Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial.

BACKGROUND: Cardiac troponin T (cTnT) and I (cTnI) concentrations provide strong prognostic information in anticoagulated patients with atrial fibrillation (AF). Whether the associations between cardiac troponin concentrations and mortality and morbidity differ by sex is not known. OBJECTIVES: To assess whether men and women have different concentrations and prognostic value of cTnT and cTnI measurements in anticoagulated patients with AF. METHODS: cTnT and cTnI concentrations were measured with high-sensitivity (hs) assays in EDTA plasma samples obtained from the multicentre ARISTOTLE trial, which randomized patients with AF and at least one risk factor for stroke or systemic embolic event to warfarin or apixaban. Patients were stratified according to sex and the associations between hs-troponin concentrations, and all-cause death, cardiac death, myocardial infarction, stroke or systemic embolic event and major bleeding were assessed in multivariable regression models. RESULTS: We found higher cardiac troponin concentrations in men (n = 9649) compared to women (n = 5331), both for hs-cTnT (median 11.8 [Q1-3 8.1-18.0] vs. 9.6 [6.7-14.3] ng L-1 , P < 0.001) and hs-cTnI (5.8 [3.4-10.8] vs. 4.9 [3.1-8.8] ng L-1 , P < 0.001). Adjusting for baseline demographics, comorbidities and medications, men still had significantly higher hs-troponin concentrations than women. C-reactive protein and N-terminal pro-B-type natriuretic peptide concentrations were higher in female patients. Both hs-cTnT and hs-cTnI concentrations were associated with all clinical outcomes similarly in men and women (p-value for interaction >0.05 for all end-points). CONCLUSION: Men have higher hs-troponin concentrations than women in AF. Regardless of sex, hs-troponin concentrations remain similarly associated with adverse clinical outcomes in anticoagulated patients with AF.

Comparison of bleeding risk scores in patients with atrial fibrillation: insights from the RE-LY trial.

BACKGROUND: Oral anticoagulation is the mainstay of stroke prevention in atrial fibrillation (AF), but must be balanced against the associated bleeding risk. Several risk scores have been proposed for prediction of bleeding events in patients with AF. OBJECTIVES: To compare the performance of contemporary clinical bleeding risk scores in 18 113 patients with AF randomized to dabigatran 110 mg, 150 mg or warfarin in the RE-LY trial. METHODS: HAS-BLED, ORBIT, ATRIA and HEMORR2 HAGES bleeding risk scores were calculated based on clinical information at baseline. All major bleeding events were centrally adjudicated. RESULTS: There were 1182 (6.5%) major bleeding events during a median follow-up of 2.0 years. For all the four schemes, high-risk subgroups had higher risk of major bleeding (all P < 0.001). The ORBIT score showed the best discrimination with c-indices of 0.66, 0.66 and 0.62, respectively, for major, life-threatening and intracranial bleeding, which were significantly better than for the HAS-BLED score (difference in c-indices: 0.050, 0.053 and 0.048, respectively, all P < 0.05). The ORBIT score also showed the best calibration compared with previous data. Significant treatment interactions between the bleeding scores and the risk of major bleeding with dabigatran 150 mg BD versus warfarin were found for the ORBIT (P = 0.0019), ATRIA (P < 0.001) and HEMORR2 HAGES (P < 0.001) scores. HAS-BLED score showed a nonsignificant trend for interaction (P = 0.0607). CONCLUSIONS: Amongst the current clinical bleeding risk scores, the ORBIT score demonstrated the best discrimination and calibration. All the scores demonstrated, to a variable extent, an interaction with bleeding risk associated with dabigatran or warfarin.

Left atrial appendage closure: outcomes and challenges.

