Daratumumab treatment in six highly sensitised solid organ transplant recipients: A case series and literature review.

We report data on six kidney or heart recipients who were administered daratumumab to treat or prevent antibody-mediated rejection (ABMR). To date, data are scarce concerning the use of daratumumab in solid organ transplantation and most reports show a decrease in donor-specific antigen (DSA) levels and an improvement in ABMR using a multiple myeloma daratumumab administration scheme, that is, with sequential systematic administration. Here, we report on the efficacy of daratumumab 1/ in reducing the histological signs of ABMR, 2/ in reducing the ability of DSA to bind to donor cells in vitro through negativation of flow cytometry crossmatching, 3/ in preferentially being directed towards antibodies sharing epitopes, suggesting that daratumumab may specifically target activated plasma cells, 4/ and when administered as a single dose. This last point suggests, for the first time, that, as for rituximab in auto-immune diseases, the scheme for daratumumab administration could be different for targeting DSA-producing plasma cells than for tumour cells.

Fifteen-year experience with the Tirone David procedure in bicuspid aortic valve: A safe option.

BACKGROUND: We evaluated short and midterm outcomes with use of aortic valve-sparing root replacement to treat bicuspid aortic valves (BAVs). METHODS: From December 2007 to January 2022, all patients with BAVs who underwent aortic root replacement using Tirone's procedure were included. This study based on department database information for retrospective and follow-up data. RESULTS: Among 51 adults undergoing aortic root replacement using Tirone's procedure, the mean age was 47.4 ± 12.5 years, and most were men (92.2%). Three presented with a dysmorphic syndrome and one had Marfan's syndrome. All patients were alive at 30 days, and as of January 2022, 45 were alive, two were lost to follow-up, and there were four noncardiac deaths. Two patients had infectious endocarditis and needed a Bentall's procedure. One patient had a double biologic valve replacement in the context of severe mitral insufficiency with moderate aortic stenosis at 4.5 years postprocedure. Echocardiographic follow-up showed a left ventricular ejection fraction of 63 ± 7% (n = 36), Vmax 2 ± 0.6 m/s (n = 17), and a mean gradient of 9.4 ± 5.4 mmHg (n = 27). No patients had grade 3 or 4 aortic regurgitation, one patient had grade 2, and four had grade 1. CONCLUSION: Tirone's procedure is an option for BAV surgery, with good safety and outcomes, especially in younger patients.

Transaortic Left Ventricular Unloading in VA-ECMO: The Transsubclavian Route.

Left ventricular unloading during extracorporeal life support aims to minimize potential side effects of increased left ventricular afterload. A transaortic catheter vent implanted through a subclavian approach was used in 2 patients. Patient 1 was a 48-year-old man with a recent history of ST-elevation myocardial infarction who developed refractory cardiogenic shock due to severe biventricular dysfunction. Patient 2 was a 56-year-old man admitted for severe flu. The unloading procedure was successful in both patients, with bridge to heart transplantation in the first case and bridge to recovery in the other.

Indications and perioperative outcomes of extracorporeal life support in clermont-ferrand.

OBJECTIVES: To report the epidemiological profile of the patients who underwent extracorporeal life support (ECLS) and then analyze the indications and outcomes of this procedure. METHODS: It consisted of a retrospective and descriptive study based on the database from the department of cardiovascular surgery. SETTING: University hospital clinic. PATIENTS: One hundred and sixty-one patients have participated in the study. Included were all patients who presented with left-sided heart or biventricular failure. Those who were suffering from either isolate respiratory failure or isolate right ventricle failure were excluded. INTERVENTIONS: Participants underwent ECLS: central ECLS or peripheral ECLS. RESULTS: : The mean age of the patients was 54 years; there were 73% of male patients and the mean duration of ECLS was 5.3 days. There were two types of ECLS: central (71%) and peripheral (29%). Indications for support were dominated by cardiogenic shock in 69%. Bleeding was the most frequent complication (23.5%). The overall in-hospital mortality of patients who underwent ECLS was 60%. CONCLUSION: The number of ECLS performed increases in proportion to mastery of surgical technique. There is a high rate of mortality and morbidity with ECLS. However, it remains a lifesaving therapy for many clinically urgent situations.

Clinical outcomes of tricuspid valve repair accompanying left-sided heart disease.

