Transcatheter aortic valve implantation (TAVi)
Medtronic key studies
Stay up to date on the latest clinical evidence from Medtronic. Key summaries demonstrate the efficacy of the CoreValve™/Evolut™ TAVI platform.
Download the Medtronic clinical trial overview brochure.
Evolut™ TAVI shows outstanding outcomes in low risk patients over time1.
Sample size
N = 730 TAVI, N = 684 SAVR
Devices
Evolut™ R 73%/Evolut™ PRO 23.4%/CoreValve 3.6%
All-cause mortality or disabling stroke
CoreValve™/Evolut™ TAVI had significantly better valve performance than surgery as assessed by bioprosthetic valve dysfunction (BVD),* with 3x lower severe PPM in randomized clinical trials at 5 years (3.7% CoreValve™/Evolut™ TAVI versus 11.8% SAVR; p < 0.001).
CoreValve™/Evolut™ TAVI demonstrated significantly lower rates of BVD versus SAVR (7.8% CoreValve™/Evolut™ TAVI versus 14.2% SAVR; p < 0.001).
Bioprosthetic valve dysfunction out to 5 years
*BVD was defined as3,4: SVD5 (mean gradient ≥ 10 mm Hg increase from discharge/30 days AND ≥ 20 mm Hg at last echo or new onset/increase of ≥ moderate intraprosthetic aortic regurgitation), NSVD (30-day severe PPM at 30-day/discharge3 or severe PVR through 5 years), clinical valve thrombosis, and endocarditis.
The cusp overlap technique, with an optimized care pathway, demonstrated excellent clinical outcomes in this interim analysis with single-digit pacemaker rates (9.8% PPI at 30 days), low rates of PVL (0% moderate/severe at discharge), and one-day median discharge from main cohort.
Sample size
N = 400 patients in the main cohort. At the conclusion of the study, more than 650 patients will have been evaluated.
Devices
Evolut™ PRO+ 91.5%/Evolut PRO 8.0%
PVL (main cohort)
†One patient with mild-moderate PVL.
Compared to SAVR at 5 years, CoreValve™/Evolut™ TAVI demonstrated no statistical difference in all-cause mortality (30.0% TAVI versus 30.8% SAVR; p = 0.85), numerically lower disabling stroke (4.1% TAVI versus 5.8% SAVR; p = 0.12), and statistically better hemodynamics with stable low gradients in intermediate-risk patients.
Sample size
N = 864 TAVI, N = 796 SAVR
Devices
CoreValve 84%/Evolut R 16%
Mean gradient and EOA over time implanted set
Dr. Popma, Dr. Reardon, and Prof. Van Mieghem discuss the data.
EXPAND TAVR II Pivotal Trial
The purpose of the EXPAND TAVR II Pivotal Trial is to explore the treatment of moderate aortic stenosis (AS) with early transcatheter aortic valve implantation (TAVI) before AS becomes severe. Early treatment of AS may help preserve cardiac function, prevent or slow further deterioration in cardiac function, and prevent death in some patients.
Real-world results
Review recent data that reinforces the excellent outcomes seen in our Medtronic clinical trials.
Procedure and performance
Discover our procedural guidance and outcomes you can expect from the Evolut platform.
References
1
Reardon M, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Aortic Stenosis Patients at Low Surgical Risk: 4-Year Outcomes from the Evolut Low Risk Trial. Presented at TCT; October 2023.
2
Yakubov S, et al. Five-Year Incidence of Bioprosthetic Valve Dysfunction in Patients Randomized to Surgery or TAVR: Insights From the CoreValve US Pivotal and SURTAVI Trials. Presented at CRT; February 2023.
3
VARC-3 Writing Committee; Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. May 14, 2021;42(19):1825–1857.
4
Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. December 1, 2017;38(45):3382–3390.
5
Adapted from VARC-3 Writing Committee, et al. and Capodanno D, et al.
6
Grubb K, et al. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights from the Optimize PRO Study. J Am Coll Cardiol. Published online March 13, 2023.
7
Van Mieghem NM, Deeb GM, Søndergaard L, et al. Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. October 1, 2022;7(10):1000–1008.
8
Strange G, Stewart S, Celermajer D, et al. Poor Long-Term Survival in Patients With Moderate Aortic Stenosis. J Am Coll Cardiol. October 15, 2019;74(15);1851-1863.