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\begin{document}

\title{Gender differences and adherence of patients treated with wearable
cardioverter-defibrillator: insights from an international multicenter
register}



\author[1]{Mohammad Abumayyaleh}%
\author[1]{Tobias C.  Dreher }%
\author[1]{Ibrahim El-Battrawy}%
\author[1]{Stephanie Rosenkaimer}%
\author[1]{Susanne Röger}%
\author[2]{Julia Erath}%
\author[3]{Norbert Klein}%
\author[4]{Boldizsar Kovacs}%
\author[4]{Firat Duru}%
\author[4]{Ardan Saguner}%
\author[1]{Ibrahim Akin}%
\affil[1]{Ruprecht-Karls-Universitat Heidelberg Medizinische Fakultat Mannheim}%
\affil[2]{Goethe-Universitat Frankfurt am Main - Campus Westend}%
\affil[3]{Klinikum Sankt Georg gGmbH}%
\affil[4]{UniversitatsSpital Zurich Klinik fur Kardiologie}%


\vspace{-1em}



  
  \date{June 14, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
\textbf{Aims} The treatment with the wearable cardioverter defibrillator
(WCD) may protect against sudden cardiac death (SCD) as a bridging
therapy until a cardioverter-defibrillator may be implanted. We analyzed
in a multicenter setting a consecutive patient cohort wearing WCD to
explore gender differences. \textbf{Methods and results} We analyzed 708
consecutive patients, 579 from whom were males and 129 females (age,
60.5\selectlanguage{ngerman}±14 vs. 61.6±17 years old; p=0.44). All patients were divided into
age quartiles for analysis. While the rate of ischemic cardiomyopathy
(ICM) as a cause of prescription of WCD was significantly higher in
males as compared to females (42.7\% vs. 26.4\%; p=0.001), females
received it more frequently due to non-ischemic cardiomyopathy (NICM)
(55.8\% vs. 42.7\%); p=0.009). The wear time of WCD was equivalent in
both groups (21.1±4.3 hours/days in males vs. 21.5±4.4 hours/days in
females; p=0.27; and 62.6±44.3 days in males vs. 56.5±39 days in
females; p=0.15). Mortality was comparable in both groups at
2-year-follow-up (6.8\% in males vs. 9.7\% in females; p=0.55).
Appropriate WCD shocks and the incidence of device implantations were
similar in both groups (2.4\% in males vs. 3.9\% in females; p=0.07)
(35.1\% in males vs. 31.8\% in females; p=0.37), respectively. In age
quartile analysis, compliance was observed more in older patients as
compared to adult patients (87.8\% vs. 68.3\%; p\textless{}0.001).
\textbf{Conclusion} Compliance for wearing WCD was excellent regardless
of gender. Furthermore, mortality and the incidence of device
implantations were comparable in both groups. Appropriate WCD shocks
tended to be higher in females as compared to males.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


Gender differences and adherence of patients treated with wearable
cardioverter-defibrillator: insights from an international multicenter
register

\textbf{Short title: Gender differences and wearable
cardioverter-defibrillator}

Mohammad Abumayyaleh, MD\textsuperscript{1}, Tobias C
Dreher\textsuperscript{1}, Ibrahim El-Battrawy, MD\textsuperscript{1},
Stephanie Rosenkaimer, MD\textsuperscript{1}, Susanne R\selectlanguage{ngerman}öger,
MD\textsuperscript{1}, Julia W Erath, MD\textsuperscript{2}, Norbert
Klein, MD\textsuperscript{3}, Boldizsar Kovacs, MD\textsuperscript{4},
Firat Duru, MD\textsuperscript{4}, Ardan M Saguner, MD,
PhD\textsuperscript{4}, Ibrahim Akin, MD, PhD\textsuperscript{1}

\textsuperscript{1}Department of Cardiology, Angiology, Haemostaseology
and Medical Intensive Care, University Medical Center Mannheim, Medical
Faculty Mannheim, Heidelberg University, Germany

\textsuperscript{2}Department of Cardiology/Division of Clinical
Electrophysiology, University Hospital Frankfurt, Goethe University,
Frankfurt a. M., Germany

\textsuperscript{3}Department of Arrhythmias \& Invasive Cardiology, St.
Georg Hospital, Leipzig, Germany

\textsuperscript{4}Department of Cardiology, University Hospital of
Zurich, Zurich, Switzerland

\textbf{Address for correspondence} : Mohammad Abumayyaleh, MD and
Ibrahim El-Battrawy, MD, Department of Cardiology, Angiology,
Haemostaseology and Medical Intensive Care, Theodor-Kutzer-Ufer 1-3,
68167 Mannheim, Germany, E-Mail:
mohammad.abumayyaleh@medma.uni-heidelberg.de,
Ibrahim.elbattrawy2006@gmail.com, Phone: +49-621-383-1447, Fax:
+49-621-383-1474.

\textbf{Word account: 2403}

\textbf{Aims}

The treatment with the wearable cardioverter defibrillator (WCD) may
protect against sudden cardiac death (SCD) as a bridging therapy until a
cardioverter-defibrillator may be implanted. We analyzed in a
multicenter setting a consecutive patient cohort wearing WCD to explore
gender differences.

\textbf{Methods and results}

We analyzed 708 consecutive patients, 579 from whom were males and 129
females (age, 60.5±14 vs. 61.6±17 years old; p=0.44). All patients were
divided into age quartiles for analysis. While the rate of ischemic
cardiomyopathy (ICM) as a cause of prescription of WCD was significantly
higher in males as compared to females (42.7\% vs. 26.4\%; p=0.001),
females received it more frequently due to non-ischemic cardiomyopathy
(NICM) (55.8\% vs. 42.7\%); p=0.009). The wear time of WCD was
equivalent in both groups (21.1±4.3 hours/days in males vs. 21.5±4.4
hours/days in females; p=0.27; and 62.6±44.3 days in males vs. 56.5±39
days in females; p=0.15). Mortality was comparable in both groups at
2-year-follow-up (6.8\% in males vs. 9.7\% in females; p=0.55).
Appropriate WCD shocks and the incidence of device implantations were
similar in both groups (2.4\% in males vs. 3.9\% in females; p=0.07)
(35.1\% in males vs. 31.8\% in females; p=0.37), respectively. In age
quartile analysis, compliance was observed more in older patients as
compared to adult patients (87.8\% vs. 68.3\%; p\textless{}0.001).

\textbf{Conclusion}

Compliance for wearing WCD was excellent regardless of gender.
Furthermore, mortality and the incidence of device implantations were
comparable in both groups. Appropriate WCD shocks tended to be higher in
females as compared to males.

\textbf{Keywords: Wearable cardioverter-defibrillator; sudden cardiac
death; gender differences; female; male.}

\textbf{Introduction}

It is well known that an implantable cardioverter-defibrillator (ICD)
improves survival and reduces the mortality rate due to ventricular
tachyarrhythmias {[}1-3{]}. The Danish Cardiac Arrest Registry showed
the superiority of early implantation of ICD in patients surviving
myocardial infarction (MI) with cardiac arrest {[}4{]}. However, some
patients do not meet the criteria for ICD implantation or are unable to
receive an implantable device such as patients in the acute phase of MI
or myocarditis. The wearable cardioverter defibrillator (WCD) may be
considered to protect these patients against malignant ventricular
tachyarrhythmias and as a bridge to decision for ICD implantation
{[}5{]}. However, compliance is impaired due to comfort issues {[}6{]}.
Poor compliance and obesity decreased the efficacy of WCD therapy
{[}7{]}. In addition, the VEST trial showed no reduction of arrhythmic
death as the primary endpoint in recent MI patients with reduced left
ventricular ejection fraction (LVEF \textless{} 35\%) {[}8{]}.

One cohort study on sudden cardiac death (SCD) reported that WCD
treatment is effective in females with a first shock success rate of
95\% {[}9{]}. WEARIT-II-Registry presented a higher rate of ventricular
and atrial arrhythmic events in females as compared to males {[}10{]}.
However, randomized controlled trials and further data on gender
differences are lacking. Therefore, we analyzed in a multicenter setting
a consecutive patient cohort wearing WCD to explore gender differences
regarding compliance, rate of appropriate WCD shocks, and mortality.

