Publications by Year: 2026

2026

Watson NW, Dubosq-Lebaz M, Schneider PA, Brodmann M, Rundback JH, Secemsky EA. Drug-Eluting Resorbable Scaffolds for Infrapopliteal Peripheral Artery Disease: A State-of-the-Art Review.. The American journal of cardiology. 2026; PMID: 42815748

Drug-eluting resorbable scaffolds (DRS) have been developed to overcome the key limitations of conventional endovascular therapies for below-the-knee peripheral artery disease (PAD), including acute recoil, restenosis, and the sequela of long-term permanent metallic implants. DRS provides a temporary mechanical support and localized antiproliferative drug delivery after which the scaffold is gradually resorbed, ultimately restoring native vessel architecture to preserve future revascularization options. Over the past decade, numerous prospective and observational studies have evaluated both polymer- and magnesium alloy-based DRS platforms and have demonstrated favorable patency, wound healing, and limb salvage outcomes in patients with advanced infrapopliteal PAD. Most recently, randomized evidence from the LIFE-BTK trial has demonstrated superior patency and reduced rates of revascularization with DRS treated lesions as compared with plain balloon angioplasty. In this state-of-the-art review, we summarize the existing evidence evaluating DRS devices for below-the-knee PAD and present an updated systematic review and meta-analysis of clinical outcomes for DRS-based endovascular interventions.

Bikdeli B, Rashedi S, Pfeferman M, Amalan C, Leyva H, Krishnathasan D, Bukhari S, Shen BH, Secemsky EA, Zhai Z, Yamashita Y, Sawano M, Angchaisuksiri P, Jimenez D, Monreal M, Sadeghipour P, Zuin M, Bertoletti L, Ramacciotti E, Klok FA, Khan F, Gibbs H, Barco S, Noubiap JJ, Goldhaber SZ, Cohen AT, Lip GYH, Connors JM, Weitz JI, Moores LK, Kindzelski A, Mensah GA, Cushman M, Krumholz HM, Piazza G. Global burden of venous thromboembolism: incidence and outcome estimates of deep-vein thrombosis and pulmonary embolism.. Nature reviews. Cardiology. 2026; PMID: 42802155

Venous thromboembolism (VTE), including deep-vein thrombosis and pulmonary embolism, is the third most common cause of vascular death worldwide and a major contributor to costly and debilitating non-fatal complications. Despite the changing landscape of risk factors, preventive and diagnostic strategies, risk stratification and therapies, no contemporary global summary of the burden of VTE is available. In a collaborative, multinational effort, we provide a global overview of the incidence and outcomes of VTE. Reliable data were available for only a limited number of countries (predominantly in Northern America, Western Europe and Oceania), with notable regional differences. During 2012-2016, the global annual incidence of deep-vein thrombosis ranged from 25.1 to 131.5 per 100,000 of the population. The incidence of pulmonary embolism rose from 2012-2016 to 2017-2022 in Northern America and Asia but remained stable in Oceania. Among patients with pulmonary embolism, 30-day all-cause mortality ranged globally from 1.0% to 9.0%, and the 1-year cumulative incidence of recurrent VTE ranged from 2.9% to 8.1%. These findings reveal the substantial global burden of VTE, sources of heterogeneity and stark regional gaps in the data, demanding coordinated surveillance, standardized reporting and research into local and global drivers to curb worldwide morbidity and mortality.

Paraskevas KI, Conte MS, Spinelli F, Farber A, Blecha M, Malas MB, Dardik A, Perler BA, Scali S, Debus S, Zeller T, Abularrage CJ, Torsello GB, Chakfe N, White J V, VAN DEN Berg JC, Zeebregts CJ, Troisi N, de Ceniga MV, Stilo F, D’Oria M, Dermody M, Myrcka P, Noronen KM, Ricco JB, Zayed H, Bosiers MJ, Morgan RA, Migliara B, Hicks CW, Sultan SA, Secemsky EA, Mansilha A, Reijnen MM, Verhagen HJ, Gargiulo M, Faggioli G, Goudot G, Valenti D, Behrendt CA, Setacci C, Svetlikov A, Pecoraro F, Bisdas T, Schmidt A, Jawien A, Csobay-Novak C, Vermassen FE, Tulamo R, Szeberin Z, Gray BH, Giaquinta A, Fernandes JFE, Liapis CD, Alexandrescu VA, Lanza G, Dias N V, Sa DCE, Yeung KK, Musialek P, Cabral G, Blessing E, Menyhei G, Lind RC, AbuRahma A, Lyden SP, Schermerhorn ML, Veith FJ, Group TAVCW. A Trans-Atlantic, Expert-Based, Delphi Consensus Document on controversial issues in the management of patients with chronic limb-threatening ischemia.. International angiology : a journal of the International Union of Angiology. 2026;45(4):287–296. PMID: 42803200

BACKGROUND: Two recent multicenter randomized controlled trials (RCTs) compared best endovascular treatment versus surgical revascularization for patients with chronic limb-threatening ischemia (CLTI) and reached opposite conclusions. The aim of this international, expert-based Delphi Consensus document was to address these conflicting results and to explore their interpretation and applicability in the real-world clinical practice.

