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

Individual patient data meta‐analysis of patients treated with a heparin‐bonded Viabahn in the femoropopliteal artery for chronic limb‐threatening ischemia

ObjectivesThe aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis.BackgroundThe patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome.MethodsAfter the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan–Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates.ResultsSeven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0–33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up.ConclusionsTreatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.</p

SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial

Contains fulltext : 96315.pdf (publisher's version ) (Open Access)BACKGROUND: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not. METHODS/DESIGN: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications. DISCUSSION: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications. TRIAL REGISTRATION: Clinicaltrials: NCT01220245

The sac evolution imaging follow-up after endovascular aortic repair:An international expert opinion-based Delphi consensus study

Objective: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. Methods: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement &lt;5%) were included in the final document. Results: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. Conclusions: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.</p

Intravascular lithotripsy: a powerful tool to treat peripheral artery calcifications.

Calcification represent one the most important predictors of treatment failure of endovascular therapy for peripheral arterial disease, since it restricts wall expansion and acts as a barrier for drug uptake. It also increases complications after PTA like dissection, perforation, and embolization with poor outcomes. Intravascular lithotripsy (IVL) is a novel approach for the treatment of vascular calcifications with the goal to optimize outcome in patients with PAD and heavy calcifications. This review gives an overview of the currently published articles regarding the use of IVL within the vascular field. In conclusion, IVL is a safe and effective approach in the treatment of highly calcified arteries with excellent results and low rates of related complications, such as embolization, dissection, and perforation. However, it seems to require adjunctive therapies to enhance long-term patency as well as an adequate sizing (1.1:1 ratio). Its use to facilitate access of large-bore devices seems to be valuable by changing vessel compliance and achieving luminal gain. Further studies are nonetheless mandatory

Balloon Angioplasty Versus Bailout Stenting for Isolated Chronic Total Occlusions in the Popliteal Artery.

AIMS: Stenting of the popliteal artery (PA) is generally considered inappropriate due to the high mechanical stress and bending of the artery during knee flexion. Nevertheless, vessel recoil remains problematic following angioplasty procedure for chronic total occlusions (CTOs) and adjunctive stenting may be required. The purpose of this study is to compare balloon angioplasty alone versus bailout stenting for isolated CTO of the PA. MATERIALS AND METHODS: Between March 2012 and October 2016, 43 patients were treated with percutaneous transluminal angioplasty with balloon alone (PTA, n = 16) or bailout stenting percutaneous transluminal angioplasty and stenting (PTAS, n = 27) for de novo CTO of PA. There was no statistically significant difference between both groups with regard to patient demographics and lesions characteristics (calcification severity and lesion length). The median lesion lengths were 67 mm (39.5-78.5) in the PTA group and 94 mm (50-114) in the PTAS group ( p = 0.14). The primary outcome measure was primary patency; secondary outcomes were technical success, primary assisted patency, major amputation, and increased Rutherford classification. RESULTS: Technical success rate was 37% and 96.3% in the PTA and PTAS groups, respectively. There was no statistical difference in 12-month primary patency rate (65.8% versus 58.7%; p = 0.15) and primary assisted patency at 12 months (75.2 versus 69.2; p = 0.47) between the 2 groups. Freedom from target lesion revascularization at 12 months was not significantly different, with 85.7% and 81.6% ( p = 0.2) in the PTA and PTAS groups, respectively. One amputation occurred in the PTA group. CONCLUSION: This small cohort suggests that stenting as a bailout procedure in CTO of the PA provides similar results to successful balloon angioplasty. Stenting should only be performed after suboptimal balloon angioplasty with vessel recoil. Due to the large lost to follow-up, strong evidence of a therapy over the other cannot be formulated. Larger studies with longer and stronger follow-up are needed to confirm those results

Management and Outcome of Prosthetic Vascular Graft Infections: A Single Center Experience.

BACKGROUND: Prosthetic vascular graft infection (PVGI) remains a severe and challenging complication in vascular surgery with high morbidity and mortality rates. Incidence has been reported between 1% and 6%. The aim of this study was to report our experience in terms of general and surgical management as well as outcome, over 15 years. METHODS: A retrospective consecutive study was conducted of all patients treated in our department for PVGI between January 2000 and December 2015. We analyzed all data relative to primary operation, duration interval between initial surgery and infections signs, infection site, type of microorganism involved, and surgical treatment modality, as well as evaluation of short- and long-term results. RESULTS: Sixty-two patients were admitted for PVGI. Primary revascularization procedures consisted of a peripheral bypass in 42 (68%) patients and an aortic bypass in the remaining 20 (32%) patients. Median interval between primary procedure and reintervention was 3 months (interquartile range 17 [IQR 17]) in the peripheral group and 48 months (IQR 70.5) in the aortic group. Complete excision of the prosthetic graft was carried out in 85% of the cases. Thirty-day mortality was 0% and 9.5% in the aortic and peripheral group, respectively. The overall survival rate was 62.3% at 2-years, 46.4% in the aortic group, and 69.7% in the peripheral group. CONCLUSIONS: Prosthetic vascular graft infection needs a multidisciplinary management with appropriate antibiotherapy, radical removal of the infected graft, and in situ reconstruction. This strategy gives satisfactory results in terms of mortality, morbidity, patency rates, and infection control

Incidence and prognostic factors related to major adverse cerebrovascular events in patients with complex aortic diseases treated by the chimney technique

OBJECTIVE: Endovascular aneurysm repair (EVAR) with the chimney technique (ch-EVAR) has been used for the treatment of aortic aneurysms as an alternative approach to fenestrated endografting or open repair. Nonetheless, the need for an upper extremity arterial access may contribute to a higher risk for periprocedural cerebrovascular events. This study reports on the perioperative cerebral and major adverse cardiac and cerebrovascular events (MACCE) after ch-EVAR. METHODS: The PERICLES registry (PERformance of the chImney technique for the treatment of Complex aortic pathoLogiES) is an international, retrospective multicenter study evaluating the performance of ch-EVAR for the treatment of complex aortic pathologies. For the purpose of the current analysis, 425 patients treated by ch-EVAR between 2008 and 2014 were included. The primary outcome of this analysis was the incidence of procedure related cerebrovascular events defined as transient ischemic attack or stroke. The secondary end point was in-hospital MACCE, including acute coronary syndrome, stroke, and death of any cause. RESULTS: The incidence of clinical relevant cerebrovascular events was 1.9% (8/425). A postoperative transient ischemic attack was observed in four patients (0.95%) and a stroke in additional four (0.95%). Three patients died during the hospital stay secondary to sequelae from postoperative stroke. A prior history of stroke/transient ischemic attack, atrial fibrillation, previous carotid revascularization, or known carotid artery disease did not significantly increase the risk for adverse neurologic events. The overall MACCE rate amounted to 8.5% (36/425). Logistic regression analysis revealed that the use of bilateral upper extremity access (odds ratio [OR], 2.79; 95% confidence interval [CI], 1.04-7.45]), aneurysm rupture (OR, 5.33; 95% CI, 1.74-16.33), and a prolonged operation time (>290 minutes; OR, 1.005; 95% CI, 1.001-1.008) were associated with a significantly increased risk for MACCE. CONCLUSIONS: This analysis demonstrates that ch-EVAR is associated with a relatively low rate of cerebrovascular events. However, a postoperative stroke is associated with increased mortality. Ruptured aneurysms, bilateral upper extremity access as in case of multiple chimney graft placement, and longer operative times were identified as independent risk factors for MACCE