Cryoballoon versus Radiofrequency Ablation for Atrial Fibrillation: A Meta-analysis of 16 Clinical Trials.

Introduction: We aimed to study the procedural characteristics, efficacy and safety of cryoballoon ablation (CBA) versus radiofrequency ablation (RFA) for catheter ablation of paroxysmal atrial fibrillation (AF). Methods: A systematic literature search was performed using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to clinical trials comparing CBA and RFA for AF. Outcomes were evaluated for efficacy, procedure characteristics and safety. For each study, odd ratio (OR) and 95% confidence intervals (CIs) were calculated for endpoints for both approaches. Results: We analyzed a total of 9,957 participants (3,369 in the CBA and 6,588 in RFA group) enrolled in 16 clinical trials. No significant difference was observed between CBA and RFA with regards to freedom from atrial arrhythmia at 12-months, recurrent atrial arrhythmias or repeat catheter ablation. CBA group had a significantly higher transient phrenic nerve injury (OR 14.19, 95% CI: 6.92-29.10;

Periprocedural Management of New Oral Anticoagulants in Atrial Fibrillation Ablation.

BACKGROUND: Patients who undergo catheter ablation for atrial fibrillation (AF) are at increased risk of developing thromboembolic and bleeding complications periprocedurally. Many patients are now on newer oral anticoagulants (NOACs), but data regarding their safety and efficacy during AF ablation are limited. METHODS AND RESULTS: This article reviews the literature in PubMed from 1998 to 2014 and includes clinical trials and meta-analysis that analyzed the safety and efficacy of NOACs during AF catheter ablation. Dabigatran seems to be as effective and safe as warfarin, although most data are from single-center studies, with small samples and very low overall bleeding and thromboembolic complications. Periprocedural anticoagulation protocols also vary greatly between studies. Some recent meta-analysis has shown that warfarin could still be a safer and more effective alternative. There are fewer studies with rivaroxaban in AF ablation, and there have been no meta-analysis yet comparing rivaroxaban to warfarin or dabigatran. There seems to be no significant differences in safety or efficacy of rivaroxaban compared to warfarin. Interestingly, there are no available data for apixaban in AF ablation yet. DISCUSSION: There are no consensus guidelines regarding the use of NOACs during AF ablation. Dabigatran and rivaroxaban seem as safe and effective as warfarin, although larger studies with standardized protocols are needed, as available studies may be underpowered to detect small differences in bleeding and thromboembolic rates

Right Ventricular Apical Versus Non-Apical Implantable Cardioverter Defibrillator Lead: a Systematic Review and Meta-Analysis.

Introduction We aimed to study the effect of right ventricular implantable cardioverter defibrillator (ICD) lead positioning on clinical outcomes in patients undergoing ICD placement. Methods A systematic literature search was performed using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to identify clinical trials comparing outcomes in patients with ICD leads in apical and non-apical positions. The primary outcome of our study was death at 1-year follow-up. Secondary outcomes studied were “death at 3 years”, “total number of shocks”, “appropriate shocks”, “inappropriate shocks” and “cut-to-suture time”. Results We analyzed a total of 3731 patients (2852 in apical and 879 in non-apical ICD groups) enrolled in 4 clinical trials. No significant difference was observed between the apical and non-apical ICD groups in all-cause mortality at 1 year (OR 0.88; 95% CI 0.51–1.49, p = 0.63; I2 = 5.32%). Similarly, no differences were seen between the two groups in death at 3 years (OR = 0.76; 95%CI 0.56–1.04, p = 0.08; I2 = 0%), total number of shocks (OR 0.99; 95% CI 0.81–1.22, p = 0.95; I2 = 0%), appropriate shocks (OR 1.00; 95% CI 0.79–1.27, p = 0.99; I2 = 0%), inappropriate shocks (OR 0.98; 95% CI 0.70–1.37, p = 0.91; I2 = 0%) and cut-to-suture time (Standard mean difference = −0.03; 95%CI -0.20 to 0.14, p = 0.73 I2 = 0%). No publication bias was seen. Conclusion Non-apical RV ICD lead implantation is non-inferior to traditional RV apical position with no significant differences in mortality, total number of shocks, appropriate shocks, inappropriate shocks and procedural time

Safety and efficacy of oral factor-Xa inhibitors versus Vitamin K antagonist in patients with non-valvular atrial fibrillation: Meta-analysis of phase II and III randomized controlled trials.

