The FREEDOM Study: A Pilot Study Examining the Feasibility and Safety of Early Walking following Femoral Manual Compression after Endovascular Interventions Using 5F Sheath-Compatible Devices.

BACKGROUND: Increasing prevalence of peripheral arterial disease (PAD) burning and pressure to reduce costs and promote patient empowerment make outpatient endovascular procedures an attractive alternative to conventional hospitalization. For outpatient peripheral endovascular procedures, femoral manual compression could replace the use of arterial closure devices for small-bore punctures. Presently, safety and feasibility evidence for femoral manual compression is still lacking. FREEDOM is a pilot study designed to demonstrate the feasibility and safety of early walking after femoral manual puncture point compression following a therapeutic endovascular procedure for PAD. METHODS: From May to August 2015, all patients requiring endovascular treatment for PAD were prospectively screened. Those patients that received therapeutic endovascular procedures involving retrograde femoral punctures with a 5F sheath were included. Manual compression and pressure dressing of the femoral puncture points was applied. The primary end point was defined as the walking ability 5 hr after index procedure (H5), which was assessed by a walk test. RESULTS: In total, 129 consecutive patients were screened, and 30 patients met the study criteria. The mean age was 66 ± 11 years. The mean duration of the procedure and of the manual compression was 63 ± 24 min and 12.8 ± 4 min, respectively. At 5 hr following the procedure, 97% of the patients were able to walk 100 m. Two patients failed to walk due to cardiac arrhythmia and to a false aneurysm at the femoral puncture site. No further complications were observed at 1 month, and quality of life assessed by EQ-5D test was significantly increased compare to baseline (72.3 vs. 60.4; P = 0.001). CONCLUSIONS: This pilot study demonstrated the benefits of manual compression to close arterial punctures over procedures using 5F shealth-compatible endovascular devices. A sufficiently powered randomized controlled trial is needed to further characterize the potential benefits of manual compression following use of low-profile devices.

Management of ambulatory (day case) endovascular procedures for peripheral arterial disease.

INTRODUCTION: Thanks to exceptional improvements in technological developments and vascular teams' expertise, endovascular repair of peripheral arterial disease (PAD) has drastically increased these past decades. Incidence of PAD rising, pressure to reduce costs and patient's empowerment make outpatient endovascular procedures for PAD an attractive alternative to conventional hospitalization. This review describes outpatient endovascular procedures for PAD in the literature. EVIDENCE ACQUISITION: We used PRISMA guidelines and Medline to conduct this systematic review. 448 relevant articles were found. Twelve articles, all published after year 2000 were included and reviewed by two independent investigators. EVIDENCE SYNTHESIS: Among 12 selected articles, 10762 outpatient endovascular procedures were performed and 3883 procedures were realized for arterial lower limb revascularization. Average age was 65.2. Major exclusion criteria were social isolation (no available accompanying adult for the first 24 hours, no available communication system) and high-risk patients (ASA 4 and above). During the perioperative period, no death was noted. Major hematoma rate was 0% to 3%, minor hematoma rate went from 1.6% to 20%. Conversion to in-patient status for overnight observation occurred in 0% to 16% in ten real life studies and was mostly due to complications at puncture site. Reintervention over the first month occurred in 0% to 4%. Readmission in the first month after being discharged occurred in 0% to 3.2%. Diabetes and critical limb ischemia were not related to higher complication rate. CONCLUSIONS: This review indicates that outpatient endovascular procedures for PAD are safe and efficient. Guidelines are necessary to enforce patients' selection and insure high quality perioperative care.

The role for DCBs in the treatment of ISR.

INTRODUCTION: Currently, endovascular therapy is the standard of care for peripheral artery disease. The main issue of these techniques is restenosis which is a complex mechanism associating elastic recoil, constrictive remodelling and intimal hyperplasia. More and more evidence show that drug-coating balloon (DCB) is a promising device to prevent and to treat restenosis. Herein we have reviewed the role for DCB's in the treatment of in-stent restenosis (ISR). EVIDENCE ACQUISITION: Currently, few studies are available regarding DCB use for femoropopliteal (FP) ISR treatment. In different studies evaluating DCB for treatment of FP ISR the freedom from target lesion revascularization rate at one year are range from 87% to 92.1%. In comparison to other devices used for treatment of FP ISR such as atherectomy, cutting balloon, standard angioplasty, DCB seems to show better results in terms of freedom from TLR and primary patency. Other devices such as drug-eluting stent, brachytherapy, covered stent show also good results for FP ISR. EVIDENCE SYNTHESIS: Majority of assessed data on FP ISR treated with DCB derived from uncontrolled study or historical comparisons. Only one randomized, controlled study compared DCB versus standard angioplasty. The FAIR trial showed better results in favour of DCB in terms of freedom from TLR at 12 months (90.8%). CONCLUSIONS: Drug coating balloon could be the first choice of devices for the treatment of FP ISR, because of its efficacy, its ease of use in comparison with more complex and less efficient devices.