A Direct Comparison of Self-Expandable Portico Versus Balloon-Expandable Sapien 3 Devices for Transcatheter Aortic Valve Replacement: A Case-Matched Cohort Study.

OBJECTIVES Pairwise comparisons of clinical and hemodynamic outcomes with new transcatheter aortic valve replacement (TAVR) prostheses are needed to help interventionists select the most appropriate device. The self-expandable Portico valve (Abbott Vascular) was compared with the balloon-expandable Sapien 3 valve (Edwards Lifesciences) at a high-volume center in a real-world setting. METHODS All patients undergoing TAVR with a new-generation device from March 2015 to September 2017 at a single center were included. Baseline, peri-interventional, and prospective 30-day follow-up data were obtained. A nearest-neighbor propensity-score matching procedure (2:1) was used, based on age, STS score, EuroScore II, New York Heart Association (NYHA) status, and sex. Primary endpoint was 30-day all-cause mortality. Secondary endpoints included procedural results, complications according to Valve Academic Research Consortium (VARC)-2 criteria, and echocardiographic findings. RESULTS A total of 177 out of 273 patients were matched (104 Portico valves and 73 Sapien 3 valves). Procedural success rates were 99.0% vs 98.6%, respectively; P=NS). Contrast dye use (160 mL for Portico vs 120 mL for Sapien 3; P<.001) and fluoroscopy time (19.0 min for Portico vs 15.5 min for Sapien 3; P=.048) were significantly lower with the Sapien 3 device. Thirty-day mortality rate was 5.8% for the Portico group vs 4.1% for the Sapien 3 group (P=.74). Complication rates were similar between Portico and Sapien 3 groups: stroke (2.9% vs 4.1%, respectively; P=.31), major bleeding (3.8% vs 5.5%, respectively; P=.51), major vascular complications (5.8% vs 5.5%, respectively; P=.99), and pacemaker implantation (21.9% vs 17.5%, respectively; P=.55). A more-than-mild paravalvular leak was observed in 8.2% vs 4.5%, respectively (P=NS). CONCLUSIONS Short-term clinical and hemodynamic outcomes were similar with Portico and Sapien 3 prostheses; no statistically significant differences were observed in mortality and major complication rates. An individually tailored prosthesis choice is suggested.