• Axel Linke, David Holzhey, Helge Möllmann, Ganesh Manoharan, Ulrich Schäfer, Christian Frerker, Stephen G Worthley, A J van Boven, Simon Redwood, Jan Kovac, Christian Butter, Lars Søndergaard, Alexander Lauten, Gerhard Schymik, and Thomas Walther.
• From the Technical University Dresden Heart Center, Germany (A.L); Herzzentrum Leipzig, Germany (D.H.); St. Johannes Hospital, Dortmund, Germany (H.M.); Royal Victoria Hospital, Belfast, United Kingdom (G.M.); University Heart Center Hamburg, Germany (U.S.); Asklepios Kliniken, Hamburg, Germany (C.F.); Genesis Care, Adelaide, Australia (S.G.W.); MC Leeuwarden, the Netherlands (A.J.v.B.); St Thomas' Hospital, London, United Kingdom (S.R.); Glenfield Hospital, Leicester, England (J.K.); Heart Center of Bernau, Germany (C.B.); Righospitalet, University of Copenhagen, Denmark (L.S.); Department of Cardiology, Charité-Universitaetsmedizin Berlin, Germany (A.L.); Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Germany (G.S.); and Universitat Frankfurt Zentrum der Chirurgie, Germany (T.W.). axel.linke@tu-dresden.de.
• Circ Cardiovasc Interv. 2018 Feb 1; 11 (2): e005206.

BackgroundThe aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS).Methods And ResultsHigh-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.6 years; 74.3% women) were enrolled across 12 centers in Europe and Australia. The study's primary end point was all-cause mortality at 30 days. A total of 209 patients who received the Portico TAVI system were available for follow-up after the 30-day visit. Data collection included hemodynamic assessment by echocardiography with core laboratory evaluation and assessment of functional status. Valve Academic Research Consortium-defined adverse events were adjudicated by an independent Clinical Events Committee. TAVI using the Portico valve led to a significant and persistent improvement in aortic valve function at 1 year. More than mild paravalvular leak was present in 5.7% and 7.5% of patients at 30 days and 1 year, respectively. Kaplan-Meier estimates at 30 days and 1 year were 3.6% and 13.8% for all-cause mortality, 3.6% and 9.6% for cardiovascular mortality, and 3.2% and 5.8% for major (disabling) stroke. After 30 days and ≤1 year of follow-up, adverse events included stage 3 acute kidney injury (n=3), major vascular complications (n=5), and life-threatening/disabling bleeding (n=3). Overall permanent pacemaker rate was 14.7%. At 1 year, 74.8% improved ≥1 New York Heart Association class compared with baseline (P<0.0001).ConclusionsThe Portico TAVI system is safe and effective at 1 year, yielding low mortality and stroke rates in high-risk patients with severe AS.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284.© 2018 American Heart Association, Inc.

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