Mid-term results of self-testing of the international normalized ratio in adults with a mechanical heart valve.

BACKGROUND: Commonly the frequency of international normalized ratio (INR) monitoring with a conventional laboratory test in stable patients is once a month. When using a dedicated personal device for INR assessment, the frequency may be increased to two or more times a month. OBJECTIVE: To show that INR assessed by self-measurement at home is reliable and feasible in the mid-term and improves medical care. PATIENTS AND METHODS: All patients in the study on INR self-measurement (clinical trial.gov: NCT00925197), conducted between 2004 and 2007, were re-contacted for mid-term follow-up. One hundred and seventy eight out of 192 patients who participated in the study answered a questionnaire. The average follow-up time was 4.2 years (±1) for the self-measurement group and 4.9 years (±1) for the laboratory-analyzed control group. RESULTS: Only 26 patients (group A) continued to use INR self-measurement to monitor treatment with vitamin K antagonists (VKA). The main reasons to stop INR self-measurement were its high cost and difficulty in obtaining strips. There were significantly fewer bleeding complications (p=0.04) and complications related to VKA (p=0.01) in self-measured patients compared to the control group. Feelings of security and quality of life were also significantly better (p=0.002) for self-measured patients. CONCLUSION: Many patients with a mechanical heart valve, who self-measured INR, continue to use this method for their follow-up because of its positive effects on their health and quality of life.

Comparison of INR stability between self-monitoring and standard laboratory method: preliminary results of a prospective study in 67 mechanical heart valve patients.

INTRODUCTION: Thromboembolic accidents and haemorrhage are the main complications observed during long-term follow-up of mechanical heart valve patients. Several suggestions for improving anticoagulation quality have been made, including international normalised ratio (INR) self-monitoring. OBJECTIVES: We report the preliminary results of a single-centre, open, randomised study (scheduled population of 200 patients), which compares monthly laboratory monitoring (group A) versus weekly self-monitoring of INR (group B). The primary aim is INR stability improvement within the target range, and the secondary aim is adverse events reduction. PATIENTS AND METHODS: Between May 2004 and June 2005, 67 patients with an average age of 56.6 years (+/-9.6), were enrolled in the study (group A: 34 patients, group B: 33 patients). The mean follow-up was 47 weeks (+/-11.5). The two groups differed only in the sex ratio (44.1 and 21.2% of women in groups A and B respectively, p=0.0459). Mechanical heart valves were aortic in 73% of patients, mitral in 13.5%, and multiple in 13.5%. Sixty-five patients (97%) were treated with fluindione, the others with acenocoumarol. The intraclass correlation coefficient between the self- and laboratory-monitored INR was 0.75. RESULTS: The time spent in the INR target range (group A: 53+/-19%, group B: 57+/--19%, p=0.45) and the time spent in the INR therapeutic range, between 2 and 4.5, (group A: 86+/-14%, group B: 91+/-7%, p=0.07) are longer in group B, but not significantly so. For patients outside the range, the absolute mean deviation of INR from the target or therapeutic range (range standardized between 0 and 100) is lower for the self-monitoring group (41.1+/-39.3 and 11.27+/-11.2) than for the control group (62.4+/-72.6 and 39.2+/-52.8). This difference is significant (p=0.0004 and p=0.0005). Eighteen adverse events were reported: 17 haemorrhages, 13 in group A (9 mild, 4 serious) and four in group B (all mild), and one sudden death in group B, two days after the patient's discharge. No thromboembolic events were reported. Six patients (8.8 %), 3 in each group, dropped out of the study. CONCLUSION: This first study evaluating INR self-monitoring in France shows that this method leads to better stability of the INR within the target range. On the basis of these preliminary data, this appears to be related to a decrease in serious haemorrhages (11.8% serious haemorrhage cases in group A versus 0% in group B, p=0.06, NS).

Unusual primary cardiac neoplasm in a nonimmunocompromised patient.

Primary cardiac lymphoma is a neoplasm with poor prognosis. It is occasionally seen in patients with AIDS and transplant recipients, and it is exceedingly rare in nonimmunocompromised hosts. Presentation is heterogeneous and nonspecific, making clinical suspicion difficult. Diagnosis is often late. There are different therapeutic options (chemotherapy, radiotherapy, monoclonal antibodies therapy, and surgery), but there is no uniform consent on the best management. Surgical treatment is controversial. We report our experience with a unique patient in 23 years.