Losartan suppressed the maximum duration and the total duration of PAF in patients with sick sinus syndrome without hemodynamic changes. This is the first study to show the effect of a renin-angiotensin system inhibitor on the secondary prevention of PAF using the dedicated functions of a pacemaker for PAF detection and electrocardiogram storage.

Pacemaker recycling: A notion whose time has come

PubMed Central

Runge, Mason W; Baman, Timir S; Davis, Sheldon; Weatherwax, Kevin; Goldman, Ed; Eagle, Kim A; Crawford, Thomas C

2017-01-01

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support. PMID:28515847

Indications for permanent pacing and pacing mode prescription from 1989 to 2006. Experience of a single academic centre in Northern Greece.

PubMed

Styliadis, Ioannis H; Mantziari, Aggeliki P; Gouzoumas, Nikolaos I; Vassilikos, Vasilios P; Paraskevaidis, Stelios A; Mochlas, Sotirios T; Boufidou, Amalia I; Parcharidis, Georgios E

2008-01-01

Indications for pacing and pacing mode prescription have changed in the past decades following advances in pacemaker technology. The aim of the present study was to evaluate changes in indications for pacing and pacing modes during the years 1989-2006 in a single academic pacemaker centre in Northern Greece. Archives of permanent pacemaker implantation procedures were studied retrospectively and data from all implants, first or replacements, were retrieved. Data from 2078 procedures were found, 78.7% of which were first implantations. Patients were 54% male with mean age 72.5 years. Main indications for pacing were atrioventricular block (AVB, 45.7%), sick sinus syndrome (SSS, 32.8%), and atrial fibrillation (12.1%). Almost half (48.9%) of the AVB cases were complete AVB, while the most common types of SSS were tachy-brady syndrome (44.1%) and asystole (27.1%). Rare indications for pacing were carotid sinus syndrome (5.0%), heart failure (3.3%) and hypertrophic obstructive cardiomyopathy (1.0%). The two most frequently used pacing modes were VVI (38.5%) and DDD (25.8%). However, pacing modes have changed greatly over the years, with a marked increase in dual-chamber pacing after 1997 and a preference for rate responsive units after 2002. Biventricular systems were also used in selected patients with heart failure from 2002 on. Indications for pacing and pacing mode prescription in our centre are similar to other pacemaker registries and reflect the global trend in pacing for mimicking the physiological activity of the heart and for addressing problems other than symptomatic bradycardia.

Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use.

PubMed

Soejima, Kyoko; Edmonson, Jonathan; Ellingson, Michael L; Herberg, Ben; Wiklund, Craig; Zhao, Jing

2016-10-01

Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Cardiac pacing for severe childhood neurally mediated syncope with reflex anoxic seizures

PubMed Central

McLeod, K; Wilson, N; Hewitt, J; Norrie, J; Stephenson, J

1999-01-01

OBJECTIVE—To determine whether permanent cardiac pacing could prevent syncope and seizures in children with frequent severe neurally mediated syncope, and if so whether dual chamber pacing was superior to single chamber ventricular pacing.
METHODS—Dual chamber pacemakers were implanted into 12 children (eight male, four female) aged 2-14 years (median 2.8 years) with frequent episodes of reflex anoxic seizures and a recorded prolonged asystole during an attack. The pacemaker was programmed to sensing only (ODO), single chamber ventricular pacing with hysteresis (VVI), and dual chamber pacing with rate drop response (DDD) for four month periods, with each patient allocated to one of the six possible sequences of these modes, according to chronological order of pacemaker implantation. The parent and patient were blinded to the pacemaker mode and asked to record all episodes of syncope or presyncope ("near miss" events). The doctor analysing the results was blinded to the patient and pacemaker mode.
RESULTS—One patient was withdrawn from the study after the pacemaker was removed because of infection. In the remaining children, both dual chamber and single chamber pacing significantly reduced the number of syncopal episodes compared with sensing only (p = 0.0078 for both). VVI was as effective as DDD for preventing syncope, but DDD was superior to VVI in reducing near miss events (p = 0.016).
CONCLUSIONS—Permanent pacing is an effective treatment for children with severe neurally mediated syncope and reflex anoxic seizures. VVI is as effective as DDD in preventing syncope and seizures, but DDD is superior in preventing overall symptoms.


Keywords: syncope; reflex anoxic seizures; pacing; paediatric cardiology PMID:10573501

Battery Malfunction of a Leadless Cardiac Pacemaker - A Worrisome Single-Center Experience.

PubMed

Richter, Sergio; Döring, Michael; Ebert, Micaela; Bode, Kerstin; Müssigbrodt, Andreas; Sommer, Philipp; Husser, Daniela; Hindricks, Gerhard

2018-03-14

Leadless cardiac pacemaker (LCP) therapy has been established clinically as a feasible and safe alternative to conventional transvenous pacemaker therapy for patients with an indication for single-chamber right-ventricular pacing. 1-3 However, reports on loss of telemetry and pacing output due to abrupt battery failure called the safety of one of the two commercially available systems seriously into question. The initial battery advisory with the Nanostim™ LCP was issued by the manufacturer in October 2016, who instantly called a global stop to Nanostim™ implants. To this day, similar battery issues have not been described for the Micra™ transcatheter pacing system. Therefore, we thought to analyze the long-term pacemaker performance and rate of battery malfunction of the Nanostim™ LCP in our patient population.

Echocardiography in patients with complications related to pacemakers and cardiac defibrillators.

PubMed

Almomani, Ahmed; Siddiqui, Khadija; Ahmad, Masood

2014-03-01

The evolving indications and uses for implantable cardiac devices have led to a significant increase in the number of implanted devices each year. Implantation of endocardial leads for permanent pacemakers and cardiac defibrillators can cause many delayed complications. Complications may be mechanical and related to the interaction of the device leads with the valves and endomyocardium, e.g., perforation, infection, and thrombosis, or due to the electrical pacing of the myocardium and conduction abnormalities, e.g., left ventricular dyssynchrony. Tricuspid regurgitation, another delayed complication in these patients, may be secondary to both mechanical and pacing effects of the device leads. Echocardiography plays an important role in the diagnosis of these device-related complications. Both two-dimensional transthoracic echocardiography and transesophageal echocardiography provide useful diagnostic information. Real time three-dimensional echocardiography is a novel technique that can further enhance the detection of lead-related complications. © 2013, Wiley Periodicals, Inc.

Primary batteries for implantable pacemakers and defibrillators

NASA Astrophysics Data System (ADS)

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

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

Pacemaker replacement in nonagenarians: Procedural safety and long-term follow-up.

PubMed

Loirat, Aurélie; Fénéon, Damien; Behaghel, Albin; Behar, Nathalie; Le Helloco, Alain; Mabo, Philippe; Daubert, Jean-Claude; Leclercq, Christophe; Martins, Raphaël P

2015-01-01

The rate of pacemaker implantation is rising. Given that the life expectancy of the population is projected to increase, a large number of elderly patients are likely to be implanted in the future. As pacemaker batteries can last for 8-10years, an increasing number of pacemaker recipients will require replacement of their devices when they become nonagenarians. To analyse the short- and long-term outcomes after device replacement in nonagenarians. Patients aged≥90years referred to a tertiary centre for pacemaker replacement from January 2004 to July 2014 were included retrospectively. Clinical follow-up data were obtained from clinical visits or telephone interviews with patients or their families. The primary clinical endpoint was total mortality. Secondary endpoints included early and delayed procedure-related complications and predictive risk factors for total mortality. Sixty-two patients were included (mean age 93.3±2.9years at time of pacemaker replacement). Mean procedure duration was 35.7±17.2minutes. Mean hospital stay was 2.2±1.1days. One patient died from a perioperative complication. Thirty-seven patients (59.7%) died during a median follow-up of 22.1months (interquartile range, 11.8-39.8months). Survival rates were 84.2% (95% confidence interval [CI] 71.8-91.5%) at 1year, 66.9% (95% CI 51.8-78.2%) at 2years and 22.7% (95% CI 10.6-37.7%) at 5years. Atrial fibrillation (hazard ratio 2.47, 95% CI 1.1-5.6) and non-physiological pacing (i.e. VVI pacing in patients in sinus rhythm) (hazard ratio 2.20, 95% CI 1.0-4.9) were predictors of mortality. Pacemaker replacement in nonagenarians is a safe and straightforward procedure. These data suggest that procedures can be performed securely in this old and frail population, with patients living for a median of 30months afterwards. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Sick sinus syndrome as a complication of mediastinal radiation therapy

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

Pohjola-Sintonen, S.; Toetterman, K.J.K.; Kupari, M.

1990-06-01

A 33-year-old man who had received mediastinal radiation therapy for Hodgkin's disease 12 years earlier developed a symptomatic sick sinus syndrome requiring the implantation of a permanent pacemaker. The sick sinus syndrome and a finding of an occult constrictive pericarditis were considered to be due to the previous mediastinal irradiation. A ventricular pacemaker was chosen because mediastinal radiotherapy also increases the risk of developing atrioventricular conduction defects.

Personal medical electronic devices and walk-through metal detector security systems: assessing electromagnetic interference effects.

PubMed

Guag, Joshua; Addissie, Bisrat; Witters, Donald

2017-03-20

There have been concerns that Electromagnetic security systems such as walk-through metal detectors (WTMDs) can potentially cause electromagnetic interference (EMI) in certain active medical devices including implantable cardiac pacemakers and implantable neurostimulators. Incidents of EMI between WTMDs and active medical devices also known as personal medical electronic devices (PMED) continue to be reported. This paper reports on emission measurements of sample WTMDs and testing of 20 PMEDs in a WTMD simulation system. Magnetic fields from sample WTMD systems were characterized for emissions and exposure of certain PMEDs. A WTMD simulator system designed and evaluated by FDA in previous studies was used to mimic the PMED exposures to the waveform from sample WTMDs. The simulation system allows for controlled PMED exposure enabling careful study with adjustable magnetic field strengths and exposure duration, and provides flexibility for PMED exposure at elevated levels in order to study EMI effects on the PMED. The PMED samples consisted of six implantable cardiac pacemakers, six implantable cardioverter defibrillators (ICD), five implantable neurostimulators, and three insulin pumps. Each PMED was exposed in the simulator to the sample WTMD waveforms using methods based on appropriate consensus test standards for each of the device type. Testing the sample PMEDs using the WTMD simulator revealed EMI effects on two implantable pacemakers and one implantable neurostimulator for exposure field strength comparable to actual WTMD field strength. The observed effects were transient and the PMEDs returned to pre-exposure operation within a few seconds after removal from the simulated WTMD exposure fields. No EMI was observed for the sample ICDs or insulin pumps. The findings are consistent with earlier studies where certain sample PMEDs exhibited EMI effects. Clinical implications were not addressed in this study. Additional studies are needed to evaluate potential PMED EMI susceptibilities over a broader range of security systems.

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

Influence of digital and analogue cellular telephones on implanted pacemakers.

PubMed

Altamura, G; Toscano, S; Gentilucci, G; Ammirati, F; Castro, A; Pandozi, C; Santini, M

1997-10-01

The aim of this study was to find out whether digital and analogue cellular 'phones affect patients with pacemakers. The study comprised continuous ECG monitoring of 200 pacemaker patients. During the monitoring certain conditions caused by interference created by the telephone were looked for: temporary or prolonged pacemaker inhibition; a shift to asynchronous mode caused by electromagnetic interference; an increase in ventricular pacing in dual chamber pacemakers, up to the programmed upper rate. The Global System for Mobile Communications system interfered with pacing 97 times in 43 patients (21.5%). During tests on Total Access of Communication System telephones, there were 60 cases of pacing interference in 35 patients (17.5%). There were 131 interference episodes during ringing vs 26 during the on/off phase; (P < 0.0001); 106 at maximum sensitivity level vs 51 at the 'base' value; P < 0.0001). Prolonged pacing inhibition (> 4 s) was seen at the pacemaker 'base' sensing value in six patients using the Global system but in only one patient using Total Access. Cellular 'phones may be dangerous for pacemaker patients. However, they can be used safely if patients do not carry the 'phone close to the pacemaker, which is the only place where high risk interference has been observed.

Cardiac rhythm management devices

PubMed

Stevenson, Irene; Voskoboinik, Alex

2018-05-01

The last decade has seen ongoing evolution and use of cardiac rhythm management devices, including pacemakers, cardiac resynchronisation therapy, implantable cardioverter defibrillators and loop recorders. General practitioners are increasingly involved in follow-up and management of patients with these devices. The aim of this article is to provide an overview of different cardiac rhythm management devices, including their role, implant procedure, post-procedural care, potential complications and follow‑up. We also include practical advice for patients regarding driving, exercise, sexual intimacy and precautions with regards to electromagnetic interference. Cardiac rhythm management devices perform many functions, including bradycardia pacing, monitoring for arrhythmias, cardiac resynchronisation for heart failure, defibrillation and anti-tachycardia pacing for tachyarrhythmias. Concerns regarding potential device-related complications should be discussed with the implanting physician. In the post-implant period, patients with cardiac rhythm management devices can expect to lead normal, active lives. However, caution must occasionally be exercised in certain situations, such as near appliances with electromagnetic interference. Future innovations will move away from transvenous leads to leadless designs with combinations of different components on a 'modular' basis according to the function required.

Effect of renal sympathetic denervation on the progression of paroxysmal atrial fibrillation in canines with long-term intermittent atrial pacing.

PubMed

Wang, Xule; Huang, Congxin; Zhao, Qingyan; Huang, He; Tang, Yanhong; Dai, Zixuan; Wang, Xiaozhan; Guo, Zongwen; Xiao, Jinping

2015-04-01

The aim of the present study was to explore the effect of renal sympathetic denervation (RSD) on the progression of paroxysmal atrial fibrillation (AF) in canines with long-term intermittent atrial pacing. Nineteen beagles were randomly divided into sham-operated group (six dogs), control group (six dogs), and RSD group (seven dogs). Sham-operated group were implanted with pacemakers without pacing; control group were implanted with pacemakers with long-term intermittent atrial pacing; and RSD group underwent catheter-based RSD bilaterally and were simultaneously implanted with pacemakers. Atrial pacing was maintained for 8 h a day and a total of 12 weeks in the control group and RSD group. Echocardiography showed that the left atrial structure and function were significantly improved in the RSD group compared with the control group (P < 0.05). Compared with the control group, the RSD group had fewer incidences of AF and a shorter duration of AF (P < 0.05) after long-term intermittent atrial pacing. In addition to increased atrial effective refractory period (AERP) and AF cycle length, AERP dispersion and P-wave duration and dispersion were significantly decreased in the RSD group compared with the control group (P < 0.05). Atrial morphological evaluation suggested that fibrosis and ultrastructural changes induced by long-term intermittent atrial pacing were markedly suppressed in the RSD dogs compared with controls (P < 0.05). Immunohistochemistry results showed that connexin 43 distribution in RSD mid-myocardial was significantly fewer heterogeneous than that in control mid-myocardial (P < 0.05). Renal denervation inhibits the progression of paroxysmal AF, which might be related to the suppression of atrial electrophysiology and structural heterogeneity. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

"Power-on resets" in cardiac implantable electronic devices during magnetic resonance imaging.

PubMed

Higgins, John V; Sheldon, Seth H; Watson, Robert E; Dalzell, Connie; Acker, Nancy; Cha, Yong-Mei; Asirvatham, Samuel J; Kapa, Suraj; Felmlee, Joel P; Friedman, Paul A

2015-03-01

Magnetic resonance imaging (MRI) has been safely performed in some patients with cardiac implantable electronic devices (CIEDs) under careful monitoring and prespecified conditions. Pacemaker-dependent patients are often excluded, partly because of the potential for "power-on reset" (PoR), which can lead to a change from asynchronous to inhibited pacing with consequent inhibition of pacing due to electromagnetic interference during MRI. The purpose of this study was to review risk factors for PoR during MRI. A prospective study was performed between January 2008 and May 2013 in patients with CIEDs undergoing clinically indicated MRI. Eligible patients were not pacemaker dependent. Devices were interrogated before and after MRI, programmed to an asynchronous mode or an inhibition mode with tachyarrhythmia therapies turned off, and reprogrammed to their original settings after MRI. MRI scans (n = 256) were performed in 198 patients with non-MRI-conditional CIEDs between 2008 and 2013 (median age 66 years; interquartile range 57-77 years; 59% men). PoR occurred during 9 MRI scans (3.5%) in 8 patients. PoR was more frequent with Medtronic devices than with other generator brands (n = 9/139 vs 0/117 [6% vs 0%]; P = .005). Devices with PoR were all released before 2002 and were implanted from 1999 to 2004. Effects of PoR included a decrease in heart rate during MRI (n = 4) and transient anomalous battery life indication (n = 1). All devices functioned normally after MRI. PoR occurs infrequently but can cause deleterious changes in pacing mode and heart rate. MRI should not be performed in pacemaker-dependent patients with older at-risk generators. Continuous monitoring during MRI is essential because unrecognized PoR may inhibit pacing or accelerate battery depletion due to high pacing output. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Lead-related complications after DDD pacemaker implantation.

PubMed

Dębski, Maciej; Ulman, Mateusz; Ząbek, Andrzej; Boczar, Krzysztof; Haberka, Kazimierz; Kuniewicz, Marcin; Lelakowski, Jacek; Małecka, Barbara

2018-04-10

Pacing leads remain the weakest link in pacemaker systems despite advances in manufacturing technology. To assess the long-term pacing lead performance in an unselected real-life cohort following primary DDD pacing system implantation. A single-centre retrospective analysis of patients who underwent DDD pacing system implantation between October 1984 and December 2014 and were followed up until August 2016 was conducted. The inclusion criterion was at least one follow-up visit following post-implant discharge. The performance of each atrial and ventricular lead implanted was evaluated during the follow-up period, and the incidence of and predictive factors for lead dislodgement and failure were analysed. The data of 3771 patients and 24431.8 patient-years of follow-up were analysed. The mean follow-up of patients was 77.7 ± 61.8 months. During the study period, 7887 transvenous atrial and right ventricular pacing leads were implanted. Lead dislodgement occurred in 94 (1.2%) leads [92 (2.4%) patients], perforation in 11 (0.1%) leads [10 (0.3%) patients] and lead failure in 329 (4.2%) leads [275 (7.3%) patients]. Atrial lead position was a predictive factor for lead dislodgement, while age at implantation, polyurethane 80A insulation, subclavian vein access, unipolar lead construction and lead manufacturer were multivariate predictors of lead failure. Leads with polyurethane 80A insulation, unipolar construction and implantation via subclavian vein puncture exhibited the worst long-term performance.

Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System.

PubMed

van der Boon, Robert M A; Van Mieghem, Nicolas M; Theuns, Dominic A; Nuis, Rutger-Jan; Nauta, Sjoerd T; Serruys, Patrick W; Jordaens, Luc; van Domburg, Ron T; de Jaegere, Peter P T

2013-09-30

To determine pacemaker (PM) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). Single center prospective observational study including 167 patients without previous PM implantation who underwent TAVI with the self-expanding Medtronic CoreValve System (MCS) between November 2005 and February 2011. PM dependency was defined by the presence of a high degree atrioventricular block (HDAVB; second [AV2] and third degree [AV3B]), or a slow (<30 bpm) or absent ventricular escape rhythm during follow-up PM interrogation. A total of 36 patients (21.6%) received a new PM following TAVI. The indication for PM was AV2B (n=2, 5.6%), AV3B (n=28, 77.8%), postoperative symptomatic bradycardia (n=3, 8.3%), brady-tachy syndrome (n=1, 2.8%), atrial fibrilation with slow response (n=1, 2.8%) and left bundle branch block (n=1, 2.8%). Long term follow-up was complete for all patients and ranged from 1 to 40 months (median (IQR): 11.5 (5.0-18.0 months). Of those patients with a HDAVB, 16 out of the 30 patients (53.3%) were PM independent at follow-up visit (complete or partial resolution of the AV conduction abnormality). Overall, 20 out of the 36 patients (55.6%) who received a new PM following TAVI were PM independent at follow-up. Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

PubMed Central

RUSSO, VINCENZO; NIGRO, GERARDO; RAGO, ANNA; ANTONIO PAPA, ANDREA; PROIETTI, RICCARDO; DELLA CIOPPA, NADIA; CRISTIANO, ANNA; PALLADINO, ALBERTO; CALABRÒ, RAFFAELE; POLITANO, LUISA

2013-01-01

The role that atrial pacing therapy plays on the atrial fibrillation (AF) burden is still unclear. Aim of the study was to evaluate the effect of the atrial preference pacing algorithm on AF burden in patients affected by Myotonic Dystrophy type 1 (DM1) followed for a long follow up period. Sixty DM1 patients were -implanted with a dual chamber pacemaker (PM) for first degree or symptomatic type 1/type 2 second degree atrio-ventricular blocks- were followed for 2-years after implantation, by periodical examination. After 1 month of stabilization, they were randomized into two groups: 1) Patients implanted with conventional dual-chamber pacing mode (DDDR group) and 2) Patients implanted with DDDR plus Atrial Preference Pacing (APP) algorithm (APP ON group). The results showed that atrial tachycardia (AT)/AF burden was significantly reduced at 1 year follow up in the APP ON group (2122 ± 428 minutes vs 4127 ± 388 minutes, P = 0.03), with a further reduction at the end of the 2 year follow up period (4652 ± 348 minutes vs 7564 ± 638 minutes, P = 0.005). The data here reported show that the APP is an efficient algorithm to reduce AT/AF burden in DM1 patients implanted with dual chamber pacemaker. PMID:24803841

Venous access and long-term pacemaker lead failure: comparing contrast-guided axillary vein puncture with subclavian puncture and cephalic cutdown.

PubMed

Chan, Ngai-Yin; Kwong, Nim-Pong; Cheong, Adrian-Piers

2017-07-01

Existing data on the relationship between venous access and long-term pacemaker lead failure (PLF) are scarce and inconsistent. We aim to study the hypothesis that contrast-guided axillary vein puncture (AP) is better than subclavian puncture (SP) and similar to cephalic vein cutdown (CV) in the incidence of PLF and the success rate of AP is higher than CV. The case records of 409 patients with 681 implantable pacemaker leads were reviewed. Two hundred and fifty-two, 217, and 212 leads were implanted via AP, CV, and SP, respectively. With a mean follow-up of 73.6 ± 33.1 months, 20 (2.9%) PLF occurred. Three (1.2%), 5 (2.3%), and 12 (5.6%) PLF occurred in the AP, CV, and SP groups, respectively. On multivariate Cox regression analysis, the only independent predictor for PLF was the use of SP instead of AP (AP vs. SP; hazard ratio: 0.261; 95% confidence interval: 0.071-0.954, P = 0.042). The success rate of CV (78.2%) was significantly lower than those of AP (97.6%) and SP (96.8%) (P < 0.001). Compared with SP, the use of AP but not CV independently predicted a lower risk of PLF. The success rates in achieving venous accesses were similar between AP and SP, but significantly lower for CV. Axillary vein puncture may thus be considered the venous access of choice for pacemaker lead implantation. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

The Safety of Cardiac and Thoracic Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices.

PubMed

Dandamudi, Sanjay; Collins, Jeremy D; Carr, James C; Mongkolwat, Pat; Rahsepar, Amir A; Tomson, Todd T; Verma, Nishant; Arora, Rishi; Chicos, Alex B; Kim, Susan S; Lin, Albert C; Passman, Rod S; Knight, Bradley P

2016-12-01

Studies reporting the safety of magnetic resonance imaging (MRI) in patients with a cardiac implantable electronic device (CIED) have mostly excluded examinations with the device in the magnet isocenter. The purpose of this study was to describe the safety of cardiac and thoracic spine MRI in patients with a CIED. The medical records of patients with a CIED who underwent a cardiac or thoracic spine MRI between January 2011 and December 2014 were reviewed. Devices were interrogated before and after imaging with reprogramming to asynchronous pacing in pacemaker-dependent patients. The clinical interpretability of the MRI and peak and average specific absorption rates (SARs, W/kg) achieved were determined. Fifty-eight patients underwent 51 cardiac and 11 thoracic spine MRI exams. Twenty-nine patients had a pacemaker and 29 had an implantable cardioverter defibrillator. Seventeen percent (n = 10) were pacemaker dependent. Fifty-one patients (89%) had non-MRI-conditional devices. There were no clinically significant changes in atrial and ventricular sensing, impedance, and threshold measurements. There were no episodes of device mode changes, arrhythmias, therapies delivered, electrical reset, or battery depletion. One study was prematurely discontinued due to a patient complaint of chest pain of which the etiology was not determined. Across all examinations, the average peak SAR was 2.0 ± 0.85 W/kg with an average SAR of 0.35 ± 0.37 W/kg. Artifact significantly limiting the clinical interpretation of the study was present in 33% of cardiac MRI studies. When a comprehensive CIED magnetic resonance safety protocol is followed, the risk of performing 1.5-T magnetic resonance studies with the device in the magnet isocenter, including in patients who are pacemaker dependent, is low. Copyright © 2016. Published by Elsevier Inc.

Atrio-ventricular junction ablation and pacemaker treatment: a comparison between men and women.

PubMed

Carnlöf, Carina; Insulander, Per; Jensen-Urstad, Mats; Iwarzon, Marie; Gadler, Fredrik

2018-06-01

To explore sex differences regarding indication for atrio-ventricular junction ablation (AVJ), choice of pacing system, complications to pacemaker treatment, long-term outcome, and cause of death after AVJ ablation. 700 patients who had undergone AVJ ablation between January 1990 and December 2010 were included. Data were retrieved from the patients´ medical records and the Swedish Pacemaker and Implantable Cardioverter-Defibrillator Registry. Information about admission to hospital and cause of death was retrieved from the National Board of Health and Welfare. Mean follow-up was 90 ± 64 months. Indication for AVJ ablation, choice of pacing system, and outcome after AVJ ablation differed between the sexes. The men had more often permanent atrial fibrillation, p = .0001, and a VVIR pacemaker or cardiac resynchronization therapy (CRT) implanted prior to ablation, p = .0001. Heart failure was present in 44% of the men vs. 28% of the women, p = .0001. LVEF decreased slightly in the whole cohort after the AVJ ablation. There were no sex differences in complication rates due to the pacemaker/ICD treatment, p = .3 or mortality due to AVJ ablation. In this long-term follow-up in patients with atrial fibrillation treated with AVJ ablation and pacing, indication, choice of pacing system, and morbidity differed but there were no sex differences regarding survival or primary cause of death found. The main factor influencing survival was age at the time of ablation. Women less often received treatment with ICD and/or CRT when indication was present compared with men.

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

PubMed Central

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

2013-01-01

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

Unexpected delayed complete atrioventricular block after Cardioband implantation.

PubMed

Sorini Dini, Carlotta; Landi, Daniele; Meucci, Francesco; Di Mario, Carlo

2018-03-06

The Cardioband system is a transcatheter direct annuloplasty device that is implanted in patients with severe symptomatic functional mitral regurgitation (MR) due to annulus dilatation and high surgical risk. This device covers the posterior two-thirds of the annulus, from the anterolateral to the posteromedial commissure, implanted in close proximity of the left circumflex artery, atrioventricular (AV) conduction system, and coronary sinus. We present the case of an 80-year-old-gentleman with prohibitive surgical risk, treated with Cardioband implantation for functional MR with an evident P1-P2 cleft and P2-P3 indentation, a relative contraindication to MitraClip implantation. We achieved procedural success with significative mitral annulus reduction (30% anteroposterior reduction from 37 to 26 mm) and MR reduction (from grade 4 to grade 1-2). A late onset Mobitz 2 AV block developed after 26 hr and evolved to complete AV block in the following day, requiring definitive biventricular pacemaker (PM). Less than 200 Cardioband implantations have been performed but, to our knowledge, this is the first reported AV block, possibly facilitated by the pre-existing bifascicular block, suggesting the opportunity of prolonged ECG monitoring after Cardioband like any other mechanical transcatheter structural intervention possibly affecting the AV conduction system. © 2018 Wiley Periodicals, Inc.

Sinus MRI scan

MedlinePlus

... your body: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Recently placed artificial joints Certain types of vascular stents Pain pumps ...

Utilization of YouTube as a Tool to Assess Patient Perception Regarding Implanted Cardiac Devices.

PubMed

Hayes, Kevin; Mainali, Prajeena; Deshmukh, Abhishek; Pant, Sadip; Badheka, Apurva O; Paydak, Hakan

2014-07-01

The outreach of YouTube may have a dramatic role in the widespread dissemination of knowledge on implantable cardioverter devices (ICD). This study was designed to review and analyze the information available on YouTube pertaining to implantable cardiac devices such as implantable cardioverter defibrillators (ICDs) and pacemakers. YouTube was queried for the terms "ICD", "Implantable Cardioverter Defibrillator", and "Pacemaker". The videos were reviewed and categorized as according to content; number of views and "likes" or "dislikes" was recorded by two separate observers. Of the 55 videos reviewed, 18 of the videos were categorized as patient education, 12 were advertisements, 8 were intraoperative videos documenting the device implantation procedures, 7 of the videos were produced to document personal patient experiences, and 4 were categorized as documentation of a public event. 3 were intended to educate health care workers. The remaining 3 were intended to raise public awareness about sudden cardiac death. The videos portraying intraoperative procedures generated the most "likes" or "dislikes" per view. While YouTube provides a logical platform for delivery of health information, the information on this platform is not regulated. Initiative by reputed authorities and posting accurate information in such platform can be a great aid in public education regarding device therapy.

Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial.

PubMed

Lopez-Villegas, Antonio; Catalan-Matamoros, Daniel; Robles-Musso, Emilio; Peiro, Salvador

2016-11-01

The purpose of the present study was to assess the effectiveness of the remote monitoring (RM) of older adults with pacemakers on health-related quality of life, functional capacity, feasibility, reliability and safety. The PONIENTE study is a controlled, non-randomized, non-blinded clinical trial, with data collection carried out during the pre-implant stage and after 12 months. Between October of 2012 and November of 2013, 82 patients were assigned to either a remote monitoring group (n = 30) or a conventional hospital monitoring (HM) group (n = 52). The EuroQol-5D (EQ-5D) and the Duke Activity Status Index were used to measure health-related quality of life and functional capacity, respectively. Baseline characteristics and number of hospital visits were also analyzed. The baseline characteristics of the two study groups were similar for both the EQ-5D (RM 0.74, HM 0.67; P = 0.404) and the Duke Activity Status Index (RM 21.42, HM 19.95; P = 0.272). At the 12-month follow up, the EQ-5D utility score was improved for both groups (RM 0.91, HM 0.81; P = 0.154), unlike the EQ-5D Visual Analog Scale (P = 0.043). The Duke Activity Status Index score was similar to the baseline score. The number of in-hospital visits was 27% lower (3 vs 4; P < 0.001) in the remote group as compared with the hospital group. The PONIENTE trial suggests that the remote monitoring of pacemakers in older adults is an equivalent option to hospital monitoring, in terms of health-related quality of life and functional capacity. Furthermore, it allows for the early detection of clinical and pacemaker-related adverse events, and significantly reduces the number of in-hospital visits. Geriatr Gerontol Int 2016; 16: 1188-1195. © 2015 Japan Geriatrics Society.

Pyloric obstruction secondary to epicardial pacemaker implantation: a case report.

PubMed

Bedoya Nader, G; Kellihan, H B; Bjorling, D E; McAnulty, J

2017-02-01

A 10-year old Lhasa Apso dog was presented for an acute history of exercise intolerance and hind limb weakness. High grade second degree atrioventricular block with an atrial rate of 200 beats per minute, ventricular rate of 40 beats per minute and an intermittent ventricular escape rhythm, was diagnosed on electrocardiograph. A transdiaphragmatic, unipolar, epicardial pacemaker was implanted without immediate surgical complications. Severe vomiting was noted 12 h post-operatively. Abdominal ultrasound and a barium study supported a diagnosis of pyloric outflow obstruction and exploratory abdominal surgery was performed. The pyloric outflow tract appeared normal and no other causes of an outflow obstruction were identified. The epicardial generator was repositioned from the right to the left abdominal wall. Pyloric cell pacing was presumed to be the cause for the pyloric obstruction and severe vomiting, and this was thought to be due to close proximity of the pacemaker generator to the pylorus situated in the right abdominal wall. Repositioning of the pulse generator to the left abdominal wall resulted in resolution of vomiting. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed

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

2017-05-10

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

PubMed Central

RUSSO, VINCENZO; RAGO, ANNA; DI MEO, FEDERICA; CIOPPA, NADIA DELLA; PAPA, ANDREA ANTONIO; RUSSO, MARIA GIOVANNA

2014-01-01

The occurrence of ventricular fibrillation, induced by bipolar electrocautery during elective dual chamber pacemaker implantation, is reported in a patient affected by Myotonic Distrophy type 1 with normal left ventricular ejection fraction PMID:25873784

Impact of Pacemaker Lead Characteristics on Pacemaker Related Infection and Heart Perforation: A Nationwide Population-Based Cohort Study.

PubMed

Lin, Yu-Sheng; Chen, Tien-Hsing; Hung, Sheng-Ping; Chen, Dong Yi; Mao, Chun-Tai; Tsai, Ming-Lung; Chang, Shih-Tai; Wang, Chun-Chieh; Wen, Ming-Shien; Chen, Mien-Cheng

2015-01-01

Several risk factors for pacemaker (PM) related complications have been reported. However, no study has investigated the impact of lead characteristics on pacemaker-related complications. Patients who received a new pacemaker implant from January 1997 to December 2011 were selected from the Taiwan National Health Insurance Database. This population was grouped according to the pacemaker lead characteristics in terms of fixation and insulation. The impact of the characteristics of leads on early heart perforation was analyzed by multivariable logistic regression analysis, while the impact of the lead characteristics on early and late infection and late heart perforation over a three-year period were analyzed using Cox regression. This study included 36,104 patients with a mean age of 73.4±12.5 years. In terms of both early and late heart perforations, there were no significant differences between groups across the different types of fixation and insulations. In the multivariable Cox regression analysis, the pacemaker-related infection rate was significantly lower in the active fixation only group compared to either the both fixation (OR, 0.23; 95% CI, 0.07-0.80; P = 0.020) or the passive fixation group (OR, 0.26; 95% CI, 0.08-0.83; P = 0.023). There was no difference in heart perforation between active and passive fixation leads. Active fixation leads were associated with reduced risk of pacemaker-related infection.

A novel method of placing right ventricular leads in patients with persistent left superior vena cava using a conventional j stylet.

PubMed

Mora, Guillermo

2014-03-01

Locating pacemaker electrodes can become complicated by congenital abnormalities such as persistent left superior vena cava (LSVC). To evaluate a technique for the implanting of ventricular electrode in patients with persistent LSVC. The study was carried out from June 2001 to June 2010 involving all patients who were admitted to the Hospital Universitario Mayor, Instituto de Corazon de Bogota and Hospital Universitario Clinica San Rafael (Bogota-Colombia) for implanting pacemakers or cardiac defibrillators. LSVC was diagnosed by fluoroscopic observation (anterior-posterior view) of the course of the stylet. Four steps were followed: 1) Move the electrode with a straight stylet to the right atrium. 2) Change the straight stylet by a conventional J stylet and push the electrode to the lateral or anterolateral wall of the right atrium. 3) Remove the guide 3-5 cm and 4) Push the electrode which crosses the tricuspid valve into the right ventricle and finally deploy the active fixation mechanism. A total of 1198 patients were admitted for pacemaker or cardiac defibrillator implant during the 9-year study period, 1114 received a left subclavian venous approach. There were 573 males and 541 females. Persistent LSVC was found in five patients (0.45%) Fluoroscopy time for implanting the ventricular electrode ranged from 60 to 250 seconds, 40 to 92 minutes being taken to complete the whole procedure. We present a simple and rapid technique for electrode placement in patients with LSVC using usual J guide and active fixation electrodes with high success.

Impact of chronic kidney disease on mortality in older adults treated with pacemaker implantation

PubMed Central

Fabbian, Fabio; De Giorgi, Alfredo; Guarino, Matteo; Malagù, Michele; Bertini, Matteo

2017-01-01

Objective To investigate whether chronic kidney disease could negatively impact survival in older adults needing pacemaker implantation after admission for bradyarrhythmias. Methods This retrospective observational study considered 538 older adults consecutively admitted, who had been followed-up for 31 ± 20 months. Subjects with poor short-term prognosis were excluded. Charlson comorbidity index (CCI) and estimated glomerular filtration rate (eGFR) was calculated, along with the independent relationship between all-cause mortality and clinical data. Hazard Ratio (HR) was calculated by Cox regression analysis. Results Mean age of the population was 85 ± 3.7 years, and causes for implantation were atrioventricular block in 51.9% and other bradyarrhythmias in 48.1% of cases. Mean eGFR was 58.3 ± 24 mL/min per 1.73 m2, and mean CCI was 3.65 ± 2.28. Death for all-causes was recorded in 213 subjects. Deceased patients were older, had lower eGFR, higher comorbidity, higher prevalence of myocardial infarction, congestive heart failure, cerebrovascular disease, dementia and chronic pulmonary disease. Age (HR: 1.081, 95% CI: 1.044–1.119; P < 001), CCI (HR: 1.651, 95% CI: 1.286–2.121, P < 001) and eGFR ≤ 45 mL/min per 1.73 m2 (HR: 1.360, 95% CI: 1.024–1.806; P = 0.033) were predictors of death. Conclusions Renal dysfunction, as well as comorbidity, impacts negatively survival of older adults treated with pacemaker implantation because of bradyarrhythmias. PMID:29238360

A pacemaker magnet check alone is sufficient for the majority of patients postpacemaker implant.

PubMed

Jones, Michael A; Wong, Kelvin C K; Qureshi, Norman; Rajappan, Kim; Bashir, Yaver; Betts, Timothy R

2014-12-01

Patients postpacemaker implant can undergo a full assessment by pacing system programmer (PSP) or a magnet check. The former takes longer, but provides more detailed information; a magnet-mode assessment is faster, but provides only capture data in an asynchronous pacing mode. A magnet-mode assessment alone may be sufficient in most cases, and current clinical practice varies considerably. A retrospective single-center assessment of all pacemaker implants receiving PSP and magnet checks between September 2009 and April 2010. Patient records were reviewed. The results of PSP and magnet checks and any subsequent device-related management were noted. A total of 168 patients underwent pacemaker implantation, magnet-mode assessment, and then PSP interrogation during this period. Magnet-mode assessment revealed a problem in only one patient-failure of atrial capture, leading to subsequent atrial lead repositioning. None of the remaining 167 patients have a serious problem at PSP interrogation; six had minor issues at PSP check, none of which required repeat surgical intervention. The magnet-mode test only provides information on lead capture in an asynchronous pacing mode, which is the most essential data postoperatively. Our study has suggested that a magnet-mode assessment without PSP interrogation may be sufficient in the immediate postimplant assessment of these patients. Routine postimplant PSP interrogation is time consuming, labor intensive, and adds only minimal additional benefit to the safe management of these patients above and beyond a magnet check, coupled with informed assessment of the associated electrocardiogram/rhythm strip, clinical examination, and chest x-ray. ©2014 Wiley Periodicals, Inc.

[Heart failure provoked by a pacemaker lead-induced tricuspid stenosis].

PubMed

Chaudesaygues, E; Ferrini, M; Ritz, B

2017-04-01

Tricuspid stenosis (TS) is an uncommon complication of ventricular pacemaker implantation. Mechanisms described by the literature are ventricular inflow obstruction by tricuspid vegetations (endocarditis) or multiple pacemaker leads and fibrosis secondary to mechanical trauma, accounting for perforation or laceration of the TV leaflets, or adherence between redundant loops and valve tissue. We present the case of iatrogenic tricuspid stenosis, observed in a 77-year-old man. Extrinsic tricuspid valve stenosis was detected by transthoracic echocardiography. Further investigations confirmed the intramyocardial lead position. Tricuspid valve stenosis due to transvenous leads are reported to be treated by surgical replacement, surgical valvuloplasty, or percutaneous balloon valvuloplasty. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Permanent right ventricular pacing through an anomalous left superior vena cava.

PubMed Central

Amikam, S; Lemer, J; Riss, E

1977-01-01

A persistent left superior vena cava can complicate the implantation of a transvenous pacemaker. In a patient who required a permanent pacemaker, this venous anomaly was discovered during the insertion of the electrode but it did not prevent long-term right ventricular pacing. This was achieved after the electrode had been manipulated through the coronary sinus and right atrium. A plan of management is proposed for dealing with this unexpected problem. Images PMID:601745

Comparative Efficacy of Nebivolol and Metoprolol to Prevent Tachycardia-Induced Cardiomyopathy in a Porcine Model.

PubMed

Nazeri, Alireza; Elayda, MacArthur A; Segura, Ana Maria; Stainback, Raymond F; Nathan, Joanna; Lee, Vei-Vei; Bove, Christina; Sampaio, Luiz; Grace, Brian; Massumi, Ali; Razavi, Mehdi

2016-12-01

Chronic tachycardia is a well-known cause of nonischemic cardiomyopathy. We hypothesized that nebivolol, a β-blocker with nitric oxide activity, would be superior to a pure β-blocker in preventing tachycardia-induced cardiomyopathy in a porcine model. Fifteen healthy Yucatan pigs were randomly assigned to receive nebivolol, metoprolol, or placebo once a day. All pigs underwent dual-chamber pacemaker implantation. The medication was started the day after the pacemaker implantation. On day 7 after implantation, each pacemaker was set at atrioventricular pace (rate, 170 beats/min), and the pigs were observed for another 7 weeks. Transthoracic echocardiograms, serum catecholamine levels, and blood chemistry data were obtained at baseline and at the end of the study. At the end of week 8, the pigs were euthanized, and complete histopathologic studies were performed. All the pigs developed left ventricular cardiomyopathy but remained hemodynamically stable and survived to the end of the study. The mean left ventricular ejection fraction decreased from baseline by 34%, 20%, and 20% in the nebivolol, metoprolol, and placebo groups, respectively. These changes did not differ significantly among the 3 groups ( P =0.51). Histopathologic analysis revealed mild left ventricular perivascular fibrosis with cardiomyocyte hypertrophy in 14 of the 15 pigs. Both nebivolol and metoprolol failed to prevent cardiomyopathy in our animal model of persistent tachycardia and a high catecholamine state.

What Pacemakers Can Teach Us about the Ethics of Maintaining Artificial Organs.

PubMed

Hutchison, Katrina; Sparrow, Robert

2016-11-01

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software-particularly software that can be remotely accessed-in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered. © 2016 The Hastings Center.

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

PubMed

Dijkman, B; Wellens, H J

2001-09-01

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

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

PubMed

Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R

2017-12-28

Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming. We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter-defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896 .).

Cardiac pacemaker battery discharge after external electrical cardioversion for broad QRS Complex Tachycardia.

PubMed

Annamaria, Martino; Andrea, Scapigliati; Michela, Casella; Tommaso, Sanna; Gemma, Pelargonio; Antonio, Dello Russo; Roberto, Zamparelli; Stefano, De Paulis; Fulvio, Bellocci; Rocco, Schiavello

2008-08-01

External electrical cardioversion or defibrillation may be necessary in patients with implanted cardiac pacemaker (PM) or implantable cardioverter defibrillator (ICD). Sudden discharge of high electrical energy employed in direct current (DC) transthoracic countershock may damage the PM/ICD system resulting in a series of possible device malfunctions. For this reason, when defibrillation or cardioversion must be attempted in a patient with a PM or ICD, some precautions should be taken, particularly in PM dependent patients, in order to prevent damage to the device. We report the case of a 76-year-old woman with a dual chamber PM implanted in the right subclavicular region, who received two consecutive transthoracic DC shocks to treat haemodynamically unstable broad QRS complex tachycardia after cardiac surgery performed with a standard sternotomic approach. Because of the sternal wound and thoracic drainage tubes together with the severe clinical compromise, the anterior paddle was positioned near the pulse generator. At the following PM test, a complete battery discharge was detected.

Chest MRI

MedlinePlus

... heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or are on dialysis (you ... Diagnose abnormal growths in the chest Evaluate blood flow Show lymph nodes and blood vessels Show the ...

Ablation and pacing: improving brain perfusion and cognitive function in patients with atrial fibrillation and uncontrolled ventricular rates.

PubMed

Efimova, Irina; Efimova, Nataliya; Chernov, Vladimir; Popov, Sergey; Lishmanov, Yuri

2012-03-01

The aim of our study was to determine if ablation and pacing improved brain perfusion (BP) and cognitive function (CF) in patients with medically refractory rapidly conducted atrial fibrillation (Med Refr RCAF). The study included 17 patients with Med Refr RCAF (average age 55.3 ± 4.5 years). All patients underwent brain single photon emission computed tomography scanning with (99m) Tc-hexamethylpropylene amine oxime and comprehensive neuropsychological testing before and after 3 months following pacemaker implantation. The BP was significantly lower in all regions in patients with Med Refr RCAF compared with the control group. The greatest BP decrease was revealed in the inferior frontal (P = 0.002) and posterior parietal (P = 0.024) brain regions. These patients showed cognitive deficit in 94%. There was a direct correlation between BP and CF parameters. Ablation followed by pacemaker implantation had a positive effect on BP and CF in all patients with Med Refr RCAF. Thus, BP increased in the right inferior frontal (P = 0.01), in the left superior frontal (P = 0.007), and in the left temporal (P = 0.005) cortex. These patients demonstrated improvements in immediate and delayed verbal memory, immediate and delayed visual memory, abstract mentation, attention, psychomotor speed, as well as in learning. Patients with atrial fibrillation and rapid ventricular rates refractory to medical treatment have marked signs of brain hypoperfusion and impaired CF. Ablation and pacing improve left ventricular systolic function, thereby increasing BP and improving CF. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-22

... triggered, inhibited, and asynchronous modes and is implanted in the human body. * * * * * (c) Date PMA or... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No..., established a comprehensive system for the regulation of medical devices intended for human use. Section 513...

76 FR 44872 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-27

... triggered, inhibited, and asynchronous devices implanted in the human body. B. Summary of Data The... human body. * * * * * (c) Date PMA or notice of completion of PDP is required. A PMA or notice of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No...

On the Evolution of the Cardiac Pacemaker

PubMed Central

Burkhard, Silja; van Eif, Vincent; Garric, Laurence; Christoffels, Vincent M.; Bakkers, Jeroen

2017-01-01

The rhythmic contraction of the heart is initiated and controlled by an intrinsic pacemaker system. Cardiac contractions commence at very early embryonic stages and coordination remains crucial for survival. The underlying molecular mechanisms of pacemaker cell development and function are still not fully understood. Heart form and function show high evolutionary conservation. Even in simple contractile cardiac tubes in primitive invertebrates, cardiac function is controlled by intrinsic, autonomous pacemaker cells. Understanding the evolutionary origin and development of cardiac pacemaker cells will help us outline the important pathways and factors involved. Key patterning factors, such as the homeodomain transcription factors Nkx2.5 and Shox2, and the LIM-homeodomain transcription factor Islet-1, components of the T-box (Tbx), and bone morphogenic protein (Bmp) families are well conserved. Here we compare the dominant pacemaking systems in various organisms with respect to the underlying molecular regulation. Comparative analysis of the pathways involved in patterning the pacemaker domain in an evolutionary context might help us outline a common fundamental pacemaker cell gene programme. Special focus is given to pacemaker development in zebrafish, an extensively used model for vertebrate development. Finally, we conclude with a summary of highly conserved key factors in pacemaker cell development and function. PMID:29367536

A Leadless Intracardiac Transcatheter Pacing System.

PubMed

Reynolds, Dwight; Duray, Gabor Z; Omar, Razali; Soejima, Kyoko; Neuzil, Petr; Zhang, Shu; Narasimhan, Calambur; Steinwender, Clemens; Brugada, Josep; Lloyd, Michael; Roberts, Paul R; Sagi, Venkata; Hummel, John; Bongiorni, Maria Grazia; Knops, Reinoud E; Ellis, Christopher R; Gornick, Charles C; Bernabei, Matthew A; Laager, Verla; Stromberg, Kurt; Williams, Eric R; Hudnall, J Harrison; Ritter, Philippe

2016-02-11

A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001). In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).

Abdominal MRI scan

MedlinePlus

... aneurysm clips Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not ... test may be used to look at: Blood flow in the abdomen Blood vessels in the abdomen ...

Breast MRI scan

MedlinePlus

... heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not ... that remains after surgery or chemotherapy Show blood flow through the breast area Guide a biopsy (not ...

Renal sympathetic denervation inhibits the development of left ventricular mechanical dyssynchrony during the progression of heart failure in dogs.

PubMed

Hu, Wei; Zhao, Qing-yan; Yu, Sheng-bo; Sun, Bin; Chen, Liao; Cao, Sheng; Guo, Rui-qiang

2014-11-22

The purpose of this study was to investigate whether transcatheter renal sympathetic denervation (RSD) interfere with the development of left ventricular (LV) mechanical dyssynchrony during the progression of heart failure (HF). Nineteen beagles were randomly divided into sham-operated group (six dogs), control group (seven dogs), and RSD group (six dogs). Sham-operated group were implanted with pacemakers without pacing; Control group were implanted with pacemakers and underwent 3 weeks of rapid right ventricular pacing; and RSD group underwent catheter-based RSD bilaterally and were simultaneously implanted with pacemakers. Both LV strain and LV dyssynchrony were analyzed via 2D speckle-tracking strain echocardiography to evaluate LV function. Longitudinal dyssynchrony was determined as the standard deviation for time-to-peak speckle-tracking strain on apical 4- and 2-chamber views. Radial and circumferential dyssynchrony was determined as the standard deviation for time-to-peak speckle-tracking strain in mid- and base-LV short-axis views. Each myocardial function was also evaluated by averaging the peak systolic strains. LV systolic pressure (LVSP) and LV end-diastolic pressure (LVEDP) were measured. The LV interstitial fibrosis was determined by histological analysis. Plasma angiotensin II (Ang II), aldosterone and norepinephrine (NE) levels were also measured. After 3 weeks, all of the dogs in both the control and RSD groups showed greater LV end-diastolic volume compared with the sham-operated group; however, the dogs in the RSD group had a higher LV ejection fraction (LVEF) than the dogs in the control group (p<0.001). The LV systolic strains were higher in the RSD group than in the control group (p<0.001 for longitudinal, circumferential and radial strain, respectively). The levels of LV dyssynchrony were lower in the RSD group than in the control group (p<0.001 for longitudinal, circumferential and radial dyssynchrony, respectively). Compared with dogs with control alone, RSD dogs had lower LV end-diastolic pressures and less fibrous tissue. The levels of plasma Ang II, aldosterone and NE were lower in the RSD group than in the control group. RSD inhibites the development of left ventricular mechanical dyssynchrony during the progression of heart failure in dogs.

Inappropriate shock and battery switching to "End of Life" in a patient with biventricular ICD during magnetic resonance imaging.

PubMed

Atar, İlyas; Bal, Uğur; Ertan, Çağatay; Özin, Bülent; Müderrisoğlu, Haldun

2016-01-01

Presence of a cardiac pacemaker or implantable cardioverter defibrillator (ICD) is a relative contraindication to magnetic resonance imaging (MRI). Biventricular ICDs are often used in the treatment of advanced heart failure; however, reports on experience with biventricular ICDs are lacking in the literature. In this case report, we describe a pacemaker-dependent patient with a biventricular ICD on whom an MRI of the lumbar spine was performed without having realized the presence of the ICD.

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

PubMed Central

2009-01-01

Background Magnetic resonance imaging (MRI) of patients with implanted cardiac pacemakers is generally contraindicated but some clinicians condone scanning certain patients. We assessed the risk of inducing unintended cardiac stimulation by measuring electric fields (E) induced near lead tips by a simulated MRI gradient system. The objectives of this study are to map magnetically induced E near distal tips of leads in a saline tank to determine the spatial distribution and magnitude of E and compare them with E induced by a pacemaker pulse generator (PG). Methods We mapped magnetically induced E with 0.1 mm resolution as close as 1 mm from lead tips. We used probes with two straight electrodes (e.g. wire diameter of 0.2 mm separated by 0.9 mm). We generated magnetic flux density (B) with a Helmholtz coil throughout 0.6% saline in a 24 cm diameter tank with (dB/dt) of 1 T/sec (1 kHz sinusoidal waveform). Separately, we measured E near the tip of leads when connected to a PG set to a unipolar mode. Measurements were non-invasive (not altering the leads or PG under study). Results When scaled to 30 T/s (a clinically relevant value), magnetically-induced E exceeded the E produced by a PG. The magnetically-induced E only occurred when B was coincident with or within 15 msec of implantable pacemaker's pulse. Conclusions Potentially hazardous situations are possible during an MR scan due to gradient fields. Unintended stimulation can be induced via abandoned leads and leads connected to a pulse generator with loss of hermetic seal at the connector. Also, pacemaker-dependent patients can receive drastically altered pacing pulses. PMID:20003479

Dual-chamber pacemakers for treating symptomatic bradycardia due to sick sinus syndrome without atrioventricular block: a systematic review and economic evaluation.

PubMed

Edwards, Steven J; Karner, Charlotta; Trevor, Nicola; Wakefield, Victoria; Salih, Fatima

2015-08-01

Bradycardia [resting heart rate below 60 beats per minute (b.p.m.)] can be caused by conditions affecting the natural pacemakers of the heart, such as sick sinus syndrome (SSS) and atrioventricular (AV) blocks. People suffering from bradycardia may present with palpitations, exercise intolerance and fainting. The only effective treatment for patients suffering from symptomatic bradycardia is implantation of a permanent pacemaker. To appraise the clinical effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber atrial pacemakers for treating symptomatic bradycardia in people with SSS and no evidence of AV block. All databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) were searched from inception to June 2014. A systematic review of the clinical and economic literature was carried out in accordance with the general principles published by the Centre for Reviews and Dissemination. Randomised controlled trials (RCTs) evaluating dual-chamber and single-chamber atrial pacemakers and economic evaluations were included. Pairwise meta-analysis was carried out. A de novo economic model was developed. Of 493 references, six RCTs were included in the review. The results were predominantly influenced by the largest trial DANPACE. Dual-chamber pacing was associated with a statistically significant reduction in reoperation [odds ratio (OR) 0.48, 95% confidence interval (CI) 0.36 to 0.63] compared with single-chamber atrial pacing. The difference is primarily because of the development of AV block requiring upgrade to a dual-chamber device. The risk of paroxysmal atrial fibrillation was also reduced with dual-chamber pacing compared with single-chamber atrial pacing (OR 0.75, 95% CI 0.59 to 0.96). No statistically significant difference was found between the pacing modes for mortality, heart failure, stroke, chronic atrial fibrillation or quality of life. However, the risk of developing heart failure may vary with age and device. The de novo economic model shows that dual-chamber pacemakers are more expensive and more effective than single-chamber atrial devices, resulting in a base-case incremental cost-effectiveness ratio (ICER) of £6506. The ICER remains below £20,000 in probabilistic sensitivity analysis, structural sensitivity analysis and most scenario analyses and one-way sensitivity analyses. The risk of heart failure may have an impact on the decision to use dual-chamber or single-chamber atrial pacemakers. Results from an analysis based on age (> 75 years or ≤ 75 years) and risk of heart failure indicate that dual-chamber pacemakers dominate single-chamber atrial pacemakers (i.e. are less expensive and more effective) in older patients, whereas dual-chamber pacemakers are dominated by (i.e. more expensive and less effective) single-chamber atrial pacemakers in younger patients. However, these results are based on a subgroup analysis and should be treated with caution. In patients with SSS without evidence of impaired AV conduction, dual-chamber pacemakers appear to be cost-effective compared with single-chamber atrial pacemakers. The risk of developing a complete AV block and the lack of tools to identify patients at high risk of developing the condition argue for the implantation of a dual-chamber pacemaker programmed to minimise unnecessary ventricular pacing. However, considerations have to be made around the risk of developing heart failure, which may depend on age and device. This study is registered as PROSPERO CRD42013006708. The National Institute for Health Research Health Technology Assessment programme.

AANA Journal Course: update for nurse anesthetists. Arrhythmia management devices and electromagnetic interference.

PubMed

Mattingly, Emily

2005-04-01

The technological complexity of implantable arrhythmia management devices, specifically pacemakers and defibrillators, has increased dramatically since their introduction only a few decades ago. Patients with such devices are encountered much more frequently in hospitals and surgery centers, yet anesthesia provider knowledge of safe and proper management is often incomplete. Anesthesia textbooks and references may provide only short paragraphs on arrhythmia management devices that do not address important perioperative management strategies for this ever-growing patient population. It is no longer satisfactory to simply place a magnet over an implanted device during surgery and assume that this action protects the patient from harm due to electromagnetic interference from inappropriate device function. This AANA Journal course serves as a concise review of basic device function, the sources and effects of electromagnetic interference in the operative setting, and patient management recommendations from current literature.

Clinically oriented device programming in bradycardia patients: part 1 (sinus node disease). Proposals from AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

PubMed

Ziacchi, Matteo; Palmisano, Pietro; Biffi, Mauro; Ricci, Renato P; Landolina, Maurizio; Zoni-Berisso, Massimo; Occhetta, Eraldo; Maglia, Giampiero; Botto, Gianluca; Padeletti, Luigi; Boriani, Giuseppe

2018-04-01

: Modern pacemakers have an increasing number of programable parameters and specific algorithms designed to optimize pacing therapy in relation to the individual characteristics of patients. When choosing the most appropriate pacemaker type and programing, the following variables must be taken into account: the type of bradyarrhythmia at the time of pacemaker implantation; the cardiac chamber requiring pacing, and the percentage of pacing actually needed to correct the rhythm disorder; the possible association of multiple rhythm disturbances and conduction diseases; the evolution of conduction disorders during follow-up. The goals of device programing are to preserve or restore the heart rate response to metabolic and hemodynamic demands; to maintain physiological conduction; to maximize device longevity; to detect, prevent, and treat atrial arrhythmia. In patients with sinus node disease, the optimal pacing mode is DDDR. Based on all the available evidence, in this setting, we consider appropriate the activation of the following algorithms: rate responsive function in patients with chronotropic incompetence; algorithms to maximize intrinsic atrioventricular conduction in the absence of atrioventricular blocks; mode-switch algorithms; algorithms for autoadaptive management of the atrial pacing output; algorithms for the prevention and treatment of atrial tachyarrhythmias in the subgroup of patients with atrial tachyarrhythmias/atrial fibrillation. The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients' clinical features.

