Mechanisms and outcome of severe mitral regurgitation after Inoue balloon valvuloplasty. North American Inoue Balloon Investigators.

OBJECTIVES: The purpose of this study was to assess the incidence, mechanism and outcome of severe mitral regurgitation after treatment of mitral stenosis with percutaneous mitral valvuloplasty using the Inoue balloon.
BACKGROUND: Severe mitral regurgitation occurs in up to 15% of percutaneous balloon valvuloplasty procedures for acquired mitral stenosis. The incidence and mechanism of production of mitral regurgitation with the recently introduced single-balloon Inoue technique have not been characterized.
METHODS: We examined the incidence, mechanism, predictors and outcome of severe mitral regurgitation after Inoue balloon valvuloplasty in 280 patients in the North American multicenter registry. Twenty-one patients who developed either clinically significant or angiographically severe regurgitation were identified, and their echocardiograms were reviewed to determine the mechanism of regurgitation. These patients were then compared with the remaining patients without severe regurgitation to identify predictors of this outcome.
RESULTS: The incidence of severe regurgitation in this study was 7.5%, and the mean grade of angiographic regurgitation in these patients increased from 0.9 +/- 1.0 to 2.8 +/- 0.7 (p < 0.05). The most common cause of regurgitation (43%) was rupture of chordae tendineae to the anterior or posterior mitral leaflet. Tearing of a leaflet (usually the posterior one) occurred in 30% of patients; and no recognizable structural abnormality, with wide splitting of the commissures and a central regurgitant jet, was present in five patients (26%). All patients with definite posterior leaflet tears had heavily calcified leaflets. Patients who developed severe regurgitation had fewer balloon inflations and a higher grade of preexisting mitral regurgitation but were otherwise similar to the remaining patients without severe regurgitation. During 6-month follow-up, 71% of the patients with severe regurgitation were treated surgically; the grade of regurgitation decreased in four patients (19%), and five patients (24%) have not required mitral valve replacement during 18 +/- 5 months of follow-up.
CONCLUSIONS: Severe mitral regurgitation is a relatively infrequent complication of Inoue balloon valvuloplasty and results from disruption of the valve integrity, including chordal rupture and leaflet tearing. Careful balloon positioning may help avoid chordal rupture, and heavily calcified posterior leaflets may be at greater risk of tearing. Most patients who develop severe regurgitation will require nonemergency mitral valve replacement.