Dataset Information

Catheter-directed mechanical aspiration thrombectomy in a real-world pulmonary embolism population: a multicenter registry.

ABSTRACT:

Aims

High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR pulmonary embolism (PE) treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population.

Methods and results

This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed using the 8F Indigo (Penumbra, Alameda, CA, USA) system bilaterally in pulmonary arteries (PAs). The primary safety endpoints included device or PE-related death during the 48-h after CDMT, procedure-related major bleeding, or other major adverse events. Secondary safety outcomes were all-cause mortality during hospitalization or the follow-up. The primary efficacy outcomes were the reduction of PA pressures and change in the right-to-left ventricular (RV/L) ratio assessed in the imaging 24-48 h after the CDMT.71.8% of patients had IHR PE and 28.2% HR PE. 11.8% of patients had a failure and 34.5% had contraindications to thrombolysis, and 2.7% had polytrauma. There was 0.9% intraprocedural death related to RV failure and 5.5% deaths within the first 48 h. CDMT was complicated by major bleeding in 1.8%, pulmonary artery injury in 1.8%, and ischaemic stroke in 0.9%. Immediate haemodynamic improvements included a 10.4 ± 7.8 mmHg (19.7%) drop in systolic PAP (P < 0.0001), a 6.1 ± 4.2 mmHg (18.8%) drop in mean PAP, and 0.48 ± 0.4 (36%) drop in RV/LV ratio (P < 0.0001).

Conclusion

These observational findings suggest that CDMT may improve hemodynamics with an acceptable safety profile in patients with IHR and HR PE.

SUBMITTER: Slawek-Szmyt S

PROVIDER: S-EPMC10519874 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Catheter-directed mechanical aspiration thrombectomy in a real-world pulmonary embolism population: a multicenter registry.

Sławek-Szmyt Sylwia S Stępniewski Jakub J Kurzyna Marcin M Kuliczkowski Wiktor W Jankiewicz Stanisław S Kopeć Grzegorz G Darocha Szymon S Mroczek Ewa E Pietrasik Arkadiusz A Grygier Marek M Lesiak Maciej M Araszkiewicz Aleksander A

European heart journal. Acute cardiovascular care 20230901 9

<h4>Aims</h4>High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR pulmonary embolism (PE) treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population.<h4>Methods and results</h4>This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed usin ...[more]

PMID: 37319339

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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:BackgroundPrior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes.MethodsThe KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months.ResultsMean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively.ConclusionsIn a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT03426124.

Project description:BackgroundPoor myocardial reperfusion due to distal embolization and microvascular obstruction after percutaneous coronary intervention is associated with increased risk of morbidity and mortality. Prior trials have not shown a clear benefit of routine manual aspiration thrombectomy. Sustained mechanical aspiration may mitigate this risk and improve outcomes. The objective of this study is to evaluate sustained mechanical aspiration thrombectomy before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients.MethodsThis prospective study evaluated the Indigo CAT RX Aspiration System (Penumbra Inc, Alameda CA) for sustained mechanical aspiration thrombectomy before percutaneous coronary intervention at 25 hospitals across the USA. Adults presenting within 12 hours of symptom onset with high thrombus burden and target lesion(s) located in a native coronary artery were eligible. The primary end point was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure within 30 days. Secondary end points included Thrombolysis in Myocardial Infarction thrombus grade, Thrombolysis in Myocardial Infarction flow, myocardial blush grade, stroke, and device-related serious adverse events.ResultsFrom August 2019 through December 2020, a total of 400 patients were enrolled (mean age 60.4 years, 76.25% male). The primary composite end point rate was 3.60% (14/389 [95% CI, 2.0-6.0%]). Rate of stroke within 30 days was 0.77%. Final rates of Thrombolysis in Myocardial Infarction thrombus grade 0, Thrombolysis in Myocardial Infarction flow 3, and myocardial blush grade 3 were 99.50%, 97.50%, and 99.75%, respectively. No device-related serious adverse events occurred.ConclusionsSustained mechanical aspiration before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients was safe and was associated with high rates of thrombus removal, flow restoration, and normal myocardial perfusion on final angiography.

Dataset Information

Catheter-directed mechanical aspiration thrombectomy in a real-world pulmonary embolism population: a multicenter registry.

Aims

Methods and results

Conclusion

Publications

Catheter-directed mechanical aspiration thrombectomy in a real-world pulmonary embolism population: a multicenter registry.

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