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BRIEF REPORT

Outcomes and Adverse Events


Among Patients With Implantable
Cardiac Defibrillators in
Cardiac Rehabilitation
A CASE-CONTROLLED STUDY
Sarah Fan, MD, Caroline E. Lyon, MD, Patrick D. Savage, MS, Al Ozonoff, PhD, Philip A. Ades, MD,
and Gary J. Balady, MD

PURPOSE: This study aimed to assess the clinical outcomes and adverse
events among patients with implantable cardiac defibrillators (ICDs)
in cardiac rehabilitation programs.
METHODS: Data were compared for 42 consecutive patients with ICDs
and 42 control patients matched by age, gender, and left ventricular
ejection fraction without ICDs and enrolled in the same program.
RESULTS: The number of cardiac rehabilitation exercise sessions for each
group was 828 and 925, respectively. Only 1 patient experienced an
ICD firing during exercise; there were no cardiac arrests and no
deaths in either group. Compliance with cardiac rehabilitation was
similar in both groups with most dropouts for nonmedical reasons
and similar rates for cardiac-related reasons. Improvements in
exercise capacity were similar between groups (30% in ICD patients
and 37% in controls).
CONCLUSIONS: Although larger studies are needed, these data suggest
that supervised exercise training in patients with ICDs appears to be
safe and effective.

Cardiac rehabilitation programs play an important


role in the treatment of patients with heart disease,1,2
including those with complex cardiovascular conditions and numerous comorbidities. The advent of
new therapies and technologies continues to change
the types of patients who present to these programs.
Several recent clinical trials have demonstrated a survival benefit from implantable cardiac defibrillators
(ICDs) in patients with ischemic or nonischemic cardiomyopathy.35 As the indications for ICD placement
expand, a growing number of patients with these
devices are enrolling in exercise-based cardiac rehabilitation programs. However, the available data
regarding the outcomes of such patients are limited to
a few small case series.610 Therefore, the purpose of

K E Y

W O R D S

cardiac rehabilitation
implantable cardiac defibrillator

Author Affiliations: Section of Cardiology,


Department of Medicine, Boston Medical
Center, Boston University School of
Medicine, Boston, Massachusetts (Drs
Fan, Ozonoff, and Balady); and Division
of Cardiology, Department of Medicine,
Fletcher Allen Health Care, University of
Vermont, Burlington (Drs Lyon and Ades
and Mr Savage).
Corresponding Author: Gary J. Balady,
MD, Section of Cardiology, Boston
Medical Center, 88 East Newton St,
Boston, MA 02118
(gary.balady@bmc.org).

this study was to assess the clinical outcomes and


adverse events in a consecutive series of patients with
ICDs who were enrolled in cardiac rehabilitation
compared with a matched series of patients without
ICDs in these programs.
A retrospective chart review on all patients who
were enrolled in the cardiac rehabilitation programs
at the Boston Medical Center and the University of
Vermont College of Medicine between January 1992
and January 2005 was conducted. Patients who
received implantation of an ICD and subsequently
enrolled in the cardiac rehabilitation programs were
identified as cases. A cohort of patients (matched
controls) without ICDs was identified from each
respective program and matched to each case based

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on the following characteristics: left ventricular ejection fraction 5%, age 5 years, and gender. Patients
who received an ICD after enrollment or completion
of the rehabilitation program were excluded from this
study.
The cardiac rehabilitation programs at each center
were conducted similarly with intake and exit evaluations and interventions as previously described.11,12
All patients underwent exercise testing (ETT) in a
standard manner, using symptom-limited treadmill
testing. For patients with an ICD, the triggering rate
(ie, the heart rate at which the ICD was programmed
to respond with either antitachycardia pacing or
shock) was obtained prior to the ETT such that the
test would be terminated if the ETT heart rate was
within 15 beats of this rate. No test needed to be terminated for this endpoint, and hence no exercise prescription was affected by the ICD triggering rate. As
per the clinical assessment protocols, exit ETTs were
performed on all patients who completed at least 8
weeks of training and attended approximately 70% of
scheduled sessions. Individual patients used the same
institutional treadmill protocol for program entry and
exit ETTs. Individualized ramp protocols13 were used
at Boston Medical Center, and the modified Balke
protocol14 was used at the University of Vermont. For
all protocols, the peak metabolic equivalent (MET)
level was estimated from the peak treadmill work rate

