Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation

Abstract

T ranscatheter aortic valve replacement (TAVR) is a complex multistep procedure that has been established as a treatment option for patients with severe aortic stenosis, considered to be inoperable or at high surgical risk. 1 In experienced centers, there has been a trend toward a simplification of the procedure, moving from general anesthesia and surgical cutdown for the femoral access, to a more minimalistic approach with conscious sedation, local anesthesia, and a fully percutaneous approach.2 Likewise, during the early days of TAVR, balloon aortic valve predilatation (BAVP) was considered an essential step to prepare the calcified aortic valve for the correct positioning and deployment of bulkier transcatheter heart valves (THV). Nonetheless, in line with this trend of making the procedure more straightforward, together with the greater experience of the operators and improvement of devices and technique, the need for predilatation has been questioned. Background-Direct

Pre‐Implantation Balloon Aortic Valvuloplasty and Clinical Outcomes Following Transcatheter Aortic Valve Implantation: A Propensity Score Analysis of the UK Registry

“…An important finding of the current study was that there were no significant differences over any of the clinical outcomes between treatment groups in the SAPIEN valve patients. These results are consistent with previous studies . A study that compared 50 transapical access patients with BAV to 50 transapical access patients without BAV found no significant differences in any of the endpoints defined in the VARC‐2 definitions; this finding was later supported with studies on transfemoral access SAPIEN‐TAVI patients .…”

“…Finally, the absence of information regarding hemodynamic performance, valve failure rates, and echocardiographic outcomes means that such outcomes were unable to be analyzed. Similarly, we were unable to investigate technical difficulties, which have previously been indicated in Direct TAVI patients …”

Degree of valve calcification in patients undergoing transfemoral transcatheter aortic valve implantation with and without balloon aortic valvuloplasty: Findings from the multicenter EASE‐IT TF registry

“…An elevated AV calcium burden, asymmetric calcification, or resulting small orifice area (<0.5 cm 2 ) has been suggested as justifiable motives for performing BAV predilation. [7][8][9] It is therefore surprising that the present analysis revealed no significant differences in the volume, distribution, or asymmetry of aortic root calcification between patients that underwent BAV and those that did not. This may be due to the Abbreviations: AnnulusCa, volume of calcification 2 mm inferior to 3 mm superior to the annulus; BAV, balloon aortic valvuloplasty; CAC, coronary artery calcium CC, coronary cusp; LeafletCa, volume of calcification from annulus plane to the superior edge of the leaflets; LVOTCa, volume of calcification 5 mm inferior to the annulus extending to the level of the annulus; OR, odds ratio; PPI, permanent pacemaker implantation; PVR, paravalvular regurgitation.…”

“…However, multiple studies in patients undergoing TF-TAVI with a balloon-expandable valve have now shown predilation to have little or no clinical value, with its omission proving both feasible and safe, without compromising hemodynamic efficacy. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15] Furthermore, a significantly lower contrast agent volume, 1,2 fluoroscopy time, [1][2][3][4] procedural duration, 3 number of pacing periods, 5 and permanent pacemaker implantation (PPI) rate 6 have been reported in patients undergoing TAVI without BAV. Considered alongside the fact that prosthesis size estimation is now largely performed via more reliable, non-invasive imaging techniques, 7 clinical opinion is moving toward the systematic omission of predilation in TAVI.…”

“…Nevertheless, it has been suggested that BAV may still be of value in patients with heavily calcified or severely stenotic valves, in order to aid the crossing of the aortic annulus, avoid instability during device positioning, and prevent prosthesis under-expansion or trapping inside the left ventricle. [7][8][9] As such, the degree of AV calcification is routinely assessed as part of TAVI pre-evaluation using multi-slice computed tomography (MSCT), the gold standard imaging technique for this purpose. 10 This allows pre-procedural identification of a particularly small AV area (AVA) or asymmetrical calcification, among other anatomical features that have been suggested as potential indications for BAV.…”