New Internet-Based Warfarin Anticoagulation Management Approach After Mechanical Heart Valve Replacement: Prospective, Multicenter, Randomized Controlled Trial

Abstract

Background Mechanical heart valve replacement (MHVR) is an effective method for the treatment of severe heart valve disease; however, it subjects patient to lifelong warfarin therapy after MHVR with the attendant risk of bleeding and thrombosis. Whether internet-based warfarin management reduces complications and improves patient quality of life remains unknown. Objective This study aimed to compare the effects of internet-based warfarin management and the conventional approach in patients who received MHVR in order to provide evidence regarding alternative strategies for long-term anticoagulation. Methods This was a prospective, multicenter, randomized, open-label, controlled clinical trial with a 1-year follow-up. Patients who needed long-term warfarin anticoagulation after MHVR were enrolled and then randomly divided into conventional and internet-based management groups. The percentage of time in the therapeutic range (TTR) was used as the primary outcome, while bleeding, thrombosis, and other events were the secondary outcomes. Results A total of 721 patients were enrolled. The baseline characteristics did not reach statistical differences between the 2 groups, suggesting the random assignment was successful. As a result, the internet-based group showed a significantly higher TTR (mean 0.53, SD 0.24 vs mean 0.46, SD 0.21; P<.001) and fraction of time in the therapeutic range (mean 0.48, SD 0.22 vs mean 0.42, SD 0.19; P<.001) than did those in the conventional group. Furthermore, as expected, the anticoagulation complications, including the bleeding and embolic events had a lower frequency in the internet-based group than in the conventional group (6.94% vs 12.74%; P=.01). Logistic regression showed that internet-based management increased the TTR by 7% (odds ratio [OR] 1.07, 95% CI 1.05-1.09; P<.001) and reduced the bleeding and embolic risk by 6% (OR 0.94, 95% CI 0.92-0.96; P=.01). Moreover, low TTR was found to be a risk factor for bleeding and embolic events (OR 0.87, 95% CI 0.83-0.91; P=.005). Conclusions The internet-based warfarin management is superior to the conventional method, as it can reduce the anticoagulation complications in patients who receive long-term warfarin anticoagulation after MHVR. Trial Registration Chinese Clinical Trial Registry ChiCTR1800016204; http://www.chictr.org.cn/showproj.aspx?proj=27518 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2019-032949

Effects of eHealth Interventions on Quality of Life and Psychological Outcomes in Cardiac Surgery Patients: Systematic Review and Meta-analysis

“…After removing duplicate studies, the remaining 2979 records were screened. After reading 41 eligible full-text articles, 22 were excluded, and 19 were selected [ 29 - 47 ]. A summary of the study characteristics and participant demographics are presented in Multimedia Appendix 3 [ 29 - 47 ].…”

“…After removing duplicate studies, the remaining 2979 records were screened. After reading 41 eligible full-text articles, 22 were excluded, and 19 were selected [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47]. A summary of the study characteristics and participant demographics are presented in Multimedia Appendix 3 [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47].…”

“…In this systematic review, we assessed the impact of eHealth interventions on cardiac surgery recovery based on the results of 19 studies. These studies reported at least an equal (n=6) [29,30,33,38,39,42] or positive effect (n=13) [31,32,[34][35][36][37]40,41,[43][44][45][46][47] of the eHealth intervention compared to conventional care. According to the results of the meta-analysis, when compared with the control group, the eHealth intervention group showed an improvement in both the physical component of quality of life and the depressive status of patients after cardiac surgery.…”

“…However, the experimental group consumed more opioid medication (mean 31.2, SD 23.2 mg) than the control group (mean 18.8, SD 15.3 mg; P=.001). Two studies [44,47] showed that the use of eHealth improved efficacy in maintaining the therapeutic range of prothrombin time.…”

A Study of the Nursing Intervention Based on Self-Efficacy Theory for Patients After Mechanical Heart Valve Replacement: A Randomized Controlled Trial

“…For patients with severe valve disease, heart valve replacement (HVR) is considered to be an effective treatment, of which mechanical heart valve replacement (MHVR) was widely adopted in China because mechanical valves were more durable over biological ones. 1 Although MHVR effectively eliminates the original valvular disease, postoperative patients must undergo lifelong anticoagulant therapy and adhere to regular follow-up. Therefore, good self-management ability was a must for patients to ensure the therapeutic effect.…”