Six-year outcomes of a phase II study of human-tissue engineered blood vessels for peripheral arterial bypass.

Objective: The human acellular vessel (HAV) was evaluated for surgical bypass in a phase II study. The primary results at 24 months after implantation have been reported, and the patients will be evaluated for ≤10 years. Methods: In the present report, we have described the 6-year results of a prospective, open-label, single-treatment arm, multicenter study. Patients with advanced peripheral artery disease (PAD) requiring above-the-knee femoropopliteal bypass surgery without available autologous graft options had undergone implantation with the HAV, a bioengineered human tissue replacement blood vessel. The patients who completed the 24-month primary portion of the study will be evaluated for ≤10 years after implantation. The present mid-term analysis was performed at the 6-year milestone (72 months) for patients followed up for 24 to 72 months. Results: HAVs were implanted in 20 patients at three sites in Poland. Seven patients had discontinued the study before completing the 2-year portion of the study: four after graft occlusion had occurred and three who had died of causes deemed unrelated to the conduit, with the HAV reported as functional at their last visit. The primary results at 24 months showed primary, primary assisted, and secondary patency rates of 58%, 58%, and 74%, respectively. One vessel had developed a pseudoaneurysm deemed possibly iatrogenic; no other signs of structural failure were reported. No rejections or infections of the HAV occurred, and no patient had required amputation of the implanted limb. Of the 20 patients, 13 had completed the primary portion of the study; however, 1 patient had died shortly after 24 months. Of the remaining 12 patients, 3 died of causes unrelated to the HAV. One patient had required thrombectomy twice, with secondary patency achieved. No other interventions were recorded between 24 and 72 months. At 72 months, five patients had a patent HAV, including four patients with primary patency. For the entire study population from day 1 to month 72, the overall primary, primary assisted, and secondary patency rate estimated using Kaplan-Meier analysis was 44%, 45%, and 60% respectively, with censoring for death. No patient had experienced rejection or infection of the HAV, and no patient had required amputation of the implanted limb. Conclusions: The infection-resistant, off-the-shelf HAV could provide a durable alternative conduit in the arterial circuit setting to restore the lower extremity blood supply in patients with PAD, with remodeling into the recipient's own vessel over time. The HAV is currently being evaluated in seven clinical trials to treat PAD, vascular trauma, and as a hemodialysis access conduit.

The Impact of a Simplified Hydrostatic Bypass Flow Technique on Error Detection during Surgical Limb Revascularization.

Technical errors have an impact on the results of surgical lower limb revascularization. Use of ultrasound scanning or angiography on the operating table is inconvenient and, in case of angiography, carries a certain risk of radiation and contrast exposure. A simpler method of screening for errors is required. This study assessed the accuracy of a new simple hydrostatic bypass flow technique during surgical limb revascularization. In all, 885 patients were included in the retrospective study. All were treated for Chronic Limb-Threatening Ischemia (CLTI) with a femoropopliteal bypass. Preoperatively, the radiological Vascular Surgery/International Society of Cardiovascular Surgery (SVS/ISCVS) score was used to assess the complexity of the anatomical changes. The surgeon made a subjective runoff assessment for every surgery. In 267 cases, the hydrostatic bypass flow (HBF) technique was used, and, in 66 cases, a digital subtraction angiography (DSA) was used. In each case, a postoperative Doppler ultrasound (DUS) examination was performed following the HBF. Good early results were achieved in 89.46%, and 154 errors (17.4%) were detected (85 were detected on the operating table, including 57 technical errors). Independent efficacy in error detection was proven with a postoperative Doppler examination (Aera Under Curve (AUC) = 0.89; criterion mid-graft peak systolic velocity (PSV) <24 cm/s, p = 0.00001) and hydrostatic bypass flow (AUC = 0.71, criterion HBF < 53 mL/min, p = 0.00001) during surgery. The hydrostatic bypass flow technique is an effective intraoperative screening method in bypass surgery. Algorithmic use of HBF, DSA if needed, and DUS postoperatively improves the outcome. HBF sufficiently reduced the need for on-table angiography.

Complete Entry and Re-entry Neutralization protocol in endovascular treatment of aortic dissection.

