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Background: In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter‐defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM‐supported follow‐up. Methods: Single‐center observational study. Results: Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow‐up. Conclusions: The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common. [ABSTRACT FROM AUTHOR]

Safe Extraction of Riata Looped Extruding Filler Cables The Riata 1590 lead model contains both electrically active cables (AC) and filler cables (FC) that run in pairs within lumens along the lead body. FC are yet to be described as lead components that may be externalized from either external abrasion or inside-out abrasion seen in the recalled St. Jude leads. Externalization of FC would not be expected to develop any electrical abnormality during routine ICD and lead evaluations. FC are fixed at their ends only with a silicone adhesive compared to mechanical crimps for AC. This glue bond can break allowing a progressive migration of the filler cable to extrude out the insulation breach forming profound loops of cables. We identify the 10 recalled Riata models that contain the electrically inactive FC that will need closer scrutiny by X-ray imaging techniques. Extraction of ICD leads with externalized cables may be difficult, with the presence of extruded loops of FC compounding procedural complexity. We describe a technique that reduced extruded loops of FC and allowed safe extraction of the lead. [ABSTRACT FROM AUTHOR]

Malfunction of Subpectorally Implanted Cardiac Resynchronization Therapy. Background: Implantable cardioverter defibrillator (ICD) implantation has increased significantly over the last 10 years. Concerns about the safety and reliability of ICD systems have been raised, with premature lead failure and battery malfunctions accounting for the majority of reported adverse events. We describe the unique mode of presentation, diagnosis, and management of cardiac resynchronization therapy defibrillators (CRT-D) malfunctions that were caused by weakened bonding between the generator and header. Methods and Results: Between June 2008 and December 2009, 22 Teligen™ ICDs and 24 Cognis™ CRT-Ds were implanted subpectorally at our institution, until a product advisory was issued. Of 24 Cognis™ CRT-D implants, 3 patients presented with CRT-D malfunctions. All our cases presented with initially intermittent and then persisting increases in shock lead impedance, associated with nonphysiological noise in the shock electrogram channels. These issues were rectified by generator change. Postexplant laboratory analysis confirmed inadequate bonding between device header and titanium casing in all cases, resulting in loosening and rocking of the header followed by fatigue-induced fracture of the shock circuitry. Conclusion: Weakened bonding between the header and generator casing of subpectorally implanted CRT-Ds can result in fractures and malfunction of the HV circuit. Physicians monitoring patients with devices affected by the product advisory should remain vigilant in order to diagnose and manage similar device malfunction expediently. (J Cardiovasc Electrophysiol, Vol. 24, pp. 351-355, March 2013) [ABSTRACT FROM AUTHOR]

Impact of Recalls on ICD Utilization. Introduction: Underutilization of ICDs is well documented. It has been hypothesized that device recalls, and the resultant negative publicity, may contribute. Methods and Results: To determine if the October 2007 recall of the Medtronic Fidelis lead was associated with a decrease in volume of ICD procedures in the United States, we analyzed data submitted to the ICD Registry™ between July 2006 and December 2008. Time-series analyses were performed comparing actual and predicted implant volumes following the recall, using monthly data from July 2006 to September 2007 to establish a trend line. Observed data points falling outside the 95% CIs from the trend line were considered statistically significant. The study cohort includes 173,616 implantations in 658 hospitals. Before October 2007, an average of 5,952 devices, 4,910 for primary prevention, were implanted per month. Following the recall, the average monthly number of implants was modestly lower at 5,623 (P = 0.05), 4,601 for primary prevention (P = 0.01.) However, as volume was decreasing prior, in time-series analysis, the observed monthly implant volume for primary prevention devices differed from expected based on the trend line for only 1 month. The proportion of Medtronic implants declined from 51.1% in the 15 months prior to the recall to 45.8% in the 15 months of the recall or after (P < 0.01), falling outside the 95% CI of the trend line for 3 months in time-series analysis. Conclusions: A recent well-publicized lead recall had minimal impact on ICD utilization either overall or for primary prevention. (J Cardiovasc Electrophysiol, Vol. 23, pp. 861-865, August 2012) [ABSTRACT FROM AUTHOR]

