Publications

BACKGROUND: Transcarotid artery revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi consensus document was to attempt to provide some guidance on these topics.

METHODS: A 3-round Delphi consensus process was performed, including 29 experts. The aim of round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During round 3, the participants had the opportunity to finalize their vote.

RESULTS: Most participants agreed that TCAR can or can probably or possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hr. It was felt that TCAR cannot or should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can or can probably be used for the treatment of restenosis following CEA or TFCAS. Finally, there is a need for a randomized controlled trial (RCT) to provide better evidence for the unresolved issues.

CONCLUSIONS: This Delphi consensus document attempted to assist the decision-making of physicians or interventionalists or vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and RCTs should provide more evidence to address the unanswered questions regarding TCAR.

BACKGROUND: Intravascular ultrasound (IVUS) use in aortic endovascular interventions, including thoracic endovascular aneurysm repair (TEVAR) and endovascular aneurysm repair (EVAR), may have similar benefits to those seen in coronary and peripheral interventions, but limited utilization and outcome data exist.

METHODS: Centers for Medicare and Medicaid Services claims data were used to identify patients undergoing TEVAR and EVAR from 2016 to 2023. Utilization trends were stratified by region, urbanicity, distressed communities index, community versus academic center, Medicare versus dual enrollment status, indication, urgency, and presence of dissection with malperfusion. Inverse probability weighting was used to assess the impact of IVUS on a composite outcome of repeat aortic intervention or death. Cox regression was used to estimate weighted hazard ratios.

RESULTS: A total of 136 540 patients underwent TEVAR and EVAR, of which 9.8% (13 364) used IVUS. IVUS use increased slightly from 2016 to 2023, driven more by use in TEVAR compared with EVAR, and was higher in academic settings, with Medicare and Medicaid dual enrollment, in the West, with dissections, with malperfusion and for elective procedures. IVUS was associated with a lower risk of the primary outcome at 30-days (hazard ratio, 0.80 [95% CI, 0.73-0.89]; P<0.001) and 6-months (hazard ratio, 0.93 [95% CI, 0.87-0.99]; P=0.022) for all-comers. Subgroup analysis suggested lower risks of the primary outcome with IVUS use for aneurysm driven by the abdominal segment, malperfusion, thoracoabdominal dissection with malperfusion, thoracoabdominal repair, and chronic kidney disease.

CONCLUSIONS: IVUS use has increased slightly in TEVAR and EVAR with heterogeneity in use. IVUS implementation during TEVAR and EVAR was associated with improved early and mid-term outcomes, particularly in certain subsets.

The objective of this study was to measure the contemporary patency rates and frequency of interventions required for arteriovenous fistula (AVF) care in a representative US population of patients with end-stage kidney disease, including by age, race, and gender. All Medicare beneficiaries aged >20 years who underwent AVF graft creation for end-stage kidney disease between 2017 and 2019 were included for analysis. The primary end points included primary patency, primary assisted patency, postintervention patency, and fistula functionality up to 1 year after AVF placement. The secondary end point included admission for an associated adverse event after AVF creation. Multivariate analysis of patency rates was also assessed. Of 43,457 patients included in the analysis, the cumulative primary patency at 90 days was 68.4% and at 1 year, 31.5%. At 1 year, the primary assisted patency rate, postintervention patency, and fistula use were 70.4%, 30.2%, and 59.1%, respectively. There was no difference in primary patency rates when comparing age groups (age 40 to 59 years: hazard ratio [HR] 1.01, 95% confidence interval [CI] 0.95 to 1.06, p = 0.84 or age ≥60 years: HR 0.99, 95% CI 0.93 to 1.04, p = 0.61) with the reference of age group 20 to 39 years. Women were at greater risk of experiencing primary patency failure than were men (HR 1.16, 95% CI 1.14 to 1.20, p <0.001), and Black patients were at greater risk of experiencing primary patency failure than were White patients (HR 1.34, 95% CI 1.31 to 1.38, p <0.001). The cumulative incidence of admissions for adverse events was 32.6% at 1 year. In conclusion, our findings suggest that the real-world AVF patency rates remain low, with disproportionately low rates in women and Black patients.

BACKGROUND: Black patients, those with low socioeconomic status (SES), and those living in rural areas have elevated rates of major lower extremity amputation, which may be related to a lack of subspecialty chronic limb-threatening ischemia care. We evaluated the association between race, rurality, SES, and preamputation vascular care.

