Transcaval Access and Closure for Transcatheter Aortic Valve Replacement

Abstract

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

Percutaneous access planning, techniques and considerations for endovascular aortic repair (EVAR)

“…This percutaneous approach can be used for thoracic aortic aneurysm repair in patients with severe peripheral arterial disease, highly unusual anatomy, or those with contraindications to arterial access due to calcification or narrowed effective lumen diameter of the iliac or femoral arteries. Because of the novelty of this technique, further investigation regarding the largerscale cost-effectiveness and safety is warranted; however, an early study has indicated a successful transcaval access and closure in 99 out of 100 attempts during TAVR procedures (28,33). The one complication in this study occurred when the guidewire failed to cross and the operator had to perform transfemoral artery TAVR, which was further complicated by iliac artery rupture.…”

First-in-Human Closed-Chest Transcatheter Superior Cavopulmonary Anastomosis

“…In unoperated patients, sharp wire puncture was used to create a restrictive 7 mm transcatheter Potts shunt (small descending thoracic aorta to left PA communication) surrogate in a small number of adults with end-stage PA hypertension (26). We employed our new transcatheter electro-wire crossing technique currently being used to enable precise crossing from inferior vena cava to aorta for temporary access prior to tract device closure (14,15). …”

“…We trained in the electro-wire crossing technique with experienced operators during clinical transcaval access for transcatheter aortic valve replacement (15). We planned the procedure step by step using pre-procedure contrast-enhanced computed tomography (CT) (Figure 2) (16).…”

“…The procedure has 3 key steps: 1) the walls of 2 nearby blood vessels to be connected (SVC and right PA) were traversed by electrifying a small, insulated commercial 0.014” guidewire as described (14,15); 2) after the wire connected the 2 large blood vessels, we implanted a covered stent (“endograft”) to bridge the 2 vessels; and 3) BMS anchoring was used as an SVC end-to-end anastomosis landing zone and to secure the right PA end-to-side anastomosis. In addition, the azygous vein was occluded with a vascular plug device to complete the flow diversion.…”

Sheathless Transcaval Transcatheter Aortic Valve Implantation Through an Abdominal Aortic Graft

“…Transcaval access appears a safe and reliable alternative for these patients. 1 Pressurization of the retroperitoneal space and consecutive drainage of aortic blood via shunting into the vena cava constitutes the pathophysiological concept underlying the feasibility of this approach. 1,2 No cases of transcatheter valve delivery via transcaval access without placing any sheath across the retroperitoneal space have been reported so far.…”