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Background: Endovascular treatment of lower-extremity peripheral disease (PAD) is associated with higher complication rates and suboptimal outcomes in women. Atherectomy has shown favourable outcomes in calcified lesions, minimising the incidence of stent placement caused by recoil or flow-limiting dissection. To date, there are no published mid-term outcomes evaluating the performance of atherectomy differentiated by sex. This study aims to evaluate sex-specific outcomes and prognostic factors affecting the results of atherectomy-assisted endovascular treatment in severe PAD. Methods: A retrospective analysis was conducted at a single centre in Germany, initiated by physicians and not sponsored by industry, on patients presenting with Rutherford categories ranging from III to V and featuring de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries. The intervention involved rotational atherectomy-assisted angioplasty utilising the Jetstream (Boston, US®) device. The point of interest of this study was postinterventional clinical improvement as well as mid-term outcomes, including primary patency, over a targeted 2-year follow-up period. Statistical analysis utilised Cox regression (survival analysis) to calculate hazard ratios according to sex category. Comparative survival analysis was performed using the log-rank test and visually represented through Kaplan–Meier curves. Risk factors associated with absence of clinical improvement were examined across both sex groups utilising the chi-square or Fisher exact test, as appropriate. Results: A total of 98 patients (103 limbs) were initially included, with >75% having moderate-to-severe lesion calcification (>50%). A total of 84 patients (97 limbs, 62 male and 35 female) proceeded to a 2-year follow-up (mean 16.4 months for males and 16.1 for females) after a successful index procedure. Age distribution, Rutherford class, diabetes, chronic kidney disease (CKD), target vessel, lesion type, and length were balanced among both groups. Similar primary patency rates, of 89% among female and 91% among male limbs, were observed (p = 0.471). Female patients exhibited a lower rate of clinical improvement based on the Rutherford scale in comparison to males (80.6% vs. 94.5%, p = 0.048). CDK was the only significant prognostic factor across pooled data (odds ratio for CKD: 15.15, p < 0.001). Conclusions: Rotational atherectomy showed comparably high rates of mid-term primary patency, with low rates of bailout stent placement. These findings highlight the beneficial use of atherectomy in female patients who are per se at risk for higher rates of complications during and after endovascular interventions. [ABSTRACT FROM AUTHOR]

Purpose: The influence of cancer development on long-term outcome after lower extremity bypass surgery in patients with critical limb threatening ischemia was investigated. Methods: Patient survival and cancer incidence were recorded for 21,082 patients with peripheral artery disease (PAD) stage III (n = 5631; 26.7%) and stage IV (n = 15,451; 73.3%) registered with the AOK health insurance company in Germany who underwent infrainguinal bypass surgery. All patients were preoperative and in their history cancer-free. Results: After a median follow-up of 44 months, 25.6% of all patients developed cancer (Kaplan–Meier estimated), with no significant differences between patients with PAD stage III and IV (cancer incidence stage III 25.7%, stage IV 25.5%; p = 0.421). In the Cox regression analysis, male gender (HR 1.885; 95% CI 1.714–2.073, p < 0.001) and age over 70 years (HR 1.399; 95% CI 1.285–1.522, p < 0.001) were significant risk factors for the development of cancer. Survival was significantly lower in stage IV (23.4%) compared to stage III (44.5%) (HR 1.720; 95% CI 1.645–1.799, p < 0.001). Cancer was a significant risk factor for overall survival in PAD stage III patients (HR: 1.326; 95% CI 1.195–1.471, p < 0.001) but not in PAD stage IV (HR 0.976; 95% CI 0.919–1.037, p = 0.434). Conclusion: Patients with PAD stage III have significantly better survival after infrainguinal bypass surgery compared to patients with stage IV. While cancer incidence was essential for survival in stage III, it was of no importance in stage IV. [ABSTRACT FROM AUTHOR]

