Publications by Year: 2026

BACKGROUND: Percutaneous aspiration thrombectomy is increasingly used as an alternative to surgery for right-sided heart masses, but nationwide data are limited.

METHODS: We analyzed Medicare fee-for-service beneficiaries aged ≥65 years who underwent percutaneous or surgical removal of right-sided heart masses from 2016 to 2021. We examined the temporal change in the number of percutaneous and surgical cases. The association between procedural types and patient characteristics was assessed using a multivariable logistic regression analysis. The primary outcomes were in-hospital and 2-year death. Given baseline differences between groups, we reported overall outcomes from the unadjusted cohort and comparative outcomes after adjustment using propensity score matching.

RESULTS: A total of 831 patients were included (447 percutaneous, 384 surgical), with the proportion of percutaneous cases increasing from 45.8% in 2016 to 65.0% in 2021. Patients with thrombosis (adjusted odds ratio, 3.42 [95% CI, 2.14-5.46]) and infective endocarditis (adjusted odds ratio, 10.08 [95% CI, 5.39-18.85]) were more often treated with percutaneous interventions. In-hospital and 2-year death in the percutaneous group were 11.0% and 43.0%, respectively. In the surgery group, those were 21.1% and 42.9%, respectively. Propensity score matching yielded 221 pairs. In the matched cohort, in-hospital death remained lower with the percutaneous group (10.4% versus 19.5%; P=0.01), while 2-year death was similar (hazard ratio, 1.00 [95% CI, 0.74-1.34]).

CONCLUSIONS: This study from a national database demonstrated that percutaneous intervention for right-sided heart masses has become the predominant strategy compared with surgery. Further trials are required to compare efficacy and safety between these interventions.

BACKGROUND: The DOAC Score is a bleeding risk score that incorporates ten common clinical variables to risk stratify major bleeding in patients with atrial fibrillation and demonstrated improved risk stratification than HAS-BLED in patients receiving direct acting oral anticoagulants (DOACs). This study evaluates the discriminative performance of the DOAC Score among patients taking vitamin K antagonists (VKAs).

METHODS: Data was obtained from COMBINE-AF and GARFIELD-AF. COMBINE-AF included patients with atrial fibrillation randomized to warfarin from four clinical trials: RE-LY, ARISTOTLE, ROCKET-AF, and ENGAGE AF-TIMI 48. GARFIELD-AF included patients with atrial fibrillation prescribed VKAs in a registry. The DOAC Score of each patient was determined, based on commonly obtained clinical variables. Patients were then stratified by DOAC Score clinical risk categories (very low [score: 0-3], low [score: 4-5], moderate [score: 6-7], high [score: 8-9], and very high [score: 10]), and the rate of major bleeding at one-year was compared between groups. Discrimination was assessed using C-statistics and compared with HAS-BLED using DeLong's test.

RESULTS: A total of 28,818 patients in COMBINE-AF and 20,183 patients in GARFIELD-AF receiving vitamin K antagonists were included. Of these individuals, 994 (3.4%) in COMBINE-AF and 313 (1.6%) in GARFIELD-AF experienced a major bleeding event at one-year. Patients in higher DOAC Score risk categories experienced greater one-year major bleeding rates in COMBINE-AF, including very low (1.8 events per 100 person-years [events/100p-y]), low (3.0 events/100 p-y), moderate (4.6 events/100 p-y), high (5.6 events/100 p-y), and very high (7.9 events/100 p-y). Discrimination in COMBINE-AF was moderate and higher than HAS-BLED at one-year (C-statistic: 0.62 vs 0.59, P<0.001). In GARFIELD-AF, higher risk categories also had higher one-year major bleeding rates: very low (0.8 events per 100 person-years [events/100 p-y]), low (1.5 events/100 p-y), moderate (2.2 events/100 p-y), high (3.2 events/100 p-y), and very high (7.6 events/100 p-y). Discrimination in GARFIELD-AF was moderate and higher than the HAS-BLED score at one-year (C-statistic: 0.65 vs 0.62, P<0.001).

CONCLUSION: In patients with atrial fibrillation taking VKAs, the DOAC Score was able to risk stratify patients based on bleeding risk, had moderate discrimination, and out-performed the HAS-BLED score in both a pooled clinical trials cohort and a usual care registry.