as per the American College of Sports Medicine.14


Supervised exercise training was conducted in standard manner at an intensity of 50% to 85% of heart
rate reserve based on the entry ETT and was further
modified by perceived exertion.15 Although the ICD
triggering rate did not affect the peak exercise heart
rate and hence did not affect the exercise prescription, no training heart rate range was within 15 beats
of the ICD triggering rate. Exercise training was performed using telemetry monitoring for 30 to 60 minutes, 3 times a week using various upper- and lowerbody training modalities.16
For all patients identified, additional information
was obtained via chart review. This included patient
demographics, medications, indication for cardiac
rehabilitation, indication for ICD implantation, time
from ICD implantation to enrollment, peak MET
achieved on entry and exit ETTs, the occurrence of
ICD firing at the rehabilitation center and outside of
the center, cardiac arrests requiring cardiopulmonary
resuscitation at the rehabilitation center and outside
of center, hospitalization during the enrollment period in the rehabilitation program, total number exercise rehabilitation sessions attended, and reasons for
dropout from the program. Attendance rates were
defined as the number of sessions attended divided
by the number of sessions scheduled. Patients were
defined as having completed the program if they had

Table 1 BASELINE CHARACTERISTICSa


ICD (n  42)
Age, y
Male
LV ejection fraction, %
-Blocker use
Angiotensin-converting enzyme blocker use
Antiarrhythmic therapy
Entry METs
Indications for rehabilitation
Myocardial infarction
Coronary bypass surgery
Percutaneous coronary intervention
Angina
Heart failure
ICD implantation time and indications
Time from implantation to enrollment (days)b
Sustained ventricular tachycardia
Cardiac arrest
Inducible ventricular tachycardia on electrophysiological study
Prior myocardial infarction with LV ejection fraction 35%
LV ejection fraction 35% and heart failure
LV ejection fraction 35% with nonsustained ventricular tachycardia
LV ejection fraction 35% with syncope

Control (n  42)

61
32
32
33
26
6
5.0

 12
(76%)
 15
(79%)
(62%)
(14%)
 2.3

61
33
36
33
30
2
6.0

 14
(79%)
 13
(79%)
(71%)
(4%)
 2.5

.82
.79
.25
1.00
.35
.20
.06

17
3
3
1
14

(40%)
(7%)
(7%)
(2%)
(33%)

15
9
10
1
7

(36%)
(21%)
(24%)
(2%)
(17%)

.82
.12
.07
1.00
.13

277
10
10
11
2
5
2
1

(366)
(24%)
(24%)
(26%)
(5%)
(12%)
(5%)
(2%)

...
...
...
...
...
...
...
...

Abbreviations: ICD, implantable cardiac defibrillator; LV, left ventricular; METs, metabolic equivalents.
a
Data are presented as mean  SD except for b which is median (interquartile range).

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Table 2 COMPLIANCE AND


ADVERSE OUTCOMES

Compliance
Patient-sessions attended
Mean number of
sessions attended
Program completion
rate, %
Dropout secondary to
cardiac reason, %
Adverse outcomes
Hospitalization (from
rehabilitation center)
Hospitalization (outside
the rehabilitation center)
ICD firings (at the
rehabilitation center)
Cardiopulmonary
resuscitation
Death

ICD

Control

(n  42)

(n  42)

828
21  13

925
22  13

.36
.6

45

62

.12

12

.75

...

