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

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
B Kovacs ◽  
S Reek ◽  
A Linka ◽  
P Ammann ◽  
A S Mueller ◽  
...  

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

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Kutyifa ◽  
K Vermilye ◽  
W Zareba ◽  
S McNitt ◽  
I Goldenberg

Abstract Background The use of the wearable cardioverter-defibrillator (WCD) in patients with non-ischemic cardiomyopathy has been less characterized. Objective We aimed to characterize WCD use and outcomes for patients with ischemic or non-ischemic cardiomyopathy, enrolled in the WEARIT-II Registry. Methods In WEARIT-II, we stratified 1,732 patients into ischemic (n=805) and non-ischemic etiology (n=927). WCD wear time, arrhythmia events during WCD use, and implantable cardioverter-defibrillator (ICD) implantation rates, or ejection fraction (EF) improvement at the end of WCD were evaluated for etiology subgroups. Results The WCD median wear time was higher in patients with non-ischemic cardiomyopathy (93 vs. 87 days, p=0.003), however daily use was similar (22.4 vs. 22.6 hours, p=0.07). There were 24 ischemic patients (3%) with sustained VT/VF events compared to 10 patients (1%) with non-ischemic cardiomyopathy (p=0.013). About 2/3 of these events were treated with WCD shock in ischemic patients, half of them in the non-ischemic group (1.9% vs. 0.4%). Atrial arrhythmias were frequent in both groups (3.1% vs. 3.1%, p=0.06). At the end of WCD use, 36% of the non-ischemic patients were implanted with an ICD compared to 42% in ischemic (p=0.01), likely due to the lower rate of sustained ventricular arrhythmias (Figure). Figure 1 Conclusions In WEARIT-II, patients with non-ischemic cardiomyopathy had longer WCD use than ischemic patients with good compliance. The rate of sustained ventricular arrhythmia events was lower in non-ischemic patients avoiding the need for an ICD implantation in more patients compared to ischemic, following a time period of risk stratification. Acknowledgement/Funding WEARIT-II was funded by an unrestricted research grant from ZOLL Inc.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Madhurmeet Singh ◽  
Krishna Alluri ◽  
Andrew Voigt ◽  
Norman Wang ◽  
Sandeep Jain ◽  
...  

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.


2020 ◽  
Vol 9 (3) ◽  
pp. 893
Author(s):  
Stephanie L. Rosenkaimer ◽  
Ibrahim El-Battrawy ◽  
Tobias C. Dreher ◽  
Stefan Gerhards ◽  
Susanne Röger ◽  
...  

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.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Chingping Wan ◽  
Steven J Szymkiewicz

Introduction: The wearable cardioverter defibrillator (WCD) has been used to protect AMI patients with reduced LVEF (≤35%) until ICD evaluation is recommended. The rate of EF improvement (e.g. EF>35%) over the initial 8-12 weeks after AMI has not been reported. METHODS: The manufacturer-maintained registry was searched for AMI patients who received a WCD shock for VT/VF between 05/2008 and 02/2013. The treated group was matched (1: ~4) with event-free WCD patients by ICD-9 code (410.*), gender, age and prescription date. Chart notes were reviewed for clinical characteristics. Follow-up was assessed through the registry and Social Security Death Master File. RESULTS: There were 992 (age=63±12, female=20.2%) AMI patients included in the final analysis, 206 treated by WCD and 786 event-free patients. Median follow-up was 334 days. Mean length of WCD use was 67±506 (median=38) days. Subgroup clinical characteristics are presented in Table 1. In the event-free group, 289 (38.9%) patients showed EF improvement to >35%. Nine (4.5%) in the treated group continued wearing the WCD until EF recovery, while 125 (60.7%) received ICD. Absence of recorded heart failure and/or diabetes were associated with LVEF recovery (p<.0001). CONCLUSION: In our study, almost 40% of AMI patients with initial EF ≤35% had EF improvement in two months. The EF recovery group had lower rates of heart failure and diabetes. WCD allows time for left ventricular function recovery in low EF post MI patients, optimizing ICD implantation decisions.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Sem Briongos‐Figuero ◽  
Arcadio García‐Alberola ◽  
Jerónimo Rubio ◽  
José María Segura ◽  
Aníbal Rodríguez ◽  
...  

