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Percutaneous transatrial mitral commissurotomy by modified technique using a JOMIVA balloon catheter: a cost-effective alternative to the Inoue balloon.
Journal of Heart Valve Disease 2004 May
BACKGROUND AND AIM OF THE STUDY: Percutaneous transatrial mitral commissurotomy (PTMC) is an established non-surgical treatment of rheumatic mitral stenosis. The study aim was to assess the safety and efficacy of PTMC using the Joseph mitral valvuloplasty (JOMIVA) balloon catheter, with a modified technique.
METHODS: PTMC was performed in 252 patients (88 males, 164 females; mean age 39.2 +/- 13.8 years; range: 10-76 years) with symptomatic mitral stenosis. Among patients, 52 (20.6%), 182 (72.2%) and 18 (7.2%) were in NYHA classes II, III and IV, respectively. Atrial fibrillation was present in 52 patients (20.6%), and mild mitral regurgitation (MR) in 26 (10.3%); 92 patients (36.5%) had a mitral valve echo score > 8. Patients were followed up with detailed clinical and echocardiography studies at three-month intervals during the first year, and at six-month intervals thereafter.
RESULTS: The procedure was technically successful in 247 patients (98%), and an optimal result was achieved in 228 (90.5%), with mean mitral valve area increased from 0.81 +/- 0.32 to 1.92 +/- 0.39 cm2 (p < 0.001). NYHA class was improved in most patients. Seven patients (2.8%) had cardiac tamponade during the procedure; one of these (0.4%) died from left ventricular tear. MR appeared (n = 10) or worsened (n = 20) in 30 patients (11.9%), among whom three (1.2%) developed severe MR. Each JOMIVA balloon catheter was used 10 to 20 times without being damaged. In total, 220 patients were followed up for between six and 54 months (mean 30 months). At follow up, 140 (63.6%) and 67 (30.5%) patients were in NYHA classes I and II, respectively. Seventeen patients (7.7%) developed mitral restenosis.
CONCLUSION: PTMC using the JOMIVA balloon catheter is a cost-effective and safe alternative to the Inoue balloon when treating symptomatic severe mitral stenosis. The hemodynamic benefits were sustained long term in a majority of patients. In particular, cost is important factor in a less wealthy country such as India.
METHODS: PTMC was performed in 252 patients (88 males, 164 females; mean age 39.2 +/- 13.8 years; range: 10-76 years) with symptomatic mitral stenosis. Among patients, 52 (20.6%), 182 (72.2%) and 18 (7.2%) were in NYHA classes II, III and IV, respectively. Atrial fibrillation was present in 52 patients (20.6%), and mild mitral regurgitation (MR) in 26 (10.3%); 92 patients (36.5%) had a mitral valve echo score > 8. Patients were followed up with detailed clinical and echocardiography studies at three-month intervals during the first year, and at six-month intervals thereafter.
RESULTS: The procedure was technically successful in 247 patients (98%), and an optimal result was achieved in 228 (90.5%), with mean mitral valve area increased from 0.81 +/- 0.32 to 1.92 +/- 0.39 cm2 (p < 0.001). NYHA class was improved in most patients. Seven patients (2.8%) had cardiac tamponade during the procedure; one of these (0.4%) died from left ventricular tear. MR appeared (n = 10) or worsened (n = 20) in 30 patients (11.9%), among whom three (1.2%) developed severe MR. Each JOMIVA balloon catheter was used 10 to 20 times without being damaged. In total, 220 patients were followed up for between six and 54 months (mean 30 months). At follow up, 140 (63.6%) and 67 (30.5%) patients were in NYHA classes I and II, respectively. Seventeen patients (7.7%) developed mitral restenosis.
CONCLUSION: PTMC using the JOMIVA balloon catheter is a cost-effective and safe alternative to the Inoue balloon when treating symptomatic severe mitral stenosis. The hemodynamic benefits were sustained long term in a majority of patients. In particular, cost is important factor in a less wealthy country such as India.
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