[Outcome comparison of different therapy procedures in surgical high-risk elderly patients with severe aortic stenosis]

Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Jan 25;45(1):13-18. doi: 10.3760/cma.j.issn.0253-3758.2017.01.004.
[Article in Chinese]

Abstract

Objective: To compare the outcome of surgical high-risk elderly patients with severe aortic stenosis(SAS) treated by different therapy procedures, including transcatheter aortic valve implantation(TAVI), surgical aortic valve replacement(SAVR), and drug therapy. Methods: We retrospectively analyzed the clinical data of 242 surgical high-risk elderly (age ≥65 years old) SAS patients hospitalized in Fuwai Hospital between September 2012 and June 2015. According to the treatment method, patients were divided into TAVI group (81 cases), SAVR group (59 cases) and drug therapy group (102 cases). The primary end point was all-cause mortality at 1 year post procedure, and secondary end point included cardiac function class(NYHA), vascular complication, valvular function, non-fatal myocardial infarction, new atrial fibrillation, stroke, bleeding, pacemaker implantation, acute renal failure, and readmission. We used the Kaplan-Meier method to estimate survival function based on follow up data and survival was compared between groups with the use of the log-rank test. Results: (1) In the baseline data, there were statistically significant difference among 3 groups for the age, left ventricular ejection fraction, cardiac function class Ⅲ and Ⅳ, rates of combined diabetes, chronic renal failure, mild and moderate mitral regurgitation (P<0.01 or 0.05). The risk score of the Society of Thoracic Surgeons(STS) was 7.28±4.98 in the TAVI group, and 5.67±3.49 in the SAVR group(P=0.036). (2) The perioperative rates of pacemaker implantation(11.3%(9/81) vs. 0, P=0.025) and mild paravalvular regurgitation(29.6%(24/81) vs.1.7%(1/59), P<0.001) were significantly higher in TAVI group than in SAVR group.(3)The rate of rehospitalization was significantly lower in TAVI group than in SAVR group(3.0%(2/67) vs. 22.7%(10/44) P=0.005) and the rate of pacemaker implantation was significantly higher in TAVI group than in SAVR group(17.5 (12/67) vs. 0, P=0.008) after 1 year. The rates of death from any cause in the TAVI (5.8%(4/67)) and SAVR group (11.4%(5/44)) were significantly lower than that in the drug therapy group (54.9%(50/91), both P<0.05) after 1 year and was similar between TAVI group and SAVR group(P=0.622). (4) The rates of cardiac function classⅠandⅡ increased and Ⅲ and Ⅳ decreased in TAVI and SAVR group after 1 year when compared with base line(P<0.001). The rates of cardiac function class Ⅱ, and Ⅲ increased , class Ⅰ and Ⅳ decreased in drug therapy group after 1 year compared with base line (P=0.020). (5)The survival rates after 1 year were significantly higher in the TAVI group and SAVR group than in the drug therapy group(log-rank test, P<0.001), and the difference was similar between TAVI group and SAVR group (log-rank test, P=0.062). Conclusion: In surgical high-risk elderly patients with SAS, the prognosis of drug therapy was poor, and TAVI and SAVR were associated with similarly improved rates of survival after 1 year, although there were significant differences in periprocedural complications between TAVI and SAVR groups.

目的: 探讨经导管主动脉瓣置入术(TAVI)、外科主动脉瓣置换术(SAVR)及药物治疗对外科高危老年重度主动脉瓣狭窄(SAS)患者预后的影响。 方法: 入选2012年9月至2015年6月在阜外医院住院治疗的≥65岁外科手术高危SAS患者242例,对其临床资料进行回顾性分析。根据治疗方式的不同,将患者分为TAVI组(81例)、SAVR组(59例)和药物治疗组(102例)。治疗后对患者进行随访,主要终点为1年内的全因死亡;次要终点包括心功能(NYHA分级)、血管并发症、瓣膜功能、非致命性心肌梗死、新发心房颤动、卒中、出血、起搏器植入、急性肾功能衰竭和再住院。使用Kaplan-Meier法估计和绘制生存曲线,使用log-rank检验进行病死率的组间比较。 结果: (1)在基线资料中,3组患者的年龄、左心室射血分数、心功能Ⅲ和Ⅳ级、合并糖尿病、慢性肾功能不全、轻和中度二尖瓣反流比例差异均有统计学意义(P<0.01或0.05);TAVI组的STS评分高于SAVR组[(7.28±4.98)分比(5.67±3.49)分,P=0.036]。(2)在围手术期并发症中,TAVI组植入起搏器[11.3%(9/81)比0, P=0.025]和轻度瓣周漏的比例均高于SAVR组[29.6%(24/81)比1.7%(1/59),P<0.001]。(3)治疗后1年,TAVI组再住院的比例低于SAVR组[3.0%(2/67)比22.7%(10/44) P=0.005],起搏器植入的比例高于SAVR组[17.5 (12/67)比0,P=0.008];TAVI组和SAVR组治疗后1年的全因死亡比例均低于药物治疗组[5.8%(4/67)和11.4%(5/44)比54.9%(50/91),P均<0.05],而TAVI组与SAVR组之间差异无统计学意义(P=0.622)。(4)与基线比较,TAVI组和SAVR组术后1年心功能Ⅰ和Ⅱ级的比例增高,而Ⅲ和Ⅳ级的比例减少(P<0.001);药物治疗组治疗后1年心功能Ⅰ和Ⅳ级的比例减少,而Ⅱ和Ⅲ级的比例增高(P=0.020)。(5)生存曲线显示,TAVR组和SAVR组的生存率均高于药物治疗组(log-rank检验,P均<0.001),而TAVR组和SAVR组之间的生存率差异无统计学意义(log-rank检验,P=0.062)。 结论: 对于外科手术高危的老年SAS患者,单纯药物治疗预后较差。TAVI及SAVR改善1年生存率的作用相似,但围手术期并发症发生率有所差异。.

Keywords: Aortic valve stenosis; Cardiac surgical procedures; Transcatheter aortic valve implantation.

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Aortic Valve
  • Aortic Valve Stenosis / therapy*
  • Atrial Fibrillation
  • Female
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Mitral Valve Insufficiency
  • Myocardial Infarction
  • Prognosis
  • Risk Factors
  • Stroke
  • Time Factors
  • Transcatheter Aortic Valve Replacement*
  • Treatment Outcome
  • Ventricular Function, Left