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In this study, the authors conducted an in-depth analysis of the health status of patients enrolled in the TRISCEND II pivotal trial (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device) to help quantify the benefit of intervention for these patients. The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater tricuspid regurgitation (TR) to transcatheter tricuspid valve replacement (TTVR) with the EVOQUE tricuspid valve plus optimal medical therapy (OMT), or OMT alone. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-OS) and the 36-Item Short Form Health Survey. Changes in health status in the span of one year were compared between treatment groups using mixed-effects repeated-measures models. The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 plus or minus 7.6 years, 75.5 percent women, 56.1 percent with massive or torrential TR). Patients had substantially impaired health status at baseline (mean KCCQ-OS 52.1 plus or minus 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 plus or minus 8.4). TTVR plus OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up point. Mean between group differences in the KCCQ-OS favored TTVR plus OMT at each point: 11.8 points (95 percent CI: 7.4-16.3 points) at 30 days, 20.8 points (95 percent CI: 16.1-25.5 points) at six months, and 17.8 points (95 percent CI: 13.0-22.5 points) at one year. Furthermore, TTVR plus OMT improved health status to a greater extent among patients with torrential or massive TR compared to those with severe TR (treatment effect 23.3 versus 22.6 versus 11.3; interaction P = 0.049). At one year, 64.6 percent of TTVR plus OMT patients were alive and well (KCCQ-OS greater than or equal to 60 points and no decline of greater than or equal to 10 points from baseline) compared with 31.0 percent in the OMT-only group. In conclusion, compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR plus OMT resulted in substantial improvement in patients’ symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through six months, and remained durable through one year. 

In the TRISCEND II trial, a total of 400 patients with severe symptomatic tricuspid regurgitation were randomized in a 2:1 ratio to undergo either transcatheter tricuspid valve replacement with medical therapy (valve-replacement group) or medical therapy alone (control group). A total of 267 patients were assigned to the valve replacement group and 133 to the control group. At one-year, tricuspid valve replacement and medical therapy were superior to medical therapy alone, with a win ratio of 2.02 (95 percent confidence interval [CI], 1.56 to 2.62; P<0.001). This was based on a hierarchical composite primary outcome that included death from any cause, implantation of a right ventricular assist device or heart transplantation, post-index tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score, an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 meters on the six-minute walk distance. Patients in the valve replacement group had more wins than the control group with respect to death from any cause (14.8 percent versus 12.5 percent), post-index tricuspid-valve intervention (3.2 percent versus 0.6 percent), and improvements in the KCCQ-OS score (23.1 percent versus 6.0 percent), NYHA class (10.2 percent versus 0.8 percent), and six-minute walk distance (1.1 percent versus 0.9 percent).  

However, the valve replacement group had fewer wins than the control group regarding the annual heart failure hospitalization rate (9.7 percent versus 10.0 percent). Furthermore, severe bleeding occurred in 15.4 percent of the valve replacement group and 5.3 percent of the control group (P=0.003), and new permanent pacemaker implantation was required in 17.4 percent and 2.3 percent, respectively (P<0.001).  

These findings suggest that transcatheter tricuspid valve replacement combined with medical therapy is superior to medical therapy alone in patients with severe tricuspid regurgitation, particular in terms of the primary hierarchical composite outcome, which was primarily driven by improvements in symptoms and quality of life. 

This article provides a consensus-based approach for determining the resectability and optimal management strategies for locally advanced non-small cell lung cancer (NSCLC). The expert panel recommends evaluating resectability through multidisciplinary tumor board (MDT) discussions, with a focus on up-front decisions based on patient operability and tumor biology. It supports neoadjuvant chemoimmunotherapy over adjuvant options for most operable patients without driver mutations, highlighting the increased survival benefits. The guidelines also advise caution with post-induction surgery in patients with extensive or bulky N2 disease, favoring non-surgical treatments unless a multidisciplinary review deems surgery feasible. 
 
This consensus provides evidence-based strategies that integrate modern immunotherapies with surgical options to improve patient outcomes in NSCLC treatment. 

Development of myocardial fibrosis in patients with aortic stenosis precedes left ventricular decompensation and is associated with an adverse long-term prognosis. This study aimed to investigate whether early valve intervention reduces the incidence of all-cause death or unplanned aortic stenosis-related hospitalization in asymptomatic patients with severe aortic stenosis and myocardial fibrosis. In this trial, asymptomatic patients with severe aortic stenosis and myocardial fibrosis were randomized to undergo early valve intervention with either transcatheter or surgical aortic valve replacement or guideline-directed conservative management. The primary outcome was a composite of all-cause death or unplanned aortic stenosis-related hospitalization in a time-to-first-event intention-to-treat analysis. The trial enrolled 224 eligible patients (mean age, 73 years; 63 women [28 percent]), a subset of the originally planned 356 patients. Surgical aortic valve replacement was performed in 80 patients (75 percent), and transcatheter aortic valve intervention in 26 patients (25 percent). The primary end point occurred in 20 of 113 patients (18 percent) in the early intervention group and 25 of 111 patients (23 percent) in the guideline-directed conservative management group (hazard ratio, 0.79 [95 percent CI, 0.44-1.43]; P = 0.44; between-group difference, -4.82 percent [95 percent CI, -15.31 percent to 5.66 percent]). All-cause death occurred in 16 of 113 patients (14 percent) in the early intervention group and 14 of 111 (13 percent) in the guideline-directed group (hazard ratio, 1.22 [95 percent CI, 0.59-2.51]). Unplanned aortic stenosis-related hospitalization occurred in 7 of 113 patients (6 percent) in the early intervention group and 19 of 111 patients (17 percent) in the guideline-directed group, respectively (hazard ratio, 0.37 [95 percent CI, 0.16-0.88]). The authors concluded that in asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization.