Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota.
Division of Cardiac Surgery, Ohio State University Medical Center, Columbus, Ohio.
J Heart Lung Transplant. 2017 Jan;36(1):1-12. doi: 10.1016/j.healun.2016.10.001. Epub 2016 Nov 16.
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.
为了解决 HeartMate II（HMII；St. Jude Medical，Inc. [Thoratec Corporation]，加利福尼亚州普莱森顿）早期（<3 个月）泵血栓形成（PT）风险，制定了包括植入技术、抗凝策略和泵速管理（PREVENT [通过临床管理预防 HeartMate II 泵血栓形成]建议）在内的推荐的结构化临床实践。我们前瞻性地评估了当前时代的 HMII PT 发生率，此时参与中心遵循 PREVENT 建议。
PREVENT 是一项前瞻性、多中心、单臂、非随机研究，共有 24 个参与中心的 300 例患者植入 HMII。在 3 个月（主要终点）和植入后 6 个月时评估确认的 PT（任何疑似 PT 通过视觉确认和/或由独立评估者裁决）。
该人群包括 83%的男性（年龄 57 岁±13 岁）、78%的终末期治疗和 83%的机械循环支持机构间注册（INTERMACS）概况 1-3。主要终点分析显示，3 个月时的确认 PT 为 2.9%，6 个月时为 4.8%。对关键建议的依从性包括 78%的手术建议、95%的肝素桥接和 79%的泵速≥9000RPMs（92%>8600RPMs）。完全遵循植入技术、肝素桥接和泵速≥9000RPMs 可显著降低 PT 风险（1.9%比 8.9%；p<0.01）和 6 个月时疑似血栓形成、溶血和缺血性中风的复合风险（5.7%比 17.7%；p<0.01）。
采用结构化手术植入技术和临床管理策略（PREVENT 建议）的所有组成部分与确认 PT 发生率低有关。
