Publications

PURPOSE: To examine the cost implications of intravascular ultrasound (IVUS) in lower extremity deep venous intervention.

MATERIALS AND METHODS: This retrospective cohort study analyzed Medicare claims data from 2016-2021 for beneficiaries aged ≥ 65 years undergoing lower extremity venous interventions. Gamma regression adjusted for demographics and comorbidities assessed cost ratios for IVUS- vs. non-IVUS-guided procedures standardized to duration of follow-up. Rates of rehospitalization for causes attributable to complications of intervention were compared between IVUS and non-IVUS guided procedures by Cox regression. Results are shown as estimates with 95% confidence intervals.

RESULTS: Among 52,610 patients, 42.6% underwent IVUS-guided procedures including stent placement, thrombolysis, or thrombectomy. IVUS use was highest in outpatient settings (75.3%) and ambulatory surgical center/outpatient-based laboratory (ASC/OBL; 86.4%), and lowest inpatient (10.4%). In all settings, IVUS use was associated with cost savings. In the inpatient setting, IVUS guidance was associated with a cost ratio of 0.91 (0.88-0.95) at 90 days, compared to 0.71 (0.6-0.73) in ASC/OBL and 0.73 (0.71-0.76) in hospital-based outpatient settings. Cost savings persisted at one- and three-year follow-up. IVUS guidance was associated with lower one-year complication-related hospitalization in outpatient procedures (HR = 0.73 [0.62-0.86]) and ASC/OBL procedures (HR = 0.78 [0.66-0.91]). Cost savings were present in stenting procedures at 90 days (cost ratio 0.71 [0.69-0.73]), whereas there was cost neutrality in thrombectomy (cost ratio 1.02 [0.97-1.08]) and thrombolysis (cost ratio 0.89 [0.75-1.05]).

CONCLUSIONS: IVUS-guided venous intervention was associated with durable cost savings and reductions in rehospitalization in all procedural settings among procedures involving stent deployment.

Outcomes in chronic limb-threatening ischemia (CLTI) depend on timely revascularization and sustained continuity of specialty care. Although community-level socioeconomic disadvantage is associated with worse outcomes, the impact of individual-level socioeconomic vulnerability on longitudinal outcomes and healthcare utilization after CLTI revascularization remains unclear. We analyzed 333,173 Medicare beneficiaries who underwent CLTI revascularization between 2016 and 2023. Socioeconomic vulnerability was defined by Dual Enrolment (DE) in Medicaid. Outcomes were assessed using Kaplan-Meier analyses and multivariable Cox proportional hazards models. The primary clinical outcome was major amputation. A composite endpoint of major amputation or death was analyzed to contextualize overall disease burden. The study period was stratified into pre-COVID (01/2016-03/2020), COVID (03/2020-12/2021), and post-COVID (12/2021-12/2023) phases. Healthcare utilization was compared between DE and Medicare-only patients. Among included patients, 26.2% were DE. DE patients were younger, more frequently female, and had a higher comorbidity burden. The crude cumulative incidence of the primary outcome was higher in DE patients (80.1% vs. 79.7%; unadjusted HR 1.07, 95%CI 1.06-1.08), but this difference was not significant after adjustment (adjusted HR 1.00, 95%CI 0.99-1.01). DE patients had higher rates of major amputation (17.8% vs. 12.7%; adjusted HR 1.10, 95%CI 1.07-1.12), with no adjusted differences in repeat revascularization or all-cause mortality. During COVID, DE patients had a higher adjusted risk of the primary outcome (HR 1.05, 95%CI 1.02-1.08), whereas risks were similar pre- and post-pandemic. DE identifies CLTI patients at increased risk of limb loss despite similar adjusted survival, highlighting individual-level barriers to care continuity and the need for targeted strategies to reduce preventable amputations.

BACKGROUND: Endovascular therapy is a cornerstone for chronic limb-threatening ischaemia (CLTI), yet the optimal device strategy remains uncertain.

AIMS: Our objective was to compare the clinical and economic outcomes between plain balloon angioplasty±bare metal stents (PBA±BMS), drug-coated balloons (DCBs)±BMS, and drug-eluting stents (DES) in a national real-world CLTI cohort.

METHODS: Medicare beneficiaries aged ≥66 years who underwent femoropopliteal revascularisation for CLTI between 2016 and 2023 were included. Patients were grouped by index device. Outcomes included a composite of all-cause mortality or major amputation, as well as major adverse limb events (MALE) and reintervention. Patients were followed from the index procedure until death, loss to follow-up, or the end of the study period. Time-to-event and cost outcomes were analysed using multivariable Cox and gamma regression models, respectively.

