TAVR术后严重出血的预测因子及预后分析

发布时间：2018-05-16 15:13

本文选题：经导管主动脉瓣置换术 + 出血　；参考：《浙江大学》2017年博士论文

【摘要】：第一部分:TAVR术后严重出血预测因子及预后的回顾性研究目的:探究经导管主动脉瓣置换(Transcatheter Aortic Valve Replacement,TAVR)术后严重出血(SevereBleeding,SB)的独立预测因子及SB对预后的影响。方法:本研究入选从2013年3月至2016年10月在浙江大学医学院第二附属医院心血管内科接受TAVR治疗且随访期满30天的重度主动脉瓣狭窄(Aortic Stenosis,AS)患者,搜集基线、化验、检查及操作相关因素的数据。使用Logistic回归模型探索 TAVR 术后 30 天内 SB、致命出血(Life-Threatening Bleeding,LTB)、输血的独立预测因子,以比值比(Odds Ratio,OR)表示风险大小。使用Cox回归模型研究SB、LTB、输血对30天及1年预后的独立影响,以风险比(Hazard Ratio,HR)表示死亡风险大小。使用生存分析曲线呈现SB、LTB、输血对1年及随访终点死亡率的影响,以Log-Rankp表示死亡率的差异。当p0.05时考虑存在统计学意义。结果:本研究入选180例TAVR患者,其中SB、LTB、输血的发生率分别为41.7%、9.4%、14.4%。SB的独立预测因子有6个:其中外周动脉疾病(OR:4.80,p=0.002)、主动脉瓣严重钙化(OR:3.14,p=0.013)、前期入选(OR:8.80,p0.001)可增加 SB 风险;而高体重指数(OR:0.82,p=0.003)、贫血(OR:0.12,p0.001)、经股动脉入路(OR:0.09,p=0.013)可降低SB风险。LTB的独立预测因子只有2个:其中前期入选(OR:4.20,p=0.041)可增加LTB风险;而经股动脉入路(OR:0.03,p=0.001)可降低LTB风险。输血的独立预测因子只有1个:经股动脉入路(OR:0.17,p=0.021)可降低输血风险。SB短期死亡风险呈增加趋势(HR:7.31,p=0.088);中期、随访终点预后均无显著差异。LTB短期死亡风险显著增加(HR:27.78,p=0.001);中期死亡率虽增加(Log-Rankp0.001),但独立死亡风险未增加;随访终点死亡率增加(Log-Rankp0.001)。输血短期(HR:8.28,p=0.036)、中期(Log-Rankp0.001)预后与LTB一致;但随访终点死亡率未增加。术后30天死亡独立预测因子包括转外科手术(HR:30.37,p=0.039)、血管并发症(HR:15.77,p=0.037);1年死亡独立预测因子包括年龄(HR:0.88,p=0.026)、局部麻醉(HR:0.167,p=0.030)、血管并发症(HR:21.48,p=0.001)。结论:外周动脉疾病、主动脉瓣严重钙化、前期入选可增加TAVR术后SB风险,而高体重指数、贫血、经股动脉入路可降低SB风险。前期入选可增加LTB风险,经股动脉入路可降低LTB风险。经股动脉入路可降低输血风险。对于TAVR术后SB、输血、LTB三种情况的整体预后,SB最佳,输血次之,LTB最差。第二部分TAVR术后严重出血预测因子的荟萃分析目的:分析总结经导管主动脉瓣置换(Transcatheter Aortic Valve Replacement,TAVR)相关研究中术后30天内严重出血(SevereBleeding,SB)的预测因子的效应估计值。方法:本研究对报道TAVR术后出血且包含感兴趣预测因子的研究进行系统回顾及荟萃分析,并提取了研究、患者以及操作相关的数据。危险比(RiskRatio,RR)与95%置信区间用随机效应模型计算,p0.05则认为具有统计学意义。结果:本研究在包含65,209个患者的47个研究分析了 15个因素。SB中位发生率为11%。其中7个因素为TAVR术后早期SB的预测因子。年龄≥90(RR:1.17;p =0.008)、女性(RR:1.13;p = 0.01)与鞘管直径19French(RR:1.19;p = 0.04)为弱预测因子。慢性肾脏病(Chronic Kidney Disease,CKD)(RR:1.94;p0.001)与经心尖途径(TransApical,TA)(RR:1.82;p0.001)为中等预测因子,几乎与 2 倍风险相关。血管并发症(Vascular Complication,VC)(RR:2.97;p0.001)与循环支持(Circulatory Support,CS)(RR:3.39;p0.001)为强预测因子,几乎与3倍风险相关。其他8个因素,包括体重指数、糖尿病、心房颤动、冠心病、外周动脉疾病、贫血、双联抗血小板治疗、经锁骨下途径,与SB风险均无显著相关性。结论:本荟萃分析发现,年龄、性别、CKD、TA、鞘管直径、VC、CS均为TAVR术后早期SB的预测因子,为TAVR术后SB的预防与管理提供了一定的指导意义。
[Abstract]:Part one: a retrospective study of predictors and prognosis for severe hemorrhage after TAVR: To explore the independent predictors of severe hemorrhage (SevereBleeding, SB) after transcatheter aortic valve replacement (Transcatheter Aortic Valve Replacement, TAVR) and the effect of SB on prognosis. Methods: This study was selected from March 2013 to October 2016 in Zhejiang Province. The cardiovascular department of the Second Affiliated Hospital of Jiangu University of Medicine received TAVR treatment and patients with severe aortic valve stenosis (Aortic Stenosis, AS) who were followed up for 30 days to collect data on baseline, test, examination, and operation related factors. The Logistic regression model was used to explore SB, fatal hemorrhage (Life-Threatening Bleeding, LTB) within 30 days after TAVR. The independent predictor of blood transfusion, using the Odds Ratio (OR) to represent the risk size. Use the Cox regression model to study the independent effects of SB, LTB, blood transfusion on the 30 and 1 year prognosis, with the risk ratio (Hazard Ratio, HR) to represent the risk of death. Use the survival analysis curve to present SB, LTB, the effect of blood transfusion on 1 years and the mortality rate of follow-up endpoints, with Log-Ra NKP showed a difference in mortality. When P0.05 was considered statistically significant. Results: 180 cases of TAVR patients were enrolled in this study, of which SB, LTB, the incidence of blood transfusion was 