PEERLESS II: A Randomized Controlled Trial of Large-Bore Thrombectomy Versus Anticoagulation in Intermediate-Risk Pulmonary Embolism.

Background: Anticoagulation (AC) is the guideline-recommended treatment for intermediate-risk pulmonary embolism (PE); however, it remains unclear whether mechanical thrombectomy provides benefit over AC alone. The PEERLESS II study aims to evaluate outcomes in intermediate-risk PE patients randomized to treatment with large-bore mechanical thrombectomy and AC vs AC alone. Methods: PEERLESS II is an international randomized controlled trial enrolling up to 1200 patients with intermediate-risk PE and additional clinical risk factors from up to 100 sites. Treatment is randomized 1:1 to large-bore mechanical thrombectomy with the FlowTriever System (Inari Medical) and AC or AC alone. Outcomes will be evaluated for up to 3 months, with safety events independently adjudicated. The primary end point is a hierarchical composite win ratio of (1) all-cause mortality by 30 days, (2) clinical deterioration (earlier of discharge or 30 days), (3) all-cause hospital readmission by 30 days, (4) bailout therapy (earlier of discharge or 30 days), and (5) Modified Medical Research Council (mMRC) dyspnea score of ≥1 at the 48-hour visit. Secondary end points include all-cause and PE-related mortality (30-day and 90-day), all-cause and PE-related readmission (30-day and 90-day), major bleeding (30-day and 90-day), clinical deterioration (earlier of discharge or 30 days), bailout (earlier of discharge or 30 days), right ventricle-to-left ventricle diameter ratio (48-hour visit), mMRC dyspnea score (48-hour, 1-month, and 3-month visits), quality of life using Pulmonary Embolism Quality of Life and EuroQol-5 Dimensions-5 Levels (1-month and 3-month visits), 6-minute walk distance (1-month visit), and post-PE impairment diagnosis (3-month visit). Conclusions: PEERLESS II will inform the understanding of mechanical thrombectomy treatment for intermediate-risk PE and provide evidence for consideration in future treatment guidelines.

Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report the first interim analysis of the STRIKE-PE study, evaluating the safety and effectiveness of computer assisted vaccum thrombectomy (CAVT) for the treatment of acute pulmonary embolism (PE). MATERIALS AND METHODS: This prospective, international, multicenter study will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle (RV)-to-left ventricle (LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT using the Indigo Aspiration System (Penumbra, Alameda, California). Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and quality-of-life (QoL) assessments. RESULTS: The first 150 consecutive patients were treated with 12F catheter CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70.0 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four (2.7%) patients experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale score and QoL measures, and the New York Heart Association class distribution returned to that reported before the index PE. CONCLUSIONS: Interim results from the STRIKE-PE study demonstrate a significant reduction in pulmonary artery pressure and RV/LV ratio, a median thrombectomy time of 33.5 minutes, a composite MAE rate of 2.7%, and significant improvements in 90-day functional and QoL outcomes.

Surgical Pulmonary Embolectomy Outcomes for Acute Pulmonary Embolism.

BACKGROUND: Acute pulmonary embolism (PE) is associated with significant mortality. Surgical embolectomy is a viable treatment option; however, it remains controversial as a result of variable outcomes. This review investigates patient outcomes after surgical embolectomy for acute PE. METHODS: An electronic search was performed to identify articles reporting surgical embolectomy for treatment of PE. 32 studies were included comprising 936 patients. Demographic, perioperative, and outcome data were extracted and pooled for systematic review. RESULTS: Mean patient age was 56.3 years (95% confidence interval [CI], 52.5, 60.1), and 50% were male (95% CI, 46, 55); 82% had right ventricular dysfunction (95% CI, 62, 93), 80% (95% CI, 67, 89) had unstable hemodynamics, and 9% (95% CI, 5, 16) experienced cardiac arrest. Massive PE and submassive PE were present in 83% (95% CI, 43, 97)] and 13% (95% CI, 2, 56) of patients, respectively. Before embolectomy, 33% of patients (95% CI, 14, 60) underwent systemic thrombolysis, and 14% (95% CI, 8, 24) underwent catheter embolectomy. Preoperatively, 47% of patients were ventilated (95% CI, 26; 70), and 36% had percutaneous cardiopulmonary support (95% CI, 11, 71). Mean operative time and mean cardiopulmonary bypass time were 170 minutes (95% CI, 101, 239) and 56 minutes (95% CI, 42, 70), respectively. Intraoperative mortality was 4% (95% CI, 2, 8). Mean hospital and intensive care unit stay were 10 days (95% CI, 6, 14) and 2 days (95% CI, 1, 3), respectively. Mean postoperative systolic pulmonary artery pressure (sPAP) was significantly decreased from the preoperative period (sPAP 57.8, mm Hg; 95% CI, 53, 62.7) to the postoperative period (sPAP, 31.3 mm Hg; 24.9, 37.8); P < .01). In-hospital mortality was 16% (95% CI, 12, 21). Overall survival at 5 years was 73% (95% CI, 64, 81). CONCLUSIONS: Surgical embolectomy is an acceptable treatment option with favorable outcomes.

