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ENDOVASCULAR DEBRANCHED AORTIC REPAIR USING THE UNITARY STENT GRAFT SYSTEM FOR TREATMENT OF VARIOUS THORACOABDOMINAL AORTOPATHIES
Stevan S. Pupovac, MD, Julia F. Chen, MD, Prashanth Vallabhajosyula, MD, Naiem Nassiri, MD.
Yale New Haven Health, New Haven, CT, USA.
OBJECTIVES: This single center experience evaluates the investigational, physician-assembled unitary stent graft (USG)
for endovascular debranched aortic repair (EDAR) of a diverse array of thoracoabdominal aortopathies.
METHODS: Between November 2021 and March 2023, 15 consecutive high-surgical risk patients underwent EDAR to treat dissecting and non-dissecting thoracoabdominal aortic aneurysms (TAAA), including failed prior repairs. The USG is assembled using the Medtronic Endurant II platform and Gore Viabhan stents to separate flow proximal to zone 6 into a visceral limb and an infrarenal limb (Figure 1). This design facilitates endoluminal bypasses to target mesenteric and renal vessels and infrarenal EVAR. A physician-sponsored investigational device exemption presubmission database (Q222702) was prospectively maintained and retrospectively reviewed. Technical success was defined as successful back-table assembly, delivery, and deployment of the USG; endoluminal bypass creation to target visceral vessels; and concomitant aortic interventions. Outcomes evaluated were 30-day mortality; major adverse events (MAE) including myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory and renal failure; and imaging follow-up.
RESULTS: There were 1 (6.7%) Type I, 3 (20%) type II, 1 (6.7%) Type III, 2 (13.3%) Type IV and 1 (6.7%) Type V Crawford TAAAs, including 7 (47%) failed prior repairs. Three (20%) were chronically dissected and 1 (6.7%) patient had Marfan syndrome. Six (40%) procedures were performed in a single stage, 6 (40%) in two, and 3 (20%) in three stages. Technical success was achieved in all (100%), including endoluminal bypasses to all intended 57 visceral vessels. There was 1 episode of multiorgan failure and in-hospital mortality (6.7%) in a patient with disseminated intravascular coagulopathy. All remaining 54 visceral vessels remained patent at 30-days. No other MAE, deaths, device-related complications, type I or III endoleaks were encountered immediately or at the median follow-up of 129 days. Median hospital stay was 5 days (interquartile range, 2). There was 1 (1.8%) case of renal artery stent-graft thrombosis refractory to revascularization at 6 months in a hypercoagulable patient.
CONCLUSIONS: EDAR using the USG is a viable, off-the-shelf option for treating a variety of thoracoabdominal aortopathies in patients deemed prohibitive risk for open surgery and/or other endovascular treatments.
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