Early experience with a novel dissection-specific stent-graft to prevent distal stent-graft-induced new entry tears after thoracic endovascular repair of chronic type B aortic dissections.

Abstract Purpose: The aim was to report short and mid-term outcomes of a novel, investigational, dissection-specific stent-graft (DSSG), specifically designed to address the features of chronic type B aortic dissection (CTBAD) and reduce the risk of distal stent-graft-induced new entry tears (dSINE). Materials and Methods: A retrospective single center cohort study of all patients undergoing TEVAR with the DSSG for CTBAD from January 1, 2017 to January 31, 2020. The DSSG, which is a modified stent-graft based on the Cook Zenith Alpha Thoracic platform, has no proximal barbs and a customized longer body length with substantial taper. The second and third distal Z-stents are sited internally to avoid any contact of the metal skeleton with the dissection membrane and have reduced radial force, while the most distal stent was removed creating a distal 30 mm unsupported Dacron graft. Results: Sixteen patients (13 males, 3 females) with a median age of 66 years (range 31-79 years) underwent elective TEVAR of CTBAD using the DSSG. Six patients (38%) had an underlying connective tissue disorder. The median tapering was 10mm (range 4mm-21mm) and median length 270mm (range 210-380 mm). Technical success was achieved in all but one case (96%). One patient died within 30 days, due to retrograde type A dissection with cardiac tamponade. The 30-day rate of stroke, spinal cord ischemia and re-interventions was 0%. After median imaging follow-up time of 17 months (range 1 – 31 months), one patient developed a dSINE four months after the index procedure. After median survival follow-up of 23 months (range 2 – 35 months), one late death occurred due to traumatic brain injury, while no aortic-related death occurred during follow-up. Complete false lumen (FL) thrombosis was achieved in nine patients while the remaining six showed partial FL thrombosis. No instances of diameter increase at the level of treated aortic segment were noted with serial measurements showing either stable (n=7) or decreased (n=8) maximal transverse diameter. Conclusions: Use of a novel DSSG with low radial force for TEVAR in the setting of CTBAD is safe and feasible. This early real-world experience shows promising mid-term effectiveness with low rates of dSINE or unplanned re-interventions and satisfactory aortic remodelling during follow-up. Longer follow-up is needed, however, before any firm conclusions can be drawn.