Noticias

Noticias

  • Título: PEVAR Rising
  • Fecha: 05-05-2015

  • Frank J Criado, MD, FACS, FSVM

    As published in the Journal of Vascular Surgery by Nelson et al. in 2014, the first multicenter randomized controlled trial on PEVAR (Percutaneous EVAR) was designed and conducted to evaluate the safety and effectiveness of the percutaneous approach technique with use of a 21F endovascular stent-graft system and either an 8F or 10F suture-mediated closure system. It was a non-inferiority study comparing percutaneous access with standard surgical femoral exposure.

    Between 2010 and 2012, 20 U.S. centers participated in this prospective FDA-approved trial to assess percutaneous femoral artery access and closure by a “preclose” technique in conjunction with EVAR repair. A total of 151 patients were enrolled and 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 (n=51) closure devices – both from Abbott Vascular. All EVAR repairs were performed using the Endologix 21F sheath-based system. Independent physician reviewers evaluated the anatomical suitability of the femoral arteries as per CT scan findings.

    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 surgical 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 surgical exposure, Perclose ProGlide and Prostar XL yielded significantly shorter times to hemostasis and procedure completion and

    favorable trends in blood loss, groin pain, and overall quality of life. Initial non-inferiority test results persisted to six months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred.

    The investigators concluded 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. These results 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. So, PEVAR has become on-label indicated AAA therapy (using the ProGlide closure system), and further expansion of such strategies to other areas and use of even larger delivery systems cannot be far away.

    PEVAR – performed mostly under local anesthesia supplemented with intravenous sedation – represents an important evolutionary advancement of EVAR therapy, but it is not without potential pitfall and danger. Careful exclusion of unsuitable anatomy and availability of surgical capabilities to convert to open access when necessary are needed – unavoidably.



  • Fuente: endovascular.es