Prospective multicentre study confirms safety and efficacy of percutaneous EVAR


The first prospective, multicentre study of unselected patients undergoing percutaneous endovascular aortic aneurysm repair (EVAR) confirms previous findings of single-centre studies that the procedure is associated with a high technical success rate when performed by experienced operators.

Writing in The Journal of Cardiovascular Surgery, Giovanni Pratesi (Unit of Vascular Surgery, Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome, Italy) and others report that the benefits attributed to percutaneous EVAR—compared with EVAR using standard femoral exposure—include “shorter procedural times, lower complication rates, and shorter hospital stays”. However, the authors note the current evidence for the procedure is “mainly based on single-centre observational studies with only two randomised controlled trials published so far, as underlined in a recent systematic review from the Cochrane collaboration”. They add that although percutaneous EVAR may reduce the rate of complications, it is not “free of complications” and that potential predictors of procedure failure include “common femoral artery calcification, obesity, scarred groins, sheath size and operator experience”. Therefore, Pratesi et al established a prospective, multicentre registry to “provide a real-world experience on the contemporary management of percutaneous EVAR”. The aim of the present study was to report the intraoperative and 30-day technical success and complication rates of patients who underwent the procedure in the registry (known as the Italian Percutaneous EVAR Registry or IPER). Another aim of the study, Pratesi et al  comment, was to identify factors affecting outcomes.

Between January 2010 and December 2014, 2,381 percutaneous EVAR procedures were performed at seven high-volume centres (to be involved in the study, a centre had to have experience of at least 50 percutaneous EVAR procedures) in 1,322 consecutive patients. Pratesi et al comment: “Prostar XL (Abbott Vascular) was the sole closure device used up to 2013 when Perclose ProGlide (also Abbott Vascular) received FDA approval for closure up to 21F in sheath size. For this reason, Prostar XL was the most commonly deployed closure device in the registry, being used in 1,867 femoral accesses whereas the remaining 514 were managed with either one or two Perclose ProGlide devices, based on sheath size according to the instructions for use.”

Percutaneous access was technically successful in 96.8% (2,305 common femoral arteries) of procedures. The causes of surgical conversion in the 3.2% of procedures that were not successful included acute bleeding (54 cases) and acute common femoral artery occlusion (22 cases) as a result of suture break, not sliding knot or detachment of the atheromatous plaque in the posterior wall.

Duplex or computed tomography examination, during the first month of follow-up, identified six puncture site complications, two pseudoaneurysms, and four common femoral artery occlusions and all of these cases required surgical open femoral repair. However, the authors note: “We did not observe any other case of access-related complication, including infection and arteriovenous fistula or neurological damage.” They state that the low rate of complications during follow-up “adds robust evidence to the current literature on the long-term effectiveness of percutaneous access.”

Pratesi et al report that multivariate logistic regression analysis “identified the presence of femoral artery calcifications as the only independent predictive factor of percutaneous access failure (=0.036)” and comment that the presence of calcifications “can directly compromise the closure system functionality by causing inappropriate needle deployment through the artery wall, inability to secure the suture and suture distribution as well”. They note that these problems are “directly related to a technical failure of the closure device” and are independent from the operator’s experience.

According to the Pratesi et al, the registry results indicated a non-significant trend towards a higher technical success rate with the Prostar XL device than with the Proglide device. However, they comment: “One can suppose that with a larger sample size of the Perclose Proglide group, differences would become significant.”

“The present experience confirms that totally percutaneous EVAR using either the Prostar XL or Proglide is a safe and effective operation,” the authors write.