| 标题： | 左室辅助装置术后并发症管理专家共识 |
| title： | Protocol for the Clinical Expert Consensus on the Management of Complications Following LVAD Implantation |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 标准指南 |
| classification： | Standard guideline |
| 领域： | 综合 |
| field： | Comprehensive guideline |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | |
| Guide users： | |
| 证据分级方法： | GRADE（推荐、评价、制定与评估分级系统） 证据质量 (Evidence Quality): 高 (High): 进一步的研究不太可能改变对效果估计的信心。 中等 (Moderate): 进一步的研究可能对效果估计的信心有重要影响，并可能改变估计值。 低 (Low): 进一步的研究很可能对效果估计的信心有重要影响，并可能改变估计值。 非常低 (Very Low): 任何效果估计都是非常不确定的。 推荐强度 (Recommendation Strength): 强推荐 (Strong): 干预的益处显著超过风险，或相反。 弱推荐 (Weak): 益处和风险之间的权衡不太明确，或证据质量较低。 |
| Evidence grading method： | GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) Evidence Quality: High: Further research is very unlikely to change confidence in the estimate of effect. Moderate: Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. Low: Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Very Low: Any estimate of effect is very uncertain. Recommendation Strength: Strong: The benefits of the intervention clearly outweigh the risks or vice versa. Weak: The trade-offs between benefits and risks are less clear, or evidence quality is lower. |
| 制定单位： | 中国医学科学院阜外医院 |
| Formulating unit： | Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College |
| 注册时间： | 2024-09-12 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN505 |
| Registration number： | |
| 指南制订的目的： | 随着左室辅助装置（LVAD）技术的不断发展，其在终末期心衰患者中的应用逐渐增多。然而，LVAD术后的并发症管理仍然面临诸多挑战，相关领域的应用规范和指征的掌握方面仍存在空白。为便于重症医学科、心外科、心内科、麻醉科医生熟悉和掌握LVAD术后并发症管理的科学方法，中国生物医学工程学会机械循环支持分会制定本共识。本工作组遵循美国医学科学院（IOM）临床实践指南的定义，参考《世界卫生组织指南制定手册》和《中国制订/修订临床诊疗指南的指导原则（2022版）》等要求，在国际实践指南与注册透明化平台注册并撰写《LVAD术后并发症管理专家共识》，并遵循共识制订流程，拟制订和发布共识文件。本计划书主要介绍《LVAD术后并发症管理专家共识》的目的、目标人群、共识制订工作小组的组成、临床问题的提出与收集、证据筛选和汇总以及推荐意见的产生等共识制订方法和流程，使之更加规范与透明。 |
| Purpose of the guideline： | The continuous advancement of left ventricular assist device (LVAD) technology has led to its increasing application in patients with end-stage heart failure. However, the management of complications following LVAD implantation remains challenging, with gaps in the mastery of application standards and indications in this field. To facilitate the familiarity and mastery of scientific methods for managing LVAD postoperative complications among doctors in critical care, cardiac surgery, cardiology, and anesthesia departments, the Mechanical Circulatory Support Committee of the Chinese Society of Biomedical Engineering has formulated this consensus. This working group follows the definition of the Clinical Practice Guidelines of the American Academy of Medical Sciences (IOM), and refers to the requirements of the World Health Organization Guidelines Development Manual and the Guiding Principles for the Development/Revision of Clinical Diagnosis and Treatment Guidelines in China (2022 Edition). They register and write the "Clinical Expert Consensus on the Management of Complications Following LVAD Implantation" on the International Practice Guidelines and Registration Transparency Platform, and follow the consensus development process to develop and publish a consensus document. This protocol mainly introduces the purpose, target population, composition of the consensus development working group, proposal and collection of clinical issues, evidence screening and summary, and generation of recommended opinions of the Clinical Expert Consensus on the Management of Complications Following LVAD Implantation, making it more standardized and transparent. |
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