Key result
The 31 mm CoreValve prosthesis was associated with significantly higher rates of postinterventional pacemaker implantations compared to the 29 mm device (35% vs. 20%; P=0.036).
Why the study?
Does the 31 mm self-expanding CoreValve bioprosthesis have similar procedural safety and short-term outcomes compared to the 29 mm device in patients with severe aortic stenosis?
Cohort (n=104)
Does the 31 mm self-expanding CoreValve bioprosthesis have similar procedural safety and short-term outcomes compared to the 29 mm device in patients with severe aortic stenosis?
Absolute Event Rate: 35% vs 20%
p-value: p=0.036
The 31 mm CoreValve prosthesis is feasible for patients with large annuli but carries a higher risk of requiring a permanent pacemaker compared to the 29 mm device.
May prompt size-specific risk stratification in large-annulus TAVR; leaves open causal size effects on conduction in randomized studies.
BACKGROUND: Transcatheter aortic valve implantation has become an established treatment for severe aortic stenosis in patients with high surgical risk. Due to its specific design, the self-expanding 31 mm CoreValve prosthesis can be technically challenging. This is especially true for patients with large annuli above 27.5 mm for which the CoreValve 31 mm device is the only option. OBJECTIVES: To evaluate procedural results and short-term outcome with the 31 mm CoreValve device in patients with large annuli. METHODS: We retrospectively analyzed 54 patients in whom we implanted a 31 mm self-expanding CoreValve bioprosthesis and compared them to 50 consecutive patients implanted with the smaller 29 mm device within the same period of time. RESULTS: Patients with the 31 mm prosthesis had significantly higher rates of postinterventional pacemaker implantations (35% vs. 20%; P = 0.036) despite similar implantation depths (6.5 ± 4 vs. 7.5 ± 4; P = 0.34). However, the number of deep implantations (>8 mm) was significantly higher (P = 0.045). No significant difference could be observed with respect to cases with ≥Grade 2 postinterventional aortic regurgitation (8% vs. 12.9%; P = 0.5294). Major vascular complications (4% vs. 3.7%; P = ns), 30-day mortality (8% vs. 7.7%; P = ns), and major stroke (3.8% vs. 2%; P = ns) were not different between the 2 groups. CONCLUSION: Despite the technical challenges, procedural results with the 31 mm self-expanding CoreValve prosthesis in large anatomies were similar to those with the smaller sized 29 mm version of the device. However, postinterventional pacemaker rates were significantly higher in the 31 mm cohort despite comparable implantation depths, which might be the result of the specific design of the device.
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Murray et al. (2014) conducted a cohort in severe aortic stenosis (n=104). 31 mm self-expanding CoreValve bioprosthesis vs. 29 mm self-expanding CoreValve bioprosthesis was evaluated on postinterventional pacemaker implantations (p=0.036). The 31 mm CoreValve prosthesis was associated with significantly higher rates of postinterventional pacemaker implantations compared to the 29 mm device (35% vs. 20%; P=0.036).
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