BACKGROUND:Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in ...Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).
METHODS:From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levelstime period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).
RESULTS:Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with deathodds ratio, 1.24 (95% CI, 1.13–1.36); bleedingodds ratio, 1.10 (95% CI, 1.00–1.21); and strokeodds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injuryodds ratio, 1.08 (95% CI, 1.00–1.17).
CONCLUSIONS:Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.
Background
Prolonged length of stay (LOS) and post‐acute care after percutaneous coronary intervention (PCI) is common and costly. Risk models for predicting prolonged LOS and post‐acute care have ...limited accuracy. Our goal was to develop and validate models using artificial neural networks (ANN) to predict prolonged LOS > 7days and need for post‐acute care after PCI.
Methods
We defined prolonged LOS as ≥7 days and post‐acute care as patients discharged to: extended care, transitional care unit, rehabilitation, other acute care hospital, nursing home or hospice care. Data from 22 675 patients who presented with ACS and underwent PCI was shuffled and split into a derivation set (75% of dataset) and a validation dataset (25% of dataset). Calibration plots were used to examine the overall predictive performance of the MLP by plotting observed and expected risk deciles and fitting a lowess smoother to the data. Classification accuracy was assessed by a receiver‐operating characteristic (ROC) and area under the ROC curve (AUC).
Results
Our MLP‐based model predicted prolonged LOS with an accuracy of 90.87% and 88.36% in training and test sets, respectively. The post‐acute care model had an accuracy of 90.22% and 86.31% in training and test sets, respectively. This accuracy was achieved with quick convergence. Predicted probabilities from the MLP models showed good (prolonged LOS) to excellent calibration (post‐acute care).
Conclusions
Our ANN‐based models accurately predicted LOS and need for post‐acute care. Larger studies for replicability and longitudinal studies for evidence of impact are needed to establish these models in current PCI practice.
IMPORTANCE: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist ...devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. OBJECTIVE: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. DESIGN, SETTING, AND PARTICIPANTS: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology’s National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. EXPOSURES: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. MAIN OUTCOMES AND MEASURES: The primary outcomes were in-hospital mortality and in-hospital major bleeding. RESULTS: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD 31.3% vs IABP 16.0%; absolute risk difference, 15.4 percentage points 95% CI, 12.5-18.2; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. CONCLUSIONS AND RELEVANCE: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.
IMPORTANCE Bleeding is the most common complication after percutaneous coronary intervention (PCI) and is associated with increased morbidity and health care costs. The incidence of bleeding-related ...mortality after PCI has not been described in a nationally representative population. Furthermore, the relationships among bleeding risk, bleeding site, and mortality are unclear. OBJECTIVES To describe the association between bleeding events and in-hospital mortality after PCI and to estimate the adjusted population attributable risk (estimated as the proportion of mortality risk associated with bleeding events), risk difference, and number needed to harm (NNH) for bleeding-related in-hospital mortality after PCI. DESIGN, SETTING, AND PATIENTS Data from 3 386 688 procedures in the CathPCI Registry performed in the United States between 2004 and 2011 were analyzed. The population attributable risk was calculated after adjustment for baseline demographic, clinical, and procedural variables. To calculate the NNH for bleeding-related mortality, a propensity-matched analysis was performed. MAIN OUTCOME MEASURES In-hospital mortality. RESULTS There were 57 246 bleeding events (1.7%) and 22 165 in-hospital deaths (0.65%) in 3 386 688 PCI procedures. The adjusted population attributable risk for mortality related to major bleeding was 12.1% (95% CI, 11.4%-12.7%) in the entire CathPCI cohort. The propensity-matched population consisted of 56 078 procedures with a major bleeding event and 224 312 controls. In this matched cohort, major bleeding was associated with increased in-hospital mortality (5.26% vs 1.87%; risk difference, 3.39% 95% CI, 3.20%-3.59%; NNH = 29 95% CI, 28-31; P < .001). The association between major bleeding and in-hospital mortality was observed in all strata of preprocedural bleeding risk (low: 1.62% vs 0.17%; risk difference, 1.45% 95% CI, 1.13%-1.77%, NNH = 69 95% CI, 57-88, P < .001; intermediate: 3.27% vs 0.71%; risk difference, 2.56% 95% CI, 2.33%-2.79%, NNH = 39 95% CI, 36-43, P < .001; and high: 8.16% vs 3.45%; risk difference, 4.71% 95% CI, 4.35%-5.07%, NNH = 21 95% CI, 20-23, P < .001). Although both access-site and non–access-site bleeding were associated with increased in-hospital mortality (2.73% vs 1.87%; risk difference, 0.86% 95% CI, 0.66%-1.05%, NNH = 117 95% CI, 95-151, P < .001; and 8.25% vs 1.87%; risk difference, 6.39% 95% CI, 6.04%-6.73%, NNH = 16 95% CI, 15-17, P < .001, respectively), the NNH was lower for nonaccess bleeding. CONCLUSIONS AND RELEVANCE In a large registry of patients undergoing PCI, postprocedural bleeding events were associated with increased risk of in-hospital mortality, with an estimated 12.1% of deaths related to bleeding complications.
