Cost-Effectiveness of Vericiguat in Patients With Heart Failure With Reduced Ejection Fraction: The VICTORIA Randomized Clinical Trial.

BACKGROUND: The VICTORIA trial (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) demonstrated that, in patients with high-risk heart failure, vericiguat reduced the primary composite outcome of cardiovascular death or heart failure hospitalization relative to placebo. The hazard ratio for all-cause mortality was 0.95 (95% CI, 0.84-1.07). In a prespecified analysis, treatment effects varied substantially as a function of baseline NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, with survival benefit for vericiguat in the lower NT-proBNP quartiles (hazard ratio, 0.82 [95% CI, 0.69-0.97]) and no benefit in the highest NT-proBNP quartile (hazard ratio, 1.14 [95% CI, 0.95-1.38]). An economic analysis was a major secondary objective of the VICTORIA research program. METHODS: Medical resource use data were collected for all VICTORIA patients (N=5050). Costs were estimated by applying externally derived US cost weights to resource use counts. Life expectancy was projected from patient-level empirical trial survival results with the use of age-based survival modeling methods. Quality-of-life adjustments were based on prospectively collected EQ-5D-based utilities. The primary outcome was the incremental cost-effectiveness ratio, comparing vericiguat with placebo, assessed from the US health care sector perspective over a lifetime horizon. Cost-effectiveness was estimated using the total VICTORIA cohort, both with and without interaction between treatment and baseline NT-proBNP. RESULTS: Life expectancy modeling results varied according to whether the observed heterogeneity of treatment effect by baseline NT-proBNP values was incorporated into the modeling. Including the interaction term, the vericiguat arm had an estimated quality-adjusted life expectancy of 4.56 quality-adjusted life-years (QALYs) compared with 4.13 QALYs for placebo (incremental discounted QALY, 0.43). Without the treatment heterogeneity/interaction term, vericiguat had 4.50 QALYs compared with 4.33 QALYs for placebo (incremental discounted QALY, 0.17). Incremental discounted costs (vericiguat minus placebo) were $28 546 with the treatment interaction and $20 948 without it. Corresponding incremental cost-effectiveness ratios were $66 509 per QALY allowing for treatment heterogeneity and $124 512 without heterogeneity. CONCLUSIONS: Vericiguat use in the VICTORIA trial met criteria for intermediate value, but the incremental cost-effectiveness ratio estimates were sensitive to whether the analysis accounted for observed NT-proBNP treatment effect heterogeneity. The cost-effectiveness of vericiguat was driven by the projected incremental life expectancy among patients in the lowest 3 quartiles of NT-proBNP. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02861534.

Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Medicine in Ischemic Cardiomyopathy: The STICH Randomized Clinical Trial.

BACKGROUND: The STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure) demonstrated that coronary artery bypass grafting (CABG) reduced all-cause mortality rates out to 10 years compared with medical therapy alone (MED) in patients with ischemic cardiomyopathy and reduced left ventricular function (ejection fraction ≤35%). We examined the economic implications of these results. METHODS: We used a decision-analytic patient-level simulation model to estimate the lifetime costs and benefits of CABG and MED using patient-level resource use and clinical data collected in the STICH trial. Patient-level costs were calculated by applying externally derived US cost weights to resource use counts during trial follow-up. A 3% discount rate was applied to both future costs and benefits. The primary outcome was the incremental cost-effectiveness ratio assessed from the US health care sector perspective. RESULTS: For the CABG arm, we estimated 6.53 quality-adjusted life-years (95% CI, 5.70-7.53) and a lifetime cost of $140 059 (95% CI, $106 401 to $180 992). For the MED arm, the corresponding estimates were 5.52 (95% CI, 5.06-6.09) quality-adjusted life-years and $74 894 lifetime cost (95% CI, $58 372 to $93 541). The incremental cost-effectiveness ratio for CABG compared with MED was $63 989 per quality-adjusted life-year gained. At a societal willingness-to-pay threshold of $100 000 per quality-adjusted life-year gained, CABG was found to be economically favorable compared with MED in 87% of microsimulations. CONCLUSIONS: In the STICH trial, in patients with ischemic cardiomyopathy and reduced left ventricular function, CABG was economically attractive relative to MED at current benchmarks for value in the United States. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00023595.

Cost-Effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy in Atrial Fibrillation: The CABANA Randomized Clinical Trial.

BACKGROUND: In the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with drug therapy by intention-to-treat, but did improve the quality of life and freedom from atrial fibrillation recurrence. In the heart failure subgroup, ablation improved both survival and quality of life. Cost-effectiveness was a prespecified CABANA secondary end point. METHODS: Medical resource use data were collected for all CABANA patients (N=2204). Costs for hospital-based care were assigned using prospectively collected bills from US patients (n=1171); physician and medication costs were assigned using the Medicare Fee Schedule and National Average Drug Acquisition Costs, respectively. Extrapolated life expectancies were estimated using age-based survival models. Quality-of-life adjustments were based on EQ-5D-based utilities measured during the trial. The primary outcome was the incremental cost-effectiveness ratio, comparing ablation with drug therapy on the basis of intention-to-treat, and assessed from the US health care sector perspective. RESULTS: Costs in the first 3 months averaged $20 794±SD 1069 higher with ablation compared with drug therapy. The cumulative within-trial 5-year cost difference was $19 245 (95% CI, $11 360-$27 170) and the lifetime mean cost difference was $15 516 (95% CI, -$2963 to $35,512) higher with ablation than with drug therapy. The drug therapy arm accrued an average of 12.5 life-years (LYs) and 10.7 quality-adjusted life-years (QALYs). For the ablation arm, the corresponding estimates were 12.6 LYs and 11.0 QALYs. The incremental cost-effectiveness ratio was $57 893 per QALY gained, with 75% of bootstrap replications yielding an incremental cost-effectiveness ratio <$100 000 per QALY gained. With no quality-of-life/utility adjustments, the incremental cost-effectiveness ratio was $183 318 per LY gained. CONCLUSIONS: Catheter ablation of atrial fibrillation was economically attractive compared with drug therapy in the CABANA Trial overall at present benchmarks for health care value in the United States on the basis of projected incremental QALYs but not LYs alone.

Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease.

BACKGROUND: PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) found that initial use of at least 64-slice multidetector computed tomography angiography (CTA) versus functional diagnostic testing strategies did not improve clinical outcomes in stable symptomatic patients with suspected coronary artery disease (CAD) requiring noninvasive testing. OBJECTIVE: To conduct an economic analysis for PROMISE (a major secondary aim of the study). DESIGN: Prospective economic study from the U.S. perspective. Comparisons were made according to the intention-to-treat principle, and CIs were calculated using bootstrap methods. (ClinicalTrials.gov: NCT01174550). SETTING: 190 U.S. centers. PATIENTS: 9649 U.S. patients enrolled in PROMISE between July 2010 and September 2013. Median follow-up was 25 months. MEASUREMENTS: Technical costs of the initial (outpatient) testing strategy were estimated from Premier Research Database data. Hospital-based costs were estimated using hospital bills and Medicare cost-charge ratios. Physician fees were taken from the Medicare Physician Fee Schedule. Costs were expressed in 2014 U.S. dollars, discounted at 3% annually, and estimated out to 3 years using inverse probability weighting methods. RESULTS: The mean initial testing costs were $174 for exercise electrocardiography; $404 for CTA; $501 to $514 for pharmacologic and exercise stress echocardiography, respectively; and $946 to $1132 for exercise and pharmacologic stress nuclear testing, respectively. Mean costs at 90 days were $2494 for the CTA strategy versus $2240 for the functional strategy (mean difference, $254 [95% CI, -$634 to $906]). The difference was associated with more revascularizations and catheterizations (4.25 per 100 patients) with CTA use. After 90 days, the mean cost difference between the groups out to 3 years remained small. LIMITATION: Cost weights for test strategies were obtained from sources outside PROMISE. CONCLUSION: Computed tomography angiography and functional diagnostic testing strategies in patients with suspected CAD have similar costs through 3 years of follow-up. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Health-related quality of life outcomes with prasugrel among medically managed non-ST-segment elevation acute coronary syndrome patients: Insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial.

