Jaffar M Khan1, Vasilis C Babaliaros2, Adam B Greenbaum2, Christian Spies3, David Daniels3, Jeremiah P Depta4, J Bradley Oldemeyer5, Brian Whisenant6, James M McCabe7, Kamran I Muhammad8, Isaac George9, Paul Mahoney10, Jonas Lanz11, Roger J Laham12, Pinak B Shah13, Adnan Chhatriwalla14, Shahram Yazdani15, George Hanzel16, Ashish Pershad17, Robert A Leonardi18, Ramzi Khalil19, Gilbert H L Tang20, Howard C Herrmann21, Shikhar Agarwal22, Peter S Fail23, Ming Zhang24, Andrei Pop25, John Lisko2, Emily Perdoncin2, Rachel L Koch2, Itsik Ben-Dor26, Lowell F Satler26, Cheng Zhang26, Jeffrey E Cohen26, Robert J Lederman27, Ron Waksman28, Toby Rogers1. 1. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA; Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. 2. Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA. 3. Burlingame Center, BASH-Sutter Health, San Francisco, California, USA. 4. Sands Constellation Heart Institute, Rochester Regional Health, Rochester, New York, USA. 5. UC Health Heart and Vascular Clinic, Medical Center of the Rockies, Loveland, Colorado, USA. 6. Department of Cardiology, Intermountain Medical Center, Salt Lake City, Utah, USA. 7. Section of Interventional Cardiology, University of Washington, Seattle, Washington, USA. 8. Section of Interventional Cardiology, Oklahoma Heart Institute, Tulsa, Oklahoma, USA. 9. Department of Surgery, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York, USA. 10. Structural Heart Center, Sentara Heart Hospital, Norfolk, Virginia, USA. 11. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 12. Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 13. Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. 14. St. Luke's Mid America Heart Institute, St. Luke's Hospital of Kansas City, Kansas City, Missouri, USA. 15. Section of Structural Heart Disease, Carient Heart and Vascular, Manassas, Virginia, USA. 16. Department of Cardiology, Beaumont Hospital, Royal Oak, Michigan, USA. 17. Section of Interventional Cardiology, Banner University Medical Center, Phoenix, Arizona, USA. 18. Lexington Heart and Vascular Center, Lexington Medical Center, West Columbia, South Carolina, USA. 19. Department of Cardiology, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA. 20. Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, New York, USA. 21. Section of Interventional Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA. 22. Geisinger Heart Institute, Geisinger Medical Center, Danville, Pennsylvania, USA. 23. Section of Interventional Cardiology, Cardiovascular Center of the South, Houma, Louisiana, USA. 24. Department of Cardiovascular Services, Swedish Medical Center, Seattle, Washington, USA. 25. AMITA Health Medical Group Heart and Vascular, Alexian Brothers Medical Center, Elk Grove Village, Illinois, USA. 26. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. 27. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA. 28. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: ron.waksman@medstar.net.
Abstract
OBJECTIVES: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. BACKGROUND: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. METHODS: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. RESULTS: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. CONCLUSIONS: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.
OBJECTIVES: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. BACKGROUND: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. METHODS: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. RESULTS: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. CONCLUSIONS: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.
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