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Background Evaluating outcome reliability is critical in real-world evidence studies. Overall survival is a common outcome in these studies; however, its capture in real-world data (RWD) sources is often incomplete and supplemented with linked mortality information from external sources. Conflicting recommendations exist for censoring overall survival in real-world evidence studies. This simulation study aimed to understand the impact of different censoring methods on estimating median survival and log hazard ratios when external mortality information is partially captured. Methods We used Monte Carlo simulation to emulate a non-randomized comparative effectiveness study of two treatments with RWD from electronic health records and linked external mortality data. We simulated the time to death, the time to last database activity, and the time to data cutoff. Death events after the last database activity were attributed to linked external mortality data and randomly set to missing to reflect the sensitivity of contemporary real-world data sources. Two censoring schemes were evaluated: (1) censoring at the last activity date and (2) censoring at the end of data availability (data cutoff) without an observed death. We assessed the performance of each method in estimating median survival and log hazard ratios using bias, coverage, variance, and rejection rate under varying amounts of incomplete mortality information and varying treatment effects, length of follow-up, and sample size. Results When mortality information was fully captured, median survival estimates were unbiased when censoring at data cutoff and underestimated when censoring at the last activity. When linked mortality information was missing, censoring at the last activity date underestimated the median survival, while censoring at the data cutoff overestimated it. As missing linked mortality information increased, bias decreased when censoring at the last activity date and increased when censoring at data cutoff. Conclusions Researchers should consider the completeness of linked external mortality information when choosing how to censor the analysis of overall survival using RWD. Substantial bias in median survival estimates can occur if an inappropriate censoring scheme is selected. We advocate for RWD providers to perform validation studies of their mortality data and publish their findings to inform methodological decisions better.

Coronary artery perforation (CP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI). Given the marked increase in high-risk and complex PCIs, careful review and understanding of PCI complications may help to improve procedural and clinical outcomes. Our aim was to study the trends, predictors and outcomes of CP in the contemporary era. This cross-sectional multicenter analysis included data collected from institutions participating in the National Cardiovascular Data Registry CathPCI Registry between July 2009 and June 2015. Multivariable logistic regression models were created to identify predictors of CP and compare the in-hospital outcomes of CP and non-CP patients. Of 3,759,268 PCIs performed during the study period, there were 13,779 CP (0.37%). During the study period, the proportion of PCI that developed CP remained unchanged (0.33% to 0.4%) (p for trend 0.16). Chronic total occlusion (CTO) PCI as percentage of total PCI volume increased over the study period (3% to 4%) (p for trend <0.001) with a concomitant significant increase in CTOs with perforation (1.2% to 1.5%, p for trend = 0.02). CTO PCI (Odds Ratio [OR] 2.59) female gender (OR 1.38), saphenous vein graft PCI (OR 1.2), ACC Type C lesion (1.48), cardiogenic shock on presentation (1.15), and use of atherectomy (laser/ rotational) (OR 2.38) were significant predictors of CP. CP patients had significantly higher rates of cardiogenic shock (7.73% vs 1.02%), tamponade (9.6% vs 0.05%) and death (4.87% vs 1.14%) compared with those without CP. Strongest predictors of any adverse events amongst CP were cardiogenic shock (OR 3.93), cardiac arrest (OR 2.02) and use of atherectomy device (OR 2.5). Use of covered stents was also strongly associated with adverse events (OR 3.67) reflecting severity of these CPs. CP in CTO PCI had higher rates of any adverse event than non-CTO CP (26.8% vs 22%, p < 0.001). However non-CTO CP had higher rates of coronary artery bypass grafting (CABG) (urgent, emergent, or salvage) (5.8% vs 4.5%, p = 0.03) and death (6.9% vs 5.6%, p = 0.04). CP in CABG PCI had fewer adverse events compared with those without previous CABG (16.1% vs 24.7%). In a large real world experience, we identified several clinical and procedural factors associated with increased risk of CP and adverse outcomes. The trends in CP remained constant over the study period.

Whether insurance status influences practice patterns in implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) defibrillators, when indicated, is not known. We analyzed the NCDR ICD Registry to evaluate associations of insurance status with guidelines-based receipt of CRT, as well as device-type, complication rates, and use of optimal medical therapy defined by guidelines. Among 798,028 patients with de novo ICD implants, we included only patients < 65 years (those older have Medicare) and excluded those admitted before 2006 (n=1,835) or with insurance coverage other than Medicare, Medicaid or private insurance (n=25,695) leaving 286,556 for analysis. Inverse probability of treatment weighting was used to control for imbalances between groups. Mean age was 53 years, 29% were female. Patients with private insurance and Medicare were more likely to receive CRT-D when indicated (79.6%, OR 1.19 95% CI 1.09-1.28, P <.001 and 78.5%, OR 1.11 95% CI 1.01-1.21 P = .03, respectively) compared to the uninsured (76.7%). The uninsured were also more likely than other groups to receive a single-chamber device. Complication rates did not differ. Uninsured patients were, however, more likely to receive optimal medical therapy, particularly in the subgroup receiving the implant for primary prevention. In propensity-weighted analysis, uninsured patients are less likely to receive CRT when indicated but more likely to be receiving optimal medical therapy at discharge. Reasons for differences in device implantation practices based on insurance status require further study.

• Children with growth hormone deficiency (GHD) are often prescribed a growth hormone called somatropin to help them grow. • As prescribed, somatropin needs to be injected once a day under the skin. Some children may miss many of their somatropin injections, and this is known as having “low adherence” to treatment. Adherence in this study refers to whether the children had enough somatropin to have daily injections as prescribed. • In this study, researchers found that children with GHD who had high adherence to daily somatropin injections grew more than children who had low adherence to daily somatropin injections. • Researchers, doctors, and nurses need to look at how they can help children with GHD follow their prescribed injection schedule and reduce the number of missed injections. The purpose of this plain language summary is to help you to understand the findings from recent research. • Somatropin is approved to treat the condition under study that is discussed in this summary. • This summary reports the results of a single study. The results of this study may differ from those of other studies. Health professionals should make treatment decisions based on all available evidence, not on the results of a single study. Glossary of commonly used terms Adherence – in this study, adherence refers to whether the children had enough medication (somatropin) to have daily injections as prescribed by their doctor. Growth hormone - a protein made in the pituitary gland that helps the body grow properly. Growth hormone deficiency – children with this condition do not have enough growth hormone in their bodies so they grow more slowly than children with normal levels of growth hormone. Somatropin - a type of human growth hormone that can be made in a laboratory and used to treat growth hormone deficiency.

Public reporting has been proposed as a strategy to improve health care quality. Percutaneous coronary interventions (PCIs) performed in the United States from July 1, 2009, to June 30, 2011, included in the CathPCI Registry were identified (n = 1,340,213). Patient characteristics and predicted and observed in-hospital mortality were compared between patients treated with PCI in states with mandated public reporting (Massachusetts, New York, Pennsylvania) and states without mandated public reporting. Most PCIs occurred in states without mandatory public reporting (88%, n = 1,184,544). Relative to patients treated in nonpublic reporting states, those who underwent PCI in public reporting states had similar predicted in-hospital mortality (1.39% vs 1.37%, p = 0.17) but lower observed in-hospital mortality (1.19% vs 1.41%, adjusted odds ratio [ORadj] 0.80; 95% confidence interval [CI] 0.74, 0.88; p <0.001). In patients for whom outcomes were available at 180 days, the differences in mortality persisted (4.6% vs 5.4%, ORadj 0.85, 95% CI 0.79 to 0.92, p <0.001), whereas there was no difference in myocardial infarction (ORadj 0.97, 95% CI 0.89 to 1.07) or revascularization (ORadj 1.05, 95% CI 0.92 to 1.20). Hospital readmissions were increased at 180 days in patients who underwent PCI in public reporting states (ORadj 1.08, 95% CI 1.03 to 1.12, p = 0.001). In conclusion, patients who underwent PCI in states with mandated public reporting of outcomes had similar predicted risks but significantly lower observed risks of death during hospitalization and in the 6 months after PCI. These findings support considering public reporting as a potential strategy for improving outcomes of patients who underwent PCI although further studies are warranted to delineate the reasons for these differences.

Substantial geographic variation exists in percutaneous coronary intervention (PCI) use across the United States. It is unclear the extent to which high PCI utilization can be explained by PCI for inappropriate indications. The objective of this study was to examine the relationship between PCI rates across regional healthcare markets utilizing hospital referral regions (HRRs) and PCI appropriateness. The number of PCI procedures in each HRR was obtained from the 2010 100% Medicare limited data set. HRRs were divided into quintiles of PCI utilization with increasing rates of utilization progressing to quintile 5. NCDR CathPCI Registry® data were used to evaluate patient characteristics, appropriate use criteria (AUC), and outcomes across the HRR quintiles defined by PCI utilization with the study population restricted to HRRs where ≥ 80% of the PCIs were performed at institutions participating in the registry. PCI appropriateness was defined using 2012 AUC by the American College of Cardiology (ACC)/American Heart Association (AHA)/The Society for Cardiovascular Angiography and Interventions (SCAI). Our study cohort comprised of 380,981 patients treated at 178 HRRs. Mean PCI rates per 1,000 increased from 4.6 in Quintile 1 to 10.8 in Quintile 5. The proportion of non-acute PCIs was 27.7% in Quintile 1 increasing to 30.7% in Quintile 5. Significant variation (p < 0.001) existed across the quintiles in the categorization of appropriateness across HRRs of utilization with more appropriate PCI in lower utilization areas (Appropriate: Q1, 76.53%, Q2, 75.326%, Q3, 75.23%, Q4, 73.95%, Q5, 72.768%; Inappropriate: Q1 3.92%, Q2 4.23%, Q3 4.32%, Q4 4.35%, Q5 4.05%; Uncertain: Q1 8.29%, Q2 8.84%, Q3 8.08%, Q4 9.01%, Q5 8.93%; Not Mappable: Q1 11.26%, Q2 11.67%, Q3 12.37%, Q4 12.69%, Q5 14.34%). There was no difference in risk-adjusted mortality across quintiles of PCI utilization. Geographic regions with lower PCI rates have a higher proportion of PCIs performed for appropriate indications. Areas that perform more PCIs also appear to perform more elective PCI and many could not be mapped by the AUC.

Repeat implantable cardioverter defibrillator (ICD) procedures are increasing and may be associated with higher risks for complications. To provide more information for clinical decision making, especially in light of recent defibrillator advisories, we examined a large national cohort to characterize repeat ICD procedural outcomes. Using data from the National Cardiovascular Data Registry (ICD Registry), we compared patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device and 81,748 patients who underwent repeat procedures with (n = 31,057) and without (n = 50,691) lead involvement. Hierarchical multivariable logistic regression was used to determine the predictors of in-hospital complications. Complication rates were higher in those who underwent repeat ICD procedures with lead involvement (lead implantation or revision), compared with patients who underwent initial implants (3.2% vs 2.6%, p <0.001) or versus those with pocket-only (e.g., generator change only) procedures (3.2% vs 0.6%, p <0.001). There were significantly more in-hospital deaths, lead dislodgements, and infections requiring antibiotics in the lead involvement cohort. Compared with those who had a pocket-only procedure, the multivariable adjusted odds ratio of any complication were increased at 4.20 (95% confidence interval: 3.66 to 4.82, p <0.001) in patients who underwent repeat procedures with lead involvement excluding lead extraction or 7.11 (95% confidence interval: 5.96 to 8.48, p <0.001) in procedures involving lead extractions. In conclusion, repeat ICD procedures, when involving the addition or revision of a lead with or without concurrent lead extraction, are associated with higher complication rates compared with initial implants and with those who underwent pocket-only procedures.

Implantable cardioverter-defibrillator (ICD) procedures performed later in the day and on weekends/holidays may be associated with adverse events due to a variety of factors including operator fatigue, handoffs, reduced staffing, and limited resource availability. We sought to determine whether patients implanted with ICDs in the afternoon/evening and on weekends/holidays are at increased risk for adverse events. We studied 148,004 first-time ICD recipients in the National Cardiovascular Data Registry–ICD Registry implanted between April 2010 and March 2012. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician, and hospital characteristics, we examined the association between both ICD implant start time and day of week with any complication, a prolonged hospital stay, and mortality. Most ICD implants (52.6%; n = 77,853) were performed in the morning (6 am-12 pm) and during the regular workweek (97.5%; n = 144,266). After multivariable adjustment, ICD recipients implanted in the afternoon (12 pm-5 pm)/evening (5 pm-6 am) compared with the morning experienced a greater odds of any complication (odds ratio [OR] 1.08; 95% CI 1.01-1.15; P = .0168), hospital stay >1 day (OR 1.29; 95% CI 1.25-1.33; P < .0001) but not inhospital death (OR 1.06; 95% CI 0.88-1.27; P = .5322). Implantable cardioverter-defibrillator recipients implanted on weekend/holidays compared with the mid-workweek also experienced a significantly greater odds of hospital stay >1 day (OR 1.40; 95% CI 1.29-1.53; P < .0001), no statistically significant differences in total complications (OR 1.14; 95% CI 0.96-1.36; P = .1371), and a trend toward more inhospital death (OR 1.52; 95% CI 0.98-2.38; P = .0642). In a large, real-world population, ICD recipients implanted in the afternoon/evening and on weekends/holidays more often experienced adverse events, particularly prolonged hospital stays.

Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 – 1.52, p <0.0001) and at 1 year (HR = 1.19, CI: 1.15 – 1.24, p <0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 – 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 – 1.20, p <0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 – 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 – 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. Differences in the risk of mortality and hospitalization were highest in the first year following device implantation.

There is an active public debate about whether patients' socioeconomic status should be included in the readmission measures used to determine penalties in Medicare's Hospital Readmissions Reduction Program (HRRP). Using the current Centers for Medicare and Medicaid Services methodology, we compared risk-standardized readmission rates for hospitals caring for high and low proportions of patients of low socioeconomic status (as defined by their Medicaid status or neighborhood income). We then calculated risk-standardized readmission rates after additionally adjusting for patients' socioeconomic status. Our results demonstrate that hospitals caring for large proportions of patients of low socioeconomic status have readmission rates similar to those of other hospitals. Moreover, readmission rates calculated with and without adjustment for patients' socioeconomic status are highly correlated. Readmission rates of hospitals caring for patients of low socioeconomic status changed by approximately 0.1 percent with adjustment for patients' socioeconomic status, and only 3-4 percent fewer such hospitals reached the threshold for payment penalty in Medicare's HRRP. Overall, adjustment for socioeconomic status does not change hospital results in meaningful ways.