Outcomes of endovascular repair of infrarenal penetrating aortic ulcers.

Background: To report technical success as well as perioperative outcomes of patients who underwent endovascular aortic repair (EVAR) of penetrating abdominal aortic ulcers ≤35 mm in diameter (PAU). Patients and methods: The abdominal aortic aneurysm (AAA) quality registry of the German institute for vascular research (DIGG) was used to identify patients with standard EVAR for infrarenal PAU ≤35 mm between 1/1/2019 and 12/31/2021. Infectious, traumatic, inflammatory PAUs, PAUs associated with connective tissue disease, PAUs following aortic dissection as well as true aneurysms were excluded. Demographics, cardiovascular comorbidity, technical success as well as perioperative morbidity and mortality were determined. Results: Amongst 11 537 patients who underwent EVAR during the study period, 405 with PAU ≤35 mm were eligible from 95 participating hospitals across Germany (22% women, 20.5% octogenarians). The median aortic diameter was 30 mm (Interquartile range 27-33). Cardiovascular comorbidities were frequent with coronary artery disease (34.8%), chronic heart failure (30.9%), history of myocardial infarction (19.8%), hypertension (76.8%), diabetes (21.7%), smoking (20.8%), history of stroke (9.4%), symptomatic lower extremity peripheral arterial disease (20%), chronic kidney disease (10.4%) and chronic obstructive pulmonary disease (9.6%). Most patients were asymptomatic (89.9%). Among the symptomatic patients, 13 presented with distal embolization (3.2%) and 3 with contained ruptures (0.7%). Technical success of endovascular repair was 98.3%. Both, percutaneous (37.1%) or femoral cut-down access approaches (58.5%) were registered. Endoleaks of any type were present with type 1 (0.5%), type 2 (6.4%) and type 3 (0.3%) endoleaks. Overall mortality was 0.5%. Perioperative complications occurred in 12 patients (3.0%). Conclusions: According to this registry data, endovascular repair of PAU is technically feasible with acceptable perioperative outcomes, but further studies investigating mid- and long-term data are needed before invasive treatment of PAU disease in an elderly and comorbid patient population should be recommended.

How German vascular surgeons and angiologists judge walking exercise for patients with PAD.

Background: To determine the physician's perspective and perception on walking exercise as well as barriers in guideline-directed best medical treatment of patients with lower extremity peripheral arterial disease (PAD). Patients and methods: All members of the German Society for Vascular Surgery and Vascular Medicine and of the German Society for Angiology - Society for Vascular Medicine with valid email address were invited to participate in an electronic survey on walking exercise for treatment of intermittent claudication that was developed by the authors. Results: Amongst 3910 invited participants, 743 (19%) provided valid responses (33% females, 84% vascular surgery, 15% angiology). Thereof, 65% were employed by non-university hospitals, 16% by university institutions, and 18% by outpatient facilities. A mean of 14 minutes were spent per patient to counsel and educate, while only 53% responded they had enough time in everyday clinical practice. While 98% were aware of the beneficial impact of structured exercise training (SET) on pain free walking distance and 90% advise their patients to adhere to SET, only 44% provided useful guidance to patients to find local SET programmes and merely 42% knew how to prescribe SET as service that can be reimbursed by medical insurances. Approximately 35% knew a local SET programme and appropriate contact person. Health-related quality of life was assessed in a structured way by only 11%. Forty-seven percent responded that medical insurances should be responsible to implement and maintain SET programmes, while only 4% held hospital physicians responsible to achieve this task. Conclusions: This nationwide survey study amongst vascular specialists illustrates the current insufficient utilisation of SET as an evidence-based therapeutic cornerstone in patients with lower extremity PAD in Germany. The study also identified several barriers and flaws from the physician's perspectives which should be addressed collectively by all health care providers aiming to increase the SET use and eventually its' impact on patients with PAD.

Impact of chronic kidney disease on the outcomes of infrapopliteal venous, and heparin-bonded expanded polytetrafluoroethylene bypass surgeries: A retrospective cohort study.

