Transcatheter mitral valve replacement (TMVR) with Abbott’s Tendyne device may be a safe, effective alternative to surgery for elderly patients, according to new research out of Germany.[1]
“In the treatment of mitral valve disease, the role of TMVI alongside other treatment modalities needs to be defined more clearly,” wrote first author Johannes A. Ziegelmueller, MD, a cardiovascular surgeon with the Technical University of Munich in Germany, and colleagues.
The study, published in EuroIntervention, included data from 40 TMVR patients treated with the Tendyne device and another 80 patients treated with surgical mitral valve replacement (SMVR). All patients received care from 2000 to 2022. Each TMVR procedure was performed with transesophageal echocardiography guidance. SMVR was performed after a full sternotomy or a left anterolateral minithoracotomy.
Ziegelmueller et al. used a matching protocol that helped ensure the two groups had similar baseline characteristics. In both groups, for example, the mean patient age was 78 years old and 60% of patients were female. Mitral valve pathology was also comparable between the two groups, as were baseline rates of atrial fibrillation, previous coronary artery bypass grafting and previous surgical aortic valve replacement. Diabetes and coronary artery disease, meanwhile, were much more common among TMVR patients.
Overall, TMVR was associated with reduced 30-day mortality (2.5% vs. 3.75%) as well as a higher Mitral Valve Academic Research Consortium (MVARC) device success rate (82.5% vs. 57.5%) and higher MVARC procedural success rate (75% vs. 52.5%). The MVARC technical success rate was 97.5% for both treatment options.
In addition, the authors noted, the ICU and hospital lengths of stays were significantly shorter among patients treated with the Tendyne device.
“These are promising data for an evolving technology which is being developed as a complementary therapy to mitral edge-to-edge repair and SMVR,” the authors wrote. “Future randomized trials are required to confirm our findings.”
The group also noted that “several transcatheter mitral valve systems with a transseptal delivery route are currently under clinical investigation and might broaden the clinical use of TMVR after achieving the relevant authorities' approval.”
The Tendyne device has not been approved by the U.S. Food and Drug Administration for TMVR in the United States, though it did gain European CE mark approval in 2020.
Click here to read the full study in EuroIntervention, a journal published by the European Society of Cardiology.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.