Objective To assess different anticoagulant regimens in pregnant women with mechanical heart valves: taking oral warfarin throughout the pregnancy, or heparin in the 1st trimester and oral warfarin for the other trimesters. The main outcome measures were major maternal complications and perinatal outcomes. Methods The MEDLINE, EMbase, CBM and CNKI were searched. The quality of the included studies was evaluated and data were extracted by two reviewers independently. Meta-analyses were performed on the results of homogeneous studies. Result Seven studies involving 629 pregnancies in 469 patients met the inclusion criteria for this review, all of which were retrospective surveys. The comparison between the administration of heparin in the 1st trimester plus oral warfarin for the other trimesters and warfarin throughout the pregnancy showed that, there are not significant different in the incidence of major maternal complications and the incidence of adverse perinatal outcomes. Conclusion Compared with the administration of warfarin throughout the pregnancy, the administration of heparin in the 1st trimester and oral warfarin for the other trimesters might increase the incidence of major maternal complications, but with a similar incidence of adverse perinatal outcomes.
Clinical application history of prosthetic heart valves has been over five decades, and mechanical heart valves have satisfactory clinical outcomes for surgical treatment of valvular heart disease. The development history of mechanical heart valves experienced from the first generation of ball valves and caged disc valves to the second generation of single tilting disc valve, and to the third generation of bileaflet valves. In 1960， ball valve was first used for heart valve replacement in abroad. In 1963， China-made ball valve was also produced and used in clinical practice. In 1969， the second generation of single tilting disc valve was developed in abroad. In 1978， China-made single tilting disc valve was produced and widely used in clinical practice with satisfactory clinical outcomes. Since 1980 when it was first produced， bileaflet valve has taken the place of above 2 types of valves for its excellent performance, and become the mainstream product all over the world. Currently, the development of China-made bileaflet valves has lagged behind， and domestic mechanical heart valve market has almost been monopolized by foreign bileaflet valve products. Therefore, the development of ideal China-made mechanical heart valve deserves further research.
Objective To explore the role of thrombus precursor protein(TPP) in the monitoring of anticoagulation in the patients with atrial fibrillation (Af) after mechanical heart valve replacement, and suggest the reasonable anticoagulant range. Methods Ninety patients were divided into Af group (n=45), sinus rhythm group (SR group, n=45), and control group (20 patients with non-valvular heart diseases), according to whether Af exist after mitral valve replacement. TPP concentrations and International Normalized Ratio(INR) in the anticoagulant patients were analyzed. Results In patients after mechanical mitral valve replacement, plasma TPP concentrations in both SR group and Af group were lower than that in control group (Plt;0.05,0.01), their INR value were higher than that in control group (Plt;0.01), and Af group had higher plasma TPP concentrations than that in SR group((Plt;)0.05). It was found that there existed contradictions between INR and plasma TPP concentrations in Af group. There were 28 patients with plasma TPP concentrations below 6 μg/ml and without spontaneous bleeding complications in the group with Af, who might be at the optimal anticoagulant status. Their 95% confidence of INR value was 1.90-2.30 and their plasma TPP concentration was 4.29±0.75μg/ml. Conclusion Patients with Af after mechanical heart valve replacement might have higher risk of thromboembolism, INR between 1.90 - 2.30 and plasma TPP concentration between 2.84-6.00 μg/ml might be the optimal anticoagulant therapeutic range.