Outcomes of extracorporeal life support for the treatment of acute massive pulmonary embolism: A systematic review.

BACKGROUND: Massive pulmonary embolism (PE) can cause hemodynamic instability leading to high mortality. Extracorporeal life support (ECLS) has been increasingly used as a bridge to definitive therapy. This systematic review investigates the outcomes of ECLS for the treatment of massive PE. METHODS: Electronic search was performed to identify all relevant studies published on ECLS use in patients with PE. 50 case series or reports were selected comprising 128 patients with acute massive PE who required ECLS. Patient-level data were extracted for statistical analysis. RESULTS: Median patient age was 50 [36, 63] years and 41.3% (50/121) were male. 67.2% (86/128) of patients presented with cardiac arrest. Median heart rate was 126 [118, 135] and median systolic pulmonary artery pressure (sPAP) was 55 [48, 69] mmHg. The majority of ECLS included veno-arterial ECLS [97.1% (99/102)]. Median ECLS time was 3 [2, 6] days. 43.0% (55/128) patients received systemic thrombolysis, 22.7% (29/128), received catheter-guided thrombolysis, and 37.5% (48/128) underwent surgical embolectomy. 85.1% (97/114) were weaned off ECLS. Post-ECLS complications included bleeding in 23.4% (30/128), acute renal failure in 8.6% (11/128), dialysis in 6.3% (8/128), heparin-induced thrombocytopenia in 3.1 (4/128), and extremity hypoperfusion in 2.3% (3/128). The most common cause of death was shock at 30.3% (10/33). The median length of hospital stay was 22 [11, 39] days including 8 [5, 13] intensive care unit (ICU) days. The 30-day mortality rate was 22% (20/91). CONCLUSIONS: ECLS is safe and effective therapy in unstable patients with acute massive pulmonary embolism and offers acceptable outcomes.

First year experience of a pulmonary embolism response team with comparisons of outcomes between catheter directed therapy versus standard anticoagulation.

Objectives: The Pulmonary Embolism Response Team (PERT) model is now widely adopted in many institutions to provide multidisciplinary care for patients with acute pulmonary embolism (PE). However, descriptive experiences of PERT operations and studies on clinical outcomes remain limited.Methods: We performed a retrospective review of PERT activations at an academic tertiary care center, with secondary aims to study outcomes associated with performing catheter directed therapies (CDT).Results: The intermediate high-risk PE category was most frequent (n = 40, 76.9%) among the 52 total cases evaluated during the study period. There was one in-hospital mortality, associated with hospice admission for a non-PE diagnosis. Six patients (11.5%) experienced a bleeding complication of any severity. Anticoagulation (AC) alone was recommended in 30 patients (57.7%) and CDT was performed in 16 patients (30.8%). There were no significant differences in patient characteristics or disease severity between patients in the AC group versus the CDT group, except for a higher prevalence of malignancy in the AC group (p = 0.037). Patients who underwent CDT demonstrated a lower, albeit non-significant, median intensive care unit (ICU) length of stay (LOS) (3 vs. 4 days, p = 0.34) and hospital LOS (4 vs. 5 days, p = 0.25), as compared to patients receiving AC alone. Bleeding rates were similar between the two groups (6.7% vs. 6.3%, p = 1.0).Conclusions: Adoption of the PERT model at an academic tertiary care center was associated with acceptably low rates of mortality and bleeding, similar to other published studies. Performing CDT in select patients under PERT consultation may be associated with shorter ICU and hospital LOS; however, larger studies are needed to validate this finding.