How Does Female Sex Affect Complex Endovascular Aortic Repair? A Single Centre Cohort Study.

OBJECTIVE: There is growing evidence of a female patient disadvantage in complex endovascular aortic repair using fenestrated and branched endografts (FB-EVAR) primarily related to peri-procedural events including ischaemic and access vessel complications. This study aimed to determine the impact of sex differences on treatment patterns, and in hospital outcomes in a single centre cohort. METHODS: This was a retrospective cross sectional single centre cohort study of all consecutive FB-EVAR procedures provided to patients with asymptomatic pararenal and thoraco-abdominal aortic aneurysm (TAAA) between 1 January 2010 and 28 February 2021. Adjusted multivariable logistic regression models were developed using backward (Wald) elimination of variables to determine the independent impact of female sex on short term outcomes. RESULTS: In total, 445 patients (24.3% females, median age 73.0 years, IQR 66, 78) were included. Female patients had a smaller aneurysm diameter, less frequent coronary artery disease (29.6% vs. 44.8%, p = .007) and history of myocardial infarction (2.8% vs. 15.4%, p < .001) when compared with males. Females were more frequently treated for TAAA than males (49.1% vs. 25.2%, p < .001). The median length of post-procedural hospital stay was 10 days in females and 9 in males. In adjusted analyses, female sex was independently associated with higher mortality (odds ratio [OR] 10.135, 95% CI 2.264 - 45.369), post-procedural complications (OR 2.500, 95% CI 1.329 - 4.702), spinal cord ischaemia (OR 4.488, 95% CI 1.610 - 12.509), sepsis (OR 4.940, 95% CI 1.379 - 17.702), and acute respiratory insufficiency (OR 3.283, 95% CI 1.015 - 10.622) after pararenal aortic aneurysm repair during the hospital stay. CONCLUSION: In this analysis of consecutively treated patients, female sex was associated with increased in hospital mortality, peri-procedural complications, and spinal cord ischaemia after elective complex endovascular repair of pararenal aortic aneurysm, while no differences were revealed in the TAAA subgroup. These results suggest that sex related patient selection and peri-procedural management should be studied in future research.

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.

Sex Disparities in Long Term Outcomes After Open Surgery for Chronic Limb Threatening Ischaemia: A Propensity Score Matched Analysis of Health Insurance Claims.

OBJECTIVE: Several studies suggest a disadvantage for women in peri-operative morbidity and mortality after open surgery in peripheral arterial occlusive disease. In addition to their heterogeneity regarding design and analysed cohorts, long term data are mostly missing. This study aimed to determine sex disparities in outcomes after open revascularisation in chronic limb threatening ischaemia (CLTI). METHODS: Using health insurance claims data of the second largest insurance fund in Germany, BARMER, a large cohort of patients was sampled consecutively for analysis including index open surgical revascularisations of CLTI performed between 1 January 2010, and 31 December 2018. Propensity score matching was used to adjust for confounding. Sex related differences regarding overall survival, amputation free survival (AFS), and cardiovascular event free survival (CVEFS) during the five years after surgery were determined using Kaplan-Meier time to event curves, log rank test, logistic, and Cox regression. RESULTS: Among 9 526 patients (49.5% women) in the entire cohort, 6 502 patients were matched. Before matching, women were older at presentation (78.0 vs. 71.8 years, p < .001) and suffered more often from multiple comorbidities (van Walraven score > 9, 55.5% vs. 50.6%, p < .001). During the hospital stay, there were 692 (7.3%) deaths, while 4 631 deaths (48.6%) occurred during the follow up. In the matched cohort, the median follow up was 746 days for women and 871 days for men. In the matched analyses, female sex was significantly associated with better overall survival (hazard ratio, HR, 0.80, log rank p < .001), AFS (HR 0.81, log rank p < .0001), and CVEFS (HR 0.84, log rank p < .001) five years after the index treatment. CONCLUSION: In this largest propensity score matched analysis of health insurance claims to date from Germany, evidence was found for better long term outcomes in women after open surgical revascularisations for chronic limb threatening ischaemia. Future guidelines and studies should address the impact of sex on patient selection practice and outcomes to determine the underlying reasons for existing disparities.

