Midterm Outcomes of an Adjustable Puncture Device for In Situ Fenestration During Thoracic Endovascular Aortic Repair.

ABSTRACT

OBJECTIVE: To evaluate the midterm outcomes of in situ fenestration (ISF) with an adjustable puncture device for aortic arch branch preservation during thoracic endovascular aortic repair (TEVAR). METHODS: From October 2016 to April 2019, patients with complicated type B aortic dissection, thoracic aortic aneurysm > 5.5 cm in diameter, or aortic penetrating ulcer with a base > 20 mm or depth > 15 mm, who received TEVAR requiring a proximal sealing beyond zone 3 and underwent ISF using an adjustable puncture device, were included. After the procedure, patients were monitored at one, three, six, and 12 months, and annually thereafter. Peri-operative and follow up data were collected and analysed. RESULTS: Fifty of 51 patients (98%) received successful ISFs. One, two, or three aortic arch branches were preserved in 44, six, and one patient, respectively. Intra-operatively, eight type Ia endoleaks and one type II endoleak were found on angiography. One patient died of cerebral hernia three days post-procedure from a severe stroke; one patient suffered from transient paraplegia but recovered in two weeks; one patient had a non-disabling stroke. The median follow up was 31 months (22.5 - 36.5 months). At six month follow up, all nine unmanaged endoleaks had disappeared. One new type Ia endoleak was identified in a patient at the one month follow up which resolved spontaneously one year later. All revascularised arteries were patent at the last follow up. No fractures, migrations, or bridging stent kinks were found. CONCLUSION: In this largest mechanical based ISF study to date, an adjustable puncture device was shown to facilitate the procedure of ISF during endovascular repair of aortic diseases involving the aortic arch, with high success. The midterm outcome demonstrates the efficacy and safety of the device in assisting with preservation of aortic arch branches.