Psychological effects of implantable cardioverter-defibrillator leads under advisory

PACE - Pacing and Clinical Electrophysiology

Volumn 34, Issue 6, 2011, Pages 694-699

  Heatherly, Steven J ^a   Simmons, Tony ^a   Fitzgerald, David M ^a   Mitchell, Mark ^b  

^a WAKE FOREST UNIVERSITY HEALTH SCIENCES   (United States)

^b FORSYTH MEDICAL CENTER   (United States)

Author keywords

Medtronic recalled ICD; psychology; recalled defibrillators

Indexed keywords

ADVISORY COMMITTEE; AGED; ARTICLE; CONTROLLED STUDY; DEFIBRILLATOR; DEMOGRAPHY; DISTRESS SYNDROME; FEMALE; GRADUATE; HIGH SCHOOL GRADUATE; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PSYCHOLOGICAL ASPECT; QUESTIONNAIRE; SHOCK;

AGED; DEFIBRILLATORS, IMPLANTABLE; ELECTRODES, IMPLANTED; EQUIPMENT FAILURE; FEMALE; HUMANS; MALE; NORTH CAROLINA; PREVALENCE; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; RISK FACTORS; STRESS, PSYCHOLOGICAL;

EID: 79958167521     PISSN: 01478389     EISSN: 15408159     Source Type: Journal    
DOI: 10.1111/j.1540-8159.2011.03046.x     Document Type: Article

References (32)

