Clinical performance and safety of a debridement pad with abrasive and non-abrasive fibres.

BACKGROUND: Debridement is key to removing devitalised tissue, debris and biofilm as part of wound-bed preparation. Unlike many other methods of debridement, mechanical debridement with a pad is effective enough to be used independently without an adjunctive method of debridement, while being more accessible than other standalone options. OBJECTIVE: To explore the clinical performance and safety of a debridement pad with both abrasive and non-abrasive surfaces in daily clinical practice. METHODS: This was a prospective, non-controlled, non-randomised, single-arm, open-label, multicentred observational evaluation. Inclusion criteria were wounds >4 cm2 covered with at least 30% debris, necrotic tissue or slough in patients aged ≥18 years. The treatment protocol comprised a single application of the debridement pad. The primary outcome measure was the amount of necrotic tissue, slough or debris in the wound bed. Secondary outcomes included the appearance of the wound bed, edges and periwound skin; self-reported pain scores; foreseeable negative impacts; and clinician satisfaction. RESULTS: A total of 62 participants with a variety of wound types were included in the analysis. Most wounds (87%) had been present for over 3 months and had high or moderate exudate levels (90%). A significant reduction was observed in all three parameters: necrotic tissue (p=0.043), slough (p<0.001) and debris (p<0.001). Necrotic tissue, slough and debris showed mean relative reductions of 40%, 72% and 40%, respectively. Of participants, 84% did not experience an increase in pain during the debridement procedure. CONCLUSION: This clinical real-world data shows the debridement pad to be an effective and well-tolerated device for debridement and wound bed preparation.

Effect of oral multispecies probiotic on wound healing, periodontitis and quality of life on patients with diabetes.

OBJECTIVE: Hard-to-heal (chronic) wounds are common in patients with diabetes and are associated with a decrease in quality of life (QoL). Pathogenic bacteria often colonise hard-to-heal wounds and hinder the healing process which poses a high risk for (systemic) infections. In this study, we aim to prove that probiotics are capable of displacing human pathogenic bacteria, ameliorating inflammation and positively influencing the microenvironment/microbiome of skin and mucosa. METHOD: In this pilot study, patients with diabetes and hard-to-heal wounds with a duration of 2-120 months received an oral multispecies probiotic daily for six months. Changes in oral, stool and wound microbiome were investigated, and the effects of the probiotic intervention on wound healing, periodontitis and wound-specific quality of life (Wound-QOL-17) were analysed throughout the course of this clinical study. RESULTS: In total, seven of the 20 patients included were unable to complete the study. After six months of oral probiotic intake supplementation in five out of the remaining 13 patients, the wounds had healed completely. Most patients reported an improvement in wound-specific QoL, with particular positive effects on pain and mobility. Microbiome analysis revealed a reduction in Staphylococcus aureus and Pseudomonas aeruginosa, and Staphylococcus epidermis in healed wounds. CONCLUSION: This findings of this study provide evidence for the beneficial effects of the oral application of a multispecies probiotic over six months in patients with diabetes and hard-to-heal wounds on wound closure, wound microbial pattern, QoL, and on dental health. A randomised, placebo-controlled, double-blinded clinical trial is required to verify the results.

Cost-Effectiveness of Open Repair of Abdominal Aortic Aneurysms with a Novel Perioperative Protocol.

BACKGROUND: In 2015, a novel perioperative protocol (nPOP), comprising of 19 evidence-based interventions, was adopted as a standard practice for open repair of abdominal aortic aneurysms (AAA) at the Humanitas Clinical and Research Center (Milan, Italy). Its implementation translated into lower complication rates, faster ambulation and return of bowel function, better nausea/vomiting and pain control, and, consequently, a shorter length of hospital stay. Because value of a patient's care cycle can be defined as clinical outcomes relative to costs, we aimed to analyze the cost-effectiveness of nPOP compared to the previously implemented protocols. METHODS: Three groups were identified and retrospectively analyzed: (A) 66 patients (September 2007 to March 2009) treated according to the traditional protocol; (B) 225 patients (April 2009 to March 2015) treated in line with a transitional protocol, incorporating 5 perioperative interventions; and (C) 103 patients (April 2015 to February 2019) treated according to nPOP. For each group a monetary value of required clinical resources and the actual total cost per patient from admission to discharge were determined. The following were analyzed (including nurse and anesthesiologist time): diagnostic tests, medications, materials, operating time, surgical team time, blood transfusion, ward stay, and intensive care unit stay. Two indicators of effectiveness were determined based on the postoperative outcomes: complication-free incidents and relative shortening of hospitalization time. A cost (€) of an improvement in effectiveness (%) was calculated. RESULTS: Alongside enhancement of clinical outcomes, nPOP constituted the cheapest approach. It consumed the least human and material resources, resulting in the direct reduction in the overall clinical cost per patient. The length-of-stay variable provided the largest reduction in total costs. The actual total clinical cost per patient in Group C was 26% lower than in Group A (4,437€ vs. 6,005€) and 39% lower than in Group B (4,437€ vs. 7,305€). Every unit of enhancement of clinical outcomes was 2.43 times more expensive for the traditional protocol and 2.23 times more costly for the transitional protocol compared to nPOP, making it the most cost-effective. CONCLUSIONS: The nPOP for AAA open repair is not inferior to other perioperative protocols while allowing for efficient utilization of limited hospital resources, thus creating a high social value. The proposed methods for cost-effectiveness analysis are easily reproducible and therefore can be applied in future projects ranging from a micro- to a macro-economic scale.

Evidence-based guideline of the European Association of Nuclear Medicine (EANM) on imaging infection in vascular grafts.

PURPOSE: Consensus on optimal imaging procedure for vascular graft/endograft infection (VGEI) is still lacking and the choice of a diagnostic test is often based on the experience of single centres. This document provides evidence-based recommendations aiming at defining which imaging modality may be preferred in different clinical settings and post-surgical time window. METHODS: This working group includes 6 nuclear medicine physicians appointed by the European Association of Nuclear Medicine, 4 vascular surgeons, and 2 radiologists. Vascular surgeons formulated 5 clinical questions that were converted into 10 statements and addressed through a systematic analysis of available literature by using PICOs (Population/problem-Intervention/Indicator-Comparator-Outcome) strategy. Each consensus statement was scored for level of evidence and for recommendation grade, according to the Oxford Centre for Evidence-based Medicine criteria. RESULTS: Sixty-six articles, published from January 2000 up to December 2021, were analysed and used for evidence-based recommendations. CONCLUSION: Computed tomography angiography (CTA) is the first-line imaging modality in suspected VGEI but nuclear medicine modalities are often needed to confirm or exclude the infection. Positron emission tomography/computed tomography (PET/CT) with 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) has very high negative predictive value but it should be performed preferably at least 4 months after surgery to avoid false positive results. Radiolabelled white blood cell (WBC) scintigraphy, given its high diagnostic accuracy, can be performed at any time after surgery. PREAMBLE: The European Association of Nuclear Medicine (EANM) is a professional no-profit medical association that facilitates communication worldwide between individuals pursuing clinical and research excellence in nuclear medicine. The EANM was founded in 1985. EANM members are physicians, technologists, and scientists specializing in the research and practice of nuclear medicine. The EANM will periodically define new guidelines for nuclear medicine practice to help advance the science of nuclear medicine and to improve the quality of service to patients throughout the world. Existing practice guidelines will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated. Each practice guideline, representing a policy statement by the EANM, has undergone a thorough consensus process in which it has been subjected to extensive review. The EANM recognizes that the safe and effective use of diagnostic nuclear medicine imaging requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guideline by those entities not providing these services is not authorized. These guidelines are an educational tool designed to assist practitioners in providing appropriate care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, the EANM suggests caution against the use of the current consensus document in litigation in which the clinical decisions of a practitioner are called into question. The ultimate judgement regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in the light of all the circumstances presented. Thus, there is no implication that an approach differing from the consensus document, standing alone, is below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the consensus document when, in the reasonable judgement of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of the consensus document. The practice of medicine includes both the art and the science of the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to this consensus document will not ensure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient, to deliver effective and safe medical care. The sole purpose of this consensus document is to assist practitioners in achieving this objective.

