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OBJECTIVE: The use of steerable sheaths to allow total transfemoral access (TFA) of branched endovascular repair (BEVAR) of thoracoabdominal aortic aneurysms has been proposed as an alternative to upper extremity access (UEA); however, multicenter results from high-volume aortic centers are lacking. MATERIALS AND METHODS: The Total Transfemoral Branched Endovascular Thoracoabdominal Aortic Repair (TORCH2) study is a physician-initiated, national, multicenter, retrospective, observational registry (Clinicaltrials.gov identifier: NCT04930172) of patients undergoing BEVAR with a TFA for the cannulation of reno-visceral target vessels (TV). The study endpoints, classified according to Society for Vascular Surgery reporting standards, were (1) technical success; (2) 30-day peri-operative major adverse events; (3) 30-day and midterm clinical success; (4) 30-day and midterm branch instability and TV-related adverse events (reinterventions, type I/III endoleaks). RESULTS: Sixty-eight patients (42 males; median age: 72 years) were treated through a TFA. All the centers included their entire experience with TFA: 18 (26%) used a homemade steerable sheath, and in 28 cases (41%), a stabilizing guidewire was employed. Steerable technical success was achieved in 66 patients (97%) with an overall in-hospital mortality of 6 patients (9%, 3 elective cases [3/58, 5%] and 3 urgent/emergent cases [3/12, 25%]) and major adverse event rate of 18% (12 patients). Overall, 257 bridging stents were implanted; of these, 225 (88%) were balloon-expandable and 32 (12%) were self-expanding. No strokes were observed among the patient completing the procedure from a TFA. One patient (2%) who failed to be treated completely from a TFA and needed a bailout UEA suffered an ischemic stroke on postoperative day 2. There were 10 (15%) major access-site complications. At 1-year follow-up, overall survival was 80%, and the rate of branch instability was 6%. CONCLUSIONS: A TFA for TV cannulation is a safe and feasible option with high technical success preventing the stroke risk of UEA. Primary patency at midterm seems comparable to historical controls, and future larger studies will be needed to assess potential differences with alternative options. CLINICAL IMPACT: Using a transfemoral approach for retrograde cannulation of reno-visceral branches is feasiable, safe and effective, thereby representing a reliable alternative for BEVAR interventions.
RESUMO
PURPOSE: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). MATERIALS AND METHODS: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. RESULTS: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69-162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53-21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55-12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12-26.18). CONCLUSION: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.