Aortic Valve Stenosis Treatment Disparities in the Underserved: JACC Council Perspectives.

Underserved minorities make up a disproportionately small subset of patients in the United States undergoing transcatheter and surgical aortic valve replacement for aortic stenosis. The reasons for these treatment gaps include differences in disease prevalence and patient, health care system, and disease-related factors. This has major implications not only for minority patients, but also for other groups who face similar challenges in accessing state-of-the-art care for structural heart disease. The authors propose the following key strategies to address these treatment disparities: 1) implementation of measure-based quality improvement programs; 2) effective culturally competent communication and team-based care; 3) improving patient health care access, education, and effective diagnosis; and 4) changing the research paradigm that creates an innovation pipeline for patients. Only a concerted effort from all stakeholders will achieve equitable and broad application of this and other novel structural heart disease treatment modalities in the future.

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.

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.

Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR).

BACKGROUND: The care pathway for patients undergoing transcatheter aortic valve replacement (TAVR), particularly in the US, was initially based on open surgical techniques and often includes general anesthesia, transesophageal echocardiographic monitoring, and cardiothoracic intensive care unit (ICU) stays. Whether a subgroup of patients could benefit from early extubation, fewer days in the ICU, and early ambulation in terms of both cost and effectiveness is unknown. METHODS AND RESULTS: A fast track (FT) protocol was initiated at two institutions in our health system with specific inclusion criteria. Patients with complications or morbidity post procedure deemed ineligible to continue on the FT pathway were designated as deviations. Baseline characteristics, success and deviations, subsequent course, and direct costs were compared for FT eligible and ineligible patients over a 6-month study period. Among 99 patients undergoing Transfemoral TAVR, 39 (39%) met FT inclusion criteria. The mean age of eligible and ineligible patients was similar at 85 years, but by design, eligible patients had fewer co-morbid conditions. Successful completion of the FT protocol was achieved in 28 patients (72%). Patients on the FT had shorter ICU stays (28 ± 103 vs 45 ± 46 hours, P < 0.0001) and post-operative length of stay (4.3 ± 4.4 vs 7.2 ± 5.3 days, P < 0.0001), and incurred lower direct costs ($44,923 ± $14,187 vs $56, 339 ± 17,808, P < 0.0001). CONCLUSIONS: It is feasible to identify a large percentage of suitable patients preprocedure who are eligible for a FT postprocedure care pathway. There was no evidence for compromise of care and successful completion of the pathway was associated with shorter length of stay and fewer direct costs.

Five-year follow-up of patients treated for coronary artery disease in the face of an increasing burden of co-morbidity and disease complexity (from the NHLBI Dynamic Registry).

Management of coronary artery disease (CAD) has evolved over the past decade, but there are few prospective studies evaluating long-term outcomes in a real-world setting of evolving technical approaches and secondary prevention. The aim of this study was to determine how the mortality and morbidity of CAD has changed in patients who have undergone percutaneous coronary intervention (PCI), in the setting of co-morbidities and evolving management. The National Heart, Lung, and Blood Institute Dynamic Registry was a cohort study of patients undergoing PCI at various time points. Cohorts were enrolled in 1999 (cohort 2, n = 2,105), 2004 (cohort 4, n = 2,112), and 2006 (cohort 5, n = 2,176), and each was followed out to 5 years. Primary outcomes were death, myocardial infarction (MI), coronary artery bypass grafting, repeat PCI, and repeat revascularization. Secondary outcomes were PCI for new obstructive lesions at 5 years, 5-year rates of death and MI stratified by the severity of coronary artery and co-morbid disease. Over time, patients were more likely to have multiple co-morbidities and more severe CAD. Despite greater disease severity, there was no significant difference in death (16.5% vs 17.6%, adjusted hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.74 to 1.08), MI (11.0% vs 10.6%, adjusted HR 0.87, 95% CI 0.70 to 1.08), or repeat PCI (20.4% vs 22.2%, adjusted HR 0.98, 95% CI 0.85 to 1.17) at 5-year follow-up, but there was a significant decrease in coronary artery bypass grafting (9.1% vs 4.3%, adjusted HR 0.44, 95% CI 0.32 to 0.59). Patients with 5 co-morbidities had a 40% to 60% death rate at 5 years. There was a modestly high rate of repeat PCI for new lesions, indicating a potential failure of secondary prevention for this population in the face of increasing co-morbidity. Overall 5-year rates of death, MI, repeat PCI, and repeat PCI for new lesions did not change significantly in the context of increased co-morbidities and complex disease.