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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. 

Neurohormonal modulation and afterload reduction are essential for treating heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), therapy with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT). In this study, the authors sought to determine whether TAVR for moderate AS provides clinical benefits to patients with HFrEF in addition to GDMT.  

Patients were randomized to either TAVR or clinical surveillance with aortic valve replacement upon progression to severe AS. The primary end point was the hierarchical occurrence of: 1) all-cause death, 2) disabling stroke, 3) disease-related hospitalizations and heart failure equivalents, and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio. A total of 178 patients were randomized to TAVR (n = 89) or clinical surveillance (n = 89). The mean age was 77 years, 20.8 percent were female, and 55.6 percent were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months).  

A total of 38 (43 percent) patients in the clinical surveillance group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months post randomization. TAVR was associated with wins in 47.6 percent of pairs, compared with 36.6 percent in the clinical surveillance group, resulting in a win ratio of 1.31 (95 percent CI: 0.91-1.88; P = 0.14). At one year, TAVR significantly improved the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the clinical surveillance group (12.8 ± 21.9 points versus 3.2 ± 22.8 points; P = 0.018). The authors concluded that TAVR was not superior to AS clinical surveillance for the primary hierarchical composite end point in patients with moderate AS and HFrEF on GDMT. 

The EARLY TAVR trial investigators randomly assigned patients with asymptomatic severe aortic stenosis to undergo either early transfemoral transcatheter aortic valve replacement (TAVR) or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was conducted in the intention-to-treat population. A total of 901 patients underwent randomization—455 patients were assigned to the TAVR group, and 446 patients were assigned to the clinical surveillance group. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8 percent, and 83.6 percent of patients were classified as low surgical risk. A primary end point event occurred in 122 patients (26.8 percent) in the TAVR group and 202 patients (45.3 percent) in the clinical surveillance group (hazard ratio, 0.50; 95 percent confidence interval, 0.40 to 0.63; P<0.001). In the TAVR and clinical surveillance groups, death occurred in 8.4 percent and 9.2 percent, respectively; stroke occurred in 4.2 percent and 6.7 percent, respectively; and unplanned hospitalization for cardiovascular causes occurred in 20.9 percent and 41.7 percent, respectively. During a median follow-up of 3.8 years, 87.0 percent of patients in the clinical surveillance group underwent aortic-valve replacement. Conversion to TAVR from the clinical surveillance group was 47.2 percent at 12 months. 

This cohort study, called the Real-World Observational Study for Investigating the Prevalence and Therapeutic Options for Atrial Functional Mitral Regurgitation (REVEAL-AFMR), aimed to investigate the prevalence, clinical characteristics, and outcomes of mitral valve (MV) surgery in atrial functional mitral regurgitation (AFMR). The study was conducted across 26 Japanese centers, reviewing all transthoracic echocardiograms performed between January and December 2019 to enroll adult patients with moderate or severe AFMR. Patients who underwent MV surgery, with or without tricuspid valve surgery, were compared to those who did not undergo surgery. The primary outcome was a composite of heart failure hospitalization and all-cause mortality. 
 
Among 177,235 patients who underwent echocardiography, a total of 8,867 had moderate or severe MR. Within this group, 1,007 (11.4 percent) were diagnosed with AFMR (mean [SD] age, 77.8 [9.5] years; 55.7 percent female), and 807 (80.1 percent) had atrial fibrillation. Of these patients, 113 underwent MV surgery, with 92 (81.4 percent) receiving concurrent tricuspid valve surgery. Despite a more severe disease status, only the surgical group showed a decrease in natriuretic peptide levels at follow-up and had a significantly lower rate of the primary outcome (three-year event rates were 18.3 percent versus 33.3 percent; log-rank P = .03). Statistical adjustments did not alter these findings. The authors conclude that in patients with AFMR, MV surgery was associated with lower rates of adverse clinical outcomes.