Dataset Information

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

ABSTRACT:

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.

SUBMITTER: Toma C

PROVIDER: S-EPMC9542558 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

Toma Catalin C Bunte Matthew C MC Cho Kenneth H KH Jaber Wissam A WA Chambers Jeffrey J Stegman Brian B Gondi Sreedevi S Leung Daniel A DA Savin Michael M Khandhar Sameer S Kado Herman H Koenig Gerald G Weinberg Mitchell M Beasley Robert E RE Roberts Jon J Angel Wesley W Sarosi Michael G MG Qaqi Osama O Veerina Kalyan K Brown Michael A MA Pollak Jeffrey S JS

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20220203 4

<h4>Objectives</h4>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.<h4>Background</h4>High- and intermediate-risk PEs are characterized by high mortality rates, frequent readm ...[more]

PMID: 35114059

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Project description:BackgroundTo our knowledge we report the first case of percutaneous mechanical thrombectomy used for the treatment of massive pulmonary embolism in the United Kingdom. Pulmonary embolism is a common disease process but can be difficult to diagnose. Massive pulmonary embolism presenting with profound hypotension, however, is rare. Both phenomena carry with them significant mortality. Traditionally those patients suffering haemodynamic compromise from pulmonary embolism are treated with intravenous or catheter-directed thrombolysis. When this is contraindicated surgical embolectomy or mechanical techniques via a right heart catheter are alternative options. The former is well established but the latter is less commonly utilised in clinical practice. Our aim is to highlight the effectiveness and relative safety of percutaneous mechanical thrombectomy as a therapeutic tool in massive pulmonary embolism.Case presentationA 70 year-old gentleman presented with a 4-month history of dry cough and general malaise. Clinical examination along with routine chest radiograph confirmed a left pleural effusion which was drained. Computed tomography of the chest, abdomen and pelvis revealed a left renal mass consistent with renal cell carcinoma plus multiple metastatic subpleural nodules. Following planned thoracoscopy and pleural biopsy the patient became acutely dyspnoeic and hypotensive. Relevant investigations including computed tomography pulmonary angiogram confirmed a large saddle embolus extending in to the lobar branches of both left and right pulmonary arteries. There were several relative contraindications to thrombolysis and so the patient proceeded to have percutaneous mechanical thrombectomy with excellent results. The patient made a full recovery from the acute episode and was discharged home on warfarin with a view to planned cyto-reductive nephrectomy.ConclusionWe illustrate here that percutaneous mechanical thrombectomy can be a safe and effective method of treating massive pulmonary embolism when thrombolysis is relatively contraindicated. It may also be of use as an adjuvant therapy in those patients able to receive thrombolysis. In the future further evaluation involving a larger cohort of subjects is necessary to determine whether this treatment is superior to surgical embolectomy when thrombolysis cannot be performed.

Project description:ObjectiveThrombolytic therapy has been a mainstay of treatment for massive or submassive pulmonary embolism (PE), a common and highly morbid pathology. New percutaneous mechanical thrombectomy (PMT) devices have recently become widely available and have been used increasingly for the treatment of acute PE, but evidence demonstrating its efficacy over standard catheter-directed lytic protocol remains limited.MethodsUsing TriNetX Data Network, a global federated database of >250 million patients, we conducted a retrospective cohort study of patients from January 2017 to August 2023 with a diagnosis of PE, treated with either PMT or catheter-directed thrombolysis (CDT). Eligible patients were 1:1 propensity score-matched for preoperative covariates including demographics and comorbidities. We calculated and compared the 30-day outcomes of all-cause mortality, bleeding complications (blood transfusion, gastrointestinal bleed, and intracranial hemorrhage), diagnosis of acute respiratory failure (RF), myocardial infarction (MI), and pulmonary hypertension (PH) using odds ratios (OR) with 95% confidence intervals (CIs). Also, the 5-year outcomes of all-cause mortality, a composite outcome of chronic PH (chronic PE, chronic cor pulmonale, chronic thromboembolic PH), right heart failure (RHF), RF, and emergency department visits, were compared using hazard ratios (HRs) with 95% CIs.ResultsWe identified 2978 patients treated with PMT and 1137 patients treated with CDT. After matching, we compared 1102 patients in each cohort. For 30-day outcomes, all-cause mortality, acute RF, and blood transfusion were similar between the two groups. However, compared with CDT, PMT was associated with a better safety profile, including lower bleeding risk for both ICH (OR, 0.46; 95% CI, 0.24-0.890) and gastrointestinal bleed (OR, 0.42; 95% CI, 0.28-0.63). PMT also demonstrated better immediate functional outcomes, with less PH (OR, 0.53; 95% CI, 0.41-0.68) and MI (OR, 0.54; 95% CI, 0.41-0.76). At 5 years, the all-cause mortality and RF for both procedures were similar, but PMT was associated with lower rates of chronic PH (HR, 0.70; 95% CI, 0.55-0.90), RHF (HR 0.49; 95% CI, 0.37-0.65), and emergency department visits (348 for PMT vs 426 for CDT; P < .01).ConclusionsIn patients undergoing catheter-based therapy for PE, PMT has an improved procedural safety profile vs CDT and results in significantly fewer 30-day postoperative complications, with fewer bleeding events, and is also associated with fewer periprocedural MIs and less acute PH. Perhaps, more important, PMT also demonstrated improved long-term outcomes with significantly fewer chronic PH and RHF diagnoses with fewer emergency department visits.

Project description:BackgroundTraditionally, mechanical thrombectomy performed for pulmonary embolism (PE) necessitates the utilization of iodinated contrast. Intravascular ultrasound (IVUS) has been used as a diagnostic and therapeutic modality in the management of acute high and intermediate-risk PE. Recently, with the shortage of contrast supplies and the considerable incidence of contrast-induced acute kidney injury (CI-AKI), other safer and more feasible IVUS methods have become desirable. The purpose of this systematic review was to evaluate the importance of IVUS in patients with PE undergoing thrombectomy.MethodsMedline/PubMed, Embase, Scopus, and Google Scholar were searched for review studies, case reports, and case series. Clinical characteristics, outcomes and the usage of IVUS-guided mechanical thrombectomy during the treatment of acute high and intermediate-risk PE were examined in a descriptive analysis.ResultsIn this systematic review, we included one prospective study, two case series, and two case reports from July 2019 to May 2023. A total of 39 patients were evaluated; most were female (53.8%). The main presenting symptoms were dyspnea and chest pain (79.5%); three patients (7.9%) presented with syncope, one with shock and one with cardiac arrest. Biomarkers (troponin and BNP) were elevated in 94.6% of patients. Most patients (87.2%) had intermediate-risk PE, and 12.8% had high-risk PE. All patients presented with right-heart strain (RV/LV ratio ≥ 0.9, n = 39). Most patients (56.4%) had bilateral PE. Mechanical thrombectomy was performed using IVUS without contrast utilization in 39.4% of the patients. After the initial learning curve, contrast usage decreased gradually over time. There was a significant decrease in the composite mean arterial pressure immediately following IVUS-guided thrombectomy from 35.1 ± 7.2 to 25.2 ± 8.3 mmHg (p < 0.001). Post-procedure, there was no reported (0%) CI-AKI, no all-cause mortality, no major bleeding, or other adverse events. There was a significant improvement in symptoms and RV function at the mean follow-up.ConclusionsNew evidence suggests that IVUS-guided mechanical thrombectomy is safe, with visualization of the thrombus for optimal intervention, and reduces contrast exposure.

Dataset Information

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

Objectives

Background

Methods

Results

Conclusions

Publications

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

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