Mitral Transcatheter Edge-to-Edge Repair at Centers With and Without On-Site Cardiac Surgery: A Comparative Registry With a Shared Interventional Team.
Giulia Marchisio, Elisa Pelloni, Francesco Pisano, Lorenzo Zaccaro, Laura Contu, Maurizio Tusa, Nedy Brambilla, Marco Guerrini, Francesco Bedogni, Paolo Scacciatella
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引用次数: 0
Abstract
Background: Comparative evidence for M-TEER performed at centers with versus without on-site cardiac surgery is lacking. We compared early outcomes at two centers that shared the same interventional operator team but differed in the availability of on-site cardiac surgery.
Methods: We retrospectively analyzed prospectively collected registry data from 64 consecutive patients with severe (4+) MR treated at a center without on-site cardiac surgery (no-CCH, n = 21) and a center with on-site cardiac surgery (CCH, n = 43). The same interventional operator team performed every procedure. At the no-CCH center, surgical expertise was provided through a shared Heart Team and a formal emergency transfer pathway. The cohorts were treated in sequential calendar periods. Principal comparative endpoints were MVARC device and procedural success at 30 days. Exploratory non-inferiority analyses used margins of -12.5% and -10%.
Results: MVARC technical success was 100% versus 97.7%. Device and procedural success were each 81.0% versus 72.1% (risk difference [RD] +8.9%, 95% CI -14.9 to +27.5; p = 0.547). Freedom from major MVARC serious adverse events was 95.2% versus 95.3%. Twelve of 16 device-success failures involved a mean transmitral gradient ≥ 5 mmHg. Surgical conversion and in-hospital death were 0% in both centers.
Conclusions: In this preliminary same-team comparison, 30-day MVARC device and procedural success rates were 81.0% at the no-CCH center and 72.1% at the CCH center. Confidence intervals were wide and non-inferiority was not established. These findings support prospective evaluation of network-based M-TEER programs with shared interventional expertise and formal surgical backup.