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

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) r...

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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, 3rd, 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 01.01.2017
Subjects:
Disease Management
Female
Follow-Up Studies
Heart Failure - mortality
Heart Failure - therapy
Heart-Assist Devices - adverse effects
Humans
Incidence
Male
Middle Aged
Postoperative Complications - epidemiology
Postoperative Complications - prevention & control
Prospective Studies
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
best practices
pump thrombosis
ISSN:1557-3117
Online Access:Get more information
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Summary: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.
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ISSN:1557-3117
DOI:10.1016/j.healun.2016.10.001