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

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• 作者：Simon Maltais ; MD ; PhD^a ; ^{Maltais.Simon@mayo.edu} ; Ahmet Kilic ; MD^b ; Sriram Nathan ; MD^c ; Mary Keebler ; MD^d ; Sitaramesh Emani ; MD^e ; John Ransom ; MD^f ; Jason N. Katz ; MD^g ; Brett Sheridan ; MD^h ; Andreas Brieke ; MDⁱ ; Gregory Egnaczyk ; MD^j ; John W. Entwistle III ; MD ; PhD^k ; Robert Adamson ; MD^l ; John Stulak ; MD^a ; Nir Uriel ; MD^m ; John B. O&rsquo ; Connell ; MDⁿ ; David J. Farrar ; PhDⁿ ; Kartik S. Sundareswaran ; PhDⁿ ; Igor Gregoric ; MD^c ; on behalf of the PREVENT Study Investigators
• 关键词：HeartMate II ; pump thrombosis ; prevention ; best practices ; continuous-flow left ventricular assist device (CF-LVAD)
• 刊名：The Journal of Heart and Lung Transplantation
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：36
• 期：1
• 页码：1-12
• 全文大小：1705 K
• 卷排序：36

文摘

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.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.