title: PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study.
abstract: 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.
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: Maltais.Simon@mayo.edu.
authors.forename: Simon
authors.initials: S
authors.lastname: Maltais
authors.affiliation: Division of Cardiac Surgery, Ohio State University Medical Center, Columbus, Ohio.
authors.forename: Ahmet
authors.initials: A
authors.lastname: Kilic
authors.affiliation: Memorial Hermann-Texas Medical Center, Houston, Texas.
authors.forename: Sriram
authors.initials: S
authors.lastname: Nathan
authors.affiliation: Vanderbilt Heart and Vascular Institute, Vanderbilt University, Nashville, Tennessee.
authors.forename: Mary
authors.initials: M
authors.lastname: Keebler
authors.affiliation: Division of Cardiovascular Medicine, Ohio State University Medical Center, Columbus, Ohio.
authors.forename: Sitaramesh
authors.initials: S
authors.lastname: Emani
authors.affiliation: Baptist Health Heart and Transplant Institute, Little Rock, Arkansas.
authors.forename: John
authors.initials: J
authors.lastname: Ransom
authors.affiliation: Division of Cardiology.
authors.forename: Jason N
authors.initials: JN
authors.lastname: Katz
authors.affiliation: Division of Cardiothoracic Surgery, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Brett
authors.initials: B
authors.lastname: Sheridan
authors.affiliation: University of Colorado School of Medicine, Denver, Colorado.
authors.forename: Andreas
authors.initials: A
authors.lastname: Brieke
authors.affiliation: Christ Hospital, Cincinnati, Ohio.
authors.forename: Gregory
authors.initials: G
authors.lastname: Egnaczyk
authors.affiliation: Thomas Jefferson University, Philadelphia, Pennsylvania.
authors.forename: John W
authors.initials: JW
authors.lastname: Entwistle
authors.affiliation: Sharp Memorial Hospital, San Diego, California.
authors.forename: Robert
authors.initials: R
authors.lastname: Adamson
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: John
authors.initials: J
authors.lastname: Stulak
authors.affiliation: University of Chicago Medical Center, Chicago, Illinois.
authors.forename: Nir
authors.initials: N
authors.lastname: Uriel
authors.affiliation: St. Jude Medical, Inc., Pleasanton, California.
authors.forename: John B
authors.initials: JB
authors.lastname: O'Connell
authors.affiliation: St. Jude Medical, Inc., Pleasanton, California.
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.affiliation: St. Jude Medical, Inc., Pleasanton, California.
authors.forename: Kartik S
authors.initials: KS
authors.lastname: Sundareswaran
authors.affiliation: Memorial Hermann-Texas Medical Center, Houston, Texas.
authors.forename: Igor
authors.initials: I
authors.lastname: Gregoric
mesh_terms: D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D058996:Quality Improvement; D012042:Registries; D012307:Risk Factors; D055502:Secondary Prevention / Q000379:methods*; D015996:Survival Rate / Q000639:trends; D013927:Thrombosis / Q000453:epidemiology / Q000517:prevention & control*; D014481:United States / Q000453:epidemiology
keywords: HeartMate II; best practices; continuous-flow left ventricular assist device (CF-LVAD); prevention; pump thrombosis