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RESEARCH ARTICLE Open Access
Frequency of arrhythmia symptoms and
acceptability of implantable cardiac
monitors in Hemodialysis patients
Naya El Hage1
, Bernard G. Jaar2,3,4
, Alan Cheng5
, Chloe Knight2
, Elena Blasco-Colmenares6
, Luis Gimenez2,4
,
Eliseo Guallar3,6,7
and Tariq Shafi2,3,7*
Abstract
Background: Arrhythmia-related complications and sudden death are common in dialysis patients. However,
routine cardiac monitoring has so far not been feasible. Miniaturization of implantable cardiac monitors offers a
new paradigm for detection and management of arrhythmias in dialysis patients. The goal of our study was to
determine the frequency of arrhythmia-related symptoms in hemodialysis patients and to assess their willingness
to undergo implantation of a cardiac monitor.
Methods: We conducted a survey of in-center hemodialysis patients at a hemodialysis clinic in Baltimore, Maryland.
We assessed the frequency of arrhythmia-related symptoms and willingness to undergo placement of an
implantable cardiac monitor (LINQ, Medtronic Inc.).
Results: Forty six patients completed the survey. The mean age of the survey respondents was 59 years and 65%
were male. Symptoms were common with 74% (n = 34) of participants reporting at least one arrhythmia-related
symptom and many [22% (n = 10)] had all 3 symptoms. Among the patients with symptoms, 57% (n = 26) reported
“heart skipping beats, flopping in chest or beating very hard,” 61% (n = 28) reported “heart racing (palpitations),” and
37% (n = 17) reported feeling that they “passed out or almost passed out.” The majority of the patients felt that the
timing of the symptoms was unrelated to dialysis treatments. The acceptability of the monitoring device implantation
was high, with 59% (n = 20) of patients with symptoms and 50% (n = 6) of patients without symptoms willing to
consider it. The main reason for not considering the device was not wanting to have an implanted device.
Conclusion: The prevalence of arrhythmia-related symptoms is high in hemodialysis patients and the majority would
consider an implantable cardiac monitor if recommended by their physicians. Routine implantation of cardiac
monitoring devices to manage arrhythmias in dialysis patients may be feasible and will provide further insights on the
leading causes of morbidity and mortality in dialysis patients.
Background
Patients with end-stage renal disease requiring dialysis
have a high risk of morbidity and mortality. The risk of
death in the year after dialysis initiation is 20% and me-
dian survival is only 3 years [1]. Despite many improve-
ments in general medical care, the 5-year mortality in
dialysis patients approaches 65% and has not improved
significantly over the last decade [1]. Cardiovascular
disease remains the leading cause of death in dialysis
patients (50% of all deaths) and the majority of these
deaths (25-40% of all deaths) are due to sudden cardiac
arrest [1]. To date, no effective strategies to prevent
these deaths have been devised.
Patients treated with dialysis also experience an
extraordinarily high risk of atrial fibrillation and
stroke. The claims-based prevalence of atrial fibrilla-
tion is 20%–50%, [2, 3] but the true prevalence is
likely much higher as atrial fibrillation episodes are mostly
asymptomatic [4–7]. In patients initiating dialysis, the risk
* Correspondence: tshafi@jhmi.edu
2
Division of Nephrology, Department of Medicine, Johns Hopkins University
School of Medicine, 301 Mason Lord Drive, Suite 2500, Baltimore, MD
21224-2780, USA
3
Welch Center for Prevention, Epidemiology and Clinical Research, Johns
Hopkins University, Baltimore, MD, USA
Full list of author information is available at the end of the article
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
El Hage et al. BMC Nephrology (2017) 18:309
DOI 10.1186/s12882-017-0740-1
of stroke is 20% and more than half of these strokes are
classified as cardioembolic or cryptogenic; [8] atrial fibril-
lation is a likely underlying culprit [9].
A major limitation to the detection and treatment of
arrhythmias in dialysis patients has been the lack of our
ability to continuously monitor cardiac rhythms. Dialysis
units are not equipped with telemetry and continuous
home monitoring with Holter devices can only be used
for short periods and is not practical for wide-scale use.
Prior attempts with larger subcutaneous implanted car-
diac monitors have not been successful [10]. A major re-
cent advancement has been the miniaturization of
cardiac monitoring technology that is leadless, contains
a battery that lasts 3 years, and can be implanted under
the skin in less than 60 s. The Reveal LINQ (Medtronic,
Mounds View, MN) measures 1.79 in. by 0.29 in. by
0.16 in. and weighs 0.09 oz and is currently indicated for
patients at risk for arrhythmia development [11].
