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Three Part Question

In [adult recipients (age 18 or older) of Implantable Cardioverter Defibrillators (ICD)] can an intervention such as [post-operative cognitive behavior therapy (CBT)] result in statistically significant bio-psychosocial outcomes among intervention group participants vs. usual care group participants, as evidenced by [greater scores on the SF-36 and Beck Depression Inventory from baseline (immediate post-op period) to 6 months post- ICD implantation] and compared between groups?

Clinical Scenario

The Implantable Cardioverter Defibrillator (ICD) has been proven to save lives through prevention of lethal ventricular dysrhythmias and sudden death. The ICD is not only for candidates who have been resuscitated from these conditions, but now is also being implanted in high-risk cardiology patients such as patients with bradyarrhythmias for pacing, tachyarrhythmias and those with heart failure and low left ventricular ejection fractions. One would assume placement of such a device that could aid in halting or postponing death would result in a sense of security and comfort. However, research reveals the opposite is likely to occur in a vast majority of recipients of the ICD. Many suffer post-implantation fear, anger, anxiety and a loss of desire to participate in any activity. It is clear that a post-operative intervention is imperative, and Cognitive Behavior Therapy (CBT) may be the solution for these ill effects toward this cardiac device. CBT could quite possibly have global application if determined to have a positive bio-psychosocial effect on this population.

Search Strategy

Ovid Medline (R) on the worldwide web 1996 to May week 2, 2006
Entrez NCBI PubMed on the worldwide web. All databases, no specific dates.
Ovid Medline (R)- [ICD] and [psychological.mp] and intervention.mp] no limits
Ovid Medline (R)- [cognitive therapy] and [defibrillators,implantable] no limits 1 and 2 yields 9 articles
Entrez NCBI PubMed- [defibrillator] and [implantable] and [cognitive therapy] no limits #1 and #2 and #3 yields 5 articles.

Search Outcome

First Ovid search yields 19 articles
Second ovid search yields 8 articles
First PubMed search yields 5 articles

