Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing.

MedStar author(s):
Citation: Jacc: Cardiovascular Interventions. 12(21):2198-2206, 2019 11 11.PMID: 31629746Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Catheterization, Peripheral | *Femoral Artery | *Hemorrhage/pc [Prevention & Control] | *Hemostatic Techniques/is [Instrumentation] | *Transcatheter Aortic Valve Replacement | *Vascular Closure Devices | *Venae Cavae | Aged | Aged, 80 and over | Animals | Aortic Valve Stenosis/dg [Diagnostic Imaging] | Catheterization, Peripheral/ae [Adverse Effects] | Catheterization, Peripheral/is [Instrumentation] | Equipment Design | Feasibility Studies | Female | Femoral Artery/dg [Diagnostic Imaging] | Hemorrhage/et [Etiology] | Hemostatic Techniques/ae [Adverse Effects] | Humans | Male | Models, Animal | Prospective Studies | Punctures | Risk Factors | Sus scrofa | Time Factors | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | Transcatheter Aortic Valve Replacement/is [Instrumentation] | Treatment Outcome | United States | Venae Cavae/dg [Diagnostic Imaging]Year: 2019Local holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.CONCLUSIONS: The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494). Copyright Published by Elsevier Inc.METHODS: Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.OBJECTIVES: The study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).RESULTS: Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.All authors: Babaliaros VC, Chen MY, Eng MH, Greenbaum AB, Khan JM, Lederman RJ, Leshnower BG, Paone G, Rogers T, Satler LF, Schenke WH, Stine AM, Waksman ROriginally published: Jacc: Cardiovascular Interventions. 2019 Oct 11Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2019-11-05
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Journal Article MedStar Authors Catalog Article 31629746 Available 31629746

Available online through MWHC library: 2008 - present

BACKGROUND: Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.

CONCLUSIONS: The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494). Copyright Published by Elsevier Inc.

METHODS: Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.

OBJECTIVES: The study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).

RESULTS: Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.

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