Utility of the Wearable Cardioverter-Defibrillator in Patients With Newly Diagnosed Cardiomyopathy

Singh, Manjulata; Wang, Norman C.; Jain, Sandeep; Voigt, Andrew; Saba, Samir; Adelstein, Evan

doi:10.1016/j.jacc.2015.09.079

Cited by 54 publications

(48 citation statements)

References 18 publications

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“…44,45 In a single-center series of 254 NICM patients prescribed WCD use over a period of 10 years, no patients received an appropriate shock. 46 Another study involving a mixed patient population who qualified for WCD use showed that only 2.7% of arrhythmias lasted more than 25 seconds, and that the majority of them were self-terminating. The rate of appropriate shocks was 1.58 per 100 patient-months, and the rate of inappropriate shocks was 0.99 per 100 patient-months.…”

Section: Wearable Cardiac Defibrillatorsmentioning

confidence: 99%

Optimal Strategies for Mitigating Sudden Cardiac Death Risk in At-risk Patients with Structural Heart Disease

Boey

Kojodjojo

2018

J Innov Cardiac Rhythm Manage

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Section: Wearable Cardiac Defibrillatorsmentioning

confidence: 99%

Optimal Strategies for Mitigating Sudden Cardiac Death Risk in At-risk Patients with Structural Heart Disease

Boey

Kojodjojo

2018

J Innov Cardiac Rhythm Manage

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“…The more recent prospective WEARIT-II registry [8] showed a 1% VT/VF event rate in 922 patients with newly diagnosed DCMP within 3 months of WCD therapy. A single center experience [10] reported no shocks for VT/VF in 271 patients with newly diagnosed non-ischemic cardiomyopathy during a median wear time of 71 days. Reversibility of the cardiomyopathy processes, as well as early improvement in LV function with vigorous pharmacological therapy, may explain the low incidence of VT/VF in this patient population, and suggests that the addition of short-term therapy with the WCD may have limited, if any, effect on overall survival.…”

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confidence: 99%

The wearable cardioverter defibrillator: Still without a compelling indication

Ott¹

2017

Cardiovasc Disord Med

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The wearable cardioverter defibrillator (WCD) has recently been introduced as a therapy to reduce mortality in patients presumed to be at increased risk for sudden arrhythmic death. Its efficacy appears to be implied by its proven ability to detect and defibrillate ventricular tachycardia/ventricular fibrillation (VT/VF). However, the currently available data on the WCD is non-randomized and comes from several reports of single center experiences, and reviews of post market release, often vendor supported, registry data. In the absence of randomized trials, the effect of the WCD on patient survival cannot be determined. The mere ability to shock terminate VT/VF by the WCD does not suffice to assume a reduction in mortality when used in large patient populations. These severe limitations have been acknowledged in the recent AHA science advisory report [1], providing a "tentative interim framework" resulting in mostly class II b recommendations ("treatment may be considered") with only level C support ("consensus opinion by experts only"). This contrast sharply with AHA class I recommendations ("treatment should be considered") with level A support ("multiple clinical randomized trials") for the implantable cardioverter defibrillator (ICD).The WCD is being heavily advertised to temporarily "protect" patients presumed at increased risk for arrhythmic death (primary prevention), in particular patients early after acute myocardial infarction (MI) or with newly diagnosed dilated cardiomyopathy. In these patient populations, several randomized trials with the implantable ICD [2-4] failed to show mortality reduction and these patients remain temporarily ineligible for device implantation for a period of 40 days (early after acute MI) or 90 days (newly diagnosed dilated cardiomyopathy). In practical terms, these time periods serve to allow for optimizing medical therapy, which often results in improvement of cardiac function with subsequent removal from ICD eligibility. The actual mortality risk, and in particular the risk of sudden arrhythmic death, and thus the utility of the WCD during these waiting periods is not well established.Clinical research has shown an increased risk of sudden death in patients early after acute MI. One of the largest trials, addressing this clinical issue, was the VALIANT trial [5], it randomized 14,609 patients after acute MI with reduced LV function and/or clinical heart failure to valsartan, captopril, or both. During 2.4 year follow up, 2,800 deaths were observed, of which 1067 were classified as either sudden death (N= 903) or resuscitated cardiac arrest (n= 104). The median time to event occurrence was 180 days, but 580 events occurred within the first 30 days (event rate 1.4%), suggesting a possible role for defibrillator therapy early after acute MI. However, two trials [2,3] in a total of 1,572 patients early after acute MI with reduced LV function and additional risk markers, randomized to medical therapy with or without ICD implantation, failed to show a reduction in overall morta...

