Wearable Cardioverter-defibrillator Use Research Articles

REAL–WORLD SINGLE CENTER EXPERIENCE WITH THE WEARABLE CARDIOVERTER DEFIBRILLATOR: SEX DIFFERENCES IN RISK STRATIFICATION FOR SUDDEN CARDIAC DEATH

Abstract Background Wearable cardioverter defibrillator (WCD) demonstrated an important role for prevention of sudden cardiac death in patients with advanced heart failure and reduced left ventricular ejection fraction. Although in randomized trial there are no gender difference in WCD use and defibrillator (ICD) implantation rate, real world data in female patients is lacking. Purposes: We aimed to describe the sex differences in WCD use, the rate of cardiac events detected with WCD and the rate of ICD implantation after WCD use in women in a real–world single center experience with reduced left ventricular ejection fraction or prior ventricular tachyarrhythmia. Methods and Results According with the current guidelines indications, between August 2017 and June 2023 ninety–six consecutive patients (mean age 66.0±11.1 years) received a WCD at Piacenza Hospitals and were retrospectively included in this analysis. There were no differences in clinical characteristics between female (18 patients, 18,8%) and male: in particular baseline left ventricular ejection fraction (LV EF) were similar between the two groups (29.5±5.2 vs 27.9±7.9, p=0.23) and no differences were found in the rate of ischaemic cardiopathy (66,6% vs 69,2% p=0.51). After 3–months follow up with WCD use, a similar rate of ventricular arrhythmias were found in the two groups (5.5% vs 3.8%, p=0.48) and no ventricular fibrillation was detected. The WCD usage period and median daily wear time were not different between female and male (55.2±50.6 vs 56.2±34.8 days p=0.53, 21.0±6.4 vs 23.1±1.5 hours p=0.48, respectively). However women presented a better LV EF improvement (12.2±9.7 vs 7.2±6.8, p=0.01), with a significant lower ICD implantation rate at the end of WCD use (55.5% vs 43.8%; p< 0.01). Conclusions In this real word analysis women presented a nice compliance using WCD. In spite of a similar burden of ventricular arrhythmic events, women presented a better LV EF improvement with a significant lower ICD implantation rate.

WEARABLE CARDIOVERTER DEFIBRILLATOR IN PATIENT WITH TRANSIENT RISK OF SUDDEN CARDIAC DEATH : SINGLE CENTRE EXPERIENCE

Abstract Background Cardiovascular disease is still the first cause of death, with sudden cardiac death ( SCD) as a first presentation in 25% of cases, related to coronary artery disease. Implantable cardioverter defibrillator (ICD) demontrated a reduction of SCD in high risk patients with good functional status. However the risk of SCD should be transient, so the use of a wearable cardioverter defibrillator (WCD) is considered in current guidelines and in clinical practice. The purpose of this study was to investigate the safety and the adherence to WCD in a real world population; moreover we reviewed the rate of ICD implantation after WCD use. Methods We considered consecutively 96 patients discharged from Piacenza cardiology department for potentially transient high risk of SCD, weared a WCD from August 2017 to June 2023. The patients were discharged in high risk mode of SCD with WCD protection and followed through remote monitoring or outpatient.A clinical and echocardiographic evalutation was performed at baseline and repeated at the end of the WCD use period. Results Out of 95 patients , with average age 66,0 ±11,1 years old and baseline average left ventricular ejection fraction (LVEF) 28,6±7,5, 81,2% were males, 72,9% suffered from arterial hypertension, 26% diabetes mellitus, 13,5% peripheral vascular disease, 14,6% chronic renal failure, 4,1% previous stroke.66% of these patients weared WCD for severe systolic disfunction in ischemic cardiac disease after recent myocardial infarction, after percutaneous coronary intervention or coronary artery bypass graft, 4% after removal of an infected ICD, 6% whilst awaiting completion of diagnostic tests (chanalopathies/right arrhythmogenic ventricular cardiomyopathy), 24% newly diagnosed cardiomyopathy. The average wearing time of WCD was 22,7±3,1 hours daily. We received these events: 1 sustained ventricular tachicardia, 2 non sustained ventricular tachicardia, 5 atrial fibrillation with 3 T wave oversensing. One patient recedived inappropriate shock. One death was detected due to severe heart failure. After 56,0±37,8 days of average wearing time 52% of patients were scheduled for ICD implantation. Conclusions In our experience we may consider that WCD use is effective, safe and with a good adherence in all patients. The WCD allows saving resources preventing inapprpriate ICD implantation in patient with transient SCD risk.

Sex differences in achieving guideline-recommended heart rate control among a large sample of patients at risk for sudden cardiac arrest

BackgroundDespite known clinical benefits, guideline-recommended HR control is not achieved for a significant proportion of patients with HF and reduced ejection fraction. The Wearable Cardioverter Defibrillator (WCD) provides continuous heart rate (HR) monitoring and alerts that could aid medication titration. ObjectiveThis study sought to evaluate sex differences in achieving guideline-recommended HR control during a period of WCD use. MethodsData from patients fitted with a WCD from 2015 to 2018 were obtained from the manufacturer´s database (ZOLL, Pittsburgh, PA). The proportion of patients with adequate nighttime resting HR control at the beginning of WCD use (BOU) and at the end of WCD use (EOU) were compared by sex. Adequate HR control was defined as having a nighttime median HR <70 bpm. ResultsA total of 21,440 women and a comparative sample of 17,328 men (median 90 days of WCD wear, IQR 59-116) were included in the final dataset. Among patients who did not receive a shock, over half had insufficient HR control at BOU (59% of women, 53% of men). Although the proportion of patients with resting HR ≥70 improved by EOU, 43% of women and 36% of men did not achieve guideline-recommended HR control. ConclusionsA significant proportion of women and men did not achieve adequate HR control during a period of medical therapy optimization. Compared to men, a greater proportion of women receiving WCD shocks had insufficiently controlled HR in the week preceding VT/VF and 43% of non-shocked women, compared to 36% of men, did not reach adequate HR control during the study period. The WCD can be utilized as a remote monitoring tool to record HR and inform adequate up-titration of BB, with particular focus on reducing the treatment gap in women.

Expanded application of wearable cardioverter defibrillators beyond current guidelines: proposal for a European register explained through single clinical scenarios

The wearable cardioverter defibrillator (WCD) is becoming a more and more widely used instrument for the prevention of sudden cardiac death of patients either with a secondary prevention implantable cardioverter...

Prior history of atrial fibrillation and arrhythmic outcomes: Data from the WEARIT-II prospective registry.

Wearable cardioverter defibrillator (WCD)is utilized in patients with assumed but not yet confirmed risk for sudden cardiac death (SCD).Many of these patients also present with atrial fibrillation (AF).However, the rate of WCD-detected ventricular or atrial arrhythmia events in this specific high-risk cohort is not well understood. In WEARIT-II,the cumulative probability of any sustained or nonsustained VT/VF(WCD-treatedand nontreated), and atrial/supraventricular arrhythmias during WCD use was assessed using the Kaplan-Meier method by prior AF, with comparisons by the log-rank test. The incidence of ventricular and atrial arrhythmia events were expressed as events per 100 patient-years, and were analyzed by prior AF using negative binomial regression. WEARIT-IIenrolled 2000 patients, 557 (28%) of whom had AF before enrollment. Cumulative probability of any sustained or nonsustained WCD-detected VT/VFduring WCD use was significantly higher among patients with a history of AF than without AF (6% vs. 3%, p = .001). Similarly, the recurrent rate of any sustained or nonsustained VT/VFwas significantly higher in patients with prior AF versus no prior AF (131.5 events per 100 patient-years vs. 22.7 events per 100 patient-years, p = .001). Patients with prior AF also had a significantly higher burden of any WCD-detected atrial arrhythmias/SVT/inappropriate arrhythmiastherapy (183.2 events per 100 patient-years vs. 74.8 events per 100 patient-years, p < .001). Our results demonstrate that patients with a history of AF wearing the WCD for risk assessment have a higher incidence of ventricular arrhythmias that may facilitate the decision making for ICD implantation.

The use of wearable cardioverter defibrillator among patients suffering from myocarditis: data from a multicenter registry

Abstract Background Data on the use of the wearable cardioverter defibrillator (WCD) among patients suffering from myocarditis in a large cohort remains sparse. Subsequently several guidelines give a different recommendation regarding WCD indication in this cohort. Methods 1596 patients were included in a multicenter registry from ten European centers. Among this cohort 132 (8%) patients received a WCD due to myocarditis. The mean follow-up time of the whole cohort was 620.2±607.8 days. The presence of ventricular tachyarrhythmias and/or WCD shocks during WCD use were evaluated. Results The mean age of patients was 52.5±16.3 years (75% males). 20% of patients suffered from atrial fibrillation, 17% diabetes mellitus, 40% were smoker and 38.9% suffered from arterial hypertension. The body-mass-index (BMI) of the cohort was 27.8±5.7 kg/m². The initial left ventricular ejection fraction (LVEF) was 33.4±14.6% and increased to 45.9±13.2% (p&amp;lt;0.05) over long-term follow-up. Patient were discharged on ACE-inhibitors (62.5%), ARNI (21.2%), aldosterone-antagonist (50%), beta-blockers (89.5%) and amiodarone (13.6%). An improvement of LVEF (LVEF&amp;gt;35%) was documented in 81.2% of patients. The BNP level was at baseline 7401±30584 pg/ml and decreased to 530±803 pg/ml (p&amp;lt;0.05) over long-term follow-up. The wear duration was 78.5±51.5 days and 34% of patients wore the WCD for longer than 90 days. The wear-hours per day were 21.1±4.8 hours. In 3.1% sustained ventricular tachycardia, 0.8% ventricular fibrillation and 9.1% non-sustained ventricular tachycardia were documented. Subsequently 3% of patients suffered from an appropriate WCD shock. The rate of inappropriate WCD shock was 0.8%. Patients suffering from WCD shock were at age 31, 31, 61, 24 and 51 years and suffered a former non-sustained ventricular tachycardia before receiving a WCD. Among these patients suffering from appropriate WCD shock only two patients showed an LVEF&amp;lt;35%. Among the myocarditis patients 48% suffered from a former ventricular tachycardia and/or ventricular fibrillation and therefore received a WCD. Conclusions Myocarditis patients can be effectively protected by WCD and may benefit from its’ use. WCD shock occurred also in patients with an LVEF &amp;gt;35%.

