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Pacemaker Selection in the Elderly - PASE
Description:
The Pacemaker Selection in the Elderly study was a 30-month, single-blind, randomized, controlled comparison of ventricular pacing and dual-chamber pacing in 407 patients 65 years of age or older in 29 centers.
Hypothesis:
Dual chamber pacemakers are more complex and expensive than single chamber pacemakers, but are also more physiologic. It is unknown which can provide better outcomes.
Study Design
Study Design:
Patients Enrolled: 407
Mean Follow Up: 550 days (average)
Mean Patient Age: >65
Female: 40
Mean Ejection Fraction: 25% had depressed ejection fraction
Patient Populations:
65 years of age or older Sinus rhythm Required a permanent pacemaker for the prevention or treatment of bradycardia
Exclusions:
Patients were excluded from the study if they could not participate in the quality-of-life assessments, had clinically overt congestive heart failure at the time of implantation, had had atrial fibrillation without any documented sinus mechanism for more than six months, had serious noncardiac illness, or had inadequate atrial-capture or sensing thresholds.
Primary Endpoints:
Health-related quality of life as measured by the 36-item Medical Outcomes Study Short-Form General Health Survey.
Drug/Procedures Used:
Intermedics dual-chamber rate-adaptive pacemakers (models 294-03, 293-03, 294-03R, and 294-05) were implanted and were randomly programmed to VVIR versus DDDR modes.
Principal Findings:
Quality of life improved significantly after pacemaker implantation (P<0.001), but there were no differences between the two pacing modes in either the quality of life or prespecified clinical outcomes (including cardiovascular events or death). However, 53 patients assigned to ventricular pacing (26 percent) were crossed over to dual-chamber pacing because of symptoms related to the pacemaker syndrome. Patients with sinus-node dysfunction, but not those with atrioventricular block, had moderately better quality of life and cardiovascular functional status with dual-chamber pacing than with ventricular pacing. Trends of borderline statistical significance in clinical end points favoring dual-chamber pacing were observed in patients with sinus-node dysfunction, but not in those with atrioventricular block.
Interpretation:
The implantation of a permanent pacemaker improves health-related quality of life. The quality-of-life benefits associated with dual-chamber pacing as compared with ventricular pacing are observed principally in the subgroup of patients with sinus-node dysfunction
References:
N Engl J Med 1998;338:1097-104
Keywords: Atrioventricular Block, Cardiac Pacing, Artificial, Quality of Life, Dichlorodiphenyldichloroethane, Sick Sinus Syndrome, Bradycardia, Single-Blind Method
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