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.