使用Perceval的15年,比较PercevalS和Perceval PLUS之间的早期结果
Delphine Szecel1, Marie Lamberigts1, Filip Rega1
1Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium.
Expert review of medical devices
|January 7, 2026
概括
新的Perceval PLUS大动脉显示出改善的血液动力学和较低的起器植入率. 这种无生物假体保持了Perceval平台的优势,并改善了早期的结果.
科学领域:
- 心血管外科心血管外科
- 生物材料科学 生物材料科学
- 医疗器械 医疗器械
背景情况:
- 珀塞瓦尔生物假体是一种无的主动脉,用于跨导管主动脉置换.
- 2020年推出的Perceval PLUS具有抗化处理和XL尺寸的修改过的戒指设计.
- 之前的版本包括Perceval S设计,具有不同的尺寸策略.
研究的目的:
- 为了评估没有接的Perceval PLUS大动脉的早期临床结果.
- 将Perceval PLUS的性能与早期的Perceval S设计进行比较.
- 评估生存率,血液动力学性能和心脏起器植入率.
主要方法:
- 对接受Perceval生物假体的1136名患者 (2007-2022) 的回顾性分析.
- 222名佩尔塞瓦尔PLUS患者和佩尔塞瓦尔S患者之间的比较 (根据大小分为S-OLD和S-NEW组).
- 评估30天死亡率,血液动力学参数 (梯度) 和永久心脏起器植入率.
主要成果:
- 两组之间30天死亡率 (3.7%) 没有显著差异.
- 与Perceval S相比,Perceval PLUS显示出明显改善的血液动力学,峰值和平均梯度较低 (p < .001).
- 在微创手术中,观察到Perceval PLUS的低永久心脏起器植入率为5.3%.
结论:
- 珀塞瓦尔PLUS大动脉显示了一个安全的配置,并保持了珀塞瓦尔平台的好处.
- 提高血液动力学性能和低永久心脏起器植入率是Perceval PLUS的关键优势.
- 早期的结果表明,Perceval PLUS是无动脉技术的有利进展.
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