BACKGROUND: Few studies have assessed treatment effects on health-related quality of life (HRQoL) in patients with acute coronary syndrome (ACS) treated without revascularization. The TRILOGY ACS trial randomized patients with ACS to either prasugrel or clopidogrel therapy plus aspirin. Outcomes showed a complex pattern suggestive of late benefits with respect to repeat clinical events and benefits confined to patients who underwent angiography. Here, we examine the HRQoL correlates of these patterns. METHODS: HRQoL was measured at baseline and 3, 12, and 24 months or end of study (EOS) in 7243 patients aged <75 years using the EuroQol 3-level, group 5-dimension index (EQ-5D). Linear mixed effects models for repeated measures were used to examine treatment differences in HRQoL overall, stratified by angiography status, and among patients who did and did not have non-fatal events. RESULTS: No baseline differences in HRQoL were seen between patients randomized to prasugrel (n=3620) or clopidogrel (n=3623). At 24 months, remaining patients assigned to prasugrel (n=1450) vs. clopidogrel (n=1443) had higher EQ-5D index scores (86.4 vs. 84.9, P=.01). Mixed effects models found no difference in EQ-5D scores among prasugrel and clopidogrel patients overall across subgroups stratified by angiography status. However, among patients with non-fatal clinical events, patients on clopidogrel reported a larger decrement in HRQoL than patients on prasugrel (79.5±18.1 vs. 80.6±18.0; P=.02). CONCLUSIONS: Overall, there was no difference in HRQoL outcomes among patients receiving prasugrel vs. clopidogrel. However, the differential effects of the treatments among patients with non-fatal events require further investigation.

Costs and outcomes after cardiac surgery in patients refusing transfusion compared with those who do not: a case-matched study.

BACKGROUND: Although numerous studies have demonstrated the feasibility of cardiac surgery for blood refusal patients, few studies match to controls, and fewer examine cost. This historical cohort study aims to compare costs and outcomes after cardiac surgery in Jehovah's Witness patients who refuse blood transfusion with a group of matched patients accepting transfusion. STUDY DESIGN AND METHODS: A retrospective database review was performed to find all patients having cardiac surgery who refused blood products from January 2005 to July 2012 at Duke University Medical Center. These 45 patients were closely matched 1:2 with controls who accepted transfusion based on characteristics likely to influence transfusion. Cost from day of surgery to hospital discharge and other outcome data (length of stay [LOS], discharge hemoglobin [Hb], acute kidney injury) were analyzed retrospectively. RESULTS: Forty-five Witnesses having cardiac surgery were temporally matched to two controls having the same surgery. Median euroSCORE was the same in both groups (6.0, p = 0.9981). In the matched-pairs comparison of cost, there was no significant difference in total cost for Witnesses and controls. There was no difference in intensive care unit LOS (median, 1 day, both groups) or total LOS (median, 9 days for Witnesses vs. 7 days for controls). Mean Hb at discharge was higher in Witnesses than in controls (11.7 g/dL vs. 9.8 g/dL, p < 0.001). Thirty-day mortality was zero in both groups. CONCLUSION: Utilizing applicable blood conservation measures, cardiac surgery may be performed with similar outcomes and cost from day of surgery to discharge compared to controls in select patients without blood transfusion.

Impact of choice of imaging modality accompanying outpatient exercise stress testing on outcomes and resource use after revascularization for acute coronary syndromes.

BACKGROUND: Exercise stress testing is commonly obtained after percutaneous coronary intervention (PCI) performed for acute coronary syndromes (ACS). We compared the relationships between exercise echocardiography and nuclear testing after ACS-related PCI on outcomes and resource use. METHODS: Longitudinal observational study using fee-for-service Medicare claims to identify patients undergoing outpatient exercise stress testing with imaging within 15 months after PCI performed for ACS between 2003 and 2004. RESULTS: Of 63,100 patients undergoing stress testing 3 to 15 months post-PCI, 31,731 (50.3%) underwent an exercise stress test with imaging. Among 29,279 patients undergoing exercise stress testing with imaging, 15.5% received echocardiography. Echocardiography recipients had higher rates of repeat stress testing (adjusted hazard ratio [HR] 2.60, CI 2.19-3.10) compared with those undergoing nuclear imaging in the 90 days after testing, but lower rates of revascularization (adjusted HR 0.87, CI 0.76-0.98) and coronary angiography (adjusted HR 0.88, CI 0.80-0.97). None of these differences persisted subsequent to 90 days after stress testing. Rates of death and readmission for myocardial infarction rates were similar. Total Medicare payments were lower initially after echocardiography (incremental difference $498, CI 488-507), an effect attributed primarily to lower reimbursement for the stress test itself, but not significantly different after 14 months after testing. CONCLUSIONS: In this study using administrative data, echocardiography recipients initially had fewer invasive procedures but higher rates of repeat testing than nuclear testing recipients. However, these differences between echo and nuclear testing did not persist over longer time frames.

