Results of the first randomized French study evaluating self-testing of the International Normalized Ratio.

BACKGROUND AND AIM OF THE STUDY: In this single-center French study, the conventional management of patients receiving vitamin K antagonists (VKAs) was compared with an International Normalized Ratio (INR) self-testing program. The aim was to determine the reliability of self-testing devices, and to estimate the variability of the self-measured INR within the therapeutic and target range. METHODS: A total of 206 patients who had undergone valve replacement with a mechanical prosthesis, with or without myocardial revascularization, between May 2004 and September 2007 was randomized into two groups. Group 1 patients (n = 103) underwent INR monitoring at a laboratory, while Group 2 patients (n = 103) underwent self-testing INR using either the CoaguChek (Roche) (Group 2A; n = 55) or INRatio (Hemosense) (Group 2B; n = 48) system. Patients in Group 1 underwent at least once-monthly INR measurement, while those in Group 2 carried out once-weekly self-testing, and also underwent once-monthly INR measurement at the laboratory. The large majority of patients (97.9%) were treated with fluindione. RESULTS: The mean follow up period was 49.0 +/- 10.3 weeks. Self-testing was reliable, with a correlation coefficient between device- and laboratory-measured INRs of 0.80 [CI: 0.78, 0.82] (p < 0.0001). The proportion of time spent within the INR target range was significantly higher for Group 2 (61.5 +/- 19.3% versus 55.5 +/- 19.9%; p < 0.05), while the absolute mean deviation of INR from the target range was higher in Group 1 (60.1 +/- 70.2% versus 47.4 +/- 51.5%). Adverse events were reported by seven patients in Group 1, but by no patients in Group 2 (p < 0.01). CONCLUSION: INR self-testing devices are reliable and beneficial. Moreover, INR self-monitoring allows an enhanced stability within a target range, and also helps to prevent serious postoperative complications.

Improving cardiac function after cardiac surgery by biventricular pacing in patient selected by three-dimensional echocardiography.

We present the case of a 57-year-old woman with severe aortic regurgitation and ventricular dysfunction (ejection fraction 34%) requiring surgical intervention. In pre-operative period, no left ventricular (LV) asynchrony was detected by QRS duration and current echocardiographic techniques, including tissue Doppler imaging. A new echocardiographic technology, the timing of regional volumetric changes by three-dimensional echocardiography (3DEcho), demonstrated an intraventricular mechanical asynchrony. Indeed, during surgery, epicardial leads were attached to the right atrium and the right ventricle as part of the standard management. Two additional epicardial leads were attached to the left ventricle on the most delayed wall localized precisely by 3DEcho on the inferolateral wall. In post-operative period, biventricular (BiV) pacing showed improvement in the LV mechanical synchronization, resulting in improvement in the LV systolic function compared with right ventricular pacing or no pacing. This case shows the potential utility of 3DEcho in prediction of favourable response of the BiV pacing in patients with depressed LV systolic function ongoing cardiac surgery.

Survey: retrospective survey of monitoring/safety devices and incidents of cardiopulmonary bypass for cardiac surgery in France.

Several surveys showed that cardiopulmonary bypass (CPB) is associated with incidents that negatively affect outcome and suggested that improved monitoring and safety could be associated with a decreased rate of incidents. In 2004, the French "Haute Autorité de Santé" (an independent French government advisory agency) and the French College of Perfusion issued recommendations concerning safety and monitoring devices for CPB. The aims of this study were to investigate the difference between the recommendations and the clinical practice of CPB shortly after publication of the recommendations and compare the 2005 situation with the results of a previous survey performed in France and to investigate the rate of perfusion incidents and their outcome. A 62-item questionnaire was sent in January 2006 to all 66 centers performing cardiac surgery and CPB in France. The survey investigated the use of safety and monitoring devices as well as perfusion incidents for 2005. Fifty-seven centers (response rate, 86%) returned the questionnaire, totaling 34,496 CPB procedures. There was a wide difference between the recommendations and the reported use of safety and monitoring devices with no clinically relevant change from the previous French survey concerning 2001. An incident was reported for every 198 CPB procedures with death at a frequency of 1:4864 and permanent sequelae of 1:11,349, respectively (a permanent injury or death in 1:3220 procedures). The three most frequent perfusion incidents were adverse effects to protamine (1:1702), dissection at the arterial cannulation site (1:1792), and coagulation of the circuit (1:4864). In conclusion, this survey showed that an important effort must be made in France to implement into clinical practice the recommendations concerning CPB monitoring and safety devices. The analysis of CPB-related incidents suggest that, with the exception of protamine adverse effects, the majority of deaths and severe permanent injuries in this survey could probably be avoided by improved use of the monitoring and safety devices.

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.

Thrombosis after mitral valvuloplasty: A review of two cases and the role of antithrombotic therapy.

We describe two cases of thrombosis after mitral valvuloplasty (MV). Antithrombotic therapy after MV in patients with no thromboembolic risk factors is essentially based on treatment with a platelet aggregation inhibitor. This strategy may not be sufficient in some cases and the introduction of oral anticoagulant therapy may be necessary.

The Sorin Bicarbon over 15 years clinical outcomes: multicentre experience in 1704 patients.

OBJECTIVES: To present the results of a 15-year follow-up of the Sorin Bicarbon prosthesis (SBP) from a European multicentre study. METHODS: From 1990 to 1996, a total of 1900 SBPs were implanted in 1704 patients, with a mean age of 59±13 years, as aortic (AVR, 922 patients), mitral (MVR, 586) or mitro-aortic (DVR, 196) valve replacement. Most patients received an SBP for rheumatic or degenerative valve disease. Concomitant procedures were performed in 25% of cases, mainly coronary artery bypass grafting (14%) or tricuspid annuloplasty (7%). RESULTS: There were 70 (4.1%) early deaths. Actuarial survival at 15 years is 61.4% (95% confidence interval (CI): 56.4-66.0) for AVR, 63.4% (59.1-67.5) for MVR, 56.4% (47.3-64.6) for DVR. Late valve-related deaths were 260 with an actuarial freedom from valve-related deaths at 15 years of 76.4% (81.5-83.7). There were 27 cases of SBP thrombosis with an actuarial freedom from this complication at 15 years of 99.6% (98.6-99.9) after AVR, 95.8% (93.0-97.5) after MVR and 97.0% (92.8-98.7) after DVR. Thrombo-embolic episodes were 159; actuarial freedom from thrombo-embolism at 15 years is 88.8% (86.8-90.5). Haemorrhages related to anticoagulant treatment occurred in 293 cases with 39 fatal episodes; actuarial freedom at 15 years is 77.5% (74.2-80.4). There were 45 episodes of endocarditis, 21 required re-operation; actuarial freedom from endocarditis at 15 years is 96.8% (95.6-97.7). Re-operation was performed in 71 patients (non-structural valve deterioration in 28, endocarditis in 21, SBP thrombosis in 15 and non-valve-related causes in seven patients). No cases of structural failure were observed. Actuarial freedom from re-operation at 15 years is 97.6% (96.3-98.5) after AVR, 92.8% (90.1-94.8) after MVR and 90.7% (85.2-94.2) after DVR. CONCLUSIONS: The SBP continues to perform satisfactorily even in the long term with low incidence of valve-related mortality and morbidity confirming to be an extremely reliable and durable mechanical valve substitute.

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).