Ron Waksman1, Toby Rogers2, Rebecca Torguson2, Paul Gordon3, Afshin Ehsan4, Sean R Wilson5, John Goncalves6, Robert Levitt7, Chiwon Hahn8, Puja Parikh9, Thomas Bilfinger10, David Butzel11, Scott Buchanan11, Nicholas Hanna12, Robert Garrett13, Federico Asch14, Gaby Weissman15, Itsik Ben-Dor2, Christian Shults16, Roshni Bastian2, Paige E Craig2, Hector M Garcia-Garcia2, Paul Kolm2, Quan Zou2, Lowell F Satler2, Paul J Corso16. 1. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net. 2. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. 3. Division of Cardiology, The Miriam Hospital, Providence, Rhode Island. 4. Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island. 5. Department of Medicine, The Valley Hospital, Ridgewood, New Jersey. 6. Cardiac Surgery Program, The Valley Hospital, Ridgewood, New Jersey. 7. Department of Cardiology, Henrico Doctors' Hospital, Richmond, Virginia. 8. Department of Cardiothoracic Surgery, Henrico Doctors' Hospital, Richmond, Virginia. 9. Department of Medicine, Stony Brook Hospital, Stony Brook, New York. 10. Department of Surgery, Stony Brook Hospital, Stony Brook, New York. 11. Cardiovascular Service Line, Maine Medical Center, Portland, Maine. 12. St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma. 13. St. John Clinic Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma. 14. MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC. 15. Department of Cardiology, MedStar Washington Hospital Center, Washington, DC. 16. Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. METHODS: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration-approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. RESULTS: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting-adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. CONCLUSIONS: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899).
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. METHODS: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration-approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. RESULTS: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting-adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. CONCLUSIONS: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899).
Authors: Luise Gaede; Johannes Blumenstein; Christoph Liebetrau; Oliver Dörr; Won-Keun Kim; Holger Nef; Oliver Husser; Jan Gülker; Albrecht Elsässer; Christian W Hamm; Stephan Achenbach; Helge Möllmann Journal: Clin Res Cardiol Date: 2019-06-24 Impact factor: 5.460
Authors: Wolfgang von Scheidt; A Welz; M Pauschinger; T Fischlein; V Schächinger; H Treede; R Zahn; M Hennersdorf; J M Albes; R Bekeredjian; M Beyer; J Brachmann; C Butter; L Bruch; H Dörge; W Eichinger; U F W Franke; N Friedel; T Giesler; R Gradaus; R Hambrecht; M Haude; H Hausmann; M P Heintzen; W Jung; S Kerber; H Mudra; T Nordt; L Pizzulli; F-U Sack; S Sack; B Schumacher; G Schymik; U Sechtem; C Stellbrink; C Stumpf; H M Hoffmeister Journal: Clin Res Cardiol Date: 2019-08-13 Impact factor: 5.460
Authors: Jaffar M Khan; Adam B Greenbaum; Vasilis C Babaliaros; Toby Rogers; Marvin H Eng; Gaetano Paone; Bradley G Leshnower; Mark Reisman; Lowell Satler; Ron Waksman; Marcus Y Chen; Annette M Stine; Xin Tian; Danny Dvir; Robert J Lederman Journal: JACC Cardiovasc Interv Date: 2019-06-12 Impact factor: 11.195
Authors: Aleksandra Gasecka; Michał Walczewski; Adam Witkowski; Maciej Dabrowski; Zenon Huczek; Radosław Wilimski; Andrzej Ochała; Radosław Parma; Piotr Scisło; Bartosz Rymuza; Karol Zbroński; Piotr Szwed; Marek Grygier; Anna Olasińska-Wiśniewska; Dariusz Jagielak; Radosław Targoński; Grzegorz Opolski; Janusz Kochman Journal: Front Cardiovasc Med Date: 2022-06-21
Authors: Sameer A Hirji; Ellen McCarthy; Dae Kim; Siobhan McGurk; Julius Ejiofor; Fernando Ramirez-Del Val; Ahmed A Kolkailah; Bernard Rosner; Douglas Shook; Charles Nyman; Natalia Berry; Piotr Sobieszczyk; Marc Pelletier; Pinak Shah; Patrick O'Gara; Tsuyoshi Kaneko Journal: JACC Cardiovasc Interv Date: 2020-02-10 Impact factor: 11.195