Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.

BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries. METHODS: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months. RESULTS: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

BACKGROUND: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. METHODS: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. RESULTS: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). CONCLUSIONS: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.

PURPOSE: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions. METHODS: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257. DISCUSSION: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.

PURPOSE: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). MATERIALS AND METHODS: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. RESULTS: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). CONCLUSION: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

BACKGROUND: The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions. METHODS: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. RESULTS: Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6% at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year. CONCLUSIONS: If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions.

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

A novel hybrid 3D endoscope zooming and repositioning system: Design and feasibility study.

BACKGROUND: Manipulation of the endoscope during minimally invasive surgery is a major source of inconvenience and discomfort. This report elucidates the architecture of a novel one-hand controlled endoscope positioning device and presents a practicability evaluation. METHODS AND MATERIALS: Setup time and total surgery time, number and duration of the manipulations, side effects of three-dimensional (3D) imaging, and ergonomic complaints were assessed by three surgeons during cadaveric and in vivo porcine trials. RESULTS: Setup was accomplished in an average (SD) of 230 (120) seconds. The manipulation time was 3.87 (1.77) seconds for angular movements and 0.83 (0.24) seconds for zooming, with an average (SD) of 30.5 (16.3) manipulations per procedure. No side effects of 3D imaging or ergonomic complaints were reported. CONCLUSIONS: The integration of an active zoom into a passive endoscope holder delivers a convenient synergy between a human and a machine-controlled holding device. It is shown to be safe, simple, and intuitive to use and allows unrestrained autonomic control of the endoscope by the surgeon.

EVOLUTION Study: 12-month results.

BACKGROUND: The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months. METHODS: Between April 2015 and November 2016, 120 patients with TASC A&B femoropopliteal lesions were included. The mean lesion length was 89.63 mm. Most of the lesions were stenotic lesions (60.00%). RESULTS: Primary patency rate for the total patient population was 86.30% at 12-month follow-up. Freedom from TLR at 12-month was 88.00%. CONCLUSIONS: These results confirm the already existing enthusiasm of the use of bare metal self-expandable nitinol stents in the treatment of TASC A&B femoropopliteal lesions. Longer follow-up and a comparison or addition with drug-eluting technology has to be studied in the future.

BeGraft Peripheral PMCF Study: 12-month results.

BACKGROUND: The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months. METHODS: Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%. RESULTS: Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%. CONCLUSIONS: These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future.

Robotically Assisted Transthoracic Cervical Rib Resection.

Several different approaches to surgical decompression of the thoracic outlet have been described. This report describes a unique case of robotically assisted transthoracic cervical rib resection for neurogenic thoracic outlet syndrome. This minimally invasive technique offers delicate tissue manipulation under optimal visualization of the thoracic outlet structures. Hence it promotes patients' safety and complete surgical decompression.

One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

PURPOSE: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. METHODS: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). RESULTS: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. CONCLUSION: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Outcome of a drug-eluting stent in longer below-the-knee lesions in patients with critical limb ischemia.

BACKGROUND: The superiority of drug eluting stents versus bare metal stents or balloon angioplasty in the treatment of patients with critical limb ischemia and infrapopliteal lesions has been established. However, only shorter lesions were evaluated. This study was designed to evaluate the immediate and long-term (up to 12 months) outcome of the Xience Prime™ Everolimus-Eluting Coronary Stent System (Abbott Vascular) in a controlled, prospective, multi-center investigation for long lesions up to 10 cm. METHODS: All patients with critical limb ischemia and long infrapopliteal lesions between 30 and 100 mm, who met the inclusion criteria, were included in this study. The primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on quantitative analysis of contrast angiography. RESULTS: Between August 2011 and October 2013, 60 patients were enrolled in this study with a mean lesion length of 47.40±25.06 mm (range 2-100 mm). The primary patency rate at 12 months was 75.4%. Freedom from target lesion revascularization was 84.9%. The amputation rate was rare (94.4% freedom from amputation). At the 12-month follow-up time point, a total of 36 out of 42 (85.7%) patients improved in their Rutherford classification by at least 1 class. CONCLUSIONS: The use of everolimus-eluting stents in longer infrapopliteal lesions in the treatment of critical limb ischemia is safe and effective with a comparable primary patency, freedom from target lesion revascularization and amputation free survival as in short lesions.

Women and men derive comparable benefits from an ultra-low-profile endograft: 1-year results of the European OVATION registry.

BACKGROUND: Female patients are underrepresented in most stent-graft (EVAR) trials due to a reduced anatomical eligibility for endovascular treatment. The purpose of this analysis was to determine the performance of the Ovation® and Ovation Prime® stent graft in women versus men for elective abdominal aortic aneurysm (AAA) repair. METHODS: From May 2011 to December 2013, 501 patients (86% men, mean age 73 years) from 30 sites were prospectively enrolled in the OVATION Registry and electively treated with endovascular aneurysm repair. Patients returned for clinical and imaging follow-up at 1 month, 6 months, and 1 year. A post-hoc analysis was performed to assess the influence of gender on patient outcomes. RESULTS: Women were older (median 77 vs. 73 years, P<0.01) although men reported a higher frequency of ASA class III/IV (54% vs. 34%), coronary artery disease (43% vs. 29%), diabetes mellitus (19% vs. 7%), and history of tobacco use (50% vs. 33%). Median external iliac diameter was 6.4 mm in women and 7.5 mm in men (P<0.001). Proximal neck diameter was larger in men versus women (24 vs. 22 mm). Technical success was 100% in women and 99.5% in men. Type I endoleak was identified in 5 men (1.5%) and a type III leak was identified in 1 (0.3%) man. No woman presented with type I or III endoleak at 1 year. The rate of AAA enlargement was similar in women (2.5%) and men (2.7%). Freedom from aneurysm-related mortality through 1 year was 100% in women and 99.3% in men (log-rank P=0.49). Freedom from all-cause mortality through 1 year was 94.0% in women and 95.8% in men (log-rank P=0.51). One contained AAA rupture was reported in a male patient. One female patient underwent conversion to open surgery. Freedom from a secondary intervention through 1 year was 88.2% in women and 93.7% in men (log-rank P=0.11). CONCLUSIONS: Women and men derive similarly favorable benefits with the Ovation stent graft through 1-year follow-up. Longer-term follow-up will be required to determine the durability of these outcomes.

