Percutaneous Balloon Versus Surgical Closed and Open Mitral Commissurotomy for Rheumatic Mitral Stenosis - Percutaneous Balloon Versus Surgical Closed and Open Mitral Commissurotomy for Rheumatic Mitral Stenosis

Jan 23, 2005
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Date Published:
01/01/1998
Date Updated:
01/23/2005
Original Posted Date:
01/23/2005
References

Description:

This was a randomized clinical trial comparing percutaneous balloon commissurotomy versus surgical closed commissurotomy versus open commissurotomy for the treatment of severe rheumatic mitral stenosis.

Hypothesis:

To determine the early and long-term (seven-year) outcomes of each of these three techniques in the treatment of severe rheumatic mitral stenosis.

Study Design

Study Design:

Patients Screened: 130
Patients Enrolled: 90
NYHA Class: 90% Class II or IV
Mean Follow Up: Seven years
Mean Patient Age: Mean 28 years
Female: 73%

Patient Populations:

Rheumatic severe mitral stenosis (valve area ≤1.3 cm2)

Exclusions:

Presence of other cardiac valvular disease; history of thromboembolism, mitral valve calcifications on fluoroscopy and two-dimensional echocardiography; or left atrial thrombus seen on transthoracic echocardiography

Primary Endpoints:

Pulmonary capillary wedge pressure, mitral valve gradient, cardiac index, Gorlin mitral valve area at six months at rest and exercise, and echo mitral valve area at six months and follow-up

Secondary Endpoints:

Drug/Procedures Used:

  1. Balloon mitral commissurotomy was performed using two pigtail balloons through a single transseptal puncture.
  2. Closed surgical commissurotomy was performed through a left lateral thoracotomy.
  3. Open mitral commissurotomy was performed through a median sternotomy.

Principal Findings:

A total of 90 patients were enrolled. The baseline characteristics of the patients in each study group were similar, with all patients having a mitral valve echo score ≤8/16, and a mean mitral valve area of 0.9 cm2. There were no periprocedural deaths or thromboembolic events.

At six-month cardiac catheterization, pulmonary capillary wedge pressure and the transmitral valve gradient decreased to a similar extent in all three study arms. However, the mitral valve area rose to a greater extent among patients treated with either balloon or open commissurotomy (1.3 cm2 increase) compared to closed commissurotomy (0.7 cm2). Residual mitral stenosis was present in 0% of patients treated with balloon or open commissurotomy compared to 27% of those treated with closed commissurotomy. Left to right interatrial shunting was observed in 17% of the balloon commissurotomy group. Six-month echocardiographic findings paralleled the findings on cardiac catheterization. The rates of mitral regurgitation were approximately 20% in each group (primarily less than grade 2).

At seven-year follow-up, all patients were alive, and the mitral valve area was 1.8 cm2 in patients treated with both balloon and open commissurotomy, while it was 1.3 cm2 in patients treated with closed commissurotomy. Restenosis (valve area <1.5 cm2) had occurred in 2/30 patients in both the balloon or open commissurotomy groups and in 11/30 patients in the closed commissurotomy group (p<0.001). More than 85% of patients in both the balloon and open commissurotomy groups were in New York Heart Association functional class I, whereas only 33% of patients who underwent closed commissurotomy were in this functional class. Freedom from re-intervention was 90% in patients who underwent balloon commissurotomy, 93% in patients who underwent open commissurotomy, and 50% in patients who underwent closed commissurotomy (p<0.001).

Interpretation:

In this randmomized single-center study of patients undergoing commissurotomy for severe rheumatic mitral stenosis, both balloon commissurotomy and open surgical commissurotomy were associated with excellent short- and long-term results, while closed surgical commissurotomy was associated with poorer outcomes. Overall, the prognosis of patients treated with each of these was excellent, but balloon mitral commissurotomy is far less invasive than the other comparable techniques in the study.

Thus, given the very similar short-term and long-term outcomes between balloon and open commissurotomy, this study would support a strategy of balloon commissurotomy as the first-line therapy for patients with severe rheumatic mitral stenosis and favorable valve morphology. One caveat is that the long-term improvements in valve area and overall success rates with ballon mitral commissurotomy in this trial were better than in other similar studies, perhaps related to the young age of the patient population and the favorable valve morphology.

References:

Ben Farhat M, Ayari M, Maatouk F, et al. Percutaneous balloon versus surgical closed and open mitral commissurotomy: seven-year follow-up results of a randomized trial. Circulation 1998;97:245-50.

Keywords: Thoracotomy, Sternotomy, Rheumatic Heart Disease, Pulmonary Wedge Pressure, Follow-Up Studies, Cardiac Catheterization, Mitral Valve Stenosis


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