Retrograde type A dissection in the Vascular Quality Initiative thoracic endovascular aortic repair for dissection postapproval project

Background: Retrograde dissection (RD) can be a serious complication after thoracic endovascular aortic repair (TEVAR), with retrograde type A dissection (RTAD) particularly life-threatening. Prior studies have suggested that treatment timing, anatomic characteristics, device selection, and procedural conduct of TEVAR performed for type B aortic dissection could mitigate the occurrence of RD. The Vascular Quality Initiative TEVAR for Dissection Registry is an ongoing project meant to satisfy Food and Drug Administration requirements for postmarket approval surveillance of the Gore conformable TAG thoracic endoprosthesis (W.L. Gore & Associates, Flagstaff, Ariz), Medtronic Valiant thoracic stent graft (Medtronic, Santa Rosa, Calif), and Cook Medical dissection devices (Cook Medical, Bloomington, Ind) and provides a unique source of evaluation for RTAD in a prospectively collected real-world registry. Methods: A total of 588 consecutive patients at 49 institutions had undergone TEVAR for acute (>= 30 days; n = 336) and chronic (=30 days; n = 252) type B aortic dissection were included. The occurrence of RD as reported by the participating centers and de-identified source documents were reviewed and confirmed independently by two of us (A.W.B. and G.W.). The demographics, procedural and device data, and anatomic considerations were evaluated, and the devices were grouped in a de-identified manner as Gore, Medtronic, and other. Results: The mean follow-up was 889 days (median, 658 days), and 408 patients had completed follow-up data available for >1 year. A total of 19 patients with RD (3.2%) were identified, 9 of whom had been treated for acute and 10 for chronic dissection, a 2.7% and 4.0% incidence, respectively (P = .48, acute vs chronic). Of the 19 RD cases, 15 were RTAD, 6 after treatment of acute and 9 after treatment of chronic dissection, a 1.8% and 3.6% incidence, respectively (P = .19, acute vs chronic). Five cases of RD had occurred intraoperatively (four of which were RTAD). The median time to RD and RTAD was 62 and 69 days, respectively (range, 0 to 1600 days). Of the 15 patients with RTAD, 12 had undergone surgical repair and 2 had not undergone repair; the treatment of one was unknown. The overall mortality was 33.3% (5 of 15). The factors associated with RTAD included more extensive dissection (mean, 5.6 zones without RTAD vs 8.5 zones with RTAD; P = .001), female sex (28.3% female without RTAD vs 53.3% with RTAD; P = .04), and non-White race (62.7% White without RTAD vs 33.3% White with RTAD; P = .05). Mean oversizing was not significantly different for those without RTAD compared with that for those with RTAD (14.0% vs 14.2%; P = .92). The device type was anonymized in this project; however, we found no significant differences between the Gore, Medtronic, and all other devices. Conclusions: The rate of RD in the present real-world postapproval project was consistent with that from previously reported studies, including highly controlled pivotal studies. Device type was not predictive of RD, and the newly identified risk factors for RTAD include more extensive dissection and a trend toward a greater risk for female sex and non-White race.