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In-Hospital Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Octogenarians.

ABSTRACT: Background Octogenarians have low physiologic reserve and may benefit more from transcatheter aortic valve replacement ( TAVR ) than surgical aortic valve replacement ( SAVR ). Methods and Results This retrospective cohort study based on the National Inpatient Sample included octogenarians who underwent TAVR or SAVR from 2012 to 2015. Crude and standardized-morbidity-ratio-weighted regression models were used to compare in-hospital outcomes. Among 19 145 TAVR and 9815 SAVR hospitalizations, TAVR patients had higher Charlson Comorbidity Index ( CCI ) scores (2.0 versus 0.8, P<0.0001) than SAVR patients. Before weighting, TAVR was associated with significantly shorter length of stay, more home discharges, and lower incidences of acute kidney injury, bleeding, and cardiogenic shock. Associations were consistent across Charlson Comorbidity Index, except for TAVR being associated with greater length of stay reductions among patients with Charlson Comorbidity Index ?2, compared with Charlson Comorbidity Index <2 (change in estimate -3.56 versus -2.61 days, P=0.004). After weighting, TAVR patients had significantly shorter length of stay (change in estimate -3.29 days, 95% CI -3.82, -2.75) and lower odds of transfer to skilled nursing facility (odds ratio 0.34, 95% CI 0.29, 0.41), acute kidney injury (odds ratio 0.55, 95% CI 0.45, 0.68), bleeding (odds ratio 0.44, 95% CI 0.37, 0.53), and cardiogenic shock (odds ratio 0.55, 95% CI 0.33, 0.92), compared with SAVR patients. Odds of permanent pacemaker implantation, transient ischemic attack/stroke, vascular complications, and in-hospital mortality were not significantly different. Conclusions TAVR may be preferred over SAVR in high-risk octogenarians because of shorter length of stay, better discharge disposition, and less acute kidney injury, and bleeding. All octogenarians may benefit more from TAVR , irrespective of comorbidity burden, but additional research is needed to confirm our findings.

SUBMITTER: Sheng SP

PROVIDER: S-EPMC6497334 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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In-Hospital Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Octogenarians.

Sheng Siyuan P SP Strassle Paula D PD Arora Sameer S Kolte Dhaval D Ramm Cassandra J CJ Sitammagari Kranthi K Guha Avirup A Paladugu Madhu B MB Cavender Matthew A MA Vavalle John P JP

Journal of the American Heart Association 20190101 2

Background Octogenarians have low physiologic reserve and may benefit more from transcatheter aortic valve replacement ( TAVR ) than surgical aortic valve replacement ( SAVR ). Methods and Results This retrospective cohort study based on the National Inpatient Sample included octogenarians who underwent TAVR or SAVR from 2012 to 2015. Crude and standardized-morbidity-ratio-weighted regression models were used to compare in-hospital outcomes. Among 19 145 TAVR and 9815 SAVR hospitalizations, TAVR ...[more]

PMID: 30663494

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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:BACKGROUND:Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. OBJECTIVES:The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. METHODS:Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ?3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. RESULTS:In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. CONCLUSIONS:Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.

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).

Dataset Information

In-Hospital Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Octogenarians.

Publications

In-Hospital Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Octogenarians.

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