RESULTS: Among 108,304 CLTI patients, 52.5% received PBA±BMS, 30.7% DCBs, and 16.8% DES. At 2 years, the composite outcome occurred in 50.54% (PBA±BMS), 43.08% (DCB±BMS), and 43.71% (DES); at 5 years, it occurred in 75.69%, 71.19%, and 71.71%, respectively. Compared with PBA±BMS, DCB±BMS (hazard ratio [HR] 0.92, 95% confidence interval [CI]: 0.90-0.93) and DES (HR 0.93, 95% CI: 0.92-0.95) were associated with a lower risk of the composite outcome. DCBs were associated with reduced major amputation (HR 0.87, 95% CI: 0.84-0.91), mortality (HR 0.93, 95% CI: 0.91-0.94), MALE (HR 0.96, 95% CI: 0.94-0.98), and reintervention (HR 0.97, 95% CI: 0.96-0.99) compared with PBA±BMS. The proportion of BMS use was 10.1% in the PBA±BMS group and 3.1% in the DCB±BMS group.

CONCLUSIONS: In this national CLTI cohort, drug-coated devices were associated with reduced amputation and mortality. Data from this study suggest that DCBs may offer consistent benefit without increased costs.

PURPOSE: Peripheral arterial disease (PAD) is a major global health burden often requiring endovascular intervention. Complex lesion morphologies such as calcification or long occlusions limit procedural success. Vessel preparation (VP) techniques, including atherectomy and intravascular lithotripsy, are increasingly adopted, but consensus on their definition, purpose, and clinical role is lacking. The main objective was to define VP in endovascular PAD interventions, determine its primary aims, and identify key barriers and enablers for its adoption in clinical practice.

MATERIALS AND METHODS: A modified Delphi process was conducted involving 103 international experts across vascular surgery, interventional radiology, angiology, and cardiology. Two rounds of online surveys and 11 structured interviews were completed, with ≥70% agreement predefined as consensus. Qualitative thematic analysis was used for free-text and interview data.

RESULTS: VP was defined as "the initial step in an endovascular procedure to facilitate subsequent interventions by modifying lesion characteristics" (93% agreement). Six core aims were established: luminal gain, improved vessel compliance, plaque/calcification reduction, enhanced drug delivery, reduced complications, and improved technical success. Barriers included high device costs and insufficient evidence. High-level agreement supported VP use in femoropopliteal and popliteal segments, with intravascular lithotripsy preferred for calcified lesions. Imaging recommendations and modality-specific VP guidance were also developed.

CONCLUSION: This work provides the first international definition and structured aims of VP in PAD. It identifies practical guidance, barriers to adoption, and priorities for future research. Findings will support standardisation in clinical practice, research, and health policy regarding VP technologies in PAD treatment(s).Clinical ImpactThis international consensus provides the first standardised definition, core aims, and practical guidance for vessel preparation in endovascular treatment of peripheral arterial disease (PAD), enabling more consistent clinical practice, research design, and health policy development worldwide.

BACKGROUND: Catheter-based interventions for acute pulmonary embolism (PE) have transformed the therapeutic landscape over the past decade despite a lack of high-quality, randomized data demonstrating clinical benefit. In addition, multicenter data describing their real-world diffusion, patient selection, and outcomes remain limited.

OBJECTIVES: This study sought to characterize national trends, patient and imaging characteristics, and institutional variation in the use of catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) across the Pulmonary Embolism Response Team (PERT) Consortium Registry from 2016 to 2024.

METHODS: The authors analyzed 2,958 patients with intermediate- or high-risk PE treated with advanced therapies from 48 U.S. institutions in the prospective PERT registry. Temporal trends in use of systemic thrombolysis, CDT, and MT were evaluated using mixed-effects Poisson models; factors associated with MT vs CDT were identified using mixed-effects logistic regression with site-level random intercepts. Patients were stratified by the European Society of Cardiology 2019 risk categories. The Composite Pulmonary Embolism Score (CPES) was used to further assess patient acuity.

RESULTS: Of the 2,958 patients who received advanced therapies, 75.9% had intermediate-risk PE and 24.1% high-risk PE. The use of MT increased by 18% per year (incident rate ratio [IRR]: 1.18; 95% CI: 1.14-1.23), surpassing CDT use by 2021, whereas the use of CDT and systemic thrombolysis declined by 13% and 12% per year, respectively. MT was independently associated with older age (≥70 years; OR: 1.37; 95% CI: 1.04-1.81), male sex (OR: 1.54; 95% CI: 1.19-1.99), vasopressor use, extracorporeal membrane oxygenation support, and saddle embolus or clot in transit, whereas CDT was more often used in younger female patients and in the presence of cardiorespiratory symptoms. The proportion of high-risk patients treated increased as did the mean CPES over the study period, reflecting treatment of progressively higher-acuity patients with catheter-based intervention.

CONCLUSIONS: Over the past decade, MT has rapidly replaced CDT as predominant catheter-based therapy for acute PE, reflecting both technological innovation and evolving operator confidence. The PERT registry captures this diffusion of innovation across institutions and patient profiles, revealing a shift toward treating sicker patients and greater procedural integration across specialties. These findings highlight the need for randomized evidence to define optimal patient selection and comparative outcomes across device classes.

