中国经导管主动脉瓣置换术后的特点和结局:来自中国主动脉瓣经导管置换登记研究(CARRY)的报告。

Characteristics and outcomes following transcatheter aortic valve replacement in China: a report from China aortic valve transcatheter replacement registry (CARRY).

机构信息

Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.

Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110000, China.

出版信息

Chin Med J (Engl). 2021 Nov 19;134(22):2678-2684. doi: 10.1097/CM9.0000000000001882.

Abstract

BACKGROUND

The past decade has witnessed an ever-increasing momentum of transcatheter aortic valve replacement (TAVR) and a subsequent paradigm shift in the contemporary management of severe aortic stenosis (AS). We conducted a multi-centric TAVR registry based on Chinese patients (the China Aortic valve tRanscatheter Replacement registrY [CARRY]) to delineate the clinical characteristics and outcomes of Chinese patients who underwent TAVR and compare the results between different valve types in different Chinese regions.

METHODS

CARRY is an all-comer registry of aortic valve disease patients undergoing TAVR across China and was designed as an observational study that retrospectively included all TAVR patients at each participating site. Seven hospitals in China participated in the CARRY, and 1204 patients from April 2012 to November 2020 were included. Categorical variables were compared using the chi-squared test, and continuous variables were analyzed using a t test or analysis of variance (ANOVA) test. The Kaplan-Meier curve was used to estimate the risk of adverse events during follow-up.

RESULTS

The mean age of the patients was 73.8 ± 6.5 years and 57.2% were male. The median Society of Thoracic Surgeon-Predicted Risk of Mortality score was 6.0 (3.7-8.9). Regarding the aortic valve, the proportion of bicuspid aortic valve (BAV) was 48.5%. During the hospital stay, the stroke rate was 0.7%, and the incidence of high-degree atrioventricular block indicating permanent pacemaker implantation was 11.0%. The in-hospital all-cause mortality rate was 2.2%. After 1 year, the overall mortality rate was 4.5%. Compared to patients with tricuspid aortic valve (TAV), those with BAV had similar in-hospital complication rates, but a lower incidence of in-hospital mortality (1.4% vs. 3.3%) and 1 year mortality (2.3% vs. 5.8%).

CONCLUSIONS

TAVR candidates in China were younger, higher proportion of BAV, and had lower rates of post-procedural complications and mortality than other international all-comer registries. Given the use of early generation valves in the majority of the population, patients with BAV had similar rates of complications, but lower mortality than those with TAV. These findings further propel the extension of TAVR in low-risk patients.

TRIAL REGISTRATION

https://www.chictr.org.cn/ (No. ChiCTR2000038526).

摘要

背景

过去十年见证了经导管主动脉瓣置换术(TAVR)的日益普及,以及严重主动脉瓣狭窄(AS)治疗的当代模式发生了转变。我们开展了一项基于中国患者的多中心 TAVR 注册研究(China Aortic valve tRanscatheter Replacement registrY [CARRY]),以阐明接受 TAVR 的中国患者的临床特征和结局,并比较不同中国地区不同瓣膜类型的结果。

方法

CARRY 是一项在中国各地开展的主动脉瓣疾病患者接受 TAVR 的登记研究,设计为回顾性观察研究,纳入了每个参与中心的所有 TAVR 患者。中国的 7 家医院参与了 CARRY,共纳入了 2012 年 4 月至 2020 年 11 月的 1204 例患者。分类变量采用卡方检验比较,连续变量采用 t 检验或方差分析(ANOVA)检验。采用 Kaplan-Meier 曲线估计随访期间不良事件的风险。

结果

患者的平均年龄为 73.8±6.5 岁,57.2%为男性。中位胸外科医师协会预测死亡率评分(STS-PROM)为 6.0(3.7-8.9)。就主动脉瓣而言,二叶式主动脉瓣(BAV)的比例为 48.5%。住院期间,卒中发生率为 0.7%,需植入永久性起搏器的高度房室传导阻滞发生率为 11.0%。住院期间全因死亡率为 2.2%。1 年后,总死亡率为 4.5%。与三叶式主动脉瓣(TAV)患者相比,BAV 患者的院内并发症发生率相似,但院内死亡率(1.4% vs. 3.3%)和 1 年死亡率(2.3% vs. 5.8%)较低。

结论

中国的 TAVR 候选人群更年轻,BAV 比例更高,术后并发症和死亡率低于其他国际全因登记研究。由于大多数人群使用的是早期一代瓣膜,BAV 患者的并发症发生率相似,但死亡率低于 TAV 患者。这些发现进一步推动了 TAVR 在低危患者中的应用。

临床试验注册

https://www.chictr.org.cn/(注册号:ChiCTR2000038526)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc4b/8631376/5d77dc55f18c/cm9-134-2678-g001.jpg

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