Publications

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.

BACKGROUND: AGENT is the only coronary drug-coated balloon (DCB) approved for treatment of in-stent restenosis (ISR) to date. In this study, we describe trends in DCB use and compare characteristics and in-hospital outcomes between patients who received DCB versus alternative treatments.

METHODS: We included patients in the American College of Cardiology National Cardiovascular Disease Registry CathPCI Registry who underwent percutaneous coronary intervention between April 2024 and June 2025 and received DCB, drug-eluting stent (DES), or plain old balloon angioplasty. Treatment groups were compared using standard mean differences.

RESULTS: Between April 2024 and June 2025, 14 946 DCBs were used in 12 337 patients across 704 CathPCI Registry sites. The monthly rate of DCB use for ISR percutaneous coronary intervention grew from <1% to 17.5% during the study period. Of 96 452 ISR procedures performed overall, 9269 (9.61%) involved the use of DCB. DCB procedures were more likely to involve the use of specialty balloons (DCB 45.3% versus DES 17.5% versus plain old balloon angioplasty 28.3%), intravascular imaging (DCB 54.5% versus DES 35.1% versus plain old balloon angioplasty 30.9%), and atherectomy (DCB 14.9% versus DES 6.0% versus plain old balloon angioplasty 7.3%). Among patients treated with DCB, 0.4% experienced myocardial infarction, 0.7% developed cardiogenic shock, 0.2% had an ischemic stroke, and 0.9% died. DCB was separately used in 3459 of 810 483 (0.43%) non-ISR percutaneous coronary interventions. Unadjusted rates of in-hospital adverse outcomes after ISR and non-ISR DCB use were like those for DES (standard mean difference <10%).

CONCLUSIONS: Real-world DCB use is increasing rapidly in the United States, driven by use in ISR lesions but also with growth among non-ISR lesions.

OBJECTIVE: Acute limb ischemia (ALI) is a limb- and life-threatening vascular emergency that necessitates prompt revascularization. While both surgical and endovascular interventions are established treatment modalities, contemporary comparative data remain limited. The study aims to evaluate and compare outcomes between these revascularization strategies.

METHODS: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic review and meta-analysis were performed. Three databases were searched through January 2026. All studies comparing endovascular versus surgical treatment for ALI were identified. Outcomes of interest included periprocedural and mid-term mortality, major amputation, and reintervention rates. Mid-term outcomes were defined as events occurring at any point during the reported follow-up period. Risk ratios (RRs) or hazard ratios (HRs) with 95% confidence intervals (CIs) were extracted and analyzed using a random-effects model.

RESULTS: Twenty-four studies (5 randomized controlled trials, 2 prospective, and 17 retrospective observational studies) comprising 382 465 patients (endovascular: 172 308; surgical: 210 157) were analyzed. In these studies, there was no difference in periprocedural mortality between endovascular and surgical treatment (RR 0.84, 95% CI 0.62-1.14). Endovascular treatment was associated with lower mid-term mortality compared with surgical revascularization (HR 0.84, 95% CI 0.76-0.94). Major amputation showed a similar trend, with comparable periprocedural risk (RR 0.93, 95% CI 0.51-1.71) and reduced mid-term risk with endovascular therapy (HR 0.84, 95% CI 0.77-0.91). Periprocedural reintervention rates were significantly higher in the endovascular group (RR 1.94, 95% CI 1.80-2.08), while mid-term reintervention rates were comparable (HR 1.79, 95% CI 0.79-4.06).

CONCLUSION: In this contemporary meta-analysis of patients treated for ALI, endovascular revascularization was associated with lower mid-term mortality and major amputation rates, whereas surgical intervention was linked to a lower risk of periprocedural reintervention. These findings underscore the importance of a multidisciplinary approach involving a dedicated vascular team to ensure optimal, patient-tailored management.

CLINICAL TRIAL REGISTRATION: Prospective Register of Systematic Reviews, ID=1042195.Clinical ImpactAcute limb ischemia (ALI) carries high morbidity and mortality, yet comparative data on endovascular versus surgical revascularization are limited. In this meta-analysis of 24 studies including 382 465 patients, periprocedural mortality was similar between approaches, but endovascular therapy reduced mid-term mortality and major amputation risk, despite higher periprocedural reintervention rates. These findings suggest that endovascular-first strategies may be a safe and effective alternative to surgical revascularization. Optimal care requires a multidisciplinary vascular team to tailor interventions, balancing immediate procedural risks with long-term outcomes for each patient.

