Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement

Concept to First-in-Human

Jaffar M. Khan, Danny Dvir, Adam B. Greenbaum, Vasilis C. Babaliaros, Toby Rogers, Gabriel Aldea, Mark Reisman, G. Burkhard Mackensen, Marvin H.K. Eng, Gaetano Paone, Dee Dee Wang, Robert A. Guyton, Chandan M. Devireddy, William H. Schenke, Robert J. Lederman

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)677-689
Number of pages13
JournalJACC: Cardiovascular Interventions
Volume11
Issue number7
DOIs
StatePublished - Apr 9 2018
Externally publishedYes

Fingerprint

Lacerations
Aortic Valve
Coronary Vessels
Swine
Catheters
Electrosurgery
Pectinidae
Equipment and Supplies
Aortic Diseases
Aortic Valve Insufficiency
Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Surgical Instruments
Stents
Hot Temperature
Hemodynamics
Stroke
Wounds and Injuries

Keywords

  • bioprosthetic heart valve failure
  • coronary artery obstruction
  • structural heart disease
  • transcatheter aortic valve replacement
  • transcatheter electrosurgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement : Concept to First-in-Human. / Khan, Jaffar M.; Dvir, Danny; Greenbaum, Adam B.; Babaliaros, Vasilis C.; Rogers, Toby; Aldea, Gabriel; Reisman, Mark; Mackensen, G. Burkhard; Eng, Marvin H.K.; Paone, Gaetano; Wang, Dee Dee; Guyton, Robert A.; Devireddy, Chandan M.; Schenke, William H.; Lederman, Robert J.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 7, 09.04.2018, p. 677-689.

Research output: Contribution to journalArticle

Khan, JM, Dvir, D, Greenbaum, AB, Babaliaros, VC, Rogers, T, Aldea, G, Reisman, M, Mackensen, GB, Eng, MHK, Paone, G, Wang, DD, Guyton, RA, Devireddy, CM, Schenke, WH & Lederman, RJ 2018, 'Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human', JACC: Cardiovascular Interventions, vol. 11, no. 7, pp. 677-689. https://doi.org/10.1016/j.jcin.2018.01.247
Khan, Jaffar M. ; Dvir, Danny ; Greenbaum, Adam B. ; Babaliaros, Vasilis C. ; Rogers, Toby ; Aldea, Gabriel ; Reisman, Mark ; Mackensen, G. Burkhard ; Eng, Marvin H.K. ; Paone, Gaetano ; Wang, Dee Dee ; Guyton, Robert A. ; Devireddy, Chandan M. ; Schenke, William H. ; Lederman, Robert J. / Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement : Concept to First-in-Human. In: JACC: Cardiovascular Interventions. 2018 ; Vol. 11, No. 7. pp. 677-689.
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abstract = "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.",
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AU - Greenbaum, Adam B.

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AU - Aldea, Gabriel

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