The goal of our study was to determine the frequency
of arrhythmia symptoms in hemodialysis patients and to
assess their willingness to undergo implantable loop re-
corder implantation for monitoring cardiac arrhythmias.
Methods
Study design
The study was approved by the Johns Hopkins Medicine
Institutional Review Board (IRB). The IRB considered
verbal consent to be adequate as the study only included
participant interview without medical record review or
longitudinal data collection. We surveyed all patients
undergoing in-center hemodialysis at a dialysis clinic in
the Baltimore, Maryland in May 2015. We excluded pa-
tients with prior pacemaker or defibrillator placement.
After obtaining verbal consent to participate in the
survey, we administered a brief questionnaire about
symptoms of common arrhythmias (Additional file 1:
Appendix). We also showed the patients an actual size
picture of the Reveal LINQ device, and asked them if
they would be willing to have the device implanted if
recommended by their doctor. We summarized the sur-
vey responses using means and proportions.
Results
Baseline characteristics
We approached 97 patients for the survey, 48 consented,
of which 2 were ineligible (due to presence of pacemaker
or defibrillator) leading to final survey sample of 46 pa-
tients. The mean age of the patients was 59 years and
65% were male (Table 1). Approximately 80% of patients
in this dialysis clinic are African-American [12]. 15%
(n = 7) of participants did not have a past history of dia-
betes, congestive heart failure, stroke, or irregular heart-
beat 33% (n = 15) had at least one of these problems,
29% (n = 13) had two, 17% (n = 8) had 3, and 7% (n = 3)
had all four of the problems.
Arrhythmia-related symptoms
Arrhythmia-related Symptoms were common (Table 2).
74% of participants reported at least one arrhythmia-
related symptom. Multiple symptoms were common,
with 59% (n = 27) of the patients reporting two or more
symptoms and 22% (n = 10) of the patients reporting all
3 symptoms. Among patients with symptoms, 57%
(n = 26) reported “heart skipping beats, flopping in chest
or beating very hard,” 61% (n = 28) reported “heart ra-
cing (palpitations),” and 37% (n = 17) reported feeling
that they “passed out or almost passed out.” Only 2 pa-
tients reported symptoms occurring all the time; the ma-
jority felt that the symptoms occurred intermittently,
and most felt that the symptoms’ occurrence was unre-
lated to dialysis treatments.
Acceptance of LINQ implantation
After simply looking at the actual size picture of the im-
plantable loop recorder (Additional file 1: Appendix)
and without further medical counselling, 56% (n = 26) of
survey respondents were willing to consider it (Table 3).
The acceptability rate was 59% (n = 20) among the 34
patients with symptoms and 50% (n = 6) among the 12
patients without symptoms. The most common reason
for refusing device implantation was simply not wanting
a device. None of the participants expressed any cos-
metic concerns for not wanting the device.
Discussion
This study of in-center hemodialysis patients from
Baltimore, Maryland provides several important observa-
tions. Among the 46 participants completing the survey,
the prevalence of arrhythmia-related symptoms was high
with 74% reporting at least one symptom and 22% report-
ing all 3 symptoms. Among patients with symptoms, the
prevalence of pre-syncope/syncope symptoms was 37% and
the prevalence of palpitations/tachyarrhythmia symptoms
was approximately 60%. Acceptability of the implantable
Table 1 Baseline characteristics of the study population
Characteristics All patients (n = 46)
Age, years 59.2 ± 14.2
Male, % 30 (65.2%)
Comorbidities
Diabetes 27 (58.7%)
Congestive Heart Failure 19 (41.3%)
Stroke 6 (13.0%)
Myocardial Infarction 5 (10.9%)
Irregular heartbeat 20 (43.5%)
El Hage et al. BMC Nephrology (2017) 18:309 Page 2 of 5
cardiac monitor was high, with 59% of patients with symp-
toms and 50% of patients without symptoms willing to con-
sider it. The main reason for not considering the device
was not wanting to have an implanted device.
Cardiovascular disease is the leading cause of death in
dialysis patients and its prevalence is 20-100 fold higher
in dialysis patients compared with the age-matched gen-
eral population [13]. Almost 25-40% of all deaths in dia-
lysis patients are classified as sudden deaths or deaths
related to arrhythmias [1, 14]. Retrospective observa-
tional studies suggest a number of risk factors for
arrhythmia-related deaths in dialysis patients, including
dialysate composition, [15] dialysis-induced rapid fluid
and electrolyte shifts, intradialytic hypotension, [16, 17]
and marked electrolyte shifts around the long interdialy-
tic interval during the weekend [18, 19]. Atrial
fibrillation is also common in dialysis patients and its
prevalence (20%-50%) is likely underestimated from
claims-based data [2, 3, 20]. Atrial fibrillation, especially
undetected paroxysmal atrial fibrillation, could be a
major contributing factor to the high incidence of stroke
in dialysis patients [8, 21].
