Failure to treat ventricular tachycardia or ventricular fibrillation by implantable cardioverter-defibrillators.

BACKGROUND: Normally functioning implantable cardioverter-defibrillators (ICDs) with intact lead systems occasionally fail to deliver therapy for ventricular tachycardia/fibrillation (VT/VF) or deliver it only after clinically significant delays (failure-to-treat). OBJECTIVE: We aimed to investigate ICD failure-to-treat VT/VF in a large patient cohort. METHODS: We searched the US Food and Drug Administration's online Manufacturer and User Facility Device Experience (MAUDE) database from 2019 to 2023 for manufacturer-verified reports in which normally functioning ICDs failed to treat VT/VF. RESULTS: We identified 854 reports classified as deaths (n = 96 [11.2%]), injuries (n = 585 [68.5%]), or malfunctions (n = 173 [20.3%]) for normally functioning ICDs. The most common causes were misclassification as supraventricular tachycardia (SVT) or atrial fibrillation (AF; 54.8%), undersensing (21.1%), and failure to satisfy programmed rate/duration criteria (8.7%). Most events caused by misclassification as SVT/AF (89.5%) and failure to satisfy rate/duration criteria (70.3%) were VT; most caused by undersensing were either VF (54.4%) or not specified as VT or VF (19.4%). Undersensing caused 65.6% of deaths, although it represented only 21.1% of reports. In the United States, the number of reports increased faster than that of ICD patients. CONCLUSION: In the largest reported series of failure-to-treat VT/VF by normally functioning ICDs, the most common cause was misclassification of VT as SVT/AF; the most common cause of death was undersensing of VF. Although relatively few patients with normally functioning ICDs experience failure-to-treat VT/VF, the absolute number of verified MAUDE reports suggests that more work is needed to quantify the magnitude of the problem, to identify root causes, and to develop solutions.

Arrhythmias in Cardiac Sarcoidosis Bench to Bedside: A Case-Based Review.

Cardiac sarcoidosis is a component of an often multiorgan granulomatous disease of still uncertain cause. It is being recognized with increasing frequency, mainly as the result of heightened awareness and new diagnostic tests, specifically cardiac magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography scans. The purpose of this case-based review is to highlight the potentially life-saving importance of making the early diagnosis of cardiac sarcoidosis using these new tools and to provide a framework for the optimal care of patients with this disease. We will review disease mechanisms as currently understood, associated arrhythmias including conduction abnormalities, and atrial and ventricular tachyarrhythmias, guideline-directed diagnostic criteria, screening of patients with extracardiac sarcoidosis, and the use of pacemakers and defibrillators in this setting. Treatment options, including those related to heart failure, and those which may help clarify disease mechanisms are included.

Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator.

BACKGROUND: Implantation of implantable cardioverter defibrillator for prevention of sudden cardiac death is deferred for 90 days after coronary revascularization, but mortality may be highest early after cardiac procedures in patients with ventricular dysfunction. We determined mortality risk in postrevascularization patients with left ventricular ejection fraction ≤35% and compared survival with those discharged with a wearable cardioverter defibrillator (WCD). METHODS AND RESULTS: Hospital survivors after surgical (coronary artery bypass graft surgery) or percutaneous (percutaneous coronary intervention [PCI]) revascularization with left ventricular ejection fraction ≤35% were included from Cleveland Clinic and national WCD registries. Kaplan-Meier, Cox proportional hazards, propensity score-matched survival, and hazard function analyses were performed. Early mortality hazard was higher among 4149 patients discharged without a defibrillator compared with 809 with WCDs (90-day mortality post-coronary artery bypass graft surgery 7% versus 3%, P=0.03; post-PCI 10% versus 2%, P<0.0001). WCD use was associated with adjusted lower risks of long-term mortality in the total cohort (39%, P<0.0001) and both post-coronary artery bypass graft surgery (38%, P=0.048) and post-PCI (57%, P<0.0001) cohorts (mean follow-up, 3.2 years). In propensity-matched analyses, WCD use remained associated with lower mortality (58% post-coronary artery bypass graft surgery, P=0.002; 67% post-PCI, P<0.0001). Mortality differences were not attributable solely to therapies for ventricular arrhythmia. Only 1.3% of the WCD group had a documented appropriate therapy. CONCLUSIONS: Patients with left ventricular ejection fraction ≤35% have higher early compared to late mortality after coronary revascularization, particularly after PCI. As early hazard seemed less marked in WCD users, prospective studies in this high-risk population are indicated to confirm whether WCD use as a bridge to left ventricular ejection fraction improvement or implantable cardioverter defibrillator implantation can improve outcomes after coronary revascularization.