新型永久性起搏器植入的预测因素及趋势：国际Navitor IDE研究的亚组分析
Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study.
作者信息
Sultan Ibrahim, Reardon Michael J, Søndergaard Lars, Chehab Bassem, Smith Dave, Walton Antony S, Worthley Stephen G, Manoharan Ganesh, Yong Gerald, Jilaihawi Hasan, Asch Federico, Bates Nicholas, Fontana Gregory P
机构信息
Division of Cardiac Surgery, Department of Cardiothoracic Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
出版信息
Struct Heart. 2024 Mar 23;8(4):100293. doi: 10.1016/j.shj.2024.100293. eCollection 2024 Jul.
BACKGROUND
The Navitor Investigational Device Exemption (IDE) study is a prospective, multicenter, global study assessing the safety and effectiveness of the Navitor valve in a population with severe, symptomatic aortic stenosis who are at high and extreme surgical risk. The impact of pre-existing conduction abnormalities and implantation technique on new permanent pacemaker implantation (PPI) for the Navitor platform is not fully understood. Therefore, the goal of this analysis was to investigate the associations between patient and procedural factors and the 30-day new PPI rate.
METHODS
A total of 260 patients who underwent implantation of a Navitor valve in the Navitor IDE study were reviewed. Patients with preprocedural permanent pacemakers (n = 28) were excluded. Baseline risk factors were assessed for statistical significance. Multivariable logistic regression analyses were performed to identify independent predictors of new PPI.
RESULTS
Mean age of the pacemaker-naïve population was 83.3 ± 5.2 years, 58.6% were female, average Society of Thoracic Surgeons score was 3.8% ± 1.9%, median frailty score was 1 (interquartile range 1, 2), and 17.7% were deemed at extreme surgical risk. Pre-existing first-degree atrioventricular block and right bundle branch block significantly increased the risk of new PPI postimplantation, whereas left bundle branch block did not. Membranous septum length in relation to noncoronary cusp implant depth was a significant predictor of new PPI, with higher rates of new PPI observed when noncoronary cusp implant depth exceeded membranous septum length. Analysis of implant depth alone revealed deeper implants were associated with a higher rate of new PPI, regardless of patient baseline conduction abnormality.
CONCLUSIONS
The 30-day rate of new PPI in the Navitor IDE study is associated with patient pre-existing baseline conduction disturbances and implantation depth.
背景
Navitor研究性器械豁免（IDE）研究是一项前瞻性、多中心、全球性研究，旨在评估Navitor瓣膜在具有严重症状性主动脉瓣狭窄且手术风险高和极高的人群中的安全性和有效性。对于Navitor平台，既往存在的传导异常和植入技术对新的永久性起搏器植入（PPI）的影响尚未完全了解。因此，本分析的目的是研究患者和手术因素与30天新PPI发生率之间的关联。
方法
回顾了Navitor IDE研究中总共260例接受Navitor瓣膜植入的患者。排除术前有永久性起搏器的患者（n = 28）。评估基线风险因素的统计学意义。进行多变量逻辑回归分析以确定新PPI的独立预测因素。
结果
未植入起搏器人群的平均年龄为83.3±5.2岁，58.6%为女性，胸外科医师协会平均评分为3.8%±1.9%，虚弱评分中位数为1（四分位间距1, 2），17.7%被认为手术风险极高。既往存在的一度房室传导阻滞和右束支传导阻滞显著增加植入后新PPI的风险，而左束支传导阻滞则不然。膜性间隔长度与无冠瓣植入深度的关系是新PPI的重要预测因素，当无冠瓣植入深度超过膜性间隔长度时，新PPI发生率更高。单独分析植入深度发现，无论患者基线传导异常如何，植入越深与新PPI发生率越高相关。
结论
Navitor IDE研究中30天新PPI发生率与患者既往基线传导障碍和植入深度有关。
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