ICDs
Decision-making, emotional distress, and quality of life in patients affected by the recall of their implantable cardioverter defibrillator
1 Virginia Commonwealth University School of Medicine, 1200 East Broad Street, PO Box 980268, Richmond, VA 23298-0268, USA; 2 Ohio State University Comprehensive Transplant Center, 700 Kinnear Road, Columbus, OH 43212, USA; 3 Virginia Commonwealth University School of Medicine, 1001 East Broad Street, PO Box 980053, Richmond, VA 23298-0268, USA
Manuscript submitted 20 December 2007. Accepted after revision 16 March 2007.
* Corresponding author. Tel: +1 804 828 4919; fax: +1 804 828 0220. E-mail address: dgibson{at}mcvh-vcu.edu
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Abstract |
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Aims: We sought to investigate whether patients with implantable cardioverter defibrillators (ICDs) were suffering from emotional distress related to the recent United States Food and Drug Administration (FDA) recalls, to better understand their decision process related to device replacement, and to assess any impact of recall on quality of life (QOL).
Methods and results: Thirty-one patients experiencing device recalls answered questions regarding their knowledge about the recall and their decision whether to replace the device. Fifty patients whose devices were not recalled reported demographic data. In both groups, psychological factors were assessed. No significant differences were found for psychological factors. Most patients reported being informed of their recall by their physician. Most estimated the risk of device failure to be low or very low, but they overestimated the fail rate. Thirty-six per cent of patients reported feeling anxious about the recall.
Conclusion: No significant differences existed in psychological factors and QOL between patients whose ICDs were recalled compared with those whose devices were not. The majority of patients whose ICDs are the subject of an FDA advisory/recall have a realistic understanding of the risks of device failure. Prompt information, support, and reassurance provided by healthcare professionals may allay patient distress.
Key Words: Implantable cardioverter defibrillator, Food and Drug Administration recall, Psychological factors, Quality of life
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Introduction |
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Sudden cardiac death remains a leading cause of mortality in the USA and Europe, with a yearly incidence of 1 per 1000.1
,2 The efficacy of implantable cardioverter defibrillators (ICDs) in reducing mortality in patients who have been resuscitated from a cardiac arrest has been well-established.3–5 Subsequently, several large clinical trials established the ICD as a first-line/prophylactic therapy for patients at risk of sudden cardiac death. These trials include the multicentre automatic defibrillator implantation trial II,6 the defibrillators in non-ischaemic cardiomyopathy treatment evaluation trial,7 the multicentre unsustained tachycardia trial,8 and the sudden cardiac death in heart failure trial.9
The evolution of ICDs to prophylactic therapy coupled with an ageing population has led to an increase in the number of devices being implanted, and it is likely that this trend will continue. Device malfunction, while unfortunate, has been documented to occur with an increasing frequency in ICD patients. Maisel et al.10 examined the number of advisories and recalls of pacemakers and ICDs from 1990 to 2000. They showed an increasing number of ICDs to have been recalled in 8 of the 11 years studied. Despite the frequency of device malfunction and recall, little attention has been paid to the emotional impact such events may have on ICD patients.11–13
Over the last 5 years, all the major device companies have suffered device failures and have had a significant number of ICDs under US Food and Drug Administration (FDA) recall or advisory. In 2005 July, the FDA issued a Class I recall of some of these devices. Although the occurrence of device advisories and recalls is not unprecedented, the impact of device recalls on patients’ psychological status has received little attention. To date, no studies have examined the decision-making process as it relates to device replacement. Specifically, patients’ perception of risk vs. actual risk, information necessary to make a decision, sources of support related to the decision, and perceived obstacles affecting their decision have not been examined. No studies have examined whether subsequent changes in quality of life occur (QOL). In one study, psychological distress was not significantly increased in patients who had recently been informed about a potential malfunction of their device.11 The goals of this study were to identify whether patients were suffering from emotional distress related to the recall, to better understand their decision process related to device replacement vs. maintenance, and to assess any impact on QOL. Increasing our awareness of patients’ experiences following a device recall may allow clinicians to facilitate decision-making and provide appropriate psychological/psychiatric intervention when indicated. Given the increase in device usage as well as the ageing population, the likelihood of an increase in such recalls and potential distress is high, making the need for improved assessment and intervention a vital aspect of ICD therapy.
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Methods |
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Participants
Participants were 81 patients with an ICD, who were followed at the electrophysiology clinic in a large university medical centre on the East Coast. Thirty-one participants were affected by an FDA recall of their ICD which required them to discuss with their physician, the option of replacing it or maintaining it with increased surveillance. Eleven of those patients had a Medtronic device (Class II advisory), 7 patients had a St Jude Medical device (Class II advisory), and 13 patients had a Guidant device (Class I advisory). Fifty participants had an ICD but were not affected by the FDA recall. Participants were predominantly Caucasian (n = 55) or African-American (n = 24) and age ranged from 24 to 93 years (M = 63.1 ± 13.5 years). The majority of participants graduated from high school (n = 65) and half had completed at least some college (n = 41). Individuals were excluded from participation if they had cognitive impairment and/or if they could not read English. All patients in this sample had previously received a letter from their physician notifying them of the recall in addition to follow-up discussions in clinic. Patients were provided information as to the nature and purpose of the study by their nurse or electrophysiologist and asked if they would be interested in participating. Informed consent from each participant was obtained and documented. The study was approved by the Virginia Commonwealth University Institutional Review Board and complies with the Declaration of Helsinki.
Instruments
Medical history form
A member of the medical team completed a medical history form for each participant which included their cardiac and electrophysiological diagnosis, date of onset, co-morbid conditions, medications, device type, date implanted, device activity history, and history of phantom shocks.
Patient information questionnaire
All participants provided demographic information including marital status, race/ethnicity, education, occupation, and income. Those whose device had been recalled completed questionnaires regarding how they were informed of the recall, who informed them, when they were informed, and whether they intended to replace their device. They also reported their estimation of risk of device failure, whether they were aware of risks associated with replacing the device, and the estimated risk of those complications. Finally, participants with recalled devices were asked to report whether the recall made them feel anxious/nervous, sad, angry, frustrated, calm, or happy.
Patient health questionnaire
The patient health questionnaire (PHQ) is a brief diagnostic instrument used to assess symptoms of depression, anxiety, alcohol abuse, somatization, and eating disorders.14 The depression category is subdivided into major depressive syndrome and other depressive syndrome, and the anxiety category is subdivided into panic syndrome and other anxiety syndrome. The eating disorders' category is subdivided into bulimia nervosa and binge eating disorder. For each condition, a specific criterion needs to be met before a diagnosis can be made. It has shown good agreement with independent mental health professionals’ ratings of psychological distress as well as other screening instruments.14
SF-36 health survey
The SF-36 health survey (SF-36v2) is a measure of health-related QOL.15 It comprised the following scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores on each scale range from 0 to 100 with higher scores indicating better functioning. It is a commonly used measure among different medical patient populations.
Procedure
Participants whose device was not recalled were informed that the study was designed to assess emotional and physical functioning in patients with ICDs. Participants whose device was recalled were informed that the study was designed to assess emotional and physical functioning in patients with ICDs as well as to assess knowledge about the recall. All participants reported demographic information and completed questionnaires designed to assess the QOL and psychological distress. In addition, participants with recalled ICDs completed additional questions about perception of risk, factors influencing their decision to either replace or maintain their current ICD, and questions assessing current feelings about the recall. Assessment instruments were given to patients by a nurse or by one of the investigators at the electrophysiology clinic. The investigators were available to answer questions if required. Following completion of the questionnaires, patients were debriefed as to the full nature and purpose of the study. This was presented orally and was accompanied by a written handout. All patients were encouraged to discuss any concerns with their electrophysiologist. It was planned to offer counselling by a licensed psychologist or make a referral to the appropriate level of care for any patients reporting emotional distress. No participants met this criterion, however, and to the best of our knowledge, none sought counselling after completing the study.
Statistical analysis
All questionnaire data were analysed using SPSS statistical software, version 14.0. For categorical data, a 
2 test was used to evaluate group differences. Independent samples t-tests were used to assess whether the two groups differed significantly on descriptive characteristics or the SF-36. For all statistical tests, 
was set at 0.05.
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Results |
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Sample characteristics
Table 1 presents the baseline data for the recall and non-recall groups. Groups did not differ significantly in age, gender, marital status, years device that had been implanted, or shock history. Ninety-one patients were asked to participate and 10 declined. It is not known whether there were baseline differences between those who participated and those who declined.
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Psychosocial data
As shown in Table 2, no statistically significant differences were observed between the groups in any of the eight domains of QOL as measured by SF-36 including physical functioning, role limitations-physical, role limitations-emotional, social functioning, bodily pain, mental health, vitality, and general health perception, F (8, 70) = 0.923, P = 0.66. There were no significant differences between the groups in anxiety (
2 = 1.36, P = 0.51), depression (2 = 2.78, P = 0.25), somatization (2 = 0.75, P = 0.39), or alcohol abuse (2 = 0.79, P = 0.37) as measured by the PHQ. None of the patients met criteria for an eating disorder on the PHQ.
