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Background: The hybrid room (HR) is a complex, high-risk environment, requiring teams (surgeons, anesthesiologists, nurses, technologists) to master various skills, including the 'As Low As Reasonably Achievable' principle of radiation safety. This prospective single center cohort reports the first use of the Operating Room Black Box (ORBB) in a HR. This medical data recording system captures procedural and audio-visual data to facilitate structured team performance analysis., Methods: Patients planned for endovascular repair of an infrarenal abdominal aortic aneurysm (EVAR) or treatment of symptomatic iliac-femoral-popliteal atherosclerotic disease (Peripheral Vascular Interventions or PVI) were included. Validated measures and established assessment tools were used to assess (non-)technical skills, radiation safety performance and environmental distractions., Results: Six EVAR and sixteen PVI procedures were captured. Technical performance for one EVAR was rated 19/35 on the procedure-specific scale, below the 'acceptable' score of 21. Technical skills were rated above acceptable in all PVI procedures. Shared decision making and leadership were rated highly in 12/22 cases, whereas surgical communication and nurses' task management were rated low in 14/22 cases. Team members rarely stepped back from the C-arm during digital subtraction angiography. Radiation safety behavior was scored below 'acceptable' in 14/22 cases. A median (interquartile range) number of 12 (6-23) auditory distractions was observed per procedure., Conclusions: The ORBB facilitates holistic workplace-based assessment of endovascular performance in a HR by combining objective assessment parameters and rating scale-based evaluations. Strengths and weaknesses were identified in team members' (non-)technical and radiation safety practices. This technology has the potential to improve vascular surgical practice, though human input remains crucial. (NCT04854278).

Background: Endovascular aortic aneurysm repair (EVAR) has become the most popular technique to treat infrarenal abdominal aortic aneurysms. In aneurysms with unsuitable anatomy open surgical repair remains the golden standard but fenestrated EVAR (FEVAR) or branched EVAR (BEVAR) may be an alternative to treat juxtarenal or thoracoabdominal aneurysms. The aim of this study was to report our results and to evaluate its safety and feasibility., Methods: This is a single center cohort study analyzing all consecutive patients undergoing FEVAR or BEVAR., Results: One hundred patients underwent a procedure between June 2012 and December 2019. Forty-seven percent had a history of coronary artery disease and 31% of previous aortic repair. Sixty percent were treated for a juxtarenal and 40% for a TAAA. Primary technical success was 87%. Overall, thirty-day mortality was 6%, with 50% of the deaths resulting from a myocardial infarction. Four percent had a bowel resection for ischemia, 3% developed a stroke and 3% spinal cord ischemia. Mean follow-up was 33.6±22.4 months, freedom from all-cause mortality was 89.3±3.2% at one year and 66.4±7.6% at five years. Six intraoperative target vessel events were noted (1.7%), six early postoperative (1.7%) and three late (0.8%). A total of ten (10%) late procedure related secondary interventions were performed, among which six for endoleak., Conclusions: This study confirms that fenestrated and branched endovascular repair is a safe and feasible treatment for juxtarenal and thoracoabdominal aortic aneurysms with acceptable complication rates. The perioperative cardiac mortality highlights the importance of preoperative risk assessment and patient selection.

Introduction: Concomitant malignant disease and abdominal aortic aneurysms (AAA) represent a challenging issue in terms of treatment priority, timing and perspectives. This systematic review provides an overview of the available literature about AAA and concomitant malignant disease., Evidence Acquisition: We conducted a literature search of all the English-language medical literature in Medline (through PubMed), Embase, Clinical Trial databases and the Cochrane Library up to December 31st, 2018., Evidence Synthesis: The literature about AAA and concomitant malignant disease is mostly based on retrospective small case series. Two recently published meta-analyses focusing on the management of AAA and concomitant abdominal neoplasms came to the same conclusion "treat what is most threatening or symptomatic first." The threshold to treat asymptomatic AAA should not be altered in patients with AAA and concomitant cancer including cases under chemotherapy. An asymptomatic AAA of at least 55 mm anatomically suitable for EVAR, should only be treated first in patients with at least a life expectancy of two years followed by staged cancer surgery two weeks later., Conclusions: Decisions about management of AAA and concomitant malignant disease should be based on clinical judgment applied individually in a multidisciplinary setting ("treat first what kills first"). The indication for treatment is not different than in patients with AAA without cancer. A staged approach is preferable and ideally the AAA should be excluded by endovascular means if anatomically suitable. An international registry should be initiated to gather more evidence about the management and outcomes of patients with AAA and concomitant carcinoma.