OBJECTIVES: The durability of percutaneous balloon angioplasty for arteriovenous fistula stenosis is short-lived. In randomized controlled trials, drug-coated balloons (DCBs) have shown promise in reducing reintervention compared to uncoated balloons (NDCBs). However, DCB device uptake and outcomes are poorly described. We assessed temporal trends, practice variation, and outcomes of outpatient drug-coated vs. uncoated balloon angioplasty for arteriovenous fistulas in the United States.

METHODS: Using a 100% sample of Medicare fee-for-service data, we identified 349,521 outpatient dialysis access angioplasty procedures (DCB = 35,644; NDCB = 313,877) from 2018-2024 for trend analyses. For comparative analyses, we further identified patients aged 20-80 years who underwent intervention on an arteriovenous fistula from 2021-2024. Outcomes of drug-coated vs. uncoated balloon angioplasty were assessed after inverse probability weighting. The primary outcome was access reintervention (a composite of angioplasty, stenting, or thrombectomy) through 12 months.

RESULTS: Proportional DCB use increased steadily following Medicare coverage in 2018 Q1 (8.6%), reaching 16.1% in 2024 Q4 (difference, 7.5%). During 2023-2024, 30.0% of hospitals used DCBs in > 30.0% of cases. For comparative analyses, a total of 64,140 procedures (DCB 12.2%, N = 7,813; NDCB 87.8%, N = 56,327) were included. The mean age was 62.6 (12.4) years, 38.7% were female, and, following weighting, there was no residual imbalance in baseline characteristics. Through 12 months, there was no difference in cumulative incidence of reintervention (adjusted cumulative incidence function DCB 57.7% vs. NDCB 56.9%, P = .22), but DCBs were associated with reduced restricted mean time lost to reintervention (adjusted restricted mean time lost difference -8.0 days, 95% confidence interval -11.1 days to -4.9 days, P < .0001).

CONCLUSIONS: Drug-coated balloon use has risen steadily but selectively since Medicare coverage. DCB use was associated with increased reintervention-free time through 12 months. These findings support the role of DCBs in delaying arteriovenous fistula reintervention among hemodialysis patients.

BACKGROUND: The optimal antithrombotic regimen for peripheral artery disease, balancing thromboembolic and bleeding risks, remains uncertain. This study aimed to compare the efficacy and safety of antithrombotic regimens in patients with peripheral artery disease.

METHODS: We reviewed randomized controlled trials evaluating antithrombotic therapies for peripheral artery disease, including aspirin, P2Y12 inhibitors, cilostazol, and rivaroxaban. The primary outcome was major adverse cardiac events, defined as a composite of cardiovascular death, myocardial infarction, and stroke. The secondary outcomes included major adverse limb events, defined as a composite of acute limb ischemia, revascularization, and amputation. The safety outcome was major bleeding, primarily assessed using the Thrombolysis in Myocardial Infarction criteria. We performed a network meta-analysis to compare antithrombotic regimens.

RESULTS: Seventeen randomized controlled trials involving 44 532 participants were included. Compared with aspirin monotherapy, the following were associated with lower risks of major adverse cardiac events: clopidogrel, 75 mg/d, plus cilostazol, 200 mg/d (hazard ratio [HR], 0.37 [95% CI, 0.20-0.72]), clopidogrel, 75 mg/d, monotherapy (HR, 0.80 [95% CI, 0.67-0.96]), aspirin plus low-dose rivaroxaban, 2.5 mg twice daily (HR, 0.81 [95% CI, 0.72-0.92]), and aspirin plus ticagrelor, 60 to 90 mg twice daily (HR, 0.81 [95% CI, 0.69-0.96]). Aspirin plus rivaroxaban or ticagrelor showed a lower risk of major adverse limb events compared with aspirin alone. Rivaroxaban monotherapy, 5 mg twice daily, and aspirin plus rivaroxaban or clopidogrel were associated with a higher risk of major bleeding.

CONCLUSIONS: Clopidogrel plus cilostazol or clopidogrel monotherapy might be a balanced strategy in patients with peripheral artery disease.

BACKGROUND: Saddle pulmonary embolism (SPE) is defined as large emboli located at the bifurcation of the main pulmonary artery. The prevalence and optimal intervention for SPE remain unclear. Herein, we focus on contemporary epidemiology and reperfusion strategies for SPE with acute cor pulmonale (SPE-ACP).

