Regional Variation in Procedural and Clinical Outcomes Among Patients With ST Elevation Myocardial Infarction With Cardiogenic Shock.

There is limited data on regional differences in patient characteristics, practice patterns, and clinical outcomes in patients with ST elevation myocardial infarction (STEMI) with cardiogenic shock (CS) in the United States (US). We aimed to identify variations in treatment methods and clinical outcomes in patients with STEMI CS between the 4 US regions. Using the National Inpatient Sample database, we identified adult patients admitted with STEMI associated with CS between 2006 and 2015 using ICD-9-DM codes. Based on the US regions (Northeast, Midwest, South, and West), we divided patients in 4 cohorts and compared baseline patient characteristics, clinical outcomes and procedural outcomes. A total of 186,316 patients with STEMI CS were included; 32,303 (17.3%) were hospitalized in the Northeast, 43,634 (23.4%) in the Midwest, 70,036 (37.8%) in the South, and 40,043 (21.5%) in the West. Although nonstatistically significant, the in-hospital mortality was higher in Northeast region (37.7%), followed by the South (36.6%), West (35.7%), and Midwest (35.2%). Rates of percutaneous coronary intervention were higher in the Midwest (68.5%) and lower in the Northeast (56%). The use of percutaneous ventricular assist device and ECMO was higher in the Northeast (3.3% and 2.2%) and lower in the West (2.1% and 0.4%). The median length of stay was similar among all 4 cohorts (6 days) but median hospital costs were higher in the West ($36, 614) and lower in the South ($28,795). In conclusion, there are significant geographic variations in practice patterns, healthcare cost, and in-hospital outcomes in patients with STEMI complicated by CS between 4 US regions.

Cost-utility of venoarterial extracorporeal membrane oxygenation in cardiogenic shock and cardiac arrest.

BACKGROUND: The use of venoarterial extracorporeal membrane oxygenation in cardiogenic shock keeps increasing, but its cost-utility is unknown. METHODS: We studied retrospectively the cost-utility of venoarterial extracorporeal membrane oxygenation in a five-year cohort of consequent patients treated due to refractory cardiogenic shock or cardiac arrest in a transplant centre in 2013-2017. In our centre, venoarterial extracorporeal membrane oxygenation is considered for all cardiogenic shock patients potentially eligible for heart transplantation, and for selected postcardiotomy patients. We assessed the costs of the index hospitalization and of the one-year hospital costs, and the patients' health-related quality of life (response rate 71.7%). Based on the data and the population-based life expectancies, we calculated the amount and the costs of quality-adjusted life years gained both without discount and with an annual discount of 3.5%. RESULTS: The cohort included 102 patients (78 cardiogenic shock; 24 cardiac arrest) of whom 67 (65.7%) survived to discharge and 66 (64.7%) to one year. The effective costs per one hospital survivor were 242,303€. Median in-hospital costs of the index hospitalization per patient were 129,967€ (interquartile range 150,340€). Mean predicted number of quality-adjusted life years gained by the treatment was 20.9 (standard deviation 9.7) without discount, and the median cost per quality-adjusted life year was 7474€ (interquartile range 10,973€). With the annual discount of 3.5%, 13.0 (standard deviation 4.8) quality-adjusted life years were gained with the cost of 12,642€ per quality-adjusted life year (interquartile range 15,059€). CONCLUSIONS: We found the use of venoarterial extracorporeal membrane oxygenation in refractory cardiogenic shock and cardiac arrest justified from the cost-utility point of view in a transplant centre setting.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Mortality and costs following extracorporeal membrane oxygenation in critically ill adults: a population-based cohort study.

