Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

Long-term outcome and cancer incidence after lower extremity bypass surgery in patients with critical limb threatening ischemia.

PURPOSE: The influence of cancer development on long-term outcome after lower extremity bypass surgery in patients with critical limb threatening ischemia was investigated. METHODS: Patient survival and cancer incidence were recorded for 21,082 patients with peripheral artery disease (PAD) stage III (n = 5631; 26.7%) and stage IV (n = 15,451; 73.3%) registered with the AOK health insurance company in Germany who underwent infrainguinal bypass surgery. All patients were preoperative and in their history cancer-free. RESULTS: After a median follow-up of 44 months, 25.6% of all patients developed cancer (Kaplan-Meier estimated), with no significant differences between patients with PAD stage III and IV (cancer incidence stage III 25.7%, stage IV 25.5%; p = 0.421). In the Cox regression analysis, male gender (HR 1.885; 95% CI 1.714-2.073, p < 0.001) and age over 70 years (HR 1.399; 95% CI 1.285-1.522, p < 0.001) were significant risk factors for the development of cancer. Survival was significantly lower in stage IV (23.4%) compared to stage III (44.5%) (HR 1.720; 95% CI 1.645-1.799, p < 0.001). Cancer was a significant risk factor for overall survival in PAD stage III patients (HR: 1.326; 95% CI 1.195-1.471, p < 0.001) but not in PAD stage IV (HR 0.976; 95% CI 0.919-1.037, p = 0.434). CONCLUSION: Patients with PAD stage III have significantly better survival after infrainguinal bypass surgery compared to patients with stage IV. While cancer incidence was essential for survival in stage III, it was of no importance in stage IV.

The Treatment of Patients With an Unruptured Abdominal Aortic Aneurysm and a Concomitant Malignancy.

BACKGROUND: Having cancer adversely effects the outcome of treatment for an unruptured abdominal aortic aneurysm (AAA). METHODS: A retrospective secondary analysis was performed on the basis of anonymized data from AOK, a German nationwide statutory healthinsurance carrier. Data were evaluated from all of the 20 683 patients who underwent either endovascular (EVAR, 15 792) or open surgical (OAR, 4891) treatment for an unruptured AAA in the years 2010-2016. It was determined in each case whether the patient had a known cancer at the time of the procedure to treat AAA. The analysis concerned patient characteristics, periprocedural complications, and survival after the procedure up to 31 December 2018. RESULTS: 18 222 patients were free of cancer. In accordance with the known 6:1 sex ratio of AAA, 85.3% of the cancer-free patients and 92.8% of those with cancer were men. At the time of their AAA procedure, 1398 had cancer of the intestine (n = 318), lung (n = 301), prostate (n = 380), or bladder or ureter (n = 399). One-year survival after the AAA procedure was 91.5% in cancer-free patients and 84%, 74.4%, 85.8%, and 85.5% in the patients with the respective types of cancer just mentioned. Having cancer was a significant risk factor for periprocedural mortality (OR 1.326, p = 0.041) and for long-term survival (HR 1.515; p < 0.001). CONCLUSION: Having cancer is a risk factor for periprocedural mortality and long-term survival in patients undergoing treatment for an unruptured AAA. This implies that the indications for surgery should be considered with care, particularly in patients with lung cancer, whose 5-year survival rate is only 37.2%.

Long-Term Outcome of Intact Abdominal Aortic Aneurysm After Endovascular or Open Repair.

OBJECTIVE: Endovascular aortic aneurysm repair (EVAR) has been established as a standard treatment option for intact abdominal aortic aneurysm (iAAA) and gained importance due to a lower perioperative mortality than open repair (OAR). However, whether this survival advantage can be maintained or if OAR is beneficial in terms of long-term complications and reinterventions remains questionable. DESIGN: In this retrospective cohort study data from patients undergoing elective EVAR or OAR for iAAAs in the years 2010-2016 was analyzed. The patients were followed through 2018. METHODS: In the propensity score matched cohorts the perioperative and long-term outcomes of the patients were assessed. We identified 20 683 patients undergoing elective iAAA repair (76.4% EVAR). The propensity matched cohorts included 4886 pairs of patients. RESULTS: The perioperative mortality was 1.9% for EVAR and 5.9% for OAR (P = <.001). The perioperative mortality was mainly influenced by patients age (Odds-Ratio (OR):1.073, confidence interval (CI):1.058-1.088, P ≤ .001) and OAR (OR:3.242, CI:2.552-4.119, P ≤ .001). The early survival benefit after endovascular repair persisted for approximately 3 years (estimated survival EVAR 82.3%, OAR 80.9%, P = .021). After that time the estimated survival curves were similar. After 9 years the estimated survival was 51.2% after EVAR as compared to 52.8% after OAR (P = .102). The operation method didn't influence long-term survival significantly (Hazard-Ratio (HR): 1.046, CI: .975-1.122, P = .211). The vascular reintervention rate was 17.4% in the EVAR cohort and 7.1% in the OAR cohort (P ≤ .001). CONCLUSION: EVAR has a significantly lower perioperative mortality than OAR, a survival benefit that lasts up to 3 years after intervention. Thereafter, no significant difference in survival was observed between EVAR and OAR. The decision between EVAR or OAR may depend on patient preference, surgeons' experience, and the institutions' ability to handle complications.

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.

Sex difference in early mortality after abdominal aortic aneurysm repair.

OBJECTIVE: Although female patients have a lower prevalence of abdominal aortic aneurysm (AAA), they seem to have a worse treatment outcome compared with male patients. Both maximum aneurysm diameter and aortic size index (ASI) are important indicators of the risk of AAA rupture, among which ASI has been shown capable of equalizing sex-related anatomical differences. Our study aimed to investigate whether sex is an independent risk factor for early postoperative mortality and how the diameter or ASI affects the association between sex and mortality. METHODS: We performed a retrospective analysis of patients who enrolled in the AAA registry of the German Society of Vascular Surgery from 2013 to 2019. The patients were treated by either open surgical repair (OSR) or endovascular aneurysm repair (EVAR). The association between sex and 30-day mortality was investigated using logistic regression analysis. The interaction and mediating effects of maximum aneurysm diameter and ASI were investigated to verify their roles in the effect of sex on mortality. The relationships between the diameter (or ASI) and the risk of 30-day mortality in different sexes were demonstrated by the restricted cubic spline. RESULTS: Overall, 23,275 cases were included in our analysis, with 20,130 male (86.5%) and 3139 female (13.5%) patients. Female patients had a smaller maximum aneurysm diameter (OSR, 55.23 ± 10.29 mm vs 58.05 ± 11.28 mm [P < .001]; EVAR, 54.06 ± 9.08 mm vs 56.11 ± 9.38 mm [P < .001]), but a higher ASI (OSR, 3.16 ± 0.71 vs 2.92 ± 0.69 [P < .001]; EVAR, 3.05 ± 0.66 vs 2.80 ± 0.59 [P < .001]) compared with male patients. The 30-day mortality rate was higher for female patients in both OSR (6.6% vs 4.2%; P = .002) and EVAR groups (1.8% vs 0.8%; P < .001). Logistic regression confirmed a significantly higher risk of 30-day mortality for female patients compared with male patients (odds ratio, 1.55; 95% confidence interval, 1.21-1.99; P = .001). No interaction was found between sex and diameter or ASI, but there were mediating effects for diameter and ASI in the effect of sex on 30-day mortality. For female patients, the risk of 30-day mortality linearly increased with the increase of diameter (PNonlinear = .089) or ASI (PNonlinear = .888), whereas the risk for male patients was U-shaped (for diameter, PNonlinear < .001; for ASI, PNonlinear = .020). CONCLUSIONS: Sex is an independent risk factor for 30-day mortality after AAA repair. Both diameter and ASI are mediating factors for the effect of sex on 30-day mortality. The relationship between diameter or ASI and the risk of 30-day mortality is different for male and female patients.

Characteristics of patients with multiple arterial aneurysms.

