Europace Advance Access originally published online on November 13, 2008
Europace 2009 11(1):26-30; doi:10.1093/europace/eun317
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Implantable Cardioverter-Defibrillators
No long-term psychological morbidity living with an implantable cardioverter defibrillator under advisory: the Medtronic Marquis experience
1 University of Ottawa Heart Institute, 40 Ruskin Road, Ottawa, ON, Canada K1Y 4W7; 2 Department of Psychology, East Carolina University, 215 Rawl Hall, Greenville, NC 27858-4353, USA; 3 Department of Internal Medicine (Cardiology), East Carolina University, 215 Rawl Hall, Greenville, NC 27858-4353, USA
Manuscript submitted 29 August 2008. Accepted after revision 27 October 2008.
* Corresponding author. Tel: +1 613 761 4914; fax: +1 613 761 4407. E-mail address: dbirnie{at}ottawaheart.ca
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Abstract |
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Aims: It is unclear whether there is important psychological morbidity associated with living with an implantable cardioverter defibrillator (ICD) under advisory and whether this should be factored into decision-making.
Methods and results: Our study focused on patients living with advisory Medtronic Marquis ICDs. Patient adjustment to the ICD was evaluated using a validated device-specific metric of patient acceptance, the Florida Patient Acceptance Survey (FPAS). A comparison group of patients with other models of ICDs that were not under an advisory also completed the study measure. The questionnaire return rate was 86/122 (70.5%) in the advisory group and 94/134 (70.1%) in the non-advisory group. Only one patient in our clinic elected for generator change due to severe anxiety. There were no differences in demographic or clinical variables between the groups. There were no differences in the mean total FPAS score between the two patient groups (advisory patients 85.97 ± 14.95 and 86.23 ± 15.76 for non-advisory, P=0.340). Also there were no differences in any of the subscores. Correlates of poor device acceptance were younger age and a history of electrical storm.
Conclusion: We found no evidence of increased long-term psychological morbidity in patients living with an ICD under advisory compared with patients with an ICD not under advisory. Our data suggest that patients and physicians should avoid hasty decisions about ICD replacement for psychological reasons.
Key Words: Psychological morbidity, ICD, Advisory, Recall, Anxiety
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Introduction |
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Implantable cardioverter defibrillators (ICDs) advisory notices are issued to patients and physicians when an ICD component is found to have the potential to malfunction. These advisories present treatment dilemmas for physicians and patients. On the one hand, the risk of device malfunction and the likely severity of clinical sequelae have to be estimated. This estimate has to be weighed against the risks of surgery to replace the advisory component. It is currently unclear whether there is important psychological morbidity associated with living with an ICD under advisory and whether this should be factored into decision-making.1
One study suggested that there was an acute increase in anxiety,2 whereas patients from two other studies did not confirm this finding.3,4 None of these studies used a device-specific measure of psychological morbidity.
The current study focused on patients living with Medtronic Marquis ICDs. Theses devices were subject to an advisory in February 2005, which indicated a life-time risk of perhaps 1% of rapid battery depletion, resulting in abrupt loss of pacing and shock capability.5 Identified advisory patients were advised to at least weekly self-test their battery status with a hand-held magnet. This self-testing likely serves as a regular reminder that there is a potential problem with the device. The objective of our study was to examine whether there is decreased patient acceptance of ICD devices when an ICD is under advisory compared with a control group of ICD patients without advisory devices, using a device-specific measure of psychological wellbeing.
