Author + information
- Received February 27, 2019
- Revision received May 7, 2019
- Accepted May 16, 2019
- Published online August 19, 2019.
- Matheus Simonato, MDa,b,∗ (, )
- John Webb, MDb,
- Sabine Bleiziffer, MDc,
- Mohamed Abdel-Wahab, MDd,
- David Wood, MDe,
- Moritz Seiffert, MDf,
- Ulrich Schäfer, MDf,
- Jochen Wöhrle, MDg,
- David Jochheim, MDh,
- Felix Woitek, MDi,
- Azeem Latib, MDj,
- Marco Barbanti, MDk,
- Konstantinos Spargias, MDl,
- Susheel Kodali, MDm,
- Tara Jones, MDn,
- Didier Tchetche, MDo,
- Rafael Coutinho, MDp,
- Massimo Napodano, MDq,
- Santiago Garcia, MDr,
- Verena Veulemans, MDs,
- Dimytri Siqueira, MDt,
- Stephan Windecker, MDu,
- Alfredo Cerillo, MDv,
- Jörg Kempfert, MDw,
- Marco Agrifoglio, MDx,
- Nikolaos Bonaros, MDy,
- Wolfgang Schoels, MDz,
- Hardy Baumbach, MDaa,
- Joachim Schofer, MDbb,
- Diego Felipe Gaia, MDa and
- Danny Dvir, MDcc
- aDivision of Cardiac Surgery, Escola Paulista de Medicina – Universidade Federal de São Paulo, São Paulo, Brazil
- bDivision of Cardiology, St. Paul’s Hospital, Vancouver, British Columbia, Canada
- cClinic for Thoracic and Cardiovascular Surgery, Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany
- dDepartment of Cardiology, Herzzentrum Leipzig, Leipzig, Germany
- eDivision of Cardiology, Vancouver General Hospital, Vancouver, British Columbia, Canada
- fDivision of Interventional Cardiology, Universitäres Herzzentrum Hamburg, Hamburg, Germany
- gDepartment of Internal Medicine II - Cardiology, Universitätsklinikum Ulm, Ulm, Germany
- hDepartment of Cardiology, Ludwig-Maximilians-Universität München, Munich, Germany
- iDivision of Cardiology, Herzzentrum Dresden Universitätsklinik, Dresden, Germany
- jDepartment of Cardiology, Montefiore Medical Center, New York, New York
- kDivision of Cardiology, Università degli Studi di Catania, Catania, Italy
- lTranscatheter Heart Valves Department, Hygeia Hospital, Athens, Greece
- mStructural Heart & Valve Center, Columbia University, New York, New York
- nDivision of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah
- oGeneral and Interventional Cardiology, Clinique Pasteur, Toulouse, France
- pDivision of Cardiac Surgery, Universidade Federal da Bahia, Salvador, Brazil
- qDepartment of Cardiovascular, Thoracic and Vascular Science, Università degli Studi di Padova, Padova, Italy
- rInterventional Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota
- sDivision of Cardiology, Pulmonology and Vascular Medicine, Universitätsklinikum Düsseldorf, Düsseldorf, Germany
- tSetor de Intervenção em Valvopatias Adquiridas, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
- uUniversitätsklinik für Kardiologie, Inselspital, Bern, Switzerland
- vDivision of Cardiac Surgery, Fondazione Toscana G. Monasterio, Massa, Italy
- wKlinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin, Berlin, Germany
- xDivision of Cardiac Surgery, Cardiologico Monzino, Milan, Italy
- yDivision of Cardiac Surgery, Medizinische Universität Innsbruck, Innsbruck, Austria
- zKlinik für Kardiologie und Angiologie, Evangelisches Klinikum Niederrhein, Duisburg, Germany
- aaAbteilung für Herz- und Gefäßchirurgie, Robert-Bosch-Krankenhaus, Stuttgart, Germany
- bbDepartment for Percutaneous Treatment of Valvular Heart Disease, Albertinen-Krankenhaus, Hamburg, Germany
- ccDivision of Cardiology, University of Washington, Seattle, Washington
- ↵∗Address for correspondence:
Dr. Matheus Simonato, Escola Paulista de Medicina – Federal University of São Paulo, R. Botucatu, 740, São Paulo, SP, Brazil 04023-900.
Objectives This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies.
Background Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients.
Methods S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%.
Results A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth.
Conclusions Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.
Dr. Webb has been a consultant to Edwards Lifesciences. Dr. Bleiziffer has been a proctor and consultant for Medtronic. Dr. Abdel-Wahab has been a proctor for Boston Scientific; has received institutional lecture fees from Boston Scientific, Medtronic, and Edwards Lifesciences; and has been a consultant to Medtronic. Dr. Wood has received grant support from Abbott and Edwards Lifesciences; and has been a consultant to Medtronic. Dr. Seiffert has received lecture honoraria or travel support from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Schäfer has been a consultant and a member of the Speakers Bureau for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Gore and New Valve Technology; and has received research support from Abbott, Boston Scientific, Edwards Lifesciences, and New Valve Technology. Dr. Latib has served on Advisory Boards for Abbott and Medtronic; and has consulted for Edwards Lifesciences. Dr. Barbanti has been a consultant for Edwards Lifesciences; and has served an Advisory Board member for Biotronik. Dr. Spargias has been a proctor and consultant to Edwards Lifesciences. Dr. Kodali has received institutional support from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; has been a consultant for Claret Medical, Abbott Vascular, Edwards Lifesciences, Medtronic, Meril Lifesciences, Boston Scientific, and Admedus; has served on Advisory Boards for Claret Medical, Admedus, Meril Lifesciences, and Abbott Vascular; and holds equity in Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical. Dr. Garcia has been a consultant to Edwards Lifesciences, Medtronic, and Abbott. Dr. Veulemans is a consultant to Edwards Lifesciences and Medtronic. Dr. Windecker has received research, educational, and travel grants to his institution from Amgen, Abbott, Bayer, BMS, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, St. Jude Medical, Sinomed, Polares, and Terumo. Dr. Cerillo has received speaker fees from Edwards Lifesciences; and is a proctor for Boston Scientific and Symetis. Dr. Kempfert has been a proctor and served on Speakers Bureau for Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr. Bonaros has received research funding from Edwards Lifesciences; and has received speaker honoraria from Edwards Lifesciences and Medtronic. Dr. Dvir has been a consultant to Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 27, 2019.
- Revision received May 7, 2019.
- Accepted May 16, 2019.
- 2019 American College of Cardiology Foundation
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