Dataset Information

Association Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes.

ABSTRACT:

Importance

The 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.

Objective

To 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 participants

This 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 measures

The 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.

Results

Among 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 relevance

Hospitals 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.

SUBMITTER: Mao J

PROVIDER: S-EPMC6583695 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceWith the approval of transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis at intermediate surgical risk, TAVR volume is projected to increase exponentially in the United States. The 30-day readmission rate for TAVR was recently reported at 17.9%. The association between institutional TAVR volume and the 30-day readmission metric has not been examined.ObjectiveTo assess the association between hospital TAVR volume and 30-day readmission.Design, setting, and participantsIn this observational study, we used the 2014 Nationwide Readmissions Database to identify hospitals with established TAVR programs (performing at least 5 TAVRs in the first quarter of 2014). Based on annual TAVR volume, hospitals were classified as low (<50), medium (≥50 to <100), and high (≥100) volume. Rates, causes, and costs of 30-day readmissions were compared between low-, medium-, and high-volume hospitals. Data were analyzed from November to December 2016.ExposureTranscatheter aortic valve replacement.Main outcomes and measuresThirty-day readmissions.ResultsOf 129 hospitals included in this study, 20 (15.5%) were categorized as low volume, 47 (36.4%) as medium volume, and 62 (48.1%) as high volume. Of 16 252 index TAVR procedures, 663 (4.1%), 3067 (18.9%), and 12 522 (77.0%) were performed at low-, medium-, and high-volume hospitals, respectively. Thirty-day readmission rates were significantly lower in high-volume compared with medium-volume (adjusted odds ratio, 0.76; 95% CI, 0.68-0.85; P < .001) and low-volume (adjusted odds ratio, 0.75; 95% CI, 0.60-0.92; P = .007) hospitals. Noncardiac readmissions were more common in low-volume hospitals (65.6% vs 60.6% in high-volume hospitals), whereas cardiac readmissions were more common in high-volume hospitals (39.4% vs 34.4% in low-volume hospitals). There were no significant differences in length of stay and costs per readmission among the 3 groups (mean [SD], 5.5 [5.0] days vs 5.9 [7.5] days vs 6.0 [5.8] days; P = .74, and $13 886 [18 333] vs $14 135 [17 939] vs $13 432 [15 725]; P = .63, respectively).Conclusions and relevanceWe report for the first time, to our knowledge, an inverse association between hospital TAVR volume and 30-day readmissions. Lower readmission at higher-volume hospitals was associated with significantly lower cost to the health care system.

Project description:ImportanceThe US Centers for Medicare and Medicaid Services recently released an updated national coverage determination proposal for transcatheter aortic valve replacement (TAVR) that maintains a focus on hospital TAVR volume and percutaneous coronary intervention (PCI) volume, and the national coverage determination for transcatheter mitral valve repair (TMVr) also has PCI volume requirements. However, the associations between hospital PCI volume and TAVR and TMVr outcomes are unknown.ObjectiveTo investigate whether hospital inpatient PCI volume is associated with rates of risk-adjusted in-hospital mortality and 30-day hospital readmission after TAVR and TMVr.Design, setting, and participantsThis population-based cross-sectional study of the 2016 Nationwide Readmissions Database included procedures completed in hospitals with a minimum of 5 TAVR or 5 TMVr procedures between January 1, 2016, and November 30, 2016.ExposuresHospitals were divided into quartiles based on annual inpatient PCI volumes.Main outcomes and measuresPrimary outcomes were in-hospital mortality and 30-day readmission rates. The associations between hospital inpatient PCI quartile and outcomes were evaluated using Kruskal-Wallis tests. Risk adjustment for in-hospital mortality rates was done through inclusion of variables based on the Elixhauser comorbidity classification, and risk adjustment for 30-day readmission rates was done in accordance with the Hospital-Wide Readmission Measure methodology used by the Centers for Medicare and Medicaid Services for public reporting.ResultsThere were 283 hospitals that performed at least 5 TAVRs, with a median inpatient PCI volume of 386 (interquartile range, 299-571) procedures, and 125 hospitals that performed at least 5 TMVr procedures, with a median inpatient PCI volume of 451 (interquartile range, 326-651) procedures. There was no association between hospital inpatient PCI volume and median TAVR risk-standardized in-hospital mortality (median [IQR] rates: bottom quartile, 1.82% [1.77%-1.90%]; second quartile, 1.81% [1.76%-1.86%]; third quartile, 1.81% [1.75%-1.90%]; top quartile, 1.82% [1.76%-1.91%]; P = .75) or the 30-day readmission (median [IQR] rates: bottom quartile, 13.6% [13.2%-14.3%]; second quartile, 13.3% [12.7%-14.0%]; third quartile, 13.5% [12.7%-14.3%]; top quartile, 13.8% [12.8%-14.3%]; P = .10) rates. Similarly, there was no association between hospital inpatient PCI volume and median TMVr risk-standardized in-hospital mortality rates (median [IQR] rates: bottom quartile, 1.84% [1.47%-2.53%]; second quartile, 1.65% [1.21%-3.02%]; third quartile, 1.80% [1.52%-3.58%]; top quartile, 1.76% [1.33%-4.20%]; P = .71) or 30-day readmission rates (median [IQR] rates: bottom quartile, 13.4% [13.1%-13.6%]; second quartile, 13.1% [12.9%-13.5%]; third quartile, 13.1% [12.9%-13.5%]; top quartile, 13.3% [12.8%-13.6%]; P = .30).Conclusions and relevanceIn this study, there was no association between inpatient PCI volume and TAVR or TMVr outcomes. Further evidence is needed to support inclusion of PCI volume minimums in national coverage determination requirements for hospital TAVR and TMVr programs.

