医学
不利影响
外科
观察研究
试验装置豁免
临床终点
气球
多中心研究
临床试验
随机对照试验
内科学
作者
Mario D’Oria,Alessandro Grandi,Giovanni Pratesi,Parlani Gianbattista,Rocco Giudice,Mauro Gargiulo,Mangialardi Nicola,Roberto Chiesa,Lepidi Sandro,Luca Bertoglio,Bastianon Martina,Carbonaro Anna Rita,Ferrer Ciro,Enrico Gallitto,S. Orsola‐Malpighi,Beatrice Grando,Giacomo Isernia,Andrea Melloni,Mena Vera Jorge Miguel
标识
DOI:10.1177/15266028231179864
摘要
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.
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