RESUMEN
BACKGROUND: Rapid deployment aortic valves may interfere with the cardiac conduction system. We investigated the need for permanent pacemaker implantation (PPI) following the implantation of Edwards INTUITY valve (Edwards Lifesciences, Irvine, CA). METHODS: One hundred twenty patients underwent aortic valve replacement (AVR) with the INTUITY valve in a combined procedure at the German Heart Centre Munich between April 2016 and December 2019. Twenty-four patients with prior PPI or concomitant ablation procedures (24/120, 20%) were excluded. Patient-specific, procedural and post-procedural outcomes were assessed in the remaining 96 cases. RESULTS: AVR was successful in all cases. Seventy-four percent of the study population were men. Mean age was 69.5±7.6 years. EuroSCORE II was 3.2±2.9. Forty-six patients (46/96, 47.9%) presented with pre-operative conduction disorders, right bundle branch block (RBBB) (17/96, 17.7%) and first-degree or second degree atrio-ventricular block (AVB) (18/96, 18.8%), in particular. In total, 9 patients (9/96, 9.4%) underwent PPI. PPI was required in 3 patients (3/50, 6.0%) who did not have a pre-existing conduction disorder due to new high degree AVB. 6 patients with pre-operative conduction disorders (6/46, 13%) needed PPI. Timing of PPI was 5.2±1.5 days (median 5). Independent predictors of PPI were preoperative RBBB [odds ratio (OR) =4.554, P=0.049] and large valve size (#27) (OR =5.527, P=0.031). CONCLUSIONS: The analysis of the data collected enabled us to identify patient factors associated with higher risk for post-operative PPI following AVR with the INTUITY valve. Patient factors associated with post-operative PPI, were RBBB and large valve size. These patients should be closely monitored following the procedure, in particular.
RESUMEN
BACKGROUND: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial. Ticagrelor, an oral, reversibly binding and direct-acting P2Y12 receptor antagonist, provides a rapid, competent, and consistent platelet inhibition and has shown beneficial results compared with clopidogrel in the subset of patients undergoing bypass surgery in a large previous trial. HYPOTHESIS: Ticagrelor is superior to ASA for the prevention of major cardiovascular events within 1 year after CABG. STUDY DESIGN: The TiCAB trial (NCT01755520) is a multicenter, phase III, double-blind, double-dummy, randomized trial comparing ticagrelor with ASA for the prevention of major cardiovascular events within 12 months after CABG. Patients undergoing CABG will be randomized in a 1:1 fashion to either ticagrelor 90 mg twice daily or ASA 100 mg once daily. The study medication will be started within 24 hours after surgery and maintained for 12 months. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, and repeat revascularization at 12 months after CABG. The sample size is based on an expected event rate of 13% of the primary end point within the first 12 months after randomization in the control group, a 2-sided α level of .0492 (to preserve the overall significance level of .05 after planned interim analysis), a power of 0.80%, 2-sided testing, and an expected relative risk of 0.775 in the active group compared with the control group and a dropout rate of 2%. According to power calculations based on a superiority design for ticagrelor, it is estimated that 3,850 patients should be enrolled. SUMMARY: There is clinical equipoise on the issue of optimal platelet inhibition after CABG. The TiCAB trial will provide a pivotal comparison of the efficacy and safety of ticagrelor compared with ASA after CABG.
