Comparison of Evolut-R 34 mm Valve and Smaller Evolut-R Valves in Patients Undergoing Transcatheter Aortic Valve Implantation and Determination of Mild Paravalvular Leak Predictors

Abstract

Objective: The main purpose of this study was to evaluate and compare the in-hospital, 1-month and 1-year post-procedure outcomes of patients treated with Evolut-R 34 mm and Evolut-R 23/26/29 mm devices. Additionally, the study aimed to identify factors that could predict the occurrence of ≥ mild paravalvular leaks (PVL). Methods: Between April 2015 and May 2022, 269 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with Evolut-R 34 mm (n = 66, 24.5%) and Evolut-R 23/26/29 mm (n = 203, 75.5%) devices in a single center were retrospectively analyzed. Results: Patients in the Evolut-R 34 mm group had a lower female sex ratio (16.7% vs. 66.5%, P < .001, respectively), ejection fraction (50.7 ± 10.1% vs. 54.5 ± 9.3%, P= .016, respectively), and mean aortic gradient (7.4 ± 3.3 vs. 9.2 ± 5.0, P= .026, respectively) compared to the Evolut-R 23/26/29 mm group. The groups did not exhibit any statistically significant distinctions with regard to technical success, the need for a permanent pacemaker, occurrences of stroke, major vascular complications, PVL, major adverse cardiovascular and cerebrovascular events, or mortality. Peak velocity was confirmed as a significant predictor of ≥mild PVL in both patient groups in the receiver operating characteristic curve analysis. In logistic regression analysis; In patients with Evolut-R 34 mm valve, pre-TAVI aortic valve peak velocity (odds ratio (OR) = 23.202; P= .019) and calcium volume 800 Hounsfield Units (mm3) (OR = 1.017; P < .001) were independent predictors of ≥mild PVL. Conclusion: The Evolut-R 34 mm valve has shown comparable in-hospital results with smaller valve sizes. Pre-TAVI aortic valve peak velocity and calcium volume predicted ≥ mild PVL in Evolut-R 34 mm patients.