Publications by Year: 2026

2026

Dubosq-Lebaz M, Li S, Gouëffic Y, Lee HH, Kim JM, Sobocinski J, Behrendt CA, Iida O, Secemsky EA. Safety and effectiveness of drug-coated devices in chronic limb-threatening ischaemia: a nationwide analysis.. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2026;22(5):e313-e325. PMID: 41770273

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.

Dangas K, Kim JM, Li S, Song Y, Chandra V, Wadhera RK, Yeh RW, Secemsky EA. Sex differences in rate and outcomes of endovascular revascularization for chronic limb-threatening ischemia.. Journal of vascular surgery. 2026; PMID: 41748041

BACKGROUND: The mainstay of treatment for chronic limb-threatening ischemia (CLTI), late-stage peripheral arterial disease, is prompt revascularization. However, contemporary data on sex differences in CLTI-related endovascular revascularization rates and outcomes remain limited.

METHODS: This retrospective cohort study used a 100% sample of Medicare fee-for-service claims from 2016 to 2023. We identified patients undergoing lower extremity endovascular revascularizations. Male and female sex was the exposure. Population rates of CLTI-related endovascular revascularization were calculated by sex. Baseline characteristics were compared using standardized mean differences. The primary outcome, a composite of major amputation and death, was analyzed using Kaplan-Meier methods and multivariable Cox regression adjusted for demographics, comorbidities, revascularization modality, disease severity, and other mediators. Nondeath outcomes included major amputation, minor amputation, repeat revascularization, and worsening of ambulatory status.

RESULTS: Among 333,173 patients undergoing revascularization for CLTI from 2016 to 2023, 146,644 (44.0%) were female. Females were older (75.7 years vs 73.3 years) and more likely to be Black and from socioeconomically distressed communities. Compared with males, female patients had a lower adjusted risk of mortality or major amputation (hazard ratio [HR], 0.91; 95% CI, 0.90-0.92; P < .0001), major amputation (HR, 0.82; 95% CI, 0.81-0.84; P < .0001), and mortality (HR, 0.93; 95% CI, 0.92-0.94; P < .0001). However, female patients were more likely to experience restriction in ambulatory function after revascularization (HR, 1.06; 95% CI, 1.05-1.08; P < .0001).

CONCLUSIONS: Females underwent CLTI revascularization at lower rates than males and experienced lower risks of mortality and major amputation, with higher rates of ambulatory decline. Continued investigation into modifiable drivers of sex differences can improve the quality of vascular care for both men and women with peripheral arterial disease.

Kim JM, Horbal SR, Mewaldt C, Ramachandran A, Yeh RW, Secemsky EA, Carroll BJ. Mechanical Thrombectomy and Catheter-Directed Thrombolysis in Acute Pulmonary Embolism: Trends and Practice Patterns in the PERT Consortium Registry (2016-2024).. Journal of the American College of Cardiology. 2026; PMID: 41739022

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.

Lee HH, Cho SMJ, McCarthy CP, Yoo TH, Wadhera RK, Secemsky EA, Natarajan P. Real-World Adoption of the 2021 Kidney Disease: Improving Global Outcomes Blood Pressure Guideline in CKD.. Journal of the American Society of Nephrology : JASN. 2026; PMID: 41719070

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.

Members WC, Creager MA, Barnes GD, Giri J, Mukherjee D, Jones WS, Burnett AE, Carman T, Casanegra AI, Castellucci LA, Clark SM, Cushman M, de Wit K, Eaves JM, Fang MC, Goldberg JB, Henkin S, Johnston-Cox H, Kadavath S, Kadian-Dodov D, Keeling WB, Klein AJP, Li J, McDaniel MC, Moores LK, Piazza G, Prenger KS, Pugliese SC, Ranade M, Rosovsky RP, Russo F, Secemsky EA, Sista AK, Tefera L, Weinberg I, Westafer LM, Young MN. 2026 AHA/ACC/ACCP/ACEP/CHEST/SCAI/SHM/SIR/SVM/SVN Guideline for the Evaluation and Management of Acute Pulmonary Embolism in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.. Circulation. 2026;153(12):e977-e1051. PMID: 41712677

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.

