|Year : 2022 | Volume
| Issue : 1 | Page : 32-35
Decision-making experiences and decisional regret in patients receiving implanted cardioverter-defibrillators
Idean Ahmad Pourshams, Bryant Lin, Paul J Wang, Randall Scott Stafford
Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA
|Date of Submission||10-Aug-2021|
|Date of Acceptance||21-Dec-2021|
|Date of Web Publication||31-Jan-2022|
Dr. Randall Scott Stafford
Stanford Prevention Research Center, 1265 Welch Rd., 3rd Floor, Stanford, CA 94305-5411
Source of Support: None, Conflict of Interest: None
Background: Patient education before the placement of an implantable cardioverter-defibrillator (ICD) is strongly recommended to prevent or mitigate feelings of regret and frustration in ICD recipients. Medicare guidelines for ICDs require a shared decision-making approach that focuses on patients' health goals, values, and preferences before implantation. However, many patients are not fully informed of what to expect when recovering from ICD placement or living with an ICD long-term. Objectives: Our objective is to understand decision-making processes and decisional regret in patients requiring ICDs using in-depth interviews. Methods: Nineteen patients at Stanford University Medical Center were recruited to participate in individual interviews using closed-ended and open-ended questions to engage dialogue. Notes taken during interviews were assessed and used to identify major themes. Results: Participants described a lack of adequate education about ICD postoperative recovery and long-term, postimplantation considerations such as avoiding electromagnetic fields, false-positive ICD shocks, and the esthetic effect of ICD implantation. In addition, feelings of fear and anxiety were prevalent in participants' recollections of accepting an ICD. Conclusion: Further improvement in patient education before ICD placement is needed. The decision-making process can be simplified and patient regret and frustration minimized by providing reliable information that is accessible and interactive.
Keywords: Implantable cardioverter-defibrillator, patient resource, qualitative study, shared decision-making
|How to cite this article:|
Pourshams IA, Lin B, Wang PJ, Stafford RS. Decision-making experiences and decisional regret in patients receiving implanted cardioverter-defibrillators. Heart Mind 2022;6:32-5
|How to cite this URL:|
Pourshams IA, Lin B, Wang PJ, Stafford RS. Decision-making experiences and decisional regret in patients receiving implanted cardioverter-defibrillators. Heart Mind [serial online] 2022 [cited 2022 May 20];6:32-5. Available from: http://www.heartmindjournal.org/text.asp?2022/6/1/32/336890
| Introduction|| |
“My sister dropped dead, 19 days before her cardiology appointment... I didn't want her fate to be mine” (56-year-old female, 1 month before implantable cardioverter-defibrillator [ICD] implantation).
A patient's understanding of their health and treatment plan is an integral component of proper medical care. This need for patient education is particularly critical with ICDs. The Centers for Medicare and Medicaid Services consider ICDs to be reasonable and necessary treatments for patients with life-threatening dysrhythmia and cardiomyopathy, with approximately 150,000 devices being implanted annually in the United States. The complicated nature of information about ICDs, including its technological complexity and the potential benefits and harms of implantation, can create a stressful decision-making experience for patients. During this time, it becomes challenging for patients to effectively communicate with their health-care providers. The often-urgent nature of ICDs can induce additional stress. Patients must grapple with details about the ICD device itself, in addition to the surgical placement procedure, and how living with an ICD may change their future lives. Adequate education may aid in reducing patient anxiety before the procedure and assist in enabling understanding and preparation for life with an ICD long term.
Currently, patient resources are available for ICD decision-making, including websites, forums, and pamphlets. This article finds details on patient experiences and current access to information a decade after similar studies., By interviewing patients who have recently received ICDs, we assessed sources of continuing patient frustration despite these resources and identified areas for further improvement.
| Methods|| |
With Institutional Review Board approval, we conducted patient interviews to gain insight into patient experiences before and after ICD placement, with a focus on issues related to sources of information, sources of support in decision-making, and feelings of regret postprocedure. We gathered data through prewritten questionnaires and open-ended interviews designed to generate conversation concerning topics of greatest relevance to patients. We contacted 26 patients who had already received or were considering receiving an ICD based on clinic schedules, assessed their interest in participation, and once consented, arranged a convenient time for a telephone or video interview.
We interviewed 19 patients aged 20–70 years and a median age of 47 years. Eleven participants were female (58%), 5 were Hispanic, 12 were caucasian, and 2 were Asian. Interviews were conducted either over the telephone (79%) or with video conferencing (21%), with each interview lasting 20–60 min and 30 min on average. During the interview, patients were free to discuss any topic based on their experience with ICDs. Four patients were interviewed before ICD placement, while 15 patients were interviewed postplacement. In addition to the interview, patients also answered a questionnaire containing five yes/no questions. These questions were answered after at least 30 days postoperative to allow time for the patient to recover and reflect upon their experience. As each interview was completed, we used transcript notes to manually analyze the content and performed thematic analyses to assess the most common topics of concern. The interviews were not recorded, but key themes were annotated.
