Safety and efficacy of using portable coagulation monitor for INR examination after left-sided mechanical prosthetic valve replacement

Warfarin is the most widely used oral anticoagulant in the world. Patients with prosthetic mechanical valve implantation require lifelong oral warfarin for anticoagulation therapy [2]. Warfarin is very effective when anticoagulation levels are maintained within the target therapeutic range, but exceeding the target therapeutic range may cause serious consequences, such as anticoagulation-related bleeding and thromboembolism, which can even lead to death in severe cases [7].

However, because of a variety of factors, the INR value often fluctuates during warfarin administration, requiring regular coagulation monitoring and dose adjustment in clinical practice. Patients are subject to require frequent visits to the clinic for coagulation testing. Some patients often reduce the frequency of testing or even do not monitor INR at all due to the great inconvenience it causes to their lives, which in turn reduces compliance with warfarin anticoagulation control, resulting in a failure to achieve anticoagulation or even a serious bleeding event [9, 24].

Due to the limitations of warfarin anticoagulation, in order to assess the effectiveness of taking warfarin anticoagulation, it is important to focus not only on INR but also on the overall quality of anticoagulation while taking warfarin. TTR is widely used as an indicator to assess the quality of anticoagulation therapy and is the gold standard used to assess the effectiveness of warfarin anticoagulation as the percentage of time a patient’s INR is within the desired therapeutic range [25]. Previous Studies have indicated that the real benefit of warfarin treatment is achieved by controlling TTR above 70%, a level that provides protection against thromboembolism without increasing the risk of bleeding [7, 8]. Our patients in both groups had a TTR close to 70%. Patients using the portable device had a higher TTR than those who revisit the clinic for coagulation testing, with a significant difference between the two groups. This indicates that patients using the portable device had better results with anticoagulation therapy.

We found that the total number of measurements was greater in patients with portable devices in this study. The availability of portable devices and home monitoring has facilitated more frequent testing. Clinical evidence suggests that more frequent testing will lead to tighter anticoagulation control, which may improve the safety of warfarin and reduce the risk of thromboembolic and major bleeding events [26].

A clinical practice guideline states that patient self-management may be recommended over routine outpatient INR monitoring for patients treated with warfarin who are motivated and can demonstrate their ability to self-manage (including self-testing devices) [27]. Surveys have shown that patient compliance is an important factor in TTR. If patient compliance is high, then TTR is usually higher [28]. The use of coagulation monitors for patient self-management enhances patient compliance as it does not require frequent trips to the hospital and the monitoring results are simple, quick and easy to obtain, which may be associated with their higher TTR. The study also showed that patients who implemented home monitoring tended to have INRs in the therapeutic range and lower rates of complications and hospitalizations than patients who had their INR monitored in the clinic visit. Patients who apply portable devices for self-management have a slightly reduced risk of death, thromboembolic risk, and risk of major bleeding. The main barrier to widespread use of patient self-management is cost, with test equipment plus a set of test strips costing thousands of dollars. This also suggests that patients who are willing to spend on equipment tend to be in a better financial position and more willing to spend on health [2]. The coagulation monitor is therefore an important aid for patients taking warfarin for the prevention of thromboembolism, where the patient’s financial situation permits. The coagulation monitor is easy to use, quick to obtain results, improves patient compliance and facilitates the adjustment of the patient’s warfarin dose, thus ensuring that the patient can truly benefit from taking warfarin.

Previous literature has shown that offering medication guidance to patients with mechanical heart valve replacement via telemedicine is safe and feasible [29]. Our institution is located in a province with many mountains and islands proximity to the coastline, a region with a population of 41.54 million according to the census, which is slightly inaccessible due to the barrier of mountains and waters. Our institution is the main centre for cardiac surgery in the region, while the rest of the region has no experience of post-operative patient management and cannot effectively assist patients. The use of the coagulation monitor and the use of smartphone communication software for follow-up visits can greatly reduce the burden of travel on patients and increase their compliance. In addition to improving patient compliance, the coagulation monitor provides immediate results so that doctors can be informed if an anticoagulation overdose is the cause. During the follow-up period of our study, a patient contacted us with unexplained black stools and the coagulation monitor measured an elevated INR. We immediately advised the patient to seek medical intervention for excessive anticoagulation, and reduced the onset to treatment time.

As China is an ageing and urbanising society, there are many elderly patients who live alone in the countryside and we have found in our clinical practice that most of these patients do not have young educated family members to accompany them after surgery. With the coagulation monitor, it is easy to use and saves the hassle of hospital visits for INR testing. Family members can remind the patient by phone or supervise the test via video communication software, enhancing patient compliance.

Limitation

Despite the results obtained in the study, however, there are still some limitations. Firstly, our study did not limit the type of coagulation testing devices purchased by patients, the small sample size of the study, and the inherent shortcomings of the TTR calculation method do not reflect the variability of the INR.

Second, the higher compliance of those who agreed to the follow-up study caused an overestimation of TTR values, which would be higher than the general population in the natural state, with selection bias.

Nevertheless, our comparisons between populations in the same region were consistent, and baseline data such as diabetes, age, and cardiac function did not differ between the two groups of patients, which still have some clinical significance.

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