Improved Right Ventricular/Left Ventricular Ratio and Functional Outcomes After Computer Assisted Vacuum Thrombectomy for Treatment of Acute Pulmonary Embolism: Analysis of the First 450 STRIKE-PE Patients

Tuesday, April 1, 2025

4:12 PM – 4:21 PM CT

Location: Music City Center, 205 BC

Presenting Author(s)

John Moriarty, MD, FSIR (he/him/his)

Professor
UCLA, United States

Author/Co-author(s)

Brian J. Schiro, MD

Vascular and Interventional Radiologist
Miami Cardiac & Vascular Institute / Radiology Associates of South Florida, United States
SD

Suhail Y. Dohad, MD, MBBS

Cardiology Specialist
Cedars-Sinai Medical Center, United States
HD

Hugh Davis, MD

Interventional Radiologist
University of Florida College of Medicine - Shands, United States
HT

Houman Tamaddon, MD

Vascular Surgeon and Endovascular Specialist
University Hospital, United States
AA

Aleksander Araszkiewicz, MD, PhD

Professor of Medicine
Poznan University of Medical Sciences, Poland
GK

Grzgorz Kopec, MD, PhD

Head of the Pulmonary Circulation Centre
agiellonian University Medical College at the St. John Paul II Hospital, Poland
JC

Juan J. Ciampi Dopazo, MD

Vascular and Interventional Radiologist
Hospital Universitario Virgen de las Nieves in Granada, Spain
Andrew Holden, FRANZCR

Associate Professor
Aukland District Health Board / Auckland Hospital, New Zealand
FW

Frances Mae West, MD, MS, FACP

Assistant Professor, Associate Program Director, Pulmonary & Critical Care Fellowship
Thomas Jefferson University, United States
WK

W. Brent Keeling, MD

Associate Professor
Emory University Hospital, United States
IW

Ido Weinberg, MD, MS

Head of Vascular Medicine
Hadassah Hebrew University Medical Center, Israel
AS

Andrew S. P. Sharp, MD, MBBS

Professor of Cardiology
University College Dublin, Ireland

Purpose: Change in the right ventricular/left ventricular (RV/LV) ratio is a commonly reported surrogate measure of the effect of treatment of acute pulmonary embolism (PE) on RV strain. Patients’ functional capacity after PE treatment can also provide insight into medium-term recovery. Reported here are periprocedural results and 90-day functional outcomes from the first 450 patients of the STRIKE-PE study.

Materials and Methods: STRIKE-PE is a prospective, international, multicenter study to enroll up to 1500 patients with acute PE symptoms of ≤14 days and an RV/LV ratio of ≥0.9 who are treated with computer assisted vacuum thrombectomy (CAVT; Penumbra Inc, Alameda, CA). The primary performance endpoint of STRIKE-PE is the change in RV/LV ratio from baseline to 48 hours postprocedure, and the primary safety endpoint is a composite of major adverse events at 48 hours postprocedure. Secondary endpoints of STRIKE-PE include additional safety measures, quality of life, and functional outcomes.

Results: Mean patient age was 61.7 ± 15.1 years, and 53.1% were male. Their PE classification of early mortality risk was high in 10.0% of the patients, intermediate-high in 83.6%, and intermediate-low in 6.4%.

Median thrombectomy time with CAVT was 30.0 minutes (IQR 21.0-43.5), and median procedure time was 62.0 minutes (IQR 48.0-81.0). Intraprocedural mean systolic pulmonary artery pressure significantly decreased from 51.4 ± 15.8 mm Hg before CAVT to 41.2 ± 15.3 mm Hg after CAVT (∆ 19.0% ± 19.2%, P < .001).

Between baseline and 48 hours, mean RV/LV ratio significantly decreased from 1.39 ± 0.37 to 0.98 ± 0.22 (∆ 27.0% ± 16.0%, P < .001). The rate of composite major adverse events within 48 hours was 1.6%. The rate of device-related serious adverse events was 0.4%. Within 30 days, the all-cause mortality rate was 1.1% and the recurrent PE rate was 0.7%.

The New York Heart Association (NYHA) class distribution at 90-day follow-up had returned to that of the pre-PE event (P = .328). The mean 6-minute walk test (6MWT) distance significantly improved from 230.0 ± 123.6 meters at discharge to 356.8 ± 129.0 meters at 90-day follow-up (∆ 126.8 ± 107.1 meters, P < .001).

Conclusion: In STRIKE-PE, results from CAVT in 450 patients demonstrate a safe, efficient, and effective procedure. At 90 days postprocedure, 6MWT distance had improved from that measured at the time of hospital discharge and NYHA functional class distribution had returned to that of the pre-PE event, suggesting good functional recovery.