Treatment of the femoropopliteal artery with the bioresorbable REMEDY stent.

OBJECTIVE: Bioresorbable stents are an emerging technology in the endovascular treatment of femoropopliteal lesions. They address the issue of leaving permanent stents in the treated arterial segment that are only temporarily needed to treat dissection or recoil. The REMEDY stent (Kyoto Medical Planning Co, Kyoto, Japan) was the first commercially available biodegradable scaffold for peripheral use. We evaluated its performance and safety in the treatment of short femoropopliteal stenosis or occlusion. METHODS: A prospective, multicenter, observational registry was set up of patients in Rutherford-Becker categories 2 to 5 with femoropopliteal lesions that could be treated with one REMEDY stent. Clinical examination and duplex ultrasound imaging were performed at 1, 6, and 12 months. The primary end point was absence of clinically driven target lesion revascularization at 12 months. Secondary end points were technical and clinical success, primary and secondary patency rate, clinically driven target vessel revascularization, major complications, and Rutherford-Becker classification at 6 and 12 months. RESULTS: The registry enrolled 99 patients between January 2011 and July 2013 in 12 centers in Belgium. Most lesions were determined as TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A (n = 80) and located in the superficial femoral artery (n = 91). There were 19 total occlusions (mean length, 41.3 mm) and 80 stenoses (mean length, 37.5 mm). Technical success was achieved in 96 patients, and clinical success was obtained in 95. Target lesion revascularization, which equalled target vessel revascularization, was 19% at 6 months and rose to 33% at 12 months. Primary patency was 68% at 6 months and 58% at 12 months. Secondary patency was 85% at 6 months and 86% at 12 months. After 12 months, two patients had undergone an amputation. CONCLUSIONS: The 1-year follow-up results of the REMEDY stent do not meet current standards set by nitinol stents. Given the significant issues concerning bioresorbable stents in femoropopliteal arteries, their use outside clinical trials should be withheld until improvements are made and better data are available.

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.

AIMS: The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation. METHODS AND RESULTS: The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use. CONCLUSIONS: The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.

Complete Endovascular Treatment of Saccular Aneurysm of the Aortic Arch by Coiling and ch-EVAR.

Saccular aneurysm of the aortic arch is a condition with a high associated mortality. Open surgery is often complicated with poor outcome and high postoperative morbidity and mortality. In this case report, we describe an alternative stepwise endovascular repair: coiling of the aneurysm followed by covering of the ostium of the saccular aneurysm by chimney endovascular aortic repair. In our opinion, this technique could be an alternative for a fully customized branched or fenestrated endoprosthesis to treat these kind of aneurysms.

Minimally invasive primary aortic valve surgery: the OLV Aalst experience.

BACKGROUND: The purpose of this study was to evaluate our in-hospital outcomes with primary J-sternotomy aortic valve surgery since the initiation of our program in 1997. METHODS: Between October 1(st) 1997 and August 31(st) 2014, 768 patients (mean age: 69.1±11.2 years, 46.6% females, 15.6% aged greater than 80 years) underwent primary JS-AVS. Additional risk factors included diabetes mellitus (n=98, 12.2%), peripheral vascular disease (n=42, 5.5%) and body mass index greater than 30 (n=144, 18.8%). The mean logistical EuroSCORE I was 5.46%±4.5%. RESULTS: Aortic valve replacement and repair were performed in 758 (98.7%) and 10 (1.3%) patients respectively, for isolated valve stenosis (n=472, 61.8%), incompetence (n=56, 7.3%) and mixed valve disease (n=236, 30.9%). Valve pathology included sclerosis (n=516, 67.2%), rheumatic disease (n=110, 14.3%) and endocarditis (n=10, 1.3%). Reasons for conversion to full sternotomy (n=23, 3.0%) included porcelain ascending aorta (n=3, 0.4%), inadequate visualization (n=2, 0.3%) and intra-operative complications (n=18, 2.3%). Mean length of hospital stay was 11.0±7.4 days. Morbidity included stroke (n=15, 2.0%), revision or re-exploration (n=52, 6.8%), atrial fibrillation (n=201, 26.2%) and sternitis (n=5, 0.7%). In-hospital mortality was 1.6% (n=12). Overall survival at 30 days was 98.0%. CONCLUSIONS: JS-AVS is safe and is our routine approach for isolated aortic valve disease. Procedure related mortality is lower than predicted, conversion rates limited and significant morbidity minimal.

Femoro-saphenous arteriovenous access-related lower limb ischemia treated by distal arteries percutaneous angioplasty.

This is the first reported case of transposed femoro-saphenous angio-access complicated after four years by distal ischemia, which was successfully treated by percutaneous transluminal angioplasty (PTA) of the distal femoral and popliteal artery. Endovascular recanalization and angioplasty of the distal vessels offers a minimally invasive approach with preservation of the angio-access in these patients with high comorbidities.