Isolated aortic valve replacement with bio-prostheses in patients age 50 to 65 years: a decade of statewide data on cost and patient outcomes.

BACKGROUND: Guidelines for choice of replacement valve-mechanical versus bio-prosthetic, are well established for patients aged <50 and >65 years. We studied the trends and implications of aortic valve replacement (AVR) with mechanical versus bioprosthetic valve in patients aged 50 to 65 years. METHODS: STS and cost database of 17 centers for isolated AVR surgery were analyzed by dividing them into bioprosthetic valve (BV) or mechanical valve (MV) groups. RESULTS: From 2002 to 2011, 3,690 patients had AVR, 18.6% with MV and 81.4% with BV. Use of BV for all ages increased from 71.5% in 2002 to 87% in 2011. There were 1127 (30.5%) patients in the age group 50-65 years. Use of BV in this group almost doubled, 39.6% in 2002 to 76.8% in 2011. Mean age of patients in BV group was higher (59.2±4.2 years vs. 56.7±4.3 years, P≤0.0001). Preoperative renal failure, heart failure and chronic obstructive pulmonary disease favored use of BV, whereas preoperative atrial fibrillation favored AVR with MV. Mortality (MV 2.2% vs. BV 2.36%) and other postoperative outcomes between the groups were similar. Cost of valve replacement increased for both groups (MV $26,191 in 2002 to $42,592 in 2011; BV $27,404 in 2002 to $44,257 in 2011). CONCLUSIONS: Use of bioprostheses for AVR has increased; this change is more pronounced in patients aged 50-65 years. Specific preoperative risk factors influence the choice of valve for AVR. Postoperative outcomes between the two groups were similar. Long-term implications of this changing practice, in particular, reoperation for bioprosthetic valve degeneration should be examined.

Primary graft dysfunction after heart transplantation: Outcomes and resource utilization.

BACKGROUND: A unified definition of primary graft dysfunction (PGD) after heart transplantation was adopted in 2014, with moderate and severe PGD defined as a need for mechanical circulatory support. While risk factors for PGD are well identified, outcomes and resource utilization have not been well-studied. We examined the resource utilization and associated costs with PGD. METHODS: All adult heart transplantations (2001-2016) from a statewide Society of Thoracic Surgery database were analyzed by dividing them into two groups-with PGD (requiring mechanical circulatory support) and without PGD. RESULTS: Of the 718 heart transplants, 110 (15.3%) patients developed PGD. Prevalence of PGD for the study duration ranged from 3.7% to 22.7% with no significant trend. The most frequently used mechanical circulatory support device was intra-aortic balloon pump (88%), followed by extracorporeal membrane oxygenation (17%), and catheter-based circulatory support devices (3%). There were no significant differences in demographics or preoperative variables between the two groups. Resource utilization such as total intensive care unit hours, ventilation hours, reoperation for bleeding, blood product transfusions, and length of stay were significantly higher in the PGD group. Postoperative complications were also higher in PGD group including operative mortality (31.8% vs 3.8%, P < .0001). The median cost of heart transplantation was significantly higher in the PGD group $229 482 ($126 044-$388 889) vs $101 788 ($72 638-$181 180) P < .0001. CONCLUSION: Primary graft dysfunction following heart transplantation developed in 15% of patients. Patients with PGD had significantly higher complications, resource utilization, and mortality. Preventive measures to address the development of PGD would reduce resource utilization and improve outcomes.

Maximize Reimbursement and Minimize Risk Under the Medicare Access and Children's Health Insurance Program Reauthorization Act (MACRA) and the Quality Payment Program (QPP).

