Dataset Information

Transcatheter Compared With Surgical Aortic Valve Replacement in Patients With Previous Chest-Directed Radiation Therapy.

ABSTRACT:

Background

Cardiac surgery for radiation-induced valvular disease is associated with adverse outcomes. Transcatheter aortic valve replacement (TAVR) is increasingly used in patients with a history of chest-directed radiation therapy and aortic stenosis (CRT-AS).

Objectives

We examined outcomes of TAVR compared with surgical aortic valve replacement (SAVR) for patients with CRT-AS.

Methods

We identified 69 patients with CRT-AS who underwent TAVR from January 2012 to September 2018. Operative mortality, postoperative morbidities, and length of hospitalization were compared with 117 contemporaneous patients with CRT-AS who underwent isolated SAVR. Age-adjusted survival was evaluated by means of Cox proportional hazards modeling.

Results

Compared with SAVR patients, TAVR patients were older (mean age 75 ± 11.5 vs 65 ± 11.5 years), with more comorbidities, such as chronic obstructive pulmonary disease, atrial fibrillation, and peripheral vascular disease (all P < 0.050). Operative mortality was 4.3% for SAVR vs 1.4% for TAVR (P = 0.41). Most SAVR deaths (4 of 5) occurred in the intermediate-/high-risk group (Society for Thoracic Surgeons predicted risk of operative mortality >3%; P = 0.026). The ratio of observed to expected mortality was better for low-risk SAVR patients and all TAVR patients (0.72 [95% confidence interval [CI]: 0.59-0.86] and 0.24 [95% CI: 0.05-0.51], respectively) compared with intermediate-/high-risk SAVR patients (2.52 [95% CI: 0.26-4.13]). SAVR patients had significantly longer median intensive care unit and overall length of stay and higher blood transfusion requirements but similar rates of stroke and pacemaker implantation.

Conclusions

TAVR was associated with excellent in-hospital outcomes and better survival compared with intermediate-/high-risk SAVR in patients with CRT-AS. While SAVR still has a role in low-risk patients or those for whom TAVR is unsuitable for technical or anatomical reasons, TAVR is emerging as the standard of care for intermediate-/high-risk CRT-AS patients.

SUBMITTER: Yazdchi F

PROVIDER: S-EPMC8463724 | 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:BackgroundRandomized 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.ObjectivesThe 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.MethodsUsing 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.ResultsIn 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.ConclusionsAmong 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.