IntroductionIn patients with conduction abnormalities or left ventricle (LV) dysfunction the use of β-blockers for post cardiac surgery rhythm control is difficult and controversial, with a paucity of information about other drugs such ivabradine used postoperatively. The objective of this study was to compare the efficacy and safety of ivabradine versus metoprolol used perioperatively in cardiac surgery patients with conduction abnormalities or LV systolic dysfunction.MethodsThis was an open-label, randomized clinical trial enrolling 527 patients with conduction abnormalities or LV systolic dysfunction undergoing coronary artery bypass grafting or valvular replacement, randomized to take ivabradine or metoprolol, or metoprolol plus ivabradine. The primary endpoints were the composites of 30-day mortality, in-hospital atrial fibrillation (AF), in-hospital three-degree atrioventricular block and need for pacing, in-hospital worsening heart failure (HF; safety endpoints), duration of hospital stay and immobilization and the above endpoint plus in-hospital bradycardia, gastrointestinal symptoms, sleep disturbances, cold extremities (efficacy plus safety endpoint).ResultsHeart rate reduction and prevention of postoperative AF or tachyarrhythmia with combined therapy was more effective than with metoprolol or ivabradine alone during the immediate postoperative management of cardiac surgery patients. In the Ivabradine group, the frequency of early postoperative pacing and HF worsening was smaller than in the Metoprolol group and in combined therapy group. The frequency of primary combined endpoint was lower in the combined Ivabradine + Metoprolol group compared with the monotherapy groups.ConclusionConsidering efficacy and safety, the cardiac rhythm reduction after open heart surgery in patients with conduction abnormalities or LV dysfunction with ivabradine plus metoprolol emerged as the best treatment in this trial.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-013-0024-1) contains supplementary material, which is available to authorized users.
Background and Objectives: Chronic severe aortic valve disease is associated with important changes in left ventricle (LV) performance associated with eccentric or concentric LV hypertrophy. We aimed to assess the immediate prognostic implications of the type of the LV diastolic filling pattern (LVDFP) compared with LV systolic performance in patients with severe aortic regurgitation (AR) undergoing aortic valve replacement (AVR) and to define the independent echographic predictors for the immediate and long-term prognoses. Materials and Methods: We performed a prospective study enrolling 332 AR patients undergoing AVR, divided into two groups: Group A—201 pts with normal LV systolic function, divided into two subgroups (A1: 129 pts with a nonrestrictive LVDFP and A2: 72 pts with restrictive LVDFP), and Group B—131 pts with LV systolic dysfunction (LV ejection fraction LVEF < 50%), divided into two subgroups (B1: 83 pts with a nonrestrictive LVDFP and B2: 48 pts with restrictive LVDFP). Results: The early postoperative mortality rate was higher in patients with a restrictive LVDFP (11.12% in A2 and 12.5% in B2) compared with normal LV filling (2.32% in A1 and 7.63% in B1, p < 0.0001), regardless of the LVEF. The restrictive LVDFP—defined by at least one of the following echographic parameters: an E/A > 2 with an E wave deceleration time (EDt) < 100 ms; an isovolumetric relaxation time (IVRT) < 60 ms; or an S/D ratio < 1 in the pulmonary vein flow—was an independent predictor for early postoperative mortality, increasing the relative risk by 8.2-fold. Other independent factors associated with early poor prognosis were an LV end-systolic diameter (LVESD) > 58 mm, an age > 75 years, and the presence of comorbidities (chronic obstructive pulmonary disease-COPD or diabetes mellitus). On a medium-term, an unfavorable evolution was associated with: an age > 75 years (RR = 8.1), an LV end-systolic volume (LVESV) > 95 cm3 (RR = 6.7), a restrictive LVDFP (RR = 9.8, p < 0.0002), and pulmonary hypertension (RR = 8.2). Conclusions: The presence of a restrictive LVDFP in patients with AR undergoing AVR is associated with both increased early and medium-term mortality rates. The LV diastolic function is a more reliable parameter for prognosis than LV systolic performance (RR 9.2 versus 2.1). Other independent predictors for increased early postoperative mortality rate were: an age > 75 years, an LVESD > 58 mm, and comorbidities (diabetes mellitus, COPD), and for unfavorable evolution at 2 years postoperatively: an age > 75 years, an LVESV > 95 cm3, and severe pulmonary hypertension.
