Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Outcomes of oesophageal variceal bleeding among patients with atrial fibrillation: a propensity-matched analysis of a nationwide inpatient sample.

INTRODUCTION: We aimed to determine the influence of atrial fibrillation (AF) on mortality, morbidity, length of hospital stay, and resource utilisation in patients with oesophageal variceal bleeding (OVB). MATERIAL AND METHODS: The National Inpatient Sample database (2016 and 2017) was used for data analysis using the International Classification of Diseases, Tenth Revision codes to identify patients with the principal diagnosis of OVB and AF. We assessed the all-cause in-hospital mortality, morbidity, predictors of mortality, length of hospital stay (LOS), and total costs between propensity-matched groups of OVB with AF vs. OVB alone. RESULTS: We identified 80,325 patients with OVB, of whom 4285 had OVB with AF, and 76,040 had OVB only. The in-hospital mortality was higher in OVB with AF (OR = 1.4, 95% CI: 1.09-1.83; p < 0.001). OVB with AF had higher odds of sepsis (OR = 1.4, 95% CI: 1.1-1.8; p = 0.007), acute kidney injury (OR = 1.2, 95% CI: 1.12-1.32; p < 0.001), and mechanical ventilation (OR = 1.2, 95% CI: 1.12-1.32; p < 0.001). Advanced age (OR = 1.06, 95% CI: 1.05-1.07; p < 0.001), congestive heart failure (OR = 1.7, 95% CI: 1.3-2.3; p < 0.001), coronary artery disease (OR = 1.4, 95% CI: 1.03-1.92; p = 0.02), and sepsis (OR = 1.3, 95% CI: 1.06-1.70; p = 0.01) were identified as predictors of mortality in OVB with AF. Mean LOS (7.5 ±7.4 vs. 6.0 ±7.2, p < 0.001) and mean total costs ($25,452 vs. $21,109, p < 0.001) were also higher. CONCLUSIONS: In this propensity-matched analysis, OVB with AF was associated with higher odds of in-hospital mortality, sepsis, acute kidney injury, and mechanical ventilation.

Effect of race on the frequency of postoperative atrial fibrillation following coronary artery bypass grafting.

Atrial fibrillation (AF) commonly complicates the postoperative course after coronary artery bypass grafting (CABG). Among the general population, African Americans have been shown to have a lower prevalence of AF than European Americans. Although many factors have been identified to predict risk for postoperative AF, race has not been examined. All patients aged ≥18 years who underwent CABG at Henry Ford Hospital during a 5-year period from January 1, 2004, to December 31, 2008, were included. Patients were excluded for any previous diagnosis of AF or if they had concomitant valve surgery at the time of CABG. The incidence of AF was determined by International Classification of Diseases, Ninth Revision, coding from postoperative hospitalization records. Overall, 1,001 patients were eligible for analysis. Of these, 731 (73%) were European American and 270 (27%) were African American. The African American group had a higher prevalence of hypertension (75.6% vs 58.8%, p <0.001) and heart failure (22.6% vs 15.7%, p = 0.01) and a trend toward a higher prevalence of diabetes mellitus (38.1% vs 33.4%, p = 0.159). Postoperative AF was diagnosed in 214 European Americans (29.3%) and 50 African Americans (18.5%) (p = 0.001). In multivariate analysis adjusting for age strata, gender, hypertension, diabetes, and heart failure, African Americans had less postoperative AF than European Americans, with an adjusted odds ratio of 0.539 (95% confidence interval 0.374 to 0.777, p = 0.001). In conclusion, African Americans have a significantly reduced incidence of AF compared to European Americans after CABG.