Peripheral arterial disease (PAD) is associated with high cardiovascular morbidity and mortality. We aimed to examine this relation in a population that tends to be under-represented in research on the topic. In a prospective observational cohort study, residents of 45 nursing homes in Germany were screened for pathological ankle-brachial index (ABI) and observed for five years. Of 1333 participants (median age 84 years), 55.5% had a pathological ABI (≤0.9 or >1.4) on one or both legs. 84.7% of the probands with a low ABI (indicating PAD) had no previously known PAD diagnosis. The five-year mortality was 73.0%. Mortality was higher in individuals with a pathological ABI (76.5%) than in those with a normal ABI (68.7%, p = 0.003). An ABI > 1.4 was associated with a higher mortality (79.4%) than a reduced (74.7%) or normal ABI (68.7%, p = 0.011). Pathological ABI values were associated with an increase in mortality after correction for age, sex and all recorded comorbidities, including cardiac disease. Although PAD is highly prevalent in nursing home residents, it is underdiagnosed and undertreated. In the study cohort, both high and low ABI were important predictors of mortality. PAD deserves more attention in this high-risk population. [ABSTRACT FROM AUTHOR]

The ankle-brachial index (ABI) is a marker of atherosclerosis and a diagnostic criterion for peripheral arterial disease (PAD). We studied the association between HbA1c and ABI in subjects with and without diabetes. In the Heinz Nixdorf Recall Study, a population-based cohort study in Germany (N = 4,814, age 45–75 years), ABI was measured at baseline, at 5- and 10-year follow-up. Subjects with ABI <0.9, ABI >1.4 or self-reported PAD at baseline were excluded from analyses. In 3199 participants, we assessed associations between HbA1c and incident PAD (ABI < 0.9) and change in ABI, respectively, using logistic and linear regression models. Subjects without diabetes, with HbA1c < 5.7% were used as reference group. Compared to the reference group, 10-year decline in ABI was −0.066 (95% confidence interval: −0.117; −0.016) and −0.021 (−0.063; 0.021) in subjects with poorly (≥7.0% HbA1c) and well (<7.0% HbA1c) controlled previously known diabetes; −0.010 (−0.054; 0.034) in those with newly detected diabetes diagnosed by HbA1c ≥ 6.5%, and −0.005 (−0.023; 0.013) in those without diabetes, with HbA1c 5.7–6.4%. For poorly controlled diabetes, odds ratios for low ABI (<0.9) were 3.5 (1.6–7.9), and 3.1 (1.3–7.0) after 5- and 10-year follow-up, respectively. The incidence of Mönckeberg disease (ABI > 1.4) was low (6/288 (2.4%) over 5 years). Decline in ABI was stronger in poorly than well-controlled diabetes. Subjects with newly detected diabetes diagnosed by the new HbA1c criterion (≥6.5%) did not show an increased decline in ABI over 10 years. Image 1 • Poorly controlled diabetes is associated with decline of ankle-brachial index (ABI). • Diabetes newly diagnosed by HbA1c is not associated with ABI decline after 10 years. • Incident Mönckeberg Disease is very rare in subjects with diabetes at baseline. [ABSTRACT FROM AUTHOR]

Objective: Our aim was to investigate the relationship between impaired peripheral arterial circulation as measured by ankle-brachial index (ABI) and restless legs syndrome (RLS) in the general population.Methods: Data are derived from three independent, German population-based, prospective studies: the control sample of BiDirect (N = 966), the second follow-up of SHIP (N = 2333), and a subsample of SHIP-Trend (N = 1269). RLS was assessed with questions based on the RLS minimal criteria. ABI was measured with an automated method in BiDirect and with Doppler ultrasound in both SHIP studies. An ABI score below 0.9 was indicative of peripheral arterial disease (PAD). Co-morbidities, medications and behavioural factors were self-reported. Additional measurements included body mass index and haemoglobin from blood serum. For BiDirect, a follow-up with identical methodology was performed after a median of 2.5 years.Results: In cross-sectional analyses, decreased ABI was not significantly associated with RLS as outcome in multivariable logistic regression models adjusted for several potential confounders (BiDirect: odds ratio (OR) = 1.07 for a -0.1 change in ABI, 95% confidence interval (CI): 0.81-1.42, p = 0.62; SHIP-2: OR = 0.99, CI: 0.85-1.16, p = 0.94; SHIP-Trend: OR = 0.99, CI: 0.87-1.13, p = 0.88). Similar non-significant results were achieved using PAD (instead of ABI) as an independent variable. In BiDirect, baseline ABI was not a significant predictor of incident RLS in longitudinal analysis (OR = 0.77, CI: 0.53-1.12, p = 0.17).Conclusion: Results from three independent studies suggest that reduced ABI is not a risk factor for RLS in the general population. [ABSTRACT FROM AUTHOR]

