Lionel Camilleri

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 patients 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).

Mitral and mitro-aortic valve replacement with Sorin Bicarbon valves compared with St. Jude Medical valves.

OBJECTIVE We assessed the clinical results of two bileaflet mechanical valves: the St. Jude Medical (SJM) and the Sorin Bicarbon (Sorin Bicarbon) used either in single mitral valve replacement (MVR) or in double, aortic and mitral, valve replacement (DVR). METHODS Between September 1990 and November 1995, 217 patients received either a St. Jude Medical (n=134) or a Sorin Bicarbon (n=86): 136 mitral valve replacement with 83 St. Jude Medical and 53 Sorin Bicarbon and 84 double valve replacement with 51 St. Jude Medical and 33 Sorin Bicarbon. There was no difference between both St. Jude Medical and Sorin Bicarbon cohorts in respect of mitral valve physiopathology, etiology of valve disease, associated lesions, echocardiographic and hemodynamic data. The only significant preoperative difference was the age of patients within the double valve replacement group and the size of implanted valves within the mitral valve replacement group. Follow-up was 100% complete with a mean of 39+/-18 months, ranging between 6 and 68 months. The total follow-up was 657 patient-years (pt-y): 396 pt-y in the mitral valve replacement group and 274 pt-y in the double valve replacement group. RESULTS Hospital mortality (St. Jude Medical: 2.2%; Sorin Bicarbon: 6.9%) and late mortality (St. Jude Medical: 8.4%; Sorin Bicarbon: 6.3%) were not significantly different. Ten deaths were considered valve-related (St. Jude Medical 6, Sorin Bicarbon 4). The estimated 4-yr overall survival, including hospital mortality, was for St. Jude Medical--mitral valve replacement: 89+/-4% and St. Jude Medical--double valve replacement: 93+/-4%, and for Sorin Bicarbon--mitral valve replacement: 87+/-5% and Sorin Bicarbon--double valve replacement: 91+/-5%. The linearized incidence (% per pt-y) of valve-related complications was 6.39 in the St. Jude Medical cohort and 9.2 in the Sorin Bicarbon cohort. The linearized incidence (% pt-y) of the prevalent complication, valve thromboembolism and bleeding, was for St. Jude Medical-mitral valve replacement: 3.41, St. Jude Medical--double valve replacement: 3.16 and for Sorin Bicarbon--mitral valve replacement: 2.17 and Sorin Bicarbon--double valve replacement: 3.67. The differences between each group of an estimated 4-yr freedom from combined thromboembolism and bleeding were not significant (St. Jude Medical--mitral valve replacement: 90+/-4%, St. Jude Medical--double valve replacement: 84+/-6%, and for Sorin Bicarbon--mitral valve replacement: 94+/-3% and Sorin Bicarbon--double valve replacement: 75+/-17%). CONCLUSIONS In this clinical non-randomized study, there was no evidence of any significant difference between St. Jude Medical and Sorin Bicarbon valves over a 4-yr follow-up.

Results of mechanical circulatory support in France.

OBJECTIVE To present the analyzed results on mechanical circulatory support (MCS) collected over a 7-year period, from 2000 to 2006, in France. METHODS A cohort of 520 patients was analyzed. Mean age was 43.7 ± 13.6 years. The main causes of cardiac failure were ischemic cardiomyopathy (39%), idiopathic dilated cardiomyopathy (41.3%), or myocarditis (6.4%). Bridge to transplantation was indicated in 87.8% of patients, bridge to recovery in 9%, while destination therapy was proposed in 3.2% of patients. RESULTS For patients in cardiogenic shock or advanced heart failure undergoing device implantation as bridge to transplantation or recovery (n=458), overall mortality was 39% (n=179). The main causes of mortality under MCS were multi-organ failure (MOF) (57.4%), neurological events (14.1%), or infections (11.9%). Heart transplantation was performed in 249 (54.3%) patients. The main causes of death following heart transplantation were primary graft failure (22.4%), MOF (14.3%), neurological event (14.3%), or infection (10.2%). Long-term survival in transplanted patients was 75 ± 2.8% at 1 year and 66 ± 3.4% at 5 years. CONCLUSIONS MCS is an essential therapeutic tool to save the life of young patients with cardiogenic shock or advanced cardiac failure. Early MCS implantation and the availability of a device that is adapted to the patients clinical status are prerequisites for reducing overall mortality rates.