Despite the overwhelming burden of arrhythmia-
related morbidity and mortality in dialysis patients, there
are very few specific interventions to modify this risk.
Most of the current dialysis management practices in
place have failed to improve this risk over the past
decade, suggesting the failure of the one-size-fits-all ap-
proach. Risk modification in individual patients cannot
occur without knowledge of specific arrhythmias and
specific arrhythmias cannot be detected without long-
term ambulatory cardiac monitoring. Our study takes an
important step in this direction by exploring patient ac-
ceptance of such a device. Further work is needed to
determine if this approach can be successfully imple-
mented in clinical practice or research settings.
Although the risk of sudden death remains constant
after dialysis initiation, it is likely that the arrhythmias
causing sudden death in dialysis patients change over
time. It is possible that ventricular tachycardia/ventricu-
lar fibrillation are more common early after dialysis initi-
ation due to the presence of occult cardiac ischemia
combined with intradialytic hypotension and postdialysis
metabolic changes such as hypokalemia, hypocalcemia,
and metabolic alkalosis. During later years of dialysis,
bradyarrhythmias may be more common due to progres-
sive calcification of the conducting system and ongoing
use of medications such as β-blockers. Indeed, recent
studies in prevalent dialysis patients with implanted car-
diac monitors reported that bradyarrhythmias rather
than tachyarrhythmias were more common [22, 23].
Knowledge of specific arrhythmias is needed to insti-
tute patient-specific management strategies, many of
which are standard of care in clinical practice. For ex-
ample, risk stratification and management of ventricular
tachycardia and bradyarrhythmias can follow standard
clinical practice guided by a cardiologist. Similarly, atrial
fibrillation may require identification of precipitating
factors (volume overload in the interdialytic interval and
rapid volume removal during dialysis) and stroke pre-
vention by anticoagulation. It is worth noting that the
prevalence of atrial fibrillation in dialysis patients is
similar or higher than in patients with cryptogenic
stroke, a condition where implantable cardiac monitors
are considered standard of care [24]. As most atrial fib-
rillation events are asymptomatic [4–7] they are less
likely to be detected without long-term ambulatory car-
diac monitoring.
Prevention and treatment of arrhythmias in dialysis
patients will require the ability to detect arrhythmias.
However, outpatient dialysis units are not equipped with
cardiac telemetry monitoring capabilities. Continuous
cardiac monitoring in dialysis patients, outside of the
hospital setting, has not been feasible either due to the
short-term monitoring periods of current external
devices (e.g., 24-48 h Holter) or the large size of
Table 2 Arrhythmia-related symptoms in hemodialysis patients
Relationship to hemodialysis (%, among those with symptoms)
Symptom question Prevalence Before During After Unrelated
Have you ever felt your heart was skipping beats, flopping in
your chest or beating very hard?
26 (56.5%) 0 0 5 (19.2%) 21 (80.8%)
Have you had any episodes where you felt like you passed out
or almost passed out?
17 (36.9%) 0 3 (17.6%) 4 (23.5%) 10 (58.8%)
Have there been times when your heart races (palpitations)? 28 (60.9%) 1 (3.6%) 2 (7.1%) 7 (25.0%) 18 (64.3%)
Table 3 Acceptability of implantable cardiac monitor
Device acceptability Symptoms
present
Symptoms
absent
N (%) 34 (73.9%) 12 (26.1%)
Device Acceptable 20 (58.8%) 6 (50%)
Device Unacceptable - Reason
Cosmetic 0 0
Concerned about procedure 3 (8.8%) 0
Concerned about complications 2 (5.9%) 2 (16.7%)
Don’t want a device 10 (30%) 3 (25%)
El Hage et al. BMC Nephrology (2017) 18:309 Page 3 of 5
implantable devices. The large size of the implantable de-
vice was likely a limiting factor in a prior study of dialysis
patients where 98% of the patients refused to participate
in the study and only 8 patients were recruited [10]. These
findings formed the rationale for our study to assess the
acceptability of a new small and non-conspicuous cardiac
monitoring device, the Reveal LINQ.