Background: The aim of this retrospective cross-sectional observational study was to determine differences of patients with multiple arterial aneurysms to patients with single arterial aneurysms. Patients and methods: Patients with the diagnosis of an arterial aneurysm from January 2006 to January 2016 in the department of vascular surgery Heidelberg were investigated. Excluded were patients with hereditary disorders of connective tissue or systemic inflammatory disease, as well as other arterial pathologies than true aneurysms. Patients with multiple aneurysms (defined by at least four aneurysms) were compared to patients with single aneurysms concerning age at initial diagnosis, sex and affected arterial site. To verify the findings, a replication of the study was performed at a comparable institution. Results: Of 3107 patients with arterial aneurysms, 918 were excluded. Of the resulting 2189 patients, 1238 (56.6%) patients had a single, 808 (36.9%) two or three, and 143 (6.5%) at least four aneurysms (group mult-AA). Nine hundred seventy-two patients (44.4%) had a single abdominal aortic aneurysm (group sing-AAA). Age at initial diagnosis differed between mult-AA (66.7±9.5 y) and sing-AAA (69.1±8.6 y) (p=0.0338). Within mult-AA, 138 patients (96.5%) were male, compared with 865 patients (89.0%) in sing-AAA (p=0.0041). The most frequent aneurysm localization shifted from the abdominal aorta and its branches in patients with a single aneurysm (n=1029; 83.1%) to pelvic and leg arteries in patients with at least four aneurysms (n=318; 63.2%). The replication of the study at the department of vascular surgery Frankfurt confirmed the younger age at initial diagnosis in mult-AA (67.3±12.5 y) compared to sing-AAA (70.9±9.6 y) (p=0.0259) and the distribution shift toward the arteries below the aortic bifurcation in mult-AA. Conclusions: Patients with multiple aneurysms are younger at initial diagnosis and differ concerning aneurysm localization compared to patients with a single aneurysm.

Long-Term Outcome of Lower Extremity Bypass Surgery in Diabetic and Non-Diabetic Patients with Critical Limb-Threatening Ischaemia in Germany.

AIM: To present the short- and long-term outcomes of lower extremity bypass (LEB) surgery in patients with critical limb-threatening ischaemia (CLTI), comparing diabetic (DM) and non-diabetic (non-DM) patients. METHODS: Retrospective analysis of anonymised data from a nationwide health insurance company (AOK). Data from 22,633 patients (DM: n = 7266; non-DM: n = 15,367; men: n = 14,523; women: n = 8110; mean patient age: 72.5 years), who underwent LEB from 2010 to 2015, were analysed. The cut-off date for follow-up was December 31, 2018 (mean follow-up period: 55 months). RESULTS: Perioperative mortality was 10.0% for DM and 8.2% for non-DM (p < 0.001). Patients with crural/pedal bypasses (n = 8558) had a significantly higher perioperative mortality (10.3%) than those with above-the-knee (n = 7246; 5.8%; p < 0.001) and below-the-knee bypasses (n = 6829; 8.9%; p = 0.003). The 9-year survival rates in DM patients were significantly worse, at 21.5%, compared to non-DM, at 31.1% (p < 0.001). This applied to both PAD stage III (DM: 34.4%; non-DM: 45.7%; p < 0.001) and PAD stage IV (DM: 18.5%; non-DM: 25.0%; p < 0.001). Patients with crural/pedal bypasses had a significantly inferior survival rate (25.5%) compared to those with below-the-knee (27.7%; p < 0.001) and above-the-knee bypasses (31.7%; p < 0.001). CONCLUSION: Perioperative and long-term outcomes regarding survival and major amputation rate for CLTI patients undergoing LEB are consistently worse for DM patients compared to non-DM patients.

Pooled human bone marrow-derived mesenchymal stromal cells with defined trophic factors cargo promote dermal wound healing in diabetic rats by improved vascularization and dynamic recruitment of M2-like macrophages.

Human Mesenchymal Stromal Cells (hMSCs) are a promising source for cell-based therapies. Yet, transition to phase III and IV clinical trials is remarkably slow. To mitigate donor variabilities and to obtain robust and valid clinical data, we aimed first to develop a manufacturing concept balancing large-scale production of pooled hMSCs in a minimal expansion period, and second to test them for key manufacture and efficacy indicators in the clinically highly relevant indication wound healing. Our novel clinical-scale manufacturing concept is comprised of six single donor hMSCs master cell banks that are pooled to a working cell bank from which an extrapolated number of 70,000 clinical doses of 1x106 hMSCs/cm2 wound size can be manufactured within only three passages. The pooled hMSC batches showed high stability of key manufacture indicators such as morphology, immune phenotype, proliferation, scratch wound healing, chemotactic migration and angiogenic support. Repeated topical hMSCs administration significantly accelerated the wound healing in a diabetic rat model by delivering a defined growth factor cargo (specifically BDNF, EGF, G-CSF, HGF, IL-1α, IL-6, LIF, osteopontin, VEGF-A, FGF-2, TGF-ß, PGE-2 and IDO after priming) at the specific stages of wound repair, namely inflammation, proliferation and remodeling. Specifically, the hMSCs mediated epidermal and dermal maturation and collagen formation, improved vascularization, and promoted cell infiltration. Kinetic analyses revealed transient presence of hMSCs until day (d)4, and the dynamic recruitment of macrophages infiltrating from the wound edges (d3) and basis (d9), eventually progressing to the apical wound on d11. In the wounds, the hMSCs mediated M2-like macrophage polarization starting at d4, peaking at d9 and then decreasing to d11. Our study establishes a standardized, scalable and pooled hMSC therapeutic, delivering a defined cargo of trophic factors, which is efficacious in diabetic wound healing by improving vascularization and dynamic recruitment of M2-like macrophages. This decision-making study now enables the validation of pooled hMSCs as treatment for impaired wound healing in large randomized clinical trials.

[Perioperative lethality after endovascular and open repair of ruptured abdominal aortic aneurysms: An analysis of administrative data of the AOK health insurance fund]. / Zur perioperativen Letalität des rupturierten Bauchaortenaneurysmas nach endovaskulärer und offener Versorgung: eine Analyse von Routinedaten der AOK Gesundheit.

OBJECTIVE: In this paper we will report the perioperative outcome after endovascular (EVAR) and open (OAR) repair of ruptured abdominal aortic aneurysms (rAAA) in Germany based on data of the AOK health insurance fund. METHODS: Anonymised data of all patients with rAAA (n = 3,227) who were treated from 01/01/2010 to 12/31/2016 were analysed, using SPSS 27 (IBM Deutschland GmbH, Ehningen, Germany). RESULTS: 41.9% (1,353/3,227) of the patients were treated with EVAR and 58.1% (1,874/3,227) with OAR. Patients ≥80 years made up 38.4% for EVAR and 32.9% for OAR (p = 0.002). The proportion of patients undergoing surgery within 24 hours after admission was significantly higher for OAR (87.8%) than for EVAR (73.0%) (p = 0.000). The perioperative lethality rate for OAR was 42.4%, and thus almost twice as high as for EVAR with 21.3% (p = 0.000). Women had higher perioperative lethality rates for both EVAR (perioperative lethality 24.6%) and OAR (perioperative lethality 51.7%) compared to men with 20.6% (EVAR) and 40.2% (OAR), respectively. With EVAR, 35.8% of the patients showed a complication-free postoperative course, with OAR it was 17.7% (p = 0.000). Blood transfusions (whole blood, red cell concentrates, and autotransfusions) were administered in 57.6% of the patients with EVAR, but in 92.3% with OAR (p = 0.000). The highest perioperative lethality was found in EVAR and OAR patients who received both surgery within 24 hours after admission and blood transfusions (perioperative lethality EVAR 36.0%, OAR 46.0%; p = 0.000). In contrast, patients who did not require blood transfusions and were treated later than 24 hours after admission had the lowest perioperative lethality with 3.2% for EVAR vs. 5.4% for OAR (p = 0.623). CONCLUSION: The data confirm the observation that the perioperative mortality of rAAA patients is lower with EVAR than with OAR. However, strict attention must be paid to the time of the intervention. The low perioperative lethality of patients who were treated later than 24 hours after hospital admission and who did not require blood transfusions indicates that cases of symptomatic AAA without rupture have also been recorded in this administrative database under the diagnosis rAAA. One point of criticism is that the decision not to adjust for the patient groups with EVAR and with OAR in order to be able to better analyse the properties of routine data includes a considerable risk of bias in the statements of this work due to confounding variables.

[Care of vascular surgery patients during COVID-19: a Germany-wide survey]. / Versorgung gefäßchirurgischer Patienten während COVID-19: eine deutschlandweite Umfrage.