Long-term incidence of cancer after index treatment for symptomatic peripheral arterial disease - a health insurance claims data analysis.

Background: Cancer as a concomitant condition in symptomatic peripheral arterial disease (PAD) patients could have an impact on further therapy and the long-term prognosis of these patients. Aim of this study was to investigate whether there is an increased incidence of cancer in PAD patients and to quantify the corresponding effect size. Materials and methods: Between January 1st, 2008 and December 31st, 2017, we analysed health insurance claims data from Germany's second-largest insurance fund, BARMER. Symptomatic PAD patients suffering from intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) were stratified by gender at index treatment. PAD patients were then followed until an incident cancer diagnosis was recorded. To adjust for age and gender, standardized incidence ratios (SIR) were computed using the 2012 German standard population as reference. Results: 96,528 PAD patients (47% female, 44% IC, mean age 72 years) were included in the current study. When compared to the overall population, female and male PAD patients have a significantly increased risk of incident cancer of the lung (SIR 3.5 vs. 2.6), bladder (SIR 3.2 vs. 4.0), pancreas (SIR 1.4 vs. 1.6), and colon (SIR 1.3 vs. 1.3). During ten years of follow-up, some 7% of males and 4% of females developed lung cancer. For bladder, colon and pancreas cancer, the cumulative hazards were 1% vs. 3.2%, 2.2% vs. 2.8%, and 0.7% vs. 0.9%, respectively. Conclusions: Patients suffering from symptomatic PAD face a markedly higher risk for incident cancer in the long-term follow-up. The cancer risk increased continuously for certain types and PAD was strongly associated with cancer of the lung, bladder, pancreas, and colon. Taking these results into account, PAD patients could benefit from secondary and tertiary screening. These results also emphasize the impact of common risk factors such as tobacco smoke as target for health prevention.

Editor's Choice - Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data.

OBJECTIVE: Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). METHODS: Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. RESULTS: There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. CONCLUSION: Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs.

Gender differences in endovascular treatment of infrainguinal peripheral artery disease.

BACKGROUND: Despite ongoing research concerning comorbidities and clinical presentation of peripheral arterial disease (PAD), the issue of gender associated differences in treatment is far from being settled. PATIENTS AND METHODS: This was a prospective, non-randomized multicentre study design. All patients suffering from intermittent claudication (IC) or critical limb ischaemia (CLI) were included. RESULTS: A total of 2,798 procedures for symptomatic PAD in the infrainguinal region were recorded, with 1,696 (61.4 %) males. Distribution of comorbidities for patients with IC were gender-specifically different. Smoking was more common in men (41.9 vs. 31.9 %, p < .001), men had more often previous coronary heart disease (35.2 vs. 27.7 %, p = .007), and suffered more often from diabetes (33.9 vs. 28.2 %, p = .037). Women were generally older (71 vs. 77 years). Men were more prone to present with IC (46.9 vs. 43.6 %, p < .001) and ulcer/gangrene (43.6 vs. 41.2 %, p < .001). Women were more likely to present with rest pain (9.5 vs. 15.1 %, p < .001). Men were more often treated for a lesion below the knee (BTK) (21.1 vs. 14.9 %, p < .001), and females above the knee (ATK) (58.1 vs. 61.5 %, p < .001). Logistic regression analysis revealed a significant association of male gender and treatment for lesions BTK (OR 1.565, 95 % CI 1.281-1.913, p < .001). Dissections and bleeding complications were more often observed in females with IC (3.3 vs. 7.2 %, p = 0.003; 0.4 vs. 1.5 %, p = 0.044). Women were rather discharged to rehabilitation and had a longer hospital stay compared to men (3.4 vs. 8.9 %, p < .001; three vs. four days, p = .023). CONCLUSIONS: The present study provides an overview on gender-specific differences in endovascular treatment of PAD. To date, available evidence on this topic is limited, emphasising the importance of further vascular research targeting this topic.