Patient-specific risk factors for reintervention following primary endovascular treatment of iliac artery disease.

OBJECTIVE: Predictive models for reintervention may guide clinicians to optimize selection, education, and follow-up of patients undergoing endovascular iliac revascularization. Although the impact of lesion- and device-related characteristics on iliac restenosis and reintervention risk is well-defined, data on patient-specific risk factors are scarce and conflicting. This study aimed to explore the value of patient-related factors in predicting the need for clinically driven target-vessel revascularization (CD-TVR) in patients undergoing primary endovascular treatment of iliac artery disease. METHODS: Consecutively enrolled patients undergoing endovascular revascularization for symptomatic iliac artery disease at a tertiary vascular referral center between January 2008 and June 2020 were retrospectively analyzed. Primary and secondary outcomes were CD-TVR occurrence within 24 months and time to CD-TVR, respectively. Patients who died or did not require CD-TVR within 24 months were censored at the date of death or at 730 days, respectively. Multiple imputation was used to account for missing data in primary analyses. RESULTS: A total of 1538 iliac interventions were performed in 1113 patients (26% females; 68 years). CD-TVR occurred in 108 limbs (74 patients; 7.0%) with a median time to CD-TVR of 246 days. On multivariable analysis, increasing age was associated with lower likelihood of CD-TVR (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.50-0.83; P = .001) and decreased risk of CD-TVR at any given time (hazard ratio [HR], 0.66; 95% CI, 0.52-0.84; P = .001). Similarly, a lower likelihood of CD-TVR (OR, 0.75; 95% CI, 0.59-0.95; P = .017) and decreased risk of CD-TVR at any given time (HR, 0.73; 95% CI, 0.58-0.93; P = .009) were observed with higher glomerular filtration rates. Lastly, revascularization of common vs external iliac artery disease was associated with lower likelihood of CD-TVR (OR, 0.48; 95% CI, 0.24-0.93; P = .030) and decreased risk of CD-TVR at any given time (HR, 0.48; 95% CI, 0.25-0.92; P = .027). No associations were observed between traditional cardiovascular risk factors (sex, hypertension, higher low-density lipoprotein cholesterol, higher hemoglobin A1c, smoking) and CD-TVR. CONCLUSIONS: In this retrospective cohort study, younger age, impaired kidney function, and external iliac artery disease were associated with CD-TVR. Traditional markers of cardiovascular risk were not seen to predict reintervention.

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review.

As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing.

Effectiveness of revascularisation for the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review.

INTRODUCTION: Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality. METHODS: Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided. RESULTS: From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions. CONCLUSIONS: The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.

Performance of non-invasive bedside vascular testing in the prediction of wound healing or amputation among people with foot ulcers in diabetes: A systematic review.

INTRODUCTION: The presence of peripheral artery disease (PAD) confers a significantly increased risk of failure to heal and major lower limb amputation for people with diabetes-related foot ulcer (DFU). Determining performance of non-invasive bedside tests for predicting likely DFU outcomes is therefore key to effective risk stratification of patients with DFU and PAD to guide management decisions. The aim of this systematic review was to determine the performance of non-invasive bedside tests for PAD to predict DFU healing, healing post-minor amputation, or need for minor or major amputation in people with diabetes and DFU or gangrene. METHODS: A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective studies that evaluated non-invasive bedside tests in patients with diabetes, with and without PAD and foot ulceration or gangrene to predict the outcomes of DFU healing, minor amputation, and major amputation with or without revascularisation, were eligible. Included studies were required to have a minimum 6-month follow-up period and report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio for the outcomes of DFU healing, and minor and major amputation. Methodological quality was assessed using the Quality in Prognosis Studies tool. RESULTS: From 14,820 abstracts screened 28 prognostic studies met the inclusion criteria. The prognostic tests evaluated by the studies included: ankle-brachial index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4 studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO2 ) in 7 studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic velocity in 1 study. Study quality was variable. Common reasons for studies having a moderate or high risk of bias were poorly described study participation, attrition rates, and inadequate adjustment for confounders. In people with DFU, toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg were associated with a moderate to large increase in pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was associated with a moderate increase in healing post-minor amputation. An ABI using a threshold of ≥0.9 did not increase the pretest probability of DFU healing, whereas an ABI <0.5 was associated with a moderate increase in pretest probability of non-healing. Few studies investigated amputation outcomes. An ABI <0.4 demonstrated the largest increase in pretest probability of a major amputation (PLR ≥10). CONCLUSIONS: Prognostic capacity of bedside testing for DFU healing and amputation is variable. A toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg are associated with a moderate to large increase in pretest probability of healing in people with DFU. There are little data available evaluating the prognostic capacity of bedside testing for healing after minor amputation or for major amputation in people with DFU. Current evidence suggests that an ABI <0.4 may be associated with a large increase in risk of major amputation. The findings of this systematic review need to be interpreted in the context of limitations of available evidence, including varying rates of revascularisation, lack of post-revascularisation bedside testing, and heterogenous subpopulations.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