Whereas the left atrial appendage plays a rather minor role under physiological circumstances, it gains an importance in patients with atrial fibrillation. Compelling evidence has revealed that the left atrial appendage is implicated as the source of thrombus in the vast majority of strokes in atrial fibrillation. Oral anticoagulation remains the standard of care for stroke prevention in atrial fibrillation; nevertheless, this treatment has several limitations and is often contraindicated, particularly in the elderly population in whom the risk of stroke is high. Therefore, occluding the left atrial appendage is a logical approach to prevent thrombus formation and subsequent cardioembolic events in these patients. We present a review of clinical outcomes of patients with atrial fibrillation undergoing left atrial appendage closure and the challenges faced in this field.

Congenital heart disease: addressing the need for novel lower-risk percutaneous interventional strategies.

INTRODUCTION: With the advent of improved neonatal care, increasingly vulnerable higher-risk patients with complex congenital heart anomalies are presenting for intervention. This group of patients will always have a higher risk of an adverse event during a procedure but by recognizing this risk and with the introduction of risk scoring systems and thus the development of novel lower risk procedures, the rate of adverse events can be reduced. AREA COVERED: This article reviews risk scoring systems for congenital catheterization and demonstrates how they can be used to reduce the rate of adverse events. Then, novel low risk strategies are discussed for low-weight infants e.g. patent ductus arteriosus (PDA) stent insertion; premature infants e.g. PDA device closure; and transcatheter pulmonary valve replacement. Finally, how risk is assessed and managed within the inherent bias of an institution is discussed. EXPERT OPINION: There has been a remarkable improvement in the rate of adverse events in congenital cardiac interventions, but now, as the benchmark of mortality rate is switched to morbidity and quality of life, continued innovation into lower risk strategies and understanding the inherent bias when assessing risk will be key to continuing this improvement.

Indications, techniques and results of percutaneous patent foramen ovale closure.

Patent foramen ovale (PFO) has been shown to be more prevalent in certain disease states, suggesting a potentially causative role in some patients with cryptogenic stroke, migraine headache or a number of other conditions. Percutaneous PFO closure has become a reasonable treatment option in a subset of those patients. Our objective is to review the possible indications of PFO closure. We further elucidate the technical aspects of PFO closure, provide an overview of the available devices and summarize results of PFO closure procedures.

Transitioning mental health & psychosocial support: from short-term emergency to sustainable post-disaster development. Humanitarian Action Summit 2011.

INTRODUCTION: The Working Group (WG) on Mental Health and Psychosocial Support participated in its second Humanitarian Action Summit in 2011. This year, the WG chose to focus on a new goal: reviewing practice related to transitioning mental health and psychosocial support programs from the emergency phase to long-term development. The Working Group's findings draw on a review of relevant literature as well as case examples. OBJECTIVES: The objective of the Working Group was to identify factors that promote or hinder the long term sustainability of emergency mental health and psychosocial interventions in crisis and conflict, and to provide recommendations for transitioning such programs from relief to development. METHODS: The Working Group (WG) conducted a review of relevant literature and collected case examples based on experiences and observations of working group members in implementing mental and psychosocial programming in the field. The WG focused on reviewing literature on mental health and psychosocial programs and interventions that were established in conflict, disaster, protracted crisis settings, or transition from acute phase to development phase. The WG utilized case examples from programs in Lebanon, the Gaza Strip, Sierra Leone, Aceh (Indonesia), Sri Lanka, and New Orleans (United States). RESULTS: The WG identified five key thematic areas that should be addressed in order to successfully transition lasting and effective mental health and psychosocial programs from emergency settings to the development phase. The five areas identified were as follows: Government and Policy, Human Resources and Training, Programming and Services, Research and Monitoring, and Finance. CONCLUSIONS: The group identified several recommendations for each thematic area, which were generated from key lessons learned by working group members through implementing mental health and psychosocial support programs in a variety of settings, some successfully sustained and some that were not.

Mental health and psychosocial support in crisis and conflict: report of the Mental Health Working Group.

