Predictors of conduction system disturbances resulting in a new permanent pacemaker implantation within the Landmark Trial
J. Am. Coll. Cardiol; 84 (18 Suppl. B), 2024
Ano de publicação: 2024
BACKGROUND The need for permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVR) is a serious complication that adds additional risk for the patient. It also lengthens the hospitalization and increases costs. Unknown is the PPMI rate of the new balloon expandable Myval transcatheter hesart valve (THV) series in comparison to the current-generation balloon and self-expandable THVs. We investigated the conduction distur bances and PPMI rates within the LANDMARK trial, a prospective randomized trial comparing the Myval THV series with contemporary THV series (the balloon-expandable Sapien and the self-expanding Evolut THV series) in patients with severe and symptomatic native aortic valve stenosis. METHODS All preprocedure and postprocedure electrograms (ECGs) up to 30 days postimplantation were analyzed, and the need for PPMI was independently assessed within both randomization arms, as well in the patient subsets receiving balloon-expandable and self- expandable THVs. Rates of PPMI among the groups according to preprocedural conduction disturbances, arrhythmia's, patient (age, diabetes mellitus, valve calcification, membranous septum length) and procedural (preimplant and postimplant dilatation) characteris- tics were compared and predictors for PPMI according to the regres sion model evaluated. RESULTS After excluding patients with preprocedure PPMI, cross- over, or no THV recipients, 706 patients with THV remained (352 ра tients in the Myval arm and 354 patients in the contemporary arm). The balloon and self-expandable THV groups consisted of 533 and 173 patients, respectively. Within 30 days post-THV implantation, 55 of 352 (15.6%) in the Myval arm and 65 of 354 (18.4%) in the contem- porary arm received a PPMI (P 0.39). In the balloon and self- expandable THV subsets, these numbers (%) were 88 of 533 (16.5%) and 32 of 173 (18.5%); P=0.63. Among the ECG, patient, and proce- dural baseline variables, patients with right bundle branch block (RBBB) with or without left anterior or posterior fascicular block had the highest PPMI rates (ranging between 30% and 57%) with no sig- nificant differences between the groups. Regression model identified RBBB at baseline as a borderline significant predictor for PPMI in the Myval THV arm (P = 0.059) whereas this was a significant predictor for PPMI in the (P = 0.02) and Evolut (P = 0.002) THV groups.g Presence of moderate calcification were significant pre- dictors for PPMI in the Myval (both P = 0.03 ) and Sapien (both P 0.01) THV groups. Presence of atrial fibrillation was also a significant predictor for PPMI in the overall THV group (P = 0.02) CONCLUSION Compared with contemporary THVs, the new Myval THV has a similar PPMI rate postprocedure. The presence of baseline RBBB with or without fascicular blocks has the highest rate of post- implant PMMI, irrespective of the type of THV. The regression model identified RBBB as a significant predictor for the Sapien and Evolut THV series groups and borderline for the Myval THV series group.