We report here the implementation and the use during 24 days of critical care beds beyond the walls during the COVID-19 outbreak in a teaching university hospital in Paris. These beds were settled in a 14-bed recovery room and two adjacent operating theatres leading to 20 additional critical care beds. The historical timeline, architectural elements, human resources, organisation and medical devices issues are presented. The benefits and limitations of this organisation are discussed.
Background: For cardiac surgery patients under chronic beta-blocker therapy, guidelines recommend their early postoperative reintroduction to decrease the incidence of postoperative atrial fibrillation. The authors hypothesized that the timing of beta-blocker reintroduction affects their effectiveness on the incidence of postoperative atrial fibrillation. Methods: This multicenter prospective French cohort study included patients on beta-blockers (more than 30 days before surgery) in sinus rhythm without a pacemaker. The primary outcome, time sequence of beta-blocker reintroduction, was analyzed for 192 h after surgery. The secondary outcome, relationship between the occurrence of postoperative atrial fibrillation and timing of beta-blocker reintroduction, was analyzed based on pre- and intraoperative predictors (full and selected sets) according to landmark times (patients in whom atrial fibrillation occurred before a given landmark time were not analyzed). Results: Of 663 patients, beta-blockers were reintroduced for 532 (80%) but for only 261 (39%) patients in the first 48 h after surgery. Median duration before reintroduction was 49.5 h (95% CI, 48 to 51.5 h). Postoperative atrial fibrillation or death (N = 4) occurred in 290 (44%) patients. After performing a landmark analysis to take into account the timing of beta-blocker reintroduction, the adjusted odds ratios (95% CI) for predictor full and selected (increased age, history of paroxysmal atrial fibrillation, and duration of aortic cross clamping) sets for the occurrence of postoperative atrial fibrillation were: adjusted odds ratio (full) = 0.87 (0.58 to 1.32; P = 0.517) and adjusted odds ratio (selected) = 0.84 (0.58 to 1.21; P = 0.338) at 48 h; adjusted odds ratio (full) = 0.64 (0.39 to 1.05; P = 0.076) and adjusted odds ratio (selected) = 0.58 (0.38 to 0.89; P = 0.013) at 72 h; adjusted odds ratio (full) = 0.58 (0.31 to 1.07; P = 0.079) and adjusted odds ratio (selected) = 0.53 (0.31 to 0.91; P = 0.021) at 96 h. Conclusions: beta-Blockers were reintroduced early (after less than 48 h) in fewer than half of the cardiac surgery patients. Reintroduction decreased postoperative atrial fibrillation occurrence only at later time points and only in the predictor selected set model. These results are an incentive to optimize (timing, doses, or titration) beta-blocker reintroduction after cardiac surgery.
We report here the implementation and the use during 24 days of critical care beds beyond the walls during the COVID-19 outbreak in a teaching university hospital in Paris. These beds were settled in a 14-bed recovery room and two adjacent operating theatres leading to 20 additional critical care beds. The historical timeline, architectural elements, human resources, organisation and medical devices issues are presented. The benefits and limitations of this organisation are discussed.
Infectious complications are a major cause of morbidity and mortality after heart transplantation (HT). However, the epidemiology and outcomes of these infections in the recent population of adult heart transplant recipients have not been investigated. We conducted a single-center retrospective study on infectious complications occurring within 180 days following HT on consecutive heart transplant recipients, from January 2011 to June 2015 at Bichat University Hospital in Paris, France. Risk factors for non-viral infections occurring within 8, 30 and 180 days after HT were investigated using competing risk analysis. Overall, 113 patients were included. Fifty-eight (51%) HTs were high-priority allocations. Twenty-eight (25%) patients had an extracorporeal membrane oxygenation (ECMO) support at the time of transplantation. Ninety-two (81%) patients developed at least one infection within 180 days after HT. Bacterial and fungal infections (n = 181 episodes) occurred in 80 (71%) patients. The most common bacterial and fungal infections were pneumonia (n = 95/181 episodes, 52%), followed by skin and soft tissue infections (n = 26/181, 14%). Multi-drug-resistant bacteria were responsible for infections in 21 (19%) patients. Viral infections were diagnosed in 44 (34%) patients, mostly Cytomegalovirus infection (n = 39, 34%). In multivariate subdistribution hazard model, prior cardiac surgery (subdistribution hazard ratio sHR = 2.7 [95% CI 1.5–4.6] p < 0.01) and epinephrine or norepinephrine at the time of HT (sHR = 2.3 [95% CI 1.1–5.2] p = 0.04) were significantly associated with non-viral infections within 8 days after HT. Prior cardiac surgery (sHR = 2.5 [95% CI 1.4–4.4] p < 0.01), recipient age over 60 years (sHR = 2.0 [95% CI 1.2–3.3] p < 0.01) and ECMO following HT (sHR = 1.7 [95% CI 1.0–2.8] p = 0.04) were significantly associated with non-viral infection within 30 days after HT, as well as within 180 days after HT. This study confirmed the high rate of infections following HT. Recipient age, prior cardiac surgery and ECMO following HT were independent risk factors for early and late bacterial and fungal infections.