AIM: To determine whether the need for additional tricuspid valve repair is an independent risk factor when surgery is required for a left-sided heart disease. METHODS: One hundred and eighty patients (68 ± 12 years, 79 males) underwent tricuspid annuoplasty. Cox proportional-hazards regression model for multivariate analysis was performed for variables found significant in univariate analyses. RESULTS: Tricuspid regurgitation etiology was functional in 154 cases (86%), organic in 16 cases (9%), and mixed in 10 cases (6%), respectively. Postoperative mortality at 30 days was 11.7%. Mean follow-up was 51.7 mo with survival at 5 years of 73.5%. Risk factors for mortality were acute endocarditis [hazard ratio (HR) = 9.22 (95%CI: 2.87-29.62), P < 0.001], ischemic heart disease requiring myocardial revascularization [HR = 2.79 (1.26-6.20), P = 0.012], and aortic valve stenosis [HR = 2.6 (1.15-5.85), P = 0.021]. Significant predictive factors from univariate analyses were double-valve replacement combined with tricuspid annuloplasty [HR = 2.21 (1.11-4.39), P = 0.003] and preoperatively impaired ejection fraction [HR = 1.98 (1.04-3.92), P = 0.044]. However, successful mitral valve repair showed a protective effect [HR = 0.32 (0.10-0.98), P = 0.046]. Additionally, in instances where tricuspid regurgitation required the need for concomitant tricuspid valve repair, mortality predictor scores such as Euroscore 2 could be shortened to a simple Euroscore-tricuspid comprised of only 7 inputs. The explanation may lie in the fact that significant tricuspid regurgitation following left-sided heart disease represents an independent risk factor encompassing several other factors such as pulmonary arterial hypertension and dyspnea. CONCLUSION: Tricuspid annuloplasty should be used more often as a concomitant procedure in the presence of relevant tricuspid regurgitation, although it usually reveals an overly delayed correction of a left-sided heart disease.

Valve-sparing aortic root replacement-midterm outcomes and quality of life.

BACKGROUND: This study evaluated the midterm outcomes, the valve related events and quality of life of patients treated by valve-sparing aortic root replacement (VSRR). METHODS: From January 2003 to December 2014, 88 consecutive patients diagnosed with an aortic root aneurysm or ascending aortic aneurysms underwent VSRR surgery. The mean age was 55±14 (range 19-77) years. A total of 84% of the patients were male; 89% were in New York Heart Association functional class I or II, 55% had aortic regurgitation (AR) grade III or IV. Twenty-four patients (27.3%) had bicuspid aortic valve. The mean left ventricular ejection fraction (LVEF) was 61%±9% (range 29-78%). Patients were yearly followed by family doctors and referent cardiologists. Doppler echocardiographic examinations were obtained annually in all patients. The midterm clinical, echocardiographic results and quality of life were analyzed. The mean follow-up was 5.3±3 (range 1-12) years. RESULTS: Hospital mortality was 1%. There were 10 late deaths (11%) including 5 cardiac cases. Two patients (2%) required an aortic valve or graft prosthesis reoperation. Aortic valve endocarditis occurred in two patients. Thromboembolic events were reported in three patients. None of the following morbidity has been observed: structural valve deterioration, nonstructural dysfunction, valve thrombosis, bleeding event. The 5- and 8-year survival were 92% and 88%, respectively. The 8-year survival free from cardiac death was 88%. The mean of EuroQoL visual analogue scale (EQ VAS) and EQ index were respectively 83±15 (range 30-100) and 0.94±0.12 (range 0.5-1). CONCLUSIONS: Eight-year clinical improvement, function of the spared aortic valve and quality of life after valve sparing aortic root surgery appear excellent.

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

BACKGROUND: Aortic 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 DESIGN: First, 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT01522352.

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.

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.

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.

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).

Right atrial tear associated with a tumour in the right atrium after blunt chest trauma.

Occult cardiac injury following blunt trauma is more common than generally suspected. Myocardial contusion is not rare, however, it is generally a benign disorder which often remains undiagnosed. We report a case of a right atrial rupture after blunt chest trauma causing a tamponade. A 24-year-old man was involved in a violent car accident and he presented in a state of collapse. A multislice computed tomography indicated a pericardial effusion (Figure 1). A transthoracic echocardiography was performed and confirmed pericardial effusion which was hyperechoic (Figure 2, Movie 1). Concerns about a possible mass in the right atrium led to examination with transesophageal echocardiography (Figure 3, Movie 2) which revealed the presence of a voluminous mass in the right atrium. The patient successfully underwent cardiac surgery to remove the mass, identified as a blood clot, and to repair the atrial tear. The present case is of special interest because of the rarity of documented incidents of blunt chest trauma causing right atrial tear and illustrates the usefulness of transesophageal echocardiography in completing the diagnosis in the event of haemopericardium.

Comparison of transthoracic echocardiography using second harmonic imaging, transcranial Doppler and transesophageal echocardiography for the detection of patent foramen ovale in stroke patients.

AIMS: The comparison of three imaging methods to determine which is the most accurate and reliable for the detection of right-to-left shunt. METHODS AND RESULTS: One hundred and seven patients who were hospitalized for stroke underwent: a transthoracic echocardiography (TTE) using second harmonic, a transcranial Doppler (TCD) and a transesophageal echocardiography (TEE) from August 2003 to April 2004. All studies were recorded on a videotape and were studied by a physician blinded to the study. With TTE and TEE, we found 44 (41%) patent foramen ovales. All contrast tests were positive with TCD for these 44 patients. For two patients, the contrast test was positive only with TTE and TCD. We found four false negative contrast tests with TTE. Among the 63 patients who had a negative contrast test with TEE and TTE, the results were the same with TCD for 59 of them; we were not able to determine a cause for the four positive tests. CONCLUSION: This study confirms that transesophageal echocardiography has limitations in the diagnosis of patent foramen ovale. In this study, the negative predictive value of transcranial Doppler was excellent. Therefore, this examination is able to exclude a patent foramen ovale with a high level of confidence.