The Wearable Cardioverter-Defibrillator: Experience in 153 Patients and a Long-Term Follow-Up

Background: The wearable cardioverter-defibrillator (WCD) is available for patients at high risk for sudden cardiac death (SCD) when immediate implantable cardioverter-defibrillator (ICD) implantation is not possible or indicated. Patient selection remains challenging especially in primary prevention. Long-term data on these patients is still lacking. Methods: 153 patients were included in this study. They were prescribed the WCD between April 2012 and March 2019 at the University Medical Center, Mannheim, Germany. The mean follow-up period was 36.2 ± 15.6 months. Outcome data, including all-cause mortality, were analyzed by disease etiology and ICD implantation following WCD use. Results: We analyzed 56 patients with ischemic cardiomyopathy, 70 patients with non-ischemic cardiomyopathy, 16 patients with prior need for ICD/CRT-D (device for cardiac resynchronization therapy with defibrillator) explanation, 8 patients with acute myocarditis and 3 patients with congenital diseases. 58% of the patients did not need ICD/CRT-D implantation after WCD use. 4% of all patients suffered from appropriate WCD shocks. 2 of these patients (33%) experienced appropriate ICD shocks after implantation due to ventricular tachyarrhythmias. Long-term follow-up shows a good overall survival. All-cause mortality was 10%. There was no significant difference between patients with or without subsequent ICD implantation (p = 0.48). Patients with ischemic cardiomyopathy numerically showed a higher long-term mortality than patients with non-ischemic cardiomyopathy (14% vs. 6%, p = 0.13) and received significantly more ICD shocks after implantation (10% of ischemic cardiomyopathy (ICM) patients versus 3% of non-ischemic cardiomyopathy (NICM) patients, p = 0.04). All patients with ventricular tachyarrhythmias during WCD use or after ICD implantation survived the follow-up period. Conclusion: Following WCD use, ICD implantation could be avoided in 58% of patients. Long-term follow-up shows good overall survival. The majority of all patients did not suffer from WCD shocks nor did receive ICD shocks after subsequent implantation. Patient selection regarding predictive conditions on long-term risk of ventricular tachyarrhythmias needs further risk stratification.

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Abstract 12637: Utility of the Wearable Cardioverter-Defibrillator for Patients With Newly Diagnosed Non-Ischemic Cardiomyopathy?

Circulation ◽

10.1161/circ.130.suppl_2.12637 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Madhurmeet Singh ◽

Krishna Alluri ◽

Andrew Voigt ◽

Norman Wang ◽

Sandeep Jain ◽

...

Keyword(s):

Ischemic Cardiomyopathy ◽

Beta Blockers ◽

Care Center ◽

Tertiary Care ◽

Newly Diagnosed ◽

Icd Implantation ◽

Cardioverter Defibrillator ◽

Wearable Cardioverter Defibrillator ◽

Inappropriate Shocks

Introduction: The wearable cardioverter-defibrillator (WCD) is approved for prevention of sudden cardiac death in patients with newly diagnosed cardiomyopathy and LVEF < 35% who do not yet meet criteria for implantation of an implantable cardioverter-defibrillator (ICD). While there are some data supporting WCD use in patients with ischemic cardiomyopathy (ICM), data in patients with nonischemic cardiomyopathy (NICM) are lacking. Methods: This was a retrospective review of outcomes for all NICM patients prescribed a WCD at a large tertiary academic center from 6/2004 - 1/2014 for a newly diagnosed cardiomyopathy and no prior sustained ventricular arrhythmia. During this time period, 454 patients were prescribed a WCD, of whom we excluded 161 patients with ICM. Results: The 183 (40%) patients with NICM consisted of 70% men, aged 57 +/- 15 years old, with mean EF 23% +/- 8% and LV end-diastolic dimension 4.5 +/- 2.8 cm. DM and HTN were prevalent (20% and 51%, respectively). At NICM diagnosis, 21% had LBBB and 36% had known history of AF. Patients wore the WCD for 13,124 patient-days, each averaging 72 +/- 55 days and with fairly high compliance (18.3 +/- 5.7 hours/day). Medication use consisted of 90% beta-blockers, 88% ACE inhibitors, 85% diuretics, 16% digoxin, and 17% anti-arrhythmic drugs. NSVT was documented in 42% of patients prior to WCD prescription. During follow-up, 60 (33%) patients improved LVEF to > 35%, obviating an indication for ICD implantation, whereas 79 (43%) patients received an ICD. The remainder died (n=17), were lost to follow-up (n=20), refused ICD implant (n=5), or are still wearing the WCD (n=2). No appropriate WCD shocks were delivered in any NICM patient, yet 3 inappropriate shocks were delivered (1.6%). Based on estimated rental costs provided by the manufacturer, the total cost of WCD use in this population was $1,449,360. Conclusions: In this large, tertiary care center registry of patients with newly recognized NICM, no patient received an appropriate shock from the WCD whereas several inappropriate shocks were delivered, despite nearly one-half of patients having documented significant ventricular ectopy. Given the significant expense and inconvenience of the WCD, its use in this population requires prospective study.

