Kasra Azarnoush

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).

The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery.

Background and Objectives The aim of this study was to assess the effects of a continuous postoperative administration of local anesthetic through 2 catheters placed deeply under fascia at the lateral edges of the sternum, close to the emergence of the intercostal nerves. We focused on pain during mobilization, as this aspect is likely to interact with postoperative morbidity. Methods Forty adult patients scheduled for open heart surgery with sternotomy were included in this randomized, placebo-controlled, double-blind study. A continuous fixed-rate infusion of 4 mL/hr of 0.2% ropivacaine or normal saline was administered during the first 48 postoperative hrs. All patients received acetaminophen and self-administered morphine. The efficacy outcomes were as follows: pain score during standardized mobilization and at rest; morphine consumption; spirometry and arterial blood gases; postoperative rehabilitation criteria, and patient satisfaction. Total ropivacaine plasma level was monitored throughout the study. Results Pain scores were lower in the ropivacaine group during mobilization (P = 0.0004) and at rest (P = 0.0006), but the analgesic effects were mostly apparent during the second day after surgery, with a 41% overall reduction in movement-evoked pain levels. The bilateral sternal block also reduced morphine consumption. It improved the patients’ satisfaction and rehabilitation, but no effects were noted on respiratory outcomes. No major adverse effect due to the treatment occurred, but the ropivacaine plasma level was greater than 4 mg/L in 1 patient. Conclusions This technique may find a role within the framework of multimodal analgesia after sternotomy, although further confirmatory studies are needed.

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.

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.

Mitochondrial protein synthesis is increased in oxidative skeletal muscles of rats with cardiac cachexia

Since cardiac cachexia could be associated with alterations in muscular mitochondrial metabolism, we hypothesized that the expected alterations in the activities of mitochondrial oxidative enzymes could be associated with changes in mitochondrial protein synthesis in oxidative skeletal muscles. Cardiac cachexia was provoked in male rats by the ligation of the left coronary artery. Six cachectic and 6 control rats were age-paired, and their food intake was observed. The synthesis of mitochondrial proteins was measured by [1-13C]-valine infusion in soleus, tibilais, myocardium, and liver. Muscles (soleus, gastrocnemius, and tibialis anterior), heart, kidneys, liver, and visceral adipose tissue were weighed. Mitochondrial cytochrome c oxydase IV as well as citrate synthase and myosin ATPase activities were measured. As expected, decreased food intake was observed in the cachectic group. Heart, kidney, and liver weights were higher in the cachectic group, while the visceral adipose tissue weight was lower (P < .01). No changes in muscle weights were observed. Soleus mitochondrial proteins fractional synthesis rate was higher in the cachectic group (P = .054). Cytochrome c oxydase IV activity was reduced (P = .009) and increased (P = .038) in the soleus and liver of the cachectic rats, respectively. No change in citrate synthase activity was observed. Myosin ATPase activity was reduced in the gastrocnemius of the cachectic group (P < .01). Mitochondrial protein synthesis is increased in the soleus of rats with cardiac cachexia, suggesting a compensatory mechanism of the impaired oxidative mitochondrial function. Further work should assess whether the mitochondrial protein synthesis is altered in chronic heart failure patients with cardiac cachexia, and whether this is the cause or the consequence of cachexia.

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.

Advantages of 18F-fluorodeoxyglucose positron emission tomography combined with computed tomography in detecting post cardiac surgery infections.

UNLABELLED The 18F-fluorodeoxyglucose positron emission tomography combined with computed tomography (FDG-PET/CT) offers an excellent negative predictive value. Consequently, it is a reliable tool for excluding an infectious phenomenon in case of negativity. In case of persistent fever of unknown origin after cardiac surgery and in combination with other bacteriological examinations and medical imaging, we can rely on FDG-PET/CT to confirm or eliminate deep infections and prosthetic endocarditis. For this reason, FDG-PET/CT should be considered among the examinations to be performed in case of suspected infection after cardiac surgery. We have reported the case of a 76-year-old man who presented with a fever of unknown origin and recurrent septic shocks after a biological Bentall procedure combined with left anterior descending (LAD) coronary artery revascularization by the left internal thoracic artery. We performed a FDG-PET/CT which showed external iliac vein and right common femoral vein hyperfixation with infiltration of adjacent soft tissues, highly suspected to be an infectious process. LEARNING OBJECTIVE The aim of this case report is to show that FDG-PET/CT, in combination with other bacteriological examinations and medical imaging, can be extremely helpful in detecting deep infectious sources, even during the early postoperative period.

