Omission of predilation in balloon-expandable transcatheter aortic valve implantation: retrospective analysis in a large-volume centre
Selected in EuroIntervention by S. Brugaletta
Karsten Hamm, Wilko Reents, Michael Zacher, Philipp Halbfass, Sebastian Kerber, Anno Diegeler, Bernhard Schieffer, Sebastian Barth,
EuroIntervention 2017;13:e161-e167 published online March 2017 published online e-edition June 2017
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What is known
Since the introduction of transcatheter aortic valve implantation (TAVI) into routine clinical practice, balloon valvuloplasty of the stenotic aortic valve prior to the positioning of the TAVI prosthesis has been an integral part of the procedure first described by Cribier. Its rationale is to facilitate passage and full expansion of the TAVI prosthesis in analogy to vascular stent implantation. However, it can have some potential complications such as prolonged hypotension, ventricular fibrillation, cardiopulmonary resuscitation (CPR), thromboembolic events of aortic or valve debris, conduction disorders or annular rupture. Omission of pre-dilation might therefore be beneficial besides simplifying the procedure. The present article analysed procedural characteristics, functional results and clinical outcome with respect to the performance of balloon valvuloplasty in a single center registry.
- 680 patients scheduled for a balloon-expandable TAVI prosthesis between January 2011 and August 2016 were included. Patients treated with or without pre-dilation were compared.
- Procedure times decreased from 85.6±42.9 to 56.7±26.1 minutes (p<0.001), fluoroscopy times from 9.5±5.7 to 6.2±3.9 minutes (p<0.001) and contrast volume from 131.9±60.8 to 85.4±37.4 ml (p<0.001) without pre-dilation.
- Intra-procedural CPR was significantly more frequent in the pre-dilation group (5.3% vs. 1.4%, p=0.01).
- Stroke rate was low at 1.5% and with no detectable difference.
- Applying VARC-2 definitions, the combined endpoints device success (88.3% vs. 92.4%, p=0.07) and clinical efficacy (88.7% vs. 92.4%, p=0.11) were comparable with or without prior valvuloplasty, while early safety was less frequent with pre-dilation (85.2% vs. 90.2%, p=0.04).
- At 30 days, all-cause mortality and cardiovascular mortality were 6.8% with pre-dilation vs. 2.9% without pre-dilation (p=0.03) and 5.3% vs. 1.4% (p=0.01).
Whereas at the beginning of TAVI era, pre-dilatation before valve implantation was mandatory, during the last years, it seems that a safer and faster procedure can be drawn without it. However, only recommendations by experts in the field are available, without data coming from real world. The present article represents a first attempt to understand why to perform a TAVI without pre-dilatation, showing in particular a better mortality without predilation at 30-day. However, two considerations should be done. First, the two groups are not comparable in terms of baseline characteristics. Second, few data are provided on how to decide for a TAVI without pre-dilatation.
Which are the factors that you take into account in deciding to not pre-dilate in a TAVI?