INTRODUCTION: The Working Group on Mental Health and Psychosocial Support was convened as part of the 2009 Harvard Humanitarian Action Summit. The Working Group chose to focus on ethical issues in mental health and psychosocial research and programming in humanitarian settings. The Working Group built on previous work and recommendations, such as the Inter-Agency Standing Committee's Guidelines on Mental Health and Psychosocial Support in Emergency Settings. OBJECTIVES: The objective of this working group was to address one of the factors contributing to the deficiency of research and the need to develop the evidence base on mental health and psychosocial support interventions during complex emergencies by proposing ethical research guidelines. Outcomes research is vital for effective program development in emergency settings, but to date, no comprehensive ethical guidelines exist for guiding such research efforts. METHODS: Working Group members conducted literature reviews which included peer-reviewed publications, agency reports, and relevant guidelines on the following topics: general ethical principles in research, cross-cultural issues, research in resource-poor countries, and specific populations such as trauma and torture survivors, refugees, minorities, children and youth, and the mentally ill. Working Group members also shared key points regarding ethical issues encountered in their own research and fieldwork. RESULTS: The group adapted a broad definition of the term "research", which encompasses needs assessments and data gathering, as well as monitoring and evaluation. The guidelines are conceptualized as applying to formal and informal processes of assessment and evaluation in which researchers as well as most service providers engage. The group reached consensus that it would be unethical not to conduct research and evaluate outcomes of mental health and psychosocial interventions in emergency settings, given that there currently is very little good evidence base for such interventions. Overarching themes and issues generated by the group for further study and articulation included: purpose and benefits of research, issues of validity, neutrality, risk, subject selection and participation, confidentiality, consent, and dissemination of results. CONCLUSIONS: The group outlined several key topics and recommendations that address ethical issues in conducting mental health and psychosocial research in humanitarian settings. The group views this set of recommendations as a living document to be further developed and refined based on input from colleagues representing different regions of the globe with an emphasis on input from colleagues from low-resource countries.

Improving access to mental healthcare for displaced Syrians: case studies from Syria, Iraq and Turkey.

The conflict in Syria has led to an unprecedented humanitarian crisis that extends across multiple countries in the area. Mental health services were undeveloped before and now face huge strain and unmet need. The World Health Organization and others have developed a programme to build capacity in the delivery of mental health services in an integrated healthcare package to refugees and displaced people. The tool used for this is the mhGAP Intervention Guide and complementary materials. In this paper we refer to training in Turkey, Iraq and Syria where health professionals were trained to roll out this community-based integrated approach through primary healthcare. We describe field case examples that show the complexity of situations that face refugees, displaced people and those caught in active conflict. Training improved the knowledge and skills for managing mental health disorders in primary healthcare. Further work needs to be done to demonstrate greater access to and utilisation of services, client outcomes and organisational change with this approach.

Physiologic significance of chronic coronary aneurysms in patients with Kawasaki disease.

OBJECTIVES: The aim of this study was to determine whether persistent coronary aneurysms in patients with Kawasaki disease are associated with altered myocardial perfusion and function. BACKGROUND: Some patients with Kawasaki disease have died suddenly because of severe coronary artery stenosis; others have chronic coronary aneurysms. METHODS: Eleven patients with chronic coronary aneurysms were enrolled in the study. The size of the aneurysms and the degree of associated stenosis were determined by angiography in nine patients and by echocardiography in two. All patients underwent simultaneous function and myocardial perfusion assessment during symptom-limited exercise by echocardiography and technetium-99m sestamibi imaging, respectively. RESULTS: Of 33 vascular territories, 18 contained coronary aneurysms measuring 3.5 to 10 mm. Three aneurysms were associated with significant stenosis as detected by angiography. Of the 18 vascular territories, 13 were normal, and 5 manifested stress-induced perfusion defects; of the latter 5 areas, 4 had associated wall motion abnormalities. The three territories supplied by stenotic coronary arteries had both abnormal regional function and perfusion demonstrated during exercise. CONCLUSIONS: Patients with chronic coronary aneurysms may have associated stenosis, as detected by angiography, with a subjacent myocardium that is subject to abnormal perfusion and function. However, the majority of coronary aneurysms are associated with normal regional coronary flow reserve, as assessed by myocardial perfusion imaging, and even giant coronary aneurysms may be associated with normal coronary flow reserve and preserved regional myocardial function during stress.

