Mechanical Thrombectomy and Catheter-Directed Lysis in Treating Intermediate-Risk Pulmonary Embolization: 30-Day Outcome

Abstract

Intermediate risk pulmonary embolism (IRPE) is defined as dilatation of the right ventricular (RV) and evidence of myocardial necrosis with stable hemodynamics in the setting of acute PE. The differences in performance among the various devices in treating IRPE remain unclear. We reviewed consecutive patients treated at 2 medical centers between January 1, 2019, and December 31, 2022, using PMC devices (FlowTriever [Inari Medical] or Ekos [Boston Scientific]). Demographics, clinical, procedural variables, in-hospital complications, and 30-day outcomes were recorded from patients' medical records. Descriptive analyses were performed. The study's primary endpoint was the mean change in the RV/LV ratio. Safety endpoints included procedural complications 30-day mortality and major bleeding. 97 consecutive patients (43 FlowTriever, 54 Ekos) were included. The mean age was 64.16 ± 13.37 years. When compared with pretreatment, PMC reduced significantly the RV/LV ratio (0.55 ± 0.49, 95% CI: 0.40, 0.71, p < 0.0001) and PA pressures (17.98 ± 14.72 mm Hg, 95% CI:10.88, 25.07, p < 0.0001) with no differences seen between the FlowTriever and Ekos. At 30-day, all-cause mortality and major bleeding were 5.2 and 7.2%, respectively, and were similar between the FlowTriever and Ekos, respectively (4.7% vs. 5.6% (p = 0.935) and 7.0% vs. 7.4% (p = 0.935)). The Ekos, however, had a shorter procedure time, and less fluoroscopy and contrast use. PMC devices reduced significantly the RV/LV ratio and PA pressures when compared with the baseline. No differences were seen between the FlowTriever and Ekos. Thirty-day mortality and major bleeding were statistically similar between the two devices.

Keywords

intermediate-risk pulmonary embolus - ultrasound-assisted lysis - mechanical thrombectomy - major bleeding

Note

The abstract of this work was presented at the CRT 2024 Conference in Washington DC as an Oral presentation with interim findings. The abstract was published in JACC: Cardiovascular Interventions, Volume 17, Issue 4, Supplement, February 26, 2024, Pages S38–S39. https://doi.org/10.1016/j.jcin.2024.01.167

Publication History

Article published online:
02 May 2025

• References

• 1 Meyer G, Vicaut E, Danays T. et al; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med 2014; 370 (15) 1402-1411
• 2 Nakamura S, Takano H, Kubota Y, Asai K, Shimizu W. Impact of the efficacy of thrombolytic therapy on the mortality of patients with acute submassive pulmonary embolism: a meta-analysis. J Thromb Haemost 2014; 12 (07) 1086-1095
• 3 Grifoni S, Olivotto I, Cecchini P. et al. Short-term clinical outcome of patients with acute pulmonary embolism, normal blood pressure, and echocardiographic right ventricular dysfunction. Circulation 2000; 101 (24) 2817-2822
• 4 Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Prognostic role of echocardiography among patients with acute pulmonary embolism and a systolic arterial pressure of 90 mm Hg or higher. Arch Intern Med 2005; 165 (15) 1777-1781
• 5 Pruszczyk P, Goliszek S, Lichodziejewska B. et al. Prognostic value of echocardiography in normotensive patients with acute pulmonary embolism. JACC Cardiovasc Imaging 2014; 7 (06) 553-560
• 6 Becattini C, Agnelli G, Vedovati MC. et al. Multidetector computed tomography for acute pulmonary embolism: diagnosis and risk stratification in a single test. Eur Heart J 2011; 32 (13) 1657-1663
• 7 Meinel FG, Nance Jr JW, Schoepf UJ. et al. Predictive value of computed tomography in acute pulmonary embolism: systematic review and meta-analysis. Am J Med 2015; 128 (07) 747-59.e2
• 8 Kucher N, Boekstegers P, Müller OJ. et al. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation 2014; 129 (04) 479-486
• 9 Piazza G, Hohlfelder B, Jaff MR. et al; SEATTLE II Investigators. A prospective, single-arm, multicenter trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute massive and submassive pulmonary embolism: the SEATTLE II study. JACC Cardiovasc Interv 2015; 8 (10) 1382-1392
• 10 Tapson VF, Sterling K, Jones N. et al. A randomized trial of the optimum duration of acoustic pulse thrombolysis procedure in acute intermediate-risk pulmonary embolism: the OPTALYSE PE trial. JACC Cardiovasc Interv 2018; 11 (14) 1401-1410
• 11 Tu T, Toma C, Tapson VF. et al; FLARE Investigators. A prospective, single-arm, multicenter trial of catheter-directed mechanical thrombectomy for intermediate-risk acute pulmonary embolism: the FLARE Study. JACC Cardiovasc Interv 2019; 12 (09) 859-869
• 12 Ortel TL, Neumann I, Ageno W. et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Adv 2020; 4 (19) 4693-4738
• 13 Monteleone P, Ahern R, Banerjee S. et al. Modern treatment of pulmonary embolism (USCDT vs MT): results from a real-world, big data analysis (REAL-PE). J Soc Cardiovasc Angiogr Interv 2023; 3 (01) 101192
• 14 Nguyen PC, Stevens H, Peter K, McFadyen JD. Submassive pulmonary embolism: current perspectives and future directions. J Clin Med 2021; 10 (15) 3383
• 15 Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli. Accessed February 3, 2025 at: https://www.fda.gov/medical-devices/medical-device-recalls/clot-removal-device-correction-inari-medical-updates-use-instructions-clottriever-xl-catheter-due?utm_medium=email&utm_source=govdelivery