TY - JOUR

T1 - Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve

T2 - One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study

AU - Linke, Axel

AU - Holzhey, David

AU - Möllmann, Helge

AU - Manoharan, Ganesh

AU - Schäfer, Ulrich

AU - Frerker, Christian

AU - Worthley, Stephen G

AU - van Boven, A J

AU - Redwood, Simon

AU - Kovac, Jan

AU - Butter, Christian

AU - Søndergaard, Lars

AU - Lauten, Alexander

AU - Schymik, Gerhard

AU - Walther, Thomas

N1 - © 2018 American Heart Association, Inc.

PY - 2018/2

Y1 - 2018/2

N2 - BACKGROUND: The 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 RESULTS: High-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).CONCLUSIONS: The 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 REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284.

AB - BACKGROUND: The 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 RESULTS: High-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).CONCLUSIONS: The 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 REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284.

U2 - 10.1161/CIRCINTERVENTIONS.117.005206

DO - 10.1161/CIRCINTERVENTIONS.117.005206

M3 - Journal article

C2 - 29444998

VL - 11

SP - 1

EP - 9

JO - Circulation: Cardiovascular Interventions

JF - Circulation: Cardiovascular Interventions

SN - 1941-7640

IS - 2

M1 - e005206

ER -