Spontaneous intramural left atrial hematoma associated with systemic amyloidosis

Spontaneous intramural left atrial hematoma is very rare. We describe a case of spontaneous intramural left atrial hematoma that had to be semiurgently resected. Postoperatively, the patient was diagnosed as having systemic immunocyte-derived (AL) amyloidosis, because of rare manifestations of fatal bleeding. Though spontaneous intramural left atrial hematoma is one of the severe complications of systemic AL amyloidosis, we believe that amyloid deposits caused fragility of the left atrial wall.

Flexible posterior mitral annuloplasty: five-year clinical and Doppler echocardiographic results

BACKGROUND Stabilization of the posterior annulus seems to be a critical factor to achieve a stable mitral valve repair. To assess the benefit of softer mural annuloplasty, we analyzed results obtained with the flexible linear reducer. METHODS From 1985 to 1993, 120 patients, with pure mitral regurgitation, mainly degenerative, had a mitral reconstruction. Mean age was 64+/-11 years and 74% of the patients were in New York Heart Association functional class III or IV. RESULTS Hospital mortality was 3.3%. Mean follow-up was 56+/-24 months. There were 23 late deaths; 10 valve-related including 7 sudden deaths. Two patients (1.7%) required a reoperation. Doppler echocardiographic studies revealed excellent valve function; 5-year freedom from significant regurgitation was 85.8%+/-5.4%. Mean mitral valve area was 2.76+/-0.77 cm2. Although 105 patients were in class I or II, 23 patients were not functionally improved. Previous myocardial infarction and shorter deceleration time of early filling were risk factors for worsening functional disability. CONCLUSIONS This support provides stable repair with excellent clinical and echographic results. Previous myocardial infarction and noncompliant left ventricle negatively influence outcome.

Surgical correction of the hypoplastic aortic arch by the subclavian free flap method in the neonate.

and regained normal immunity to ensure success. In agreement with other authors, ~ we never found that cervicothoracic access was not needed for simple repair of a TEF. Thus the risks of postoperative assisted ventilation (which constitute the main cause of relapse) are greatly reduced, resulting in an acceptable rate of mortality (about 10% according to Marzelle and associates1). A left lateral cervical incision gives very satisfactory access for simple closure of a TEF, with better visibility and adequate operative space compared with the median approach, and has the advantage of being able to be transformed to a cervical incision at the neck if necessary. Placement of a muscular flap between the two viscera is another indispensable element for success. The partial relapse in our second patient was due, in our opinion, to the insertion of a muscular flap that was too thin (omohyoidal muscle). In cases of associated tracheal stenosis, which occurs in about 22% of patients with a TEF, 1 the possible anastomotic resection of even a small segment (a rare event) greatly increases the surgical risk. For this reason, in two of our patients with associated tracheal lesions, we opted for t reatment with a dilating endoprosthesis.

Coil embolization of a false aneurysm with aorto-cutaneous fistula after prosthetic graft replacement of the ascending aorta

AIM To report palliative embolization of a false aneurysm over the distal suture line of an ascending aorta graft replacement. MATERIAL AND METHOD A 78-year-old male patient was admitted for increasing bleeding of a chronic Manubrium ulceration, 20 months after coronary artery bypass complicated by perioperative ascending aorta dissection requiring prosthetic graft replacement. One month later, he underwent epiploplasty for a mediastinitis followed by long-term antibiotic therapy. Five months later, he presented with a Manubrium ulceration of the sternotomy. Spiral computerized tomography (CT) and aortography revealed a 20 mm anterior peri-prosthetic false aneurysm with a wide neck. Advanced age, active mediastinitis and patients objection led us to perform percutaneous occlusion according to the Moret remodeling technique while protecting the coils release with balloon catheter inflation. RESULTS No post-operative complication was observed and at 1-year follow-up the patient was doing well with no recurrent bleeding. Magnetic resonance imaging (MRI) and spiral CT controls confirmed coils stability without any internal flow. CONCLUSION Percutaneous coils embolization of a large false aneurysm in the ascending aorta can be a palliative treatment in a surgically unsuited patient.

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.

Arterial Injury Complicating Subclavian Central Venous Catheter Insertion

n i a a g n c INADEQUATE PLACEMENT of a subclavian venous catheter in the subclavian artery is a well-known complication.1,2 Three cases of accidental arterial puncture occurred with the implantation of subclavian venous catheters, 2 of which involved the subclavian artery leading to percutaneous treatment; and the other involved the aortic arch, resulting in surgical management, are described.

Effectiveness of anticoagulant therapy in the treatment of post-TAVI bioprosthetic thrombosis

Bioprosthetic thromboses are rarely reported in post-transcatheter aortic valve implantation (TAVI). We describe herein the case of bioprosthetic valve thrombosis in an 82-year-old patient which resolved completely after anticoagulant therapy.