The Congress recently passed legislation to repeal the Sustainable Growth Rate Formula and replace it with the Medicare Access and Children Health Plan Reauthorization Act's Quality Payment Program. The Quality Payment Program is designed to move physician payment from a volume-based to a value-based methodology. There are two pathways of payment that diverge and are differentiated by managing risks or managing rewards. The Merit-based Incentive Payment System (MIPS) is a competitive payment system that is budget neutral and results in defined winners and losers with potential losses/gains in payments from 4% in 2019 to 9% in 2022. Characteristically, this is not dissimilar to the Sustainable Growth Rate Formula of days past but with quality measures applied. The second pathway is that toward Alternative Payment Models (APMs) that allow clinicians to participate in payment models that that provide rewards for higher-quality, lower-cost care with entry bonuses as high as 5%. The Virginia Cardiac Services Quality Initiative, a well-known regional quality collaborative, was awarded a federal grant as a Support and Alignment Network 2.0 in September 2016. As an awardee, the Virginia Cardiac Services Quality Initiative is offering, free of charge, educational support to clinicians to understand the Medicare Access and Children Health Plan Reauthorization Act, MIPS, and APMs. These support services will include on-site education, continual evaluation, and guided transformation of practices to move from MIPS, a very competitive and possibly very difficult system for Society of Thoracic Surgeons members, toward Advanced APMs, where they can self-direct their measurement and rewards, allowing success financially under the Medicare Access and Children Health Plan Reauthorization Act.

Impact of Regional Collaboration on Quality Improvement and Associated Cost Savings in Coronary Artery Bypass Grafting.

BACKGROUND: A statewide database identified prolonged ventilation (PV) and acute renal failure (RF) as the biggest cost drivers after isolated coronary artery bypass grafting. Reducing these complications through regional collaboration should improve outcomes and lower health care costs. METHODS: A total of 27,978 patients who underwent isolated coronary artery bypass grafting were divided into pre- and post-quality improvement initiative groups (early era: 2008 to 2011, n = 15,176; later era: 2012 to 2015, n = 12,802). Focused learning sessions on PV and postoperative RF were undertaken in the earlier era. Incidence of death, PV, and RF in the two groups was analyzed using one-way analysis of variance and Fisher exact tests. RESULTS: The Society of Thoracic Surgeons (STS) predicted risk of mortality and predicted risk of mortality/morbidity were significantly higher in the later era (p < 0.01), as were STS predicted PV (10.1% vs 11.3%) and RF (3.4% vs 3.8%). Despite these increased risks, STS observed-to-expected ratios for mortality and mortality/morbidity fell. Observed rates for PV (10.5% vs 8.8%, p < 0.01) and RF (3.6% vs 2.3%, p < 0.01) were associated with STS observed-to-expected ratios of PV (1.04 vs 0.78) and RF (1.03 vs 0.60). Adjusting for case volume in the two eras, 271 cases of PV and 170 of RF were avoided, with estimated cost savings of $10,212,637 and $8,519,630, respectively. CONCLUSIONS: A regional collaboration using a statewide STS and an all-payor database with focused quality improvement is a powerful tool for change. Despite rising risks for mortality and morbidity, outcomes for PV and RF improved and produced significant cost savings. Applying these efforts nationally can enormously affect patient care and health care costs.

Cost of individual complications following coronary artery bypass grafting.

OBJECTIVE: The financial implications of postoperative complications in cardiac surgery remain poorly understood. The purpose of this study was to define the cost of surgery without complications and demonstrate the incremental cost of each complication. METHODS: All patients undergoing isolated coronary artery bypass grafting (CABG) were evaluated (2006-2015) from a statewide Society of Thoracic Surgeons database collaborative (N = 36,588). Patients were stratified by presence of postoperative complications, including major morbidities as defined by the Society of Thoracic Surgeons (ie, prolonged ventilation, renal failure, reoperation, stroke, and deep sternal wound infection). Hierarchical modeling was used to identify the independent inflation-adjusted cost of each complication while controlling for hospital variation and time. RESULTS: The median age was 64 years, 74.3% were men, and average predicted risk of mortality was 1.9%. A total of 24,738 (67.7%) patients experienced no complications at an average cost of $36,580. Each complication independently increases the cost of care and resulted in an exponential increase in cost. After accounting for incidence and incremental costs, institutions in our collaborative have spent an estimated $59.1 million on prolonged ventilation, $8.3 million on renal failure, $7.6 million on reoperation, $3.3 million on stroke, and $256,000 on deep sternal wound infections over the past 10 years. CONCLUSIONS: The average cost of CABG without complication was $36,580. Each additional major complication resulted in an exponential increase in cost. Over the past 10 years, the total cost of complications after isolated CABG was $78.6 million, emphasizing the importance of quality improvement projects to contain costs.

