Safety and Performance of a New Burr Hole Covering Device: Results of the Multicenter COVER Registry

新型钻孔覆盖装置的安全性和性能:多中心 COVER 登记研究结果

阅读:15
作者:Carlos Asencio-Cortés, Gloria Villalba, Álex De Vilalta, Laura Serrano, María Jesús Álvarez-Holzapfel, Guillermo Montes-Graciano, Xavier Málaga, Fernando Muñoz-Hernandez, Andreu Gabarrós

Background

Burr hole covering in brain surgical procedures can avoid complications and unaesthetic

Conclusion

Cranial COVER is a safe and reliable burr hole covering system that offers excellent cosmetic results and high satisfaction rates for both surgeons and patients. Cranial COVER is highly adaptable to the skull surface, and it was predominantly used in frontal locations due to their cosmetic importance.

Methods

A multicenter, prospective, clinical registry design was used for the study. All the patients who fulfilled the inclusion criteria were included in the study and followed up for 6 months. Baseline clinical parameters, surgical variables (technical success of the implantation, surgeon satisfaction), postoperative variables (aesthetic and functional

Results

Forty-three Cranial COVER devices were implanted in 30 patients. Most of them were implanted in frontal locations (53.5%). After implantation, 97.7% of the devices completely covered the burr hole, and 100% perfectly adapted to the skull surface. All surgeons ranked their satisfaction with the implantation procedure as very high or high. No artifacts were detected in any of the neuroimaging studies performed and no adverse events related with the device or its implantation were reported during the follow-up. There were significantly more scalp depressions associated with uncovered than with Cranial COVER-covered burr holes (p = 0.040). Patient satisfaction with covered burr holes located in the frontal and parietal areas was 9.0 ± 1.4 over 10.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。