Background: The MISAGO ILIAC Study is a prospective, non-randomized, multicenter, bi-national, monitored trial, conducted in 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study was primary patency, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR), within 12 months., Methods: Between September 2011 and April 2012, 120 patients with TASC II Class A or TASC II Class B aortoiliac lesions were included. The cumulative lesion length in the overall population was 45.49 mm with a maximum stenosis pre-treatment of 83.76%. The demographic data were compatible for the TASC II class A and TASC II class B cohort. One patient with a TASC II class C was included as a protocol deviation., Results: The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II class A and TASC II class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (P=0.6407)., Conclusions: Our findings confirm that nowadays primary stenting with modern generation stents replaced the more invasive surgery as the golden standard treatment for patients with TASC II class A and B aortoiliac lesions.

Bioresorbable stents or scaffolds are a new technology in the treatment of coronary and peripheral vascular disease. Their goal is to provide adequate support to the dilated vessel segment for the time needed and to disappear through a controlled resorption process afterwards. Doing so they can offer the early advantages and avoid the late complications related to stent placement such as stent-induced restenosis, stent fracture and problems at reintervention. Although the first implantation dates from more than ten years ago, this technology is still in its infancy and experience is still being built up. Most studies till now have been performed in the coronary arteries although the superficial femoral artery is an equally appealing area of application. Bioresorbable scaffolds are made of resorbable polymers or metals with or without antiproliferative drug elution. Early experiences in coronary arteries as well as in other areas such as the superficial femoral artery (SFA) have shown the importance of the material that is used, the design of the device and the duration of the absorption process. They suggest that elution of an antiproliferative drug might be necessary to obtain clinically acceptable results. Although initial results are promising with some of the newer generation devices results of larger studies with longer follow-up are eagerly awaited to define the precise place of this new technology. This article gives an overview of the existing evidence, the available devices, the clinical studies that have been performed in different areas and the preliminary results of a large multicenter study with a bioresorbable stent in the SFA.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Reduced training times, increasing complexity of endovascular and open vascular interventions and concerns for patient's safety have necessitated a modernisation in surgical training. A more strategic approach is required to facilitate the acquisition of surgical skills outside the operating room and to minimize the risks to patients as surgeons develop their technical expertise. Virtual reality simulation has been proposed as a means to train and objectively assess technical endovascular performance without risks to patient safety. This article reviews the evidence and the limitations for this adjunctive tool, the implementation in current training programmes and future applications to maintain the highest standards of care for treatment of vascular disease.

Aim: It was the objective of the Cryoplasty CLIMB to evaluate the effectiveness of the PolarCath device in a standard clinical practice in the treatment of infrapopliteal lesions in critical limb ischemia patients., Methods: Between May 2007 and July 2008, 100 patients (72 years, 67%male) with CLI were enrolled in the trial for the treatment of 100 infrapopliteal stenoses or occlusions. The mean lesion length and diameter stenosis were 54.9+/-55.8 mm and 91.3+/-8.3%. Primary endpoint was defined as 12-month primary patency based on duplex. Secondary endopoints were immediate success and 12-month limb salvage and survival rate., Results: Multiple cryoplasty cycles were performed in 56 cases (2.1 inflations per patient) and in 4 the use of a different size balloon was required. The immediate technical success rate was 95.0% and the stent rate was 17.0%. The 12 month primary patency, limb salvage and survival rates were 55.9+/-7.4%, 93.8+/-2.5% and 81.8+/-3.9%, respectively. Stratification for lesion length did not show significant outcome differences for lesions < or =50.0 mm and those >50.0 mm neither for primary patency (P=0.94), nor for limb salvage (P=0.32)., Conclusion: The cryoplasty technique is effective for the treatment of infrapopliteal lesions in CLI patients. The results seem to be within the range of those of conventional PTA. Especially for shorter lesion (<50.0 mm), the wide-spread use of cryoplasty is not recommended. For lesions with a minimal length of 50.0 mm, the results are encouraging.