Incidence of sustained ventricular tachyarrhythmias in patients with non-ischemic cardiomyopathy in a multicenter multinational WCD cohort

Abstract Background Defibrillator use in patients with non-ischemic cardiomyopathy (NICM) and HFrEF remains controversial after the DANISH study. The new ESC guidelines recommend individualized risk stratification in these patients. The wearable cardioverter-defibrillator (WCD) seems to be appropriate to both protect and screen patients with HFrEF at risk for sudden cardiac death (SCD). Puropose: To evaluate the rate of ventricular tachyarrhythmias (VT/VF) in NICM vs. ICM patients receiving a WCD for temporary SCD protection. Methods 1157 patients were included in a multicenter registry from eight European centers. Among these patients, 602 patients received a WCD due to ischemic cardiomyopathy (ICM) and 555 patients for non-ischemic cardiomyopathy (NICM). Incidence of VT/VF and/or appropriate WCD shock discharge during WCD use were evaluated. The mean follow-up (FU) time of the whole cohort was 620.2±607.8 days. Results NICM patients were younger (mean 56.5±14.8a vs 63.9±11.6a; p&amp;lt;0.001) and less often male (75% vs. 87.2%; p&amp;lt;0.001) compared to ICM patients. Heart failure medication at hospital discharge did not differ between the two groups except for a higher prescription rate of aldosterone-antagonists in NICM compared to ICM patients (73.8% vs. 66.7%; p=0.02). The index left ventricular ejection fraction (LVEF) was significantly lower in NICM compared to ICM patients (mean 26.1±9.1% versus 29.5±9.2%; p&amp;lt;0.001). A larger extent of LVEF recovery was detected in NICM patients compared to ICM patients up to the end of WCD use (mean LVEF post WCD: 45.7±35.4% vs. 40.2±11.8%; p=0.02). Average daily WCD wear-time was significantly lower in NICM patients compared to ICM patients (mean 20.7±4.9h vs. 21.6±3.7h; p=0.01). NICM patients had a significantly lower incidence of sustained ventricular tachyarrhythmia (VT/VF) compared to ICM patients (3.4% vs. 6.6%; p=0.02). Consistently, rate of appropriate WCD shock was significantly lower in NICM vs. ICM patients (0.7% vs. 3.7%; p&amp;lt; 0.001), as was rate of re-hospitalization (30.2% vs. 46.1%; p&amp;lt;0.001). Both groups showed a similar mortality rate during FU. Conclusions Patients at risk for SCD with NICM showed a more pronounced LVEF recovery, significantly lower incidence of VT/VF with concomitant shocks and hospitalization, while overall mortality was unchanged compared to ICM patients. These results indicate that WCD use might facilitate individual SCD risk stratification in NICM patients.

Wearable cardioverter defibrillator after ICD-system explantation: data from a multicenter registry