A Systematic Review on Thoracic Endovascular Repair Outcomes in Blunt Thoracic Aortic Injuries.

PURPOSE: Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR. MATERIALS AND METHODS: We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up. RESULTS: From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16-89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001, I2=0%). Mortality at 30 days was 5.0% (OR, 95% CI=0.03, 0.06, p<0.001, I2=5.56%). Spinal cord ischemia occurred in 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and stroke rate was 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%). The available follow-up was estimated at 29 months (range=3-119 months) with mortality rate at 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and re-intervention rate at 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=10.5%). CONCLUSION: Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed. CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.

External Validation of the OAC3-PAD Bleeding Score in a Nationwide Population of Patients Undergoing Invasive Treatment for Peripheral Arterial Disease.

OBJECTIVE: The OAC3-PAD score was developed to predict bleeding risk in patients with lower extremity peripheral arterial disease (PAD), but its performance in concomitant international cohorts is largely unknown. This study aimed to validate the OAC3-PAD score in an unselected nationwide population of patients undergoing invasive treatment for symptomatic PAD. METHODS: This was a nationwide cohort study including all patients who underwent a first revascularisation procedure or major amputation for symptomatic PAD in Denmark from 2000 - 2021. The study population was stratified based on OAC3-PAD score, and the one year risk of major bleeding was assessed, accounting for the competing risk of death. The score performance was evaluated using calibration plots, C statistic, Brier score, and the index of prediction accuracy (IPA). RESULTS: A total of 52 016 patients were included (mean age 71 years, 43.8% female). The one year risk of major bleeding increased with higher OAC3-PAD score, ranging from 1.6% (95% confidence interval [CI] 1.4 - 1.8%) to 2.3% (95% CI 2.0 - 2.5%), 3.5% (95% CI 3.2 - 3.8%), and 5.2% (95% CI 4.8 - 5.6%) for patients with low, low moderate, moderate high, and high score, respectively. Using patients with low risk as reference, the OAC3-PAD score effectively categorised patients, demonstrating statistically significant differences in bleeding risk across strata. However, the score showed modest discriminative performance, with a C statistic of 65% (95% CI 63 - 66%) and a Brier score of 2.6% (95% CI 2.5 - 2.7%). Nevertheless, it performed significantly better than the null model, as indicated by an IPA of 3.1%. CONCLUSION: Among patients who underwent invasive treatment for symptomatic PAD in routine care, the OAC3-PAD score was associated with greater risk of major bleeding with increasing score level. However, its discriminatory ability was modest, and the clinical utility remains to be determined.

Short Term Outcomes and Treatment Intensity of Major Cardiovascular Emergencies During the COVID-19 Pandemic in Germany.

OBJECTIVE: There has been a decline in hospital admission rates in many countries since the beginning of the COVID-19 pandemic. Patient selection differed from episodes before the pandemic. This study investigated changes in baseline characteristics as well as the short term mortality rate and probability of receiving an invasive procedure while considering sex disparities. METHODS: Claims data provided by Germany's second largest insurance fund, BARMER, were used. Patients without COVID-19 who were treated for ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), acute limb ischaemia (ALI), and stroke between 1 January 2018 and 31 December 2021 were included. Outcomes were compared separately for both sexes between the years before the pandemic (2018/2019) and during the pandemic (2020/2021). Propensity scores with exact matching were used to balance confounders including age, drug prescriptions in the previous year, federal state, month of admission, domiciliary care, and the Elixhauser comorbidities. Short term death and probability of invasive procedures were determined using cumulative incidence functions and Cox regressions. RESULTS: The cohort consisted of 140 989 hospitalisations of 122 340 individual patients (48.3% female) with 102 960 matched cases. Baseline characteristics were similar between episodes in the unmatched cohort. Earlier discharge was observed for all strata except for males with ALI or STEMI, where the probability of early discharge was unchanged. The probability of receiving an invasive procedure was increased for both sexes with ALI, NSTEMI, and STEMI but not for stroke. The analyses suggested neither a statistically significant increase of the in hospital mortality rate nor the 30 day mortality rate after the pandemic started. CONCLUSION: There was no evidence for a direct or indirect impact of the pandemic on major short term hospital outcomes. While the probability of receiving an invasive procedure increased for STEMI, NSTEMI, and ALI, the overall short term mortality rate was unaffected for both sexes.

