In-hospital mortality for CS has declined but remains high. Rates of CS have outpaced MCS utilisation which remains uncommon in non-MI hospitalisations with shock. MCS is associated with utilisation of other procedures during hospitalisation.

Current PCI public reporting programs can foster risk-averse clinical practice patterns, which do not vary significantly between interventional cardiologists in New York and Massachusetts. Coordinated efforts by policy makers, health systems leadership, and the interventional cardiology community are needed to mitigate these unintended consequences.

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Background: Randomized controlled trials (RCTs) are the "gold standard" for comparing the safety and efficacy of therapies, but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial based variables for exposures and outcomes.

Objectives: Increasing age is a well-recognized risk factor for in-hospital mortality in patients receiving extracorporeal membrane oxygenation (ECMO) for cardiogenic shock (CS), but the shape of this relationship is unknown. In addition, the impact of age on hospital length of stay (LOS), patterns of patient disposition, and costs have been incompletely characterized.

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Background: Limited knowledge exists on inter-hospital variation in the utilization of short-term, non-durable mechanical circulatory support (MCS) for myocardial infarction (MI) complicated by cardiogenic shock (CS). Methods and Results: Hospitalizations for MI with CS in 2014 in a nationally representative all-payer database were included. The proportion of hospitalizations for MI with CS using MCS (MCS ratio) and in-hospital mortality were evaluated. Hospital characteristics and outcomes were compared across quartiles of MCS usage. Of 1,813 hospitals evaluated, 1,440 (79.4%) performed ≥10 PCIs annually. Of these, 1,064 [73.9%] had at least one code for MCS. Forty-one percent of hospitals did not use MCS. The median (interquartile range [IQR]) proportion of MCS use among admissions for MI with CS was 33.3% (0.0–50.0%). High MCS utilizing hospitals were larger (p <0.001). Eighty-five percent (2808/3301) of MCS use was intra-aortic balloon pump (IABP). There was significant variation in receipt of MCS at different hospitals (median OR of receiving MCS at two random hospitals: 1.58; 95% CI 1.45–1.70). Adjusted in-hospital mortality was not different across quartiles of MCS use (Q4 vs Q1; OR 0.95; 95% CI 0.77–1.16, p = 0.58). Conclusions: Wide variation exists in hospital use of MCS for MI with CS, unexplained by patient characteristics. The predominant form of MCS use is IABP. Risk-adjusted mortality rates were not different between higher and lower MCS-utilizing hospitals.

Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims, 1/1/2003-12/31/2016. Primary (e.g. death and stroke) and secondary trial endpoints, were compared across treatment arms (e.g. TAVR vs. SAVR) using trial-adjudicated outcomes versus outcomes derived from claims at 1-year (HiR) or 2-years (SURTAVI). Results: Among 600 linked CoreValve HiR participants (linkage rate 80.0%), the rate of the trial's primary endpoint of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1-year using both trial data (HR 0.84, 95% CI 0.65-1.09; p= 0.33) and claims data (HR 0.86, 95% CI 0.66-1.11; p = 0.34; interaction p-value = 0.80). Noninferiority of TAVR relative to SAVR was seen using both trial and claims-based outcomes (p noninferiority < 0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate 60.5%), the trial's primary endpoint was 12.9% for TAVR and 13.1% for SAVR using trial data (HR 1.08, 95% CI 0.79-1.48, p = 0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (HR 1.02, 95% CI 0.73-1.41, p = 0.58; interaction p-value = 0.89). TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority < 0.001 for both). Rates of procedural secondary outcomes (e.g. aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than non-procedural outcomes (e.g., stroke, bleeding, cardiogenic shock). Conclusions: In the CoreValve HiR and SURTAVI trials, ascertainment of trial primary endpoints using claims reproduced both the magnitude and direction of treatment effect compared with adjudicated event data, but non-fatal and non-procedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes, but may be less suitable for other endpoints.