Thomas Tu1, Catalin Toma2, Victor F Tapson3, Christopher Adams4, Wissam A Jaber5, Mitchell Silver6, Sameer Khandhar7, Rohit Amin8, Mitchell Weinberg9, Tod Engelhardt10, Monica Hunter11, David Holmes12, Glenn Hoots13, Hussam Hamdalla14, Robert L Maholic15, Scott M Lilly16, Kenneth Ouriel17, Kenneth Rosenfield18. 1. Baptist Health Louisville, Louisville, Kentucky. Electronic address: ttu@bellsouth.net. 2. University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania. 3. Cedars-Sinai Medical Center, Los Angeles, California. 4. CAMC Memorial Hospital, Charleston, West Virginia. 5. Emory University Hospital, Atlanta, Georgia. 6. OhioHealth Heart and Vascular Physicians, Columbus, Ohio. 7. Penn Medicine, Philadelphia, Pennsylvania. 8. Sacred Heart Hospital Pensacola, Pensacola, Florida. 9. North Shore University Hospital, Northwell Health, Manhasset, New York. 10. East Jefferson General Hospital, Metairie, Louisiana. 11. St. Vincent's Birmingham, Birmingham, Alabama. 12. East Alabama Medical Center, Opelika, Alabama. 13. Tampa General Hospital, Tampa, Florida. 14. Ephraim McDowell Regional Medical Center, Danville, Kentucky. 15. University of Pittsburgh Medical Center Hamot, Erie, Pennsylvania. 16. The Ohio State University Wexner Medical Center, Columbus, Ohio. 17. Syntactx, New York, New York. 18. Massachusetts General Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). BACKGROUND: Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis. METHODS: Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy. RESULTS: From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up. CONCLUSIONS: Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.
OBJECTIVES: The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). BACKGROUND: Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis. METHODS:Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy. RESULTS: From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up. CONCLUSIONS: Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.
Authors: Romain Chopard; Umberto Campia; Lucas Morin; Karola S Jering; Zaid I Almarzooq; Julia Elizabeth Snyder; Samantha Rizzo; Aaron B Waxman; Samuel Z Goldhaber; Gregory Piazza Journal: J Thromb Thrombolysis Date: 2022-09-03 Impact factor: 5.221
Authors: Brett J Carroll; Sebastian E Beyer; Tyler Mehegan; Andrew Dicks; Abby Pribish; Andrew Locke; Anuradha Godishala; Kevin Soriano; Jaya Kanduri; Kelsey Sack; Inbar Raber; Cara Wiest; Isabel Balachandran; Mason Marcus; Louis Chu; Margaret M Hayes; Jeff L Weinstein; Kenneth A Bauer; Eric A Secemsky; Duane S Pinto Journal: Am J Med Date: 2020-05-19 Impact factor: 4.965
Authors: Efthymios D Avgerinos; Wissam Jaber; Joan Lacomis; Kyle Markel; Michael McDaniel; Belinda N Rivera-Lebron; Charles B Ross; Jacob Sechrist; Catalin Toma; Rabih Chaer Journal: JACC Cardiovasc Interv Date: 2021-06-28 Impact factor: 11.075