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Letter by Lewis et al Regarding Article,
“REPLACE DARE (Death After Replacement
Evaluation) Score: Determinants of All-Cause
Mortality After Implantable Device Replacement
or Upgrade From the REPLACE Registry”
Research investigating the suitability of cardiac implantable electric
device (CIED) replacement is gaining momentum. Chung et al
1
devel-
oped the REPLACE Death After Replacement Evaluation (DARE)
score to identify patients with limited expected longevity after CIED
replacement. We congratulate the authors for their important contribu-
tion for informing CIED replacement decision making. Consideration
of harms of CIED replacement is equally as important as benefits for
these types of medical decisions.
However, we disagree with the authors’ conclusions stating
that reassessment of CIED replacement would seem appropriate
in patients with high scores. We argue that generator replacement
should be reassessed in all implantable cardioverter-defibrillator
(ICD) replacement patients regardless of their expected longevity.
We agree with Chung et al that comorbidity and competing mortality
risks are important, but they should not be the only factors informing
ICD generator replacement decisions.
2
Patients’ expectations and personal experiences of living with an
ICD shape their preferences for continued ICD therapy. Hence, their
expectations and preferences for ICD therapy should also inform the
decision for or against replacement. This approach is consistent with
evidence-based decision making. In our recent survey of patients
who underwent ICD pulse generator replacement,
3
55 of 106 (51.9%)
respondents were unaware that ICD replacement was not mandatory.
Of those who were unaware, 15 (27.2%) said that given the option
they would have considered not replacing their ICD. There were no
baseline predictors of likelihood to decline replacement, but a non-
statistical trend was noted toward younger patients (61.1 versus 68.0
years; P=0.06) being more likely to consider declining. Our survey
also found that many patients grossly overestimated the benefits of
ICD therapy and underestimated the risks of ICD generator change.
3
Ensuring that patients have an accurate understanding of the risks and
benefits of their ICDs is necessary for informed consent. But ensuring
that decisions also reflect patients’ informed preferences is essential
for achieving high-quality health decisions.
4
Although the REPLACE DARE risk score advances our under-
standing, caution is advised, as the simple application of a risk score
may further perpetuate a paternalistic rather than a patient-centered
decision-making process. Given the preference-sensitive nature of
ICD therapy, the importance of engaging all patients approaching
ICD replacement in shared decision making cannot be overstressed.
Shared decision making for these types of preference-sensitive deci-
sions can be facilitated using patient decision aids, which have been
shown to increase knowledge, patient engagement, and improve
patients’ realistic perceptions of their treatment choices.
5
To bet-
ter support all patients, regardless of their clinical presentation, to
participate in this increasingly common decision, our group is cur-
rently developing a decision aid focused on ICD pulse generator
replacement (Decision Aid Library Inventory, 2014, https://decision-
aid.ohri.ca/cochinvent.php).
In summary, the evidence about risks and harms arising from the
study of Chung et al is important to inform decision making with
all patients. Using a shared decision making approach requires a
discussion that includes both the benefits and harms of ICD pulse
generator replacement. In this way, patients will have an oppor-
tunity to share their informed preferences to ultimately achieve a
quality decision.
Disclosures
None.
Krystina B. Lewis, RN, MN, CCN(C)
School of Nursing
University of Ottawa
Pacemaker and Defibrillator Clinic
University of Ottawa Heart Institute
Ottawa, Canada
Dawn Stacey, RN, PhD
School of Nursing
University of Ottawa
Ottawa Hospital Research Institute
Ottawa, Canada
David H. Birnie, MBChB, MD
Division of Cardiology, Department of Medicine
University of Ottawa Heart Institute
Ottawa, Canada
References
1. Chung MK, Holcomb RG, Mittal S, Steinberg JS, Gleva MJ, Mela T,
Uslan DZ, Mitchell K, Poole JE; REPLACE Investigators. REPLACE
DARE (Death After Replacement Evaluation) score: determinants of all-
cause mortality after implantable device replacement or upgrade from the
REPLACE registry. Circ Arrhythm Electrophysiol. 2014;7:1048–1056.
doi: 10.1161/CIRCEP.114.001671.
2. Kramer DB, Buxton AE, Zimetbaum PJ. Time for a change–a new ap-
proach to ICD replacement. N Engl J Med. 2012;366:291–293. doi:
10.1056/NEJMp1111467.
3. Lewis KB, Nery PB, Birnie DH. Decision making at the time of ICD gen-
erator change: patients’ perspectives. JAMA Intern Med. 2014;174:1508–
1511. doi: 10.1001/jamainternmed.2014.3435.
4. Elwyn G, O’Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson
R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V,
Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid
N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International
Patient Decision Aids Standards (IPDAS) Collaboration. Developing
a quality criteria framework for patient decision aids: online interna-
tional Delphi consensus process. BMJ. 2006;333:417. doi: 10.1136/
bmj.38926.629329.AE.
5. Stacey D, Légaré F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-
Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu
JH. Decision aids for people facing health treatment or screening decisions.
Cochrane Database Syst Rev. 2014;1:CD001431. doi: 10.1002/14651858.
CD001431.pub4.
(Circ Arrhythm Electrophysiol. 2015;8:512. DOI: 10.1161/CIRCEP.115.002754.)
© 2015 American Heart Association, Inc.
Circ Arrhythm Electrophysiol is available at http://circep.ahajournals.org DOI: 10.1161/CIRCEP.115.002754
Correspondence
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