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.

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.

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.

Gender differences in abdominal aortic aneurysm therapy - a systematic review.

This article analyses if and to what extent gender differences exist in abdominal aortic aneurysm (AAA) therapy. For this purpose Medline (PubMed) was searched from January 1999 to January 2018. Keywords were: "abdominal aortic aneurysm", "gender", "prevalence", "EVAR", and "open surgery of abdominal aortic aneurysm". Regardless of open or endovascular treatment of abdominal aortic aneurysms, women have a higher rate of complications and longer hospitalizations compared to men. The majority of studies showed that women have a lower survival rate for surgical and endovascular treatment of abdominal aneurysms after both elective and emergency interventions. Women receive less surgical/interventional and protective medical treatment. Women seem to have a higher risk of rupture, a lower survival rate in AAA, and a higher rate of complications, regardless of endovascular or open treatment. The gender differences may be due to a higher age of women at diagnosis and therapy associated with higher comorbidity, but also because of genetic, hormonal, anatomical, biological, and socio-cultural differences. Strategies for treatment in female patients must be further defined to optimize outcome.

Gender differences in abdominal aortic aneurysms in Germany using health insurance claims data.

BACKGROUND: Endovascular aortic repair (EVAR) has emerged as standard of care for abdominal aortic aneurysm (AAA). Real-world evidence is limited to compare this technology to open repair (OAR). Major gaps exist related to short-term and long-term outcomes, particularly in respect of gender differences. MATERIALS AND METHODS: Health insurance claims data from Germany's third largest insurance provider, DAK-Gesundheit, was used to investigate invasive in-hospital treatment of intact (iAAA) and ruptured AAA (rAAA). Patients operated between October 2008 and April 2015 were included in the study. RESULTS: A total of 5,509 patients (4,966 iAAA and 543 rAAA) underwent EVAR or OAR with a median follow-up of 2.44 years. Baseline demographics, comorbidities, and clinical characteristics of DAK-G patients were assessed. In total, 84.6 % of the iAAA and 79.9 % of the rAAA were male. Concerning iAAA repair, the median age (74 vs. 73 years, p < .001) compared to men was higher in females, but their EVAR-rate (66.8 % vs. 71.1 %, p = .018) was lower. Besides higher age of female patients (80 vs. 75 years, p < .001), no further statistically significant differences were seen following rAAA repair. In-hospital mortality was slightly lower in males compared to females following iAAA (2.3 % vs. 3.1 %, p = .159) and rAAA (37.3 % vs. 43.1 %, p = .273) repair. Concerning iAAA repair, a higher rate of female patients was transferred to another hospital (3.7 % vs. 2.0 %, p = 0.008) or discharged to rehabilitation (6.0 % vs. 2.7 %, p < .001) compared to male patients. CONCLUSIONS: In this large German claims data cohort, women are generally older and more often transferred to another hospital or discharged to rehab following iAAA repair. Nonetheless, no significantly increased risk of in-hospital or late death appeared for women in multivariate analyses. Further studies are necessary to evaluate the impact of recent gender-specific treatment strategies on overall outcome under real-world settings.

Initial experience with a new quantitative assessment tool for fluorescent imaging in peripheral artery disease.

BACKGROUND: Perioperative evaluation in peripheral artery disease (PAD) by common vascular diagnostic tools is limited by open wounds, medial calcinosis or an altered collateral supply of the foot. Indocyanine green fluorescent imaging (ICG-FI) has recently been introduced as an alternative tool, but so far a standardized quantitative assessment of tissue perfusion in vascular surgery has not been performed for this purpose. The aim of this feasibility study was to investigate a new software for quantitative assessment of tissue perfusion in patients with PAD using indocyanine green fluorescent imaging (ICG-FI) before and after peripheral bypass grafting. PATIENTS AND METHODS: Indocyanine green fluorescent imaging was performed in seven patients using the SPY Elite system before and after peripheral bypass grafting for PAD (Rutherford III-VI). Visual and quantitative evaluation of tissue perfusion was assessed in an area of low perfusion (ALP) and high perfusion (AHP), each by three independent investigators. Data assessment was performed offline using a specially customized software package (Institute for Laser Technology, University Ulm, GmbH). Slope of fluorescent intensity (SFI) was measured as time-intensity curves. Values were compared to ankle-brachial index (ABI), slope of oscillation (SOO), and time to peak (TTP) obtained from photoplethysmography (PPG). RESULTS: All measurements before and after surgery were successfully performed, showing that ABI, TTP, and SOO increased significantly compared to preoperative values, all being statistically significant (P < 0.05), except for TTP (p = 0.061). Further, SFI increased significantly in both ALP and AHP (P < 0.05) and correlated considerably with ABI, TTP, and SOO (P < 0.05). CONCLUSIONS: In addition to ABI and slope of oscillation (SOO), the ICG-FI technique allows visual assessment in combination with quantitative assessment of tissue perfusion in patients with PAD. Ratios related to different perfusion patterns and SFI seem to be useful tools to reduce factors disturbing ICG-FI measurements.

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.

Gender differences in patients with carotid stenosis.

This overview analyses gender differences in prevalence, epidemiology, risk factors and therapy in patients with carotid stenosis in a systematic review. Ischemic stroke is a leading cause of death in Western society, where about 20% of cases are triggered by a carotid stenosis or occlusion, which occurs more frequently in men than in women. The stroke-protective effect of carotid endarterectomy is greater in men. Men have lower peri-procedural stroke and death rates. Particularly men with carotid stenosis and a life expectancy of at least 5 years benefit from surgical treatment. Also, the recurrence rate of ipsilateral stroke 5 years after initial surgery is lower in men than in women. It is not yet fully clarified whether there are significant gender differences regarding the outcome after endovascular versus surgical treatment. Gender differences in the outcome of carotid artery repair may be caused by biological, anatomical (smaller vessel diameter in women) or hormonal differences as well as a protracted development of atherosclerotic changes in women and different plaque morphology. Moreover, women are on average older at the time of surgery and their surgical treatment is often delayed. To reduce the risk of stroke and to improve treatment outcome especially for women, further research on gender differences and their causes is mandatory and promising.

Cost-of-illness of chronic leg ulcers in Germany.

Chronic wounds are important because of their frequency, their chronicity and high costs of treatment. However, there are few primary data on the cost-of-illness in Germany. The aim was to determine the cost-of-illness of venous leg ulcers (VLU) in Germany. Prospective cost-of-illness study was performed in 23 specialised wound centres throughout Germany. Direct, medical, non medical and indirect costs to the patient, statutory health insurers and society were documented. Thereover, health-related quality of life (QoL) was recorded as intangible costs using the Freiburg quality of life assessment for wounds (FLQA-w, Augustin). A total of 218 patients (62.1% female) were recruited consecutively. Mean age was 69.8 +/- 12.0 years. The mean total cost of the ulcer per year and patient was 9569 euros, [8658.10 euros (92%) direct and 911.20 euros (8%) indirect costs]. Of the direct costs, 7630.70 euros was accounted for by the statutory health insurance and 1027.40 euros by the patient. Major cost factors were inpatient costs, outpatient care and non drug treatments. QoL was strikingly reduced in most patients. In Germany, VLU are associated with high direct and indirect costs. As a consequence, there is a need for early and qualified disease management. Deeper-going cost-of-illness-studies and cost-benefit analyses are necessary if management of chronic wounds is to be improved.