Author + information
- Received October 20, 2017
- Revision received December 19, 2017
- Accepted January 1, 2018
- Published online April 2, 2018.
- Jaffar M. Khan, BM BCha,
- Danny Dvir, MDb,
- Adam B. Greenbaum, MDc,
- Vasilis C. Babaliaros, MDd,
- Toby Rogers, PhD, BM BCha,
- Gabriel Aldea, MDb,
- Mark Reisman, MDb,
- G. Burkhard Mackensen, MDb,
- Marvin H.K. Eng, MDc,
- Gaetano Paone, MDc,
- Dee Dee Wang, MDc,
- Robert A. Guyton, MDd,
- Chandan M. Devireddy, MDd,
- William H. Schenke, BSa and
- Robert J. Lederman, MDa,∗ ()
- aCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- bUniversity of Washington, Seattle, Washington
- cCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan
- dStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. Robert J. Lederman, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 2c713, MSC 1538, Bethesda, Maryland 20892-1538.
Objectives This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA).
Background Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR).
Methods We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual.
Results TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days.
Conclusions BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested.
- bioprosthetic heart valve failure
- coronary artery obstruction
- structural heart disease
- transcatheter aortic valve replacement
- transcatheter electrosurgery
Supported by the National Heart, Lung, and Blood Institute, National Institutes of Health (Z01-HL006040-7), and by the intramural programs of the participating centers. National Heart, Lung, and Blood Institute has a collaborative research and development agreement with Edwards Lifesciences on transcatheter modification of the mitral valve. Dr. Dvir is a consultant for Edwards Lifesciences, Medtronic, and St. Jude Medical. Dr. Greenbaum is a proctor for Edwards Lifesciences and Abbott St. Jude Medical. Dr. Babaliaros is a consultant for Edwards Lifesciences and Abbott Vascular; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific. Dr. Eng is a proctor for Edwards Lifesciences. Dr. Paone is a proctor for Edwards Lifesciences. Dr. Wang is a consultant for Edwards Lifesciences. Dr. Guyton’s employer has research contracts for clinical investigation of aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Devireddy is a consultant for Medtronic; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Khan and Dvir contributed equally to this work.
- Received October 20, 2017.
- Revision received December 19, 2017.
- Accepted January 1, 2018.
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