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Comparative Study
. 2024 Jul;104(1):125-133.
doi: 10.1002/ccd.31088. Epub 2024 May 20.

Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience

Ilan Merdler  1 , Brian C Case  1 , Sukhdeep Bhogal  1 , Pavan K Reddy  1 , Cheng Zhang  1 , Syed Ali  1 , Paige E Gallino  1 , Caroline Jackman  1 , Itsik Ben-Dor  1 , Lowell F Satler  1 , Jeffery E Cohen  1 , Toby Rogers  1   2 , Ron Waksman  1
Affiliations
Comparative Study

Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience

Ilan Merdler et al. Catheter Cardiovasc Interv. 2024 Jul.

Abstract

Background: The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time.

Aims: This study aimed to examine whether these changes impacted clinical outcomes.

Methods: EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+ SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared.

Results: Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43).

Conclusion: During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV.

Trial registration: ClinicalTrials.gov NCT03423459.

Keywords: TAVR; aortic stenosis; self‐expanding valve.

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References

REFERENCES

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