Mediastinal irradiation for Hodgkin's lymphoma, may cause, years later, cardiac damages, termed “radiation-induced heart disease”. The objective of this study was to report the management of symptomatic radiation-induced valvular heart disease in the modern area with the development of transcatheter therapies. We retrospectively enrolled all patients who underwent a surgical or transcatheter procedure between January 2006 and January 2016 at our institution for a symptomatic radiation-induced valvular heart disease due to Hodgkin's lymphoma. Clinical preoperative characteristics, procedural data, immediate and mid-term outcomes were reported according to the procedure decided by the Heart Team. Thirty-seven patients (mean age 56 years, 70% men) were included: seventeen underwent a surgical valvular replacement, 16 a Transcatheter Aortic Valve Implantation (TAVI) and 4 a Transcatheter Mitral Valve Implantation (TMVI). In hospital and mid term outcomes are summarized in Table 1. Surgery was mostly used in combined procedures (P < 0.001). In-hospital mortality was 14%: 25% in surgical group, 6% in TAVI group and 0% in TMVI group (P = 0.19). Twenty-two patients (59%) underwent some in-hospital complications, without significant difference between the 3 groups (P = 0.44). In-hospital stay was lower in transcatheter groups (surgery: 14 days [10–17], TAVI: 7 days [5.5–14.5], TMVI: 6 days [5–12]). One-year mortality was 24%: 25% in surgical group, 18% in TAVI group and 50% in TMVI group (P = 0.4). Cardiac outcome was acceptable in survivors. Survival curves are presented in Fig. 1. Valvular replacement in radiation-induced valvular heart disease is associated with high rate of morbidity and mortality. Transcatheter interventions appeared a reasonable alternative to surgery, particularly in case of isolated valve disease although experience with TMVI was limited and require further validation.
L'antibiothérapie adaptée des pneumopathies acquises sous ventilation mécanique (PAVM) et des pneumopathies nosocomiales (PN) sévères permet de réduire leur morbi-mortalité. Un traitement antibiotique probabiliste doit être instauré dans les premières 48 heures en attendant les résultats bactériologiques. Le test Unyvero hospitalized pneumonia (HPN Curetis) est une PCR mutliplex (21 bactéries, 19 gènes de résistance) qui peut être réalisée sur les prélèvements respiratoires afin d'obtenir un résultat rapide. Nous avons évalué la performance du test Unyvero HPN chez des patients de réanimation. Dans cette étude prospective conduite dans trois services de réanimation, nous avons réalisé un test Unyvero HPN sur des lavages broncho-alvéolaires (LBA) ou des prélèvements distaux protégés (PDP) de patients avec une suspicion de PAVM ou de PN sévère dont l'examen direct montrait des bacilles gram négatif ou des cocci gram positif en amas. Nous avons évalué la performance (sensibilité et spécificité) du test comparé aux techniques conventionnelles. Le gold-standard était la culture quantitative avec les seuils diagnostics habituels (104 ufc/mL pour les LBA et 103 ufc/mL pour les PDP). Nous avons analysé 43 prélèvements (33 LBA, 10 PDP) provenant de 37 patients, 27 hommes, d'âge médian 62 ans (IQR, 54–69) avec une suspicion de PAVM (n = 31) ou de PN sévère (n = 12). Le temps médian du test Unyvero HPN était de 4,6 heures (IQR, 4,5–4,9). Globalement, 42/51 bactéries ont été identifiées par le test Unyvero dont la sensibilité était de 82 % (95 % CI, 69–92 %) et la spécificité de 99 % (95 % CI, 98–100). Nous avons observé une sensibilité de 100 % et une spécificité de 97 % pour Pseudomonas aeruginosa qui était le pathogène le plus fréquent (n = 14). Les bactéries pour lesquelles le test a montré la plus faible sensibilité étaient Enterobacter cloacae (75 %, n = 4), Staphylococcus aureus (60 %, n = 5), Morganella morganii (0 %, n = 2) et Streptococcus pneumoniae (0 %, n = 1). Nous avons identifié 4 bêtalactamases à spectre étendu (BLSE) et 1 carbapénèmase (NDM) qui ont toutes été détectées par le test Unyvero. Cette étude pilote a montré des résultats prometteurs sur la performance du test Unyvero HPN. Une analyse précise des dossiers de cette étude permettra d'évaluer l'intérêt de ce test pour améliorer la prescription d'antibiothérapie probabiliste. Des études prospectives interventionnelles semblent nécessaires pour déterminer la meilleure façon d'utiliser cette technique.
