The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study.
The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study.
- 2019
Available online through MWHC library: 2008 - present
BACKGROUND: Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. CONCLUSIONS: Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824). Copyright Published by Elsevier Inc. METHODS: The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). OBJECTIVES: The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. RESULTS: 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury.
English
1936-8798
10.1016/j.jcin.2018.11.035 [doi] NIHMS1521040 [mid] PMC6531678 [pmc] S1936-8798(18)32390-2 [pii]
*Aortic Valve/su [Surgery]
*Catheterization, Peripheral/mt [Methods]
*Transcatheter Aortic Valve Replacement
*Vena Cava, Inferior
Aged
Aged, 80 and over
Alloys
Aortic Valve/dg [Diagnostic Imaging]
Aortic Valve/pp [Physiopathology]
Catheterization, Peripheral/ae [Adverse Effects]
Equipment Design
Feasibility Studies
Female
Humans
Male
Prospective Studies
Punctures
Time Factors
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/is [Instrumentation]
Transcatheter Aortic Valve Replacement/mo [Mortality]
Treatment Outcome
Vascular Closure Devices
Vascular System Injuries/et [Etiology]
Vena Cava, Inferior/dg [Diagnostic Imaging]
MedStar Heart & Vascular Institute
Journal Article
Available online through MWHC library: 2008 - present
BACKGROUND: Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. CONCLUSIONS: Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824). Copyright Published by Elsevier Inc. METHODS: The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). OBJECTIVES: The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. RESULTS: 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury.
English
1936-8798
10.1016/j.jcin.2018.11.035 [doi] NIHMS1521040 [mid] PMC6531678 [pmc] S1936-8798(18)32390-2 [pii]
*Aortic Valve/su [Surgery]
*Catheterization, Peripheral/mt [Methods]
*Transcatheter Aortic Valve Replacement
*Vena Cava, Inferior
Aged
Aged, 80 and over
Alloys
Aortic Valve/dg [Diagnostic Imaging]
Aortic Valve/pp [Physiopathology]
Catheterization, Peripheral/ae [Adverse Effects]
Equipment Design
Feasibility Studies
Female
Humans
Male
Prospective Studies
Punctures
Time Factors
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/is [Instrumentation]
Transcatheter Aortic Valve Replacement/mo [Mortality]
Treatment Outcome
Vascular Closure Devices
Vascular System Injuries/et [Etiology]
Vena Cava, Inferior/dg [Diagnostic Imaging]
MedStar Heart & Vascular Institute
Journal Article