Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification

Europace

Volumn 13, Issue 9, 2011, Pages 1292-1298

  Pedersen, Susanne S ^a,b   Versteeg, Henneke ^a   Nielsen, Jens C ^c   Mortensen, Peter T ^c   Johansen, Jens B ^b,d  

^a TILBURG UNIVERSITY   (Netherlands)

^b ODENSE UNIVERSITY HOSPITAL   (Denmark)

^c AARHUS UNIVERSITY HOSPITAL   (Denmark)

^d Danish ICD Register ^*  (Denmark)

Author keywords

Anxiety; Device advisory; Health status; Implantable cardioverter defibrillator; Patient reported outcomes; Sprint Fidelis

Indexed keywords

ADULT; AGED; ANXIETY; ARTICLE; CONTROLLED STUDY; DEFIBRILLATOR; DENMARK; DEPRESSION; FEMALE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; MENTAL HEALTH; PRIORITY JOURNAL;

AGED; DEFIBRILLATORS, IMPLANTABLE; DENMARK; ELECTRODES, IMPLANTED; EQUIPMENT FAILURE; FEMALE; HUMANS; MALE; MIDDLE AGED; SELF REPORT; TREATMENT OUTCOME;

EID: 80052192441     PISSN: 10995129     EISSN: 15322092     Source Type: Journal    
DOI: 10.1093/europace/eur157     Document Type: Article

References (35)

