Cardiovascular Diseases Clinical Trial
To determine if dual chamber rate-modulated pacing (DDDR) in patients with sick sinus syndrome is superior to single chamber pacing (VVIR) with respect to subsequent frequency of adverse clinical events such as stroke, quality of life and function, and cost effectiveness.
BACKGROUND:
Permanent pacing is estimated to cost one billion dollars annually in health care costs in
the United States. Initially, pacing was primarily confined to ventricular pacing with
limited sensing, programming and pacing capacity. Tremendous growth has occurred in pacing
technology, making available dual chamber pacing with sophisticated sensing, pacing, and
rate control. These more advanced pacemakers are more costly and complicated to place
surgically.
One of the most common indications for pacing is sick sinus syndrome. Initial therapy is
usually medical to inhibit the tachyarrhythmias (most commonly paroxysmal atrial
fibrillation). However, if symptomatic bradycardia results, then permanent pacing is
commonly employed. The appropriate type of pacing in this setting is not clearly defined and
is controversial.
The development of atrioventricular pacing was principally aimed at improving cardiac
hemodynamics and creating a more physiological heart rate control. Hemodynamic studies have
clearly shown the benefit of this approach in many patients, particularly those with
decreased left ventricular compliance in whom atrial activity contributes significantly to
cardiac output. Lack of synchronization between the upper and lower chambers of the heart
caused by pacing the ventricle alone can result in a constellation of symptoms commonly
referred to as "pacemaker syndrome".
The underlying mechanisms by which dual chamber pacing is purported to improve outcome is
straightforward; in patients with normal sinus rhythm, cardiac output is improved by 15 to
30 percent. In addition, a number of retrospective studies that have compared single chamber
with atrial-based or dual chamber pacing have suggested that the latter may prevent adverse
clinical events such as atrial fibrillation, congestive heart failure, cerebral vascular
accidents, and death. While none of these studies was a randomized trial, the literature is
consistent with a concept that dual mode pacing results in improved hemodynamics and a more
favorable outcome in patients with sick sinus syndrome. However, the data do not provide
definitive answers because of small sample sizes and methodological problems. A major
problems with all previous studies is probable selection bias favoring implantation of dual
chamber devices in younger, healthier patients.
Several small studies have compared functional status and other quality of life measures
between single and dual chamber pacing modes and have suggested better quality of life
outcomes for the dual chamber mode. Again, these conclusions are severly hampered by the
sample sizes, the lack of random assignment or adequate statistical adjustment to control
for confounding, use of outdated and/or invalid measures, and potential response bias due to
awareness of mode assignment.
DESIGN NARRATIVE:
A multicenter, randomized clinical trial. All patients received a dual chamber pacemaker
capable of either single or dual chamber rate modulated pacing. Patients were then
randomized to either the single chamber mode or the dual chamber mode. Patients with prior
stroke were pre-stratified. Clinical and electrocardiographic data were collected during a
1.5 to 4.5 year follow-up. The primary endpoint was either: first occurrence of stroke, or;
total (all-cause) mortality. Secondary endpoints included health status, cost-effectiveness,
cardiovascular mortality, composite of any of the three major adverse effects expected in
sick sinus syndrome patients (total mortality alone or first stroke or congestive heart
failure hospitalization), first occurrence of atrial fibrillation, heart failure score,
pacemaker syndrome, health status in women and in the elderly, and outcome of patients with
risk factors for pacemaker syndrome. Enrollment was completed in October, 1999 with a total
of 2,010 patients.
Quality of life and economic issues were assessed in patients at entry and annually for
three years. Questionnaire-based measures of health status and quality of life were compared
in the two pacing groups for the entire population and subgroups defined by age and gender.
The economic substudy measured the comparative costs, both direct and indirect medical and
nonmedical, of the two pacing modes in an attempt to determine the most cost-effective
approach to pacemaker treatment of sick sinus syndrome.
Recruitment started October 1, 1995 and was completed October 4, 1999 with 2,010 patients
enrolled.
;
Allocation: Randomized, Primary Purpose: Treatment
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