Infectious Disease Clinical Research Program, Bethesda, Maryland.
JAMA Intern Med. 2013 Sep 9;173(16):1495-504. doi: 10.1001/jamainternmed.2013.8203.
There are limited prospective, controlled data evaluating survival in patients receiving early surgery vs medical therapy for prosthetic valve endocarditis (PVE).
To determine the in-hospital and 1-year mortality in patients with PVE who undergo valve replacement during index hospitalization compared with patients who receive medical therapy alone, after controlling for survival and treatment selection bias.
DESIGN, SETTING, AND PARTICIPANTS: Participants were enrolled between June 2000 and December 2006 in the International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), a prospective, multinational, observational cohort of patients with infective endocarditis. Patients hospitalized with definite right- or left-sided PVE were included in the analysis. We evaluated the effect of treatment assignment on mortality, after adjusting for biases using a Cox proportional hazards model that included inverse probability of treatment weighting and surgery as a time-dependent covariate. The cohort was stratified by probability (propensity) for surgery, and outcomes were compared between the treatment groups within each stratum.
Valve replacement during index hospitalization (early surgery) vs medical therapy.
In-hospital and 1-year mortality.
Of the 1025 patients with PVE, 490 patients (47.8%) underwent early surgery and 535 individuals (52.2%) received medical therapy alone. Compared with medical therapy, early surgery was associated with lower in-hospital mortality in the unadjusted analysis and after controlling for treatment selection bias (in-hospital mortality: hazard ratio [HR], 0.44 [95% CI, 0.38-0.52] and lower 1-year mortality: HR, 0.57 [95% CI, 0.49-0.67]). The lower mortality associated with surgery did not persist after adjustment for survivor bias (in-hospital mortality: HR, 0.90 [95% CI, 0.76-1.07] and 1-year mortality: HR, 1.04 [95% CI, 0.89-1.23]). Subgroup analysis indicated a lower in-hospital mortality with early surgery in the highest surgical propensity quintile (21.2% vs 37.5%; P = .03). At 1-year follow-up, the reduced mortality with surgery was observed in the fourth (24.8% vs 42.9%; P = .007) and fifth (27.9% vs 50.0%; P = .007) quintiles of surgical propensity.
Prosthetic valve endocarditis remains associated with a high 1-year mortality rate. After adjustment for differences in clinical characteristics and survival bias, early valve replacement was not associated with lower mortality compared with medical therapy in the overall cohort. Further studies are needed to define the effect and timing of surgery in patients with PVE who have indications for surgery.
目前针对接受早期手术与单纯药物治疗的人工瓣膜心内膜炎（PVE）患者的生存情况，前瞻性、对照研究数据有限。
在控制生存和治疗选择偏倚后，确定在索引住院期间接受瓣膜置换术的 PVE 患者与仅接受药物治疗的患者的院内和 1 年死亡率。
设计、地点和参与者：参与者于 2000 年 6 月至 2006 年 12 月期间参加了国际心内膜炎合作前瞻性队列研究（ICE-PCS），这是一项针对感染性心内膜炎患者的前瞻性、多国、观察性队列研究。纳入索引住院期间确诊为右或左心瓣膜 PVE 的患者进行分析。我们使用 Cox 比例风险模型评估了治疗分配对死亡率的影响，该模型包括逆概率治疗加权和手术作为时间依赖性协变量，以校正生存和治疗选择偏倚。该队列按手术概率（倾向）分层，并在每个分层内比较治疗组之间的结局。
索引住院期间进行瓣膜置换术（早期手术）与药物治疗。
院内和 1 年死亡率。
在 1025 例 PVE 患者中，490 例（47.8%）接受了早期手术，535 例（52.2%）仅接受了药物治疗。未经调整分析和校正治疗选择偏倚后，与药物治疗相比，早期手术与较低的院内死亡率相关（院内死亡率：风险比[HR]，0.44 [95%CI，0.38-0.52]；1 年死亡率：HR，0.57 [95%CI，0.49-0.67]）。校正幸存者偏倚后，手术相关死亡率并未持续存在（院内死亡率：HR，0.90 [95%CI，0.76-1.07]；1 年死亡率：HR，1.04 [95%CI，0.89-1.23]）。亚组分析表明，在手术倾向最高的五分位数中，早期手术的院内死亡率较低（21.2% vs 37.5%；P = .03）。在 1 年随访时，在第四（24.8% vs 42.9%；P = .007）和第五（27.9% vs 50.0%；P = .007）五分位数的手术倾向中观察到手术降低死亡率。
人工瓣膜心内膜炎仍然与 1 年高死亡率相关。在校正临床特征和生存偏倚差异后，与药物治疗相比，早期瓣膜置换术在整个队列中与较低的死亡率无关。需要进一步研究来确定有手术适应证的 PVE 患者手术的效果和时机。