Declaration of Ethical Approval
The study was approved by FWA00000935 (SU) for Stanford University and FWA00000934 (SHC) for Stanford Health Care on 7/20/2020 with no expiration date, the eProtocol is # 49771.
| Results|| |
Participant responses to the short questionnaire indicated that 53% of the respondents believed that the quantity of information they received was insufficient before ICD placement. Of the respondents, 33% believed that the quality of information was insufficient, 73% relied on support from loved ones to assist in their final decision about ICD acceptance, and overall, 60% endorsed experiencing fear, stress, or anxiety during the decision-making process. The interviewees uniformly understood the need for an ICD, and each denied regretting their decision [Table 1]. Patient formal education levels are listed in [Table 2].
During the interviews, four recurring themes were common: lack of access to reliable information, fear of ICD activation, reliance on supportive family or friends when deciding, and unexpected postoperative pain or physical limitations [Table 3].
|Table 3: Implantable cardioverter-defibrillator indications for implantation|
Click here to view
Reliable information was available to patients, but when left alone to search for answers, they could not readily find the best source of information. Some patients did not know what to ask during their clinical visits, while other patients hesitated to ask all of their questions. One patient who participated in our study expressed worry that they would take up too much of the clinician's time.
All patients acknowledged the value of available information packages and pamphlets provided by clinicians and staff, but in hindsight felt they were inadequate overall. Mainly, the pamphlet pictures and diagrams of the ICD device were helpful in facilitating understanding of the device and implantation. Nevertheless, all interviewed patients endorsed a lack of complete understanding. This was particularly noted by patients whose ICDs were implanted urgently.
Another common theme from the patient interviews was fear of ICD activation and fear of sudden death should the ICD fail. One patient worried about causing an accident and hurting others on the road if the ICD was activated while driving. Other patients were unclear about what levels of exercise would be considered safe while living with an ICD. For example, patients who enjoy swimming expressed concern about drowning. Receiving the first ICD shock, a false positive in this example, provided some level of relief for a patient who then knew what to expect. The experience described by the patient was compared to being “kicked in the chest.” The interviews elicited common issues for many ICD patients.
Potential ICD patients do seek support from family and friends when making their decision to accept the implanted device and relying on support was common among the interviewees as well. In addition to discussions with their care team and independent research, 73% of the patients mentioned support from friends and family in making their decision.
Another commonly mentioned concern was postoperative recovery and physical limitations. The patients were unclear if they would go home in an arm sling and whether they could use their left arm, and if not, for what duration. Shoulder pain led to a “frozen shoulder” for one patient who expressed regret that mobility exercises were not discussed before the surgery. Up to 6 months after surgery, female patients in our study described continued pain from slightly fitted clothing and the inability for some to wear bras.
A few respondents touched on the importance of psychological preparation for living with an ICD. Patients mentioned surprise about how big the ICD looked after implantation and the protrusion causing an unsatisfactory appearance. This made the patients self-conscious and affected intimacy. Interviewees stressed the importance of understanding the possibility of such results in order to anticipate and mentally prepare for living with an ICD long-term.
One patient described an unusual event resulting from a screening mammogram. Due to difficulty in positioning for the mammogram, the patient's ICD was dislodged. Surgery was eventually required to reposition the ICD after the patient waited several weeks. Patient quotations are shared in [Table 4].
| Discussion|| |
ICDs are implanted because the benefits of the device outweigh the risks of the procedure and long-term sequelae. The first symptom of dysrhythmia could be death; thus, patients understand the need for an ICD despite their fears or associated risks. However, the consensus from the patient interviews is that more information about what to expect is necessary for patients before ICD placement.
Our findings of shortfalls in meeting the informational needs of ICD patients suggest the need for enhanced, extensive patient education before ICD placement. Patients may suddenly learn that they need an ICD due to dysrhythmia and the risk of sudden cardiac death. In some cases, the death of a family member identifies a familial genetic predisposition urgently requiring an ICD. Such a scenario can weigh heavily on a patient while considering treatments and procedures, and this urgency may lead to a fast-paced search for answers to many questions, as we see from the interviewees with 60% endorsing fear, stress, or anxiety. Social media support groups were used by some interviewed patients to meet and discuss experiences with others who have undergone similar procedures. However, the risk for misinformation and desire for privacy may limit patient reliance on information that is not provided directly by clinicians.
Clinical visits often have a time limit, especially in busy practices. Patients often describe a lack of adequate time for an in-depth discussion with the clinician and a subsequent need to search for information online. In some cases, patients' procedures were performed urgently, leaving insufficient time for preparation and resultant lingering frustrations. Patients may be fearful, some thoroughly surprised by an ICD recommendation. The emotions make it difficult for the patient to engage in meaningful discussion during clinic visits.
Patients are not always thoroughly informed about the dangers to avoid when living with an ICD, as we also saw with our cohort of patients, and 53% report an insufficient quantity of information. For example, working on cars may not be safe due to the electromagnetic field associated with a running motor. Similarly, it is essential to avoid cell phone proximity to the implanted device. In addition to information, patients also need encouragement and reassurance that they can still live a meaningful life with continued participation in their activities of interest.