The aim of this study was to analyze the results of infrapopliteal venous and prosthetic bypass surgeries for patients with chronic limb-threatening ischemia (CLTI) and moderate to severe chronic kidney disease (CKD). All consecutive patients undergoing infrapopliteal bypass surgeries at two academic vascular centers between March 2002 and November 2018 were included in this retrospective study. During this timeframe, infrapopliteal grafts were performed for 487 patients. Of these patients, 160 (32.9%; group 1) had normal renal function, 248 (50.9%; group 2) had moderate CKD, and 79 (16.2%; group 3) had severe CKD according to the Kidney Disease Improving Global Outcomes guidelines. After 5 years' follow-up, the primary patency rate was 46.0% and the secondary patency rate was 54.9% without statistical significance noted between the CKD groups. Limb salvage (65.3%, p = 0.024) and long-term survival (19.6%, p < 0.001) were considerably lower in patients with severe CKD. In subgroup analysis, vein grafts had significantly better long-term patency rates compared to prosthetic grafts, regardless of CKD group. However, in patients with severe CKD, patency rates of vein and heparin-bonded expanded polytetrafluoroethylene (HePTFE) grafts were comparable at the 1-year mark. Our study shows that autologous vein grafts remain the first choice for infrapopliteal bypass surgeries in patients with CKD. HePTFE grafts showed good short-term results in patients with severe CKD. Given the short life expectancy of these high-risk patients, prosthetic HePTFE grafts may be reasonable in this population if a suitable vein is absent.

Midterm outcome of biosynthetic collagen prosthesis for treating aortic and peripheral prosthetic graft infections.

OBJECTIVES: To report the midterm outcomes of treating prosthetic peripheral and aortic graft infections using a biosynthetic collagen prosthesis in a tertiary vascular center. METHODS: A retrospective analysis of all patients with prosthetic peripheral and aortic graft infections who underwent in situ reconstruction using a biosynthetic collagen prosthesis between March 2015 and November 2020 was conducted. Perioperative and midterm outcomes were analyzed. RESULTS: A biosynthetic collagen prosthesis was used in 19 patients (14 males, median age 66 years) to reconstruct the femoral artery (n = 6), iliac artery (n = 1), and infrarenal aorta (n = 12). All patients were treated for a prosthetic vascular graft infection. The median follow-up period was 26.6 months (range 1-66 months). The 30-day graft failure rate was 15.7% (n = 3), leading to a major amputation in one patient (5.3%). All grafts were occluded aortofemoral reconstructions in patients with occluded superficial femoral artery and were treated by immediate thrombectomy. The 30-day mortality rate was 5.3% (n = 1), and survival after 3 years was 63.2%. The reinfection rate was 5.3% (n = 1). At 13.6 months, the occlusion of a femoral graft was detected in 5.3% (n = 1) and was treated with a new interposition graft. We observed no graft rupture or degeneration during follow-up. CONCLUSIONS: Although results of in situ repair with autologous vein seem to be superior with little or none reinfection and low number of occlusions, biosynthetic collagen prostheses show acceptable midterm outcomes in terms of graft occlusion and mortality after prosthetic peripheral and aortic graft infections. Similar to other xenogenous materials, the reinfection rate is low with this prosthesis. With regard to immediate availability and easy handling, the use of a biosynthetic collagen prosthesis might be favorable compared to other replacement materials while treating prosthetic graft infections.

Short and long-term outcome after common femoral artery hybrid procedure in patients with intermittent claudication and chronic limb threatening ischemia.

Background: This study aimed to evaluate the differences between the outcomes of patients with intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) who underwent a hybrid procedure comprising common femoral artery endarterectomy and endovascular therapy. Patients and methods: This was a retrospective single-center study of all patients with peripheral arterial occlusive disease (PAD) who underwent the hybrid procedure between March 2007 and August 2018. The primary endpoint was primary patency after 7 years. The secondary endpoints were primary-assisted patency, secondary patency, limb salvage, and survival. Results: During the follow-up period, 427 limbs in 409 patients were treated. A total of 267 and 160 patients presented with clinical signs of IC and CLTI, respectively. The 30-day mortality was 1.4% (IC: 0% vs. CLTI: 3.8%, p=0.001). The overall 30-day major amputation rate was 1.6% (IC: 0% vs. CLTI: 4.4, p=0.001). The rates of primary and secondary patency after 7 years were 63% and 94%, respectively, in the IC group and 57% and 88%, respectively, in the CLTI group; the difference was not significant. Limb salvage (94% vs. 82%, p=0.000) and survival (58% vs. 29%, p=0.000) were significantly higher in the IC group. In a multivariate analysis, CLTI was the only risk factor for major amputation. CLTI and single vessel run-off were risk factors for death. Statin therapy was a protective factor. Conclusions: The hybrid procedure provides excellent results as a treatment option for multilevel lesions in patients with PAD. However, patients with CLTI had a shorter long-term survival and lower limb salvage rate.