Cardiac Conduction through Engineered Tissue

PubMed Central

Choi, Yeong-Hoon; Stamm, Christof; Hammer, Peter E.; Kwaku, Kevin F.; Marler, Jennifer J.; Friehs, Ingeborg; Jones, Mara; Rader, Christine M.; Roy, Nathalie; Eddy, Mau-Thek; Triedman, John K.; Walsh, Edward P.; McGowan, Francis X.; del Nido, Pedro J.; Cowan, Douglas B.

2006-01-01

In children, interruption of cardiac atrioventricular (AV) electrical conduction can result from congenital defects, surgical interventions, and maternal autoimmune diseases during pregnancy. Complete AV conduction block is typically treated by implanting an electronic pacemaker device, although long-term pacing therapy in pediatric patients has significant complications. As a first step toward developing a substitute treatment, we implanted engineered tissue constructs in rat hearts to create an alternative AV conduction pathway. We found that skeletal muscle-derived cells in the constructs exhibited sustained electrical coupling through persistent expression and function of gap junction proteins. Using fluorescence in situ hybridization and polymerase chain reaction analyses, myogenic cells in the constructs were shown to survive in the AV groove of implanted hearts for the duration of the animal’s natural life. Perfusion of hearts with fluorescently labeled lectin demonstrated that implanted tissues became vascularized and immunostaining verified the presence of proteins important in electromechanical integration of myogenic cells with surrounding recipient rat cardiomyocytes. Finally, using optical mapping and electrophysiological analyses, we provide evidence of permanent AV conduction through the implant in one-third of recipient animals. Our experiments provide a proof-of-principle that engineered tissue constructs can function as an electrical conduit and, ultimately, may offer a substitute treatment to conventional pacing therapy. PMID:16816362

Right versus left atrial pacing in patients with sick sinus syndrome and paroxysmal atrial fibrillation (Riverleft study): study protocol for randomized controlled trial.

PubMed

Ramdjan, Tanwier T T K; van der Does, Lisette J M E; Knops, Paul; Res, Jan C J; de Groot, Natasja M S

2014-11-17

The incidence of sick sinus syndrome will increase due to population ageing. Consequently, this will result in an increase in the number of pacemaker implantations. The atrial lead is usually implanted in the right atrial appendage, but this position may be ineffective for prevention of atrial fibrillation. It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes. The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome. This study is designed as a multicenter, randomized controlled trial. Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage. Randomization is stratified for all participating centers. Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted. The ventricular lead will be implanted in the right ventricular apex. The first three months of the 36-month follow-up period are considered as run-in time. During the pre-randomization visit and follow-up, an interview, electrocardiogram and pacemaker assessment will be performed, prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-36 questionnaire. An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year. Home monitoring will be used to send daily reports in case of atrial fibrillation episodes. This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage. Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes. Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences, this study will redefine the preferential location of an atrial lead for preventive pacing. Current Controlled Trials ISRCTN65911661, registered on 8 July 2013.

MRI

MedlinePlus

... the test, tell your provider if you have: Artificial heart valves Brain aneurysm clips Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not ... artificial joints Vascular stents Worked with sheet metal in ...

Magnetic resonance angiography

MedlinePlus

... your provider if you have: Brain aneurysm clips Artificial heart valve Heart defibrillator or pacemaker Inner ear (cochlear) implants Insulin or chemotherapy port Intrauterine device (IUD) Kidney ... artificial joints Vascular stent Worked with sheet metal in ...

Enhanced Antimicrobial Effects of Decellularized Extracellular Matrix (CorMatrix) with Added Vancomycin and Gentamicin for Device Implant Protection.

PubMed

Deering, Thomas F; Chang, Carlos; Snyder, Carl; Natarajan, Selvamuthu K; Matheny, Robert

2017-06-01

The incidence of cardiac implantable electronic device (CIED) infections has risen significantly over the past years. Although several devices are currently available to decrease the incidence of infection, most are made from nonviable synthetic material and are more prone to infection than vascularized tissue. This study was undertaken to assess the resistance to infection of the CorMatrix CanGaroo (CorMatrix Cardiovascular, Roswell, GA, USA), a CIED envelope made of decellularized extracellular matrix (ECM) hydrated in different antibiotic solutions. This study was comprised of two in vitro tests and one animal trial. For all the tests, the ECM was hydrated in a mixture of vancomycin (25 mg/mL) and gentamicin (20 mg/mL) or gentamicin alone (40 mg/mL). The drug elution characteristics were assessed followed by the effectiveness of CanGaroo to prevent the bacterial growth of Staphylococcus aureus and Staphylococcus epidermidis in culture. Then, the direct inoculation of pacemaker implant pockets with both Staphylococcus species was performed in rabbits implanted with either a pacemaker alone or a pacemaker with antibiotic-soaked CorMatrix ECM pouches. The hydration of CanGaroo envelopes in both antibiotic mixtures resulted in antimicrobial activity against both Staphylococcus species, with an early bolus release of antibiotics followed by a slow release lasting for up to 6 days. In vivo, there was a substantial decrease in the occurrence of infection. The hydration of the CanGaroo ECM with an antibiotic solution prevented Staphylococcus species growth in vitro and substantially reduced the incidence of CIED pocket infections in an in vivo rabbit model. © 2017 Wiley Periodicals, Inc.

Transcatheter leadless cardiac pacing: The new alternative solution.

PubMed

Da Costa, Antoine; Axiotis, Amandine; Romeyer-Bouchard, Cécile; Abdellaoui, Loucif; Afif, Zahi; Guichard, Jean Baptiste; Gerbay, Antoine; Isaaz, Karl

2017-01-15

A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Energy harvesting by implantable abiotically catalyzed glucose fuel cells

NASA Astrophysics Data System (ADS)

Kerzenmacher, S.; Ducrée, J.; Zengerle, R.; von Stetten, F.

Implantable glucose fuel cells are a promising approach to realize an autonomous energy supply for medical implants that solely relies on the electrochemical reaction of oxygen and glucose. Key advantage over conventional batteries is the abundant availability of both reactants in body fluids, rendering the need for regular replacement or external recharging mechanisms obsolete. Implantable glucose fuel cells, based on abiotic catalysts such as noble metals and activated carbon, have already been developed as power supply for cardiac pacemakers in the late-1960s. Whereas, in vitro and preliminary in vivo studies demonstrated their long-term stability, the performance of these fuel cells is limited to the μW-range. Consequently, no further developments have been reported since high-capacity lithium iodine batteries for cardiac pacemakers became available in the mid-1970s. In recent years research has been focused on enzymatically catalyzed glucose fuel cells. They offer higher power densities than their abiotically catalyzed counterparts, but the limited enzyme stability impedes long-term application. In this context, the trend towards increasingly energy-efficient low power MEMS (micro-electro-mechanical systems) implants has revived the interest in abiotic catalysts as a long-term stable alternative. This review covers the state-of-the-art in implantable abiotically catalyzed glucose fuel cells and their development since the 1960s. Different embodiment concepts are presented and the historical achievements of academic and industrial research groups are critically reviewed. Special regard is given to the applicability of the concept as sustainable micro-power generator for implantable devices.

Implant of permanent pacemaker during acute coronary syndrome: Mortality and associated factors in the ARIAM registry.

PubMed

Pola-Gallego-de-Guzmán, María Dolores; Ruiz-Bailén, Manuel; Martínez-Arcos, Maria-Angeles; Gómez-Blizniak, Artur; Castillo Rivera, Ana-Maria; Molinos, Jesus Cobo

2018-04-01

Patients with acute coronary syndrome complicated with high degree atrioventricular block still have a high mortality. A low percentage of these patients need a permanent pacemaker (PPM) but mortality and associated factors with the PPM implant in acute coronary syndrome patients are not known. We assess whether PPM implant is an independent variable in the mortality of acute coronary syndrome patients. Also, we explored the variables that remain independently associated with PPM implantation. This was an observational study on the Spanish ARIAM register. The inclusion period was from January 2001 to December 2011. This registry included all Andalusian acute coronary syndrome patients. Follow-up for global mortality was until November 2013. We selected 27,608 cases. In 62 patients a PPM was implanted (0.024%). The mean age in PPM patients was 70.71±11.214 years versus 64.46±12.985 years in patients with no PPM. PPM implant was associated independently with age (odds ratio (OR) 1.031, 95% confidence interval (CI) 1.007-1.055), with left ventricular branch block (OR 6.622, 95% CI 2.439-18.181), with any arrhythmia at intensive care unit admission (OR 2.754, 95% CI 1.506-5.025) and with heart failure (OR 3.344, 95% CI 1.78-8.333). PPM implant was independently associated with mortality (OR 11.436, 95% CI 1.576-83.009). In propensity score analysis PPM implant was still associated with mortality (OR 5.79, 95% CI 3.27-25.63). PPM implant is associated with mortality in the acute coronary syndrome population in the ARIAM registry. Advanced age, heart failure, arrhythmias and left ventricular branch block at intensive care unit admission were found associated factors with PPM implant in acute coronary syndrome patient.

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker electrode function tester. 870.3720... electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is... measuring the patient's pacing threshold and intracardiac R-wave potential. (b) Classification. Class II...

Percutaneous pacemaker or implantable cardioverter-defibrillator lead removal in an attempt to improve symptomatic tricuspid regurgitation.

PubMed

Nazmul, Mohammed N; Cha, Yong-Mei; Lin, Grace; Asirvatham, Samuel J; Powell, Brian D

2013-03-01

Pacemaker and implantable cardioverter-defibrillator (ICD) leads can cause tricuspid valve regurgitation (TR). Few data are available on the best management of significant TR that develops after pacemaker or ICD implantation and regarding any benefits of right ventricular (RV) lead extraction. We sought to determine the impact of RV lead removal on lead-induced TR. We reviewed all patients between 1 January 2000 and 31 December 2010 at the tertiary care hospital who had a preoperative indication of TR and underwent percutaneous extraction of an RV lead with the intent of trying to correct moderate or severe TR. Pre- and post-procedure echoes and clinical data were retrospectively reviewed. In the four patients identified, the RV lead was removed and placed in the coronary sinus to try to improve moderate or severe TR due to lead impingement. There was no significant improvement in the degree of TR except one patient where TR improved slightly from moderate to mild-moderate. All patients had a dilated tricuspid valve annulus by the time of lead extraction. Tricuspid annulus dilatation appeared to account for the persistent TR after RV lead removal. A greater degree of tricuspid valve annulus dilatation may be a marker and mechanism for irreversible lead-induced TR. Further studies are needed to determine whether surgical tricuspid valve repair or replacement combined with RV lead extraction would result in better outcomes than a percutaneous lead extraction approach.

Should physicians instead of industry representatives be the main actor of cardiac implantable electronic device follow-up? (Super Follow-up)

PubMed Central

Üreyen, Çağın Mustafa; Baş, Cem Yunus; Yüksel, İsa Öner; Kuş, Görkem; Çağırcı, Göksel; Arslan, Şakir

2017-01-01

Objective: This retrospective study sought to research the adequacy of the follow-up and optimization of cardiac implantable electronic devices (CIEDs) performed by industry representatives. Methods: A total of 403 consecutive patients (35% females; median age, 67 years; age range 18–97 years) with either pacemakers (n=246), implantable cardioverter-defibrillators (ICDs), (n=117) or cardiac resynchronization therapy with defibrillator (CRT-D) (n=40) applied to our hospital’s outpatient pacemaker clinic for follow-up. These patients had been followed up by industry representatives alone until September 2013 and then by a cardiologist who is dealing with cardiac electrophysiology and has a knowledge of CIED follow-up. Results: It was ascertained that 117 (47.6%) of 246 patients with pacemakers had a programming error. Forty-three (36.8%) of 117 patients were symptomatic, and after reprogramming, all symptoms diminished partially or completely during the follow-up. Moreover, 30 (25.6%) of 117 patients with ICDs had a programming error. Furthermore, 6 (15%) of 40 patients with CRT-Ds had a programming error. To conclude, when all patients with CIEDs were assessed together, it was ascertained that 153 (38%) of 403 patients had programming errors. Conclusion: The prevalence of inappropriate programming of CIEDs by industry representatives was quite higher than expected. Therefore, our study strongly demonstrates that CIED follow-up should not be allowed to be performed entirely by manufacturers’ representatives alone. PMID:28430113

Implantation of VVI pacemaker in a patient with dextrocardia, persistent left superior vena cava, and sick sinus syndrome

PubMed Central

Guo, Gongliang; Yang, Lili; Wu, Jinyi; Sun, Liqun

2017-01-01

Abstract Background: Dextrocardia, or right-lying heart, is an uncommon congenital heart disease in which the apex of the heart is located on the right side of chest. Persistent left superior vena cava (PLSVA) is a rare venous anomaly that is often associated with the abnormalities of cardiac transduction system. A case with combination of dextrocardia, persistent left superior vena cava, and sick sinus syndrome has not been reported. Methods: We used different techniques including cardiac color Doppler echocardiography, 24-hour Holter monitoring, and abdominal ultrasound to make a diagnosis and treated the patient by implanting a VVI pacemaker. Results: A 50-year-old woman was admitted with a syncope. Angiography of the right atrium and superior vena cava, echocardiography, electrocardiography, and abdominal ultrasound revealed the presence of the combination of mirror image dextrocardia, PLSVA, and sick sinus syndrome. The complex structural anomalies presented great technical challenges for interventional treatments. After thorough examination and understanding of the structural anatomy and anomalies of the superior and inferior vena cava and cardiac chambers, we successfully treated this patient by implanting a VVI pacemaker. Conclusion: Physicians must be aware of the complexity of the morphological and anatomical structures of dextrocardia accompanying PLSVC. Given that the diagnosis of situs inversus was performed at a relatively advanced age, it is therefore important to make such a correct diagnosis followed by appropriate therapeutic intervention. PMID:28151908

Effect of radiation therapy on permanent pacemaker and implantable cardioverter-defibrillator function.

PubMed

Makkar, Akash; Prisciandaro, Joann; Agarwal, Sunil; Lusk, Morgan; Horwood, Laura; Moran, Jean; Fox, Colleen; Hayman, James A; Ghanbari, Hamid; Roberts, Brett; Belardi, Diego; Latchamsetty, Rakesh; Crawford, Thomas; Good, Eric; Jongnarangsin, Krit; Bogun, Frank; Chugh, Aman; Oral, Hakan; Morady, Fred; Pelosi, Frank

2012-12-01

Radiation therapy's (RT's) effects on cardiac implantable electronic devices (CIEDs) such as implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs) are not well established, leading to device removal or relocation in preparation for RT. To determine the effect of scattered RT on CIED performance. We analyzed 69 patients--50 (72%) with PMs and 19 (28%) with ICDs--receiving RT at the University of Michigan. Collected data included device model, anatomic location, and treatment beam energies, treatment type, and estimated dose to the device. Patients were treated with either high-energy (16-MV) and/or low-energy (6 MV) photon beams with or without electron beams (6-16 MeV). The devices were interrogated with pre- and post-RT and/or weekly with either in-treatment or home interrogation, depending on the patient's dependence on the device and the estimated or measured delivered dose. Outcomes analyzed were inappropriate ICD therapies, device malfunctions, or device-related clinical events. The PMs were exposed to 84.4 ± 99.7 cGy of radiation, and the ICDs were exposed to 92.1 ± 72.6 cGy of radiation. Two patients with ICDs experienced a partial reset of the ICD with the loss of historic diagnostic data after receiving 123 and 4 cGy, respectively. No device malfunction or premature battery depletion was observed at 6-month follow-up from RT completion. CIED malfunction due to indirect RT exposure is uncommon. Regular in-treatment or home interrogation should be done to detect and treat these events and to ensure that diagnostic data are preserved. Copyright © 2012 Elsevier Inc. All rights reserved.

The Popeye domain containing genes: essential elements in heart rate control

PubMed Central

Schindler, Roland F.; Poon, Kar Lai; Simrick, Subreena

2012-01-01

The Popeye domain containing (Popdc) gene family displays preferential expression in skeletal muscle and heart. Only recently a significant gain in the understanding of the function of Popdc genes in the heart has been obtained. The Popdc genes encode membrane proteins harboring an evolutionary conserved Popeye domain, which functions as a binding domain for cyclic adenosine monophosphate (cAMP). Popdc proteins interact with the two-pore channel TREK-1 and enhance its current. This protein interaction is modulated by cAMP. Null mutations of members of the Popdc gene family in zebrafish and mouse are associated with severe cardiac arrhythmia phenotypes. While in zebrafish an atrioventricular block was prevalent, in mouse a stress-induced sinus bradycardia was observed, which was due to the presence of sinus pauses. Moreover, the phenotype develops in an age-dependent manner, being absent in the young animal and becoming increasingly severe, as the animals grow older. This phenotype is reminiscent of the sick sinus syndrome (SSS), which affects mostly the elderly and is characterized by the poor ability of the cardiac pacemaker to adapt the heart rate to the physiological demand. While being a prevalent disease, which is responsible for a large fraction of pacemaker implantations in Western countries, SSS is poorly understood at the molecular level. It is therefore expected that the study of the molecular basis of the stress-induced bradycardia in Popdc mice will shed new light on the etiology of pacemaker disease. PMID:24282731

The Popeye domain containing genes: essential elements in heart rate control.

PubMed

Schindler, Roland F; Poon, Kar Lai; Simrick, Subreena; Brand, Thomas

2012-12-01

The Popeye domain containing (Popdc) gene family displays preferential expression in skeletal muscle and heart. Only recently a significant gain in the understanding of the function of Popdc genes in the heart has been obtained. The Popdc genes encode membrane proteins harboring an evolutionary conserved Popeye domain, which functions as a binding domain for cyclic adenosine monophosphate (cAMP). Popdc proteins interact with the two-pore channel TREK-1 and enhance its current. This protein interaction is modulated by cAMP. Null mutations of members of the Popdc gene family in zebrafish and mouse are associated with severe cardiac arrhythmia phenotypes. While in zebrafish an atrioventricular block was prevalent, in mouse a stress-induced sinus bradycardia was observed, which was due to the presence of sinus pauses. Moreover, the phenotype develops in an age-dependent manner, being absent in the young animal and becoming increasingly severe, as the animals grow older. This phenotype is reminiscent of the sick sinus syndrome (SSS), which affects mostly the elderly and is characterized by the poor ability of the cardiac pacemaker to adapt the heart rate to the physiological demand. While being a prevalent disease, which is responsible for a large fraction of pacemaker implantations in Western countries, SSS is poorly understood at the molecular level. It is therefore expected that the study of the molecular basis of the stress-induced bradycardia in Popdc mice will shed new light on the etiology of pacemaker disease.

Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial.

PubMed

Muto, Carmine; Calvi, Valeria; Botto, Giovanni Luca; Pecora, Domenico; Ciaramitaro, Gianfranco; Valsecchi, Sergio; Malacrida, Maurizio; Maglia, Giampiero

2014-11-01

The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID:NCT01647490). Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov: NCT01647490. Copyright © 2014 Elsevier Inc. All rights reserved.

Association of Sick Sinus Syndrome with Incident Cardiovascular Disease and Mortality: The Atherosclerosis Risk in Communities Study and Cardiovascular Health Study

PubMed Central

Alonso, Alvaro; Jensen, Paul N.; Lopez, Faye L.; Chen, Lin Y.; Psaty, Bruce M.; Folsom, Aaron R.; Heckbert, Susan R.

2014-01-01

Background Sick sinus syndrome (SSS) is a common indication for pacemaker implantation. Limited information exists on the association of sick sinus syndrome (SSS) with mortality and cardiovascular disease (CVD) in the general population. Methods We studied 19,893 men and women age 45 and older in the Atherosclerosis Risk in Communities (ARIC) study and the Cardiovascular Health Study (CHS), two community-based cohorts, who were without a pacemaker or atrial fibrillation (AF) at baseline. Incident SSS cases were validated by review of medical charts. Incident CVD and mortality were ascertained using standardized protocols. Multivariable Cox models were used to estimate the association of incident SSS with selected outcomes. Results During a mean follow-up of 17 years, 213 incident SSS events were identified and validated (incidence, 0.6 events per 1,000 person-years). After adjustment for confounders, SSS incidence was associated with increased mortality (hazard ratio [HR] 1.39, 95% confidence interval [CI] 1.14–1.70), coronary heart disease (HR 1.72, 95%CI 1.11–2.66), heart failure (HR 2.87, 95%CI 2.17–3.80), stroke (HR 1.56, 95%CI 0.99–2.46), AF (HR 5.75, 95%CI 4.43–7.46), and pacemaker implantation (HR 53.7, 95%CI 42.9–67.2). After additional adjustment for other incident CVD during follow-up, SSS was no longer associated with increased mortality, coronary heart disease, or stroke, but remained associated with higher risk of heart failure (HR 2.00, 95%CI 1.51–2.66), AF (HR 4.25, 95%CI 3.28–5.51), and pacemaker implantation (HR 25.2, 95%CI 19.8–32.1). Conclusion Individuals who develop SSS are at increased risk of death and CVD. The mechanisms underlying these associations warrant further investigation. PMID:25285853

Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial.

PubMed

Bauer, A; Vermeulen, J; Toivonen, L; Voitk, J; Barr, C; Peytchev, P

2015-12-01

Unnecessary ventricular pacing is associated with increased morbidity and mortality. Over the years different algorithms have been developed to reduce right ventricular pacing. Goal of the present study was to test the efficacy of the ventricular intrinsic preference (VIP) algorithm in patients with atrioventricular intact (AVi) and atrioventricular compromised (AVc) AV-conduction. Evaluation of VIP feature in pacemaker patients (EVITA) was a multicenter, prospective, randomized trial (Trials.gov Identifier: NCT00366158). In total, 389 patients were randomized to AVc group: n = 140/132 VIP OFF/VIP On, AVi group: n = 54/63 VIP OFF/VIP ON). One-month post-implantation AV conduction testing (AVc: PR/AR interval > 210 ms) was performed. Follow-up visits occurred 6 and 12 months after DDD-pacemaker implantation. In AVi and AVc-patients initiation of the VIP feature significantly reduced incidence of ventricular pacing (AVi: 53 ± 38 vs. 9 ± 21%, p = 0.0001; AVc: 79 ± 31 vs. 28 ± 35%, p = 0.0001). DDD-pacemaker implantation per se significantly reduced incidence of AF in VIP ON (AVi 27 vs. 0%, p < 0.0001; AVc 29 vs. 3%, p < 0.0001) and VIP OFF patients (AVi 43 vs. 4%, p < 0.0001; AVc 33 vs. 3, p < 0.0001), without significant differences between VIP ON and OFF groups (p > 0.05). In the AVc group activation of VIP significantly reduced incidence of adverse events (AE). All-cause mortality was not significantly different in VIP ON (n = 5) and VIP OFF (n = 4, p > 0.05) patients. AV search hysteresis (VIP) markedly reduces ventricular pacing both in patients with normal AV conduction and in patients with prolonged PR interval or intermittent AV block.

The influence of cholinesterase inhibitor therapy for dementia on risk of cardiac pacemaker insertion: a retrospective, population-based, health administrative databases study in Ontario, Canada.

PubMed

Huang, Allen R; Redpath, Calum J; van Walraven, Carl

2015-04-28

Cholinesterase inhibitors are used to treat the symptoms of dementia and can theoretically cause bradycardia. Previous studies suggest that patients taking these medications have an increased risk of undergoing pacemaker insertion. Since these drugs have a marginal impact on patient outcomes, it might be preferable to change drug treatment rather than implant a pacemaker. This population-based study determined the association of people with dementia exposed to cholinesterase inhibitor medication and pacemaker insertion. We used data from the Ontario health administrative databases from January 1, 1993 to June 30, 2012. We included all community-dwelling seniors who had a code for dementia and were exposed to cholinesterase inhibitors (donezepil, galantamine, and rivastigmine) and/or drugs used to treat co-morbidities of hypertension, diabetes, depression and hypothyroidism. We controlled for exposure to anti-arrhythmic drugs. Observation started at first exposure to any medication and continued until the earliest of pacemaker insertion, death, or end of study. 2,353,909 people were included with 96,000 (4.1%) undergoing pacemaker insertion during the observation period. Case-control analysis showed that pacemaker patients were less likely to be coded with dementia (unadjusted OR 0.42 [95%CI 0.41-0.42]) or exposed to cholinesterase inhibitors (unadjusted OR 0.39 [95%CI 0.37-0.41]). That Cohort analysis showed patients with dementia taking cholinesterase inhibitors had a decreased risk of pacemaker insertion (unadj-HR 0.58 [0.55-0.61]). Adjustment for patient age, sex, and other medications did not notably change results, as did restricting the analysis to incident users. Patients taking cholinesterase inhibitors rarely undergo, and have a significantly reduced risk of, cardiac pacemaker insertion.

Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators Groupe de rythmologie et stimulation cardiaque de la Société française de cardiologie et Société française de gériatrie et gérontologie.

PubMed

Fauchier, Laurent; Alonso, Christine; Anselme, Frédéric; Blangy, Hugues; Bordachar, Pierre; Boveda, Serge; Clementy, Nicolas; Defaye, Pascal; Deharo, Jean-Claude; Friocourt, Patrick; Gras, Daniel; Halimi, Franck; Klug, Didier; Mansourati, Jacques; Obadia, Benjamin; Pasquié, Jean-Luc; Pavin, Dominique; Sadoul, Nicolas; Taieb, Jérôme; Piot, Olivier; Hanon, Olivier

2016-09-01

Despite the increasingly high rate of implantation of pacemakers (PM) and cardioverter-defibrillators (ICD) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety, and effectiveness of the conventional pacing, ICD and cardiac resynchronization therapy (CRT) in elderly patients. Although peri-procedural risk may be slightly higher in the elderly, the procedure of implantation of PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, a general consensus is that dual chamber pacing, along with the programming of an algorithm to minimise ventricular pacing is preferred. In very old patients presenting with intermittent or suspected AV block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is comparable in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantage of the device on arrhythmic death may be attenuated by a higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live >5-7 years after implantation. The elderly patients usually experience a significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non responders remains globally the same, while considering a less aggressive approach in terms of re interventions (revision of LV lead placement, addition of a RV or LV lead, LV endocardial pacing configuration). Overall, age, comorbidities and comprehensive geriatric assessment should be the decisive factor in making a decision on device implantation selection for survival and well-being benefit in elderly patients.

Inadvertent transarterial insertion of atrial and ventricular defibrillator leads.

PubMed

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

2009-01-01

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

Potential biomedical applications of ion beam technology

NASA Technical Reports Server (NTRS)

Banks, B. A.; Weigand, A. J.; Babbush, C. A.; Vankampen, C. L.

1976-01-01

Electron bombardment ion thrusters used as ion sources have demonstrated a unique capability to vary the surface morphology of surgical implant materials. The microscopically rough surface texture produced by ion beam sputtering of these materials may result in improvements in the biological response and/or performance of implanted devices. Control of surface roughness may result in improved attachment of the implant to soft tissue, hard tissue, bone cement, or components deposited from blood. Potential biomedical applications of ion beam texturing discussed include: vascular prostheses, artificial heart pump diaphragms, pacemaker fixation, percutaneous connectors, orthopedic pros-thesis fixtion, and dental implants.

Potential biomedical applications of ion beam technology

NASA Technical Reports Server (NTRS)

Banks, B. A.; Weigand, A. J.; Van Kampen, C. L.; Babbush, C. A.

1976-01-01

Electron bombardment ion thrusters used as ion sources have demonstrated a unique capability to vary the surface morphology of surgical implant materials. The microscopically rough surface texture produced by ion beam sputtering of these materials may result in improvements in the biological response and/or performance of implanted devices. Control of surface roughness may result in improved attachment of the implant to soft tissue, hard tissue, bone cement, or components deposited from blood. Potential biomedical applications of ion beam texturing discussed include: vascular prostheses, artificial heart pump diaphragms, pacemaker fixation, percutaneous connectors, orthopedic prosthesis fixation, and dental implants.

Case studies on the effect of exercise and hot water submersion on intracardiac temperature and the performance of a pacemaker which varies pacing rate based on temperature.

PubMed

Fearnot, N E; Kitoh, O; Fujita, T; Okamura, H; Smith, H J; Calderini, M

1989-05-01

The effectiveness of using blood temperature change as an indicator to automatically vary heart rate physiologically was evaluated in 3 patients implanted with Model Sensor Kelvin 500 (Cook Pacemaker Corporation, Leechburg, PA, USA) pacemakers. Each patient performed two block-randomized treadmill exercise tests: one while programmed for temperature-based, rate-modulated pacing and the other while programmed without rate modulation. In 1 pacemaker patient and 4 volunteers, heart rates were recorded during exposure to a hot water bath. Blood temperature measured at 10 sec intervals and pacing rate measured at 1 min intervals were telemetered to a diagnostic programmer and data collector for storage and transfer to a computer. Observation comments and ECG-derived heart rates were manually recorded. The temperature-based pacemaker was shown to respond promptly not only to physical exertion but also to emotionally caused stress and submersion in a hot bath. These events cause increased heart rate in the normal heart. Using a suitable algorithm to process the measurement of blood temperature, it was possible to produce appropriate pacing rates in paced patients.