METHODS: Among patients aged 66 to 86 years with fee-for-service Medicare who underwent major lower extremity amputation for chronic limb-threatening ischemia from July 2010 to December 2019, we compared the proportion who received vascular care in the 12 months before amputation by race (Black versus White), rurality, and SES (dual eligibility for Medicaid versus no dual eligibility) using multivariable logistic regression adjusting for clinical and demographic covariates.

RESULTS: Among 73 237 patients who underwent major lower extremity amputation, 40 320 (55.1%) had an outpatient vascular subspecialist visit, 60 109 (82.1%) had lower extremity arterial testing, and 28 345 (38.7%) underwent lower extremity revascularization in the year before amputation. Black patients were less likely to have an outpatient vascular specialist visit (adjusted odds ratio [adjOR], 0.87 [95% CI, 0.84-0.90]) or revascularization (adjOR, 0.90 [95% CI, 0.86-0.93]) than White patients. Compared with patients without low SES or residing in urban areas, patients with low SES or residing in rural areas were less likely to have an outpatient vascular specialist visit (adjOR, 0.62 [95% CI, 0.60-0.64]; low SES versus nonlow SES; adjOR, 0.82 [95% CI, 0.79-0.85]; rural versus urban), lower extremity arterial testing (adjOR, 0.78 [95% CI, 0.75-0.81]; low SES versus nonlow SES; adjOR, 0.90 [95% CI, 0.0.86-0.94]; rural versus urban), or revascularization (adjOR, 0.65 [95% CI, 0.63-0.67]; low SES versus nonlow SES; adjOR, 0.89 [95% CI, 0.86-0.93]; rural versus urban).

CONCLUSIONS: Black race, rural residence, and low SES are associated with failure to receive subspecialty chronic limb-threatening ischemia care before amputation. To reduce disparities in amputation, multilevel interventions to facilitate equitable chronic limb-threatening ischemia care are needed.

OBJECTIVE: Percutaneous deep venous arterialisation (pDVA) is a state of the art technique for treating patients with chronic limb threatening ischaemia (CLTI) with no conventional option for revascularisation. There are limited large scale data examining the clinical effectiveness of pDVA for patients with end stage CLTI.

DATA SOURCES: MEDLINE, Embase, Google Scholar, and Cochrane databases.

REVIEW METHODS: Four databases were searched from January 2018 to June 2024 to identify studies investigating the feasibility and clinical outcomes of pDVA for patients with CLTI with no conventional revascularisation options. Meta-analysis of time to event outcomes (mean ± standard deviation) was performed for amputation free survival as the primary outcome, and freedom from amputation and overall survival as secondary outcomes. Other secondary outcomes (mean and 95% confidence interval [CI]) were procedural success rate, patency, re-intervention, and complete wound healing.

RESULTS: Ten non-randomised studies were included with 351 patients. The mean patient age was 70.3 years, and 67.6% were male. Most procedures used the posterior tibial artery. The aggregated rate of amputation free survival at six and twelve months (five studies, 260 patients) was 72.6 ± 2.8% and 66.0 ± 3.1%, respectively, while the overall survival at six and twelve months (five studies, 260 patients) was 85.0 ± 2.3% and 77.7 ± 2.9%, respectively. The procedural success rate (nine studies, 330 patients) was 95.5% (95% CI 92.4 - 98.7%). Primary and secondary patency at six months (four studies, 241 patients) was 23.4% (95% CI 13.6 - 33.2%) and 54.9% (95% CI 34.3 - 75.5%), respectively. The rates of re-intervention (four studies, 190 patients) and complete wound healing (five studies, 190 patients) at twelve months were 41.7% (95% CI 25.7 - 57.7%) and 46.0% (95% CI 31.7 - 60.3%), respectively.

CONCLUSION: This meta-analysis demonstrated acceptable feasibility for no option CLTI at highly specialised institutions for patients undergoing pDVA. Meta-analysis of time to event outcomes revealed that pDVA provides reasonable amputation free survival for up to twelve months, albeit with a overall low certainty of evidence. Wider adoption of pDVA may be considered in selected patients with CLTI, although its clinical impact and cost effectiveness require further evaluation.