Project description:ImportanceHospital outcomes for transcatheter aortic valve replacement (TAVR) may be dependent on the quality of evaluation, personnel, and procedural and postprocedural care common to patients undergoing cardiac surgery.ObjectivesWe sought to assess whether those hospitals with better patient outcomes for surgical aortic valve replacement (SAVR) subsequently achieved better TAVR outcomes after launching TAVR programs.Design, setting, and participantsThis national cohort included US patients 65 years and older. The analysis used the Centers for Medicare and Medicaid Services' Medicare Provider and Review data collected between January 1, 2010, and September 29, 2015. Only hospitals performing at least 1 SAVR prior to September 1, 2011, and performing at least 1 TAVR after this date were included in the analysis. Data analysis was completed from June 2018 to August 2018.InterventionsIsolated aortic valve replacements.Main outcomes and measuresHospital risk-adjusted 30-day mortality for SAVR in the pre-TAVR period was used as a surrogate for SAVR quality. Thirty-day and 1-year TAVR mortality rates were examined after stratification by quartile of baseline hospital risk-adjusted SAVR mortality.ResultsA total of 51 924 TAVR procedures were performed in 519 hospitals, of which 19 798 were performed at hospitals in quartile 1 (the lowest risk-adjusted SAVR mortality rate), 7663 were performed in quartile 2, 10 180 were performed in quartile 3, and 14 283 were performed in quartile 4 (the highest risk-adjusted SAVR mortality rate). Observed mortality rates at 30 days consistently increased with increasing baseline hospital SAVR risk-adjusted mortality (quartile 1, 917 patients [4.6%]; quartile 2, 381 [5.0%]; quartile 3, 521 [5.1%]; quartile 4, 800 [5.6%]; P < .001). The same pattern was observed in 1-year mortality (quartile 1, 3359 [17.0%]; quartile 2, 1337 [17.5%]; quartile 3, 1852 [18.2%]; quartile 4, 2652 [18.6%]; P < .001). After multivariable analysis, compared with the lowest quartile of SAVR mortality, undergoing TAVR at a hospital with higher baseline SAVR mortality continued to be associated with higher 30-day mortality (odds ratios: quartile 2, 1.02 [95% CI, 0.87-1.21]; quartile 3, 1.13 [95% CI, 1.02-1.26]; quartile 4, 1.23 [95% CI, 1.07-1.40]; P = .02) and 1-year mortality (hazard ratios: quartile 2, 1.04 [95% CI, 0.92-1.17]; quartile 3, 1.14 [95% CI, 1.02-1.28]; quartile 4, 1.16 [95% CI, 1.05-1.28]; P = .02).Conclusions and relevanceHospitals with higher SAVR mortality rates also had higher short-term and long-term TAVR mortality after initiating TAVR programs. Quality of cardiac surgical care may be associated with a hospital's performance with new structural heart disease programs.