Hear from the experts
Predictability is your superpower
Predictability affects accuracy. Procedural approaches like the cusp overlap technique and commissure alignment amplify the strengths of the Evolut™ platform design by enabling more predictable and reproducible outcomes.
Dr Gada's 4 essential steps of the Cusp Overlap Technique
Utilization of the four essential cusp overlap technique steps lowers pacemaker implantation rates4.
1) Reconstructed angiography overlay of Cusp Overlap View (COV)
2) Fluoro image of Lunderquist®* wire positioned in the left ventricle
3) Fluoro image demonstrating 3 mm depth in COV prior to/after full annular contact below the non-coronary cusp
4) Final aortography performed in COV
View the cusp overlap technique in this short animation
Accuracy when it matters most
Outcomes matter
Cusp overlap technique with an optimized care pathway, as shown in the Optimize PRO study, provides excellent clinical outcomes.*1
1. 9.8% at 30 days
single digit pacemaker rate when
key COT steps applied, pacemaker
rate was lower (5.8%)
2. Low Rates of PVL
0% moderate/severe PVL at discharge
3. One Day
median discharge
Aortic regurgitation at discharge†
Optimize PRO study
Devices used: 91.3% Evolut™ PRO+/8.3% Evolut™ PRO.
*One patient with mild-moderate PVL.
†This is an interim analysis of 504 patients (104 roll-in and 400 main cohort). At the conclusion of the study, more than 650 patients will have been evaluated.
‡Echocardiographic outcomes assessed on the implanted population (N = 398) and reviewed by a central core laboratory.
PPI rates continue downward trend
Data from the TVT Registry shows a consistent, downward trend of permanent pacemaker rates with the latest figure of 8.8% in Q2 of 2021.
TVT Registry2
% Evolut patients with in-hospital
permanent pacemaker implantation
(excluding baseline PPI/ICD)
Predictability drives precision
Visualize the accuracy
The commissure alignment technique allows for more accurate placement with Evolut TAVI.
Alignment of the THV commissure to the native valve commissure
Native valve
Commissure alignment
Accuracy improves commissure alignment
Positioning the flush port at 3 o’clock has been shown to significantly improve commissure alignment and has demonstrated a nearly 80% success rate.3
Incidence of severe§ commissure misalignment on one or both coronaries.3
§Defined as THV commissure landing within 0–20 degrees of the CA based on the axial view.
References
1
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.
2
Harvey JE, et al. Decreasing Permanent Pacemaker Implantation Rates in the STS/ACC TVT Registry with a Supra-annular Self-expanding Transcatheter Heart Valve. Presented at TVT 2022. PPI rate trending at in-hospital includes baseline PPI/ICD, TAV-in-SAV, and TAV-in-TAV.
3
Tang GHL, Sengupta A, Alexis SL, et al. Conventional versus modified delivery system technique in commissural alignment from the Evolut low-risk CT substudy. Catheter Cardiovasc Interv. February 2022;99(3):924-931.
4
Gada H, et al. Adherence to Key Cusp Overlap Steps Reduced Pacemaker Implantation in the Optimize PRO Study. Presented at TCT 2022.
DISCLAIMER
See the CoreValve™ Evolut™ R, the CoreValve™ Evolut™ PRO and the Evolut™ PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.
For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
The commercial name of the Evolut™ R device is Medtronic CoreValve™ Evolut™ R System, the commercial name of the Evolut™ PRO device is Medtronic CoreValve™ Evolut™ PRO System, and the commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System.
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