Vascular Registries Contributing to VASCUNET Collaborative Abdominal Aortic Aneurysm Outcome Projects: A Scoping Review.

OBJECTIVE: Vascular surgery registries report on procedures and outcomes to promote patient safety and drive quality improvement. International registries have contributed significantly to the VASCUNET collaborative abdominal aortic aneurysm (AAA) outcome projects. This scoping review aimed to outline the national registries in vascular surgery that currently participate in the VASCUNET collaborative AAA projects. METHODS: A scoping review of all published VASCUNET AAA studies and validation reports between 1997 and 2024 was undertaken. A survey was conducted among representatives of the international vascular registries contributing to VASCUNET collaborative AAA projects. RESULTS: Currently, vascular registries from 10 countries (Australia, Denmark, Finland, Hungary, Iceland, New Zealand, Norway, Sweden, Switzerland, and the UK) contribute to the current VASCUNET collaborative AAA project, of which eight have national coverage. In the past, three countries (Germany, Malta, and Italy) have participated in previous VASCUNET AAA projects, and a further three countries (Serbia, Greece, and Portugal) have planned participation in future projects. External validity is high for all current registries, with most reporting rates of > 90%. The majority have internal validation processes to assess data accuracy. VASCUNET mediated validation has also been performed by the consortium for five countries to date (Hungary, Sweden, Denmark, Malta, and Switzerland), for which a high degree of external and internal validity was identified. Most registries have established mechanisms for data linkage with national administrative datasets or insurance claims datasets and contribute to quality improvement through regular reporting to participating centres. CONCLUSION: National vascular registries from nations participating in the VASCUNET collaborative AAA projects are largely comprehensive, with high case ascertainment rates and good quality data with internal quality assurance. This provides a template for new registries wishing to join the VASCUNET collaboration and a benchmark for future research.

Adherence and Persistence to Antiplatelet Therapy in Lower Extremity Peripheral Arterial Disease: A Danish Population Based Cohort Study.

OBJECTIVE: Adherence to antiplatelet therapy is recommended but unexplored in patients with symptomatic lower extremity peripheral arterial disease (PAD). Therefore, this study aimed to determine adherence and persistence to antiplatelet therapy in patients with PAD, defined as intermittent claudication and chronic limb threatening ischaemia. DESIGN: Population based nationwide cohort study. METHODS: This study included all Danish citizens aged ≥ 40 years with a first inpatient or outpatient diagnosis of symptomatic PAD between 2010 - 2017, and who had at least one prescription claim for aspirin and/or clopidogrel within 90 days after diagnosis. Adherence was determined by the proportion of days covered (PDC) during the first year after diagnosis. Persistence was defined as no treatment gap ≥ 30 days between prescription renewals over three year follow up. RESULTS: A total of 39 687 patients were eligible for inclusion, of whom 23 279 (58.7%) claimed a prescription for aspirin and/or clopidogrel within 90 days of diagnosis. Among these, 12 898 (55.4%) were prevalent users, while the remainder comprised new users who initiated the therapy after the index PAD diagnosis. The mean PDC was 74.5% (SD 35.0%) for prevalent users and 60.5% (SD 30.5%) for new users. Adherence increased with age and number of concomitant drugs. The overall one year cumulative incidence treatment discontinuation was 13.0% (95% CI 12.5 - 13.4%) overall, 17.2% (CI 16.6 - 17.9%) for prevalent users, and 7.9% (CI 7.4 - 8.4%) for new users. At three year follow up, the cumulative incidence of discontinuation was 31.5% (CI 30.9 - 32.2%) overall, 44.6% (CI 43.7 - 45.4%) for prevalent users, and 14.6% (CI 13.9 - 15.3) for new users. CONCLUSION: Less than 60% of patients with newly diagnosed symptomatic PAD claimed a prescription for antiplatelet therapy within 90 days of diagnosis, and both adherence and persistence were moderate during the first year after diagnosis. These findings underscore the importance of efforts to improve the initiation and continuation of antiplatelet therapy in patients with PAD.

