title: Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation.
abstract: BACKGROUND
  Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access.
  
  
  OBJECTIVE
  The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access.
  
  
  METHODS
  A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%.
  
  
  RESULTS
  Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge.
  
  
  CONCLUSIONS
  Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).
authors.affiliation: Henry Ford Hospital, Detroit, Michigan.
authors.forename: Adam B
authors.initials: AB
authors.lastname: Greenbaum
authors.affiliation: Emory University, Atlanta, Georgia.
authors.forename: Vasilis C
authors.initials: VC
authors.lastname: Babaliaros
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Marcus Y
authors.initials: MY
authors.lastname: Chen
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Annette M
authors.initials: AM
authors.lastname: Stine
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Toby
authors.initials: T
authors.lastname: Rogers
authors.affiliation: Henry Ford Hospital, Detroit, Michigan.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.affiliation: Henry Ford Hospital, Detroit, Michigan.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Paone
authors.affiliation: Emory University, Atlanta, Georgia.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Oklahoma Heart Institute, Tulsa, Oklahoma.
authors.forename: Kamran I
authors.initials: KI
authors.lastname: Muhammad
authors.affiliation: Lexington Medical Center, West Columbia, South Carolina.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Leonardi
authors.affiliation: Ochsner Medical Center, New Orleans, Louisiana.
authors.forename: Stephen
authors.initials: S
authors.lastname: Ramee
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: James F
authors.initials: JF
authors.lastname: Troendle
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: lederman@nih.gov.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lederman
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D002404:Catheterization / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D014684:Venae Cavae
keywords: caval-aortic access; nontransfemoral access; structural heart disease; transcatheter aortic valve replacement; transcaval; vascular access