Urinary Incontinence Surgery: When Other Treatments Aren't Enough

MedlinePlus

... surgery. Certain procedures to treat overactive bladder involve stimulation — using small, electrical impulses — of the nerves that signal the need to urinate. Sacral nerve stimulation. Your surgeon implants a small, pacemaker-like device ...

78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-13

... committee regarding classification of triple chamber pacing system analyzers (PSAs) with external pacing... chamber PSA is intended to be used during the implant procedure of pacemakers and defibrillators...

Cervical MRI scan

MedlinePlus

... you have: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not be able to receive contrast) Recently placed artificial joints Certain types of vascular stents Worked with ...

Lumbar MRI scan

MedlinePlus

... you have: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not be able to receive contrast) Recently placed artificial joints Certain types of vascular stents Worked with ...

Shoulder MRI scan

MedlinePlus

... you have: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not be able to receive contrast) Recently placed artificial joints Certain types of vascular stents Worked with ...

Recommendations for pacemaker implantation for the treatment of atrial tachyarrhythmias and resynchronisation therapy for heart failure: A report from the task force on pacemaker indications of the Dutch Working Group on Cardiac Pacing.

PubMed

van Hemel, N M; Dijkman, B; de Voogt, W G; Beukema, W P; Bosker, H A; de Cock, C C; Jordaens, L J L M; van Gelder, I C; van Gelder, L M; van Mechelen, R; Ruiter, J H; Sedney, M I; Slegers, L C

2004-01-01

Today, new pacing algorithms and stimulation methods for the prevention and interruption of atrial tachyarrhythmias can be applied on patients who need bradycardia pacing for conventional reasons. In addition, biventricular pacing as additive treatment for patients with severe congestive heart failure due to ventricular systolic dysfunction and prolonged intraventricular conduction has shown to improve symptoms and reduce hospital admissions. These new pacing technologies and the optimising of the pacing programmes are complex, expensive and time-consuming. Based on many clinical studies the indications for these devices are beginning to emerge. To support the cardiologist's decision-making and to prevent waste of effort and resources, the 'ad hoc committee' has provided preliminary recommendations for implantable devices to treat atrial tachyarrhythmias and to extend the treatment of congestive heart failure respectively.

Y2K: effects on pacemaker and implantable defibrillator programmers.

PubMed

Flynn, D P; Daubert, J P; Huang, D T; Ocampo, C M; O'Gorman, E

1999-01-01

All permanent pacemakers and implantable defibrillators (PPM/ICDs) will continue to function as programmed without regard to the date in the year 2000 (Y2K). All manufacturers contacted reassured us that some of these devices incorporate a day/year clock in the circuitry; however, these are not involved in sensing or delivering programmed therapy. Some manufacturers' device programmers will roll over to the year 2000 without any problems at all, whereas others may have difficulty with date and time stamping on printed reports. We tested 14 different types of PPM/ICD programmers for Y2K compliance using 8 tests. Five of the 14 models passed each test and were labeled at our institution with a green "Y2K" sticker to identify them as Y2K compatible and needing no special attention after December 31, 1999. The most common test failed was the ability to roll the date forward from December 31, 1999, with the programmer power off. Organizations should consider testing and replacing noncompliant device programmers or placing a red sticker with "Y2K" crossed out on noncompliant pieces. The red sticker alerts the advanced practice nurse or physician to the need to confirm the appropriate date and time in the programmer after startup in the year 2000 and before interrogating or programming any PPM/ICD, to avoid inappropriate date and time stamping on printed reports from that programmer.

Modern Perspectives on Numerical Modeling of Cardiac Pacemaker Cell

PubMed Central

Maltsev, Victor A.; Yaniv, Yael; Maltsev, Anna V.; Stern, Michael D.; Lakatta, Edward G.

2015-01-01

Cardiac pacemaking is a complex phenomenon that is still not completely understood. Together with experimental studies, numerical modeling has been traditionally used to acquire mechanistic insights in this research area. This review summarizes the present state of numerical modeling of the cardiac pacemaker, including approaches to resolve present paradoxes and controversies. Specifically we discuss the requirement for realistic modeling to consider symmetrical importance of both intracellular and cell membrane processes (within a recent “coupled-clock” theory). Promising future developments of the complex pacemaker system models include the introduction of local calcium control, mitochondria function, and biochemical regulation of protein phosphorylation and cAMP production. Modern numerical and theoretical methods such as multi-parameter sensitivity analyses within extended populations of models and bifurcation analyses are also important for the definition of the most realistic parameters that describe a robust, yet simultaneously flexible operation of the coupled-clock pacemaker cell system. The systems approach to exploring cardiac pacemaker function will guide development of new therapies, such as biological pacemakers for treating insufficient cardiac pacemaker function that becomes especially prevalent with advancing age. PMID:24748434

The Prognostic Impact of New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Implantation: A Meta-analysis.

PubMed

Ando, Tomo; Takagi, Hisato

2016-09-01

New-onset persistent left bundle branch block (NOP-LBBB) is one of the most common conduction disturbances after transcatheter aortic valve implantation (TAVI). We hypothesized that NOP-LBBB may have a clinically negative impact after TAVI. To find out, we conducted a systematic literature search of the MEDLINE/PubMed and Embase databases. Observational studies that reported clinical outcomes of NOP-LBBB patients after TAVI were included. The random-effects model was used to combine odds ratios, risk ratios, or hazard ratios (HRs) with 95% confidence intervals. Adjusted HRs were utilized over unadjusted HRs or risk ratios when available. A total of 4049 patients (807 and 3242 patients with and without NOP-LBBB, respectively) were included. Perioperative (in-hospital or 30-day) and midterm all-cause mortality and midterm cardiovascular mortality were comparable between the groups. The NOP-LBBB patients experienced a higher rate of permanent pacemaker implantation (HR: 2.09, 95% confidence interval: 1.12-3.90, P = 0.021, I(2) = 83%) during midterm follow-up. We found that NOP-LBBB after TAVI resulted in higher permanent pacemaker implantation but did not negatively affect the midterm prognosis. Therefore, careful observation during the follow-up is required. © 2016 Wiley Periodicals, Inc.

Diagnostic yield of device interrogation in the evaluation of syncope in an elderly population.

PubMed

D'Angelo, Robert N; Pickett, Christopher C

2017-06-01

Device interrogation has become a standard part of the syncope evaluation for patients admitted with permanent pacemakers (PPM) or implantable cardiac defibrillators (ICD), although few studies have shown interrogation yields clinically useful data. The purpose of this study is to determine the diagnostic yield of device interrogation as well as other commonly performed tests in the workup of unexplained syncope in patients with previously implanted PPMs or ICDs. We retrospectively reviewed records of 88 patients admitted to our medical center for syncope with previously implanted pacemakers between January 1, 2005 and January 1, 2015 using ICD-9 billing data. Pacemaker interrogation demonstrated an arrhythmia as the cause for syncope in 4 patients (4%) and evidence of device failure secondary to perforation in 1 patient (1%). The cause of syncope was unknown in 34 patients (39%). Orthostatic hypotension was the most commonly identified cause of syncope (26%), followed by vasovagal syncope (13%), autonomic dysfunction (5%), ventricular arrhythmia (3%), atrial arrhythmia (2%), congestive heart failure (2%), stroke (2%), and other less common causes (8%). History was the most important determinant of syncope (36%), followed by orthostatic vital signs (14%), device interrogations (4%), head CT (2%), and transthoracic echocardiogram (1%). Device interrogation is rarely useful for elucidating a cause of syncope without concerning physical exam, telemetry, or EKG findings. Interrogation may occasionally yield paroxysmal arrhythmias responsible for syncopal episode, but these rarely alter clinical outcomes. Interrogation appears to be more useful in patients with syncope after recent device placement. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The effect of hyperkalaemia on cardiac rhythm devices.

PubMed

Barold, S Serge; Herweg, Bengt

2014-04-01

In patients with pacemakers, hyperkalaemia causes three important abnormalities that usually become manifest when the K level exceeds 7 mEq/L: (i) widening of the paced QRS complex from delayed intraventricular conduction velocity, (ii) Increased atrial and ventricular pacing thresholds that may cause failure to capture. In this respect, the atria are more susceptible to loss of capture than the ventricles, and (iii) Increased latency (usually with ventricular pacing) manifested by a greater delay of the interval from the pacemaker stimulus to the onset of depolarization. First-degree ventricular pacemaker exit block may progress to second-degree Wenckebach (type I) exit block characterized by gradual prolongation of the interval from the pacemaker stimulus to the onset of the paced QRS complex ultimately resulting in an ineffectual stimulus. The disturbance may then progress to 2 : 1, 3 : 1 pacemaker exit block, etc., and eventually to complete exit block with total lack of capture. Ventricular undersensing is uncommonly observed because of frequent antibradycardia pacing. During managed ventricular pacing, hyperkalaemia-induced marked first-degree atrioventricular block may induce a pacemaker syndrome. With implantable cardioverter-defibrillators (ICDs) oversensing of the paced or spontaneous T-wave may occur. The latter may cause inappropriate shocks. A raised impedance from the right ventricular coil to the superior vena cava coil may become an important sign of hyperkalaemia in the asymptomatic or the minimally symptomatic ICD patient.

Modeling and experimental verification of a fan-folded vibration energy harvester for leadless pacemakers

NASA Astrophysics Data System (ADS)

Ansari, M. H.; Karami, M. Amin

2016-03-01

This paper studies energy harvesting from heartbeat vibrations for powering leadless pacemakers. Unlike traditional pacemakers, leadless pacemakers are implanted inside the heart and the pacemaker is in direct contact with the myocardium. A leadless pacemaker is in the shape of a cylinder. Thus, in order to utilize the available 3-dimensional space for the energy harvester, we choose a fan-folded 3D energy harvester. The proposed device consists of several piezoelectric beams stacked on top of each other. The volume of the energy harvester is 1 cm3 and its dimensions are 2 cm × 0.5 cm × 1 cm. Although high natural frequency is generally a major concern with micro-scale energy harvesters, by utilizing the fan-folded geometry and adding tip mass and link mass to the configuration, we reduced the natural frequency to the desired range. This fan-folded design makes it possible to generate more than 10 μ W of power per cubic centimeter. The proposed device is compatible with Magnetic Resonance Imaging. Although the proposed device is a linear energy harvester, it is relatively insensitive to the heart rate. The natural frequencies and the mode shapes of the device are calculated analytically. The accuracy of the analytical model is verified by experimental investigations. We use a closed loop shaker system to precisely replicate heartbeat vibrations in vitro.

Splinter haemorrhages, Osler's nodes, Janeway lesions and Roth spots: the peripheral stigmata of endocarditis.

PubMed

Sethi, Karishma; Buckley, Jim; de Wolff, Jacob

2013-09-01

Infective endocarditis is a serious endo-vascular infection, potentially affecting not only native heart valves, but also intra-vascularly implanted foreign materials such as valvular prostheses and pacemaker electrodes (Westphal et al, 2009).

Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions.

PubMed

Bailey, William M; Mazur, Alexander; McCotter, Craig; Woodard, Pamela K; Rosenthal, Lawrence; Johnson, Whitney; Mela, Theofanie

2016-02-01

Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). The purpose of the ProMRI Phase B Study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI pacemaker system in patients undergoing thoracic spine and cardiac MRI. The ProMRI Phase B study enrolled 245 patients with stable baseline pacing indices implanted with an Entovis pacemaker (DR-T or SR-T) and Setrox 53-cm and/or 60-cm lead(s). Device interrogation was performed at enrollment, pre- and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects through 1 month post-MRI; (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V); and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. In total, 216 patients completed the MRI and 1-month post-MRI follow-up. One adverse event possibly related to the implanted system and the MRI procedure occurred, resulting in a serious adverse device effect-free rate of 99.6% (220/221; P < .0001. Freedom from atrial and ventricular pacing threshold increase was 100% (194/194, P < .001) and 100% (206/206, P < .001) respectively. Freedom from P- and R-wave amplitude attenuation was 98.2% (167/170, P < .001) and 100% (188/188, P < .001) respectively. The results of the ProMRI Phase B study demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac MRI conditions. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions.

PubMed

Bailey, William M; Rosenthal, Lawrence; Fananapazir, Lameh; Gleva, Marye; Mazur, Alexander; Rinaldi, C A; Kypta, Alexander; Merkely, Béla; Woodard, Pamela K

2015-06-01

Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions. The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI, (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V), and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. Two hundred twenty-six patients completed the MRI and 1-month post-MRI follow-up. No adverse events related to the implanted system and the MRI procedure occurred, resulting in an SADE-free rate of 100.0% (229/229, P <.001). Freedom from atrial and ventricular pacing threshold increase was 99.0% (189/191, P = .003) and 100% (217/217, P <.001), respectively. Freedom from P- and R- wave amplitude attenuation was 99.4% (167/168, P <.001) and 99.5% (193/194, P <.001), respectively. The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Circadian Activators Are Expressed Days before They Initiate Clock Function in Late Pacemaker Neurons from Drosophila.

PubMed

Liu, Tianxin; Mahesh, Guruswamy; Houl, Jerry H; Hardin, Paul E

2015-06-03

Circadian pacemaker neurons in the Drosophila brain control daily rhythms in locomotor activity. These pacemaker neurons can be subdivided into early or late groups depending on whether rhythms in period (per) and timeless (tim) expression are initiated at the first instar (L1) larval stage or during metamorphosis, respectively. Because CLOCK-CYCLE (CLK-CYC) heterodimers initiate circadian oscillator function by activating per and tim transcription, a Clk-GFP transgene was used to mark when late pacemaker neurons begin to develop. We were surprised to see that CLK-GFP was already expressed in four of five clusters of late pacemaker neurons during the third instar (L3) larval stage. CLK-GFP is only detected in postmitotic neurons from L3 larvae, suggesting that these four late pacemaker neuron clusters are formed before the L3 larval stage. A GFP-cyc transgene was used to show that CYC, like CLK, is also expressed exclusively in pacemaker neurons from L3 larval brains, demonstrating that CLK-CYC is not sufficient to activate per and tim in late pacemaker neurons at the L3 larval stage. These results suggest that most late pacemaker neurons develop days before novel factors activate circadian oscillator function during metamorphosis. Copyright © 2015 the authors 0270-6474/15/358662-10$15.00/0.

Position paper for management of elderly patients with pacemakers and implantable cardiac defibrillators: Groupe de Rythmologie et Stimulation Cardiaque de la Société Française de Cardiologie and Société Française de Gériatrie et Gérontologie.

PubMed

Fauchier, Laurent; Alonso, Christine; Anselme, Frederic; Blangy, Hugues; Bordachar, Pierre; Boveda, Serge; Clementy, Nicolas; Defaye, Pascal; Deharo, Jean-Claude; Friocourt, Patrick; Gras, Daniel; Halimi, Franck; Klug, Didier; Mansourati, Jacques; Obadia, Benjamin; Pasquié, Jean-Luc; Pavin, Dominique; Sadoul, Nicolas; Taieb, Jerome; Piot, Olivier; Hanon, Olivier

2016-10-01

Despite the increasingly high rate of implantation of pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety and effectiveness of conventional pacing, ICDs and cardiac resynchronization therapy (CRT) in elderly patients. Although periprocedural risk may be slightly higher in the elderly, the implantation procedure for PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, the general consensus is that DDD pacing with the programming of an algorithm to minimize ventricular pacing is preferred. In very old patients presenting with intermittent or suspected atrioventricular block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is similar in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantageous effect of the device on arrhythmic death may be attenuated by higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live more than 5-7years after implantation. Elderly patients usually experience significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non-responders remains globally the same, while considering a less aggressive approach in terms of reinterventions (revision of left ventricular [LV] lead placement, addition of a right ventricular or LV lead, LV endocardial pacing configuration). Overall, physiological age, general status and comorbidities rather than chronological age per se should be the decisive factors in making a decision about device implantation selection for survival and well-being benefit in elderly patients. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Direct His bundle pacing post AVN ablation.

PubMed

Lakshmanadoss, Umashankar; Aggarwal, Ashim; Huang, David T; Daubert, James P; Shah, Abrar

2009-08-01

Atrioventricular nodal (AVN) ablation with concomitant pacemaker implantation is one of the strategies that reduce symptoms in patients with atrial fibrillation (AF). However, the long-term adverse effects of right ventricular (RV) apical pacing have led to the search for alternating sites of pacing. Biventricular pacing produces a significant improvement in functional capacity over RV pacing in patients undergoing AVN ablation. Another alternative site for pacing is direct His bundle to reduce the adverse outcome of RV pacing. Here, we present a case of direct His bundle pacing using steerable lead delivery system in a patient with symptomatic paroxysmal AF with concurrent AVN ablation.

Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

PubMed

Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

2015-05-01

Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

Clear cell hidradenocarcinoma developing in pacemaker pocket.

PubMed

Reyes, Cesar V

2008-11-01

An octagenerian woman developed clear cell hidradenocarcinoma, a rare neoplasm of eccrine sweat gland origin, 4 years following pacemaker implantation in her right lateral chest. The tumor immunohistochemically mimicked a metastatic lobular breast carcinoma, for example, strongly positive estrogen, weakly positive progesterone, and weakly reactive mammoglobin. A complete surgical excision of the tumor was complemented with ipsilateral dissection of involved adjacent axillary lymph nodes. Recommended irradiation was refused by the patient. Retrospective 3-year mammogram review, 2-year postsurgery follow-up, and complete postmortem evaluation failed to prove a primary breast malignancy or other metastatic lesion elsewhere.

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

Entrainment and phase-shifting by centrifugation abolished in mice lacking functional vestibular input

NASA Astrophysics Data System (ADS)

Fuller, Charles; Ringgold, Kristyn

The circadian pacemaker can be phase shifted and entrained by appropriately timed locomotor activity, however the mechanism(s) involved remain poorly understood. Recent work in our lab has suggested the involvement of the vestibular otolith organs in activity-induced changes within the circadian timing system (CTS). For example, we have shown that changes in circa-dian period and phase in response to locomotion (wheel running) require functional macular gravity receptors. We believe the neurovestibular system is responsible for the transduction of gravitoinertial input associated with the types of locomotor activity that are known to af-fect the pacemaker. This study investigated the hypothesis that daily, timed gravitoinertial stimuli, as applied by centrifugation. would induce entrainment of circadian rhythms in only those animals with functional afferent vestibular input. To test this hypothesis, , chemically labyrinthectomized (Labx) mice, mice lacking macular vestibular input (head tilt or hets) and wildtype (WT) littermates were implanted i.p. with biotelemetry and individually housed in a 4-meter diameter centrifuge in constant darkness (DD). After 2 weeks in DD, the mice were exposed daily to 2G via centrifugation from 1000-1200 for 9 weeks. Only WT mice showed entrainment to the daily 2G pulse. The 2G pulse was then re-set to occur at 1200-1400 for 4 weeks. Only WT mice demonstrated a phase shift in response to the re-setting of the 2G pulse and subsequent re-entrainment to the new centrifugation schedule. These results provide further evidence that gravitoinertial stimuli require a functional vestibular system to both en-train and phase shift the CTS. Entrainment among only WT mice supports the role of macular gravity receptive cells in modulation of the CTS while also providing a functional mechanism by which gravitoinertial stimuli, including locomotor activity, may affect the pacemaker.

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker generator function analyzer. 870.3630 Section 870.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker...

Living with a pacemaker: patient-reported outcome of a pacemaker system.

PubMed

Magnusson, Peter; Liv, Per

2018-06-04

The aim of this study was to assess among pacemaker patients their overall satisfaction with the pacemaker system, pain, soreness/discomfort, cosmetic results, restrictions due to impaired movement of the shoulder/arm/chest, related sleep disturbances, and concern about possible device malfunction. The seven-item questionnaire was mailed to patients from a single center who had a pacemaker implant or replacement between 2006 and 2016. A higher score indicated worse outcome on a visual analog scale (VAS) of 0-100 mm. The response rate was 75.5% and 342 questionniares were analyzed. Median age of respondents was 77.6 years and 57.0% were males. In total, 65 complications requiring surgery (10 pocket corrections (2.9%), 5 in females) occurred during a median follow-up of 5.6 years.The distribution of the primary outcome had a median score of 5 while the 75th percentile was 13. Cosmetic appearance was significantly associated with reoperation (but not other variables). Overall scores for men and women were 5 vs. 6, respectively, which achieved significance (p = 0.042). Median ratings of pain, soreness/discomfort, cosmetic appearance, range of motion, sleep, and concern about device malfunction were all ≤5. Females reported worse outcomes for all questions, except for cosmetic results and concern about malfunction. The vast majority of patients report excellent overall satisfaction with the pacemaker system, and are not affected by pain, soreness/discomfort, or concern about device malfunction. They also reported favourable outcomes with respect to cosmetic results, shoulder movement, and sleep. However, some patients underwent a surgical correction of the pacemaker pocket.

Inductively powered wireless pacing via a miniature pacemaker and remote stimulation control system.

PubMed

Abiri, Parinaz; Abiri, Ahmad; Packard, René R Sevag; Ding, Yichen; Yousefi, Alireza; Ma, Jianguo; Bersohn, Malcolm; Nguyen, Kim-Lien; Markovic, Dejan; Moloudi, Shervin; Hsiai, Tzung K

2017-07-21

Pacemakers have existed for decades as a means to restore cardiac electrical rhythms. However, lead-related complications have remained a clinical challenge. While market-released leadless devices have addressed some of the issues, their pacer-integrated batteries cause new health risks and functional limitations. Inductive power transfer enables wireless powering of bioelectronic devices; however, Specific Absorption Rate and size limitations reduce power efficiency for biomedical applications. We designed a remote-controlled system in which power requirements were significantly reduced via intermittent power transfer to control stimulation intervals. In parallel, the cardiac component was miniaturized to facilitate intravascular deployment into the anterior cardiac vein. Given size constraints, efficiency was optimal via a circular receiver coil wrapped into a half-cylinder with a meandering tail. The pacemaker was epicardially tested in a euthanized pig at 60 beats per minute, 2 V amplitude, and 1 ms pulse width, restoring mean arterial pressure from 0 to 37 mmHg. Power consumption was 1 mW at a range of > 3 cm with no misalignment and at 2 cm with 45° displacement misalignment, 45° x-axis angular misalignment, or 45° y-axis angular misalignment. Thus, we demonstrated a remote-controlled miniaturized pacing system with low power consumption, thereby providing a basis for the next generation of wireless implantable devices.

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

PubMed

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

2004-11-01

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

Rupture of a pacemaker lead during the course of infective endocarditis.

PubMed

Akgüllü, Çağdaş; Eryılmaz, Ufuk; Kurtoğlu, Tünay; Özpelit, Ebru

2013-01-01

A 23-year-old male who had a VDDR pacemaker implanted seven years ago due to sick sinus syndrome and recurrent syncope episodes was admitted with symptoms of dyspnea, fever, and tachycardia, which were present for a few days. He was suspected to be suffering from pneumonia and underwent computed tomography scanning of the thorax, which revealed widespread infiltration in the lung parenchyma and pulmonary emboli. Transthoracic echocardiography revealed an extremely mobile echogenic structure in the right atrium, which was determined to be the free portion of a ruptured pacemaker lead. There was an overlying thrombus and/or vegetation-like organized soft tissue within the right ventricle around the lead component. In this article, the rupture of a permanent pacemaker lead, which complicated the course of infective endocarditis associated with pulmonary embolism and pneumonia is reported. We hypothesize that the underlying mechanism for the rupture is soft tissue entrapment within the right ventricle. Unfortunately, this rare and life-threatening situation led to the death of our patient after the surgical removal of the device and its components.

Clinical characteristics associated with pacing-induced cardiac dysfunction: a high incidence of undiagnosed cardiac sarcoidosis before permanent pacemaker implantation.

PubMed

Wakabayashi, Yasushi; Mitsuhashi, Takeshi; Akashi, Naoyuki; Hayashi, Takekuni; Umemoto, Tomio; Sugawara, Yoshitaka; Fujita, Hideo; Momomura, Shin-Ichi

2018-06-21

Previous studies suggested that right ventricular pacing was associated with pacing-induced cardiac dysfunction (PICD). The purpose of this study was to investigate the clinical characteristics including the incidence of undiagnosed cardiac sarcoidosis (CS) in patients with atrioventricular block (AVB) who manifest PICD. We retrospectively investigated consecutive patients with permanent pacemaker (PPM) undergoing a first-generator replacement surgery with a new PPM or an upgrade procedure to a cardiac resynchronization therapy (CRT) device between December 1, 2011 and June 30, 2017. Patients with AVB showing normal echocardiographic findings before PPM implantation were included and divided into 2 groups: patients with post-PPM left ventricular ejection fraction (LVEF) < 40% and/or undergoing an upgrade procedure to CRT (PICD group) and patients with post-PPM LVEF ≥ 40% who underwent replacement surgery with a new PPM (no-PICD group). There were 15 and 41 patients in the PICD and no-PICD groups, respectively. A wider-paced QRS duration just after the PPM implantation and/or lower pre-PPM LVEF was observed in the PICD group. Furthermore, 46.7% of the PICD patients (7/15) satisfied the diagnostic criteria for CS according to the guideline of the Japanese Circulation Society, although no patients fulfilled these criteria before PPM implantation. In conclusion, a high incidence of CS was observed in patients with AVB who had PICD. However, none of these patients was diagnosed with CS before PPM implantation.

A Meta-Analysis Examining Differences in Short-Term Outcomes Between Sutureless and Conventional Aortic Valve Prostheses.

PubMed

Hurley, Eoghan T; O'Sullivan, Katie E; Segurado, Ricardo; Hurley, John P

2015-01-01

Sutureless aortic valve prostheses are anchored by radial force in a mechanism similar to that of transcatheter aortic valve implantation. Transcatheter aortic valve implantation is associated with an increased permanent pacemaker (PPM) requirement in a significant proportion of patients. We undertook a meta-analysis to examine the incidence of PPM insertion associated with sutureless compared with conventional surgical aortic valve replacement. A systematic review was conducted in accordance with the Prisma guidelines. All searches were performed on August 10, 2014. Studies between 2007 and 2014 were included in the search. A total of 832 patients were included in the sutureless group and 3,740 in the conventional group. Aortic cross-clamp (39.8 vs 62.4 minutes; P < 0.001) and cardiopulmonary bypass (64.9 vs 86.7 minutes; P = 0.002) times were shorter in the sutureless group. Permanent pacemaker implantation rate was higher in the sutureless cohort (9.1% vs 2.4%; P = 0.025). Sutureless aortic valve prostheses are associated with significantly shorter cardiopulmonary bypass and aortic cross-clamp times and a higher incidence of PPM insertion than conventional. Further investigation of the prognostic significance is required.

Energy harvesting from the cardiovascular system, or how to get a little help from yourself.

PubMed

Pfenniger, Alois; Jonsson, Magnus; Zurbuchen, Adrian; Koch, Volker M; Vogel, Rolf

2013-11-01

Human energy harvesting is envisioned as a remedy to the weight, the size, and the poor energy density of primary batteries in medical implants. The first implant to have necessarily raised the idea of a biological power supply was the pacemaker in the early 1960s. So far, review articles on human energy harvesting have been rather unspecific and no tribute has been given to the early role of the pacemaker and the cardiovascular system in triggering research in the field. The purpose of the present article is to provide an up-to-date review of research efforts targeting the cardiovascular system as an alternative energy source for active medical implants. To this end, a chronological survey of the last 14 most influential publications is proposed. They include experimental and/or theoretical studies based on electromagnetic, piezoelectric, or electrostatic transducers harnessing various forms of energy, such as heart motion, pressure gradients, and blood flow. Technical feasibility does not imply clinical applicability: although most of the reported devices were shown to harvest an interesting amount of energy from a physiological environment, none of them were tested in vivo for a longer period of time.

Rescuing cardiac automaticity in L-type Cav1.3 channelopathies and beyond.

PubMed

Mesirca, Pietro; Bidaud, Isabelle; Mangoni, Matteo E

2016-10-15

Pacemaker activity of the sino-atrial node generates the heart rate. Disease of the sinus node and impairment of atrioventricular conduction induce an excessively low ventricular rate (bradycardia), which cannot meet the needs of the organism. Bradycardia accounts for about half of the total workload of clinical cardiologists. The 'sick sinus' syndrome (SSS) is characterized by sinus bradycardia and periods of intermittent atrial fibrillation. Several genetic or acquired risk factors or pathologies can lead to SSS. Implantation of an electronic pacemaker constitutes the only available therapy for SSS. The incidence of SSS is forecast to double over the next 50 years, with ageing of the general population thus urging the development of complementary or alternative therapeutic strategies. In recent years an increasing number of mutations affecting ion channels involved in sino-atrial automaticity have been reported to underlie inheritable SSS. L-type Ca v 1.3 channels play a major role in the generation and regulation of sino-atrial pacemaker activity and atrioventricular conduction. Mutation in the CACNA1D gene encoding Ca v 1.3 channels induces loss-of-function in channel activity and underlies the sino-atrial node dysfunction and deafness syndrome (SANDD). Mice lacking Ca v 1.3 channels (Ca v 1.3 -/- ) fairly recapitulate SSS and constitute a precious model to test new therapeutic approaches to handle this disease. Work in our laboratory shows that targeting G protein-gated K + (I KACh ) channels effectively rescues SSS of Ca v 1.3 -/- mice. This new concept of 'compensatory' ion channel targeting shines new light on the principles underlying the pacemaker mechanism and may open the way to new therapies for SSS. © 2016 The Authors. The Journal of Physiology © 2016 The Physiological Society.

