Europe needs guidelines for outpatient endovascular repair

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Yann Gouëffic

European guidelines should do more to promote the use of ambulatory endovascular peripheral interventions and to support physicians wishing to set up an outpatient centre, said Yann Gouëffic (Nantes, France) at the Charing Cross Symposium (CX; 15–18 April, London, UK).

“DRGs [device-related guidelines] should be revised to promote outpatient [care], and guidelines should be released to help vascular interventionalists to organise their practice in the most appropriate and safe conditions,” he said. And he echoed Enrico Ascher’s conclusions, pointing out: “Outpatient management is safe and efficient. We know that it works.”

Gouëffic presented the European perspective on how ambulatory treatments are moving on in the field of arterial disease, outlining how practice differs across different European nations, “according to the type of DRG in each country, and according to the type of vascular interventionalist”.

He described the growth of office-led intervention in the USA as “amazing”. In France, the rate of ambulatory treatment for peripheral arterial disease (PAD) using endovascular repair was about 11% in 2018. In the UK, almost 30% of procedures for the same indications are performed in an outpatient setting.

European guidelines, in place since 2003, recommend overnight observation after a percutaneous transluminal angioplasty (PTA) procedure. The French Society of Vascular and Endovascular Surgery (SCVE) in 2019 released the first guidelines for outpatient management in France, providing help to physicians on how to deal with legal issues. Concerns about how to deal with complications is one of the issues that may be affecting the development of outpatient endovascular intervention, he suggested. Other factors are economic and clinical.

Economic factors, he said, may be related to regulatory issues, but also to the need to demonstrate societal cost-effectiveness. Clinical issues relate to the need to demonstrate the safety and efficiency of ambulatory management, the benefits of different devices, and whether it is possible to perform manual compression.

Gouëffic said: “Further evidence is required to ensure the clinical, legal, and medical economic value of outpatient management.” He described three trials that are aiming to do so.

One, the Freedom registry, has been set up to demonstrate the feasibility of same-day discharge after manual puncture point compression in patients treated for PAD by endovascular technique with a 5F sheath femoral approach. So far, 111 of the 150 patients to be included in the trial have been recruited.

A second, the STEP study, is a randomised trial comparing two arterial devices to assess their value in outpatient management. At the time of the presentation, only one patient remained to be enrolled, with 229 of the required 230 patients already recruited.

Gouëffic also outlined details of a medical economics study, the AMBUVASC trial, which has finished recruiting patients. This is a French multicentre randomised controlled trial to evaluate the efficiency of outpatient versus hospital PAD intervention.

“We have no medical economic study available to assess the cost-efficiency of outpatient [treatment]. The objective of AMBUVASC is to compare the utility cost of conventional hospitalisation versus ambulatory hospitalisation using an arterial closure device.”

The primary endpoint of the study is the incremental cost-effective ratio (ICER). This describes the extra cost per one additional unit of patient outcome, and consists of a cost utility and a cost-effectiveness analysis. Quality adjusted life years (QALYs) are also used to measure ICER. Secondary endpoints include safety, complication rates, functional improvements, and time taken to return to employment.

A vote at the end of the audience discussion that followed indicated that 63% among the audience would recommend ambulatory treatment for their own patients with PAD.

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