Background
Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access.
Objectives
We performed a prospective, independently-adjudicated, multi-center, single-arm Investigational Device Exemption trial of transcaval access for TAVR in patients ineligible for femoral artery access and high or prohibitive risk of complications from transthoracic access.
Methods
100 subjects underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing into a prepositioned 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 lab analyzed pre-discharge and 30-day abdominal CT. The STS predicted risk of mortality was 9.6 ± 6.3%.
Results
Transcaval access was successful in 99/100 subjects. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) was 98/99, except for one closed only with a covered stent. Inpatient survival was 96% and 30-day survival was 92%. VARC2 life-threatening bleeding and modified VARC2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 (2–6) days. There were no vascular complications after discharge.
Conclusion
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.
Clinical trial
NCT02280824 on clinicaltrials.gov