| Background:Warfarin is an effective and most widely prescribed oral anticoagulant agent for patients after mechanical heart valve replacement(MHVR)currently,which has a narrow therapeutic range.Consequently,patients need to routinely test the international standardized ratio(INR)to monitor the patient's response to anticoagulant therapy after discharge,and an appropriate dosage of warfarin should be provided according to the INR to maintain a stable anticoagulant effect.Despite the importance of maintaining the stability of INR,the study about which anticoagulation management model can effectively improve the quality of anticoagulant therapy,reduce anticoagulant-related complications(such as bleeding and thromboembolism),and improve their long-term survival rate in China is currently lacking.Therefore,we propose to establish an internet-based follow-up management application(App)based on smartphones for the patients after MHVR.The system will provide doctors and patients with a more standardized and safer method of follow-up to further reduce the risk of anticoagulation-related complications and improve their treatment effects.To evaluate whether the internet-based anti coagulation management system based on a smartphone App is better than traditional anticoagulation management,we conducted this randomized controlled trial(RCT).Method:This paper reported preliminary results from a single center of the multi-center RCT study.Patients who meet the entry criteria will be randomly divided into a novel anticoagulation management group and traditional anticoagulation management group.Patients in the novel anticoagulation management group will use a smartphone App for anticoagulation management,while others will be managed by clinicians.The primary end point was the time in therapeutic range(TTR)during one-year follow-up.At the same time,all patients were followed up prospectively for adverse cardiovascular events,including all-cause death,thromboembolic events,major bleeding events and minor bleeding events.Composite endpoints are defined as all-cause death,thromboembolism events,and major bleeding events.Kaplan-Meier curve model was used to estimate the event-free cumulative survival rate of different anticoagulation managements,and the log-rank test was used to compare the differences between the two groups.Results:In this prospective RCT study,our center has currently enrolled 330 patients undergoing MHVR surgery.The current results are a preliminary analysis of 258 patients who has completed the follow-up investigation.128 patients were included in the novel anticoagulation management group,and 130 patients were included in the traditional anticoagulation management group.Among all patients,there were 134 males(51.9%)with an average age of 49.5± 10.1 years.There were no differences in the demographic data between two groups like gender,age,smoking history,and diabetes history at baseline.The detailed information on the surgery and treatment discharged also showed no statistical difference between the two groups,indicating that the two groups of patients were comparable.The median follow-up period for all patients was 12.9 months(range:10.3 to 15.4 months),of which the novel anticoagulation management group was 12.7 months(range:10.3 to 15.4 months)and the traditional anticoagulation management group was 13.1 months(range:10.8 to 14.2 months).The TTR of the new anticoagulation management group and the traditional anticoagulation management group were 60.88%±28.87%and 60.98%±25.92%,and the difference was not statistically significant.INR variation rates were 0.26±0.18 and 0.26±0.17,respectively.The proportions of INRs in range(PINRR)was 57.33%±21.98%and 54.58%±21.69%and the difference was not statistically significant.The incidences of thromboembolism events and bleeding events in the new and traditional anticoagulation management groups were 1.6%vs.0.8%,and 25.7%vs.31.5%,respectively,which did not reach statistical significance.The incidences of the composite end point were similar in both groups(3.1%).Kaplan-Meier curve showed that compared with the traditional anticoagulation management group,the difference in cumulative event-free survival rate of the new anticoagulation management group did not reach statistical significance.After excluding patients without INR test records after 1-month post-surgery,sensitivity analysis was performed on the remaining 210 patients.Among 98 patients in the new anticoagulation management group,TTR and PINRR were 62.44%±27.01%and 58.24%±18.24%,and 112 patients in the traditional anticoagulation management group,TTR and PINRR were 63.80%±24.50%and 56.47%±20.15%.No statistical difference between the two groups were found in TTR and PINRR.The incidences of all-cause death,thromboembolism,bleeding,and composite endpoints between the two groups were similar.Conclusions:In patients undergoing MHVR surgery,compared with traditional anticoagulation management,the novel anticoagulation management based on smartphone App reached a similar level of control.There was no statistically significant difference in TTR between the two groups.The incidences of adverse cardiovascular events were similar between the two groups,and sensitivity analysis showed robust results.The trial is ongoing,further longitudinal,and larger sample size analysis are required to verify our preliminary results.Background:Atrial fibrillation is associated with an increased 3-5 times risk of stroke,and most embolic originate from the left atrial appendage.This finding led to a series of studies evaluating the impact of concomitant surgical left atrial appendage occlusion(SLAAO)in patients receiving cardiac surgery on clinical outcomes.SLAAO may be associated with a lower risk of thromboembolism(TE)in patients with AF during cardiac surgery.Patients with a mechanical heart valve usually take anticoagulant therapy to prevent TE.However,evidence regarding the effectiveness of SLAAO among patients receiving-mechanical heart valve replacement(MHVR)is lacking.Therefore,this study aims to evaluate the association of SLAAO with the risk of cardiovascular outcomes in patients with atrial fibrillation(AF)undergoing the MHVR procedure.Methods:A total of 497 patients with AF(27.6%of patients received SLAAO procedure)were retrospectively included in this analysis.The primary outcome was a composite of ischemic stroke(IS),systemic embolism(SE),and all-cause