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.
【摘要】 目的 分析心脏瓣膜置换术后死亡案例的法医病理学特点，探讨有关瓣膜置换术后死亡案例的法医病理学鉴定思路及原则。 方法 从手术方式、术前心脏状况及术中所见、法医病理检验所见、死亡时间、死亡原因等方面，对2008年1月-2010年2月4例心脏瓣膜置换术后死亡案例进行综合研究分析。 结果 4例均患有风湿性心脏病，且术前心功能较差；3例二尖瓣瓣膜置换术，3例主动脉瓣瓣膜置换术，2例三尖瓣成形术；二尖瓣瓣膜置换术1例平行房间沟的左房纵行切口，1例右心房-房间隔切口，1例右心房-房间隔-左房联合切口；主动脉瓣瓣膜置换术均行升主动脉根部斜形切口或S状切口；死亡时间为1例术中，1例术后30 min，1例术后2 d，1例术后8 d；死亡原因为1例心肌炎，1例传导系统出血，2例失血性休克；1例术前有潜在感染灶。 结论 对有关心脏瓣膜置换术后死亡案例的法医病理学鉴定时，应在了解患者瓣膜置换术前心脏情况以及手术方式、手术路径和缝合方法的基础上，结合法医病理组织学检查进行综合分析。【Abstract】 Objective To analyze the forensic pathological characteristics of those who died after cardiac valve replacement and explore the mentality and principle of documentary evidence of medicolegal expertise. Methods Four death cases after cardiac valve replacement between January 2008 and February 2010 were comprehensively analyzed from various aspects of surgery style, preoperational heart condition, peri-operational observations, results of forensic pathological tests, time of death, and causes of death. Results All cases were rheumatic heart disease and the preoperational heart function was poor. Of the four cases, three had mitral valve replacement (MVR), three had aortic valve replacement (AVR) and two had tricuspid valvuloplasty. Of the three MVR cases, cutting on the left atrium paralleling the interatrial groove was performed in one case, cutting through right atrium and interauricular septum was performed in one case, and cutting left atrium and right atrium through interauricular septum was performed in another case. For all the three AVR cases, cutting on the root of aorta with the shape of diagonal or ’S’ was carried out. One patient died during operation, one died thirty minutes after operation, one died two days after operation and one died eight days after operation. Among them, one died of myocarditis, one died of hemorrhage in the conducting system and two died of hemorrhagic shock. Besides, one patient had potential bacterial infection before surgery. Conclusion For patients who died after cardiac valve replacement, we should acquaintance ourselves with the preoperational heart condition, surgery style, surgical approach and the methods of stitch to make a comprehensive analysis with forensic pathology examination.
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.
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.