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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| Veröffentlicht in: | The Journal of heart and lung transplantation Jg. 36; H. 1; S. 1 - 12 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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United States
01.01.2017
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| ISSN: | 1557-3117 |
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| 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. |
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| AbstractList | BACKGROUNDRecommended 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.METHODSPREVENT 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.RESULTSThe 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.CONCLUSIONSAdoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT. 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. |
| Author | Brieke, Andreas Katz, Jason N Farrar, David J Egnaczyk, Gregory Uriel, Nir O'Connell, John B Adamson, Robert Sheridan, Brett Nathan, Sriram Emani, Sitaramesh Stulak, John Ransom, John Entwistle, 3rd, John W Kilic, Ahmet Sundareswaran, Kartik S Keebler, Mary Maltais, Simon Gregoric, Igor |
| Author_xml | – sequence: 1 givenname: Simon surname: Maltais fullname: Maltais, Simon email: Maltais.Simon@mayo.edu organization: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: Maltais.Simon@mayo.edu – sequence: 2 givenname: Ahmet surname: Kilic fullname: Kilic, Ahmet organization: Division of Cardiac Surgery, Ohio State University Medical Center, Columbus, Ohio – sequence: 3 givenname: Sriram surname: Nathan fullname: Nathan, Sriram organization: Memorial Hermann-Texas Medical Center, Houston, Texas – sequence: 4 givenname: Mary surname: Keebler fullname: Keebler, Mary organization: Vanderbilt Heart and Vascular Institute, Vanderbilt University, Nashville, Tennessee – sequence: 5 givenname: Sitaramesh surname: Emani fullname: Emani, Sitaramesh organization: Division of Cardiovascular Medicine, Ohio State University Medical Center, Columbus, Ohio – sequence: 6 givenname: John surname: Ransom fullname: Ransom, John organization: Baptist Health Heart and Transplant Institute, Little Rock, Arkansas – sequence: 7 givenname: Jason N surname: Katz fullname: Katz, Jason N organization: Division of Cardiology – sequence: 8 givenname: Brett surname: Sheridan fullname: Sheridan, Brett organization: Division of Cardiothoracic Surgery, University of North Carolina, Chapel Hill, North Carolina – sequence: 9 givenname: Andreas surname: Brieke fullname: Brieke, Andreas organization: University of Colorado School of Medicine, Denver, Colorado – sequence: 10 givenname: Gregory surname: Egnaczyk fullname: Egnaczyk, Gregory organization: Christ Hospital, Cincinnati, Ohio – sequence: 11 givenname: John W surname: Entwistle, 3rd fullname: Entwistle, 3rd, John W organization: Thomas Jefferson University, Philadelphia, Pennsylvania – sequence: 12 givenname: Robert surname: Adamson fullname: Adamson, Robert organization: Sharp Memorial Hospital, San Diego, California – sequence: 13 givenname: John surname: Stulak fullname: Stulak, John organization: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota – sequence: 14 givenname: Nir surname: Uriel fullname: Uriel, Nir organization: University of Chicago Medical Center, Chicago, Illinois – sequence: 15 givenname: John B surname: O'Connell fullname: O'Connell, John B organization: St. Jude Medical, Inc., Pleasanton, California – sequence: 16 givenname: David J surname: Farrar fullname: Farrar, David J organization: St. Jude Medical, Inc., Pleasanton, California – sequence: 17 givenname: Kartik S surname: Sundareswaran fullname: Sundareswaran, Kartik S organization: St. Jude Medical, Inc., Pleasanton, California – sequence: 18 givenname: Igor surname: Gregoric fullname: Gregoric, Igor organization: Memorial Hermann-Texas Medical Center, Houston, Texas |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27865732$$D View this record in MEDLINE/PubMed |
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| Title | PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study |
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