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery.

PubMed

Shepard, Suzanne M; Tejman-Yarden, Shai; Khanna, Sandeep; Davis, Christopher K; Batra, Anjan S

2011-01-01

Dexmedetomidine (DEX; Precedex) is an alpha-2 adrenergic receptor agonist that produces anxiolysis and sleep-like sedation without narcosis or respiratory depression and has relatively few cardiovascular side effects. Given its favorable sedative properties combined with its limited effects on hemodynamic and respiratory function, it is widely used in pediatric intensive care and anesthesia settings. Case report. Pediatric intensive care unit. A three-yr-old girl was admitted after mitral valve replacement for persistent severe mitral insufficiency. Her prior history was significant for tetralogy of Fallot which was repaired at nine months of age. A year later the patient developed mitral and tricuspid valve insufficiency and subsequently underwent mitral and tricuspid valve repair, pulmonary valve replacement, and a maze procedure (the latter was performed for persistent atrial flutter). Following that operation she developed sinus node dysfunction and had a permanent epicardial dual-chamber pacemaker implanted. Due to remaining severe mitral insufficiency the patient had increasing pulmonary symptoms, necessitating the most recent surgery to replace her mitral valve. On postoperative day two the patient was hemodynamically stable and weaning off mechanical ventilation. Tracheal extubation was anticipated to occur within the next 24 hrs. A DEX infusion of 0.6 mcg/kg/hr was initiated. A pacemaker interrogation performed on postoperative day three, 21 hrs after the initiation of DEX, revealed unsuccessful atrial capture. Dexmedetomidine was subsequently discontinued and the patient's pacemaker was reinterrogated. The interrogation findings were similar to those seen prior to the initiation of DEX. As a result of these findings, caution is warranted in the administration of DEX to patients with predisposing conduction abnormalities and patients who are pacemaker-dependent.

Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.

PubMed

Ritter, Philippe; Duray, Gabor Z; Steinwender, Clemens; Soejima, Kyoko; Omar, Razali; Mont, Lluís; Boersma, Lucas V A; Knops, Reinoud E; Chinitz, Larry; Zhang, Shu; Narasimhan, Calambur; Hummel, John; Lloyd, Michael; Simmers, Timothy Alexander; Voigt, Andrew; Laager, Verla; Stromberg, Kurt; Bonner, Matthew D; Sheldon, Todd J; Reynolds, Dwight

2015-10-01

Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms. Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial. ClinicalTrials.gov ID NCT02004873. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Subclinical atrial fibrillation and the risk of stroke.

PubMed

Healey, Jeff S; Connolly, Stuart J; Gold, Michael R; Israel, Carsten W; Van Gelder, Isabelle C; Capucci, Alessandro; Lau, C P; Fain, Eric; Yang, Sean; Bailleul, Christophe; Morillo, Carlos A; Carlson, Mark; Themeles, Ellison; Kaufman, Elizabeth S; Hohnloser, Stefan H

2012-01-12

One quarter of strokes are of unknown cause, and subclinical atrial fibrillation may be a common etiologic factor. Pacemakers can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented atrial fibrillation. We evaluated whether subclinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation. We enrolled 2580 patients, 65 years of age or older, with hypertension and no history of atrial fibrillation, in whom a pacemaker or defibrillator had recently been implanted. We monitored the patients for 3 months to detect subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) and followed them for a mean of 2.5 years for the primary outcome of ischemic stroke or systemic embolism. Patients with pacemakers were randomly assigned to receive or not to receive continuous atrial overdrive pacing. By 3 months, subclinical atrial tachyarrhythmias detected by implanted devices had occurred in 261 patients (10.1%). Subclinical atrial tachyarrhythmias were associated with an increased risk of clinical atrial fibrillation (hazard ratio, 5.56; 95% confidence interval [CI], 3.78 to 8.17; P<0.001) and of ischemic stroke or systemic embolism (hazard ratio, 2.49; 95% CI, 1.28 to 4.85; P=0.007). Of 51 patients who had a primary outcome event, 11 had had subclinical atrial tachyarrhythmias detected by 3 months, and none had had clinical atrial fibrillation by 3 months. The population attributable risk of stroke or systemic embolism associated with subclinical atrial tachyarrhythmias was 13%. Subclinical atrial tachyarrhythmias remained predictive of the primary outcome after adjustment for predictors of stroke (hazard ratio, 2.50; 95% CI, 1.28 to 4.89; P=0.008). Continuous atrial overdrive pacing did not prevent atrial fibrillation. Subclinical atrial tachyarrhythmias, without clinical atrial fibrillation, occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism. (Funded by St. Jude Medical; ASSERT ClinicalTrials.gov number, NCT00256152.).

Diaphragmatic reinnervation in ventilator-dependent patients with cervical spinal cord injury and concomitant phrenic nerve lesions using simultaneous nerve transfers and implantable neurostimulators.

PubMed

Kaufman, Matthew R; Elkwood, Andrew I; Aboharb, Farid; Cece, John; Brown, David; Rezzadeh, Kameron; Jarrahy, Reza

2015-06-01

Patients who are ventilator dependent as a result of combined cervical spinal cord injury and phrenic nerve lesions are generally considered to be unsuitable candidates for diaphragmatic pacing due to loss of phrenic nerve integrity and denervation of the diaphragm. There is limited data regarding efficacy of simultaneous nerve transfers and diaphragmatic pacemakers in the treatment of this patient population. A retrospective review was conducted of 14 consecutive patients with combined lesions of the cervical spinal cord and phrenic nerves, and with complete ventilator dependence, who were treated with simultaneous microsurgical nerve transfer and implantation of diaphragmatic pacemakers. Parameters of interest included time to recovery of diaphragm electromyographic activity, average time pacing without the ventilator, and percent reduction in ventilator dependence. Recovery of diaphragm electromyographic activity was demonstrated in 13 of 14 (93%) patients. Eight of these 13 (62%) patients achieved sustainable periods (> 1 h/d) of ventilator weaning (mean = 10 h/d [n = 8]). Two patients recovered voluntary control of diaphragmatic activity and regained the capacity for spontaneous respiration. The one patient who did not exhibit diaphragmatic reinnervation remains within 12 months of initial treatment. Surgical intervention resulted in a 25% reduction (p < 0.05) in ventilator dependency. We have demonstrated that simultaneous nerve transfers and pacemaker implantation can result in reinnervation of the diaphragm and lead to successful ventilator weaning. Our favorable outcomes support consideration of this surgical method for appropriate patients who would otherwise have no alternative therapy to achieve sustained periods of ventilator independence. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Cardiac Sarcoidosis: The Impact of Age and Implanted Devices on Survival.

PubMed

Zhou, Ying; Lower, Elyse E; Li, Hui-Ping; Costea, Alexandru; Attari, Mehran; Baughman, Robert P

2017-01-01

To assess the clinical characteristics, diagnosis, and outcome of cardiac sarcoidosis in a single institution sarcoidosis clinic. Patients with cardiac sarcoidosis were identified using refined World Association of Sarcoidosis and Other Granulomatous Diseases (WASOG) criteria of highly probable and probable. Patient demographics, local and systemic treatments, and clinical outcome were collected. Of the 1,815 patients evaluated over a 6-year period, 73 patients met the WASOG criteria for cardiac sarcoidosis. The median age at diagnosis was 46 years, with a median follow-up of 8.8 years. Reduced left ventricular ejection fraction (LVEF) was the most common manifestation (54.8%). Patients with arrhythmias experienced ventricular tachycardia or severe heart block, (35.6% and 19.2%, respectively) with or without reduced LVEF. A total of 45 (61.6%) patients underwent cardiac PET scan and/or MRI, with 41 (91.1%) having a positive study. During follow-up, 10 patients (13.7%) either underwent transplant (n = 3) or died (n = 7) from sarcoidosis. Kaplan-Meier survival curves revealed 5- and 10-year survival rates of 95.5% and 93.4%, respectively. Univariate factors of age at diagnosis < 46 years, implantation of pacemaker or defibrillator, mycophenolate treatment, or LVEF > 40% were associated with improved survival. Cox regression analysis demonstrated that age ≥ 46 years and lack of an implanted pacemaker or defibrillator were the only independent predictors of mortality. The new WASOG criteria were able to characterize cardiac involvement in our sarcoidosis clinic. Age and lack of pacemaker or defibrillator were the significant predictors of mortality for cardiac sarcoidosis, and reduced LVEF < 40% was associated with worse prognosis. ClinicalTrials.gov; No.: NCT02356445; URL: www.clinicaltrials.gov. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

[Return to work of a pacemaker bearing worker: the relationship between health problems and electromagnetic interferences].

PubMed

Taino, G; Frigerio, F

2004-01-01

The potential effects of electromagnetic fields is a problem that interest the public opinion, as the modern society expose all people to electromagnetic non ionizing radiations. The problem has a particular and important meaning facing the return to normal life and work conditions of a cardiopatic subject bearing a pacemaker (PM) or implantable cardioverter defibrillator (ICD). Electromagnetic interferences can produce temporary or permanent malfunctions in these devices. Checking for the absence of electromagnetic interferences is necessary considering that correct functioning of these medical devices is essential for the life of the bearer. Precautions normally adopted by these subjects are generally adequate to ensure protection from interferences present in life environment; for occupational environment, there is often lack of adequate information, also due to late involving of the doctor specialist in occupational health. This work intends to study in depth a specific job, a carpentry-workshop with welding activities, starting with a case of a PM bearer who asked a doctor specialist in occupational health to evaluate the problems involved in his return to work. Electric and magnetic fields produced by equipments present in the workshop were measured and compared to data supplied by the literature to evaluate the possibility of interactions in the normally functioning of implanted electronic devices. On the basis of our experience, we have found some criterions for specific risk assessement to adopt for the definition of operative protocols for return to work of PM or ICD carriers, also considering the lack of specific procedures and indications for the doctor specialist in occupational health. The collected information and data from the literature suggest that welding can be a risk for a subject with PM; as observed in experimental conditions, electromagnetic radiations can alter particular sensitive devices and those with uncorrected settings.

Of pacemakers and statistics: the actuarial method extended.

PubMed

Dussel, J; Wolbarst, A B; Scott-Millar, R N; Obel, I W

1980-01-01

Pacemakers cease functioning because of either natural battery exhaustion (nbe) or component failure (cf). A study of four series of pacemakers shows that a simple extension of the actuarial method, so as to incorporate Normal statistics, makes possible a quantitative differentiation between the two modes of failure. This involves the separation of the overall failure probability density function PDF(t) into constituent parts pdfnbe(t) and pdfcf(t). The approach should allow a meaningful comparison of the characteristics of different pacemaker types.

Perioperative Interrogation of St. Jude Cardiovascular Implantable Electronic Devices: A Guide for Anesthesiologists.

PubMed

Cronin, Brett; Essandoh, Michael K

2018-04-01

Feelings of trepidation or uncertainty regarding cardiovascular implantable electronic devices (CIEDs) in the perioperative period can often be mitigated by a thorough knowledge of societal recommendations, recommended management options, and familiarity with CIEDs. Given that effective interpretation of an interrogation report is vital to determining perioperative management options and applying societal recommendations, the creation and interpretation of St. Jude CIED interrogation reports are discussed. In an effort to increase the familiarity with St. Jude transvenous CIEDs amongst anesthesiologists, basic programming of a St. Jude pacemaker and implantable cardioverter defibrillator (ICD) also are described. Published by Elsevier Inc.

Initial experience with remote magnetic navigation for left ventricular lead placement.

PubMed

Mischke, Karl; Knackstedt, Christian; Schmid, Michael; Hatam, Nima; Becker, Michael; Spillner, Jan; Fache, Kerstin; Kelm, Malte; Schauerte, Patrick

2009-08-01

A novel magnetic navigation system allows remote steering of guidewires and catheters. This system may be used for left ventricular lead placement for cardiac resynchronization therapy (CRT). We sought to evaluate the feasibility and safety of magnetic guidewire navigation for CRT procedures. 123 consecutive patients underwent CRT implantation/revision procedures (including pacemaker upgrades in n=22 and left ventricular lead placement after dislocation in n=4 patients). Left ventricular lead placement in a coronary sinus side branch was performed either conventionally or using magnetic navigation. The magnetic navigation system (Niobe) consists of two permanent magnets creating a steerable magnetic field. Guidewires with integrated magnets align to the magnetic field and were used for over-the-wire implantation of pacemaker leads in the coronary sinus. Patients were assigned to conventional (n=93) or magnetic (n=30) navigation according to room availability. Venography of the coronary venous system was performed to select a target vessel for lead implantation. Guidewire access to the target vessel was achieved in 100% using magnetic navigation compared to 87% with the conventional approach (P < 0.05). Implantation success rates, total procedure and fluoroscopy times did not differ significantly between groups. No periprocedural death and no intraoperative device dysfunction occurred in either group.The magnetic guidewire ruptured in one patient. Left ventricular lead placement using magnetic guidewire navigation to engage the desired coronary sinus side branch can be successfully performed for CRT.

Electromagnetic immunity of implantable pacemakers exposed to wi-fi devices.

PubMed

Mattei, Eugenio; Censi, Federica; Triventi, Michele; Calcagnini, Giovanni

2014-10-01

The purpose of this study is to evaluate the potential for electromagnetic interference (EMI) and to assess the immunity level of implantable pacemakers (PM) when exposed to the radiofrequency (RF) field generated by Wi-Fi devices. Ten PM from five manufacturers, representative of what today is implanted in patients, have been tested in vitro and exposed to the signal generated by a Wi-Fi transmitter. An exposure setup that reproduces the actual IEEE 802.11b/g protocol has been designed and used during the tests. The system is able to amplify the Wi-Fi signal and transmits at power levels higher than those allowed by current international regulation. Such approach allows one to obtain, in case of no EMI, a safety margin for PM exposed to Wi-Fi signals, which otherwise cannot be derived if using commercial Wi-Fi equipment. The results of this study mitigate concerns about using Wi-Fi devices close to PM: none of the PM tested exhibit any degradation of their performance, even when exposed to RF field levels five times higher than those allowed by current international regulation (20 W EIRP). In conclusion, Wi-Fi devices do not pose risks of EMI to implantable PM. The immunity level of modern PM is much higher than the transmitting power of RF devices operating at 2.4 GHz.

Mathematical Models of Cardiac Pacemaking Function

NASA Astrophysics Data System (ADS)

Li, Pan; Lines, Glenn T.; Maleckar, Mary M.; Tveito, Aslak

2013-10-01

Over the past half century, there has been intense and fruitful interaction between experimental and computational investigations of cardiac function. This interaction has, for example, led to deep understanding of cardiac excitation-contraction coupling; how it works, as well as how it fails. However, many lines of inquiry remain unresolved, among them the initiation of each heartbeat. The sinoatrial node, a cluster of specialized pacemaking cells in the right atrium of the heart, spontaneously generates an electro-chemical wave that spreads through the atria and through the cardiac conduction system to the ventricles, initiating the contraction of cardiac muscle essential for pumping blood to the body. Despite the fundamental importance of this primary pacemaker, this process is still not fully understood, and ionic mechanisms underlying cardiac pacemaking function are currently under heated debate. Several mathematical models of sinoatrial node cell membrane electrophysiology have been constructed as based on different experimental data sets and hypotheses. As could be expected, these differing models offer diverse predictions about cardiac pacemaking activities. This paper aims to present the current state of debate over the origins of the pacemaking function of the sinoatrial node. Here, we will specifically review the state-of-the-art of cardiac pacemaker modeling, with a special emphasis on current discrepancies, limitations, and future challenges.

[Right heart failure after pacemaker implantation].

PubMed

Gallego Galiana, Juan; López Castellanos, Genoveva; Gioia, Francesca; Ruiz Ortega, Raúl Antonio; Cobo Reinoso, Maria Eugenia; Manzano Espinosa, Luis

2015-06-22

Severe tricuspid regurgitation (TR) secondary to interference pacemaker (PM) cable is a rare cause of progressive right heart failure (HF), which can worsen patient outcomes. We present 3 clinical cases of right HF secondary to TR after PM implantation. In these patients the clinic is right HF, which can appear early, as in our second patient, or after years of implementation of the PM, as in the first and third patients. The diagnosis is confirmed by echocardiography, the most accurate 3D, followed by transesophageal. The 2D transthoracic can not detect it, because it has low sensitivity for TR associated with PM. Medical treatment is always the first choice, since any other procedure carries significant morbidity and mortality. Probably this is a condition that we will diagnose with increasing frequency, because there are more and more patients with devices and, at the same time, the diagnostic tools are improving. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

A novel approach to the pacemaker infection with non-thermal atmospheric pressure plasma

NASA Astrophysics Data System (ADS)

Zhang, Yuchen; Li, Yu; Li, Yinglong; Yu, Shuang; Li, Haiyan; Zhang, Jue

2017-08-01

Although the pacemaker (PM) is a key cardiac implantable electrical device for life-threatening arrhythmias treatment, the related infection is a challenge. Thus, the aim of this study is to validate cold plasma as a potential technology for the disinfection of infected pacemakers. Fifty donated PMs were cleaned and sterilized before use and then infected with Staphylococcus aureus ( S. aureus). Then, each experimental group was treated with cold plasma treatment for 1 min, 3 min, 5 min and 7 min, while the control group was immersed with sterilized water. Effectiveness of disinfection was evaluated by using CFU counting method and confocal laser scanning microscopy (CLSM). The physicochemical properties of water treated with cold plasma at different time were evaluated, including water temperature change and oxidation reduction potential (ORP). The major reactive species generated by the cold plasma equipment during cold plasma were analyzed with optical emission spectroscopy (OES). No live bacteria were detected with CFU counting method after 7 min of cold plasma treatment, which matches with the CLSM results. The ORP value of water and H2O2 concentration changed significantly after treating with cold plasma. Furthermore, reactive oxygen species (ROS) and reactive nitrogen species (RNS), especially NO, O (777 nm) and O (844 nm) were probably key inactivation agents in cold plasma treatment. These results indicate that cold plasma could be an effective technology for the disinfection of implantable devices.

Optogenetics-enabled assessment of viral gene and cell therapy for restoration of cardiac excitability

PubMed Central

Ambrosi, Christina M.; Boyle, Patrick M.; Chen, Kay; Trayanova, Natalia A.; Entcheva, Emilia

2015-01-01

Multiple cardiac pathologies are accompanied by loss of tissue excitability, which leads to a range of heart rhythm disorders (arrhythmias). In addition to electronic device therapy (i.e. implantable pacemakers and cardioverter/defibrillators), biological approaches have recently been explored to restore pacemaking ability and to correct conduction slowing in the heart by delivering excitatory ion channels or ion channel agonists. Using optogenetics as a tool to selectively interrogate only cells transduced to produce an exogenous excitatory ion current, we experimentally and computationally quantify the efficiency of such biological approaches in rescuing cardiac excitability as a function of the mode of application (viral gene delivery or cell delivery) and the geometry of the transduced region (focal or spatially-distributed). We demonstrate that for each configuration (delivery mode and spatial pattern), the optical energy needed to excite can be used to predict therapeutic efficiency of excitability restoration. Taken directly, these results can help guide optogenetic interventions for light-based control of cardiac excitation. More generally, our findings can help optimize gene therapy for restoration of cardiac excitability. PMID:26621212

Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery.

PubMed

Tom, James

2016-01-01

The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias.

Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery

PubMed Central

Tom, James

2016-01-01

The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias. PMID:27269668

Wenckebach upper rate response in single chamber pacemaker.

PubMed

Barold, S S

2000-07-01

The Medtronic Minix pacemaker during normal function in the VVT mode was found to exhibit a Wenckenbach upper rate response similar to that of dual chamber devices. This behavior occurred only when the upper rate interval was longer than the pacemaker refractory period. In a single chamber device this response may simulate pacemaker malfunction.

Global health resource utilization associated with pacemaker complications.

PubMed

Waweru, Catherine; Steenrod, Anna; Wolff, Claudia; Eggington, Simon; Wright, David Jay; Wyrwich, Kathleen W

2017-07-01

To estimate health resource utilization (HRU) associated with the management of pacemaker complications in various healthcare systems. Electrophysiologists (EPs) from four geographical regions (Western Europe, Australia, Japan, and North America) were invited to participate. Survey questions focused on HRU in the management of three chronic pacemaker complications (i.e. pacemaker infections requiring extraction, lead fractures/insulation breaches requiring replacement, and upper extremity deep venous thrombosis [DVT]). Panelists completed a maximum of two web-based surveys (iterative rounds). Mean, median values, and interquartile ranges were calculated and used to establish consensus. Overall, 32 and 29 panelists participated in the first and second rounds of the Delphi panel, respectively. Consensus was reached on treatment and HRU associated with a typical pacemaker implantation and complications. HRU was similar across regions, except for Japan, where panelists reported the longest duration of hospital stay in all scenarios. Infections were the most resource-intensive complications and were characterized by intravenous antibiotics days of 9.6?13.5 days and 21.3?29.2 days for pocket and lead infections respectively; laboratory and diagnostic tests, and system extraction and replacement procedures. DVT, on the other hand, was the least resource intensive complication. The results of the panel represent the views of the respondents who participated and may not be generalizable outside of this panel. The surveys were limited in scope and, therefore, did not include questions on management of acute complications (e.g. hematoma, pneumothorax). The Delphi technique provided a reliable and efficient approach to estimating resource utilization associated with chronic pacemaker complications. Estimates from the Delphi panel can be used to generate costs of pacemaker complications in various regions.

Economic Value and Cost-Effectiveness of Cardiac Resynchronization Therapy Among Patients With Mild Heart Failure: Projections From the REVERSE Long-Term Follow-Up.

PubMed

Gold, Michael R; Padhiar, Amie; Mealing, Stuart; Sidhu, Manpreet K; Tsintzos, Stelios I; Abraham, William T

2017-03-01

This study investigated the cost effectiveness of early cardiac resynchronization therapy (CRT) implantation among patients with mild heart failure (HF). The differential cost effectiveness between CRT using a defibrillator (CRT-Ds) and CRT using a pacemaker (CRT-P) was also assessed. Cardiac resynchronization has been shown to be cost effective in New York Heart Association (NYHA) functional classes III/IV but is less studied in class II HF. The incremental costs of early CRT implementation in mild HF compared with the costs potentially avoided because of delaying disease progression to advanced HF are also unknown. Finally, combined biventricular pacing and defibrillator (CRT-D) devices are more expensive than biventricular pacemakers (CRT-P), but the relative cost effectiveness is controversial. Data from the 5-year follow-up phase of REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) were used. The economics were evaluated from the U.S. Medicare perspective based on published clinical projections. Probabilistic estimates yielded $8,840/quality-adjusted life year (QALY) gained (95% confidence interval [CI]: $6,705 to $10,804/QALY gained) for CRT-ON versus CRT-OFF (i.e., programmed "ON" or "OFF" at pre-specified post-implantation timings) and $43,678/QALY gained for CRT-D versus CRT-P (95% CI: $35,164 to $53,589/QALY gained) over the patient's lifetime. Results were robust to choice of patient subgroup and alterations of ±10% to key model parameters. An "early" CRT-D class II strategy totaled $95,292 compared with $91,511 for a "late" implantation. An "early" implant offered on average 1.00 year of additional survival for $3,781, resulting in an ICER of $3,795/LY gained. This study demonstrates CRT cost effectiveness in mild HF. The incremental CRT-D costs are justified by the anticipated benefits, despite increased procurement costs and shorter generator longevities. "Early" CRT-D implants have essential cost parity with "late" implants while increasing the patient's survival. (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction [REVERSE]; NCT00271154). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Do prehospital discharge pacemaker checks provide any additional clinical benefit?

PubMed

Wheelan, Kevin R; Legge, Darlene M; Sakowski, Brent C; Bruce, Susan S; Roberts, David C; Johnston, L Murphy; Moore, B Jane; Beveridge, Thomas P; Wells, Peter J; Vallabahn, Ravi; Donsky, Michael S; Franklin, Jay O

2005-08-01

We performed a retrospective analysis of 250 records of consecutive, newly implanted, pacemaker patients from a single center to determine the rate of postimplant complications and observations discovered before and during the prehospital discharge evaluation. No observations occurred in 246 of 250 patients (98.4%) (1-sided 95% confidence interval 96.4%). Of the 250 patients, 4 had observations that were discovered at the prehospital discharge check and required reprogramming to increase the sensitivity safety margin (3 atrial and 1 ventricular). We documented only 1 complication that was discovered before the predischarge evaluation through telemetry and resulted in an atrial lead revision.

Transvenous demand Pacemaker Treatment for intermittent complete Heart Block in a Cat.

PubMed

Forterre, S; Nürnberg, J H; Forterre, F; Skrodzki, M; Lange, P E

2001-11-01

A 13-year-old male neutered domestic shorthaired cat had repeated syncopal episodes over a 6 month period, which had variable duration and continued to increase in frequency. Intermittent ventricular asystole, due to complete heart block, and hyperthyroidism were documented. As the syncopal episodes did not respond to a 4-week medical treatment and symptoms became severe, a transvenous ventricular demand pacemaker system (VVIM) was implanted via the external jugular vein. The unipolar lead was tunneled subcutaneously and connected with the generator in a preformed ventral abdominal muscle pocket. During follow up of 18-months there were no recurrences of the syncopal episodes.

The Current Indication for Pacemaker in Patients with Cardioinhibitory Vasovagal Syncope

PubMed Central

da Silva, Rose Mary Ferreira Lisboa

2016-01-01

The most frequent cause of syncope is vasovagal reflex. It is associated with worse quality of life, depression, fatigue and physical injury. Recurrence of vasovagal syncope is an aggravating, reaching the rate of 69%. Initial step and pharmacological treatment may not work, especially in patients with recurrent syncope without prodrome. These patients can present cardioinhibitory response with asystole. Studies were designed to analyses the effectiveness of pacemaker for prevention of syncope. In this review, nonrandomized clinical trials, open-label randomized, double-blind randomized, placebo-controlled, and studies based on tilt test or Implantable Loop Recorder findings will be discussed. PMID:27651841

Permanent pacemaker insertion following isolated aortic valve replacement before and after the introduction of TAVI.

PubMed

Kogan, Alexander; Sternik, Leonid; Beinart, Roy; Shalabi, Amjad; Glikson, Michael; Spiegelstein, Danny; Levin, Shany; Raanani, Ehud

2015-04-01

Permanent pacemaker (PPM) implantation is required in 3-12% of all patients undergoing surgical aortic valve replacement (AVR). Our aim was to evaluate the contemporary incidence and impact of the introduction of transcatheter aortic valve implantation (TAVI) for PPM insertion after isolated AVR. Since 2004, during a 10-year period, a total of 858 patients underwent isolated AVR at our institution. Forty-one patients with PPM before operation were excluded from the study and 817 patients were included in the statistical analysis. Of these, 20 patients (2.45%) developed significant conduction disorders, leading to PPM implantation within 120 days postoperatively. Patients were further divided into two groups. Before (Group I: June 2004 to September 2008) and after (Group II: October 2008 to May 2014) the introduction of the TAVI program. There were 343 patients in Group I and 475 patients in Group II. The incidence of PPM implantation decreased from 3.79% (13 patients) in Group I to 1.47% (seven patients) in Group II (P < 0.001). Risk factors for permanent pacing identified by univariate analysis were: Group I (before introducing TAVI program), pulmonary hypertension, preoperative anemia, age older than 75 years, and previous myocardial infarction. Multivariate analysis identified Group I (before introducing TAVI program; P < 0.005; odds ratio [OR] 15.2, 95% confidence interval [CI] 6.3-19.9) and pulmonary hypertension (P < 0.005; OR 12.5, 95% CI 3.2-18.3) to be significant. Irreversible atrio-ventricular block or symptomatic bradycardia requiring PPM implantation is a relatively rare complication. The incidence of PPM implantation after isolated surgical AVR decreased in a contemporary setting after the introduction of the TAVI program. ©2015 Wiley Periodicals, Inc.

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

PubMed

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

2018-05-01

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

A rare coexistence of complete atrioventricular block and preexcitation in an elderly symptomatic patient.

PubMed

Erdogan, Okan

2008-07-01

The present case report describes an elderly patient with complete atrioventricular nodal block coexisting with intermittent preexcitation, which resulted in paroxysmal complete loss of atrioventricular conduction and symptoms. The patient ended up with pacemaker implantation without requiring ablation of accessory pathway.

Spontaneous Reduction in Abnormal Myocardial Uptake of Fluorine-18 Fluorodeoxygluose in a Patient with Cardiac Sarcoidosis.

PubMed

Terasaki, Fumio; Fujita, Shu-Ichi; Kanzaki, Yumiko; Hirose, Yoshinobu; Ishizaka, Nobukazu

2018-05-30

Fluorine-18 fluorodeoxygluose ( 18 F-FDG) positron emission tomography (PET) is a useful tool for evaluating disease activity in sarcoidosis including cardiac involvement. A 67-year-old patient who developed atrioventricular block requiring permanent pacemaker implantation was diagnosed with cardiac sarcoidosis. The patient did not undergo steroid or immunosuppressive therapy but underwent serial 18 F-FDG PET examination, which showed spontaneous reduction in the myocardial FDG uptake, indicating the remission of immune-inflammatory activity. Although the global systolic function remained preserved, thinning of the septal wall emerged during the clinical course of follow-up, which is characteristic for cardiac sarcoidosis.