Background: COVID-19 resulted in postponement and cancellation of elective operations in all surgical disciplines worldwide, especially in the first weeks of the pandemic. The specific situation in vascular surgery clinics in Germany during this period has not yet been described. Objective: The purpose of the survey was to record the provision of vascular surgery services in the period from March 2020 to December 2020 as well as logistical and infrastructural changes that resulted from the pandemic situation. The focus of the survey was on mapping the supply situation as realistically as possible based on the assessment of the lead vascular surgeons. Material and methods: In cooperation with the German Society for Vascular Surgery and Vascular Medicine (DGG), the senior medical staff of all vascular centers in Germany were asked to take part in the survey. The questions were answered anonymously. Results: COVID-19 and corresponding measures resulted in relevant cancellations and postponements of operations, a loss of capacities and an increased workload. During the observational period there was a delay in the treatment of vascular surgical diseases and an increased occurrence of severe clinical stages compared to the corresponding period of the previous year. All levels of care were and continue to be affected. Discussion: In order to counteract the structural weakening and the restrictions in patient care, clinical processes, patient education and prioritization must be optimized. New concepts such as telemedicine and closer clinical control may make sense. A necessary infrastructure for emergency management (COVID) must not negatively affect the quality of care for (vascular) surgical patients in everyday life.

Towards a better treatment of patients with vascular malformations: certified interdisciplinary centers are mandatory.

BACKGROUND: Vascular anomalies are orphan diseases that occur in all age groups and range from purely aesthetic to potentially life-threatening conditions. This thesis paper outlines the typical conferring problems in patient management and possible structural solutions for a better patient treatment in the future. METHODS: A multi-perspective author panel consisting of key stakeholders from the German Interdisciplinary Society of Vascular Anomalies and the German Society for Surgery defined problem areas and possible solutions including quality indicators as criteria for certified interdisciplinary Vascular Anomalies Centers (VAC). RESULTS: According to the literature available, clearly defined nomenclature and nosological entities often remain unused in this field, and consented diagnostic and therapeutic evidence is rare. Expert opinions dominate and in some cases lead to disparate recommendations. Typical patient problems arise from this situation, exemplified in patient vignettes. Centralized and standardized patient treatment in interdisciplinary VAC may be a solution to this problem. These centers should agree on a set of general principles and quality indicators with an additional minimum set of structural and procedural criteria. DISCUSSION: The present position paper outlines perspectives for implementing certified interdisciplinary VAC. There is a need for a comprehensive nomenclature, access to interdisciplinary treatment centers, more scientific evidence, and further education in this rare group of diseases. CONCLUSION: Use of scientifically sound and patient-relevant criteria for certifying the interdisciplinary quality of VAC is expected to improve health care in Germany.

Real-world data of popliteal artery aneurysm treatment: Analysis of the POPART registry.

OBJECTIVE: Popliteal artery aneurysm (PAA) is a rare disease with a prevalence of 0.1% to 1%. Within previous years, endovascular repair (ER) of PAAs has been performed more frequently despite the lack of high-level evidence compared with open surgical repair (OSR). In 2014, the POPART registry was initiated to validate the current treatment options for PAA repair. METHODS: POPART is a multinational multicenter registry of the peri- and postoperative outcomes of ER and OSR for PAAs. Data sets were recorded using the online survey tool SurveyMonkey (available at: https://www.surveymonkey.com/). Regular monitoring and plausibility checks of the data sets are performed to ensure reliability. The aim of the present study was to report the findings from the POPART registry, which includes data from 41 centers. RESULTS: From June 2014 to August 2019, 794 cases had been recorded in the POPART registry. OSR had been performed in 662 patients and ER in 106 patients; 23 patients had been treated conservatively. Of the 106 patients in the primary ER group, 4 had required conversion to OSR. The ER patients were significantly older (ER, median, 71 years; OSR, median, 67 years; P < .05). No other significant differences were present in the demographic data, comorbidities, or aneurysm morphology between the two groups. Of the 662 patients in the OSR group, 50.3% were symptomatic compared with 29.2% of the 106 patients in the ER group (P < .05). Emergency treatment because of acute ischemia, critical ischemia, or rupture was necessary for 149 patients (22.5%) in the OSR group and 11 patients (10.3%) in the ER group. The most frequent postoperative complications were impaired wound healing (OSR, n = 47 [7.1%]; ER, n = 3 [2.8%]; P > .05) and major bleeding (OSR, n = 26 [3.9%]; ER, n = 3 [2.8%]; P > .05). The in-hospital length of stay was significantly longer for the OSR group than for the ER group (median, 10 days; range, 3-65 days; vs median, 7 days; range, 1-73 days). The overall patency for the OSR and ER groups after 12 and 24 months was 83.2% and 44.7% (P < .005) and 74.2% and 29.1% (P < .005), respectively. The outcomes with a prosthetic graft vs an autologous vein were significantly poorer in the OSR group (primary patency, 71.4% vs 88.1% at 12 months). CONCLUSIONS: To evaluate new treatment techniques such as ER for PAAs, real-world data are of essential importance. The present analysis of the first results for the POPART registry shows good perioperative results for endovascular treatment of PAA in asymptomatic patients with good outflow vessels. The perioperative complication rate is low and the postoperative hospital stay is shorter than after OSR. However, the patency rates after 12 and 24 months are low in the ER group compared to patients treated with open repair. More follow-up data is required for further interpretation; the completion of the data sets in the registry is ongoing.