Abstract Background Data on the use of wearable cardioverter defibrillator (WCD) among patients after cardiac implantable electronic device explantation of 1- to 3-chamber Implantable Cardioverter-defibrillator system (ICD) are sparse. Subsequently several guidelines give a different recommendation regarding WCD indication in this cohort. Objectives We aimed to study the baseline characteristics and outcome of patients treated with WCD after ICD explantation. The primary outcome is appropriate WCD shock. Methods 1104 patients were included in a multicenter registry from seven European centers. Among this cohort 109 patients received a WCD to bridge the time after ICD-system explantation until reimplantation due to a persistent ICD-indication. The mean follow-up time of the whole cohort was 824±773 days. Cardiovascular history and non-cardiovascular morbidities were evaluated. In addition, the presence of ventricular tachyarrhythmias and/or WCD shocks was evaluated in the explantation group. Furthermore, after ICD-reimplantation the rate of rehospitalization for ventricular tachyarrhythmias, atrial fibrillation, stroke and congestive heart failure was followed. Results In the explantation group patients were older (65±14 versus 59±15; p&amp;lt;0.001) and were hospitalized longer (21±15 days versus 14±12 days; p&amp;lt;0.001). The index LVEF differed significantly (35.7±14.1% versus 29.3±11.5%; p&amp;lt;0.001). The LVEF value did not differ significantly over short-term follow-up (35.7±14.2% versus 37.9±11.9%; p=0.204). Wear days among patients after ICD-system explantation were 61±46 days. An appropriate WCD shock was documented in 7.3% after ICD-system explantation during WCD use. Up to 80.6% of patients after ICD-system explantation received a reimplantation. The rate of rehospitalization due to ventricular tachyarrhythmias was 7.3%, due to heart failure 6.8% and due to atrial fibrillation 4.1%. After ICD-implantation the rate of appropriate shocks was 12/89 (13.4%). In the multivariable regression analysis myocarditis and ICD-system explantation were positive predictors for the risk of ventricular tachyarrhythmias, but nevertheless an improved left ventricular ejection fraction (LVEF) and use of aldosterone antagonists were negative predictors for the risk of ventricular tachyarrhythmias. Conclusions Cccurrence of malignant arrythmia after ICD-system explantation is high and the use of WCD among these patients could be beneficial in preventing sudden cardiac death.

Abstract 15446: Impact of Patient Demographics on Optimal Beta-Blocker Use After New-Onset Heart Failure: Analysis of the HF-OPT Study (Heart Failure Optimization Study)

Background: While beta-blockers (BB) have helped to improved outcomes in patients with heart failure and a low ejection fraction (HFrEF), the titration to target doses has been suboptimal and it is not clearly understood why. The Heart Failure Optimization Study (HF-OPT) study in newly diagnosed HF patients (pts) collected baseline data, arrhythmias during wearable cardioverter defibrillator (WCD), as well as medications and dosing. Purpose: The objective was to assess which factors were associated with receiving BB at target doses by day 180. Methods: Data from pts with newly diagnosed HFrEF during WCD use was collected from 487 pts (54% from US, 72% male, age 59±13) in the HF-OPT study. Target dose of BB were defined as the lowest maximum dose from either the ESC or ACC/AHA/HFSA guidelines. Supraventricular tachycardia (SVT) was used to label all dysrhythmias originating at or above the atrioventricular node and captured by the WCD. Association between BB and other variables were assessed using logistic regression. Results: 6 months after a new diagnosis of HFrEF, 97% of pts were prescribed BB, but only 25% were on target doses. Univariate analysis showed that only BMI, age, sex, black race, a history of hypertension, and no history of PCI or angina, were associated with receiving target doses of BBs by 180 days. Having episodes of SVT during the first 180 days were also associated with receiving target BB doses (Table). In multivariate analysis, all were significantly associated with target BB dose except BMI, SVT during WCD use and history of PCI. Conclusions: The full beneficial effects of BB may not be achieved in patients with HFrEF if the patients are not recieving target doses. In the HF-OPT study, factors positively associated with reaching target BB doses included younger age, black race, being male, and a history of hypertension. Having a history of angina was associated with not achieving target BB doses. The significance of these differences should be further explored.

Abstract 18973: Regional Differences in Optimization of Medical Therapy for Heart Failure With Reduced Ejection Fraction: Data From the HF-OPT Trial (Heart Failure Optimization Trial)

Background: Society guidelines for the optimization of guideline-directed medical therapy (GDMT) in patients with heart failure (HF) are almost identical between the United States (US) and Europe (EU). While GDMT has helped to improve survival and reduce HF hospitalization in this population, the initiation as well as titration to target doses shown to be safe and effective in clinical trials has been suboptimal. Purpose: The objective of this analysis was to assess regional differences in GDMT prescription in the United States (US) vs. Europe (EU) between 2017 and 2022.Methods: Medication data from patients (pts) with newly diagnosed heart failure with reduced ejection fraction (HFrEF) during wearable cardioverter-defibrillator use was collected from 487 pts (54% from US, 72% male, age 59±13 years). Target dose of GDMT was defined as the lowest maximum dose from either the ESC or ACC/AHA/HFSA guidelines. ACE-I/ARB/ARNI (AAA), beta blockers (BB), and mineralocorticoid receptor antagonists (MRA), were the main GDMT options for HFrEF patients at the time of HF-OPT. Association between medication with region and gender were assessed using logistic regression. Results: Compared to patients in the US, EU (Germany, Austria, France) pts were significantly more likely to receive ACE-I/ARB/ARNI and MRA and to achieve target doses by 90 and 180 days (p&lt;0.01). Interestingly, ARNI prescription rates did not differ between US and EU (39% and 47%, p=0.09) by 180 days, although target doses were more likely to be reached in the EU by 180 days (23% vs. 12%, p&lt;0.01). In contrast, rates of BB use and achieving target doses did not differ between regions (Figure). Finally, pts in the EU were more likely to receive all three medication classes by 180 days (80% vs 42%, p&lt;0.001), and more likely to be prescribed target doses of all three medications (12% vs. 7%, p&lt;0.05). After adjusting for region, there was no difference in gender for day 90 and 180 prescriptions and target doses for BB, AAA, and MRA.Conclusions: Adherence to GDMT was superior in the EU compared to the US with regards to ACE-I/ARB/ARNI and MRA. There was no difference in BB use between regions. Target dosage rates, however, were overall low in both regions.

