Analysis Of Outcomes And Risk Factors Of Transcatheter Aortic Valve Replacement And The Effects Of Different Anesthesia Methods On Outcome

Part Ⅰ:A single-center analysis of outcomes,risk factors in patients treated with early transcatheter aortic valve implantationBackground:Transcatheter aortic valve implantation(TAVI)has been wildly accepted as strategies for valve disease treatment.China initiated the first TAVI in 2010,Up to now,only a few studies reported outcomes more than 100 cases in a single center in China.In recent years,several Chinese-designed TAVI devices emerged and have been approved for sale,including Venus A,J-Valve,TaurusOne,VitaFlow.However,the comparative performance of these valves has not yet been investigated in the literature.This manuscript was designed for three major destination:to analyze the midterm outcomes and current status of TAVI applied in a single-center in China,and to identify key risk factors associated with poor outcomes.Lastly,we provided comparative results of newly designed Chinese valves applied in the TAVI group.Methods:Consecutive patients who were scheduled for elective TAVI between September 2012 and January 2018 in fuwai Hospital were considered for inclusion in this study.After preliminarily estimating the age distribution of patients with TAVI,we found that at least 90%of patients were over 69 years old.Accordingly,we enrolled elderly patients(≥69 years)who underwent surgical aortic valve replacement(SAVR)in addition to the TAVI cohort.The primary endpoint was all-cause mortality.Secondary endpoints included stroke,new-onset atrial fibrillation(NOAF),permanent pacemaker implantation(PPI),myocardial infarction(MI),heart failure(HF),readmission,paravalvular regurgitation(PVR).A composite of all-cause mortality,stroke,NOAF,PPI,MI,HF,and high-grade atrioventricular block(HAVB)was used to evaluate the endpoints among the different valves.To reduce potential bias,we introduced inverse probability of treatment weighting(IPTW).Kaplan-Meier survival analysis was used to describe the time to events,followed by the log-rank test comparing the endpoints between groups.The Cox proportional hazards model was then applied to analyze the predictors of all-cause mortality,postoperative stroke,and postoperative HF in both the weighted and unweighted samples.Results:Follow-up was performed for a median of 29 months(16.5,46).TAVI group also had a shorter operative duration(115 vs.184 min,P<0.001).Participants in the TAVI group were less likely to require general anesthesia(38.9%vs.100%,P<0.001)and intensive care unit(ICU)admission(37.1%vs.100%,P<0.001)than the patients in the SAVR group,and these outcomes were robust after IPTW adjustment(IPTW-adjusted P<0.001).The TAVI cohort also appeared to have higher rates of all-cause mortality(16.3%vs.4.4%,TAVI vs.SAVR,HR:3.79,95%CI:1.31 to 10.96,P=0.014)and PPI(17.0%vs.2.9%,TAVI vs.SAVR,HR:6.17,95%CI:1.87 to 20.36,P=0.003)at 3 years than the SAVR cohort.These results were in line with the effects after IPTW adjustment(all-cause mortality:11.4%vs.2.4%,HR:4.79,95%CI:1.47 to 15.57,IPTW-adjusted P=0.009;PPI:14.6%vs.1.6%,HR:9.98,95%CI:2.71 to 36.67,TAVI vs.SAVR,IPTW-adjusted P<0.001).With regard to postoperative HF,the TAVI cohort had a higher rate of HF(7.2%vs.1.8%,TAVI vs.SAVR,HR:3.57,95%CI:0.79 to 16.1,P=0.098)at 3 years than the SAVR cohort,although there was no statistical difference.However,the difference became slightly significant after IPTW adjustment(4.9%vs.0.9%,TAVI vs.SAVR,HR:4.89,95%CI:1.0 to 23.95,IPTW-adjusted P=0.051).The differences in stroke(5.6%vs.6.4%,IPTW-P=0.930)、NOAF(9.2%vs.19.1%,IPTW--adjusted P=0.249)、readmission(11.8%vs.18.1%,IPTW-adjusted P=0.213)at 3 years between the TAVI and SAVR cohorts were not statistically significant.The rate of>mild PVR in the TAVI cohort at 1 week,1 month,and 1 year after surgery was 6.6%,5.5%,and 2.6%,respectively.Compared with SAVR(following which no cases of mild,moderate,or severe PVR were reported),TAVI was still inferior(P<0.001).In the multivariable Cox regression analysis based on the entire sample,liver disease was associated with all-cause mortality(HR:5.080,95%CI:1.067 to 24.174,P=0.041),A smoking history was associated with an increased risk of postoperative heart failure(HR:4.902,95%CI:1.265 to 18.999,P=0.022).Additionally,age(HR:1.141,95%CI:1.010 to 1.288,P=0.034)and diabetes(HR:7.301,95%CI:2.414 to 22.079,P<0.001)were identified as predictors of postoperative stroke.In the new valve subgroups,the 1-year composite endpoints were 38.2%(Venus A),35.3%(TaurusOne),34%(J-Valve),and 28%(VitaFlow)(P=0.857).We ran Cox regression separately to explore whether the type of valve used had an impact on all-cause mortality,stroke,postoperative HF,and readmission.The results revealed that