Clinicians are urged to screen ICD patients for depression. Some patients have support from friends and family members, but it is important to remain mindful of the emotional impact a patient experiences when learning they need an ICD. Patients want to receive proper information and have all questions answered to reassure that they will live a normal life.
Our findings are similar to other published studies, which have demonstrated that patients frequently experience difficulty navigating the decision-making process for an ICD., The patients also relied on support from family members. However, the interviews also showed that some patients are not fully informed or prepared for the surgical procedure or living with an ICD. Our data suggest that patients want a full and accurate list of expectations immediately after the surgery as well as over time.
Currently, there are helpful resources, such as the University of Colorado's patient decision aid website., This resource provides patients with pictures of different ICD devices, charts to understand the mortality of dysrhythmia, as well as videos of patients describing their experience of having an ICD and how they ultimately decided to accept the device. Patient outcomes were improved by incorporating these resources as a part of shared decision-making with their health-care providers. Of the interviewees, none had used the resources of this or other available websites, implying the need to guide patients to existing websites or more proactively provide similar, detailed information.
Newer digital provider–patient-shared decision-making platforms may be an additional resource that extends this form of information by providing patient-tailored information, greater reliance on visual aids, more detailed information, greater interactivity, and full integration with clinician workflow. Such a yet-to-be-developed tool used in clinical settings might help ICD patients better understand their medical condition and treatment while enhancing overall satisfaction and reducing conflict and regret associated with ICD decision-making.
While this study used a small cohort of 19 participants in a single academic medical center, it nonetheless identified consistent common concerns reported by these ICD patients. Additional limitations include the limited racial/ethnic and socioeconomic diversity of the participants and the exploratory strategies for data collection and analysis.
| Conclusion|| |
This analysis demonstrates that even with the use of recommended, medicare-required decision-making tools, there are continuing gaps in communication for patients undergoing ICD placement with respect to the quantity and quality of information obtained. Current online resources provide valuable content, but patients are not always able to readily find this information. There is a continuing need to improve patient education so that patients know what to expect before, during, and after an ICD implantation. While substantial efforts have been made to improve patient decision-making, our conversations with recent ICD patients demonstrate that there are remaining unfilled needs.
We would like to thank our patients for their time and effort in participating in this study. We also thank Dr. Vaishnavi Bhamidi for her assistance in editing this manuscript, as well as Dr. Samuel Sears for guidance in the design and implementation of the study.
Financial support and sponsorship
This study was financially supported by the American Heart Association, Strategically Focused AHA-PCORI DECIDE Research Network (18SFRN3424003).
Conflicts of interest
There are no conflicts of interest.
| References|| |
Dunbar SB, Dougherty CM, Sears SF, Carroll DL, Goldstein NE, Mark DB, et al.
Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families: A scientific statement from the American Heart Association. Circulation 2012;126:2146-72.
Decision Memo for Implantable Cardioverter Defibrillators. Centers for Medicare & Medicaid Services. Available from: https://Cms.gov
. [Last accessed on 2018 Feb 15].
Friedman DJ, Parzynski CS, Varosy PD, Prutkin JM, Patton KK, Mithani A, et al.
Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States. JAMA Cardiol 2016;1:900-11.
Hazelton AG, Sears SF, Ford J, Cahill J, Nekkanti R, Deantonio H, et al.
Decisional balance among potential implantable cardioverter defibrillator recipients: Development of the ICD-Decision Analysis Scale (ICD-DAS). Pacing Clin Electrophysiol 2014;37:63-72.
Varghese S, Geller JC, Ohlow MA. Decision regret in implantable cardioverter-defibrillator recipients: A cross-sectional analysis on patients that regret their decision after ICD implantation. Herzschrittmacherther Elektrophysiol 2020;31:77-83.
Green AR, Jenkins A, Masoudi FA, Magid DJ, Kutner JS, Leff B, et al.
Decision-making experiences of patients with implantable cardioverter defibrillators. Pacing Clin Electrophysiol 2016;39:1061-9.
Matlock DD, Nowels CT, Masoudi FA, Sauer WH, Bekelman DB, Main DS, et al.
Patient and cardiologist perceptions on decision making for implantable cardioverter-defibrillators: A qualitative study. Pacing Clin Electrophysiol 2011;34:1634-44.
Lewis KB, Stacey D, Matlock DD. Making decisions about implantable cardioverter-defibrillators from implantation to end of life: An integrative review of patients' perspectives. Patient 2014;7:243-60.
Carroll SL, Embuldeniya G, Pannag J, Lewis KB, Healey JS, McGillion M, et al
. “I don't know exactly what you're referring to”: The challenge of values elicitation in decision making for implantable cardioverter-defibrillators. Patient Prefer Adherence 2018;12:1947-54.
Baykaner T, Pundi K, Mahaffey K, Lin B, Liu Y, Stafford R, et al.
Incorporation of Design into Creating a New Tool for Shared Decision Making in Atrial Fibrillation. Baltimore, MD: AHA Strategically Focused Research Network Meeting; 2019.
[Table 1], [Table 2], [Table 3], [Table 4]