Vasa-european Journal of Vascular Medicine最新文献

Background: The OAC³-PAD bleeding risk score was developed to assess the bleeding risk in patients with peripheral arterial disease (PAD), however its performance in patients treated exclusively with endovascular revascularisation has not yet been tested. We aimed to externally validate the bleeding risk score for this patient cohort. Patients and methods: A retrospective observational study, analysing the data of all PAD patients successfully treated with endovascular revascularisation in a single centre within a five-year period. The performance of the Cox proportional hazards (CPH) model, upon which the OAC³-PAD bleeding risk score is based, was tested using calibration methods, discrimination, and a scaled Brier score for overall performance. The OAC³-PAD bleeding risk score was calculated for all patients, classifying them into the four respective risk groups. Kaplan-Meier curves were plotted for all risk groups and discrimination was tested using log-rank tests. Results: While discrimination of the CPH model was adequate, calibration of the model was poor and the scaled Brier score was 3.27% (95% CI 0.65%-4.40%). Of the 1,434 patients, 33 (2.3%) experienced a major bleeding event. The frequency of bleeding was 0.4% in the low risk group (3/736 patients), 0.8% in the low-to-moderate risk group (2/243 patients), 5.8% in the moderate-to-high risk group (15/258 patients), and 6.6% in the high risk group (13/197 patients). The OAC³-PAD score successfully discriminated each of the two lower bleeding risk groups from one of the two higher risk groups, but failed to discriminate among the two lower risk groups and the two higher risk groups, respectively. Conclusions: Although the OAC³-PAD score did not stratify patients into the four respective risk groups, it allowed discrimination between the low risk patients and the high risk patients. It could therefore become a useful tool for predicting major bleeding events in patients with PAD after endovascular revascularisation.

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/μl vs. 234×1000/μl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.

Background: Walking rehabilitation is the cornerstone of patients with peripheral arterial disease (PAD) treatment. In order to propose a personalised walking rehabilitation program to each patient, it is important to know the PAD-patients walking characteristics. Such data are lacking in the literature. The aim of this study was to analyse the spontaneous walking characteristics of PAD patients. Patients and methods: This study was conducted between May 2016 and March 2018. Walking characteristics (cadence, stride, number of daily walking episodes, duration of an episode, distance covered during an episode, daily total walking duration and distance, walking speed) were recorded by Withings Pulse O2® activity trackers for one week in patients with asymptomatic or symptomatic PAD. Walking intensity was classified as ambling pace (<2 METs), slow walking (2-3 METs) and active walking (>3 METs). Study protocol has been approved by an independent ethics committee. Results: Eighty-seven patients were included (males 87%, mean age 66 ± 9 years, intermittent claudication 86%, right ankle brachial index (ABI) = 0.80 ± 0.19 and left ABI = 0.79 ± 0.15). The mean recording duration was 8 ± 1.2 days. Most of the steps were shuffling pace (shuffling pace 55.7%, active walking 32.8%, slow walking 11.5%). There was no significant difference between weekdays and weekend days nor for cadence, stride, episode duration, distance covered during an episode, number of daily walking episodes, daily total walking duration and distance. The average duration of active walking episodes was 3 minutes. Duration of active walking was less than 3 minutes in 66% of patients with a mean duration of 1 minute and 55 seconds. Conclusion: Analysis of PAD patients spontaneous walking characteristics with an activity tracker can get the maximum active walking duration achieved by each patient and be useful to offer a personalised walking rehabilitation program.

Post thrombotic syndrome (PTS) is a frequent complication occurring in patients with deep venous thrombosis (DVT). This chronic condition is associated with a negative impact on quality of life and substantial economic costs. Despite current treatment with anticoagulants and compression therapy, a significant proportion of DVT patients develop PTS. Optimising the diagnosis and identification of high-risk patients is important to provide more appropriate individualised treatment. In addition, a better understanding of the pathogenesis is leading to the necessary improvement of both current treatment strategies and the development of new treatment modalities. Treatments aimed at prevention as well as those aimed at reducing the symptoms of already manifested PTS should be further investigated. Research is currently taking place on promising therapeutical targets including pharmacological (anti-inflammatory and venoactive drugs), and interventional approaches (e.g. mechanical thrombectomy) in patients at different stages of PTS. Progress in all these areas is needed to solve the complex problem of PTS.

Background: Aim of this study was to analyze the effect of medical compression stockings (MCS) class I (according to the German classification "RAL-GZ 387"; 18-21 mmHg) on symptoms in patients with uncomplicated varicose veins (C2s-C4a). Patients and methods: We conducted a randomized (1:1), controlled, clinical trial enrolling patients with uncomplicated varicose veins (CEAP: C2s-C4a). The study consisted of a one-week baseline period and a four-week follow-up period with MCS treatment (compression class I, 18-21 mmHg) in the intervention group and non-treatment in the control group. The frequency and severity of symptoms on the leg including heaviness, pain, swelling, throbbing and itching were measured every evening using an app-based measuring tool. The primary endpoint was the reduction of symptoms during compression therapy, measured by a symptom sum score over a period of 5 weeks ranging from 0 (no symptoms during the day) to 25 (symptoms all day). Results: Patients treated with MCS (n = 25) showed a significant improvement in the overall symptom sum score from 8.90 ± 4.26 at baseline to 6.37 ± 3.55 at follow-up (p = 0.004) whereas for patients in the control group without MCS (n = 25) the overall score remained unchanged (baseline: 7.46 ± 3.71; follow-up: 7.67 ± 4.74; p = 0.293). The intervention group reported significant improvements in symptom frequency scores for pain, leg swelling and feeling of leg heaviness (p ≤ 0.002). In the control group the score for pain significantly increased during the follow-up period. Leg itching was numerically more frequent in patients with MCS. Conclusion: This study indicates that medical compression stockings class I (according to the German classification "RAL-GZ 387"; 18-21 mmHg) significantly improve the frequency and severity of symptoms in patients with uncomplicated varicose veins (CEAP: C2s-C4a).

Background: Growing body of evidence suggests that the atherogenic dyslipidemia phenotype is a precursor to Peripheral Arterial Disease (PAD). Nonetheless, there is limited research regarding the association between Atherogenic Index of Plasma (AIP) and PAD which utilized a community population-based database in the United States. We sought to fill this knowledge gap. Methods: A total of 3,517 participants from the National Health and Nutrition Examination Survey 1999-2004 cycles were enrolled in our study. AIP was calculated as log10 (triglycerides/high-density lipoprotein cholesterol). Logistic regression models were adopted to reveal the relationship of AIP and PAD. Additionally, stratified and interaction analyses were also undertaken to see if the relationship was stable in different subgroups. Results: Participants in the higher tertile of AIP tended to have higher prevalence of PAD. A positive correlation was identified between AIP increase and PAD after fully multivariate adjustment (OR=1.30, 95% CI: 1.06-1.59). The multivariable-adjusted OR and 95% CI of the highest AIP tertile compared with the lowest tertile was 1.50 (1.07-2.1). Subgroup analysis demonstrated that the positive association between AIP and PAD was persistent across population subgroups. Conclusions: Our findings demonstrate a positive association between AIP and the incidence of PAD among adults in American adults. Specifically, 1 unit increase in AIP led to a 30% greater risk of PAD.

Background: The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. Methods: A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. Results: 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. Conclusions: This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients.

Materials and methods: We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSS^TM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention.

Results: Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m². Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions.

Conclusion: The BYCROSS^TM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSS^TM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.