Coronary artery bypass grafting bundled payment proposal will have significant financial impact on hospitals.

OBJECTIVES: The Centers for Medicare and Medicaid Services plans to institute a 5-year trial of bundled payments for coronary artery bypass grafting through 90 days after discharge. To investigate the impact, we reviewed actual inpatient costs for patients undergoing bypass surgery relative to the target price. METHODS: A total of 13,276 Medicare patients with estimated cost data underwent isolated coronary artery bypass grafting from 2008 to 2015 in 18 hospitals over 8 Medicare-defined regions within the Commonwealth of Virginia. Actual 2015 inpatient costs were compared with estimated target prices for each year of the pilot, based on the previous 3 years and stratified by Diagnosis-Related Group. RESULTS: The mean 2015 cost per patient was $50,394 with high variation (range, $27,862-$74,169). On average, hospitals would receive a refund of $17,682 in year 1, but then owe Medicare increasing amounts up to $367,985 in year 5. If 2015 were the final year of the pilot, 13 of the 18 hospitals (72%) would have owed Medicare for cost overruns averaging $614,270 (range, $67,404-$2,102,292). Costs were below the target price at 5 of 18 hospitals, and the Centers for Medicare and Medicaid Services would have paid them an extra $272,355 on average (range, $88,628-$567,429). CONCLUSIONS: Hospitals will face immediate financial pressure due to average cost increases of 3.6% per year and an automatic reduction in payment. As regional pricing is phased in, hospitals can expect to owe Medicare increasing amounts. The net effect is shifting of financial risks to hospitals, which could restrict access to care for higher-risk patients.

Impact of Medicaid Expansion on Cardiac Surgery Volume and Outcomes.

BACKGROUND: Thirty-one states approved Medicaid expansion after implementation of the Affordable Care Act. The objective of this study was to evaluate the effect of Medicaid expansion on cardiac surgery volume and outcomes comparing one state that expanded to one that did not. METHODS: Data from the Virginia (nonexpansion state) Cardiac Services Quality Initiative and the Michigan (expanded Medicaid, April 2014) Society of Thoracic and Cardiovascular Surgeons Quality Collaborative were analyzed to identify uninsured and Medicaid patients undergoing coronary bypass graft or valve operations, or both. Demographics, operative details, predicted risk scores, and morbidity and mortality rates, stratified by state and compared across era (preexpansion: 18 months before vs postexpansion: 18 months after), were analyzed. RESULTS: In Virginia, there were no differences in volume between eras, whereas in Michigan, there was a significant increase in Medicaid volume (54.4% [558 of 1,026] vs 84.1% [954 of 1,135], p < 0.001) and a corresponding decrease in uninsured volume. In Virginia Medicaid patients, there were no differences in predicted risk of morbidity or mortality or postoperative major morbidities. In Michigan Medicaid patients, a significant decrease in predicted risk of morbidity or mortality (11.9% [8.1% to 20.0%] vs 11.1% [7.7% to 17.9%], p = 0.02) and morbidities (18.3% [102 of 558] vs 13.2% [126 of 954], p = 0.008) was identified. Postexpansion was associated with a decreased risk-adjusted rate of major morbidity (odds ratio, 0.69; 95% confidence interval, 0.51 to 0.91; p = 0.01) in Michigan Medicaid patients. CONCLUSIONS: Medicaid expansion was associated with fewer uninsured cardiac surgery patients and improved predicted risk scores and morbidity rates. In addition to improving health care financing, Medicaid expansion may positively affect patient care and outcomes.