Catheter closure of moderate- to large-sized patent ductus arteriosus using the new Amplatzer duct occluder: immediate and short-term results.

OBJECTIVES: The aim of this study was to assess the immediate and short-term results of anterograde catheter closure of a moderate- to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder (ADO) device. BACKGROUND: Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts. METHODS: Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7+/-1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow-up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure. RESULTS: Twenty three of the 24 patients had successful device placement. Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients. The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day. There were no complications. Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure. CONCLUSIONS: Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm. Further clinical trials are underway.

Results of anterograde transcatheter closure of patent ductus arteriosus using single or multiple Gianturco coils.

Retrograde coil embolization of the patent ductus arteriosus (PDA) has been reported for ducts < 3.3 mm in diameter using 5 to 5.5Fr catheters. Our objective was to assess the immediate and short-term results of anterograde transcatheter closure of the PDA using single or multiple Gianturco coils. Thirty-three patients (11 males and 22 females) underwent an attempt at transcatheter closure of the PDA anterogradely at a median age of 2.8 years (range 0.1 to 19) and median weight of 14 kg (range 2.3 to 64). The median PDA diameter at its narrowest segment was 2.8 mm (range 0.5 to 5.3). A 4Fr catheter was used for delivery of the coils in 30 patients and a 3Fr catheter was used in 3 patients. Eighteen patients underwent multiple coil closure for a PDA diameter of > or = 2.5 mm (using 2 coils in 9, 3 coils in 6, 4 coils in 1, and 5 coils in 2 patients). Follow-up evaluation was performed with color flow mapping of the main pulmonary artery. Thirty-one of the 33 patients had complete closure by the coil technique. The 2 unsuccessful attempts were in 2 patients with a large ductus measuring > or = 4.3 mm and of angiographic type B. For all 13 patients in whom a single coil and in 17 patients in whom multiple coils were placed, there was immediate complete closure that persisted at a median follow-up period of 3.8 months. The median fluoroscopy time was 24 minutes.(ABSTRACT TRUNCATED AT 250 WORDS)

Transcatheter closure of patent ductus arteriosus using coils.

Ninety-seven of 100 patients had a successful attempt at coil closure of the patent ductus arteriosus. For all 46 patients in whom a single coil and in 47 patients in whom multiple coils were placed, there was immediate complete closure that persisted at a median follow-up period of 1.9 years.

Effect of multiple coil closure of patent ductus arteriosus on blood flow to the left lung as determined by lung perfusion scans.

Lung perfusion scans reveal that multiple-coil closure of the ductus does not interfere with pulmonary blood flow. However, caution is necessary when placing multiple coils in small infants.

Immediate and six-month results of the profile of the Amplatzer septal occluder as assessed by transesophageal echocardiography.

Catheter closure of secundum atrial septal defect (ASD) using the Amplatzer septal occluder (ASO) is a potential alternative for open surgical repair. However, the large profile of the device obtained immediately after closure continues to raise some concerns regarding its long-term safety. To evaluate the changes in the profile of the device after being deployed, transesophageal echocardiography was performed in 70 patients (17 men and 53 women) who underwent catheter closure of ASDs immediately after and at 6-month follow-up. The median age at closure was 16 years (range 1.9 to 75) and the median size of the ASD as assessed by transesophageal echocardiography was 14 mm (range 3 to 25). The thickness (profile) of the device was assessed in the 4-chamber, short- and long-axis views of the interatrial septum, and measured at its middle and at the junction of the waist with the disc at its 2 ends. Seventy-three devices were deployed in the 70 patients. The median size of the device was 19 mm (range 8 to 34). Complete closure was achieved in 81.4% and 91.4% immediately after and at 6-months follow-up, respectively. The thickness of the device at its middle decreased from 12.2 +/- 4.3, 12.2 +/- 3.7, and 12.5 +/- 4.3 mm in the 4-chamber, short- and long-axis views to 6.5 +/- 2.0, 6.3 +/- 1.9, and 6.5 +/- 2.2 mm, respectively. The thickness of the device at its superior, inferior, anterior, and posterior edges also decreased by 41.8% +/- 14.0% to 43.7% +/- 9.8%. The changes in the thickness were related to device size. Larger devices were thicker after being deployed. We conclude that the thickness of the ASO decreases by 42% to 48% within 6 months after deployment, resulting in a lower profile.