none of the valves had a significant association with all-cause mortality,postoperative stroke,or HF(P>0.05).Conclusion:We found that TAVI is associated with higher rates of all-cause mortality,PPI,HF,and PVR than SAVR;however,it has lower rates of general anesthesia use and ICU admission,as well as a shorter operative duration.For patients wiith liver disease,smoking history,higher age and diabetes,great care can not be emphasized more during the operation.In the early years when we initiated TAVI at our hospital,TAVI was mainly applied to specific patients.Compared with SAVR,TAVI didn’t attain satisfactory outcomes.Further investigations are needed to explore the characteristics of Chinses TAVI,and to help improve the therapies and perioperative management suitable for Chinese people.Part Ⅱ:A comparable analysis of different anesthetic strategies in transcatheter aortic implantationBackground:General anesthesia(GA)has been adopted as the standard since transcatheter aortic valve implantation(TAVI)was adopted.Nowadays,there is a trend toward the more liberal use of local or combined with conscious sedation(CS)for TAVI.However,it still remains debated what kind of anesthetic strategies led to optimized outcomes.Previous studies have described that the use of CS correlated with improved outcomes compared with GA,including decreased in-hospital or 30-day mortality,lower expenditures of health care resources,briefer intensive care unit(ICU)and hospital length of stay,and reduced risk of postoperative delirium.From these points,the risk related to GA might outweigh its benefits.Additionally,acute kidney injury(AKI)and new-onset atrial fibrillation(NOAF)are common complications after valve replacement,but the relationship between anesthesia strategies and AKI or NOAF is lacking.Currently,anesthetic experience related to TAVI has been less reported,and CS has been the major method since TAVI was first initiated in our center.This study aimed to explore the impact of different anesthetic strageties on outcomes,and to help improve the perioperative management by summarizing the experience.Methods:All consecutive patients who underwent transfemoral(TF),transapical(TA),and transaortic(TAO)TAVI in fuwai Hospital from 2012 to 2018 were retrospectively collected and analyzed the outcomes under GA or CS.A subgroup analysis of GA-TF-TAVI,GA-TAO-TAVI,GA-TA-TAVI,and additionally all TF-TAVR subdivided into 2 subgroups to verify the effect of different strategies on patients.Binary logistic regression and adjusted multilevel logistic regression were performed to analyze the predictors of AF and AKI.Variables chosen for inclusion in the model predicting AF were age,COPD,GA,reintervention,NYHA class>II,peripheral vascular disease,diabetes,and TAO approach.Variables in the AKI predicting model included GA,age,diabetes,NYHA class>II,glomerular filtration rate(GFR)>60 mL/min/1.73m2,anesthetic duration,peripheral vascular disease,reintervention,ACEI/ARB drugs within 48 h,TAO approach,and male.Results:A total of 173 patients were enrolled:107 TAVR were under CS,and 66 under GA.In the GA group,27 cases were performed via TF approach,13 via TA approach,and 26 via TAO approach,whereas 107 patients in the CS cohort were conducted via TF access.There were in all 134 TF-TAVR based on the above summary.Preoperative characteristics were similar between the 2 groups.No significant differences between the GA and CS groups were observed in the aspects of operative duration(GA 120 min vs.CS 115 min;P=0.811),anesthetic duration(GA 163 min vs.CS 159 min;P=0.645),postoperative length of stay(GA 9 days vs.CS 8 days;P=0.081),all-cause mortality(CS 4.7%vs.GA 10.8%,P=0.130),stroke(3.7%vs.6.1%,P=0.481),permanent pacemaker implantation(17.8%vs.7.9%,P=0.063),valve thrombosis(0.9%vs.1.7%,P=0.718).Available data exhibited that there was no significant difference in ≥ mild paravalvular regurgitation between GA and CS at 1 week(GA 34.9%vs.CS 37.9%;P=0.703),1 month(GA 36.7%vs.CS 36.7%;P=0.998),and 1 year(GA 36.4%vs.CS 31.4%;P=0.589).The GA group had a significantly higher rate of AKI(28.8%vs.14.0%,P=0.018)and NOAF(15.2%vs.5.5%at 1 year,P=0.036).Adjusted multilevel logistic regression confirmed GA to be a significant predictor of new-onset AF(odds ratio(OR)3.237,95%confidence interval(CI):1.059 to 9.894;P=0.039)and AKI(OR:2.517,95%CI:1.013 to 6.250,P=0.047).We also set an adjusted model exclusively based on TF-TAVI to avoid the bias that comes with approach.Results revealed the effect of GA on AF(OR:5.193,95%CI:1.288 to 20.943,P=0.021)and AKI(OR:4.596,95%CI:1.167 to 18.096,P=0.029)still remained in the TF-TAVR despite that the sample was limited.Conclusion:GA was associated with postoperative AKI,and NOAF.Patients could benefit from CS if CS was suitable for TAVI.