Complex abdominal aortic aneurysms (CAAAs) are defined as the absence of an infrarenal aortic collar allowing the placement of a standard aortic stentgraft. They include juxtarenal aneurysms (JRAs), suprarenal aneurysms (SRAs), and type IV thoracoabdominal aneurysms (TAA IV). Open surgery (OS) and fenestrated stentgrafts (FSG) are currently the two gold standard procedures for the treatment of CAAAs. Some data in the literature suggest that FSGs could reduce early morbidity and mortality but the real cost/effectiveness advantage over the mid- and long-term is uncertain. A prospective randomized study would provide robust comparative data but it is difficult to set up because of the expertise acquired by some surgeons and/or centers for either technique, and the anticipated difficulties in obtaining patient consent for randomization. A prospective, multicenter, comparative cost-effectiveness study that does not change current practice in each center but reduces confounding bias by applying a propensity score in the analysis and excluding patients who cannot benefit from both techniques appears to have the best feasibility/evidence ratio. The objective of the multicenter ORFEVAR study was to compare prospectively the 36-month cost-utility ratio of OS versus FSGs in the real-life management of CAAAs.
This was a prospective and multicentric study evaluating the postoperative and one-year results of proximal scalloped custom-made stentgrafts for the endovascular treatment of the lesions of the aortic arch.
Introduction: To report the results of RelayPlus (Terumo Aortic, Sunrise, FL, USA) which is CE-marked for the endovascular treatment of aneurysms of the descending thoracic aorta (DTA), aortic dissection (AD), aortic transection (AT) and penetrating aortic ulcers (PAU). This study was a postmarket surveillance requirement. The device is available in bare-stent (BS) and non-bare stent (NBS) configurations and a dual-sheath delivery system includes a flexible inner catheter. Methods: A prospective, non-randomized, observational study using a standard treatment and follow-up protocol enrolled consecutive patients treated with the device in 10 sites between January 2015 and December 2018. Standard endpoints (mortality, neurological deficits, endoleaks, all complications, migration, device integrity) are assessed at 30 days and through five years; one-year results are reported here. Results: The study enrolled 170 patients. Data from 148 patients with a mean follow-up of 379 days are reported here; mean age was 67.4 years (25−93), mostly male (n=104, 70%), 78 (52.7%) ASA ≥3. Patients were treated in 59 cases (40%) for DTA, 61 (41%) Type B AD, 16 (11%) AT, and 12 (8%) PAU. Average aneurysm diameter was 57 (28−106) mm. An average of 1.4 units was used per patent. BS or NBS was physician preference: NBS was more typical in AD (n=39, 64%) and AT (n=9, 56%). Landing was in Z0 (6%), Z1 (5%), Z2 (18%), Z3 (43%), and Z4 (28%). Revascularization of the innominate (n=1) and left subclavian (n=16) arteries were associated. There was no surgical conversion. At 30 days, mortality was 2.7%, there were no stroke, 0.6% paraplegia (n=2), no retrograde dissection and 6% type I endoleaks (7 Ia, 4 Ib). At one year, there were 2 non-TEVAR-related deaths (6 in total, all-cause mortality 4%), one type I endoleak, four type II and no conversion to open repair, migration or endograft collapse. There were 15 (10%) secondary interventions for endoleak (n=9, 6%), aneurysm expansion (n=5, 3%), and rupture (n=1, 0.6%). Average aneurysm diameter at one year was 46 (26−74) mm. Conclusion: Real world, standard clinical practice in the treatment of thoracic aortic pathologies with RelayPlus is highly predictable with a low number of units per patients and acceptable rates of mortality and reintervention in a challenging patient population. Disclosure: Nothing to disclose