Expert questions conclusions of similar mortality risk with EVAR, open repair in AAA

HOLLYWOOD, Fla. — Endovascular aneurysm repair, if it can be performed, confers lower risk for mortality compared with open repair in patients with abdominal aortic aneurysm, an expert said at the International Symposium on Endovascular Therapy.

Frank J. Veith, MD, professor of surgery at NYU School of Medicine, consultant in vascular surgery at Cleveland Clinic, and chairman of VEITHsymposium, presented analysis of why recent findings of randomized controlled trials that suggest no difference in mortality between endovascular aneurysm repair (EVAR) and open repair are false and misleading.

“In my opinion, despite these trials, EVAR is the best that can be done,” he said.

According to Veith, the first U.S. EVAR trial in 1992 and other results showed that EVAR improved treatment outcomes for ruptured abdominal aortic aneurysm (AAA), but since then, there has been a growing controversy over the effectiveness of EVAR. Some critics have said the good results were due to case selection, and findings from three randomized controlled studies suggest that there is no difference in mortality between EVAR and open repair.

Veith, however, said he disagrees with those results. The ECAR (French) and AJAX (Dutch) trials were both small trials that excluded high-risk patients in shock and those too sick for open repair.

“That is precisely those patients most likely to benefit from EVAR,” he said.

In addition, he said, both of these trials “did not use optimally three adjuncts for improving EVAR: hypotensive hemostasis minimizing fluid resuscitation, aortic balloon control, and improved diagnosis and treatment of abdominal compartment syndrome.”

The third trial Veith analyzed was IMPROVE, a large U.K. trial that also showed no difference in 30-day mortality between the two approaches. According to Veith, a closer look at the data indicates a lower mortality risk for EVAR in patients with ruptured AAA.

IMPROVE randomly assigned 316 patients to an endovascular strategy and 297 to open repair. The 30-day mortality for endovascular strategy was 35% vs. 37% for open repair. He said, however, that of those randomly assigned to the endovascular strategy, only 154 actually had EVAR, and their 30-day mortality was 27%. In that same group, 112 had open repair with a 30-day mortality rate of 38%.

Of the patients randomly assigned to open repair, only 220 had open repair. Thirty-six patients, according to Veith, had EVAR, with a mortality rate of 22%. The 220 patients who underwent open repair had a 37% 30-day mortality.

He said when the two groups are combined, the mortality of all patients treated by EVAR was 25%, whereas for those treated with open repair or no treatment at all, it was much higher, at 44%.

“To me, it seems the IMPROVE trial clearly shows that EVAR is the better treatment for ruptured AAA patients if it can be done,” Veith said during the presentation.

A 2012 article in the Annals of Surgery supports this conclusion, according to Veith. In this two-centered study in Sweden and Zurich, 100% of the 70 patients with ruptured AAA were treated by EVAR, and although 24% of them required a chimney or periscope graft afterward, there was only a 24% 30-day mortality.

Veith concluded that EVAR is superior to open repair for ruptured AAAs if it can be performed. – by Tracey Romero

Reference s :

Mayer D, et al. Ann Surg. 2012;doi:10.1097/SLA.0b013e318271cebd.

Veith FJ. Session VII: EVAR State of the Art. Presented at: International Symposium on Endovascular Therapy; Feb. 6-10, 2016; Hollywood, Fla.

Disclosure: Veith reports no relevant financial disclosures.