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Duncan said operators have been implanting Tendyne for at least 7 years now, but the purpose of this analysis was to look beyond that device and to assess the real-world outcomes of symptomatic patients with at least moderate MR who were at prohibitive risk for surgery or anatomically unsuitable for TEER. Data from other, small feasibility studies testing other systems have been presented, but follow-up is shorter and fewer patients have been treated. It is also the device with the longest follow-up to date, including 2-year data from the Global Feasibility Study of 100 patients at high/prohibitive risk for surgery, and 6-year follow up from a small compassionate-use case series. In Europe, Tendyne (Abbott) is the only device with CE Mark approval for transcatheter mitral valve replacement. To us, it seems that TMVI may be a reasonable alternative for patients with severe symptomatic MR, who are considered unsuitable for standard mitral regurgitation therapies following a discussion with the heart team.” TMVR produced elimination, not just a reduction, of mitral regurgitation in the vast majority of patients, irrespective of their etiology. “That seemed to be the case in our study at 30 days and this was sustained to 1 year. “Access-site complications are a potential downside to transapical TMVR, but one of the pluses is the very predictable and durable elimination of mitral regurgitation,” Duncan told TCTMD. Still, access-site complications were relatively common (9.6%) and roughly 40% of the 229 high-risk patients who underwent TMVR had either died or were hospitalized for heart failure (HF) at 1 year, a rate that is relatively high but lower than that seen in patients who received medical therapy alone, reported Alison Duncan, MBBS, PhD (Royal Brompton Hospital, London, England), during a hotline session this week at PCR London Valves 2021.
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Additionally, nearly three-quarters of patients remained free from MR at 1-year follow-up.
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In the CHOICE-MI registry, TMVR using a range of 10 different devices, the vast majority via transapical access, was associated with high technical success (> 95%) and a relatively low risk of procedural complications. For patients with significant mitral regurgitation (MR) who are unsuitable for surgical intervention or transcatheter edge-to-edge repair (TEER), transcatheter mitral valve replacement (TMVR) appears a viable option with durable benefits, according to new real-world data from a multicenter registry.