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Lisa Smith, Ph.D. & Dov Fogel, M.D. & Steven Friedman, Ph.D. July 8, 1997 U.S.A.	36 y/o CF with right-ventricular dysplasia.	Case Report Subsequent to ICD implantation patient experienced stacked shocks (6 or 7) while walking to work. Soon after she began experiencing flashbacks of the jolts, nightmares and agorophobic avoidance. She also had dizziness, fatigue and nausea, not due to dysrhythmia. Symptoms tapered after 3 weeks. 3 months later she had an episode of pacing activity which triggered her panic attacks and agoraphobia. She also began having feelings of depression. At this time she completed the following questionnaires during a counseling session: Anxiety Disorders Interview Schedule, the Marks and Matthews Fear Questionnaire, the Body Sensations Questionnaire, the Mobility Inventory for Agoraphobia and the Beck Depression Inventory. She was then diagnosed with panic disorder with agoraphobia, major depressive disorder and post-traumatic stress disorder, in remission from a rape 14 years earlier. Cognitive Behavior Treatment was initiated and she recieved a total of 15 sessions over 12 months.	pre and post treatment clinical measures resulted in a significant reduction of symptoms, which remained decreased at the 3 month follow-up.	Further development and application of CBT treatments to enhance quality of life are warranted.	No weaknesses are mentioned; however, the fact that she had been raped 14 years earlier may have contributed to the severity of her psychological response to the stacked shocks and pacing episode.
Pauli, P., & Wiedemann, G., M.D. & Dengler,W., M.D. & Blauman-Benninghoff,G. & Kuhlkamp, V. M.D. Jan-Feb, 1999 Germany	61 AICD patients aged below 65 years from the Medical Clinic of the University of Tubingen, Tubingen, Germany.	Non-randomized controlled trial AICD patients compared to panic disorder patients All participants completed the following questionnaires: The ACQ (German version), the BSQ (German version), the FSS (German version), the TAI (German version), the BAI, the BDI and the MI (German version). 26% of the AICD patients still feared dying, which was positively associated with shock experience. Anxiety and depression levels were closely associated with their anxiety related to future shocks.	The catastrophic negative interpretation of bodily symptoms and anxiety related to possible AICD shocks presumably triggers anxiety and leads to higher levels of anxiety and depression as well as avoidance behavior.		Multiple comparisons were made without correcting the alpha error. However, it is noted that correction of alpha error would simultaneously reduce the power of tests, leading to a different type of error, and the unusual nature of the population warranted consideration of any possible difference. The study used self-report measures only, and the AICD questionnaire consists of single-item questions with unknown reliability and validity.
Wallace, R. & Sears, S. PhD. & Lewis, T., PhD. & Griffis, J., M.D. & Curtis, A., M.D. & Conti, J.,MD July-August, 2002 USA	58 patients who had received an ICD between 1995 and 1998 at a university medical center at least one year prior to the interview.	Quantitative telephone interview with self-report questionnaires. The following questionnaires were completed: The State Trait Personality Inventory, the Antiarrhythmics vs Implantable Defibrillator Checklist (AVID), the Medical Outcomes Study Short Form-12 (SF-12).	21% of the ICD patients reported elevated levels of trait anxiety and 5% experienced elevated levels of depression. 11% reported low levels of support.	Long-term ICD recipients can benefit from cardiac rehabilitation interventions aimed at increasing social support, reducing anxiety levels and educating about the ICD.	No comparisons on the Antiarrhythmics vs Implantable Defibrillator Checklist were possible because normative data were lacking on the measure. The study was limited by the number of participants. Also, it was a self-report measure which can be influenced by what the patient feels may be the expected answer.
Sears, S. & Conti, J. 2002 USA	Review of the literature of ICD recipients and their reported quality of life	Systematic review of the published literature on ICD recipients and their quality of life with regard to psychological functioning.	The most common problems for ICD recipients in daily life include driving restrictions/limitations, coping with ICD shocks and depression. A	Measurement and interventions should focus on patient acceptance of the device. It is suggested that routine consideration of psychosocial needs be integrated into the clinical care of ICD patients worldwide.	The author states that the majority of the quality of life data trials of ICD recipients has not yet been published, and that this review is of several small studies.
Kamphuis, H. & De Leeuw, J. & Derksen, R. & Hauer, R. & Winnubst, J. June 15, 2003 The Netherlands	167 consecutive patients who were admitted to the hospitals after an out-of-hospital cardiac arrest. 132 patients received an ICD, the other 35 received other treatment.	a 12-month Longitudinal Prospective Study Participants completed the following questionnaires: the Rand-36, the Heart Patient Psychological Questionnaire (HPPQ), the State-Trait Anxiety Inventory (STAI), and the Centre for Epidemiological Studies Depression Scale (CES-D).	22%-66% could be diagnosed with clinical depression from discharge to 12 months post-discharge. Mental health became worse in the first 6 months of patients who were shocked. Those who received a shock felt limited in their ADLs and were susceptible to depression and anxiety.	The data indicates that patients who have shocks do not adapt well to living with an ICD. Conclusion is that the lasting psychological distress from an ICD and shocks will not dissipate spontaneously or naturally and that psychosocial interventions may be warranted.	The variables of social support, cognitive and bio-medical performance, ICD complications, mobility and drug therapy were not taken into account in this study. The effect of cognitive performance was not assessed, and therefore it's effect on quality of life could not be studied.
