Glucocorticoids to reduce permanent pacemaker implantation after TAVI: the GLUCO-TAVI randomised trial

BACKGROUND: Despite the growing demand for transcatheter aortic valve implantation (TAVI), there is no strategy to prevent its most common complication: cardiac conduction disturbances (CCD). These disturbances often necessitate permanent pacemaker implantation (PPI), leading to high morbidity and costs. Post-TAVI CCD may be transient, resulting from inflammation. AIMS: We aimed to evaluate the feasibility, safety, and preliminary efficacy of glucocorticoids in preventing PPI in patients undergoing TAVI. METHODS: This pilot study followed a Prospective Randomised Open-label Blinded Endpoint (PROBE) design. One hundred TAVI patients were randomised 1:1 to standard care or methylprednisolone (7 mg/kg administered 1 hour preprocedure), followed by prednisone (15 mg every 12 hours for 5 days). Electrocardiograms and inflammatory biomarkers were assessed pre- and post-intervention, and at 1 month and 1 year. The primary efficacy endpoint was the 1-month incidence of PPI. Secondary outcomes included 1-year PPI, new left bundle branch block (LBBB), LBBB and PPI, other CCD, mortality, and procedural complications. RESULTS: The primary efficacy outcome occurred in 16% of the control group and 8% of the intervention group, reflecting a 50% relative risk (RR) reduction in PPI (RR 0.50, 95% confidence interval [CI]: 0.16-1.55; p=0.23). There was no significant difference in 1-year PPI (RR 0.67, 95% CI: 0.26-1.73; p=0.41) or new LBBB (RR 1.12, 95% CI: 0.66-1.89; p=0.66). The intervention was safe, without differences in complications, mortality (4% vs 12%; p=0.27), or adverse events (n=3). CONCLUSIONS: Glucocorticoids in TAVI are feasible and safe. The observed numerical difference in PPI did not reach statistical significance. Large-scale trials are needed to confirm the results of this pilot study.