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‘Fast-Track’ EVAR confers positive outcomes, lowers costs
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LAS VEGAS — A less-invasive, more streamlined approach to endovascular aneurysm repair was associated with positive 30-day clinical outcomes and reduced health care costs, according to findings presented at VIVA 16.
Researchers analyzed 250 patients undergoing endovascular aneurysm repair (EVAR) with an abdominal stent graft platform (Ovation Prime, Endologix) at 40 U.S. centers. All were participants of the prospective LIFE registry and were enrolled in a “Fast-Track” protocol including bilateral percutaneous access, no use of general anesthesia, performance of the procedure in the cath lab, no ICU admission and next-day discharge.
Zvonimir Krajcer, MD, and colleagues assessed major adverse events at 30 days and conducted a comparison of the costs of the fast-track protocol with those of a conventional strategy.
Eighty-seven percent of patients completed the fast-track protocol. Compared with those who did not complete the protocol, completers had a shorter procedure time (84 minutes vs. 110 minutes), less blood loss, less use of general anesthesia (0% vs. 18%), less need for the ICU (0% vs. 32%) and a shorter length of hospital stay (1.2 days vs. 1.9 days). Because complication rates were so low, none of the differences reached statistical significance, according to Krajcer, who is an interventional cardiologist and director of the Peripheral Vascular Program at Texas Heart Institute and St. Luke’s Hospital in Houston and clinical professor of medicine at Baylor College of Medicine.
“The main reason for patients to fall out of the fast track was a more than 1-day stay in the hospital, which was at the physician’s discretion,” Krajcer said during a press conference.
Successful deployment of the stent graft occurred in all patients and successful access-site repair occurred in 97% of patients, he said. Freedom from rupture, conversion to open surgery or secondary interventions was 100%, he added.
The rate of major adverse events at 30 days was 0.4% (95% CI, 0-1.8; P vs. historical performance goal of 10.4% < .001). This is “the lowest number reported for any EVAR trial anywhere,” Krajcer said.
The rate of freedom from type I endoleak was 99% and the rate of freedom from type III endoleak was 100%, he said.
One patient with cardiomyopathy and respiratory insufficiency died within 28 days of the procedure, but the death was adjudicated as not related to the device or the procedure, according to Krajcer.
The mean procedure costs for the patients in the fast-track protocol were $8,200 compared with $29,300 for 8,306 patients from an inpatient discharge database. This yielded a savings of $21,100 per patient, he said. The savings were driven by no ICU admission, shorter length of stay and less need for readmission or reintervention at 30 days.
“The results of this study definitely warrant establishment of a fast-track protocol in experienced EVAR centers nationwide and worldwide,” Krajcer said.
Patients appropriate for the fast-track protocol include those with a suitable access site and those free from conditions such as morbid obesity, extreme calcification and small vessels, and those without comorbid conditions or characteristics that would preclude next-day discharge, he said. – by Erik Swain
Reference:
Krajcer Z, et al. Late-Breaking Clinical Trials. Presented at: VIVA 16; Sept. 18-22, 2016; Las Vegas.
Disclosure: Krajcer reports no relevant financial disclosures.
Perspective
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Mark W. Burket, MD
Reducing costs for procedures performed by experienced operators very comfortable with percutaneous delivery by this much is a major achievement. The protocol is very safe and the results are remarkable. Whether a center should adopt this protocol probably depends not so much on center size but on dedication. In other words, if there are people who are really committed to this fast-track approach, they should have the opportunity to participate in it.
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