Key result
Max-pressure balloon dilation fails to significantly deform semi-rigid or rigid mitral annuloplasty rings.
Why the study?
Pre-procedural balloon annulus dilation is often performed before valve-in-ring transcatheter mitral valve replacement to reduce misalignment and paravalvular leakage, but little evidence exists to support this practice.
Does balloon dilation significantly deform annuloplasty rings prior to valve-in-ring transcatheter mitral valve replacement?
Does balloon dilation significantly deform annuloplasty rings prior to valve-in-ring transcatheter mitral valve replacement?
Balloon dilation does not significantly deform semi-rigid or rigid annuloplasty rings at maximum rated pressures, suggesting that pre-dilation before valve-in-ring transcatheter mitral valve replacement may be unnecessary for these ring types.
Answers are grounded in this paper and cite their sources.
Should not yet alter pre-dilation practice in valve-in-ring TMVR; leaves open need for human validation studies.
ObjectivesAn increasing number of high-risk patients with previous mitral valve annuloplasty require transcatheter mitral valve replacement due to recurrent regurgitation. Annulus dilation with a transcatheter balloon is often performed before valve-in-ring transcatheter mitral valve replacement, which is believed to reduce misalignment and paravalvular leakage, yet little evidence exists to support this practice. Our objective was to generate intuitive annuloplasty ring analyses for improved valve-in-ring transcatheter mitral valve replacement planning.MethodsWe generated a mathematical model that calculates image-tracked differential ring curvature to build quantifications for improved planning for valve-in-ring procedures. Carpentier-Edwards Physio M24 and M30 (n = 2 each), Physio II M24 and M26 (n = 3 each), LivaNova AnnuloFlex M26 (n = 2), and Edwards Geoform M28 (n = 2) rings were tested with a 30-mm Toray Inoue balloon inflated to maximum rated pressures.ResultsCurvature variance reduces with larger ring sizes, indicating that larger rings are initially more circular than smaller ones. Evaluated semi-rigid and rigid rings showed little to no difference between pre- and post-dilation states. Annuloflex rings (flexible band) showed a postdilation variance reduction of 32.83% (P < .001) followed by an increase after 10 minutes of relaxation that was still reduced by 19.62% relative to the initial state (P < .001).ConclusionsWe discovered that balloon dilation does not significantly deform evaluated semi-rigid or rigid rings at maximum rated balloon pressures. This may mean that dilation for these conditions before valve-in-ring transcatheter mitral valve replacement is unnecessary. Our mathematical approach creates a foundation for extended classification of this practice, providing meaningful quantification of ring geometry.
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Park et al. (2023) studied Mitral valve annuloplasty (In vitro model) (n=14). Transcatheter balloon dilation (30-mm Toray Inoue balloon) vs. Initial pre-dilation state was evaluated on Curvature variance change from initial to final state (32.83% variance reduction in flexible Annuloflex rings; no significant change in semi-rigid/rigid rings, p=<0.001). Balloon dilation at maximum rated pressures does not significantly deform evaluated semi-rigid or rigid mitral annuloplasty rings, suggesting that pre-dilation before valve-in-ring transcatheter mitral valve replacement may be unnecessary.
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