Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation (RESHAPE-HF2)
Anker S et al. NEJM (August 2024)
Bottom Line: This randomized, controlled trial involved 505 patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. Patients were assigned 1:1 to receive either transcatheter mitral-valve repair with guideline-recommended medical therapy (device group) or medical therapy alone (control group). The primary outcomes were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death at 24 months, the rate of first or recurrent hospitalization for heart failure during 24 months, and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire — Overall Summary (KCCQ-OS; scores ranging from 0 to 100 with higher scores indicating better health status). The intervention group had a significantly lower rate of hospitalization for heart failure or cardiovascular death at 37.0 events per 100 patient-years, compared to 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P=0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P=0.002). The intervention group had better health status, with a mean increase of 21.6±26.9 points in KCCQ-OS score compared to 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 1.6% of patients. Thus, in this patient population, the addition of transcatheter mitral-valve repair led to a lower rate of hospitalization for heart failure or cardiovascular death at 24 months and better health status at 12 months compared to medical therapy alone.
Investigating the effect of enhanced cleaning and disinfection of shared medical equipment on health-care-associated infections in Australia (CLEEN): a stepped-wedge, cluster randomised, controlled trial
Browne K et al. The Lancet (December 2024)
Bottom Line: This study was a stepped-wedge, cluster randomized controlled trial conducted in a single hospital in New South Wales, Australia. The intervention group received 3 additional hours per weekday of enhanced cleaning and disinfection of shared medical equipment by 21 dedicated staff members, while the comparator group received standard environmental cleaning practices over a period of 6 weeks. The primary outcome was the number of confirmed cases of healthcare-associated infections (HAIs) measured through fortnightly point prevalence surveys. The study included 5002 hospitalized patients aged 18 years or older in 10 wards of the selected hospital. Results showed a relative reduction of -34.5% in HAIs following the intervention (odds ratio 0.62, 95% CI 0.45 to 0.80; p=0.0006), with no reported adverse effects. The study highlights the importance of dedicated cleaning approaches for shared medical equipment in reducing HAIs.
Combination of carvedilol with variceal band ligation in prevention of first variceal bleed in Child-Turcotte-Pugh B and C cirrhosis with high-risk oesophageal varices: the ‘CAVARLY TRIAL’
Tevethia HV et al. BMJ (July 2024)
Bottom line: This prospective study compared the effectiveness of carvedilol (group A), variceal band ligation (VBL; group B), and a combination of both (group C) in preventing first variceal bleed in Child-Turcotte-Pugh (CTP) B and C cirrhosis patients with high-risk varices. The primary endpoint was reduction in the incidence of first variceal bleed at 12 months, and secondary endpoints included overall mortality, bleed-related mortality, new-onset decompensation, change in hepatic vein pressure gradient (HVPG), and treatment-related adverse events. The combination arm (group C) showed a significant reduction in incidence of first variceal bleed by 62.9% as compared to group B (HR 0.37, 95% CI 0.192 to 0.716, p<0.003) and by 69.3% as compared with group A (HR 0.31, 95% CI 0.163 to 0.578, <0.001). Overall mortality was 13.6%, with lowest 1-year mortality in group C among the three groups (A, B, C=20%, 14.5%, 6.3%, p=0.012). Reduction in HVPG (20.8% vs 25.1%, p=0.54) and the rate of non-response to carvedilol (53.4% vs 41.25%, p=0.154) were not different between group A and C patients. No significant differences were found in adverse events, including new-onset ascites, spontaneous bacterial peritonitis, shock, acute kidney injury, and post-bleed organ failure, between groups. The study concluded that the combination of carvedilol and VBL is more effective for primary prevention of variceal bleeding in this patient population.
Trial Files Issue #2025-01
