Wearable Cardioverter Defibrillator Therapy Research Articles

Cardiovascular Rehabilitation With a WCD-Data From the CR3 Study (Cardiac Rehab Retrospective Review).

Patients at risk for sudden cardiac death may temporarily need a wearable cardioverter-defibrillator (WCD). Exercise-based cardiac rehabilitation (CR) has a class I recommendation in patients with cardiac disease. The aim of this study was to evaluate the safety and feasibility of undergoing CR with a WCD. We performed a retrospective analysis of all patients with a WCD who completed a CR in Austria (2010-2020). Patients (n = 55, 60 ± 11 yr, 16% female) with a median baseline left ventricular ejection fraction (LVEF) of 36 (30, 41)% at the start of CR showed a daily WCD wearing duration of 23.4 (22, 24) hr. There were 2848 (8 [1, 26]/patient) automatic alarms and 340 (3 [1, 7]/patient) manual alarms generated. No shocks were delivered by the WCD during the CR period. One patient had recurrent hemodynamically tolerated ventricular tachycardias that were controlled with antiarrhythmic drugs.No severe WCD-associated adverse events occurred during the CR stay of a median 28 (28, 28) d. The fabric garment and the device setting needed to be adjusted in two patients to diminish inappropriate automatic alarms. Left ventricular ejection fraction after CR increased significantly to 42 (30, 44)% ( P < .001). Wearable cardioverter-defibrillator therapy was stopped due to LVEF restitution in 53% of patients. In 36% of patients an implantable cardioverter-defibrillator was implanted, 6% had LVEF improvement after coronary revascularization, one patient received a heart transplantation (2%), two patients discontinued WCD treatment at their own request (4%). Completing CR is feasible and safe for WCD patients and may contribute positively to the restitution of cardiac function.

Wearable cardioverter defibrillator for preventing sudden cardiac death in patients at risk: An updated systematic review of comparative effectiveness and safety.

To synthesise the available evidence of wearable cardioverter defibrillator (WCD) therapy as an add-on measure to optimal medical therapy (OMT) or as a replacement of hospital stay. An update systematic review (SR) of comparative effectiveness and safety of WCD therapy was conducted. We included randomised controlled trials (RCT), prospective comparative studies and prospective uncontrolled studies with at least 100 patients. A narrative synthesis of the evidence was conducted. One RCT (n = 2348) and further eleven observational studies (n = 5345) fulfilled our inclusion criteria. In the only available RCT, the use of the WCD was not statistically associated with a clinical benefit on arrhythmic mortality in post-myocardial infarction (MI) patients with an ejection fraction of ≤35%. The compliance with WCD therapy was low in the RCT and high in observational studies, with ten observational studies reporting on a daily wear time between 20 and 23.5 h. The range of percentage of patients receiving at least one appropriate shock was 1-4.8% and the rate of first shock success was reported to be 100% in three studies. Serious adverse events (SAEs) such as inappropriate shocks occurred rarely, with between 0% and 2% of patients being inappropriately shocked within ten observational studies. In one of the observational studies, two patients (2%) were allergic to nickel developing skin rash and false alarms occurred in 58 patients (57%) in this study. Another registry study (n = 448) reported milder AEs, such as dermatitis and pressure marks, occurring in 0.9% and 0.2% of enrolled patients, respectively. The only available RCT failed to show superiority of add-on use of WCD in post MI patients. Observational evidence shows that the compliance with WCD is good, but the evidence is afflicted with selection bias and the inclusion of diverse mixed patient populations diluting the ability to draw indication-specific conclusions on the utility of the device. More comparative data is needed to justify continuing or expanding use of WCD therapy.

Patient-reported outcomes using a wearable cardioverter-defibrillator: results from a systematic review.