METHODS: The National Inpatient Sample of the USA (2016-2022) was analyzed. Diagnoses and procedures were identified by International Classification of Diseases, Tenth Revision (ICD-10) codes. Therapies were classified as conventional therapy (CT), systemic fibrinolysis (SF), catheter-directed thrombolysis (CDTL), and catheter-directed mechanical thrombectomy (CDMT). Outcomes evaluated were bleeding, transfusion, discharge to home, and in-hospital mortality. Statistical analyses included chi-squared tests, Wilcoxon rank-sum tests, propensity score matching, and logistic regression.

RESULTS: SPE-ACP constituted 1.7% of all PEs (frequency-trend, 2016-2022, ptrend < 0.001); 49.2% of patients received CT. Among advanced reperfusion therapies (ARTs), SF was associated with higher risks of major bleeding and mortality (vs CDTL/CDMT, p < 0.05). CDTL was associated with lower transfusion risk (vs SF/CDMT, p < 0.01) and higher rates of discharge to home (vs SF, p = 0.009). Notably, CDMT showed increasing trends in utilization and discharge to home, and decreasing trends in transfusion and mortality (2016-2022, all ptrend < 0.05). Except for transfusion (p = 0.013), the outcomes became comparable between CDTL and CDMT (2020-2022, all p > 0.10). SPE-ACP with acute popliteal/femoral deep vein thrombosis (DVT) was associated with lower mortality risk (vs no femoropopliteal DVT, all p < 0.05).

CONCLUSION: SPE-ACP, an uncommon condition, showed a substantially increased prevalence over time. Among ARTs, favorable outcomes were observed with CDTL during 2016-2022; CDMT may be evolving into an alternative strategy given its relatively comparable outcomes during 2020 to 2022. SPE-ACP with concomitant acute femoral/popliteal DVT may be associated with lower mortality risk.

OBJECTIVE: Endovascular aortic operations entail significant radiation exposure to healthcare personnel and patients. Therefore, development and implementation of techniques to achieve radiation reduction remains a key objective. This paper presents considerations and consensus from a roundtable discussion between physicians with experience in endovascular aortic surgery and medical physicists regarding promising radiation reducing techniques.

METHODS: A focused literature review was first performed to identify potentially eligible techniques. Subsequently, the items identified were discussed and a final list was approved by consensus: radiation reduction protocols; simulation training; electromagnetic tracking (EMT), Fiber Optic RealShape (FORS), fusion imaging, and intravascular ultrasound. Three main domains were evaluated for each technique: current status of the technique, potential impact on radiation reduction, and feasibility of implementation.

RESULTS: The current status varies from the development to assessment phase, indicating that all techniques are already being used in clinical practice in some form. However, except for radiation reduction protocols, none has yet been widely adopted. All the studied techniques had a substantial (at least potential) impact on radiation reduction. Regarding feasibility and implementation, there is a wide variety among the techniques. Radiation reduction protocols are implemented in almost all hardware and therefore easy to implement, while FORS and EMT require substantial investment and specific hardware, which is not compatible with all vendors.

CONCLUSIONS: This multidisciplinary consensus document provides expert driven, evidence based considerations on the current status of six techniques that may play a pivotal role toward achieving the zero radiation goal for endovascular aortic surgery, while balancing their radiation reduction potential against barriers for widespread adoption. Further refinement will come through close multidisciplinary collaboration between surgeons and industry. Educating physicians regarding benefits and limitations of all available modalities will assist with planning better operative approaches, and increasing radiation safety.

BACKGROUND: Severe atherosclerotic internal carotid artery stenosis may progress to complete internal carotid artery occlusion (ICAO). Therefore, ICAO represents an advanced form of carotid artery disease. We sought to investigate the association between ICAO with atherosclerotic disease in other arterial beds and vascular risk factors and to identify the patient implications of the diagnosis of ICAO.

MATERIALS AND METHODS: Using the term "Internal carotid artery occlusion", a search of PubMed/MEDLINE, Scopus and Embase between 1980 and 2025 revealed 10,588 results. After exclusion of case reports, letters to the Editor and Editorials, 5,771 reports were identified. Following meticulous screening of the identified reports, 28 studies specifically addressing ICAO patient cohorts were included in the final analysis. A quantitative and qualitative synthesis analysis was performed. A questionnaire was subsequently developed and sent out to 63 participants from the United States (n=21) and several European countries (n=42), aiming to achieve consensus regarding the optimal management of patients with ICAO. Three participants did not respond. The Consensus Coordinator abstained from voting to avoid introducing bias, resulting in a final voting panel of 60 participants.