Safety and efficacy of endovenous laser ablation (EVLA) using 1940 nm and radial emitting fiber: 3-year results of a prospective, non-randomized study and comparison with 1470 nm.

OBJECTIVES: To evaluate the safety, efficacy and ≥36 months outcomes of endovenous laser ablation (EVLA) by means of 1940 nm laser with radial fiber for the treatment of truncal vein insufficiency and compare the results to a historical cohort, obtained via reviewing the literature. METHODS: This prospective, non-randomized, single-center clinical study included 139 consecutive patients with 177 incompetent great saphenous (GSV, n = 135) and short saphenous veins (SSV, n = 42). The maximum laser power (Pmax. 10 W) and pullback velocity were adjusted individually (Vmax = 1 mm/s). The laser fiber was placed at the junction to the deep vein under duplex monitoring. Simultaneous phlebectomies were performed on all the patients. Regular follow up with clinical and duplex ultrasound examination (DUS) were carried out postoperatively at 1 month (1 M), 6 months (6 M), 12 months (12 M), 24 months (24 M), 36 months, and after that (≥36 M). The results were compared with three cohorts (total 616 EVLA procedures with 1470 nm laser and radial fiber) from literature (criteria: >100 procedures, follow-up of ≥2 years). RESULTS: The follow-up rate was 100%, 91%, 73%, 48%, and 23% of the truncal veins at 1, 6, 12, 24, and ≥36 M, respectively. In comparison to the literature using 1470, a lower average linear endovenous energy density (LEED) (53 vs. 77-82 J/cm) resulted in 100% (6 M) and 96.5% (24 M) occlusion rates, reduced local ecchymosis (2.2% vs. 3.2%-18.7%) and reduced average postoperative pain levels (1.3 vs. 2.18). Regarding adverse events, induration (1.1% vs. 1.8%), skin burns (0% vs. 0.45%), endovenous heat-induced thrombus propagation (EHIT) in the deep veins (2.3% vs. 1.8%) and laser-induced persistent paresthesia (2.2% vs. 0.5%-2.9%) were comparable. Recanalizations observed in this study (GSV 0, SSV 3) were asymptomatic and required no treatment. At ≥36 M reflux in the accessory veins was observed in 5% versus 10.5% of patients. Reintervention was required in none (0% vs. 21%). At >36 M, short average stump lengths of 1 cm (GSV) and 0.3 cm (SSV) were observed. CONCLUSION: EVLA with 1940 nm laser with radial emitting fiber is as safe and effective as 1470 nm laser for the treatment of truncal vein insufficiency. Lower postoperative pain, low analgesic requirements, short convalescence add to patients' comfort. EVLA with 1940 nm laser-guided by intraoperative DUS permits reproducible placement of the radial fiber at the saphenofemoral and saphenopopliteal junction, enabling further studies to assess the effect of shorter stump length on patterns and frequency of recurrence without increased risk of EHIT.

Quiescent-Interval Slice Selective Magnetic Resonance Angiography for Abdominal Aortic Aneurysm Treatment Planning.

