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
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引用次数: 0
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.
期刊介绍:
Respiratory Research publishes high-quality clinical and basic research, review and commentary articles on all aspects of respiratory medicine and related diseases.
As the leading fully open access journal in the field, Respiratory Research provides an essential resource for pulmonologists, allergists, immunologists and other physicians, researchers, healthcare workers and medical students with worldwide dissemination of articles resulting in high visibility and generating international discussion.
Topics of specific interest include asthma, chronic obstructive pulmonary disease, cystic fibrosis, genetics, infectious diseases, interstitial lung diseases, lung development, lung tumors, occupational and environmental factors, pulmonary circulation, pulmonary pharmacology and therapeutics, respiratory immunology, respiratory physiology, and sleep-related respiratory problems.