Association Between Carotid Atherosclerosis and Atrial Fibrillation, Cardiac, and Renal Function.

OBJECTIVE: The aim was to analyse whether the association between carotid atherosclerosis (CA) and atrial fibrillation (AF), heart function, and renal function is mediated by traditional risk factors. METHODS: In the prospective, single centre, long term, population based Hamburg City Health Study citizens, between 45 and 74 years of age were studied by cross sectional analysis of the first cohort. Laboratory values, blood pressure, heart rhythm, and body mass index (BMI) were examined. Carotid intima media thickness (CIMT) and plaques were assessed by carotid ultrasound, and CA was defined as either CIMT ≥ 1 mm or presence of plaques or both. N-terminal pro-brain natriuretic peptide (NT-proBNP), and glomerular filtration rate (eGFR) were quantified as measures of heart and renal function. Association between CA and AF, NT-proBNP, and eGFR was analysed by multivariable linear and logistic regression. RESULTS: Of the first 10 000 participants, carotid ultrasound was available for 9 466 (95%). Of these, 2 937 (31%) had carotid plaques, 643 (7%) had CIMT ≥ 1 mm, and 412 (4%) presented with both, so that 3 168 (34%) had CA. Participants with CA had AF more frequently (9.6% vs. 4.3%; p < .001), higher levels of NT-proBNP (median 100 vs. 73 pg/mL; p < .001), and lower eGFR (82.8 vs. 87.1 mL/min; p < .001) than those without CA. Adjusted for age and sex, CA was associated with AF (p = .01; OR 1.29) and higher NT-proBNP levels (p < .001; ß = 0.12), but not with eGFR. After further adjustment for vascular risk factors and history of cardiovascular diseases, CA remained associated with NT-proBNP (p < .001; ß = 0.10), but additionally adjusted for NT-proBNP (p < .001; OR 2.80) not with AF. CONCLUSION: CA is independently associated with higher levels of NT-proBNP, through common risk factors and NT-proBNP with AF, and not with renal function. CA's association with a marker of cardiac dysfunction beyond known common risk factors supports the value of carotid ultrasound in defining patients' cardiovascular risk profile. The measures of CA, i.e., CIMT and carotid plaque, had an equally directed and additive influence.

Feasibility and Preliminary Patency of Prophylactic Hypogastric Artery Stenting for Prevention of Spinal Cord Ischemia in Complex Endovascular Aortic Repair.

BACKGROUND: To report early results of feasibility and patency of prophylactic hypogastric artery (HA) stenting during complex endovascular aortic repair. METHODS: This is a single centre retrospective non comparative cohort study of all consecutive patients undergoing prophylactic HA stenting during fenestrated and/or branched EVAR (F/B EVAR) in order to prevent spinal cord ischemia (SCI). Endpoints included technical success and early outcomes in terms of morbidity, mortality and patency of the implanted stents. RESULTS: Between May 2014 and June 2019 prophylactic HA stenting was performed in 36 consecutive patients with significant HA stenosis during F/B EVAR to prevent SCI. 69.4% of patients presented with asymptomatic, 25% with symptomatic and 5.6% with ruptured aortic aneurysms. 55.6% were treated for thoracoabdominal aortic aneurysms, 44.4% for pararenal abdominal aortic aneurysms. In 13.9% aortic coverage was limited to the abdominal aorta. In 86.1% the aortic coverage was in the thoracoabdominal aortic segment. Unilateral HA stenting was performed in 91.7%, whereas 8.3% underwent bilateral stenting. Technical success was 100%. The primary patency of the implanted stents after a median follow-up time of 9.5 months was 97.5%. One intraprocedural bleeding from an HA branch occurred and was successfully treated by coil embolization. No further procedure-related complications occurred. 11.1% of the patients developed SCI. CONCLUSIONS: HA stenting is feasible and safe with high rates of technical success and short-term patency.

Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.

BACKGROUND: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. METHODS: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization. RESULTS: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71-1.01) with clopidogrel and 0.86 (95% CI, 0.73-1.01) without clopidogrel without statistical heterogeneity (P for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14-1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22-1.01] without clopidogrel; P for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (P for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44-7.13]) compared with shorter durations of clopidogrel (P for trend=0.06). CONCLUSIONS: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02504216.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Vascular Diagnostic and Surgical Treatments Before Lower Limb Amputations in Patients with Arterial Vascular Diseases: A Population Based Study from 2013 to 2015 in Germany.

OBJECTIVE: Patients with peripheral artery disease (PAD) have an increased risk of lower limb amputation. Given the international wide variance in major amputations, the high mortality rates and follow up costs as well as the significantly reduced quality of life of patients with amputations, vascular diagnostics and vascular surgery treatments are of great importance for lower limb preservation in patients with PAD. This study examines these guideline based procedures in patients before a first lower limb amputation and PAD. METHODS: This was a retrospective longitudinal study. Data from a large German statutory health insurance scheme were examined on patients with first amputation of lower extremities and PAD between 2013 and 2015 (incidence). Pre-defined vascular diagnostic and vascular surgical procedures were considered, as specified by guidelines within inpatient and outpatient care in a defined time before lower limb amputation. RESULTS: The overall estimated incidence of lower extremity amputations in the total population was 0.12% from 2013 to 2015. Of these, 51.7% had PAD; 81.8% of patients received at least one vascular diagnostic measure and 61.0% a vascular surgery procedure before the lower extremity amputation. There were only minor variations in the use of diagnostic or surgical treatments between patients with major and minor amputation. In total, 63.9% of patients had vascular surgery before the incident major amputation compared with 60.0% of patients with a minor amputation. Noticeable regional differences were found ranging from 91% (Berlin) to 67% (Bremen) regarding diagnostic procedures provided before amputation, and from 83% (Hamburg) to 55% (Saxony-Anhalt) regarding vascular surgery before amputations. CONCLUSION: Of patients with PAD, 18.2% did not receive a vascular diagnostic examination before amputation as specified in the guidelines, which reflects an underuse of health services. In one third of patients who did not receive vascular surgery, major amputation probably could have been avoided.

Perioperative Outcome of Fenestrated and Branched Stent Grafting after Previous Open or Endovascular Abdominal Aortic Repair.

BACKGROUND: To compare the perioperative outcome of patients treated with elective or urgent fenestrated and branched stent grafting (fbEVAR) for pararenal (pAAA) and thoracoabdominal aortic aneurysm (TAAA) after previous open with previous endovascular abdominal aortic repair. METHODS: Single center retrospective analysis of all patients undergoing fbEVAR after previous open (post-open fbEVAR group) or endovascular abdominal aortic repair (post-endo fbEVAR group) between January 2015 and December 2017. Primary outcomes were technical success and in-hospital all-cause mortality. RESULTS: We identified 42 patients undergoing fbEVAR after previous open or endovascular abdominal aortic repair during this period. Twenty-one patients (post-open fbEVAR group) had previous open abdominal aortic repair, 13 with a bifurcated and 8 with a tube graft. Of these, 2 patients presented with pAAA and 19 with TAAA. Twenty-one patients (post-endo fbEVAR group) had previous EVAR. Thirteen patients presented with pAAA, 3 of them with additional type Ia endoleak, 2 with stent-graft migration and 2 with previously failed fEVAR. Eight presented with TAAA. Median interval between previous repair and fbEVAR was 84 months (IQR 60-156) for the post-open fbEVAR group and 72 months (IQR 36-96) for the post-endo fbEVAR group (P = 0.746). Eighteen patients (86%) had branched stent grafting in the post-open versus 11 (52%) in the post-endo group (P < 0.01). In 2 patients in the post-open group, 3 renal arteries were not catheterized due to severe ostial stenosis, resulting in technical success of 91% in the post-open and 100% in the post-endo fbEVAR group. Four patients (19%) in the post-open fbEVAR group died in hospital, 2 due to cerebral hemorrhage and 2 due to pneumonia, and none in the post-endo fbEVAR group (P = 0.101). There were 5 nonstent-graft-related reinterventions, 2 (10%) in the post-open fbEVAR group and 3 (14%) in the post-endo fbEVAR group (P = 0.844). After 12 months there were 4 events in the post-endo fbEVAR group: one renal artery stent occluded, one renal artery stent required relining because of disconnection and 2 type II endoleaks were embolized with coils. There were no reinterventions in the post-open fbEVAR group during 12 months. CONCLUSIONS: Fenestrated and branched repair after previous open or endovascular abdominal aortic repair appears safe with high technical success rate. There is no difference in the technical success and in-hospital all-cause mortality rates between fbEVAR after previous open or endovascular abdominal aortic repair.

