Long-term risk of reintervention after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has surpassed surgical aortic valve replacement (SAVR) as the predominant mode of valve replacement for the treatment of severe aortic stenosis (AS). However, the long-term need for valvular reintervention after TAVR remains unknown. METHODS: Using data from the Medicare Fee for Service 100% dataset, all patients receiving TAVR between July 2011 and December 2020 were identified. Patients were categorized as receiving a valve reintervention (either surgical or transcatheter) or not using the appropriate International Classification of Diseases 10th Revision Procedure Coding System (ICD-10-PCS). A competing risk regression model was used to estimate the cumulative probability of valve reintervention. RESULTS: Of 230,644 TAVR patients were identified, of whom 1,880 received a reintervention. Patients receiving a reintervention were younger and more likely to be male. At 10 years, the crude rate of reintervention was 0.59% within a surviving cohort of 341 patients. After adjusting for the competing risk of death and other covariates, the adjusted cumulative incidence of reintervention at 10 years after TAVR was 1.63%. When the rate of reinterventions was compared between early (2011-2016) and later (2017-2020) time periods, the risk-adjusted rate of reintervention at 4 years had decreased over time (0.85% vs 0.51%). CONCLUSION: The 10-year risk of valve reintervention after TAVR is low and appears to be decreasing over time. Further research is necessary to determine the driving factors contributing to valve reintervention in the current era.

Dose-dependent relation between metformin and the risk of hormone receptor-positive, her2-negative breast cancer among postmenopausal women with type-2 diabetes.

PURPOSE: Metformin has demonstrated a chemoprotective effect in breast cancer but there is limited evidence on the effect of cumulative exposure to metformin and the risk of hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR + /HER2-) breast cancer. This study assessed this risk with dose and intensity of metformin in postmenopausal women with type-2 diabetes mellitus (T2DM). METHODS: This nested case-control study used the Surveillance, Epidemiology, and End Results-Medicare data (2008-2015). Cohort entry was the date of incident T2DM diagnosis. Cases were those diagnosed with HR + /HER2- breast cancer (event date) as their first/only cancer. Non-cancer T2DM controls were matched using variable-ratio-matching. Cumulative dose and average intensity of metformin were measured during the 1-year lookback period. Dose(mg) was categorized as: (1)0, (2)0-30,000, (3)30,001-136,000, (4)136,001-293,000, and (5) > 293,000, and intensity(mg/day) as: 0, 1-500, and > 500. Covariates were conceptualized using the Andersen Behavioral Model. Conditional logistic regression was used to assess the risk of HR + /HER2- breast cancer with metformin-use. RESULTS: There were 690 cases and 2747 controls. The median duration of T2DM was 1178 days in controls and 1180 days in cases. Higher cumulative dose categories: 4 (adjusted odds ratio(aOR) = 0.72, 95% CI 0.55-0.95,p = 0.02), and 5 (OR = 0.60, 95% CI 0.42-0.85,p < 0.01) had significantly lower odds of HR + /HER2- breast cancer compared to category 0. The highest intensity category of metformin had 39% lower odds of HR + /HER2- breast cancer (OR = 0.61, 95% CI 0.46-0.82,p < 0.01) compared to the 0 mg/day group. CONCLUSIONS: Higher metformin exposure was associated with reduced risk of HR + /HER2- breast cancer, adding to the evidence supporting metformin's chemoprotective effect.