Safety and efficacy of percutaneous balloon mitral valvotomy in severe mitral stenosis with moderate mitral regurgitation - A prospective study.

Abstract Background Percutaneous balloon mitral valvotomy (PBMV) is generally considered as a contraindication in patients with mitral stenosis (MS) associated with moderate to severe mitral regurgitation (MR). We sought to compare the safety and efficacy of PBMV in patients with severe MS and with moderate MR with those with less than moderate or no MR. Materials and methods Symptomatic patients of MS with mitral valve area ≤1.5 cm 2 were screened into two groups: Group I with moderate MR and Group II with less than moderate or no MR. Clinical and echocardiographic assessments were done at 24 h, 1 month, and 6 months post-procedure. A treadmill testing was done prior to PBMV and at 6 months. Primary safety outcome was a composite of cardiovascular death and development of severe MR with or without requirement for mitral valve replacement at 30 days of procedure. Efficacy of the procedure was measured as improvement in functional class, treadmill time, and mitral valve area (MVA) at 6 months. Results Seventeen patients with moderate MR and 208 patients with less than moderate MR underwent PBMV. Primary outcome showed no significant difference [2 (11.7%) in Group I vs. 8 (3.85%) in Group II, p  = 0.36]; occurrence of severe MR was higher in Group I [RR = 4.87, 95% C.I. = 1.42–16.69]. In Group I patients, improvement in treadmill time was seen in 12 (70.59%), functional class in 13 (76.47%), and MVA in all patients. Conclusion In patients having severe MS associated with moderate MR, PBMV may be a safe option and provides sustained symptomatic benefit.