Objective: To determine the incidence, microbiology and risk factors for sternal wound infection (SWI) with extended-spectrum 13-lactamase-producing Enterobacteriaceae (ESBL-PE) following cardiac surgery. Methods: We performed a retrospective analysis between January 2006 and December 2015 of prospective surveillance of a cohort of patients with cardiac surgery at a single centre (Paris, France). SWI was defined as the need for reoperation due to sternal infection. All patients with an initial surgery under extracorporeal circulation and diagnosed with an SWI caused by Enterobacteriaceae isolates were included. We compared patients infected with at least one ESBL-PE with those with SWI due to other Enterobacteriaceae by logistic regression analysis. Results: Of the 11 167 patients who underwent cardiac surgery, 412 (3.7%) developed SWI, among which Enterobacteriaceae were isolated in 150 patients (36.5%), including 29 ESBL-PE. The main Enterobacteriaceae (n = 171) were Escherichia coli in 49 patients (29%) and Enterobacter cloacae in 26 (15%). Risk factors for SWI with ESBL-PE in the multivariate logistic regression were previous intensive care unit admission during the preceding 6 months (adjusted odds ratio (aOR) 122; 95% CI 33-44.8), postoperative intensive care unit stay before surgery for SWI longer than 5 days (aOR 4.6; 95% CI 1.7-11.9) and being born outside France (aOR 3.2; 95% CI 1.2-8.3). Conclusions: Our results suggest that SWI due to ESBL-PE was associated with preoperative and postoperative unstable state, requiring an intensive care unit stay longer than the usual 24 or 48 postoperative hours, whereas being born outside France may indicate ESBL-PE carriage before hospital admission. S. Jolivet, Clin Microbiol Infect 2018;24:283 (C) 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Introduction: Sternal wound infection (SWI) after cardiac surgery is a severe complication. Among preventive measures, pre-operative decolonization of nasal carriage of Staphylococcus aureus has recently been shown to be beneficial. This quasi-experimental study assessed the effect of decolonization on the incidence of S. aureus-associated SWI based on 19 years of prospective surveillance. Methods: Segmented negative binomial regression was used to analyse the change over time in the incidence of S. aureus mediastinitis requiring re-operation after cardiac surgery in a French university hospital between 1996 and 2014. Universal nasal decolonization with mupirocin was introduced in December 2001. The association between pre-operative nasal carriage and SWI due to S. aureus was analysed between 2006 and 2012. Results: Among 17,261 patients who underwent a cardiac surgical procedure, 565 developed SWI (3.3%), which was caused by S. aureus in 181 cases (1%). The incidence of mediastinitis caused by S. aureus decreased significantly over the study period (1.43% in 1996-2001 vs 0.61% and 0.64% in 2002-2005 and 2006-2014, respectively; P<0.001). In segmented analysis, there was a significant break in 2002, corresponding to the introduction of decolonization. Despite this intervention, pre-operative nasal carriage remained a significant risk factor for S. aureus mediastinitis (adjusted odds ratio 2.2; 95% confidence interval 1.2-4.2), as were obesity, critical pre-operative status, coronary artery bypass grafting (CABG), and combined surgery with valve replacement and CABG. Conclusion: Universal nasal decolonization before cardiac surgery was effective in decreasing the incidence of mediastinitis caused by S. aureus. Nasal carriage of S. aureus remained a risk factor for S. aureus-associated SWI. (C) 2018 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.
