Background <p>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.</p> Methods <p>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&#xa0;h after the CDMT. Multivariate regression analyzed characteristics associated with RV/LV improvement.</p> Results <p>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&#xa0;h post CDMT. Immediate hemodynamic improvements included a mean 11.3±10 mmHg (22.1%) drop in systolic pulmonary arterial pressure (<i>p</i> &lt; 0.0001) and a median 0.33 (0.25–0.45), (25.2%) drop in RV/LV ratio (<i>p</i> &lt; 0.0001 for paired values),</p> Conclusions <p>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.</p> Trial registration <p> NCT04879069 – date of registration 04.05.2021.</p>

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

  • Sylwia Sławek-Szmyt,
  • Jakub Stępniewski,
  • Marcin Kurzyna,
  • Jacek Klaudel,
  • Wiktor Kuliczkowski,
  • Maciej Lewandowski,
  • Marek Grabka,
  • Marek Roik,
  • Rasa Ordiene,
  • Stanisław Jankiewicz,
  • Grzegorz Kopeć,
  • Szymon Darocha,
  • Ewa Mroczek,
  • Katarzyna Widecka,
  • Paweł Kurzyna,
  • Maciej Lesiak,
  • Piotr Pruszczyk,
  • Aleksander Araszkiewicz

摘要

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.