1. Epstein AE. Benefits of the implantable cardioverter-defibrillator. J Am Coll Cardiol 2008;52:1122-7.
2. Nery PB, Fernandes R, Nair GM, Sumner GL, Ribas CS, Divakara Menon SM et al. Device-related infection among patients with pacemakers and implantable defibrillators: Incidence, risk factors, and consequences. J Cardiovasc Electrophysiol 2010;21:786-790.
3. Faulknier BA, Traub DM, Aktas MK, Aguila A, Rosero S, Daubert JP et al. Timedependent risk of Fidelis lead failure. Am J Cardiol 2010;105:95-9.
4. Ellenbogen KA, Wood MA, Swerdlow CD. The Sprint Fidelis lead fracture story: What do we really know and where do we go from here? Heart Rhythm 2008;5: 1380-1.
5. Carlson MD, Wilkoff BL, Maisel WH, Ellenbogen KA, Saxon LA, Prystowsky EN et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm 2006;3:1250-73. (Pubitemid 44464165)
6. Cannom DS, Fisher J. The Fidelis recall: How much pressure can the ICD world bear? Pacing Clin Electrophysiol 2008;31:1233-5.
7. Feder BJ. Defibrillators are lifesaver, but risks give pause. New York Times, 2008.
8. Pedersen SS, van den Berg M, Theuns DA. A viewpoint on the impact of device advisories on patient-centered outcomes. Pacing Clin Electrophysiol 2009;32: 1006-11.
9. van den Broek KC, Denollet J, Nyklicek I, van der Voort PH. Psychological reaction to potential malfunctioning of implantable defibrillators. Pacing Clin Electrophysiol 2006;29:953-6. (Pubitemid 44392882)
10. Sneed NV, Finch NJ, Leman RB. The impact of device recall on patients and family members of patients with automatic implantable cardioverter defibrillators. Heart Lung 1994;23:317-22. (Pubitemid 24242841)
11. Undavia M, Goldstein NE, Cohen P, Sinthawanarong K, Singson M, Bhutani D et al. Impact of implantable cardioverter-defibrillator recalls on patients' anxiety, depression, and quality of life. Pacing Clin Electrophysiol 2008;31:1411-8.
12. Gibson DP, Kuntz KK, Levenson JL, Ellenbogen KA. Decision-making, emotional distress, and quality of life in patients affected by the recall of their implantable cardioverter defibrillator. Europace 2008;10:540-4. (Pubitemid 351775302)
13. Cuculi F, Herzig W, Kobza R, Erne P. Psychological distress in patients with ICD recall. Pacing Clin Electrophysiol 2006;29:1261-5. (Pubitemid 44707110)
14. Birnie DH, Sears SF, Green MS, Lemery R, Gollob MH, Amyotte B. No long-term psychological morbidity living with an implantable cardioverter defibrillator under advisory: The Medtronic Marquis experience. Europace 2009;11:26-30.
15. Heatherly S, Simmons T, Fitzgerald D, Mitchelle M. Psychological effects of recalled implantable cardioverter-defibrillators. Pacing Clin Electrophysiol 2011;34: 694-9.
16. Keren A, Sears SF, Nery P, Shaw J, Green MS, Lemery R et al. Psychological adjustment in ICD patients living with advisory Fidelis leads. J Cardiovasc Electrophysiol 2011;22:57-63.
17. Johansen JB, Pedersen SS, Spindler H, Andersen K, Nielsen JC, Mortensen PT. Symptomatic heart failure is the most important clinical correlate of impaired quality of life, anxiety, and depression in implantable cardioverter-defibrillator patients: A single-centre, cross-sectional study in 610 patients. Europace 2008; 10:545-51. (Pubitemid 351775296)
18. Pedersen SS, Spindler H, Johansen JB, Mortensen PT. Clustering of poor device acceptance and Type D personality is associated with increased distress in Danish cardioverter-defibrillator patients. Pacing Clin Electrophysiol 2009;32: 29-36.
19. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361-70. (Pubitemid 13098606)
20. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002;52: 69-77. (Pubitemid 34192886)
21. Herrmann C. International experiences with the Hospital Anxiety and Depression Scale-a review of validation data and clinical results. J Psychosom Res 1997;42:17-41. (Pubitemid 27095712)
22. Frizelle DJ, Lewin B, Kaye G, Moniz-Cook ED. Development of a measure of the concerns held by people with implanted cardioverter defibrillators: The ICDC. Br J Health Psychol 2006;11:293-301. (Pubitemid 43799743)
23. Pedersen SS, van Domburg RT, Theuns DAMJ, Jordaens L, Erdman RAM. Concerns about the implantable cardioverter defibrillator: A determinant of anxiety and depressive symptoms independent of experienced shocks. Am Heart J 2005;149:664-9.
24. Pedersen SS, van den Broek KC, Erdman RAM, Jordaens L, Theuns DAMJ. Pre implantation ICD concerns and Type D personality increase the risk of mortality in patients with an implantable cardioverter defibrillator. Europace 2010;12: 1446-52.
25. Burns JL, Serber ER, Keim S, Sears SF. Measuring patient acceptance of implantable cardiac device therapy: Initial psychometric investigation of the Florida Patient Acceptance Survey. J Cardiovasc Electrophysiol 2005;16:384-90.
26. Pedersen SS, Spindler H, Johansen JB, Mortensen PT, Sears SF. Correlates of patient acceptance of the cardioverter defibrillator: Cross-validation of the Florida Patient Acceptance Survey in Danish patients. Pacing Clin Electrophysiol 2008;31:1168-77.
27. Rector TS, Kubo SH, Cohn JN. Patients' self-assessment of their congestive heart failure (Part 2). Content, reliability, and validity of a new measure: The Minnesota Living with Heart Failure Questionnaire. Heart Failure 1987;10:198-209.
28. Ware JE, Sherbourne CD. The MOS 36-item Short-Form Health Survey. Med Care 1993;30:473-83.
29. Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol 1998;51:1055-68. (Pubitemid 28527161)
30. Fisher JD, Koulogiannis KP, Lewallen L, Katz D, Kim SG, Ferrick KJ et al. The psychological impact of implantable cardioverter-defibrillator recalls and the durable positive effects of counseling. Pacing Clin Electrophysiol 2009;32:1012-6.
31. Stutts LA, Conti JB, Aranda JM Jr., Miles WM, Burkart TA, Sears SF. Patient evaluation of ICD recall communication strategies: A vignette study. Pacing Clin Electrophysiol 2007;30:1105-11. (Pubitemid 47300650)
32. Kirian KB, Sears SF, Shea JB. Cardiology patient pages. How to respond to an implantable cardioverter-defibrillator recall. Circulation 2009;119:e189-91.
33. Newall EG, Lever NA, Prasad S, Hornabrook C, Larsen PD. Psychological implications of ICD implantation in a New Zealand population. Europace 2007;9:20-4. (Pubitemid 46157948)
34. Pedersen SS, Sears SF, Burg MM, Van Den Broek KC. Does ICD indication affect quality of life and levels of distress? Pacing Clin Electrophysiol 2009;32:153-6.
35. Hevey D, McGee HM, Horgan J. Relationship of initial level of distress to changes in health-related quality of life during cardiac rehabilitation or usual care. Psychosom Med 2007;69:793-7. (Pubitemid 350287487)