Author + information
- Received January 22, 2019
- Revision received February 20, 2019
- Accepted March 11, 2019
- Published online June 12, 2019.
- Jaffar M. Khan, BM BCha,
- Adam B. Greenbaum, MDb,c,
- Vasilis C. Babaliaros, MDc,
- Toby Rogers, BM BCh, PhDa,d,
- Marvin H. Eng, MDb,
- Gaetano Paone, MDb,
- Bradley G. Leshnower, MDc,
- Mark Reisman, MDe,
- Lowell Satler, MDd,
- Ron Waksman, MDd,
- Marcus Y. Chen, MDa,
- Annette M. Stine, RNa,
- Xin Tian, PhDa,
- Danny Dvir, MDe and
- Robert J. Lederman, MDa,∗ ()
- aCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- bCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan
- cStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia
- dMedstar Washington Hospital Center, Washington, DC
- eUniversity of Washington, Seattle, Washington
- ↵∗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 The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.
Background Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.
Methods Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.
Results Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.
Conclusions BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.
- bioprosthetic heart valve failure
- coronary artery obstruction
- structural heart disease
- transcatheter aortic valve replacement
- transcatheter electrosurgery
This work was supported by the Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health (Z01-HL006040-7), and by the intramural programs of the participating centers. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and a consultant for Transmural Systems. Dr. Babaliaros has served as 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. Rogers has served as a consultant for Medtronic; and a physician proctor for Edwards Lifesciences and Medtronic. Drs. Eng and Paone have served as proctors for Edwards Lifesciences. Dr. Leshnower has served on the Medtronic Speakers Bureau. Dr. Waksman has served on the advisory board for Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips Volcano, and Pi-Cardia; has served as a consultant for Abbott Vascular, Amgen, Boston Scientific, Biotronik, Biosensors, Cardioset, Cardiovascular Systems, Philips Volcano, Pi-Cardia, and Medtronic; has received grant support from Abbott Vascular, AstraZeneca, Boston Scientific, and Chiesi; has served on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in MedAlliance. Dr. Dvir has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Vascular. Drs. Khan, Rogers, and Lederman are co-inventors on patents, assigned to the National Institutes of Health, on catheter devices to lacerate valve leaflets. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Lars Soendergaard, MD, served as the Guest Editor for this paper.
- Received January 22, 2019.
- Revision received February 20, 2019.
- Accepted March 11, 2019.
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