Outcomes Following Intact and Ruptured Aneurysm Repair across Nations: Analysis of International Registry Data from the VASCUNET Collaboration 2014 - 2019.

OBJECTIVE: To determine the peri-operative mortality rate for intact and ruptured abdominal aortic aneurysm (AAA) repair in 10 countries and to compare practice and outcomes over a six year period by age, sex, and geographic location. METHODS: This VASCUNET study used prospectively collected data from vascular registries in 10 countries on primary repair of intact and ruptured AAAs undertaken between January 2014 and December 2019. The primary outcome was peri-operative death (30 day or in hospital). Logistic regression models were used to estimate the association between peri-operative death, patient characteristics, and type of procedure. Factors associated with the use of endovascular aortic aneurysm repair (EVAR) were also evaluated. RESULTS: The analysis included 50 642 intact and 9 453 ruptured AAA repairs. The proportion of EVARs for intact repairs increased from 63.4% in 2014 to 67.3% in 2016 before falling to 62.3% in 2019 (p < .001), but practice varied between countries. EVAR procedures were more common among older patients (p < .001) and men (p < .001). Overall peri-operative mortality after intact AAA repair was 1.4% (95% confidence interval [CI] 1.3 - 1.5%) and did not change over time. Mortality rates were stable within countries. Among ruptured AAA repairs, the proportion of EVARs increased from 23.7% in 2014 to 35.2% in 2019 (p < .001). The average aortic diameter was 7.8 cm for men and 7.0 cm for women (p < .001). The overall peri-operative mortality rate was 31.3% (95% CI 30.4 - 32.2%); the rates were 36.0% (95% CI 34.9 - 37.2%) for open repair and 19.7% (95% CI 18.2 - 21.3%) for EVAR. This difference and shift to EVAR reduced peri-operative mortality from 32.6% (in 2014) to 28.7% (in 2019). CONCLUSION: The international practice of intact AAA repair was associated with low mortality rates in registry reported data. There remains variation in the use of EVAR for intact AAAs across countries. Overall peri-operative mortality remains high after ruptured AAA, but an increased use of EVAR has reduced rates over time.

Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results. METHODS: This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated. RESULTS: A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%. CONCLUSIONS: The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.

Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.

AIMS: Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy. METHODS AND RESULTS: Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints. CONCLUSION: Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.

Screening for Peripheral Vascular Stiffness in Lipedema Patients by Automatic Electrocardiogram-Based Oscillometric Detection.

Body mass index (BMI) is seen as a predictor of cardiovascular disease (CVD) in lipedema patients. A valid predictor of CVD is increased aortic stiffness (IAS), and previous research described IAS in lipedema. However, it is not known if this applies to all patients. In this cross-sectional single-center cohort study, peripheral pulse wave velocity (PWV) as a non-invasive indicator of aortic stiffness was measured in 41 patients with lipedema, irrespective of stage and without pre-existing cardiovascular conditions or a history of smoking and a maximum body mass index (BMI) of 35 kg/m2. Automatically electrocardiogram-triggered oscillometric sensor technology by the Gesenius-Keller method was used. Regardless of the stage of lipedema disease, there was no significant difference in PWV compared to published standard values adjusted to age and blood pressure. BMI alone is not a predictor of cardiovascular risk in lipedema patients. Measuring other anthropometric factors, such as the waist-hip ratio or waist-height ratio, should be included, and the existing cardiovascular risk factors, comorbidities, and adipose tissue distribution for accurate risk stratification should be taken into account. Automated sensor technology recording the PWV represents a valid and reliable method for health monitoring and early detection of cardiovascular risks.

Awareness of smoking cessation amongst German vascular surgeons.