Tagney, J. & James, J. & Albarran, J. September, 2003 United Kingdom	8 patients who are ICD recipients and their spouses/partners	Qualitative study of 8 patients recruited from one regional cardiothoracic centre and interviewed in their homes using semi-structured schedules	this study illustrates that patients are likely to experience varying degrees of psychological, social and physical adjustment both leading up to and following ICD implant.	It is apparent that without appropriate support and information from healthcare professionals, this group of patients resorts to do-it-yourself rehabilitation and adjustment, some of which appears to be inappropriate.	sample size restricts generalizability Deliberate concealment of symptoms was admitted by patients who did not want to cause panic in their providers and spouses.
Kamphuis, H. & Verhoeven, N. & DeLeeuw, R. & Derksen, R. & Hauer, R. & Winnubst, J. 19 March, 2004 the Netherlands	21 patients who recieved and ICD were interviewed at one, 6 and 12 months post discharge from the hospital.	Qualitative semi-structured interviews in the patients' homes	Implantation of an ICD changes many things in the lives of the patients, psychologically, socially and physically. Anxiety and uncertainty are chief contributors to these changes. Disappointment and frustration is also experienced. Confrontation with mortality was a common theme throughout all 3 interviews.	The results show that in order to provide ICD recipients with adequate care and improve early return to normal life, attention must be paid to the psychosocial aspects of their lives.	This research shows the perception of ICD recipients in general. It is impossible to prove that these perceptions can be ascribed to the ICD; these perceptions may also be ascribed to having survived cardiac arrest.
Godemann, F., & Butter, C. & Lampe, F. & Linden, M. & Werner, S. & Behrens, S. March, 2004 Berlin, Germany	93 patients with their first ICD implant in the past 1-6 years.	Cross-sectional quantitative design Patients completed the following questionnaires: the German version SF-36, the Frieberg Questionnaire on Disease Coping (short version-16), and the Franke's (German version) of the Derogatis' SCL-90-R Symptom Check Index.	Psychiatric symptoms like somatization and phobic anxieties have a considerable influence on the physical and psychological QoL in ICD patients.	Behavioral treatment procedures of phobic anxieties and somatization could improve QoL in ICD patients.	Missing 25% of patients who refused to participate.
Frizelle, D.J., Lewin, R., Kaye, G., Hargreaves, C., Hasney, K., Beaumont, N., Moniz-Cook, E. 2004 United Kingdom	Randomized Controlled Trial	A comprehensive 12 week cognitive-behavioural cardiac rehabilitation programme modified to meet the needs of this population. Baseline and outcome measures consisted of the following questionnaires: The Hospital Anxiety and Depression Scale(HADS), The ICD patient Total Concerns Questionnaire(TCQ), The MacNew Quality of Life after MI Questionnaire (constructed for this study), and the EuroQual	Statistically significant benefits from the 12-week programme were observed on all psychological and exercise ability outcome measures.	In a small-scale pilot study, a multidisciplinary, cognitive-behavioural, hospital-based cardiac rehab programme that included exercise training significantly reduced anxiety, depression and concerns, improved quality of life and increased the exercise capacity of the ICD patients involved in the study.	Small number of 21 participants. More than 30% of the notified potential participants did not reply to the inital contact, therefore some selection bias is possible.
Burns, J. & Serber, E. & Keim, S. & Sears, S. April, 2005 USA	238 total patients: ICD-N=58, ICD-AT-N=96, Pacemaker-N=84. 96 patients were ICD-AT patients already participating in the PASSAT study (Patient Atrial Shock Survey of Acceptance and Tolerance Study), 58 were ICD patients recruited from clinic, and 84 were pacemaker patients recruited from the Watson Outpatient EP Clinic in Lakeland, Fla.	This study sought to validate a new measure of patient acceptance of cardiac implantable devices called the Florida Patient Acceptance Survey (FPAS). Participants completed the following questionnaires: the FPAS, the SF-36 health survey, the Atrial Fibrillation Symptoms Severity Scale (AFSS), the Center for Epidemiological Studies-Depression Scale (CES-D), the State Trait Anxiety Inventory (STAI) and the Illness Intrusive Rating Scale (IIRS).	Evidence provided by the current research indicates that using the FPAS in conjunction with the SF-36 when measuring post-implantation quality of life may help providers determine if a psychosocial intervention would improve patients' acceptance of a device and subsequently, increase patients' health-related quality of life.	This initial psychometric investigation of the FPAS suggests that the FPAS may be useful in both clinical and research settings to assess patient acceptance of implantable cardiac devices.	Duration of time patients had their devices was not collected in all of the samples and therefore could not be compared. Reliance on self-report is another potential limitation. The ICD-AT patients were highlt selected and may not represent the average drug-refractory atrial fibrillation patient.
Sola, C., D.O. & Bostwick, M., M.D. February, 2005 USA	Literature review of ICD patients experiencing psychosocial effects from implantation	Systematic Literature Review a Medline Database Search yielded 42 journal articles which were reviewed. Terms utilized in the search were Implantable cardioverter-defibrillator, ICD, psychopathology, anxiety, depression and quality of life.	up to 38% of ICD recipients develop diagnosable anxiety disorders. The strongest correlate to anxiety is the frequency and recency of the ICD firing.	Large-scale randomized, prospective studies using validated structured interview tools rather than self-reported measures or unstructured assessments are needed to determine categorically which patients meet criteria for anxiety disorders before and after implantation.	The small sample size in most studies preclude adequate power to generate statistically significant findings. Because of their diversity, these studies cannot be readily combined meta-analytically to achieve statistical power. Thus, this review reflects the present inadequate state of knowledge about the psychological issues surrounding ICD implantation and its aftermath.