BACKGROUND: Aim of our study was to assess the safety and efficacy on factor-Xa inhibitors (FXIs) in patients with non-valvular atrial fibrillation (NVAF) as compared to Vitamin K antagonist (VKA). METHODS: Phase II and III randomized controlled trials that reported clinical safety and efficacy of FXI in patients with NVAF were identified from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials through December 10, 2015. The primary safety outcome of our study was composite of stroke and systemic embolic event. Secondary outcomes studied were individual endpoints of primary safety outcome, major bleeding, clinically relevant non-major bleed (CRNMB), and all-cause mortality. RESULTS: We included 11 RCTs with a total of 59,164 participants, of which 34,231 patients received oral FXI and 24,933 patients were on VKA with a mean follow-up of 369days. There was a significant reduction in primary outcome with FXI compared to VKA, 1,112 (3.4%) versus 816 (3.6%) events, respectively (OR 0.82; 95% CI 0.68-0.99). Use of FXI significantly reduced major bleeding events compared to VKA, OR 0.74, 95% CI 0.58-0.96, test for heterogeneity (I(2)=74%). Incidence of CRNMB was not different between FXI and VKA groups, OR 0.84, 95% CI 0.68-1.04. There was a significant reduction in all-cause mortality in FXI group compared to VKA group, OR 0.88, 95% CI 0.83-0.94 with no significant heterogeneity. CONCLUSION: Use of FXI was associated with a significant reduction in major bleeding events and all-cause mortality without increased risk of stroke or SEE compared to VKA

Gastrointestinal complications associated with catheter ablation for atrial fibrillation.

Atrial fibrillation is the most common arrhythmia in the United States. With the ageing population, the incidence and prevalence of atrial fibrillation are on the rise. Catheter ablation of atrial fibrillation is a widely accepted treatment modality in patients with drug refractory symptomatic paroxysmal or persistent atrial fibrillation. The close proximity to the left atrium posterior wall makes the thermosensitive esophagus a potential site of injury during catheter ablation of AF leading to various gastrointestinal complications. The major gastrointestinal complications associated with catheter ablation include atrioesophageal fistula, gastroparesis, esophageal thermal lesions and esophageal ulcers. Multiple studies, case reports and series have described these complications with various catheter ablation techniques such as radiofrequency, cryoenergy and high frequency focused ultrasound energy ablation. This review addresses the gastrointestinal complications after AF ablation procedures and aims to provide the clinicians with an overview of clinical presentation, etiology, pathogenesis, prevention and management of these conditions

Right vVentricular Apical Versus Non-Apical Implantable Cardioverter Defibrillator lead: A Systematic Review and Meta-Analysis.

INTRODUCTION: We aimed to study the effect of right ventricular implantable cardioverter defibrillator (ICD) lead positioning on clinical outcomes in patients undergoing ICD placement. METHODS: A systematic literature search was performed using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to identify clinical trials comparing outcomes in patients with ICD leads in apical and non-apical positions. The primary outcome of our study was death at 1-year follow-up. Secondary outcomes studied were death at 3years , total number of shocks , appropriate shocks , inappropriate shocks and cut-to-suture time . RESULTS: We analyzed a total of 3731 patients (2852 in apical and 879 in non-apical ICD groups) enrolled in 4 clinical trials. No significant difference was observed between the apical and non-apical ICD groups in all-cause mortality at 1year (OR 0.88; 95% CI 0.51-1.49, p=0.63; I(2)=5.32%). Similarly, no differences were seen between the two groups in death at 3years (OR=0.76; 95% CI 0.56-1.04, p=0.08; I(2)=0%), total number of shocks (OR 0.99; 95% CI 0.81-1.22, p=0.95; I(2)=0%), appropriate shocks (OR 1.00; 95% CI 0.79-1.27, p=0.99; I(2)=0%), inappropriate shocks (OR 0.98; 95% CI 0.70-1.37, p=0.91; I(2)=0%) and cut-to-suture time (Standard mean difference=-0.03; 95% CI -0.20 to 0.14, p=0.73; I(2)=0%). No publication bias was seen. CONCLUSION: Non-apical RV ICD lead implantation is non-inferior to traditional RV apical position with no significant differences in mortality, total number of shocks, appropriate shocks, inappropriate shocks and procedural time