Effect of pulmonary artery stenoses on the cardiopulmonary response to exercise following repair of tetralogy of Fallot.

Data from exercise tests, echocardiograms, and lung perfusion scans were analyzed to determine whether the excessive minute ventilation (VE) often encountered among patients with tetralogy of Fallot is due to ventilation-perfusion mismatch secondary to branch pulmonary artery stenoses. Patients with branch PA stenoses had lower peak oxygen consumptions and higher VE during exercise than did patients without stenoses, and a strong correlation existed between the degree of pulmonary blood flow maldistribution on lung perfusion scan and the amount of excessive VE during exercise.

Fenestrated Fontan operation with delayed transcatheter closure of atrial septal defect. Improved results in high-risk patients.

Ten patients, each with two or more risk factors for morbidity and death, underwent a fenestrated Fontan procedure in which a 4 to 6 mm circular fenestration was left between the systemic and pulmonary venous chambers. None died; a similar group of high-risk patients without fenestration had a mortality rate of 2 of 8. Patients with fenestration had significantly less drainage from the chest tube, less need for inotropic support, and shorter intensive care and hospital stays than did patients without fenestration. Comparison with a group of low-risk patients undergoing the Fontan operation showed no statistical difference in these postoperative parameters. Fenestrations were closed in all 10 patients at from 9 days to 6 months after operation by means of the transcatheter clamshell occluder device. Two patients had left pulmonary artery balloon angioplasty and three patients had other atrial communications closed with additional clamshell devices. During short-term follow-up periods averaging 18 months, all patients were clinically well; however, one patient with mitral atresia required reoperation for obstruction between the left atrium and the tricuspid valve, not related to the clamshell device. These data indicate that fenestration may be one method of achieving lower morbidity and mortality rates among high-risk patients undergoing the Fontan procedure.

Transcatheter closure of large patent ductus arteriosus (> or = 4 mm) with multiple Gianturco coils: immediate and mid-term results.

OBJECTIVE: To assess the immediate and mid-term results of transcatheter closure of patent ductus arteriosus (PDA) > or = 4 mm with multiple Gianturco coils. (Transcatheter closure of large PDAs using the Rashkind occluder or the buttoned device is associated with a 7-38% incidence of residual shunt.) METHODS: 19 patients (7 male, 12 female) underwent an attempt at anterograde transcatheter closure with multiple Gianturco coils of a large PDA at a median age of 3.8 yr (range 2 weeks-34 yr) and median weight of 14 kg (range 2.3-80 kg). RESULTS: The median PDA diameter at the narrowest segment was 4.3 mm (range 4-7 mm) and the mean (SD) Qp/Qs was 1.9 (0.8). Each patient had left atrial and left ventricular volume overload. A 4F catheter was used to deliver the coils in all patients. There was immediate and complete closure in 16/18; one patient had residual shunt that was closed at a second procedure and the other had spontaneous disappearance of the residual shunt at the six week visit. A short ductus (angiographic type B) in one patient could not be closed. The median number of coils placed at the first attempt to close the ductus was 4 (range 2-6 coils) and the median fluoroscopy time was 40 minutes (range 13-152 minutes). Mild left pulmonary artery stenosis occurred in the two smallest patients. Coil migration to the lung occurred in 3 patients with retrieval of coils in two patients. All procedures but one were done on an outpatient basis. At a median follow up of 1.6 yr (range 2 weeks-2.2 yr) all patients had complete closure with no new complications. CONCLUSIONS: Anterograde transcatheter closure with multiple Gianturco coils is an effective treatment for most patients with large PDA of diameters up to 7 mm. This technique can be performed in small infants on an outpatient basis without the need for general endotracheal anaesthesia.

