Early clinical and procedural outcomes in large series of 34‐mm self‐expanding transcatheter aortic valve replacement

Ali, Zuber; Sharma, Payal; Mengesha, Tadele; Dalmar, Ahmed; Ammar, Khawaja Afzal; Allaqaband, Suhail; O’Hair, Daniel; Khandheria, Bijoy K.; Jain, Renuka; Bajwa, Tanvir

doi:10.1002/ccd.28634

Cited by 3 publications

(2 citation statements)

References 32 publications

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“…Although we found the rate of moderate-severe PVL similar to previous studies, we found a lower rate of mild PVL. 6 , 7 , 10 We also observed that PVL improved over time in patients treated with self-expandable valves, as previously reported. 7 In a study published in 2021, 60° aortic angulation was found to be a predictor of ≥moderate PVL for the Evolut-R 34 mm valve.…”

Section: Discussionsupporting

confidence: 88%

“… 6 , 7 , 10 We also observed that PVL improved over time in patients treated with self-expandable valves, as previously reported. 7 In a study published in 2021, 60° aortic angulation was found to be a predictor of ≥moderate PVL for the Evolut-R 34 mm valve. 10 However, in our study, we aimed to determine the predictors of ≥mild PVL in both Evolut-R 34 mm and Evolut-R 23/26/29 mm valves.…”

Section: Discussionsupporting

confidence: 88%

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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

Kılıç

2024

Anatol J Cardiol

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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 (mm 3 ) (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.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 88%

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

Kılıç

2024

Anatol J Cardiol

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Self-Expanding TAVR in Large Annuli: Challenges and Implications

Fiorilli

Halaby

2022

Cardiovascular Revascularization Medicine

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Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

Armijo

Tang

Kooistra

et al. 2020

Circ: Cardiovascular Interventions

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Background: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. Methods: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. Results: Median aortic annulus area and perimeter were 617 mm 2 (591–657) and 89.1 mm (87.0–92.1), respectively (704 mm 2 [689–743] and 96.0 mm [94.5–97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P =0.001), with a higher rate of significant paravalvular leak ( P =0.004), second valve implantation ( P =0.013), and valve embolization ( P =0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. Conclusions: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

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Early clinical and procedural outcomes in large series of 34‐mm self‐expanding transcatheter aortic valve replacement

Cited by 3 publications

References 32 publications

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

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

Self-Expanding TAVR in Large Annuli: Challenges and Implications

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

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