BACKGROUND The largest recommended annular area for TAVR with 29mm Sapien3 (S3) valve is 683 mm2. We report the first multicenter experience of S3 TAVR in extremely large annuli greater than 683 mm2. METHODS From 6/2013 to 6/2017, 69 patients across 14 centers with annular area >683mm2 (mean 723+/-42 mm2, range 684-882 mm2) by computed tomography (CT) underwent S3 TAVR for symptomatic severe aortic stenosis (Figure). Transfemoral approach was used in 93% and 32% were under conscious sedation. Patient, anatomic and procedural characteristics were retrospectively analyzed. VARC-2 outcomes were reported. RESULTS Procedural success and 30-day mortality were 100% and 4.3% respectively, with 1 stroke and 1 major vascular complication at 30 days. Post dilatation occurred in 23% with balloon overfilling (1-3cc extra) in 59% of patients. Implant depth by angiography averaged 25+/-13% (range 5-60%) by non-coronary cusp and 22+/-10% (range 3-48%) by left coronary cusp. New left bundle branch block occurred in 17% and 12% required new permanent pacemaker. Pre-discharge echocardiography showed excellent valve hemodynamics with mild paravalvular leak (PVL) in 25%, 4% moderate and none severe. There was no annular rupture or coronary obstruction. CONCLUSION TAVR with 29mm S3 valve beyond recommended range is safe, with acceptable PVL and pacemaker rates. Overexpansion of the S3 frame can be achieved by adding balloon volume before valve deployment or post dilatation with additional volume. Post-TAVR CT may further determine the theoretical annular limit of safe implantation of 29mm S3 valve.
Tang, G., Zaid, S., George, I., Khalique, O., Abramowitz, Y., Makkar, R., … Kodali, S. (2017). TCT-306 Transcatheter Aortic Valve Replacement with Extremely Large Annuli Greater Than 683 mm2 Using Edwards Sapien 3 Valve – A Multicenter Experience. Journal of the American College of Cardiology, 70(18), B126. https://doi.org/10.1016/j.jacc.2017.09.389