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

PREVENT Study Investigators

Research output: Contribution to journalArticle

102 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-12
Number of pages12
JournalJournal of Heart and Lung Transplantation
Volume36
Issue number1
DOIs
StatePublished - Jan 1 2017

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Thrombosis
Hemolysis
Heparin
Stroke

Keywords

  • best practices
  • continuous-flow left ventricular assist device (CF-LVAD)
  • HeartMate II
  • prevention
  • pump thrombosis

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

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

In: Journal of Heart and Lung Transplantation, Vol. 36, No. 1, 01.01.2017, p. 1-12.

Research output: Contribution to journalArticle

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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.",
keywords = "best practices, continuous-flow left ventricular assist device (CF-LVAD), HeartMate II, prevention, pump thrombosis",
author = "{PREVENT Study Investigators} and Simon Maltais and Ahmet Kilic and Sriram Nathan and Mary Keebler and Sitaramesh Emani and John Ransom and Katz, {Jason N.} and Brett Sheridan and Andreas Brieke and Gregory Egnaczyk and Entwistle, {John W.} and Robert Adamson and John Stulak and Nir Uriel and O'Connell, {John B.} and Farrar, {David J.} and Sundareswaran, {Kartik S.} and Igor Gregoric",
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T1 - PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management

T2 - The PREVENT multi-center study

AU - PREVENT Study Investigators

AU - Maltais, Simon

AU - Kilic, Ahmet

AU - Nathan, Sriram

AU - Keebler, Mary

AU - Emani, Sitaramesh

AU - Ransom, John

AU - Katz, Jason N.

AU - Sheridan, Brett

AU - Brieke, Andreas

AU - Egnaczyk, Gregory

AU - Entwistle, John W.

AU - Adamson, Robert

AU - Stulak, John

AU - Uriel, Nir

AU - O'Connell, John B.

AU - Farrar, David J.

AU - Sundareswaran, Kartik S.

AU - Gregoric, Igor

PY - 2017/1/1

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N2 - 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.

AB - 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.

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KW - continuous-flow left ventricular assist device (CF-LVAD)

KW - HeartMate II

KW - prevention

KW - pump thrombosis

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