Sameh Sayfo

BACKGROUND: Recent observational studies have suggested that early treatment (P =0.071). Mean pulmonary artery pressure decreased significantly more in patients receiving early thrombectomy (8.6±5.2 versus 5.8±5.0 mm Hg; P =0.006). The major adverse events rate was similar ( P =0.431) between groups, and there were no mortalities. The differences in efficacy outcomes were greatest in higher-risk patients per the Composite Pulmonary Embolism Shock score. CONCLUSIONS: Early mechanical thrombectomy was associated with larger reductions in right ventricle–to–left ventricle ratio and mean pulmonary artery pressure, with no significant differences in safety event rates compared with patients who underwent late thrombectomy. Randomized trials are needed to test these associations. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT06062329.

BACKGROUND: Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration–approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism. METHODS: Patients with intermediate-risk pulmonary embolism (systolic blood pressure ≥90 mm Hg; right ventricle-to-left ventricle ratio >0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academic independent safety board. The primary efficacy end point was the core laboratory–assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. Prespecified performance goals were set for both. Exploratory end points included immediate postprocedure change in mean pulmonary artery pressure and change in modified Miller index at 48 hours. Safety was assessed in the intention-to-treat cohort and efficacy in the modified intention-to-treat cohort, excluding patients receiving nonstudy device treatments. RESULTS: Between December 2023 and May 2025, 109 patients were treated at 17 US centers (intention-to-treat), with 106 in the modified intention-to-treat cohort. The major adverse events rate was 0.9% (1/109), with an upper 97.5% CI of 5.7%, meeting the P 0.20 performance goal ( P P <0.001. CONCLUSIONS: These data support the safety and effectiveness of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT06062329.

The heart team approach is now the standard of care for patients with complex coronary artery disease; however, the definition of a heart team is variable. We embarked on a project to create an extended, multidisciplinary heart team to evaluate patients we deemed high risk for coronary revascularization. In doing so, we created a new service, workflow, and paradigm. Herein, we describe the process through which we created our high-risk percutaneous coronary intervention team, our criteria for determining risk, our process for evaluating these patients, and quality assurance. Additionally, we describe the design of our prospective study assessing 200 patients with complex coronary artery disease. The primary outcomes include the final heart team revascularization decision, all-cause mortality, major adverse cardiac events, acute kidney injury, postintervention bleeding, and length of stay. Establishing a multidisciplinary heart team may help with complex and high-risk patient and family scenarios and potentially improve patient outcomes. A study has been initiated to test this hypothesis formally.