Objective

The aim of this study was to investigate the association between post-implantation syndrome (PIS) and long term outcomes, with emphasis on cardiovascular prognosis.

Methods

One hundred and forty-nine consecutive patients undergoing EVAR in a tertiary institution were previously included in a study investigating the risk factors and short term consequences of PIS (defined as tympanic temperature ≥ 38°C and CRP > 10 mg/L, after excluding complications with an effect on inflammatory markers). This study was based on a prospectively maintained database. Survival status was derived from inquiry of civil registry database information and causes of death from the Dutch Central Bureau of Statistics. The primary endpoint was cardiovascular events. Secondary endpoints were overall and specific cause mortality (cardiovascular, ischaemic heart disease, AAA, and cancer related mortality). Aneurysm sac dynamics and occurrence of endoleaks were also analysed. Survival estimates were obtained using Kaplan–Meier plots and a multivariable model was constructed to correct for confounders.

Results

The PIS incidence was 39% (58/149). At the time of surgery, patients had a mean age of 73 ± 7 years and were predominantly male. There were no baseline differences between the PIS and non-PIS groups. The median follow up was 6.4 years (3.2 – 8.3), similar in both groups (p = .81). There was no difference in cardiovascular events for PIS and non-PIS patients (p = .63). However, Kaplan–Meier plots suggest a trend towards a higher rate of cardiovascular events in PIS patients during the first years: freedom from cardiovascular events at one year was 94% vs. 89% and at three years 90% vs. 82%. No differences were found in overall and specific cause mortality. There was a higher rate of type II endoleaks for non-PIS patients (28% vs. 9%, p = .005). Sac dynamics were similar in both groups.

Conclusion

The results suggest that PIS is not associated with a statistically significantly higher risk of cardiovascular events. PIS had no impact on mortality. Lastly, PIS patients had fewer type II endoleaks, but sac dynamics were analogous.

中文翻译：

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血管内动脉瘤修复术后植入后综合征的长期结果

客观的

本研究的目的是调查植入后综合征 (PIS) 与长期结果之间的关联，重点是心血管预后。

方法

149 名在三级机构接受 EVAR 的连续患者先前被纳入一项研究 PIS 的风险因素和短期后果（定义为鼓室温度 ≥ 38°C 和 CRP > 10 mg/L，排除并发症后对炎症标志物有影响）。本研究基于前瞻性维护的数据库。生存状况来自荷兰中央统计局对民事登记数据库信息和死因的查询。主要终点是心血管事件。次要终点是总体和特定原因的死亡率（心血管、缺血性心脏病、AAA 和癌症相关死亡率）。还分析了动脉瘤囊动力学和内漏的发生。

结果

PIS 发生率为 39% (58/149)。手术时，患者的平均年龄为 73 ± 7 岁，主要是男性。PIS 组和非 PIS 组之间没有基线差异。中位随访时间为 6.4 年 (3.2 – 8.3)，两组相似 ( p  = .81)。PIS 和非 PIS 患者的心血管事件没有差异 ( p  = .63)。然而，Kaplan-Meier 图表明 PIS 患者在最初几年心血管事件发生率较高的趋势：一年时心血管事件的发生率为 94%对89%，三年时为 90%对82%。在总体和特定原因死亡率方面没有发现差异。非 PIS 患者的 II 型内漏发生率较高 (28%与9%，p  = .005）。两组的囊动态相似。

结论

结果表明，PIS 与心血管事件的统计学显着较高风险无关。PIS 对死亡率没有影响。最后，PIS 患者的 II 型内漏较少，但囊动力学相似。