Computer Assisted Vacuum Thrombectomy With 16F Lightning Flash for Acute Pulmonary Embolism Patients: STRIKE-PE Analysis of 164 Patients

Sunday, March 30, 2025

3:18 PM – 3:27 PM CT

Location: Music City Center, 201 AB

Presenting Author(s)

Brian J. Schiro, MD

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

Author/Co-author(s)

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

Professor
UCLA, 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
GC

George S. Chrysant, MD

Chairman, Department of Cardiology
INTEGRIS Baptist Medical Center / INTEGRIS Cardiovascular Physicians, United States
PM

Patrick Muck, MD

Chief of Vascular Surgery & Program Director Vascular Fellowship & Integrated Residency
TriHealth – Good Samaritan Hospital, United States
SS

Sanjum S. Sethi, MD, MPH

Assistant Professor of Medicine, Interventional Cardiology
Columbia University Medical Center, United States
Matthew Scheidt, MD

Faculty
Medical College Wisconsin, United States
PP

Paul E. Perkowski, MD, RPVI

Associate Professor of Surgery
LSUHS - Shreveport, United States
Vivian Bishay, MD

Associate Professor
Icahn School of Medicine at Mount Sinai Hospital, United States
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
Andrew Holden, FRANZCR

Associate Professor
Aukland District Health Board / Auckland Hospital, New Zealand
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: Endovascular therapies for treating pulmonary embolism (PE) are evolving and now include computer assisted vacuum thrombectomy (CAVT). This analysis of the STRIKE-PE study reports periprocedural and functional results of the first 164 acute PE patients enrolled in the study and treated with CAVT using the 16F Lightning Flash system (Penumbra Inc, Alameda, CA).

Materials and Methods: STRIKE-PE is a prospective, international, multicenter study that will enroll up to 1500 patients with acute PE symptoms of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9. The primary endpoints for this study are the change in RV/LV ratio and a composite of major adverse events (MAEs) from baseline to 48 hours postprocedure. Secondary endpoints include additional safety measures, functional outcomes, and quality of life. In this analysis, 164 patients were treated with Lightning Flash, a new CAVT iteration that comprises a 16F aspiration catheter and a microprocessor programmed to optimize regulation of aspiration by using pressure differential and flow-based algorithms to rapidly detect thrombus from blood flow.

Results: Mean patient age was 61.6 years, and 53.7% were male. PE risk classification was high in 4.9% of patients, intermediate-high in 86.6%, and intermediate-low in 8.5%.

Median thrombectomy time was 25.5 minutes, and median procedure time was 59.0 minutes. Mean on-table pulmonary artery pressures (PAPs) significantly decreased—systolic PAP from 50.8 mm Hg to 38.8 mm Hg (∆ 23.4%, P < .001), and mean PAP from 31.2 mm Hg to 23.5 mm Hg (∆ 24.5%, P < .001).

Mean RV/LV ratio significantly decreased from 1.34 at baseline to 0.94 at 48 hours (∆ 27.8%, P < .001). One composite MAE (0.6%) occurred within 48 hours. No device-related serious adverse events occurred. Specifically, no major bleeding required transfusion and there were no device-related transfusions.

Median Borg dyspnea score at rest significantly decreased from 5.0 (severe [heavy]) at baseline to 0.5 (very, very slight [just noticeable]) at discharge (∆ 3.0, P < .001).

Conclusion: In this analysis of 164 patients within STRIKE-PE, use of the 16F Lightning Flash system improved hemodynamics, RV/LV ratio, and dyspnea in a highly efficient manner, requiring just 25.5 minutes of device time. The safety profile was excellent, with no patients’ requiring procedure-related blood transfusion and an overall MAE rate of under 1%.