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\begin{document}

\title{Patients' and Family Members' Views on Pacemaker Reuse: an International
Survey}



\author[1]{Andrew Hughey}%
\author[2]{Palaniappan  Muthappan}%
\author[3]{Auroa  Badin}%
\author[4]{Timir Baman}%
\author[5]{Naila  Baig-Ansari}%
\author[6]{Fayez  Jawed}%
\author[5]{Abdul  Khan}%
\author[1]{Qingmei  Jiang}%
\author[1]{Katherine  Hughey}%
\author[7]{Rolando  Toruño}%
\author[8]{Christian Machado}%
\author[9]{Marwan Refaat}%
\author[10]{Patrick Zakka}%
\author[9]{Mostafa  Hotait}%
\author[1]{Kim Eagle}%
\author[11]{Thomas Crawford}%
\affil[1]{University of Michigan Michigan Medicine}%
\affil[2]{Wright State University Boonshoft School of Medicine}%
\affil[3]{The University of Texas Health Science Center at San Antonio}%
\affil[4]{OSF Healthcare}%
\affil[5]{Indus Hospital}%
\affil[6]{Sofregen Inc.}%
\affil[7]{Centro Nacional Cardiologia}%
\affil[8]{Providence Hospital and Medical Center}%
\affil[9]{American University of Beirut Medical Center}%
\affil[10]{Emory University School of Medicine}%
\affil[11]{University of Michigan}%


\vspace{-1em}



  
  \date{June 03, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Introduction The reuse of cardiac implantable electronic devices may
help increase access to these therapies in low- and middle-income
countries (LMICs). No published data exist regarding the views of
patients and family members in LMICs regarding this practice. Methods
and Results A paper questionnaire eliciting attitudes regarding
pacemaker reuse was administered to ambulatory adult patients and
patients' family members at outpatient clinics at Centro Nacional
Cardiologia in Managua, Nicaragua, Indus Hospital in Karachi, Pakistan,
Hospital Carlos Andrade Mar\selectlanguage{ngerman}ín and Hospital Eugenio Espejo in Quito,
Ecuador, and American University of Beirut Medical Center in Beirut,
Lebanon. There were 945 responses (Nicaragua -- 100; Pakistan -- 493;
Ecuador -- 252; Lebanon -- 100). A majority of respondents agreed or
strongly agreed that they would be willing to accept a reused pacemaker
if risks were similar to a new device (707, 75\%), if there were a
higher risk of device failure compared to a new device (584, 70\%), or
if there were a higher risk of infection compared to a new device (458,
56\%). A large majority would be willing to donate their own pacemaker
at the time of their death (884, 96\%) or the device of a family member
(805, 93\%). Respondents who were unable to afford a new device were
more likely to be willing to accept a reused device (79\% vs. 63\%,
P\textless{}0.001). Conclusions Patients and their family members
support the concept of pacemaker reuse for patients who cannot afford
new devices.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


Patients' and Family Members' Views on Pacemaker Reuse: an International
Survey

Andrew B. Hughey, MD,\textsuperscript{1} Palaniappan Muthappan,
MD,\textsuperscript{2} Auroa Badin, MD,\textsuperscript{3} Timir Baman,
MD,\textsuperscript{4} Naila Baig-Ansari, PhD,\textsuperscript{5} Fayez
Jawed, MSc,\textsuperscript{6} Abdul B. Khan,
MBBS,\textsuperscript{7}Qingmei Jiang, MA, MS,\textsuperscript{1}
Katherine L. Hughey, MD,\textsuperscript{8} Rolando Jir\selectlanguage{ngerman}ón Toruño,
MD,\textsuperscript{9}Christian Machado, MD,\textsuperscript{10} Marwan
M. Refaat,\textsuperscript{11} MD, Patrick Zakka,
MD,\textsuperscript{12}Mostafa Hotait, MD,\textsuperscript{11} Kim A.
Eagle, MD,\textsuperscript{1} Thomas C. Crawford, MD\textsuperscript{1}

\textsuperscript{1} University of Michigan, Michigan Medicine, Internal
Medicine, Ann Arbor, MI, USA

\textsuperscript{2} Wright State University Boonshoft School of
Medicine, Internal Medicine, Dayton, OH, USA

\textsuperscript{3} University of Texas Health Science Center at San
Antonio, Internal Medicine, San Antonio, Texas, USA

\textsuperscript{4} OSF Healthcare, Cardiology, Peoria, IL, USA

\textsuperscript{5} The Indus Hospital, Indus Hospital Research Center,
Karachi, Pakistan

\textsuperscript{6} Sofregen Inc., Medford, MA, USA

\textsuperscript{7} Indus Hospital, Indus Hospital Research Center,
Karachi, Pakistan

\textsuperscript{8} University of Michigan, Michigan Medicine, Family
Medicine Ann Arbor, MI, USA

\textsuperscript{9} Centro Nacional Cardiologia, Cardiologia, Managua,
Nicaragua

\textsuperscript{10} Providence Hospital and Medical Center,
Cardiology/Electrophysiology, Southfield, Michigan, USA, Wayne State
University, Internal Medicine, Detroit, Michigan, USA

\textsuperscript{11} Department of Internal Medicine, Cardiovascular
Medicine Division, American University of Beirut Medical Center, Lebanon

\textsuperscript{12} Emory University School of Medicine, Internal
Medicine, Atlanta, Georgia, USA

Short Title: Patients' and Family Members' views on pacemaker reuse

\textbf{Conflict of interest statements:}

AH -- None

PM -- None

TM -- None

NB -- None

FJ -- None

AK -- None

QJ -- None

KH -- None

RJ -- None

CM -- None

AB -- None

MR -- None

PZ -- None

MH -- None

KA -- None

TC -- None

Correspondence and reprint requests:

Thomas C. Crawford, MD

University of Michigan, Michigan Medicine

Internal Medicine

1500 East Medical Center Drive SPC 5853

Ann Arbor, Michigan 48109-5853, USA

Fax: 734-936-7026

Email: thomcraw@med.umich.edu

Abstract

Introduction

The reuse of cardiac implantable electronic devices may help increase
access to these therapies in low- and middle-income countries (LMICs).
No published data exist regarding the views of patients and family
members in LMICs regarding this practice.

Methods and Results

A paper questionnaire eliciting attitudes regarding pacemaker reuse was
administered to ambulatory adult patients and patients' family members
at outpatient clinics at Centro Nacional Cardiologia in Managua,
Nicaragua, Indus Hospital in Karachi, Pakistan, Hospital Carlos Andrade
Marín and Hospital Eugenio Espejo in Quito, Ecuador, and American
University of Beirut Medical Center in Beirut, Lebanon. There were 945
responses (Nicaragua -- 100; Pakistan -- 493; Ecuador -- 252; Lebanon --
100). A majority of respondents agreed or strongly agreed that they
would be willing to accept a reused pacemaker if risks were similar to a
new device (707, 75\%), if there were a higher risk of device failure
compared to a new device (584, 70\%), or if there were a higher risk of
infection compared to a new device (458, 56\%). A large majority would
be willing to donate their own pacemaker at the time of their death
(884, 96\%) or the device of a family member (805, 93\%). Respondents
who were unable to afford a new device were more likely to be willing to
accept a reused device (79\% vs. 63\%, P\textless{}0.001).

Conclusions

Patients and their family members support the concept of pacemaker reuse
for patients who cannot afford new devices.

Key Words: pacemaker, reutilization, reuse, views, global health

Introduction

Pacemakers remain unaffordable for many individuals in low- and
middle-income countries (LMICs), resulting in disparities in pacemaker
utilization.\textsuperscript{1} The reuse of pacemakers - which involves
extraction of devices from deceased donors, resterilization, and
reimplantation in recipient patients -- has been proposed as a potential
solution to this unmet need.\textsuperscript{2} Pacemaker reuse has been
previously conducted in LMICs on a small scale and these experiences
suggest that it is safe, efficacious, and feasible.\textsuperscript{3-5}

Previously published survey data have shown that the vast majority of
funeral directors, patients withs with pacemakers, and their families in
the United States support donation of explanted
pacemakers.\textsuperscript{6} An international survey of the members of
the Heart Rhythm Society indicated that the concept of pacemaker reuse
was well supported by the respondents in potential donor and recipient
countries.\textsuperscript{7} Yet to our knowledge no study to date has
assessed the attitudes toward postmortem pacemaker reuse among potential
device recipients LMICs. Understanding these viewpoints is critical to
the successful adoption of a wide-scale reuse program, specifically
regarding religious, cultural, and psychological factors, which may
impact the acceptance of reconditioned pacemakers from deceased persons.
In this study we aimed to quantitatively evaluate the opinions of
pacemaker reuse among patients and family members in LMICs and to
identify demographic factors which may predict these views.

Methods

Study Design

This study utilized an anonymous, fourteen-question paper survey
originally written in English and translated into Urdu, Spanish, and
Arabic. The survey instrument is shown in the Appendix. Demographic
questions included age, gender, country of residence, health status,
level of education, marital and employment status, the presence of a
personal or family history of heart disease, and the ability to afford
the full cost of a new pacemaker whose market value was estimated to be
\$700 USD (or equivalent amount of local currency). Of note, pacemaker
cost is the responsibility of the patient in the absence of private
insurance in the countries surveyed. Respondents were asked to rate
their level of agreement with five positive statements regarding
pacemaker reuse using a five-point Likert-type scale (1 = strongly
agree, 2 =agree, 3 = neutral, 4 = disagree, and 5 = strongly disagree).

The University of Michigan Institutional Review Board (IRB) declared the
study exempt from review due to a lack of identifying information
collected and no capacity for patient harm. In Nicaragua, the survey was
approved by the Ministry of Health; in Pakistan, it was approved by the
local IRB; in Ecuador and Lebanon, it was approved by the local hospital
administrations.

The survey was administered to patients and family members in the
waiting room of the outpatient clinics at Centro Nacional Cardiologia in
Managua, Nicaragua (over a two-day period in April 2012), Indus Hospital
in Karachi, Pakistan (over a two-week period in May 2012), Hospital
Carlos Andrade Marín and Hospital Eugenio Espejo in Quito, Ecuador (over
a two-week period in July 2014) and American University of Beirut
Medical Center in Beirut, Lebanon (over a two-month period from June to
July 2015). The World Bank classifies Nicaragua and Pakistan's economies
as ``lower-middle income'' with per capita gross national incomes (GNI)
of \$1,910 USD and \$1,530 USD, respectively; it classifies Ecuador and
Lebanon's economies as ``upper-middle income'' with per capita GNI of \$
6,080 USD and \$7,600, respectively.\textsuperscript{8}

No compensation was provided for participation. Respondents were advised
that survey participation was voluntary, responses would remain
anonymous, and that their participation and responses would not affect
their clinical care or eligibility for charity care. Participants
returned surveys to the study personnel distributing surveys. Study
personnel assisted respondents who wished to participate in the survey
but were unable to do so (generally due to illiteracy or infirmity).

Data Analysis

Views regarding pacemaker reuse were represented as the number of
respondents who indicated ``agree'' or ``strongly agree'' for each
question as a proportion of non-neutral responses. Demographic variables
were analyzed as categorical variables and agreement with each statement
regarding pacemaker reuse was tabulated by country of origin and by
demographic variables. Differences in opinion across countries or
demographic variables were tested using the \selectlanguage{greek}χ\selectlanguage{english}2 test. Multivariate
logistic regression using the \selectlanguage{greek}χ\selectlanguage{english}2 test was performed to assess whether
country of residence and/or ability to afford a new device were
independent predictors of various opinions of device reuse.

Analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC).
P \textless{} 0.05 was deemed statistically significant.

Results

Respondent Characteristics

A total of 945 respondents participated in the survey (Nicaragua -- 100;
Pakistan -- 493; Ecuador -- 252; Lebanon -- 100). The demographic
characteristics of survey respondents are shown in Table 1. The mean age
of respondents was 48. The majority (582, 62\%) were women. Less than
half of respondents (354, 38\%) were married or living with a partner.
Most of the respondents had no more than ten years of formal education
(536, 57\%) and most were not employed outside the home (576, 61\%). A
majority of respondents classified their own health as fair or poor
(565, 60\%) and 725 respondents (77\%) reported a history of heart
disease either in themselves or a family member. A significant majority
of respondents reported being unable to afford the full cost of a new
pacemaker (537, 78\%).

Opinions Regarding Pacemaker Reuse

Patient and family members' level of agreement with various statements
about pacemaker reuse stratified by country of residence and demographic
characteristics is shown in Table 2. Attitudes regarding device donation
and reuse were overall positive. A majority of respondents agreed or
strongly agreed that they would be willing to accept a reused pacemaker
if risks were similar to a new device (707, 75\%), if there were a
higher risk of device failure compared to a new device (584, 70\%), or
if there were a higher risk of infection compared to a new device (458,
56\%). A large majority would be willing to donate their own pacemaker
at the time of their death (884, 96\%) or the device of a family member
(805, 93\%).