Bypass Grafting vs Endovascular Therapy in Patients With Non-Dialysis-Dependent Chronic Kidney Disease and Chronic Limb-Threatening Ischemia (CRITISCH Registry).

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.

Treatment of Lymphatic Complications after Common Femoral Artery Endarterectomy.

BACKGROUND: This study analyzes the outcome of lymphatic complications after a standard vascular procedure. METHODS: This is a retrospective study including patients who had a lymphatic complication after endarterectomy and patch of the common femoral artery in our clinic between March 2007 and June 2018. Therapy of choice was selected according to wound situation and amount of lymphatic liquid. If signs of a wound infection occurred, a surgical therapy was performed; in all other cases a nonsurgical treatment (conservative treatment, radiotherapy) was chosen. RESULTS: We performed 977 index operations, a lymphatic complication occurred in 112 cases (11.5%). In 69 cases the lymphatic complication presented as lymphatic fistula (Group 1), in 43 cases as lymphorrhea from the wound (Group 2). Nonsurgical treatment was done in 66 cases (Group 1: 76.8% vs. Group 2: 30.2%; P < 0.000), and a surgical treatment was necessary in 46 cases (Group 1: 23.2% vs. Group 2: 69.8%; P < 0.000). Indication for surgery was Szilagyi 1 infection in 25 cases, Szilagyi 2 infection in 11 cases, and Szilagyi 3 infection in 10 cases. Patients with Szilagyi 1 infections received negative wound pressure therapy (NWPT). A muscle flap in combination with an NWPT was performed in patients with Szilagyi 2 infections. In Szilagyi 3 infections, the patch was replaced; additionally, a muscle flap and an NWPT were performed. The median hospital stay was 13 days in the nonsurgical group and 22.5 days in the surgical group. We had no bleeding complications and no reinfection during follow-up. The median observation period was 23.0 months. Age ≥80 years was associated with an increased risk for lymphatic complications. CONCLUSIONS: The therapy of lymphatic complications should be done in accordance with clinical symptoms. A nonsurgical treatment is often sufficient. However, in cases of a wound infection different surgical treatments are necessary.

Remote iliac artery endarterectomy with selective stent use at the proximal dissection zone in TransAtlantic Inter-Society Consensus C and D lesions.

BACKGROUND: Remote iliac artery endarterectomy (RIAE) is a challenging technique in the treatment of arterial occlusive disease. The impact of proximal transection zone stenting on patency rates is still unclear. METHODS: This is a retrospective analysis of all patients who underwent RIAE in our hospital between March 2007 and October 2017. A stent was used in cases with a dissection flap or a stenosis at the proximal transection zone after RIAE. In all other cases, we did not use a stent. Study end points were patency rates, limb salvage, and survival after 5 years. RESULTS: There were 115 RIAEs performed in 108 patients. All lesions were TransAtlantic Inter-Society Consensus C (61.7%) or D (38.3%) lesions. The median follow-up time was 38.5 months (range, 0-117 months). The indications were claudication in 67.0% and critical limb ischemia in 33.0%. Group 1 (n = 56) included all patients without a stent; group 2 (n = 59) included all patients with stenting of the proximal dissection zone. Risk factors were similar between the groups. The 30-day morbidity and mortality rates between the groups were not significantly different. The primary patency rate was 81.6% (group 1, 76.2%; group 2, 87.6%; P = .286), the primary assisted patency rate was 91.9% (group 1, 94.0%; group 2, 90.0%; P = .512), and the secondary patency rate was 93.8% (group 1, 94.0%; group 2, 91.6%; P = .435) after 5 years. Limb salvage (97.2%; group 1, 100%; group 2, 94.5%; P = .084) and survival time (57.1%; group 1, 66.7%; group 2, 43.5%; P = .170) were also not significantly different between the groups. A restenosis at the transection zone occurred in 14.3% in group 1 and 1.7% in group 2 (P = .013) during follow-up. A newly formed occlusion of the hypogastric artery was seen in 5.2% of patients after RIAE. CONCLUSIONS: RIAE is a safe procedure with excellent patency rates. However, the restenosis rate is higher in cases without stenting.

