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Multicenter Study
. 2021 May 10;14(9):941-948.
doi: 10.1016/j.jcin.2021.02.035. Epub 2021 Mar 6.

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry

Jaffar M Khan  1 , Vasilis C Babaliaros  2 , Adam B Greenbaum  2 , Christian Spies  3 , David Daniels  3 , Jeremiah P Depta  4 , J Bradley Oldemeyer  5 , Brian Whisenant  6 , James M McCabe  7 , Kamran I Muhammad  8 , Isaac George  9 , Paul Mahoney  10 , Jonas Lanz  11 , Roger J Laham  12 , Pinak B Shah  13 , Adnan Chhatriwalla  14 , Shahram Yazdani  15 , George Hanzel  16 , Ashish Pershad  17 , Robert A Leonardi  18 , Ramzi Khalil  19 , Gilbert H L Tang  20 , Howard C Herrmann  21 , Shikhar Agarwal  22 , Peter S Fail  23 , Ming Zhang  24 , Andrei Pop  25 , John Lisko  2 , Emily Perdoncin  2 , Rachel L Koch  2 , Itsik Ben-Dor  26 , Lowell F Satler  26 , Cheng Zhang  26 , Jeffrey E Cohen  26 , Robert J Lederman  27 , Ron Waksman  28 , Toby Rogers  1
Affiliations
Multicenter Study

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry

Jaffar M Khan et al. JACC Cardiovasc Interv. .

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.

Keywords: cerebral embolic protection; coronary artery obstruction; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures This work was supported by National Heart, Lung, and Blood Institute grant Z01-HL006061. Drs. Khan, Rogers, and Lederman are co-inventors on patents, assigned to National Institutes of Health, on catheter devices to lacerate valve leaflets. Dr. Khan has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Babaliaros has served as a consultant for Edwards Lifesciences, Abbott Vascular, and Transmural Systems; 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. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and owns equity in Transmural Systems. Dr. Depta has served as a consultant and on the advisory board for Edwards Lifesciences, Boston Scientific, and W.L. Gore and Associates. Dr. McCabe has received honoraria from and served as a consultant for Medtronic and Edwards Lifesciences. Dr. Muhammad has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott. Dr. Mahoney has served as a consultant and proctor for Edwards Lifesciences and Medtronic. Dr. Shah has served as a proctor Edwards Lifesciences; and has received educational grants from Edwards Lifesciences, Abbott, and Medtronic. Dr. Chhatriwalla has served on the Speakers Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic; has served as a consultant for Boston Scientific and Silk Road Medical; has received research grant support from Boston Scientific; and has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Leonardi has served as a proctor for Edwards Lifesciences. Dr. Khalil has served as a proctor for Medtronic and Edwards Lifesciences. Dr. Tang has served as a physician proctor for Medtronic; and has served as a consultant for Medtronic, Abbott Structural Heart, and W.L. Gore and Associates. Dr. Herrmann has received institutional research funding from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting and speaking honoraria from Edwards Lifesciences and Medtronic. Dr. Fail has served as a proctor for Medtronic. Dr. Pop has served as consultant for Edwards Lifesciences. Dr. Lederman has served as the principal investigator on a Cooperative Research and Development Agreement between the National Institutes of Health and Edwards Lifesciences on transcatheter modification of the mitral valve. Dr. Waksman has served as a consultant for Medtronic and Abbott Vascular; and has received grant support from Abbott Vascular. Dr. Rogers has served as a consultant or proctor for Edwards Lifesciences and Medtronic; and owns equity in Transmural Systems. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1:
Figure 1:
Representative BASILICA procedure. A) Pre-procedure CT demonstrates high risk of both left and right coronary artery obstruction in a patient with a degenerated Trifecta valve. B) Fluoroscopy showing left leaflet traversal with a guidewire. C) Left and right BASILICA system in place ready for laceration. D) Aortic root angiography after BASILICA and TAVR demonstrates patent coronary arteries. BASILICA: Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction; CT: computed tomography; TAVR: transcatheter aortic valve replacement; VTC: virtual transcatheter to coronary distance.
Central Illustration:
Central Illustration:
Outcomes from the International BASILICA Registry
See this image and copyright information in PMC

Comment in

References

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