Pacemaker implantation and quality of life in the Mode Selection Trial (MOST)
Received 22 September 2005; accepted 24 February 2006. published online 15 March 2006.
Background
Dual-chamber pacemakers restore AV synchrony compared with ventricular pacemakers, but the effects on health-related quality of life (QOL) are uncertain.
Objectives
The purpose of this study was to assess the effect of pacemaker implantation, clinical factors, and pacing mode on QOL.
Methods
The Mode Selection Trial (MOST) randomized 2,010 patients with sinus node dysfunction to rate-modulated right ventricular (VVIR) or dual-chamber (DDDR) pacing. A longitudinal analysis of serial QOL measures (Short Form-36 [SF-36], Specific Activity Scale, and time trade-off utility) was performed. In patients who crossed over from VVIR to DDDR because of severe pacemaker syndrome, the last known QOL prior to crossover was carried forward.
Results
Pacemaker implantation resulted in substantial improvement in almost all QOL measures. Subjects 75 years or older experienced significantly less improvement in functional status and physical component summary scores than did younger subjects. In longitudinal analyses of the effect of pacing mode on QOL, significant improvement in three SF-36 subscales was observed with DDDR pacing compared with VVIR pacing: role physical [62.8 points (95% confidence interval [CI] 60.2, 65.5) vs 56.4 (95% CI 53.7, 59.1)], role emotional [85.0 (95% CI 82.9, 87.0) vs 81.9 (95% CI 79.9, 84.0)], and vitality [51.8 (95% CI 50.3, 53.3) vs 49.3 (95% CI 47.8, 50.7)], but not in other SF-36 subscales, the Specific Activity Scale, or utilities. The gains in QOL were larger than the declines associated with 1 year of aging but smaller than those associated with heart failure.
Conclusion
Pacemaker implantation improved health-related QOL. The mode selected was associated with much smaller, but significant, improvements in several domains, particularly role physical function.
aDepartment of Medicine, the University of California, San Francisco, San Francisco, California
bDepartment of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
cDivision of Cardiology, Mount Sinai Medical Center, Miami Heart Institute, Miami Beach, Florida
dDepartment of Medicine, David Geffen School of Medicine at University of California, Los Angeles, California
eNational Heart, Lung, and Blood Institute, Bethesda, Maryland
fDuke Clinical Research Institute and Duke University School of Medicine, Durham, North Carolina.
Address reprint requests and correspondence: Dr. Kirsten E. Fleischmann, UCSF Medical Center, 505 Parnassus Avenue, Box 0124, San Francisco, California 94030.
This study was supported by Grants UO1-HL-49804 to Dr. Lamas, UO1-HL-53973 to Dr. Lee, and UO1-HL-55981 to Dr. Goldman from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH). Medtronic, Inc., Guidant Corporation, and St. Jude Medical donated support for study meetings and ancillary studies. Dr. Mangione’s work on this project is partially supported by the Resource Centers for Minority Aging Research/Center for Health Improvement of Minority Elderly (RCMAR/CHIME), funded by Grant P30-AG-21684 from the National Institute of Aging of the NIH. Dr. Lamas reports receiving grants and acting as a consultant and speaker for Medtronic and Astra-Zeneca; consulting for Guidant; and serving as a speaker and grantee for Novartis and a speaker for Glaxo-Smith-Kline. Dr. Goldman serves on the Advisory Board of Proventys but holds no stock or options. Dr. Fleischmann participates in CME and QI initiatives sponsored by Pfizer.
ABSTRACT