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Evaluating the Safety and Efficacy of the AlphaVac F1885 System in Acute Intermediate Risk PE Patients: APEX-AV Trial
William Brent Keeling, Emory University, Atlanta, GA
William Brent Keeling, Emory University, Atlanta, GA and Mona Ranade, MD, University of California, Los Angeles, Los Angeles, CA
Keywords: Pulmonary Embolism (PE)
Background:
P
ulmonary Embolism (PE) represents the third leading cause of cardiovascular mortality with 100000 to 180000 deaths per year. Several catheter directed therapies have been developed to improve the overall safety, efficacy and the quality of life in acute PE patients. The APEX-AV (Acute Pulmonary Embolism Extraction Trial with the AlphaVac System) study was designed to determine whether catheter-directed mechanical thrombectomy with the AlphaVac F1885 System is safe and effective in patients with acute intermediate-risk PE. Methods:
The APEX-AV is a prospective, single-arm, multicenter investigational device exemption trial in which patients with acute intermediate-risk PE were treated with the AlphaVac F1885 aspiration system. Patients 18 years and above with computed tomography (CT) detected PE < 14 days duration were eligible for enrollment. Patients were required to have a heart rate of less than 130 beats/min, systolic blood pressure greater than 90 mm Hg at baseline assessment, and site-reported RV/LV ratio of greater than 0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab–adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device related death, major bleeding, and device-related serious adverse events.
Results:
122 patients were treated with the AlphaVac system at 25 US sites. Mean Procedural time (device time) was 37.2 ± 17.72 minutes. At 48 hours post-procedure, the average reduction in the RV/LV ratio was 0.45 with 35.5% reduction in the overall clot burden from baseline. Five patients had major adverse events (includes five major bleeding events) within the 48 hour visit. No patient required thrombolytics within 48 hours of Index procedure. No death was reported and one patient had symptomatic PE recurrence during the 30 day follow up.
Conclusions:
Overall, the AlphaVac F1885 system is safe and effective in patients with acute intermediate-risk PE, with significant improvement in the RV function and minimal major adverse events. The potential advantages of the AlphaVac system also include large reduction in thrombus burden and shorter procedure time.