Objective To investigate the risk factors and the prevention and cure methods of ischemic stroke during low intensity anticoagulation therapy after mechanical heart valve replacement. Methods From March 2004 to July 2008，twentythree patients with ischemic stroke after mechanical heart valve replacement had been researched(ischemic stroke group). One hundred and twenty patients who had undergone mechanical heart valve replacement were randomly chosen in the same period as control group. Gender, age, the dose of warfarin , anticoagulation intensity(INR), INR review interval, left atrial diameter and heart rhythm were compared between the two groups, and the risk factors of ischemic stroke were analyzed by logistic regression analysis. Results (1) Patients in ischemic stroke group all discharged from hospital after treatment, and they were followed up for 1 month-3 years after discharged. All the patients’ neurological complications improved obviously, and no recurrent embolism and severe hemorrhage was found. (2) There was no statistical significance between two groups in gender, age and the dose of warfarin（Pgt;0.05）. (3) Nonconditional logistic regression analysis on influence factors showed that atrial fibrillation（P=0.000）, left atrial enlargement（P=0.002）, low anticoagulation intensity（P=0.012） and longtime INR review interval（P=0.047）were the risk factors of ischemic stroke during low intensity anticoagulation therapy after mechanical heart valve replacement. Conclusions (1)The prognosis of ischemic stroke during low intensity anticoagulation therapy after mechanical heart valve replacement is better than that of intracranial hemorrhage, and the occurrence of ischemic stroke is related to many risk factors. (2)The influences of risk factors should be minimized in order to avoid ischemic stroke. (3) Early low intensity anticoagulation therapy is safe and effective for patients with ischemic stroke after heart valve replacement.
Abstract： Objective To construct an Anticoagulation Therapy Database of Chinese Patients after Heart Valve Replacement in accordance with blood coagulation characteristics of Chinese patients， fill the gap of Chinese clinical research in valvular heart diseases， and provide a scientific and objective basic data and information exchange platform. Methods A national multicentre，prospective and cohort clinical research method was applied to establish an anticoagulation therapy database of Chinese patients after heart valve replacement， using the Internet as a platform. A case report form （CRF）， which was in line with the actual situation of Chinese anticoagulation patients after heart valve surgery， was formulated through the discussion of experts from 36 cardiovascular surgery centers in China in the starting meeting of National Science amp; Technology Support Program during the Twelfth Five-year Plan Period.We planned to prospectively include patients receiving warfarin anticoagulation therapy and formal anticoagulation monitoring after heart valve replacement from January 1, 2011 to December 31, 2014. Database was constructed using warehousing technology， which allowed not only data monitoring， query and statistics， but also regular data backup and system updates. Results A network database entitled Anticoagulant Therapy Database of Chinese Patients after Heart Valve Replacement was constructed and linked with the homepage of Chinese Journal of Clinical Thoracic and Cardiovascular Surgery （http：//www. zgxxwkzz. com）， which constituted a national Internet information platform. From 1 January 2011 to 1 December 2012， 8 452 anticoagulation patients after heart valve replacement from 34 level-3A hospitals in China had been registered in the database. Further follow-up of these patients was being carried out in respective hospitals. Conclusion A large multi-center and open database and network information platform has been constructed. The database variables are in line with clinical characteristics of Chinese anticoagulation patients after heart valve replacement， which provide scientific and objective basic data and support for future clinical research and systemic analysis.