Quality of life after late invasive therapy for occluded arteries.

BACKGROUND: The open-artery hypothesis postulates that late opening of an infarct-related artery after myocardial infarction will improve clinical outcomes. We evaluated the quality-of-life and economic outcomes associated with the use of this strategy. METHODS: We compared percutaneous coronary intervention (PCI) plus stenting with medical therapy alone in high-risk patients in stable condition who had a totally occluded infarct-related artery 3 to 28 days after myocardial infarction. In 951 patients (44% of those eligible), we assessed quality of life by means of a battery of tests that included two principal outcome measures, the Duke Activity Status Index (DASI) (which measures cardiac physical function on a scale from 0 to 58, with higher scores indicating better function) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being). Structured quality-of-life interviews were performed at baseline and at 4, 12, and 24 months. Costs of treatment were assessed for 458 of 469 patients in the United States (98%), and 2-year cost-effectiveness was estimated. RESULTS: At 4 months, the medical-therapy group, as compared with the PCI group, had a clinically marginal decrease of 3.4 points in the DASI score (P=0.007). At 1 and 2 years, the differences were smaller. No significant differences in psychological well-being were observed. For the 469 patients in the United States, cumulative 2-year costs were approximately $7,000 higher in the PCI group (P<0.001), and the quality-adjusted survival was marginally longer in the medical-therapy group. CONCLUSIONS: PCI was associated with a marginal advantage in cardiac physical function at 4 months but not thereafter. At 2 years, medical therapy remained significantly less expensive than routine PCI and was associated with marginally longer quality-adjusted survival. (ClinicalTrials.gov number, NCT00004562.)

Downstream procedures and outcomes after stress testing for chest pain without known coronary artery disease in the United States.

BACKGROUND: Millions of Americans with suspected coronary artery disease undergo noninvasive cardiac stress testing annually. Downstream procedures and subsequent outcomes among symptomatic patients without known coronary disease referred for stress testing are not well characterized in contemporary community practice. METHODS: We examined administrative insurance billing data from a national insurance provider from November 2004 through June 2007. After excluding patients with prior cardiac disease or chest pain evaluation, we identified 80,676 people age 40 to 64 years with outpatient cardiac stress testing within 30 days after an office visit for chest pain. We evaluated rates of invasive coronary angiography, coronary revascularization, and cardiovascular events after stress testing. RESULTS: Within 60 days, only 8.8% of stress test patients underwent cardiac catheterization and only 2.7% underwent revascularization; within 1 year, only 0.5% died and had myocardial infarction or stroke. There were marked geographic variations in 1-year rates of catheterization (3.8%-14.8%) and revascularization (1.2%-3.0%) across 20 hospital referral regions. CONCLUSIONS: In this large national cohort of middle-aged patients without previously coded cardiac diagnosis who were referred for stress testing after outpatient chest pain evaluation, few proceeded to invasive angiography or revascularization, and subsequent cardiovascular events were infrequent.

Nonfatal myocardial infarction and long-term outcomes in coronary artery disease.

