Background— Safety data on percutaneous left atrial appendage closure arises from centers with considerable expertise in the procedure or from clinical trial, which might not be reproducible in clinical practice. We sought to estimate the frequency and predictors of adverse outcomes and costs of percutaneous left atrial appendage closure procedure in the US. Methods and Results— The data were obtained from the Nationwide Inpatient Sample from the years 2006 to 2010. The Nationwide Inpatient Sample is the largest all-payer inpatient data set in the US. Complications were calculated using patient safety indicators and International Classification of Diseases -Ninth Revision, Clinical Modification codes. Annual hospital volume was calculated using unique hospital identifiers. Weights provided by the Nationwide Inpatient Sample were used to generate national estimates. A total of 268 (weighted=1288) procedures were analyzed. The overall composite rate of mortality or any adverse event was 24.3% (65), with 3.4% patients required open cardiac surgery after procedure. Average length of stay was 4.61±1.05 days and cost of care was 26 024±34 651. Annual hospital procedural volume was significantly associated with reduced complications and mortality (every unit increase: odds ratio, 0.89; 95% confidence interval, 0.85–0.94; P <0.001), decrease in length of stay (every unit increase: hazard ratio, 0.95; 95% confidence interval, 0.92–0.98; P <0.001) and cost of care (every unit increase: hazard ratio, 0.96; 95% confidence interval, 0.93–0.98; P <0.001). Conclusions— Our study demonstrates that the frequency of inhospital adverse outcomes associated with percutaneous left atrial appendage closure is higher in the real-world population than in clinical trials. We also demonstrate that higher annual hospital volume is associated with safer procedures, with lower length of stay and cost.

Atrial fibrillation (AF) ablation has made tremendous progress over the past decade [ [1] Wann L.S. Curtis A.B.. January C.T. et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm. 2011; 8: 157-176 Abstract Full Text Full Text PDF PubMed Google Scholar ]. The number of operators and hospitals performing this procedure is increasing. Data on the frequency of complications of AF ablation comes mainly from large randomized clinical trials (RCTs). This data may not be very representative of 'real world' complications due to many reasons. Firstly, the procedures in RCTs are performed at high volume centers at the hands of experienced operators. Secondly, patients in RCTs receive a strict protocol based care in contrast to individualized care in daily practice. This could potentially lead to a discrepancy in the net safety of the procedure. In the past few years, studies have evaluated 'real world' complications of atrial fibrillation ablation [ 2 Ellis E.R. Culler S.D. Simon A.W. Reynolds M.R. Trends in utilization and complications of catheter ablation for atrial fibrillation in medicare beneficiaries. Heart Rhythm. 2009; 6: 1267-1273 Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar , 3 Piccini J.P. Sinner M.F. Greiner M.A. et al. Outcomes of medicare beneficiaries undergoing catheter ablation for atrial fibrillation. Circulation. 2012; 126: 2200-2207 Crossref PubMed Scopus (123) Google Scholar , 4 Shah R.U. Freeman J.V. Shilane D. Wang P.J. Go A.S. Hlatky M.A. Procedural complications, rehospitalizations, and repeat procedures after catheter ablation for atrial fibrillation. J Am Coll Cardiol. 2012; 59: 143-149 Abstract Full Text Full Text PDF PubMed Scopus (230) Google Scholar , 5 Deshmukh A. Patel N.J. Pant S. et al. In-hospital complications associated with catheter ablation of atrial fibrillation in the united states between 2000 and 2010: analysis of 93 801 procedures. Circulation. 2013; 128: 2104-2112 Crossref PubMed Scopus (457) Google Scholar , 6 Cappato R. Calkins H. Chen S.A. et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010; 3: 32-38 Crossref PubMed Scopus (1605) Google Scholar ]. We sought to compare safety outcomes of AF ablation from real world data to major RCTs and provide insight into possible differences that might exist.

