Avoiding Untimely Implantable Cardioverter/Defibrillator Implantation by Intensified Heart Failure Therapy Optimization Supported by the Wearable Cardioverter/Defibrillator—The PROLONG Study

Abstract

BackgroundOptimal timing of implantation of an implantable cardioverter/defibrillator (ICD) after newly diagnosed heart failure is unclear given that late reverse remodelling may occur. We aimed to analyze left ventricular ejection fraction (LVEF) after diagnosis of an LVEF ≤35% during optimization of heart failure drug therapy.Methods and ResultsOne hundred fifty‐six patients with newly diagnosed LVEF ≤35% receiving a wearable cardioverter/defibrillator (WCD) were analyzed. WCD was prescribed for 3 months until first re‐evaluation. Indications for prolongation of WCD wearing period instead of ICD implantation were: (1) LVEF at 3‐month visit 30% to 35%; (2) increase in LVEF of ≥5% compared to the last visit; and (3) nonoptimized heart failure medication. Mean LVEF was 24±7% at diagnosis and 39±11% at last follow‐up (mean, 12±10 months). Whereas 88 patients presented a primary preventive ICD indication (LVEF ≤35%) at 3‐month follow‐up, only 58 showed a persistent primary preventive ICD indication at last follow‐up. This delayed improvement in LVEF was related to nonischemic origin of cardiomyopathy, New York Heart Association functional class at baseline, heart rate, better LVEF after 3 months, and higher dosages of mineralocorticoid receptor antagonist. Twelve appropriate WCD shocks for ventricular tachycardia/ventricular fibrillation occurred in 11 patients. Two patients suffered from ventricular tachycardia/ventricular fibrillation beyond 3 months after diagnosis.ConclusionsA relevant proportion of patients with newly diagnosed heart failure shows recovery of LVEF >35% beyond 3 months after initiation of heart failure therapy. To avoid untimely ICD implantation, prolongation of WCD period should be considered in these patients to prevent sudden cardiac death while allowing left ventricular reverse remodeling during intensified drug therapy.

Risk for life-threatening arrhythmia in newly diagnosed peripartum cardiomyopathy with low ejection fraction: a German multi-centre analysis

“…A structured approach for prolonged but, however, secured optimization of heart failure therapies has been recently published [17]. …”

Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study

“…DANISH underlines that it is important to establish optimal HF medication before decision for permanent ICD implantation is taken. Optimization of HF medication and reverse ventricular remodeling takes time, which can be securely provided by the WCD as presented in the PROLONG study …”

“…The PROLONG study included patients being prescribed with a WCD at Hannover Medical School between June 2012 and January 2016. The detailed study protocol and results have been published elsewhere . The study complies with the Declaration of Helsinki and was approved by the local ethics committee.…”

Absence of left bundle branch block and blood urea nitrogen predict improvement in left ventricular ejection fraction in patients with cardiomyopathy and wearable cardioverter defibrillators

“…As LVEF improves, the need for an ICD for primary prevention of SCD decreases. A study by Duncker et al also showed similar results, with approximately 1/3rd of the patients who received ICDs experiencing LVEF improvement beyond the currently recommended 90 day waiting period …”