P265 REAL–WORLD SINGLE CENTER EXPERIENCE WITH THE WEARABLE CARDIOVERTER DEFIBRILLATOR: SEX DIFFERENCES IN RISK STRATIFICATION FOR SUDDEN CARDIAC DEATH

Abstract Background Previous studies established a role for the wearable cardioverter defibrillator (WCD) in patients with transient risk os sudden cardiac death ( SCD) . The WEARIT–II Registry highlighted an higher burden of ventricular and atrial arrhythmic events in women than in men, in spite of a similar ICD implantation rates. Objectives We aimed to describe the sex differences in WCD use and compliance. Moreover we reviewed the rate of cardiac events detected with WCD and the rate of ICD implantation in women in a real–world single center experience. Methods and results Between August 2017 and June 2022, 60 consecutive patients receiving a WCD at Piacenza Hospitals were retrospectively included in this analysis: mean age 66.9±11.9 years, 56.6% with ischaemic cardiomyopathy, 38.3% with dilated cardiomyopathy, 5% after implantable cardioverter–defibrillator explant. 8 patients were women (13.3%). Women and men presented similar clinical characteristics. Median WCD usage period and median daily wear time were not different between women and men (49.6±25.3 vs 51.8±32.8 days, 23.6±0.3 vs 23.1±1.7 hours, respectively). No ventricular fibrillation was detected in the monitoring period. Non–sustained ventricular tachycardia and atrial arrhythmias were similar between women and men. However, ICD implantation rate at the end of WCD use was significantly lower in women than and men (25% vs 61.5%; p&amp;lt; 0.01). Conclusions In this real word analysis WCD was underused in women despite a nice compliance. A similar burden of ventricular and atrial arrhythmic events were detected, with a lower ICD implantation rate at the end of WCD use in women than in men.

P262 PREDICTORS OF ICD IMPLANTATION: THE ROLE OF THE WEARABLE CARDIOVERTER DEFIBRILLATOR

Abstract Background Previous studies established a role for the wearable cardioverter defibrillator (WCD) In patients with transient risk of sudden cardiac death ( SCD) . In clinical trials, nearly 40% of patients received implantable cardioverter–defibrillator (ICD) implantation at the end of WCD use. It’ unknown if WCD can be usefull in final ICD implantation indication. Objectives We aimed to describe the clinical predictors of ICD implantation rate at the end of WCD use in a real–world single center experience. Methods and results Between August 2017 and June 2022, 60 consecutive patients receiving a WCD at Piacenza Hospitals were retrospectively included in this analysis: : mean age 66.9±11.9 years, 56.6% with ischaemic cardiomyopathy, 38.3% with dilated cardiomyopathy, 5% after implantable cardioverter–defibrillator explant. A total of 34 participants (56.6%) received implantable cardioverter–defibrillator (ICD) implantation at the end of WCD use. We evaluated clinical features related to ICD implantation rate with Chi Square test and Student’s t test. Female sex was related with no ICD implantation ( ICD 5,9% vs no ICD 23,1%, p= 0,03), whilst Low ejection fraction at beginning of evaluation was related with ICD implantation ( ICD 27.1±9.3 vs no ICD 33.1±11.9, p=0,03). Although in our population there weren’t shock of WCD, the strongest clinical predictor was arrhythmic event recordered at WCD monitoring both non sustained ventricular tachicardia, sustained ventricular tachicardia and supraventricular tachicardia ( ICD 20 vs no ICD 0, p &amp;lt; 0,01). Age ( ICD 66.6±11.9 vs NO ICD 67.4±11.9, p=0,7) and etiology of cardiopathy both ischemic and non ischemic ( ICD 52% vs no ICD 53,8%, P=0.5) were not factors associated with ICD implantation. Conclusion In our study the rate of ICD implantation after wearing time of WCD is consistent but slightly major to European registries. Arrhythmic Event recordered at WCD monitoring is related with ICD implantation, so WCD, when it is used, may be a further help in final ICD implantation.