Minimally Invasive Catheter Procedures to Assist Complicated Pacemaker Lead Extraction and Implantation in the Operating Room

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

Kroepil, Patric; Lanzman, Rotem S., E-mail: rotemshlomo@yahoo.de; Miese, Falk R.

2011-04-15

We report on percutaneous catheter procedures in the operating room (OR) to assist complicated manual extraction or insertion of pacemaker (PM) and implantable cardioverter defibrillator leads. We retrospectively reviewed complicated PM revisions and implantations performed between 2004 and 2009 that required percutaneous catheter procedures performed in the OR. The type of interventional procedure, catheter and retrieval system used, venous access, success rates, and procedural complications were analyzed. In 41 (12 female and 29 male [mean age 62 {+-} 17 years]) of 3021 (1.4%) patients, standard manual retrieval of old leads or insertion of new leads was not achievable and thusmore » required percutaneous catheter intervention for retrieval of misplaced leads and/or recanalisation of occluded central veins. Thirteen of 18 (72.2%) catheter-guided retrieval procedures for misplaced (right atrium [RA] or ventricle [RV; n = 3], superior vena cava [n = 2], brachiocephalic vein [n = 5], and subclavian vein [n = 3]) lead fragments in 16 patients were successful. Percutaneous catheter retrieval failed in five patients because there were extremely fixed or adhered lead fragments. Percutaneous transluminal angiography (PTA) of central veins for occlusion or high-grade stenosis was performed in 25 patients. In 22 of 25 patients (88%), recanalization of central veins was successful, thus enabling subsequent lead replacement. Major periprocedural complications were not observed. In the case of complicated manual PM lead implantation or revision, percutaneous catheter-guided extraction of misplaced lead fragments or recanalisation of central veins can be performed safely in the OR, thus enabling subsequent implantation or revision of PM systems in the majority of patients.« less

Monitoring the radiation dose to a multiprogrammable pacemaker during radical radiation therapy: A case report

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

Muller-Runkel, R.; Orsolini, G.; Kalokhe, U.P.

1990-11-01

Multiprogrammable pacemakers, using complimentary metaloxide semiconductor (CMOS) circuitry, may fail during radiation therapy. We report about a patient who received 6,400 cGy for unresectable carcinoma of the left lung. In supine treatment position, arms raised above the head, the pacemaker was outside the treated area by a margin of at least 1 cm, shielded by cerrobend blocking mounted on a tray. From thermoluminescent dosimeter (TLD) measurements, we estimate that the pacemaker received 620 cGy in scatter doses. Its function was monitored before, during, and after completion of radiation therapy. The pacemaker was functioning normally until the patient's death 5 monthsmore » after completion of treatment. The relevant electrocardiograms (ECGs) are presented.« less

Incidence of Bradycardia and Outcomes of Patients Who Underwent Orbital Atherectomy Without a Temporary Pacemaker.

PubMed

Lee, Michael S; Nguyen, Heajung; Shlofmitz, Richard

2017-02-01

We analyzed the incidence of bradycardia and the safety of patients with severely calcified coronary lesions who underwent orbital atherectomy without the insertion of a temporary pacemaker. The presence of severely calcified coronary lesions can increase the complexity of percutaneous coronary intervention due to the difficulty in advancing and optimally expanding the stent. High-pressure inflations to predilate calcified lesions may cause angiographic complications like perforation and dissection. Suboptimal stent expansion is associated with stent thrombosis and restenosis. Orbital atherectomy safely and effectively modifies calcified plaque to facilitate optimal stent expansion. The incidence of bradycardia in orbital atherectomy is unknown. Fifty consecutive patients underwent orbital atherectomy from February 2014 to September 2016 at our institution, none of whom underwent insertion of a temporary pacemaker. The final analysis included 47 patients in this retrospective study as 3 patients were excluded because of permanent pacemaker implantation. The primary endpoint was significant bradycardia, defined as bradycardia requiring emergent pacemaker placement or a heart rate <50 bpm at the end of atherectomy. The primary endpoint occurred in 4% of all patients, all driven by patients who experienced a heart rate decreasing to <50 bpm. The major adverse cardiac and cerebral event rate was 6%, driven by death (2%) and myocardial infarction (4%). No patient experienced target-vessel revascularization, stroke, or stent thrombosis. Angiographic complications included perforation in 2%, slow-flow in 4%, and flow-limiting dissection in 0%. Significant bradycardia was uncommon during orbital atherectomy. Performing orbital atherectomy without a temporary pacemaker appears to be safe.

Sensors for rate responsive pacing

PubMed Central

Dell'Orto, Simonetta; Valli, Paolo; Greco, Enrico Maria

2004-01-01

Advances in pacemaker technology in the 1980s have generated a wide variety of complex multiprogrammable pacemakers and pacing modes. The aim of the present review is to address the different rate responsive pacing modalities presently available in respect to physiological situations and pathological conditions. Rate adaptive pacing has been shown to improve exercise capacity in patients with chronotropic incompetence. A number of activity and metabolic sensors have been proposed and used for rate control. However, all sensors used to optimize pacing rate metabolic demands show typical limitations. To overcome these weaknesses the use of two sensors has been proposed. Indeed an unspecific but fast reacting sensor is combined with a more specific but slower metabolic one. Clinical studies have demonstrated that this methodology is suitable to reproduce normal sinus behavior during different types and loads of exercise. Sensor combinations require adequate sensor blending and cross checking possibly controlled by automatic algorithms for sensors optimization and simplicity of programming. Assessment and possibly deactivation of some automatic functions should be also possible to maximize benefits from the dual sensor system in particular conditions. This is of special relevance in patient whose myocardial contractility is limited such as in subjects with implantable defibrillators and biventricular pacemakers. The concept of closed loop pacing, implementing a negative feedback relating pacing rate and the control signal, will provide new opportunities to optimize dual-sensors system and deserves further investigation. The integration of rate adaptive pacing into defibrillators is the natural consequence of technical evolution. PMID:16943981

77 FR 14989 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' in section 1861(s)(8) of the Act. Prosthetic devices are defined as devices (other than dental) which replace... examples of prosthetic devices include cardiac pacemakers, cochlear implants, electrical continence aids...

Functional Capacity of Patients with Pacemaker Due to Isolated Congenital Atrioventricular Block

PubMed Central

de Oliveira Júnior, Roberto Márcio; da Silva, Kátia Regina; Kawauchi, Tatiana Satie; Alves, Lucas Bassolli de Oliveira; Crevelari, Elizabeth Sartori; Martinelli, Martino; Costa, Roberto

2015-01-01

Background Isolated congenital atrioventricular block (CAVB) is a rare condition with multiple clinical outcomes. Ventricular remodeling can occur in approximately 10% of the patients after pacemaker (PM) implantation. Objectives To assess the functional capacity of children and young adults with isolated CAVB and chronic pacing of the right ventricle (RV) and evaluate its correlation with predictors of ventricular remodeling. Methods This cross-sectional study used a cohort of patients with isolated CAVB and RV pacing for over a year. The subjects underwent clinical and echocardiographic evaluation. Functional capacity was assessed using the six-minute walk test. Chi-square test, Fisher's exact test, and Pearson correlation coefficient were used, considering a significance level of 5%. Results A total of 61 individuals were evaluated between March 2010 and December 2013, of which 67.2% were women, aged between 7 and 41 years, who were using PMs for 13.5 ± 6.3 years. The percentage of ventricular pacing was 97.9 ± 4.1%, and the duration of the paced QRS complex was 153.7 ± 19.1 ms. Majority of the subjects (95.1%) were asymptomatic and did not use any medication. The mean distance walked was 546.9 ± 76.2 meters and was strongly correlated with the predicted distance (r = 0.907, p = 0.001) but not with risk factors for ventricular remodeling. Conclusions The functional capacity of isolated CAVB patients with chronic RV pacing was satisfactory but did not correlate with risk factors for ventricular remodeling. PMID:25387405

Pacemakers charging using body energy

PubMed Central

Bhatia, Dinesh; Bairagi, Sweeti; Goel, Sanat; Jangra, Manoj

2010-01-01

Life-saving medical implants like pacemakers and defibrillators face a big drawback that their batteries eventually run out and patients require frequent surgery to have these batteries replaced. With the advent of technology, alternatives can be provided for such surgeries. To power these devices, body energy harvesting techniques may be employed. Some of the power sources are patient's heartbeat, blood flow inside the vessels, movement of the body parts, and the body temperature (heat). Different types of sensors are employed, such as for sensing the energy from the heartbeat the piezoelectric and semiconducting coupled nanowires are used that convert the mechanical energy into electricity. Similarly, for sensing the blood flow energy, nanogenerators driven by ultrasonic waves are used that have the ability to directly convert the hydraulic energy in human body to electrical energy. Another consideration is to use body heat employing biothermal battery to generate electricity using multiple arrays of thermoelectric generators built into an implantable chip. These generators exploit the well-known thermocouple effect. For the biothermal device to work, it needs a 2°C temperature difference across it. But there are many parts of the body where a temperature difference of 5°C exists – typically in the few millimeters just below the skin, where it is planned to place this device. This study focuses on using body heat as an alternative energy source to recharge pacemaker batteries and other medical devices and prevent the possibility of life-risk during repeated surgery. PMID:21814432

A Screening of UNF Targets Identifies Rnb, a Novel Regulator of Drosophila Circadian Rhythms.

PubMed

Kozlov, Anatoly; Jaumouillé, Edouard; Machado Almeida, Pedro; Koch, Rafael; Rodriguez, Joseph; Abruzzi, Katharine C; Nagoshi, Emi

2017-07-12

Behavioral circadian rhythms are controlled by multioscillator networks comprising functionally different subgroups of clock neurons. Studies have demonstrated that molecular clocks in the fruit fly Drosophila melanogaster are regulated differently in clock neuron subclasses to support their specific functions (Lee et al., 2016; Top et al., 2016). The nuclear receptor unfulfilled ( unf ) represents a regulatory node that provides the small ventral lateral neurons (s-LNvs) unique characteristics as the master pacemaker (Beuchle et al., 2012). We previously showed that UNF interacts with the s-LNv molecular clocks by regulating transcription of the core clock gene period ( per ) (Jaumouillé et al., 2015). To gain more insight into the mechanisms by which UNF contributes to the functioning of the circadian master pacemaker, we identified UNF target genes using chromatin immunoprecipitation. Our data demonstrate that a previously uncharacterized gene CG7837 , which we termed R and B ( Rnb ), acts downstream of UNF to regulate the function of the s-LNvs as the master circadian pacemaker. Mutations and LNv-targeted adult-restricted knockdown of Rnb impair locomotor rhythms. RNB localizes to the nucleus, and its loss-of-function blunts the molecular rhythms and output rhythms of the s-LNvs, particularly the circadian rhythms in PDF accumulation and axonal arbor remodeling. These results establish a second pathway by which UNF interacts with the molecular clocks in the s-LNvs and highlight the mechanistic differences in the molecular clockwork within the pacemaker circuit. SIGNIFICANCE STATEMENT Circadian behavior is generated by a pacemaker circuit comprising diverse classes of pacemaker neurons, each of which contains a molecular clock. In addition to the anatomical and functional diversity, recent studies have shown the mechanistic differences in the molecular clockwork among the pacemaker neurons in Drosophila Here, we identified the molecular characteristics distinguishing the s-LNvs, the master pacemaker of the locomotor rhythms, from other clock neuron subtypes. We demonstrated that a newly identified gene Rnb is an s-LNv-specific regulator of the molecular clock and essential for the generation of circadian locomotor behavior. Our results provide additional evidence to the emerging view that the differential regulation of the molecular clocks underlies the functional differences among the pacemaker neuron subgroups. Copyright © 2017 the authors 0270-6474/17/376673-13$15.00/0.

External closed-circuit cooling system for management of patients after device implantation: A feasibility study.

PubMed

Giofrè, Fabrizio; Ferrari, Paola; Leidi, Cristina; Foschi, Maria Laura; Senni, Michele; De Filippo, Paolo

2017-08-15

In the first 24h after pacemaker or implantable cardioverter/defibrillator (ICD) implantation or replacement, the occurrence of hematoma and pain in the surgically treated region is not infrequent and may result in re-intervention and/or more severe complications, such as infections. Currently, the post-implant phase management is very empiric. The aim of this study was to test the clinical applicability and usefulness of an external close-circuit cooling system for the management of the early post-implant period in patients with high risk of hematoma due to anticoagulant and/or antiplatelet therapy. We studied 135 patients (78M; 71±11years) with high risk of hematoma occurrence after pace-maker (63 patients) or ICD (72 patients) implantation or replacement. Immediately after the intervention, a closed-circuit cooling system (CAREPACE™ system, Zamar, Italy) was externally applied on the pre-pectoral region to each patient and maintained for 24h. The system has a compressive pad and a refrigerating circuit in which non-toxic glycolic fluid is pumped. The fluid temperature was set and kept at 5°C for the whole period. The compressive and cooling effect of the system was well tolerated by all the patients at the temperature set. Four patients complained of noise due to machine operation, but in none the treatment was interrupted. The average length of hospital stay was 2.8±0.4days. No clinically significant hematoma was observed at discharge and after one month follow-up visit. This new system can be used for the management of the early phase after device implantation or replacement and appears clinically useful and well tolerated. Further studies on a larger scale are needed to test the potential reduction of post-intervention complications and the cost-effectiveness of this device. Copyright © 2017 Elsevier B.V. All rights reserved.

Exposed Subcutaneous Implantable Devices: An Operative Protocol for Management and Salvage

PubMed Central

D’Arpa, Salvatore; Cordova, Adriana; Moschella, Francesco

2015-01-01

Background: Implantable venous and electrical devices are prone to exposure and infection. Indications for management are controversial, but—especially if infected—exposed devices are often removed and an additional operation is needed to replace the device, causing a delay in chemotherapy and prolonging healing time. We present our protocol for device salvage, on which limited literature is available. Methods: Between 2007 and 2013, 17 patients were treated (12 venous access ports, 3 cardiac pacemakers, and 2 subcutaneous neural stimulators). Most patients were operated within 7 days from exposure. All patients received only a single perioperative dose of prophylactic antibiotic. In cases of gross infection (n = 1), the device was immediately replaced. In the absence of clinical signs of infection: Complete capsulectomy and aggressive cleaning with an n-acetylcysteine solution and saline solution. Primary exposure of venous ports with sufficient skin coverage (n = 10): the device was covered with local skin flaps. Recurrent cases, cases with insufficient skin coverage or big devices (n = 7): the device was moved to a subpectoral pocket. Mean follow-up was 19 months. Results: Sixteen devices were saved. Only one grossly infected pacemaker was removed and replaced immediately. Only in 1 case, exposure of a venous port recurred after 18 months and was successfully moved to a subpectoral pocket. Chemotherapy was always restarted as scheduled and electrical devices remained functional. Conclusions: This protocol allows—with a straightforward operation and simple measures—to save exposed devices even several days after exposure. Submuscular placement or immediate replacement is indicated only in selected cases. PMID:26034650

Enhancing the Performance of Medical Implant Communication Systems through Cooperative Diversity

PubMed Central

Hegyi, Barnabás; Levendovszky, János

2010-01-01

Battery-operated medical implants—such as pacemakers or cardioverter-defibrillators—have already been widely used in practical telemedicine and telecare applications. However, no solution has yet been found to mitigate the effect of the fading that the in-body to off-body communication channel is subject to. In this paper, we reveal and assess the potential of cooperative diversity to combat fading—hence to improve system performance—in medical implant communication systems. In the particular cooperative communication scenario we consider, multiple cooperating receiver units are installed across the room accommodating the patient with a medical implant inside his/her body. Our investigations have shown that the application of cooperative diversity is a promising approach to enhance the performance of medical implant communication systems in various aspects such as implant lifetime and communication link reliability. PMID:20379346

76 FR 18472 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

....Prosthetic devices are included in the definition of ``medical and other health services'' under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as ``devices (other than... intraocular lens.'' Other examples of prosthetic devices include cardiac pacemakers, cochlear implants...

Leadless Pacing: Current State and Future Direction.

PubMed

Merkel, Matthias; Grotherr, Philipp; Radzewitz, Andrea; Schmitt, Claus

2017-12-01

Leadless pacing is now an established alternative to conventional pacing with subcutaneous pocket and transvenous lead for patients with class I or II single-chamber pacing indication. Available 12-month follow-up data shows a 48% fewer major complication rate in patients with Micra™ compared to a historical control group in a nonrandomized study [1]. There is one system with Food and Drug Administration (FDA) approval and two with the Communauté Européenne (CE) mark. The OPS code for the implantation is 8-83d.3 and the procedure has recently been rated as a "new Examination and Treatment Method (NUB)" in the German DRG system, meaning adequate reimbursement is negotiable with health insurance providers. The systems offer similar generator longevity and programming possibilities as conventional pacemaker systems, including rate response, remote monitoring, and MRI safety. The biggest downsides to date are limitations to single-chamber stimulation, lack of long-time data, and concerns of handling of the system at the end of its life span. However, implant procedure complication rates and procedure times do not exceed conventional pacemaker operations, and proper training and patient selection is provided.

Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study.

PubMed

López-Villegas, Antonio; Catalán-Matamoros, Daniel; Robles-Musso, Emilio; Peiró, Salvador

2016-04-01

The purpose of this study was to assess the burden borne by and the costs to informal caregivers of patients with remotely monitored (RM) pacemakers. The PONIENTE study was a controlled, non-randomised clinical trial, with data collected from informal caregivers, 12 months after implantation of pacemakers. The survey on disabilities, personal autonomy, and dependency situations was used to gather information on demographic and social characteristics, levels of professionalism, time and types of care, difficulties in providing care, health status, professional aspects, economic and family or leisure impacts due to informal caregiving for patients with pacemakers. During 14 months, 76 caregivers were enrolled in the PONIENTE trial. Of which, 26 were included in the RM group and 50 in the hospital-monitored group (HM). The mean ages were 58.62 ± 16.51 and 61.10 ± 12.67 years, respectively (p = 0.56) in the groups, and 69.7 % were females. The majority (96.1 %) of the caregivers declared that they had to provide their services between 6 and 7 days per week (88.5 % in RM group versus 100 % in HM group; p = 0.037). The costs related to care provided by the informal caregivers were 21.38 % lower in the RM group than in the HM group (p = 0.033). The PONIENTE study shows a significant impact of informal care on relatives and friends of patients with pacemakers in terms of their well-being and costs. ClinicalTrials.gov NCT02234245.

Association of cardiac implantable electronic devices with survival in bifascicular block and prolonged PR interval on electrocardiogram.

PubMed

Moulki, Naeem; Kealhofer, Jessica V; Benditt, David G; Gravely, Amy; Vakil, Kairav; Garcia, Santiago; Adabag, Selcuk

2018-06-16

Bifascicular block and prolonged PR interval on the electrocardiogram (ECG) have been associated with complete heart block and sudden cardiac death. We sought to determine if cardiac implantable electronic devices (CIED) improve survival in these patients. We assessed survival in relation to CIED status among 636 consecutive patients with bifascicular block and prolonged PR interval on the ECG. In survival analyses, CIED was considered as a time-varying covariate. Average age was 76 ± 9 years, and 99% of the patients were men. A total of 167 (26%) underwent CIED (127 pacemaker only) implantation at baseline (n = 23) or during follow-up (n = 144). During 5.4 ± 3.8 years of follow-up, 83 (13%) patients developed complete or high-degree atrioventricular block and 375 (59%) died. Patients with a CIED had a longer survival compared to those without a CIED in the traditional, static analysis (log-rank p < 0.0001) but not when CIED was considered as a time-varying covariate (log-rank p = 0.76). In the multivariable model, patients with a CIED had a 34% lower risk of death (hazard ratio 0.66, 95% confidence interval 0.52-0.83; p = 0.001) than those without CIED in the traditional analysis but not in the time-varying covariate analysis (hazard ratio 1.05, 95% confidence interval 0.79-1.38; p = 0.76). Results did not change in the subgroup with a pacemaker only. Bifascicular block and prolonged PR interval on ECG are associated with a high incidence of complete atrioventricular block and mortality. However, CIED implantation does not have a significant influence on survival when time-varying nature of CIED implantation is considered.

Tackling the Issue of High Postoperative Pacemaker Implantation Rates in Sutureless Aortic Valve Replacement: Should Balloon Inflation be Removed from the Implantation Method of the Perceval Prosthesis?

PubMed

Charles Blouin, Mathieu; Bouhout, Ismail; Demers, Philippe; Carrier, Michel; Perrault, Louis; Lamarche, Yoan; El-Hamamsy, Ismail; Bouchard, Denis

2017-05-01

Sutureless aortic valve replacement (AVR) is an emerging alternative to standard AVR in elderly and high-risk patients. This procedure is associated with a high rate of postoperative permanent pacemaker implantation (PPI). The study aim was to assess the impact on the rate of PPI of implanting the Perceval prosthesis without using balloon inflation. A total of 159 patients who underwent sutureless AVR using the Perceval prosthesis was included. Balloon inflation was used in 132 patients (Balloon group) and not used in the remaining 27 (No-Balloon group). Clinical, echocardiographic and electrocardiographic outcomes were assessed. There was no significant difference in PPI rate between the two groups (26% for Balloon group versus 22% in No-Balloon group; p = 0.700). Balloon inflation had no significant impact on the incidence of paravalvular leaks (p = 0.839), or on the need to return to cardiopulmonary bypass (CPB) intraoperatively due to paravalvular leak or unsatisfactory deployment (p >0.999). Mean and peak transaortic pressure gradients were similar between the two groups (p = 0.417 and p = 0.522, respectively). Cross-clamp and CPB times were shorter in the No-Balloon group (49.6 ± 15.9 min versus 61.1 ± 25.6 min and 64.1 ± 26.3 min versus 79.6 ± 35.4 min, respectively; p = 0.027 and p = 0.012, respectively). The two groups had similar postoperative PPI rates. Implanting the Perceval prosthesis without balloon inflation is safe and had no impact on paravalvular leaks, intraoperative complications or hemodynamic results. Reductions in aortic cross-clamp time and CPB time were observed when the balloon was not used.

The impact of overhead lines for employees with stents

NASA Astrophysics Data System (ADS)

Syrek, P.; Skowron, M.

2017-05-01

The aim of article is to discuss interaction between stents implanted in the body of worker and harmonic magnetic field in the vicinity of electric wires. In last decades, a growing proportion of people has any devices implanted, to list: cardiac pacemakers, cardioverter - defibrillators. Recommendations of International Commision on Non-ionizing Radiation Protection (ICNIRP), and resctrictions imposed in different states, may exlude specific individuals from their duties. The autors focused on the situation, when the employee with stent, works in the immediate vicinity of overhead electric wires, cleaning with dry ice the electric insulators.

Loeffler endocarditis: silent right ventricular myocardium!

PubMed

Çetin, Süha; Heper, Gülümser; Gökhan Vural, Mustafa; Hazirolan, Tuncay

2016-07-01

We present the case of a 54-year-old male patient with Loeffler endocarditis. It is a rare disorder characterized by fibrous thickening of the endocardium leading to apical obliteration and restrictive cardiomyopathy resulting in heart failure, thromboembolic events or atrial fibrillation. To the best of our knowledge, this is the first case reporting the electrical silence of the right ventricular (RV) apex caused by fibrothrombotic thickening of this area. Under these circumstances RV apical implantation of an implantable cardioverter defibrillator (ICD) or pacemaker electrode may lead to unsuccessful stimulation of these devices.

Visualization and appearance of artifacts of leadless pacemaker systems in cardiac MRI : An experimental ex vivo study.

PubMed

Edlinger, Christoph; Granitz, Marcel; Paar, Vera; Jung, Christian; Pfeil, Alexander; Eder, Sarah; Wernly, Bernhard; Kammler, Jürgen; Hergan, Klaus; Hoppe, Uta C; Steinwender, Clemens; Lichtenauer, Michael; Kypta, Alexander

2018-05-23

Leadless pacemaker systems are an important upcoming device in clinical rhythmology. Currently two different products are available with the Micra system (Medtronic) being the most used in the clinical setting to date. The possibility to perform magnetic resonance imaging (MRI) is an important feature of modern pacemaker devices. Even though the Micra system is suitable for MRI, little is yet known about its impact on artifacts within the images. The aim of our ex vivo study was to perform cardiac MRI to quantify the artifacts and to evaluate if artifacts limit or inhibit the assessment of the surrounding myocardium. After ex vivo implantation of the leadless pacemaker (LP) in a porcine model, hearts were filled with saline solution and fixed on wooden sticks on a plastic container. The model was examined at 1.5 T and at 3 T using conventional sequences and T2 mapping sequences. In addition, conventional X‑rays and computed tomography (CT) scans were performed. Correct implantation of the LP could be performed in all hearts. In almost all MRI sequences the right ventricle and the septal region surrounding the (LP) were altered by an artifact and therefore would sustain limited assessment; however, the rest of the myocardium remained free of artifacts and evaluable for common radiologic diagnoses. A characteristic shamrock-shaped artifact was generated which appeared to be even more intense in magnitude and brightness when using 3 T compared to 1.5 T. The use of the Micra system in cardiac MRI appeared to be feasible. In our opinion, it will still be possible to make important clinical cardiac MRI diagnoses (the detection of major ischemic areas or inflammatory processes) in patients using the Micra system. We suggest the use of 1.5 T as the preferred method in clinical practice.

Prevalence and clinical significance of left bundle branch block according to classical or strict definition criteria in permanent pacemaker patients.

PubMed

Mazza, Andrea; Bendini, Maria Grazia; De Cristofaro, Raffaele; Lovecchio, Mariolina; Valsecchi, Sergio; Leggio, Massimo; Boriani, Giuseppe

2017-06-01

Previous studies have shown that the presence of left bundle branch block (LBBB) is associated with an increased risk of cardiac mortality and heart failure (HF). Recently, new criteria to define strict LBBB have been proposed: QRS duration ≥140 ms for men and ≥130 ms for women, along with mid-QRS notching or slurring in ≥2 contiguous leads. We assessed the prevalence and prognostic significance of LBBB according to classical (QRS duration ≥120ms) and strict criteria in permanent pacemaker patients. We retrospectively enrolled 723 consecutive patients who had undergone single- or dual-chamber pacemaker implantation at the study center from July 2002 to December 2014. Patients with a left ventricular ejection fraction ≤35% or a prior diagnosis of HF were excluded. LBBB was reported in 54 (7%) patients, and strict-LBBB in 15 (2%) patients. During a median follow-up of 48 months (range, 18-92 months), 147 (20%) patients reached the combined endpoint of death or HF hospitalization. Patients with LBBB and those with strict-LBBB displayed significantly higher rates of death or HF hospitalization (log-rank test, all P < 0.0001). In particular, strict-LBBB was associated with the worst outcome. The presence of LBBB according to classical definition criteria (hazard ratio [HR] = 1.98, confidence interval [CI]: 1.23-3.19, P = 0.005) and to strict criteria (HR = 2.20; CI: 1.04-4.65; P = 0.039) were both confirmed as independent predictors of death or HF hospitalization after adjustment for relevant clinical covariates. Among patients who had undergone standard pacemaker implantation, the prevalence of LBBB was 7% according to classical definition criteria and 2% according to strict criteria. The presence of LBBB, and particularly of strict-LBBB, at the baseline predicted a poor outcome in terms of death or HF hospitalization. © 2017 Wiley Periodicals, Inc.

Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator.

PubMed

Russo, Robert J; Costa, Heather S; Silva, Patricia D; Anderson, Jeffrey L; Arshad, Aysha; Biederman, Robert W W; Boyle, Noel G; Frabizzio, Jennifer V; Birgersdotter-Green, Ulrika; Higgins, Steven L; Lampert, Rachel; Machado, Christian E; Martin, Edward T; Rivard, Andrew L; Rubenstein, Jason C; Schaerf, Raymond H M; Schwartz, Jennifer D; Shah, Dipan J; Tomassoni, Gery F; Tominaga, Gail T; Tonkin, Allison E; Uretsky, Seth; Wolff, Steven D

2017-02-23

The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).

Long-term survival after ablation of the atrioventricular node and implantation of a permanent pacemaker in patients with atrial fibrillation.

PubMed

Ozcan, C; Jahangir, A; Friedman, P A; Patel, P J; Munger, T M; Rea, R F; Lloyd, M A; Packer, D L; Hodge, D O; Gersh, B J; Hammill, S C; Shen, W K

2001-04-05

In patients with atrial fibrillation that is refractory to drug therapy, radio-frequency ablation of the atrioventricular node and implantation of a permanent pacemaker are an alternative therapeutic approach. The effect of this procedure on long-term survival is unknown. We studied all patients who underwent ablation of the atrioventricular node and implantation of a permanent pacemaker at the Mayo Clinic between 1990 and 1998. Observed survival was compared with the survival rates in two control populations: age- and sex-matched members of the Minnesota population between 1970 and 1990 and consecutive patients with atrial fibrillation who received drug therapy in 1993. A total of 350 patients (mean [+/-SD] age, 68+/-11 years) were studied. During a mean of 36+/-26 months of follow-up, 78 patients died. The observed survival rate was significantly lower than the expected survival rate based on the general Minnesota population (P<0.001). Previous myocardial infarction (P<0.001), a history of congestive heart failure (P=0.02), and treatment with cardiac drugs after ablation (P=0.03) were independent predictors of death. Observed survival among patients without these three risk factors was similar to expected survival (P=0.43). None of the 26 patients with lone atrial fibrillation died during follow-up (37+/-27 months). The observed survival rate among patients who underwent ablation was similar to that among 229 controls with atrial fibrillation (mean age, 67+/-12 years) who received drug therapy (P=0.44). In the absence of underlying heart disease, survival among patients with atrial fibrillation after ablation of the atrioventricular node is similar to expected survival in the general population. Long-term survival is similar for patients with atrial fibrillation, whether they receive ablation or drug therapy. Control of the ventricular rate by ablation of the atrioventricular node and permanent pacing does not adversely affect long-term survival.

Zebrafish heart as a model to study the integrative autonomic control of pacemaker function

PubMed Central

Stoyek, Matthew R.; Quinn, T. Alexander; Croll, Roger P.

2016-01-01

The cardiac pacemaker sets the heart's primary rate, with pacemaker discharge controlled by the autonomic nervous system through intracardiac ganglia. A fundamental issue in understanding the relationship between neural activity and cardiac chronotropy is the identification of neuronal populations that control pacemaker cells. To date, most studies of neurocardiac control have been done in mammalian species, where neurons are embedded in and distributed throughout the heart, so they are largely inaccessible for whole-organ, integrative studies. Here, we establish the isolated, innervated zebrafish heart as a novel alternative model for studies of autonomic control of heart rate. Stimulation of individual cardiac vagosympathetic nerve trunks evoked bradycardia (parasympathetic activation) and tachycardia (sympathetic activation). Simultaneous stimulation of both vagosympathetic nerve trunks evoked a summative effect. Effects of nerve stimulation were mimicked by direct application of cholinergic and adrenergic agents. Optical mapping of electrical activity confirmed the sinoatrial region as the site of origin of normal pacemaker activity and identified a secondary pacemaker in the atrioventricular region. Strong vagosympathetic nerve stimulation resulted in a shift in the origin of initial excitation from the sinoatrial pacemaker to the atrioventricular pacemaker. Putative pacemaker cells in the sinoatrial and atrioventricular regions expressed adrenergic β2 and cholinergic muscarinic type 2 receptors. Collectively, we have demonstrated that the zebrafish heart contains the accepted hallmarks of vertebrate cardiac control, establishing this preparation as a viable model for studies of integrative physiological control of cardiac function by intracardiac neurons. PMID:27342878

Development of the cardiac pacemaker

PubMed Central

Liang, Xingqun; Evans, Sylvia M.

2017-01-01

The sinoatrial node (SAN) is the dominant pacemaker of the heart. Abnormalities in SAN formation and function can cause sinus arrhythmia, including sick sinus syndrome and sudden death. A better understanding of genes and signaling pathways that regulate SAN development and function is essential to develop more effective treatment to sinus arrhythmia, including biological pacemakers. In this review, we briefly summarize the key processes of SAN morphogenesis during development, and focus on the transcriptional network that drives SAN development. PMID:27770149

Implantable power generation system utilizing muscle contractions excited by electrical stimulation.

PubMed

Sahara, Genta; Hijikata, Wataru; Tomioka, Kota; Shinshi, Tadahiko

2016-06-01

An implantable power generation system driven by muscle contractions for supplying power to active implantable medical devices, such as pacemakers and neurostimulators, is proposed. In this system, a muscle is intentionally contracted by an electrical stimulation in accordance with the demands of the active implantable medical device for electrical power. The proposed system, which comprises a small electromagnetic induction generator, electrodes with an electrical circuit for stimulation and a transmission device to convert the linear motion of the muscle contractions into rotational motion for the magneto rotor, generates electrical energy. In an ex vivo demonstration using the gastrocnemius muscle of a toad, which was 28 mm in length and weighed 1.3 g, the electrical energy generated by the prototype exceeded the energy consumed for electrical stimulation, with the net power being 111 µW. It was demonstrated that the proposed implantable power generation system has the potential to replace implantable batteries for active implantable medical devices. © IMechE 2016.

Cardiac pacemaker dysfunction in children after thoracic drainage catheter manipulation.

PubMed

Lobdell, K W; Walters, H L; Hudson, C; Hakimi, M

1997-05-01

Two children underwent placement of permanent, epicardial-lead, dual-chamber, unipolar pacemaker systems for complete heart block. Postoperatively, both patients demonstrated subcutaneous emphysema-in the area of their pulse generators-temporally related to thoracic catheter manipulation. Acutely, each situation was managed with manual compression of the pulse generator, ascertaining appropriate pacemaker sensing and pacing. Maintenance of compression with pressure dressings, vigilant observation/monitoring, and education of the care givers resulted in satisfactory pacemaker function without invasive intervention.

Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.

PubMed

Halimi, Franck; Clémenty, Jacques; Attuel, Patrick; Dessenne, Xavier; Amara, Walid

2008-12-01

The OEDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme. Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4-6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI -2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies. Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure.

Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial

PubMed Central

Halimi, Franck; Clémenty, Jacques; Attuel, Patrick; Dessenne, Xavier; Amara, Walid

2008-01-01

Aims The ŒDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme. Methods and results Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4–6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI −2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies. Conclusion Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure. PMID:18775878

A new trick to a routine procedure: taking the fear out of the axillary vein stick using the 35° caudal view.

PubMed

Yang, Felix; Kulbak, Guy

2015-07-01

The axillary vein is frequently used to implant pacemaker and defibrillator leads. We describe a technique utilizing the caudal fluoroscopic view to facilitate axillary venous access without contrast. Outcomes of device implants or upgrades utilizing this technique were examined during a 1-year period at our institution. Of 229 consecutive implants, only 9 patients required an alternate technique for lead implantation. There were zero cases of pneumothorax. The caudal view allows for optimal appreciation of the anterior border of the lung and the first rib. This simple technique increases the implanter's appreciation of and control over the access needle depth relative to the lung and first rib, thereby reducing pneumothorax risk. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Centrifuge-simulated suborbital spaceflight in subjects with cardiac implanted devices.

PubMed

Blue, Rebecca S; Reyes, David P; Castleberry, Tarah L; Vanderploeg, James M

2015-04-01

Future commercial spaceflight participants (SFPs) with conditions requiring personal medical devices represent a unique challenge. The behavior under stress of cardiac implanted devices (CIDs) such as pacemakers is of special concern. No known data currently exist on how such devices may react to the stresses of spaceflight. We examined the responses of two volunteer subjects with CIDs to G forces in a centrifuge to evaluate how similar potential commercial SFPs might tolerate the forces of spaceflight. Two subjects, 75- and 79-yr-old men with histories of atrial fibrillation and implanted dual-lead, rate-responsive pacemakers, underwent seven centrifuge runs over 2 d. Day 1 consisted of two +Gz runs (peak = +3.5 Gz, run 2) and two +Gx runs (peak = +6.0 Gx, run 4). Day 2 consisted of three runs approximating suborbital spaceflight profiles (combined +Gx/+Gz). Data collected included blood pressures, electrocardiograms, pulse oximetry, neurovestibular exams, and postrun questionnaires regarding motion sickness, disorientation, greyout, and other symptoms. Despite both subjects' significant medical histories, neither had abnormal physiological responses. Post-spin analysis demonstrated no lead displacement, damage, or malfunction of either CID. Potential risks to SFPs with CIDs include increased arrhythmogenesis, lead displacement, and device damage. There are no known prior studies of individuals with CIDs exposed to accelerations anticipated during the dynamic phases of suborbital spaceflight. These cases demonstrate that even individuals with significant medical histories and implanted devices can tolerate the acceleration exposures of commercial spaceflight. Further investigation will determine which personal medical devices present significant risks during suborbital flight and beyond.

In vitro assessment of tissue heating near metallic medical implants by exposure to pulsed radio frequency diathermy

NASA Astrophysics Data System (ADS)

Ruggera, P. S.; Witters, D. M.; von Maltzahn, G.; Bassen, H. I.

2003-09-01

A patient with bilateral implanted neurostimulators suffered significant brain tissue damage, and subsequently died, following diathermy treatment to hasten recovery from teeth extraction. Subsequent MRI examinations showed acute deterioration of the tissue near the deep brain stimulator (DBS) lead's electrodes which was attributed to excessive tissue heating induced by the diathermy treatment. Though not published in the open literature, a second incident was reported for a patient with implanted neurostimulators for the treatment of Parkinson's disease. During a diathermy treatment for severe kyphosis, the patient had a sudden change in mental status and neurological deficits. The diathermy was implicated in causing damage to the patient's brain tissue. To investigate if diathermy induced excessive heating was possible with other types of implantable lead systems, or metallic implants in general, we conducted a series of in vitro laboratory tests. We obtained a diathermy unit and also assembled a controllable laboratory exposure system. Specific absorption rate (SAR) measurements were performed using fibre optic thermometry in proximity to the implants to determine the rate of temperature rise using typical diathermy treatment power levels. Comparisons were made of the SAR measurements for a spinal cord stimulator (SCS) lead, a pacemaker lead and three types of bone prosthesis (screws, rods and a plate). Findings indicate that temperature changes of 2.54 and 4.88 °C s-1 with corresponding SAR values of 9129 and 17 563 W kg-1 near the SCS and pacemaker electrodes are significantly higher than those found in the proximity of the other metallic implants which ranged from 0.04 to 0.69 °C s-1 (129 to 2471 W kg-1). Since the DBS leads that were implanted in the reported human incidents have one-half the electrode surface area of the tested SCS lead, these results imply that tissue heating at rates at least equal to or up to twice as much as those reported here for the SCS lead could occur for the DBS leads.

Telemetry Option in the Measurement of Physical Activity for Patients with Heart Failure

ERIC Educational Resources Information Center

Melczer, Csaba; Melczer, László; Oláh, András; Sélleyné-Gyúró, Mónika; Welker, Zsanett; Ács, Pongrác

2015-01-01

Measurement of physical activity among patients with heart failure typically requires a special approach due to the patients' physical status. Nowadays, a technology is already available that can measure the kinematic movements in 3-D by a pacemaker and implantable defibrillator giving an assessment on software. The telemetry data can be…

Efficacy of postoperative prophylactic antibiotics in reducing permanent pacemaker infections.

PubMed

Lee, Wen-Huang; Huang, Ting-Chun; Lin, Li-Jen; Lee, Po-Tseng; Lin, Chih-Chan; Lee, Cheng-Han; Chao, Ting-Hsing; Li, Yi-Heng; Chen, Ju-Yi

2017-08-01

Despite limited evidence, postoperative prophylactic antibiotics are often used in the setting of permanent pacemaker implantation or replacement. The aim of this study is to investigate the efficacy of postoperative antibiotics. Postoperative prophylactic antibiotics may be not clinically useful. We recruited 367 consecutive patients undergoing permanent pacemaker implantation or generator replacement at a tertiary referral center. Baseline demographics, clinical characteristics, and procedure information were collected, and all patients received preoperative prophylactic antibiotics. Postoperative prophylactic antibiotics were administered at the discretion of the treating physician, and all patients were seen in follow-up every 3 to 6 months for an average follow-up period of 16 months. The primary endpoint was device-related infection. A total of 110 patients were treated with preoperative antibiotics only (group 1), whereas 257 patients received both preoperative and postoperative antibiotics (group 2). After a mean follow-up period of 16 months, 1 patient in group 1 (0.9%) and 4 patients in group 2 (1.5%) experienced a device-related infection. There was no significant difference in the rate of infection between the 2 groups (P = 0.624). In the univariate analysis, only the age (60 ± 11 vs 75 ± 12 years, P < 0.001) was significantly different between the infected and noninfected groups. In the multivariate analysis, younger age was an independent risk factor for infective complications (odds ratio = 1.08, P = 0.016). Patients treated with preoperative and postoperative antibiotics had a similar rate of infection as those treated with preoperative antibiotics alone. Further studies are needed to confirm these preliminary findings. © 2017 Wiley Periodicals, Inc.

Recurrent FUO due to intermittent Enterobacter cloacae bacteremias from an infected pacemaker lead diagnosed by gallium scan.

PubMed

Cunha, Burke A; Jimada, Ismail

2018-01-01

Fever of unknown origin (FUO) refers to fevers of ≥101° F that persist for ≥3 weeks and remain undiagnosed after a focused inpatient or outpatient workup. FUO may be due to infectious, malignant/neoplastic, rheumatic/inflammatory, or miscellaneous disorders. Recurrent FUOs are due to the same causes of classical FUOs. Recurrent FUOs may have continuous or intermittent fevers and are particularly difficult to diagnose. With intermittent fever, recurrent FUO diagnostic tests are best obtained during fever episodes. With recurrent FUOs, the periodicity of febrile episodes is unpredictable. We present a case of a 70-year-old male who presented with recurrent FUO. Multiple extensive FUO workups failed to determine the source of his fever. During his last two episodes of fever/chills, blood cultures were positive for Enterobacter cloacae. Episodic E. cloacae bacteremias suggested a device-related infection, and the patient had a penile implant and permanent pacemaker (PPM). Following febrile episodes, he was treated with multiple courses of appropriate antibiotics, but subsequently fever/chills recurred. Since a device-associated infection was suspected, indium and PET scans were done, but were negative. The source of his intermittent E. cloacae bacteremias was finally demonstrated by gallium scan showing enhanced uptake on a cardiac lead, but not the penile implant or PPM. Gallium scanning remains useful in workup of FUOs, particularly when false-negative indium or PET scans are suspected. The involved pacemaker lead was explanted, grew E. cloacae and the patient has since remained fever free.

A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker.

PubMed

Lakkireddy, Dhanunjaya; Knops, Reinoud; Atwater, Brett; Neuzil, Petr; Ip, John; Gonzalez, Elkin; Friedman, Paul; Defaye, Pascal; Exner, Derek; Aonuma, Kazutaka; Doshi, Rahul; Sperzel, Johannes; Reddy, Vivek

2017-12-01

The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported. As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Long-Term Outcome of Single-Chamber Atrial Pacing Compared with Dual-Chamber Pacing in Patients with Sinus-Node Dysfunction and Intact Atrioventricular Node Conduction

PubMed Central

Kim, Won Ho; Joung, Boyoung; Shim, Jaemin; Park, Jong Sung; Hwang, Eui-Seock; Pak, Hui-Nam; Kim, Sungsoon

2010-01-01

Purpose The optimal pacing mode with either single chamber atrial pacemaker (AAI or AAIR) or dual chamber pacemaker (DDD or DDDR) is still not clear in sinus-node dysfunction (SND) and intact atrioventricular (AV) conduction. Materials and Methods Patients who were implanted with permanent pacemaker using AAI(R) (n = 73) or DDD(R) (n = 113) were compared. Results The baseline characteristics were comparable between the two groups, with a mean follow-up duration of 69 months. The incidence of death did not show statistical difference. However, the incidence of hospitalization for congestive heart failure (CHF) was significantly lower in the AAI(R) group (0%) than the DDD(R) group (8.8%, p = 0.03). Also, atrial fibrillation (AF) was found in 2.8% in the AAI(R) group, which was statistically different from 15.2% of patients in the DDD(R) group (p = 0.01). Four patients (5.5%) with AAI(R) developed AV block, and subsequently switched to DDD(R) pacing. The risk of AF was lower in the patients implanted with AAI(R) than those with DDD(R) [hazard ratio (HR), 0.84; 95% confidence interval, 0.72 to 0.97, p = 0.02]. Conclusion In patients with SND and intact AV conduction, AAI(R) pacing can achieve a better clinical outcome in terms of occurrence of CHF and AF than DDD(R) pacing. These findings support AAI(R) pacing as the preferred pacing mode in patients with SND and intact AV conduction. PMID:20879047

The retrospectroscope-the invention of the rechargeable cardiac pacemaker: vignette #9.

PubMed

Fischell, R E

1990-01-01

The idea for a rechargeable cardiac pacemaker came to the author in the late 1960s after reading an advertisement stating that a company's batteries were so good they would last two years in a heart pacemaker. This meant that pacemaker patients would have to undergo surgery for their replacement frequently. Having worked on the development of hermetically sealed, nickel-cadmium batteries that could function for a decade or longer in an orbiting spacecraft, the author constructed the first prototype of a rechargeable cardiac pacemaker around 1968 to show cardiologists at Johns Hopkins Hospital that a pacemaker of indefinitely long life and much smaller size and weight could be built readily. The subsequent development and marketing of the device, which came on the market in 1973, is recounted.

Cardiac or Other Implantable Electronic Devices and Sleep-disordered Breathing – Implications for Diagnosis and Therapy

PubMed Central

Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf

2014-01-01

Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment. PMID:26835077

Post-implantation erythema in 3 patients and a review of reticular telangiectatic erythema.

PubMed

Aneja, Savina; Taylor, James S; Billings, Steven D; Honari, Golara; Sood, Apra

2011-05-01

The appearance of erythematous, blanchable patches or plaques overlying an implant suggests possible reticular telangiectatic erythema (RTE). RTE is a benign reactive cutaneous manifestation that can present following the implantation of a cardiac pacemaker, defibrillator or intrathecal infusion pump in an otherwise asymptomatic, non-infectious patient. To demonstrate the variety in clinical presentation of patients presenting with RTE or similar patch test-negative post-implantation erythema. After institutional board approval had been obtained, patient information was obtained from electronic medical record files, which included surgical reports, pathology reports, and notes from outpatient encounters. We report post-implantation erythema following insertion of an elbow prosthesis, a knee prosthesis, and a spinal cord stimulator, which have not previously been cited as aetiologies of RTE. Owing to the delayed onset and variable recovery, RTE remains a diagnostic challenge. RTE should be included in the differential diagnosis of any patient presenting with erythema over the site of a previously implanted device. © 2011 John Wiley & Sons A/S.

Cardiac or Other Implantable Electronic Devices and Sleep-disordered Breathing - Implications for Diagnosis and Therapy.

PubMed

Fox, Henrik; Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf

2014-08-01

Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment.

Neuropeptide Secreted from a Pacemaker Activates Neurons to Control a Rhythmic Behavior

PubMed Central

Wang, Han; Girskis, Kelly; Janssen, Tom; Chan, Jason P.; Dasgupta, Krishnakali; Knowles, James A.; Schoofs, Liliane; Sieburth, Derek

2013-01-01

Summary Background Rhythmic behaviors are driven by endogenous biological clocks in pacemakers, which must reliably transmit timing information to target tissues that execute rhythmic outputs. During the defecation motor program in C. elegans, calcium oscillations in the pacemaker (intestine), which occur about every 50 seconds, trigger rhythmic enteric muscle contractions through downstream GABAergic neurons that innervate enteric muscles. However, the identity of the timing signal released by the pacemaker and the mechanism underlying the delivery of timing information to the GABAergic neurons are unknown. Results Here we show that a neuropeptide-like protein (NLP-40) released by the pacemaker triggers a single rapid calcium transient in the GABAergic neurons during each defecation cycle. We find that mutants lacking nlp-40 have normal pacemaker function, but lack enteric muscle contractions. NLP-40 undergoes calcium-dependent release that is mediated by the calcium sensor, SNT-2/synaptotagmin. We identify AEX-2, the G protein-coupled receptor on the GABAergic neurons, as the receptor of NLP-40. Functional calcium imaging reveals that NLP-40 and AEX-2/GPCR are both necessary for rhythmic activation of these neurons. Furthermore, acute application of synthetic NLP-40-derived peptide depolarizes the GABAergic neurons in vivo. Conclusions Our results show that NLP-40 carries the timing information from the pacemaker via calcium-dependent release and delivers it to the GABAergic neurons by instructing their activation. Thus, we propose that rhythmic release of neuropeptides can deliver temporal information from pacemakers to downstream neurons to execute rhythmic behaviors. PMID:23583549

Feasibility of dual-chamber (DDD) pacing via a single-pass (VDD) pacing lead employing a floating atrial ring (dipole): case series, future considerations, and refinements.

PubMed

Kassotis, John; Voigt, Louis; Mongwa, Mbu; Reddy, C V R

2005-01-01

The objective of this study was to assess the feasibility of DDD pacing from a standard single-pass VDD pacemaker system. Over the past 2 decades significant advances have been made in the development of single-pass VDD pacing systems. These have been shown in long-term prospective studies to effectively preserve atrioventricular (AV)synchrony in patients with AV block and normal sinus node function. What remains problematic is the development of a single-pass pacing system capable of DDD pacing. Such a lead configuration would be useful in those patients with peripheral venous anomalies and in younger patients with congenital anomalies, which may require lead revisions in the future. In addition, with the increased use of resynchronization (biventricular pacing) therapy, the availability of a reliable single-pass lead will minimize operative time, enhance patient safety, and minimize the amount of hardware within the heart. The feasibility of DDD pacing via a Medtronic Capsure VDD-2 (Model #5038) pacing lead was evaluated. Twenty patients who presented with AV block and normal sinus node function were recruited for this study. Atrial pacing thresholds and sensitivities were assessed intraoperatively in the supine position with various respiratory maneuvers. Five patients who agreed to participate in long-term follow-up received a dual-chamber generator and were evaluated periodically over a 12-month period. Mean atrial sensitivity was 2.35 +/- 0.83 mV at the time of implantation. Effective atrial stimulation was possible in all patients at the time of implantation (mean stimulation threshold 3.08 +/- 1.04 V at 0.5 ms [bipolar], 3.34 +/- 0.95 V at 0.5 ms [unipolar]). Five of the 20 patients received a Kappa KDR701 generator, and atrial electrical properties were followed up over a 1-year period. There was no significant change in atrial pacing threshold or incidence of phrenic nerve stimulation over the 1-year follow-up. A standard single-pass VDD pacing lead system was capable of DDD pacing intraoperatively and during long-term follow-up. Despite higher than usual thresholds via the atrial dipole, pacemaker telemetry revealed < 10% use of atrial pacing dipole over a 12-month period, which would minimally deplete the pacemaker's battery. In addition, the telemetry confirmed appropriate sensing and pacing of the atrial dipole throughout the study period. At this time such systems can serve as back-up DDD pacing systems with further refinements required to optimize atrial thresholds in all patients.

[Lifetime achievements of Milan H. Djordjević. 1933-1993].

PubMed

Pavlović, Sinisa U

2002-09-01

Professor Dr. Sci. Milan Djordjevitsh was an excellent cardiovascular surgeon and results of his professional and research work were well known to professional public in the country and over the world. He was born in Smederevska Palanka in 1933. He finished the University Schfool of Medicine in Belgrade in 1961 and specialized general surgery at the II Department of Surgery in Belgrade. His teacher, prof. dr. Vojislav Stojanovitsh, recognized his special interest for clinical and research work from the beginning. His doctor's thesis (1976) was "The Role of Veinous Valvula in Aortocoronographic Bypass During Increased Coronary Flow". In 1981 he formed a Bypass Centre of the Republic of Serbia which became later the Yugoslav European Reference Centre for pacemaker therapy. The same year (1981) he was rewarded "The October Award of the City of Belgrade" for science. He was the first to implant an implantable cardioverter defibrillator. This technique was carried out in Serbia only two months after the implantation of a similar system in Europe. Professor Djordjevitsh gave many lectures over the world: Detroit (1975), Huston (1975), Budapest (1978), Warsaw (1980), Stockholm (1982), Aman (1984), New-York (1988), Berlin (1987), Vienna (1998), Stockholm (1989), Moscow (1990). The professional and research work of professor Djordjevitsh in the field of electrostimulation of the heart was characterised by original ideas and permanent search for new possibilities, especially in the multidisciplinary field. Therefore, professor Djordjevitsh is considered to be the founder of modern clinical pacemaker therapy. He also practiced artistic and scientific photography. Since 1984 professor Djordjevitsh was member of the Nucleus of the European working group for heart electrostimulation and electrophysiology, and was elected in the presidency of the Nucleus; later he was its president. His interest was directed to the maturation of endocardial stimulation threshold; use of non-atrial sensors in the frequent adaptation of a permanent artificial conductor of cardiac rhythm-pacemaker to load; use of continuous electrostimulation of spinal cord in patients in terminal state of vasospastic and occlusive vascular diseases; study of the effort of electromagnetic fields on pacemaker inhibition and senzation; study of biologic-synthetic grafts. As a man of high standing, professor Djordjevitsh was expert for cardiovascular diseases and modern technology in the World Health Organization since 1988. On the basis of his great professional reputation in the country and abroad, professor Djordjevitsh was elected a corresponding member of the Serbian Academy of Science and Arts. After a few scientific meetings excellently organized by professor Djordjevitsh in the country (Dubrovnik, 1988 and in 1990 under the auspices of NASPE), professor Djordjevitsh had to organize a European congress on Pacemaker Therapy and Electrophysiology in Belgrade in 1993. Unfortunately, political events and early death of professor Djordjevitsh were the reasons why the congress was not held as planned. Professor Djordjevic died in Paris, but was buried in Belgrade in January 1993.

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Indirect pacemaker generator function analyzer. 870.3640 Section 870.3640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3640...

Remote monitoring: a cost or an investment?

PubMed

Burri, Haran; Heidbüchel, Hein; Jung, Werner; Brugada, Pedro

2011-05-01

Remote management of pacemakers and implantable defibrillators is being increasingly used in Europe, due to its potential to improve follow-up efficiency and patient outcome. However, this paradigm shift needs to be economically viable for it to be sustainable in the long term. This article covers the economic aspects of remote device management, and reviews the current evidence in this field.

Intercostal muscle twitching: An unusual manifestation of extracardiac stimulation related to right ventricular outflow tract pacing

PubMed Central

Erdogan, Okan

2007-01-01

The present case report describes a patient who underwent successful dual-chamber pacemaker implantation with active ventricular lead fixation at a high septal region in the right ventricular outflow tract. Unexpectedly, stimulation at a high output in the right ventricular outflow tract caused an unusual extracardiac stimulation, specifically, intercostal muscle twitching. PMID:17703261

[Vasovagal syncope as a cause of serious body injury - two case reports].

PubMed

Gajek, Jacek; Zyśko, Dorota

2003-04-01

Vasovagal syncope is a reflex reaction, leading to marked hypotension and/or bradycardia with transient loss of consciousness and the postural muscle tone. The recovery is spontaneous and usually rapid. Serious body injuries caused by fainting are rare. We present two patients with vasovagal syncope which caused serious injury. Different therapeutic options, including pacemaker implantation, are discussed.

Paroxysmal atrioventricular block: Electrophysiological mechanism of phase 4 conduction block in the His-Purkinje system: A comparison with phase 3 block.

PubMed

Shenasa, Mohammad; Josephson, Mark E; Wit, Andrew L

2017-11-01

Paroxysmal atrioventricular (A-V) block is relatively rare, and due to its transient nature, it is often under recognized. It is often triggered by atrial, junctional, or ventricular premature beats, and occurs in the presence of a diseased His-Purkinje system (HPS). Here, we present a 45-year-old white male who was admitted for observation due to recurrent syncope and near-syncope, who had paroxysmal A-V block. The likely cellular electrophysiological mechanisms(s) of paroxysmal A-V block and its differential diagnosis and management are discussed. Continuous electrocardiographic monitoring was done while the patient was in the cardiac unit. Multiple episodes of paroxysmal A-V block were documented in this case. All episodes were initiated and terminated with atrial/junctional premature beats. The patient underwent permanent pacemaker implantation and has remained asymptomatic since then. Paroxysmal A-V block is rare and often causes syncope or near-syncope. Permanent pacemaker implantation is indicated according to the current guidelines. Paroxysmal A-V block occurs in the setting of diseased HPS and is bradycardia-dependent. The detailed electrophysiological mechanisms, which involve phase 4 diastolic depolarization, and differential diagnosis are discussed. © 2017 Wiley Periodicals, Inc.

Prevalence and mechanism of tricuspid regurgitation following implantation of endocardial leads for pacemaker or cardioverter-defibrillator.

