Transcaval Access and Closure for TAVR Prospective Trial

Study Questions:

What is the safety and feasibility of transcaval access to enable fully percutaneous transcatheter aortic valve replacement (TAVR)?

Methods:

The investigators performed a prospective, independently-adjudicated, multicenter, 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. A total of 100 patients 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 predischarge and 30-day abdominal computed tomography. The Society of Thoracic Surgeons (STS) predicted risk of mortality was 9.6 ± 6.3%.

Results:

Transcaval access was successful in 99/100 patients. 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%. Second Valve Academic Research Consortium (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.

Conclusions:

The authors concluded that transcaval access enabled TAVR in patients who were not good candidates for transthoracic access.

Perspective:

This single-arm cohort study reports that 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 appear acceptable in this high-risk cohort. While cautious optimism is warranted, additional studies are indicated to investigate transcaval access in patients with and without good access options. Purpose-built closure devices are in development and may possibly simplify the procedure and reduce bleeding.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Nuclear Imaging

Keywords: Aorta, Abdominal, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Stents, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, Vascular Closure Devices


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