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Methods |
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Advisory details and patients
In February 2005, Medtronic announced a world-wide advisory on Marquis ICDs manufactured between April 2001 and December 2003. Nine patients out of 87 000 had experienced rapid battery depletion due to an internal battery short. The projected life-time risk of this occurring was estimated to be 0.2–1.5%. Rapid battery depletion would lead to an abrupt loss of pacing output and shock capability.5
Patients affected by the advisory at our institution were immediately contacted. They were invited to special information sessions which consisted initially of a 1 h lecture for them and their relatives, with the opportunity to ask questions after the lecture. The patients were then seen individually by an electrophysiologist to discuss the most appropriate plan of action for them. Two options were discussed with all patients. The first was to have their device changed and the risks of this were reviewed with the patient. All patients were offered the option of device change, although this was only recommended in the pacemaker-dependent group. The second option was regular testing with a self-applied magnet. All patients in our practice who still had an implanted advisory Marquis device in December 2007 (i.e. 32 months after the advisory) were eligible for this study. Patients who had had their device changed to an alternative device were excluded from the study.
Non-advisory patients
All contemporaneous patients in our practice with models of ICDs that were not under any advisory formed the control group. No ICD leads in either group were under advisory.
Questionnaire
The Florida Patient Acceptance Survey (FPAS) measures device patient acceptance using 18 items rated on a 5-point Likert scale from 0 (strongly disagree) to 5 (strongly agree), with a high score indicating more acceptance.6,7 Four subscale scores can be derived from the patient responses, including: (i) return to function (four items; e.g. ‘I am confident about my ability to work if I want to’); (ii) device-related distress (five items; e.g. ‘When I think about the device, I avoid doing things that I enjoy’); (iii) positive appraisal (four items; e.g. ‘I would receive this device again’); and (iv) body image concerns (two items; e.g. ‘I feel less attractive because of my device’). The remaining three items are filler items. A composite score referring to total patient acceptance is also possible. Total FPAS score and return-to-function and positive appraisal scores are positively correlated with device acceptance, i.e. a lower score reflects poorer device acceptance; in contrast, device-related distress and body image concern subscores are negatively correlated with device acceptance, i.e. a higher score means lesser device acceptance.
This tool is considered to be a more sensitive instrument than general quality-of-life or anxiety measurement tools because it is a disease-specific instrument specifically assessing symptoms relevant to ICD patients.6,7 The questionnaire was mailed to all patients. If the patient did not reply within 3 weeks, they were contacted by telephone and the questionnaire was completed verbally by a trained nurse.
Clinical and demographic characteristics
Clinical variables were recorded from our device clinic charts and database (PACEART, Medtronic, Minneapolis, MN, USA). Device type, age, gender, New York Heart Association (NYHA) class at implant, left ventricular ejection fraction (LVEF), primary or secondary indication, and shock history including history of electrical storm (defined as at least three shocks in 24 h8) were collected.
Statistics
Quantitative variables (age, length of follow-up, LVEF) were analysed using the Wilcoxin two-sample test or the Kruskall–Wallis test where appropriate. Categorical variables (gender, primary/secondary indication, aetiology, NYHA class, history of any shock, and history of electrical storm) were analysed using Fisher's exact test. A priori on the basis of the literature, we decided to include the following variables in multiple linear regression models, as they have been associated with patient-centred outcomes in ICD patients: age, gender, length of follow-up, advisory status, history of any shock, and history of electrical storm.7,9,10 These variables were entered into multiple linear regression models using FPAS scores as the dependent variables. For the models, using a Bonferonni correction, a P-value <0.01 was used to indicate statistical significance. It can be estimated that with a sample size of 86 in the advisory group and 94 in the non-advisory group, there is 99.25% power, with alpha=0.05, to detect a 10% reduction in the total FPAS score (based on data from11). The statistics were calculated using SAS version 9.1.
Ethics
The protocol received ethics approval from the University of Ottawa Heart Institute ethics board, and all patients signed informed consent.
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Results |
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Patients
A total of 241 patients in our clinic were implanted with an advisory Marquis. Nine patients were recommended to have a generator change, because of pacemaker dependency, and all agreed to this. One other patient elected for generator change due to severe anxiety. Fifty-eight patients have subsequently died and three patients have undergone cardiac transplantation. Thirty-six patients have reached elective replacement interval and undergone pulse generator change and 11 patients had declined to be approached for research. This study consisted of the residual 122 patients who are still living with a device under advisory. It should be noted that no patient in the Marquis group had suffered sudden battery depletion. The control group consisted of all contemporaneous patients in our practice with models of ICDs that were not under any advisory (n = 134). The questionnaire return rate was 86/122 (70.5%) in the advisory group and 94/134 (70.1%) in the non-advisory group.