Outcomes After Endovascular Revascularization in Octogenarians and Non-Octogenarians With Critical Limb Ischemia.

PURPOSE: To determine the outcome and periprocedural risk of endovascular revascularization in octogenarians with critical limb ischemia (CLI) compared with their younger counterparts. METHODS: The multicenter, prospective registry for First-line Treatments in Patients With Critical Limb Ischemia (CRITISCH) enrolled 642 patients treated with endovascular techniques ( ClinicalTrials.gov identifier NCT01877252). The patients were dichotomized according to age <80 years (n=421; mean age 69 years, 292 men; group 1) or ≥80 years (n=221; mean age 85 years, 113 men; group 2). The groups had similar distributions in Rutherford categories 4 to 6, but group 1 had more men, smokers, diabetics, and patients on dialysis. The primary composite endpoint of the study was amputation and/or death. Key secondary endpoints were in-hospital mortality and major amputation, as well as major adverse limb events (MALE; any reintervention or major amputation involving the index limb) at 1 year. RESULTS: The in-hospital mortality was 1% in group 1 and 2% in group 2 (p=0.204) and the major amputation rates were 4% and 2% (p=0.169), respectively. Amputation-free survival at 1 year was 75% in group 1 and 77% in group 2 (p=0.340), whereas freedom from MALE was significantly different between the groups [62% group 1 vs 72% group 2; hazard ratio (HR) 1.45, 95% confidence interval (CI) 1.09 to 1.93, p=0.016). Limb salvage was 90% in group 1 and 95% in group 2 (HR 2.16, 95% CI 1.27 to 3.69, p=0.01). CONCLUSION: Octogenarians with CLI treated by endovascular means showed comparable early and 1-year amputation-free survival rates vs their younger counterparts, and limb salvage and freedom from MALE rates were even higher in octogenarians. APPENDIX: The CRITISCH collaborators are Farzin Adili, MD (Darmstadt), Kai Balzer, MD (Bonn), Arend Billing, MD (Offenbach), Dittmar Böckler, MD (Heidelberg), Daniel Brixner, MD (Offenbach), Sebastian E. Debus, MD (Hamburg), Hans-Henning Eckstein, MD (München), Hans-Joachim Florek, MD (Freital), Asimakis Gkremoutis, MD (Frankfurt), Reinhardt Grundmann, MD (Bad Krozingen), Thomas Hupp, MD (Stuttgart), Se-Won Hwang, MD (Muenster), Tobias Keck, MD (Lübeck), Wojciech, Klonek, MD (Cloppenburg), Werner Lang, MD (Erlangen), Björn May (Freital), Alexander Meyer, MD (Erlangen), Bernhard Mühling, MD (Biberach), Alexander Oberhuber, MD (Düsseldorf), Holger Reinecke, MD (Münster), Christian Reinhold, MD (Mönchengladbach), Ralf-Gerhard Ritter, MD (Bielefeld), Hubert Schelzig, MD (Düsseldorf), Christian Schlensack, MD (Tübingen), Thomas Schmitz-Rixen, MD (Frankfurt), Karl-Ludwig Schulte, MD (Berlin), Matthias Spohn, MD (Bamberg), Konstantinos Stavroulakis, MD (Münster), Martin Storck, MD (Karlsruhe), Matthias Trede, MD (Bremen), Barbara Weis-Müller, MD (Mönchengladbach), Heiner Wenk (Bremen), Thomas Zeller, MD (Bad Krozingen), Sven Zhorzel, MD (Munich), and Alexander Zimmermann, MD (Munich).

Credentialing in interventional therapy in Europe - comparison of curricula including endovascular therapy of arterial diseases.

The prevalence of peripheral artery disease (PAD) is continuously increasing. In addition, the treatment of PAD has changed substantially over the last decades. Novel treatment modalities and diagnostic tools were developed and endovascular therapy was established as a first-line therapy. In consequence, vascular medicine has become an interdisciplinary field, involving different specialties such as internal medicine/cardiology, internal medicine/angiology, vascular surgery, and (interventional) radiology. Attributed to the expanding field and to ensure high quality and standardized training, various curricula were developed. Not only within the different medical disciplines but across countries. We compared the training programmes in Germany, Switzerland, and Europe and found a great variety in these curricula and programmes. Nevertheless, we identified first attempts to harmonize training requirements within the various societies: the interdisciplinary guidelines of the German Society for Cardiology (DGK) and the German Society of Angiology, the adoption of European standards on a national level, and the Swiss initiative of the Union of Vascular Societies of Switzerland (UVSS). The standard and level of training is high in all curricula and societies. However, further harmonization is needed to optimize patient care and ensure a uniform quality level across different vascular societies.