41.7%, 9.4%, 14.4%.SB independent predictors of 6: peripheral artery disease (OR:4.80, p=0.002), aortic valve severe calcification (OR:3.14, p=0.013), early selection (OR:8.80, OR:8.80, P0.001) can increase the risk of SB; while OR:0.82 (p=0.003), anemia (OR:0.12, p0.001), only 2 independent predictors of SB risk.LTB can be reduced via the femoral artery approach (OR:0.09, p=0.013). There were only 1 independent predictors: OR:0.17 (p=0.021) could reduce the risk of blood transfusion in.SB (HR:7.31, p=0.088). In the medium term, there was no significant difference in the prognosis of.LTB short term death (HR:27.78, p=0.001) at the end point of follow-up (HR:27.78, p=0.001); the risk of independent death was no longer (Log-Rankp0.001), but the risk of independent death was not. Increased follow-up end point mortality increased (Log-Rankp0.001). Blood transfusion short-term (HR:8.28, p=0.036), intermediate (Log-Rankp0.001) prognosis was consistent with LTB; but the mortality rate at the end of follow-up did not increase. The 30 day postoperatively independent predictors of death included transthoracic surgery (HR:30.37, p=0.039), vascular complications (HR:15.77, p=0.037), and 1 year mortality independent predictors including Age (HR:0.88, p=0.026), local anesthesia (HR:0.167, p=0.030), vascular complications (HR:21.48, p=0.001). Conclusions: peripheral arterial disease, severe calcification of the aortic valve, and early entry of the aortic valve can increase the risk of SB after TAVR, while high body mass index, anemia, and femoral artery approach can reduce the risk of SB. Early admission can increase the risk of LTB and reduce the risk of LTB by femoral artery approach. Low LTB risk. Transfemoral approach can reduce the risk of blood transfusion. For the overall prognosis of SB, blood transfusion, and LTB three cases after TAVR, SB is the best, blood transfusion is the best, LTB is the worst. The meta analysis of the predictors of severe hemorrhage after the second part of TAVR: analysis and summary of transcatheter aortic valve replacement (Transcatheter Aortic Valve Replacement, TAVR) phase Effect estimates of the predictors of severe bleeding (SevereBleeding, SB) within 30 days of the study. Methods: a systematic review and meta-analysis of the study on TAVR postoperative bleeding and the inclusion of a predictive factor of interest was carried out, and the study, patients, and operation related data were extracted. The risk ratio (RiskRatio, RR) and the 95% confidence interval were extracted. With a random effect model, P0.05 was considered to be statistically significant. Results: in this study, 47 studies involving 65209 patients showed that the median incidence of.SB was 11%., of which 7 factors were predictors of early SB after TAVR. Age more than 90 (RR:1.17; P =0.008), women (RR:1.13; P = 0.01) and 19French (RR:1) sheath diameter (RR:1) .19; P = 0.04) is a weak predictor. Chronic renal disease (Chronic Kidney Disease, CKD) (RR:1.94; p0.001) and the apical pathway (TransApical, TA) (RR:1.82; p0.001) are medium predictors, almost 2 times the risk. 001) for strong predictors, almost 3 times the risk. Other 8 factors, including body mass index, diabetes, atrial fibrillation, coronary heart disease, peripheral artery disease, anemia, double antiplatelet therapy, and subclavian pathway, were not associated with SB risk. Conclusion: this meta-analysis shows that age, sex, CKD, TA, sheath diameter, VC, CS are TAVR Predictors of early postoperative SB provide guidance for prevention and management of SB after TAVR.

【学位授予单位】：浙江大学
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R654.2

【参考文献】