Geographically Derived Socioeconomic Factors to Improve Risk Prediction in Patients Having Aortic Valve Replacement.

Socioeconomic status (SES) has been associated with adverse outcomes after cardiac surgery, but is not included in commonly applied risk adjustment models. This study evaluates whether inclusion of SES improves aortic valve replacement (AVR) risk prediction models, as this is the most common elective operation performed at our institution during the study period. All patients who underwent AVR at a single institution from 2005 to 2015 were evaluated. SES measures included unemployment, poverty, household income, home value, educational attainment, housing density, and a validated SES index score. The risk scores for mortality, complications, and increased length of stay were generated using models published by the Society for Thoracic Surgeons. Univariate models were fitted for each SES covariate and multivariable models for mortality, any complication, and prolonged length of stay (PLOS). A total of 1,386 patients underwent AVR with a 2.7% mortality, 15.1% complication rate, and 9.7% PLOS. In univariate models, higher education was associated with decreased mortality (odds ratio [OR] 0.96, p = 0.04) and complications (OR 0.97, p <0.01). Poverty was associated with increased length of stay (OR 1.02, p = 0.02). In the multivariable models, the inclusion of SES covariates increased the area under the curve for mortality (0.735 to 0.750, p = 0.14), for any complications (0.663 to 0.680, p <0.01), and for PLOS (0.749 to 0.751, p = 0.12). The inclusion of census-tract-level socioeconomic factors into the the Society of Thoracic Surgeons risk predication models is new and shows potential to improve risk prediction for outcomes after cardiac surgery. With the possibility of reimbursement and institutional ranking based on these outcomes, this study represents an improvement in risk prediction model.

Outcomes, readmissions, and costs in transfemoral and alterative access transcatheter aortic valve replacement in the US Medicare population.

OBJECTIVE: To comprehensively evaluate and compare utilization, outcomes, and especially costs of transfemoral (TF), transapical (TA), and transaortic (TAO) transcatheter aortic valve replacement (TAVR). METHODS: All Medicare fee-for-service patients undergoing TF (n = 4065), TA (n = 691), or TAO (n = 274) TAVR between January 1, 2011, and November 30, 2012, were identified using Health Care Procedure Classification Codes present on Medicare claims. Hospital charges from Medicare claims were converted to costs using hospital-specific Medicare cost-to-charge ratios. RESULTS: TA and TAO patients were similar in age, race, and common comorbidities. Compared with TF patients, TA and TAO patients were more likely to be female and to have peripheral vascular disease, chronic lung disease, and renal failure. Thirty-day mortality rates were higher among TA and TAO patients than among TF patients (TA, 9.6%; TAO, 8.0%; TF, 5.0%; P < .001). Adjusted mortality beyond 1 year did not differ by access. TA patients were more likely to require cardiopulmonary bypass (CPB). Increased adjusted mortality was associated with CPB (hazard ratio, 2.13; P < .01) and increased 30-day cost ($62,000 [interquartile range (IQR)], $45,100-$86,400 versus $48,800 [IQR, $38,100-$62,900]; P < .01). Cost at 30 days was lowest for TF ($48,600) compared with TA ($49,800; P < .01) and TAO ($53,200; P = .03). CONCLUSIONS: For patients ineligible to receive TF TAVR, TAO and TA approaches offer similar clinical outcomes at similar cost with acceptable operative and 1-year survival, except for higher rates of CPB use in TA patients. CPB was associated with worse survival and increased costs.

Cost and contribution margin of transcatheter versus surgical aortic valve replacement.

