Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.

BACKGROUND: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. METHODS: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. RESULTS: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. CONCLUSIONS: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).

Extracorporeal Membrane Oxygenation for Graft Dysfunction Early After Heart Transplantation: A Systematic Review and Meta-analysis.

INTRODUCTION: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a prevailing option for the management of severe early graft dysfunction. This systematic review and individual patient data (IPD) meta-analysis aims to evaluate (1) mortality, (2) rates of major complications, (3) prognostic factors, and (4) the effect of different VA-ECMO strategies on outcomes in adult heart transplant (HT) recipients supported with VA-ECMO. METHODS AND RESULTS: We conducted a systematic search and included studies of adults (≥18 years) who received VA-ECMO during their index hospitalization after HT and reported on mortality at any timepoint. We pooled data using random effects models. To identify prognostic factors, we analysed IPD using mixed effects logistic regression. We assessed the certainty in the evidence using the GRADE framework. We included 49 observational studies of 1477 patients who received VA-ECMO after HT, of which 15 studies provided IPD for 448 patients. There were no differences in mortality estimates between IPD and non-IPD studies. The short-term (30-day/in-hospital) mortality estimate was 33% (moderate certainty, 95% confidence interval [CI] 28%-39%) and 1-year mortality estimate 50% (moderate certainty, 95% CI 43%-57%). Recipient age (odds ratio 1.02, 95% CI 1.01-1.04) and prior sternotomy (OR 1.57, 95% CI 0.99-2.49) are associated with increased short-term mortality. There is low certainty evidence that early intraoperative cannulation and peripheral cannulation reduce the risk of short-term death. CONCLUSIONS: One-third of patients who receive VA-ECMO for early graft dysfunction do not survive 30 days or to hospital discharge, and one-half do not survive to 1 year after HT. Improving outcomes will require ongoing research focused on optimizing VA-ECMO strategies and care in the first year after HT.

Outcomes of Orthotopic Heart Transplantation in the Setting of Acute Kidney Injury and Renal Replacement Therapy.

OBJECTIVE: Heart transplantation in the setting of renal insufficiency is controversial. The objective of this study was to perform a descriptive analysis of patients who underwent orthotopic heart transplantation and renal replacement therapy (RRT) due to acute kidney injury (AKI). DESIGN: An observational cohort study with retrospective data collection. SETTING: A tertiary care hospital. PARTICIPANTS: Fifty-one patients underwent orthotopic heart transplantation with cardiogenic shock under inotrope dependence, with nine patients having preoperative RRT and 42 patients not having preoperative RRT. INTERVENTIONS: There were no interventions. MEASUREMENTS AND MAIN RESULTS: Hospital mortality occurred in eight (15.6%) patients. Although there were no significant differences between the study groups (preoperative RRT 33.3% v controls 11.9%, p = 0.1), this study was underpowered to detect differences in mortality. Dialysis also was required in 52.4% of patients who were not on preoperative RRT. All survivors had full recovery of kidney function with similar timing after transplant (18.5 days v 15 days, p = 0.75). Actuarial survival was 82.4%, 76.5%, and 66.5% at six months, one year, and five years, respectively. A cold ischemic time greater than 180 minutes (hazard ratio [HR] 4.37 95% confidence interval [CI] 1.51-12.6; p = 0.006) and pretransplant RRT (HR = 7.19 95% CI 1.13-45.7; p = 0.04) were independent predictors of long-term mortality. CONCLUSIONS: In a health system with limited funding and availability of mechanical circulatory support, heart transplantation in the setting of AKI, RRT, and low Interagency Registry for Mechanically Assisted Circulatory Support profile was associated with important hospital mortality. Among hospital survivors, however, all patients had full renal recovery and by 25 months there was no difference in mortality between those who required preoperative RRT and those who did not.

A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial.

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.

Does the anthropometric profile influence infection morbidity after coronary artery bypass grafting?

BACKGROUND: Infection after cardiovascular surgery is multifactorial. We sought to determine whether the anthropometric profile influences the occurrence of infection after isolated coronary artery bypass grafting (CABG). METHODS: Between January 2011 and June 2016, 1777 consecutive adult patients were submitted to isolated coronary artery bypass grafting. Mean age was 61.7 ± 9.8 years and 1193 (67.1%) were males. Patients were divided into four groups according to the body mass index (BMI) classification: underweight (BMI < 18.5 kg/m2 ; N = 17, 0.9%), normal range (BMI: 18.5-24.99 kg/m2 ; N = 522, 29.4%), overweight (BMI: 25-29.99 kg/m2 ; N = 796, 44.8%), and obese (BMI > 30 kg/m2 ; N = 430, 24.2%). In-hospital outcomes were compared and independent predictors of infection were obtained through multiple Poisson regression with a robust variation. RESULTS: Independent predictors of any infection morbidity were female sex (relative ratio [RR], 1.47; p = .002), age > 60 years (RR, 1.85; p < .0001), cardiopulmonary bypass > 120 min (RR, 1.89; p = .0007), preoperative myocardial infarction < 30 days (RR, 1.37; p = .01), diabetes mellitus (RR, 1.59; p = .0003), ejection fraction < 48% (RR, 2.12; p < .0001), and blood transfusion (RR, 1.55; p = .0008). Among other variables, obesity, as well as diabetes mellitus, were independent predictors of superficial and deep sternal wound infection. CONCLUSIONS: Other factors rather than the anthropometric profile are more important in determining the occurrence of any infection after CABG. However, surgical site infection has occurred more frequently in obese patients. Appropriate patient selection, control of modifiable factors, and application of surgical bundles would minimize this important complication.

Penetrated inferior vena cava filter retrieved by open surgery with deep hypothermic circulatory arrest.

BACKGROUND AND AIM: Complications of inferior vena cava filters are relatively common, and they vary according to different filter types and designs. We aim to present a case of penetrated inferior vena cava filter into the liver. METHODS: Case report. RESULTS: A 42-year old man with thrombophilia (prothrombin gene mutation) required the insertion of an inferior vena cava filter because of recurrent gastrointestinal bleeding associated with oral anticoagulation. However, it penetrated through the retro-hepatic vena cava into the liver, being manifested by constant, blunt abdominal pain. Endovascular retrieval was considered of extreme risk, though a surgical approach was performed under cardiopulmonary bypass with deep hypothermic circulatory arrest. The patient has recovered uneventfully with complete symptom relief. CONCLUSIONS: In symptomatic penetrated vena cava filters in which endovascular retrieval is not feasible, a surgical approach with appropriate planning is a safe and effective treatment.

Is shortage of heart donors a real problem? Insights from a Brazilian Mid-West heart transplant program.

BACKGROUND AND AIM OF THE STUDY: In developed countries, the shortage of viable donors is the main limiting factor of heart transplantation. The aim of this study is to determine whether the same reality applies to Brazil. METHODS: Between January 2012 and December 2014, 299 adult heart donor offers were studied in terms of donor profiles and reasons for refusal. The European donor scoring system was calculated, being high-risk donors defined as more than 17 points. The donor scoring system was used to objectively determine the donor profile and correlate with donor acceptance and posttransplant primary graft dysfunction and recipient survival. Cox proportional hazard model was used in determining the predictors of long-term mortality. RESULTS: The rates of donor acceptance and heart transplants performed were 45.8% and 19.3%, respectively. Reasons for refusal were mostly nonmedical (53.7%). The majority of donors were classified as high-risk (65.5%). Hearts from high-risk donors did not impact primary graft dysfunction (14.3% vs 10%; P = .6), neither long-term survival (P = .4 by logrank test). Recipient's age was greater than 50 years (hazard ratio, 6.02; 95% confidence interval, 2.41-16.08; P < .0001) and was the only predictor of long-term mortality. CONCLUSIONS: The shortage of donors is not the main limiting factor of heart transplantation in the Mid-West of Brazil. Nonmedical issues represent the main reason for organ discard. Most of the donors are classified as high risk which indicates that an expanded donor pool is a routine practice in our region, and donor scoring does not seem to influence to proceed with the transplant.

Metabolomic insights in advanced cardiomyopathy of chronic chagasic and idiopathic patients that underwent heart transplant.

