Key result
M-TEER without on-site cardiac surgery fails to establish non-inferiority for procedural success.
Why the study?
Comparative evidence for mitral transcatheter edge-to-edge repair (M-TEER) performed at centers with versus without on-site cardiac surgery was lacking.
Does M-TEER performed at a center without on-site cardiac surgery achieve non-inferior device and procedural success compared to a center with on-site cardiac surgery?
Cohort (n=64)
Yes
Does M-TEER performed at a center without on-site cardiac surgery achieve non-inferior device and procedural success compared to a center with on-site cardiac surgery?
Effect estimate: RD +8.9% (95% CI -14.9 to +27.5)
Absolute Event Rate: 81% vs 72.1%
p-value: p=0.547
M-TEER performed at centers without on-site cardiac surgery using a shared interventional team and formal surgical backup network demonstrates high procedural success and safety, supporting further prospective evaluation of network-based structural programs.
Noninferiority of off-site M-TEER not established; leaves open feasibility of shared-team networks pending prospective trials.
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.
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Marchisio et al. (2026) conducted a cohort in Severe (4+) mitral regurgitation (n=64). M-TEER at center without on-site cardiac surgery vs. M-TEER at center with on-site cardiac surgery was evaluated on MVARC device and procedural success at 30 days (RD +8.9%, 95% CI -14.9 to +27.5, p=0.547). M-TEER without on-site cardiac surgery achieved 81.0% device and procedural success vs 72.1% with on-site surgery, but wide CIs meant non-inferiority was not established (p=0.547).
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