Late Breaking

Safety and Efficacy of the Indigo Aspiration System in Patients with Acute Pulmonary Embolism: Results from a Prospective, Single-Arm, Multicenter IDE Study (EXTRACT-PE)

Presented During:

Sat, 6/13/2020: 12:41 PM  - 12:50 PM 
Webinar  
Room: Webinar  

Final ID:

LB03 

Authors:

A Sista1, J Horowitz2, V Tapson3, J Benenati4

Institutions:

1NYU School of Medicine, New York, NY, 2NYU Langone Health, Brooklyn, NY, 3Cedars Sinai, Los Angeles, CA, 4Maimi Cardiac and Vascular Institute, Miami, FL

First Author:

Akhilesh K. Sista, MD, FSIR  
NYU School of Medicine
New York, NY

Co-Author(s):

James Horowitz, MD  
NYU Langone Health
Brooklyn, NY
Victor Tapson, MD  
Cedars Sinai
Los Angeles, CA
James F. Benenati, MD, FSIR  
Maimi Cardiac and Vascular Institute
Miami, FL

Presenting Author:

Akhilesh K. Sista, MD, FSIR  
NYU School of Medicine
New York, NY

Purpose:

To evaluate the safety and efficacy of aspiration thrombectomy with the Indigo® Aspiration System (Penumbra, Inc., Alameda CA) in patients with acute pulmonary embolism (PE).

Materials:

EXTRACT-PE was a prospective, single-arm, multicenter IDE trial that enrolled patients with symptomatic acute PE ≤14 days duration diagnosed by computed tomography angiography (CTA). Patients were included if they had a systolic BP ≥90 mmHg, a right ventricular (RV)/left ventricular (LV) ratio >0.9, and if they were ≥18 years of age. The primary efficacy endpoint was reduction in RV/LV ratio from baseline to 48 hours, assessed by CTA. The primary safety endpoint was the rate of major adverse events, a composite of device-related death, major bleeding, and device-related SAEs (clinical deterioration, pulmonary vascular injury, and cardiac injury) within 48 hours.

Results:

119 patients (mean age of 59.8±15.0 years) were enrolled at 22 US sites from Nov 2017 to Mar 2019. Median time from device insertion to removal was 37.0 min (IQR 23.5-60.0). Two patients (1.7%) received intraprocedural thrombolytics. Median hospital ICU stay was 1.0 day (IQR 1.0-2.0). Mean reduction in systolic pulmonary artery pressures from pre- to post-Indigo and pre- to post-procedure were 4.3 mm Hg (95% CI 2.6-5.9; p<0.0001) and 4.7 mm Hg (95% CI 3.0-6.4; p<0.0001), respectively.
Mean RV/LV ratio reduction at 48 hours was 0.43 (95% CI 0.38-0.47; p<0.0001) corresponding to a 27.3% reduction. The rate of major adverse events was 1.7% (2 patients experienced 3 events). Secondary safety endpoints included rates of cardiac injury (0%), pulmonary vascular injury (1.7%), clinical deterioration (1.7%), major bleeding (1.7%), and device-related death (0.8%) within 48 hours. Rates of any-cause mortality, device-related SAEs, and symptomatic PE recurrence within 30 days were 2.5%, 1.7%, and 0%, respectively.

Conclusions:

Aspiration thrombectomy with the Indigo Aspiration System rapidly reduced intra-procedure pulmonary artery pressure, was associated with a significant reduction in the RV/LV ratio at 48 hours, and met its pre-specified safety endpoint. These results were achieved without the use of intraprocedural thrombolytics in 98.3% of patients.

Abstract Categories:

Venous Interventions: Thrombolysis/Thrombectomy

Keywords:

Aspiration Thrombectomy
Pulmonary embolism