BACKGROUND: Therapies may reduce short-term rates of nonfatal myocardial infarction (MI) without a detectable effect on mortality. We sought to estimate the long-term clinical implications of nonfatal MI occurring within the first 3 and 6 months after initial cardiac catheterization. METHODS: We included consecutive patients with significant coronary artery disease (≥75% stenosis in ≥1 epicardial segments) undergoing diagnostic catheterization between January 1, 1999, and September 30, 2006. Landmark analyses were performed for patients surviving at 3- and 6-month follow-up. At these times, patients were divided into groups based upon occurrence of a nonfatal MI subsequent to catheterization. RESULTS: Among 14,890 patients alive at 3 months (669 with MI and 14,221 without an MI), having an MI during the initial 3-month period was a significant predictor of reduced 4-year survival (77.1% vs 83.5%, hazard ratio 1.40, 95% CI 1.21-1.63, P < .001), survival free of MI (68.4% vs 78.5%, hazard ratio 1.50, 95% CI 1.32-1.71, P < .001), and survival free of MI or revascularization (59.7% vs 68.5%, hazard ratio 1.34, 95% CI 1.19-1.51, P < .001). Adjusted hazard ratios were similar for patients surviving to 6 months (804 with MI and 13,842 without an MI). CONCLUSIONS: Nonfatal MIs occurring within the first 3 and 6 months after diagnostic catheterization are associated with a significant increase in the risk for subsequent clinical events. Clinical studies with limited follow-up periods may underestimate the long-term value of therapies that reduce early MI rates as downstream benefits continue to accrue over time.

Evolving Cost-Quality Relationship in Pediatric Heart Surgery.

BACKGROUND: For the more than 40,000 children in the United States undergoing congenital heart surgery annually, the relationship between hospital quality and costs remains unclear. Prior studies report conflicting results and clinical outcomes have continued to improve over time. We examined a large contemporary cohort, aiming to better inform ongoing initiatives seeking to optimize health care value in this population. METHODS: Clinical information (The Society of Thoracic Surgeons Congenital Database) was merged with standardized cost data (Pediatric Health Information Systems) for children undergoing heart surgery from 2010 to 2015. In-hospital cost variability was analyzed using Bayesian hierarchical models adjusted for case-mix. Quality metrics examined included in-hospital mortality, postoperative complications, postoperative length of stay (PLOS), and a composite. RESULTS: Overall, 32 hospitals (n = 45,315 patients) were included. Median adjusted cost per case varied across hospitals from $67,700 to $51,200 in the high vs low cost tertile (ratio 1.32; 95% credible interval, 1.29 to 1.35), and all quality metrics also varied across hospitals. Across cost tertiles, there were no significant differences in the quality metrics examined, with the exception of PLOS. The PLOS findings were driven by high-risk The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery categories 4 and 5 cases (adjusted median length of stay 16.8 vs 14.9 days in high vs low cost tertile [ratio 1.13, 1.05 to 1.24]), and intensive care unit PLOS. CONCLUSIONS: Contemporary congenital heart surgery costs vary across hospitals but were not associated with most quality metrics examined, highlighting that performance in one area does not necessarily convey to others. Cost variability was associated with PLOS, particularly related to intensive care unit PLOS and high-risk cases. Care processes influencing PLOS may provide targets for value-based initiatives in this population.

Association between physician billing and cardiac stress testing patterns following coronary revascularization.

CONTEXT: The degree to which financial factors may influence use of cardiac stress imaging procedures is unknown. OBJECTIVE: To examine the association of physician billing and nuclear stress and stress echocardiography testing following coronary revascularization. DESIGN, SETTING, AND PATIENTS: Using data from a national health insurance carrier, 17,847 patients were identified between November 1, 2004, and June 30, 2007, who had coronary revascularization and an index cardiac outpatient visit more than 90 days following the procedure. Based on overall billings, physicians were classified as billing for both technical (practice/equipment) and professional (supervision/interpretation) fees, professional fees only, or not billing for either. Logistic regression models were used to evaluate the association between physician billing and use of stress testing, after adjusting for patient and other physician factors. MAIN OUTCOME MEASURES: Incidence of nuclear and echocardiographic stress tests within 30 days of an index cardiac-related outpatient visit. RESULTS: The overall cumulative incidence of nuclear or echocardiography stress testing within 30 days of the index cardiac-related outpatient visit following revascularization was 12.2% (95% CI, 11.8%-12.7%). The cumulative incidence of nuclear stress testing was 12.6% (95% CI, 12.0%-13.2%), 8.8% (95% CI, 7.5%-10.2%), and 5.0% (95% CI, 4.4%-5.7%) among physicians who billed for technical and professional fees, professional fees only, or neither, respectively. For stress echocardiography, the cumulative incidence of testing was 2.8% (95% CI, 2.5%-3.2%), 1.4% (95% CI, 1.0%-1.9%), and 0.4% (95% CI, 0.3%-0.6%) among physicians who billed for the technical and professional fees, professional fees only, or neither, respectively. Adjusted odds ratios (ORs) of nuclear stress testing among patients treated by physicians who billed for technical and professional fees and professional fees only were 2.3 (95% CI, 1.8-2.9) and 1.6 (95% CI, 1.2-2.1), respectively, compared with those patients treated by physicians who did not bill for testing (P < .001). The adjusted OR of stress echocardiography testing among patients treated by physicians billing for both or professional fees only were 12.8 (95% CI, 7.6-21.6) and 7.1 (95% CI, 4.0-12.9), respectively, compared with patients treated by physicians who did not bill for testing (P < .001). CONCLUSION: Nuclear stress testing and stress echocardiography testing following revascularization were more frequent among patients treated by physicians who billed for technical fees, professional fees, or both compared with those treated by physicians who did not bill for these services.

Initial and Longitudinal Cost of Surgical Resection for Lung Cancer.

BACKGROUND: The longitudinal cost of treating patients with non-small cell lung cancer (NSCLC) undergoing surgical resection has not been evaluated. We describe initial and 4-year resource use and cost for NSCLC patients aged 65 years of age or greater who were treated surgically between 2008 and 2013. METHODS: Using clinical data for NSCLC resections from The Society of Thoracic Surgeons General Thoracic Surgery Database linked to Medicare claims, resource use and cost of preoperative staging, surgery, and subsequent care through 4 years were examined ($2017). Cost of hospital-based care was estimated using cost-to-charge ratios; professional services and care in other settings were valued using reimbursements. Inverse probability weighting was used to account for administrative censoring. Outcomes were stratified by pathologic stage and by surgical approach for stage I lobectomy patients. RESULTS: Resection hospitalizations averaged 6 days and cost $31,900. In the first 90 days, costs increased with stage ($12,430 for stage I to $26,350 for stage IV). Costs then declined toward quarterly means more similar among stages. Cumulative costs ranged from $131,032 (stage I) to $205,368 (stage IV). In the stage I lobectomy cohort, patients selected for minimally invasive procedures had lower 4-year costs than did thoracotomy patients ($120,346 versus $136,250). CONCLUSIONS: The 4-year cost of surgical resection for NSCLC was substantial and increased with pathologic stage. Among stage I lobectomy patients, those selected for minimally invasive surgery had lower costs, particularly through 90 days. Potential avenues for improving the value of surgical resection include judicious use of postoperative intensive care and earlier detection and treatment of disease.

Costs Associated With Lobectomy for Lung Cancer: An Analysis Merging STS and Medicare Data.

BACKGROUND: Costs related to care of patients who undergo lobectomy for lung cancer may vary depending on patient, disease, and treating facility characteristics. We aimed to identify underlying case mix factors that contribute to variability of 90-day costs of lobectomy for early-stage lung cancer. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for lobectomy for clinical stage I lung cancer (2008-2013). Demographics, clinical outcomes, and 90-day episode-of-care costs across all care settings were analyzed for patients successfully linked to Medicare data. Hospital costs were estimated from charges using cost-to-charge ratios. Comprehensive regression models were created to identify impact of preoperative patient factors and hospital characteristics on costs, and to delineate additive costs due to perioperative outcomes and complications. RESULTS: The mean 90-day cost for lobectomy was $45,080 ± $38,239. Variables associated with significant additive costs were age greater than or equal to 75 years, American Society of Anesthesiologists classification III or IV, forced expiratory volume in 1 second less than 80% predicted, body mass index less than 18.5 or greater than 35, current or past smoker, cerebrovascular disease, chronic kidney disease, impaired functional status, open thoracotomy, prolonged operative time, government hospitals, metropolitan setting, and geographic location. Patients with 1 or more postoperative complication resulted in an overall mean added cost of $27,259. Added costs increased with the number of complications; isolated recurrent laryngeal nerve paresis ($3,911) and respiratory failure ($35,011) were associated with the least and most additive cost, respectively. CONCLUSIONS: Lobectomy is associated with substantial variability of episode-of-care costs. Variability is driven by patient demographic and clinical factors, hospital characteristics, and the occurrence and severity of complications.