PURPOSE: Extracorporeal membrane oxygenation (ECMO) is used as temporary cardiorespiratory support in critically ill patients. Little is known about population-level short- and long-term outcomes following ECMO, including healthcare use and health system cost across a wide range of sectors. METHODS: Population-based cohort study in Ontario, Canada (October 1, 2009-March 31, 2017) of adult patients (≥ 18 years) receiving ECMO for cardiorespiratory support. We captured outcomes through linkage to health administrative databases. Primary outcome was mortality during hospitalization, as well as at 7 days, 30 days, 1 year, 2 years, and 5 years following ECMO initiation. We analyzed health system costs (in Canadian dollars) in the 1 year following the date of the index admission. RESULTS: A total of 692 patients were included. Mean (standard deviation [SD]) age was 51.3 (16.0) years. Median (interquartile range [IQR]) time to ECMO initiation from date of admission was 2 (0-9) days. In-hospital mortality was 40.0%. Mortality at 1 year, 2 years, and 5 years was 45.1%, 49.0%, and 57.4%, respectively. Among survivors, 78.4% were discharged home, while 21.2% were discharged to continuing care. Median (IQR) total costs in the 1 year following admission among all patients were Canadian $130,157 (Canadian $58,645-Canadian $240,763), of which Canadian $91,192 (Canadian $38,507-Canadian $184,728) were attributed to inpatient care. CONCLUSIONS: Hospital mortality among critically ill adults receiving ECMO for advanced cardiopulmonary support is relatively high, but does not markedly increase in the years following discharge. Survivors are more likely to be discharged home than to continuing care. Median costs are high, but largely reflect inpatient hospital costs, and not costs incurred following discharge.

Rehospitalization and resource use after inpatient admission for extracorporeal life support in the United States.

BACKGROUND: With increasing dissemination and improved survival after extracorporeal life support, also called extracorporeal membrane oxygenation, the decrease in readmissions after hospitalization involving extracorporeal life support is an emerging priority. The present study aimed to identify predictors of early readmission after extracorporeal life support at a national level. METHODS: This was a retrospective cohort study using the Nationwide Readmissions Database. All patients ≥18 years who underwent extracorporeal life support from 2010 to 2015 were identified. Patients were stratified into the following categories of extracorporeal life support: postcardiotomy, primary cardiogenic shock, cardiopulmonary failure, respiratory failure, transplantation, and miscellaneous. The primary outcome of the study was the rate of 90-day rehospitalization after extracorporeal life support admission. A multivariable logistic regression model was developed to predict the odds of unplanned 90-day readmission. Kaplan-Meier analyses were also performed. RESULTS: An estimated 18,748 patients received extracorporeal life support with overall mortality of 50.2%. Of the patients who survived hospitalization, 30.2% were discharged to a skilled nursing facility, and 21.1% were readmitted within 90 days after discharge. After adjusting for patient and hospital characteristics, cardiogenic shock was associated with the greatest odds of mortality (adjusted odds ratio 1.6; 95% confidence interval, 1.09-1.46; C-statistic, 0.64). The cohort with respiratory failure had decreased odds of readmission (adjusted odds ratio 0.76; 95% confidence interval, 0.58-0.99). Discharge to skilled nursing facility (adjusted odds ratio 1.64; 95% confidence interval, 1.36-1.97) was independently associated with readmission. Cardiac and respiratory-related readmissions comprised the majority of unplanned 90-day rehospitalizations. CONCLUSION: In this large analysis of readmissions after extracorporeal life support in adults, 21% of extracorporeal life support survivors were rehospitalized within 90 days of discharge. Disposition to a skilled nursing facility, but not advanced age nor female sex, was associated with readmission.

Frequency of 30-day readmission and its causes after percutaneous coronary intervention in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Survival after percutaneous coronary intervention (PCI) in acute myocardial infarction complicated by cardiogenic shock (AMI-CS) has increased over the years. Short-term readmission rates in this high-risk population remain unknown. METHODS: We queried the United States (U.S.) Nationwide Readmission Database (NRD) from January 2010 to November 2014 using the International Classification of Diseases-Ninth edition, Clinical Modification (ICD-9 CM) codes to identify all patients ≥18 years readmitted within 30 days after surviving an index hospitalization for PCI in AMI-CS. Incidence, etiologies, and predictors of 30-day readmission were analyzed. RESULTS: Among 46,435 patients who survived to discharge after PCI in AMI-CS, 9,020 (19.4%) were readmitted within 30 days. Median time to 30-day readmission was 11 days. Cardiac conditions were the most common causes of readmission (57.8%). Heart failure was the leading readmission diagnosis (24.8%). Private insurance including HMO and self-pay were predictive of lower 30-day readmission. Among other covariates, female sex, comorbidities such as heart failure, atrial fibrillation, in-hospital complications such as major bleeding, sepsis, respiratory complications, AKI requiring dialysis, utilization of mechanical circulatory support (IABP and ECMO) were independently predictive of 30-day readmission. Trend analysis showed decline in 30-day readmission rates from 21.9% in 2010 to 17.9% in 2014 (ptrend < 0.001). CONCLUSION: In this large real-world database, one in five patients receiving PCI in AMI-CS was readmitted within 30 days after discharge. Cardiac conditions were the most common causes of readmission. Insurance type had significant influence on 30-day readmission.

Extracorporeal Membrane Oxygenation Use in Cardiogenic Shock: Impact of Age on In-Hospital Mortality, Length of Stay, and Costs.

OBJECTIVES: Increasing age is a well-recognized risk factor for in-hospital mortality in patients receiving extracorporeal membrane oxygenation for cardiogenic shock, but the shape of this relationship is unknown. In addition, the impact of age on hospital length of stay, patterns of patient disposition, and costs has been incompletely characterized. DESIGN: Retrospective analysis of the National Inpatient Sample. SETTING: U.S. nonfederal hospitals, years 2004-2016. PATIENTS: Adults with cardiogenic shock treated with extracorporeal membrane oxygenation (3,094; weighted national estimate: 15,415). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The mean age of extracorporeal membrane oxygenation recipients was 54.8 ± 15.4 years (range, 18-90 yr). Crude in-hospital mortality was 57.7%. Median time-to-death was 8 days (interquartile range, 3-17 d). A linear relationship between age and in-hospital mortality was observed with a 14% increase in the adjusted odds of in-hospital mortality for every 10-year increase in age (adjusted odds ratio, 1.14; 95% CI, 1.08-1.21; p < 0.0001). Thirty-four percent of patients were discharged alive at a median time of 30 days (interquartile range, 19-48 d). The median length of stay and total hospitalization costs were 14 days (interquartile range, [5-29 d]) and $134,573 ($71,782-$239,439), respectively, both of which differed significantly by age group (length of stay range from 17 d [18-49 yr] to 9 d [80-90 yr]; p < 0.0001 and cost range $147,548 [18-49 yr] to $105,350 [80-90 yr]; p < 0.0001). CONCLUSIONS: Age is linearly associated with increasing in-hospital mortality in individuals receiving extracorporeal membrane oxygenation for cardiogenic shock without evidence of a threshold effect. Median time-to-death is approximately 1 week. One third of patients are discharged from the hospital alive, but the median time-to-discharge is 1 month. Median length of stay ranges from 9 to 17 days depending on age. Hospitalization costs exceed $100,000 in all age groups.

ECMO use and mortality in adult patients with cardiogenic shock: a retrospective observational study in U.S. hospitals.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is increasingly used in resuscitation of critically ill patients with documented improved survival. Few studies describe ECMO use in cardiogenic shock. This study examines ECMO use and identifies variables associated with mortality in patients treated for cardiogenic shock in US hospitals. METHODS: A retrospective observational study of the US Nationwide Emergency Department Sample (NEDS) database of 2013 was conducted. Weighted visits for cardiogenic shock (discharge diagnosis) with ECMO use were included. Collected data was analyzed and variables associated with mortality were identified. RESULTS: A total of 922 weighted patients with cardiogenic shock and ECMO were included. Mean age was 50.8 years. They were more commonly males (66.3%; n = 658). Slightly over half (51.0%, n = 506) survived to hospital discharge. Mean charges per patient were $589,610.5. Mean length of stay was 21.8 days. Increased mortality was associated with presence of respiratory diseases (OR = 3.83), genitourinary diseases (OR = 4.97), undergoing an echocardiogram (OR = 4.63), and presenting during seasons other than Fall. Lower mortality was noted in patients with injury and poisoning (OR = 0.47), in those who underwent certain vascular procedures (OR = 0.49) and those with increasing length of stay (OR = 0.90). CONCLUSION: Mortality in patients with cardiogenic shock remains high despite ECMO use. Season of admission (other than Fall) and presence of specific comorbidities (Respiratory and genitourinary diseases) are associated with increased mortality in this population. Familiarity with these variables can help identify patients at higher risk of death and can help improve outcomes further in cardiogenic shock.

