Dataset Information

In-hospital outcomes of transapical versus surgical aortic valve replacement: from the U.S. national inpatient sample

ABSTRACT:

OBJECTIVE

To compare the outcomes of transapical transcatheter aortic valve replacement (TA-TAVR) and surgical aortic valve replacement (SAVR) using a large US population sample.

METHODS

The U.S. National Inpatient Sample was queried for all patients who underwent TA-TAVR or SAVR during the years 2016−2017. The primary outcome was all-cause in-hospital mortality. Secondary outcomes were in-hospital stroke, pericardiocentesis, pacemaker insertion, mechanical ventilation, vascular complications, major bleeding, acute kidney injury, length of stay, and cost of hospitalization. Outcomes were modeled using multi-variable logistic regression for binary outcomes and generalized linear models for continuous outcomes.

RESULTS

A total of 1560 TA-TAVR and 44,280 SAVR patients were included. Patients who underwent TA-TAVR were older and frailer. Compared to SAVR, TA-TAVR correlated with a higher mortality (4.5% vs. 2.7%, effect size (SMD) = 0.1) and higher periprocedural complications. Following multivariable analysis, both TA-TAVR and SAVR had a similar adjusted risk for in-hospital mortality. TA-TAVR correlated with lower odds of bleeding with (adjusted OR (aOR) = 0.26; 95% CI: 0.18−0.38;P < 0.001), and a shorter length of stay (adjusted mean ratio (aMR) = 0.77; 95% CI: 0.69−0.84; P < 0.001), but higher cost (aMR = 1.18; 95% CI: 1.10−1.28; P < 0.001). No significant differences in other study outcomes. In subgroup analysis, TA-TAVR in patients with chronic lung disease had higher odds for mortality (aOR = 3.11; 95%CI: 1.37−7.08; P = 0.007).

CONCLUSION

The risk-adjusted analysis showed that TA-TAVR has no advantage over SAVR except for patients with chronic lung disease where TA-TAVR has higher mortality.

SUBMITTER: Abugroun A

PROVIDER: S-EPMC8501380 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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: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.