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Recall questionnaire
Responses from the recall questionnaire are summarized in Table 3. Most patients whose device had been recalled reported having been informed of the recall by their physician (61%), but the remaining patients reported being informed from the newspaper, television, or other sources. The majority of patients (n = 20) decided to keep their original device, whereas six patients decided to replace their device and five were undecided. Most patients estimated the risk of device failure to be low or very low (67.7%), and only 9.7% of patients estimated it to be high. The majority (80.6%) did not know the device failure rate when guessing and 71% overestimated it. The majority of patients were aware that there is risk associated with replacing their device (90.3%). When asked how they felt about the recall, 36% of recall patients reported feeling anxious/nervous, 13% reported feeling sad, 13% reported feeling angry, and 23% reported feeling frustrated. Interestingly, 39% of recall patients reported feeling calm about the recall and 10% even reported feeling happy.
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Discussion |
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The purpose of this study was to assess whether patients whose ICDs have been recalled have more psychological distress and worse QOL than patients whose ICDs have not been recalled. Moreover, the study aimed to assess the patients’ perception of risk as well as their decision-making process as it related to device replacement vs. maintenance. Although no significant differences were observed between the groups, important information was gained about patients who had experienced a device recall. All patients in this sample had received a letter from their physician notifying them of the recall in addition to follow-up discussions in clinic, yet only 61% recalled learning of the recall from their physician. Although most patients correctly estimated the risk of device failure to be low or very low, they actually overestimated the rate of failure. Out of the six participants who reported knowing the failure rate, only one participant accurately reported it. Few patients sought to have their devices removed/replaced and the majority was aware that there were risks associated with replacing the device. ‘Calm’ was the most commonly endorsed feeling associated with recall, followed by ‘anxious/nervous’.
In examining the results of the questionnaire completed by the recall group only, information regarding their experience as well estimation of danger and decision-making was acquired. Although patients tended to correctly estimate the risk of device failure to be low, they were likely to overestimate the odds of device failure. Eighty per cent of the patients reported not being aware of the potential failure rate. This may explain why only one patient correctly estimated the actual failure rate.
Some limitations of the current study include the relatively small sample size, the broad measure of psychological distress used, and possible selection bias. Recalls do not affect all ICD patients equally,12 and our sample size may not have been sufficient to detect differences that may exist between the groups. Although the PHQ is a useful diagnostic instrument, it may not detect psychological distress specifically related to the device (ICD) and/or device recall. As with most measures of psychological distress, the PHQ assesses symptoms indicative of a clinical diagnosis (e.g. major depressive disorder, panic disorder, etc.). Our results did not reveal any significant psychological distress in either the recall or non-recall ICD patients. It is possible that patients experience distress in the form of decreased confidence in their device in addition to other fears (hypervigilance of somatic symptoms, avoidance, and catastrophic thinking) associated with having an ICD. This possibility is suggested by the fact that 36% of the recall patients reported feeling anxious/nervous about the device recall. Although these concerns may not result in an identifiable psychiatric diagnosis, they may have an impact on behaviour and adjustment which is not captured by many assessment instruments. Our sample was drawn from one academic medical centre’s electrophysiology clinic, and it is possible that the results would differ in other settings. It is also possible that the 11% of the patients who declined to participate in our study might differ in some respects from the 89% who agreed. However, the one other study comparable with ours found essentially the same result, relatively normal levels of psychological distress and no difference between patients with recalled vs. unaffected ICDs.11
There are little empirical data in the medical or psychiatric literature about whether the recent ICD recalls have affected patient function and QOL. This study was one of the first to assess whether recent recalls have impacted ICD patients’ QOL and psychological functioning. Our data did not reveal that patients with recalled ICDs experience significantly more emotional distress or diminished QOL than non-recall patients. A study conducted in Switzerland compared 30 patients with recalled devices with 25 with unaffected ICDs. They found that indices of psychological distress were within the normal range in both groups, and they reported no increase in psychological distress in patients who had recently been informed of a potential device malfunction.11 This is consistent with our study’s findings. Investigators in the Netherlands compared anxiety levels in 33 patients with recalled ICDs before and after a public statement of potential malfunctioning of their device.13 They found a high level of anxiety in two patients (6.1%) at baseline and eight patients (24.2%) at follow-up (P = 0.031), but there was no comparison group of patients with unrecalled devices. It may be that our patients with ICDs who were affected by the recent FDA recalls were not more distressed because they received prompt and up-to-date information, support, and reassurance from their healthcare professionals. In addition, the majority of patients in our study reported believing the risk of device failure was low, likely decreasing their fear of personal device failure.
Research has shown that patients with ICDs are at increased risk for psychological distress.16 The results of this study preliminarily suggest that ICD recalls do not contribute to further distress. Future research should utilize a larger sample size as well as measures of ICD-specific concerns to further explore the impact of recalls in patients with ICDs.
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This study was conducted at Virginia Commonwealth University Medical Centre, Richmond, Virginia, USA.
Conflict of interest: K.E. receives grants from Medtronic, Boston Scientific and St. Jude Medical and has received honoraria from all three for consulting work.
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