\textbf{Methods}

\textbf{Study design}

Between April 2012 and March 2019, we included 708 patients with HFrEF
who received a WCD (ZOLL Life Vest \selectlanguage{english}system, Pittsburgh, USA) at the
University Medical Centre in Mannheim, Heidelberg University, Department
of Cardiology, University Hospital Frankfurt, Department of Arrhythmias
\& Invasive Cardiology, St. Georg Hospital Leipzig, and Department of
Cardiology, University Hospital of Zurich. This multicenter register is
designed as a retrospective cohort registry without any financial
support. Patients were treated according to the current European
guidelines for heart failure {[}11{]}.

We divided the collective according to gender (male=579; female=129).
Furthermore, all patients were divided into age quartiles for analysis:
161 patients in 14-51 years old group, 375 patients in 52-72 years old
group, and 172 patients in 73-91 years old group. Baseline
characteristics such as indications for WCD use were gathered. Wear time
of WCD and WCD shocks during WCD use were documented. Echocardiographic
assessments were collected. The death rate due to a cardiovascular cause
during a 2-year-follow-up was evaluated. These data were assessed by
chart and/or telephone review at mean 2-year-follow-up. LVEF
\textgreater{} 35\% led to stop WCD wearing and was recorded as an
improvement of the LVEF.

LVEF was calculated by using biplane Simpson's method, using
echocardiography and/or cardiac MRI. This study was executed in
compliance with the fifth revision of the Declaration of Helsinki
regarding investigations in human subjects and the study protocol was
approved by the Ethics Committee in all involved centers {[}12{]}.

\textbf{Description of WCD}

The WCD consists of a two-channel electrocardiogram that records the
front-back and left-right site as bipolar leading to continuous
electrocardiographic analysis. If a life-threatening heart rhythm such
as ventricular tachycardia (VT) or ventricular fibrillation (VF) is
detected, it delivers a shock to restore sinus rhythm. The detection
until shock delivery takes 45-55 s including initial detection of VT/VF
5 s to 10 s, tachycardia confirmation 10 s, and alarm time 25 s. Shock
can be avoided by pressing the stop button. The WCD has a memory for ECG
analysis from 30 s before starting the arrhythmia alarm until 15 s after
the alarm stop {[}13{]}.

\textbf{Statistics}

We present the data as mean +- standard deviation for continuous
variables with a normal distribution. Median (interquartile range) was
used for continuous variables with a non-normal distribution, and as
frequency (\%) for categorical variables. The Kolmogorov--Smirnov test
was used to assess normal distributions. Student's t-test and the
Mann--Whitney U-test were used to compare continuous variables with
normal and non-normal distributions, respectively. Additionally, the
Chi-squared test or Fisher's exact test was used to compare categorical
variables. The Wilcoxon signed-rank test was used for paired
nonparametric quantitative variables. The McNemar test was used for
paired qualitative variables. Statistical analysis was performed using
IBM SPSS Statistics for Macintosh (Version 25.0 Armonk, NY, USA: IBM
Corp.).

\textbf{Results}

\textbf{Baseline characteristics of 708 patients with WCD}

In this multicenter study, the male group had an average age of 60.5+-14
years old, and the female group of 61.6+-17 years old; p=0.44,
respectively. The indication for WCD use was several, \textbf{table 1} .
In patients who received WCD, 42.7\% of males and 26.4\% of females
suffered from ischemic cardiomyopathy (ICM) with LVEF \selectlanguage{english}[?]35\%; p=0.001. On
the other hand, 55.8\% of females and 42.7\% of males suffered from
non-ischemic cardiomyopathy (NICM); p=0.009. Other indications for WCD
were myocarditis, device explanation cause of device infection,
hypertrophic cardiomyopathy (HCM), and channelopathies with a similar
frequency in both genders.