ObjectiveTo evaluate the reasonableness of anticoagulation management strategy in patients after mechanical heart valve replacement. MethodsAll patients were followed and registered continually at outpatient clinic from July 2011 to February 2013, with a minimum of 6 months after surgery. Targeted international normalized rate (INR) 1.60 to 2.20 and warfarin weekly dosage adjustment were used as the strategy of anticoagulation management. Except bleeding, thrombogenesis and thromboembolism, time in therapeutic range (TTR) and fraction of TTR (FTTR) were adopted to evaluate the quality of anticoagulation management. ResultsA total 1 442 patients and 6 461 INR values were included for data analysis. The patients had a mean age of 48.2±10.6 years (14-80 years) and the following up time were 6 to 180 months (39.2±37.4 months) after surgery. Of these patients, 1 043 (72.3%) was female and 399 (27.7%) was male. INR values varied from 0.90-8.39 (1.85±0.49) and required weekly doses of warfarin were 2.50-61.25 (20.89±6.93 mg). TTR of target INR and acceptable INR were 51.1% (156 640.5 days/306 415.0 days), 64.9% (198 856.0 days/306 415.0 days), respectively. FTTR of target INR and acceptable INR were 49.4% (3 193 times/6 461 times), 62.6% (4 047 times/6 461 times). There were 8 major bleeding events, 7 mild bleeding events, 2 thromboembolism events, and 2 thrombogenesis in the left atrium. ConclusionIt is reasonable to use target INR 1.60-2.20 and warfarin weekly dosage adjustment for patients after mechanical heart valve replacement.
ObjectiveTo systematically review therapy-related complications incidences of warfarin with different anticoagulation intensity in Chinese after mechanical heart valve replacement, and to explore the suitable anticoagulation intensity of warfarin. MethodsWe electronically searched The Cochrane Library (Issue 2, 2013), EMbase, PubMed, CNKI, CBM, WanFang Data and VIP for studies about therapy-related complications rates of warfarin with different anticoagulation intensity in Chinese after mechanical heart valve replacement from inception to March 2013. Two reviewers independently screened literature according to inclusion and exclusion criteria, extracted data, and assessed methodological quality of included studies. Then meta-analysis was performed using RevMan 5.2. ResultsA total of 7 studies involving 3 787 cases were finally included, 2 985 cases in Group A (targeted INR≤2.3) and 802 cases in Group B (targeted INR > 2.3). The results of meta-analysis showed that, compared with Group B, the total therapy-related complications incidence of warfarin with different anticoagulation intensity significantly decreased in Group A (OR=0.35, 95%CI 0.28 to 0.44, P < 0.000 01). The incidence of hemorrhage in Group A (OR=0.15, 95%CI 0.08 to 0.27, P < 0.000 01) was lower than that in Group B. However, the incidence of embolism in Group A was higher than that in Group B (OR=2.77, 95%CI 1.54 to 4.98, P=0.000 7). ConclusionApplying low-intensity anticoagulation for Chinese patients after mechanical heart valve replacement could reduce the overall incidences of anticoagulation-related complications and hemorrhage, but it could also significantly increase the incidence of thrombosis.
ObjectiveTo describe the status of quality of life (QOL) and self-management behavior in patients following mechanical heart valve replacement, and explore the relationship between QOL and self-management behavior. MethodsConvenient sampling was used to recruit 352 patients following mechanical heart valve replacement in a high-level hospital in Chengdu between January 2011 and June 2012. General information questionnaire, MOS SF-36 scales, and self-management behavior questionnaire were used to collect data. T-test was used to analyze the difference between patients and normal people. And correlation analysis was used to see the correlation between QOL and self-management. ResultsFor MOS SF-36 scale results in patients within one year after surgery, physical functioning (PF) score was 73.44±15.11, role-physical (RP) was 49.52±39.17, body pain (BP) was 63.13±17.93, general health (GH) was 58.85±14.88, vitality (VT) was 63.54±18.10, social functioning (SF) was 76.67±17.40, role-emotional (RE) was 64.96±41.37, and mental health (MH) was 72.76±17.40. All these scores of the patients were significantly lower than the norm of Sichuan Province (P<0.05) except the dimension of mental health. For patients one year or more after surgery, PF score was 76.53±14.41, RP 58.44±39.21, BP 68.16±18.26, GH 61.39±13.57, VT 68.47±16.37, SF 79.79±19.34, RE 72.94±37.29, and MH 75.87±14.70, among which PF, RE, BP and GH scores were lower than the norm (P<0.05). The average total score of self-management behavior was 143.21±20.63. QOL and self-management behavior were positively correlated. ConclusionThere is still a gap between patients following mechanical heart valve replacement and normal people in terms of quality of life. Patients' self-management behavior is positively correlated with the quality of life. Good self-management behavior contributes to the improvement of QOL.