PURPOSE: Diagnostic imaging of Abdominal aortic aneurysm (AAA) almost exclusively employs CT angiography (CTA) involving X-ray exposure and contrast medium that may harm some patients. Quiescent-Interval Slice Selective MR (QISS-MR) depicts vascular anatomy without radiation or contrast medium. The diagnostic quality of QISS-MRA and CTA were compared in regard to length and diameter measurements in AAA patients. Suitability of QISS-MRA for AAA treatment planning was evaluated. MATERIALS AND METHODS: The details of 30 patients with AAA who received both a QISS-MR and CTA for a known infrarenal AAA were obtained retrospectively that was approved by the local research ethics board. Two observers analyzed each dataset in terms of image quality and determined lumen diameter and length of 15 vessel segments. RESULTS: Highly accurate agreement between the diagnostic scores from the two observers was achieved. There was no significant difference between CTA and QISS-MRA for all 15 measured vessels. Although information on calcification was lacking and intraluminal thrombus was visualized in only 25 patients out of 30 patients, a founded decision to carry out OR or EVAR was possible with both imaging modalities. CONCLUSION: QISS-MRA presents a radiation and contrast free method for preoperative diagnostic AAA imaging. While QISS-MRA does not deliver exact information regarding calcification and thrombus formation, it does accurately allow measurement of vessel diameter and length. Therefore, it is potentially useful for EVAR planning in selected patients with impaired renal function.

[Use of surgical simulators in further education-A nationwide analysis in Germany]. / Einsatz chirurgischer Simulatoren in der Weiterbildung ­ eine deutschlandweite Analyse.

BACKGROUND: In addition to learning theoretical knowledge, the medical specialist training in surgery necessitates the acquisition of practical surgical competences. Simulation-based teaching concepts represent an alternative to education and advanced training on patients. The aim of this study was to analyze the distribution and implementation of surgical simulators in German hospitals. METHODS: The data analysis was carried out based on an individual on-line questionnaire with a total of 19 standardized questions. This was sent to the senior surgeons in hospitals and clinics via the email distributors of specialist societies for surgery in Germany. RESULTS: A total of 267 complete datasets were analyzed (response rate 12%). Of the participants 84% reported that they were active in a teaching hospital. At the time of the investigation 143 surgical simulators were in use at 35% of the hospitals and clinics included in the evaluation. There were clear regional differences between the individual federal states. Of the participants, 21.1% did not have a simulator at the hospital but the acquisition of one was planned. Simulation training was most frequently used by students (41.1%) and physicians during further education (32.5%). Simulators were not integrated into advanced surgical training in 81.8%. Of the participating hospitals, 94% showed an interest in integration into surgical specialist training in the future. CONCLUSION: The results of this survey confirmed the special importance of simulation-based training for surgical education in German hospitals; however, at the same time there were clear deficits in information concerning user behavior and a deficiency in the perceived integration of simulation training in advanced training for surgery.

Early outcomes of patients with chronic kidney disease after revascularization for critical limb ischemia.

BACKGROUND: The aim of this study was to report early outcomes of patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) after revascularization for critical limb-threatening ischemia (CLTI). METHODS: Perioperative data of patients from the CRITISCH (critical limb ischemia) Registry, who also had NDD-CKD (stages 3 and 4), were compared to their counterparts with normal renal function (NRF) or mild renal insufficiency (stages 1 and 2). Patient characteristics and type of first-line treatment were assessed. Amputation-free survival was the primary composite endpoint. Secondary endpoints included major adverse cardiovascular and cerebral events (MACCE) and hemodynamic failure of revascularization. Multivariable logistic regression determined risk factors for the endpoints. RESULTS: 424 patients with NDD-CKD were identified. Endovascular revascularization (ER) was performed in 251 patients (59.2%). Eighty-six patients (20.3%) underwent bypass surgery (BS) and 29 patients (6.8%) femoral artery patchplasty (FAP). Conservative treatment (CT) was offered to 46 patients (10.9%); 12 patients (2.8%) underwent primary major amputation (PMA). Logistic regression analysis showed an increased early risk for amputation/death (OR=1.92, 95% CI: 1.09-3.40), death (OR=5.53, 95% CI: 1.92-15.90) and hemodynamic failure of the revascularization (OR=1.80, 95% CI: 1.19-2.72) compared to patients with NRF. Patients with NDD-CKD also seem to carry a higher risk for MACCE (OR=1.82, 95% CI: 0.99-3.36). NDD-CKD was not a risk factor for limb loss alone (OR=1.05, 95% CI: 0.49-2.22). CONCLUSIONS: NDD-CKD was an independent risk factor for early postoperative mortality, morbidity and reduced patency, but not for limb loss. Robust follow-up is necessary to monitor for such events, as well as to prevent readmission.

Comparison of Abdominal Aortic Aneurysm Sac and Neck Wall Motion with 4D Ultrasound Imaging.