Publication Performance in German Academic Heart Surgery.

BACKGROUND: This study was designed to evaluate the publication performance of management teams consisting of chief and senior physicians in German university cardiac surgery units over a 10-year period and to facilitate benchmarking. METHODS: The cutoff date for consideration of staffing from the unit Web site and publications was July 1, 2017. The literature search was based on an evaluation of the PubMed database. The 5-year impact factor (IF) from 2016 was assigned to each journal. RESULTS: Two thousand five hundred thirty-five publications (average IF 3.02) were registered, published in 323 journals. Of a total of 341 management team members, 235 (68.9%) published as first or last author over the 10-year period. The number of publications from the units divided into quintiles varied considerably with the first six units contributing 39.0% of all publications and the last nine units 9.4%. With a cumulative IF total of 3265, the publications of the first six units accounted for 42.7% of the cumulative IF, the last unit quintile amounted to 621 (8.1%) of the cumulative IF. When considering publications per managing member, the first quintile averaged 11.9 publications (29.6 IF) per managing member, the last quintile 3.3 publications (8.0 IF) per member. CONCLUSIONS: The six units of the first quintile published on average 3.6 times more per managing member than the nine units in the last quintile and the average cumulative IF per member in the first quintile was almost five times higher. Further investigation must show whether this considerable difference in publication activity between the university units is also observed in other operative fields.

The interrelationship between diabetes mellitus and peripheral arterial disease.

This systematic review examined the interrelationship between concomitant diabetes mellitus (DM) and peripheral arterial disease (PAD). The objective was to determine differences in the prevalence as well as in the outcomes in diabetic vs. non-diabetic PAD patients. The current review followed a study protocol that was published online in German in 2017. The search included societal practice guidelines, consensus statements, systematic reviews, meta-analyses, and observational studies published from 2007 to 2020 reporting symptomatic PAD and concomitant DM in patients undergoing invasive open-surgical and endovascular revascularizations. German and English literature has been considered. Eligibility criteria were verified by three independent reviewers. Disagreement was resolved by discussion involving a fourth reviewer. 580 articles were identified. After exclusion of non-eligible studies, 61 papers from 30 countries remained, respectively 850,072 patients. The included studies showed that PAD prevalence differed between diabetic vs. non-diabetic populations (20-50% vs. 10-26%), and further by age, gender, ethnicity, duration of existing diabetes, and geographic region. The included studies revealed worse outcomes regarding perioperative complications, amputation rate, and mortality rate in diabetic patients when compared to non-diabetic patients. In both groups, the amputation rates decreased during the research period. This review emphasizes an interrelationship between PAD and DM. To improve the outcomes, early detection of PAD in diabetic patients, and vice versa, should be recommended. The results of this systematic review may help to update societal practice guidelines.