Objective To explore the safety and efficacy of mobile APP in telemanagement for patients who received oral warfarin anticoagulant therapy after mechanical heart valve replacement. Methods A prospective cohort study was performed. According to the inclusion and exclusion criteria, a total of 80 patients who underwent mechanical heart valve replacement for more than half a year and received oral warfarin anticoagulant therapy in outpatient department were included in our hospital from January 1, 2017 to December 31, 2017. These patients were divided into a telemanagement group (40 paitents, telemanagement using mobile APP) and a control group (40 patients, anticoagulant management in outpatient clinics) according to patients' wishes and local hospital international normalized ratio (INR) monitoring conditions. After 12-month follow-up, clinical effect of the two groups was compared. The INR, time in therapeutic range (TTR), fraction in therapeutic range (FTTR), anticoagulation-related complications and patient satisfaction were analyzed. Results During the follow-up period of anticoagulation, there was no significant difference in INR between the two groups (P=0.732). The average interval of INR monitoring in the telemanagement group was 3-65 (21.4 ± 12.5) days, while that in the control group was 7-93 (39.6 ± 14.7) days (P=0.012). TTR was 42.7% (6 027.6 d/14 116.0 d) in the control group and 67.9% (10 168.6 d/14 972.0 d) in the telemanagement group (P=0.018). And FTTR in the two groups was 45.6% (144/316) and 67.1% (432/644), respectively (P=0.015). No serious thromboembolism or hemorrhage events occurred in the 80 patients during the 12-month follow-up period. There was no significant difference in the incidence of anticoagulation-related complications, general bleeding and embolism between the two groups (P>0.05). Conclusion For patients with stable anticoagulation after cardiac mechanical valve replacement, it is safe and effective to telemanagement by mobile APP. Telemanagement can increase the frequency of anticoagulation monitoring without increasing anticoagulation risk, meanwhile, it also could obtain more convenient and rapid consultation, save time and economic costs,and improve the quality of life and patient satisfaction.
ObjectivesTo investigate the correlation of warfarin dose genetic and polymorphism of Han-patients after heart valve replacement, to forecast the anticoagulation therapy with warfarin reasonable dosage, and to realize individualized management of anticoagulation monitoring. MethodsWe selected 103 patients between January 1, 2011 and December 31, 2012 in West China Hospital of Sichuan University who were treated by oral warfarin after heart valve replacement with monitoring anticoagulation by international normalized ratio (INR) in Anticoagulation Therapy Database of Chinese Patients after Heart Valve Replacement. There were 32 males and 71 female at age of 21-85 (48.64± 11.66) years. All the patients' CYP2C9 and VKORC1 genetic polymorphisms were detected by using polymerase chain reaction-restriction fragment length polymorphism (PCR-RELP) method and gene sequencing technology. Warfarin concentration in plasma was determined by high performance liquid chromatography (HPLC) method. The activity of coagulation factorⅡ, Ⅶ, Ⅸ, Ⅹwas determined by Sysmex CA7000 analyzer. ResultsThe multivariate linear regression analysis showed that age, body surface area, and coagulation factor activity had no significant effect on warfarin dosage. While the gene polymor-phisms of CYP2C9 and VKORC1, warfarin concentration, and age had significant contributions to the overall variability in warfarin dose with decisive coefficients at 1.2%, 26.5%, 43.4%, and 5.0% respectively. The final equation was:Y=1.963-0.986× (CYP2C9* 3) +0.893× (VKORC1-1639) +0.002× (warfarin concentration)-0.019× (age). ConclusionMultiple regression equation including gene polymorphisms of CYP2C9 and VKORC1, non-genetic factors of coagulation factor activity, warfarin concentration, age, and body surface area can predict reasonable dosage of warfarin for anticoagulation to achieve individualized management of anticoagulation monitoring and reduce the anticoagulation complications.