Hospital-Based Resource Use and Costs Among Patients With Idiopathic Pulmonary Fibrosis Enrolled in the Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare and serious condition that is associated with high health-care resource use. The goal of this study was to estimate hospital-related resource use and costs by using a national, prospective registry of patients who were diagnosed with IPF or who had their diagnosis confirmed at the enrolling center in the past 6 months in the United States. METHODS: Participants enrolled between June 5, 2014, and April 12, 2016, in the ongoing Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry were included (N = 300). Time to first hospitalization was analyzed by using Kaplan-Meier methods. Annualized costs were estimated for hospitalizations, ICU admissions, and ED visits. RESULTS: At enrollment, most participants were male (75%), white (95%), commercially insured (64%), smokers (68%), had an FVC between 50% and 80% predicted (66%), and received antifibrotic drugs (55%). During the first 12 months of follow-up, participants averaged 0.11 ED visit, 0.42 hospitalization, 0.08 ICU admission, 2.18 hospital days, and 0.45 ICU day. Probability of hospitalization was 18% and 30% at 6 and 12 months, respectively, and was highest for those with FVC < 50% predicted/diffusing lung capacity for carbon monoxide < 30% predicted. Mean annual costs (95% CI) for ICU admission and inpatient care were $10,098 ($4,732-$16,662) and $13,975 ($8,482-$20,918), respectively, per patient. CONCLUSIONS: IPF is associated with a substantial economic burden incurred by patients requiring hospital care. Future research in IPF should focus on improving clinical outcomes while reducing cost of care in hospitals. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01915511; URL: www.clinicaltrials.gov.

Equivalent Survival Between Lobectomy and Segmentectomy for Clinical Stage IA Lung Cancer.

BACKGROUND: The oncologic efficacy of segmentectomy is controversial. We compared long-term survival in clinical stage IA (T1N0) Medicare patients undergoing lobectomy and segmentectomy in The Society of Thoracic Surgeons database. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was linked to Medicare data in 14,286 lung cancer patients who underwent segmentectomy (n = 1654) or lobectomy (n = 12,632) for clinical stage IA disease from 2002 to 2015. Cox regression was used to create a long-term survival model. Patients were then propensity matched on demographic and clinical variables to derive matched pairs. RESULTS: In Cox modeling segmentectomy was associated with survival similar to lobectomy in the entire cohort (hazard ratio, 1.04; 95% confidence interval, 0.89-1.20; P = .64) and in the matched subcohort. A subanalysis restricted to the 2009 to 2015 population (n = 11,811), when T1a tumors were specified and positron emission tomography results and mediastinal staging procedures were accurately recorded in the database, also showed that segmentectomy and lobectomy continue to have similar survival (hazard ratio, 1.00; 95% confidence interval, 0.87-1.16). Subanalysis of the pathologic N0 patients demonstrated the same results. CONCLUSIONS: Lobectomy and segmentectomy for early-stage lung cancer are equally effective treatments with similar survival. Surgeons from The Society of Thoracic Surgeons database appear to be selecting patients appropriately for sublobar procedures.

Estimating Resource Utilization in Congenital Heart Surgery.

