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Rigshospitalet - en del af Københavns Universitetshospital
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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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • 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
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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.

OriginalsprogEngelsk
TidsskriftCirculation. Cardiovascular interventions
Vol/bind11
Udgave nummer2
Sider (fra-til)e005206
ISSN1941-7640
DOI
StatusUdgivet - feb. 2018

ID: 56522605