Impact of Transcatheter Technology on Surgical Aortic Valve Replacement Volume, Outcomes, and Cost.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) represents a disruptive technology that is rapidly expanding in use. We evaluated the effect on surgical aortic valve replacement (SAVR) patient selection, outcomes, volume, and cost. METHODS: A total of 11,565 patients who underwent SAVR, with or without coronary artery bypass grafting (2002 to 2015), were evaluated from the Virginia Cardiac Services Quality Initiative database. Patients were stratified by surgical era: pre-TAVR era (2002 to 2008, n = 5,113), early-TAVR era (2009 to 2011, n = 2,709), and commercial-TAVR era (2012 to 2015, n = 3,743). Patient characteristics, outcomes, and resource utilization were analyzed by univariate analyses. RESULTS: Throughout the study period, statewide SAVR volumes increased with median volumes of pre-TAVR: 722 cases/year, early-TAVR: 892 cases/year, and commercial-TAVR: 940 cases/year (p = 0.005). Implementation of TAVR was associated with declining Society of Thoracic Surgeons predicted risk of mortality among SAVR patients (3.7%, 2.6%, and 2.4%; p < 0.0001), despite increasing rates of comorbid disease. The mortality rate was lowest in the current commercial-TAVR era (3.9%, 4.3%, and 3.2%; p = 0.05), and major morbidity decreased throughout the time period (21.2%, 20.5%, and 15.2%; p < 0.0001). The lowest observed-to-expected ratios for both occurred in the commercial-TAVR era (0.9 and 0.9, respectively). Resource utilization increased generally, including total cost increases from $42,835 to $51,923 to $54,710 (p < 0.0001). CONCLUSIONS: At present, SAVR volumes have not been affected by the introduction of TAVR. The outcomes for SAVR continue to improve, potentially due to availability of transcatheter options for high-risk patients. Despite rising costs for SAVR, open approaches still provide a significant cost advantage over TAVR.

Obesity Increases Risk-Adjusted Morbidity, Mortality, and Cost Following Cardiac Surgery.

BACKGROUND: Despite the epidemic rise in obesity, few studies have evaluated the effect of obesity on cost following cardiac surgery. We hypothesized that increasing body mass index (BMI) is associated with worse risk-adjusted outcomes and higher cost. METHODS AND RESULTS: Medical records for 13 637 consecutive patients who underwent coronary artery bypass grafting (9702), aortic (1535) or mitral (837) valve surgery, and combined valve-coronary artery bypass grafting (1663) procedures were extracted from a regional Society of Thoracic Surgeons certified database. Patients were stratified by BMI: normal to overweight (BMI 18.5-30), obese (BMI 30-40), and morbidly obese (BMI >40). Differences in outcomes and cost were compared between BMI strata and also modeled as a continuous function of BMI with adjustment for preoperative risk using Society of Thoracic Surgeons predictive risk indices. Morbidly obese patients incurred nearly 60% greater observed mortality than normal weight patients. Moreover, morbidly obese patients had greater than 2-fold increase in renal failure and 6.5-fold increase in deep sternal wound infection. After risk adjustment, a significant association was found between BMI and mortality (P<0.001) and major morbidity (P<0.001). The risk-adjusted odds ratio for mortality for morbidly obese patients was 1.57 (P=0.02) compared to normal patients. Importantly, risk-adjusted total hospital cost increased with BMI, with 17.2% higher costs in morbidly obese patients. CONCLUSIONS: Higher BMI is associated with increased mortality, major morbidity, and cost for hospital care. As such, BMI should be more strongly considered in risk assessment and resource allocation.

Delayed Sternal Closure After Continuous Flow Left Ventricle Assist Device Implantation: Analysis of Risk Factors and Impact on Outcomes and Costs.

