Won-Keun Kim1, Miriam Brinkert2, Norman Mangner3, Fernando Gatto4, Oliver Husser5, Matthias Renker6, Christoph Liebetrau7, Tomasz Gasior3, Mirko Doss8, Thomas Walther8, Christian Hamm7, Axel Linke3, Stefan Toggweiler2, Helge Möllmann5. 1. Kerckhoff Heart Center, Department of Cardiology, Benekestr. 2-8, 61231 Bad Nauheim, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhein-Main, Frankfurt am Main, Germany; Kerckhoff Heart Center, Department of Cardiac Surgery, Benekestr. 2-8, 61231 Bad Nauheim, Germany; Justus-Liebig University of Giessen, Department of Cardiology, Rudolf-Buchheim-Str. 6, 35392 Giessen, Germany. Electronic address: w.kim@kerckhoff-klinik.de. 2. Heart Center Lucerne, Luzerner Kantonsspital, Bahnhofstrasse 3, 6002 Lucerne, Switzerland. 3. University of Leipzig-Heart Center, Department of Internal Medicine/Cardiology, Strümpellstrasse 39, 04289 Leipzig, Germany. 4. Völklingen Heart Center, Internal Medicine Clinic I, Pasteurstraße 11, 66333 Völklingen, Germany. 5. St.-Johannes-Hospital Dortmund, Department of Cardiology, Johannesstraße 9-17, 44137 Dortmund, Germany. 6. Kerckhoff Heart Center, Department of Cardiology, Benekestr. 2-8, 61231 Bad Nauheim, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhein-Main, Frankfurt am Main, Germany; Kerckhoff Heart Center, Department of Cardiac Surgery, Benekestr. 2-8, 61231 Bad Nauheim, Germany. 7. Kerckhoff Heart Center, Department of Cardiology, Benekestr. 2-8, 61231 Bad Nauheim, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhein-Main, Frankfurt am Main, Germany; Justus-Liebig University of Giessen, Department of Cardiology, Rudolf-Buchheim-Str. 6, 35392 Giessen, Germany. 8. Kerckhoff Heart Center, Department of Cardiac Surgery, Benekestr. 2-8, 61231 Bad Nauheim, Germany.
Abstract
BACKGROUND: The ACURATE neo prosthesis is commonly implanted using introducer sheaths with inner diameters of up to 20 French. The use of only the expandable mesh component of the transGlide introducer system (Meshonly) would substantially decrease the inner diameter to 13 French. We sought to assess the feasibility and safety of using Meshonly for femoral access of the ACURATE neo device and to compare outcomes with patients in whom standard sheaths were used. METHODS AND RESULTS: We retrospectively analyzed a total of 551 patients with severe aortic stenosis from 4 high volume centers in Germany and Switzerland undergoing transfemoral TAVI between February 2016 and February 2018 with implantation of the ACURATE neo device. The median age was 81.7 [78.3-85.2], 67.0% were female, the STS score was 4.2% [2.8-6.5]. The use of the Meshonly was feasible in all attempted cases (n = 272); in all other patients, a standard sheath was used. Major vascular complications at the main access-site (VARC-2) were less frequent in the Meshonly group than in the standard sheath group (1.5% vs. 7.9%; p < 0.001). In the multivariable analysis, the use of Meshonly was independently associated with less major vascular complications (odds ratio 0.10 [95% CI 0.02-0.48]; p = 0.004). CONCLUSIONS: Transfemoral implantation of the ACURATE neo device using the Meshonly was associated with a lower rate of major access-related complications when compared to the standard of care.
BACKGROUND: The ACURATE neo prosthesis is commonly implanted using introducer sheaths with inner diameters of up to 20 French. The use of only the expandable mesh component of the transGlide introducer system (Meshonly) would substantially decrease the inner diameter to 13 French. We sought to assess the feasibility and safety of using Meshonly for femoral access of the ACURATE neo device and to compare outcomes with patients in whom standard sheaths were used. METHODS AND RESULTS: We retrospectively analyzed a total of 551 patients with severe aortic stenosis from 4 high volume centers in Germany and Switzerland undergoing transfemoral TAVI between February 2016 and February 2018 with implantation of the ACURATE neo device. The median age was 81.7 [78.3-85.2], 67.0% were female, the STS score was 4.2% [2.8-6.5]. The use of the Meshonly was feasible in all attempted cases (n = 272); in all other patients, a standard sheath was used. Major vascular complications at the main access-site (VARC-2) were less frequent in the Meshonly group than in the standard sheath group (1.5% vs. 7.9%; p < 0.001). In the multivariable analysis, the use of Meshonly was independently associated with less major vascular complications (odds ratio 0.10 [95% CI 0.02-0.48]; p = 0.004). CONCLUSIONS: Transfemoral implantation of the ACURATE neo device using the Meshonly was associated with a lower rate of major access-related complications when compared to the standard of care.
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