RESULTS: Across included studies, the proportion of patients with ICAO presenting with neurologic symptoms varied widely, ranging from 38-100%, while approximately 24-27% of patients were asymptomatic at the time of diagnosis. Consensus (≥75%) was achieved in 11 of the 17 (64.7%) pre-specified statements. Most participants agreed that atherosclerotic ICAO represents a systemic manifestation of advanced atherosclerosis rather than isolated cerebrovascular pathology (56/60; 93.3%). Duplex ultrasound should be used as the first-line diagnostic tool for suspected ICAO, with CTA or MRA confirmation if necessary (59/60; 98.3%). Optimal medical therapy (including antiplatelet, antihypertensives, statins, and glycemic control) remains the cornerstone of ICAO management (59/60; 98.3%). Lifestyle and metabolic risk factor optimization, smoking cessation, optimizing body weight, a healthy diet and exercise, should be strongly advised in all ICAO patients (60/60; 100%). Most participants concurred that ICAO revascularization should be centralized in specialized vascular-neuro centers equipped for intra-operative neuromonitoring and advanced hemodynamic control (57/60; 95.0%). Finally, most participants agreed that current evidence for ICAO intervention is insufficient and that a global registry should be created to record outcomes and guide future trials (56/60; 93.3%).

CONCLUSIONS: This international, multi-specialty consensus highlights ICAO as a marker of advanced, systemic atherosclerosis. Management should emphasize comprehensive evaluation for multisystem vascular disease and aggressive modification of cardiovascular risk factors. Best medical therapy remains the cornerstone of the management of patients with ICAO, with conservative or invasive interventions considered selectively based on symptom status, anatomic considerations, procedural risk, and institutional expertise, to reduce the overall cardiovascular disease burden.

BACKGROUND: Intravascular ultrasound (IVUS) may be beneficial for guiding endovascular revascularization in patients with chronic limb-threatening ischemia (CLTI); however, its use remains limited.

METHODS: We surveyed interventional radiologists, vascular surgeons, and interventional cardiologists in the United States, Canada, and the United Kingdom using a 13-question, anonymous online questionnaire to evaluate clinical equipoise, willingness to randomize, and opinions and perceptions regarding IVUS use in patients with CLTI undergoing endovascular revascularization.

RESULTS: A total of 105 operators (5.7% response rate) participated in the survey: 42 interventional radiologists, 40 vascular surgeons and 23 interventional cardiologists. Operators indicated the main obstacles to adopting or expanding IVUS for endovascular revascularization were cost or lack of reimbursement (69.5%), concerns about longer procedural time (47.6%), and the absence of randomized data supporting its benefit (39.0%). Overall, 80.0% of operators agreed that a large, multicenter, randomized trial was required, and 77.1% were willing to randomize patients in such a trial.

CONCLUSION: In this multidisciplinary survey, the identified barriers for IVUS use in CLTI revascularization were cost/non-reimbursement, increased procedural time, and lack of randomized evidence. Given respondents' clinical equipoise and willingness to randomize, large randomized controlled trials are needed to inform clinical practice.

It has long been accepted that observational analyses have an important role in evaluating use patterns and assessing the safety of different treatments, including cardiovascular devices, in clinical practice. With the proliferation of large electronic databases, there has been increasing interest in using observational analyses to also examine the comparative effectiveness of devices. However, these analyses are often met with skepticism because of concerns about whether they can generate credible evidence about causal effects. This is in part a result of the difficulty in meeting the assumptions necessary to interpret observational associations as causal effects and of the wide variability in analytic rigor. In this review, we outline frameworks and review methods for using observational analyses to answer questions about the effectiveness and safety of cardiovascular devices. We highlight the target trial framework as a practical tool for guiding observational comparative effectiveness analyses. We illustrate how the framework allows investigators planning and conducting observational analyses to organize their activities as responses to 3 prompting questions. First, what is the research question of the study (ie, "What do we want?")? Second, what are the resources-including background knowledge, research concepts, principles and methods, and available data-that can be brought to bear on the research question (ie, "What do we have?")? And third, what specific steps should be taken to use the available resources to answer the research question (ie, "What do we do?")? We focus our exposition on the evaluation of cardiovascular devices, for which randomized trial data are often limited and there is a strong need for real-world evidence. In this setting, real-world evidence is usually derived from observational comparisons of the treatment of interest with relevant comparator groups using data captured during routine care. A principled approach to the planning and conduct of observational analyses can improve the quality of real-world evidence generation and ensure that the results of observational studies on medical devices can support meaningful conclusions about the risks and benefits of new devices.