Transcatheter Aortic Valve Replacement with Evolut-R Department of Transcatheter Heart Valves and 2 nd Cardiothoracic Surgery Clinic K. Spargias, M.Chrissoheris, A.Halapas, I. Nikolaou, S.Pattakos
Disclosures I and the HYGEIA Hospital «Heart Team» have received research and/or travel grants and/or lecture fees from: - Edwards Lifesciences - Medtronic - St Jude, Europe - ABBOTT Vascular, Europe HYGEIA Hospital Heart Team Cardiologists: A Chalapas, M Chrissoheris, K Spargias CT Surgeons: N Bouboulis, S Skardoutsos, A Tsolakis, S Pattakos Congenital Heart Disease: A Tzifa Anesthesiologists: C Nastoulis, I Nikolaou Vascular Surgeons: I Belos, S Kaliafas Radiologists: F Laspas, C Mourmouris Electrophysiologists: L Papavasileiou, G Zervopoulos, T Apostolopoulos
Building on the CoreValve Foundation Proven in More Than 65,000 Implants Worldwide Self-Expanding Frame Conforms and seals to the annulus The foundation for recapturability Supra Annular Valve Design Maximize flow and optimize coaptation Porcine Pericardial Tissue Thinness for low profile delivery Strength and pliability for long-term durability INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
CoreValve Evolut R System Recapturable valve and delivery catheter with loading system Catheter Delivery System 14Fr-equivalent profile Loading System Transcatheter Valve INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
Design Goals For Evolut R 1 Low Sheath OD to Femoral Artery Ratio (SFAR) Reduces risk of major vascular complications and improves access 2 Positioning Accuracy Key to achieving superior clinical outcomes, including PVL performance and conduction disturbances (Hayashida K., Lefevre T., Chevalier B.; et al. Transfemoral Aortic Valve Implantation; New Criteria to Predict Vascular Complications, J Am Coll Cardiol Intv 4 2011 851-858) (TcheTche, et. al. EuroIntervention 2012) 3 Annular sealing Reduces paravalvular leak Ease-of-use 4 CT images courtesy of Dr. Piazza and Prof. Lange, German Heart Center, Munich Germany INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
The Patient 83 year-old male, NYHA III dyspnea Severe aortic stenosis PG 91mmHg, MG 51mmHg, AVA 0.9cm 2 LVEF 65% Coronaries Patent stent in RCA, 60% mid LAD, conservative Comorbidities Parkinson RBBB/1AVB Euroscore 27%, STS 4.4%
Echocardiography
MDCT
Heart Team Discussion Severe aortic stenosis and symptoms Class I indication for replacement Due to advanced age and comorbidities decision for transcatheter aortic valve replacement, transfemoral approach Evolut R 29mm, without predilatation general anesthesia
Iliofemoral Angiography
Lowest Delivery Profile, 14Fr-Equivalent System with InLine Sheath across All Valve Sizes Improves Access and Reduces Risk of Major Vascular Complications* NOW Indicated for Minimum Transarterial Access Vessel Diameters 5.0 mm! Sheath to Femoral Artery Ratio (SFAR) great than 1.05 predicted higher rates of VARC major vascular complications. Hayashida K, et al. Transfemoral aortic valve implantation. JACC Intv 2011;4(8):851-8. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
Insertion of Evolut R Delivery System
Initial Positioning
Positioning Accuracy: Self-Centering INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
Displacement over Aortic Annulus
Positioning Accuracy: Ability to Recapture and Reposition EnVeo R provides option to recapture and reposition up to three times before reaching the Point of No Recapture * Tactile Indicator ~ 2/3 Deployment Just Prior to Point of No Recapture ~ 80% Deployment* * Up to 80% deployment INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
Final Result Transient complete heart block Pacemaker implanted
Enhanced Annular Sealing: Extended Sealing Skirt 1 For Exceptional Valve Performance and Reduced Significant PVL 2 Outflow shortened and redesigned for improved anatomic fit Extended Sealing Skirt 1 Scalloped skirt creates longer landing zone for better sealing 1. Available on 26 and 29 mm sizes 2. Medtronic data on file. 23R comparison of CoreValve to CoreValve Evolut. Significant PVL defined as moderate PVL. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve Evolut R is approved. Medtronic, Inc. 2015. All Rights Reserved.
Echocardiography at 1 month Mean gradient 9mmHg, AR 0, AVA 1.7cm 2
In Summary Case demonstrates advantages of new Evolut-R Repositionable, resheathable, retreavable Minimal paravalvular leak Ability to implant without predilatation (with optional post-dilatation) Low delivery profile of 14F