AIMS:

Contemporary catheter-directed mechanical thrombectomy (CDMT) plays an emerging role in the treatment of intermediate-high (IHR) and high-risk (HR) pulmonary embolism (PE). Recently, a new Lightning 12, intelligent computer-assisted vacuum aspiration system (Penumbra, Alameda, CA, USA) has been introduced, which is thought to more efficiently regulate aspiration, and reduce blood loss in comparison to the previous generation device (Indigo CAT8). This study aims to evaluate the outcomes of the Lightning 12 aspiration system in real-life setting.  

METHODS AND RESULTS:

In this prospective, single-arm observational study, all consecutive patients aged >18 years who were admitted due to IHR or HR PE and undergoing CDMT with Lightning 12 system were included. 30 patients, 11 women (37.9%) and 29 men (62.1%) with a mean age of 60 (16) years participated in the study. 8 patients (27.6%) were categorized as HR PE and 22 (72.4%) as IHR PE. Demographic, clinical, laboratory, and imaging studies (echocardiography and computed tomography angiography) data during hospitalization and 30-day follow-up were analyzed. The primary endpoints included left ventricular/righ ventricular diameter (LV/RV) ratio decrease 48h after the procedure, device or PE-related death during 48 hours after CDMT, procedure-related major bleeding (BARC type 3a or greater), or other procedure-related major adverse events. Heart rate and respiratory rate significantly decreased and arterial pO2 increased notably (110.1±22.1 bpm to 83.1±5.2; p=0.0004 and 27.8±7.0 rpm to 15.6±1.4; p=0.0006). Systolic pulmonary artery pressure decreased from 52.4±13.6 mmHg to 40.0±12 mmHg (p<0.0001), and mean pulmonary pressure dropped from 30.5±6.9mmHg to 22.9±5.7mmHg (p<0.0001). Of note, the cardiac index increased from 2.4±0.6 to 3.1±0.9 l/min/m2 (p=0.01). Right ventricular to left ventricular (RV/LV) ratio decreased from 1.36±0.17 to 0.98±0.16 (p<0.0001) and tricuspid annular plane systolic motion (TAPSE) increased from 14.8±3.2 to 20.2±6.4mm (p<0.0001). NT-pro BNP (4892±6296.7 to 2768.1±3736.4 pg/ml; p=0.001), troponin I, and lactate (2.7±1.4 mmol/l to 1.6±0.6; p=0.018) concentrations also significantly reduced quickly after the procedure. We observed no major bleeding requiring a blood transfusion. The mean procedure-related blood loss was 337 (±128.7) ml. We observed only one hemorrhagic stroke in a patient with a previous ischemic stroke. There was one death during the procedure due to disseminated intravascular coagulation in a patient with persistent obstructive shock and failed ST. We observed no deaths during 30-day follow-up. No other major adverse events, including cardiac tamponade, pulmonary artery injury, sustained ventricular arrhythmias or cardiac arrest, were noted.

CONCLUSION:

The use of computer-assisted vacuum thrombectomy with Lightning 12 device appears to be a reasonable option in the treatment of intermediate- and high-risk PE patients due to fast reducing right ventricular strain and improving clinical and functional outcomes and at the same time the treatment is safe and effectively reduce the blood loss despite using of the larger-bore catheter.