METHODS
Study population:
This was a multi-center, retrospective, observational cohort study of one-quarter of worldwide patients who underwent TMVI between October 2014 and October 2019 using the Tendyne system (Tendyne Holdings Roseville, Minnesota) [12, 13]. The cohort included 41 patients enrolled in the Tendyne Expanded Feasibility Study and 5 patients treated under a Compassionate Use protocol. Patients were considered ineligible for TMVI if they had a pulmonary artery systolic pressure (PASP) >70mmHg or severe RV dysfunction. Details of the procedure and patient outcomes at 30-days and 1-year have been described previously [12, 13]. The study was approved by the respective local hospital Ethics Committee. All demographic data were manually extracted from the electronic medical records.