\textbf{Follow-Up}

At baseline, the mean LVEF was comparable in both groups (29.5\%+-10.98\%
in males vs. 30.2\%+-12.2\% in females; p=0.55). At follow-up, the mean
LVEF increased during 3-6 months to 37.1\%+-12.1\% in males and
37.95\%+-12.1\% in females; p=0.49. The improvement of LVEF was
numerically observed in both groups, more in females as compared to
males (51.9\% vs. 44.7\%; p=0.16). The incidence of device implantation
was comparable in both groups (35.1\% in males vs. 31.8\% in females;
p=0.37). The wear time of WCD was similar in both groups, 21.1+-4.3
hours/days in males as compared to 21.5+-4.4 hours/days in females;
p=0.27, and documented in days 62.6+-44.3 days in males in comparison to
56.5+-39 days in females; p=0.15. The rate of appropriate shocks was
similar in both groups, 2.4\% in the male and 3.9\% in the female group;
p=0.07, with a higher tendency in females, \textbf{table 1.} In
addition, the rate of mortality was comparable in both groups (6.8\% in
males vs. 9.7\% in females; p=0.55)

\textbf{The quartile range of age}

A high incidence of male as gender was observed in all age groups
(81.9\% in 14-51, 84.8\% in 52-72, and 75\% in 73-91 years old group).
However, ICM was more observed in 52-72- and 73-91-years old groups as
compared to 14-51 years old group, respectively (48.3\% in 73-91 years
old group vs. 18.6\% in 14-51 years old group; p\textless{}0.001)
(44.8\%in 52-72 years old group vs. 18.6\% in 14-51 years old group;
p\textless{}0.001). On the other hand, NICM was more revealed in adult
as compared to older patients (57.8\% in 14-51 years old group vs.
43.7\% in 52-72 years old group; p=0.003) (57.8\% in 14-51 years old
group vs. 36\% in 73-91 years old group; p\textless{}0.001). Devices
were more implanted after WCD wearing in older patients as compared to
adult patients (40.7\% in 73-91 years old group vs. 26.1\% in 14-51
years old group; p=0.005). The compliance was observed more in older as
compared to adult patients (87.8\% in 73-91 years old group vs. 68.3\%
in 14-51 years old group; p\textless{}0.001). At 3-months follow-up,
LVEF was 39.34\%+-14.24 in adult group and 36.24\%+-11.72 in older
patients; p=0.03.

\textbf{Discussion}

We present the clinical outcome including mortality rate in WCD patients
divided into male and female groups up to 2 years. The main findings of
the study are (1) The improvement of LVEF was revealed in both groups;
(2) Mortality rate was similar in both groups; (3) The wearing time is
comparable in male and female participants, but the appropriate shock
rate tended to be higher in females as compared to males.

The WCD may be considered in selected patients with a high risk of SCD,
if the implantation of conventional ICD is temporarily contraindicated
(e.g. poor LVEF after acute myocardial infarction until LV function
improves, before heart transplantation) {[}14{]}. Therefore, the
American Heart Association (AHA), American College of Cardiology (ACC),
Heart Rhythm Society (HRS), and European Society of Cardiology (ESC)
provide class II, level of evidence C for the use of WCD in these
selected patients {[}15, 16{]}.

\textbf{Epidemiological data}

Both groups had a similar average age of 60.5+-14 in males and 61.6+-17
years old in females. While 42.7\% of males suffered from ICM with LVEF
\selectlanguage{english}[?]35\%, only 26.4\% of females suffered from ICM who received WCD.
Following our data, the Israeli-ICD registry showed comparable
epidemiological frequency regarding gender differences. The average age
in both genders was similar, 64+-14 in females and 64+-13 in male
participants. In addition, ICM was significantly more observed in males
as compared to the female group (79\% vs. 46\%). On the other hand, more
women suffered from dilated cardiomyopathy (DCM) in comparison to men's
participants (38\% vs. 18\%) {[}17{]}. In the VEST trial, the device
group consisted of 72.8\% male participants with the percutaneous
coronary intervention (PCI) during the index hospitalization {[}8{]}.
Males have a higher propensity for developing coronary heart disease as
well as ICM {[}18{]}. To summarize, our multicenter data corresponds
with previously published ICD data.

