Key result
Over-expanding an under-sized SAPIEN 3 Ultra is linked to ~40% fewer major events versus nominal sizing.
Why the study?
For patients with borderline annulus areas between two valve sizes, the optimal sizing strategy for SAPIEN 3 Ultra transcatheter heart valves was unclear.
Does over-expanding an under-sized SAPIEN 3 Ultra transcatheter heart valve reduce the composite of in-hospital mortality, aortic injury, PVL, PPM, stroke, or conversion to surgery in patients with borderline annulus area?
Cohort (n=336)
Yes
Does over-expanding an under-sized SAPIEN 3 Ultra transcatheter heart valve reduce the composite of in-hospital mortality, aortic injury, PVL, PPM, stroke, or conversion to surgery in patients with borderline annulus area?
Absolute Event Rate: 13.69% vs 22.63%
p-value: p=0.04
Overinflating a smaller-sized SAPIEN 3 Ultra transcatheter heart valve may be a safer option with fewer periprocedural complications compared to nominal sizing in patients with borderline annular area.
Should not yet change sizing practice in borderline annuli; leaves open need for randomized confirmation.
BACKGROUND: For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. OBJECTIVES: To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. METHODS: 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. RESULTS: Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. CONCLUSION: Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.
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Basman et al. (2022) conducted a cohort in Borderline annulus area undergoing TAVR (n=336). Over-expanding an under-sized SAPIEN 3 Ultra transcatheter heart valve vs. Nominal-sized THV was evaluated on in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery (p=0.04). Over-expanding an under-sized SAPIEN 3 Ultra valve in patients with borderline annuli reduced the primary composite endpoint compared to nominal sizing (13.69% vs. 22.63%, p=0.04).
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