In this study, we tried to compare the efficacy and safety of betaxolol vs. metoprolol immediately postoperatively in coronary artery bypass grafting (CABG) patients and to determine whether prophylaxy for atrial fibrillation (AF) with betaxolol could reduce hospitalization and economic costs after cardiac surgery. Our trial was open-label, randomized, multicentric enrolling 1352 coronary surgery patients randomized to receive betaxolol or metoprolol. The primary endpoints were the composites of 30-day mortality, in-hospital AF (safety endpoints), duration of hospitalization and immobilization, quality of life, and the above endpoint plus in-hospital embolic event, bradycardia, gastrointestinal symptoms, sleep disturbances, cold extremities (efficacy plus safety endpoint). At the end of the study the incidence and probability of early postoperative AF with betaxolol was lower than with metoprolol in coronary surgery (P<0.0001). In the two study groups minor side effects were similar and no major complication was reported (P<0.001). Patient compliance was good and the general condition improved due to shortened hospitalization and immobilization with subsequent improvement in the psychological status, less arrhythmias and lack of significant side effects. In conclusion, because of its efficacy and safety, betaxolol was superior to metoprolol for the prevention of the early postoperative AF in coronary surgery.
Background and Objectives: Patients with surgical aortic stenosis (AS) show impaired diastolic filling, which is a risk factor for early and late mortality after aortic valve replacement (AVR). There is a paucity of information concerning the impact of restrictive diastolic filling and the evolution of diastolic dysfunction in the early and medium terms post-AVR. We aimed to determine the prognostic value of the presence of a restrictive left-ventricular (LV) diastolic filling pattern (LVDFP) and dilated left atrium (LA) in patients with AS and LV systolic dysfunction (LVEF < 40%) who underwent AVR, and to define the independent predictors for immediate and long-term prognosis and their value for preoperative risk estimation. Materials and Methods: The study was prospective and included 197 patients with surgical AS and LVEF <40% who underwent AVR. Preoperative echocardiographic examinations were repeated at day 10, at 1, 3 and 6 months, and at 1 and 2 years after surgery, with evaluation of LVEF, diastolic function and LA dimension index (mm/m2). Depending on LV systolic performance, patients were classified as Group A (LVEF: 30–40%) or Group B (LVEF < 30%). Results: The main echographic independent parameters for early and late postoperative death were: restrictive LVDFP, significant pulmonary hypertension, LV end-systolic diameter (LVESD) >55 mm and the presence of second-degree mitral regurgitation. Restrictive LVDFP and LA dimension >30 mm/m2 were independent predictors for fatal outcome (p = 0.0017). Conclusions: Assessment of diastolic function and LA dimension are reliable parameters in predicting fatal outcome and hospitalization for heart failure, having an independent and incremental prognostic value in patients with surgical AS. Complete evaluation of LVDFP with all the echographic measurements (including TDI) should routinely be part of the preoperative assessment of patients with LV systolic dysfunction undergoing AVR.