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P5692Catheter ablation of ventricular tachyarrhythmias in ischemic patients may contribute to better survival: a new clinical challenge

European Heart Journal ◽

10.1093/eurheartj/ehz746.0634 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

S Garkina ◽

R Tatarskii ◽

E Mikhaylov ◽

V Lebedeva ◽

T Lyubimtseva ◽

...

Keyword(s):

Myocardial Infarction ◽

Ischemic Cardiomyopathy ◽

Life Quality ◽

Functional Class ◽

Electrical Storm ◽

Ventricular Tachyarrhythmias ◽

Nyha Functional Class ◽

Long Term Follow Up

Abstract Background Ventricular arrhythmias contribute to significant escalation of mortality rate in patients with ischemic cardiomyopathy (ICM). Risk of sudden cardiac death (SCD) could be reduced after implantation of a cardioverter-defibrillator (ICD), yet at the same time more frequent shock episodes are associated with poor life quality and higher hospitalization rate. Radiofrequency (RF) ablation of triggering ventricular premature beats or substrate-based catheter treatment are considered to be effective in patients with ICM but prognosis remains controversial. Objective To evaluate role of catheter treatment of ventricular tachyarrhythmias (VTA) and its effect on survival in patients with ischemic cardiomyopathy. Methods We enrolled 72 consecutive patients (mean age 64±13 years, 63 male) with prior myocardial infarction (more than 40 days ago) and documented ventricular tachycardia (VT) episodes, including 12 patients which underwent emergency electrical storm ablation. Considering number of VT recurrence episodes after catheter treatment all patients were divided into two groups. First group consisted of 27 patients (37%) with recurrent sustained VT (mean age 62±10 years) while second group included 45 patients (63%) without VT recurrence (mean age 63±12 years). During follow up most of VT episodes were registered in 13±9 years after acute myocardial infarction. Catheter treatment included mapping during hemodynamically tolerated clinically relevant VT and then ablation of VT triggers with subsequent homogenization of the scar. Patients with “fast” VT underwent primary scar homogenization. Results Effectiveness of clinically relevant VT ablation in patients with ICM was 63%. During follow-up period all patients were alive and remained relatively stable. Long-term effectiveness of ES elimination was 100% while freedom from clinically significant VTA was up to 79% due to repeated ablation procedures. We also observed improvement of NYHA functional class in 80% of patients. Conclusion Catheter ablation of VTA may be effective treatment both in acute period and long term follow up. It also may be effective in improvement of heart failure NYHA functional class in some patients and contributes to better survival in patients with ICM.

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911Which patients are most likely to benefit from the wearable cardioverter-defibrillator? Findings from the Swiss WCD registry

EP Europace ◽

10.1093/europace/euaa162.296 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

B Kovacs ◽

S Reek ◽

A Linka ◽

P Ammann ◽

A S Mueller ◽

...