Objective To discuss the application value in increasing the frequency of monitoring and ensuring the safety of anticoagulation therapy in patient self-monitoring (PST) and self-management (PSM) of portable coagulometer. Method This non-randomized prospective controlled study was conducted in 100 patients receiving oral warfarin anticoagulation therapy after heart valve replacement and met the inclusion criteria in our hospital between March 2013 and April 2014 year. All the patients were divided into three groups including an outpatient follow-up group(outpatient group), a self-monitoring group and a self-management group. Meanwhile, the patients in the outpatient group visited professional institutions, performed international normalized ratio (INR) testing with central lab and adjusted the dosage of orally administered warfarin by the doctors. And the other two groups performed INR testing with CoaguChek XS portable coagulometer by themselves, and the patients in the self-management group performed management by themselves. The follow-up time was 6 months. The dates of time in therapeutic range (TTR), fraction of time in therapeutic range (FTTR) and anticoagulation complications in the three groups were analyzed and compared. Results There was no significant difference in the INR results obtained from the follow-up time among the three groups (P=0.845) . TTR value of INR of the outpatient group, the self-monitoring group, and the self-management group was 45.9% (4368.0 days/9517.0 days), 61.2% (6057.0 days/9897.0 days), and 65.4% (2833.8 days/4333.0 days), respectively with a statistical difference among the three groups (P<0.001) . FTTR value of INR obtained from the outpatient group, the self-monitoring group, and the self-management group was 48.3% (99 times/205 times), 60.7% (164 times/270 times), and 64.9% (100 times/154 times) respectively. There was a statistical difference in the FTTR between the outpatient group and the self-monitoring group (P=0.007) , and also between the outpatient group and the self-monitoring group (P=0.002) . But there was no statistical difference between the self-monitoring group and the self-management group (P=0.392) . There were not any major bleeding and thrombosis complications in all study. And there was no statistical difference in the total complications, thrombosis, and bleeding complications rates between the outpatient group and the self-monitoring group, and also between the outpatient group and the self-management group (P>0.05) . Conclusions The patients receiving oral anticoagulation after heart valve replacement or their care providers were able to perform PST and PSM. The use of portable coagulometer for self-monitoring and self-management can increase the frequency of anticoagulation monitoring and achieve better INR target value control. PST and PSM could achieve higher quality of anticoagulation management and life and without increasing the risk of oral anticoagulation than the traditional monitoring method. The monitoring frequency of once a month is reasonable for the patients receiving oral anticoagulation more than half a year after heart valve replacement.
Objective To explore clinical application and significance of coronary angiography （CAG） prior to heart valve replacement for patients with rheumatic valvular heart disease （RVHD）. Methods We retrospectively analyzed clinical data of 313 RVHD patients who underwent heart valve replacement in the First Affiliated Hospital of Chongqing Medical University from January 2002 to June 2012. All the patients received screening CAG before surgery. According to CAG results，313 patients were divided into two groups. In the coronary artery lesion （CAL） group，there were 29 patients including 17 male and 12 female patients with their age of 60.0±5.2 years. In the non-coronary artery lesion （non-CAL）group，there were 284 patients including 98 male and 186 female patients with their age of 57.0±5.4 years. Surgicaloutcomes were compared between the two groups. Univariate analysis and multivariate logistic regression were performed to analyze risk factors of CAL for RVHD patients. Results CAG showed 29 patients with CAL，and the overall prevalence of CAL was 9.27%. In CAL group，11 patients underwent concomitant coronary artery bypass grafting with 2.2 grafts for each patient on the average. Postoperatively 1 patient （3.45%） died of low cardiac output syndrome （LCOS）. In non-CAL group，5 patients （1.76%） postoperatively died mainly because of LCOS，ventricular fibrillation，sudden cardiac arrest or respiratory failure. Cardiopulmonary bypass time and aortic cross-clamp time of CAL group were significantly longer than those of non-CAL group （P＜0.05）. There was no statistical difference in postoperative mortality，incidence of LCOS，acute renal failure，respiratory failure，reexploration for bleeding，intraoperative blood loss，mechanical ventilation time or hospital stay between the two groups（P＞0.05）. There was no significant correlation between the types of valvular lesions and CAL. Age≥ 55 years （OR=5.534，P=0.005），male gender （OR=2.335，P=0.038） and diabetes mellitus （OR=4.265，P=0.006） were independent risk factors of CAL for RVHD patients undergoing heart valve replacement. Conclusion For RVHD patients with independent risk factors of CAL （age≥55 years，male gender and diabetes mellitus），CAG must beseriously considered before heart valve replacement. RVHD patients with CAL can obtain similarly satisfactory surgicaloutcomes of heart valve replacement as RVHD patients without CAL by appropriate surgical strategy and strengthened perio-perative management.
