Management of Peripheral Vascular Interventions in an Ambulatory Setting: A Single-Center Retrospective Analysis.

BACKGROUND: The development of minimally invasive devices to treat peripheral artery disease led to a reduction of complications, particularly of the puncture or access site. Subsequently, the number of ambulatory procedures increased, saving costs and resources. This analysis was performed to provide data on patients treated with 4 French (F) compatible devices in ambulatory and in-hospital settings. METHODS: This is a single-center retrospective analysis of prospectively collected data. Consecutive patients who received peripheral vascular interventions from 2013 to 2015 were included. Data were extracted from electronic patients' files; data until the time of last contact were collected. Arterial puncture was performed under ultrasound guidance; 4F compatible devices ought to be selected and compression devices were used to seal the puncture site. The primary outcome was the rate of ambulatory failure in the ambulatory group. RESULTS: A total of 219 patients (68.5% male, 69.5 ± 12.8 years) were included in the analysis. Thereof 71 patients with 80 procedures were hospitalized, predominantly for social reasons (42/80, 52.5%) or emergency conditions (18/80, 22.5%). In the ambulatory group (148 patients), 183 procedures were performed, thereof 92.9% (170/183) with a 4F compatible equipment. Procedural success was 91.8% (168/183) in the ambulatory group and 82.5% (66/80) in the hospitalized group (P = 0.027). Patients in an ambulatory setting were younger and more frequently males. Ambulatory success was 99.2% (181/183). One puncture site complication was observed in each group but no other procedural complication, and all patients were alive after 1 month. In the ambulatory group, the mean follow-up was of 148 ± 260 days and in the hospitalized group, the mean follow-up was of 126 ± 199 days; no patient died during follow-up in the ambulatory group but 3 patients died in the hospitalized group. CONCLUSIONS: Ambulatory endovascular procedures can be safely performed in a large proportion of patients with peripheral artery disease.

French Guidelines for the Management of Ambulatory Endovascular Procedures for Lower Extremity Peripheral Artery Disease.

BACKGROUND: Ambulatory hospitalization for endovascular repair of lower extremity peripheral arterial disease (PAD) could be a real opportunity to respond to the burden of PAD, to reduce costs, and to improve patients' empowerment. The French Society of Vascular and Endovascular Surgery (SCVE) established guidelines to facilitate the development of ambulatory hospitalization in France. METHODS: In 2017, we used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and MEDLINE database to conduct a systematic review of available literature. A total of 448 relevant articles were found. Twelve articles, all published after the year 2000, were included and reviewed by two independent investigators. The SCVE mandated a scientific committee to collectively establish these guidelines. RESULTS: Eligibility for ambulatory management shall be based on the assessment of the triad: (1) patient, (2) procedure, and (3) structure. Comprehensive information and a detailed procedural pathway should be provided for the patient. No age limit is recommended. American Society of Anesthesiologists I, II, and III stable patients are eligible for ambulatory intervention. Specific comorbidities such as severe obesity, sleep apnea, and/or chronic kidney failure should be assessed preoperatively. Critical limb ischemia and complex lesions have not been considered as exclusion criteria. Antiplatelet drug use (aspirin and/or clopidogrel) has not been considered as a contraindication. Femoral ultrasound-guided puncture is recommended. Manual compression or closure devices have been recommended for 7F sheath or less. A minimum of 4 hours of monitoring after percutaneous femoral access is required before discharge. CONCLUSIONS: The SCVE guidelines aim to frame the practice of ambulatory endovascular procedures for lower extremity peripheral artery disease and to give vascular interventionalists help in their routine practice.

Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial.

PURPOSE: Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. MATERIALS AND METHODS: BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. RESULTS: The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively. CONCLUSIONS: Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.