Outcomes in Cardiogenic Shock Patients with Extracorporeal Membrane Oxygenation Use: A Matched Cohort Study in Hospitals across the United States.

BACKGROUND: ECMO is increasingly used for patients with critical illnesses. This study examines ECMO use in patients with cardiogenic shock in US hospitals and associated outcomes (mortality, hospital length of stay, and total hospital charges). METHODS: A matched cohort retrospective study was conducted using the 2013 Nationwide Emergency Department Sample. Cardiogenic shock visits were matched (1 : 1) and compared based on ECMO use. RESULTS: Patients with ECMO (N = 802) were compared to patients without ECMO (N = 805). Mortality was higher in the ECMO group (48.9% versus 4.0%, p < 0.001). Visits with ECMO use also had higher average hospital charges ($580,065.8 versus $156,436.5, p < 0.001) and average hospital LOS (21.3 versus 11.6 days, p < 0.001). After adjusting for confounders, mortality (OR = 8.52 (95% CI: 2.84-25.58)) and charges (OR = 1.03 (95% CI: 1.02-1.05)) remained higher in the ECMO group, while LOS was similar (OR = 1.01 (95% CI: 0.99-1.02)). CONCLUSIONS: Patients with cardiogenic shock who underwent ECMO had increased mortality and higher cost of care without significant increase in LOS when compared to patients with cardiogenic shock without ECMO use. Prospective evaluation of this observed association is needed to improve outcomes and resources' utilization further.

Etiologies and predictors of 30-day readmissions in patients undergoing percutaneous mechanical circulatory support-assisted percutaneous coronary intervention in the United States: Insights from the Nationwide Readmissions Database.

BACKGROUND: Patients undergoing percutaneous mechanical circulatory support (pMCS)-assisted percutaneous coronary intervention (PCI) represent a high-risk group vulnerable to complications and readmissions. HYPOTHESIS: Thirty-day readmissions after pMCS-assisted PCI are common among patients with comorbidities and account for a significant amount of healthcare spending. METHODS: Patients undergoing PCI and pMCS (Impella, TandemHeart, or intra-aortic balloon pump) for any indication between January 1, 2012, and November 30, 2014, were selected from the Nationwide Readmissions Database. Patients were identified using appropriate ICD-9-CM codes. Clinical risk factors and complications were analyzed for association with 30-day readmission. RESULTS: Our analysis included 29 247 patients, of which 4535 (15.5%) were readmitted within 30 days. On multivariate analysis, age ≥ 65 years, female sex, hypertension, diabetes, chronic lung disease, heart failure, prior implantable cardioverter-defibrillator, liver disease, end-stage renal disease, and length of stay ≥5 days during index hospitalization were independent predictors of 30-day readmission. Cardiac etiologies accounted for ~60% of readmissions, of which systolic or diastolic heart failure (22%), stable coronary artery disease (11.1%), acute coronary syndromes (8.9%), and nonspecific chest pain (4.0%) were the most common causes. In noncardiac causes, sepsis/septic shock (4.6%), hypotension/syncope (3.2%), gastrointestinal bleed (3.1%), and acute kidney injury (2.6%) were among the most common causes of 30-day readmissions. Mean length of stay and cost of readmissions was 4 days and $16 191, respectively. CONCLUSIONS: Thirty-day readmissions after pMCS-assisted PCI are common and are predominantly associated with increased burden of comorbidities. Reducing readmissions for common cardiac etiologies could save substantial healthcare costs.

Prevalence, Causes, and Predictors of 30-Day Readmissions Following Hospitalization With Acute Myocardial Infarction Complicated By Cardiogenic Shock: Findings From the 2013-2014 National Readmissions Database.

BACKGROUND: Prior studies have shown that survivors of acute myocardial infarction (AMI) complicated by cardiogenic shock are likely to have increased risk of readmissions in the early post-discharge period. However, the contemporary prevalence, reasons, and predictors of 30-day readmissions are not well known. METHODS AND RESULTS: Hospitalizations for a primary diagnosis of AMI complicated by cardiogenic shock, and discharged alive, were identified in the 2013 and 2014 Nationwide Readmissions Databases. Prevalence and reasons for 30-day unplanned readmissions were investigated. A hierarchical logistic regression model was used to identify independent predictors of 30-day readmissions. Among 1 116 933 patient hospitalizations with AMI, 39 807 (3.6%) had cardiogenic shock and were discharged alive. Their 30-day readmission rate was 18.6%, with a median time for readmission 10 days post discharge. Predictors of readmission included: non-ST-segment elevation myocardial infarction, female sex, low-income status, nonprivate insurance, chronic renal failure, long-term ventricular assist device or intra-aortic balloon placement, and tachyarrhythmia. The majority of readmissions were attributable to cardiac-related causes (52%); heart failure being the most frequent cardiac cause (39% of all cardiac causes). Noncardiac-related readmissions included infections (14.9%), bleeding (5.3%), and respiratory causes (4.9%). The median cost per readmission was $9473 US dollars ($5037-20 199). CONCLUSIONS: Among survivors of AMI complicated by cardiogenic shock who were discharged from hospital, almost 1 in 5 are readmitted at 30 days, mainly because of cardiac reasons such as heart failure and new AMI. The risk of readmission was associated with certain baseline patient/hospital characteristics.

National trends, predictors of use, and in-hospital outcomes in mechanical circulatory support for cardiogenic shock.

AIMS: Despite rising rates of cardiogenic shock (CS), data on trends and in-hospital outcomes of short-term non-durable mechanical circulatory support (MCS) are limited. Thus, we aimed to identify recent national trends in MCS utilisation in the USA, patient-level predictors of MCS use, and in-hospital outcomes in CS inclusive of extracorporeal membrane oxygenation (ECMO). METHODS AND RESULTS: Hospitalisations of US adults with a discharge diagnosis of CS, from January 2004 to December 2014, in the National Inpatient Sample were included. Rates of MCS were stratified by device type and clinical presentation. Outcomes included in-hospital mortality, hospitalisation costs, and number of procedures. A total of 183,516 hospitalisations with CS (47,636 [25.9%] involving MCS) were included. MCS recipients were younger, less frequently female, received more procedures, had higher costs, and more frequently presented with MI (MCS vs. non-MCS: 71.6% vs. 42.9%; p<0.0001). Growth in CS hospitalisations (214.4%) outpaced annual MCS use (160.0%), with relative declines in intra-aortic balloon pump use starting in 2008. Right heart catheterisation rates for both groups remained low (MCS vs. non-MCS: 5.9% vs. 3.3%; p<0.0001). In-hospital mortality declined but remained high in both groups (MCS vs. non-MCS [2014]: 32.7% vs. 41.5%; p<0.0001). CONCLUSIONS: 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.

Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial.

INTRODUCTION: Emergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial. METHODS AND ANALYSIS: The economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients' characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country's national health services, where costs will be expressed in euros adjusted for purchasing power parity. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors at www.twitter.com and www.researchgate.net. TRIAL REGISTRATION NUMBER: NCT01927549; Pre-results.

Clinical and economic effectiveness of percutaneous ventricular assist devices for high-risk patients undergoing percutaneous coronary intervention.

BACKGROUND: Comparative effectiveness research (CER) is taking a more prominent role in formalizing hospital treatment protocols and health-care coverage policies by having health-care providers consider the impact of new devices on costs and outcomes. CER balances the need for innovation with fiscal responsibility and evidence-based care. This study compared the clinical and economic impact of percutaneous ventricular assist devices (pVAD) with intraaortic balloon pumps for high-risk patients undergoing percutaneous coronary intervention (PCI). METHODS: This study conducted a review of all comparative randomized control trials of the pVADS (Impella and TandemHeart) vs IABP for patients undergoing high-risk percutaneous coronary intervention (PCI). A retrospective analysis of the 2010 and 2011 Medicare MEDPAR data files was also performed to compare procedural costs and hospital length of stay (LOS). Readmission rates between the devices were also studied. RESULTS: Based on available trials, there is no significant clinical benefit with pVAD compared to IABP. Use of pVADs is associated with increased length of Intensive Care Unit stay and a total longer LOS. The incremental budget impact for pVADs was $33,957,839 for the United States hospital system (2010-2011). CONCLUSIONS: pVADs are not associated with improved clinical outcomes, reduced hospital length of stay, or reduced readmission rates. Management of high-risk PCI and cardiogenic shock patients with IABP is more cost effective than a routine use of pVADS. Use of IABP as initial therapy in high-risk PCI and cardiogenic shock patients may result in savings of up to $2.5 billion annually of incremental costs to the hospital system.

