scholarly journals New internet-based warfarin anticoagulation management approach after mechanical heart valve replacement: a prospective, multicenter, randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Zhihui Zhu ◽  
Chenyu Li ◽  
Jinglun Shen ◽  
Kaisheng Wu ◽  
Yuehuan Li ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Therapeutic Range ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Secondary Outcome ◽  
The Internet ◽  
Traditional Group ◽  
Multicenter Randomized Controlled Trial

BACKGROUND Mechanical heart valve replacement (MHVR) is an effective method for the treatment of severe heart valve disease, while the patient who was administered with warfarin therapy after MHVR facing a high risk of bleeding and thrombosis. Therefore, as internet-based warfarin management emerged, whether it reduces the complications and improves patient’s life quality remain unknown. OBJECTIVE This study aimed to compare effects of internet-based warfarin management and conventional approach in patients who received MHVR. In order to provide evidence regarding alternative strategies for a long-term anticoagulation. METHODS This is a prospective, multicenter, randomized, open-label, controlled clinical trial with a follow-up for 1 year. Patients who need long-term warfarin anticoagulation after MHVR were enrolled, then randomly divided into traditional and internet-based management group. The percentage of time in the therapeutic range (TTR) was used as the primary outcome, and the bleeding, thrombosis and other event as secondary outcome. RESULTS A total of 721 patients were enrolled and the baseline is not reach statistical different between the two groups, suggesting the random assignment is successful. As a result, the internet-based group showed a significantly higher TTR (0.53±0.24 vs. 0.46±0.21, P<0.01) and fraction of time in therapeutic range (FTTR, 0.48±0.22 vs. 0.42±0.19, P<0.01), than those in the traditional group. Furthermore, as expected, the anticoagulation complications, including the bleeding and embolic events (6.94% vs. 12.74%, P<0.01) have lower frequency in the internet-based group than in the traditional group. Logistic regression shows that internet-based management increased the TTR by 7% (OR=1.07, 95%CL 1.05-1.09, P<0.01), and reduced the bleeding and embolic risk by 6% (OR=0.94, 95%CL 0.92-0.96, P<0.05). Moreover, low TTR is the risk factor of bleeding and embolic events (OR=0.87, 95%CL 0.83-0.91, P<0.05) CONCLUSIONS The internet-based warfarin management is superior than the traditional way by reducing the anticoagulation complications in patients who received long-term warfarin anticoagulation after MHVR. CLINICALTRIAL ChiCTR1800016204; http://www.chictr.org.cn/showproj.aspx?proj=27518 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2019-032949

Long-term anticoagulation self-testing after mechanical heart valve replacement

2007 ◽  
Vol 55 (S 1) ◽  
Author(s):  
H Mair ◽  
B Reichart ◽  
I Kaczmarek ◽  
G Juchem ◽  
P Überfuhr ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Self Testing

scholarly journals New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032949 ◽  
Author(s):  
Zhihui Zhu ◽  
Yuehuan Li ◽  
Xu Meng ◽  
Jie Han ◽  
Yan Li ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Anticoagulation Therapy ◽  
Internet Technology ◽  
Heart Valve Replacement ◽  
Management Model ◽  
The Internet ◽  
Anticoagulation Management

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.

scholarly journals Retrospective investigation of anticoagulant complications in long term after mechanical heart valve replacement surgery in Turkey

2020 ◽  
Keyword(s):  
Emergency Department ◽  
Valve Replacement ◽  
Heart Valve ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Factors Affecting ◽  
Replacement Surgery ◽  
The Mean ◽  
Valve Replacement Surgery

Background: Patients with mechanical heart valve replacement surgery (MHVRS) should be followed up in terms of prosthetic valve-related and open heart surgery complications. This study aimed to determine the anticoagulant complications in long term in patients with MHVRS. Methods: This retrospective and descriptive study was conducted in a university hospital, İzmir, Turkey. The data were collected from July to December 2019. In total, 73 patients referring for regular check-ups to the hospital with intervals not exceeded more than 90 days, and those who had international normalized ratio (INR) measurements for January-April-July-October 2018 were included in this study. Results: The mean age of the patients was obtained at 58.98±12.89 years, and 53.4% (n=39) of the cases were male. Moreover, the mean follow-up period was estimated at 65.98±28.47 months. According to the results, complications developed in 60 patients (82.2%). The first hospitalized unit was the emergency department. The factors affecting the development of complications after MHVRS were evaluated, and a difference was found regarding gender (X2=6.18, P=0.013), comorbidities (X2=25.58, P=0.018), and monthly referral for regular check-ups to the hospital (X2=5.20, P=0.023). There was no relationship between the INR levels and the development of complications. Furthermore, the results of evaluating the factors affecting the number of hospitalizations after MHVRS revealed that monthly referral to hospital for check-ups (t=3.18, P=0.002) and history of previous valve surgery (Z=201.00, P=0.03) affected the number of hospitalizations. Conclusions: It was observed that patients frequently refer to the emergency department and struggled with various complications. Moreover, it was found that the patients had frequent bleeding and refer to the emergency service repeatedly. Accordingly, there is a need for interventional studies to reduce postoperative complications and provide the therapeutic INR level.

scholarly journals Calculation of Time in Therapeutic Range (TTR) in valve clinic follow up patients with mechanical heart valve replacement

2014 ◽  
Vol 66 ◽  
pp. S136-S137
Author(s):  
K. Naresh ◽  
D. Rajasekhar ◽  
V. Vanajakshamma ◽  
D. Sarath
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Therapeutic Range ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Time In Therapeutic Range

scholarly journals Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions

2011 ◽  
Vol 14 (3) ◽  
pp. 253-257 ◽  
Author(s):  
H. Mair ◽  
J. Sachweh ◽  
R. Sodian ◽  
P. Brenner ◽  
M. Schmoeckel ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Anticoagulation Therapy ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Self Management

Factors Influencing Patient Knowledge of Warfarin Therapy After Mechanical Heart Valve Replacement

2006 ◽  
Vol 21 (3) ◽  
pp. 169-175 ◽  
Author(s):  
Amanda Hu ◽  
Chi-Ming Chow ◽  
Diem Dao ◽  
Lee Errett ◽  
Mary Keith
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Warfarin Therapy ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Patient Knowledge ◽  
Factors Influencing
Sign in / Sign up

Export Citation Format

Share Document