[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.

[Inpatient rehabilitation for patients 65 years and older with abdominal aortic aneurysm repair: Indications and long-term outcome]. / Stationäre Frührehabilitation nach endovaskulärer und offener Versorgung eines Bauchaortenaneurysmas bei über 65-Jährigen: Indikation und langfristiges Outcome.

BACKGROUND: In Germany, there is no data available on the frequency of inpatient rehabilitation (IR) after elective endovascular (EVAR) and open (OAR) abdominal aortic aneurysm (AAA) repair. OBJECTIVE: To report for the first time on the outcome of patients 65 years and older and thus of retirement age with and without IR after AAA repair in a retrospective analysis of routine data from all eleven regional companies of the AOK health insurance fund (AOK-Gesundheit). METHODS: Anonymized data of 16,358 patients 65 years and older with intact abdominal aortic aneurysm treated with EVAR (n = 12,960) or OAR (n = 3,398) between 01/01/2010 and 12/31/2016 were analyzed. Patients with postoperative IR (n = 1,531) were compared to those without postoperative IR (n = 14,827) with respect to general patient characteristics, comorbidities, perioperative and postoperative outcomes, and survival. The average follow-up of patients with postoperative and without postoperative IR was 49.9 months and 51.8 months, respectively. RESULTS: 5.4% of EVAR patients, but 24.6% of OAR patients were referred to IR (p < 0.001). Patients with IR were sicker than those without IR. Parameters significantly influencing the use of IR included OAR vs EVAR (Odds Ratio [OR] 6.03), condition after cerebral infarction (OR 1.53), and women vs men (OR 1.49). Perioperative influencing parameters were cerebral infarction (OR 2.40), blood transfusions (OR 2.21) and complex critical care (OR 2.15). After nine years, the Kaplan-Meier estimated survival was 41.9% for patients with vs 43.4% for those without IR in the EVAR group (p = 0.178). For OAR, it was 50.2% for patients with IR vs 49.8% for patients without IR (p = 0.006). In multivariate regression analysis, postoperative IR had a significant effect on long-term survival in OAR but not in EVAR patients. CONCLUSION: There are no generally binding guidelines for the indication of IR after AAA repair. It should therefore be a requirement for the future that the fitness of each patient with elective AAA repair be determined with a score before and after the procedure in order to make indications for AHB more comparable. The score should be documented in the hospital discharge letter.

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.

Prospects of Endovenous Laser Ablation (EVLA) Standardization-Mid-Term Results of a Four-Zone Dosimetry Guiding Tool for 1940 nm Laser.

BACKGROUND: Heterogeneity regarding dosimetry and reporting of endovenous laser ablation (EVLA) mandates the development of a standardized protocol. This study presents the mid-term results of EVLA with 1940 nm-laser and radial-fibre, supported by a four-zone dosimetry tool. MATERIALS AND METHODS: Four anatomical dosimetry zones for great saphenous veins (GSV) and two for small saphenous veins (SSV) were defined with set power levels. Zone-1G (4 W) extended from the inguinal ligament to the apex of femoral triangle, Zone-2G (4 W) from the apex of femoral triangle to the upper border of patella. Zone-3G (3 W) from the patella to the tibial tuberosity. Zone-4G (2 W) extended from the tibial tuberosity to the ankle. Zone-1S from the sapheno-popliteal junction to the tibial tuberosity. Zone-2S from the tibial tuberosity to the ankle. Power was increased by 1 W for veins >10 mm and decreased by 1 W when fibre sticking was encountered. Pullback-velocity was max. 1 mm/s. RESULTS: A total of 152 consecutive patients (185 procedures) were recruited. Mean follow-up time was 11.9 months. Mean linear endovenous energy density for GSV was Zone-1G:42 J/cm, Zone-2G:33 J/cm, Zone-3G:27 J/cm, Zone-4G:22 J/cm, Zone-1S:34 J/cm, Zone-2S:27 J/cm. Occlusion rates were 98.9% (1-month) and 93.7% (12-months). Complications at 1 M were low, namely laser-induced paraesthesia (LIP) 2.2% and endovenous heat-induced thrombosis (EHIT) 1.6%. Persistent LIP (12 M) was observed in 0.5%. CONCLUSION: The proposed four-zone guiding tool is a step towards standardizing dosimetry and documentation for EVLA with 1940 nm. This strategy shows good mid-term results with minimal complications. Long-term follow-up and application in further centres are necessary to prove its reproducibility. Such a guiding tool could improve the ability to analyse, compare and review different EVLA wavelengths and fibre types.