The prospective GermanVasc cohort study.

Background: Previous observational studies reported a wide variation and possible room for improvement in the treatment of patients suffering from symptomatic peripheral artery disease (PAD). Yet, systematic assessment of everyday clinical practice is lacking. A General Data Protection Regulation (GDPR) compliant registry was developed and used to collect comprehensive data on clinical treatment and outcomes regarding PAD in Germany. Here, we report baseline characteristics of patients prospectively enrolled until the end of 2020. Methods: The GermanVasc registry study is a prospective longitudinal multicentre cohort study. Between 1st May 2018 and 31st December 2020, invasive endovascular, open-surgical, and hybrid revascularisations of patients suffering from chronic symptomatic PAD were prospectively included after explicit informed consent (NCT03098290). For ensuring high quality of the data, we performed comprehensive risk-based and random-sample external and internal validation. Results: In total, 5608 patients from 31 study centres were included (34% females, median 69 years). On-site monitoring visits were performed at least once in all centres. The proportion of chronic limb-threatening ischaemia was 30% and 13% were emergent admissions. 55% exhibited a previous revascularisation. Endovascular techniques made 69% among all documented invasive procedures (n=6449). Thirty-five percent were classified as patients with severe systemic disease, and 3% exhibited a constant threat to life according to the American Society of Anaesthesiologists classification. The risk profile comprised of 75% former or current smokers, 36% diabetes mellitus, and in 30% a current ischemic heart disease was present. At discharge, 93% of the patients received antiplatelets and 77% received statins. Conclusions: The GermanVasc registry study provides insights into real-world practice of treatment and outcomes of 5,608 patients with symptomatic PAD in Germany. The cohort covers a broader range of disease severity and types of interventions than usually found in trials. In future studies, comparative outcomes will be analysed in more detail.

Fenestrated endovascular repair for diseases involving the aortic arch.

OBJECTIVE: Extension of aortic disease to the aortic arch is common, frequently requiring cervical debranching procedures to maintain patency of supra-aortic branches. Endovascular aortic arch repair is an attractive alternative in the treatment of aortic arch disease for high-risk patients with thoracoabdominal diseases encroaching on the arch. The aim of our study was to report our experience of fenestrated endovascular repair in the aortic arch. METHODS: A retrospective review of prospectively collected data involving consecutive patients in a single tertiary center treated with custom-made fenestrated endografts for the aortic arch (Cook Medical, Bloomington, Ind) was undertaken. End points included technical success, perioperative mortality and morbidity, reintervention, and late survival. RESULTS: Between 2011 and 2017, there were 44 patients with a mean age of 67 ± 9 years (27 male [61%]) who were treated with fenestrated endografts for arch aneurysm (n = 11 [25%]), arch penetrating aortic ulcer (n = 6 [14%]), thoracoabdominal aneurysm with arch involvement (n = 11 [25%]), postdissection false lumen aneurysm (n = 13 [29%]), or lusorian artery aneurysm (n = 3 [7%]). The proximal landing zone was at Ishimaru zone 0 in 12 cases (27%), zone 1 in 27 cases (62%), and zone 2 in 5 cases (11%). Nine patients (20%) underwent a unilateral carotid-subclavian bypass, two (5%) a bilateral carotid-subclavian bypass, and four (9%) a subclavian transposition. In total, of the 73 target supra-aortic vessels (average of 1.7 target vessels per patient), 37 were treated with fenestrations and 36 with scallops. The mean operation time, fluoroscopy time, and contrast material volume were 215 ± 152 minutes, 33 ± 23 minutes, and 114 ± 45 mL, respectively. Technical success was 95% (42/44). The median intensive care unit and hospital stays were 3 ± 1 days and 7 ± 6 days, respectively. The 30-day mortality was 9% (4/44; one graft displacement and stroke, one retrograde type A dissection, one access complication and stroke, and one death of unknown cause). Major stroke occurred in three (7%), minor stroke in one (2%), temporary spinal cord ischemia in three (7%), and renal injury in three (7%) patients, whereas three (7%) patients required early reintervention. With mean follow-up of 18 ± 17 months, 10 more patients required secondary interventions, most of which (90%) were planned distal intervention to complete the repair of thoracoabdominal diseases. Overall survival rates were 78% ± 7% and 72% ± 8% at postoperative years 1 and 2, respectively. CONCLUSIONS: Fenestrated endograft repair of aortic arch disease is a feasible technique with a high technical success rate and acceptable rates of stroke and paraplegia. A high number of secondary interventions were needed to complete the treatment of underlying diseases.

Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis.

OBJECTIVE: The aim of this study was to determine the survival of patients after use of paclitaxel coated devices (PCX), as a recent meta-analysis of randomised trials reported higher mortality in patients treated with PCX balloons and stents METHODS: A retrospective health insurance claims analysis of patients covered by the second largest insurance fund in Germany, BARMER, was used to identify index femoropopliteal arterial interventions between 1 January 2010 and 31 December 2018. To ensure first PCX exposure, patients with prior deployment of PCX were excluded. The study cohort was stratified into patients with chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC), then into balloons vs. stents cohorts. Within each stratum PCX were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 37 914 patients (mean age 73.3 years; 48.8% female) included in the study. The annual proportion of PCX use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both p < .001). Paclitaxel coated balloons and stents were associated with improved overall survival (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.77-0.90), amputation free survival (HR 0.85, 95% CI 0.78-0.91), and freedom from major cardiovascular events (HR 0.82, 95% CI 0.77-0.89) vs. uncoated devices at five years for CLTI. In IC cohort, mortality was significantly lower after using drug coated balloons (DCB) (HR 0.87, 95% CI 0.76-0.99) or combined DCB and drug eluting stents (HR 0.88, 95% CI 0.80-0.98). CONCLUSION: In this large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI.

Periodontal treatment and peripheral arterial disease severity - a retrospective analysis of health insurance claims data.

Background: Although epidemiological data suggest an association between periodontitis (PD) and peripheral arterial disease (PAD), it is currently unclear whether treatment of PD influences the severity of PAD. Patients and methods: Whether periodontal treatment is associated with PAD disease severity was examined by analysing health insurance claims data of patients insured by the German health insurance fund, BARMER, between January 1, 2012 and December 31, 2016. The presence of PAD was determined in individuals using International Classification of Diseases (ICD) 10th revision codes for intermittent claudication (IC) or chronic limb threatening ischaemia (CLTI). Treatment of PD was assessed by adequate ambulatory coding for non-surgical and surgical treatment of PD. Multivariate logistic regression analysis was performed to evaluate the association between PAD stages and periodontal treatment, adjusted for diabetes, age and sex. Results: The study cohort included 70,944 hospitalized patients with a diagnosis of symptomatic PAD (54.99 % women, 49.05 % IC). Among these patients, 3,567 (5.03 %) had received prior treatment for PD by supra- or sub-gingival debridement. PAD patients who had received periodontal treatment showed a lower proportion of CLTI (28.76 % among treated vs. 52.12 % among non-treated). Using multivariable regression methods, exhibiting a CLTI (vs. IC) was associated with not being treated for PD (Odds Ratio 1.97, 95 %-CI 1.83-2.13) after adjustment for age, gender, and diabetes. Conclusions: In this large-scale retrospective analysis of health insurance claims data comprising hospitalized symptomatic PAD patients, treatment of PD was associated with PAD disease severity independent of age, gender and diabetes. A potential benefit of periodontal treatment in relation to PAD will have to be determined in further prospective studies.

Safety and durability of infrarenal aorta as distal landing zone in fenestrated or branched endograft repair for thoracoabdominal aneurysm.