OBJECTIVE: The rupture of abdominal aortic aneurysms (AAAs) is associated with high mortality despite surgical developments. The determination of aneurysm diameter allows for follow up of aneurysm growth but fails in precisely predicting aneurysm rupture. In this study, time resolved three dimensional ultrasound (4D ultrasound) based wall motion indices (WMIs) are investigated to see if they are capable of distinguishing between uneven affected regions of the aneurysm wall. METHODS: In a prospective study, 56 patients with an AAA were examined using 4D ultrasound. Local longitudinal, circumferential, and shear strains were computed using custom methods. The deformation of the neck and sac of each aneurysm was characterised by statistical indices of the obtained distributions of local wall strains (WMIs): mean and peak strain, heterogeneity index, and local strain ratio. The locations of regions with highest local peak strain were determined. RESULTS: Compared with the aneurysm neck, the sac is characterised by low mean strain, but highly heterogeneous deformation, described by high local strain ratio and heterogeneity index. Differences were highly significant (p < .001) for all strain components. The regions with the highest circumferential peak strain were found more often in the posterior part of the aneurysm neck (p < .050) and sac (p < .001) regions, compared with other wall regions. No statistically significant correlation was found between the WMIs and maximum AAA diameter, except for longitudinal mean strain, which decreased with the increasing diameter (rho = -.42, p < .010). CONCLUSION: Characterisation of wall kinematics by 4D ultrasound based WMIs provides a new and independent criterion for the distinction of diseased tissue in the AAA sac and the less affected neck region. This is a promising step towards the establishment of new biomarkers to differentiate between the mechanical instability of the AAA and rupture risk.

IL10 Alters Peri-Collateral Macrophage Polarization and Hind-Limb Reperfusion in Mice after Femoral Artery Ligation.

Arteriogenesis is a process by which a pre-existing arterioarterial anastomosis develops into a functional collateral network following an arterial occlusion. Alternatively activated macrophages polarized by IL10 have been described to promote collateral growth. This study investigates the effect of different levels of IL10 on hind-limb reperfusion and the distribution of perivascular macrophage activation types in mice after femoral artery ligation (FAL). IL10 and anti-IL10 were administered before FAL and the arteriogenic response was measured by Laser-Doppler-Imaging perioperatively, after 3, 7, and 14 d. Reperfusion recovery was accelerated when treated with IL10 and impaired with anti-IL10. Furthermore, symptoms of ischemia on ligated hind-limbs had the highest incidence after application of anti-IL10. Perivascular macrophages were immunohistologically phenotyped using CD163 and CD68 in adductor muscle segments. The proportion of alternatively activated macrophages (CD163+/CD68+) in relation to classically activated macrophages (CD163-/CD68+) observed was the highest when treated with IL10 and suppressed with anti-IL10. This study underlines the proarteriogenic response with increased levels of IL10 and demonstrates an in-vivo alteration of macrophage activation types in the perivascular bed of growing collaterals.

The Lipopeptide MALP-2 Promotes Collateral Growth.

Beyond their role in pathogen recognition and the initiation of immune defense, Toll-like receptors (TLRs) are known to be involved in various vascular processes in health and disease. We investigated the potential of the lipopeptide and TLR2/6 ligand macrophage activating protein of 2-kDA (MALP-2) to promote blood flow recovery in mice. Hypercholesterolemic apolipoprotein E (Apoe)-deficient mice were subjected to microsurgical ligation of the femoral artery. MALP-2 significantly improved blood flow recovery at early time points (three and seven days), as assessed by repeated laser speckle imaging, and increased the growth of pre-existing collateral arteries in the upper hind limb, along with intimal endothelial cell proliferation in the collateral wall and pericollateral macrophage accumulation. In addition, MALP-2 increased capillary density in the lower hind limb. MALP-2 enhanced endothelial nitric oxide synthase (eNOS) phosphorylation and nitric oxide (NO) release from endothelial cells and improved the experimental vasorelaxation of mesenteric arteries ex vivo. In vitro, MALP-2 led to the up-regulated expression of major endothelial adhesion molecules as well as their leukocyte integrin receptors and consequently enhanced the endothelial adhesion of leukocytes. Using the experimental approach of femoral artery ligation (FAL), we achieved promising results with MALP-2 to promote peripheral blood flow recovery by collateral artery growth.