Comparative study on safety, efficacy, and midterm results of balloon mitral valvotomy performed with triple lumen and double lumen mitral valvotomy catheters.

BACKGROUND

The triple lumen Inoue balloon is routinely used for balloon mitral valvotomy (BMV) in India. Its major limitation is the high cost. The double lumen Accura balloon is less expensive, making it an attractive alternative in the developing countries. The study was meant to assess the safety, efficacy and midterm results of Accura balloon with respect to the Inoue balloon.

PATIENTS AND

METHODS

816 consecutive patients, who underwent elective BMV in this Institute from 1997 to 2003, were included in the study. The data of 487 patients who underwent BMV with Accura balloon was compared with 329 patients who underwent BMV with Inoue balloon. The clinical, echocardiographic, and hemodynamic data of these patients were analyzed retrospectively to assess the safety and efficacy of Accura balloon with respect to the Inoue balloon.

RESULTS

Immediate procedural success (93.9% in Inoue group and 91.6% in Accura group p. NS) and complications (6.6% in Inoue group and 5.6% in Accura group p. NS) were comparable between the study groups. The two study population had similar restenosis rate and events at 1 year after BMV. Both balloons could be reused multiple times without compromising on the safety and effectiveness. Accura balloons were less costly than Inoue balloon. The reusability with Accura was slightly more and found to be more cost-effective.

CONCLUSIONS

Both Accura and Inoue balloon mitral valvotomy balloons are effective in providing relief from hemodynamically significant mitral stenosis in terms of gain in valve area and reduction in trans mitral gradient. Both groups have similar procedural success and complication rates, restenosis, and follow-up events at 1 year. Both balloons could be reused multiple times and Accura balloon is found to be more cost effective.