Objective To evaluate the quality of anticoagulant therapy in patients with mechanical prosthetic valve replacement during early period through time in therapeutic range(TTR) and fraction of time in therapeutic range(FTTR), and to provide an objective evidence for further improving quality of anticoagulant therapy. Methods All the patients were followed and registered in hospital and at outpatient clinic from July 2012 through April 2014, with a maximum of 6 months after surgery. Targeted international normalized rate (INR) was 1.60 to 2.20, acceptable INR was 1.50 to 2.30. And warfarin weekly dosage adjustment was used as the strategy of anticoagulation management. Adjusting the warfarin dosage when INR was beyond acceptable INR. Events of bleeding, thrombogenesis and thromboembolism, TTR and FTTR of these patients during the follow-up were collected to evaluate quality of anticoagulant therapy in these patients. Results A total 477 patients and 2 755 reports of INR values were included for data analysis. The follow-up time was 78 918 days. Values of INR varied from 0.92 to 7.72(1.83±0.64). Required weekly doses of warfarin in target INR and acceptable INR were 5.00–35.00(18.15±3.99) mg/week and 5.00–39.38(18.29±4.08) mg/week. TTR of target INR and acceptable INR was 36.85%(27 079.5 d/78 918.0 d) and 49.84% (39 331.5 d/78 918.0 d), respectively. FTTR of target INR and acceptable INR was 37.31% (1 028 times/2 755 times), 50.01% (1 378 times/2 755 times), respectively. TTR of target INR and acceptable INR was 46.04%(3 902.5 d/8 475.5 d), 59.49%(5 042 d/8 475.5 d) when the patients’ follow-up was up to six months and FTTR of target INR and acceptable INR value of these patients was 46.81%(206 times/440 times), 60.45%(266 times/440 times). During the follow-up, there were 3 thromboembolism events, 1 transient physical abnormal activity, and 1 thrombogenesis in the left atrium, and there was no bleeding and death events. Conclusion The strategy of anticoagulation management used in our study is reasonable. In order to further improve the patients’ quality of anticoagulant therapy, it is necessary to start anticoagulation after operation as soon as possible, to strengthen the education of patients with anticoagulant knowledge and to increase INR test frequency properly.
The patients with mechanical prosthetic valve replacement need anticoagulant therapy for all their life. The incidence of thromboembolism and anticoagulation-related bleeding events still account for major postoperative complications after mechanical heart valve replacement. Most of the complications happen in the first half year after operation. Therefore, early anticoagulation therapy is very important. Of course, so far most guidelines focus stating their opinions on long-term anticoagulant therapy. However, there is no consensus about anticoagulant therapy in the early period of postoperation. In this review, we summarize early anticoagulant therapy of the patients with mechanical heart valve replacement through consulting domestic and abroad relevant research in recent years and give an overview of the present situations of early anticoagulant therapy.
ObjectiveTo investigate the factors influencing international normalized ratio (INR)>3.0 in patients undergoing warfarin anticoagulation therapy after mechanical heart valve replacement. MethodsA retrospective analysis was performed on the clinical data of patients who underwent mechanical heart valve replacement surgery and received warfarin anticoagulation therapy at West China Hospital of Sichuan University from January 1, 2011 to June 30, 2022. The factors associated with INR>3.0 at the time of discharge were analyzed. ResultsA total of 8901 patients were enrolled, including 3409 males and 5492 females, with a median age of 49.3 (43.5, 55.6) years. Multivariate logistic regression analysis revealed that lower body mass index (BMI), preoperative prothrombin time (PT)>15 s, and mitral valve replacement were independent risk factors for INR>3.0 at discharge (P<0.05). ConclusionBMI, preoperative PT, and surgical site are factors influencing INR>3.0 at discharge in patients undergoing warfarin anticoagulation therapy after mechanical heart valve replacement. Special attention should be given to patients with lower BMI, longer preoperative PT, and mitral valve replacement to avoid excessive anticoagulation therapy.