METHODS: A three-round Delphi Consensus document was completed by 51 European and 17 USA-based experts addressing five pre-specified CLTI clinical scenarios and two questions regarding the applicability of the two RCTs. All answers were provided anonymously. The response rate for each round was 100%. Consensus was reached when ≥70% of the participants agreed on a response showing preference for a specific approach.

RESULTS: Most participants (43/68; 63.3%) preferred a venous bypass for a patient with segmental occlusions of the lower limb arteries and an available distal target vessel, although this did not reach consensus. In contrast, consensus was achieved (49/68; 72.2%) for a diabetic patient with occlusion of all three infrapopliteal vessels for whom most experts favored angioplasty of any possible tibial artery. In case of previous endovascular recanalization failure, options were divided between repeat angioplasty (27 of 68; 39.7%) and venous bypass (35 of 68; 51.5%). The majority of participants reported that their approach had not changed following publication of the two RCTs (50 of 68; 73.5%) and did not believe that the trials had changed significantly the management of patients with CLTI in their clinical practice (53 of 68; 77.9%). In a subgroup analysis comparing European vs. USA-based physicians, there were minor differences in specific topics.

CONCLUSIONS: In the present Expert-based Consensus document, considerable heterogeneity was found between USA-based and European participants on several topics related to CLTI and consensus was not always achieved. Endovascular and open surgical techniques should be regarded as complementary strategies, rather than as competing alternatives. Treatment should be individualized based on individual patient anatomy, extent of ischemia, presence of tissue loss, foot infection and conduit availability.

Hiruma Y, Aikawa T, Kawamura I, Iwagami M, Kampaktsis P, Briasoulis A, Hassanabad AF, Hosseini K, Leone PP, Slipczuk L, Wiley J, Secemsky E, Laham R, Kuno T. Left Atrial Appendage Occlusion vs Direct Oral Anticoagulants for Atrial Fibrillation: Network Meta-Analyses.. JACC. Advances. 2026;5(10 Pt 2):103269. PMID: 42777587

BACKGROUND: Left atrial appendage occlusion (LAAO) is a treatment option to prevent thromboembolic events in patients with atrial fibrillation. However, it remains unclear whether LAAO offers superior efficacy and safety compared with oral anticoagulation for these patients.

OBJECTIVES: This study aimed to assess the efficacy and safety of LAAO vs direct oral anticoagulants (DOACs).

METHODS: We reviewed randomized controlled trials comparing oral anticoagulation and LAAO, using MEDLINE and CENTRAL. The primary outcome was a composite of stroke, systemic embolism, and cardiovascular death, whereas the safety outcome was major bleeding. Two network meta-analyses were conducted to assess LAAO vs DOAC, incorporating indirect comparisons: 1 comparing LAAO, DOACs, and vitamin K antagonist (3 arms), and the other comparing Watchman, Amulet, DOACs, and vitamin K antagonist (4 arms).

RESULTS: A total of 67,693 patients from 11 randomized controlled trials were included, of whom 5,735 underwent LAAO. In the three-arm network meta-analysis, LAAO and DOACs demonstrated statistically similar risks for both the primary efficacy outcome (HR: 1.02; 95% CI: 0.88-1.19; I2 = 0%) and the safety outcome (HR: 0.98; 95% CI: 0.78-1.23; I2 = 70.5%). In the 4-arm network meta-analysis, both Amulet and Watchman were associated with similar risks of the primary outcome, comparable to those of DOACs, as well as the risk of major bleeding.

CONCLUSIONS: LAAO devices did not demonstrate statistical superiority over DOACs in reducing thromboembolic events and major bleeding. Further trials are warranted to define patients for whom LAAO may offer the most significant benefit, such as those with high bleeding risk (CRD420251237886).

Watson NW, Bukhari S, Rashedi S, Pfeferman M, Ujueta F, Bacare B, Weber BN, Zarghami M, Kanthi Y, Secemsky EA, Connors JM, Barnes GD, Uljon S, Goldhaber SZ, Weitz JI, Costenbader KH, Krumholz HM, Piazza G, Cushman M, Anderson CD, Elkind MS V, Bikdeli B. Prevalence and Clinical Relevance of Antiphospholipid Antibodies in Ischemic Stroke: A Systematic Review and Meta-Analysis.. Stroke. 2026; PMID: 42663055

BACKGROUND: Antiphospholipid antibodies (aPL) are associated with an increased risk of thrombosis. However, individual studies have reported conflicting findings regarding the prevalence of aPL in patients with ischemic stroke and their association with first or recurrent events.