Patient and institutional factors predictive of delayed sternal closure (DSC) practice and its impact on clinical and cost outcomes when compared with primary sternal closure (PSC) following continuous-flow left ventricular assist device (CF-LVAD) implantation were examined. Statewide Society of Thoracic Surgeons and hospital cost data on CF-LVADs implanted were analyzed. Between January 2007 and December 2013, 558 CF-LVADs were implanted (PSC = 464, 83.2%; DSC = 94, 16.8%). Among the six institutions implanting CF-LVADs, DSC practice ranged from 3.1% to 37.8%. Compared with PSC, the DSC group had higher body mass index (BMI), renal failure, anemia, IIb/IIIa inhibitor use, emergency surgery, and extracorporeal membrane oxygenation (ECMO) support. Delayed sternal closure patients had significantly longer bypass time (139 ± 63 min vs. 107.6 ± 42 min) and higher use of intraoperative blood products (82% vs. 69%) and right ventricular assist device (RVAD) support (4.3% vs. 0.2%). Postoperative morbidities and mortality (23.4% vs. 6.5%; p ≤ 0.0001) were higher in the DSC group compared with PSC. Mean hospital costs for DSC were higher than PSC ($249,144 ± 123,273 vs. $155,915 ± 95,032; p ≤ 0.0001). Multivariate predictors of DSC include institution with higher DSC practice, preoperative ECMO support, use of IIb/IIIa inhibitors, tricuspid valve surgery, and intraoperative red blood cell transfusion. Delayed sternal closure was an independent risk factor for postoperative mortality, odds ratio 3.0 (1.2-7.2).

Minimally Invasive Mitral Valve Surgery Provides Excellent Outcomes Without Increased Cost: A Multi-Institutional Analysis.

BACKGROUND: Minimally invasive mitral valve surgery (mini-MVR) has grown in popularity. Although single centers have reported excellent outcomes, data on real-world outcomes and costs of mini-MVR are limited. Moreover, mini-MVR has been criticized as adding additional cost without clear benefit. We hypothesized that mini-MVR provides superior outcomes with incremental increased costs in a multi-institutional cohort. METHODS: Records for patients undergoing mitral valve surgical procedures with or without atrial ablation from 2011 to 2014 were extracted from a multi-institutional, regional Society of Thoracic Surgeons database and stratified according to right chest approach/minimally invasive or conventional sternotomy. Patients undergoing coronary artery bypass grafting or other concomitant procedures were excluded. Patients undergoing isolated mitral surgical procedure were propensity matched according to factors, including age, comorbidities, and preoperative laboratory values; clinical outcomes and cost differences were assessed by approach. RESULTS: A total of 1,304 patients underwent mitral operations, including 425 (32.6%) by minimally invasive approach. In the propensity-matched analysis (n = 355 per group), patients undergoing mini-MVR had similar rates of mortality, stroke, and other complications compared with conventional MVR. Meanwhile, patients with mini-MVR experienced shorter intensive care unit and hospital lengths of stay and fewer transfusions. Importantly, total hospital costs were no different between the two matched groups. CONCLUSIONS: Compared with conventional sternotomy, mini-MVR in the "real world" demonstrated no differences in rates of major morbidity, but it was associated with shorter length of stay and fewer transfusions. Contrary to our hypothesis, mini-MVR can be performed with similar total hospital costs as conventional sternotomy. In summary, minimally invasive mitral surgical procedure in select patients can provide superior outcomes without increased cost.

Cost, quality, and value in coronary artery bypass grafting.

OBJECTIVE: Pay-for-performance measures, part of the Affordable Care Act, aim to reduce health care costs by linking value with Medicare payments, but until now the concept of value has not been applied to specific procedures. We sought to define value in coronary artery bypass grafting (CABG) and provide a framework to identify high-value centers. METHODS: In a multiinstitutional statewide database, clinical patient-level data from 42,839 patients undergoing CABG were matched with cost data. Hierarchical models adjusting for relevant preoperative patient characteristics and comorbidities were used to estimate center-specific risk-adjusted costs and risk-adjusted postoperative length of stay. Variation in value across centers was assessed by the correlation between risk-adjusted measures of quality (mortality, morbidity/mortality) and resource use (costs and length of stay). RESULTS: There were no significant correlations between risk-adjusted costs and risk-adjusted mortality (r = 0.20, P = .45) or morbidity/mortality (r = 0.15, P = .57) across centers. Risk-adjusted costs and length of stay were not significantly associated (r = 0.23, P = .37) because of cost accounting differences across centers. This may explain the lack of correlation between risk-adjusted quality and risk-adjusted cost measures. When risk-adjusted length of stay and morbidity/mortality were used for the framework, there was a strong positive correlation (r = 0.67, P = .003), indicating that higher risk-adjusted quality is associated with shorter risk-adjusted length of stay. CONCLUSIONS: Risk-adjusted length of stay and risk-adjusted combined morbidity/mortality are important outcome measures for assessing value in cardiac surgery. The proposed framework can be used to define value in CABG and identify high-value centers, thereby providing information for quality improvement and pay-for-performance initiatives.