There have been indisputable developments in techniques for stabilizing acute aortic syndromes. However, aneurysmal degeneration following aortic dissection remains a problem to be solved. The currently available treatment options for aortic dissection still fail to take into account the known risk factors for aneurysmal degeneration. This is why we introduced a new approach to treating patients with an aortic dissection, called Complete Entry and Re-entry Neutralization (CERN). This is our initial report on the promising interim results. MATERIAL AND METHODS: 68 patients qualified for endovascular treatment of an acute or chronic aortic dissection. Computed tomography was performed post-operatively to assess aortic remodeling after 1/6/12/24/36 months. RESULTS: the 30-day mortality rate was 4.4%. In 29 cases (43%) unfavorable remodeling was noted in the follow-up. The most important factors leading to unfavorable remodeling were: uncovered re-entry tear including the infra-renal segment, no relining of dissection membranes and insufficient coverage of the descending aorta. We analyzed these factors to develop the CERN protocol. This concept consists of six basic rules: A. cover all entry tears, B. amplify the BMS radial force, C. use the STABILISE technique, D. consider using thrombus plugs, E. avoid stenting the visceral branches, F. spare the intercostal and lumbar side branches. CERN improves the rate of favorable remodeling from 25% to 85% (P = 0.0067). CONCLUSION: Introduction of the Complete Entry and Re-entry Neutralization protocol improves the rate of favorable remodeling following endovascular treatment of aortic dissection in mid-term follow-up in patients with diffused aortic dissection.

Arterial reconstruction with human bioengineered acellular blood vessels in patients with peripheral arterial disease.

OBJECTIVE: Vascular conduit is essential for arterial reconstruction for a number of conditions, including trauma and atherosclerotic occlusive disease. We have developed a tissue-engineered human acellular vessel (HAV) that can be manufactured, stored on site at hospitals, and be immediately available for arterial vascular reconstruction. Although the HAV is acellular when implanted, extensive preclinical and clinical testing has demonstrated that the HAV subsequently repopulates with the recipient's own vascular cells. We report a first-in-man clinical experience using the HAV for arterial reconstruction in patients with symptomatic peripheral arterial disease. METHODS: HAVs were manufactured using human vascular smooth muscle cells grown on a biodegradable scaffold. After the establishment of adequate cell growth and extracellular matrix deposition, the vessels were decellularized to remove human cellular antigens. Manufactured vessels were implanted in 20 patients with symptomatic peripheral arterial disease as above-knee, femoral-to-popliteal arterial bypass conduits. After HAV implantation, all patients were assessed for safety, HAV durability, freedom from conduit infection, and bypass patency for 2 years. RESULTS: Twenty HAVs were placed in the arterial, above-knee, femoral-to-popliteal position in patients with rest pain (n = 3) or symptomatic claudication (n = 17). All HAVs functioned as intended and had no evidence of structural failure or rejection by the recipient. No acute HAV infections were reported, but three surgical site infections were documented during the study period. Three non-HAV-related deaths were reported. One vessel developed a pseudoaneurysm after suspected iatrogenic injury during a balloon thrombectomy. No amputations of the HAV implanted limb occurred over the 2-year period, and no HAV infections were reported in approximately 34 patient-years of continuous patient follow-up. CONCLUSIONS: Human tissue engineered blood vessels can be manufactured and readily available for peripheral arterial bypass surgery. Early clinical experience with these vessels, in the arterial position, suggest that they are safe, have acceptable patency, a low incidence of infection, and do not require the harvest of autologous vein or any cells from the recipient. Histologic examination of tissue biopsies revealed vascular remodeling and repopulation by host cells. This first-in-man arterial bypass study supports the continued development of human tissue engineered blood vessels for arterial reconstruction, and potential future expansion to clinical indications including vascular trauma and repair of other size-appropriate peripheral arteries.

Aortic Remodeling After Extended PETTICOAT Technique in Acute Aortic Dissection Type III B.

