Introduction: With the technical advancements and expanding indications, utilization of TAVR is on the rise among various institutions in the United States .While appropriate patient selection and better techniques are essential to improving outcomes, the impact of institutional design (or hospital setting) on outcomes with TAVR has yet to be examined. Objective: The objective of our study is to compare TAVR complication rates among teaching vs non-teaching centers in the United States Methods: We used Healthcare Cost and Utilization Project - National Inpatient Sample (NIS) data , the largest all payer database of hospital inpatient stay available in United States, to identify patients (age ≥18 years) who underwent TAVR from Jan-Dec 2012. We constructed multivariable models to determine independent predictors (age, sex, race, Charlson’s comorbidity index, hospital size, hospital location and TAVR approach) of TAVR-associated complications. Statistical analysis was performed using Stata IC 11.0 (Stata-Corp, College Station, TX). Results: We identified 7,405 TAVR procedures performed in the United States in 2012. 88% of TAVR were performed in teaching centers. There was no difference in mortality following TAVR between teaching and non-teaching centers. The occurrence of any in-hospital complication was lower in teaching centers as compared to non-teaching centers (42% vs. 50%, p<0.001). Rates of individual complications in teaching vs. non-teaching centers are illustrated in the figure. In adjusted analysis, hemorrhage requiring transfusion (13.2% vs. 20.8%, p<0.001), renal complications requiring dialysis (1.2% vs. 2.3%, p=0.009), respiratory complications (7.5% vs. 11%, p<0.001) and complications requiring open-heart surgery (2% vs. 4.6%, p<0.001) were lower in teaching centers as compared to non-teaching centers. Vascular access site complications, pacemaker insertion, pericardial and neurological complications were similar between teaching and non-teaching centers (Figure). Conclusion: Institutional design impacts TAVR complication rates albeit no difference in mortality. In general, complication rates are lower in teaching centers compared to non-teaching centers.
Temporal trends of in‐hospital complications associated with catheter ablation of atrial fibrillation in the United States: An update from Nationwide Inpatient Sample database (2011–2014)
AbstractBackgroundCatheter ablation is widely accepted intervention for atrial fibrillation (AF) refractory to antiarrhythmic drugs, but limited data are available regarding contemporary trends in major complications and in‐hospital mortality due to the procedure. This study was aimed at exploring the temporal trends of in‐hospital mortality, major complications, and impact of hospital volume on frequency of AF ablation–related outcomes.MethodsThe Nationwide Inpatient Sample database was utilized to identify the AF patients treated with catheter ablation. In‐hospital death and common complications including vascular access complications, cardiac perforation and/or tamponade, pneumothorax, stroke, and transient ischemic attack, were identified using International Classification of Disease (ICD‐9‐CM) codes.ResultIn‐hospital mortality rate of 0.15% and overall complication rate of 5.46% were noted among AF ablation recipients (n = 50,969). Significant increase in complications during study period (relative increase 56.37%, P‐trend < 0.001) was observed. Cardiac (2.65%), vascular (1.33%), and neurological (1.05%) complications were most common. On multivariate analysis (odds ratio [OR]; 95% confidence interval [95% CI]; P value), significant predictors of complications were female sex (OR = 1.40; CI = 1.17–1.68; P value < 0.001), high burden of comorbidity as indicated by Charlson Comorbidity Index ≥2 (OR = 2.84; CI = 2.29–3.52; P value < 0.001), and low hospital volume (< 50 procedures).ConclusionOur study noted a decline in AF ablation–related hospitalizations and complications associated with the procedure. These findings largely reflect shifting trends of outpatient performance of the procedure and increasing safety profile due to improved institutional expertise and catheter techniques.
Procedural trends, outcomes, and readmission rates pre‐and post‐FDA approval for MitraClip from the National Readmission Database (2013–14)
AbstractBackgroundThere are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip®. Whether a complex new technology can be disseminated safely and quickly is controversial.MethodsThe study cohort was derived from the National Readmission Data (NRD) 2013–14. MitraClip® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD‐9‐CM) codes. The primary outcome was a composite of in‐hospital mortality + procedural complications. Secondary outcome included 30‐day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes.ResultsOur analysis included 2003 MitraClip® procedures. Overall in‐hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post‐FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in‐hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in‐hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30‐day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in‐hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures.ConclusionA significant increase in MitraClip® procedural volumes occurred post‐FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.
Response by Vaidya et al to Letter Regarding Article, “Burden of Arrhythmia in Pregnancy”
Background— Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. Methods and Results— Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. Conclusions— The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.