A 76-year-old woman with degenerative mitral valve disease was referred for refractory heart failure. An echocardiogram showed the presence of a massive mitral annular calcification with severe stenosis (mitral valve area, 1.0 cm2; mean gradient, 11 mm Hg) and a small left ventricular cavity with a
Competitive flows syndrome result in severe regional hypoxemia when the deoxygenated flow from the native left ventricle (LV) competes with oxygenated flow from extracorporeal life support (ECLS) pump with potentially severe consequences for the cerebral and coronary circulations. Fast correction of hypoxemia could be obtained by decreasing native LV flow by infusion of a short-acting beta-blocker (esmolol). Our purpose was to retrospectively review the efficacy of esmolol in this situation and hypothesize on the potential mechanisms of action and the associated risks. This is a retrospective analysis of five clinical cases, who underwent lung transplantation and a femoro-femoral venoarterial (VA) ECLS. The patients presented severe hypoxemia (SpO2 < 85%) measured through photoplethysmography on a right hand finger. From the patients' medical records and anesthesia flowcharts, hemodynamic, right heart catheterization, echocardiography variables, and arterial blood gas results were noted before and after injection of esmolol. Mechanical ventilation and VA ECLS function variables were optimized and unchanged before and after esmolol injection. All patients had terminal respiratory failure with pulmonary hypertension and conserved LV systolic function. Immediately following esmolol injection (1.3 ± .7 mg/kg; mean ± 1 SD), SpO2 increased from 73% ± 12 to 95% ± 6; blood to arterial partial pressure in CO2 (PaCO2) decreased from 52 ± 18 to 35 ± 7 mmHg systolic pulmonary artery pressure decreased from 61 ± 8 to 50 ± 12 mmHg; the pulmonary artery oxygen saturation (SvO2); increased from 51% ± 24 to 77% ± 12; systemic arterial pressure or catecholamine requirements were unchanged. In conclusion, these results suggest that injection of esmolol allowed rapid correction of regional hypoxemia occurring during lung transplantation despite femoro-femoral VA ECLS. The mechanism is probably a decreased cardiac output of the native LV due to esmolol-induced negative inotropic and chronotropic effects without significant adverse effects on systemic tissue perfusion.
TAVI is increasingly used but few data exist on long-term outcome. We analyzed 7-year outcome after TAVI and its predictive factors. Between 2006 and 2011, 289 consecutive high-risk patients (EuroScore 23±14%) underwent TAVI in our institution. Mean age was 82±9 years and 85% were in NYHA class III–IV. Procedural success was achieved in 265 pts (92%). At 30 days, 34 patients died (congestive heart failure in 14, peri-procedural death in 10 and septic shock in 10). We focused on the 255 patients discharged alive after TAVI to analyze long-term outcome. Follow-up was complete in 100% of patients. During a mean follow-up of 4.1±0.2 years, 139 patients died, half of deaths being non-cardiac. Overall 7-year survival rate was 26±9%. We identified 5 preprocedural predictive factors of late mortality in multivariate analysis: cancer (p=0.001), diabetes under insulin therapy (p=0.02), NYHA class III-IV (p=0.03), atrial fibrillation (p=0.04), higher creatinin level (p<0.0001) and 2 post-procedural factors: higher systolic PAP (p=0.02) and arrhythmias (p=0.02). Whereas conduction disorders are more frequent after TAVI (29% of cases in this series) and may often lead to pace-maker implantation, only post-TAVI arrhythmias (supraventricular in 32 patients or ventricular in 4) were predictive of late mortality. Finally, in the 116 survivors, 70% were in NYHA class I-II at last follow-up. At 7-year follow-up after TAVI, the survival rate was 27% and most patients have few or no symptoms. The predictive factors of late mortality emphasized the weight of comorbidities. Particular awareness is needed toward the occurrence of post-TAVI arrhythmias which identifies high-risk patients.
