Endovascular Thoracic Aneurysm Challenging
Repair procedure has steep learning curve,
high risk of endoleak.
Emerging methods of thoracic endovascular aortic repair show lower morbidity and mortality than open surgical repair, but questions remain.
“I would not call this the new standard of care. That is too euphemistic, without a question mark attached,” Christoph A. Nienaber, MD, University of Rostock in Germany, said during a presentation yesterday.
Data on endovascular thoracic aneurysm repair are limited to registries rather than randomized controlled trials. The largest of these, the Talent Thoracic Retrospective registry, has collected data on 457 patients from seven centers in Europe. To be included, patients had to receive thoracic endovascular therapy with a stent graft (Talent, Medtronic).
Follow-up lasted about three months. Researchers evaluated outcomes including mortality, graft-related mortality, endoleak, aortic rupture, reintervention, stent fracture and migration.
Early results showed technical failure in 2.2% of procedures. Less than 1% (0.7%) of patients were converted to open repair procedures.
In-hospital complications occurred in 12.6% of patients, including paraplegia/paraparesis in 1.7%, cerebrovascular events in 3.7% and local vascular events in 3.2%.
Primary endoleak was the most common complication, occurring about 20% of the time. Of the 98 patients who experienced primary endoleak, 26 spontaneously resolved, 10 were converted to surgery and 15 received adjunctive treatment. Even after these interventions, 44 patients (9.6%) persisted with primary endoleak.
“Endoleak is a huge problem, and to avoid it the procedure has to be technically flawless, so there is a steep learning curve,” Nienaber said.
Nienaber said that late follow-up (24 months) has shown an 8.5% mortality rate (Figure). Results of the Talent Thoracic Retrospective registry were recently published in the Journal of Thoracic Cardiovascular Surgery.
IRAD registry
Nienaber also presented data on the IRAD registry, a smaller registry (n = 208) scheduled for publication in Circulation. Patients received medical therapy, surgery or endovascular treatment for thoracic aneurysm.
“After four years of follow-up, we are not seeing any difference in the survival curves,” Nienaber said.
Although there have not yet been any randomized trials, researchers have published a meta-analysis of 39 studies, which included 609 patients who had aortic dissection. Mean age of patients was 61 years, and 76% were men.
Overall, the complication rate was 13.6%, with major complications accounting for 11.2%.
When single centers were evaluated separately, the overall complication rate at a high-volume center was 8.4%, 2.4% of which were major complications.
“Learning curve definitely plays a role,” Nienaber said.