Aim: The Propaten European Product Evaluation (PEPE II) study was a product evaluation intended to characterize the performance of the GORE PROPATEN vascular graft in above-knee (AK) and below-knee bypass (BK) surgery., Methods: This prospective multicenter trial enrolled 142 patients with peripheral arterial disease. In 87 patients AK and in 52 patients BK bypasses (including 15 femorocrural) were implanted (67.6% males, 32.4% females)., Results: The one-year overall primary and secondary patency rates were 80% and 84.7%, respectively. Overall limb salvage rate at 12-months was 96.2%. The primary patency rate for AK bypasses was 82.7%, for BK femoro-popliteal bypasses 74.2% and for BK tibial-peroneal bypasses 79.4%. Secondary patency rates were 87.3%, 78.8% and 85.1%, respectively. Primary patency rates decreased depending on the number of patent run-off vessels (three 84.3%, two 80.8%, one 73.3%). Subgroup analysis showed that female patients had a significantly higher primary patency rate for BK bypasses (95.5% vs. 67.8%, P=0.037 ) compared to male patients. Subgroup analysis comparing patients younger and older than 70 years did not show a statistically significant difference in patency rates. Twenty-one patients underwent 42 reinterventions after bypass surgery., Conclusions: Present data show that the end-point heparin-bonded polytetrafluoroethylene graft yields patency rates comparable to those obtained with other graft material in above-knee locations. The encouraging results for BK bypasses suggests that this graft is an excellent option for small diameter vascular reconstructions when autologous vein is unavailable.

Aim: The aim of this study was to describe the results and long-term follow-up of the Vanguard endovascular graft for infrarenal abdominal aortic aneurysm (AAA) repair., Methods: Between February 1997 and October 1999, 76 patients were treated with a median aneurysm diameter of 52 mm (39-90 mm). All were followed up according to the Eurostar criteria., Results: The primary technical success rate was 100%. Perioperative mortality was 1.3%. During follow-up (median 75 months, 6-112 months) 9 aneurysm related deaths occurred. A total of 79 late complications occurred in 45 patients (64%). Complications were noticed more frequently in the group of aneurysms larger than 5.5 cm (P=0.014). Patients who ultimately developed aneurysm rupture after endovascular repair had more postoperative complications compared to the majority who did not rupture their aneurysm. (P=0.001) Secondary interventions were mandatory in 23 patients, surgical conversion in 9. At 72 months this has resulted in an overall survival rate of 57%, an aneurysm rupture free survival of 88%, a conversion free survival of 95%, an endoleak free survival of 83% and a secondary intervention free survival of 82% (Kaplan Maier)., Conclusion: The importance of life-long strict surveillance of patients treated with a Vanguard endograft was confirmed. Patients with graft-related complications should be treated accordingly.

Ruptured anastomotic aneurysms after aortobifemoral surgery are potentially life threatening. The preferred technique consists of resection of the pseudoaneurysm and interposition of a new graft. We present a case in which an endovascular approach was chosen for treatment of a ruptured femoral false aneurysm. An endograft was inserted and complete exclusion of the pseudoaneurysm was achieved.

In order to evaluate various protocols for the preservation of venous allografts 162 arterial reconstructions were performed in mongrel dogs bypassing their ligated femoral arteries. The cumulative 6-month patency-rates as determined by weekly palpation and regular angiography were. Group I = Synthetic grafts: (a) Dacron 48%, (b) PTFE 53%. Group II = Fresh venous grafts: (a) autografts 100%, (b) allografts 37%. Group III = Veins preserved in saline at 4 degrees C for 1 month: (a) autografts 44%, (b) allografts 34%. Group IV = Veins preserved in saline at -70 degrees C: (a) autografts 58%, (b) allografts 47%. Group V = Veins preserved in glutaraldehyde solution: (a) autografts 26%, (b) allografts 22%. Group VI = Veins preserved in Hanks-solution with 15% DMSO at -160 degrees C: (a) autografts 77%, (b) allografts 35%. Histological as well as immunological studies suggest that these results are determined by the preservation protocol in Groups III, IV and V and by the presence of rejection in Groups I and VI. As the results with the allografts are not superior to those obtained with synthetic grafts, their use should be confined to those cases where the use of synthetic materials should be avoided at any price. Further experiments with immunosuppression and antigenic matching are indicated to see whether this would improve the results obtained with viable venous allografts.