AIMS:So far, a total of five patients with eclipsed mitral regurgitation (MR) have been reported in the literature by three different teams. The aim of this article was to detail clinical and echocardiographic characteristics, and outcome of patients presenting eclipsed MR.METHODS AND RESULTS:We defined eclipsed MR as spontaneous appearance, at rest, from 1 min to the next of an acute restriction in the motion of mitral leaflets preventing coaptation and leading to massive MR in patients with normal left ventricular end-diastolic diameter, left ventricular ejection fraction >45%, and baseline MR ≤2. Spontaneous regression occurred within 30 min, and no obvious trigger such as acute hypertension, new-onset arrhythmia, or myocardial ischaemia is present. Clinical data, ECG, echocardiographic data, surgery report, and follow-up status of six patients with eclipsed MR are reported: all were post-menopausal women with median age of 74 [57-80] years presenting hypertension (4/6), chronic kidney disease (5/6), or chronic anaemia (4/6). Five out of six patients experienced acute pulmonary oedema requiring hospitalization and underwent mitral valve replacement because of heart failure recurrence. Two patients died in the first days after surgery while the three others are free of symptoms at, respectively, 56, 18, and 10 months follow-up.CONCLUSION:Eclipsed MR is a clinical and echocardiographic syndrome responsible for heart failure with preserved EF. It is presently underdiagnosed and should be evoked in cases of recurrent acute pulmonary oedema without obvious trigger, in particular in patients presenting discordant evaluation of MR severity over time.
Tricuspid valve disease is mainly represented by tricuspid regurgitation (TR), which is a predictor of poor outcome. TR is usually secondary, caused by right ventricle pressure or volume overload, the leading cause being left-sided heart valve diseases. Tricuspid surgery for severe TR is recommended during left valve surgery, and consists of either a valve replacement or, most often, a tricuspid repair with or without prosthetic annuloplasty. When TR persists or worsens after left valvular surgery, redo isolated tricuspid surgery is associated with high mortality. In addition, a sizeable proportion of patients present with tricuspid surgery deterioration over time, and need a reintervention, which is associated with high morbi-mortality rates. In this context, and given the recent major breakthrough in the percutaneous treatment of aortic and mitral valve diseases, the tricuspid valve appears an appealing challenge, although it raises specific issues. The first applications of transcatheter techniques for tricuspid valve disease were valve-in-valve and valve-in-ring implantation for degenerated bioprosthesis or ring annuloplasty. Some concerns remain regarding prosthesis sizing, rapid ventricular pacing and the best approach, but these procedures appear to be safe and effective. More recently, bicuspidization using a transcatheter approach for the treatment of native tricuspid valve has been published, in two patients. Finally, other devices are in preclinical development.
En el presente manuscrito se revisarán diversos aspectos del proceso de mentoría, fundamentalmente en el ámbito médico (tanto docente como investigador), con el propósito de describir cuál es el papel del mentor, las características del mentor y del aprendiz ideal, cómo buscar un buen mentor, los tipos de mentoría, los beneficios de una relación mentor-aprendiz, así como sus potenciales barreras y posibles soluciones. Nuestro objetivo final será estimular a aquellos potenciales mentores a que pongan en práctica las funciones de mentoría, y a los potenciales aprendices a que busquen activamente un mentor y no pierdan la oportunidad de recibir este precioso regalo que muchos de nosotros hemos tenido la suerte de disfrutar.This study will review various aspects of the mentoring process, mainly in the medical field (both educational and research), in order to describe the mentor's role, the characteristics of the ideal mentor and mentee, how to find a good mentor, mentoring types, the benefits of a mentor-mentee relationship, and potential obstacles and possible solutions. Our ultimate goal is to encourage potential mentors to become actual mentors, and potential mentees to actively seek a mentor and not lose the opportunity to receive this precious gift that many of us have been fortunate to enjoy.
