Thirty-Day Results Support St. Jude Medical's Portico TAVR System

August 22, 2016—The 30-day safety and performance results from the PORTICO TF EU trial of St. Jude Medical’s Portico resheathable, annular functioning, self-expanding transcatheter aortic valve replacement (TAVR) system and transfemoral (TF) delivery system were published by Ganesh Manoharan, MD, et al in EuroIntervention (2016;12:768–774). 

As summarized in EuroIntervention, the prospective, single-arm, multicenter PORTICO TF EU study evaluated the 18-F Portico system with either a 23- or a 25-mm valve. Patient follow-up was at 30 days, 90 days, 180 days, and 1 year. The current article presents the results up to 30 days.

Adverse events were categorized by Valve Academic Research Consortium definitions and adjudicated by an independent events committee. An independent laboratory evaluated echocardiography. All patients underwent neurological assessment at baseline, postprocedure, 30 days, and 1 year. The primary endpoint was all-cause mortality at 30 days. 

PORTICO TF EU enrolled a total of 102 patients (mean age, 84.1 ± 4.8 years; 97% women; median Society for Thoracic Surgeons score, 5.6). The 30-day mortality, disabling stroke, and major vascular complication rates were 2.9%, 2.9%, and 5.9%, respectively. Resheathing and repositioning (23.8%) was successful in all instances. Paravalvular leak at 30 days was none/trace in 30.4%, mild in 65.8%, and moderate in 3.8%. The mean gradient improved from 45.3 ± 13.8 mm Hg to 8.9 ± 3.8 mm Hg, and the valve area improved from 0.6 ± 0.2 cm² to 1.7 ± 0.4 cm². Permanent pacemaker implantation was required in 9.8% of patients.

The novel Portico TAVR system is safe and effective at treating high-risk patients with symptomatic severe aortic stenosis, allowing safe repositioning and optimization of device position, concluded the investigators in EuroIntervention.