[Management of Endograft Infection After EVAR and TEVAR - a Case Series and Literature Review]. / Management von Stentprotheseninfektionen nach EVAR und TEVAR ­ Fallserie und Literaturübersicht.

Introduction Endograft infection after EVAR (Endovascular aortic repair) or TEVAR (Thoracic endovascular aortic repair) is a rare but severe complication with high mortality. As the number of patients with endovascular aneurysm repair has increased over the last decade, the number of patients with endograft infection might also have increased. However, no guideline defines the treatment of endograft infection. Diagnosis is difficult and depends on clinical symptoms, radiological imaging and blood cultures. Surgery with graft excision, debridement and revascularisation should be proposed. Several techniques and graft materials are used. Additionally long term antibiotic therapy under close control of inflammation markers is always required. Methods We conducted a retrospective analysis of all patients treated for infected aortic endografts in our hospital between January 2008 and May 2017. Study endpoints were freedom from reinfection, survival and primary patency. An extensive electronic health database search was performed to identify articles reporting endograft infection after EVAR and TEVAR. Results We detected aortic endograft infection in three patients (100% male, median age 77 years). In all cases, infrarenal endovascular aortic aneurysm repair had been performed. The infected stent grafts were removed and anatomical revascularisation performed. One homograft and two xenografts were used as graft material. No patient was treated conservatively. A causative organism was found in 2 of the 3 cases. The patients received antibiotics for 12 weeks. Thirty day mortality was 0%. During follow-up, one patient died from bowel perforation after 2 months and another from lung cancer after 92 months. There were no reinfections. Primary patency of the reconstructions was 100%. Publications report high mortality after conservative therapy of endograft infection. There is evidence for lower mortality in patients who underwent surgery. Conclusions Removal of the infected graft, anatomical revascularisation and antibiotic therapy are important for long term survival after aortic endograft infection. Conservative therapy is only warranted in patients unsuitable for surgical treatment.

Tibial and peroneal bypasses in octogenarians and nonoctogenarians with critical limb ischemia.

BACKGROUND: Elderly patients with critical limb ischemia are increasingly treated through interventional therapy. The outcome of tibial and peroneal bypasses in octogenarians who were unsuitable for endovascular therapy remains unclear. METHODS: We conducted a retrospective analysis of all patients who underwent tibial or peroneal bypass surgery in our clinic between October 2007 and April 2015. In Group 1 we included all patients 80 years and older and in group 2 all patients under 80 years. Vein was used whenever possible (diameter not less than 3 mm, not more than two segments for sufficient length). Study end points were primary and secondary patency, limb salvage and survival after 3 years. RESULTS: Indications were rest pain in 32.2% and ulcer and gangrene in 67.8%. There were 92 cases in Group 1 (median age, 85 years) and 178 in group 2 (median age, 70 years). Risk factors and indications were similar in both groups except for gender, renal insufficiency and smoking. 30-day mortality was 9.7% in group 1 and 1.1% in group 2 (P = .001). There was no significant difference in 30-day graft failure and major amputation. At 3 years primary patency in group 1 was 58.9% vs 49.7% (P = .058), secondary patency was 73.0% vs 54.7% (P = .007). Limb salvage was 80.1% in group 1 vs 73.0% in group 2 (P = .446), survival was 44.0% vs 71.2% (P = .000). CONCLUSIONS: Our analysis showed good results in octogenarians undergoing tibial and peroneal bypass surgery with regard to patency rates and limb salvage. However, octogenarians had a significantly higher perioperative mortality rate.

Comparison of venous and HePTFE tibial and peroneal bypasses in critical limb ischemia patients unsuitable for endovascular revascularization.