Comparison between advisory and non-advisory patients on baseline characteristics and device acceptance
There were no statistically significant differences in baseline demographic and clinical variables [age, gender, NYHA class at implant, LVEF, aetiology, primary or secondary ICD indication, and shock history including history of electrical storm (Table 1)]. There were no differences in the total FPAS score (advisory patients 85.97 ± 14.95 and 86.23 ± 15.76 for non-advisory, P = 0.340). There was no difference in any of the FPAS subscores between the two patient groups (Table 2).
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Effect of other clinical variables on Florida Patient Acceptance Survey scores
Shock history and history of electrical storm were univariate correlates of adverse FPAS return-to-function scores. The mean score in 93 patients who had never experienced a shock was 67.69 ± 24.96. In comparison, the score in 46 patients who had had shocks but not electrical storm was 63.70 ± 26.46 and in 16 patients who had had storm was 48.79 ± 22.45 (P = 0.020). History of electrical storm was an independent correlate of adverse FPAS return-to-function scores (P = 0.005, Table 3). Age was an independent correlate of device-related distress, with older people having more favourable scores (P = 0.009). There was a trend for older patients to have higher total FPAS scores, i.e. greater device acceptance (P = 0.028).
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Discussion |
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We found no evidence of reduced patient acceptance of devices in patients living with an ICD under advisory compared with patients with an ICD not under advisory. These data extend the current literature related to the impact of recalls on ICD patients because a device-specific metric (i.e. the FPAS) with likely greater sensitivity was employed. Previous work examining this question used generic measures of anxiety and produced conflicting results in small numbers of patients. Van Den Broek et al.2
studied 33 patients with devices subject to the same advisory as in our study using the State-Trait Anxiety Inventory. These patients were already recruited to an ongoing study of ICD patient anxiety prior to the recall event and then were re-assessed immediately after being informed of the recall. They found that a high level of anxiety was experienced by two patients at baseline and eight patients immediately post-recall (P = 0.031).2 In contrast, Cuculi et al.3 reported on 30 patients implanted with an ICD recall device and compared this group with 25 patients with unaffected ICD devices. They had no data on these patients prior to their recall. Again the psychological assessment was conducted on the same day as the recall information was first reviewed with the patient by their cardiologist. The study used a generic measure of distress, the Brief Symptom Inventory, and failed to show differences between study groups. Similarly, Gibson et al.4 compared 31 patients with advisory ICDS with 50 unaffected controls and found no difference using standard psychological (Patient Health Questionnaire) and quality-of-life (SF-36) questionnaires.
We chose to use a device-specific measure of psychological well-being because it has been shown that the FPAS is able to detect differences between patients that were not detected by general quality-of-life scores, for example the SF-36.6 The SF-36 may not have the specificity needed to detect subtle differences in changes of health statutes in patients after they have been treated.6 Also previous work has shown that general quality-of-life tools are not sensitive enough to detect differences in psychological well-being between pacemaker and ICD patients.12,13 In contrast, Burns et al.6 found that the total FPAS score and the four subscores were all significantly different between ICD and pacemaker patients, with ICD patients showing lower device acceptance in all domains.
The current study confirmed that the FPAS had utility in detecting differences in important subgroups of ICD patients, including sex differences, shock differences, and age differences. These important differences are consistent with previous work that outlined ‘at risk’ groups for psychosocial difficulties in ICD patients such as the young and shocked patients.9 Recently, Pedersen et al.7 performed the most detailed assessment to the FPAS in 566 ICD patients. They found that correlates of poor device acceptance included older age, symptomatic heart failure, Type D personality, anxiety, and depression.7 Despite these capabilities of the FPAS to detect important differences in psychological well-being, the FPAS did not detect differences between advisory vs. non-advisory patients in our study. Hence, although patients often feel acutely anxious after notification of device advisories, our data suggest that patients and physicians should avoid hasty decisions about ICD replacement for psychological reasons.