Heart failure (HF) studies typically focus on ischemic and idiopathic heart diseases. Chronic chagasic cardiomyopathy (CCC) is a progressive degenerative inflammatory condition highly prevalent in Latin America that leads to a disturbance of cardiac conduction system. Despite its clinical and epidemiological importance, CCC molecular pathogenesis is poorly understood. Here we characterize and discriminate the plasma metabolomic profile of 15 patients with advanced HF referred for heart transplantation - 8 patients with CCC and 7 with idiopathic dilated cardiomyopathy (IDC) - using gas chromatography/quadrupole time-of-flight mass spectrometry. Compared to the 12 heart donor individuals, also included to represent the control (CTRL) scenario, patients with advanced HF exhibited a metabolic imbalance with 21 discriminating metabolites, mostly indicative of accumulation of fatty acids, amino acids and important components of the tricarboxylic acid (TCA) cycle. CCC vs. IDC analyses revealed a metabolic disparity between conditions, with 12 CCC distinctive metabolites vs. 11 IDC representative metabolites. Disturbances were mainly related to amino acid metabolism profile. Although mitochondrial dysfunction and loss of metabolic flexibility may be a central mechanistic event in advanced HF, metabolic imbalance differs between CCC and IDC populations, possibly explaining the dissimilar clinical course of Chagas' patients.

Recurrent Cardiac Sarcoma Resection With Modified Partial Autotransplantation.

Primary cardiac sarcomas are very aggressive, being a challenge to cardio-oncology specialty. Surgical planning and innovative techniques have enhanced the possibility of resection. We have described a case of recurrent primary left atrium angiosarcoma, successfully resected with a modified partial autotransplantation technique, planned using a 3-dimensional model created from computed tomography. (Level of Difficulty: Intermediate.).

Innovative Approaches to Assess Intermediate Cardiovascular Risk Subjects: A Review From Clinical to Metabolomics Strategies.

Current risk stratification strategies for coronary artery disease (CAD) have low predictive value in asymptomatic subjects classified as intermediate cardiovascular risk. This is relevant because not all coronary events occur in individuals with traditional multiple risk factors. Most importantly, the first manifestation of the disease may be either sudden cardiac death or acute coronary syndrome, after rupture and thrombosis of an unstable non-obstructive atherosclerotic plaque, which was previously silent. The inaccurate stratification using the current models may ultimately subject the individual to excessive or insufficient preventive therapies. A breakthrough in the comprehension of the molecular mechanisms governing the atherosclerosis pathology has driven many researches toward the necessity for a better risk stratification. In this Review, we discuss how metabolomics screening integrated with traditional risk assessments becomes a powerful approach to improve non-invasive CAD subclinical diagnostics. In addition, this Review highlights the findings of metabolomics studies performed by two relevant analytical platforms in current use-mass spectrometry (MS) hyphenated to separation techniques and nuclear magnetic resonance spectroscopy (NMR) -and evaluates critically the challenges for further clinical implementation of metabolomics data. We also discuss the modern understanding of the pathophysiology of atherosclerosis and the limitations of traditional analytical methods. Our aim is to show how discriminant metabolites originated from metabolomics approaches may become promising candidate molecules to aid intermediate risk patient stratification for cardiovascular events and how these tools could successfully meet the demands to translate cardiovascular metabolic biomarkers into clinical settings.

Autologous pericardium patch aneurysm after ventricular septal defect closure and arterial switch operation.

A neonate with L-transposition of the great arteries with ventricular septal defect underwent complete repair using fresh autologous pericardium to close the ventricular septal defect as well as to reconstruct the neo pulmonary artery sinuses. Four months later, the child came back with right ventricular inflow obstruction related to aneurysmal pericardial patch, severe tricuspid regurgitation, and severe supra-valvular pulmonic stenosis. At reoperation, there was a redundant, aneurysmal pericardial patch densely adherent to the septal and posterior leaflets of the tricuspid valve, which was damaged. The pericardial patch was replaced, the pulmonary artery enlarged, and tricuspid valve repaired. Postoperative course was uneventful, but residual moderate tricuspid regurgitation required intensive medical treatment.

Transvenous dual-chamber pacemaker after paediatric heart transplantation using left ventricle pacing through the coronary sinus.

A 12-year-old child with end-stage heart failure due to restrictive cardiomyopathy was submitted to orthotopic heart transplantation. Primary graft dysfunction required venous arterial extra-corporeal membrane oxygenation. Heart function normalized, but complete atrioventricular block remained after 3 weeks. A dual-chamber pacing with transvenous left ventricle pacing through the coronary sinus was performed. At 5-year follow-up, the patient is stable with the same pacing system and with preserved ventricular function.

Is It Conceivable to Still Perform the Cut and Sew Cox Maze III Procedure in the Current Era?