Keyword(s):

Heart Disease ◽

Ischemic Cardiomyopathy ◽

Icd Implantation ◽

Cardioverter Defibrillator ◽

Wear Time ◽

Wearable Cardioverter Defibrillator ◽

Time Period ◽

Appropriate Therapy ◽

The Mean

Abstract OnBehalf Swiss WCD Registry Introduction The wearable cardioverter-defibrillator (WCD) has established itself as a temporary protection from sudden arrhythmogenic death in selected patients at risk. However, it is still of debate which patients and for what duration benefit from its use. Therefore, appropriate patient selection is key. Purpose: This study reports the results of the Swiss WCD registry with an emphasis on implantable cardioverter-defibrillator (ICD) implantation rate and ICD therapies. Methods We retrospectively reviewed the indications, baseline characteristics and administered therapies in patients prescribed a WCD at 12 participating centers rom 2014 until 2018 in Switzerland. Further data on medical therapy, WCD therapy adherence, and ICD implantation rates were collected. Results 456 patients were included in our study comprising of 66% of all Swiss patients prescribed a WCD in the examined time period. The mean age was 57 ±14 years, 18% were female and the mean ejection fraction (EF) was 32% ± 13. Indications for WCD use and appropriate shock rate are shown in the figure. Patients wore the WCD over a median of 58 days (range 1-455) with a median daily average wear-time of 22.6 hours (range 0.6-23.8). 17 appropriate therapies were administered by the WCD to a total of 12 patients leading to a therapy rate of 2.6% over a median wear-time of 16 days (range 2-79) and to a therapy rate of 3.9% in patients with ischemic cardiomyopathy (ICM) with an EF ≤35%. ICM with an EF ≤35% and bridging to ICD-implantation or heart transplantation as indication for WCD prescription were significantly associated with an appropriate therapy (p = 0.046 and 0.003, respectively). One patient with non-ischemic cardiomyopathy (NICM) received an appropriate therapy (0.8%). The mean EF in patients receiving an appropriate therapy by the WCD was also significantly lower (p = 0.04). No patient with wearing the WCD for congenital/inherited heart disease or risk stratification with an EF >35% had a therapy administered by the WCD. There were no inappropriate therapies during the investigated time period. After cessation of WCD use EF improved to 38% ±13; ultimately, 212 patients (46%) were implanted with an ICD. During a follow-up of 476 days (range 7-2347) 22 (9.8%) patients received an appropriate therapy by their ICD. Four of the 22 had prior appropriate therapy by the WCD. Conclusions ICM with severely reduced EF was the most common indication for WCD use leading to a high rate of appropriate therapy by the WCD. This, however, did not translate in a higher rate of appropriate ICD-therapies during follow-up in this subpopulation possibly due to significant improvements in their ejection fractions. Patients with NICM or congenital/inherited heart disease seldom had an appropriate therapy by the WCD. Abstract Figure. Indications for WCD use and therapy rate

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Small left ventricular size predicts implantable cardioverter defibrillator therapy in long-term observation of patients with left ventricular assist device for non-ischemic cardiomyopathy

EP Europace ◽

10.1093/europace/euab116.333 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

M Nakao ◽

M Watanabe ◽

T Koizumi ◽

T Kadosaka ◽

T Koya ◽

...

Keyword(s):