mortality.The secondary outcome was a composite of IS,SE,all-cause death and major bleeding.Cumulative event-free survival rates were estimated by the Kaplan-Meier curve,and the multivariate Cox analyses were performed to evaluate the association between SLAAO and outcomes.Besides,one-to-one propensity score matching(PSM)was used to balance baseline characteristics and matching pairs were derived and analyzed.Subgroup analysis were performed based on the patient's baseline characteristics,which aimed to assess the impact of MHVR undergoing SLAAO surgery on the risk of cardiovascular outcome events between different subgroups.Results:A total of four hundred and ninety-seven patients with AF who underwent MHVR were enrolled(mean age:55.9±8.6;female:61.8%).Patients were divided into SLAAO group(N=137)and No-SLAAO group(N=360)according to whether underwent SLAAO and MHVR surgery at the same time.Five patients died within 30 days after surgery.The incidence of in-hospital complications between the two groups,including the incidence of secondary thoracotomy,the rate of postoperative red blood cell transfusion and the incidence of acute kidney injury were not statistically different(all P>0.05).After a median follow-up of 13.6 months,a total of 14 primary events occurred,death occurred in 4 patients,IS in 8 and SE in 2.Kaplan-Meier curves showed no difference in the cumulative incidence of freedom from primary outcome,hemorrhagic event and the composite outcome between the 2 groups.After adjustment for a number of traditional cardiovascular risk factors,multivariable Cox proportional hazards regression analysis showed no association between SLAAO and any outcomes.After the 1:1 PSM,120 pairs of patients were matched from the SLAAO group and the No-SLAAO group,and there was no significant statistical difference between the baseline characteristic variables of the two groups after matching.Multivariate Cox proportional hazards regression analysis showed no association between MHVR combined with SLAAO surgery and a lower incidence of primary or secondary endpoint events.Subgroup analysis were performed based on the patient's gender,body mass index,CHA2DS2-VASc score,previous coronary heart disease history,left atrium inner diameter,and antiplatelet drug use.Subgroup analysis showed that compared with MHVR surgery,SLAAO combined with MHVR surgery did not significantly reduce the primary end point events.Conclusion:In this retrospective study,in patients with AF,concomitant SLAAO procedure was associated with longer length of stay,CPB and aortic cross-clamp time,but was not associated with additional protection effects against thromboembolic events and mortality during a one-year follow-up.Background:More than one-third of patients with valvular heart disease(VHD)also have coronary artery disease(CAD).When patients undergoing valvular surgery have severe or critical CAD,concomitant coronary artery bypass grafting(CABG)is recommended to avoid perioperative myocardial infarction.Patients receiving Mechanical heart valve replacement(MHVR)and CABG have higher postoperative thromboembolic events,which indicates that anticoagulation and antithrombotic treatment therapy for these patients are worthy of attention.However,the antithrombotic and antithrombotic strategy of patients undergoing MHVR and CABG remains undetermined.It is unclear whether long-term aspirin treatment based on warfarin treatment could bring benefits to cardiovascular events.Therefore,this study aimed to evaluate the impact of postoperative aspirin therapy on cardiovascular adverse events during follow-up,and the risk factors for early surgical-related adverse events and cardiovascular adverse events during the 1-year follow-up period in patients with MHVR combined with CABG surgery.Methods:Patients who underwent MHVR surgery and CABG surgery in our hospital during the same period from January 1,2016 to December 31,2018 were consecutively enrolled.Patients were grouped by aspirin treatment and prospectively followed discharge.Cardiovascular adverse events included all-cause death,myocardial infarction(MI),ischemic stroke,systemic embolism,major bleeding,and coronary revascularization.The primary endpoint was defined as all-cause death,MI,ischemic stroke,systemic embolism,and coronary.revascularization.The secondary endpoint was defined as major bleeding and a composite endpoint of all events.The embolism-related endpoint was defined as MI,ischemic stroke,systemic embolism,and coronary revascularization.Hard endpoint was defined as MI,ischemic stroke,systemic embolism,and all-cause death.The Kaplan-Meier curves were used to estimate the cumulative event-free survival rate.The univariate and multivariate Cox proportional hazard models were used to assess the relationship between aspirin use and cardiovascular adverse events after discharge with hazard ratios(HR)and 95%confidence intervals(CI).Results:A total of 535 patients were followed up for one year.Among them,491 patients were treated with warfarin plus aspirin and 44 patients only treated with warfarin.During follow-up,28(5.2%)primary endpoint,20(3.7%)embolism-related endpoint,26(4.9%)hard endpoint,6(1.1%)primary bleeding and 34(6.4%)composite endpoint were recorded.The Kaplan-Meier curve showed that the incidence of major bleeding endpoints during follow-up was significantly lower in the aspirin group compared with non-aspirin group(Log-rank p=0.024),while the incidence of other endpoints were low,but the difference did not reach statistical significance.The univariate Cox regression analysis showed that aspirin therapy showed a statistically negative association with major bleeding,while aspirin therapy did not associate with other endpoints.After adjusting for multiple cardiovascular risk factors,aspirin therapy did not reach a statistically significant negative correlation with all cardiovascular adverse events.Conclusion:In patients with MHVR combined with CABG surgery,postoperative aspirin treatment was associated with lower cardiovascular adverse events,but the difference did not reach statistical significance.This result indicated that aspirin treatment showed non-significant cardiovascular benefits in one year after surgery,but it did not significantly increase bleeding-related safety events.Further longitudinal and larger sample size studies are required to verify our results. |
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