Gender Differences and Predictors of Mortality in Takotsubo Cardiomyopathy: Analysis from the National Inpatient Sample 2009-2010 Database.

OBJECTIVES: Takotsubo cardiomyopathy (TC) is characterized by left-ventricle apical ballooning with elevated cardiac biomarkers and electrocardiographic changes similar to an acute coronary syndrome. We studied the prevalence, in-hospital mortality, and predictors of mortality in TC. METHODS: All patients ≥18 years of age diagnosed with TC were identified in the Nationwide Inpatient Sample (NIS) 2009-2010 database using the 9th revision of the International Classification of Diseases (ICD) 429.83. Demographics, conventional risk factors (diabetes, hypertension, hyperlipidemia, and tobacco abuse), acute critical illnesses like sepsis, acute cerebrovascular disease (cerebrovascular accident; CVA), acute respiratory insufficiency, and acute renal failure, and chronic conditions (anxiety, depression, and malignancy) were studied. RESULTS: The prevalence of TC was 0.02% (n = 7,510). The total in-hospital mortality rate was 2.4%, with a higher mortality in men (4.8%) than in women (2.1%). Sepsis (9 vs. 4.2%; p \u3c 0.01) was more prevalent in men with an increased prevalence of other critical illness, although this was not statistically significant. Age (OR 1.05; 95% CI 1.01-1.09), malignancy (OR 3.38; 95% CI 1.35-8.41), acute renal failure (OR 5.4; 95% CI 2.2-13.7), acute CVA (OR 9.4; 95% CI 2.96-29.8), and acute respiratory failure (OR 11.1; 95% CI 3.9-31.1) predicted mortality in fully adjusted models. CONCLUSION: A higher mortality was seen in men, likely related to the increased prevalence of acute critical illnesses, ventricular arrhythmia, and sudden cardiac arrest. Acute CVA and respiratory failure were the strongest predictors of mortality. © 2015 S. Karger AG, Basel

Milestones: a rapid assessment method for the Clinical Competency Committee

A b s t r a c t Introduction: Educational milestones are now used to assess the developmental progress of all U.S. graduate medical residents during training. Twice annually, each program's Clinical Competency Committee (CCC) makes these determinations and reports its findings to the Accreditation Council for Graduate Medical Education (ACGME). The ideal way to conduct the CCC is not known. After finding that deliberations reliant upon the new milestones were time intensive, our internal medicine residency program tested an approach designed to produce rapid but accurate assessments. Material and methods: For this study, we modified our usual CCC process to include pre-meeting faculty ratings of resident milestones progress with in-meeting reconciliation of their ratings. Data were considered largely via standard report and presented in a pre-arranged pattern. Participants were surveyed regarding their perceptions of data management strategies and use of milestones. Reliability of competence assessments was estimated by comparing pre-/post-intervention class rank lists produced by individual committee members with a master class rank list produced by the collective CCC after full deliberation. Results: Use of the study CCC approach reduced committee deliberation time from 25 min to 9 min per resident (p < 0.001). Committee members believed milestones improved their ability to identify and assess expected elements of competency development (p = 0.026). Individual committee member assessments of trainee progress agreed well with collective CCC assessments. Conclusions: Modification of the clinical competency process to include pre-meeting competence ratings with in-meeting reconciliation of these ratings led to shorter deliberation times, improved evaluator satisfaction and resulted in reliable milestone assessments