Background: Angiography-derived fractional flow reserve (Angio-FFR) is an emerging tool for guiding percutaneous coronary intervention (PCI). Its uptake and outcomes compared to pressure wire (PW)-based assessment in the US are unknown. Methods: We conducted a cohort study of US Medicare beneficiary data from 1 January 2019 to 31 December 2024. Propensity score matching (1:3) of Angio-FFR to PW was performed in patients who underwent PCI during the same procedure, and separately among those who did not undergo PCI during the same procedure. The primary outcome was the cumulative incidence of major adverse cardiovascular events (MACE) through 2 years, including all-cause death, myocardial infarction (MI) and repeat revascularization. Secondary outcomes included individual MACE components, 30-day acute kidney injury and 30-day major bleeding. Falsification endpoints (hospitalization for pneumonia and hip fracture) were used to assess unmeasured confounding. Results: Of 466,535 angiograms that included intra-procedural physiologic assessment, 1.00% (N=4,672) used Angio-FFR. Annual use increased from 0.47% in 2019 to 3.85% in 2024. Among PCI patients, 1,591 Angio-FFR and 4,773 PW matched PCI patients had similar MACE rates through 2 years (24.8% vs 23.5%; HR 1.01, 95% CI 0.85 - 1.20). Secondary outcomes and falsification endpoints were not significantly different. In non-PCI patients, 2,532 Angio-FFR and 7,596 PW matched patients also had similar MACE through 2 years (24.1% vs 23.9%; HR 0.97, 95% CI 0.84 - 1.11). Conclusions: Angio-FFR usage in the US is modest but increasing. Angio-FFR guidance during angiography versus PW was associated with comparable outcomes through 2 years.

BACKGROUND: The real-world uptake of the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) blood pressure (BP) guideline, which lowered the systolic BP target to <120 mmHg for patients with chronic kidney disease (CKD), is poorly understood. We examined the adoption of the 2021 KDIGO systolic BP target in clinical practice and its association with clinical outcomes.

METHODS: The study was based on data from the Mass General Brigham healthcare network, an integrated healthcare system spanning primary to tertiary care in New England. In serial cross-sectional analysis, we identified ∼50 000 patients with CKD stage 3-4 in each year from 2020 to 2024 and assessed the annual proportion of patients within the 2021 KDIGO systolic BP target. In longitudinal analysis, we identified 18 996 patients with incident CKD stage 3-4 in 2014-2019 and evaluated the association between systolic BP above vs. within the target and clinical outcomes.

RESULTS: In serial cross-sectional analysis, 18.3% of patients with CKD had systolic BP within the 2021 KDIGO target in 2020 (pre-guideline). The proportion changed only marginally after the guideline's publication-18.0% in 2021 (absolute difference, -0.3% [95% CI, -1.2 to 1.3]), 19.3% in 2022 (absolute difference, 1.0% [95% CI, -0.1 to 2.0]), 20.0% in 2023 (absolute difference, 1.7% [95% CI, 0.2 to 3.1]), and 21.9% in 2024 (absolute difference, 3.6% [95% CI, 1.9 to 5.3]). In longitudinal analysis, patients with systolic BP above the 2021 KDIGO target exhibited higher risks of cardio-kidney end points, lower risk of hypotension, and no differences in other safety end points compared to those within the target.

CONCLUSIONS: Adoption of the 2021 KDIGO BP guideline remained limited in real-world practice. As of 2024, nearly 4 in 5 patients with CKD had systolic BP above the new guideline target.

AIM: The "2026 AHA/ACC/ACCP/ACEP/CHEST/SCAI/SHM/SIR/SVM/SVN Guideline for the Evaluation and Management of Acute Pulmonary Embolism in Adults" is a de novo guideline that provides comprehensive recommendations for the evaluation, management, and follow-up of adult patients (≥18 years of age) with acute pulmonary embolism (PE). A key feature of this guideline is the introduction of the AHA/ACC Acute Pulmonary Embolism Clinical Categories, which enhance the precision of severity classification, prognosis assessment, and evidence-based therapeutic decision-making.

METHODS: A comprehensive literature search was conducted from February 2024 to October 2024 to identify clinical studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Select key studies published until April 2025 were added by the guideline writing committee as appropriate.

STRUCTURE: The focus of this clinical practice guideline is an evidence-based and patient-centered approach for acute PE evaluation and management of the adult patient. This guideline encompasses the period from the onset of symptoms through clinical follow-up, focusing on risk outcomes assessment, clinical diagnosis of acute PE, appropriate use of adjunctive cardiovascular testing, and management in both the acute and early post-acute phases of PE. It addresses evidence-based diagnostic and management strategies (including pharmacological therapies, advanced interventional therapies, and in-hospital support) for acute PE and associated outcomes.