The right ventricle in congenital heart disease.

An increasing number of children with congenital heart disease are surviving into adulthood, creating new, unusual patients with different physiologic and anatomic problems for the adult cardiologist. This article discusses those lesions affecting primarily the right ventricle.

Early ECG abnormalities associated with transcatheter closure of atrial septal defects using the Amplatzer septal occluder.

UNLABELLED: Conduction abnormalities and arrhythmias may occur in patients following secundum atrial septal defect (ASD) closure using the Amplatzer septal occluder (ASO). Therefore, the aim of this study was to prospectively perform ambulatory ECG monitoring to assess the electrocardiographic effects of transcatheter closure (TCC) of ASD using the ASO device. From 5/97 to 3/99, 41 patients with secundum ASD, underwent TCC using the ASO device at a median age of 9.2[emsp4 ]y. (0.5-87[emsp4 ]y.) and median weight of 34[emsp4 ]kg (5. 6-88[emsp4 ]kg.). Ambulatory Holter monitoring was performed pre- and immediately post TCC. Holter analysis included heart rate (HR), ECG intervals, supraventricular ectopy (SVE), ventricular ectopy (VE), and AV block. No change in baseline rhythm was noted in 37 patients (90%). Changes in AV conduction occurred in 3 patients (7%), including intermittent second degree AV block type II, and complete AV dissociation post closure. SVE was noted in 26 patients (63%) post closure, ranging from 5-2207 supraventricular premature beats (SVPB), including 9 patients (23%) with non-sustained supraventricular tachycardia (SVT), 3 of whom had short runs of SVT prior to closure. A significant increase in post-closure number of SVPB per hour (p=0.047) was noted. No significant difference was noted in PR interval, ventricular premature beats per hour, or QRS duration. CONCLUSIONS: Based on ambulatory ECG analysis, TCC of ASD with the ASO device is associated with an acute increase in SVE and a small risk of AV conduction abnormalities, including complete heart block. Long term follow-up studies will be necessary to determine late arrhythmia prevalence and relative frequency compared with standard surgical ASD repair.

Palliative balloon pulmonary valvuloplasty in tetralogy of fallot: echocardiographic predictors of successful outcome.

Although balloon pulmonary valvuloplasty (BPV) has been advocated as a means of palliating patients with tetralogy of Fallot (TOF), the results of this procedure were not uniformly good in this patient population. The purpose of this study was to review our institutionOs experience with BPV in patients with TOF, and to determine whether echocardiographic criteria exist that may be used to identify patients likely to derive prolonged benefit from this procedure. Between 1991 and 1999, nine patients with TOF, ages 0. 4Eth 26.1 weeks (mean, 7.4 +/- 7.6 weeks) underwent BPV due to cyanosis and other associated medical conditions (e.g., coronary artery anomalies, small size) that rendered immediate surgical intervention undesirable. Data from the catheterization and pre-BPV echocardiograms were analyzed. All patients had at least transient improvement in oxygen saturation. However, 4 patients (Group 1) required intervention (1 open-heart repair, 3 palliative shunts) within 5 weeks of BPV due to recurrent desaturation. In the remaining 5 patients (Group 2), open-heart repair was delayed 8Eth 36 weeks (mean, 23 +/- 13 weeks). Groups 1 and 2 did not differ regarding pulmonary valve annulus, main pulmonary artery or branch pulmonary artery diameter. However, the diastolic diameter of the right ventricular outflow tract (RVOT) was significantly smaller in Group 1 (18.3 +/- 3.5 mm/m2 versus 24.4 +/- 4.1 mm/m2 in Group 2; p < 0.05). Four out of five patients with a RVOT diameter < 23 mm/m2 were in Group 1, and all patients with RVOT diameter greater than 25 mm/m2 were in Group 2. We conclude that BPV can effectively palliate patients with TOF whose RVOT diastolic diameter is > 25 mm/m2. However, patients with a diastolic RVOT diameter < 23 mm/m2 are unlikely to have sustained improvement following BPV.