In a single-centre feasibility trial, six patients underwent office-based percutaneous endovascular aneurysm repair (PEVAR) with a “largely perfect” outcome. Principal investigator Stuart Harlin, Coastal Vascular Interventional Center, Pensacola, USA, told Vascular News that office-based PEVAR is a “natural progression” as the in-hospital procedure is no longer financially sustainable.
The prospective, single-centre, non-randomised trial study examined the initial experience of performing elective PEVAR in an office-based centre with same day discharge. The devices used for these procedures were the AFX endovascular AAA system (Endologix) and the Perclose ProGlide suture mediated closure system (Abbott Vascular).
The primary endpoint was 30-day treatment success. Secondary evaluations included all serious and non-serious adverse events, perioperative evaluations: anaesthesia time; fluoroscopy time; contrast volume used; time to haemostasis; procedure time; estimated blood loss; time to ambulation; time to normal diet; time to actual discharge; use of analgesic for groin pain, stent graft patency and integrity, quality of life survey.
Harlin explained that patients were carefully chosen based on their anatomy and health status. Six subjects between the ages of 52 and 87 undergoing elective PEVAR were enrolled. The aneurysms varied from 4.4cm and 5.8cm (all meeting inclusion criteria), 100% of patients were current smokers and had high cholesterol, 66.6% of patients were being treated for hypertension, 50% had coronary artery disease, 33.3% were diagnosed with diabetes.
All patients were treated with PEVAR and discharged the same day. A combination of PO Valium (10mg), IV Fentanyl (2.4mg) and IV Versed (130mcg) was used for sedation. Ultrasound was used to gain access into the common femoral arteries. All patients received 5000 IU Heparin IV. Bilateral ilio-inguinal blocks utilising Marcaine were administered.
“The average case time was 50 minutes and all the patients did perfectly. We got the patients up at four hours and they were discharged at six hours. We saw them the following day and then weekly for a month, and then did follow-up studies at one month. We had a largely perfect outcome—no one was admitted to the hospital, there were no infections and no anaesthesia complications,” Harlin reported.
Prior to discharge a femoral ultrasound was performed to evaluate access site integrity. During follow-up, access sites, pulse, pain tolerance and overall health were monitored. A CTA of the abdomen and pelvis, and femoral ultrasound was performed at 30 days. Two of the six patients reported use of painkillers within 24 hours post operation, but none used painkillers thereafter. One patient experienced penile swelling at nine days, but this resolved without treatment.
In terms of the true difference between in-hospital and office-based PEVAR, Harlin explained that technically, the procedure is carried out the same way, but there is an OR team on standby in the building rather than in the room.
“As far as the conduct of the aneurysm repair, it is exactly the same way as they do it in the hospital. We use exactly the same imaging systems, catheters, guidewires. We do not have an OR team in the room. Our cathlab team was in the room and the doctors were in the room, but other than that we try to make this procedure exactly the same as the hospital, just in a less acute setting,” he said.
Harlin went on to say that the greatest concern throughout the trial as it relates to risk was how they would respond if one of the patients suffered a complication, for example, a cardiac event.
“So we had a transfer agreement with one of the hospitals already in place and with the ambulance service such that if there was a complication we had immediate access to get the patient to the hospital within 10 or 15 minutes. We had everything in place beforehand, but really our consideration was to minimise the risk of complication by choosing the patients very carefully,” he stated.
Harlin said that there will be a separate publication on the cost-effectiveness of outpatient PEVAR, indicating that based on recent publications on in-hospital PEVAR, the former cuts the cost by 45%.
“The total cost for these cases was a little less than US$18,000, including grafts, our centre costs, balloons, bandages, antibiotics, pain killers, everything. That is out-the-door cost. If you compare it to in-hospital procedure, in all honesty, it is a little less than half,” he reported.
In June, Harlin will be part of a debate at the Vascular Annual Meeting (5–7 June, Boston, USA) about whether office-based PEVAR is going to become the future of aortic intervention. He divulged that one of his primary arguments in favour of this is going to be the cost.
“I think this is a natural progression of the process. The novelty of same day discharge is no longer there, and it seems a natural progression to do it in an outpatient centre where it costs less money to do. The overheads in these centres are so much less that it makes a giant cost difference,” he said.
Harlin added that the next step from the feasibility trial will be to a multicentre trial to demonstrate the safety of office-based PEVAR across several centres and then from that to define the specific patient population that will benefit. He said that those patients with challenging anatomy are not appropriate for an outpatient setting, at least not initially. Moreover, Harlin maintained that going forward, it will also be important to identify the doctors who can perform PEVAR safely in an office-based setting.