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Multicenter Study
. 2017 Feb 18;6(2):e004695.
doi: 10.1161/JAHA.116.004695.

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

Glen P Martin  1 , Matthew Sperrin  1 , Rodrigo Bagur  2 , Mark A de Belder  3 , Iain Buchan  1 , Mark Gunning  4 , Peter F Ludman  5 , Mamas A Mamas  6   4   7
Affiliations
Multicenter Study

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

Glen P Martin et al. J Am Heart Assoc. .

Abstract

Background: Aortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short-term outcomes in the UK TAVI registry.

Methods and results: Eleven clinical endpoints were investigated, including 30-day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety. All endpoints were defined as per the VARC-2 definitions. Odd ratios of each endpoint were estimated using logistic regression, with data analyzed in balloon- and self-expandable valve subgroups. Propensity scores were calculated using patient demographics and procedural variables, which were included in the models of each endpoint to adjust for measured confounding. Between 2007 and 2014, 5887 patients met the study inclusion criteria, 1421 (24.1%) of whom had no BAV before TAVI valve deployment. We observed heterogeneity in the use of BAV nationally, both temporally and by center experience; rates of BAV in pre-TAVI workup varied between 30% and 97% across TAVI centers. All endpoints were similar between treatment groups in SAPIEN (Edwards Lifesciences Inc., Irvine, CA) valve patients. After correction for multiple testing, none of the endpoints in CoreValve (Medtronic, Minneapolis, MN) patients were significantly different between patients with or without predilation.

Conclusions: Performing TAVI without predilation was not associated with adverse short-term outcomes post procedure, especially when using a balloon-expandable prosthesis. Randomized trials including different valve types are required to provide conclusive evidence regarding the utility of predilation before-TAVI.

Keywords: aortic stenosis; balloon valvuloplasty; balloon‐expandable; self‐expandable; transcatheter aortic valve implantation.

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Figures

Figure 1
Figure 1
Flow chart illustrating the exclusion criteria applied to the UK TAVI registry. BAV indicates balloon aortic valvuloplasty; TAVI, transcatheter aortic valve implantation.
Figure 2
Figure 2
Longitudinal changes in the proportion of TAVI patients having BAV during‐TAVI BAV (no BAV before TAVI) and direct TAVI in the whole cohort and by access route. BAV indicates balloon aortic valvuloplasty; TAVI, transcatheter aortic valve implantation.
Figure 3
Figure 3
Proportion of patients having during‐TAVI BAV (no BAV prior to TAVI) and direct TAVI over the 32 centers running active TAVI programs in England and Wales by 2014. The centers on the x‐axis have been sorted based on the total number of TAVI procedures each has conducted. BAV indicates balloon aortic valvuloplasty; TAVI, transcatheter aortic valve implantation.
Figure 4
Figure 4
Proportion of patients in each treatment group by center experience. The x‐axis shows the number of TAVI procedures conducted within a center before each patient within that center. BAV indicates balloon aortic valvuloplasty; TAVI, transcatheter aortic valve implantation.
Figure 5
Figure 5
Odds ratios of variables that were identified as independent predictors of a patient being in the during‐TAVI BAV group. BAV indicates balloon aortic valvuloplasty; MI, myocardial infarction; NYHA, New York Heart Association; TF‐Access, transfemoral access route; TAVI, transcatheter aortic valve implantation.
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