The Reveal LINQ is implanted subcutaneously over the
pericardium via a short procedure that takes about 1 min
with an incision that is < 1 cm and closed by Steri-strips
without the need for sutures. This device can continuously
record surface electrocardiogram of symptomatic episodes
for up to 15 min (four 7.5 min episodes, three 10 min epi-
sodes, two 15 min episodes). The device data are then
transmitted wirelessly to a central monitoring facility. Re-
veal LINQ has a lithium carbon monofluoride battery with
a battery life of 3 years. The device is currently used for
patients with unexplained syncope, those with transient
symptoms that may suggest cardiac arrhythmias, sus-
pected atrial fibrillation, or cryptogenic stroke, and those
at high risk of cardiac arrhythmias. Complications in non-
dialysis patients associated with device implantation
are minimal and include infection (1.2%), device migra-
tion (< 1%), and pain at the insertion site (< 1%) [11].
Several important limitations of our study are also
worth noting. First, we surveyed patients in one inner-
city dialysis clinic with a majority of African-American
patients. Patients from other settings may have a differ-
ent prevalence of symptoms and acceptability of the
device implantation. Second, we only have data on
participants that agreed to answer the survey and selec-
tion bias could be a factor in these findings. Third, our
survey was conducted by study coordinators that are not
medically certified in history-taking or patient counsel-
ing, and the questions were limited to the survey. It is
possible that the prevalence of these symptoms may be
higher when this information is obtained by a trained
clinician, or lower if the patients attributed non-specific
symptoms to one of the questions that was being asked.
Fourth, we did not specifically ask the patients if they
will be willing to travel outside the dialysis unit to get
the device implanted. However, this was implied as no
procedures outside of hemodialysis treatment, including
access-related procedures, occur in the dialysis unit. It is
possible that patients may be less enthusiastic about a
procedure that requires additional appointments at a
location different from the dialysis unit. Finally, the
assumption of the potential benefit of implantable loop
recorders in dialysis patients is based on the high risk of
arrhythmias and arrhythmic death in dialysis patients
combined with the clinical experience and evidence in
non-dialysis populations. Such a use of implantable loop
recorders in dialysis patients mirrors clinical manage-
ment of many other conditions such as management of
hypertension and diabetes, where management is based
on data from non-dialysis populations. Whether existing
data on the potential benefits of implantable loop re-
corders will be sufficient to convince providers to rec-
ommend these devices for their dialysis patients and
whether the patients will be willing to undergo these
procedures in routine clinical practice is an important
question that was not addressed by our study and will
need future investigation. We believe that our study
provides important preliminary data that can be used to
pursue these future investigations and management of
arrhythmia-related complications, the major cause of mor-
bidity and mortality in dialysis patients.
Conclusions
In conclusion, we report a high prevalence of
arrhythmia-related symptoms and a high acceptability of
a new small implantable loop recorder in hemodialysis
patients. Routine implantation of these devices to man-
age arrhythmias and related complications in dialysis pa-
tients may be feasible.
Additional file
Additional file 1: Study Questionnaire: Appendix. Study Questionnaire.
(PDF 157 kb)
Acknowledgements
We would like to thank the patients and staff at MedStar Good Samaritan
Hospital Dialysis Units and the Nephrology Center of Maryland for their
support of this study.
Funding
Dr. Shafi is supported by R03-DK-104012 and R01-HL-132372-01.
Dr. Cheng is supported by R01-HL-132372-01.
Dr. Guallar is supported by R01-HL-132372-01.
Availability of data and materials
The datasets used and/or analyzed during the current study are available
from the corresponding author on reasonable request.
Authors’ contributions
TS, AC, EBC, and EG designed the study with input from BJ and LG. NH and
CK collected the data. NH and TS analyzed the data and drafted the
manuscript. All authors read and approved the final manuscript.
Ethics approval and consent to participate
The study was approved by the Johns Hopkins Medicine Institutional Review
Board (IRB) with verbal consent (IRB00054481).
Consent for publication
Not applicable. No individual details.
Competing interests
Dr. Alan Cheng is an employee of Medtronic, manufacturer of the LINQ
device, but was not employed by Medtronic when the study was
conducted. Medtronic or its employees had no involvement in study design,
data collection or data analysis. Dr. Bernard Jaar is a Section Editor and
Dr. Tariq Shafi is an Associate Editor for BMC Nephrology.