Predictors of Attitude Toward Pacemaker Reuse

Respondents who reported being unable to afford a new pacemaker were
more likely to accept a reused device if the risks were similar to a new
device (79\% vs. 63\%, P\textless{}0.001), or if the risk of device
malfunction were greater (74\% vs. 63\%, P\textless{}0.001). Those with
a personal or family history of a heart condition were slightly less
likely to be willing to donate a family member's pacemaker (92\% vs.
96\%, P=0.049). The vast majority of respondents who were married or
living with a partner would be willing to donate their own pacemaker at
the time of their death but at a slightly lower rate than other
respondents (97\% vs. 93\%, P=0.043). Other analyzed demographic
variables including age group, gender, health, level of education, or
employment status were not associated with variation in attitude toward
pacemaker reuse.

Compared to respondents from other countries, those from Lebanon were
more likely to be able to afford a new device (66\% vs. 15\%,
P\textless{}0.001) and less likely to be willing to undergo
reimplantation with a reused device (51\% vs. 78\%, P\textless{}0.001).
Lebanese respondents were also less willing than other respondents to
undergo reimplantation if there were a greater risk of device
malfunction (56\% vs. 63\%, P\textless{}0.001) or if there were a
greater risk of infection (30\% vs. 51\%, P\textless{}0.001).

Multivariable logistic regression was performed to determine whether
country of residence or ability afford a device were independent
predictors of positive viewpoints of device reuse. This analysis showed
that Lebanese residence and ability to afford a new pacemaker were each
independent negative predictors of willingness to accept a used
pacemaker for two statements regarding reuse (``if risks similar'' and
``if higher risk of failure''; P\textless{}0.05) but the ability to
afford a new pacemaker did not independently predict the other
statements.

Discussion

Major Findings

A large majority of respondents in the four surveyed low- to middle-
income countries have positive attitudes towards postmortem donation of
pacemakers and embrace the concept of a reconditioned device for their
medical care. These positive attitudes persist even in a hypothetical
scenarios in which these devices carry a higher risk of device
malfunction or infection.

A successful wide-scale pacemaker reutilization program requires
participation of patients, their family members, the funeral industry in
donor counties, as well as health authorities, physicians, patients, and
the families in recipient countries. With regards to patients in
potential donor countries, Gakenheimer \emph{et al} reported that 87\%
of patients with cardiac implantable electronic devices (CEIDs) and 71\%
of the general population in the United States would be willing to
donate them to indigent patients in LMICs.\textsuperscript{6} This study
also found that 89\% of Michigan funeral directors would support a
cardiac device reuse initiative. From the physician perspective, in a
web based survey of 429 Heart Rhythm Society (HRS) members (primarily
cardiac electrophysiologists), 81\% of physician respondents reported
being comfortable asking their patients to consider donating their CIED
and 84\% reported willingness to reimplant a resterilized device if the
practice were legally sanctioned. Importantly, HRS members from
high-income countries supported CIED reuse at rates similar to those
from lower- and upper-middle income countries.\textsuperscript{7} The
present study complements the existing survey data by demonstrating
broad support for pacemaker reuse among patients and their family
members in LMICs, where an unmet need for pacemakers persists despite
economic progress.

Respondents were less likely to accept a reused pacemaker in a
hypothetical scenario in which a reused device is more likely to
malfunction and even less likely in a hypothetical scenario in which a
reused device is more likely to cause infection, although a majority of
respondents were still agreeable to accepting a pacemaker under either
of these scenarios. In the aforementioned survey of HRS members, when
asked about their potential concerns about CIED reuse, 64\% of
physicians cited infection and 29\% cited device
malfunction.\textsuperscript{7} In a meta-analysis comprising 18 studies
and 2,270 patients who underwent pacemaker reuse, device malfunction was
more frequent with reused devices than new ones (odds ratio 5.80 {[}1.93
to 17.47{]}, P = 0.002), but only occurred in 0.7\% of reimplanted
devices. Most malfunctions were related to set screw abnormalities,
which may be identified during a thorough validation process prior to
donation, or even during the implantation procedure when the pacemaker
with the faulty screw may be replaced by a back-up device. The risk of
infection among reconditioned devices was 2.0\%, statistically similar
to the risk for new devices.\textsuperscript{9} Standardized
sterilization protocols are needed to minimize the risk of infection.
Our group proposed a standardized sterilization protocol to clean, test,
and sterilize CIEDs to meet industry standards for sterility of
reconditioned implantable medical devices\textsuperscript{10} Yet even
if the risks associated with reused devices are higher, our survey
suggests that patients in LMICs perceive an increased risk of infection
or malfunction to be an acceptable tradeoff when the alternative is not
receiving appropriate care due to lack of access to a new device.
Reconditioned pacemakers should only be offered to patients, who would
not otherwise be able to obtain a new device, and such implantation
should only be performed following a thorough informed
consent.\textsuperscript{7} Ethically, we may be obligated to offer such
a resterilized device to those whom no other treatment is
available.\textsuperscript{11}