1. Glikson M, Friedman PA,. The implantable cardioverter defibrillator. Lancet 2001; 357: 1107-1117. (Pubitemid 32322546)
2. Sears SF, Todaro JF, Lewis TS, Sotile W, Conti JB,. Examining the psychosocial impact of implantable cardioverter defibrillators: A literature review. Clin Cardiol 1999; 22: 481-489. (Pubitemid 29302759)
3. Thomas SA, Friedmann E, Kao CW, Inguito P, Metcalf M, Kelley FJ, Gottlieb SS,. Quality of life and psychological status of patients with implantable-cardioverter defibrillators. Am J Crit Care 2006; 15: 389-398. (Pubitemid 44859179)
4. Schron E, Exner D, Yao Q, Jenkins L, Steinberg J, Cook J, Kutalek S, 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: 589-594. (Pubitemid 34123433)
5. Irvine J, Dorian P, Baker B, O'Brien BJ, Roberts R, Gent M, Newman D, et al,. Quality of life in the Canadian implantable defibrillator study (CIDS). Am Heart J 2002; 144: 282-290.
6. Namerow PB, Firth BR, Heywood GM, Windle JR, Parides MK,. Quality of life six months after CABG surgery in patients randomized to ICD versus no ICD therapy: Findings from the CABG patch trial. Pacing Clin Electrophsiol 1999; 22: 1305-1313. (Pubitemid 29485030)
7. Kamphuis HC, de Leeuw JR, Derksen R, Hauer RN, Winnubst JA,. Implantable cardioverter defibrillator recipients: Quality of life in recipients with and without ICD shock delivery: A prospective study. Europace 2003; 5: 381-389. (Pubitemid 37336967)
8. Kuhl EA, Dixit NK, Walker RL, Conti JB, Sears SF,. Measurement of patient fears about implantable cardioverter defibrillator shock: An initial evaluation of the Florida Shock Anxiety Scale. Pacing Clin Electrophysiol 2006; 29: 614-618. (Pubitemid 43886613)
9. Godemann F, Butter C, Lampe F, Linden M, Werner S, Behrens S,. Determinants of the quality of life (QoL) in patients with an implantable cardioverter-defibrillator (ICD). Qual Life Res 2004; 13: 411-416. (Pubitemid 38392269)
10. Francis J, Johnson B, Niehaus M,. Quality of life in patients with implantable cardioverter defibrillators. Indian Pace J Electrophysiol 2006; 6: 173-181. (Pubitemid 44027597)
11. Sears SF, Lewis TS, Kuhl EA, Conti JB,. Predictors of quality of life in patients with implantable cardioverter defibrillators. Psychosomatics 2005; 46: 451-457. (Pubitemid 46173204)
12. Whang W, Albert CM, Sears SF Jr, Lampert R, Conti JB, Wang PJ, Singh JP, et al,. Depression as a predictor for appropriate shocks among patients with implantable cardioverter defibrillators: Results from the Triggers of Ventricular Arrhythmias (TOVA) study. J Am Coll Cardiol 2005; 4: 1090-1095. (Pubitemid 40432444)
13. Pedersen SS, van Domburg RT, Theuns DA, Jordaens L, Erdman RA,. Concerns about the implantable cardioverter defibrillator: A determinant of anxiety and depressive symptoms independent of experienced shocks. Am Heart J 2005; 149: 664-669.
14. Lüderitz B, Jung W, Deister A, Marneros A, Manz M,. Patient acceptance of the implantable cardioverter defibrillator in ventricular tachyarrhythmias. Pacing Clin Electrophysiol 1993; 16: 1815-1821. (Pubitemid 23277772)
15. Lampert R, Joska T, Burg MM, Batsford WP, McPherson CA, Jain D,. Emotional and physical precipitants of ventricular arrhythmia. Circulation 2006; 106: 1800-1805.
16. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM,. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001; 286: 793-799. (Pubitemid 33015572)
17. Danik SB, Mansour M, Singh J, Reddy VY, Ellinor PT, Milan D, Heist EK, Increased incidence of subacute lead perforation noted with an implantable cardioverter-defibrillator. Heart Rhythm 2007; 4: 439-442. (Pubitemid 46610410)
18. Urgent Medical Device Information. Sprint Fidelis Lead Patient Management Physician Letter. Minneapolis, MN, Medtronic, 2007.
19. Kallinen LM, Hauser RG, Lee KW, Almquist AK, Katsiyiannis WT, Tang CY, Melby DP, et al,. Failure of impendance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2008; 5: 775-779.
20. 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: 1006-1011.
21. 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 (part 2): 293-301. (Pubitemid 43799743)
22. Cuculi F, Herzig W, Kobza R, Erne P,. Psychological distress in patients with ICD recall. Pacing Clin Electrophysiol 2006; 29: 1261-1265. (Pubitemid 44707110)
23. Undavia M, Goldstein NE, Cohen P, Sinthawanarong K, Singson M, Bhutani D, Munson T,. Impact of cardioverter-defibrillator recalls on patient's anxiety, depression and quality of life. Pacing Clin Electrophysiol 2008; 31: 1411-1418.
24. 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.
25. Keren A, Sears S, Nery P, Shaw J, Green M, Lemery R, Gollob M, et al,. Psychological adjustment in ICD patients living with advisory fidelis leads. J Cardiovasc Electrophysiol 2011; 22: 57-63.
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: 1168-1177.
27. Krahn AD, Champagne J, Healey JS, Cameron D, Simpson C, Thibault B, Mangat I, et al,. Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: A report from the Canadian Heart Rhythm Society Device Advisory Committee. Heart Rhythm 2009; 5: 639-642.
28. Sears S, Conti J,. Understanding implantable cardioverter defibrillator shocks and storms: Medical and psychosocial considerations for research and clinical care. Clin Cardiol 2003; 26: 107-111. (Pubitemid 36330858)
29. Pederson S, Sears S, Burg M, Van Den Broek KC,. Does ICD indication affect quality of life and levels of distress. Pacing Clin Electrophysiol 2009; 2: 153-156.
30. Pederson S, van Domburg, RT, Theuns D, Jordaens L, Erdman R,. Concerns about the implantable cardioverter defibrillator: A determinant of anxiety and depressive symptoms independent of experienced shocks. Am Heart J 2005; 149: 664-669.
31. Gibso 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: 540-544. (Pubitemid 351775302)
32. Fisher JD, Koulogiannis KP, Lewallen L, Katz D, Kim DG, Ferrick KJ, Gross JN, et al,. The psychological impact of ICD recalls and the durable positive effects of counseling. Pacing Clin Electrophysiol 2009; 32: 1012-1016.