Heart Failure ◽

Implantable Cardioverter Defibrillator ◽

Ischemic Cardiomyopathy ◽

Left Ventricular ◽

Idiopathic Dilated Cardiomyopathy ◽

Electrical Storm ◽

Cardioverter Defibrillator ◽

Long Term Follow Up

Abstract Funding Acknowledgements Type of funding sources: None. Background The number of patients who received left ventricular assisted device (LVAD) implantation because of end-stage heart failure has been increasing. In those patients, ventricular arrhythmias (VAs) occur commonly, and electrical storm (ES) and shock therapies by implantable cardioverter-defibrillator (ICD) are considered to increase mortality. Although it is important to identify patients with higher risk of VA events, there have been limited data reporting the risk of VAs in LVAD patients during long-term follow up, especially in non-ischemic cardiomyopathy (NICM). Purpose We sought to clarify the predictors of ICD therapies in LVAD patients diagnosed as NICM during long-term follow up. Methods We retrospectively analyzed non-ischemic heart failure patients whom a continuous flow LVAD was implanted as a bridge to transplantation therapy from July 2011 to February 2019. ICD programming was generally set as follows; one zone setting (VF zone with maximum shocks) for primary prevention or two zone setting (VF with maximum shocks and VT with ATPs and shocks) for secondary prevention. ICD settings were generally unchanged after LVAD implantation. Clinical and echocardiographic data were collected before and 3 months after LVAD implantation. Device interrogation was performed every 4 - 6 months at out-patient clinic. Patients were followed until May 2019. Results A total of 25 patients were included in the study. The mean age was 49 years, 88% were men. They majority of patients (52%) were diagnosed as idiopathic dilated cardiomyopathy. During the median follow up duration of 889 days (IQR 546 – 2070), 27 appropriate shock events occurred in 7 patients and 154 appropriate ATP-only events in 10 patients. The group with appropriate ICD event (11 patients, 44%) had significantly smaller LVDd (65.2 ± 4.0 vs. 79.4 ± 3.5 mm; p = 0.01) and higher LVEF (26.2 ± 1.6 vs. 20.5 ± 1.4 %; p = 0.02) before LVAD implantation. When patients were divided into 2 groups based on the median value (70.0 mm) of LVDd before LVAD implantation (pre LVDd), patients with smaller pre LVDd (≤ 70mm) had significantly higher rate of appropriate ICD treatment than those with larger pre LVDd (> 70 mm) (Log-rank p < 0.01). In univariate cox regression analysis, pre LVDd was negatively associated with appropriate ICD therapy (hazard ratio 0.94, 95% confidence interval 0.88 - 0.99; p = 0.02). Conclusion Smaller LVDd before LVAD implantation might be a possible predictor of appropriate ICD treatment in patients with NICM. Abstract Figure.

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Predictors of all-cause mortality among patients with implantable cardiac defibrillators for nonischemic heart failure with reduced ejection fraction

EP Europace ◽

10.1093/europace/euab116.423 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

G Cinier ◽

MI Hayiroglu ◽

AC Yumurtas ◽

Z Kolak ◽

T Cetin ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Cox Regression ◽

Icd Implantation ◽

Reduced Ejection Fraction ◽

All Cause Mortality ◽

Long Term Follow Up ◽

Implantable Cardiac Defibrillators

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardiac defibrillators (ICD’s) are recommended in patients with heart failure with reduced ejection fraction (HFrEF) of nonischemic etiology. Determining patients who are at high risk despite ICD implantation is of clinical value. Methods Between 2009-2019 patients who were implanted ICD due to nonischemic HFrEF were included to the present analysis. Baseline characteristics, laboratory parameters and echocardiographic findings were obtained from the electronic database. The primary outcome was all-cause mortality. Appropriate and inappropriate device therapies were also extracted from the database and was confirmed with patients’ reports. Predictors for long term all-cause mortality was determined by using Cox regression analysis. Results Overall, 1199 patients were screened and 238 were eligible for the analysis. ICD’s were implanted for primary and secondary prevention in 68 (28.6%) and 170 (71.4%) of patients respectively. Multivariate analysis revealed that increased pro-BNP [Hazard ratio (HR): 1.001, 95% Confidence interval (CI): 1.000 – 1.001, p = 0.024] and reduced left ventricle ejection fraction (HR: 0.950, 95% CI: 0.907 – 0.994, p: 0.026) predicted all-cause mortality during long term follow up. Pro-BNP > 425 pg/ml has sensitivity and specificity of 74% for each in predicting all-cause mortality. Conclusion Among patients who were implanted ICD for HFrEF of nonischemic etiology, higher pro-BNP prior to the implantation and lower LVEF predicted all-cause mortality during long term follow up. Table 1Univariate analysisP valueHR (95% CI)Multivariate analysisP valueHR (95% CI)Diabetes mellitus0.0062.587 (1.315 - 5.090)Diabetes mellitus0.1441.837 (0.812 - 4.153)Atrial fibrillation0.0023.080 (1.531 - 6.195)Atrial fibrillation0.1811.738 (0.774 - 3.903)NYHA > 20.0172.394 (1.168 - 4.908)NYHA > 20.2531.642 (0.701 - 3.847)RDW0.0441.191 (1.005 - 1.412)RDW0.6461.046 (0.862 - 1.270)Lymphocytes0.0220.616 (0.408- 0.932)Lymphocytes0.1650.683 (0.399 - 1.170)Blood urea nitrogen0.0381.015 (1.001- 1.030)Blood urea nitrogen0.1521.015 (0.995 - 1.036)Pro-BNP<0.0011.001 (1.000 - 1.001)Pro-BNP0.0241.001 (1.000 - 1.001)Albumin<0.0010.252 (0.143 - 0.444)Albumin0.0790.525 (0.256 - 1.079)Ejection fraction<0.0010.921 (0.885 - 0.959)Ejection fraction0.0260.950 (0.907 - 0.994)LVEDD0.0011.408 (1.017 - 1.079)LVEDD0.1521.078 (0.973 - 1.194)LVESD0.0041.038 (1.012 - 1.065)LVESD0.2890.957 (0.883 - 1.038)Appropriate shock in follow-up0.0102.407 (1.237 - 4.684)Appropriate shock in follow-up0.1561.768 (0.805 - 3.883)Univariate and multivariate Cox regression analyses for long-term mortality after ICD implantation Abstract Figure 1