To determine whether cut and sew Cox maze III procedure is still associated with adequate safety endpoints when performed in conjunction with other open-heart procedures. Between January 2008 and January 2015, 113 consecutive adult patients were submitted to cut and sew Cox maze III procedure in association with other operations for structural heart disease. Mean age was 49 years and 80 (70.8%) were females. Longstanding or persistent atrial fibrillation has occurred in 87.6% and rheumatic heart disease in 80.7%. Valve surgery was performed in 98.2%. The number of associated procedures was correlated with morbidity and hospital mortality. Overall mean cardiopulmonary bypass and aortic cross-clamping times were 129 ±â€¯26 and 105 ±â€¯23 minutes, respectively. Hospital mortality was 1.77%, re-exploration for bleeding 0.9%, cerebrovascular accident 1.8%, and acute renal failure requiring hemodialysis 2.6%. The greater number of associated procedures did not correlate with poorer safety outcomes. Permanent pacemaker was required in 18.2% of those with three associated procedures, as opposed to 4% with two procedures and no requirement with one procedure (P = .01). Frequency of sinus rhythm was 88%, 88%, and 85% at 6, 12, and 24 months, respectively. In a contemporary single-center cohort of predominantly rheumatic patients, the surgical treatment of atrial fibrillation associated with structural heart disease by means of cut and sew Cox maze III procedure is safe, with low morbidity and mortality rates. Surgical complexity, defined by number of associated procedures, did not translate into poorer safety endpoints, except for greater need of permanent pacemaker.

The ultimate development of mitral valve endocarditis: atrioventricular separation, atrioventricular groove abscess and hemorrhagic pericarditis.

A 52-year-old non-insulin-dependent diabetic man presented with cerebral emboli and mitral valve endocarditis with posterior leaflet vegetations and perforation. Surgical intervention demonstrated hemorrhagic pericarditis and an atrioventricular groove abscess. Extensive debridement of the pericardium, valve and abscess cavities, reconstruction of the mitral annulus with a patch of fresh autologous pericardium, and mitral valve replacement with a pericardial bioprosthesis was performed. The chest was left open. Postoperatively, the patient required dialysis and prolonged mechanical ventilation, but recovered well without recurrent endocarditis and was discharged home after 40 days.

Tricuspid valve repair for biopsy-induced regurgitation in a heart transplant recipient.

Tricuspid regurgitation (TR) is a frequent complication after heart transplantation. The etiology of TR is multifactorial, but biopsy-induced flail leaflet is one of the most important mechanisms. A 61-year-old woman underwent heart transplant, but experienced several rejection episodes which required multiple surveillance endomyocardial biopsies. At three months after transplant, she required tricuspid valve repair due to symptomatic severe TR. The anterior leaflet was flail, with rupture of primary and secondary chordae. Valve repair was performed with a triple leaflet edge-to-edge technique. The procedure consisted of suture fixation of the prolapsed anterior leaflet joining to the septal and posterior leaflets, and placement of a 30-mm annuloplasty ring. The patient was uneventfully discharged home on day 7 with trivial TR. At a four-years post-transplant evaluation, she was in NYHA functional class I, with preserved ventricular function and trivial TR. She has been followed closely because of post-transplant coronary artery disease.

Combined minimally invasive pulmonary vein isolation, left atrial appendage excision and cardiac resynchronization therapy for heart failure: case report.

A 76-year-old male with ischemic cardiomyopathy presented with heart failure symptoms in the absence of angina. Several hospitalizations were required due to heart failure exacerbation and paroxysmal atrial fibrillation. Electrocardiography and tissue synchronization imaging confirmed ventricular dyssynchrony, requiring biventricular pacing. After a failed attempt of percutaneous placement of the left ventricular lead, a novel minimally invasive approach was indicated. It consisted of left ventricular epicardial lead placement, microwave pulmonary vein isolation, and left atrial appendage excision through bilateral minithoracotomies. The postoperative recovery was unremarkable, with reestablishment of the ventricular synchrony and regular rhythm.

Unusual mechanism of myocardial infarction in prosthetic valve endocarditis.