BACKGROUND: We examined short- and long-term outcomes of tibial and peroneal venous and heparin-bonded expanded polytetrafluoroethylene bypasses in patients with critical limb ischemia who were unsuitable for endovascular revascularization. METHODS: A retrospective analysis was done for all patients who underwent tibial and peroneal bypass surgery in our department between October 2007 and October 2012. Vein was the preferred graft material and used whenever possible. RESULTS: One hundred and ninety-eight crural grafts were included. Indications for the surgery were rest pain (30.3%) or ulcer or gangrene (69.7%). Autologous veins were used in 109 cases (vein group) and heparin-bonded expanded polytetrafluoroethylene grafts were used in 89 cases (heparin-bonded expanded polytetrafluoroethylene group). At three years, primary patency for the vein group was 68.2% versus 34.1% for the heparin-bonded expanded polytetrafluoroethylene group (P = .000) and secondary patency was 69.8% versus 35.5% (P = .001). Limb salvage was 81.8% for the vein group versus 56.5% for the heparin-bonded expanded polytetrafluoroethylene group (P = .000) and survival was 62.8% versus 46.7% (P = .019). CONCLUSIONS: The results of our study show that autologous vein grafts are still first choice for tibial and peroneal bypasses in patients with critical limb ischemia. If no adequate vein is available, heparin-bonded expanded polytetrafluoroethylene bypasses are an acceptable alternative to an otherwise impending major amputation.

The influence of continuous local wound infusion on postoperative pain in patients undergoing transfemoral amputation.

BACKGROUND: This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics. PATIENTS AND METHODS: We included 42 patients in this prospective observational pilot study. Patients were divided into two groups. One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment (Group 1). Group 2 was treated with analgesics in accordance with the WHO standard pain management protocol, exclusively. RESULTS: The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group 1 for the first 5 days. Furthermore, the intake of opiates was significantly reduced in Group 1 (day 1, Group 1: 42.1 vs. Group 2: 73.5, p = 0.010; day 2, Group 1: 27.7 vs. Group 2: 52.5, p = 0.012; day 3, Group 1: 23.9 vs. Group 2: 53.5, p = 0.002; day 4, Group 1: 15.7 vs. Group 2: 48.3, p = 0.003; day 5, Group 1 13.3 vs. Group 2: 49.9, p = 0.001). There were no significant differences between the two groups, neither in phantom pain intensity at discharge nor postoperative complications and death. CONCLUSIONS: Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation. Phantom pain was not significantly affected.

Retrograde thrombendarterectomy vs. ilio-femoral bypass in unilateral iliac TASC C and D lesions.

BACKGROUND: To compare short and long term results of retrograde Thrombendarterectomy (rTEA) and ilio-femoral Bypass (IFBP) to treat iliac TASC C and D lesions. PATIENTS AND METHODS: Retrospective analysis of 108 patients treated at a single vascular center by either rTEA (n = 42) or IFBP (n = 66) over a period of 4 years. RESULTS: Both methods did not significantly differ in 30-day (rTEA 0 % vs IFBP 2 %) or long-term mortality (rTEA 24 % vs IFBP 30 % at 4 years) with a median follow-up of 46 months. There were no procedure related deaths. Patency was similar for both groups (rTEA 93 % vs IFBP 98 % at 30 days; rTEA 83 % vs 92 % IFBP at 4 years). We could not find a significant difference in limb salvage rates (rTEA 93 % vs IFBP 100 % at 30 days and at 4 years). The incidence of prolonged lymphorrhea was significantly higher in the IFBP group (rTEA 0 % vs IFBP 21 %). In 4 IFBP patients a prosthetic graft infection occurred. CONCLUSIONS: Regarding short and long term results operative procedures as rTEA and IFBP still represent the gold standard in the treatment of TASC C and D lesions of the external iliac artery especially in patients with additional lesions in the common femoral and profundal femoral artery. Taking into account certain anatomical characteristics (heavily calcified lesions, narrow external iliac arteries or very tortuous iliac segments) and individual local conditions (prior vascular procedures involving the femoral bifurcation) the single incision retrograde approach to the EIA with rTEA may have advantages over IFBP, especially concerning postoperative complications like lymphorrhea and graft infection.

Pedal bypass surgery after crural endovascular intervention.

