Balloon Valvuloplasty Registry
Balloon Valvuloplasty Registry
To establish a registry in order to collect and analyze baseline and outcome data on patients
 with severe valvular stenosis treated with balloon valvuloplasty.
BACKGROUND:

 Valvular stenosis or incompetence results in an estimated 41,000 valve replacements in the
 United States each year. These replacements are equally distributed between the aortic and
 mitral valves. An estimated 60 percent of aortic valve replacements are the result of valve
 stenosis; 20-30 percent of mitral valve replacements are due to stenosis. The risk of
 operative mortality in single valve replacement ranges from 3 percent to as high as 15
 percent depending upon patient characteristics. Morbidity associated with open heart
 procedures includes wound infection, reoperation for bleeding, and post-operative pain. Most
 patients with artificial valves require anticoagulant therapy for the rest of their lives and
 thus face the competing risks of hemorrhage and valve thrombosis/embolism. In addition, there
 are a number of patients with aortic stenosis who are not candidates for aortic valve
 replacement because of unacceptable operative risks who might be dramatically improved by
 balloon valvuloplasty.

 The pathophysiologic processes underlying valvular stenosis at the aortic and mitral
 positions are quite different. Mitral stenosis is an outcome of rheumatic fever. Rheumatic
 fever is quite unusual in this country but it and its sequelae, rheumatic valvular disease,
 persist as major public health problems in the Third World. Aortic stenosis is most commonly
 the result of calcific degeneration of a normal tricuspid aortic valve in the elderly or the
 result of rheumatic fever but can also develop in a congenital bicuspid aortic valve which
 becomes progressively more stenotic with age and the wear of abnormal flow patterns.

 The results of surgical valvuloplasty differ for mitral and aortic valves. Surgical
 valvuloplasty (commissurotomy) for mitral stenosis is currently a well-established and
 commonly used treatment for symptomatic patients with mitral stenosis. Similar attempts at
 repair of aortic stenosis have been largely unsuccessful. Surgical valvuloplasty for aortic
 stenosis has, for this reason, been abandoned in favor of valve replacement. Initial attempts
 at aortic balloon valvuloplasty were, therefore, undertaken in patients who were not surgical
 candidates; these initial efforts in a small number of patients, coming as they did in the
 wake of abandoned surgical attempts, were surprisingly successful in reducing gradients and
 increasing valve area without complications such as embolism or significant regurgitation.

 Balloon valvuloplasty began with pediatric cardiologists using catheters designed for
 dilatation of peripheral arterial stenosis in children with pulmonic stenosis and those with
 coarctation of the aorta. Balloon dilatation has been quite successful with pulmonic
 stenosis, and is now an accepted therapeutic maneuver. It is less successful with coarctation
 of the aorta. As a direct outgrowth of this research, investigators have applied this
 procedure to mitral and aortic stenosis in adults.

 Balloon valvuloplasty is performed in the cardiac catheterization laboratory without general
 anesthesia. A balloon catheter is inserted percutaneously in the venous side of the
 circulation and is placed across the mitral valve after puncture of the atrial septum.
 Inflation of appropriately sized balloons has resulted in marked reduction of transvalvular
 gradients and increase in calculated valve area in most of the cases thus far reported. Given
 the success of closed commissurotomy, these are not surprising findings.

 A similar procedure has been used in severely stenotic aortic valves by either advancing the
 balloon through the mitral valve into the aortic position or approaching the valve
 retrograde. Aortic balloon valvuloplasty has thus far been employed largely in severely ill,
 elderly patients who are judged not able to tolerate valve replacement. As noted above,
 results have been quite promising; low mortality and morbidity, substantial hemodynamic
 improvement and short hospital stays have been observed. These anecdotal reports have led to
 the application of balloon valvuloplasty in increasing numbers of patients. Major issues
 needed to be addressed prior to general acceptance of this therapy for both aortic and mitral
 stenosis and for operative and nonoperative candidates. The issues include: definition of
 risk of mortality and morbidity overall and in subgroups defined by baseline characteristics;
 success rate defined clinically and hemodynamically overall and in subgroups; the durability
 of this procedure, that is, how long will a given improvement in clinical and hemodynamic
 measures persist; definition of subgroups with particularly favorable or unfavorable
 outcomes. These questions were addressed by the NHLBI Balloon Valvuloplasty Registry.

 DESIGN NARRATIVE:

 Investigators treating patients with balloon valvuloplasty voluntarily collected and
 submitted data on consecutive cases of valvuloplasty for two years of active recruitment and
 followed patients at selected intervals for a minimum of two and a half years. Demographic,
 clinical, and hemodynamic data were collected on each patient during the valvuloplasty
 hospitalization. The data were submitted from the participating clinical units to the
 Coordinating Center.
No eligibility criteria