Creager MA, Barnes GD, Giri J, Mukherjee D, Jones WS, Burnett AE, Carman T, Casanegra AI, Castellucci LA, Clark SM, Cushman M, de Wit K, Eaves JM, Fang MC, Goldberg JB, Henkin S, Johnston-Cox H, Kadavath S, Kadian-Dodov D, Keeling WB, Klein AJP, Li J, McDaniel MC, Moores LK, Piazza G, Prenger KS, Pugliese SC, Ranade M, Rosovsky RP, Russo F, Secemsky EA, Sista AK, Tefera L, Weinberg I, Westafer LM, Young MN. 2026 AHA/ACC/ACCP/ACEP/CHEST/SCAI/SHM/SIR/SVM/SVN Guideline for the Evaluation and Management of Acute Pulmonary Embolism in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.. Journal of the American College of Cardiology. 2026; PMID: 41712898

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 (acute 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.

Saratzis A, Patrone L, Secemsky EA, Dua A, Zayed H, Torsello G, Van Herzeele I, Stavroulakis K, collaborators V. Use of Vessel Preparation in Endovascular Peripheral Arterial Disease (PAD) Interventions: A Global Qualitative Analysis.. Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2026;:15266028261424732. PMID: 41711060

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.

Rashedi S, Bukhari S, Krishnathasan D, Khairani CD, Bejjani A, Pfeferman MB, Malejczyk J, Zarghami M, Secemsky EA, Rahaghi FN, Hussain MA, Mojibian H, Goldhaber SZ, Jiménez D, Monreal M, Yang R, Zhou L, Piazza G, Krumholz HM, Wang L, Bikdeli B. Optimizing the Accuracy of Natural Language Processing Tools for Pulmonary Embolism Detection Through Integration with Claims Data: The PE-EHR+ Study.. Thrombosis and haemostasis. 2026; PMID: 41605431

Rule-based natural language processing (NLP) tools can identify pulmonary embolism (PE) via radiology reports. However, their external validity remains uncertain.In this cross-sectional study, 1,712 hospitalized patients (with and without PE) at Mass General Brigham (MGB) hospitals (2016-2021) were analyzed. Two previously published NLP algorithms were applied to radiology reports to identify PE. Chart review by two physicians was the reference standard. We tested three approaches: (A) NLP applied to all patients; (B) NLP limited to radiology reports of patients with principal or secondary International Classification of Diseases 10th revision (ICD-10) PE discharge codes; and (C) NLP applied to patients with PE discharge codes or a Present-on-Admission (POA) indicator ("Y") for PE. All others were assumed PE-negative in Approaches B and C to minimize NLP false positives. Weighted estimates were derived from the MGB hospitalized cohort (n = 381,642) to calculate F1 scores (as the harmonic mean of sensitivity and positive predictive value [PPV]).In Approach A, both NLP tools showed high sensitivity (82.5%, 93.0%) and specificity (98.9%, 98.7%) but low PPV (60.3%, 59.6%). Approach B improved PPV (95.2%, 94.9%) but reduced sensitivity (74.1%, 76.2%), while Approach C preserved both high sensitivity (82.5%, 93.0%) and PPV (95.6%, 95.8%). Approach C demonstrated the best performance, yielding significantly higher F1 scores for both NLP tools (88.6%, 94.4%) compared with Approach A (69.7%, 72.6%) and Approach B (83.3%, 84.5%) (P < 0.001).The accuracy of PE detection improves when rule-based NLP algorithms are operationalized using administrative claims data in addition to radiology reports.

Cho SMJ, Ruan Y, Lee HH, Koyama S, Juraschek SP, Allen NB, Yang E, McEvoy JW, Secemsky EA, Honigberg MC, Fahed AC, Patel AP, Hornsby WE, Natarajan P. Blood Pressure Polygenic Score Predicts Long-Term Blood Pressure Control and Treatment-Resistant Hypertension.. Hypertension (Dallas, Tex. : 1979). 2026;83(3):e26399. PMID: 41532316

BACKGROUND: Suboptimal blood pressure (BP) control remains a major cardiovascular disease risk factor. Whether genetically predicted BP independently predicts long-term BP control is unknown. We examined the associations of BP polygenic scores (PGSs) with long-term BP control and treatment-resistant hypertension.

