Transcatheter mitral valve implantation (TMVI) with the novel Tendyne transcatheter heart valve showed a high success rate, with significant reduction in mitral regurgitation (MR) and symptoms improvement at 30 days after the procedure, in patients not eligible for transcatheter edge-to-edge repair (TEER) of the mitral valve, according to late-breaking trial results presented Wednesday at Transcatheter Valve Therapies (TVT) 2021.
TMVI is an evolving treatment option for mitral valve disease. An initial feasibility study (IFS) demonstrated the safety of the procedure.
Jörg Hausleiter, MD, of Ludwig-Maximilians University, Munich, presented data from the investigator-initiated TENDER (TENDyne European expeRience registry study) observational registry at TVT in Miami Beach, Florida. The registry included 108 patients from 26 European centers enrolled between January 2020 and April 2021 who received the Tendyne valve (Abbott Vascular), which is implanted using a transapical approach. Tendyne received the CE mark in January 2020.
The primary endpoint was procedural success rate at 30 days according to the Mitral Valve Academic Research Consortium criteria. The secondary endpoints were technical success rate, mortality, mitral valve re-intervention or surgery and hospitalization for heart failure.
The patients (mean age of 75±7 years, 57% men) had high risk scores (mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 7.2% ± 5.3%), history of coronary artery disease (63%), coronary artery bypass graft (30%) and previous mitral valve intervention or surgery (16%). They had a mean New York Heart Association Functional Class (NYHA FC) of ≥III/IV (86%), and almost 78% of the patients had chronic renal disease (glomerular filtration rate <60 ml/min).
The main indications for TMVI were non-eligibility of TEER (90% of patients), short leaflet/restricted movements (53%), calcification (36%), small valve area (23%) and prior TEER with high gradient (12%). Most of the patients had moderate-to-severe or severe MR, grade 3+/4+ (94%), with mean left ventricular end diastolic diameter of 57±8 mm on echocardiography. TENDER also included patients with left ventricular ejection fraction ≤ 30% (13%), systolic pulmonary artery pressure ≥70 mmHg (13%), severe tricuspid regurgitation (16%), mitral stenosis gradient >5 mmHg (18%) and moderate to severe mitral annular calcification (20%), who were excluded from the IFS trial. The predicted neo-left ventricular outflow tract (LVOT) area was 419±129 mm2 via computed tomography scan in the cohort.
Only 25% (27/108) were treated off-label. The study unveiled an excellent technical success rate of 96% and improvement in MR (99% of patients with MR grade ≤1+) at the end of the procedure, with a procedural mortality of 2%.
Only 2% of patients had LVOT obstruction and 3% requiring conversion to open heart surgery. The procedural success rate according to MVARC criteria was 80%, with a majority of patients with MR <1+ on echocardiography and improvement in NYHA FC symptoms, at 30-day follow-up. There were no statistical predictors of procedural success.
In comparison to the IFS study, technical success and reduction of MR to trace or none are similar, with slightly higher procedural and all-cause mortality likely due to the higher-risk patients in the real-world cohort.
The study result suggests the expansion of catheter-based treatment options for patients primarily considered non-eligible for TEER or MV surgery.