Publication performance of university maxillofacial surgeons in Germany.

The aim of this bibliometric analysis was to benchmark the publication activities of German university departments of oral and maxillofacial surgery. The publication performance of staff surgeons (chief and consultants), documented by first or last authorship, from 37 German university departments was captured over a 10-year period (January 1, 2010, to December 31, 2019). All publications listed in PubMed were included. Additionally, the Impact Factor (IF) was determined. A total of 213 surgeons were identified, of whom 158 (74.2%) were publishing. The number of publications was 1,777, published in 311 journals. Publication activity ranged from an average of 23.3 publications per staff surgeon in the top-ranked department to 0 publications in the last-ranked. The same trend was observed for the total cumulative IFs (CIFs) per member (range from 56.2 to 0). The most common used journal was the Journal of Cranio-Maxillofacial Surgery (19.7%), with focus on "dentoalveolar surgery" (24%) and "operative techniques and procedures" (28.3%). Women constituted 19.2% of the staff, contributing to 8.5% of the publications. The publication performance of German university departments of oral and maxillofacial surgery exhibits a high variance, which did not correlate with the number of personnel and could only be explained by different research motivations.

Quantitative Insights and Visualization of Antimicrobial Tolerance in Mixed-Species Biofilms.

Biofilms are a major problem in hard-to-heal wounds. Moreover, they are composed of different species and are often tolerant to antimicrobial agents. At the same time, interspecific synergy and/or competition occurs when some bacterial species clash. For this reason, the tolerance of two dual-species wound biofilm models of Pseudomonas aeruginosa and Staphylococcus aureus or Enterococcus faecium against antimicrobials and antimicrobial dressings were analyzed quantitatively and by confocal laser scanning microscopy (CLSM). The results were compared to findings with planktonic bacteria. Octenidine-dihydrochloride/phenoxyethanol and polyhexamethylene biguanide (PHMB) irrigation solutions showed a significant, albeit delayed reduction in biofilm bacteria, while the PHMB dressing was not able to induce this effect. However, the cadexomer-iodine dressing caused a sustained reduction in and killed almost all bacteria down to 102 cfu/mL within 6 days compared to the control (1010 cfu/mL). By means of CLSM in untreated human biofilm models, it became evident that P. aeruginosa dominates over E. faecium and S. aureus. Additionally, P. aeruginosa appeared as a vast layer at the bottom of the samples, while S. aureus formed grape-like clusters. In the second model, the distribution was even clearer. Only a few E. faecium were visible, in contrast to the vast layer of P. aeruginosa. It seems that the different species avoid each other and seek their respective niches. These mixed-species biofilm models showed that efficacy and tolerance to antimicrobial substances are nearly species-independent. Their frequent application appears to be important. The bacterial wound biofilm remains a challenge in treatment and requires new, combined therapy options.

First in Human Implantation of the Thoracoflo Graft: A New Hybrid Device for Thoraco-Abdominal Aortic Repair.

Introduction: Despite a high rate of success when performed in specialised centres, current techniques for thoraco-abdominal aortic repair are associated with serious complications. The problem of spinal cord ischaemia remains unsolved. Surgical technique: The new hybrid graft for thoraco-abdominal aortic repair was developed based on the frozen elephant trunk principle. The device consists of a proximal stent graft for transabdominal retrograde delivery to the descending thoracic aorta, combined with a distal six branched abdominal device for open aortic repair. An additional seventh branch is provided for possible lumbar artery re-implantation. Because the stent graft is implanted via a transabdominal approach, it avoids the need for thoracotomy and extracorporeal circulation. A 56 year old patient with Loeys-Dietz syndrome was placed in a supine position. The aorto-iliac axis was exposed via a midline transperitoneal approach. Following an end to side anastomosis of the iliac branch to the left common iliac artery, the stent graft portion was inserted into the thoracic aorta via the coeliac trunk ostium. After stent implantation and graft de-airing by needle puncture, retrograde blood flow to the abdominal aortic segment, and the lumbar and visceral arteries was established via the end to side iliac anastomosis creating an extra-anatomic bypass. Subsequently, the visceral and renal arteries were anastomosed to the branches. Finally, the aorta was opened and surgical graft attached via the collar. The reconstruction ended with end to end anastomoses of both common iliac arteries to the graft branches. Discussion: The first and successful implantation of the new Thoracoflo hybrid device via a novel surgical technique is reported, eliminating the need for thoracotomy and extracorporeal circulation for thoraco-abdominal aortic repair.

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.

Bibliometric Analysis of Research Areas, Publication Hierarchy and Gender Authorship in German University Orthopaedic Surgery. / Bibliometrische Analyse von Forschungsgebieten, Publikationshierarchie und Autorengeschlecht der deutschen universitären Unfallchirurgie und Orthopädie.