Background Large‐scale studies describing modern populations using an implantable cardioverter‐defibrillator (ICD) are lacking. We aimed to analyze the incidence of arrhythmia, device interventions, and mortality in a broad spectrum of real‐world ICD patients with different heart disorders. Methods and Results The UMBRELLA study is a prospective, multicenter, nationwide study of contemporary patients using an ICD followed up by remote monitoring, with a blinded review of arrhythmic episodes. From November 2005 to November 2017, 4296 patients were followed up. After 46.6±27.3 months, 16 067 episodes of sustained ventricular arrhythmia occurred in 1344 patients (31.3%). Appropriate ICD therapy occurred in 27.3% of study population. Patients with ischemic cardiomyopathy (hazard ratio [HR], 1.51; 95% CI, 1.29–1.78), dilated cardiomyopathy (HR, 1.28; 95% CI, 1.07–1.53), and valvular heart disease (HR, 1.94; 95% CI, 1.43–2.62) exhibited a higher risk of appropriate ICD therapies, whereas patients with hypertrophic cardiomyopathy (HR, 0.72; 95% CI, 0.54–0.96) and Brugada syndrome (HR, 0.25; 95% CI, 0.14–0.45) showed a lower risk. All‐cause death was 13.4% at follow‐up. Ischemic cardiomyopathy (HR, 3.09; 95% CI, 2.58–5.90), dilated cardiomyopathy (HR, 3.33; 95% CI, 2.18–5.10), and valvular heart disease (HR, 3.97; 95% CI, 2.25–6.99) had the worst prognoses. Delayed high‐rate detection was enabled in 39.7% of patients, and single‐zone programming occurred in 52.6% of primary prevention patients. Both parameters correlated with lower risk of first appropriate ICD therapy, with no excess risk of mortality. The rate of inappropriate shocks at follow‐up was low (6%) and did not differ among type of ICD but was lower in SmartShock‐capable devices. Conclusions Irrespective of the cause, contemporary ICD patients with heart failure–related disorders had a similar risk of ICD life‐saving interventions and death. Current ICD programming recommendations still need to be implemented. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NTC01561144.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sisir Siddamsetti ◽  
Mojgan Golzy ◽  
Sandeep Gautam

Introduction: Cardiac amyloidosis is associated with high risk for sudden cardiac death. However, the potential benefit of implantable cardioverter defibrillator (ICD) implantation in CA is unknown due to limited available data regarding outcomes following ICD implantation in this patient population. We sought to perform a meta-analysis of trials that evaluated the outcomes of ICD implantation in CA. Methods: We performed a systematic literature review in PubMed, SCOPUS, and Cochrane to identify all studies that evaluated ICD therapy in CA until May 2020. Outcomes analyzed were all-cause mortality and appropriate ICD therapy rates. A random effects model was used to calculate percentages and 95% confidence intervals (CI) of outcomes. Results: Of the screened articles, 5 observational studies were included for analysis. A total of 151 patients were analyzed. Mean age of population was 61.6 +/- 0.7 years and 79.2% were male. The all-cause mortality rate was 33% (95% CI:16 to 51%) and the incidence of appropriate ICD therapy was 23% (95% CI:16 to 30%) over a mean follow up period of 16 months (Figure). In trials that evaluated ICD therapy in non-ischemic cardiomyopathy such as DANISH, DEFINITE and SCD-HeFT trials mortality rates in the ICD arm were 21.6 % over 67.6 months, 9.4% over 29 months and 16.7% over 45.5 months, respectively. The incidence of appropriate therapy in DANISH, DEFINITE and SCD-HeFT trials were 28.9%, 19.8 % and 21% respectively. Conclusions: CA patients with ICD have equivalent appropriate therapy with disproportionately higher mortality over a shorter follow up compared to randomized trials of primary prevention ICD placement in NICMP. The benefit of ICD placement for mortality reduction in CA remains unclear and further large-scale studies are required to address this issue.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Marijon ◽  
R Garcia ◽  
D Gras ◽  
N Sadoul ◽  
L Guedon-Moreau ◽  
...  

Abstract Background The wearable cardioverter defibrillator (WCD) has been shown to be useful during transient periods of high sudden cardiac death risk, and the issue of compliance recently pointed out. This Registry was designed to provide real-world data on WCD use in France, in terms of compliance, potential adverse events, as well as efficacy. Methods and results Multicenter evaluation (WEARIT FRANCE Registry) was conducted in France between January 2017 and March 2018. Overall, 1,157 patients were analyzed: 950 with ischemic heart disease (82%, including 647 patients after myocardial infarction), 119 after ICD explant (10%), and 88 pre-transplant (8%). The median age was 61 years; the median ejection fraction was 25%. Median WCD wear time was 62 days, with median daily use of 23.4 hours. Less than 1% of patients did not wear WCD at least 4 hours per day. During follow-up, a total of 42 sustained ventricular tachyarrhythmias (VT/VF) occurred in 36 patients, of whom 50% (n=18) received appropriate WCD shocks, giving an incidence of appropriate therapy of 1.56%. The rate of all VT/VF episodes were 3.1% among patients with ischemic cardiomyopathy (n=29/950) versus 3.4% for the others (n=7/207). Of the ischemic patients wearing beyond 30 days (N=784), 5 received appropriate therapy of VT/VF episodes. Overall shock survival was 100%. At the end of the WCD period, 586 patients (51%) were implanted with an implantable cardioverter defibrillator. Eight patients (0.69%) received inappropriate WCD shocks. Regarding the apparent very low proportion of women considered for WCD therapy, we aimed to appreciate in which extent Conclusions In this multicenter nationwide WCD evaluation, 3.1% of patients presented with sustained VT/VF with 47% of those patients developing VT/VF after 30 days. The incidence of inappropriate therapy was low. The compliance to WCD in this real life evaluation was very high. These data suggest that the WCD, when worn appropriately, may be helpful in the arsenal to protect high-risk patients against SCD, especially in case of transient risk situations. Acknowledgement/Funding Zoll


Author(s):  
Olimpia Karczewska ◽  
Agnieszka Młynarska

Background and Objectives: The aim of the study was to assess the factors that influence the occurrence of concerns and their intensification after the implantation of a cardioverter defibrillator. Materials and Methods: This was a prospective and observational study including 158 patients. The study was conducted in two stages: stage I before implantable cardioverter defibrillator (ICD) implantation and stage II follow-up visit six months after ICD implantation. Standardized questionnaires were used in both stages. Results: Age and female gender were significantly correlated with the occurrence and intensity of concerns. Patients who had a device implanted for secondary prevention also experienced higher levels of concern. Additionally, a multiple regression model using the stepwise input method was performed. The model was statistically significant and explained 42% of the observed variance in the dependent variable (p = 0.0001, R2 = 0.4215). The analysis showed that age (p = 0.0036), insomnia (p = 0.0276), anxiety (p = 0.0000) and negative emotions (p = 0.0374) were important predictors of the dependent variable and enabled higher levels of the number of concerns to be predicted. Conclusions: There is a relationship between the severity of the concerns related to an implanted ICD and age, gender, anxiety, negative emotions and insomnia. Indications for ICD implantation may be associated with increased concerns about ICD.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Ehmsen ◽  
H Keller ◽  
C Stoellberger

Abstract Background The use of the Wearable Cardioverter Defibrillator (WCD) is recommended in national, European and American guidelines. However, there are almost exclusively data from the manufacturer's own data network. Independent data on the experience with the WCD are rare. Objective The aim of the retrospective study from one cardiologic department was to record efficiency, safety and compliance of the WCD. Patients and methods The study included all patients, to whom a WCD was described between 1.11.2010 and 1.5.2018 at one cardiologic department. Clinical data were obtained from the patients' records and the data about the WCD from the information network of the manufacturer. Results This study enrolled 66 patients, 51 males (77%) and 15 females (23%). The median age was 55 years (IQR: 45–63). They suffered from ischemic cardiomyopathy (n=33; 49%), dilated cardiomyopathy (n=12; 18%), myocarditis (n=7; 11%), explantation of an implantable cardioverter/defibrillator (ICD; n=5; 8%) and other indications (n=6; 9%). The median wearing time of the WCD was 73 days (interquartile range-IQR: 39–126), with median daily use of 22.91 h (IQR: 19.58–23.61). Among 38 patients with LVEF ≤35%, LVEF improved to ≥35% in 19 patients (50%) during WCD therapy. Over 1600 times the WCD detected a VT falsely. Four patients (8%) suffered from 212 non-sustained VT. One patient was successfully shocked because of ventricular fibrillation (appropriate shock rate: 1.5%). There were no inappropriate shocks. All patients, who wore the WCD, survived and one patient died when he did not wear the WCD. At the end of therapy 32 patients (48%) received an ICD. In terms of wearing time and events (shocks, arrhythmias, artifacts) there were no significant differences between patients receiving ICD and those who did not receive an ICD. Patients who received an ICD had a significantly lower LVEF after 3 months than patients who did not receive an ICD. Conclusion Our data confirm, that the WCD is safe and that the patients, who wear a WCD, have a high adherence. More than half of the patients with reduced LVEF improved their systolic function during WCD therapy, thus obviating the need for ICD implantation. Questions about the effectiveness of the detection algorithm remained open. Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Javier Jiménez-Candil ◽  
Olga Duran ◽  
Armando Oterino ◽  
Jendri Pérez ◽  
Juan Carlos Castro ◽  
...  

Abstract Background ICD patients with episodes of nonsustained ventricular tachycardias (NSVT) are at risk of appropriate therapies. However, the relationship between the cycle length (CL) of such NSVTs and the subsequent incidence of appropriate interventions is unknown. Methods 416 ICD patients with LVEF < 45% were studied. ICD programming was standardized. NSVT was defined as any VT of 5 or more beats at ≥ 150 bpm occurred in the first 6 months after implantation that terminated spontaneously and was not preceded by any appropriate therapy. The mean follow-up was 41 ± 27 months. Results We analyzed 2201 NSVTs (mean CL = 323 ms) that occurred in 250 patients; 111 of such episodes were fast (CL ≤ 300 ms). Secondary prevention (HR = 1.7; p < 0.001), number of NSVT episodes (HR = 1.05; 95% CI 1.04–1.07; p < 0.001) and beta-blocker treatment (HR = 0.7; p = 0.04) were independent predictors of appropriate interventions; however, the mean CL of NSVTs was not (p = 0.6). There was a correlation between the mean CL of NSVTs and the CL of the first monomorphic VT: r = 0.88; p < 0.001. This correlation was especially robust in individuals with > 5 NSVTs (r = 0.97; p < 0.001), with an agreement between both values greater than 95%. Patients with any fast NSVT experienced a higher incidence of VF episodes (26%) compared to those without NVSTs (3%) or with only slow NSVTs (7%); p < 0.001. Conclusions Unlike the burden, the CL of NSVTs is not a predictor of subsequent appropriate interventions. However, there is a close relationship between the CL of NSVTs and that of arrhythmias that will later lead to appropriate therapies.


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