El Hage et al. BMC Nephrology (2017) 18:309 Page 4 of 5
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1
Western Pennsylvania Hospital, Pittsburgh, PA, USA. 2
Division of Nephrology,
Department of Medicine, Johns Hopkins University School of Medicine, 301
Mason Lord Drive, Suite 2500, Baltimore, MD 21224-2780, USA. 3
Welch
Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins
University, Baltimore, MD, USA. 4
Nephrology Center of Maryland, Baltimore,
MD, USA. 5
Division of Cardiology, Department of Medicine, Johns Hopkins
University School of Medicine, Baltimore, MD, USA. 6
Division of General
Internal Medicine, Department of Medicine, Johns Hopkins University School
of Medicine, Baltimore, MD, USA. 7
Department of Epidemiology, Johns
Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Received: 21 March 2017 Accepted: 25 September 2017
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Implantable Cardiac Monitor Acceptability in Hemodialysis Patients

  • 1. RESEARCH ARTICLE Open Access Frequency of arrhythmia symptoms and acceptability of implantable cardiac monitors in Hemodialysis patients Naya El Hage1 , Bernard G. Jaar2,3,4 , Alan Cheng5 , Chloe Knight2 , Elena Blasco-Colmenares6 , Luis Gimenez2,4 , Eliseo Guallar3,6,7 and Tariq Shafi2,3,7* Abstract Background: Arrhythmia-related complications and sudden death are common in dialysis patients. However, routine cardiac monitoring has so far not been feasible. Miniaturization of implantable cardiac monitors offers a new paradigm for detection and management of arrhythmias in dialysis patients. The goal of our study was to determine the frequency of arrhythmia-related symptoms in hemodialysis patients and to assess their willingness to undergo implantation of a cardiac monitor. Methods: We conducted a survey of in-center hemodialysis patients at a hemodialysis clinic in Baltimore, Maryland. We assessed the frequency of arrhythmia-related symptoms and willingness to undergo placement of an implantable cardiac monitor (LINQ, Medtronic Inc.). Results: Forty six patients completed the survey. The mean age of the survey respondents was 59 years and 65% were male. Symptoms were common with 74% (n = 34) of participants reporting at least one arrhythmia-related symptom and many [22% (n = 10)] had all 3 symptoms. Among the patients with symptoms, 57% (n = 26) reported “heart skipping beats, flopping in chest or beating very hard,” 61% (n = 28) reported “heart racing (palpitations),” and 37% (n = 17) reported feeling that they “passed out or almost passed out.” The majority of the patients felt that the timing of the symptoms was unrelated to dialysis treatments. The acceptability of the monitoring device implantation was high, with 59% (n = 20) of patients with symptoms and 50% (n = 6) of patients without symptoms willing to consider it. The main reason for not considering the device was not wanting to have an implanted device. Conclusion: The prevalence of arrhythmia-related symptoms is high in hemodialysis patients and the majority would consider an implantable cardiac monitor if recommended by their physicians. Routine implantation of cardiac monitoring devices to manage arrhythmias in dialysis patients may be feasible and will provide further insights on the leading causes of morbidity and mortality in dialysis patients. Background Patients with end-stage renal disease requiring dialysis have a high risk of morbidity and mortality. The risk of death in the year after dialysis initiation is 20% and me- dian survival is only 3 years [1]. Despite many improve- ments in general medical care, the 5-year mortality in dialysis patients approaches 65% and has not improved significantly over the last decade [1]. Cardiovascular disease remains the leading cause of death in dialysis patients (50% of all deaths) and the majority of these deaths (25-40% of all deaths) are due to sudden cardiac arrest [1]. To date, no effective strategies to prevent these deaths have been devised. Patients treated with dialysis also experience an extraordinarily high risk of atrial fibrillation and stroke. The claims-based prevalence of atrial fibrilla- tion is 20%–50%, [2, 3] but the true prevalence is likely much higher as atrial fibrillation episodes are mostly asymptomatic [4–7]. In patients initiating dialysis, the risk * Correspondence: tshafi@jhmi.edu 2 Division of Nephrology, Department of Medicine, Johns Hopkins University School of Medicine, 301 Mason Lord Drive, Suite 2500, Baltimore, MD 21224-2780, USA 3 Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, MD, USA Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. El Hage et al. BMC Nephrology (2017) 18:309 DOI 10.1186/s12882-017-0740-1
