Thomas G Gleason1, Michael J Reardon2, Jeffrey J Popma3, G Michael Deeb4, Steven J Yakubov5, Joon S Lee6, Neal S Kleiman2, Stan Chetcuti4, James B Hermiller7, John Heiser8, William Merhi8, George L Zorn9, Peter Tadros9, Newell Robinson10, George Petrossian10, G Chad Hughes11, J Kevin Harrison11, John V Conte12, Mubashir Mumtaz13, Jae K Oh14, Jian Huang15, David H Adams16. 1. Departments of Cardiothoracic Surgery and Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: gleasontg@upmc.edu. 2. Departments of Cardiothoracic Surgery and Interventional Cardiology, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas. 3. Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 4. Departments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan. 5. Department of Interventional Cardiology, Riverside Methodist-Ohio Health, Columbus, Ohio. 6. Departments of Cardiothoracic Surgery and Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 7. Department of Interventional Cardiology, St. Vincent's Medical Center, Indianapolis, Indiana. 8. Departments of Cardiothoracic Surgery and Interventional Cardiology, Spectrum Health Hospitals, Grand Rapids, Michigan. 9. Departments of Thoracic Surgery and Interventional Cardiology, The University of Kansas Hospital, Kansas City, Kansas. 10. Departments of Cardiothoracic Surgery and Interventional Cardiology, St. Francis Hospital, Roslyn, New York. 11. Departments of Cardiothoracic Surgery and Interventional Cardiology, Duke University Medical Center, Durham, North Carolina. 12. University of Pittsburgh Medical Center-Pinnacle, Wormleysburg, Pennsylvania. 13. Department of Cardiothoracic Surgery, The Johns Hopkins Hospital, Baltimore, Maryland. 14. Division of Cardiology, Mayo Clinic, Rochester, Minnesota. 15. Statistical Services, Medtronic, Minneapolis, Minnesota. 16. Department of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, New York.
Abstract
BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS:Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
RCT Entities:
BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
Authors: Michael J Reardon; Ted E Feldman; Christopher U Meduri; Raj R Makkar; Daniel O'Hair; Axel Linke; Dean J Kereiakes; Ron Waksman; Vasilis Babliaros; Robert C Stoler; Gregory J Mishkel; David G Rizik; Vijay S Iyer; Thomas G Gleason; Didier Tchétché; Joshua D Rovin; Thibault Lhermusier; Didier Carrié; Robert W Hodson; Dominic J Allocco; Ian T Meredith Journal: JAMA Cardiol Date: 2019-03-01 Impact factor: 14.676
Authors: Muhammad Z Khan; Muhammad U Khan; Muhammad Bilal Munir; Safi U Khan; Mohammed Osman; Sudarshan Balla Journal: Catheter Cardiovasc Interv Date: 2020-03-04 Impact factor: 2.692
Authors: William D Toff; David Hildick-Smith; Jan Kovac; Michael J Mullen; Olaf Wendler; Anita Mansouri; Ines Rombach; Keith R Abrams; Simon P Conroy; Marcus D Flather; Alastair M Gray; Philip MacCarthy; Mark J Monaghan; Bernard Prendergast; Simon Ray; Christopher P Young; David C Crossman; John G F Cleland; Mark A de Belder; Peter F Ludman; Stephen Jones; Cameron G Densem; Steven Tsui; Manoj Kuduvalli; Joseph D Mills; Adrian P Banning; Rana Sayeed; Ragheb Hasan; Douglas G W Fraser; Uday Trivedi; Simon W Davies; Alison Duncan; Nick Curzen; Sunil K Ohri; Christopher J Malkin; Pankaj Kaul; Douglas F Muir; W Andrew Owens; Neal G Uren; Renzo Pessotto; Simon Kennon; Wael I Awad; Saib S Khogali; Maciej Matuszewski; Richard J Edwards; Bandigowdanapalya C Ramesh; Miles Dalby; Shahzad G Raja; Giovanni Mariscalco; Clinton Lloyd; Ian D Cox; Simon R Redwood; Mark G Gunning; Paul D Ridley Journal: JAMA Date: 2022-05-17 Impact factor: 157.335
Authors: Oliver K Jawitz; Brian C Gulack; Maria V Grau-Sepulveda; Roland A Matsouaka; Michael J Mack; David R Holmes; John D Carroll; Vinod H Thourani; J Matthew Brennan Journal: JACC Cardiovasc Interv Date: 2020-06-10 Impact factor: 11.195
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