Curtis, Jeptha P.

ObjectiveThe aim of our study was to study the impact of glycoprotein IIb/IIIa inhibitors (GPI) on in‐hospital outcomes.BackgroundThere is paucity of data regarding the impact of GPI on the outcomes following peripheral endovascular interventions.MethodsThe study cohort was derived from Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database between the years 2006 and 2011. Peripheral endovascular interventions and GPI utilization were identified using appropriate ICD‐9 Diagnostic and procedural codes. Two‐level hierarchical multivariate mixed models were created. The study outcomes were: primary (in‐hospital mortality and amputation studied separately) and secondary (composite of in‐hospital mortality and postprocedural complications). Hospitalization costs were also assessed.ResultsGPI utilization (OR, 95% CI, P‐value) was independently predictive of lower amputation rates (0.36, 0.27–0.49, <0.001). There was no significant difference in terms of in‐hospital mortality (0.59, 0.31–1.14, P 0.117), although GPI use predicted worse secondary outcomes (1.23, 1.03–1.47, 0.023). Following propensity matching, the amputation rate was lower (3.2% vs. 8%, P < 0.001), while hospitalization costs were higher in the cohort that received GPI ($21,091 ± 404 vs. 19,407 ± 133, P < 0.001).ConclusionsMultivariate analysis revealed GPI use in peripheral endovascular interventions to be suggestive of an increase in composite end‐point of in‐hospital mortality and postprocedural complications, no impact on in‐hospital mortality alone, significantly lower rate of amputation, and increase in hospitalization costs. © 2016 Wiley Periodicals, Inc.

Background— Cardiac resynchronization therapy with defibrillator (CRT-D) reduces morbidity and mortality among selected patients with heart failure in clinical trials. The effectiveness of this therapy in clinical practice has not been well studied. Methods and Results— We compared a cohort of 4471 patients from the National Cardiovascular Data Registry’s Implantable Cardioverter-Defibrillator (ICD) Registry hospitalized primarily for heart failure and who received CRT-D between April 1, 2006, and December 31, 2009, to a historical control cohort of 4888 patients with heart failure without CRT-D from the Acute Decompensated Heart Failure National Registry (ADHERE) hospitalized between January 1, 2002, and March 31, 2006. Both registries were linked with Medicare claims to evaluate longitudinal outcomes. We included patients from the ICD Registry with left ventricular ejection fraction ≤35% and QRS duration ≥120 ms who were admitted for heart failure. We used Cox proportional hazards models to compare outcomes with and without CRT-D after adjustment for important covariates. After multivariable adjustment, CRT-D was associated with lower 3-year risks of death (hazard ratio, 0.52; 95% confidence interval, 0.48–0.56; P <0.001), all-cause readmission (hazard ratio, 0.69; 95% confidence interval, 0.65–0.73; P <0.001), and cardiovascular readmission (hazard ratio, 0.60; 95% confidence interval, 0.56–0.64; P <0.001). The association of CRT-D with mortality did not vary significantly among subgroups defined by age, sex, race, QRS duration, and optimal medical therapy. Conclusions— CRT-D was associated with lower risks of mortality, all-cause readmission, and cardiovascular readmission than medical therapy alone among patients with heart failure in community practice.

Background— Guidelines recommend that implantable cardioverter-defibrillator (ICD) candidates have an estimated longevity of ≥1 year. Longevity can be affected by chronic kidney disease (CKD). Methods and Results— Using the National Cardiovascular Data Registry ICD registry linked with the Social Security Death Master File, we assessed the rate of death after primary prevention ICD placement between January 1, 2006, and December 31, 2007, according to CKD stage. Using Cox models, we identified factors associated with death among patients with CKD. Compared with patients without CKD (n=26 056), those with CKD (n=21 226) were older, less commonly men, more often white, and more frequently had comorbid illness. Compared with patients without CKD, patients with a glomerular filtration rate 30 to 60, glomerular filtration rate <30, and end-stage renal disease on dialysis had a higher risk of death after ICD placement (hazard ratio, 2.08; 95% confidence interval, 1.99–2.18; P <0.0001; hazard ratio, 4.20; 95% confidence interval, 3.92–4.50; P <0.0001; and hazard ratio, 4.80; 95% confidence interval, 4.46–5.17; P <0.0001, respectively). Corresponding 1-year death rates were 4.4%, 9.1%, 20.2%, and 22.4%. Among patients with CKD, factors associated with increased risk of death included CKD severity, age >65 years, heart failure symptoms, diabetes mellitus, lung disease, serum sodium <140 mEq/L, atrial fibrillation or flutter, and a lower ejection fraction. Conclusions— The risk of death after primary prevention ICD placement is proportional to CKD severity. Among patients with CKD, several factors are prognostically significant and could inform clinical decision making on primary prevention ICD candidacy.