P10 REAL–WORLD SINGLE CENTER EXPERIENCE WITH THE WEARABLE CARDIOVERTER DEFIBRILLATOR: SEX DIFFERENCES IN RISK STRATIFICATION FOR SUDDEN CARDIAC DEATH

Abstract Background Previous studies established a role for the wearable cardioverter defibrillator (WCD) in patients with transient risk os sudden cardiac death (SCD). The WEARIT–II Registry highlighted an higher burden of ventricular and atrial arrhythmic events in women than in men, in spite of a similar ICD implantation rates. Objectives We aimed to describe the sex differences in WCD use and compliance. Moreover we reviewed the rate of cardiac events detected with WCD and the rate of ICD implantation in women in a real–world single center experience. Methods and results Between August 2017 and June 2022, 60 consecutive patients receiving a WCD at Piacenza Hospitals were retrospectively included in this analysis: mean age 66.9±11.9 years, 56.6% with ischaemic cardiomyopathy, 38.3% with dilated cardiomyopathy, 5% after implantable cardioverter–defibrillator explant. 8 patients were women (13.3%). Women and men presented similar clinical characteristics. Median WCD usage period and median daily wear time were not different between women and men (49.6±25.3 vs 51.8±32.8 days, 23.6±0.3 vs 23.1±1.7 hours, respectively). No ventricular fibrillation was detected in the monitoring period. Non–sustained ventricular tachycardia and atrial arrhythmias were similar between women and men. However, ICD implantation rate at the end of WCD use was significantly lower in women than and men (25% vs 61.5%; p&amp;lt; 0.01). Conclusions In this real word analysis WCD was underused in women despite a nice compliance. A similar burden of ventricular and atrial arrhythmic events were detected, with a lower ICD implantation rate at the end of WCD use in women than in men.

Wearable cardioverter defibrillator shortens the length of stay: a single center real-world experience

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): ZOLL France supported with an unrestricted grant. Background The wearable cardioverter defibrillator (WCD) has been proven to have efficacy in treating sudden cardiac death (SCD) in patients soon after acute myocardial infarction (AMI) and left ventricular ejection fraction (LVEF) ≤35%. However, data regarding hospitalization rate and length of stay among these patients have not yet been evaluated. Purpose WCD can shorten hospital stays (total length, time in intensive care unit (ICU) and in cardiac intensive care unit (CICU)) of patients post-AMI, with severe reduced LVEF. Methods We performed a single center, retrospective observational study of patients prescribed WCD upon hospital discharge, from June 2016 to June 2022. We selected patients referred for management of SCD, post-AMI, with age over 18 years and LVEF ≤35%. Patients who already had ICD or CRT-D (or who had previously received it) were excluded from the analysis. Patients with the same characteristics, and who were discharged from the hospital without WCD or ICD served as a control group. Clinical characteristics were obtained from hospital electronic and WCD specific database. The clinical characteristics and length of index hospitalization of two groups were compared. An initial propensity score analysis was performed, then a weighted regression models for total hospitalization, days in ICU, and days in CICU were conducted. Results 101 patients in the WCD group and 29 in the control group were enrolled in the analysis (Figure 1). The two groups showed similar clinical characteristics (Table 1), even if patients in the WCD group had lower LVEF (p &amp;lt;0.001), more cardiogenic shocks (p = 0.045) and higher NT-proBNP values (p = 0.033). After a propensity score analysis and a weighted regression model, LVEF emerged as independent variable for WCD use (odds ratio (OR) 0.755, confidence interval (CI) 95% 0.654 – 0.872, p &amp;lt;0.001). Left ventricular thrombosis also affected the use of WCD (OR 5.574, CI 95% 1.139 – 27.267, p = 0.0339). In a weighted regression model, WCD significantly influenced the days spent in CICU (p&amp;lt;0.001), and those in ICU even without statistical significance (p = 0.251). Even after excluding all patients undergoing extracorporeal membrane oxygenation (ECMO) or heart transplantation, WCD reduced days spent in CICU (p&amp;lt;0.001). Furthermore, when excluding from the analysis all patients with very long hospitalizations (&amp;gt; 30 days), WCD patients showed significantly shorter total hospitalization (p=0.005) and days spent in CICU (p&amp;lt;0.001), compared with control group. Conclusions At the propensity score analysis, WCD reduce CICU length of stay for patients post-AMI with LVEF ≤35%. The association between WCD use and hospitalization is more relevant for days spent in CICU, but there is also a positive trend for the days spent in ICU. The study has the limitation of a retrospective analysis and can only serve as hypothesis-generating research, which will be verified with further randomized clinical trial.

Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study.

While elevated resting heart rate measured at a single point of time has been associated with cardiovascular outcomes, utility of continuous monitoring of nocturnal heart rate (NHR) has never been evaluated. We hypothesized that dynamic NHR changes may predict, at short term, impending cardiovascular events in patients equipped with a wearable cardioverter-defibrillator (WCD). The WEARIT-France prospective cohort study enrolled heart failure patients with WCD between 2014 and 2018. Night-time was defined as midnight to 7 a.m. NHR initial trajectories were classified into four categories based on mean NHR in the first week (High/Low) and NHR evolution over the second week (Up/Down) of WCD use. The primary endpoint was a composite of cardiovascular death and heart failure hospitalization. A total of 1013 [61 (interquartile range, IQR 53-68) years, 16% women, left ventricular ejection fraction 26% (IQR 22-30)] were included. During a median WCD wear duration of 68 (IQR 44-90) days, 58 patients (6%) experienced 69 events. After considering potential confounders, High-Up NHR trajectory was significantly associated with the primary endpoint compared to Low-Down [adjusted hazard ratio (HR) 6.08, 95% confidence interval (CI) 2.56-14.45, P < 0.001]. Additionally, a rise of >5 bpm in weekly average NHR from the preceding week was associated with 2.5 higher composite event risk (HR 2.51, 95% CI 1.22-5.18, P = 0.012) as well as total mortality (HR 11.21, 95% CI 3.55-35.37, P < 0.001) and cardiovascular hospitalization (HR 2.70, 95% CI 1.51-4.82, P < 0.001). Dynamic monitoring of NHR may allow timely identification of impending cardiovascular events, with the potential for 'pre-emptive' action. Clinical Trials.gov Identifier: NCT03319160.

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.

A novel artificial intelligence based algorithm to reduce wearable cardioverter-defibrillator alarms.

The wearable cardioverter defibrillator (WCD) is an important tool in mitigating sudden cardiac death (SCD). The WCD provides patient alarms for detected arrhythmias or electrical noise/artifact. Some patients experience frequent alarms for artifact. We soughtto evaluate the effects of a novel artificial intelligence algorithm to reduce alarms related to electrical noise or artifact (advanced arrhythmia discrimination algorithm, AArD). A retrospective review of a large commercial database of prescribed WCD. Patients prescribed the WCD during the years 2017 (discrimination algorithm, DA group) or during 2019 (advanced arrhythmia discrimination algorithm, AArD) were analyzed. A total of 96,000 patients were sampled, 48,000 in the control group (using standard direct algorithm, DA) and compared to 48,000 in the intervention AArD (4000 per group per month) for 12 months. The AArD further discriminates ECG signals based on a machine-learning algorithm utilizing intensity and frequency beyond the standard DA. Outcomes regarding alarms, arrhythmias, and safety were analyzed. The AArD algorithm was associated with a significant decrease in frequency of alarms over the course of WCD use; 54% of patients in the AARD versus 27% of DA had 0 alarms (P < .001). In the entire cohort, there was a 56% relative reduction in alarms with the use of AArD. Appropriate arrhythmia treatment time was not significantly different between the groups (44 s DA vs 45 s AArD [p = ns]). A novel artificial intelligence algorithm reduces alarms without delaying appropriate therapy for VT/VF. These changes may improve compliance and quality of life in patients with a WCD.

Wearable cardioverter defibrillator after cardiac surgery: Analysis of real-life data from patients at transient risk of sudden cardiac death.

Especially in the first 3months after cardiac surgery, patients are at transient risk of sudden cardiac death (SCD). To close the gap between hospital discharge and the final implantable cardioverter-defibrillator (ICD) decision, guidelines recommend temporarily using a wearable cardioverter-defibrillator (WCD) to protect these patients from SCD. We investigated real-life data on the safety, effectiveness, and compliance of the WCD in this population. Data for analysis were collected via the Zoll Patient Management Network (ZPM) from patients who underwent cardiac surgery and who were discharged with a WCD between 2018 and 2021 at the Cardiac Surgery Center of the University of Erlangen in Germany. The majority of the 55 patients were male (90.9%) and underwent a coronary artery bypass graft (80.0%). The number of patients with left ventricular ejection fraction (LVEF) >35% increased from 9.1% at the beginning of WCD use to 58.2% at the end of WCD use. Six ventricular tachycardia (VT) episodes occurred in four patients. The WCD appropriately defibrillated two patients with VT episodes. There were no inadequate shocks and no fatalities during the observation time. WCD wearing compliance was high, with a median wear time of 23.3h/day. This retrospective analysis in a single cardiac surgery center confirms prior data on the safety and effectiveness of the WCD in patients in post-surgery care in a real-life setting. The WCD successfully protected patients from SCD during life-threatening VT episodes. WCD wearing compliance was high.

