Peter R Nelson1, Zvonimir Kracjer2, Nikhil Kansal3, Vikram Rao4, Christian Bianchi5, Homayoun Hashemi6, Paul Jones7, J Michael Bacharach8. 1. University of South Florida, Tampa, Fla. Electronic address: pnelson1@health.usf.edu. 2. St. Luke's Episcopal Hospital at Texas Heart Institute, Houston, Tex. 3. VA San Diego, San Diego, Calif. 4. Lake Health, Willoughby, Ohio. 5. VA Loma Linda, Loma Linda, Calif. 6. Inova Fairfax Hospital, Falls Church, Va. 7. Mercy Hospital, Chicago, Ill. 8. North Central Heart Institute, Sioux Falls, SDak.
Abstract
OBJECTIVE: The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure. METHODS:Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8 F Perclose ProGlide (n = 50 [PG]) or the 10 F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months. RESULTS: Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred. CONCLUSIONS: Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes. Published by Mosby, Inc.
RCT Entities:
OBJECTIVE: The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure. METHODS: Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8 F Perclose ProGlide (n = 50 [PG]) or the 10 F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months. RESULTS: Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred. CONCLUSIONS: Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes. Published by Mosby, Inc.
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Authors: Georgios Karaolanis; Ioannis D Kostakis; Demetrios Moris; Viktoria-Varvara Palla; Konstantinos G Moulakakis Journal: Int J Angiol Date: 2018-01-22