Background: Obstructive sleep apnoea (OSA) has interdependently been related to the onset and progression of a large portion of atherosclerotic cardiovascular disorders. In due consideration of OSA-mediated endothelial dysfunction, its impact on peripheral artery disease is conceivable, but undefined. Objectives: The aim of this study was to identify the prevalence of OSA in a lower extremity artery disease (LEAD) study population. Methods: A total of 91 patients receiving in- and outpatient treatment for LEAD were included in this prospectively conducted trial. In addition to an angiological examination, all patients underwent nocturnal screening for sleep-disordered breathing by use of SOMNOcheck micro® (SC micro) and - depending on the results obtained - polysomnography. Results: Patients were principally late middle-aged (69.3 ± 10.8 years), male (71.4%) and slightly overweight (BMI 26.8 ± 3.9). Overnight screening determined a sleep apnoea prevalence of 78.0%, of which 90.1% exhibited a predominantly obstructive genesis. The mean apnoea-hypopnoea index (AHI; events/h) and oxygen desaturation index (events/h) averaged 11.8 ± 13.4 and 8.9 ± 14.2, respectively. The individual AHI categories of non-pathological (<5), mild (5 to <15), moderate (15 to <30) and severe sleep apnoea (≥30) accounted for 22.0, 59.3, 13.2 and 5.5%, respectively. A distributive examination of AHI within LEAD severity groups evinced a significant association (p = 0.047). In cases of at least moderate sleep apnoea (AHI ≥15) polysomnography was performed (n = 17, 18.7% of the whole collective). Correlative analysis revealed a significant correlation between values obtained by SC micro recording and polysomnography, establishing the diagnostic accuracy of the screening results. Conclusions: OSA exhibits an important prevalence of 70.3% in LEAD patients with prior undiagnosed sleep-disordered breathing, indicating major OSA unawareness in this cardiovascular cohort. However, the impact of OSA treatment on LEAD propagation remains to be determined. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: In patients with peripheral artery disease (PAD), the impact of diabetes mellitus (DM) on patient-profile and adverse in-hospital events is not well investigated. Methods: The German nationwide inpatient sample 2005–2019 was used for this analysis. Hospitalized PAD patients were stratified for DM and the influence of DM on patient-profile and adverse in-hospital events was investigated. Results: Our study comprised 2,654,871 hospitalizations (54.3% aged ≥70 years, 36.7% females) of patients with PAD in Germany 2005–2019. Among these, 864,691 (32.6%) patients had DM and 76,716 (2.9%) died during hospitalization. Diabetic PAD patients revealed an aggravated cardiovascular profile (Charlson Comorbidity Index: 6.0 (5.0–8.0) vs. 4.0 (3.0–5.0), p < 0.001). PAD patients with DM showed a higher rate of in-hospital mortality (3.5% vs. 2.6%, p < 0.001), as well as major adverse cardiovascular and cerebrovascular events (MACCE, 4.7% vs. 3.3%, p < 0.001) and had more often operated with amputation surgery (16.4% vs. 9.1%, p < 0.001). DM was an independent predictor of in-hospital mortality (OR 1.077 (95%CI 1.060–1.093), p < 0.001) and MACCE (OR 1.118 (95%CI 1.103–1.133), p < 0.001). In addition, amputations were also associated with DM (OR 1.804 (95%CI 1.790–1.818)), p < 0.001). Conclusions: DM is associated with an unfavorable clinical patient-profile and higher risk for adverse events in PAD patients, including substantially increased in-hospital mortality as well as MACCE rate, and were more often associated with amputation surgeries. [ABSTRACT FROM AUTHOR]

We aimed to determine the long-term results after infrapopliteal PTA (primary patency, limb salvage, survival) and examine for association with risk factors (e.g. diabetes, infection, etc). We studied 268 patients with 282 critically ischemic limbs treated with PTA of at least one crural artery during a six-year period. Data included TASC II morphological classification of lesions and risk factors. Technical success rate was 97.2%, and overall mortality 0.7%. Patients with milder TASC lesions preserved primary patency longer than patients with more severe lesions. Similar results were obtained for limb salvage and survival. Fontaine stage, TASC class and postoperative infection of operated limb increased the risk for loss of primary patency and major amputation. Concomitant carotid stenosis was associated with loss of primary patency. Diabetes mellitus, preoperative ulcer or gangrene were associated with need of major amputation. PTA was a safe and effective treatment for CLI due to lesions of infrapopliteal vessels. [ABSTRACT FROM PUBLISHER]