Author + information
- Received February 23, 2015
- Revision received March 20, 2015
- Accepted March 26, 2015
- Published online June 1, 2015.
- Robert P. Gooley, MD∗,†,
- Andrew H. Talman, MD∗,†,
- James D. Cameron, MD∗,†,
- Siobhan M. Lockwood, MD∗,† and
- Ian T. Meredith, AM, MD∗,†∗ ()
- ∗MonashHeart, Monash Health, Clayton, Victoria, Australia
- †Monash Cardiovascular Research Centre, Monash University, Clayton, Victoria, Australia
- ↵∗Reprint requests and correspondence:
Dr. Ian T. Meredith, Monash Heart, Monash Health, 246 Clayton Road, Clayton, Victoria, 3168 Australia.
Objectives The aim of this study was to determine whether transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus valve (Boston Scientific, Natick Massachusetts) offers potential benefits over treatment with the self-expanding CoreValve (Medtronic, Minneapolis, Minnesota).
Background New-generation transcatheter aortic valve systems are emerging in clinical trials and practice with design features aimed at improving safety and efficacy. To date, these devices have not been compared systematically with current-generation devices.
Methods A total of 100 patients (83.4 ± 4.8 years of age, 44% male, Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 2.4) were assessed. Fifty consecutive patients undergoing a Lotus transcatheter aortic valve replacement were enrolled and compared with 50 matched patients treated with a CoreValve. An independent core laboratory reviewed all echocardiographic data, and an independent clinical events committee adjudicated all events.
Results Valve Academic Research Consortium 2–defined device success was 84% and 64% in the Lotus and CoreValve cohorts, respectively (p = 0.02). This difference was driven by lower rates of moderate or greater aortic regurgitation (4% vs. 16.7%, respectively; p = 0.04) and higher rates of successfully implanting a single device in the correct anatomic position (100% vs. 86%, respectively; p = 0.06). Cardiovascular mortality rate (0% vs. 4%, respectively; p = 0.32), major stroke rate (4% vs. 2%, respectively; p = 0.56), and permanent pacemaker insertion rate (28% vs. 18%, respectively; p = 0.23) were not different at 30 days in the Lotus and CoreValve cohorts.
Conclusions In this matched comparison of high surgical risk patients undergoing transcatheter aortic valve replacement, the use of the Lotus device was associated with higher rates of Valve Academic Research Consortium 2–defined device success compared with the CoreValve. This was driven by higher rates of correct anatomic positioning and lower incidences of moderate paraprosthetic regurgitation. The clinical significance of these differences needs to be tested in a large randomized, controlled trial.
Dr. Gooley, Dr. Lockwood, and Prof. Meredith receive modest consulting fees from Boston Scientific. Prof. Meredith serves on the Strategic Advisory Boards of Boston Scientific and Medtronic. Dr. Gooley receives a research scholarship from the National Health and Medical Research Council of Australia. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 23, 2015.
- Revision received March 20, 2015.
- Accepted March 26, 2015.
- American College of Cardiology Foundation