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Author Notes:

Address for correspondence: Dr. Robert J. Lederman, Cardiovascular and Pulmonary 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. lederman@nih.gov

Dr. Greenbaum is a proctor for Edwards Lifesciences and St. Jude Medical; and his employer receives research support from St. Jude Medical.

Dr. Babaliaros is a researcher and consultant for Edwards Lifesciences and Abbott Vascular; and his employer receives research support from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific.

Dr. O’Neill is a consultant for Edwards Lifesciences, Medtronic, St. Jude Medical, and Boston Scientific.

Dr. Paone is a consultant and proctor for Edwards Lifesciences.

Dr. Thourani is a consultant for Edwards Lifesciences and Abbott Vascular; and his employer receives research support from Edwards Lifesciences, Boston Scientific, Medtronic, St. Jude Medical, and Abbott Medical.

Dr. Muhammad is a consultant for Edwards Lifesciences and Abiomed.

Dr. Leonardi is a consultant for St. Jude Medical; and a paid speaker for Edwards Lifesciences.

Dr. Ramee is an investigator for Edwards Lifesciences and St. Jude Medical; and has received honoraria from Edwards Lifesciences and Medtronic.

Drs. Greenbaum, Rogers, and Lederman are co-inventors of devices, not tested in this protocol, intended to close transcaval access.

The other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Subject:

Research Funding:

Supported by the NHLBI Division of Intramural Research Z01-HL006040.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • caval-aortic access
  • nontransfemoral access
  • structural heart disease
  • transcatheter aortic valve replacement
  • transcaval
  • vascular access
  • INTERMEDIATE-RISK PATIENTS
  • IMPLANTATION
  • REGISTRY
  • STENOSIS
  • BIOPROSTHESIS
  • EXPERIENCE
  • OUTCOMES
  • SURGERY

Transcaval Access and Closure for Transcatheter Aortic Valve Replacement A Prospective Investigation

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Journal Title:

Journal of the American College of Cardiology

Volume:

Volume 69, Number 5

Publisher:

, Pages 511-521

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Background Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. Objectives 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)

Copyright information:

© 2017

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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