OBJECTIVE: To compare the cost of and payments for transcatheter aortic valve replacement (TAVR), a novel and expensive technology, and surgical aortic valve replacement (SAVR). METHODS: Medicare claims provided hospital charges, payments, and outcomes between January and December 2012. Hospital costs and charges were estimated using hospital-specific cost-to-charge ratios. Costs and payments were examined in propensity score- matched TAVR and SAVR patients. RESULTS: Medicare spent $215,770,200 nationally on 4083 patients who underwent TAVR in 2012. Hospital costs were higher for TAVR patients (median, $50,200; interquartile range [IQR], $39,800-$64,300) than for propensity-matched SAVR patients ($45,500; IQR, $34,500-$63,300; P < .01), owing largely to higher estimated medical supply costs, including the implanted valve prosthesis. Postprocedure hospital length of stay (LOS) length was shorter for TAVR patients (median, 5 days [IQR, 4-8 days] vs 7 days [IQR, 5-9 days]; P < .01), as was total intensive care unit (ICU) LOS (median, 2 days [IQR, 0-5 days] vs 3 days [IQR, 1-6 days]; P < .01). Medicare payments were lower for TAVR hospitalizations (median, $49,500; IQR, $36,900-$64,600) than for SAVR (median, $50,400; IQR, $37,400-$65,800; P < .01). The median of the differences between payments and costs (contribution margin) was -$3380 for TAVR hospitalizations and $2390 for SAVR hospitalizations (P < .01). CONCLUSIONS: TAVR accounted for $215 million in Medicare payments in its first year of clinical use. Among SAVR Medicare patients at a similar risk level, TAVR was associated with higher hospital costs despite shorter ICU LOS and hospital LOS. Overall and/or medical device cost reductions are needed for TAVR to have a net neutral financial impact on hospitals.

Variation in use of echocardiography among veterans who use the Veterans Health Administration vs Medicare.

BACKGROUND: Rapid growth in the provision of cardiac imaging tests has led to concerns about overuse. Little is known about the degree to which health care delivery system characteristics influence use and variation in echocardiography. METHODS: We analyzed administrative claims of veterans with heart failure older than 65 years from 2007 to 2010 across 34 metropolitan service areas (MSAs). We compared overall rates and geographic variation in use of transthoracic echocardiography (TTE) between veterans who used the Veterans Health Administration (VA) and propensity-matched veterans who used Medicare. "Dual users" were excluded. RESULTS: There were no significant differences in clinical characteristics or mortality between the propensity-matched cohorts (overall n = 30,404 veterans, mean age 76 years, mortality rate 52%). The Medicare cohort had a significantly higher overall rate of TTE use compared with the VA cohort (1.25 vs 0.38 TTEs per person-year, incidence rate ratio 2.89 [95% CI 2.80-3.00], both P < .001), but a similar coefficient of variation across MSAs (0.36 [95% CI 0.27-0.45] vs 0.48 [95% CI 0.37-0.59]). There was a moderate to strong correlation in variation at the MSA level between cohorts (Spearman r = 0.58, P < .001). CONCLUSION: Overall rates of TTE use were significantly higher in a Medicare cohort compared with a propensity score-matched VA cohort of veterans with heart failure living in urban areas, with similar relative degrees of geographic variation and moderate to strong regional correlation. Rates of TTE use may be strongly influenced by health care system characteristics, but local practice styles influence echocardiography rates irrespective of health system.

Transcatheter and Surgical Aortic Valve Replacement in Dialysis Patients: A Propensity-Matched Comparison.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) clinical trials in North America excluded patients on dialysis and, consequently, the outcomes of TAVR in dialysis-dependent patients remain unknown. METHODS: All Medicare fee-for-service patients undergoing TAVR (n = 5,005) or surgical aortic valve replacement (SAVR) (n = 32,634) between January 1, 2011, and November 30, 2012, were identified using procedural codes collected by the Centers for Medicare & Medicaid Services. Dialysis status and comorbidities were identified using diagnosis codes present on arrival for TAVR hospitalization. Patients supported on dialysis who underwent TAVR (n = 224) were compared with non-dialysis patients who underwent TAVR as well as a propensity-matched group of contemporaneous dialysis patients who underwent SAVR (n = 194 pairs). RESULTS: The TAVR patients on dialysis were younger than non-dialysis TAVR patients (79.2 years vs 84.1 years; p < 0.01) but had higher prevalence of comorbidities. Dialysis TAVR patients had increased mortality at 30 days (13% vs 6%, p < 0.01) and significantly worse survival by Kaplan-Meier analysis. Multivariable regression found dialysis to be independently associated with worse survival (hazard ratio, 1.73; 95% confidence interval, 1.33% to 2.25%, p < 0.01) in TAVR patients. Propensity-matched dialysis SAVR and dialysis TAVR patients had no significant differences in demographic or risk factors. Matched dialysis TAVR patients had shorter length of stay (6 interquartile range, 4 to 10] vs 10 [IQR 7 to 18] days; p < 0.01) and comparable survival. CONCLUSIONS: TAVR in dialysis patients is associated with decreased survival compared with non-dialysis patients; however, it is comparable with SAVR in high risk dialysis patients based on a propensity-matched comparison.

