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采用开窗分支型血管内移植物对肾周和胸腹主动脉瘤进行腔内修复后健康相关生活质量的前瞻性评估。

Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts.

机构信息

Mayo Clinic Aortic Center, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.

Department of Health Science Research, Mayo Clinic, Rochester, Minn.

出版信息

J Vasc Surg. 2019 May;69(5):1356-1366.e6. doi: 10.1016/j.jvs.2018.07.060. Epub 2018 Oct 24.

Abstract

OBJECTIVE

The objective of this study was to investigate changes in health-related quality of life (QOL) in patients treated for pararenal aortic aneurysms (PAAs) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated-branched endovascular aneurysm repair (F-BEVAR).

METHODS

A total of 159 consecutive patients (70% male; mean age, 75 ± 7 years) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (2013-2016). All patients were observed for at least 12 months (mean follow-up time, 27 ± 12 months). Patients' health-related QOL was assessed using the 36-Item Short Form Health Survey questionnaire at baseline (N = 159), 6 to 8 weeks (n = 136), 6 months (n = 129), and 12 months (n = 123). Physical component scores (PCSs) and mental component scores (MCSs) were compared with historical results of patients enrolled in the endovascular aneurysm repair (EVAR) 1 trial who were treated by standard EVAR for simple infrarenal abdominal aortic aneurysms.

RESULTS

There were 57 patients with PAAs and 102 patients with TAAAs (50 extent IV and 52 extent I-III TAAAs). There were no 30-day deaths, in-hospital deaths, conversions to open surgery, or aorta-related deaths. Survival was 96% at 1 year and 87% at 2 years. Major adverse events occurred in 18% of patients, and 1-year reintervention rate was 14%. There were no statistically significant differences between the groups in 30-day outcomes. Patients treated for TAAAs had lower baseline scores compared with those treated for PAAs (P < .05). PCS declined significantly 6 to 8 weeks after F-BEVAR in both groups and returned to baseline values at 12 months in the PAA group but not in the TAAA group. Patients with TAAAs had significantly lower PCSs at 12 months compared with those with PAAs (P < .001). There was no decline in mean MCS. Major adverse events were associated with decline in PCS assessed at 6 to 8 weeks (P = .021) but not in the subsequent evaluations. Reinterventions had no effect on PCS or MCS. Overall, patients treated by F-BEVAR had similar changes in QOL measures as those who underwent standard EVAR in the EVAR 1 trial, except for lower PCS in TAAA patients at 12 months.

CONCLUSIONS

Patients treated for TAAAs had lower scores at baseline in their physical aspect of health-related QOL. F-BEVAR was associated with significant decline in PCSs in both groups, which improved after 2 months and returned to baseline values at 12 months in patients with PAAs but not in those with TAAAs. Patients treated for PAAs had similar changes in QOL compared with those treated for infrarenal aortic aneurysms with standard EVAR.

摘要

目的

本研究旨在探讨采用分支型腔内覆膜支架治疗肾周主动脉瘤(PAAs)和胸腹主动脉瘤(TAAAs)患者的健康相关生活质量(QOL)变化。

方法

共纳入 159 例连续患者(70%为男性;平均年龄 75±7 岁),采用前瞻性、非随机单中心研究方法,使用定制的分支型腔内覆膜支架(2013-2016 年)。所有患者均至少随访 12 个月(平均随访时间 27±12 个月)。使用 36 项简短健康调查问卷评估患者的健康相关 QOL,基线时(N=159)、6-8 周(n=136)、6 个月(n=129)和 12 个月(n=123)进行调查。与接受标准血管内修复术(EVAR)治疗简单肾下腹主动脉瘤的 EVAR1 试验中接受标准 EVAR 治疗的患者的历史结果进行比较,评估身体成分评分(PCS)和精神成分评分(MCS)。

结果

57 例患者为 PAAs,102 例患者为 TAAAs(50 例为 IV 期,52 例为 I-III 期 TAAAs)。无 30 天内死亡、院内死亡、转为开放手术或主动脉相关死亡。1 年生存率为 96%,2 年生存率为 87%。18%的患者发生重大不良事件,1 年再干预率为 14%。两组间 30 天结局无统计学差异。与治疗 PAAs 的患者相比,治疗 TAAAs 的患者基线评分较低(P<0.05)。两组患者在 F-BEVAR 后 6-8 周 PCS 显著下降,PAAs 组在 12 个月时恢复至基线水平,但 TAAA 组未恢复。12 个月时,TAAA 患者的 PCS 明显低于 PAAs 患者(P<0.001)。MCS 平均无下降。重大不良事件与 6-8 周时 PCS 下降有关(P=0.021),但与后续评估无关。再干预对 PCS 或 MCS 无影响。总体而言,接受 F-BEVAR 治疗的患者与 EVAR1 试验中接受标准 EVAR 治疗的患者的 QOL 测量结果相似,除 TAAA 患者 12 个月时 PCS 较低外。

结论

TAAA 患者在健康相关 QOL 的身体方面基线评分较低。F-BEVAR 治疗后两组 PCS 均显著下降,2 个月后改善,PAAs 组恢复至基线水平,但 TAAA 组未恢复。与接受标准 EVAR 治疗肾下主动脉瘤的患者相比,接受 PAAs 治疗的患者 QOL 变化相似。

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