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Research Letter |

Decision Making at the Time of ICD Generator Change Patients' Perspectives FREE

Krystina B. Lewis, RN, MN, CCN(C)1,2; Pablo B. Nery, MD3; David H. Birnie, MBChB, MD3
[+] Author Affiliations
1School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada
2Pacemaker and Defibrillator Clinic, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
3Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
JAMA Intern Med. 2014;174(9):1508-1511. doi:10.1001/jamainternmed.2014.3435.
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Published online

There are increasing numbers of patients who are faced with implantable cardioverter-defibrillator (ICD) generators that are low in voltage and require replacement to remain functional. This is an ideal time to reevaluate health care goals and explore personal preferences regarding continuing ICD therapy. We aim herein to assess patient awareness that ICD generator replacement is optional, to gauge their understanding of the risks and benefits of ICD replacement, and to gain insight into their decision-making process.

This study was approved by the University of Ottawa institutional research ethics board, and all participants provided their written informed consent. Consecutive patients who underwent ICD generator replacement at our institution between 2009 and 2012 were invited to participate. Eligible participants were 18 years or older, were not pacemaker dependent, and did not have cardiac resynchronization therapy. Our questionnaire captured patients’ demographics, perspectives on the ICD replacement decision-making process, and perceptions of surgical risks and ICD benefits. Data on quality of life, device-related psychological well-being, and readiness for decision-making measures were also collected.

We received 106 responses (72% response rate). In total, 55 of 106 patients (51.9%) were unaware that ICD generator replacement was not compulsory. If given the option, 15 of 55 (27.2%) stated that they would have considered nonreplacement. For 88 of 106 patients (83.0%), it was “important” or “very important” to discuss risks and benefits of continued therapy before deciding.

Table 1 lists the characteristics of patients who would have considered nonreplacement vs those who would not. There were no differences in demographic or clinical variables. Patients who would have considered nonreplacement scored lower on device acceptance measures (P = .04), particularly on body image (P = .03) and positive appraisal (P = .02) dimensions. Patients’ understanding of ICD pulse generator surgical risks and benefits vs the ICD risks and benefits reported in the literature are listed in Table 2. Most patients either overestimated the benefits of ICD therapy, underestimated the risks of ICD generator change, or did not know.

Table Graphic Jump LocationTable 1.  Characteristics of Patients Who Would Consider ICD Nonreplacement and Patients Who Would Nota
Table Graphic Jump LocationTable 2.  Patient Perceptions of ICD Benefits and Generator Replacement Risks

We found that more than half of the patients did not know that ICD generator replacement was optional. Of these, 27% would have considered nonreplacement. The proportion of patients who thought that ICD replacement was mandatory raises important questions regarding patients’ awareness of the legalities of treatment refusal and their right to autonomous decision making. Expert guidelines have stated that there is no difference between refusing ICD therapy prior to initial implant and requesting its withdrawal.1 Engaging patients in shared decision making related to their ICD has been the subject of recent investigations.2,3 It is considered a preference-sensitive decision; individuals place varying degrees of importance on the life-saving benefit vs potential life-altering risks.1

For 88 of 106 patients (83.0%), it was “important” or “very important” to discuss risks and benefits of continued therapy before deciding. Shared decision making is meant to facilitate a quality decision by offering a balanced presentation of the options—including no action—and amalgamating evidence-based information with patients’ preferences.4 A discussion regarding their clinical state and health care goals, a reassessment of their risk for sudden death, the operative risks, and reflecting on their experience of living with an ICD could lead a patient to decide against replacement.

We also found that many patients overestimated the life-saving benefits and underestimated the risks of ICD generator change. In particular, patients were not aware of the substantial risk and clinical significance of pocket infection.5 Finally, there were no demographic or clinical variables that suggested the type of patient who would consider not replacing their ICD generator. Hence, it seems important to discuss these issues with all patients.

The idea that patients are unaware about the noncompulsory nature of ICD replacement has been recently raised by experts in the field.6 To our knowledge, this is the first study to quantify the issue. The incorporation of patient preferences into decision making is a key feature of patient-centered medicine. To achieve this, a thoughtful review of the way ICD replacement is approached is warranted.