Background: Kidney involvement is a frequent complication of systemic lupus erythematosus (SLE) and kidney biopsy is essential in differentiating lupus nephritis (LN) from thrombotic microangiopathy (TMA) secondary to antiphospholipid autoantibodies (aPL). Association between antiphospholipid syndrome (APS) and acquired hemophilia due to inhibitors was very rarely described in SLE patients. Case presentation: We present the case of a 61-year-old male diagnosed with SLE who acquired deficiency of clotting factor VIII due to circulating inhibitors, admitted for acute kidney injury (AKI), microangiopathic hemolytic anemia, thrombocytopenia, and diplopia. Kidney biopsy showed TMA due to APS, but no signs of LN. Head computed tomography identified low dense areas in the white matter, suggesting small blood vessels’ involvement. A diagnosis of probable catastrophic antiphospholipid syndrome (CAPS) was established and treatment with low molecular weight heparin, intravenous methylprednisolone, plasmapheresis, and rituximab was initiated, followed by resolution of AKI, diplopia, and TMA with complete depletion of CD19+B-lymphocytes (CD19+B-Ly) after one month. We further review the current knowledge regarding pathogenesis and management of CAPS in SLE patients. Conclusions: Targeted therapy was possible after kidney biopsy, improving renal and general prognosis. CD19+B-Ly repopulation preceded biological relapse, so monitoring of CD19+B-Ly may serve as a tool to predict relapses and guide rituximab therapy.
(1) Background: Acute kidney injury (AKI) is a serious complication of hematopoietic stem cell transplantation (HSCT). (2) Methods: The aim was to identify the incidence, severity, and risk factors for AKI during the first 100 days after allo-HSCT; we performed a prospective observational study on 135 consecutive patients. (3) Results: The mean age was 38.3 ± 11.9 years (50.6% females), AKI developed in 93 patients (68.9%), the median time of appearance was 28 days, and the mean serum creatinine at the time of AKI was 1.8 ± 0.8 mg/dL. A total of 36 (38.7%) patients developed stage 1 AKI, 33 (35.5%) patients developed stage 2, and 24 (25.8%) patients developed stage 3; eight (8.6%) patients required temporary hemodialysis, and the mortality rate in these patients was 87.5%. Death was twice as frequent in the AKI subgroup, without statistical significance. Cyclosporine overdose (HR = 2.36, 95% CI: 1.45–3.85, p = 0.001), tacrolimus overdose (HR = 4.72, 95% CI: 2.22–10.01, p < 0.001), acute graft-versus-host disease (aGVHD) (HR = 1.96, 95% CI: 1.13–3.40, p = 0.01), and CRP level (HR = 1.009, 95% CI: 1.007–1.10, p < 0.001) were independent risk factors for AKI. Sepsis (HR = 5.37, 95% CI: 1.75–16.48, p = 0.003) and sinusoidal obstruction syndrome (HR = 5.10, 95% CI: 2.02–12.85, p = 0.001) were found as independent risk factors for AKI stage 3. (4) Conclusions: AKI occurs with high incidence and increased severity after allo-HSCT. Careful monitoring of calcineurin inhibitors and proper management of sepsis may reduce this risk.
Background and Objectives: The prognosis of patients with aortic stenosis (AS) adding pulmonary hypertension (PHT) is worse than in those with normal pulmonary artery pressure (PAP), and there are few results reported for the association between PHT and adverse outcomes of AS. We aimed to determine the predictive factors for the development of PHT in patients with surgical AS and to identify those factors that may predict the surgical prognosis. We aimed to identify the independent predictors for PHT regression at 2 years after surgery. Additionally, we tried to evaluate the involvement of PHT as an additional perioperative risk factor in patients with AS undergoing surgical aortic valve replacement (AVR). Materials and Methods: We carried out a two-year prospective study on 340 patients with AS undergoing surgical AVR. Results: The independent predictors for the occurrence of PHT in patients with surgical AS were: age > 75 years (RR = 6, p = 0.001), a restrictive left ventricle diastolic filling pattern (LVDFP) (RR = 9, p = 0.001) and associated moderate mitral regurgitation (MR) (RR = 9, p = 0.0001). The presence of severe PHT increased by 7.6 times the early postoperative risk of death, regardless of the presence of other parameters. The independent predictors for early postoperative mortality were: severe PHT, restrictive left ventricle diastolic pattern, age > 75 years, interventricular septum (IVS) thickness >18 mm and the presence of comorbidities. Conclusions: The presence of a severe PHT in patients with AS undergoing surgical AVR is associated with an early postoperative increased mortality rate. The mean PAP is a more reliable parameter for prognosis appreciation than the LV systolic function.
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