BACKGROUND: The aim of this paper was to evaluate a new technique called an "extended" provisional extension to induce complete attachment (e-PETTICOAT) technique. METHODS: In this prospective single-center clinical study, the primary safety end mid-term remodeling is evaluated for the new endovascular technique. It was based on a standard Petticoat and limited Stabilize technique, extended by the placement of 2 covered stents within the abdominal bare metal stent as parallel iliac stent grafts down to the iliac bifurcations. Computed tomographic angiography was performed postoperatively to assess aortic remodeling after 12 and 24 months. Changes in aortic size and volumes of the false and true lumen were assessed. RESULTS: Between January 2014 and December 2015, 17 patients were treated due to acute, complicated aortic dissection type III B, according to the DaBekey classification. All patients presented with branch vessel obstruction/compromise, including six cases with aortic impending rupture. A 100% technical success rate was recorded regarding the resolution of complications. Favorable remodeling was achieved in 100% of the cases. Complete false lumen thrombosis in the thoracic, infra-renal aorta and the iliac artery was noted. A small volume (9.51 ± 6.9 mL) contrast-enhanced false lumen in the abdominal aorta was observed in 76% of cases with stable aortic size after 1 and 2 years. No visceral branch occlusion, type I endo-leak, renal insufficiency or paraplegia was recorded in follow-up. CONCLUSIONS: The expanded PETTICOAT technique was feasible in achieving favorable remodeling in acute extensive aortic dissection. Extended followup is needed to ascertain long-term results. This article presents a series of 17 cases of a new endovascular method called E-PETTICOAT (EJVES 2018 https://doi.org/10.1016/j.ejvs.2018.07.038) used in complicated acute and extensive type IIIB dissections. Favorable remodeling was achieved in 100% cases with stable aorta diameter after 1 and 2 years. It was shown that the extended PETTICOAT technique gives good remodeling in acute and extensive aortic dissection. This method can potentially provide a one-step solution and an easier alternative to FEVAR/BEVAR procedures. In order to ensure favorable results, further research is needed on a wider scale with long-term followup.

Expanded Petticoat technique to promote the reduction of contrasted false lumen volume in patients with chronic type B aortic dissection.

OBJECTIVE: This study examined the outcomes of our novel concept of expanded provisional extension to induce complete attachment strategy (Petticoat) for safety, durability, and remodeling of chronic type B dissections. METHODS: Twenty patients with chronic type B aortic dissection with aneurysmal degeneration qualified for an expanded Petticoat strategy (stent graft in the thoracic, plus additional distal bare stent into the abdominal and infrarenal aorta, followed by parallel stent grafts into common iliac arteries). Computed tomography was performed preoperatively and at 1, 6, and 12 months after surgery. RESULTS: The primary technical success was 100%. The 30-day mortality rate was 0%. At 12 months, favorable aortic remodeling and complete false lumen (FL) thrombosis were noted as 100% in the thoracic and infrarenal aorta. The volume of contrast-enhanced FL decreased from 186 ± 75.4 mL all along the dissection preoperatively (range, 70-360 mL), to 6.32 ± 5.4 mL postoperatively (range, 0.0-19.6 mL) and was only observed in the visceral aorta (P = .000089). Despite persistent flow in a small area of the FL, the maximal aortic size was stable in follow-up. Neither paraplegia nor visceral branch occlusion were noted in the follow-up. CONCLUSIONS: The treatment of aortic dissections with an expanded Petticoat strategy seems to be safe and offers good early results. It significantly reduced the volume of contrast enhanced FL. Further investigation of any subsequent results will be necessary.

Multi-organ trauma with rupture and Stanford type B dissection of thoracic aorta. Management sequence. Current possibilities of medical treatment.

A case of a 46-year-old car driver struck with great force by a tram through the driver's door is presented. The main trauma consisted in chest injury with multi-rib fracture along with rupture and dissection of the thoracic aorta. Immediate medical rescue actions consisted only in procedures necessary to support vital functions; the patient survived owing to being promptly transported to the Emergency Department to undergo thoracotomy and laparotomy with massive blood transfusion. Polytrauma angio-CT scan revealed a posttraumatic thoracic aorta lesion which in turn was treated by deployment of an endovascular thoracic stent graft. This way, the immediate risk of death was averted, and the remaining traumatic lesions and conditions could be treated. Patient was discharged to a Rehabilitation Center on the 49th day of treatment. The authors stress that trauma resulting from accidents with this particular mechanism, i.e. lateral car crash on the driver's side with the driver's door being staved in by the tram, should be managed by immediate transport of the patient to the Emergency Center. In such cases early drainage of the pleural cavity can deteriorate patient's status by increasing the bleeding from the ruptured aorta.

The role of neck wrinkles for cosmetic effect during carotid artery endarterectomy.

INTRODUCTION: Minimally invasive procedures in carotid endarterectomy are currently preferred. Smaller skin incisions (transverse or longitudinal) and the mapping of carotid artery bifurcation with Doppler ultrasound are promoted. There is a lack of papers about cosmetic effects and patients' preferences. The aim of this study was to qualify natural skin wrinkles as potential anatomical markers of carotid artery bifurcation and scar camouflage. MATERIAL AND METHODS: 50 patients underwent carotid endarterectomy in 2013-2014 in the Vascular Surgery Department of the Pomeranian Medical University in Szczecin. The positions of wrinkles were compared with the anatomical location of carotid artery bifurcation with the use of Doppler - Duplex Ultrasound. Patients' preferences and cosmetic effect were also assessed. RESULTS: 50% of patients declared the cosmetic effect important. Nevertheless, every patient preferred a transverse incision along a wrinkle line. The wound scar was invisible in 76% of cases 3-6 months after surgery. Wrinkles were close, within 1 centimeter, to carotid artery bifurcation in 80% of cases. It was mainly 4-5 cm from the angle of the mandible. Surgical access along wrinkles located 3, 4, 5, 6, 7 cm from the gonial angle was technically easy in 55%, 77%, 79%, 45%, and 21% of cases, respectively. Using ultrasound before surgery allows the planning of the optimal incision in 98% of cases. CONCLUSIONS: Transverse incision hidden in the wrinkles of the neck gives a good cosmetic effect and allows carotid endarterectomy in every case when carotid artery bifurcation is marked prior to surgery.

Leucocytosis as a specific risk predictor after abdominal aortic aneurysm open repair.

INTRODUCTION: Prediction of early death in abdominal aortic aneurysm - open repair is widely described. There is no superiority of any risk stratification tool. Some of the risk calculators are quite accurate, but very complicated (e.g. P-POSSUM, V-POSSUM). Some are simpler but never used in vascular surgery (e.g. ECOG). Therefore, only leucocytosis itself appears to be an independent and highly specific factor in prediction of early death prior to surgery. This might be used as an early warning factor raising surgeons' attention, especially in centers not using any risk calculators on a regular basis. The aim of this study was to comparison of commonly used early death prediction calculators for abdominal aortic aneurysm - open repair. We took into account the following scales: Glasgow Aneurysm Score (GAS), V-POSSUM, Eagle score, American Society of Anesthesia Score, ECOG, Goldman/Detsky. However, we also have been looking for independent risk factors of early postoperative death. MATERIAL AND METHODS: Retrospective analysis of 79 patients who underwent elective open repair of abdominal aortic aneurysm over 3 years (2011-2013 Szczecin, Poland). We have excluded patients treated due to ruptured aneurysms and with the use of a stentgraft. Receiver operating curve analysis was used to asses all prediction abilities. RESULTS: We noted 6 deaths (7.59%). Receiver operating curve analysis confirms good prediction force for V-POSSUM (p = 0.0001, criterion over 1.9%) and GAS (p = 0.0109, criterion over 73 pt.). Areas under curve are respectively 0.806 and 0.743. However, leucocytosis itself over 10 T/L was the most specific (over 88%) risk factor in early death prediction (p < 0.0001). CONCLUSION: V-POSSUM and GAS are suitable risk calculators for abdominal aortic aneurysm - open repair. Leucocytosis discovered prior to the surgery is a highly specific early death predictor.

[Kidney protection therapy in acute limb ischemia]. / Leczenie nefroprotekcyjne w ostrym niedokrwieniu konczyn dolnych.

Acute limb ischaemia is relatively frequent in the population (800:1 million, with about 1000 cases per year in Zachodniopomorskie province) and is a life-threatening condition due to significant mortality (about 15%) and a high percentage of amputation (up to 25%). Early death is mainly caused by metabolic disorders associated with reperfusion syndrome following surgical revascularisation. Muscle injury caused by rhabdomyolysis leads to acute renal failure, cardiopulmonary insufficiency and generalised inflammatory reaction. Prompt treatment according to the current recommendations, including extensive fasciotomy and intensive and early nephroprotective and renal replacement therapy, offers the only chance to reduce early mortality in patients suffering from this disease. Differences in approach to the problem of renal replacement therapy presented by nephrologists/internists and surgeons are frequent and do not improve treatment outcome. The aim of this paper is to establish a standard consensus between the approach of the vascular surgeon, nephrologist and internist to achieve the best possible treatment outcomes in patients with acute limb ischaemia.