Dataset Information

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

ABSTRACT:

Background

Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain.

Methods

FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores (QoL) were assessed.

Results

In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204 ± 46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P < .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P < .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P < .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P < .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%.

Conclusions

In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.

SUBMITTER: Khandhar S

PROVIDER: S-EPMC11307656 | biostudies-literature | 2023 Jul-Aug

REPOSITORIES: biostudies-literature

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Publications

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

Khandhar Sameer S Jaber Wissam W Bunte Matthew C MC Cho Kenneth K Weinberg Mitchell D MD Mina Bushra B Stegman Brian B Pollak Jeffrey J Khosla Akhil A Elmasri Fakhir F Zlotnick David D Brancheau Daniel D Koenig Gerald G Bisharat Mohannad M Li Jun J Toma Catalin C

Journal of the Society for Cardiovascular Angiography & Interventions 20230519 4

<h4>Background</h4>Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain.<h4>Methods</h4>FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute w ...[more]

PMID: 39131661

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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: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.

Dataset Information

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

Background

Methods

Results

Conclusions

Publications

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

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