Introduction: Implantable cardioverter defibrillators (ICD) advisory notices present treatment dilemmas for physicians and patients. On one side, the risk of device malfunction and the likely severity of clinical sequelae have to be estimated. This estimate has to be weighed against the risks of surgery to replace the advisory component. It is unclear whether there is important psychological morbidity associated with living with an ICD under advisory and whether this should be factored into decision making. The study had 2 objectives: (1) to examine whether there is adverse psychological adjustment when an ICD is under advisory, and (2) to assess the psychological sequel of advisory ICD component malfunction. Methods: This study focused on the Sprint Fidelis advisory. All patients in our practice who still had an in service Medtronic Fidelis lead were included in the study. Three groups were compared: advisory group but no fracture (n = 249), advisory group with lead fracture (n = 24), and a control group (n = 143). For both objectives, we used a general anxiety and depression instrument and also device-specific measures of psychological well being. Results and Conclusions: First, there was no evidence of differences in the psychological functioning of patients at risk of ICD lead malfunction compared to a control group. Second, patients who had experienced an ICD lead fracture had adverse psychological morbidity compared to control patients, and this appeared, primarily, to be related to receiving inappropriate shock(s) at the time of the fracture. (J Cardiovasc Electrophysiol, Vol. 22, pp. 57-63, January 2011) [ABSTRACT FROM AUTHOR]

Implantable cardioverter-defibrillator (ICD) malfunctions sometimes need recall. Despite the increasing number of device implantation, ICD recalls and advisories' impacts have been little studied. The aim of this study was to determine the rate of ICD generator advisory in our center and to examine its clinical and financial implication. We analyzed weekly Food and Drug Administration (FDA) Enforcement Reports issued between January 2000 and December 2008 to identify all advisories involving ICD generators and leads. We performed a retrospective analysis of all implanted patients affected by an advisory in our Cardiology department. During the 8 years of the study period, 13 advisories were issued for generators and one for leads, leading to a total number of 278 of 1,051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients, whereas nine patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in one patient (lead extraction failure). Recalls accounted for 593 extra outpatient visits with a mean number of 2.20 ± 2.19 per patient. The total estimated cost of the device advisories in our population was 334,528 €. ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they do not appear to be associated with substantial complications. Financial implications are important. (PACE 2011; 96-103) [ABSTRACT FROM AUTHOR]

Device advisories due to potential hardware failure comprise one of the downsides of implantable cardioverter defibrillator (ICD) therapy. The impact of advisories on patient-centered outcomes has largely been overlooked. We examined the impact of ICD advisories on patient-centered outcomes via a systematic literature review. PubMed was searched in the period from 1980 to present using a combination of at set of a priori search terms. The reference lists of the included papers were searched by hand. A total of six studies were identified. All advisories were Class I, Class II, or a combination. The sample size across studies varied between 30 and 86 patients subject to an advisory; four of six studies used a case-control design and two of six a prospective study design. There was considerable variability between notification of the advisory and assessment of the patient-centered outcomes, ranging from 1 to 24 months. A mixture of generic and disease-specific patient-centered outcome measures was used. The evidence for an impact on device advisories was mixed, with the two prospective studies showing an increase in anxiety over time, whereas none of the larger case-control studies found a difference in patient-centered outcomes between cases and controls. Evidence for an impact of device advisories on patient-centered outcomes is mixed. In order to incorporate a patient-centered approach in clinical care, patient-centered outcomes should form part of standard clinical practice and if available the assessments entered into ICD registries. Such registries would provide important insights into the impact of ICD advisories on patients’ well being. [ABSTRACT FROM AUTHOR]