Dunbar, S., D.S.N., R.N. July, 2005 USA	Review of the Literature of ICD patients experiencing psychosocial responses to the device.	Systematic Review of the Literature She discusses briefly her own RCT comparing usual care ICD recipients with an intervention group receiving psychoeducational intervention, information and Cognitive Behavioral Therapy.	Anxiety, depression, pain and sleep disorders are frequently reported.	The theoretical formulations and the descriptive and experimental data published to date suggest approaches that may be effective for ICD recipients, such as interventions including education, use of therapeutic communication techniques, follow-up assessment and intervention and psychological approaches.	none reported or noted
Dougherty, C., & Thompson, E., & Lewis, F. November, 2005 USA	Usual care group- control group Intervention group received usual care plus a structured 8 week post-hospital telephone nursing intervention, in addition to 24/7 access to an expert cardiac nurse plus structured information..	2 group Randomized Controlled Trial	The 6 and 12 month benefits of the intervention were a reduction of reported PCA physical concerns, STAI anxiety and PCA2 fear of dying. The SCA-SE self confidence and knowledge to manage the ICD recovery were both enhanced at 6 and 12 months.	An education-psychological based telephone intervention delivered within the first 8 weeks after an ICD by expert cardiovascular nurses had significant sustained influence on physical and psychosocial outcomes at 6 and 12 months.	The randomization process resulted in more intervention subjects versus usual care received the ICD for out of hospital VF cardiac arrest, and were therefore slightly more physically impaired at the time they entered the study. We controlled for these differences in our analysis. We did not intervene with partners or spouses, so there is uncertainty whether living with a spouse or partner aids or impairs adjustment after receiving an ICD. The use of self-report; the inability to measure actual behavioral change. The questionnaire packet was burdensome, which resulted in some withdrawal from the study, therefore may have created bias in that the most cognitively intact and motivated individuals were able to complete them in a timely manner.
Sears, S. & Lewis, T. & Kuhl, E. & Conti, J. September-October, 2005 USA	88 patients who received their first ICD for a life-threatening ventricular arrhythmia. They were recruited from the EP clinic at Shands Hospital, Gainsville, Fla. and the EP clinic at Vanderbilt University, Nashville, TN.	Prospective Study: Meta-analysis patient assessment instruments were administered at the initial assessment, then again at 6-9 months and again at 12-15 months.	Pre-implant depression, trait anxiety, dispositional optimism and social support uniquely account for as much if not more of the variance in QoL outcomes as do age and ejection fraction.	Psychological characteristics were the most significant predictors of poor QoL at both follow-up times, results that are consistent with the ample literature that suggests that psychological traits like anxiety are valid predictors of QoL.	Subject group was demographically restricted to older, male, caucasian patients. Both the short and long-term follow-up intervals were marked by sizable attrition, which suggests that a self-selection bias took place such that participants with worse QoL were less likely to participate in follow-up. Patient participation in psychological intervention by private providers, support groups, etc. after ICD implantation was not assessed.
Pedersen, S. & VanDomberg, R. & Theuns, D. & Jordaens, L. & Erdman 2005 the Netherlands	Consecutive surviving patients ( n = 182, response rate = 82%) having had an ICD implanted between October 1998 and January 2003 at the Erasmus Medical Centre Rotterdam were asked to fill in the ICD Patient Concerns Questionnaire and the Hospital Anxiety and Depression Scale.	Cross-Sectional design	In conclusion, we found that ICD concerns were associated with an increased risk of anxiety and depressive symptoms irrespective of shocks. This finding suggests that we may need to expand our view of indicators of psychosocial adjustment in ICD patients. Large-scale prospective studies that include preimplantation and postimplantation assessments are now warranted to examine the relationship between shocks, concerns, and psychological morbidity.	Psychosocial interventions targeting the concerns that patients may have about their ICD are also required given our findings that concerns were a determinant of psychological morbidity independent of shocks	The nature of the design does not allow for the determination of cause and effect and also provides no information about fluctuations over time in concerns and psychological morbidity. We also had no information about previous psychiatric history and the use of psychotropic medication before implantation. Previous psychiatric history is a known predictor of future psychopathology. In addition, we could not make a distinction between appropriate and inappropriate shocks. Inappropriate shocks have been associated with more psychological distress, but this finding was based on only 25 patients, and the determination of appropriateness was based on the patient's subjective interpretation
Dickerson, S., & Wu, Y., & Kennedy, M. 2006 May-June USA	A convenience sample of all implantable cardioverter defibrillator recipients during a 10-year time frame from the Buffalo, New York metropolis were invited to participate. 112 Surveys were returned. 2 groups- those who attended support group, and those who did not.	A cross-sectional retrospective survey design, utilizing the Ferrans and Powers' Quality of Life Index: Cardiac Version and demographic questionnaire.	Anecdotally, the participants indicated positive comments about the support group: "the group has helped me to understand-the voice from experience can teach more than a book." Also, "I'd be lost without the support group, it is valuable for knowledge, understanding and just being with people with the same problem."	It is important for the CNS to contact the ICD recipients during hospitalization to make them aware of the service. Individuals may seek assistance in managing this issue through attendance at the support group as they provide an opportunity for sharing and learning	The ability to determine the effect of one intervention retrospectively is difficult. No before and after QLI scores were measured; therefore, a prospective study of QLI before and after intervention may offer more insight into this issue.

