PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study

• Published in: The Journal of heart and lung transplantation Vol. 36; no. 1; pp. 1 - 12
• Main Authors: Maltais, Simon, Kilic, Ahmet, Nathan, Sriram, Keebler, Mary, Emani, Sitaramesh, Ransom, John, Katz, Jason N., Sheridan, Brett, Brieke, Andreas, Egnaczyk, Gregory, Entwistle, John W., Adamson, Robert, Stulak, John, Uriel, Nir, O’Connell, John B., Farrar, David J., Sundareswaran, Kartik S., Gregoric, Igor
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2017
• Subjects: best practices; continuous-flow left ventricular assist device (CF-LVAD); Disease Management; Female; Follow-Up Studies; Heart Failure - mortality; Heart Failure - therapy; Heart-Assist Devices - adverse effects; HeartMate II; Humans; Incidence; Male; Middle Aged; Postoperative Complications - epidemiology; Postoperative Complications - prevention & control; prevention; Prospective Studies; pump thrombosis; Quality Improvement; Registries; Risk Factors; Secondary Prevention - methods; Survival Rate - trends; Thrombosis - epidemiology; Thrombosis - prevention & control; United States - epidemiology; HeartMate II; continuous-flow left ventricular assist device (CF-LVAD); prevention; pump thrombosis; best practices
• ISSN: 1053-2498; 1557-3117
• DOI: 10.1016/j.healun.2016.10.001

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. 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. 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. Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT.