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

ABSTRACT: 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.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.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).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.

SUBMITTER: Hawkins RB

PROVIDER: S-EPMC5596915 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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

Hawkins Robert B RB Downs Emily A EA Johnston Lily E LE Mehaffey J Hunter JH Fonner Clifford E CE Ghanta Ravi K RK Speir Alan M AM Rich Jeffrey B JB Quader Mohammed A MA Yarboro Leora T LT Ailawadi Gorav G

The Annals of thoracic surgery 20170424 6

<h4>Background</h4>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.<h4>Methods</h4>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- ...[more]

PMID: 28450137

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Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Project description:Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S.Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ?$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S.With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).

Project description:BACKGROUND:Two large, randomized trials are underway evaluating transcatheter aortic valve replacement (AVR) against conventional surgical AVR. We analyzed contemporary, real-world outcomes of surgical AVR in low-risk patients to provide a practical benchmark of outcomes and cost for evaluating current and future transapical AVR technology. METHODS:From 2010 to 2015, 2,505 isolated AVR operations were performed for severe aortic stenosis at 18 statewide cardiac institutions. Of these, 2,138 patients had a Society of Thoracic Surgeons predicted risk of mortality of less than 4%, and 1,119 met other clinical and hemodynamic criteria as outlined in the PARTNER 3 (The Placement of Transcatheter Aortic Valves) protocol. Patients with endocarditis, end-stage renal disease, ejection fraction of less than 0.45, bicuspid valves, and previous valve replacements were excluded. Outcomes of interest included operative death and postoperative adverse events. RESULTS:The median Society of Thoracic Surgeons predicted risk of mortality for the study-eligible patients was 1.44%, with a median age of 72 years (interquartile range [IQR], 65 to 78 years). Operative mortality was 1.3%, permanent stroke was 1.3%, and pacemaker requirement was 4.2%. The most common adverse events were transfusion of 2 or more units of red blood cells (18%) and atrial fibrillation (28%). The median length of stay was 6 days (IQR, 5 to 8 days). Median total hospital cost was $37,999 (IQR, $30,671 to $46,138). Examination of complications by age younger than 65 vs 65 or older demonstrated a significantly lower need for transfusion (11.2%, p < 0.001) and incidence of atrial fibrillation (17.1%, p < 0.001) but no difference in operative mortality (2.2% vs 0.9%, p = 0.1), major morbidity (10.4% vs 12.6%, p = 0.3), or total hospital costs. CONCLUSIONS:Low-risk patients undergoing surgical AVR in the current era have excellent results. The most common complications were atrial fibrillation and bleeding. These real-world results should provide additional context for upcoming transcatheter clinical trial data.

Project description:BackgroundIn patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), studies have suggested that reduced left ventricular (LV) ejection fraction (LVEF) and low aortic valve gradient (AVG) are associated with worse long-term outcomes. Because these conditions commonly coexist, the extent to which they are independently associated with outcomes after TAVR is unknown.ObjectivesThe purpose of this study was to evaluate the impact of LVEF and AVG on clinical outcomes after TAVR and to determine whether the effect of AVG on outcomes is modified by LVEF.MethodsUsing data from 11,292 patients who underwent TAVR as part of the Transcatheter Valve Therapies Registry, we examined rates of 1-year mortality and recurrent heart failure in patients with varying levels of LV dysfunction (LVEF <30% vs. 30% to 50% vs. >50%) and AVG (<40 mm Hg vs. ≥40 mm Hg). Multivariable models were used to estimate the independent effect of AVG and LVEF on outcomes.ResultsDuring the first year of follow-up after TAVR, patients with LV dysfunction and low AVG had higher rates of death and recurrent heart failure. After adjustment for other clinical factors, only low AVG was associated with higher mortality (hazard ratio: 1.21; 95% confidence interval: 1.11 to 1.32; p < 0.001) and higher rates of heart failure (hazard ratio: 1.52; 95% confidence interval: 1.36 to 1.69; p <0.001), whereas the effect of LVEF was no longer significant. There was no evidence of effect modification between AVG and LVEF with respect to either endpoint.ConclusionsIn this series of real-world patients undergoing TAVR, low AVG, but not LV dysfunction, was associated with higher rates of mortality and recurrent heart failure. Although these findings suggest that AVG should be considered when evaluating the risks and benefits of TAVR for individual patients, neither severe LV dysfunction nor low AVG alone or in combination provide sufficient prognostic discrimination to preclude treatment with TAVR.

Dataset Information

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

Publications

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

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