Comment(s)

Since the approval of the Implantable Cardioverter Defibrillator (ICD) in 1985, it has become the "gold standard" in treatment of life-threatening arrhythmias. It far surpasses tolerability compared to anti-arrhythmic medications. Advancement in technology related to the ICD has resulted in a less-invasive implantation no longer requiring thoracotomy, anesthesia or a CT surgeon. The size of the device is now 83% smaller than the original ones used in the early 1980s, and they are now functioning as pacemakers, cardioverters and defibrillators. They are not only being utilized in ventricular dysrhythmias, but now have an evidence-based clinical use in prevention of life-threatening dysrhythmias in patients with Atrial Tachycardia, Atrial Fibrillation and Congested Heart Failure. Through prolongation of life we should see an improvement in Quality of Life and device acceptance, but that is not the case for many ICD recipients. The literature I have reviewed details various statistics regarding post-implantation anxiety, depression and adjustment issues, but all of the studies have a common theme: Adjustment to the ICD implantation results in some degree of anxiety, fear and physical restriction, and that lack of support, education and preparation of living with the device is a major contributor to these bio-psychosocial responses. The solution to these bio-psychosocial issues related to implantation of the ICD clearly needs to be planned, executed and followed closely, from the time the device is placed until after the patient is discharged from the hospital. There should be an assessment done by a Psyche Liasion prior to discharge. Discharge planning should include educational materials not only related to the device, but also related to how to live with the device. That is, how to increase their exercise, how to sleep, how and when they can drive, have sexual relations, etc. The patient should have a cardiac case manager available for questions, and have access to a support group or counselor for Cognitive Behavior Therapy should the need arise. They should also be referred to a Cardiac Rehab Center close to their home.

Clinical Bottom Line

Bio-psychosocial issues related to the implantation of an ICD require intervention. This intervention needs to be initiated while the patient is still in the hospital, prior to discharge planning. A Psychiatric assessment with a broad and a specific measure should be utilized to capture early signs of poor adjustment to the device, and an intervention should be planned including Cardiac Rehab, counseling with possible Cognitive Behavior Therapy, and access to educational tools to aid in living with a cardiac device. Assessment of social support access will also be beneficial, and including family in discharge planning will be supportive. Access to the cardiac case management staff for questions has also been determined to be beneficial for this population. A good follow-up plan, education and intervention should provide the tools for healthy adjustment to the ICD.

References

1. Lisa Smith, Ph.D. Cognitive-Behavioral Treatment of Panic Disorder With Agoraphobia Triggered by AICD Implant Activity The Academy of Psychosomatic Medicine September-October, 1998. Volume 39, 5, pp. 474-477.
2. Pauli, P. Anxiety in Patients With an Automatic Implantable Cardioverter Defibrillator: What Differentiates Them From Panic Patients? Lippincott Williams & Wilkins Psychosomatic Medicine Volume 61(1), Jan/Feb 1999, pp. 69-76
3. Wallace, R., M.S. Predictors of Quality of Life in Long-term Recipients of Implantable Cardioverter Defibrillators Journal of Cardiopulmonary Rehabilitation: Lippincott Williams & Wilkins 2002 Jul-Aug;22(4):278-81
4. Sears, S., Ph.D. Quality of Life and Psychological Functioning of ICD Patients Heart Online 2002;87:488-493
5. Kamphuis, H. Implantable Cardioverter Defibrillator Recipients: Quality of Life in Recipients With and Without ICD Shock Delivery Europace 2003, 5(4):381-389
6. Tagney, J. Exploring the patient's experiences of learning to live with an implantable cardioverter defibrillator (ICD) from one UK centre: a qualitative study. European Journal of Cardiovascular Nursing: Elsevier 2003 Sep;2(3):195-203.
7. Kamphuis, H., MSc, R.N. ICD: a qualitative study of patient experience the first year after implantation Journal of Clinical Nursing: Blackwell Publishing Ltd. 2004:13, 1008-1016
8. Godemann, F. Determinants of the quality of life (qol) in patients with an implantable cardioverter/defibrillator (ICD). Quality of Life Research: Kluwer Academic Publishers 2004:13:411-416
9. Frizelle, D.J. Cognitive-behavioural rehabilitation programme for patients with an implanted cardioverter defibrillator: A pilot study. British Journal of Health Psychology: The British Psychological Society 2004:, 9, 381-392
10. Sears, S. Measuring Patient Acceptance of Implantable Cardiac Device Therapy: Initial Psychometric Investigation of the Florida Patient Acceptance Survey Journal of Cardiovascular Electrophysiology: Blackwell Publishing Ltd. April, 2005, 16, No.4,pp. 384-390
11. Bostwick, M., M.D. Implantable Cardioverter-Defibrillators, Induced Anxiety, and Quality of Life Mayo Clinic Proceedings: 2005;80(2):232-237
12. Dunbar, S., D.S.N., R.N. Psychosocial Issues of Patients With Implantable Cardioverter Defibrillators American Journal of Critical Care: July, 2005(14):4:pp.294-303.
13. Dougherty, C. Long-Term Outcomes of a Telephone Intervention After an ICD Pacing Clinical Electrophysiology 2005;(28):1157-1167
14. Sears, S. Predictors of Quality of Life in Patients With Implantable Cardioverter Defibrillators Psychosomatics September-October, 2005(46):5:451-457
15. Pedersen, S. Concerns About the Implantable Cardioverter Defibrillator: A Determinant of Anxiety and Depressive Symptoms Independent of Experienced Shocks Am Heart Journal : Mosby, Inc. 2005; 149 (4): 664-669.
16. Dickerson, S., D.N.S., R.N. A CNS-Facilitated ICD Support Group: A Clinical Project Evaluation Clinical Nurse Specialist: Lippincott Williams and Wilkins 2006 May-Jun; 20(3) :146-53