Abstract 17101: Low-intensity Anticoagulant Treatment in Chinese Patients with Mechanical Heart Valve Prostheses: Early Outcomes of a Prospective, Multicenter Registry in China

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
JIA HU ◽  
BO FU ◽  
Jian-ping Xu ◽  
Ying-kang Shi ◽  
Li Dong

Background: Current guidelines recommend vitamin K antagonist treatment with relatively higher international normalized ratio (INR) targets for patients with mechanical heart valve prostheses. However, there is lack of data from large clinical trials about the outcomes of low-intensity anticoagulant treatment in Chinese patients with mechanical heart valves. Methods: The Low-intensity Anticoagulation Therapy after Heart Valve Replacement is an ongoing multicenter, prospective, observational cohort study (ChiCTR-OCH-10001185). Between January 2011 and August 2013, qualified patients from 34 cardiac centers in China mainland were recruited in the Anticoagulation Therapy Database of Chinese Patients after Heart Valve Replacement. Baseline characteristics were collected and patients were followed up for anticoagulant treatment, INRs and adverse events till March 2014. Results: The database recruited 11,769 patients, and 11,040 patients (93.8%) undergoing mechanical heart valve replacement were analyzed in this study. The mean age was 48.9±11.5 years and 6,227 patients (56.4%) were female. A total of 9,870 patients (89.4%) of the baseline population completed at least 6 months follow-up. The median follow-up time was 1.2 years (range 0.5-2.2). For all 9,870 patients, 143,115 measurements of the INR were obtained. The average warfarin dosage was 2.98±1.16mg/d and the mean INR was 1.81±0.46, and 88.7% patients had an INR level≤2.5 during the follow-up period. The incidence of hemorrhagic events was the lowest in patients with an INR≤2.0, whereas the risk of thromboembolic complications in this group of patients was not significantly increased (Table 1). Conclusions: Low-intensity anticoagulation with an INR of 1.5 to 2.5 is safe and effective for Chinese patients with mechanical heart valves in short-term. The optimal INR targets for mechanical valve recipients with different implanting positions and risk factors require further investigation.

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032949 ◽  
Author(s):  
Zhihui Zhu ◽  
Yuehuan Li ◽  
Xu Meng ◽  
Jie Han ◽  
Yan Li ◽  
...  

IntroductionWarfarin is an effective anticoagulant and the only oral anticoagulant available for patients with mechanical heart valves. The prothrombin time and the associated international normalised ratio (INR) are routinely tested to monitor the response to anticoagulation therapy in patients. Patients who undergo mechanical heart valve replacement need lifelong anticoagulation therapy, and their INR is regularly measured to adjust the anticoagulation strength and the dose of anticoagulation drugs. Appropriate warfarin anticoagulation management can reduce patient complications, such as bleeding and thrombosis, and improve the long-term survival rate. We propose modern internet technology as a platform to build a warfarin anticoagulation follow-up system after valve replacement surgery. This system will provide doctors and patients with more standardised and safer follow-up methods as well as a method to further reduce the risk of warfarin anticoagulation-related complications and improve its therapeutic effects.Methods and analysisA prospective, multicentre, randomised, controlled trial will be conducted. A total of 700 patients who require long-term warfarin anticoagulation monitoring after heart valve replacement will be enrolled and randomly divided at a 1:1 ratio into a traditional outpatient anticoagulation management group and a group undergoing a new method of management based on the internet technology with follow-up for 1 year. Differences in the percentage of time in the therapeutic range (TTR), drug dose adjustments, bleeding/thrombosis and other related complications will be observed. The primary endpoint is the difference in the TTR between the two groups. The purpose of this study is to explore a safer and more effective mode of doctor–patient interaction and communication in the internet era. As of 13 July 2019, 534 patients had been enrolled.Ethics and disseminationThis study protocol was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University. The results will be published in a peer-reviewed medical journal.Trial registration numberChiCTR1800016204.


2011 ◽  
Vol 128 (5) ◽  
pp. e91-e94 ◽  
Author(s):  
Ming-Feng Dong ◽  
Zeng-Shan Ma ◽  
Sheng-Jun Ma ◽  
Shou-Dong Chai ◽  
Pei-Zhe Tang ◽  
...  

2018 ◽  
Vol 68 (02) ◽  
pp. 099-106 ◽  
Author(s):  
Charles Mve Mvondo ◽  
Marta Pugliese ◽  
Jean Claude Ambassa ◽  
Alessandro Giamberti ◽  
Emanuele Bovio ◽  
...  

Abstract Background The management of patients with mechanical heart valves remains a major concern in populations with limited resources and medical facilities. This study reports the clinical outcomes of patients who underwent mechanical valve implantation in a sub-Saharan center over an 8-year period. Methods A total of 291 mechanical valves were implanted in 233 patients in our institution between February 2008 and June 2016. A total of 117 patients underwent mitral valve replacement (MVR, 50.2%), 57 had aortic valve replacement (AVR, 24.4%), and 59 underwent both AVR and MVR (double valve replacement [DVR], 25.7%). The mean age at surgery was 27.6 ± 13.4 years (range, 7–62 years). Rheumatic etiology was found in 80.6% of the patients. Hospital mortality, late deaths, and valve-related events were reviewed at follow-up (839 patient-years, range: 1–9.4 years, complete in 93%). Results The 30-day mortality was 4.7% (11/233). The overall survival at 1 and 6 years for the whole cohort was 88.8 ± 2.1% and 78.7 ± 3.3%, respectively. The 6-year survival for AVR, MVR, and DVR was 89.3 ± 4.8%, 73.2 ± 5.4%, and 79.3 ± 5.8%, respectively (p = 0.15). The freedom from neurologic events and anticoagulation-related bleeding at 6 years was 93.1 ± 2.1% and 78.9 ± 3.7%, respectively. No patient had reoperation at follow-up. No case of prosthetic valve thrombosis was identified. Eight full-term pregnancies were reported. Conclusion This preliminary experience reports acceptable midterm results after mechanical heart valve implantation in our region. Both accurate surgical evaluation and strategies, either financial or social, facilitating patient's education and medical assistance are crucial to ensure good results. Long-term follow-up and further studies comparing current nonthrombogenic options are warranted to draw reliable conclusions.


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