One Year Outcomes Of A Multicenter Clinical Study Evaluating A Novel Self-expanding Transcatheter Aortic Valve System
Thomas Walther1, Axel Linke2, Ganesh Manoharan3, Helge Möllmann4, Stephen Worthley5, David Holzhey2.
1Kerckhoff Klinik-Bad Nauheim, Bad Nauheim, Germany, 2Herzzentrum Leipzig, Leipzig, Germany, 3Royal Victoria Hospital, Belfast, United Kingdom, 4St. Johannes Hospital, Dortmund, Germany, 5GenesisCare, Adelaide, Australia.
OBJECTIVE: The Portico™ transcatheter aortic heart valve (St. Jude Medical, Minnesota, US) is a fully resheathable, repositionable and self-expanding bioprosthesis designed to achieve optimal valve position, hemodynamic performance and limit conduction disturbances. We present 1 year outcomes in patients implanted with the full range of Portico valves in a prospective, multicenter cohort study.
METHODS: Between December 2011 and September 2015, 222 patients with symptomatic (≥ NYHA II) severe aortic stenosis (AS) considered by a multidisciplinary Heart Team to be high risk for surgery were enrolled at 12 sites in Europe and Australia. Patients were implanted with the full range of Portico valves (23, 25, 27 or 29mm) using an 18 or 19F Transfemoral Delivery System. Adverse events were defined according to VARC criteria and adjudicated by an independent Clinical Events Committee. Echocardiographic data was evaluated by an independent core laboratory. Functional status was assessed by NYHA class.
RESULTS: 220 patients (mean age: 83.0 ± 4.6 years, 74.3% female, mean STS score 5.8%) were implanted with the Portico valve and 1-year clinical follow-up was available for 160 patients. Resheathing and repositioning of the valve was performed in 33% of procedures and was successful in all instances. Average depth of implant into LVOT was 6.1±2.2mm. Successful vascular access, valve delivery and deployment and retrieval of the delivery system was 97.3%. Kaplan-Meier estimates of all-cause mortality was 3.6% and 13.1% at 30 days and 1 year, respectively. Permanent pacemaker implantation (PPI) was required in 13.5% of patients at 30 days, and increased marginally to 14.9% at 1 year. Compared with baseline, indexed valve area, valve mean gradient and peak velocity significantly improved at 30 days and at 1-year (all comparisons p<0.0001). Paravalvular aortic regurgitation was absent/trace in 48.3%, mild in 44.2%, moderate in 6.8% and severe in 0.7% patients at 1 year. NYHA functional class improved in 74.8% of patients at 1 year compared to baseline (p<.0001).
CONCLUSIONS: At 1 year, the resheathable Portico™ transcatheter aortic heart valve was safe and was associated with good hemodynamic performance, significant improvements in functional class and low rates of PPI in high risk patients.
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