Objective Surgery for aortic stenosis in patients with thoracic radiation therapy is associated with high morbimortality. Trans-catheter aortic valve implantation (TAVI) represents an alternative but has never been studied in this population. We aimed to compare outcomes in radiation and matched control patients undergoing TAVI and to identify predictive factors of survival.Methods Between 2006 and 2011, 288 consecutive patients underwent TAVI in our institution, of whom 26 had previous chest radiation. They were matched 1: 1 for age, sex and TAVI approach with controls.Results In both groups, median age was 73 years, 50% of patients were male and 15% had a transapical approach. Procedural success was 88% in the radiation group versus 100% in controls (p<0.001) and 30-day survival was 92% in both groups. Five-year survival was 33%+/- 10% in the radiation group and 42%+/- 11% in controls (p=0.26). In radiation patients, the main cause of death was respiratory insufficiency in 40%. We identified four independent predictive factors of death in the radiation group: extracardiac arteriopathy (p=0.002) and the absence of beta-blocker therapy (p=0.005) as preprocedural variables, and infectious complications (p=0.009) and a higher peak creatinine level (p=0.009) as postprocedural variables. In the radiation group, 89% of survivors were in New York Heart Association class I-II at last follow-up.Conclusions Patients in the radiation group displayed high mortality rates although not significantly different from the controls. Respiratory failure was the main cause of death, emphasising the need for a careful pulmonary evaluation. Finally, we show a sustained improvement in functional results after TAVI in this population.
OBJECTIVES:Octogenarians considered for cardiac surgery encounter more complications than other patients. Postoperative complications raise the question of continuation of high-cost care for patients with limited life expectancy. Duration of hospitalization in intensive care after cardiac surgery may differ between octogenarians and other patients. The objectives were evaluating the mortality rate of octogenarians experiencing prolonged hospitalization in intensive care and defining the best cut-off for prolonged intensive care unit length of stay.DESIGN:A single-center observational study.SETTING:A postoperative surgical intensive care unit in a tertiary teaching hospital in Paris, France.PARTICIPANTS:All consecutive patients older than 80 years considered for aortic valve replacement for aortic stenosis were included.MEASUREMENTS AND MAIN RESULTS:Mortality rate was determined among patients experiencing prolonged stay in intensive care with organ failure and without organ failure. An ROC curve determined the optimal cut-off defining prolonged hospitalization in intensive care according to the occurrence of postoperative complications. Multivariate analysis determined risk factors for early death or prolonged intensive care stay. The optimal cut-off defining prolonged intensive care unit length of stay was 4 days. Low ventricular ejection fraction (odds ratio [OR] = 0.95; 95% confidence interval [CI] 0.96-0.83; p = 0.0016), coronary disease (OR = 2.34; 95% CI 1.19-4.85; p = 0.014), and need for catecholamine (OR = 2.79; 95% CI 1.33-5.88; p = 0.0068) were associated with eventful postoperative course. There was not a hospitalization duration beyond which the prognosis significantly worsened.CONCLUSIONS:Prolonged length of stay in ICU without organ failure is not associated with increased mortality. No specific duration of hospitalization in intensive care was associated with increased mortality. Continuation of care should be discussed on an individual basis.
OBJECTIVESThe use of heparin exposes patients to heparin-induced thrombocytopenia, which is a challenging issue for both diagnosis and patient management. We sought to describe the clinical presentation, management and outcome of a series of patients diagnosed with heparin-induced thrombocytopenia after heart valve surgery.METHODSAll consecutive patients diagnosed with heparin-induced thrombocytopenia during the postoperative period of heart valve surgery over a 6-year period were prospectively enrolled in a single-centre registry. Clinical and biological data were collected. In-hospital and mid-term outcomes were assessed. Information regarding the occurrence of all medical events including death, recurrence of thromboembolic events and/or thrombocytopenia was collected.RESULTSWe identified 93 patients (incidence proportion = 2.8%). Most patients (82%) were asymptomatic with isolated thrombocytopenia at the time of diagnosis. The other main circumstance of diagnosis was the occurrence of thromboembolic events in 17 patients (6 strokes, 10 prosthetic valve thrombosis and 1 peripheral embolic event). The in-hospital mortality rate was 1%. No thrombolysis, interventional procedure or redo surgery was performed. Danaparoid sodium was used as heparin replacement therapy in most cases (96%) and leading to complete and uneventful thrombus resolution in all cases with only one possibly related major bleeding complication. During a mean follow-up of 36 ± 20 months, no patient presented recurrence of any heparin-induced thrombocytopenia-related complication.CONCLUSIONSIn this contemporary series of patients, heparin-induced thrombocytopenia incidence was low and isolated thrombocytopenia was the most frequent presentation. Conservative management with early diagnosis and substitutive anticoagulation therapy introduction was associated with a low rate of clinical events and a remarkably good outcome with a low mortality rate.