We also believe our data will help patients contemplating ICD implantation (and their physicians). Since the recent ICD advisories, we and many electrophysiologists have had high-risk patients refusing ICDs because of concerns about reliability. The falling ICD sales have been ascribed to these concerns. As part of the discussion, patients need to be informed that they are quite likely to have an ICD component under advisory at some point, they are likely to adjust well to living with an advisory ICD (based on our data), the risk of death from an ICD malfunction is very small, and it is far more likely that they will benefit from an ICD than come to harm from ICD malfunction.14
The influence of shocks on ICD patients' psychological state is subject to debate with some10,15,16 but not all studies,11,12,17,18 confirming a relationship between shocks and adverse outcomes. The inconsistency in findings is likely multi-factorial, including whether potential confounders were controlled for; the way that shocks were assessed; and the questionnaire used (all previous studies used generic anxiety and/or quality-of-life tools). In our study, using an ICD patient-specific tool and controlling for likely confounding, we found that history of electrical storm was an independent correlate of adverse patient device acceptance.
Our study has a number of limitations. First, we did not have detailed information on patient co-morbidity, which has previously been shown to influence ICD patient's quality of life. However, our two groups were well matched on all other variables and hence we do not expect that this is an important factor. Second, the findings of this study are related to one specific advisory and may not be generalizable to other advisories. For example, in the Marquis advisory, patients were at risk of sudden battery failure with abrupt loss of pacing output and shock capability but with no risk of inappropriate shocks. Hence it is possible that, for example, the Fidelis advisory19,20 with the risk of inappropriate shocks may affect patients differently. Thirdly, all patients were from the same clinic and all received a rapid information and counselling programme. Thus, the results might not generalize to situations where an advisory is handled differently. Fourth, the study was performed 2 years after the advisory notification, and hence there may have been a period of lower quality of life that resolved by the time of the testing. Finally, it is possible that anxious patients may be over-represented in the 30% of patients that did not respond to the questionnaires. However, it is reassuring in this regard that the non-response rate was the same in both advisory and non-advisory groups.
In conclusion, our study focused on patients living with Medtronic Marquis ICDs. These devices were subject to an advisory (February 2005), indicating a risk of rapid battery depletion. Only one patient in our clinic elected for generator change due to severe anxiety. We found no evidence of increased long-term psychological morbidity in patients living with an ICD under advisory compared with patients with an ICD not under advisory. Patients often feel acutely anxious after notification of device advisories, but our data suggest that patients and physicians should avoid hasty decisions about ICD replacement for psychological reasons.
Conflict of interest: none declared.
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[1] Sears SF Jr, Conti JB. Psychological aspects of cardiac devices and recalls in patients with implantable cardioverter defibrillators. Am J Cardiol (2006) 98:565–7.[CrossRef][Web of Science][Medline]
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[16] Schron EB, Exner DV, Yao Q, Jenkins LS, Steinberg JS, Cook JR, et al. Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation (2002) 105:589–94.
[17] Pedersen SS, Theuns DA, Muskens-Heemskerk A, Erdman RA, Jordaens L. Type-D personality but not implantable cardioverter-defibrillator indication is associated with impaired health-related quality of life 3 months post-implantation. Europace (2007) 9:675–80.
[18] Irvine J, Dorian P, Baker B, O'Brien BJ, Roberts R, Gent M, et al. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J (2002) 144:282–9.[Web of Science][Medline]
[19] Medtronic Inc. Urgent Medical Device Information: Sprint Fidelis Lead Recall and Patient Management Recommendations (2007) Minnesota, USA: Medtronic Inc.
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