ObjectiveTo investigate the mid-to-long term quality of life (QOL) and influencing factors in the patients after heart valve replacement.MethodsConvenient sampling method was used to recruit 224 patients who had heart valve replacement surgery in our hospital from June 2008 to June 2017. There were 63 males and 161 females, aged 18-83 (51.49±10.60) years. General information questionnaire and MOS SF-36 scale were used to collect data. Univariate analysis and multiple linear regression analysis were used to analyze and determine the influencing factors for the QOL.ResultsThe total score of QOL of 224 patients was 71.78±17.60 points. All these scores of the patients were significantly lower than those of the general population of Chengdu (P<0.05) except the dimension of vitality. The QOL scores differences between sex, marital status, family income, working condition, the occurrence of anticoagulant complications and other complications were significant (P<0.05). Multivariate analysis showed that family income, working condition, the occurrence of anticoagulant complications and other complications could be included in the regression model, explaining 26.8% of total variance. ConclusionThe mid-to-long term QOL is lower in the patients after heart valve replacement. Family income, working condition, anticoagulant complications and other complications are the main influencing factors for mid-to-long term QOL for patients after heart valve replacement.
ObjectiveTo investigate clinical outcomes and risk factors of patients with valvular heart disease (VHD) and giant left ventricle undergoing heart valve replacement (HVR). MethodsClinical data of 144 VHD patients with giant left ventricle who underwent HVR in Union Hospital of Tongji Medical College, Huazhong University of Science and Technology from January 2009 to December 2012 were retrospectively analyzed. There were 116 male and 28 female patients with their age of 15-69 (44.9±11.9) years and disease duration of 57.8±98.3 months (range, 1 month to 40 years). There were 92 patients with rheumatic VHD, 28 patients with degenerative VHD, 15 patients with congenital VHD, and 9 patients with infective endocarditis. A total of 137 patients who were discharged alive were followed up. Risk factors of postoperative mortality, morbidity and late death of VHD patients with giant left ventricle undergoing HVR were analyzed with t-test, chi-square test or Fisher's exact test, and logistic regression analysis. The life-table method was used to calculate long-term survival rate and draw the survival curve. ResultsMajor postoperative complications included low cardiac output syndrome (LCOS) in 19 patients (13.2%), ventricular arrhythmias in 56 patients (38.9%), prosthetic paravalvular leaks in 7 patients (4.9%), pleural effusion in 33 patients (22.9%), pericardial effusion in 8 patients (5.6%), liver failure in 23 patients (16.0%), and renal failure in 5 patients (3.5%). Seven patients (4.9%) died postoperatively. Logistic univariate analysis showed that advanced-age ( > 50 years), rheumatic VHD, higher preoperative NYHA class (Ⅲ or Ⅳ), long disease duration, poor preoperative left ventricular function[left ventricular ejection fraction (LVEF) < 40%], double valve replace-ment (DVR), other concomitant intracardiac procedures, prolonged cardiopulmonary bypass (CPB) time and aortic cross-clamping time, postoperative LCOS and ventricular arrhythmias were risk factors of early mortality of VHD patients with giant left ventricle undergoing HVR (P < 0.05). Logistic multivariate analysis showed that advanced age ( > 50 years), long disease duration, higher preoperative NYHA class (Ⅳ), poor preoperative left ventricular function (LVEF < 40%), DVR, prolonged CPB time were independent predictors of early mortality (P < 0.05). Logistic multivariate analysis showed that higher preoperative NYHA class (Ⅲ or Ⅳ), other concomitant intracardiac procedures, poor preoperative left ventricular function (LVEF < 50%) were independent predictors of postoperative LCOS (P < 0.05). Higher preoperative NYHA class (Ⅲ or Ⅳ) and preoperative non-sinus rhythm were independent predictors of postoperative ventricular arrhy-thmias (P < 0.05). Within 2 weeks after the operation, left ventricular end-diastolic dimension (LVEDD), left atrial diameter (LAD), LVEF and left ventricular fractional shortening (LVFS) were all significantly reduced compared with preoperative parameters (P < 0.05). Five patients died during follow-up. One-year, 2-year, 3-year and 4-year survival rates were 97.1%, 95.0%, 92.7% and 92.7% respectively. Preoperative LVEF, LVEDD and NYHA were significantly different between patients who died or survived during follow-up. ConclusionsHVR can produce low postoperative mortality, high long-term survival rates and satisfactory clinical outcomes for VHD patients with giant left ventricle. Advanced age ( > 50 years), long disease duration, higher preoperative NYHA class (Ⅳ), preoperative non-sinus rhythm, poor preoperative left ventricular function (LVEF < 40%), DVR and prolonged operation time may be risk factors of postoperative mortality and morbidity. Poor preoperative left ventricular function and significantly enlarged left ventricle may be risk factors of late death after HVR.
ObjectiveTo analyze the risk factors for the prolonged time of intensive care unit (ICU) stay after isolated heart valve replacement. MethodWe retrospectively analyzed the clinical data of 400 patients underwent heart valve replacement surgery in our hospital in 2013 year. There were 208 males and 192 females with a mean age of 50.5±11.1 years ranging from 11-85 years. We divided them into an A group with the time of ICU stay shorter than 48 hours and a B group with the time of ICU stay longer than 48 hours. We recorded the demographic characteristics, preoperative data, intraoperative data and postoperative data and analyzed those data with univariate and multivariate methods. ResultThere was a statictical difference in the demographic characteristics, preoperative data, intraoperative data and postoperative data between the 2 groups (P < 0.05). The logistic result showed that if we didn't consider the postoperative factors the prolonged time of ICU stay statistically related with age over 70 year(OR 2.024, 95%CI 1.182-3.466, P < 0.05), the cardiac grade of New York Heart Association at Ⅲ-Ⅳ(OR 3.295, 95% CI 1.030-10.544, P < 0.05), preoperative hemoglobin concentration less than 120 g/l (OR 0.500, 95%CI 0.263-0.950, P < 0.05), and the cardiopulmonary bypass time more than 180 min (OR 2.486, 95%CI 1.006-6.143, P < 0.05). If we considered the postoperitive factors, the prolonged time of ICU stay statistically linked to the cardiopulmonary bypass time longer than 180 min (OR 3.295, 95% CI 1.030-10.544, P < 0.05), the postoperative blood glucose more than 10 mmol/l (OR 2.954, 95%CI 1.334-6.543, P < 0.05), and the pulling out trachea canula 24 hours after operation (OR 6.742, 95% CI 3.005-15.124, P < 0.05). ConclusionThe prolonged time of ICU stay after valve replacement surgery is associated with a number of risk factors before, during and after heart valve replacement surgery. Targeting the risk factors, especially the postoperitive risk factors, can be effective to shorten the ICU residence time.
Recent clinical trials showed that dabigatran was superior to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation, however whether it is suitable for the lifelong anticoagulation in patients after heart valve replacement, remains controversial. Many animal experiments showed that dabigatran group was better than heparin and warfarin in the prevention of thrombosis and bleeding complications after valve replacement. Randomized, phaseⅡstudy to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN) clinical trial showed that dabigatran wasn't as effective as warfarin in preventing thrombosis, but increases the risk of bleeding. And there are some case reports about thrombosis and bleeding complications after taking dabigatran. At present, the efficacy and safety of dabigatran applying in patients after heart valve replacement still needs further study.