Key result
Low calcification burden is linked to ~1.3 mL greater TAVI deployment balloon overfilling volumes.
Why the study?
Data on deployment balloon overfilling strategies during balloon-expandable TAVI in aortic annuli above 29 mm in daily clinical practice were scarce.
What deployment balloon overfilling strategies are utilized and are they safe and effective during TAVI with balloon-expandable valves in patients with large aortic annuli?
Observational (n=45)
What deployment balloon overfilling strategies are utilized and are they safe and effective during TAVI with balloon-expandable valves in patients with large aortic annuli?
In TAVI for large aortic annuli (>29 mm), the extent of deployment balloon overfilling is safely tailored based on calcification burden, with profound overfilling used in mildly calcified valves.
Variable overfilling volumes used in large-annuli BE-TAVI; leaves open optimal strategy and safety data.
OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. METHODS: Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. RESULTS: Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. CONCLUSION: Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.
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Schneeberger et al. (2023) conducted an observational in Aortic valve stenosis with large aortic annuli (n=45). Low calcification burden (<750 mm³) vs. Significant calcification burden (≥750 mm³) was evaluated on Overfilling volumina of the deployment balloon (p=<0.001). Patients with a low calcification burden (<750 mm³) had significantly higher deployment balloon overfilling volumes compared to those with significant calcification (2.1 vs. 0.8 mL; p<0.001).
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