Key result
Transcaval access for TAVR achieves ~99% device success in patients ineligible for femoral access.
Why the study?
Transcaval access may allow percutaneous TAVR without the risks and discomfort of transthoracic access in patients ineligible for femoral access.
Does transcaval access and closure allow for successful TAVR in patients ineligible for femoral and transthoracic access?
Does transcaval access and closure allow for successful TAVR in patients ineligible for femoral and transthoracic access?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“While devices have improved, there remains a need for robust techniques to provide TAVR to patients without adequate femoral access. Our guidelines focus on the safest and most effective alternative access methods based on observational evidence.”
“With this expert consensus document, we aim to help clinicians better care for their patients by providing guidance on the safest and most efficacious routes for alternative access to TAVR. This is crucial as the TAVR population continues to grow.”
Transcaval access provides a feasible alternative route for TAVR in patients without femoral or transthoracic access options, with acceptable complication rates for a high-risk cohort.
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).
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Greenbaum et al. (2016) studied Aortic stenosis requiring TAVR (n=100). Transcaval access for TAVR was evaluated on Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue).
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