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Background: Pulmonary embolism is associated with a significant burden of morbidity, mortality, and health care costs. Catheter-directed thrombolysis has emerged as a promising option for patients with intermediate-risk pulmonary embolism which aims to improve outcomes over standard anticoagulation., Methods: We constructed a decision-analytic model comparing the cost-effectiveness of catheter-directed thrombolysis to anticoagulation alone for the management of intermediate-risk pulmonary embolism. Cost-effectiveness was determined by calculating deaths averted and incremental cost-effectiveness ratios (ICER). Uncertainty was addressed by plotting cost-effectiveness planes and acceptability curves for various willingness-to-pay thresholds. The main outcome was ICER (US dollars/deaths averted)., Results: In the base case analysis, derived using systemic lysis data, the cost associated with catheter-directed thrombolysis was estimated at $22,353 with a probability of survival at 1 month of 0.984. For the anticoagulation alone strategy, the cost was $25,060, and the probability of survival at 1 month was 0.958. Overall, catheter-directed thrombolysis resulted in savings of $104,089 per death averted (ICER,-$104,089 per death averted). Sensitivity analysis revealed that catheter-directed thrombolysis would no longer be cost-effective when its associated mortality is greater than 0.042. In the probabilistic analysis, at a willingness-to-pay of $100,000, catheter-directed thrombolysis had a 63% chance of being cost-effective, and in cost-effectiveness acceptability curves, it was cost-effective in 63%-78% of simulations for a willingness to pay ranging from $0 to $100,000., Conclusions: If the assumptions made in our model are shown to be accurate then CDT would be cost-effective and may lead to considerable cost savings if used where clinically appropriate., (© 2024 Wiley Periodicals LLC.)

Objectives: Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE)., Methods: This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization., Results: 458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups., Conclusions: In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics., (© 2022 Wiley Periodicals LLC.)

Objectives: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH., Background: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics., Methods: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function., Results: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up., Conclusions: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objective: Examine FlowTriever thrombectomy feasibility in high-risk PE patients., Background: The FlowTriever thrombectomy system (Inari Medical, Irvine, CA) can reduce right ventricle (RV) strain in acute submassive pulmonary embolism (PE) patients. This technology has not been studied in higher risk PE patients., Methods: This multicenter retrospective analysis included patients treated with FlowTriever between 2017 and 2019 if they met at least one of the following: vasopressor dependence, PE induced respiratory failure, or decreased cardiac index (CI) measured by right heart catheterization., Results: Analysis included 34 patients: 18 massive, four intubated, 12 normotensive but with CI < 1.8. Average age was 56 and their median simplified PE severity index was 2. Patients had high bleeding risk, with 13 having recent surgery, six posttrauma, and four recent strokes. Six patients received cardiopulmonary resuscitation, and two received additional mechanical circulatory support. All patients had RV dilatation and elevated biomarkers. Clot removal was successful in 32/34 patients. CI improved from 2.0 ± 0.1 L/min/m 2 before thrombectomy to 2.4 ± 0.1 L/min/m 2 after (p = .01). The mean pulmonary artery pressure decreased from 33.2 ± 1.6 mmHg to 25.0 ± 1.5 mmHg (p = .01). The two patients-both with no or minimal thrombus removed-deteriorated during the procedure: one died and the other was successfully stabilized on ECMO. There were no other major complications. All other patients were alive at the time of data collection (mean follow-up of 205 days)., Conclusion: Aspiration thrombectomy appears feasible in higher risk acute PE patients with immediate hemodynamic improvement and low in-hospital mortality., (© 2020 Wiley Periodicals LLC.)

Objectives: To investigate the invasive hemodynamics in patients with intermediate-risk pulmonary embolism (PE) and the change that occurs with catheter-directed thrombolysis (CDT)., Background: Intermediate-risk PE is associated with right ventricular strain and worse outcomes yet the invasive hemodynamics have not been well described., Methods: Ninety-two consecutive patients with intermediate-risk PE referred for CDT at two tertiary medical centers with Pulmonary Embolism Response Teams were included in this prospective cohort study. Hemodynamics at baseline and after CDT therapy was measured. Patients with cardiac index (CI) ≤1.8 L min -1 m -2 were compared to those without shock (CI > 1.8). Linear regression analysis was performed to study the relationship between clinical variables and low CI., Results: Thirty-seven out of 92 (40%) had a CI less than 1.8 L min -1 m -2 . When comparing the low CI to the normal CI groups, most demographics, vital signs, biomarkers, and PE severity index (PESI) scores were similar. The low CI group had more females and slightly lower systolic blood pressures although still in the normal range (122 vs. 132 mmHg, p = .026). Treatment with CDT was associated with significant improvement in CI, heart rate, and pulmonary artery pressures in both groups. Linear regression analysis did not reveal a strong correlation between CI and noninvasive metrics such as heart rate, blood pressure, or PESI score., Conclusions: Forty percent of patients with submassive PE had a depressed CI and treatment with CDT lead to hemodynamic improvements. Invasive hemodynamics may help better identify higher risk patients and guide therapy., (© 2019 Wiley Periodicals, Inc.)

Background: Acute coronary syndrome (ACS) complicated by shock is associated with high mortality despite the use of percutaneous support devices. Extracorporeal membrane oxygenation (ECMO) offers cardiopulmonary support but its safety and efficacy in the ACS setting is still under investigation., Methods: We reviewed the clinical characteristics and course of 18 consecutive patients who received femoral veno-arterial ECMO in the cardiac catheterization lab for severe shock due to ACS at our center between 2007 and 2013., Results: The average age was 59.9 years, 72.2% male. Of the 18 patients, 83% had a ST-segment elevation myocardial infarction, of which 55% had a left main or left anterior descending artery occlusion. Thirteen patients received stents, three were referred for coronary artery bypass grafting alone, and two received balloon angioplasty. All patients received aspirin, a thienopyridine (either clopidogrel or ticagrelor), and heparin. Five patients received a glycoprotein IIb/IIIa inhibitor during the catheterization. The average length of ECMO was 3.2 ± 2.5 days, length of stay was 23.4 days, and 67% survived to discharge. Seventeen of eighteen patients (94%) required at least one blood transfusion and use of blood products was significantly higher in the group receiving glycoprotein IIb/IIIa inhibitors [19 U of packed red blood cells (PRBC) vs. 8.2 U (P = 0.003)]., Conclusions: In patients with severe shock or refractory ventricular arrhythmias due to ACS, VA-ECMO likely offers an alternative form of biventricular support albeit with significant resource utilization and morbidity. A better understanding of how to manage patients with ACS requiring VA-ECMO support including the associated morbidities such as bleeding is necessary., (© 2015 Wiley Periodicals, Inc.)