Study findings published in Feb 10 edition of JACC: Cardiovascular Interventions detail the effectiveness of transapical transcatheter mitral valve replacement (TMVR) following failed transcatheter edge-to-edge repair (M-TEER). Led by Daryoush Samim, MD, from Bern University Hospital in Switzerland, the research presents transapical TMVR as a viable, less invasive alternative to traditional surgical intervention. “Transapical TMVR after ELASTA-Clip is a feasible and less invasive option for the management of failed M-TEER that can be performed with acceptable results in a carefully selected patient population," said the authors of the paper. The investigation, which was also published Monday online, set out to evaluate the safety and efficacy of a novel approach, which adopts electrosurgical leaflet laceration and stabilization of the implant (ELASTA-Clip) followed by transapical TMVR using the Abbott Tendyne system. Among 22 high-risk patients, who had symptomatic MR (grade 3+ or higher) or mitral valve stenosis following failed M-TEER, findings revealed that the ELASTA-Clip procedure (90.9% [20/22] transseptal, 9.1% [2/22] transapical) followed by TMVR were successful in all patients (22/22). According to definitions set out by the Mitral Valve Academic Research Consortium (MVARC), technical success was achieved in 21 patients (21/22, 95.4%) without left ventricular outflow tract obstruction or conversion to sternotomy. MR reduction Further findings revealed that baseline mitral regurgitation (MR) (≥3+ in 95.5% [21/22]) was reduced to grade 1+ or less in all patients with durable results in 89.5% (17/19) (P < 0.001). The research team, which included colleagues from Abbott Northwestern Hospital in Minneapolis, Minnesota, noted that the New York Heart Association (NYHA) functional class significantly improved to ≤II in 81.3% (13/16) at discharge (P < 0.001) and 72.2% (13/18) at last follow-up (P < 0.001). Findings related to survival and safety also proved promising with all patients (20/20) remaining alive at 30 days. Three patients (3/20, 15.0%) were rehospitalized for heart failure (uncontrolled atrial fibrillation in 2 cases) with 1 (1/22, 4.5%) undergoing a reintervention (valve retensioning). “Particular attention is required to avoid paravalvular leakage and measures to minimize the risk of periprocedural cerebrovascular events need to be implemented in future larger-scale prospective studies with longer-term follow-up." M-TEER challenges In an accompanying editorial, Paolo Denti, MD from the University Hospital Istituti di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele (The San Raffaele Hospital) in Milan, Italy, began by describing the long-term challenges of M-TEER. Its emergence as an important therapeutic strategy is a timely one with recent figures identifying around 10% of individuals aged 75 years as having clinically relevant MR. “Unfortunately, mid/long-term M-TEER failure should be expected if younger patients with more complex anatomies and longer life expectancy are treated, especially in lower-volume centers with less experienced operators in transcatheter therapies," said Dr Denti. He goes onto highlight that in primary MR, the loss of leaflet insertion or leaflet tear seemed to be the predominant mechanism. Meanwhile in secondary MR, more than one-half of the patients were not presenting any disorder of the clip or leaflets, showing that there was a progression of annular/ventricular dysfunction. Alternative solutions Dr. Denti went on to discuss alternative solutions for failed M-TEER commenting that once the TEER devices were implanted, conventional approaches were repeat M-TEER or surgical repair/replacement (an option that in many has been excluded at the index procedure). “Repeat M-TEER could be an option, but the risk of increasing the mitral gradient is significant and more detrimental than regurgitation alone," he pointed out. Dr. Denti used his editorial to flag up possible concerns about stroke and safety commenting that the only remarkable negative result in terms of safety was a significant stroke incidence of 15%. “[This] is higher than any other data published on MTEER or TMVI,” he said. “These data raise awareness that percutaneous electrosurgery generates ash, and this could have a role in the incidence of thromboembolic events.” The commentary concluded with a forward-looking viewpoint, in which Dr. Denti said that, despite the ELASTA-Clip procedure requiring high expertise, there was the risk that no TMVI would be suitable for that anatomy. "Nowadays, there is not a reliable device for percutaneous annuloplasty,” he added. “The importance of an annuloplasty ring could have a double effect on patients undergoing M-TEER." "ELASTA-CLIP and TMVI with Tendyne are feasible and can be performed with acceptable results in a carefully selected patient population,” the editorial commentary piece concluded. “Paramount importance must be dedicated to mitigating the risk of cerebrovascular events." Study methodology A total of 22 patients (mean age 77.8±9.2 years, 40.9% [9/22] female) at high surgical risk (EuroSCORE II 8.0±0.4, STS score 7.2%±1.1%) with symptomatic residual MR ≥3+ (n=21) or iatrogenic MV stenosis (n=1) after failed M-TEER were followed for a median period of 8.5 [Q1-Q3: 2.6-11.6] months. Data from patients with failed M-TEER who underwent ELASTA-Clip followed by compassionate use or commercial transapical TMVR using the Abbott Tendyne system was then retrospectively collected from 8 tertiary care centers in 4 countries. The safety and efficacy of the procedure were assessed at the time of device implantation, discharge, and at 30-day follow-up and up to 1 year. Study endpoints comprised of technical success and key clinical endpoints according to Mitral Valve Academic Research Consortium (MVARC), residual MR severity and NYHA functional class. Sources: Samim D, Sorajja P, Lanz J, et al. Transapical Transcatheter Mitral Valve Replacement After Failed Transcatheter Edge-to-Edge Repair: A Multicenter Experience. JACC Cardiovasc. Interv. 2025;18:311–321. Denti P. Lifelong M-TEER Patients’ Management. JACC Cardiovasc. Interv. 2025;18: 322–324. Image Credit: ibreakstock – stock.adobe.com