Background Assessing hospital quality in the performance of carotid endarterectomy ( CEA ) requires appropriate risk adjustment across hospitals with varying case mixes. The aim of this study was to develop and validate a prediction model to assess the risk of in‐hospital stroke or death after CEA that could aid in the assessment of hospital quality. Methods and Results Patients from National Cardiovascular Data Registry (NCDR)'s Carotid Artery Revascularization and Endarterectomy (CARE) Registry undergoing CEA without acute evolving stroke from 2005 to 2013 were included. In‐hospital stroke or death was modeled using hierarchical logistic regression with 20 candidate variables and accounting for hospital‐level clustering. Internal validation was achieved with bootstrapping; model discrimination and calibration were assessed. A total of 213 (1.7%) primary end point events occurred during 12 889 procedures. Independent predictors of stroke or death included age, prior peripheral artery disease, diabetes mellitus, prior coronary artery disease, having a symptomatic carotid lesion, having a contralateral carotid occlusion, or having New York Heart Association Class III or IV heart failure. The model was well calibrated and demonstrated moderate discriminative ability (c‐statistic 0.65). The NCDR CEA score was then developed to support simple, prospective risk quantification in the clinical setting. Conclusions The NCDR CEA score, comprising 7 clinical variables, predicts in‐hospital stroke or death after CEA . This model can be used to estimate hospital risk‐adjusted outcomes for CEA and to assist with the assessment of hospital quality.

Background— A simple risk score to predict long-term mortality after percutaneous coronary intervention (PCI) using preprocedural risk factors is currently not available. In this study, we created one by simplifying the results of a Cox proportional hazards model. Methods and Results— A total of 11 897 patients who underwent PCI from October through December 2003 in New York State were randomly divided into derivation and validation samples. Patients’ vital statuses were tracked using the National Death Index through the end of 2008. A Cox proportional hazards model was fit to predict death after PCI using the derivation sample, and a simplified risk score was created. The Cox model identified 12 separate risk factors for mortality including older age, extreme body mass indexes, multivessel disease, a lower ejection fraction, unstable hemodynamic state or shock, several comorbidities (cerebrovascular disease, peripheral vascular disease, congestive heart failure, chronic obstructive pulmonary disease, diabetes mellitus, and renal failure), and a history of coronary artery bypass graft surgery. The C statistics of this model when applied to the validation sample were 0.787, 0.785, and 0.773 for risks of death within 1, 3, and 5 years after PCI, respectively. In addition, the point-based risk score demonstrated good agreement between patients’ observed and predicted risks of death. Conclusions— A simple risk score created from a more complicated Cox proportional hazards model can be used to accurately predict a patient’s risk of long-term mortality after PCI.

Background— The ICD Registry was established in 2006 in part to measure quality of care in patients undergoing implantation of implantable cardioverter-defibrillators (ICDs); however, whether outcomes have improved since initiation of the registry is unknown. Our objective was to examine changes over time in 3 quality metrics available from the registry. Methods and Results— We performed an observational study of 367 153 patients who received new ICD implants from April 2006 to March 2010. Three quality metrics were selected: Adverse events (in-hospital complications or mortality), optimal medical therapy (OMT), and cardiac resynchronization therapy (CRT). OMT was defined as prescription of β-blocker and either angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in eligible patients. CRT eligibility was determined by QRS ≥120 ms, left ventricular ejection fraction ≤35%, and New York Heart Association class III/IV. Observation periods were divided into four 12-month intervals. We analyzed changes over time and used hierarchical logistic regression to adjust for potential confounders. Adverse events decreased over time (3.7% to 2.8%, P <0.001). Among eligible patients, rates of OMT and CRT increased over time (OMT: 69.0% to 74.3%, P <0.001; CRT: 80.5% to 84.2%, P <0.001). After adjustment for potential confounders, patients were significantly less likely to experience adverse events in year 4 than in year 1 (odds ratio, 0.75; 95% confidence interval, 0.71–0.79) and significantly more likely to receive OMT (odds ratio, 1.29; 95% confidence interval, 1.26–1.32) and CRT (odds ratio, 1.42; 95% confidence interval, 1.35–1.49). Conclusions— Since initiation of the ICD Registry, adverse events have been decreasing, and rates of OMT and CRT among eligible patients have been increasing, although there is still significant room for improvement.

ABSTRACTObjectivesIdentifying the distributions and determinants of fluoroscopy time for invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI).BackgroundICA and PCI are significant contributors to radiation exposure from medical imaging in the US. Fluoroscopy time is a potentially modifiable determinant of radiation exposure for these procedures, but has not been well characterized in contemporary practice.MethodsWe evaluated the distribution of fluoroscopy time in patients undergoing ICA and/or PCI in the CathPCI Registry®, stratifying patients by numerous clinical scenarios. Hierarchical models were used to determine patient, procedure, operator and hospital‐level factors associated with fluoroscopy time for these procedures.ResultsOur study included a total of 3,295,348 ICA and PCI procedures performed by 9,600 operators from January 2005 through June 2009. There was wide variation in fluoroscopy times for these procedures with median [IQR] fluoroscopy times of 2.6 [1.7–4.5] minutes for ICA, 6.7 [4.2–10.8] minutes for ICA in patients with prior coronary artery bypass grafting (CABG), 10.1 [6.0–17.4] minutes for PCI, 10.7 [7.0–16.9] minutes for PCI with ICA, and 16.0 [10.6–24.0] minutes for PCI and ICA in patients with prior CABG. Prolonged fluoroscopy times (>30 minutes) were rare for ICA, but occurred in 6.7% of PCIs and 14.7% of PCIs in patients with prior CABG. After accounting for patient characteristics and procedure complexity, operator and hospital‐level factors explained nearly 20% of the variation in fluoroscopy time.ConclusionsFluoroscopy times vary widely during ICA and PCI with operator and hospital‐level factors contributing substantially to these differences. A better understanding of potentially modifiable sources of this variation will elucidate opportunities for enhancing the radiation safety of these procedures. © 2013 Wiley Periodicals, Inc.