Abstract
To evaluate the usage pattern, feasibility, and complications associated with use of the Solopath Introducer System (Terumo Medical; Tokyo, Japan), a balloon-expandable, re-collapsible sheath in patients undergoing thoracic aortic endovascular repair (TEVAR). Of 212 consecutive TEVAR procedures from 6/2014 - 8/2018, the Solopath Introducer System was used in 22 (13 female) patients. Mean age was 71.9 (range 59-82) years and mean body mass index was 26.5 (range 17-40) kg/m2. All patients underwent TEVAR for aneurysm, dissection, and/or intramural hematoma; three presented with acute aortic rupture. Each of the 22 patients who underwent attempted placement of the balloon-expandable sheath had narrow, calcified, and/or tortuous iliac arteries. Mean minimal iliac diameter was 5.4 mm and most commonly occurred in the external iliac artery (17/22 patients, 77%). The balloon-expandable sheath was successfully used to complete 19 of 22 procedures (86%). Unsuccessful uses were due to lack of device length, inadequate inner diameter to pass the endograft, or tortuous aortic anatomy. In 8 patients, a balloon expandable sheath was used successfully after initial difficulty advancing a non-expandable sheath. There was 1 sheath malfunction (the balloon component could not be completely deflated at the end of the case which was subsequently removed without complication). Procedural complications in 3 patients (14%) included external iliac dissection/occlusion requiring stenting, external iliac artery extravasation requiring stenting, and right groin hematoma managed conservatively. Average blood loss during the procedures was 464 mL (median 400 mL), with four patients (18%) requiring transfusions. Mean fluoroscopy time was 49 minutes, and mean radiation dose was 2131 mGy. The endografts deployed were Gore C-TAG (20/22 patients), Cook Zenith Alpha (1/22 patients), and Medtronic Valiant (1/22 patients). Average length of stay following the procedure was 8.1 days and 30-day mortality was 17%. Utilizing the Solopath Introducer System for vascular access during TEVAR is a safe, feasible alternative to non-expandable sheaths in patients with small and tortuous iliac vessels.
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