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.

Comparison of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease with Flat-Panel Detectors on Mobile C-arm versus Fixed Systems.

BACKGROUND: Flat-panel detectors on mobile C-arm (MC-arm) systems are currently challenging fixed C-arm (FC-arm) systems used in hybrid operating rooms. MC-arm systems offer an alternative to FC-arm systems in the endovascular treatment of peripheral arterial disease (PAD) but their efficiency has not been evaluated comparatively. METHODS: Two series of patients undergoing arteriography with intention to treat were included. Each series consisted of 2 nonrandomized groups: an MC-arm group and an FC-arm group. Series 1 evaluated exposure to the patient (MC-arm, n = 113; FC-arm, n = 206) while series 2 evaluated exposure to patients and also health care personnel (MC-arm, n = 24; FC-arm, n = 76). The primary end points for evaluating exposure were air kerma (AK, in mGy) for patients and effective dose for health care personnel (in µSv). RESULTS: After adjustment for the effect of body mass index (analysis of covariance test), AK was found to be lower in the MC-arm group than in the FC-arm group (124.1 ± 142 vs. 173.3 ± 248.7, P = 0.025). There was no difference between the groups with regard to effective dose recorded for senior surgeons or for operating room nurses. However, a higher effective dose was recorded by the MC-arm group external dosimeter for the trainee resident and for nurse anesthetists. CONCLUSIONS: In endovascular treatment of lower limb PAD, use of an FC-arm system is associated with more radiation exposure to the patient than an MC-arm system. However, this type of imaging system does not appear to affect exposure to health care personnel.

Impact of Vascular Calcifications on Long Femoropopliteal Stenting Outcomes.

BACKGROUND: Vascular calcifications (VCs) may be a prognostic factor for outcome after endovascular treatment of peripheral arterial disease (PAD). Semiquantitative analysis with X-ray imaging is the main limiting factor for assessing VCs. The aim of the present study was to find a correlation between the amount of VC with computed tomography (CT) scan quantification and midterm results of endovascular treatment of Trans-Atlantic Inter-Society Consensus C/D femoropopliteal (FP) lesions. METHODS: Patients belonging to 2 previously published registries (STELLA and STELLA PTX) and who underwent a preoperative CT scan were retrospectively included in the study. VC quantification was performed with a dedicated workstation (EndoSize, Therenva) on the basis of Hounsfield units (HU). The VC percentage was calculated as the ratio between VC volume and the volume of the region of interest. For the analysis, patients were divided into 3 groups according to VC percentage, from lowest to highest: group 1 (G1) included the first quartile of VCs, group 2 (G2) included the second and third quartiles, and group 3 (G3) included the fourth quartile. Risk of in-stent thrombosis was analysed using a multivariate model. RESULTS: Thirty-nine patients were included (10 in G1, 19 in G2, and 10 in G3), and mean follow-up duration was 24 ± 14.6 months. Patients in G1 and G3 had, respectively, a VC rate of <1% (no VC) and >20% (severe VC). In G2, VC was considered to be intermediate. There was no statistical difference in the cardiovascular risk factors and preoperative medication. A significant difference was found for the healthy FP diameter between G1 (4.6 ± 0.8 mm) and G3 (6.8 ± 0.8 mm, P < 0.0001) and between G2 (5.2 ± 1 mm) and G3 (P < 0.0001). The rate of drug-eluting stents was similar in all groups. There was no difference between groups concerning the rate of in-stent restenosis, target lesion revascularization, and target extremity revascularization. There was a higher rate of in-stent thrombosis for G1 versus G2 (P = 0.037), and no difference was noted between G1 versus G3 (P = 0.86) or G2 versus G3 (P = 0.12). G3 was associated with early stent thrombosis (<1 month), while G1 was associated with late stent thrombosis (6-24 months). On multivariate analysis, only one predictive factor for stent thrombosis was found: patients with intermediate VC seemed to be protected against in-stent thrombosis (odds ratio = 0.27, 95% confidence interval: 0.1-0.77; P = 0.014). CONCLUSIONS: The study showed that VC quantification with CT imaging is feasible and useful for comparing outcomes following PAD endovascular revascularization. Below a certain threshold, the presence of VC might be necessary for plaque stability and may protect against in-stent thrombosis.

Bare Metal Versus Paclitaxel-Eluting Stents for Long Femoropopliteal Lesions: Prospective Cohorts Comparison Using a Propensity Score-Matched Analysis.

BACKGROUND: The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES). METHODS: In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent®, Bard Peripheral) and PES (Zilver® PTX®, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18 months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias. RESULTS: In total, 110 limbs were treated (STELLA: n = 62; STELLA PTX: n = 48). We noted some difference between both cohorts regarding type 2 diabetes (P = 0.05), vitamin K antagonist use (P = 0.05), and angiotensin II receptor blocker use (P = 0.002). More stents were implanted in the STELLA PTX cohort (P < 0.0013). At 12 months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P = 0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P = 0.25), primary patency (P = 0.07), and survival (P = 0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P = 0.79), freedom from TLR (P = 0.59), and primary patency (P = 0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency. CONCLUSIONS: Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.

Long-Term Outcomes of Common Femoral Artery Stenting.

BACKGROUND: The purpose of this study was to report the 5-year outcome relative to endovascular repair of the common femoral artery (CFA) for occlusive disease. METHODS: Thirty-six consecutive patients (40 limbs) underwent stenting for CFA lesions. Patients were followed up systematically within a prospectively maintained database over 5 years. Follow-up included clinical examination, duplex scan, and biplane X-ray at 1, 6, 12 months and yearly thereafter. RESULTS: Indications for endovascular repair of the CFA included 25 patients (70%) for claudication and 11 patients (30%) for critical limb ischemia. Mean follow-up was 64 months. Two patients were lost to follow-up. The mortality rate at 5 years was 38%. At 3 and 5 years, primary sustained clinical improvements were 77% and 73%, respectively. In-stent restenosis rate was 28%. The significant predictors of in-stent restenosis were deep femoral artery stenting (P = 0.0007) and type III lesions (P = 0.014). Freedom from target lesion revascularization and target extremity revascularization were 79% and 73%, respectively. One stent fracture was noted at the first year follow-up without clinical consequence, and no other stent fracture was noted during the remainder of the study. CONCLUSIONS: Endovascular repair of the CFA and its bifurcation seems to provide sustained clinical and morphological long-term results. Fear of stent fracture and local complications due to hip mobility are no longer relevant.

Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial.

BACKGROUND: Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm). METHODS/DESIGN: A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease. DISCUSSION: This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.