{"title":"新植入永久起搏器的预测因素和趋势：国际 Navitor IDE 研究子分析","authors":"","doi":"10.1016/j.shj.2024.100293","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>The 30-day rate of new PPI in the Navitor IDE study is associated with patient pre-existing baseline conduction disturbances and implantation depth.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000241/pdfft?md5=f090c0fa12f2f2db915e5e42d33854cd&pid=1-s2.0-S2474870624000241-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study\",\"authors\":\"\",\"doi\":\"10.1016/j.shj.2024.100293\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>The 30-day rate of new PPI in the Navitor IDE study is associated with patient pre-existing baseline conduction disturbances and implantation depth.</p></div>\",\"PeriodicalId\":36053,\"journal\":{\"name\":\"Structural Heart\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2474870624000241/pdfft?md5=f090c0fa12f2f2db915e5e42d33854cd&pid=1-s2.0-S2474870624000241-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Structural Heart\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2474870624000241\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Structural Heart","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2474870624000241","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景Navitor研究性设备豁免（IDE）研究是一项前瞻性、多中心、全球性研究，目的是评估Navitor瓣膜在有症状的重度主动脉瓣狭窄患者中的安全性和有效性，这些患者面临极高的手术风险。目前还不完全清楚已有的传导异常和植入技术对 Navitor 平台新永久起搏器植入（PPI）的影响。因此，本分析的目的是研究患者和手术因素与 30 天新的 PPI 率之间的关系。方法回顾了 Navitor IDE 研究中接受 Navitor 瓣膜植入术的 260 例患者。排除了术前植入永久起搏器的患者（28 例）。对基线风险因素进行了统计学意义评估。结果 未安装起搏器患者的平均年龄为 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（四分位间范围为 1、2），17.7% 被认为具有极高的手术风险。植入前存在的一级房室传导阻滞和右束支传导阻滞会显著增加植入后出现新的PPI的风险，而左束支传导阻滞则不会。膜室间隔长度与非冠状动脉尖植入深度的关系是新发 PPI 的重要预测因素，当非冠状动脉尖植入深度超过膜室间隔长度时，新发 PPI 的发生率更高。结论 Navitor IDE 研究中的 30 天新发 PPI 率与患者原有的基线传导障碍和植入深度有关。
Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study
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.
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