BACKGROUND: Optimal methods to assess resource utilization in congenital heart surgery remain unclear. We compared traditional cost-to-charge ratio methods with newer standardized cost methods that aim to more directly assess resources consumed. METHODS: Clinical data from The Society of Thoracic Surgeons Database were linked with resource use data from the Pediatric Health Information Systems Database (2010 to 2015). Standardized cost methods specific to the congenital heart surgery population were developed and compared with cost-to-charge ratio methods. Resource use in the overall population and variability across hospitals were described using hierarchical mixed effect models adjusting for case-mix. RESULTS: Overall, 43 hospitals (65,331 patients) were included. There were minimal population-level differences in the distribution of resource use as estimated by the two methods. At the hospital level, there was less apparent variability in resource use across centers with the standardized cost vs cost-to-charge ratio method, overall (coefficient of variation 20% vs 25%) and across complexity (The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery [STAT]) categories. When hospitals were categorized into tertiles by resource use, 33% changed classification depending on which resource use method was used (26% by one tertile and 7% by two tertiles). CONCLUSIONS: In this first evaluation of standardized cost methodology in the congenital heart population, we found minimal differences vs traditional methods at the population level. At the hospital level, the magnitude of variation in resource use was less with standardized cost methods, and approximately one third of centers changed resource use categories depending on the methodology used. Because of these differences, care should be taken in future studies and in benchmarking and reporting efforts in selecting optimal methodology.

Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.

OBJECTIVE: In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures. METHODS: Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs. RESULTS: The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165). CONCLUSIONS: Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.

Acute and 1-Year Hospitalization Costs for Acute Myocardial Infarction Treated With Percutaneous Coronary Intervention: Results From the TRANSLATE-ACS Registry.

Background Hospitalization for acute myocardial infarction (MI) in the United States is both common and expensive, but those features alone provide little insight into cost-saving opportunities. Methods and Results To understand the cost drivers during hospitalization for acute MI and in the following year, we prospectively studied 11 969 patients with acute MI undergoing percutaneous coronary intervention at 233 US hospitals (2010-2013) from the TRANSLATE-ACS (Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) registry. Baseline costs were collected in a random subset (n=4619 patients, 54% ST-segment-elevation MI [STEMI]), while follow-up costs out to 1 year were collected for all patients. The mean index length of stay was 3.1 days (for both STEMI and non-STEMI) and mean intensive care unit length of stay was 1.2 days (1.4 days for STEMI and 1.0 days for non-STEMI). Index hospital costs averaged $18 931 ($19 327 for STEMI, $18 465 for non-STEMI), with 45% catheterization laboratory-related and 20% attributable to postprocedure hospital stay. Patient factors, including severity of illness and extent of coronary disease, and hospital characteristics, including for profit status and geographic region, identified significant variations in cost. Intensive care was used for 53% of non-STEMI and increased costs by $3282. Postdischarge 1-year costs averaged $8037, and 48% of patients were rehospitalized (half within 2 months and 57% with a cardiovascular diagnosis). Conclusions While much of the cost of patients with acute MI treated with percutaneous coronary intervention is probably not modifiable by the care team, cost reductions are still possible through quality-preserving practice efficiencies, such as need-based use rather than routine use of intensive care unit for patients with stable non-STEMI. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00097591.

Lack of correlation between short- and long-term performance after lung cancer surgery.

OBJECTIVE: Outcomes for lung cancer surgery are currently measured according to perioperative morbidity and mortality. However, the oncologic efficacy of the surgery is reflected by long-term survival. We examined correlation between measures of short-term and long-term performance for lung cancer surgery. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database linked to Medicare survival data was queried for pathologic stage I lung cancer resected between 2009 and 2013. Two separate multivariable models were created: (1) short-term: avoidance of perioperative major morbidity and mortality; and (2) long-term: 3-year survival. Standardized incidence ratios were calculated for the Society of Thoracic Surgeons programs (participants) to determine risk-adjusted participant performance measures for the short- and long-term time points. Correlation of participant standardized incidence ratios for short- and long-term performance was assessed using the Pearson correlation coefficient. RESULTS: The study population included 12,596 patients from 229 participating programs. One hundred fifty-one participants met minimum volume and follow-up requirements for analysis. Overall, performance for the short-term measure was uniform with only 2 (1.3%) participants performing better than expected and 2 (1.3%) worse than expected. For the long-term measure, 9 (6%) participants achieved better than expected and 5 (3.3%) worse than expected survival. No participant was an above or below average performer for the short- and long-term measures. Further, no correlation was observed between participant short- and long-term performance (Pearson correlation coefficient, 0.12; 95% confidence interval, -0.04 to 0.28; P = .14). CONCLUSIONS: Avoidance of perioperative morbidity and mortality is an incomplete measure of performance in lung cancer surgery. Lung cancer surgery performance metrics should assess the safety of surgery and long-term survival.