  • 2. of stroke is 20% and more than half of these strokes are classified as cardioembolic or cryptogenic; [8] atrial fibril- lation is a likely underlying culprit [9]. A major limitation to the detection and treatment of arrhythmias in dialysis patients has been the lack of our ability to continuously monitor cardiac rhythms. Dialysis units are not equipped with telemetry and continuous home monitoring with Holter devices can only be used for short periods and is not practical for wide-scale use. Prior attempts with larger subcutaneous implanted car- diac monitors have not been successful [10]. A major re- cent advancement has been the miniaturization of cardiac monitoring technology that is leadless, contains a battery that lasts 3 years, and can be implanted under the skin in less than 60 s. The Reveal LINQ (Medtronic, Mounds View, MN) measures 1.79 in. by 0.29 in. by 0.16 in. and weighs 0.09 oz and is currently indicated for patients at risk for arrhythmia development [11]. The goal of our study was to determine the frequency of arrhythmia symptoms in hemodialysis patients and to assess their willingness to undergo implantable loop re- corder implantation for monitoring cardiac arrhythmias. Methods Study design The study was approved by the Johns Hopkins Medicine Institutional Review Board (IRB). The IRB considered verbal consent to be adequate as the study only included participant interview without medical record review or longitudinal data collection. We surveyed all patients undergoing in-center hemodialysis at a dialysis clinic in the Baltimore, Maryland in May 2015. We excluded pa- tients with prior pacemaker or defibrillator placement. After obtaining verbal consent to participate in the survey, we administered a brief questionnaire about symptoms of common arrhythmias (Additional file 1: Appendix). We also showed the patients an actual size picture of the Reveal LINQ device, and asked them if they would be willing to have the device implanted if recommended by their doctor. We summarized the sur- vey responses using means and proportions. Results Baseline characteristics We approached 97 patients for the survey, 48 consented, of which 2 were ineligible (due to presence of pacemaker or defibrillator) leading to final survey sample of 46 pa- tients. The mean age of the patients was 59 years and 65% were male (Table 1). Approximately 80% of patients in this dialysis clinic are African-American [12]. 15% (n = 7) of participants did not have a past history of dia- betes, congestive heart failure, stroke, or irregular heart- beat 33% (n = 15) had at least one of these problems, 29% (n = 13) had two, 17% (n = 8) had 3, and 7% (n = 3) had all four of the problems. Arrhythmia-related symptoms Arrhythmia-related Symptoms were common (Table 2). 74% of participants reported at least one arrhythmia- related symptom. Multiple symptoms were common, with 59% (n = 27) of the patients reporting two or more symptoms and 22% (n = 10) of the patients reporting all 3 symptoms. Among patients with symptoms, 57% (n = 26) reported “heart skipping beats, flopping in chest or beating very hard,” 61% (n = 28) reported “heart ra- cing (palpitations),” and 37% (n = 17) reported feeling that they “passed out or almost passed out.” Only 2 pa- tients reported symptoms occurring all the time; the ma- jority felt that the symptoms occurred intermittently, and most felt that the symptoms’ occurrence was unre- lated to dialysis treatments. Acceptance of LINQ implantation After simply looking at the actual size picture of the im- plantable loop recorder (Additional file 1: Appendix) and without further medical counselling, 56% (n = 26) of survey respondents were willing to consider it (Table 3). The acceptability rate was 59% (n = 20) among the 34 patients with symptoms and 50% (n = 6) among the 12 patients without symptoms. The most common reason for refusing device implantation was simply not wanting a device. None of the participants expressed any cos- metic concerns for not wanting the device. Discussion This study of in-center hemodialysis patients from Baltimore, Maryland provides several important observa- tions. Among the 46 participants completing the survey, the prevalence of arrhythmia-related symptoms was high with 74% reporting at least one symptom and 22% report- ing all 3 symptoms. Among patients with symptoms, the prevalence of pre-syncope/syncope symptoms was 37% and the prevalence of palpitations/tachyarrhythmia symptoms was approximately 60%. Acceptability of the implantable Table 1 Baseline characteristics of the study population Characteristics All patients (n = 46) Age, years 59.2 ± 14.2 Male, % 30 (65.2%) Comorbidities Diabetes 27 (58.7%) Congestive Heart Failure 19 (41.3%) Stroke 6 (13.0%) Myocardial Infarction 5 (10.9%) Irregular heartbeat 20 (43.5%) El Hage et al. BMC Nephrology (2017) 18:309 Page 2 of 5
  • 3. cardiac monitor was high, with 59% of patients with symp- toms and 50% of patients without symptoms willing to con- sider it. The main reason for not considering the device was not wanting to have an implanted device. Cardiovascular disease is the leading cause of death in dialysis patients and its prevalence is 20-100 fold higher in dialysis patients compared with the age-matched gen- eral population [13]. Almost 25-40% of all deaths in dia- lysis patients are classified as sudden deaths or deaths related to arrhythmias [1, 14]. Retrospective observa- tional studies suggest a number of risk factors for arrhythmia-related deaths in dialysis patients, including dialysate composition, [15] dialysis-induced rapid fluid and electrolyte shifts, intradialytic hypotension, [16, 17] and marked electrolyte shifts around the long interdialy- tic interval during the weekend [18, 19]. Atrial fibrillation is also common in dialysis patients and its prevalence (20%-50%) is likely underestimated from claims-based data [2, 3, 20]. Atrial fibrillation, especially undetected paroxysmal atrial fibrillation, could be a major contributing factor to the high incidence of stroke in dialysis patients [8, 21]. Despite the overwhelming burden of arrhythmia- related morbidity and mortality in dialysis patients, there are very few specific interventions to modify this risk. Most of the current dialysis management practices in place have failed to improve this risk over the past decade, suggesting the failure of the one-size-fits-all ap- proach. Risk modification in individual patients cannot occur without knowledge of specific arrhythmias and specific arrhythmias cannot be detected without long- term ambulatory cardiac monitoring. Our study takes an important step in this direction by exploring patient ac- ceptance of such a device. Further work is needed to determine if this approach can be successfully imple- mented in clinical practice or research settings. Although the risk of sudden death remains constant after dialysis initiation, it is likely that the arrhythmias causing sudden death in dialysis patients change over time. It is possible that ventricular tachycardia/ventricu- lar fibrillation are more common early after dialysis initi- ation due to the presence of occult cardiac ischemia combined with intradialytic hypotension and postdialysis metabolic changes such as hypokalemia, hypocalcemia, and metabolic alkalosis. During later years of dialysis, bradyarrhythmias may be more common due to progres- sive calcification of the conducting system and ongoing use of medications such as β-blockers. Indeed, recent studies in prevalent dialysis patients with implanted car- diac monitors reported that bradyarrhythmias rather than tachyarrhythmias were more common [22, 23]. Knowledge of specific arrhythmias is needed to insti- tute patient-specific management strategies, many of which are standard of care in clinical practice. For ex- ample, risk stratification and management of ventricular tachycardia and bradyarrhythmias can follow standard clinical practice guided by a cardiologist. Similarly, atrial fibrillation may require identification of precipitating factors (volume overload in the interdialytic interval and rapid volume removal during dialysis) and stroke pre- vention by anticoagulation. It is worth noting that the prevalence of atrial fibrillation in dialysis patients is similar or higher than in patients with cryptogenic stroke, a condition where implantable cardiac monitors are considered standard of care [24]. As most atrial fib- rillation events are asymptomatic [4–7] they are less likely to be detected without long-term ambulatory car- diac monitoring. Prevention and treatment of arrhythmias in dialysis patients will require the ability to detect arrhythmias. However, outpatient dialysis units are not equipped with cardiac telemetry monitoring capabilities. Continuous cardiac monitoring in dialysis patients, outside of the hospital setting, has not been feasible either due to the short-term monitoring periods of current external devices (e.g., 24-48 h Holter) or the large size of Table 2 Arrhythmia-related symptoms in hemodialysis patients Relationship to hemodialysis (%, among those with symptoms) Symptom question Prevalence Before During After Unrelated Have you ever felt your heart was skipping beats, flopping in your chest or beating very hard? 26 (56.5%) 0 0 5 (19.2%) 21 (80.8%) Have you had any episodes where you felt like you passed out or almost passed out? 17 (36.9%) 0 3 (17.6%) 4 (23.5%) 10 (58.8%) Have there been times when your heart races (palpitations)? 28 (60.9%) 1 (3.6%) 2 (7.1%) 7 (25.0%) 18 (64.3%) Table 3 Acceptability of implantable cardiac monitor Device acceptability Symptoms present Symptoms absent N (%) 34 (73.9%) 12 (26.1%) Device Acceptable 20 (58.8%) 6 (50%) Device Unacceptable - Reason Cosmetic 0 0 Concerned about procedure 3 (8.8%) 0 Concerned about complications 2 (5.9%) 2 (16.7%) Don’t want a device 10 (30%) 3 (25%) El Hage et al. BMC Nephrology (2017) 18:309 Page 3 of 5
  • 4. implantable devices. The large size of the implantable de- vice was likely a limiting factor in a prior study of dialysis patients where 98% of the patients refused to participate in the study and only 8 patients were recruited [10]. These findings formed the rationale for our study to assess the acceptability of a new small and non-conspicuous cardiac monitoring device, the Reveal LINQ. The Reveal LINQ is implanted subcutaneously over the pericardium via a short procedure that takes about 1 min with an incision that is < 1 cm and closed by Steri-strips without the need for sutures. This device can continuously record surface electrocardiogram of symptomatic episodes for up to 15 min (four 7.5 min episodes, three 10 min epi- sodes, two 15 min episodes). The device data are then transmitted wirelessly to a central monitoring facility. Re- veal LINQ has a lithium carbon monofluoride battery with a battery life of 3 years. The device is currently used for patients with unexplained syncope, those with transient symptoms that may suggest cardiac arrhythmias, sus- pected atrial fibrillation, or cryptogenic stroke, and those at high risk of cardiac arrhythmias. Complications in non- dialysis patients associated with device implantation are minimal and include infection (1.2%), device migra- tion (< 1%), and pain at the insertion site (< 1%) [11]. Several important limitations of our study are also worth noting. First, we surveyed patients in one inner- city dialysis clinic with a majority of African-American patients. Patients from other settings may have a differ- ent prevalence of symptoms and acceptability of the device implantation. Second, we only have data on participants that agreed to answer the survey and selec- tion bias could be a factor in these findings. Third, our survey was conducted by study