Background: Smoking represents the well-known enemy of vascular well-being. Numerous previous studies emphasised the important role of smoking on the development and progression of atherosclerotic cardiovascular disease. The current study aimed to identify hurdles and barriers for an insufficient implementation of secondary prevention in the treatment of lower extremity peripheral arterial disease (PAD). Methods: All members of the German Society for Vascular Surgery and Vascular Medicine (DGG) with valid email addresses were invited to participate in an electronic survey on smoking. Results are descriptively presented. Results: Amongst 2716 invited participants, 327 (12%) submitted complete responses, thereof 33% women and 80% between 30 and 59 years old (87% board certified specialists). 83% were employed by hospitals (56% teaching hospital, 14% university, 13% non-academic) and 16% by outpatient facilities. 6% are active smokers (63% never) while a mean of five medical education activities on smoking cessation were completed during the past five years of practice. Only 27% of the institutions offered smoking cessation programs and 28% of the respondents were aware of local programs while a mean of 46% of their patients were deemed eligible for participation. 63% of the respondents deemed outpatient physicians primarily responsible for smoking cessation, followed by medical insurance (26%). Conclusions: The current nationwide survey of one scientific medical society involved in the care of patients with vascular disease revealed that smoking cessation, although being commonly accepted as important pillar of comprehensive holistic care, is not sufficiently implemented in everyday clinical practice.

Long-term Mortality and Reintervention After Endovascular and Open Abdominal Aortic Aneurysm Repairs in Australia, Germany, and the United States.

OBJECTIVE: To examine long-term outcomes after endovascular (EVAR) and open repairs (OAR) for intact abdominal aortic aneurysms in Australia, Germany, and the United States, using a unified study design. BACKGROUND: Similarities and differences in long-term outcomes after EVAR versus OAR across countries remained unclear, given differences in designs across existing studies. METHODS: We identified patients aged >65 years undergoing intact abdominal aortic aneurysm repairs during 2010-2017/2018. We compared long-term patient mortality and reintervention after EVAR and OAR using Kaplan-Meier analyses and Cox regressions. Propensity score matching was performed within each country to adjust for differences in baseline patient characteristics between procedure groups. RESULTS: We included 3311, 4909, and 145363 patients from Australia, Germany, and the United States, respectively. The median patient age was 76 to 77 years, and most patients were males (77%-84%). Patient mortality was lower after EVAR than OAR within the first 60 days and became similar at 3-year follow-up (Australia 14.7% vs 16.5%, Germany 18.2% vs 19.7%, United States: 24.4% vs 24.4%). At the end of follow-up, patient mortality after EVAR was higher than OAR in Australia [ hazard ratio (HR) 95% CI: 1.21 (0.96-1.54)] but similar to OAR in Germany [HR 95% CI: 0.92 (0.80-1.07)] and the United States [HR 95% CI: 1.02 (0.99-1.05)]. The risk of reintervention after EVAR was more than twice that after OAR in Australia [HR 95% CI: 2.60 (1.09-6.15)], Germany [HR 95% CI: 4.79 (2.56-8.98)], and the United States [HR 95% CI: 2.67 (2.38-3.00)]. The difference in reintervention risk appeared early in German and United States patients. CONCLUSIONS: This multinational study demonstrated important similarities in long-term outcomes after EVAR versus OAR across 3 countries. Variation in long-term mortality and reintervention comparisons indicates possible differences in patient profiles, surveillance, and best medical therapy across countries.

Systematic review of reintervention with fenestrated or branched devices after failed previous endovascular aortic aneurysm repair.

BACKGROUND: A proximal seal extension, after previously failed standard endovascular abdominal aortic aneurysm repair (EVAR), has been described using various endovascular techniques. The aim of the present systematic review was to assess the technical success, 30-day mortality, and mortality and reintervention rates during the available follow-up for patients managed with endovascular methods after failed endovascular repair. METHODS: The present systematic review followed the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and was preregistered at PROSPERO (no. CRD42022350436). A search of the English literature, via Ovid, using the MEDLINE, EMBASE, and CENTRAL databases, until June 15, 2022, was performed. Observational studies (2000-2022) and case series with at least five patients who had undergone fenestrated/branched EVAR (F/BEVAR) after failed EVAR were considered eligible. Technical success and mortality at 30 days and the mortality and reintervention rates during available follow-up had to have been reported. The Newcastle-Ottawa scale was used to assess the risk of bias. The primary outcome was technical success and mortality at 30 days. RESULTS: The initial search yielded 2558 reports. Ten studies were considered eligible, two of which were prospective. A total of 423 patients had undergone F/BEVAR after failed EVAR. The indication for reintervention was the presence of a type Ia endoleak in 44.9%. Technical success was reported in seven studies, and 319 of 336 interventions were considered successful (94.9%), according to each study's criteria. Of the 423 patients, 10 had died within 30 days (2.4%). Seven patients had presented with spinal cord ischemia (2.4%). Twenty-three acute kidney injury events were reported (6.8%). The mean follow-up was 18 months (range, 1-77 months). During follow-up, 47 deaths were reported (14.8%). Finally, 50 reinterventions of 303 procedures (16.5%) had been performed. CONCLUSIONS: According to the available literature, F/BEVAR after failed EVAR can be performed with high technical success and low mortality during the perioperative period. The midterm mortality and reintervention rates were acceptable. However, further data are needed to provide firm conclusions regarding the safety and durability of F/BEVAR after failed EVAR.