Severe non-traumatic bleeding events detected by computed tomography: do anticoagulants and antiplatelet agents have a role?

PurposeBleeding is the most common and most serious complication of anticoagulant (AC) and antiplatelet agents (APA) which are increasingly used in every day practice. The aim of this study was to enlist and analyze the most severe bleeding events revealed during computed tomography scanner (CT scan) examinations over a 1-year period at our University Hospital and to evaluate the role of ACs and APAs in their occurrence.MethodsThis descriptive monocentric retrospective study included all patients who benefited from an emergency CT scan with a diagnosis of severe non-traumatic bleeding. Patients were divided into two groups: those treated with ACs and/or APAs, and those not treated with ACs or APAs.ResultsAfter applying the inclusion criteria, 93 patients were enrolled. Sixty-one patients received an anticoagulant or antiplatelet treatment, and 32 did not receive any AC or APA therapy. Seventy nine percent presented with an intracranial hemorrhage, 17% with a rectus sheath or iliopsoas bleeding or hematoma, and 4% with a quadriceps hematoma. Only patients who received ACs or APAs suffered a muscular hematoma (p <0.0001). Among patients treated with vitamin K antagonists, 6/43 (14%), had an international normalized ratio (INR) higher than the therapeutic range (INR >3).ConclusionsIn our series, intracranial hemorrhage was preponderant and muscular hematomas occurred exclusively in patients treated with ACs and/or APAs. This study needs to be extended to evaluate the impact of new anticoagulant and antiplatelet agents.

Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial

BackgroundAortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the ‘gold standard’ treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses.Methods and designFirst, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery.DiscussionThis prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient’s morphological characteristics.Trial registrationClinicalTrials.gov Identifier: NCT01522352

Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial

BACKGROUND The continuous bilateral infusion of a local anaesthetic solution around the sternotomy wound (bilateral sternal) is an innovative technique for reducing pain after sternotomy. OBJECTIVE To assess the effects of the technique on the need for intensive care in cardiac patients at increased risk of respiratory complications. DESIGN Randomised, observer-blind controlled trial. SETTING Single centre, French University Hospital. PATIENTS In total, 120 adults scheduled for open-heart surgery, with one of the following conditions: age more than 75 years, BMI >30 kg m−2, chronic obstructive pulmonary disease, active smoking habit. INTERVENTION Either a bilateral sternal infusion of 0.2% ropivacaine (3 ml h−1 through each catheter; ‘intervention’ group), or standardised care only (‘control’ group). Analgesia was provided with paracetamol and self-administered intravenous morphine. MAIN OUTCOME MEASURES The length of time to readiness for discharge from ICU, blindly assessed by a committee of experts. RESULTS No effect was found between groups for the primary outcome (P = 0.680, intention to treat); the median values were 42.4 and 37.7 h, respectively for the control and intervention groups (P = 0.873). Similar nonsignificant trends were noted for other postoperative delays. Significant effects favouring the intervention were noted for dynamic pain, patient satisfaction, occurrence of nausea and vomiting, occurrence of delirium or mental confusion and occurrence of pulmonary complications. In 12 patients, although no symptoms actually occurred, the total ropivacaine plasma level exceeded the lowest value for which neurological symptoms have been observed in healthy volunteers. CONCLUSION Because of a small size effect, and despite significant analgesic effects, this strategy failed to reduce the time spent in ICU. TRIAL REGISTRATION EudraCT (N°: 2012-005225-69); ClinicalTrials.gov (NCT01828788).