Abstract 13825: Clinical and Echocardiographic Outcomes Associated With Early Initiation of Beta Blockers Use Among Patients With Recently Diagnosed Non-Ischemic Cardiomyopathy Treated With a Wearable Cardioverter Defibrillator

Introduction: Beta-blocker (BB) therapy was shown to improve clinical outcomes among heart failure patients with reduced ejection fraction. However, there are limited data on the efficacy of BB use among patients with recently diagnosed non-ischemic heart cardiomyopathy (NICM) who are treated with the wearable cardioverter defibrillator (WCD) until a decision on the need for an ICD is made. Aim: Determine if BB use is associated with improved outcomes in patients with NICM treated with the WCD. Methods: The study population comprised 1195 patients with recently diagnosed NICM enrolled in the prospective WEARIT-II Registry. Clinical data, arrhythmia events, ICD implantation, and improvement in left ventricular ejection fraction (LVEF) were captured. Multivariate logistic regression was used to estimate the odds ratio (OR) of LVEF improvement to &gt;35% by BB usage. The risk of death at 1-year by BB use was assessed using a multivariate cox-proportional hazards modeling. Results: Patients treated with BBs at baseline were more likely to experience an improvement in LVEF to &gt;35% that patients who did not receive treatment with BB (43% vs 29%, respectively; adjusted OR=1.67 95% CI [1.15-2.41] p=0.007; Figure: panel A and were less likely to receive an ICD at the end of the WCD use (37% vs 47%; adjusted OR=0.64 95% CI [0.46-0.90] p=0.024; Figure: panel B). At 12 months of follow-up the probability of death was significantly lower among patients who received BB therapy during WCD use vs. those who did not.,(p=0.007 Figure: panel C), corresponding to a significant 59% lower risk of death at one year associated with early BB use (adjusted HR=0.41 95% CI [0.21-0.80] p&lt;0.01). Conclusions: Among patients newly diagnosed NICM who are treated with a WCD until a decision on the need for an ICD is made, early initiation of BB is independently associated with a greater likelihood of improvement in EF, a lower probability of needing an ICD at end of WCD use, and a lower risk of death at 1-year.

ECG as a risk stratification tool in patients with wearable cardioverter-defibrillator

BackgroundThe wearable cardioverter defibrillator (WCD) is increasingly used in patients at elevated risk for ventricular arrhythmias but not fulfilling the indications for an implantable cardioverter defibrillator (ICD). Currently, there is an insufficient risk prediction of fatal arrhythmias in patients at risk. In this study, we assessed the prognostic role of baseline electrocardiogram (ECG) in WCD patients. MethodsWCD patients from diverse clinical institutions in Germany (n = 227) were retrospectively enrolled and investigated for the incidences of death or ventricular arrhythmias during WCD wearing. In addition, the widely accepted ECG predictors of adverse outcome were analyzed in patients with arrhythmic events. ResultsLife-threatening arrhythmias occurred in 22 (9.7 %) patients, mostly in subjects with ischemic heart disease (15 of 22). There was no difference in baseline left ventricular ejection fraction (LVEF) in subjects with and without arrhythmic events (31.3 ± 7.9 % vs. 32.6 ± 8.3 %; p = 0,24). Patients with arrhythmia exhibited significantly longer QRS duration (109.5 ± 23.1 ms vs. 100.6 ± 22.3 ms, p = 0,04), Tpeak-Tend (Tp-e) (103.1 ± 15.6 ms vs. 93.2 ± 19.2 ms, p = 0,01) and QTc (475.0 ± 60.0 ms vs. 429.6 ± 59.4 ms, p < 0,001) intervals. In contrast, no significant differences were found for incidences of fragmented QRS (27.3 % vs. 24 %, p = 0.79) and inverted/biphasic T-waves (16.6 % vs. 22.7 %, p = 0,55). In multivariate regression analysis both Tp-e (HR 1.03; 95 % CI 1.001–1.057; p = 0.02) and QTc (HR 1.02; 95 % CI 1.006–1.026; p < 0.001) were identified as independent predictors of ventricular arrhythmias.After WCD use, the prophylactic ICD was indicated in 76 patients (33 %) with uneventful clinical course but persistent LVEF ≤35 %. The ECG analysis in these subjects did not reveal any relevant changes in arrhythmogenesis markers. ConclusionsECG repolarization markers Tp-e and QTc are associated with malignant arrhythmias in WCD patients and may be used - in addition to other established risk markers - to identify appropriate patients for ICD implantation.