BACKGROUND: The aim of the present bibliometric study was to record the focus of publications, type of study and publication activities depending on the hierarchy level and gender of the authors of German university departments for orthopaedic surgery. MATERIAL AND METHODS: The publication performance of the staff surgeons, consisting of chief and senior physicians, section and division heads of 39 German university departments of orthopaedic surgery university hospitals, was recorded over a period of 10 years (January 1, 2010 to December 31, 2019). All publications were considered that were listed in PubMed and for which the staff surgeons were first or last authors. In addition, the impact factor (IF) and the h-index were determined. RESULTS: 1739 (39.2%) publications were compiled by 180 staff surgeons of university departments for trauma surgery and 2699 (60.8%) publications by 343 surgeons in departments of orthopaedics and trauma surgery. Most publications were related to injuries or impairments of the lower extremity including the hip (n = 1626; 38.1%), followed by the upper extremity (n = 737; 17.3%). These publications focussed on diagnostic testing (25.5%), surgical techniques (19.1%) or special osteosyntheses (16.9%). The highest average IF per publication was achieved by publications on plastics (IF 2.02), on outcome (IF 1.96) and on diagnostic testing (IF 1.93). Heads of departments were first authors in 18.8%, senior physicians with management functions in 40.7% and senior physicians without management functions in 69% of papers and last authors in 81.2%, 49.3% and 31.0% of articles, respectively. 64 of 523 staff surgeons (12.2%) were women. 306 authors (6.1%) were women, corresponding to 4.8 authorships per female surgeon - significantly for male surgeons (10.3 authorships per male surgeon). CONCLUSION: In the present study, among senior physicians with a management function, the share of publishing surgeons was 59.1% for women, but 85.5% for men. In contrast, in the group of senior physicians without management function female and male surgeons were almost equally represented (57.5% vs. 60.5%). It must therefore be asked whether the work life balance is more difficult to meet for women than for men with longer careers. Mentoring programs are required to support the publication activities of the increasing number of female applicants in the future.

Sleep apnea predicts cardiovascular death in patients with Marfan syndrome: a cohort study.

Background: Surgical replacement of the aortic root is the only intervention that can prevent aortic dissection and cardiovascular death in Marfan syndrome (MFS). However, in some individuals, MFS also causes sleep apnea. If sleep apnea predicts cardiovascular death, a new target for predictive, preventive, and personalized medicine (PPPM) may emerge for those individuals with MFS who have sleep apnea. Methods: This is an investigator-initiated study with long-term follow-up data of 105 individuals with MFS. All individuals were screened for sleep apnea regardless of symptoms. Cardiovascular death served as a primary endpoint, and aortic events as a secondary outcome. Results: Sleep apnea with an apnea-hypopnea index (AHI) > 5/h was observed in 21.0% (22/105) with mild sleep apnea in 13% (14/105) and moderate to severe sleep apnea in 7.6% (8/105). After a median follow-up of 7.76 years (interquartile range: 6.84, 8.41), 10% (10/105) had died, with cardiovascular cause of death in 80% (8/10). After adjusting for age and body mass index (BMI), the AHI score emerged as an independent risk factor for cardiovascular death (hazard ratio 1.712, 95% confidence interval [1.061-2.761], p = 0.0276). The secondary outcome of aortic events occurred in 33% (35/105). There was no effect of the AHI score on aortic events after adjusting for age and BMI (hazard ratio 0.965, 95% confidence interval [0.617-1.509]), possibly due to a high number of patients with prior aortic surgery. Interpretation: Sleep apnea is emerging as an independent predictor of cardiovascular death in MFS. It seems mandatory to screen all individuals with MFS for sleep apnea and to include these individuals, with both MFS and sleep apnea, in further studies to evaluate the impact of preventive measures with regard to cardiovascular death. Supplementary Information: The online version contains supplementary material available at 10.1007/s13167-022-00291-4.

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.

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.

Determining the Minimal Important Difference for the Wound-QoL Questionnaire.

BACKGROUND: The questionnaire for the quality of life with chronic wounds (Wound-QoL) is a valid and reliable instrument to determine the disease-specific health-related QoL of patients with chronic wounds. For the interpretation of HRQoL scores, it is additionally important to know which differences in scores are considered meaningful. The minimal important difference (MID) is defined as a change in HRQoL that a patient would consider meaningful, such that the patient would judge a treatment to be beneficial and worthy of repeating. OBJECTIVE: To interpret changes in the Wound-QoL scores and draw conclusions regarding the relevance of detected changes; the purpose of this study was to estimate the MID of the Wound-QoL global score and its subscales for patients with chronic wounds. PATIENTS AND METHODS: Patients completed the Wound-QoL before and four to six weeks after treatment and additionally gave a global rating of wound status change after treatment. The global rating of change served as an anchor question. MIDs were calculated based on an anchor-based and a distribution-based method. RESULTS: In total, 227 patients participated in the study. The mean age of the study population was 66.9 (± 12.7) median was 69.5, and 51.5% of the patients were female. MIDs for the Wound-QoL global score ranged from 0.47 to 0.52, proposing an overall estimation of 0.50. CONCLUSION: The results can be used to measure and interpret changes in wound-specific QoL over time.

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.

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study.

BACKGROUND: Randomized controlled trials have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, while observational studies have reported the opposite. This study aims to determine the underlying factors and cohort differences that may explain these opposite results, with specific focus on sex differences in treatment and outcomes. METHODS: Multicenter health insurance claims data from a large insurance fund, BARMER, were studied. A homogeneous sample of patients with an index of endovascular revascularization for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. Adjusted logistic regression and Cox regression models were used to determine the factors predicting allocation to paclitaxel-coated devices and sex-specific 5-year all-cause mortality, respectively. RESULTS: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years. Females were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with males. Mortality differences were mostly attributable to the female subgroup who were revascularized above the knee (hazard ratio, HR 0.78, 95% CI: 0.64-0.95), while no statistically significant differences were observed in males. CONCLUSIONS: This study found that females treated above the knee benefited from paclitaxel-coated devices, while no differences were found in males. Ongoing and future registries and trials should take sex disparities into account.

Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial.

BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown. OBJECTIVES: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events. METHODS: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models. RESULTS: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) and total vascular events (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003). An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years. CONCLUSIONS: Patients with symptomatic PAD who are undergoing LER have a high total event burden that is significantly reduced with rivaroxaban. Total event reduction may be a useful metric to quantify the efficacy of rivaroxaban in this setting. (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities [VOYAGER PAD]; 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.

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.