\textbf{Adherence}

The wear time of WCD was comparable in males with 21.1+-4.3 and female
group with 21.5+-4.4 hours/days, the rate of compliance was revealed in
77\% of male and 84.5\% of female participants, there were no
significant differences in this regard. One observational study has
presented a similar adherence rate with daily use of 23 h per day in
6043 patients {[}19{]}. The wear time in the VEST trial was 18 h, also
less than the wear time in our patients {[}8{]}. Most cases of death
occurred in patients who were not using the WCD {[}8{]}. In this regard,
one important and possible cause for death was non-compliance in wearing
the WCD. However, suffering from cardiac arrest during the index MI, and
an increase of creatinine were independent predictors for a high WCD
wearing time {[}20{]}. In addition, the indication for WCD in one large
cohort was equivalent in accordance with our study concerning the
different number of cases including ICM or DCM, genetic or congenital
disease, ICD explanations, or myocarditis {[}19{]}. In our quartile age
analysis, adherence was more observed in older as compared to adult
patients. In this regard, the WEARIT-France study showed that younger
age was associated with lower compliance {[}21{]}.

\textbf{Clinical Efficacy}

In male and female patients, the incidence of appropriate shocks was
comparable, but with a higher tendency in females. In 1998, Auricchio et
al. presented successfully arrhythmia detection and defibrillation in 9
patients out of 10{[}22{]}. Other randomized trials showed the safety
and efficacy of WCD in the termination of VT/VF. In this regard, first
shock success was in 79 of 80 (99\%) among all patients from whom were
74\% male participants, respectively {[}23{]}.

\textbf{Impact on mortality}

The mortality rate was similar between both genders in our multicenter
register. For this purpose, one large trial investigating gender
differences after ICD showed no differences in the mortality rate
between males and females during follow-up {[}17{]}. In the United
States (US) registry, WCD use reduced the rate of mortality up to 67\%
reduction analyzed with the propensity-score-matching method {[}24{]}.
In this trial, 19\% of all participants were female and
3-month-mortality was 2.2\% in all patients. In the VEST trial, the
mortality rate was 3.1\% at 3 months {[}8{]}. These rates are less than
in our trial, but our follow-up time is longer as compared to
US-registry and VEST trial. In addition, the VEST trial had high
selected exclusion criteria as compared to our real-world experience.

To summarize, in a real-world setting, we do not observe any differences
in adherence, efficacy, and impact on mortality in male and female
patients after WCD use. The improvement of LVEF was observed in both
groups. However, LVEF improved more in adult than in older patients.

\textbf{Limitations}

Our trial has several limitations. The majority of patients were male to
make qualitative assessments. We did not evaluate other diagnostic
methods as MRI to identify patients with a high risk for arrhythmias and
SCD. The order of WCD was based on individual patient risk. In the
follow-up time, the cause of death was not reported and could not be
analyzed.

\textbf{Conclusion}

The same level of patient compliance for wearing WCD was revealed in
both groups regardless of gender differences. At follow-up, LVEF
improved in both groups. The mortality rate was comparable in both
groups.

\textbf{Conflict of interest}

The authors declare that they have no conflict of interest.

\textbf{Clinical perspectives}

WCD is a good treatment approach in patients suffering from reduced left
ventricular ejection fraction for example after myocardial infarction or
myocarditis to avoid unnecessary implantation of implantable
cardioverter-defibrillator regardless of gender.

\textbf{Funding}

None

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23 MK Chung, SJ Szymkiewicz, M Shao, E Zishiri, MJ Niebauer, BD Lindsay,
et al., Aggregate national experience with the wearable
cardioverter-defibrillator: Event rates, compliance, and survival. J Am
Coll Cardiol 56(3) (2010) 194-203.

24 ET Zishiri, S Williams, EM Cronin, EH Blackstone, SG Ellis, EE
Roselli, et al., Early risk of mortality after coronary artery
revascularization in patients with left ventricular dysfunction and
potential role of the wearable cardioverter defibrillator. Circ Arrhythm
Electrophysiol 6(1) (2013) 117-128.

\textbf{Table legend}

\textbf{Table 1:} Baseline characteristics in males vs. females with
Wearable Cardioverter Defibrillator (WCD)

\textbf{Table 2} : The impact on outcome according to quartile of age

\textbf{Hosted file}

\verb`Table.docx`  available at \url{https://authorea.com/users/455800/articles/553059-gender-differences-and-adherence-of-patients-treated-with-wearable-cardioverter-defibrillator-insights-from-an-international-multicenter-register}

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