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

Authors

• Simon Maltais
• Ahmet Kilic
• Sriram Nathan
• Mary Keebler
• Sitaramesh Emani
• John Ransom
• Jason N Katz
• Brett Sheridan
• Andreas Brieke
• Gregory Egnaczyk
• John W Entwistle
• Robert Adamson
• John Stulak
• Nir Uriel
• John B O'Connell
• David J Farrar
• Kartik S Sundareswaran
• Igor Gregoric

Publication/Presentation Date

1-1-2017

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.

Volume

36

Issue

1

First Page

1

Last Page

12

ISSN

1557-3117

Published In/Presented At

Maltais, S., Kilic, A., Nathan, S., Keebler, M., Emani, S., Ransom, J., Katz, J. N., Sheridan, B., Brieke, A., Egnaczyk, G., Entwistle, J. W., 3rd, Adamson, R., Stulak, J., Uriel, N., O'Connell, J. B., Farrar, D. J., Sundareswaran, K. S., Gregoric, I., & PREVENT Study Investigators (2017). PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 36(1), 1–12. https://doi.org/10.1016/j.healun.2016.10.001

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

27865732

Department(s)

Administration and Leadership

Document Type

Article