Economic implications of intra-aortic balloon support for myocardial infarction with cardiogenic shock: an analysis from the IABP-SHOCK II-trial.

BACKGROUND: The Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial has demonstrated the safety of intra-aortic balloon (IABP) support in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock, but no beneficial effect on mortality. Currently, intra-aortic balloon pumping is still the most widely used support device. However, little is known about the economic implications associated with this device. METHODS: Data of 600 patients included in the IABP-SHOCK II trial (registered at ClinicalTrials.gov, NCT00491036) with follow-up at 30 days, 6 and 12 months were subjected to an economic analysis. Patients with cardiogenic shock complicating AMI were randomly assigned to IABP additionally to optimal medical therapy (OMT; n = 301) or OMT alone (n = 299) before early revascularization. Costs were calculated from the perspective of a German healthcare payer. Cost-effectiveness and cost-utility analyses were performed using quality-adjusted life years (QALY) and reduction in New York Heart Association (NYHA) and Canadian Cardiac Society (CCS) class as effectiveness measures. RESULTS: There was a statistically significant difference in overall costs between the IABP (33,155 ± 14,593 ) and the control group (32,538 ± 14,031 , p < 0.00001). This was predominantly attributed to the IABP costs in the IABP (760 ± 174 ) versus control group (64 ± 218 , p < 0.0001) whilst the intensive care unit costs did not differ between the groups (29,177 ± 12,013 and 29,401 ± 12,063 , p = 0.82). There was no significant difference in QALY or NYHA and CCS reduction, respectively (p = n.s.). CONCLUSION: IABP support is associated with higher healthcare costs as compared to conservative treatment regimens. Clinically, IABP support cannot generally be recommended in AMI complicated by cardiogenic shock in the absence of a mortality benefit. However, economically considering the relatively little contribution to overall costs generated by IABP therapy it may still be considered if clinical scenarios with an IABP-induced benefit may be identified in the future.

Venoarterial extracorporeal membrane oxygenation for patients in shock or cardiac arrest secondary to cardiotoxicant poisoning: a cost-effectiveness analysis.

PURPOSE: Venoarterial extracorporeal membrane oxygenation represents an emerging and recommended option to treat life-threatening cardiotoxicant poisoning. The objective of this cost-effectiveness analysis was to estimate the incremental cost-effectiveness ratio of using venoarterial extracorporeal membrane oxygenation for adults in cardiotoxicant-induced shock or cardiac arrest compared with standard care. MATERIALS AND METHODS: Adults in shock or in cardiac arrest secondary to cardiotoxicant poisoning were studied with a lifetime horizon and a societal perspective. Venoarterial extracorporeal membrane oxygenation cost effectiveness was calculated using a decision analysis tree, with the effect of the intervention and the probabilities used in the model taken from an observational study representing the highest level of evidence available. The costs (2013 Canadian dollars, where $1.00 Canadian = $0.9562 US dollars) were documented with interviews, reviews of official provincial documents, or published articles. A series of one-way sensitivity analyses and a probabilistic sensitivity analysis using Monte Carlo simulation were used to evaluate uncertainty in the decision model. RESULTS: The cost per life year (LY) gained in the extracorporeal membrane oxygenation group was $145 931/18 LY compared with $88 450/10 LY in the non-extracorporeal membrane oxygenation group. The incremental cost-effectiveness ratio ($7185/LY but $34 311/LY using a more pessimistic approach) was mainly influenced by the probability of survival. The probabilistic sensitivity analysis identified variability in both cost and effectiveness. CONCLUSION: Venoarterial extracorporeal membrane oxygenation may be cost effective in treating cardiotoxicant poisonings.

The cost impact of short-term ventricular assist devices and extracorporeal life support systems therapies on the National Health Service in the UK.

