Page 6 - Journal of Structural Heart Disease Volume 1, Issue 3

Original Scientific Article
Journal of Structural Heart Disease, September 2015, Volume 1, Issue 3: 112-126
DOI: http://dx.doi.org/10.12945/j.jshd.2015.019-14
Received: December 29, 2014 Accepted: January 05, 2015 Published online: September 2015
Update on New Devices for Transcatheter Aortic Valve Replacement
Yigal Abramowitz, MD, Tarun Chakravarty, MD, Hasan Jilaihawi, MD, Raj R. Makkar, MD* Heart Institute, Cedars-Sinai Medical Center, Los-Angeles, California, USA
Abstract
Transcatheter aortic valve replacement (TAVR) for se- vere symptomatic aortic stenosis is the standard of care in inoperable patients and an alternative to sur- gical aortic valve replacement in high-risk operable patients. Several issues affecting outcomes with im- plantation of the first-generation TAVR devices remain unresolved, including neurological and vascular com- plications, atrioventicular conduction abnormalities, and paravalvular aortic regurgitation. New-generation TAVR devices are currently in different stages of clinical development and evaluation. Modifications in the new devices include the ability to reposition the valve be- fore final deployment, features to reduce paravalvular leakage, lower-profile delivery systems, and cerebral protection devices. The purpose of this manuscript is to give an update on the new-generation transcathe- ter valvular technologies, focusing on the unique fea- tures and describing the initial clinical experience for each device.
Copyright © 2015 Science International Corp.
Key Words:
New devices • Transcatheter aortic valve replacement • Transcatheter aortic valve implantation • TAVR • Transcatheter aortic valve implantation (TAVI)
Introduction
Transcatheter aortic valve replacement (TAVR) has emerged as a treatment option for inoperable or high-risk surgical patients with severe aortic stenosis (AS) [1, 2]. Since the first-in-human TAVR procedure
performed by Professor Alan Cribier in 2002 [3], more than 100,000 TAVR procedures have been performed worldwide. Considerable experience has been ac- quired with the two first-generation TAVR devices: the balloon-expandable Edwards SAPIEN/SAPIEN XT (Edwards Lifesciences, Irvine, CA, USA) and the self- expandable Medtronic CoreValve (Medtronic, Min- neapolis, MN, USA). Randomized clinical trials com- paring this technology in high risk patients against surgery or medical therapy, as well as multicenter national registries have shown high success rate and increasingly predictable results [2, 4–7].
Clinical outcomes of TAVR have improved over the years, mainly as a result of appropriate patient selection, growing operator experience, and major technical refinements. Nonetheless, the rate of com- plications related to TAVR remains substantial. A re- cent meta-analysis found the risk of periprocedural stroke following TAVR to be 1.5% and a 30-day stroke/ transient ischemic attack (TIA) rate of 3.3%. Paraval- vular aortic regurgitation (PV-AR) after TAVR, includ- ing small or trace leaks is quite common (incidence 50–85%), with the vast majority of cases graded as mild or less [8, 9]. Increasing severity of PV-AR follow- ing TAVR have been directly associated with increased mortality [2, 7, 9, 10]. Other issues affecting short and long term outcome following TAVR include hemor- rhagic and vascular complications, atrioventricular conduction abnormalities, valve malpositioning and coronary obstruction [11]. To overcome these obsta- cles, and in order to enable the utilization of TAVR for lower risk populations, new-generation TAVR devices
*Corresponding Author:
Raj R. Makkar, MD
Cedars-Sinai Heart Institute
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Tel: +1 310 423 3977, Fax: +1 310 423 0106, E-Mail: Raj.Makkar@cshs.org
Fax +1 203 785 3346
E-Mail: jshd@scienceinternational.org http://structuralheartdisease.org/
© 2015 Journal of Structural Heart Disease Published by Science International Corp. ISSN 2326-4004
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