Key result
TAVI with the large Evolut R 34 valve resulted in lower device success compared to smaller Evolut valves (78.57% vs. 96.6%) due to a higher frequency of moderate paravalvular leaks.
Why the study?
Implantation of larger prostheses in large annuli during TAVI is often associated with more procedural problems that may affect outcomes.
Does TAVI with the large Medtronic Evolut R 34 valve affect device success and safety compared to smaller Evolut valves in patients with severe aortic stenosis?
Observational (n=87)
No
Does TAVI with the large Medtronic Evolut R 34 valve affect device success and safety compared to smaller Evolut valves in patients with severe aortic stenosis?
TAVI with the large 34 mm Evolut R valve is more challenging and associated with lower device success and more paravalvular leaks compared to smaller valves, though 30-day safety remains similar.
May warrant caution selecting the 34 mm Evolut R for TAVI; leaves open need for prospective validation of device performance.
Introduction: Indications for transcatheter aortic valve implantation (TAVI) continue to expand.Very often TAVI must be done in large annuli.Implantation of the bigger prostheses is often associated with more procedural problems, which may affect the outcomes.Aim: To compare the outcomes of TAVI procedures using the self-expandable Medtronic Evolut R 34 with the smaller Evolut R or Evolut Pro 23, 26 or 29.Material and methods: We analysed 87 patients who received self-expandable Medtronic Evolut R and Pro valves.Group I consisted of 59 (67.81%) patients with Evolut 23, 26 or 29, and group II consisted of 28 (32.18%)patients who received an Evolut 34 valve.Results: EuroSCORE II was 5.59 in group I vs 7.87 in group II (p = 0.02).The oversizing rate was higher in group II: 24.1% vs. 18.5% (p < 0.001).The procedure and fluoroscopy times were longer in group II: 209 vs. 187 min (p = 0.03), 44 vs. 27 min (p = 0.01).Moderate paravalvular leak was found more frequently in group II: 5 v 1 (p = 0.04).There was less device success in group II: 22 (78.57%) vs. 57 (96.6%) (p = 0.05).Early safety criteria were similar in both groups: 52 (88.1%) and 24 (92.3%)(p = 0.56).30-day mortality was similar: 4 (6.7%) vs. 0 in group I and II respectively (p = 0.16).Conclusions: TAVI procedures in patients requiring an Evolut R 34 prosthesis are more challenging than in those who need smaller valves.Paravalvular leaks are more frequently observed after TAVI with Evolut R 34, which results in lower device success.
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Wilczek et al. (2023) conducted an observational in Severe aortic stenosis (n=87). Medtronic Evolut R 34 valve vs. Medtronic Evolut R and PRO 26 and 29 valves was evaluated on Device success (VARC-2 criteria) (p=0.05). TAVI with the large Evolut R 34 valve resulted in lower device success compared to smaller Evolut valves (78.57% vs. 96.6%) due to a higher frequency of moderate paravalvular leaks.
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