Publications

Pulmonary embolism (PE) remains a leading cause of cardiovascular morbidity and mortality, with right ventricular failure, from increased pulmonary vascular resistance due to thrombus obstruction and hypoxia-induced vasoconstriction, driving adverse outcomes in intermediate-high and high-risk presentations. Despite advances in imaging and therapeutic technology, guidance on escalation beyond anticoagulation is limited, and management strategies continue to vary widely across institutions. The Pulmonary Embolism Response Team model was developed to address these gaps through real-time multidisciplinary evaluation and individualized treatment decisions. This article summarizes the evolution of evidence and guideline recommendations shaping contemporary PE care.

BACKGROUND: Severe coronary calcification complicates percutaneous coronary intervention by limiting lesion compliance and impairing stent expansion.

OBJECTIVES: To evaluate the safety and effectiveness of the SonicForce Coronary Intravascular Lithotripsy System (Abbott Vascular) in severely calcified de novo coronary lesions.

METHODS: TECTONIC CAD intravascular lithotripsy investigational device exemption (NCT06885177) was a prospective, multicenter, single-arm study of 335 patients at 40 U.S.

CENTERS: The primary safety endpoint was 30-day target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. The primary effectiveness endpoint was procedural success. Each endpoint was tested against a prespecified performance goal. A prespecified optical coherence tomography (OCT) substudy evaluated calcium modification and stent expansion.

RESULTS: A total of 335 patients were included in the full analysis set, with 330 and 334 as the evaluable populations for the primary safety and primary effectiveness endpoints, respectively, and a median follow-up duration of 36 days (Q1-Q3: 28-37 days). Thirty-day target lesion failure was 0.3% (1 of 330; exact 2-sided 95% CI: 0.0%-1.7%); the upper 1-sided 97.5% confidence bound was 1.7%, below the 12.9% performance goal (P < 0.0001). Procedural success was 97.0% (324 of 334; exact 2-sided 95% CI: 94.6%-98.6%); the lower 1-sided 97.5% confidence bound was 94.6%, above the 87.1% performance goal (P < 0.0001). In the OCT substudy, mean calcium length was 22.2 ± 10.3 mm, and the maximum contiguous calcium site had a calcium arc of 247.3 ± 99.0° and a thickness of 0.90 ± 0.25 mm at baseline. At this site, final stent area was 7.1 ± 1.9 mm2, with stent expansion of 95.9% ± 18.6%. Calcium fracture was identified in 62.5% (50 of 80) of lesions after intravascular lithotripsy and 66.3% (53 of 80) after stenting.

CONCLUSIONS: TECTONIC CAD met both prespecified coprimary safety and effectiveness endpoints, demonstrating low 30-day target lesion failure and high procedural success. OCT demonstrated calcium fracture and favorable stent expansion at maximum contiguous calcium.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) provides bi-ventricular support for patients with myocardial infarction-related cardiogenic shock (MI-CS); comparative effectiveness data relative to other mechanical circulatory support remain limited. We characterize contemporary ECMO utilization for MI-CS and compare short-term mortality across ECMO and non-ECMO treatment strategies.

METHODS: We compared baseline characteristics and temporal trends in mechanical circulatory support utilization among Medicare beneficiaries hospitalized with MI-CS from 2016 to 2023 and treated with ECMO, Impella, intra-aortic balloon pump, or medical management alone. Patient outcomes for each group were evaluated using inverse probability of treatment weighting, G-formula approach, and grace period analysis. The primary endpoint was 30-day all-cause mortality.

RESULTS: The cohort included 102 718 patients: 1165 (1.1%) treated with ECMO, 10 064 (9.8%) Impella, 24 631 (24.0%) intra-aortic balloon pump, and 66 858 (65.1%) medical management alone. From 2016 to 2023, ECMO use for MI-CS increased from 0.8% to 1.8%. The percentage of hospitals using ECMO increased from 9.2% to 17.1%. Unadjusted 30-day mortality was higher for ECMO (69%) compared with Impella (60%), intra-aortic balloon pump (39%), and medical management (46%) (all P<0.0001). Adjusted inverse probability of treatment weighting and G-formula analyses revealed a 30-day mortality rate of 68%-70% for ECMO, which was higher than that for other therapies. The grace period analysis revealed similar mortality between patients treated with ECMO (54%) and Impella (54%).

CONCLUSIONS: ECMO use in a contemporary Medicare cohort of patients with MI-CS was infrequent (1.1%) and associated with high 30-day mortality. Despite use of complementary causal inference methods, we were unable to establish valid causal inferences on ECMO use and patient survival.

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.

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.

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.

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).