OBJECTIVE: Manufacturers often recommend the iliac arteries as the distal landing zone in fenestrated or branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aneurysm. It is not uncommon to choose distal landing at the infrarenal aorta for preservation of lumbar arteries or the inferior mesenteric artery (IMA); however, the safety and durability of this procedure have not been verified in the literature. METHODS: Consecutive patients who underwent FB-EVAR with distal landing at the infrarenal aorta were reviewed retrospectively. The primary outcome measured any type IB endoleak over time. Secondary outcomes measured perioperative complications of paraplegia and bowel ischemia, preservation of lumbar artery and IMA, and degeneration of infrarenal aorta (diameter of infrarenal aorta at landing zone) and common iliac arteries (maximum diameters) over time. RESULTS: Between August 2011 and August 2017, 40 patients (40% male with a mean age of 72 ± 8 years) affected by types I (37.5%), II (25.0%), III (20.0%), and V (17.5%) thoracoabdominal aneurysms were included. The mean aneurysm diameter was 6.4 ± 1.5 cm. There was no immediate or delayed type IB endoleak with mean follow-up period of 15 ± 18 months (range, 0-72 months). Postoperative complications included six (15%) spinal cord ischemia (five temporary and one permanent) and no mesenteric ischemia. There were three deaths (7.5%) within 30 days. Follow-up with computed tomography arteriography showed that 37 patients (92.5%) had at least one lumbar artery preserved. Out of the 31 preoperatively patent IMA, 23 (74.2%) were preserved. There was one incidental finding of new focal dissection distal to the stent graft end. Mean infrarenal aorta diameters were 24.8, 27.7, 27.7, and 29.4 mm immediately preoperatively, and at 1 and 2 years postoperatively, respectively. The mean maximal right common iliac diameters were stable and measured 15.8, 15.9, and 14.8 mm preoperatively, immediately postoperatively, and 1 year postoperatively, respectively. Mean maximal left common iliac diameters were also stable and measured 15.7, 15.9, and 14.7 mm preoperatively, immediately postoperatively, and at 1 year postoperatively, respectively. CONCLUSIONS: Our early experience showed that distal landing at the infrarenal aorta was secure in FB-EVAR with no type IB endoleak, although the observation of gradual infrarenal aortic degeneration mandates regular surveillance.

Impact of weekend treatment on short-term and long-term survival after urgent repair of ruptured aortic aneurysms in Germany.

OBJECTIVE: There is some evidence that weekend admission to the hospital is associated with worse outcomes compared with weekday admission. However, only a few studies have focused on weekend vs weekday surgery outcomes. This study aimed to determine whether there is a weekend effect on outcomes in the treatment of ruptured aortic aneurysms in Germany. METHODS: Health insurance claims of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate short-term and long-term mortality after weekend vs weekday treatment of ruptured aortic aneurysm. Patients undergoing endovascular repair (ER) or open surgical repair (OSR) between January 2008 and December 2016 were included in the study. Both propensity score matching and regression methods were used to adjust for confounding. RESULTS: There were 1477 patients in the cohort, of whom 517 (35.0%) underwent ER and 960 (65.0%) OSR. Overall, 995 (67.4%) patients underwent an operation on weekdays (Monday to Thursday), and 482 (32.6%) patients underwent an operation on a weekend (Friday to Sunday). In multivariable models, patients who underwent an operation on a weekend were at higher risk of in-hospital death after OSR (49.2% vs 38.0%; odds ratio [OR], 1.61; P = .001), and there was a trend toward higher in-hospital mortality after ER (29.5% vs 21.2%; OR, 1.55; P = .056). The ER of thoracic or thoracoabdominal aortic ruptures was associated with significantly higher in-hospital mortality compared with ER of abdominal aortic aneurysm (OR, 1.69; P = .026). CONCLUSIONS: Weekend repairs of ruptured aortic aneurysms are associated with worse in-hospital survival compared with weekday surgery. ER of thoracic or thoracoabdominal aortic ruptures is associated with worse in-hospital survival compared with ER of ruptured abdominal aortic ruptures. This might be an international phenomenon requiring joint learning and action in times of centralization of aortic procedures.