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

• Published in: Catheterization and cardiovascular interventions Vol. 104; no. 1; pp. 125 - 133
• Main Authors: Merdler, Ilan, Case, Brian C., Bhogal, Sukhdeep, Reddy, Pavan K., Zhang, Cheng, Ali, Syed, Gallino, Paige E., Jackman, Caroline, Ben‐Dor, Itsik, Satler, Lowell F., Cohen, Jeffery E., Rogers, Toby, Waksman, Ron
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-07-2024
• Subjects: Aged; Aged, 80 and over; aortic stenosis; Aortic valve; Aortic Valve - diagnostic imaging; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Clinical outcomes; Female; Heart Valve Prosthesis; Hemodynamics; Humans; Male; Pacemakers; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Recovery of Function; Registries; Risk Factors; self‐expanding valve; TAVR; Time Factors; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Treatment Outcome; Trends; TAVR; self‐expanding valve; aortic stenosis
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.31088

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.