Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study.

Abstract

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.

• Authors: 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, Thomas Walther
• Journal: Circulation. Cardiovascular interventions (Circ Cardiovasc Interv) Vol. 11 Issue 2 Pg. e005206 (02 2018) ISSN: 1941-7632 [Electronic] United States
• PMID: 29444998 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 American Heart Association, Inc.

Topics

• Aged
• Aged, 80 and over
• Aortic Valve (diagnostic imaging, physiopathology, surgery)
• Aortic Valve Stenosis (diagnostic imaging, mortality, physiopathology, surgery)
• Australia (epidemiology)
• Cardiac Catheters
• Europe (epidemiology)
• Female
• Heart Valve Prosthesis
• Hemodynamics
• Humans
• Male
• Postoperative Complications (epidemiology)
• Prospective Studies
• Prosthesis Design
• Recovery of Function
• Severity of Illness Index
• Time Factors
• Transcatheter Aortic Valve Replacement (adverse effects, instrumentation, mortality)
• Treatment Outcome