Author + information
- Received December 20, 2011
- Revision received February 27, 2012
- Accepted March 2, 2012
- Published online May 1, 2012.
- Danny Dvir, MD⁎,
- Ifat Lavi, PhD⁎,
- Hélène Eltchaninoff, MD†,
- Dominique Himbert, MD‡,
- Yaron Almagor, MD§,
- Fleur Descoutures, MD‡,
- Alec Vahanian, MD‡,
- Christophe Tron, MD†,
- Alain Cribier, MD† and
- Ran Kornowski, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Ran Kornowski, Department of Cardiology, Rabin Medical Center, Beilinson Campus, 39 Jabotinski Street, Petach Tikva 49100, Israel
Objectives This study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment.
Background Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results.
Methods This multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel).
Results The location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 ± 16.3% of device height below the plane of the lower sinus border versus 32.6 ± 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 ± 1.43 mm, range: −1.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 ± 1.4 mm vs. 0.75 ± 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49% higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = −0.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width.
Conclusions The final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment.
The study was sponsored by Paieon Medical (Rosh Ha'Ayin, Israel). Dr. Almagor is a proctor for Edwards Lifesciences. Dr. Vahanian received honoraria from Edwards Lifesciences and is on the advisory board of Abbott, Medtronic, and Valtech. Dr. Cribier received significant honorarium as a consultant for Edwards Lifesciences and served as a certified TAVR proctor for Edwards Lifesciences and his interventional cardiology department received in 2011 a research grant ($3,000 only) from Paieon Medical company in Israel. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 20, 2011.
- Revision received February 27, 2012.
- Accepted March 2, 2012.
- 2012 American College of Cardiology Foundation