Akhilesh K Sista1, Rohit Bhatheja2, Parth Rali3, Kannan Natarajan4, Philip Green5, Gregory Piazza6, Anthony J Comerota7, Sahil A Parikh5, Vladimir Lakhter8, Riyaz Bashir8, Kenneth Rosenfield9. 1. Division of Interventional Radiology, Department of Radiology, New York University School of Medicine (A.K.S.). 2. Florida Heart Group, Florida Hospital, Orlando (R.B.). 3. Department of Thoracic Medicine and Surgery (P.R.), Lewis Katz School of Medicine, Temple University, Philadelphia, PA. 4. St. Vincent Hospital and Health Care Center, Indianapolis, IN (K.N.). 5. Division of Cardiology and the Center for Interventional Vascular Therapy, New York Presbyterian-Columbia University Medical Center (P.G., S.A.P.). 6. Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (G.P.). 7. Inova Heart and Vascular Institute, Inova Alexandria Hospital, Virginia (A.J.C.). 8. Division of Cardiovascular Diseases (V.L., R.B.), Lewis Katz School of Medicine, Temple University, Philadelphia, PA. 9. Department of Cardiology, Massachusetts General Hospital, Boston, MA (K.R.).
Abstract
BACKGROUND: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE). METHODS: Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy. RESULTS: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 (P=0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 (P=0.0005; [95% CI, 5.5-13.4]; 37.1% reduction). CONCLUSIONS: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.
BACKGROUND: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE). METHODS:Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy. RESULTS: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 (P=0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 (P=0.0005; [95% CI, 5.5-13.4]; 37.1% reduction). CONCLUSIONS: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.
Entities:
Keywords:
angiography; fibrinolysis; nitinol; pulmonary embolism; right ventricular dysfunction
Authors: Catalin Toma; Matthew C Bunte; Kenneth H Cho; Wissam A Jaber; Jeffrey Chambers; Brian Stegman; Sreedevi Gondi; Daniel A Leung; Michael Savin; Sameer Khandhar; Herman Kado; Gerald Koenig; Mitchell Weinberg; Robert E Beasley; Jon Roberts; Wesley Angel; Michael G Sarosi; Osama Qaqi; Kalyan Veerina; Michael A Brown; Jeffrey S Pollak Journal: Catheter Cardiovasc Interv Date: 2022-02-03 Impact factor: 2.585