BACKGROUND: Many centers choose endovascular intervention as their first-line treatment for crural occlusions in patients with critical limb ischemia (Rutherford 4-6). However, unsuccessful interventions often result in major amputation. Therefore, pedal bypass surgery should be considered as an alternative first-line treatment. We reviewed the impact of a prior endovascular intervention on the outcome of our patients' pedal bypass procedures. METHODS: A retrospective analysis was conducted for all patients who had undergone pedal bypass surgery in our department from February 2008 to October 2012. We performed 75 pedal bypass operations in 71 patients (male, 54; female, 17; median age, 72 years; range, 29-90 years). In 36 of those cases, patients had undergone a prior infrapopliteal endovascular intervention (PEI group). In 39 cases, patients underwent bypass surgery as first-line treatment because their prior angiography had resulted in either unsuccessful endovascular intervention, or intervention had been deemed 'not feasible' (BSF group). Only autologous vein grafts were used, and no retrograde intervention was done via the pedal arteries. Endpoints of the analysis were primary and secondary patency rates, mortality, and limb salvage at 1 year postoperatively. RESULTS: Overall primary patency at 1 year was 58.3%, and secondary patency was 61.3%. Limb salvage was 76.8% and survival was 80.4%. Graft occlusion within 30 days was 18.7%. Revision in those cases was futile and 78.6% of patients had to undergo major amputation. Primary patency at 1 year was 67.0% in PEI group vs 48.3% in BSF group (P = .409) and secondary patency was 73.5% vs 48.6% (P = .100). Prior endovascular intervention had no significant impact on either limb salvage (82.3% vs 71.6% at 1 year; P = .515) or graft occlusions within 30 days (19.4% vs 17.9%; P = .547). Survival rate at 1 year was 79.5% in PEI group and 81.3% in BSF group (P = .765). Risk factors and indications were similar in both groups. CONCLUSIONS: Crural endovascular intervention does not seem to have a negative impact on the outcome of subsequent pedal bypass surgery. Requirements are avoiding a destruction of the target vessel and opting for timely bypass surgery whenever endovascular treatment does not achieve a sufficient perfusion for wounds to heal. Early graft occlusions are associated with a higher risk for major amputation.

[Recommendations for the specialist further training of nursing personnel on intensive care units in the treatment of abdominal aortic aneurysms: results of a modified Delphi procedure with experts]. / Empfehlungen zur Fachweiterbildung von Pflegefachpersonen der Intensivstation bei der Behandlung des Bauchaortenaneurysmas: Ergebnisse eines modifizierten Delphi-Verfahrens mit Expert:innen.

INTRODUCTION: The medical development in the previous 15 years and the changes in treatment reality of the comprehensive elective treatment of abdominal aortic aneurysms necessitate a re-evaluation of the quality assurance guidelines of the Federal Joint Committee in Germany (QBAA-RL). In the current version this requires a specialist further training quota for nursing personnel in intensive care wards of 50%. The quota was determined in 2008 based on expert opinions, although a direct empirical evidence base for this does not exist. METHODS: Representatives from the fields of patient representation, physicians, nursing personnel and other relevant interface areas were invited to participate in a modified Delphi procedure. Following a comprehensive narrative literature search, a survey and focus group discussions with national and international experts, a total of three anonymized online-based voting rounds were carried out for which previously determined key statements were assessed with a 4­point Likert scale (totally disagree up to totally agree). In addition, the expert panel had also defined a recommendation for a minimum quota for the specialist training of nursing personnel on intensive care wards in the treatment of abdominal aortic aneurysms, whereby an a priori agreement of 80% of the participants was defined as the consensus limit. RESULTS: Overall, 37 experts participated in the discussions and three successive voting rounds (participation rate 89%). The panel confirmed the necessity of a re-evaluation of the guideline recommendations and recommended the introduction of a shift-related minimum quota of 30% of the full-time equivalent of nursing personnel on intensive care wards and the introduction of structured promotional programs for long-term elevation of the quota. CONCLUSION: In this national Delphi procedure with medical and nursing experts as well as representatives of patients, the fundamental benefits and needs of professional specialist qualifications in the field of intensive care medicine were confirmed. The corresponding minimum quota for specialist further training of intensive care nursing personnel should generally apply without limitations to specific groups. The expert panel stipulates a shift-related minimum quota for intensive care nursing personnel with specialist training of 30% of the nursing personnel on intensive care wards and the obligatory introduction of structured and transparent promotion programs for the long-term enhancement.

FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

BACKGROUND: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited. OBJECTIVE: The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease. METHODS: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12­month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5 years. RESULTS: Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023. CONCLUSIONS: The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51480.