METHODS: Systematic searches of PubMed and Embase through May 13, 2025 were conducted to identify case-control, cohort, or cross-sectional studies investigating 3 questions related to aPL seropositivity (defined as positivity for either immunoglobulin G/immunoglobulin M anticardiolipin antibody, immunoglobulin G/immunoglobulin M anti-β2 glycoprotein I antibody, or a lupus anticoagulant): (1) the prevalence of aPL seropositivity among individuals with ischemic stroke; (2) the association between aPL seropositivity and the risk of first ischemic stroke; and (3) the association between aPL seropositivity and the risk of recurrent ischemic stroke. Random-effects models with inverse weighting were used to calculate pooled prevalences and odds ratios (OR) with 95% CIs. Risk of bias was assessed using the ROBINS-I tool.

RESULTS: A total of 52 studies were included (40 case-control, 12 cohort). The pooled prevalence of seropositivity for any aPL among patients with ischemic stroke (51 studies, 9438 patients) was 19.1% (95% CI, 15.4%-23.0%; I2=95.8%). aPL seropositivity was associated with higher odds of first ischemic stroke (43 studies, 19 097 patients; OR, 2.93 [95% CI, 2.31-3.73]; I2=68.7%). The strongest associations were for lupus anticoagulant (OR, 6.69 [95% CI, 2.94-15.2]; I2=92.6%) and immunoglobulin G anticardiolipin antibody (OR, 2.56 [95% CI, 1.96-3.35]; I2=92.5%). The odds of recurrent ischemic stroke among patients with versus without any aPL seropositivity were not significantly different (OR, 1.20 [95% CI, 0.87-1.67]; 9 studies, 2873 patients, I2=11.4%).

CONCLUSIONS: Seropositivity for any aPL was present in nearly 1-in-5 patients with ischemic stroke and was associated with increased odds of ischemic stroke at presentation.

Dioni P, Bertoglio L, D’Amico F, Secemsky EA, Hussain MA, Schermerhorn ML, Antonello M, Tshomba Y, Gennai S, Pratesi G, Farber M, Jongkind V, Tessarek J, Holden A, Delaney C, Mani K, Saricilar EC, Gallitto E, Khashram M, Tan GWL, Dias N V, Mees B, Milner R, Piazza M, Maldonado T, Oderich GS, Kölbel T, Tinelli G, Beck AW, Vasudevan T, Oberhuber A, Bonardelli S, Lepidi S, D’Oria M. The Role of Intravascular Ultrasound in Aortoiliac Endovascular Interventions: International Expert-Based Delphi Consensus.. Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2026;:15266028261479540. PMID: 42648739

INTRODUCTION: Intravascular ultrasound (IVUS) provides cross-sectional information on the intraluminal features of blood vessels, aiding procedural planning and postprocedural assessment of results. Although the use of IVUS in aortic procedures is increasing worldwide, consensus on best practices in aortoiliac interventions is still lacking. This study aims to obtain experts' consensus and define recommendations regarding applications of intravascular ultrasound in aortoiliac endovascular interventionsMethods:Delphi consensus methodology was performed over 3 rounds, using a panel of 27 experts. Each member was asked to grade (grade A-grade D) 26 statements regarding various applications of IVUS in aortoiliac surgery. Statements that passed the first round were proposed at the second round unmodified. Statements that failed the first round underwent stylistic modifications without altering their meaning and were proposed in the second and third rounds. Agreement and consistency were used to develop recommendations on the applications of IVUS in aortoiliac endovascular interventions.

RESULTS: After 3 rounds, 17 recommendations were made (16 grade B, 1 grade A), whereas 8 statements were rejected, and the core team eliminated 1. Ten recommendations (58.8%) obtained grade IV (poor), 1 (5.9%) grade III (fair), 2 (11.8%) grade II (high), and 4 (23.5%) were classified as grade I (very high).

CONCLUSIONS: Intravascular ultrasound is an important adjunct imaging technology in hybrid rooms. Most of the recommendations concerned the use of IVUS in aortic dissection. Other important recommendations for preoperative planning and evaluation of postoperative results were made in radioprotection, aortic aneurysms, and blunt thoracic aortic injury. Intravascular ultrasound assistance in aortoiliac occlusive disease is not routinely recommended at the present time.Clinical ImpactThis international expert-based Delphi consensus provides a comprehensive perspective on the current applications of intravascular ultrasound across various aspects of aortoiliac endovascular therapy. Clinical practice guidelines are currently lacking recommendations on the use of intravascular ultrasound (IVUS) as an adjunctive tool in aortoiliac endovascular surgery; therefore, this study aims to fill the current gap in the literature by assessing the role of IVUS across high-volume aortic centers and offering recommendations on possible IVUS applications in aortoiliac endovascular interventions. Areas of ongoing debate regarding IVUS are also highlighted in this article, to provide inputs for further research.