Literature DB >> 31257214

A Direct Comparison of Self-Expandable Portico Versus Balloon-Expandable Sapien 3 Devices for Transcatheter Aortic Valve Replacement: A Case-Matched Cohort Study.

Silvia Mas-Peiro1, Philipp Christian Seppelt, Helge Weiler, Gina-Lisa Mohr, Nestoras Papadopoulos, Thomas Walther, Andreas M Zeiher, Stephan Fichtlscherer, Mariuca Vasa-Nicotera.   

Abstract

OBJECTIVES: Pairwise comparisons of clinical and hemodynamic outcomes with new transcatheter aortic valve replacement (TAVR) prostheses are needed to help interventionists select the most appropriate device. The self-expandable Portico valve (Abbott Vascular) was compared with the balloon-expandable Sapien 3 valve (Edwards Lifesciences) at a high-volume center in a real-world setting.
METHODS: All patients undergoing TAVR with a new-generation device from March 2015 to September 2017 at a single center were included. Baseline, peri-interventional, and prospective 30-day follow-up data were obtained. A nearest-neighbor propensity-score matching procedure (2:1) was used, based on age, STS score, EuroScore II, New York Heart Association (NYHA) status, and sex. Primary endpoint was 30-day all-cause mortality. Secondary endpoints included procedural results, complications according to Valve Academic Research Consortium (VARC)-2 criteria, and echocardiographic findings.
RESULTS: A total of 177 out of 273 patients were matched (104 Portico valves and 73 Sapien 3 valves). Procedural success rates were 99.0% vs 98.6%, respectively; P=NS). Contrast dye use (160 mL for Portico vs 120 mL for Sapien 3; P<.001) and fluoroscopy time (19.0 min for Portico vs 15.5 min for Sapien 3; P=.048) were significantly lower with the Sapien 3 device. Thirty-day mortality rate was 5.8% for the Portico group vs 4.1% for the Sapien 3 group (P=.74). Complication rates were similar between Portico and Sapien 3 groups: stroke (2.9% vs 4.1%, respectively; P=.31), major bleeding (3.8% vs 5.5%, respectively; P=.51), major vascular complications (5.8% vs 5.5%, respectively; P=.99), and pacemaker implantation (21.9% vs 17.5%, respectively; P=.55). A more-than-mild paravalvular leak was observed in 8.2% vs 4.5%, respectively (P=NS).
CONCLUSIONS: Short-term clinical and hemodynamic outcomes were similar with Portico and Sapien 3 prostheses; no statistically significant differences were observed in mortality and major complication rates. An individually tailored prosthesis choice is suggested.

Entities:  

Keywords:  Portico; Sapien 3; Valve Academic Research Consortium (VARC)-2 criteria; aortic stenosis; new-generation device; transcatheter aortic valve replacement

Year:  2019        PMID: 31257214

Source DB:  PubMed          Journal:  J Invasive Cardiol        ISSN: 1042-3931            Impact factor:   2.022


  5 in total

1.  Overcoming the transcatheter aortic valve replacement Achilles heel: conduction abnormalities-a systematic review.

Authors:  Alberto Alperi; Guillem Muntané-Carol; Afonso B Freitas-Ferraz; Lucia Junquera; David Del Val; Laurent Faroux; François Philippon; Josep Rodés-Cabau
Journal:  Ann Cardiothorac Surg       Date:  2020-11

Review 2.  Transcatheter Aortic Valve Replacement Programs: Clinical Outcomes and Developments.

Authors:  Vinayak Kumar; Gurpreet S Sandhu; Charles M Harper; Henry H Ting; Charanjit S Rihal
Journal:  J Am Heart Assoc       Date:  2020-04-17       Impact factor: 5.501

3.  Comparison of latest generation supra-annular and intra-annular self-expanding transcatheter heart valves.

Authors:  Costanza Pellegrini; Tobias Rheude; Jonathan Michel; Hector A Alvarez-Covarrubias; Sarah Wünsch; N Patrick Mayr; Erion Xhepa; Adnan Kastrati; Heribert Schunkert; Michael Joner; Markus Kasel
Journal:  J Thorac Dis       Date:  2020-11       Impact factor: 2.895

Review 4.  An Update on New Generation Transcatheter Aortic Valves and Delivery Systems.

Authors:  Gloria Santangelo; Alfonso Ielasi; Mariano Pellicano; Azeem Latib; Maurizio Tespili; Francesco Donatelli
Journal:  J Clin Med       Date:  2022-01-19       Impact factor: 4.241

5.  Thirty-day incidence of stroke after transfemoral transcatheter aortic valve implantation: meta-analysis and mixt-treatment comparison of self-expandable versus balloon-expandable valve prostheses.

Authors:  Philipp C Seppelt; Silvia Mas-Peiro; Roberta De Rosa; Zisis Dimitriasis; Andreas M Zeiher; Mariuca Vasa-Nicotera
Journal:  Clin Res Cardiol       Date:  2020-11-29       Impact factor: 5.460

  5 in total

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