Corresponding Author: Krystina B. Lewis, RN, MN, CCN(C), Pacemaker and Defibrillator Clinic, University of Ottawa Heart Institute, 40 Ruskin St, Room H1285, Ottawa, ON K1Y 4W7, Canada (KBLewis@ottawaheart.ca).

Published Online: July 28, 2014. doi:10.1001/jamainternmed.2014.3435.

Author Contributions: Ms Lewis and Dr Birnie had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Lewis, Birnie.

Acquisition, analysis, or interpretation of data: Lewis, Nery, Birnie.

Drafting of the manuscript: Lewis, Birnie.

Critical revision of the manuscript for important intellectual content: Lewis, Nery, Birnie.

Statistical analysis: Lewis, Birnie.

Administrative, technical, or material support: Lewis, Nery, Birnie.

Study supervision: Birnie.

Conflict of Interest Disclosures: None reported.

Lampert  R, Hayes  DL, Annas  GJ,  et al; American College of Cardiology; American Geriatrics Society; American Academy of Hospice and Palliative Medicine; American Heart Association; European Heart Rhythm Association; Hospice and Palliative Nurses Association.  HRS Expert Consensus Statement on the management of cardiovascular implantable electronic devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010;7(7):1008-1026.
PubMed   |  Link to Article
Dodson  JA, Fried  TR, Van Ness  PH, Goldstein  NE, Lampert  R.  Patient preferences for deactivation of implantable cardioverter-defibrillators. JAMA Intern Med. 2013;173(5):377-379.
PubMed   |  Link to Article
Hauptman  PJ, Chibnall  JT, Guild  C, Armbrecht  ES.  Patient perceptions, physician communication, and the implantable cardioverter-defibrillator. JAMA Intern Med. 2013;173(7):571-577.
PubMed   |  Link to Article
Elwyn  G, Edwards  A, Kinnersley  P, Grol  R.  Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract. 2000;50(460):892-899.
PubMed
Poole  JE, Gleva  MJ, Mela  T,  et al; REPLACE Registry Investigators.  Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010;122(16):1553-1561.
PubMed   |  Link to Article
Kramer  DB, Buxton  AE, Zimetbaum  PJ.  Time for a change: a new approach to ICD replacement. N Engl J Med. 2012;366(4):291-293.
PubMed   |  Link to Article

Figures

Tables

Table Graphic Jump LocationTable 1.  Characteristics of Patients Who Would Consider ICD Nonreplacement and Patients Who Would Nota
Table Graphic Jump LocationTable 2.  Patient Perceptions of ICD Benefits and Generator Replacement Risks

References

Lampert  R, Hayes  DL, Annas  GJ,  et al; American College of Cardiology; American Geriatrics Society; American Academy of Hospice and Palliative Medicine; American Heart Association; European Heart Rhythm Association; Hospice and Palliative Nurses Association.  HRS Expert Consensus Statement on the management of cardiovascular implantable electronic devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010;7(7):1008-1026.
PubMed   |  Link to Article
Dodson  JA, Fried  TR, Van Ness  PH, Goldstein  NE, Lampert  R.  Patient preferences for deactivation of implantable cardioverter-defibrillators. JAMA Intern Med. 2013;173(5):377-379.
PubMed   |  Link to Article
Hauptman  PJ, Chibnall  JT, Guild  C, Armbrecht  ES.  Patient perceptions, physician communication, and the implantable cardioverter-defibrillator. JAMA Intern Med. 2013;173(7):571-577.
PubMed   |  Link to Article
Elwyn  G, Edwards  A, Kinnersley  P, Grol  R.  Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract. 2000;50(460):892-899.
PubMed
Poole  JE, Gleva  MJ, Mela  T,  et al; REPLACE Registry Investigators.  Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010;122(16):1553-1561.
PubMed   |  Link to Article
Kramer  DB, Buxton  AE, Zimetbaum  PJ.  Time for a change: a new approach to ICD replacement. N Engl J Med. 2012;366(4):291-293.
PubMed   |  Link to Article

Correspondence

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