Prediction of costs and length of stay in coronary artery bypass grafting.

BACKGROUND: Although more than 200,000 bypass operations are performed in the United States annually, few data exist on the predictors of costs and resource use for this procedure. Questions related to clinical outcomes, costs, and resource use in coronary artery bypass grafting (CABG) were addressed. METHODS: In a multiinstitutional statewide database, patient level data from 42,839 patients undergoing isolated CABG were combined with cost data. After adjustment for cost-to-charge ratios and inflation, the association of length of stay and costs with the Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) was analyzed. Patients were randomly divided into development (60%) and validation (40%) cohorts. Regression models were developed to analyze the impact of patient characteristics, comorbidities, and adverse events on postoperative length of stay and total costs. RESULTS: Postoperative length of stay and total direct costs for CABG averaged 6.9 days and $38,847. Length of stay and costs increased from 5.4 days and $33,275 in the lowest-risk decile (mean STS-PROM of 0.6%) to 13.8 days and $69,122 in the highest-risk decile (mean STS-PROM 19%). Compared with adverse events, patient characteristics had little impact on length of stay and costs. on validation, the models that combined preoperative and postoperative variables explained variance better (R(2) = 0.51 for length of stay; R(2) = 0.47 for costs) and were better calibrated than the preoperative models (R(2) = 0.10 for length of stay; R(2) = 0.14 for costs). CONCLUSIONS: The STS-PROM and preoperative regression models are useful for preoperative prediction of costs and length of stay for groups of patients, case-mix adjustment in hospital benchmarking, and pay for performance measures. The combined preoperative and postoperative models identify incremental costs and length of stay associated with adverse events and are more suitable for prioritizing quality improvement efforts.

Costs for surgical aortic valve replacement according to preoperative risk categories.

BACKGROUND: The introduction of transcatheter aortic valve replacement (TAVR) led to more rigorous evaluation of surgical aortic valve replacement (SAVR) as a benchmark for TAVR. However, limited real-life cost data of SAVR are available. Therefore, the purpose of our study was to assess actual costs and resource utilization of SAVR in patients at different operating risk. METHODS: Study data were drawn from a multi-institutional statewide database comprised of all cardiac surgical procedures in the Commonwealth of Virginia. The study included 2,530 elective, primary, isolated SAVRs performed from 2003 to 2012. Clinical data were matched with universal billing data. Patients were stratified into low-, intermediate- and high-risk categories according to the Society of Thoracic Surgeons- Predicted Risk of Mortality (STS-PROM) score: 0% to 4%, 4% to 8% , and greater than 8%, respectively. Clinical outcomes, resource use, and costs were compared between categories. RESULTS: With increasing risk, there were higher rates of postoperative mortality (low 1.2% versus intermediate 2.7% versus high 6.2%, p < 0.001) and renal failure (2.7% vs 7.2% vs 10.6%; p < 0.001). The proportion of patients with any postoperative complication was higher with increasing risk (34% vs 48% vs 53%; p < 0.001). Length-of-stay increased from 6.8 days in the low-risk category to 10.2 and 11.3 days in the intermediate- and high-risk category, respectively (p < 0.001). There was an increase in mean total costs from the low- (n = 2,002) to intermediate- (n = 415) to high-risk (n = 113) category ($35,021 ± $22,642 vs $46,101 ± $42,460 vs $51,145 ± $31,655; p < 0.001). CONCLUSIONS: Higher STS-PROM was significantly associated with higher postoperative mortality, complications, length-of-stay, and costs. The SAVR cost data provide a basis for the analysis of TAVR cost-effectiveness and its impact on payment systems.