Implantable cardioverter-defibrillator (ICD) and pacemaker (PM) advisories may have a significant impact on patient management. Surveys of clinical practice have shown a great deal of variability in patient management after a device advisory. We compared our management of consecutive patients in a single large university practice with device advisories to the “best” patient management strategy predicted by a decision analysis model. Methods: We performed a retrospective review of all patients who had implanted devices affected by an advisory at our medical center between March 2005 and May 2006 and compared our actual patient management strategy with that subsequently predicted by a decision analysis model. Results: Over 14 months, 11 advisories from three different manufacturers affected 436 patients. Twelve patients (2.8%) were deceased and 39 patients (8.9%) were followed at outside facilities. Management of the 385 remaining patients varied based on type of malfunction or potential malfunction, manufacturer recommendations, device dependency, and patient or physician preferences. Management consisted of the following: 57 device replacements (15.2%), 44 devices reprogrammed or magnets issued (11.7%), and 268 patients underwent more frequent follow-up (71.3%). No major complications, related to device malfunction or device replacement, occurred among any patient affected with a device advisory. Concordance between the decision analysis model and our management strategy occurred in 57.1% of cases and 25 devices were replaced when it was not the preferred treatment strategy predicted by the decision model (43.9%, 37.3% when excluding devices replaced based on patient preference). The decision analysis favored replacement for all patients with PM dependency, but only for four patients with ICDs for secondary prevention. No devices were left implanted that the decision analysis model predicted should have been replaced. Conclusions: We found that despite a fairly conservative device replacement strategy for advisories, we still replaced more devices when it was not the preferred device management strategy predicted by a decision analysis model. This study demonstrates that even when risks and benefits are being considered by experienced clinicians, a formal decision analysis can help to develop a systematic evidence based approach and potentially avoid unnecessary procedures. [ABSTRACT FROM AUTHOR]

Introduction: Communication about the unprecedented number of implantable cardioverter defibrillator (ICD) recalls has proved challenging. While initial studies have explored the psychological impact of recalls on patients, the optimal way to communicate recalls is not currently known. This study investigated the way communication of a recall can affect patients' responses. Methods: Sixty-six ICD patients read one of six vignettes that detailed a hypothetical device recall. Vignette variables included the source of recall dissemination (physician vs. media vs. device manufacturer) and the personal relevance (own brand is recalled vs. different brand is recalled). Subsequently, patients rated their agreement to 12 statements concerning their response to the recall on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Results: Patients were significantly more confident in the accuracy of recall information from both their physician and their manufacturer compared with the media, F (2, 63) = 36.10, P < 0.01, η2= 0.53. Interestingly, patients were concerned about the recall regardless of whether their brand of ICD was recalled. Survey results indicated that 78.6% of patients reported learning about recalls from the media. In stark contrast, 77.0% of patients asserted preferring to learn about recalls from their physician. Conclusions: ICD patients report increased confidence in the accuracy of the recall information from physicians and manufacturers compared with the media in reporting recalls. Because it seems that most ICD patients learn about recalls from the media, these results demonstrate a disconnect between the initial source of recall information and the patients' desired sources. [ABSTRACT FROM AUTHOR]

Background: Multiple clinical trials have shown that a properly functioning implantable cardioverter-defibrillator (ICD) is capable of interrupting sudden death caused by ventricular tachyarrhythmias. However, ICDs are complex medical devices, and they do not always perform as expected or they may fail completely. Exposure of ICD recipients to professional or media reports that their specific device type is potentially malfunctioning could negatively influence their psychological status. Methods: This study aimed to evaluate and quantify psychological distress in patients implanted with an ICD-recall device. Thirty patients implanted with ICD-recall devices (ICD-recall group) and 25 patients with unaffected ICD devices (ICD-control group) were interviewed using the Brief Symptom Inventory (a psychological self-report symptom scale). Results: Mean values of all primary psychiatric distress symptom dimensions and global indices were within the normal range for both the ICD-recall and the ICD-control group. New York Heart Association (NYHA) class was a predictor of higher distress symptoms in all categories, independently of the ICD group. NYHA II group patients tended toward higher stress levels than the NYHA I group, but only somatization was significantly different. An upward, but not significant, trend in 7 of the 12 scales was associated with symptomatic shock experience. Conclusion: This study demonstrates that psychological distress was not significantly increased in patients recently informed about a potential malfunction of their device. [ABSTRACT FROM AUTHOR]