Objectives This study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions. Background Acute kidney ...injury (AKI) is a serious and potentially preventable complication of percutaneous coronary interventions (PCIs) that is associated with adverse outcomes. The contemporary incidence, predictors, and outcomes of AKI are not well defined, and clarifying these can help identify high-risk patients for proactive prevention. Methods A total of 985,737 consecutive patients underwent PCIs at 1,253 sites participating in the National Cardiovascular Data Registry Cath-PCI registry from June 2009 through June 2011. AKI was defined on the basis of changes in serum creatinine level in the hospital according to the Acute Kidney Injury Network (AKIN) criteria. Using multivariable regression analyses with generalized estimating equations, we identified patient characteristics associated with AKI. Results Overall, 69,658 (7.1%) patients experienced AKI, with 3,005 (0.3%) requiring new dialysis. On multivariable analyses, the factors most strongly associated with development of AKI included ST-segment elevation myocardial infarction (STEMI) presentation (odds ratio OR: 2.60; 95% confidence interval CI: 2.53 to 2.67), severe chronic kidney disease (OR: 3.59; 95% CI: 3.47 to 3.71), and cardiogenic shock (OR: 2.92; 95% CI: 2.80 to 3.04). The in-hospital mortality rate was 9.7% for patients with AKI and 34% for those requiring dialysis compared with 0.5% for patients without AKI (p < 0.001). After multivariable adjustment, AKI (OR: 7.8; 95% CI: 7.4 to 8.1, p < 0.001) and dialysis (OR: 21.7; 95% CI: 19.6 to 24.1; p < 0.001) remained independent predictors of in-hospital mortality. Conclusions Approximately 7% of patients undergoing a PCI experience AKI, which is strongly associated with in-hospital mortality. Defining strategies to minimize the risk of AKI in patients undergoing PCI are needed to improve the safety and outcomes of the procedure.
This study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions.
Acute kidney injury (AKI) is a ...serious and potentially preventable complication of percutaneous coronary interventions (PCIs) that is associated with adverse outcomes. The contemporary incidence, predictors, and outcomes of AKI are not well defined, and clarifying these can help identify high-risk patients for proactive prevention.
A total of 985,737 consecutive patients underwent PCIs at 1,253 sites participating in the National Cardiovascular Data Registry Cath-PCI registry from June 2009 through June 2011. AKI was defined on the basis of changes in serum creatinine level in the hospital according to the Acute Kidney Injury Network (AKIN) criteria. Using multivariable regression analyses with generalized estimating equations, we identified patient characteristics associated with AKI.
Overall, 69,658 (7.1%) patients experienced AKI, with 3,005 (0.3%) requiring new dialysis. On multivariable analyses, the factors most strongly associated with development of AKI included ST-segment elevation myocardial infarction (STEMI) presentation (odds ratio OR: 2.60; 95% confidence interval CI: 2.53 to 2.67), severe chronic kidney disease (OR: 3.59; 95% CI: 3.47 to 3.71), and cardiogenic shock (OR: 2.92; 95% CI: 2.80 to 3.04). The in-hospital mortality rate was 9.7% for patients with AKI and 34% for those requiring dialysis compared with 0.5% for patients without AKI (p < 0.001). After multivariable adjustment, AKI (OR: 7.8; 95% CI: 7.4 to 8.1, p < 0.001) and dialysis (OR: 21.7; 95% CI: 19.6 to 24.1; p < 0.001) remained independent predictors of in-hospital mortality.
Approximately 7% of patients undergoing a PCI experience AKI, which is strongly associated with in-hospital mortality. Defining strategies to minimize the risk of AKI in patients undergoing PCI are needed to improve the safety and outcomes of the procedure.
Background
We developed risk models for predicting acute kidney injury (AKI) and AKI requiring dialysis (AKI‐D) after percutaneous coronary intervention (PCI) to support quality assessment and the ...use of preventative strategies.
Methods and Results
AKI was defined as an absolute increase of ≥0.3 mg/dL or a relative increase of 50% in serum creatinine (AKIN Stage 1 or greater) and AKI‐D was a new requirement for dialysis following PCI. Data from 947 012 consecutive PCI patients and 1253 sites participating in the NCDR Cath/PCI registry between 6/09 and 7/11 were used to develop the model, with 70% randomly assigned to a derivation cohort and 30% for validation. AKI occurred in 7.33% of the derivation and validation cohorts. Eleven variables were associated with AKI: older age, baseline renal impairment (categorized as mild, moderate, and severe), prior cerebrovascular disease, prior heart failure, prior PCI, presentation (non‐ACS versus NSTEMI versus STEMI), diabetes, chronic lung disease, hypertension, cardiac arrest, anemia, heart failure on presentation, balloon pump use, and cardiogenic shock. STEMI presentation, cardiogenic shock, and severe baseline CKD were the strongest predictors for AKI. The full model showed good discrimination in the derivation and validation cohorts (c‐statistic of 0.72 and 0.71, respectively) and identical calibration (slope of calibration line=1.01). The AKI‐D model had even better discrimination (c‐statistic=0.89) and good calibration (slope of calibration line=0.99).
Conclusion
The NCDR AKI prediction models can successfully risk‐stratify patients undergoing PCI. The potential for this tool to aid clinicians in counseling patients regarding the risk of PCI, identify patients for preventative strategies, and support local quality improvement efforts should be prospectively tested.
Objectives This study sought to evaluate the costs of transradial percutaneous coronary intervention (TRI) and transfemoral percutaneous coronary intervention (TFI) from a contemporary hospital ...perspective. Background Whereas the TRI approach to percutaneous coronary intervention (PCI) has been shown to reduce access-site complications compared with TFI, whether it is associated with lower costs is unknown. Methods TRI and TFI patients were identified at 5 U.S. centers. The primary outcome was the cost of percutaneous coronary intervention (PCI) hospitalization, defined as cost on the day of PCI through hospital discharge. Cost was obtained from each hospital’s cost accounting system. Independent costs of TRI were identified using propensity-scoring methods with inverse probability weighting. Secondary outcomes of interest were bleeding, in-hospital mortality, and length of stay, which were stratified by pre-procedural risk and PCI indication. Results In 7,121 PCI procedures performed from January 1, 2010, to March 31, 2011, TRI was performed in 1,219 (17%) patients and was associated with shorter lengths of stay (2.5 vs. 3.0 days; p < 0.001) and lower bleeding events (1.1% vs. 2.4%, adjusted odds ratio OR: 0.52, 95% confidence interval CI: 0.34 to 0.79; p = 0.002). TRI was associated with a total cost savings of $830 (95% CI: $296 to $1,364; p < 0.001), of which $130 (95% CI: –$99 to $361; p = 0.112) were procedural savings and $705 (95% CI: $212 to $1,238; p < 0.001) were post-procedural savings. There was an associated graded increase in savings among patients at higher predicted risk of bleeding: low risk: $642 (95% CI: $43 to $1,236; p = 0.035); moderate risk: $706 (95% CI: $104 to $1,308; p = 0.029); and high risk: $1,621 (95% CI: $271 to $2,971, p = 0.039). Conclusions TRI was associated with a cost savings exceeding $800 per patient relative to TFI. Increased adoption of TRI may result in cost savings at hospitals.
Background Although an acute worsening in renal function (WRF) commonly occurs among patients hospitalized for acute myocardial infarction (AMI), its long-term prognostic significance is unknown. We ...examined predictors of WRF and its association with 4-year mortality. Methods Acute myocardial infarction patients from the multicenter PREMIER study (N = 2,098) who survived to hospital discharge were followed for at least 4 years. Worsening in renal function was defined as an increase in creatinine during hospitalization of ≥0.3 mg/dL above the admission value. Correlates of WRF were determined with multivariable logistic regression models and used, along with other important clinical covariates, in Cox proportional hazards models to define the independent association between WRF and mortality. Results Worsening in renal function was observed in 393 (18.7%) of AMI survivors. Diabetes, left ventricular systolic dysfunction, and a history of chronic kidney disease (documented history of renal failure with baseline creatinine >2.5 mg/dL) were independently associated with WRF. During 4-year follow-up, 386 (18.6%) patients died. Mortality was significantly higher in the WRF group (36.6% vs 14.4% in those without WRF, P < .001). After adjusting for other factors associated with WRF and long-term mortality, including baseline creatinine, WRF was independently associated with a higher risk of death (hazard ratio = 1.64, 95% CI 1.23-2.19). Conclusions Worsening in renal function occurs in approximately 1 of 6 AMI survivors and is independently associated with an adverse long-term prognosis. Further studies on interventions to minimize WRF or to more aggressively treat patients developing WRF should be tested.
Key Points
Acute myocardial infarction with cardiogenic shock is a costly condition associated with poor clinical outcomes.
This analysis used Medicare cost data for selected patients with acute ...myocardial infarction complicated by cardiogenic shock treated with the percutaneous left ventricular assist device (pVAD) or extracorporeal membrane oxygenation (ECMO) and found that the pVAD was associated with lower costs and better outcomes.
Patients treated with ECMO tend to have more severe shock than those treated with pVAD, and unmeasured confounders make any comparison challenging to interpret.
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