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.

[Long-term Results after Endovascular and Open Repair of Ruptured Abdominal Aortic Aneurysm - a Propensity Score Matched Analysis]. / Langzeitergebnisse nach endovaskulärer und offener Versorgung des rupturierten Bauchaortenaneurysmas ­ eine Propensity-Score-Analyse.

BACKGROUND: This retrospective propensity score matched study presents the perioperative mortality and long-term survival up to 9 years after endovascular (EVAR) and open (OAR) repair of patients with ruptured abdominal aortic aneurysm (rAAA) in Germany using health insurance data. MATERIALS AND METHODS: 2170 patients treated between January 1st, 2010 and December 31st, 2016, for rAAA within 24 hours of hospital admission and receiving blood transfusions were enrolled in the study and tracked until December 31st, 2018. For better comparability of EVAR and OAR, a 1:1 propensity score matching with 624 pairs according to patient age, sex and comorbidities was carried out using the R program (Foundation for Statistical Computing, Vienna, Austria). RESULTS: In the unadjusted groups, 29.1% (631/2170) of the patients were treated with EVAR and 70.9% (1539/2170) with OAR. EVAR patients had a significantly higher overall rate of comorbidities. After adjustment, EVAR patients showed significantly better perioperative survival (EVAR 35.7%, OAR 51.0%, p = 0.000). Perioperative complications occurred in 80.4% of EVAR patients and 80.3% of OAR patients (p = 1.000). At the end of follow-up, Kaplan-Meier estimated that 15.2% of patients survived after EVAR vs. 19.5% after OAR (p = 0.027). In the multivariate Cox regression analysis, OAR, age ≥ 80 years, diabetes mellitus type 2 and renal failure stages 3 to 5 had a negative impact on overall survival. Patients treated on weekdays had a significantly lower perioperative mortality than patients treated during the weekend (perioperative mortality on weekdays 40.6% vs. 53.4% during the weekend; p = 0.000) and a better overall survival as estimated by Kaplan-Meier. CONCLUSION: Significantly better perioperative and overall survival was observed with EVAR than with OAR in patients with rAAA. The perioperative survival benefit of EVAR was also found in patients older than 80 years. Female gender had no significant influence on perioperative mortality and overall survival. Patients treated on weekends had a significantly poorer perioperative survival than patients treated on weekdays, and this lasted through the end of follow-up. The extent to which this was dependent on hospital structure was unclear.

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.

Changes in Aortic Diameter and Wall Strain in Progressing Abdominal Aortic Aneurysms.

OBJECTIVES: The analysis of wall strain opens new perspectives in the prediction of abdominal aortic aneurysm (AAA) rupture. This study investigates the capability of four-dimensional ultrasound (4D US) to detect and characterize changes in wall strain in the same patients during follow-up observations. METHODS: Eighteen patients were examined by 64 4D US scans during a median follow-up period of 24.5 months. After performing the 4D US and manual aneurysm segmentation, kinematic analysis was performed using a customized interface and evaluation of the mean and peak circumferential strain, as well as spatial heterogeneity. RESULTS: All aneurysms showed a continuous diameter growth with a mean rate of 4% per year (P < .001). The mean circumferential strain (MCS) tends to increase from a median 0.89% by 10.49% per year in follow-up independent of the aneurysm diameter (P = .063). The subgroup analysis reveals a cohort with increasing MCS and decreasing spatial heterogeneity, as well as a cohort with nonincreasing MCS and increasing spatial heterogeneity (P < .05). CONCLUSIONS: The 4D US is able to register the strain changes in AAA follow-up. The MCS tends to increase during the observation time in the entire cohort, but the changes were independent of the maximum aneurysm diameter. The kinematic parameters allow the entire AAA cohort to differentiate into two subgroups and provide additional information about the pathologic behavior of the aneurysm wall.

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.

Changes in miRNA expression in patients with peripheral arterial vascular disease during moderate- and vigorous-intensity physical activity.