Abbreviation: ICD, implantable cardiac defibrillator.

attended at least 70% of scheduled sessions. Data are


reported as mean  SD or frequency (%). Initial and
posttraining exercise and outcome variables were
compared within and between groups, using paired
and nonpaired t tests for continuous variables or 2
evaluation tests for categorical variables. All hypothesis tests were 2-sided, and a P value of  .05 was
considered statistically significant. The study was
approved with waiver of requirement for informed
consent by the institutional review boards at Boston
Medical Center and at the Fletcher Allen Health Care
University of Vermont.
A total of 42 patients met inclusion criteria, and 42
controls were systematically selected from the database based on matching criteria as defined above.
Demographics and clinical characteristics of study
patients are shown in Table 1. Patients in both groups
were well matched in terms of age, left ventricular
ejection fraction, and gender. There was a trend
toward a higher percentage of patients in the ICD
group enrolled in the program for heart failure and a
trend toward a higher usage of antiarrhythmic medication in the ICD group. When patients with ICDs
were stratified on the basis of indication for ICD
implantation, 78% received it for secondary prophylaxis, such as sustained ventricular tachycardia or cardiac arrest. ICDs were placed for primary prophylaxis in 18% of patients.
As shown in Table 2, the program completion rate
is slightly, but not significantly (P  .12), lower in the
ICD group compared with the matched control

Figure 1. Change in exercise capacity (peak METs) with training in


patients with implantable cardiac defibrillators (ICD, n  15) and
in matched controls (n  15). Dark bar (entry test); light bar (exit
test). aP  .004 within group; bP  .0001 within group; there was
no significant difference in between-group change in METs.

group. However, a similar percentage of patients in


each group dropped out secondary to cardiac reasons, such as chest pain, myocardial infarction, or
worsening of their existing cardiac condition. The
completion rate for both groups was within the
reported range of 39% to 86% for cardiac rehabilitation programs.6,17 Patients in the ICD group and
matched control group exercised for a similar number
of sessions (P  .36). Only 1 patient experienced ICD
firing while exercising at the rehabilitation center.
This patient had been experiencing very mild intermittent atypical chest pain during the day prior to
arrival at the cardiac rehabilitation center. He was felt
to be stable for exercise by the program staff and
observed carefully during his session. He initially did
well during 25 minutes of treadmill exercise at a heart
rate of 115 beats per minute (ICD firing rate  180
beats per minute), but within 2 minutes of rowing
exercise at a similar heart rate, he experienced 2
sequential ICD firings. He was placed in the supine
position, never lost consciousness, and remained
hemodynamically stable with normal sinus rhythm.
He was subsequently hospitalized for medication
adjustment and monitoring and was discharged on
hospital Day 4. He chose not to return to cardiac
rehabilitation.
None of the 42 patients in the ICD group experienced ICD firing outside of the rehabilitation center.
More patients in the ICD group were hospitalized
during the enrollment period, but only the 1 patient
previously described above was hospitalized directly
from the rehabilitation center. No patient in either
group died or required cardiopulmonary resuscitation. There were 15 patients in the ICD group and 15
in the matched control group who performed both an

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entry and an exit ETT. Figure 1 demonstrates a 30%


improvement in MET level in the ICD group (P 
.004) and a 37% improvement in the matched control
group after training (P  .001). There was no significant between-group difference in the change in peak
MET level.
In summary, these data demonstrate that patients
with ICD implantation do not appear to experience a
higher rate of adverse outcomes during exercisebased cardiac rehabilitation compared with matched
patients without ICDs. Only 1 patient experienced
ICD firing while at the rehabilitation center, and no
other events were reported during exercise in either
group. Thus, the adverse event rate was 1/828
patient-sessions in the ICD group and 1/1,753
patient-sessions for the entire cohort. ICD patients
tended to have a lower program completion rate,
although the dropout rate due to cardiac-related reasons was similar for both groups. Both groups
showed a marked improvement in exercise capacity
after training; however, these data are limited to those
15 patients in each group who underwent follow-up
testing. While this is the largest reported series to
date, it is limited by its retrospective design as well as
the low number of events that prevents a robust comparison between the groups. It appears that much
larger prospective studies are needed to better define
the risk of exercise-based rehabilitation in patients
with ICDs because of the low frequency of events.
Nonetheless, taken with other studies,610 these data
suggest that supervised exercise training in patients
with ICDs is safe and effective. Finally, the majority of
patients in this study received their ICD for secondary
prophylaxis. In view of recent clinical trials showing
survival benefit for ICD use in primary prophylaxis,4,5
it is anticipated that an increasing number of these
latter patients will present to cardiac rehabilitation.
While this is yet to be studied, it is likely that their
risk of adverse events in cardiac rehabilitation would
be even less.

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