Effect of Clinical Trial Experience on Transcatheter Aortic Valve Replacement Outcomes.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) was approved by the Food and Drug Administration (FDA) in November 2011 after a collaborative technology development process involving professional medical societies, the medical device industry, and the FDA. After FDA approval, TAVR was adopted by numerous hospitals that had not participated in TAVR clinical trials. It is uncertain if outcomes at these hospitals were comparable with those at clinical trial hospitals. METHODS AND RESULTS: All patients with Medicare physician claims for TAVR between January 1, 2011, and November 30, 2012, were identified, and postoperative mortality was assessed using Medicare enrollment data. Risk-adjusted mortality was calculated via a multivariable model that adjusted for demographics and comorbidities. We identified 5009 patients who underwent TAVR, with 3617 TAVRs performed at 68 hospitals that had participated in clinical trials and 1392 TAVRs performed at 140 nontrial hospitals. The preoperative characteristics of patients at trial versus nontrial hospitals were similar. There were no significant differences in risk-adjusted 30-day mortality (5.9% versus 5.6%, odds ratio, 0.88; 95% confidence interval, 0.66-1.15; P=0.34) or 180-day mortality (16.5% versus 15.8%, odds ratio, 0.99; 95% confidence interval, 0.75-1.3; P=0.94). CONCLUSIONS: Patients undergoing TAVR at nontrial hospitals had comparable clinical outcomes to patients undergoing TAVR at clinical trial hospitals. This finding contrasts with several other cardiovascular devices and procedures for which higher mortality was observed at hospitals that did not participate in clinical trials. The unique policy and regulatory environment governing TAVR adoption by hospitals may have contributed to better outcomes during the technology diffusion process.

Increasing Frequency of Left Ventricular Assist Device Exchanges in the United States.

BACKGROUND: Recent reports indicate an increased prevalence and earlier onset of pump thrombosis and associated pump exchanges after left ventricular assist device (LVAD) implantation. Questions remain regarding the current rate and clinical effect of pump exchanges. METHODS: All United States Medicare fee-for-service patients undergoing LVAD implantations (n = 3,166) between January 2009 and December 2012 were identified by procedural codes present on carrier claims collected by the Centers for Medicare & Medicaid Services. Pump exchange, pump removal, heart transplantation, and death were collected from subsequent carrier claim and denominator files. Comorbidities present before implantation were generated using the Elixhauser comorbidity index. RESULTS: Compared with patients who received LVADs before March 1, 2011, LVAD recipients after March 1, 2011, were older on average (63.9 vs 62.2 years, p < 0.01), more likely to be male (82.3% vs. 79.4%, p = 0.04), and had a higher incidence of common comorbidities. The later cohort had higher occurrence of pump exchange by Kaplan-Meier time-to-event estimates and Fisher exact tests at 3 months (1.8 vs 0.8, p = 0.02), 6 months (3.3 vs 1.0, p < 0.01), and 12 months (4.9 vs 2.2, p < 0.01). Cox regression analysis found time-dependent pump exchange was associated with worse survival (hazard ratio, 2.5; 95% confidence interval, 1.8 to 3.62; p < 0.01) after adjusting for age, gender, and comorbidities. CONCLUSIONS: Although LVAD exchanges remain relatively uncommon, a significant increase in the incidence of the procedure has occurred since March 1, 2011. Pump exchanges are highly associated with death, and further research is required to understand the cause of this disturbing trend and surveillance to determine its trajectory.