Individuals with lower extremity peripheral artery disease (LE PAD) represent a subset of patients with atherosclerotic cardiovascular disease that are among the highest risk for major adverse cardiovascular and limb events. Despite this, LE PAD is frequently under diagnosed, and an individual patient's risk for cardiovascular morbidity and limb loss is often underestimated and undertreated. To change the course of PAD disease progression, aggressive secondary prevention therapies are required. This is of particular importance among individuals undergoing surgical or endovascular lower extremity revascularization (LER), who represent the PAD subgroup with the highest risk of cardiovascular and limb adverse events. The cornerstone of secondary prevention is centered on symptom control, lifestyle and behavioural interventions that include exercise therapy, smoking cessation, healthy nutrition and weight management. Individuals with high-risk concomitant comorbidities, such as ongoing smoking, diabetes, and chronic kidney disease, represent an even higher risk population that warrant stringent monitoring and may benefit the most from pharmacological therapies. Guideline-recommended pharmacological therapies include antiplatelet and anticoagulant medications, lipid lowering therapies, diabetes medications, and cilostazol. Despite guideline recommendations, these medical therapies remain under-utilized in patients with PAD. Based on the elevated risk profile of individuals with LE PAD undergoing LER, increased efforts are required to initiate and escalate secondary prevention therapies. To achieve this, the development of effective, patient-centred and scalable implementation strategies remains a priority.

PURPOSE OF REVIEW: Renal denervation has emerged as a new therapeutic option for blood pressure (BP) control and is now incorporated into contemporary hypertension guidelines. Here, we review the evolution of evidence for renal denervation, approaches to assessing treatment response, and emerging technological developments.

RECENT FINDINGS: Early non-sham-controlled trials of renal denervation showed substantial reductions in BP, whereas the first sham-controlled trial, SYMPLICITY HTN-3, yielded neutral findings. To address its limitations, subsequent trials incorporated key design modifications - including strict restriction of changes in background antihypertensive medications, procedural standardization, and separate conduct of trials in "on-medication" and "off-medication" cohorts - and have since consistently demonstrated the efficacy of renal denervation. In these studies, efficacy was assessed primarily by reductions in systolic BP, with additional measures including reductions in diastolic BP and antihypertensive medication burden. Alternative ablative mechanisms (e.g., alcohol-mediated neurolysis) are currently under investigation, along with multi-organ denervation approaches aimed at augmenting BP reduction while providing additional metabolic benefits.

SUMMARY: Evidence supporting renal denervation has continued to accumulate, demonstrating consistent BP reductions. The field is evolving, with new approaches using alternative ablative mechanisms or targeting multi-organ sympathetic pathways on the horizon.

OBJECTIVE: Studies have reported conflicting data regarding the prognostic significance of concomitant deep vein thrombosis (DVT) in acute pulmonary embolism (PE). Understanding the potential differences between PE with and without DVT is crucial for optimizing strategies.

METHODS: Using data from The PERT Consortium Registry, this study examined the association between concomitant DVT and clinical outcomes in patients with predominantly acute intermediate and high-risk PE. A secondary aim was to assess the impact of DVT on treatment selection, particularly the use of advanced therapies.

RESULTS: Among 7,346 patients with acute PE, 5,076 (69%) had concomitant DVT. Patients with DVT were more frequently classified as intermediate-risk compared to patients without DVT, including intermediate-high (59.31% vs 51.9%, <0.001) and intermediate-low risk PE (19.4% vs. 17.7%, <0.001). The presence of DVT was significantly associated with higher odds of receiving advanced therapies (OR 2.49, 95% CI 2.14-2.81), particularly catheter-directed therapy (CDT) (OR 2.44, 95% CI 2.12-2.83), with the strongest association observed in the intermediate-high-risk group (OR 2.67, 95% CI 2.25-3.18). Concomitant proximal DVT was not associated with increased in-hospital mortality (OR 0.87, 95% CI 0.69-1.09), 30-day mortality (OR 0.96, 95% CI 0.77-1.20), 1-year mortality (OR 0.87, 95% CI 0.73-1.03), or ICU admission (OR 1.05, 95% CI 0.93-1.20), after adjustment for advanced therapy use.

CONCLUSIONS: In this large contemporary cohort of predominantly intermediate- and high-risk PE, concomitant DVT was common and associated with more severe presentation and greater use of advanced therapies, but not with higher short- or long-term mortality.