BACKGROUND: Incidence and prevalence of mitral stenosis is declining in the US. We performed this study to determine recent trends in utilization, complications, mortality, length of stay, and cost associated with balloon mitral valvuloplasty.METHODS: Utilizing the nationwide inpatient sample database from 1998 to 2010, we identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure code for "percutaneous valvuloplasty." Patients >= 18 years of age with mitral stenosis were included. Patients with concomitant aortic, tricuspid, or pulmonic stenosis were excluded. Primary outcome included death and procedural complications.RESULTS: A total of 1308 balloon mitral valvuloplasties (weighted n = 6540) were analyzed. There was a 7.5% decrease in utilization of the procedure from 24.6 procedures/10 million population in 1998-2001 to 22.7 procedures/10 million population in 2008-2010 (P for trend = .098). We observed a 15.9% overall procedural complication rate and 1.7% mortality rate. The procedural complication rates have increased in recent years (P = .001), corresponding to increasing age and burden of comorbidities in patients. The mean cost per admission for balloon mitral valvuloplasty has gone up significantly over the 10 years, from $11,668 +/- 1046 in 2001 to $23,651 +/- 301 in 2010 (P < .001).CONCLUSIONS: In a large cross-sectional study of balloon mitral valvuloplasty in the US, we have reported trends of decreasing overall utilization and increasing procedural complication rates and cost over a period of 13 years. (C) 2014 Elsevier Inc. All rights reserved.

Ventricular septal myomectomy (VSM) is the primary modality for left ventricular outflow tract gradient reduction in patients with obstructive hypertrophic cardiomyopathy with refractory symptoms. Comprehensive postprocedural data for VSM from a large multicenter registry are sparse. The primary objective of this study was to evaluate postprocedural mortality, complications, length of stay (LOS), and cost of hospitalization after VSM and to further appraise the multivariate predictors of these outcomes. The Healthcare Cost and Utilization Project's Nationwide Inpatient Sample was queried from 1998 through 2010 using International Classification of Diseases, Ninth Revision, procedure codes 37.33 for VSM and 425.1 for hypertrophic cardiomyopathy. The severity of co-morbidities was defined using the Charlson co-morbidity index. Hierarchical mixed-effects models were generated to identify independent multivariate predictors of in-hospital mortality, procedural complications, LOS, and cost of hospitalization. The overall mortality was 5.9%. Almost 9% (8.7%) of patients had postprocedural complete heart block requiring pacemakers. Increasing Charlson co-morbidity index was associated with a higher rate of complications and mortality (odds ratio 2.41, 95% confidence interval 1.17 to 4.98, p = 0.02). The mean cost of hospitalization was $41,715 +/- $1,611, while the average LOS was 8.89 +/- 0.35 days. Occurrence of any postoperative complication was associated with increased cost of hospitalization (+ $33,870, p <0.001) and LOS (+ 6.08 days, p <0.001). In conclusion, the postoperative mortality rate for VSM was 5.9%; cardiac complications were most common, specifically complete heart block. Age and increasing severity of comorbidities were predictive of poorer outcomes, while a higher burden of postoperative complications was associated with a higher cost of hospitalization and LOS. (C) 2014 Elsevier Inc. All rights reserved.

Although left ventricular (LV) hypertrophy has been proposed as a factor predisposing to atrial fibrillation (AF), its relevance to prognosis and selection of therapeutic strategies is unclear. We identified 2,105 patients with echocardiographic data on LV mass enrolled in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial. LV hypertrophy was defined as increased LV mass, stratified by American Society of Echocardiography criteria. The primary end point was all-cause mortality, secondary end point was as per AFFIRM trial definition, and tertiary end point was cardiovascular hospitalizations. We compared "strict" versus "lenient" rate control in patients with increased LV mass, and studied association of heart failure (HF) with preserved and decreased systolic function in patients with increased LV mass. Over 6 years, 332 deaths (15.7%) were reported. Adjusted hazard ratio (HR) of severely increased LV mass for all-cause mortality was 1.34 (95% confidence interval [CI] 1.01 to 1.79, p=0.045) for the overall population and 1.61 (95% CI 1.09 to 2.37, p=0.016) for the rhythm-control arm. Increased LV mass was a predictor of cardiovascular hospitalizations in the lenient rate-control group (HR 1.72, 95% CI 1.05 to 2.82, p=0.03) but not in the strict rate-control group. Severely increased LV mass was predictive of cardiovascular hospitalizations in patients with HF with preserved (HR 1.8, 95% CI 1.0 to 3.2, p=0.03) and decreased LV systolic function (HR 2.4, 95% CI 1.1 to 5.2, p=0.02). Thus, LV hypertrophy is a significant independent predictor of mortality in patients with AF, especially those managed with rhythm control. In patients with LV hypertrophy, strict rate control may be associated with better outcomes than lenient rate control. LV hypertrophy portends higher cardiovascular morbidity in patients with AF and HF.

We assessed the predictors of length of hospital stay (LOS) and cost of care related to percutaneous closure of ASD and PFO closure. We examined the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) database from 2001 to 2010 using ICD 9-CM code for percutaneous ASD/PFO

Background: Septal Myomectomy (MM) is the primary modality for left ventricular outflow tract (LVOT) gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM) patients with refractory symptoms. Extended follow-up data for MM from a large multi-center registry is sparse. METHODS: We queried the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) between 1998 and 2010 using ICD9 procedure code 37.33 for MM. Only adult patients with HOCM (ICD-9-CM code 425.1) were included. Out of these, patients with any arrhythmia diagnosis were excluded. The NIS represents 20% of all hospitals in the US. We defined severity of co-morbidities using Deyo modification of Charlson co-morbidity index (CCI), where higher scores (0-33) represent increasing burden. Three level hierarchical mixed models were created to identify independent multivariate predictors of complications and mortality for MM. Hierarchical mixed effects linear regression models were used to evaluate cost of hospitalization and length of stay (LOS). RESULTS: The overall mortality was 5.9%. 5.4% of the patients had significant post-operative bleeding necessitating transfusion while 8.7% had complete heart block requiring a pacemaker. Increasing CCI was associated with a higher rate of complications and mortality (OR 2.42, 95% CI (1.17-4.98), p-value 0.02). The mean cost of hospitalization was $40,444 +/- 1,786 while the average LOS was 8.69 +/- 0.35 days. Occurrence of any post-operative complications was associated with an increased cost of hospitalization (+$33,870, p<.01) and LOS (+6.1 days, p<.01). Conclusions: We observed a relatively higher mortality rate for surgical MM than published literature with cardiac complications being most common specifically complete heart block. Increasing severity of co-morbidities was predictive of poorer outcomes while a higher burden of post-operative complications was associated with a higher cost of hospitalization and LOS.

Introduction: Percutaneous coronary intervention (PCI) volume is often used as a surrogate to define quality and maintain proficiency (> 75 PCI/year). Currently there lacks definite evidence to sup...

Digoxin significantly improves all-cause mortality in atrial fibrillation patients with severely reduced left ventricular systolic function☆☆☆ Nileshkumar J. Patel , Michael Hoosien , Abhishek Deshmukh , Apurva O. Badheka , PeeyushM. Grover , Neeraj Shah , Vikas Singh , KathanMehta , Ankit Chothani , Ghanshyambhai T. Savani , Shilpkumar Arora , Vipulkumar Bhalara , Nilay Patel , Dhaval Khalpada , Ankit Rathod , Thomas J. Vazzana , James Lafferty , Juan F. Viles-Gonzalez , Raul D. Mitrani b,⁎

We assessed the trend, predictors and operator volume influence of complication related to Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO). We examined the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) database from 2001 to 2010 using

Background: Obesity is considered to be an important co-morbidity in patients with atrial fibrillation (AF). However, its direct implication in terms of cost and length of stay is missing. METHODS: We queried the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) between 2000 and 2010 using the ICD9-CM code of 427.31 for atrial fibrillation as a primary discharge diagnosis and 278.01 for obesity as a secondary diagnosis. Participants with >18 years of age were only included. The NIS represents 20% of all hospitals in the US. All analyses were performed using the designated weighting specified to the NIS data base to represent national trends. We compared baseline characteristics, length of stay and total cost in obese and non-obese group. RESULTS: We studied 4092578 patients admitted with primary diagnosis of AF. Obese population was younger, had more diabetes and hypertension. Obese population had more private insurance including HMO and fewer medicares and Medicaid insurance. They were more likely to have invasive cardiac work-up including percutaneous cardiac interventions (PCI). Compare to non-obese population, obese patients had a longer length of stay (4.07 vs. 3.59, p<0.0001) mainly driven by length of stay >2 days (61.6% vs. 52%). Their adjusted total hospitalization cost was also higher as compared to non-obese population ($ 25632 vs. $ 21957, p<0.0001). CONCLUSION: This is one of the largest studies to evaluate the implications of obesity on health care resource utilization in patients admitted with atrial fibrillation. Length of stay and cost were higher in obese population as compared to non-obese population. Considering the fact that both obesity and atrial fibrillation are in epidemic proportion right now, financial implication can be huge.

Introduction: The availability, national scope and perceived unbiased nature of administrative data make it the preferred choice for evaluating quality and outcomes. We calculated Atrial Fibrillation ablation complication rates from national administrative data and compared them with data from randomized control trials (RCT). Methods: Using the Nationwide Inpatient Sample (NIS) we identified patients treated with AF ablations. We investigated complications described with AF ablation and defined them by validated Clinical Modification (ICD-9-CM) diagnosis codes. We compared them with the complication rates reported from AF ablation from widely quoted RCTs. (AF ablation vs. Antiarrhythmics) Results: We analyzed complication rates from 47042 AF ablations performed from the years 2000 to 2008 from the NIS. We also analyzed pooled complication rates from large RCTs. Cardiac tamponade and/or effusion and vascular access complication appear to be the most frequent complications. The NIS data had a higher rate of cardiac tamponade/effusion (21.5 vs. 12.5), vascular access complications (21.2 vs. 19.7) and deaths (4.0 vs. 3.0) when compared to RCTs. Interestingly, RCTs reported a higher rate of stroke/TIA (13.2 vs. 7) when compared to the national administrative data. Conclusion: Despite substantial improvement, “real-world” complication rates from administrative data remain higher than those reported in RCTs. The discrepancy may be attributable to differences in operator skills, selection bias and variation in data quality.

Background: Prior studies analyzing the effect of infection and cardiovascular events have met with contradictory results. We investigated whether infectious burden increases cardiovascular mortality in a cross sectional US population. Methods: The public dataset of the National Health and Nutrition Examination Survey III (NHANES III) between the years 1988-1994 was used for the analysis. We included patients >18 years with data on positive antibodies against Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis E, Herpes simplex virus 1 and 2, Toxoplasma, Varicella, Cytomegalovirus (CMV), Human herpes virus -8 and Toxocara (n= 7,876). These infections were combined to create a total infection burden variable. This variable was split into quartiles. The primary outcome was cardiovascular (CV) mortality. Traditional cardiac risk factors along with C-reactive protein (CRP) and social class (insurance, income and education level) were adjusted for in the multivariable analysis. Results: 431 (5.5%) of cardiovascular deaths were reported with a mean follow up of 14.5 years. On a univariable analysis only positive toxoplasma antibody (HR, 95% CI, p-value) were predictive of CV mortality (1.18.,1.03-1.36, 0.02). Independent predictors of CV mortality in the multivariable model were age, female gender, CRP titers, hypertension, smoking, and diabetes. Social class (insurance, income and education level) and total infection burden, quartiles 2 (p = 0.1), 3 (p = 0.4) and 4 (p = 0.1) were not predictive of CV mortality when keeping quartile 1 as the referent. Conclusion: Our observational study in a large database suggests that presence of antibodies against certain viral and parasitic infections is not associated with increased cardiovascular mortality in a nationally representative cohort.

Introduction: Radiofrequency ablation (RFA) of atrial flutter (AFL) is considered as a reasonable approach due to its effectiveness, feasibility and safety. Data regarding the utilization and safety of RFA for AFL outside of selected centers of excellence and in older patients are limited. Methods: Using the Nationwide Inpatient Sample (NIS) between the years 2000-2008, we developed a coding algorithm to identify AFL patients treated with ablations. We investigated common complications like cardiac perforation and/or tamponade, pneumothorax, stroke, transient ischemic attack (TIA), vascular access complication (consisting of hemorrhage/hematoma, vascular complication requiring surgical repair, and accidental puncture), and in-hospital death described with AFL ablation and defined them by validated International Classification of Diseases (9th Edition) Clinical Modification (ICD-9-CM) diagnosis codes. Results: There were a total of 38,881 AFL ablations performed from the years 2000 to 2008. Majority of ablations were performed in patients with age > 65 years, men, white race, less severe comorbidities, large bed size and teaching hospitals. The overall inhospital mortality was 15/1000. The overall complication rate was 0.3%. On multivariate analysis, apart from male gender, patient and hospital characteristics were not associated with increased complications. The length of stay and total charges were 1.5 and 2.5 times more in hospitalizations associated with complications. Conclusions: AFL ablation is safe with perforation/tamponade and vascular access complications accounting for the majority

We assessed the trend, predictors and operator volume influence of complication related to Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO). We examined the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) database from 2001 to 2010 using