Journal and News Scan

The DEDICATE-DZHK6 is a non-industry sponsored randomized noninferiority trial conducted at 38 sites in Germany, where patients with severe aortic stenosis who were at low or intermediate surgical risk were randomly assigned to undergo either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). TAVI and SAVR prostheses were selected at the operator's discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at one year. A total of 1,414 patients underwent randomization, 701 to the TAVI group and 713 to the SAVR group). The mean age was 74±4 years, 57 percent were men, and the median Society of Thoracic Surgeons risk score was 1.8 percent. The Kaplan–Meier estimate of the primary outcome at one year was 5.4 percent in the TAVI group and 10 percent in the SAVR group (hazard ratio (HR) for death or stroke, 0.53; 95 percent confidence interval [CI], 0.35 to 0.79; P <0.001 for noninferiority). The incidence of death from any cause was 2.6 percent in the TAVI group and 6.2 percent in the SAVR group (HR 0.43; 95 percent CI, 0.24 to 0.73). The incidence of stroke was 2.9 percent and 4.7 percent in the TAVI and SAVR groups, respectively (HR 0.61; 95 percent CI, 0.35 to 1.06). The authors concluded that among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at one year.

In this recent paper, the authors set out to describe trends and outcomes for patients undergoing surgical aortic valve replacement in the Netherlands. They utilized the Netherlands Heart Registration database to analyze cases completed between 2007 and 2018. A total of 17,142 cases were completed in this time period, with 77.9 percent using a biological prosthesis. Further analysis of patients under 60 years of age showed no difference in ten-year survival between patients undergoing biological versus mechanical prosthesis, but a significant difference in freedom from reintervention, with 90 percent in tissue valves versus 95.9 percent in those receiving a mechanical valve. Overall, the age and risk profile of patients undergoing aortic valve replacement decreased, particularly in those receiving a biological prosthesis.  

This retrospective study used KROK registry data from Poland between 2012 and 2022 to examine six-year survival after treatment for atrial fibrillation (AF), comparing no treatment, surgical ablation (SA), left atrial appendage occlusion (LAAO), or SA plus LAAO. 33,949 patients were included in the final analysis. 81 percent of patients had no AF treatment, 11 percent had SA alone, 4 percent had LAAO alone, and 3 percent had combined SA and LAAO. Compared with no treatment, all other strategies had survival benefits. The gradient of survival benefit was SA and LAAO, then SA, and finally LAAO. Mortality benefits were similar when stratified for surgery type, except for aortic valve surgery, where LAAO alone was worse than no treatment. The findings support the use of both SA and LAAO in surgical management of AF.

The NOTION-2 trial aimed to compare transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in low-risk patients less than 75 years old, including with both tricuspid and bicuspid aortic stenosis (AS). Low-risk patients aged less than 75 years with severe symptomatic AS were enrolled and randomized to TAVI or SAVR. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization related to the procedure, valve, or heart failure at 12 months. A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1 percent. A total of 100 patients had bicuspid AS. While major bleeding and new-onset atrial fibrillation were more common among SAVR patients, non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation were more frequent in the TAVI group. Overall, the rate of the composite of death, stroke, or rehospitalization at one year was similar between TAVI (10.2 percent) and SAVR (7.1 percent). The absolute risk difference was 3.1 percent with a 95 percent confidence interval (CI), −2.7 percent to 8.8 percent; hazard ratio (HR) 1.4, 95 percent CI: 0.7 to 2.9; p = 0.3. The risk of the primary composite endpoint was 8.7 percent and 8.3 percent in patients with tricuspid AS (HR 1.0, 95 percent CI: 0.5 to 2.3) and 14.3 percent and 3.9 percent in patients with bicuspid AS (HR 3.8, 95 percent CI: 0.8 to 18.5) treated with TAVI or SAVR, respectively (P for interaction = 0.1). Based on the results, the authors call for caution in young bicuspid AS TAVI patients.