The aim of this study was to assess the effect of the wearable cardioverter-defibrillator (WCD) on patient-reported outcomes (PRO) in adult patients with high risk for sudden cardiac arrest. We performed a systematic literature search in Medline (via PubMed) and Cochrane Library in February 2022 and included studies with a study population ≥18years and prescribed WCD. PRO include health-related quality of life (QoL), symptoms, utilities, or satisfaction ratings. Study selection was done by two reviewers independently using predefined inclusion and exclusion criteria. Quality assessment of studies as well as data extraction was performed by one author and approved by a second author. Results of the included studies are presented quantitatively. One randomized controlled trial (RCT), one comparative non-randomized trial, and three single-arm trials were included. QoL was assessed in four studies, but with different assessment tools. One study additionally evaluated the change in depressive symptoms and anxiety and one study focused on acceptability of WCD but evaluated items that are closely related to QoL. Results of the RCT show no statistically significant difference in QoL assessed by SF-36 and EQ-5D comparing WCD and Guideline-Directed Medical Therapy (GDMT) versus GDMT alone. One comparative study reports an improvement in depressive symptoms and anxiety within groups but no significant difference between groups. Further, one single-arm study reported improvement in QoL between baseline and day 90 and day 180. The available evidence demonstrates that the usage of WCD is not affecting PRO, like QoL, depressive symptoms or anxiety negatively.

Risk Factors for Arrhythmic Death, Overall Mortality, and Ventricular Tachyarrhythmias Requiring Shock After Myocardial Infarction

The VEST (Vest Prevention of Early Sudden Death Trial) showed a trend toward decreased sudden death and lower overall mortality with a wearable cardioverter-defibrillator (WCD) in the postmyocardial infarction (post-MI) period. However, it is unclear which patients should receive WCD therapy. We aimed to identify the risk factors for arrhythmic death, all-cause mortality, and ventricular tachyarrhythmias requiring appropriate shock to identify patients most likely to benefit from a WCD. The VEST trial included patients with acute MI with ejection fraction ≤35%. Using logistic regression, 7 risk factors were evaluated for association with arrhythmic death, all-cause mortality, and appropriate shock. Among 2,302 participants, 44 had arrhythmic death (1.9%) and 86 died of any cause (3.7%). Among 1,524 participants randomized to WCD, 20 experienced appropriate shock (1.3%) over 90days. In the multivariable analyses, lower systolic blood pressure (SBP; odds ratio [OR] 1.64 per 10mm Hg) and higher heart rate at discharge (OR 1.19 per 10beats/min) were associated with arrhythmic death. Lower SBP (OR 1.37) and higher heart rate (OR 1.10) were associated with all-cause mortality. Higher heart rate (OR 1.20) was associated with appropriate shock. Patients with both SBP ≤100 and heart rate ≥100 were at increased odds of arrhythmic death (OR 4.82), all-cause mortality (OR 3.10), and appropriate shock (OR 6.13). In patients with acute MI and reduced ejection fraction, lower SBP and higher heart rate at discharge were strongly associated with arrhythmic death and all-cause mortality. In conclusion, these risk factors identify a select group at high risk of adverse events in a setting where WCD therapy is reasonable.

B-PO02-180 HIGH BURDEN OF INAPPROPRIATE ALARMS BY THE WEARABLE CARDIOVERTER-DEFIBRILLATOR IN OBESE PATIENTS - FINDINGS FROM THE SWISS WCD REGISTRY

The wearable cardioverter-defibrillator (WCD) uses surface electrodes built into the vest to detect underlying arrhythmia before initiating a treatment sequence. Before a shock is administered an alarm consisting of vibratory and auditory signals is emitted to warn the patient. Some patients frequently experience alarms. The aim of this study is to assess the alarm burden in patients and its possible impact on clinical outcomes. The aim of this study is to assess the alarm burden in patients and its possible impact on clinical outcomes. The Swiss WCD Registry is a nationwide retrospective registry including patients with a history of WCD use. Patients were included since 2011 until February 2018. Baseline characteristics and data on WCD usage were analysed. As sustained ventricular tachycardia or fibrillation (VT/VF) requires arrhythmia duration of ≥30s, only recordings ≥30s of length were analysed and categorized as appropriate (VT/VF), or inappropriate (atrial fibrillation, supraventricular tachycardia and artefact). A total of 10’653 alarms were documented in the total registry including 456 patients over a mean WCD wear-time of 2 months (±1.6). One hundred and thirty-two patients (28.9%) had zero alarms. A recording with a length ≥30s was present in 2996. One hundred and eleven (3.7%) of these were VT/VF episodes. The remaining recordings were inappropriate arrhythmia detections: 2736 artefacts (91%), 117 atrial fibrillation episodes (3.7%) and 48 supraventricular tachycardia episodes (1.6%). Two-hundred and seven patients (45%) had ≥3 alarms per months, and 49 patients (10.7%) had ≥1 alarm per day. BMI ≥30kg/m2 was significantly associated with ≥3 alarms per month (p=0.002), and increasing BMI correlated with increasing total number of alarms (p<0.001). ≥3 alarms per months were not associated with a lower average daily wear time (20.8 vs 20.7 hours, p=0.785) or a decreased ICD implantation rate after stopping WCD use (48 vs 47.3%, p=0.156). Inappropriate alarms emitted by the WCD are frequent and significantly associated with obesity. They did not lead to a decreased adherence to WCD therapy.

Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

Aims We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability.Methods and results Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37–97) days. Median daily wear time of WCD was 23.4 (22.2–23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95–0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%).ConclusionOur real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.

The Wearable Cardioverter/ Defibrillator: retrospective analysis of efficacy, safety and adherence

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

Collaborative care for the wearable cardioverter defibrillator patient: Getting the patient and medical team "vested and active".

Patients with a reduced ejection fraction of 35% or less and a history of myocardial infarction (MI) are at increased risk of sudden cardiac death (SCD). These patients have a class I indication for an implantable cardioverter-defibrillatorafter allowing time for medical therapy optimization and potential cardiac recovery. The rates of SCD are highest in this "gap" period early after a cardiac event, and the wearable cardioverter-defibrillator (WCD) is an intervention that can be used to protect against SCD during this time period. There has been a clinical trial that randomized patients with a reduced ejection fraction at the time of MIto a WCD versus control. Results of the trial showed no statistically significant difference in the primary endpoint of SCD. There are many intricacies to the interpretation of the trial, including the importance of patient adherence to WCD therapy, which is affected by the patient experience and psychological factors. Patients with a new cardiomyopathy are affected by a mix of psychological factors, including the feeling of safety and protection from a WCD contrasted by the WCD providing a reminder of awareness and fear of ventricular arrhythmias and SCD. Beyond the capabilities of a WCD to defibrillate a life-threatening ventricular arrhythmia, the device can also provide activity and heart failure diagnostics monitoring. Patients need to be engaged in shared decision-making conversations about a WCD, so that patients can make a decision based on their own values construct, ultimately increasing adherence among the patients that want a WCD.

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

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 &amp;gt;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

917Appropriate shocks in WCD patients - Results from the Austrian WCD registry

Abstract Background The wearable cardioverter-defibrillator (WCD) is a temporary treatment option for patients at high risk for sudden cardiac death (SCD) and/or for patients in whom implantation of a cardioverter defibrillator (ICD) is temporarily not possible. Purpose To investigate incidence and predictors of appropriate WCD shocks. Methods We performed a retrospective analysis of all patients with appropriate shocks delivered by a WCD in the cohort of the Austrian WCD registry between 2010 and 2018. Within this dataset, we identified predictors within the baseline characteristics, the indication for the WCD and preceding alarms automatically recorded by the WCD. Results: Baseline Within 879 registered in the Austrian WCD registry, 31 patients (3,5%) received appropriate WCD shocks due to ventricular tachycardia (VT) or ventricular fibrillation (VF). Compared to the total cohort, shocked patients were elder (mean age 67 ± 14 vs. 60 ± 14 years, p = 0,001) and the percentage of female patients was lower (11% vs. 21%, p = 0,262). The mean baseline LVEF at prescription was 33 ± 15% in the population with appropriate shocks compared to 32 ± 14% in the all-over cohort (p = ns). In the Austrian WCD population, 378/879 patients had a WCD due to secondary prevention. Within this cohort 5,6% (21/378) had shocks for VT/VF again, compared to 10/501 (2%) shocked patients in the primary prevention cohort. 31/879 (3.5%) patients received 57 appropriate shocks, the per patient shock rate was 2 [1;5]. These shocks were induced by 25 ventricular tachycardia and 26 times ventricular fibrillation. The octagenarians with 11% (7/34) shocked patients, showed a significant higher likelihood to receive shocks (p = 0,008) as well as the cohort of secondary preventive prescribed WCD-patients (p = 0,007). There were more shocks in patients, when prescribed with a WCD due to ICD associated infections (p = 0,001), when used as a bridge to ICD (p = 0,042) and in patients with ongoing risk stratification (p = 0,009). Looking through the automatically recorded alarms preceding a WCD shock, shocked patients experienced significantly more often non sustained VTs (p &amp;lt; 0,0005) and sustained VTs that were haemodynamically tolerated and did not require a treatment (p &amp;lt; 0,0005). Conclusion The WCD is effective in preventing SCD and an important risk stratification tool. We identified advanced age, patients with either already confirmed indication for ICD implantation (either temporary contraindication for implantation or temporary explantation) or risk stratification of an unclear cardiomyopathy, the cohort of secondary prevention and preceding nsVTs and stable VTs as predictors for appropriate WCD therapies.

Outcomes during and after the use of the wearable cardioverter-defibrillator in a tertiary-care and a regional hospital in Switzerland.

The wearable cardioverter-defibrillator (WCD) has established itself in treatment of potentially life-threatening ventricular arrhythmias, when implantation of an implantable cardioverter-defibrillator (ICD) is not warranted. Careful patient selection for this therapy is crucial, but unfortunately very little information from randomised controlled trials is available to guide clinical decision-making. Consequently, data from real-world patient registries play a more important role in this context. A retrospective observational study was conducted at the University Hospital of Zurich and the GZO Regional Healthcare Centre in Wetzikon. Clinical databases were screened for patients with a history of WCD use from the time of its approval in Switzerland in July 2014 until February 2018. Baseline characteristics, WCD data and outcome data, with an emphasis on ICD implantation and ICD therapies, were collected and analysed. Two-hundred and seven patients were included in the primary analysis. Eighty-six percent were male and the mean age was 58 &plusmn; 13 years. The underlying heart disease was ischaemic cardiomyopathy (ICM), non-ischaemic cardiomyopathy (NICM) and congenital/inherited heart diseases in 60, 35 and 5%, respectively. The most common indication for WCD use was heart failure with an ejection fraction (EF) &lt;35% due to ICM or NICM (43 and 27%, respectively). Three of the 207 patients received an appropriate shock over a median WCD wear-time of 62 days (interquartile range [IQR] 35&ndash;95). No inappropriate shocks were registered. Median average daily wear-time was 22.6 hours (IQR 19.9&ndash;23.2) and was significantly shorter for patients for whom WCD discontinuation was due to comfort issues (17 patients, p = 0.003). After the end of WCD therapy, 48% were implanted with an ICD. In those receiving an ICD, the rate of appropriate ICD therapies (either shock or antitachycardia pacing) was 8% during a median follow-up of 110 days (IQR 23&ndash;421). The WCD is safe and effective in terminating malignant ventricular arrhythmias. A substantial subgroup of patients, however, discontinued WCD use prematurely because of comfort issues. This subset of patients deserves further attention in clinical practice to ensure therapy adherence. &nbsp.

2404The use of wearable cardioverter defibrillator in France

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

Who Should Receive a Wearable Defibrillator Vest at Hospital Discharge?

To discuss the role of wearable cardioverter defibrillator (WCD) vests in preventing sudden cardiac death (SCD) in at-risk populations. The impact of randomized-controlled trials with implantable cardioverter-defibrillators (ICD) therapy is well established in randomized clinical trials in ischemic cardiomyopathy. Although the benefits are not as clear in non-ischemic cardiomyopathy, meta-analyses show significant mortality benefits from immediate electrical cardioversion strategies. The role of WCDs in at-risk populations in whom ICD therapy is temporarily not indicated is not as well-established. Smaller cohort trials have shown efficacy in patients with newly-diagnosed cardiomyopathy, requiring temporary ICD explantation, and others with less common indications for WCD therapy. The Vest Prevention of Early Sudden Death Trial was a landmark randomized control study seeking to examine the benefits of WCD therapy in at-risk population, and although the primary endpoint of reducing arrhythmic death was not reached, the structure of the trial and significant differences in total mortality make a compelling case for continued use of WCD therapies in our healthcare systems.

Recent Updates in the Role of Wearable Cardioverter Defibrillator for Prevention of Sudden Cardiac Death.

The wearable cardioverter defibrillator (WCD) or LifeVest may protect against sudden cardiac death (SCD) in patients awaiting insertion of an implantable cardioverter defibrillator (ICD). The purpose of this communication is to review the rationale behind WCD therapy and to critically analyze recent data regarding its clinical efficacy. We seek to provide evidence-based recommendations regarding the potential role of the WCD in certain populations. The only randomized controlled trial that evaluated WCD therapy did not demonstrate a reduced rate of arrhythmic death in patients prescribed the WCD during the first 90-day post-myocardial infarction (MI). However, when considering trial results alongside previous retrospective data, patient noncompliance with WCD therapy-rather than ineffectiveness of WCD therapy-remains an important theme. The uncertainty of data regarding the use of WCD therapy in patients during ICD waiting periods should be considered as part of the shared decision processes between healthcare providers and patients. Higher rates of adherence are needed to ensure efficiency. Well-designed future studies with appropriate cost-effectiveness analyses are indicated to define the clinical efficacy of WCD therapy on arrhythmic and non-arrhythmic morbidity and mortality in patients who are not yet candidates for ICDs.

Wearable Cardioverter-Defibrillator Therapy for the Prevention of SuddenCardiac Death: A Systematic Review and Meta-Analysis.

This study sought to synthesize the available evidence on the use of the wearable cardioverter-defibrillator (WCD). Observational WCD studies for the prevention of sudden cardiac death have provided conflicting data. The VEST (Vest Prevention of Early Sudden Death) trial was the first randomized controlled trial (RCT) showing no reduction in sudden cardiac death as compared to medical therapy only. We searched PubMed, EMBASE, and Google Scholar for studies reporting on the outcomes of patients wearing WCDs from January 1, 2001, through March 20, 2018. Rates of appropriate and inappropriate WCD therapies were pooled. Estimates were derived using DerSimonian and Laird's method. Twenty-eight studies were included (N = 33,242; 27 observational, 1 RCT-WCD arm). The incidence of appropriate WCD therapy was 5 per 100 persons over 3 months (95% confidence interval [CI]: 3.0 to 6.0, I2= 93%). In studies on ischemic cardiomyopathy, the appropriate WCD therapy incidence was lower in the VEST trial (1 per 100 persons over 3 months; 95% CI: 1.0 to 2.0) as compared with observational studies (11 per 100 persons over 3 months; 95% CI: 11.0 to 20.0; I2= 93%). The incidence of inappropriate therapy was 2 per 100 persons over 3 months (95% CI: 1.0 to 3.0; I2= 93%). Mortality while wearing WCD was rare at 0.7 per 100 persons over 3 months (95% CI: 0.3 to 1.7; I2= 94%). The rate of appropriately treated WCD patients over 3 months of follow-up was substantial; higherin-observational studies as compared with the VEST trial. There was significant heterogeneity. More RCTs areneeded to justify continued use of WCD in primary prevention.

Long-term use of the wearable cardioverter defibrillator in patients with explanted ICD

ObjectivesTo evaluate the effectiveness of wearable cardioverter defibrillator (WCD) use in protecting patients from sudden cardiac arrest (SCA) while they were treated in nonhospital settings until re-implantation of an Implantable cardioverter-defibrillator (ICD) was feasible. We sought to determine whether the WCD could be successfully utilized long term (≥1 year) after ICD extraction in patients at continued risk of SCD in which ICD re-implantation was not practical. BackgroundICDs have proven to improve mortality in patients for both secondary and primary prevention of SCA. Increased ICD implantation in older patients with comorbid conditions has resulted in higher rates of cardiac device infections. Currently, a wearable cardioverter defibrillator (WCD) is an alternative management for SCA prevention in specific cases. MethodsThis a retrospective analysis based on consecutive WCD patients who underwent ICD explant due to device-related infections or mechanical reasons between April 2007 and July 2014. A total of 102 patients were identified from the national database maintained by ZOLL (Pittsburgh, PA, USA). We analyzed the reason for WCD use, demographic information, device data, compliance and duration of WCD use, detected arrhythmias and therapies, and reason for discontinuing WCD use. ResultsIn these long term WCD users, average length of WCD use was 638 ± 361 days. Nine patients (8.8%) had a sustained ventricular arrhythmia that was successfully resuscitated by the WCD. Six patients (5.8%) experienced inappropriate shocks. Two patients (1.9%) died of asystole events while wearing the WCD and an additional 10 patients died while not monitored by the WCD. Thirty-nine patients (38.2%) ended WCD use when a new ICD was implanted and 15 patients (14.7%) were still wearing the WCD at the time of analysis. ConclusionsWe found that extending use of the WCD to ≥1 year is a safe and effective alternative treatment for patients with explanted ICDs who are not pacemaker dependent.

Impairment of Quality of Life among Patients with Wearable Cardioverter Defibrillator Therapy (LifeVest®): A Preliminary Study.

Background Wearable cardioverter defibrillator (WCD) therapy is feasible and safe in patients as a transient protection against sudden cardiac death (SCD). However, the impact of WCD therapy on quality of life (QoL) has not been studied. Methods In our single-centre study, 109 consecutive patients with a prescription of WCD were retrospectively analysed. Quality of life has been assessed by a standardized questionnaire (EQ-5D-3L, modified). Additionally, clinical baseline and follow-up data and recorded arrhythmic episodes were evaluated. Results Mean WCD therapy time was 56.2 (± 42.4) days, with a daily wear time of 19.7 (± 5) hours. A total of 3441 arrhythmia episodes were detected. Of these, 27 (1%) were adequate but did not require shock therapy. Likewise, no inadequate shock therapy occurred. WCD therapy negatively affected quality of life: 43% of patients reported mental health issues. 37% reported pain or discomfort. Self-care, usual activities, and mobility were restricted in 17%, 48%, and 36%, respectively. 29% were afraid of receiving shock therapy, and 48% suffered from sleep disturbance. However, 64% indicated having felt safe during WCD therapy. Accordingly, average quality of life was rated 70/100 points. Conclusion In our cohort, no SCD was prevented by WCD therapy. In contrast, in this preliminary study quality of life was reduced. Thus, careful recommendation of WCD therapy for high risk patients should be considered.

Use of the wearable cardioverter-defibrillator (WCD) and WCD-based remote rhythm monitoring in a real-life patient cohort.

The wearable cardioverter-defibrillator (WCD) was introduced to provide protection from sudden cardiac death (SCD) in patients with transiently elevated risk or during ongoing risk stratification. Benefits and clinical characteristics of routine WCD use remain to be assessed in larger patient populations. This study aims to identify determinants of WCD compliance, therapies, and inappropriate alarms in a real-life cohort. A total of 106 cases (68.9% male) were included between 11/2010 and 04/2016. WCD therapies, automatically recorded arrhythmia episodes, inappropriate WCD alarms, patient compliance, and outcome after WCD prescription were analyzed. Median duration of WCD use was 58.5days. Average daily wearing time was 22.7h. Compliance was reduced in patients ≤ 50years. Three patients received WCD therapies (2.8%). In one case ventricular fibrillation (VF) was appropriately terminated with the first shock. Two patients received inappropriate WCD therapies due to WCD algorithm activation during ventricular pacemaker stimulation. One patient died of asystole while carrying a WCD (0.9%). Additional arrhythmias detected comprised self-terminating sustained ventricular tachycardia (VT; 2.8%), non-sustained VT (2.8%), and supraventricular arrhythmias (5.7%). Inappropriate WCD alarms due to over-/undersensing occurred in 77/106 patients (72.6%), of which 41 (38.7%) experienced ≥ 10 inappropriate WCD alarms during the prescription period. Thirteen patients (12.3%) displayed a mean of > 1 inappropriate alarms/day. WCD use was associated with high compliance and provided protection from VT/VF-related SCD. The majority of patients experienced inappropriate WCD alarms. Alterations in QRS morphology during pacemaker stimulation require consideration in WCD programming to prevent inappropriate alarms.

Therapy optimization in patients with heart failure: the role of the wearable cardioverter-defibrillator in a real-world setting

BackgroundThe wearable cardioverter-defibrillator (WCD) has emerged as a valuable tool to temporarily protect patients at risk for sudden cardiac death (SCD). The aim of this study was to determine the value of the WCD for therapy optimization of heart failure patients.MethodsOne hundred five consecutive patients that received WCD between 4/2012 and 9/2016 were included in the study. All patients were followed for clinical outcome and echocardiographic parameters during WCD therapy and had continued follow-up after WCD therapy, irrespective of subsequent implantable cardioverter-defibrillator (ICD) implantation.ResultsThe most common indication for WCD were newly diagnosed ischemic (ICM) or non-ischemic cardiomyopathy (NICM) with left ventricular ejection fraction (LVEF) ≤35%. Mean WCD wear time was 68.8 ± 50.4 days with a mean daily use of 21.5 ± 3.5 h. Five patients (4.8%) received a total of five appropriate WCD shocks.During WCD wear, patients with ICM and NICM showed significant improvement in LVEF, reducing the proportion of patients with a need for primary preventive ICD implantation to 54.8% (ICM) and 48.8% (NICM). An ICD was finally implanted in 51.4% of the study patients (24 trans-venous ICDs, 30 subcutaneous ICDs).After discontinuation of WCD therapy, all patients were followed for a mean of 18.6 ± 12.3 months. 5.6% of patients with implanted ICDs received appropriate therapies. No patient with subcutaneous ICD needed change to a trans-venous device. None of the patients without an implanted ICD suffered from ventricular tachyarrhythmias and no patient died suddenly.In patients with NICM a significant LVEF improvement was observed during long-term follow-up (from 34.8 ± 11.1% to 41.0 ± 10.2%).ConclusionsWCD therapy successfully bridged all patients to either LVEF recovery or ICD implantation. Following WCD, ICD implantation could be avoided in almost half of the patients. In selected patients, prolongation of WCD therapy beyond 3 months might further prevent unnecessary ICD implantation. The WCD as an external monitoring system contributed important information to optimize device selection in patients that needed ICD implantation.

P1220Impairment of quality of life among patients with wearable cardioverter defibrillator therapy (lifevest)

P1220Impairment of quality of life among patients with wearable cardioverter defibrillator therapy (lifevest)