Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

Abstract

BackgroundPredilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry.MethodsPatients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared. We hypothesised that BAV may be safely omitted in many patients and omission could be associated with procedural benefits.ResultsOverall, 196 consecutive patients underwent TF-TAVI, 56 with BAV and 140 without. The mean age was 81.2±6.2 years, and the mean logistic EuroSCORE I was 17.1±13.6. Device success according to Valve Academic Research Consortium-2 (VARC-2) was achieved in 96.4%. The median procedural duration was shorter without BAV (56 min vs 90 min; p=0.001), as was fluoroscopy time (10 min vs 13 min; p=0.001). The need for balloon postdilation was less frequent in patients without BAV (15.7% vs 30.4%, p=0.029). There was no difference in the proportion of patients meeting the VARC-2 defined composite safety endpoint at 30 days (9.3% without vs 8.9% with BAV; adjusted OR (adjOR) 2.55; 95% CI 0.56 to 18.84) and at 6 months (15.2% without vs 16.4% with BAV; adjOR 1.66; 95% CI 0.49 to 6.55).ConclusionsIn the majority of patients, BAV can be safely omitted from the TAVI procedure without adverse effects. The omission of BAV is associated with shorter procedural duration and could be advantageous for the majority of patients.Trial registration numberNCT02760771.

Impact of balloon predilatation in patients with reduced versus preserved ejection fraction during transcatheter aortic valve implantation

“…However, the PPI rate in our study was only 6.4% with no significant differences between patients with reduced versus preserved EF (7.9% vs. 5.5%; p = 0.37). In addition, Bonaros et al 19 and Schymik et al 20 compared TAVI with and without predilatation and noticed a similar incidence of conduction defects for both groups.…”

Pre-dilation and Post-dilation in Transcatheter Aortic Valve Replacement: Indications, Benefits and Risks

“…In fact, in the EASE-IT TF registry the perceived risk of atrioventricular block was cited as the reason for avoiding pre-BAV in 22% of cases planned for implantation of the Edwards Sapien 3 valve. 6 Nuis et al have previously shown that 46% of new conduction disorders occurring during implantation of the CoreValve system occurred after BAV, with a high proportion persisting at discharge; and similarly, an analysis of the Brazilian TAVR registry demonstrated higher rates of new-onset left bundle branch block (LBBB) that persisted at discharge in patients who received a CoreValve after pre-BAV. 14,26 A 'two-hit model' was proposed by Lange et al, in which the conduction system received a first hit during BAV (resulting in inflammation and intramural haematoma), with the second hit being valve implantation.…”

“…2 versus direct TAVR in studies with balloon-expandable prostheses, selfexpandable prostheses, and in studies containing both types. 2,[5][6][7][8][9][10][11][12][13][14] The result has been a progressive decline in the use of BAV before TAVR, with many registries demonstrating direct TAVR implantation in approximately 50% of patients. 2,15 Given, however, that many of the studies included in these meta-analyses were registries without randomisation or prespecified criteria for pre-BAV versus direct TAVR, it is inevitable that there exists a selection bias in terms of those patients who underwent BAV versus those who had direct TAVR.…”

“…17 Other studies have found additional benefits to the omission of pre-BAV including simplification of the TAVR procedure, resulting in reduced procedure time, reduced contrast volume, fewer cases of acute kidney injury (AKI) and reduced fluoroscopy time; these findings, however, were not replicated in the DIRECTAVI trial. 5,6,12,17,19,20 As such, pre-BAV is likely to remain an important step for some patients, and understanding the potential risks and benefits is essential when choosing the TAVR strategy for an individual patient (Figure 1). These will be discussed in the following sections.…”

“…22 However, the same finding was not replicated in the EASE-IT TF registry and, furthermore, in an analysis of the Brazilian TAVR registry, Bernardi et al reported haemodynamic instability related to valve positioning in those patients undergoing direct TAVR implantation in 2.8% of cases. 6,14 Nonetheless, greater troponin rises have been noted with predilation and rapid pacing, suggesting that the haemodynamic effects of these steps can result in myocardial damage, which should be considered, particularly in patients who have baseline ventricular dysfunction. 12,23…”