Background:Prosthetic valve endocarditis (PVE) is a rare but critical mechanism of valve failure and death after transcatheter and surgical aortic valve replacement (TAVR, SAVR) warranting further analysis in modern aortic valve replacement experience. We characterize the incidence, risk factors, microbiological profile and outcomes of PVE from the PARTNER trials and registries (Placement of Aortic Transcatheter Valve).Methods:We analyzed a pooled cohort of all patients in PARTNER 1 and PARTNER 2 trials and registries. Patients had severe aortic stenosis, were treated with TAVR or SAVR, and were analyzed with respect to development of PVE. PVE adjudication by a clinical events committee was based on modified Duke Criteria. The incidence, infection timing, organism, and association between PVE and all-cause mortality were analyzed.Results:8530 patients were included. PVE occurred in 107 cases (5.06 PVE events per 1000 person-years over a mean follow-up of 2.69±1.55 years [95% CI, 4.19–6.12]). The incidence of TAVR-PVE (5.21 PVE per 1000 person-years [95% CI, 4.26–6.38]) was not significantly different from SAVR-PVE (4.10 per 1000 person-years [95% CI, 2.33–7.22]; incident rate ratio, 1.27 [95% CI, 0.70–2.32]; P=0.44). Temporal risk of PVE was similar for TAVR and SAVR, even after adjusting for competing risk of death (hazard ratio, 1.15 [95% CI, 0.58–2.28]; P=0.69). Through multivariable analysis, PVE was associated with baseline cirrhosis (incident rate ratio, 2.86 [95% CI, 1.33–6.16]; P=0.007), pulmonary disease (incident rate ratio, 1.70 [95% CI, 1.16–2.48]; P=0.006), and renal insufficiency (incident rate ratio, 1.71 [95% CI, 1.03–2.83]; P=0.04). Timing of PVE was similar between TAVR and SAVR (<30 days: 4.2% vs 8.3%; 31 days to 1 year: 52.6% vs 66.7%; >1 year: 43.2% vs 25.0%; P=0.28). Staphylococcus occurred more commonly after SAVR (58.3% vs 28.4% in TAVR; P=0.04). PVE was strongly associated with all-cause mortality after endocarditis diagnosis (hazard ratio, 4.4 [95% CI, 3.42–5.72]; P<0.0001).Conclusions:The widespread adoption of TAVR and application to lower-risk patients makes understanding mechanisms of valve failure increasingly important. PVE is an established mechanism of prosthetic valve failure post-SAVR and TAVR with unclear differences between approaches. We herein demonstrate in the largest trials and registries of TAVR that PVE remains rare, but often fatal, in modern AVR experience and that there is no difference in incidence, predictors, or risk of PVE between TAVR and SAVR.Clinical Trial Registration:https://www.clinicaltrials.gov. Unique identifiers: NCT00530894 (PARTNER 1), NCT01314313 (PARTNER 1IA), NCT02184442 (PARTNER 1IB), NCT03222141 (PII S3HR), NCT03222128 (PII S3i).

中文翻译：

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TAVR和SAVR后的人工瓣膜心内膜炎：来自PARTNER试验的见解。

背景：人工瓣膜心内膜炎（PVE）是经导管和外科主动脉瓣置换术（TAVR，SAVR）后瓣膜衰竭和死亡的罕见但关键机制，值得在现代主动脉瓣置换术中进行进一步分析。我们通过PARTNER试验和登记处（主动脉导管的放置）来表征PVE的发生率，危险因素，微生物学特征和结局。方法：我们分析了PARTNER 1和PARTNER 2试验和登记处所有患者的汇总队列。患有严重主动脉瓣狭窄的患者，接受TAVR或SAVR治疗，并就PVE的发展进行分析。临床事件委员会对PVE的裁决基于修改后的Duke标准。分析了PVE的发生率，感染时间，有机体以及PVE与全因死亡率之间的关联。包括8530名患者。PVE发生在107例中（每1000人年5.06次PVE事件，平均随访2.69±1。55年[95％CI，4.19–6.12]）。TAVR-PVE的发生率（每千人年5.21 PVE [95％CI，4.26-6.38]）与SAVR-PVE的发生率（每千人年4.10 PVE [95％CI，2.33-7.22]）无显着差异。比率1.27 [95％CI 0.70–2.32]；P＝ 0.44）。即使调整了竞争性死亡风险，TAVR和SAVR的PVE的暂时风险也相似（风险比为1.15 [95％CI，0.58–2.28]；P = 0.69）。;通过多变量分析，PVE用基线肝硬化（发生率比率，2.86 [95％CI，1.33-6.16]相关联的P，肺疾病（发生率比率，1.70 [95％CI，1.16-2.48] = 0.007）; P = 0.006）和肾功能不全（发生率比率为1.71 [95％CI，1.03-2.83]；P = 0.04）。TAVR和SAVR之间的PVE时间相似（<30天：4.2％vs 8.3％； 31天至1年：52.6％vs 66.7％；> 1年：43.2％vs 25.0％；P = 0.28）。SAVR后葡萄球菌更常见（58.3％vs TAVR中的28.4％；P= 0.04）。心内膜炎诊断后，PVE与全因死亡率密切相关（危险比，4.4 [95％CI，3.42-5.72]；P<0.0001）。结论：TAVR的广泛采用和对低风险患者的应用使得对瓣膜衰竭机制的了解变得越来越重要。PVE是SAVR和TAVR后人工瓣膜衰竭的既定机制，但方法之间的差异尚不清楚。我们在最大的TAVR试验和注册中证明，在现代AVR经验中，PVE仍然很少见，但通常是致命的，并且TAVR和SAVR之间的PVE发生率，预测因子或风险没有差异。 //www.clinicaltrials.gov。唯一标识符：NCT00530894（PARTNER 1），NCT01314313（PARTNER 1IA），NCT02184442（PARTNER 1IB），NCT03222141（PII S3HR），NCT03222128（PII S3i）。