PubMed

Al-Mohaissen, Maha A; Chan, Kwan Leung

2012-03-01

Endocardial lead-induced tricuspid regurgitation has not been well recognized, either clinically or echocardiographically, and yet it is likely a preventable iatrogenic disease. In severe cases, it can lead to right ventricular failure and require tricuspid valve surgery. This complication will become increasingly important, because the numbers of permanent pacemakers and implantable cardioverter-defibrillators are expected to increase because of the aging population and the expanding capabilities of these devices. Published studies are largely retrospective, and serial studies to assess the time course of the development of tricuspid regurgitation are lacking. The mechanisms and severity of tricuspid regurgitation may not be well evaluated by two-dimensional echocardiography. Real-time three-dimensional echocardiography appears to be a promising technique to evaluate the mechanism of tricuspid regurgitation and may allow the early detection of patients who will develop severe lead-induced tricuspid regurgitation. A better understanding of the mechanism of lead-induced tricuspid regurgitation will be essential to the development of preventive strategies, which can then be tested in future clinical trials. Copyright © 2012 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

Characterization of piezoelectric device for implanted pacemaker energy harvesting

NASA Astrophysics Data System (ADS)

Jay, Sunny; Caballero, Manuel; Quinn, William; Barrett, John; Hill, Martin

2016-10-01

Novel implanted cardiac pacemakers that are powered by energy harvesters driven by the cardiac motion and have a 40 year lifetime are currently under development. To satisfy space constraints and energy requirements of the device, silicon-based MEMS energy harvesters are being developed in the EU project (MANpower1). Such MEMS harvesters for vibration frequencies below 50 Hz have not been widely reported. In this paper, an analytical model and a 3D finite element model (FEM) to predict displacement and open circuit voltage, validated through experimental analysis using an off-the-shelf low frequency energy harvester, are presented. The harvester was excited through constant amplitude sinusoidal base displacement over a range of 20 to 70 Hz passing through its first mode natural frequency at 47 Hz. At resonance both models predict displacements with an error of less than 2% when compared to the experimental result. Comparing the two models, the application of the experimentally measured damping ratio differs for accurate displacement prediction and the differences in symmetry in the measured and modelled displacement and voltage data around the resonance frequency indicate the two piezoelectric voltage models use different fundamental equations.

Hybrid Therapy in the Management of Atrial Fibrillation

PubMed Central

Stárek, Zdeněk; Lehar, František; Jež, Jiří; Wolf, Jiří; Novák, Miroslav

2015-01-01

Atrial fibrillation is the most common sustained arrhythmia. Because of the sub-optimal outcomes and associated risks of medical therapy as well as the recent advances in non-pharmacologic strategies, a multitude of combined (hybrid) algorithms have been introduced that improve efficacy of standalone therapies while maintaining a high safety profile. Antiarrhythmic administration enhances success rate of electrical cardioversion. Catheter ablation of antiarrhythmic drug-induced typical atrial flutter may prevent recurrent atrial fibrillation. Through simple ablation in the right atrium, suppression of atrial fibrillation may be achieved in patients with previously ineffective antiarrhythmic therapy. Efficacy of complex catheter ablation in the left atrium is improved with antiarrhythmic drugs. Catheter ablation followed by permanent pacemaker implantation is an effective and safe treatment option for selected patients. Additional strategies include pacing therapies such as atrial pacing with permanent pacemakers, preventive pacing algorithms, and/or implantable dual-chamber defibrillators are available. Modern hybrid strategies combining both epicardial and endocardial approaches in order to create a complex set of radiofrequency lesions in the left atrium have demonstrated a high rate of success and warrant further research. Hybrid therapy for atrial fibrillation reviews history of development of non-pharmacological treatment strategies and outlines avenues of ongoing research in this field. PMID:25028165

Effect of monopolar radiofrequency energy on pacemaker function.

PubMed

Govekar, Henry R; Robinson, Thomas N; Varosy, Paul D; Girard, Guillaume; Montero, Paul N; Dunn, Christina L; Jones, Edward L; Stiegmann, Greg V

2012-10-01

This study aimed to quantify the clinical parameters of mono- and bipolar instruments that inhibit pacemaker function. The specific aims were to quantify pacer inhibition resulting from the monopolar instrument by altering the generator power setting, the generator mode, the distance between the active electrode and the pacemaker, and the location of the dispersive electrode. A transvenous ventricular lead pacemaker overdrive paced the native heart rate of an anesthetized pig. The primary outcome variable was pacer inhibition quantified as the number of beats dropped by the pacemaker during 5 s of monopolar active electrode activation. Lowering the generator power setting from 60 to 30 W decreased the number of dropped paced events (2.3 ± 1.2 vs 1.6 ± 0.8 beats; p = 0.045). At 30 W of power, use of the cut mode decreased the number of dropped paced beats compared with the coagulation mode (0.6 ± 0.5 vs 1.6 ± 0.8; p = 0.015). At 30 W coagulation, firing the active electrode at different distances from the pacemaker generator (3.75, 7.5, 15, and 30 cm) did not change the number of dropped paced beats (p = 0.314, analysis of variance [ANOVA]). The dispersive electrode was placed in four locations (right/left gluteus, right/left shoulder). More paced beats were dropped when the current vector traveled through the pacemaker/leads than when it did not (1.5 ± 1.0 vs 0.2 ± 0.4; p < 0.001). Clinical parameters that reduce the inhibition of a pacemaker by monopolar instruments include lowering the generator power setting, using cut (vs coagulation) mode, and locating the dispersive electrode so the current vector does not traverse the pacemaker generator or leads.

Novel experience of laser-assisted 'inside-out' central venous access in a patient with bilateral subclavian vein occlusion requiring pacemaker implantation.

PubMed

Aye, Thandar; Phan, Thanh Trung; Muir, Douglas Findlay; Linker, Nicholas John; Hartley, Richard; Turley, Andrew John

2017-10-01

This new laser facilitated 'inside-out' technique was used for transvenous pacemaker insertion in a pacemaker-dependent patient with bilateral subclavian occlusion and a failed epicardial system who is not suitable for a transfemoral approach. Procedure was undertaken under general anaesthesia with venous access obtained from right femoral vein and left axillary vein. 7F multipurpose catheter was used to enter proximal edge of the occluded segment of subclavian vein via femoral approach, which then supported stiff angioplasty wires and microcatheters to tunnel into the body of occlusion. When encountered with impenetrable resistance, 1.4 mm Excimer laser helped delivery of a Pilot 200 wire, which then progressed towards the distal edge of occlusion. Serial balloon dilatations allowed wire tracked into subintimal plane, advanced towards left clavicle using knuckle wire technique, which was then externalized with blunt dissection from infraclavicular pocket area. It was later changed to Amplatz superstiff wire exiting from both ends to form a rail, which ultimately allowed passage of pacing leads after serial balloon dilatation from clavicular end. Our hybrid 'inside-out' technique permitted transvenous pacemaker insertion without complication and this is, to our knowledge, the first case using laser in this context. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: formal monitoring of performance is still needed. BILITCH Registry and STIMAREC.

PubMed

Kawanishi, D T; Song, S; Furman, S; Parsonnet, V; Pioger, G; Petitot, J C; Godin, J F

1996-11-01

Formal Monitoring of Performance is Still Needed. In order to detect trends in the number of device or component failures that have occurred among permanent pacemaker systems since the 1970s, we reviewed the data of the five largest pacemaker manufacturers from the Bilitch Registry of permanent pacemaker pulse generators, the Stimarec failure registry, the general accounting office summaries of the United States Veterans Administration (VA) Registry of Pacemaker Leads, and the Implantable Lead Registry, from the Cleveland Clinic Lead registry, and the recalls and safety alerts issued by the United States Food and Drug Administration (FDA) over the last 20 years. The definition of failure followed the criterion, or criteria, developed within each registry and differed significantly between the registries. The 20-year period between 1976 and 1995 was divided into 5-year quartiles (QT): QT 1 = 1976-1980; QT2 = 1981-1985; QT3 = 1986-1990; and QT4 = 1991-1995. For pulse generators, the number of models with failures in each quartile in the Bilitch Registry were: QT 1 = 9; QT 2 = 11; QT3 = 17; QT4 = 13. In Stimarec, the number of units reported as having reached a dangerous condition were: QT1 = 710; QT2 = 212; QT3 = 114; QT4 = 310. From the FDA reports, the number of units included in recalls or safety alerts were: QT3 = 6,085; QT4 = 135,766. For permanent pacemaker leads, the numbers of failed or dangerous leads recorded in Stimarec were: QT3 = 16; QT4 = 32. In the VA Registry, the number of models having a below average survival was 2/92 (2.7%). In the Implantable Lead Registry, the number of models having a below average survival was 3/21 (14%). In the Cleveland Clinic series, 6/13 (46%) of lead models were recognized to have some failure involving the conductor, insulation, or connector. In the FDA reports, the number of leads involved in either recall or safety alert were: QT3 = 20,354; QT4 = 332,105. For programmers, the number of units involved either in a recall or safety alert were: QT3 = 11,124; QT4 = 3,528. In all of these series, each of the five largest manufacturers had some models or units involved in each time period. This review of programs has revealed: 1. The incidence of failures, recalls, or safety alerts did not decline over time; and 2. Despite changes in technology, formal monitoring of pacemaker systems is still warranted.

Cardiobacterium hominis and Cardiobacterium valvarum: Two Case Stories with Infective Episodes in Pacemaker Treated Patients.

PubMed

Bonavent, Tina Bennett; Nielsen, Xiaohui Chen; Kristensen, Kjeld Skødebjerg; Ihlemann, Nikolaj; Moser, Claus; Christensen, Jens Jørgen

2016-01-01

Cardiobacterium hominis and Cardiobacterium valvarum are well known, though rare, etiologic agents of infective endocarditis. Cardiac devices are increasingly implanted. Two cases of infective episodes in pacemaker (PM) treated patients with respectively C. hominis and C. valvarum are presented. In one case blood-culture bottles yielded growth of C. hominis at two episodes with two years apart. At the second episode a vegetation was recognized at the PM lead and the PM device and lead was removed. In the C. valvarum case, echocardiography revealed a bicuspid aortic valve with severe regurgitation and a more than 1 cm sized vegetation. The cases illustrate the diversity in disease severity by Cardiobacterium species. Careful follow up has to be performed in order not to overlook a relatively silent relapsing infection.

Embryological development of pacemaker hierarchy and membrane currents related to the function of the adult sinus node: implications for autonomic modulation of biopacemakers.

PubMed

Opthof, Tobias

2007-02-01

The sinus node is an inhomogeneous structure. In the embryonic heart all myocytes have sinus node type pacemaker channels (I (f)) in their sarcolemma. Shortly before birth, these channels disappear from the ventricular myocytes. The response of the adult sinus node to changes in the interstitium, in particular to (neuro)transmitters, results from the interplay between the responses of all of its constituent cells. The response of the whole sinus node cannot be simply deduced from these cellular responses, because all cells have different responses to specific agonists. A biological pacemaker will be more homogeneous. Therefore it can be anticipated that tuning of cycle length may be problematic. It is discussed that efforts to create a biological pacemaker responsive to vagal stimulation, may be counterproductive, because it may have the potential risk of 'standstill' of the biological pacemaker. A normal sinus node remains spontaneously active at high concentrations of acetylcholine, because it has areas that are unresponsive to acetylcholine. The same is pertinent to other substances with a negative chronotropic effect. Such functional inhomogeneity is lacking in biological pacemakers.

Pacemaker failure associated with therapeutic radiation

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

Brooks, C.; Mutter, M.

1988-11-01

A 48-year-old white man with a multiprogrammable Intramedics 259-01 pacemaker was treated for inoperable lung cancer with a course of cobalt-60 radiotherapy (total 3500 rad). Several weeks subsequent to his last radiation treatment, the patient presented to the emergency department with chest and abdominal pain, shortness of breath, hypotension, and tachycardia. A paced tachycardia was noted, and application of a magnet over the pacemaker completely inhibited its function, allowing a normal sinus rhythm to ensue and the patient's symptoms to be relieved. Pacemaker failure probably was a complication of radiotherapy.

ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs).

PubMed

Dubner, Sergio; Auricchio, Angelo; Steinberg, Jonathan S; Vardas, Panos; Stone, Peter; Brugada, Josep; Piotrowicz, Ryszard; Hayes, David L; Kirchhof, Paulus; Breithardt, Günter; Zareba, Wojciech; Schuger, Claudio; Aktas, Mehmet K; Chudzik, Michal; Mittal, Suneet; Varma, Niraj

2012-02-01

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.

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

PubMed

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

2015-12-01

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

Influence of electromagnetic interference on implanted cardiac arrhythmia devices in and around a magnetically levitated linear motor car.

PubMed

Fukuta, Motoyuki; Mizutani, Noboru; Waseda, Katsuhisa

2005-01-01

This study was designed to determine the susceptibility of implanted cardiac arrhythmia devices to electromagnetic interference in and around a magnetically levitated linear motor car [High-Speed Surface Transport (HSST)]. During the study, cardiac devices were connected to a phantom model that had similar characteristics to the human body. Three pacemakers from three manufacturers and one implantable cardioverter-defibrillator (ICD) were evaluated in and around the magnetically levitated vehicle. The system is based on a normal conductive system levitated by the attractive force of magnets and propelled by a linear induction motor without wheels. The magnetic field strength at 40 cm from the vehicle in the nonlevitating state was 0.12 mT and that during levitation was 0.20 mT. The magnetic and electric field strengths on a seat close to the variable voltage/variable frequency inverter while the vehicle was moving and at rest were 0.13 mT, 2.95 V/m and 0.04 mT, 0.36 V/m, respectively. Data recorded on a seat close to the reactor while the vehicle was moving and at rest were 0.09 mT, 2.45 V/m and 0.05 mT, 1.46 V/m, respectively. Measured magnetic and electric field strengths both inside and outside the linear motor car were too low to result in device inactivation. No sensing, pacing, or arrhythmic interactions were noted with any pacemaker or ICD programmed in either bipolar and unipolar configurations. In conclusion, our data suggest that a permanent programming change or a device failure is unlikely to occur and that the linear motor car system is probably safe for patients with one of the four implanted cardiac arrhythmia devices used in this study under the conditions tested.

Fully digital data processing during cardiovascular implantable electronic device follow-up in a high-volume tertiary center.

PubMed

Staudacher, Ingo; Nalpathamkalam, Asha Roy; Uhlmann, Lorenz; Illg, Claudius; Seehausen, Sebastian; Akhavanpoor, Mohammadreza; Buchauer, Anke; Geis, Nicolas; Lugenbiel, Patrick; Schweizer, Patrick A; Xynogalos, Panagiotis; Zylla, Maura M; Scholz, Eberhard; Zitron, Edgar; Katus, Hugo A; Thomas, Dierk

2017-10-11

Increasing numbers of patients with cardiovascular implantable electronic devices (CIEDs) and limited follow-up capacities highlight unmet challenges in clinical electrophysiology. Integrated software (MediConnect ® ) enabling fully digital processing of device interrogation data has been commercially developed to facilitate follow-up visits. We sought to assess feasibility of fully digital data processing (FDDP) during ambulatory device follow-up in a high-volume tertiary hospital to provide guidance for future users of FDDP software. A total of 391 patients (mean age, 70 years) presenting to the outpatient department for routine device follow-up were analyzed (pacemaker, 44%; implantable cardioverter defibrillator, 39%; cardiac resynchronization therapy device, 16%). Quality of data transfer and follow-up duration were compared between digital (n = 265) and manual processing of device data (n = 126). Digital data import was successful, complete and correct in 82% of cases when early software versions were used. When using the most recent software version the rate of successful digital data import increased to 100%. Software-based import of interrogation data was complete and without failure in 97% of cases. The mean duration of a follow-up visit did not differ between the two groups (digital 18.7 min vs. manual data transfer 18.2 min). FDDP software was successfully implemented into the ambulatory follow-up of patients with implanted pacemakers and defibrillators. Digital data import into electronic patient management software was feasible and supported the physician's workflow. The total duration of follow-up visits comprising technical device interrogation and clinical actions was not affected in the present tertiary center outpatient cohort.

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-Surgical aortic valve replacement (redo-SAVR): A systematic review and meta-analysis.

PubMed

Nalluri, Nikhil; Atti, Varunsiri; Munir, Abdullah B; Karam, Boutros; Patel, Nileshkumar J; Kumar, Varun; Vemula, Praveen; Edla, Sushruth; Asti, Deepak; Paturu, Amrutha; Gayam, Sriramya; Spagnola, Jonathan; Barsoum, Emad; Maniatis, Gregory A; Tamburrino, Frank; Kandov, Ruben; Lafferty, James; Kliger, Chad

2018-05-20

Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak. © 2018, Wiley Periodicals, Inc.

Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association.

PubMed

Mairesse, Georges H; Braunschweig, Frieder; Klersy, Katherine; Cowie, Martin R; Leyva, Francisco

2015-05-01

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

A cardiac implantable device infection by Raoultella planticola in an immunocompromized patient.

PubMed

Adjodah, Chandra; D'Ivernois, Chistophe; Leyssene, David; Berneau, Jean-Baptiste; Hemery, Yann

2017-02-01

Introduction. Infection of cardiac implantable electronic devices is a severe condition associated with high mortality, particularly in patients who are dependent upon heart-pacing devices. Staphylococci are found in 70 % of reported cases. Case presentation. We report the case of a cardiac-pacemaker infection in a 79-year-old man, cumulating a history of rheumatoid arthritis treated by corticosteroids and methotrexate by a recently identified micro-organism: Raoultella planticola . He presented local signs of infection on his VVI pacemaker implantation site and underwent urgent pocket device replacement under cefamandole antibioprophylaxis. On incision thick pus oozed out. It was necessary to perform a complete hardware extraction comprising the pulse generator and the ancient lead. Pus was inoculated into aerobic and anaerobic culture vials and Gram staining unveiled Gram-negative rods. Microbiology analysis identified the organism as R. planticola. A new pacing device was inserted on the contrlateral pectoral region. Ciprofloxacin enabled full recovery. A literature review concerning this pathogen revealed that it is involved in severe infections such as bloodstream infections, peritonitis, cellulitis, pneumonia and lung abscesses, and urinary tract infections. In these case reports, underlying co-morbidities were identified such as solid active neoplasia, recent chemotherapy, corticosteroids, solid-organ-recipient patients and recent open surgery. Conclusion. R. planticola is a serious emerging pathogen and contributes to the burden of various infectious conditions. Its pathogenicity and occurrence should be known by clinicians and a high level of awareness is necessary to precisely identify it provide the correct antibiotic regimen.

Neuropeptide secreted from a pacemaker activates neurons to control a rhythmic behavior.

PubMed

Wang, Han; Girskis, Kelly; Janssen, Tom; Chan, Jason P; Dasgupta, Krishnakali; Knowles, James A; Schoofs, Liliane; Sieburth, Derek

2013-05-06

Rhythmic behaviors are driven by endogenous biological clocks in pacemakers, which must reliably transmit timing information to target tissues that execute rhythmic outputs. During the defecation motor program in C. elegans, calcium oscillations in the pacemaker (intestine), which occur about every 50 s, trigger rhythmic enteric muscle contractions through downstream GABAergic neurons that innervate enteric muscles. However, the identity of the timing signal released by the pacemaker and the mechanism underlying the delivery of timing information to the GABAergic neurons are unknown. Here, we show that a neuropeptide-like protein (NLP-40) released by the pacemaker triggers a single rapid calcium transient in the GABAergic neurons during each defecation cycle. We find that mutants lacking nlp-40 have normal pacemaker function, but lack enteric muscle contractions. NLP-40 undergoes calcium-dependent release that is mediated by the calcium sensor, SNT-2/synaptotagmin. We identify AEX-2, the G-protein-coupled receptor on the GABAergic neurons, as the receptor for NLP-40. Functional calcium imaging reveals that NLP-40 and AEX-2/GPCR are both necessary for rhythmic activation of these neurons. Furthermore, acute application of synthetic NLP-40-derived peptide depolarizes the GABAergic neurons in vivo. Our results show that NLP-40 carries the timing information from the pacemaker via calcium-dependent release and delivers it to the GABAergic neurons by instructing their activation. Thus, we propose that rhythmic release of neuropeptides can deliver temporal information from pacemakers to downstream neurons to execute rhythmic behaviors. Copyright © 2013 Elsevier Ltd. All rights reserved.

Design of a Biorthogonal Wavelet Transform Based R-Peak Detection and Data Compression Scheme for Implantable Cardiac Pacemaker Systems.

PubMed

Kumar, Ashish; Kumar, Manjeet; Komaragiri, Rama

2018-04-19

Bradycardia can be modulated using the cardiac pacemaker, an implantable medical device which sets and balances the patient's cardiac health. The device has been widely used to detect and monitor the patient's heart rate. The data collected hence has the highest authenticity assurance and is convenient for further electric stimulation. In the pacemaker, ECG detector is one of the most important element. The device is available in its new digital form, which is more efficient and accurate in performance with the added advantage of economical power consumption platform. In this work, a joint algorithm based on biorthogonal wavelet transform and run-length encoding (RLE) is proposed for QRS complex detection of the ECG signal and compressing the detected ECG data. Biorthogonal wavelet transform of the input ECG signal is first calculated using a modified demand based filter bank architecture which consists of a series combination of three lowpass filters with a highpass filter. Lowpass and highpass filters are realized using a linear phase structure which reduces the hardware cost of the proposed design approximately by 50%. Then, the location of the R-peak is found by comparing the denoised ECG signal with the threshold value. The proposed R-peak detector achieves the highest sensitivity and positive predictivity of 99.75 and 99.98 respectively with the MIT-BIH arrhythmia database. Also, the proposed R-peak detector achieves a comparatively low data error rate (DER) of 0.002. The use of RLE for the compression of detected ECG data achieves a higher compression ratio (CR) of 17.1. To justify the effectiveness of the proposed algorithm, the results have been compared with the existing methods, like Huffman coding/simple predictor, Huffman coding/adaptive, and slope predictor/fixed length packaging.

High prevalence of baffle leaks in adults after atrial switch operations for transposition of the great arteries.

PubMed

De Pasquale, Gabriella; Bonassin Tempesta, Francesca; Lopes, Bruno Santos; Babic, Daniela; Oxenius, Angela; Seeliger, Theresa; Gruner, Christiane; Tanner, Felix C; Biaggi, Patric; Attenhofer Jost, Christine; Greutmann, Matthias

2017-05-01

To determine the prevalence of baffle leaks in adults after atrial switch operations for transposition of the great arteries, as these may predispose to paradoxical embolic events, particularly in patients with transvenous pacemaker or defibrillator leads. We routinely perform contrast echocardiography with agitated saline in all patients after atrial switch operations. For this study, we analysed patients who had saline contrast echocardiography between 2010 and 2012. The presence of baffle leaks and the severity of right-to-left shunting were assessed. We compared baseline characteristics and oxygen saturation at rest and during exercise between patients with and without baffle leaks. A total of 65 patients (56 Senning and 9 Mustard repair) without previously known baffle leaks were included (mean age 32 ± 8 years, 77% males). Right-to-left shunting was identified in 42 patients (65%) and occurred without provocation manoeuvres in 88%. There were no differences in baseline characteristics, echocardiographic findings, or exercise capacity between patients with and without baffle leaks, except for lower oxygen saturation at peak exercise in those with baffle leaks (29% had oxygen saturations below 90% at peak exercise compared to none without baffle leaks, P = 0.011). Four patients with baffle leaks had previous implantation of transvenous pacemaker leads; one of them had suffered a stroke. Two other patients with baffle leaks had a history of potential embolic stroke. Because of the high prevalence of baffle leaks in adults after atrial switch operations, we propose routine screening with agitated saline contrast, particularly prior to implantation of transvenous pacemaker or defibrillator leads. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Validation of a real-time wireless telemedicine system, using bluetooth protocol and a mobile phone, for remote monitoring patient in medical practice.

PubMed

Yousef, Jasemian; Lars, A N

2005-06-22

This paper validates the integration of a generic real-time wireless telemedicine system utilising Global System for Mobile Communications (GSM), BLUETOOTH protocol and General Packet Radio Service (GPRS) for cellular network in clinical practice. In the first experiment, the system was tested on 24 pacemaker patients at Aalborg Hospital (Denmark), in order to see if the pacemaker implant would be affected by the system. I the second experiment, the system was tested on 15 non risky arrhythmia heart patients, in order to evaluate and validate the system application in clinical practice, for patient monitoring. Electrocardiograms were selected as the continuously monitored parameter in the present study. The results showed that the system had no negative effects on the pacemaker implants. The experiment results showed, that in a realistic environment for the patients, the system had 96.1 % up-time, 3.2 (kbps) throughput, 10(-3) (packet/s) Packet Error Rate and 10(-3) (packet/s) Packet Lost Rate. During 24 hours test the network did not respond for 57 minutes, from which 83.1 % was in the range of 0-3 minutes, 15.4 % was in the range of 3-5 minutes, and only 0.7 % of the down-time was > or = 5 and < or = 6 minutes. By a subjective evaluation, it was demonstrated that the system is applicable and the patients as well as the healthcare personals were highly confident with the system. Moreover, the patients had high degree of mobility and freedom, employing the system. In conclusion, this generic telemedicine system showed a high reliability, quality and performance, and the design can provide a basic principle for real-time wireless remote monitoring systems used in clinical practice.

Current facts on pacemaker electromagnetic interference and their application to clinical care

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

Sager, D.P.

1987-03-01

The development of the sensing demand cardiac pacemaker brought with it the problem of interference as a result of extraneous electric current and electromagnetic fields. This problem still deserves consideration, not only because harmful disruption of pacemaker function, while infrequent, can occur but also because myths and misunderstandings have flourished on the subject. Misinformation has often led to needless patient anxiety and unnecessary restrictions in activities of daily living. Similarly, when health care practitioners are misinformed about pacemaker interference, potentially hazardous situations can occur in the clinical environment. This article is a review of current information on the sources andmore » effects of electromagnetic interference (EMI) on pacemakers and includes a discussion of their application to patient care.« less

Prognosis of super-elderly healthy Japanese patients after pacemaker implantation for bradycardia.

PubMed

Yamaguchi, Tetsuo; Miyamoto, Takamichi; Iwai, Takamasa; Yamaguchi, Junji; Hijikata, Sadahiro; Miyazaki, Ryoichi; Miwa, Naoyuki; Sekigawa, Masahiro; Hara, Nobuhiro; Nagata, Yasutoshi; Nozato, Toshihiro; Yamauchi, Yasuteru; Obayashi, Toru; Isobe, Mitsuaki

2017-07-01

The prognosis of super-elderly patients (age≥85 years) who undergo bradycardia pacemaker (PM) implantation remains unknown. We retrospectively enrolled 868 patients (men 49.0%, 76.6±10.6 years) who could walk unassisted and whose expected life expectancy was more than 1 year, receiving their first bradycardia PM implantation between January 1, 2006, and June 30, 2013. Clinical outcomes were compared between super-elderly patients (n=201, mean age 88.6±3.2 years) and younger patients (n=667, 73.0±9.3 years). At the end of a median 1285-day follow-up, 128 patients (14.7%) died, of which 54 were cardiac deaths (42.2%). Mortality rates were similar between the groups (16.4% vs. 14.2%, log-rank p=0.56) and across different indications for implantation (atrio-ventricular conduction disturbance or sick sinus syndrome, p=0.59), initial rhythms (sinus rhythm or persistent atrial fibrillation, p=0.62), pacing modes (dual chamber pacing or VVI pacing, p=0.26), and ventricular lead positions (septum or apex, p=0.52). On Cox proportional hazard model analysis, hypertension [hazard ratio (HR)=1.74, 95% confidence interval (CI)=1.19-2.54, p=0.004], diabetes mellitus (HR=2.18, 95% CI=1.51-3.14, p<0.001), history of myocardial infarction (HR=3.59, 95% CI=2.49-5.16, p<0.001), and history of stroke (HR=2.26, 95% CI=1.51-3.37, p<0.001) were independent predictors for mortality. The mortality rate of super-elderly patients who had no critical illnesses and were healthy enough to walk unassisted at the time of PM implantation was not inferior to that of younger patients. Prognosis was determined by comorbidities, but not by age, PM indication, initial rhythm, pacing leads, or mode. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

PubMed Central

Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard; Jørgensen, Ole Dan; Nielsen, Jens Cosedis

2014-01-01

Aims Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. Methods and results Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3). Conclusion CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment. PMID:24347317

The re-design at the transformer portion of transcutaneous energy transmission system for all implantable devices.

PubMed

Watada, Masaya; Saisho, Ryohei; Kim, Yong-Jae; Ohuchi, Katsuhiro; Takatani, Setsuo; Um, Yong-Su

2007-01-01

All implantable devices, such as an artificial heart, an artificial lung, a pacemaker, a defibrillator, need electric power. So the electric power supply through the skin is requested. Then, it is transcutaneous energy transmission system (TETS) that has been studied and used a lot. TETS is the system which performs an electric power supply by non-contact transcutaneously using the electromagnetic induction phenomenon of an external primary side coil and a secondary side coil in human body. In this research, we are developing the core type TETS which applied for the implantable devices. In this paper, corresponding to various conditions, such as a difference in required electric power and transmission distance change, the core type transformer which can hold high transmission efficiency is designed.

Thermionic Energy

NASA Technical Reports Server (NTRS)

1985-01-01

Thermionic energy conversion is the production of energy from a nuclear source. It is a technology advanced by SNSO, a joint research and development organization formed by NASA and the AEC. SNSO contracted with Thermo Electron Corporation to develop high temperature applications, i.e., metals with high melting points. Thermo Electron Corporation's expertise resulted in contracts for products made from exotic metals such as bone implants, artificial hips, and heart pacemakers.

Seckel syndrome with severe sinus bradycardia.

PubMed

Ramasamy, Chandramohan; Satheesh, Santhosh; Selvaraj, Raja

2015-03-01

Seckel syndrome is an uncommon form of microcephalic dwarfism. The authors report a young boy with Seckel syndrome who presented with severe sinus bradycardia with symptoms of syncope and presyncope. Implantation of a permanent pacemaker was necessary in view of the severe symptoms. Although uncommon, cardiac abnormalities have been rarely reported in Seckel syndrome. This is the one of the few reports of rhythm abnormalities in this condition.

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

PubMed

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

2004-06-01

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