Worldwide pacemaker and defibrillator reuse: Systematic review and meta-analysis of contemporary trials.

BACKGROUND: Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices. OBJECTIVE: We sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices. METHODS: We searched online indexing sites to identify recent studies. Peer-reviewed manuscripts reporting infection, malfunction, premature battery depletion, and device-related death with reused devices were included. The primary study outcome was the composite risk of infection, malfunction, premature battery depletion, and death. Secondary outcomes were the individual risks. RESULTS: Nine observational studies (published 2009-2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in meta-analysis (2,114 devices; 1,258 new vs 856 reused). All device reuse protocols employed interrogation to confirm longevity and functionality, disinfectant therapy, and, usually, additional biocidal agents, packaging, and ethylene oxide gas sterilization. Demographic characteristics, indications for pacing, and median follow-up were similar. There were no device-related deaths reported and no statistically significant difference in risk between new versus reused devices for the primary outcome (2.23% vs 3.86% respectively, P = 0.807, odds ratio = 0.76). There were no significant differences seen in the secondary outcomes for the individual risks of infection, malfunction, and premature battery depletion. CONCLUSIONS: Device reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or device-related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial.

Unregulated online sales of cardiac implantable electronic devices in the United States: A six-month assessment.

BACKGROUND: An estimated 1 million patients require cardiac implantable electronic devices (CIEDs) but go without annually. This disparity exists in low-to-middle-income nations largely owing to the cost of CIED hardware. Humanitarian reuse of CIEDs has been shown to be safe and feasible. However, recent publications have raised concern that promotion of CIED reuse may foster a CIED "black market," to the dismay of manufacturers, regulators, and clinicians alike. OBJECTIVE: To determine if unregulated CIED sales for potential human use is a real issue by investigating unregulated public online CIED sale listings in the United States of America. METHODS: An observational study was undertaken over 6 months using multiple internet search engines from May 1 to November 1, 2019. We cataloged usable CIEDs (still in packaging, manufactured <7 years) and pricing. Manufacturers were contacted to determine status of sellers and unregulated CIEDs using model/serial numbers. RESULTS: In total, 58 CIEDs-47 implantable cardioverter-defibrillators and 11 permanent pacemakers-from 4 manufacturers were listed for sale on 3 websites. During the study period, 8 of 11 pacemakers and 37 of 47 implantable cardioverter-defibrillators were sold (price range: $100-$1500 [US dollars]). No new listings were seen in the last 3 months of observation, possibly owing to concomitant industry investigation. CONCLUSION: There does exist a public online market for unregulated CIED sales in the United States. This specific market seems to be small and unlikely to significantly expand with active monitoring by manufacturers and regulators.

Reverse Twiddler's syndrome.

Twiddler's syndrome is classically described as withdrawal of pacing or defibrillator leads from their position in the heart as a result of arm motion or manipulation of the pulse generator site. Reverse Twiddler's syndrome is now reported as advancement of the leads into the heart by a similar repetitive motion but opposite in direction.

Limitation of programmed alerts to predict ICD lead failures.

A 75-year-old man with a Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) experienced inappropriate shocks after sudden failure of the right ventricular (RV) pace-sense connector resulting in noise. Interrogation of the implantable cardioverter-defibrillator pulse generator revealed that the 3 AM daily measurement of RV pacing impedance was slightly higher (750 Omega) than the baseline (approximately 450-550 Omega)(although below the recommended alert level of 1,000 Omega) and markedly higher at 4 AM (1,552 Omega) when therapies were delivered. The event occurred before the patient could be alerted by the audible tones. Thus, the manufacturer's recommended impedance monitoring alert parameters will not predict all lead failures.

Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study.

BACKGROUND: Pacemakers have improved the lives of patients worldwide. Unfortunately, the medical community has had little independent information regarding the performance of these vital medical devices. OBJECTIVES: The purpose of this study was to examine the reasons pacemaker pulse generators and transvenous leads were removed from service. We evaluated the causes and major adverse clinical events associated with device end-of-service life behavior and how they were detected and managed. METHODS: Pulse generator and lead data were entered prospectively using a web-based format. Normal battery depletion was signified by the elective replacement indicator appearing >3 years after implant. Lead failure was a device defect causing pacing, sensing, or fixation malfunction, high threshold, or abnormal impedance. Major adverse clinical events were death, angina, heart failure, syncope, and perioperative surgical complications. RESULTS: From 1998 to 2006, 2,652 pulse generator and 615 leads were removed from service. The average pulse generator was implanted for 7.3 +/- 3.1 years (range <1 day to 26 years). The majority of pulse generators (n = 2,317 [87%]) were replaced for normal battery depletion. Severe and accelerated battery depletion, manufacturers' advisories, and electronic or connector defects accounted for 13% of pulse generator removals. The proportion of pulse generators removed from service as a result of manufacturers' advisories, electronic failure, and housing defects were 4%, 2%, and 1%, respectively. Models with rate response capability had shorter battery longevities than those without rate response capability. Major adverse clinical events due to pulse generator end-of-service life behavior were related to electronic and connector defects, and both normal and severe battery depletion. Median time to lead failure was 7.2 +/- 5.2 years. Insulation defects caused the majority of lead failures, and most of these leads used polyurethane materials. Lead failure was associated with a 16% incidence of major adverse clinical events. No major adverse clinical events occurred when impending lead failure was detected at routine follow-up. Lead extraction was associated with a 5.6% complication rate, including one death. CONCLUSION: Overall pulse generator performance was satisfactory. Differences in battery longevity were observed among models. In some patients, elective replacement indicators signifying normal battery depletion resulted in major adverse clinical events. Pacemaker follow-up effectively identified pulse generator end-of-service life and often detected impending lead failure, thus avoiding major adverse clinical events. Long-term studies are needed to assess chronic lead performance so that appropriate clinical management strategies, including recommendations for lead extraction, can be developed.

Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators.

BACKGROUND: Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and longevity. OBJECTIVES: The purpose of this study was to examine the performance of contemporary ICD pulse generators that failed or were replaced because of manufacturers recalls. METHODS: ICD data were entered prospectively by nine participating centers. ICD pulse generator failure was defined as removal from service because the device was not functioning according to the manufacturer's specifications. A recalled ICD was a normally functioning pulse generator that was replaced as the result of a recall or advisory. RESULTS: From 1998 to 2005, 1,220 ICDs failed and 135 were recalled and replaced. The average implant time of failed ICDs was 4.4 +/- 1.5 years and of recalled ICDs was 1.7 +/- 0.8 years. The average implant time of single- and dual-chamber ICDs with rate responsive or cardiac resynchronization (CRT-D) pacing capabilities was significantly shorter than the average implant time of single- or dual-chamber devices without these features (P <.001). ICDs that provided rate responsive or CRT-D pacing failed earlier because of battery depletion (P <.001) and were significantly more prone to unexpected electronic or housing failure (9% vs 5%, P = .008) and recalls (25% vs 1%, P <.0001). Major adverse events included death (n = 2), failure to convert ventricular tachyarrhythmias (n = 6), and inappropriate shocks (n = 11). CONCLUSION: Based on our analysis of failed and recalled devices, the performance of contemporary ICDs has been adversely affected by premature battery depletion, electronic failure, and manufacturers' recalls. Additional studies are needed to precisely estimate ICD longevity and to determine the incidence of unexpected ICD failure.

Right ventricular outflow tract pacing: practical and beneficial. A 9-year experience of 460 consecutive implants.

BACKGROUND: Pacing from the right ventricular apex (RVA) in patients with ventricular dysfunction has been identified as a possible contributor to deterioration of ventricular function. Therefore, alternative pacing sites such as the right ventricular outflow tract (RVOT) are receiving intensified scrutiny. An unresolved question is whether technical, procedural, and stability issues are comparable for the RVA and the RVOT. METHODS: This report details 460 consecutive ventricular pacing lead implants with the primary intended site in the RVOT. Patients were evaluated for success, complication rates, and followed-up for stability of pacing parameters. The total patient implant population included 300 male and 170 female patients with a mean age of 70.6 years. Ten patients were excluded from the analysis, since there was a primary indication and intention to implant in the RVA, leaving a total of 460 patients for analysis. The indications for pacing were symptomatic bradycardia due to any cause and/or Mobitz II or complete heart block. There was no clinical evidence of heart failure in 420 patients. In 40 patients with heart failure, the indication for pacing was cardiac resynchronization therapy using the RVOT as an alternate site when pacing from a branch vein of the coronary sinus was not possible. Outcome information was obtained from the implanter's clinic. RESULTS: The overall success rate in the RVOT was 84% over the total 9-year period with a 92% success rate in the last 4(1/2) years, using the RVOT technique described. At 20 months in a subgroup comparison of RVOT and RVA implants, there was no significant difference in pacing threshold, R-wave sensing, or pacing lead impedance. Dislodgment occurred in only 1 of 460 patients. Reasons for failure to implant in the RVOT include inability to find a stable position with adequate pacing and sensing thresholds (related to anatomy, scarred myocardium, pulmonary hypertension, tricuspid regurgitation), hemodynamic instability limiting time for implant, and a learning curve. Long-term stability and lead performance were excellent, and certain acute and chronic complications of RV pacing did not occur.

Biventricular pacing using dual-site right ventricular stimulation: is it placebo effect?

Alternate site lead placement in cardiac resynchronization therapy has been used successfully but remains to be validated. A 62-year-old heart failure patient in whom coronary sinus lead placement was not possible underwent implantation of the lead in the right ventricular outflow tract (RVOT) and demonstrated clinical improvement as measured by New York Heart Association class and noninvasive parameters. When heart failure recurred, it was determined that his RVOT electrode had been pulled back (Twiddler's syndrome). Repositioning again improved his clinical status and noninvasive hemodynamic measurements. With dual-site right ventricular (RV) pacing there was no echocardiographic measurable intraventricular dyssynchrony. Tissue Doppler imaging correlated with clinical improvement using dual-site RV pacing, providing evidence that this technique may represent a viable alternative in cardiac resynchronization therapy.

Orthotripsy mimicking asystole.

An insertable loop recorder implanted to evaluate dizziness, documented an apparent arrhythmia during an orthotripsy procedure. Review of the tracing revealed artefact related to an electrostatic discharge that should not be mistaken for ventricular asystole.