OBJECTIVES: The objective of the study was to assess the cost of using different blood pumps for short-term ventricular assist device (VAD) and extracorporeal life support (ECLS) systems for cardiac and cardiorespiratory failure in the UK. METHODS: The cost analysis presented was based on evaluation of the time required to provide circulatory support for the following indications: post-cardiac surgery cardiogenic shock, postacute myocardial infarction cardiogenic shock, deteriorating end-stage heart failure (ESHF) and the ability of different blood pumps to provide support for the necessary duration. The maximum length of support for each device was based on the manufacturers' recommendations. Direct medical cost of each treatment was evaluated only for the period of mechanical circulatory support in adults and children. Only the cost of device, placement and replacement procedures were considered. List prices were used for devices; resource use was based on expert opinion; unit costs were obtained from official UK sources and Wythenshawe hospital, Manchester, UK. Hospital perspective was utilized for analysis. Three VADs were selected for comparison in adults and two in children. Four centrifugal ECLS systems were selected for comparison in adults and two in children. RESULTS: In both VAD and ECLS indications, the CentriMag® was the least expensive when used for support of patients with end-stage heart failure. Compared with Cardiohelp® for ECLS (which has the same maximum claim duration of support of 30 days), CentriMag® lead to cost savings of £4294 per patient in all three clinical conditions considered. In post-cardiac surgery cardiogenic shock, CentriMag® VAD lead to savings of £5014 per patient compared with BPX-80. Results were robust in one-way sensitivity analysis in comparison with Cardiohelp®. CONCLUSIONS: CentriMag® and PediVAS® blood pumps can lead to significant cost savings to the National Health Service, when used instead of other pumps for short-term VAD or ECLS treatment.

Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States.

BACKGROUND: Limited information is available on the contemporary and potentially changing trends in the incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: We queried the 2003-2010 Nationwide Inpatient Sample databases to identify all patients ≥ 40 years of age with STEMI and cardiogenic shock. Overall and age-, sex-, and race/ethnicity-specific trends in incidence of cardiogenic shock, early mechanical revascularization, and intra-aortic balloon pump use, and inhospital mortality were analyzed. From 2003 to 2010, among 1 990 486 patients aged ≥ 40 years with STEMI, 157 892 (7.9%) had cardiogenic shock. The overall incidence rate of cardiogenic shock in patients with STEMI increased from 6.5% in 2003 to 10.1% in 2010 (P(trend)<0.001). There was an increase in early mechanical revascularization (30.4% to 50.7%, P(trend)<0.001) and intra-aortic balloon pump use (44.8% to 53.7%, P(trend)<0.001) in these patients over the 8-year period. Inhospital mortality decreased significantly, from 44.6% to 33.8% (P(trend)<0.001; adjusted OR, 0.71; 95% CI, 0.68 to 0.75), whereas the average total hospital cost increased from $35 892 to $45 625 (P(trend)<0.001) during the study period. There was no change in the average length of stay (P(trend)=0.394). These temporal trends were similar in patients <75 and ≥ 75 years of age, men and women, and across each racial/ethnic group. CONCLUSIONS: The incidence of cardiogenic shock complicating STEMI has increased during the past 8 years together with increased use of early mechanical revascularization and intra-aortic balloon pumps. There has been a concomitant decrease in risk-adjusted inhospital mortality, but an increase in total hospital costs during this period.

Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: cost-effectiveness in the emergent setting.

UNLABELLED: This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. BACKGROUND: Previous research has demonstrated the cost-effectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). METHODS: National utilization and outcome data from the 2010-2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n = 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n = 305). RESULTS: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, P < 0.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, P = 0.055) and a significantly lower cost of the index admission ($90,929 and $144,257, respectively, P < 0.001). Cost-effectiveness analysis based on the national data demonstrated that pVAD achieved improved outcomes at lower cost. Data were also collected for similar patients who underwent protocol-guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (n = 30). At this site, the survival rate increased to 60%, length of hospitalization was shortened to 6 days, and admission costs were lowered to $53,850 relative to the surgical alternatives strategy. CONCLUSIONS: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost, and a survival benefit when compared with traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population.