Catheter-directed mechanical aspiration thrombectomy in a real-world pulmonary embolism population: a multicenter registry

Abstract

Background High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR PE treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population. Methods This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed using the 8F Indigo (Penumbra, Alameda, US) system bilaterally in pulmonary arteries (PAs). The primary safety endpoints included device or PE-related death during the 48-hour after CDMT, procedure-related major bleeding, or other major adverse events. Secondary safety outcomes were all-cause mortality during hospitalization or the follow-up. The primary efficacy outcomes were the reduction of PA pressures and change in the RV-to-left ventricular (RV/L) ratio assessed in the imaging 24-48 hours after the CDMT. Results 71.8% of patients had IHR PE and 28.2% HR PE. 11.8% of patients had a failure and 34.5% had contraindications to thrombolysis, and 2.7% had polytrauma. There was 0.9% intraprocedural death related to RV failure and 5.5% deaths within the first 48 hours. CDMT was complicated by major bleeding in 1.8, pulmonary artery injury in 1.8%, and ischemic stroke in 0.9%. Immediate hemodynamic improvements included a 10.4 ± 7.8 mmHg (19.7%) drop in systolic PAP (p < 0.0001), a 6.1 ± 4.2 mmHg (18.8%) drop in mean PAP, and 0.48 ± 0.4 (36%) drop in RV/LV ratio (p < 0.0001). Conclusions These observational findings suggest that CDMT may improve hemodynamics with an acceptable safety profile in patients with IHR and HR PE.

Outcomes With Hybrid Catheter-Directed Therapy Compared With Aspiration Thrombectomy for Patients With Intermediate-High Risk Pulmonary Embolism

“…No patients required a blood transfusion due to aspiration. These results are in line with other reports with the use of Penumbra 8F catheter with estimated overall blood loss < 400 ml [20,30]. Similar results were obtained when comparing large-bore CDMT with CDL [37].…”

“…In the EXTRACT-PE trial, the 30-day mortality was 2.5% [20]. Advanced oncological disease is reported to be the most common cause of death in the posthospital period [30][31][32]. A recent study indicated three times higher mortality during 12 months after PE diagnosis as compared to non-oncological patients [33].…”

Endovascular treatments of acute pulmonary embolism in the post-fibrinolytic era: an up-to-date review

“…The wide diameter of thrombectomy devices allow to effectively extract large organized and adherent emboli through aspiration. Clinical single-arm studies completed on these devices have shown a lower major bleeding incidence and mortality, significant reduction of RV dysfunction and PA pressure and lower mean stay in intensive care units, strengthening their role in determined clinical scenarios and creating opportunities for RCT's [27][28][29][30][31][32][33][34]. This review will discuss the most studied products available.…”

Lightning 12 — an intelligent computer-assisted vacuum aspiration thrombectomy system in the treatment of pulmonary embolism: An initial experience

“…Recently, a new Lightning 12, intelligent computer-assisted vacuum aspiration system (Penumbra, Alameda, CA, US) has been introduced, which is thought to more efficiently regulate aspiration, and reduce blood loss in comparison to the previous generation device (Indigo CAT8) [4][5][6]. This study aims to evaluate the outcomes of the Lightning 12 aspiration system.…”

“…Moreover, the 12F catheter's flexibility advantageously improves maneuvers within tortuous vessels and enlarged right heart ventricles. A larger diameter, improved catheter design, and an intelligent control unit allow for the more adequate removal of thrombi from both pulmonary arteries without increasing periprocedural blood loss compared to the previous generation of the device (Indigo CAT8 device) [5,[9][10][11]. Using larger-bore catheters and sheaths seems feasible and effective.…”