经导管主动脉瓣置换术早期治疗高危患者的 10 年随访结果。

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

机构信息

Center for Heart Valve Innovation, St Paul's Hospital, University of British Columbia, Vancouver, Canada.

出版信息

Catheter Cardiovasc Interv. 2021 Feb 15;97(3):E431-E437. doi: 10.1002/ccd.29124. Epub 2020 Jul 6.

Abstract

BACKGROUND

The long-term clinical performance of transcatheter heart valves (THV) is unknown.

AIMS

This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up.

METHODS

Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients.

RESULTS

At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%.

CONCLUSION

Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

摘要

背景

经导管心脏瓣膜(THV)的长期临床效果尚不清楚。

目的

本研究评估了经导管主动脉瓣置换术(TAVR)后 10 年随访患者的临床结局、结构性瓣膜退化(SVD)和生物瓣失效的发生率。

方法

连续纳入 2005 年至 2009 年在我院行 TAVI 治疗的原发性主动脉瓣狭窄或主动脉外科生物瓣失效的患者。共纳入 235 例连续患者。

结果

TAVI 时的平均年龄为 82.4±7.9 岁。所有患者均被判定为高危患者,STS 评分>8 者占 53.6%。植入的 THV 为 Cribier-Edwards(20.9%)、Edwards SAPIEN(77.4%)或 CoreValve(1.7%)。1、5 和 10 年随访时的死亡率分别为 23.4%、63%和 91.6%。在总队列中,15 例患者发生结构性瓣膜退化/生物瓣失效,10 年累积发生率为 6.5%(95%CI 3.3%,9.6%)。4、6、8 和 10 年时的 SVD/BVF 发生率分别为 0.4%、1.7%、4.7%和 6.5%。9 例患者发生中度 SVD,6 例患者发生重度 SVD。6 例重度 SVD 患者中,2 例患者接受了再介入治疗(1 例患者行再次 TAVR,另 1 例患者行外科主动脉瓣置换术)。10 年随访时的存活者(n=19),平均梯度为 14.0±7.6mmHg,主动脉瓣反流≥中度者占 5%。10 年存活者的生活质量测量结果显示,ADLs 为 6/6 的占 43.8%,无移动辅助工具的步行能力为 62.5%。

结论

在高危人群中使用早期的球囊扩张型 THV,10 年随访时结构性瓣膜退化和瓣膜失效的发生率较低。本研究提供了关于经导管心脏瓣膜长期性能和患者自我报告获益的见解。

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