Transcatheter aortic valve replacement (TAVR)

Medtronic key studies

Stay up to date on the latest clinical evidence from Medtronic. Key summaries demonstrate the efficacy of the CoreValve™/Evolut™ TAVR platform.

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Cath lab showing diagnostic imaging equipment used to visualize the arteries of the heart
Alert Indications, Safety, and Warnings

Evolut Low Risk Trial1

The Evolut TAVR platform performed numerically better than SAVR in primary endpoint of all-cause mortality or disabling stroke at 3 years (7.4% TAVR versus 10.4% SAVR; p = 0.051). The Evolut platform also showed statistically better hemodynamics than SAVR at 3 years.

Sample size

N = 730 TAVR, N = 684 SAVR

Devices

Evolut™ R 73%/Evolut™ PRO 23.4%/CoreValve 3.6%

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All-cause mortality or disabling stroke

Graph of Evolut Low Risk three-year results for all-cause mortality or disabling stroke with the Medtronic TAVR/TAVI platform

TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.

CoreValve and Evolut Pooled Analysis: 5-year Incidence of BVD2

CoreValve/Evolut TAVR 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 TAVR versus 11.8% SAVR; p < 0.001).

CoreValve/Evolut TAVR demonstrated significantly lower rates of BVD versus SAVR (7.8% CoreValve/Evolut TAVR versus 14.2% SAVR; p < 0.001). 

Sample size

N = 2,099

Devices

CoreValve 88%/Evolut R 12%

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Bioprosthetic valve dysfunction out to 5 years

Chart showing bioprosthetic valve dysfunction at five years between surgery transcatheter aortic valve replacement

*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.

TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.

Impact of a standardized TAVR technique and care pathway in the Optimize PRO study6

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%

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PVL (main cohort)

Bar chart data showing rates of PVL in patients who underwent TAVR or TAVI, depending on country or region

†One patient with mild-moderate PVL.

TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.

SURTAVI 5-year Trial7

Compared to SAVR at 5 years, CoreValve/Evolut TAVR demonstrated no statistical difference in all-cause mortality (30.0% TAVR versus 30.8% SAVR; p = 0.85), numerically lower disabling stroke (4.1% TAVR versus 5.8% SAVR; p = 0.12), and statistically better hemodynamics with stable low gradients in intermediate-risk patients.

Sample size

N = 864 TAVR, N = 796 SAVR

Devices

CoreValve 84%/Evolut R 16%

Mean gradient and EOA over time implanted set

Graph showing the SURTAVI five-year results on the Medtronic TAV platform for intermediate-risk patients

Dr. Popma, Dr. Reardon, and Prof. Van Mieghem discuss the data.

TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.

Real-world results

Review recent data that reinforces the excellent outcomes seen in our Medtronic clinical trials.

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Procedure and performance

Discover our procedural guidance and outcomes you can expect from the Evolut platform.

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Build your knowledge

Medtronic Academy offers a wide range of resources for the Evolut TAVR platform.

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References

1

Forrest JK, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Aortic Stenosis Patients at Low Surgical Risk: 3-Year Outcomes from the Evolut Low Risk Trial. Presented at ACC; March 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. Impact of a standardized TAVI technique and care pathway in the Optimize PRO study. Presented at EuroPCR 2022; May 17, 2022; Paris, France.

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.