目前对患儿和先天性心脏病患者的设备需求
Heather M Giacone1, Anne M Dubin1
1Department of Pediatric Cardiology, Lucile Packard Children's Hospital at Stanford University, 750 Welch Road, Palo Alto, CA 94304, USA.
Cardiac electrophysiology clinics
|October 21, 2023
概括
儿科电生理学家缺乏针对儿童的专用心脏植入式电子设备 (CIED),导致更高的并发症率. 对于需要CIED的儿科和先天性心脏病患者,正在出现改善的法规和临床试验支持.
科学领域:
- 儿童心脏病学 儿童心脏病学
- 生物医学工程 生物医学工程
- 医疗器械规则 医疗器械规则
背景情况:
- 儿科电生理学家面临着专门为儿童设计的心脏植入式电子设备 (CIED) 的短缺.
- 独特的儿科患者特征,包括血管和解剖学差异以及生长潜力,限制了可用的CIED选择.
- 儿科和先天性心脏病 (CHD) 患者的CIED相关并发症发生率高于成年人群.
研究的目的:
- 为了突出儿童CIED植入的挑战.
- 强调儿童专用设备开发和倡导的必要性.
- 讨论对儿科CIEDs监管改进和临床试验支持的进展.
主要方法:
- 关于儿科CIED挑战的文献综述和专家意见综合.
- 分析影响器械选择和结果的患者特定因素.
- 审查监管机构,行业和医学协会之间的合作努力.
主要成果:
- 儿科适合的CIED存在显著的缺陷,影响了患者的护理.
- 儿科和心血管疾病患者的CIED相关并发症风险增加.
- 合作倡议加强了监管框架,并促进了儿科器械的临床试验.
结论:
- 解决儿科CIED缺乏的问题对于改善患者的治疗结果至关重要.
- 持续的合作对于推动设备创新和确保患者安全至关重要.
- 监管进步和试验支持对于满足儿童患者日益增长的需要需要CIEDs至关重要.
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