Abstract
Purpose
ICDs can improve survival in at-risk patients but no consensus exists with respect to their impact on health-related quality of life (QOL). Moreover, the data are unclear on QOL benefits in specific patient subgroups. We sought to analyze, in the INTRINSIC RV ICD trial population, health-related QOL longitudinally following ICD implant and consider impact of age, gender, and ICD shocks on QOL by employing a global measure of health-related QOL.
Methods
One thousand five hundred thirty patients had an ICD implanted. One week after implant (n = 1461), 988 patients were randomized to DDDR with AV search hysteresis (n = 502) or VVI (n = 486) programming. QOL data, using the SF-36 short form, were obtained for the 1461 patient cohort, irrespective of randomization status, at baseline and prospectively for 1 year following ICD implant.
Results
Longitudinal mixed-effect analyses revealed significant improvements from baseline across all SF-36 subscales and component scores for the overall study cohort. Women had a substantially lower QOL at baseline, although their improvement after implant was similar to men. Patients <50 years scored consistently worse at baseline but experienced the greatest QOL improvement versus other age groups. Patients with higher NYHA class, angina, and diabetes had greater QOL improvements. There was no significant difference in QOL between patients with and without ICD shocks.
Conclusions
Our findings indicate that QOL was reportedly better post-implant and suggest that benefits associated with ICD implantation go beyond the direct treatment of arrhythmias, with benefits seen across genders and different age groups. These results further highlight that ICD implantation, in and of itself, does not reduce QOL.
Similar content being viewed by others
Abbreviations
- ICD:
-
Implantable cardioverter defibrillator
- HF:
-
Heart failure
- RV:
-
Right ventricle
- AVSH:
-
AV search hysteresis
- QOL:
-
Quality of life
- SF-36:
-
Medical Outcome Study 36-item Short Form Survey Instrument
References
Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225–37.
Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346(12):877–83.
Exner DV, Pinski SL, Wyse DG, Renfroe EG, Follmann D, Gold M, et al. Electrical storm presages nonsudden death: the antiarrhythmics versus implantable defibrillators (AVID) trial. Circulation. 2001;103(16):2066–71.
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(4):384–90.
Oldridge NB. Outcome assessment in cardiac rehabilitation. Health-related quality of life and economic evaluation. J Cardpulm Rehabil. 1997;17(3):179–94.
Oldridge N, Gottlieb M, Guyatt G, Jones N, Streiner D, Feeny D. Predictors of health-related quality of life with cardiac rehabilitation after acute myocardial infarction. J Cardpulm Rehabil. 1998;18(2):95–103.
McEntee DJ, Badenhop DT. Quality of life comparisons: gender and population differences in cardiopulmonary rehabilitation. Heart Lung. 2000;29(5):340–7.
Sears Jr SF, Todaro JF, Lewis TS, Sotile W, Conti JB. Examining the psychosocial impact of implantable cardioverter defibrillators: a literature review. Clin Cardiol. 1999;22(7):481–9.
Steinke EE. Sexual concerns of patients and partners after an implantable cardioverter defibrillator. Dimens Crit Care Nurs. 2003;22(2):89–96.
Sears Jr SE, Conti JB. Understanding implantable cardioverter defibrillator shocks and storms: medical and psychosocial considerations for research and clinical care. Clin Cardiol. 2003;26(3):107–11.
Serber ER, Sears SF, Sotile RO, Burns JL, Schwartzman DS, Hoyt RH, et al. Sleep quality among patients treated with implantable atrial defibrillation therapy: effect of nocturnal shock delivery and psychological distress. J Cardiovasc Electrophysiol. 2003;14(9):960–4.
Lemon J, Edelman S, Kirkness A. Avoidance behaviors in patients with implantable cardioverter defibrillators. Heart Lung. 2004;33(3):176–82.
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(5):589–94.
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(2):282–9.
Sears SF, Matchett M, Conti JB. Effective management of ICD patient psychosocial issues and patient critical events. J Cardiovasc Electrophysiol. 2009;20(11):1297–304.
Mark DB, Anstrom KJ, Sun JL, Clapp-Channing NE, Tsiatis AA, Davidson-Ray L, et al. Quality of life with defibrillator therapy or amiodarone in heart failure. N Engl J Med. 2008;359(10):999–1008.
Sears SF, Kirian K. Shock and patient-centered outcomes research: is an ICD shock still a critical event? Pacing Clin Electrophysiol. 2010;33(12):1437–41.
Morken IM, Isaksen K, Karlsen B, Norekval TM, Bru E, Larsen AI. Shock anxiety among implantable cardioverter defibrillator recipients with recent tachyarrhythmia. Pacing Clin Electrophysiol. 2012;35(11):1369–76.
Sears SF, Whited A, Volosin KJ. Enhancing patient care by estimation and discussion of risk for ICD shock. Pacing Clin Electrophysiol. 2015;38(1):1–7.
Olshansky B, Day JD, Moore S, Gering L, Rosenbaum M, McGuire M, et al. Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study. Circulation. 2007;115(1):9–16.
Ware J. SF-36 Health Survey: manual and interpretation guide. Boston, Mass: Nimrod Press; 1993.
Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics. 1999;15(2):141–55.
Steinberg JS, Joshi S, Schron EB, Powell J, Hallstrom A, McBurnie M, et al. Psychosocial status predicts mortality in patients with life-threatening ventricular arrhythmias. Heart Rhythm. 2008;5(3):361–5.
Amiaz R, Asher E, Rozen G, Czerniak E, Glikson M, Weiser M. Do implantable cardioverter defibrillators contribute to new depression or anxiety symptoms? A retrospective study. Int J Psychiatry Clin Pract. 2016;20(2):101–5.
Thylen I, Dekker RL, Jaarsma T, Stromberg A, Moser DK. Characteristics associated with anxiety, depressive symptoms, and quality-of-life in a large cohort of implantable cardioverter defibrillator recipients. J Psychosom Res. 2014;77(2):122–7.
Falcoz PE, Chocron S, Laluc F, Puyraveau M, Kaili D, Mercier M, et al. Gender analysis after elective open heart surgery: a two-years comparative study of quality of life. Ann Thorac Surg. 2006;81(5):1637–43.
Bhatia SC, Bhatia SK. Depression in women: diagnostic and treatment considerations. Am Fam Physician. 1999;60(1):225–34. 39–40.
Pigott T. Anxiety disorders. In: Kornstein S, Clayton AH, editors. Women’s mental health: a comprehensive textbook. New York: Guilford Press; 2002.
Walker RL, Campbell KA, Sears SF, Glenn BA, Sotile R, Curtis AB, et al. Women and the implantable cardioverter defibrillator: a lifespan perspective on key psychosocial issues. Clin Cardiol. 2004;27(10):543–6.
Luderitz B, Jung W, Deister A, Marneros A, Manz M. The quality of life after the implantation of a cardioverter/defibrillator in malignant arrhythmias. Dtsch Med Wochenschr. 1993;118(9):285–9.
Dubin AM, Batsford WP, Lewis RJ, Rosenfeld LE. Quality-of-life in patients receiving implantable cardioverter defibrillators at or before age 40. Pacing Clin Electrophysiol. 1996;19(11 Pt 1):1555–9.
Sears Jr SF, Burns JL, Handberg E, Sotile WM, Conti JB. Young at heart: understanding the unique psychosocial adjustment of young implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2001;24(7):1113–7.
Juenger J, Schellberg D, Kraemer S, Haunstetter A, Zugck C, Herzog W, et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart. 2002;87(3):235–41.
Dougherty CM, Dewhurst T, Nichol WP, Spertus J. Comparison of three quality of life instruments in stable angina pectoris: Seattle angina questionnaire, short form health survey (SF-36), and quality of life index-cardiac version III. J Clin Epidemiol. 1998;51(7):569–75.
Wilkoff BL, Williamson BD, Stern RS, Moore SL, Lu F, Lee SW, et al. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol. 2008;52(7):541–50.
Sears SF, Whited A, Koehler J, Gunderson B. Examination of the differential impacts of antitachycardia pacing vs. shock on patient activity in the EMPIRIC study. Europace. 2015;17(3):417–23.
Tomzik J, Koltermann KC, Zabel M, Willich SN, Reinhold T. Quality of life in patients with an implantable cardioverter defibrillator: a systematic review. Front Cardiovasc Med. 2015;2:34.
Pauli P, Wiedemann G, Dengler W, Blaumann-Benninghoff G, Kuhlkamp V. Anxiety in patients with an automatic implantable cardioverter defibrillator: what differentiates them from panic patients? Psychosom Med. 1999;61(1):69–76.
Sears Jr SF, Conti JB. Quality of life and psychological functioning of ICD patients. Heart. 2002;87(5):488–93.
Acknowledgments
The authors thank the INTRINSIC RV patients, investigators, and institutions for their participation.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Sources of funding
This study was funded by Boston Scientific CRM.
Rights and permissions
About this article
Cite this article
Gopinathannair, R., Lerew, D.R., Cross, N.J. et al. Longitudinal changes in quality of life following ICD implant and the impact of age, gender, and ICD shocks: observations from the INTRINSIC RV trial. J Interv Card Electrophysiol 48, 291–298 (2017). https://doi.org/10.1007/s10840-017-0233-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10840-017-0233-y