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

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.

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Low-Dose International Normalized Ratio Self-Management: A Promising Tool to Achieve Low Complication Rates After Mechanical Heart Valve Replacement

The Annals of Thoracic Surgery ◽

10.1016/j.athoracsur.2004.09.012 ◽

2005 ◽

Vol 79 (6) ◽

pp. 1909-1914 ◽

Cited By ~ 16

Author(s):

Heinrich Koertke ◽

Armin Zittermann ◽

Kazutomo Minami ◽

Gero Tenderich ◽

Otto Wagner ◽

...

Keyword(s):

Valve Replacement ◽

Heart Valve ◽

Low Dose ◽

Mechanical Heart Valve ◽

International Normalized Ratio ◽

Heart Valve Replacement ◽

Self Management ◽

Complication Rates ◽

Promising Tool

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Self-Management in Patients with Heart Valve Replacement and Its Clinical Outcomes: A Systematic Review

10.21203/rs.3.rs-49208/v1 ◽

2020 ◽

Author(s):

Shirdel Zandi ◽

Behzad Imani ◽

Salman khazaei ◽

GHolamreza Safarpor

Keyword(s):

Systematic Review ◽

Clinical Outcomes ◽

Valve Replacement ◽

Heart Valve ◽

Low Dose ◽

Anticoagulation Therapy ◽

Heart Valve Replacement ◽

Self Management ◽

Screening Process ◽

Valve Function

Abstract Background: For patients with heart valve replacement, self-management can play an important role in controlling the patient's condition, therefore, the purpose of this review was to identify the aspects of self-management and its clinical outcomes in patients with heart valve replacement. Methods: We conducted a systematic review of peer-reviewed research literature focused on self-management in patients with heart valve replacement. The databases of PubMed, Scopus, and web of science were searched until May 2020 free from time and language limitation. Al documents were assessed for eligible articles by title or abstract according to the search strategy.The screening process of articles was conducted by two independent authors. The selected articles were checked regarding to inclusion and exclusion criteria.Results: Finally, 25 studies were considered in this systematic review. Self-management of these patients has prerequisites and requires appropriate training. Self-management in these patients is applicable in the aspects of Anticoagulation therapy self-management, INR self-testing, Low-dose INR Self-management, and Heart valve function self-monitoring. In this method, with better control of INR levels and Anticoagulation therapy, the incidence of complications will be reduced and patients will be able to diagnose functional disorders in the early stages by monitoring the function of valve, which will prevent the progression of complications. Conclusion: The results of this review clearing that self-management is applicable in the aspects of Anticoagulation therapy, INR control, low dose INR management, and monitoring of cardiac valve function and by improving care standards, it will improve the quality of treatment for these patients.

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

10.32592/ircmj.2021.23.1.13 ◽

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.

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