BACKGROUND: Walking is the preferred therapy for peripheral arterial disease in early stage. An effect of walking exercise is the increase of blood flow and fluid shear stress, leading, triggered by arteriogenesis, to the formation of collateral blood vessels. Circulating micro-RNA may act as an important information transmitter in this process. We investigated the acute effects of a single bout of 1) aerobic walking with moderate intensity; and 2) anaerobic walking with vigorous intensity on miRNA parameters related to vascular collateral formation. METHODS: Ten (10) patients with peripheral arterial disease with claudication (age 72 ± 7 years) participated in this two-armed, randomized-balanced cross-over study. The intervention arms were single bouts of supervised walking training at (1) vigorous intensity on a treadmill up to volitional exhaustion and (2) moderate intensity with individual selected speed for a duration of 20 min. One week of washout was maintained between the arms. During each intervention, heart rate was continuously monitored. Acute effects on circulating miRNAs and lactate concentration were determined using pre- and post-intervention measurement comparisons. RESULTS: Vigorous-intensity walking resulted in a higher heart rate (125 ± 21 bpm) than the moderate-intensity intervention (88 ± 9 bpm) (p < 0.05). Lactate concentration was increased after vigorous-intensity walking (p = 0.005; 3.3 ± 1.2 mmol/l), but not after moderate exercising (p > 0.05; 1.7 ± 0.6 mmol/l). The circulating levels of miR-142-5p and miR-424-5p were up-regulated after moderate-intensity (p < 0.05), but not after vigorous-intensity training (p > 0.05). CONCLUSION: Moderate-intensity walking seems to be more feasible than vigorous exercises to induce changes of blood flow and endurance training-related miRNAs in patients with peripheral arterial disease. Our data thus indicates that effect mechanisms might follow an optimal rather than a maximal dose response relation. Steady state walking without the necessity to reach exhaustion seems to be better suited as stimulus.

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.

Age and Oversizing Influence Iliac Dilatation after EVAR.

In the past two decades, endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) has become the first line treatment for infrarenal AAA repair in many countries. While short-term results are good, concerns have been raised about long-term durability. Changes in aortoiliac anatomy, especially at the landing zones, could play a role in EVAR failure over time. The current study aimed to determine certain morphological changes in the distal iliac landing zone after EVAR implantation, as well aspossible risk factors associated with iliac sealing failure. In a retrospective analysis of a tertiary single-centre registry, including patients treated with EVAR between January 2008 and July 2018, clinical follow-up data were assessed, and computer tomography (CT) imaging was evaluated regarding morphological changes in the iliac anatomy during follow-up. For clinical analysis all patients with a minimum follow-up of one year were included; for morphological analysis of iliac anatomy all patients with available CT follow-up of a minimum of one year and a minimum of two CT scans were included. Overall, 127 out of 241 treated patients (92.1% male) were included in the clinical follow-up. Complete CT imaging of 99 iliac arteries in 55 patients was available for morphological analysis. Median postoperative follow-up (FU) for these patients was 33 months (IQR 31; min−max: 12−124). Incidence of type 1b endoleak was 3% but iliac limb detachment from the vessel wall was seen in 18.2% of the target vessels. There was a significant difference in oversizing in iliac limbs with detachment (median 13.9%, IQR 23.1) vs. without detachment (median 23.1%, IQR 19.1) (p = 0.034). Iliac arteries at the landing zone showed a significant diameter increase independent of an endoleak presence (overall cohort median diameter increase at one year 23.1 mm; at two years 0 mm; at three years 4.9 mm). Iliac arteries with detachment (median 14.4%; IQR 23.9) showed a significantly higher diameter increase at the landing zone after four years compared to arteries without detachment (median 5.3%; IQR 9) (p = 0.042). Oversizing correlated positively with an iliac diameter increase at the landing zone over time (3 m: p= 0.001; one year: p < 0.001; two years: p < 0.001; three years: p = 0.006). Older patients showed a significantly lower diameter increase at the distal landing zone over time than younger patients in the first two years after EVAR (p < 0.001/r = −0.606 after two years). In the current study, iliac limb oversizing was associated with increased dilatation of the distal landing zone during a three-year follow-up, while iliac limb detachment was observed less often. An older age was inversely associated to the iliac diameter increase. Future studies should clarify the association between stent graft oversizing, age, and changes in the iliac anatomy in order to identify parameters that affect EVAR durability.

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.