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Observational Study
. 2025 Mar 5;26(1):87.
doi: 10.1186/s12931-025-03162-4.

Multicentre, real-world data of next-generation computer-assisted vacuum aspiration thrombectomy in acute pulmonary embolism

Sylwia Sławek-Szmyt  1 , Jakub Stępniewski  2   3 , Marcin Kurzyna  4 , Jacek Klaudel  5 , Wiktor Kuliczkowski  6 , Maciej Lewandowski  7 , Marek Grabka  8 , Marek Roik  9 , Rasa Ordiene  10 , Stanisław Jankiewicz  11 , Grzegorz Kopeć  2 , Szymon Darocha  4 , Ewa Mroczek  6 , Katarzyna Widecka  7 , Paweł Kurzyna  4 , Maciej Lesiak  11 , Piotr Pruszczyk  9 , Aleksander Araszkiewicz  11
Affiliations
Observational Study

Multicentre, real-world data of next-generation computer-assisted vacuum aspiration thrombectomy in acute pulmonary embolism

Sylwia Sławek-Szmyt et al. Respir Res. .

Abstract

Background: Data on interventional treatment of intermediate-high (and high-risk pulmonary embolism (PE) are limited. The authors sought to evaluate the safety and efficacy of catheter-directed mechanical aspiration thrombectomy (CDMT) in a real-world PE patient population.

Methods: This multicenter, prospective registry enrolled PE patients treated with CDMT using the Lightning 12 System. The primary safety endpoints included in-hospital all-cause mortality, procedure-related major bleeding, clinical deterioration, or bailout to another strategy. The primary efficacy outcomes included the reduction of pulmonary arterial pressures and change in the right-to-left ventricular (RV/LV) ratio 48 h after the CDMT. Multivariate regression analyzed characteristics associated with RV/LV improvement.

Results: Our analysis included 150 patients, 72% with intermediate-high PE and 28% with high-risk PE. Systemic thrombolysis was contraindicated in 33.3%, whereas in 4% it failed. There were 2% intraprocedural deaths (1.3% due to RV failure and 0.7% due to massive interstitial bleeding), with no more deaths during follow-up. In 0.7%, CDMT was converted to open surgery, and in 0.7%, bailout systemic thrombolysis and extracorporeal oxygenation support. Major bleedings occurred in 1.3% within 48 h post CDMT. Immediate hemodynamic improvements included a mean 11.3±10 mmHg (22.1%) drop in systolic pulmonary arterial pressure (p < 0.0001) and a median 0.33 (0.25-0.45), (25.2%) drop in RV/LV ratio (p < 0.0001 for paired values), CONCLUSIONS: Aspiration thrombectomy with the Lightning 12 system characterizes an acceptable safety profile, substantial improvements in hemodynamic outcomes, and low mortality for patients with intermediate-high and high-risk PE.

Trial registration: NCT04879069 - date of registration 04.05.2021.

Keywords: High-risk catheter-directed mechanical thrombectomy; Intermediate-high risk; Percutaneous thrombectomy; Pulmonary embolism.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by the bioethics committee of the coordinating center (Poznan University of Medical Sciences Bioethics Committee; approval number 271/2021). The study was also registered at ClinicalTrials.gov (NCT04879069). All patients signed informed consent. Consent for publication: The authors affirm that human research participants provided informed consent for the anonymized data publication. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Key hemodynamic outcomes. #Values are expressed as mean ± SD, or median [IQR]. CDMT: catheter-directed mechanical thrombectomy; CI: cardiac index; CO: cardiac output; mPAP: mean pulmonary artery pressure; mRAP: mean right atrial pressure; PAPI: pulmonary artery pulsatility index; PVR: pulmonary vascular resistance; sPAP: systolic pulmonary artery pressure; SVR: systemic vascular resistance
Fig. 2
Fig. 2
Multiple linear regression model of absolute reduction in RV/LV ratio. # Composite used CTPA or echo measurements, prioritizing CTPA if both were available. * statistically significant. FiO2: fraction of inspired oxygen; hs: high sensitive; NT-proBNP: N-terminal pro-brain natriuretic peptide; RV/LV right-to-left ventricle ratio; sPAP: systolic pulmonary artery pressure; TAPSE: tricuspid annular plane systolic excursion
See this image and copyright information in PMC

References

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