Applications of artificial intelligence for patients with peripheral artery disease.

OBJECTIVE: Applications of artificial intelligence (AI) have been reported in several cardiovascular diseases but its interest in patients with peripheral artery disease (PAD) has been so far less reported. The aim of this review was to summarize current knowledge on applications of AI in patients with PAD, to discuss current limits, and highlight perspectives in the field. METHODS: We performed a narrative review based on studies reporting applications of AI in patients with PAD. The MEDLINE database was independently searched by two authors using a combination of keywords to identify studies published between January 1995 and December 2021. Three main fields of AI were investigated including natural language processing (NLP), computer vision and machine learning (ML). RESULTS: NLP and ML brought new tools to improve the screening, the diagnosis and classification of the severity of PAD. ML was also used to develop predictive models to better assess the prognosis of patients and develop real-time prediction models to support clinical decision-making. Studies related to computer vision mainly aimed at creating automatic detection and characterization of arterial lesions based on Doppler ultrasound examination or computed tomography angiography. Such tools could help to improve screening programs, enhance diagnosis, facilitate presurgical planning, and improve clinical workflow. CONCLUSIONS: AI offers various applications to support and likely improve the management of patients with PAD. Further research efforts are needed to validate such applications and investigate their accuracy and safety in large multinational cohorts before their implementation in daily clinical practice.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes mellitus and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

Association between sex and long-term outcomes of endovascular treatment for peripheral artery disease.

BACKGROUND: Endovascular peripheral vascular intervention (PVI) has become the primary revascularization technique used for peripheral artery disease (PAD). Yet, there is limited understanding of long-term outcomes of PVI among women versus men. In this study, our objective was to investigate sex differences in the long-term outcomes of patients undergoing PVI. METHODS: We performed a cohort study of patients undergoing PVI for PAD from January 1, 2010 to September 30, 2015 using data in the Vascular Quality Initiative (VQI) registry. Patients were linked to fee-for-service Medicare claims to identify late outcomes including major amputation, reintervention, major adverse limb event (major amputation or reintervention [MALE]), and mortality. Sex differences in outcomes were evaluated using cumulative incidence curves, Gray's test, and mixed effects Cox proportional hazards regression accounting for patient and lesion characteristics using inverse probability weighted estimates. RESULTS: In this cohort of 15,437 patients, 44% (n = 6731) were women. Women were less likely to present with claudication than men (45% vs. 49%, p < 0.001, absolute standardized difference, d = 0.08) or be able to ambulate independently (ambulatory: 70% vs. 76%, p < 0.001, d = 0.14). There were no major sex differences in lesion characteristics, except for an increased frequency of tibial artery treatment in men (23% vs. 18% in women, p < 0.001, d = 0.12). Among patients with claudication, women had a higher risk-adjusted rate of major amputation (hazard ratio [HR] = 1.72, 95% confidence interval [CI]: 1.18-2.49), but a lower risk of mortality (HR = 0.86, 95% CI: 0.75-0.99). There were no sex differences in reintervention or MALE for patients with claudication. However, among patients with chronic limb-threatening ischemia, women had a lower risk-adjusted hazard of major amputation (HR = 0.79, 95% CI: 0.67-0.93), MALE (HR = 0.86, 95% CI: 0.78-0.96), and mortality (HR = 0.86, 95% CI: 0.79-0.94). CONCLUSION: There is significant heterogeneity in PVI outcomes among men and women, especially after stratifying by symptom severity. A lower overall mortality in women with claudication was accompanied by a higher risk of major amputation. Men with chronic limb-threatening ischemia had a higher risk of major amputation, MALE, and mortality. Developing sex-specific approaches to PVI that prioritizes limb outcomes in women can improve the quality of vascular care for men and women.