Improving health status is a primary indication for peripheral endovascular intervention (PVI) for symptomatic peripheral arterial disease. The data informing mid- and long-term changes and predictors of health status following PVI are limited. LIBERTY 360, a prospective, nonrandomized, multicenter study evaluated outcomes in patients undergoing PVI. Health status measures were assessed at 30-days, 1 and 3-years using EQ-VAS (0-100,100 best health) and VascuQol-25 (1-7,7 best health), stratified by claudication (Rutherford 2-3), and chronic limb-threatening ischemia (CLTI, Rutherford 4-6). Multivariable regression identified predictors of health status at 1-year. Repeated measures models were constructed based on patients with available data through 3 years. Outcomes including major adverse events, all-cause death, major amputation/death, target vessel/lesion revascularization, and major adverse limb events (MALE)/post-operative death were reported. Claudication (n = 501, 41.6%) had higher baseline VascuQol total scores (4.3 ± 1.3) compared to CLTI (n = 703, 58.4%) (3.8 ± 1.4). The VascuQol total score improved at 30-days with claudication (5.4 ± 1.3, p < 0.0001) and CLTI (4.7 ± 1.4, p < 0.0001). Baseline EQ-VAS was higher with claudication (68.3 ± 19.7) than with CLTI (63.1 ± 20.1). EQ-VAS improved at 30-days with claudication (74.9 ± 17.9, p < 0.0001) and CLTI (68.6 ± 19.2, p-value:<0.0001). Improvements were maintained through 3-years. Baseline health status, history of PVI, and comorbidities predicted health status after PVI. While major adverse events rates were high at 3-years, this was driven by target vessel/lesion revascularization with high rates of freedom from major amputation, all-cause death, and MALE in both groups. In conclusion, PVI is associated with mid- long-term improvements in health status across peripheral arterial disease severity. Baseline characteristics were associated with health status at 1-year and may inform patient selection.

BACKGROUND: Pulmonary embolism (PE) is the third-leading cause of cardiovascular mortality, accounting for 100,000 deaths per year in the United States. Although sex-based disparities have previously been described in this population, it is unclear if these differences have persisted with the expansion of PE evaluation and treatment approaches. The purpose of this study is to investigate sex-based differences in the evaluation, management, and outcomes of patients with acute PE.

METHODS: We performed a retrospective analysis of patients enrolled in the national Pulmonary Embolism Response Team (PERT) Consortium database between October 2015 and October 2022. We evaluated patient demographics, clinical characteristics, diagnostic imaging performed, treatment at several phases of care (pre-PERT, PERT recommendations, and post-PERT), and clinical outcomes.

RESULTS: A total of 5722 patients with acute PE (2838 [49.6%] women) from 35 centers were included. There were no differences in PE risk category between male and female patients. Women were less likely to undergo echocardiography (76.9% vs 73.8%) and more likely to receive no anticoagulation prior to PERT evaluation (35.5% vs 32.9%). PERT teams were more likely to recommend catheter-based interventions for men (26.6% vs 23.1%), and men were more likely to undergo these procedures (21.9% vs 19.3%). In a multivariable analysis, female sex was a predictor of in-hospital mortality (OR 1.53, 95% CI 1.06 to 2.21).

CONCLUSIONS: In this analysis, we identified sex-based differences in the evaluation and management of patients presenting with acute PE. Subsequently, women presenting with acute PE were at higher risk of in-hospital mortality.

BACKGROUND: Many research investigations for pulmonary embolism (PE) rely on the International Classification of Diseases 10th Revision (ICD-10) codes for analyses of electronic databases. The validity of ICD-10 codes in identifying PE remains uncertain.

OBJECTIVES: The objective of this study was to validate an algorithm to efficiently identify pulmonary embolism using ICD-10 codes.

METHODS: Using a prespecified protocol, patients in the Mass General-Brigham hospitals (2016-2021) with ICD-10 principal discharge codes for PE, those with secondary codes for PE, and those without PE codes were identified (n = 578 from each group). Weighting was applied to represent each group proportionate to their true prevalence. The accuracy of ICD-10 codes for identifying PE was compared with adjudication by independent physicians. The F1 score, which incorporates sensitivity and positive predictive value (PPV), was assessed. Subset validation was performed at Yale-New Haven Health System.

RESULTS: A total of 1712 patients were included (age: 60.6 years; 52.3% female). ICD-10 PE codes in the principal discharge position had sensitivity and PPV of 58.3% and 92.1%, respectively. Adding secondary discharge codes to the principal discharge codes improved the sensitivity to 83.2%, but the PPV was reduced to 79.1%. Using a combination of ICD-10 PE principal discharge codes or secondary codes plus imaging codes for PE led to sensitivity and PPV of 81.6% and 84.7%, respectively, and the highest F1 score (83.1%; P < .001 compared with other methods). Validation yielded largely similar results.

CONCLUSION: Although the principal discharge codes for PE show excellent PPV, they miss 40% of acute PEs. A combination of principal discharge codes and secondary codes plus PE imaging codes led to improved sensitivity without severe reduction in PPV.