NYU Langone Hospital – Long Island is a hospital in Mineola, New York that is the Long Island hospital base of NYU Langone Health System. It was previously known as Nassau Hospital and later Winthrop-University Hospital..
BACKGROUND:Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis. However, long-term outcomes data are lacking for TAVR, particularly with newer-generation transcatheter heart valves. OBJECTIVES:The purpose of this study was to compare 10-year outcomes of intermediate-risk patients who underwent TAVR with the third-generation, balloon-expandable SAPIEN 3 valve in the PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i) with those who underwent surgery in the PARTNER 2A (P2A) randomized trial. METHODS:Intermediate-risk patients were enrolled in the P2A trial from 2011 through 2013 and in the P2S3i registry in 2014. These prospective, multicenter studies used the same eligibility criteria and stratified patients based on suitability for transfemoral or transthoracic (transapical/transaortic) access. Ten-year outcomes were evaluated, including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. Patient reconsent was required at 5 years for extended 10-year follow-up, and vital status sweeps were implemented to improve data completeness for all-cause mortality. To account for potential baseline differences and reduce confounding, P2S3i TAVR patients were propensity score-matched 1:1 to P2A surgical patients. RESULTS:Among 2,005 patients who received a valve, 1,069 underwent TAVR in P2S3i and 936 underwent surgery in P2A. After propensity score matching (N = 783 patients in each group), baseline characteristics were similar between groups: mean age was approximately 82 years, 43% were female, and mean Society of Thoracic Surgeons score was 5.5%. At 10 years, all-cause mortality rate was 83.4% after TAVR and 82.3% after surgery, respectively (HR: 1.01 [95% CI: 0.91-1.13]; P = 0.82). Aortic valve reintervention rates adjusted for competing mortality were 2.0% for TAVR and 1.9% for surgery (P = 0.47). Among 32 TAVR and 30 surgical patients with available echocardiographic data at 10 years, mean gradients were 11.0 mm Hg and 12.6 mm Hg, respectively. CONCLUSIONS:At 10 years, TAVR with the SAPIEN 3 valve and surgery resulted in similar rates of mortality and aortic valve reintervention, and similar hemodynamics in intermediate-risk patients with symptomatic severe aortic stenosis. This analysis highlights challenges associated with extended long-term follow-up of clinical trials, including differential loss to follow-up and the competing risk of mortality in elderly populations. (PARTNER 2A Trial; NCT01314313; PARTNER 2 SAPIEN 3 Intermediate-Risk Registry; NCT03222128).
PURPOSE:We report long-term follow-up on participants in the QUILT-3.032 study in BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) ± papillary disease using nogapendekin alfa inbakicept (NAI) approved by the FDA (ANKTIVA) in combination with BCG. MATERIALS AND METHODS:Participants received 400 mcg NAI in combination with 50 mg BCG through intravesical instillation weekly for 6 weeks, with optional reinduction if complete response (CR) was not achieved at month 3. Primary endpoints were CR rate at any time; secondary endpoints were duration of CR (DOR), progression-free survival, overall survival, disease-specific survival (DSS), and time to cystectomy. RESULTS:The CR rate (n = 100) was 71% (95% CI, 61.1-79.6) with a median DOR of 26.6 months (range, 0.03-53.62). The cystectomy-free rate in the 71 responders at 24 and 36 months was 90.3% (95% CI 79.7-95.6) and 84.2% (95% CI 69.6-92.1), respectively. DSS was 100% (95% CI 100.0-100.0) at 12 months and 98.2% (95% CI 88.2-99.8) at 36 months. Treatment-related adverse events were largely grade 1 to 2 (61%), with 3% grade 3 and no grade 4 or 5 treatment-related adverse event observed with this biological combination. CONCLUSIONS:The CR rate and durability of responses that surpass 53 months reveal the efficacy of NAI in combination with BCG for treating BCG-unresponsive NMIBC with CIS ± Ta/T1 disease. The high cystectomy-free rate of 84% and DSS of 98% at 36 months suggest that NAI plus BCG is a safe and efficacious option for NMIBC with CIS ± Ta/T1 disease.
Objective: Exposure to antidepressants, particularly agents that work through serotonin-reuptake inhibition, may increase potential for bleeding, especially among patients with other bleeding risk factors. There is limited guidance for clinicians in the use of serotonin reuptake inhibitors (SRIs) and other antidepressants in the setting of increased bleeding risk. Methods: A PubMed literature search was conducted for English-language articles (1992-2024) examining the bleeding risk associated with antidepressants. Physicians from the Association of Medicine and Psychiatry then convened to develop consensus recommendations. Results: Consensus recommendations were established for managing antidepressant use in patients with medical and psychiatric comorbidities. Additionally, a clinical decision algorithm was created to assist clinicians in assessing the appropriateness of antidepressant prescribing in patients at risk for bleeding. Conclusions: The proposed algorithm can aid clinicians in determining whether antidepressant (including SRI) initiation, discontinuation, or dose adjustment should be considered for patients susceptible to bleeding. These guidelines preserve a role for clinical judgment in selection of treatments that balance the risks and benefits, which may be particularly relevant for patients with complex medical and psychiatric comorbidities. Additional studies are needed to better guide clinical decision making.