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Long-term Follow-up of the The Danish Study to Assess theEfficacy of ICDs in Patients with Non-ischemic Systolic HeartFailure on Mortality (DANISH)

Circulation ◽

10.1161/circulationaha.121.056072 ◽

2021 ◽

Author(s):

Adelina Yafasova ◽

Jawad H. Butt ◽

Marie B. Elming ◽

Jens C. Nielsen ◽

Jens Haarbo ◽

...

Keyword(s):

Heart Failure ◽

Systolic Heart Failure ◽

Cardiovascular Death ◽

Control Group ◽

Icd Implantation ◽

All Cause Mortality ◽

Long Term Follow Up ◽

Overall Survival Benefit

Background: The Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators (ICDs) in Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH) found that primary-prevention ICD implantation was not associated with an overall survival benefit in patients with non-ischemic systolic heart failure during a median follow-up of 5.6 years, though there was a beneficial effect on all-cause mortality in patients ≤70 years. This study presents an additional four years of follow-up data from DANISH. Methods: In DANISH, 556 patients with non-ischemic systolic heart failure were randomized to receive an ICD and 560 to receive usual clinical care and followed until June 30, 2016. In this long-term follow-up study, patients were followed until May 18, 2020. Analyses were conducted for the overall population and according to age (≤70 and >70 years). Results: During a median follow-up of 9.5 years (25 th -75 th percentile, 7.9-10.9 years), 208/556 patients (37%) in the ICD group and 226/560 patients (40%) in the control group died. Compared with the control group, the ICD group did not have significantly lower all-cause mortality (HR 0.89 [95%CI,0.74-1.08]; P=0.24). In patients ≤70 years (n=829), all-cause mortality was lower in the ICD group than the control group (117/389 [30%] vs 158/440 [36%]; HR 0.78 [95%CI,0.61-0.99]; P=0.04), whereas in patients >70 years (n=287), all-cause mortality was not significantly different between the ICD and control group (91/167 [54%] vs 68/120 [57%]; HR 0.92 [95%CI,0.67-1.28]; P=0.75). Cardiovascular death showed similar trends (overall, 147/556 [26%] vs 164/560 [29%], HR 0.87 [95%CI,0,70-1.09], P=0.20; ≤70 years, 87/389 [22%] vs 122/440 [28%], HR 0.75 [95%CI,0.57-0.98], P=0.04; >70 years, 60/167 [36%] vs 42/120 [35%], HR 0.97 [95%CI,0.65-1.45], P=0.91). The ICD group had a significantly lower incidence of sudden cardiovascular death in the overall population (35/556 [6%] vs 57/560 [10%]; HR 0.60 [95%CI,0.40-0.92]; P=0.02) and in patients ≤70 years (19/389 [5%] vs 49/440 [11%]; HR 0.42 [95%CI,0.24-0.71]; P=0.0008), but not in patients >70 years (16/167 [10%] vs 8/120 [7%]; HR 1.34 [95%CI,0.56-3.19]; P=0.39). Conclusions: During a median follow-up of 9.5 years, ICD implantation did not provide an overall survival benefit in patients with non-ischemic systolic heart failure. In patients ≤70 years, ICD implantation was associated with a lower incidence of all-cause mortality, cardiovascular death, and sudden cardiovascular death. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00542945.

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