coordinators that are not medically certified in history-taking or patient counsel- ing, and the questions were limited to the survey. It is possible that the prevalence of these symptoms may be higher when this information is obtained by a trained clinician, or lower if the patients attributed non-specific symptoms to one of the questions that was being asked. Fourth, we did not specifically ask the patients if they will be willing to travel outside the dialysis unit to get the device implanted. However, this was implied as no procedures outside of hemodialysis treatment, including access-related procedures, occur in the dialysis unit. It is possible that patients may be less enthusiastic about a procedure that requires additional appointments at a location different from the dialysis unit. Finally, the assumption of the potential benefit of implantable loop recorders in dialysis patients is based on the high risk of arrhythmias and arrhythmic death in dialysis patients combined with the clinical experience and evidence in non-dialysis populations. Such a use of implantable loop recorders in dialysis patients mirrors clinical manage- ment of many other conditions such as management of hypertension and diabetes, where management is based on data from non-dialysis populations. Whether existing data on the potential benefits of implantable loop re- corders will be sufficient to convince providers to rec- ommend these devices for their dialysis patients and whether the patients will be willing to undergo these procedures in routine clinical practice is an important question that was not addressed by our study and will need future investigation. We believe that our study provides important preliminary data that can be used to pursue these future investigations and management of arrhythmia-related complications, the major cause of mor- bidity and mortality in dialysis patients. Conclusions In conclusion, we report a high prevalence of arrhythmia-related symptoms and a high acceptability of a new small implantable loop recorder in hemodialysis patients. Routine implantation of these devices to man- age arrhythmias and related complications in dialysis pa- tients may be feasible. Additional file Additional file 1: Study Questionnaire: Appendix. Study Questionnaire. (PDF 157 kb) Acknowledgements We would like to thank the patients and staff at MedStar Good Samaritan Hospital Dialysis Units and the Nephrology Center of Maryland for their support of this study. Funding Dr. Shafi is supported by R03-DK-104012 and R01-HL-132372-01. Dr. Cheng is supported by R01-HL-132372-01. Dr. Guallar is supported by R01-HL-132372-01. Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Authors’ contributions TS, AC, EBC, and EG designed the study with input from BJ and LG. NH and CK collected the data. NH and TS analyzed the data and drafted the manuscript. All authors read and approved the final manuscript. Ethics approval and consent to participate The study was approved by the Johns Hopkins Medicine Institutional Review Board (IRB) with verbal consent (IRB00054481). Consent for publication Not applicable. No individual details. Competing interests Dr. Alan Cheng is an employee of Medtronic, manufacturer of the LINQ device, but was not employed by Medtronic when the study was conducted. Medtronic or its employees had no involvement in study design, data collection or data analysis. Dr. Bernard Jaar is a Section Editor and Dr. Tariq Shafi is an Associate Editor for BMC Nephrology. El Hage et al. BMC Nephrology (2017) 18:309 Page 4 of 5
  • 5. Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Author details 1 Western Pennsylvania Hospital, Pittsburgh, PA, USA. 2 Division of Nephrology, Department of Medicine, Johns Hopkins University School of Medicine, 301 Mason Lord Drive, Suite 2500, Baltimore, MD 21224-2780, USA. 3 Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, MD, USA. 4 Nephrology Center of Maryland, Baltimore, MD, USA. 5 Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 6 Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 7 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Received: 21 March 2017 Accepted: 25 September 2017 References 1. 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Monitoring in dialysis (MiD) study: exploring the timeline and etiology of increased arrhythmias in hemodialysis (HD) patients. San Diego, CA: American Society of Nephrology Kidney Week; 2015. 24. Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, et al. 2016 European guidelines on cardiovascular disease prevention in clinical practice: the sixth joint task force of the European Society of Cardiology and Other Societies on cardiovascular disease prevention in clinical practice (constituted by representatives of 10 societies and by invited experts)developed with the special contribution of the European Association for Cardiovascular Prevention & rehabilitation (EACPR). Eur Heart J. 2016;37(29):2315–81. • We accept pre-submission inquiries • Our selector tool helps you to find the most relevant journal • We provide round the clock customer support • Convenient online submission • Thorough peer review • Inclusion in PubMed and all major indexing services • Maximum visibility for your research Submit your manuscript at www.biomedcentral.com/submit Submit your next manuscript to BioMed Central and we will help you at every step: El Hage et al. BMC Nephrology (2017) 18:309 Page 5 of 5
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