Sahmin Lee1, Duk-Hyun Kang2, Dae-Hee Kim1, Jong-Min Song1, Jae-Kwan Song1, Seong-Wook Park1, Seung-Jung Park3. 1. Divisions of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea. 2. Divisions of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea. Electronic address: dhkang@amc.seoul.kr. 3. Divisions of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea. Electronic address: sjpark@amc.seoul.kr.
Abstract
BACKGROUND: Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double-balloon techniques up to 25 years in a randomized trial. METHODS:Between 1989 and 1995, 302 patients (77 men, 41 ± 11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n = 152; group I) or double-balloon technique (n = 150; group D). The end points were the composite events of death, mitral surgery, repeat PMC, or deterioration of New York Heart Association (NYHA) class ≥3. RESULTS: During median follow-up of 20.7 years (maximum, 25.6), clinical events occurred in 82 (53.9%) patients in group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs, 3 NYHA class ≥3) and in 79 (52.7%) patients in group D (34 deaths, 51 mitral surgeries, 5 repeat PMCs, 4 NYHA class ≥3). Event-free survival rates at 24 years were not significantly different between group I and group D (40.8% and 42.6%, respectively; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.65-1.20; P = .423). On multivariate analysis, absence of post-PMC commissural mitral regurgitation (MR) (HR, 1.84; 95% CI, 1.28-2.63; P = .001) and immediate post-PMC mitral valve area (MVA) <1.8 cm2 (HR, 1.53; 95% CI, 1.04-2.25; P = .031) were independently correlated with clinical events after successful PMC. CONCLUSIONS: The Inoue and double-balloon methods showed similar good clinical outcomes up to 25 years, and the achievement of effective commissurotomy to develop post-PMC commissural MR or immediate post-PMC MVA ≥1.8 cm2 is important in optimizing the late results of PMC.
RCT Entities:
BACKGROUND: Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double-balloon techniques up to 25 years in a randomized trial. METHODS: Between 1989 and 1995, 302 patients (77 men, 41 ± 11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n = 152; group I) or double-balloon technique (n = 150; group D). The end points were the composite events of death, mitral surgery, repeat PMC, or deterioration of New York Heart Association (NYHA) class ≥3. RESULTS: During median follow-up of 20.7 years (maximum, 25.6), clinical events occurred in 82 (53.9%) patients in group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs, 3 NYHA class ≥3) and in 79 (52.7%) patients in group D (34 deaths, 51 mitral surgeries, 5 repeat PMCs, 4 NYHA class ≥3). Event-free survival rates at 24 years were not significantly different between group I and group D (40.8% and 42.6%, respectively; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.65-1.20; P = .423). On multivariate analysis, absence of post-PMC commissural mitral regurgitation (MR) (HR, 1.84; 95% CI, 1.28-2.63; P = .001) and immediate post-PMC mitral valve area (MVA) <1.8 cm2 (HR, 1.53; 95% CI, 1.04-2.25; P = .031) were independently correlated with clinical events after successful PMC. CONCLUSIONS: The Inoue and double-balloon methods showed similar good clinical outcomes up to 25 years, and the achievement of effective commissurotomy to develop post-PMC commissural MR or immediate post-PMC MVA ≥1.8 cm2 is important in optimizing the late results of PMC.
Authors: Anan A Abu Rmilah; Mahmoud A Tahboub; Adham K Alkurashi; Suhaib A Jaber; Asil H Yagmour; Deema Al-Souri; Bradley R Lewis; Vuyisile T Nkomo; Patricia J Erwin; Guy S Reeder Journal: Int J Cardiol Heart Vasc Date: 2021-04-01