METHODS: We identified 22 456 Mass General Brigham Biobank participants with hypertension. Longitudinal BP control was defined as the percentage of time above-target systolic BP (SBP) ≥130 mm Hg or diastolic BP (DBP) ≥80 mm Hg over 5 years. Using multivariable regression, we assessed the associations of BP PGS with duration above-target BP and lifetime treatment-resistant hypertension incidence. Incremental prognostic utility of BP PGSs was assessed based on the discrimination C-index, Brier score, and net reclassification index. Validation was performed in the population-based UK Biobank cohort using the SBP/DBP ≥140/90 mm Hg threshold.

RESULTS: Among 10 853 (48.3%) were female, the mean SBP/DBP (SD) at index date was 132 (18)/75 (11) mm Hg, and 4126 (18.4%) developed treatment-resistant hypertension over lifetime. In reference to the low (<20th percentile) PGS group, the high (≥80th percentile) BP PGS was associated with 8.01 (95% CI, 6.68%-9.34%) longer duration with above-target SBP and 6.19 (95% CI, 5.05%-7.33%) with high DBP. Each high SBP and DBP PGS conferred 2.36 (95% CI, 2.07-2.68) and 1.75 (95% CI, 1.55-1.99)-fold higher odds of treatment-resistant hypertension. Adding BP PGSs to traditional risk factors improved treatment-resistant hypertension prediction from C-index (95% CI), 0.74 (0.73-0.75) to 0.78 (0.77-0.79). BP PGSs consistently predicted longitudinal BP management to a comparable extent in the UK Biobank.

CONCLUSIONS: Harnessing BP PGSs may inform anticipated trends in BP control to warrant vigilant monitoring and augment prioritization of intensive therapy.

Gusdorf J, Earle WB, Li S, Krawisz A, Juraschek SP, Cluett JL, Carroll BJ, Secemsky EA. Renal Artery Stent Procedural Trends and Disparities in a National Cohort.. The American journal of cardiology. 2026;262:52–60. PMID: 41475453

Atherosclerotic renal artery stenosis (RAS) affects nearly 7% of adults over age 65 and is associated with increased cardiovascular and renal morbidity. Although early observational studies suggested benefit from renal artery stenting, subsequent randomized trials failed to show improvement in major clinical endpoints, contributing to substantial declines in procedural use. To characterize contemporary practice, we conducted a retrospective cohort study of Medicare beneficiaries older than 65 years who underwent renal artery stenting for atherosclerotic RAS between 2016 and 2020. Using Medicare claims data, we evaluated baseline characteristics, temporal utilization, and postprocedural outcomes, stratified by race, geographic region, and dual Medicare-Medicaid enrollment status. Among 19,130 patients, the mean age was 76.0 years (±6.4), 59.2% were female, and 90.3% were White; 84.2% had chronic kidney disease and 48.7% had heart failure. Procedural rates declined by 41.1% over the study period. Compared with White patients, Black patients had higher adjusted risks of hypertensive crisis hospitalization (aHR 1.45, 95% CI, 1.24-1.70) and dialysis initiation (aHR 1.78, 95% CI, 1.39-2.27); patients of Other races also had greater risk of dialysis initiation (aHR 1.98, 95% CI, 1.50-2.63). Patients in the South experienced higher unadjusted cardiovascular event rates (50.0%) but similar adjusted mortality compared with those in the Northeast (aHR 1.09, 95% CI, 0.98-1.21). Dual enrollment was associated with increased all-cause mortality (aHR 1.31, 95% CI, 1.20-1.43). In conclusion, renal artery stenting rates continued to decline in recent years, and contemporary recipients constitute an older, comorbid population with substantial cardiovascular risk. Outcomes differed markedly by race, socioeconomic status, and geography, highlighting the need for improved risk stratification and prospective evaluation of stenting in high-risk cohorts.