Simon Maltais1, Ahmet Kilic2, Sriram Nathan3, Mary Keebler4, Sitaramesh Emani5, John Ransom6, Jason N Katz7, Brett Sheridan8, Andreas Brieke9, Gregory Egnaczyk10, John W Entwistle11, Robert Adamson12, John Stulak13, Nir Uriel14, John B O'Connell15, David J Farrar15, Kartik S Sundareswaran15, Igor Gregoric3. 1. Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: Maltais.Simon@mayo.edu. 2. Division of Cardiac Surgery, Ohio State University Medical Center, Columbus, Ohio. 3. Memorial Hermann-Texas Medical Center, Houston, Texas. 4. Vanderbilt Heart and Vascular Institute, Vanderbilt University, Nashville, Tennessee. 5. Division of Cardiovascular Medicine, Ohio State University Medical Center, Columbus, Ohio. 6. Baptist Health Heart and Transplant Institute, Little Rock, Arkansas. 7. Division of Cardiology. 8. Division of Cardiothoracic Surgery, University of North Carolina, Chapel Hill, North Carolina. 9. University of Colorado School of Medicine, Denver, Colorado. 10. Christ Hospital, Cincinnati, Ohio. 11. Thomas Jefferson University, Philadelphia, Pennsylvania. 12. Sharp Memorial Hospital, San Diego, California. 13. Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. 14. University of Chicago Medical Center, Chicago, Illinois. 15. St. Jude Medical, Inc., Pleasanton, California.
Abstract
BACKGROUND: Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations. METHODS: PREVENT was a prospective, multi-center, single-arm, non-randomized study of 300 patients implanted with HMII at 24 participating sites. Confirmed PT (any suspected PT confirmed visually and/or adjudicated by an independent assessor) was evaluated at 3 months (primary end-point) and at 6 months after implantation. RESULTS: The population included 83% men (age 57 years ± 13), 78% destination therapy, and 83% Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1-3. Primary end-point analysis showed a confirmed PT of 2.9% at 3 months and 4.8% at 6 months. Adherence to key recommendations included 78% to surgical recommendations, 95% to heparin bridging, and 79% to pump speeds ≥9,000 RPMs (92% >8,600 RPMs). Full adherence to implant techniques, heparin bridging, and pump speeds ≥9,000 RPMs resulted in a significantly lower risk of PT (1.9% vs 8.9%; p < 0.01) and lower composite risk of suspected thrombosis, hemolysis, and ischemic stroke (5.7% vs 17.7%; p < 0.01) at 6 months. CONCLUSIONS: Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT.
BACKGROUND: Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations. METHODS: PREVENT was a prospective, multi-center, single-arm, non-randomized study of 300 patients implanted with HMII at 24 participating sites. Confirmed PT (any suspected PT confirmed visually and/or adjudicated by an independent assessor) was evaluated at 3 months (primary end-point) and at 6 months after implantation. RESULTS: The population included 83% men (age 57 years ± 13), 78% destination therapy, and 83% Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1-3. Primary end-point analysis showed a confirmed PT of 2.9% at 3 months and 4.8% at 6 months. Adherence to key recommendations included 78% to surgical recommendations, 95% to heparin bridging, and 79% to pump speeds ≥9,000 RPMs (92% >8,600 RPMs). Full adherence to implant techniques, heparin bridging, and pump speeds ≥9,000 RPMs resulted in a significantly lower risk of PT (1.9% vs 8.9%; p < 0.01) and lower composite risk of suspected thrombosis, hemolysis, and ischemic stroke (5.7% vs 17.7%; p < 0.01) at 6 months. CONCLUSIONS: Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT.