Totally percutaneous endovascular aneurysm repair (PEVAR) with an adjunctive preclose technique (Perclose ProGlide) is safe and effective, with minimal access-related complications, and it is non-inferior to standard open femoral exposure, according to results of a randomised trial published in the Journal of Vascular Surgery. Compared with femoral exposure approach, the percutaneous access yielded significantly shorter times to haemostasis and procedure completion and favourable trends in blood loss, groin pain, and quality of life.
The first multicentre randomised controlled trial on PEVAR was designed and conducted to assess the safety and effectiveness of the percutaneous technique with use of a 21F endovascular stent graft system and either an 8F or 10F suture-mediated closure system. The PEVAR trial was a non-inferiority study comparing percutaneous access with standard open femoral exposure.
Between 2010 and 2012, 20 US institutions participated in the prospective, FDA-approved 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). PEVAR procedures were performed with either the 8F Perclose ProGlide (n=50) or the 10F Prostar XL (n=51) closure devices, both from Abbott Vascular. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21F profile (outer diameter) sheath-based system.
In the paper, published by Peter R Nelson, Division of Vascular Surgery, University of South Florida, Tampa, USA, and colleagues, the authors explain that 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 endpoint (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 six months.
Baseline characteristics were similar among groups. Procedural technical success was 94% with Perclose ProGlide, 88% with Prostar XL, and 98% with femoral exposure. One-month primary treatment success was 88% with Perclose ProGlide, 78% with Prostar XL, and 78% with femoral exposure, demonstrating non-inferiority vs. femoral exposure for Perclose ProGlide (p=0.004) but not for Prostar XL (p=0.102). Failure rates in the access closure substudy analyses demonstrated non-inferiority of Perclose ProGlide (6%; p=0.005), but not of Prostar XL (12%; p=0.100), vs. femoral exposure (10%). Compared with femoral exposure, Perclose ProGlide and Prostar XL yielded significantly shorter times to haemostasis and procedure completion and favourable trends in blood loss, groin pain, and overall quality of life. Initial non-inferiority test results persist to six months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred.
The investigators conclude that, amongst 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 non-inferior to standard open femoral exposure. “Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes,” they write.
According to Nelson, these results have led to the FDA approval of the preclose technique for large bore access closure up to 21F using the ProGlide device and for totally percutaneous EVAR using the Endologix system.
He noted that the PEVAR study had several important implications: “First, PEVAR now has an on-label indication, alleviating concerns of many early non-adopters and allowing them to safely offer this strategy to their patients. Second, these data show that PEVAR is as good if not better for patients than standard femoral exposure, so we will be able to quickly address any cost disincentives to use this approach. And, finally these findings open the door to pursue totally percutaneous indications for treatment in other areas that require large profile devices (ie. TEVAR, FEVAR, TAVI).”
Investigation on the potential to expand the indications for PEVAR to a broader set of patients (ie. obese, scarred groins, calcified femoral vessels) is underway. “This will also determine if the percutaneous approach makes outpatient EVAR under local anaesthesia for some a reality,” Nelson said.