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“…It has been marketed for use in patients deemed at elevated risk of SCD from ventricular arrhythmias in whom a permanent ICD is either contraindicated or under consideration. To date, there have been several publications describing its use in clinical registries [5,6], national experiences [4,7], and single-center studies [8], primarily as a short-term means of mitigating risk while patients undergo more comprehensive evaluation or titration of medical therapy. There are, at present, no currently published randomized WCD clinical trials demonstrating a mortality benefit.…”

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confidence: 99%

“…On a psychosocial level, wearing the WCD consistently for a year requires tremendous personal fortitude. If one assumes a monthly fee of $3000 for the WCD [8], its cost over 1 year is similar to an ICD, yet after that year, additional protection against SCD will require additional financial input.…”

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confidence: 99%

“…The most disconcerting aspects of this manuscript are the unorthodox reasons listed for prolonged WCD use. Appropriate WCD shocks are relatively rare during the period of medical titration [8], particularly among non-ischemic primary prevention patients, so long-term WCD use in this population may reflect physicians' perceived risk rather than actual risk. Immediately after myocardial infarction, ICDs have no demonstrated survival benefit; therefore, the role of the WCD in this population is also unclear [10,11].…”

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Long-term use of the wearable cardioverter-defibrillator: prolonging life or prolonging indecision?

Adelstein

2016

J Interv Card Electrophysiol

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Predicting future risk is difficult. Predicting sudden cardiac death (SCD) is a particular challenge, given its finality, suddenness, inherent unpredictability, and medicolegal ramifications. Yet the task of prognosticating SCD risk is often thrust upon electrophysiologists in the setting of a new cardiomyopathy.The implantable cardioverter-defibrillator (ICD) mitigates SCD risk in patients at increased risk for ventricular arrhythmias. Its effectiveness is largely not questioned [1], although the appropriate population who should receive an ICD is still being refined [2]. The wearable cardioverter-defibrillator (WCD) was approved by the U.S. Food and Drug Administration in 2001 as a temporary device that continuously monitors cardiac rhythm and is highly effective in terminating potentially lethal arrhythmias [3][4][5]. It has been marketed for use in patients deemed at elevated risk of SCD from ventricular arrhythmias in whom a permanent ICD is either contraindicated or under consideration. To date, there have been several publications describing its use in clinical registries [5,6], national experiences [4,7], and single-center studies [8], primarily as a short-term means of mitigating risk while patients undergo more comprehensive evaluation or titration of medical therapy. There are, at present, no currently published randomized WCD clinical trials demonstrating a mortality benefit.In this issue of the Journal of Interventional Cardiac Electrophysiology, Lamichhane et al. [9] describe the U.S. experience with long-term WCD use in patients with ischemic or non-ischemic cardiomyopathy, primary or secondary prevention indication, no prior ICD, and LVEF ≤35%. Remarkably, 220 patients were prescribed with the WCD for ≥1 year, and the median number of actual use days was 394. Despite such prolonged use, over half of all the patients wore the WCD >80% of the day.Long-term WCD use has not been heretofore described in the literature. In the present study, some reasons cited for longterm use rather than ICD implantation included continued optimization of medical therapy (7.7%), non-compliance for follow-up (10%), patient postponement or unwillingness to have an ICD (16.8%), ongoing evaluation for an ICD (34.5%), and contraindication to an ICD because of cancer, poor prognosis, or vascular access issues (23.2%). The incidence of appropriate shocks was 4.1%; 9 of the 220 patients received a shock, 3 of whom already had prior sustained ventricular arrhythmias (i.e., secondary prevention indication). Of the remaining 6 (2.9%) primary prevention patients, 4 had ischemic cardiomyopathy and 2 had non-ischemic cardiomyopathy. One non-ischemic patient had reported WolffParkinson-White syndrome, and another had chronic lymphocytic leukemia.The WCD has proven effectiveness in terminating tachyarrhythmias. In this study, the WCD successfully terminated 92% of VT/VF episodes. However, there is no mention of cost, either personal or monetary. On a psychosocial level, wearing the WCD consistently for a year requires tremendous pers...

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Utility of the Wearable Cardioverter-Defibrillator in Patients With Newly Diagnosed Cardiomyopathy

Cited by 54 publications

References 18 publications

Optimal Strategies for Mitigating Sudden Cardiac Death Risk in At-risk Patients with Structural Heart Disease

Optimal Strategies for Mitigating Sudden Cardiac Death Risk in At-risk Patients with Structural Heart Disease

The wearable cardioverter defibrillator: Still without a compelling indication

Long-term use of the wearable cardioverter-defibrillator: prolonging life or prolonging indecision?

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