Circulation, Vol 83, 1179-1185, Copyright © 1991 by American Heart Association
ZG Turi, VP Reyes, BS Raju, AR Raju, DN Kumar, P Rajagopal, PV Sathyanarayana, DP Rao, K Srinath and P Peters
BACKGROUND. We performed a prospective, randomized trial comparing
percutaneous balloon commissurotomy with surgical closed commissurotomy in
40 patients with severe rheumatic mitral stenosis. METHODS AND RESULTS.
Data were analyzed by investigators who were masked to treatment assignment
or phase of study. Patients randomized to balloon (n = 20) or surgical (n =
20) commissurotomy had severe mitral stenosis without significant baseline
differences (left atrial pressure, 26.1 +/- 4.2 versus 27.6 +/- 6.2 mm Hg;
mitral valve gradient, 18.0 +/- 4.2 versus 19.7 +/- 6.3 mm Hg; mitral valve
area, 1.0 +/- 0.2 versus 1.0 +/- 0.4 cm2, respectively). At 1-week
follow-up after balloon commissurotomy, pulmonary wedge pressure was 14.3
+/- 7.2 mm Hg; mitral valve gradient was 9.6 +/- 5.1 mm Hg; and mitral
valve area was 1.6 +/- 0.6 cm2 (all p less than 0.0001). At 1-week
follow-up after surgical closed commissurotomy, wedge pressure was 13.7 +/-
5.4 mm Hg; mitral valve gradient was 9.4 +/- 4.2 mm Hg (both p less than
0.0001); and mitral valve area was 1.6 +/- 0.7 cm2 (p less than 0.003). At
8-month follow-up, improvement occurred in both groups: Mitral valve area
was 1.6 +/- 0.6 cm2 in the balloon commissurotomy group (p less than 0.002)
and was 1.8 +/- 0.6 cm2 in the surgical closed commissurotomy group (p less
than 0.0001). There was no difference between the groups at 1-week or
8-month follow-up (all p greater than 0.4). One case of severe mitral
regurgitation occurred in each group; complications were otherwise related
to transseptal catheterization. There was no death, stroke, or myocardial
infarction. Cost analysis revealed that balloon commissurotomy may
substantially exceed the cost of surgical commissurotomy in developing
countries, whereas it may represent a significant savings in industrialized
nations. CONCLUSIONS. We conclude that percutaneous balloon commissurotomy
and surgical closed commissurotomy result in comparable hemodynamic
improvement that is sustained through 8 months of follow-up.
ARTICLES
Percutaneous balloon versus surgical closed commissurotomy for mitral stenosis. A prospective, randomized trial
Department of Medicine, Harper Hospital, Detroit, MI 48201.
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