The finding that respondents who are unable to afford a new device were
more likely to be willing to accept a reused device is not surprising
given that the primary justification for device reuse is cost reduction.
It is remarkable that the rates of acceptance of a reused pacemaker were
greater than 50\% even among patients who stated that they
\emph{could}afford a new device, suggesting that the cost savings of a
reused device is a tangible benefit even when a new device is not
prohibitively expensive.

The finding that respondents from Lebanon were less likely than
respondents from other countries to be willing to undergo reimplantation
is partly due to the fact that these respondents were more likely be
able to afford a new device, which we found in logistic regression to be
negatively associated with willingness to accept a new device even when
accounting for country of residence. Lebanon is the highest-income
country among our survey sample and these trends of opinion may be
similar in other upper-middle income countries.

Study Limitations

Since this survey was voluntary, there is a risk of participation bias
in that individuals who agreed to complete the survey may have been
predisposed to have positive viewpoints of device reuse compared to
those who declined, or that the researchers were wanting them to approve
of the practice. The response rate was not quantitatively tracked. Our
sample was limited to patients and family members in the waiting rooms
of a small subset of outpatient clinics in four countries. Many factors
-- such as the local economy, the healthcare system, level of trust in
the healthcare system, and variations in ethical standards and cultural
beliefs -- may have influenced these opinions and these findings are
therefore not necessarily generalizable to all LMICs or the global
community. Despite these potential biases, the overwhelmingly positive
attitudes toward the donation and acceptance of reused pacemakers among
this large and geographically diverse sample suggests that these
opinions are likely to at least directionally reflect the views of
people living in other LMICs as well.

Conclusions

Reuse of properly reconditioned pacemakers may allow patients in LMICs
to receive essential bradycardia therapy despite their financial
inability to obtain a new device. A significant majority of patients and
family members residing in countries that could benefit from reuse have
positive attitudes toward the postmortem donation of pacemakers. This
finding underscores the importance of further study to better
demonstrate the safety of pacemaker reuse and to advocate for changes in
the regulatory environment to enable pacemaker reuse for the benefit of
needy patients in LMICs.

Acknowledgements / Funding Sources:

My Heart Your Heart initiative is supported by generous grants from
Sheldon and Marion Davis, as well as William and Delores Brehm. We would
like to thank all of the individuals who helped facilitate survey
administration, including Andrea Cho, Angie Arellano, and Raul
Benavides.

Author Contributions:

AH -- data collection, data analysis/interpretation, manuscript
development; PM -- concept/design, data collection, manuscript
development; critical revision of article; TM -- critical revision of
article; NB -- data collection, critical revision of article; FJ -- data
collection, critical revision of article; AK -- data collection,
critical revision of article; QJ -- statistics; KH --data collection,
critical revision of article; RJ -- data collection, critical revision
of article; CM -- data collection, critical revision of article; AB --
data collection, critical revision of article; MR -- data collection,
critical revision of article; PZ -- data collection, critical revision
of article; MH -- data collection, critical revision of article; KE --
concept/design, critical revision of article; TC -- concept/design;
critical revision of article.

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2. Marine JE, Crawford TC, Sinha SK, et al. Global disparities in
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3. Khairy TF, Lupien MA, Nava S, et al. Infections Associated with
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7. Hughey AB, Desai N, Baman TS, et al. Heart Rhythm Society members'
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8. \emph{World Bank
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9. Baman TS, Meier P, Romero J, et al. Safety of pacemaker reuse: a
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10. Crawford TC, Allmendinger C, Snell J, et al. Cleaning and
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11. Aragam KG, Baman TS, Kirkpatrick JN, et al. The ethics of pacemaker
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