A 46-year-old man with bicuspid aortic valve and severe calcific aortic stenosis was submitted to aortic valve replacement with a stented bioprosthesis. He developed Staphylococcus epidermidis prosthetic valve endocarditis a month later, presenting in the emergency room with acute myocardial infarction. The mechanism of myocardial ischemia was a large aortic root abscess causing left main extrinsic compression. He was urgently taken to the operating room, and an aortic root replacement with cryopreserved homograft was performed, associated with autologous pericardium patch closure of aortic to right atrium fistula and coronary artery bypass grafting of the left anterior descending. After a difficult postoperative period with multiple problems, he was eventually discharged home. At 36-month follow-up, he is asymptomatic with no recurrent infection, and the left main coronary artery is widely patent on control chest computed tomography.

Long-term results of correction of tetralogy of Fallot in adulthood.

OBJECTIVES: The natural history of tetralogy of Fallot (TOF) allows that a minority of patients reach adulthood without any treatment, representing mild forms of the disease. The aim of this study is the long-term evaluation of patients with TOF surgically treated in adulthood, in order to define its real benefit. METHODS: Between November 1982 and January 2001, 39 patients older than 18 years of age with tetralogy of Fallot underwent total correction. Mean age was 26.6 years (range 18-67) and 21 patients (53.8%) were females. A previous modified Blalock-Taussig shunt was performed in four patients (10.3%). Fifteen patients (38.5%) were in NYHA functional class III or IV. Mean hematocrit was 53.6+/-10% and the mean gradient across the right-ventricular outflow tract was 93.9+/-24.8 mmHg. The operation was performed via transatrial/transpulmonary approach in 16 patients (41%) and six patients (15.4%) required transannular patch. Pulmonary valvotomy was necessary in 13 patients (33.3%) and pulmonary valve replacement with bioprosthesis in 3 patients (7.7%). RESULTS: Hospital and late mortality were 5.1 and 7.7%, respectively. The mean follow-up was 45.1 months (range 1-194 months). Actuarial survival was 91.2+/-4.9%, 85.5+/-7.2% and 68.4+/-16.3% at 3, 7 and 15 years, respectively. In the latest follow-up, 27 (79.4%) of the survivals are presently in NYHA functional class I (P<0.001). Echocardiography has shown moderate/severe pulmonary insufficiency in 9 patients (26.5%), moderate pulmonary stenosis in 3 patients (8.8%) and residual ventricular septal defect in 4 patients (11.8%). Arrhythmias were identified in 38.9% of patients with symptoms suspicious of rhythm disturbances. There was impairment of right-ventricular function in 13 patients (38.2%). Three patients were reoperated on to close residual ventricular septal defects in two patients and for pulmonary valve replacement in one patient. CONCLUSIONS: The overall survival of surgically treated adult patients with TOF is acceptable. The great benefit of the complete repair at this age is the functional improvement. On the other hand, late complications closely related to chronic hypoxia, such as arrhythmia and ventricular dysfunction might direct for a more careful follow-up after the surgical correction.

Impact of type of procedure and surgeon on EuroSCORE operative risk validation.

OBJECTIVE: EuroSCORE has been used in cardiac surgery operative risk assessment, despite important variables were not included. The objective of this study was to validate EuroSCORE on mortality prediction in a Brazilian cardiovascular surgery center, defining the influence of type of procedure and surgical team. METHODS: Between January 2006 and June 2011, 2320 consecutive adult patients were studied. According to additive EuroSCORE, patients were divided into low risk (score<2), medium risk (3 - 5), high risk (6 - 11) and very high risk (>12). The relation between observed mortality (O) and expected mortality (E) according to logistic EuroSCORE was calculated for each of the groups, types of procedures and surgeons with > 150 operations, and analyzed by logistic regression. RESULTS: EuroSCORE correlated to the observed mortality (O/E=0.94; P<0.0001; area under the curve 0.78). However, it overestimated the mortality in very high risk patients (O/E=0.74; P=0.001). EuroSCORE tended to overestimate isolated myocardial revascularization mortality (O/E=0.81; P=0.0001) and valve surgery mortality (O/E=0.89; P=0.007) and it tended to underestimate combined procedures mortality (O/E=1.09; P<0.0001). EuroSCORE overestimated surgeon A mortality (O/E=0.46; P<0.0001) and underestimated surgeon B mortality (O/E=1.3; P<0.0001), in every risk category. CONCLUSION: In the present population, EuroSCORE overestimates mortality in very high risk patients, being influenced by type of procedure and surgical team. The most appropriate surgical team may minimize risks imposed by preoperative profiles.