Author + information
- Received September 11, 2011
- Revision received December 14, 2011
- Accepted January 5, 2012
- Published online May 1, 2012.
- Eric Durand, MD, PhD⁎,
- Bogdan Borz, MD⁎,
- Matthieu Godin, MD⁎,
- Christophe Tron, MD⁎,
- Pierre-Yves Litzler, MD, PhD†,
- Jean-Paul Bessou, MD†,
- Karim Bejar, MD⁎,
- Chiara Fraccaro, MD⁎,
- Carlos Sanchez-Giron, MD⁎,
- Jean-Nicolas Dacher, MD, PhD‡,
- Fabrice Bauer, MD, PhD⁎,
- Alain Cribier, MD⁎ and
- Hélène Eltchaninoff, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Hélène Eltchaninoff, Department of Cardiology, Charles Nicolle Hospital, University of Rouen, 1 Rue de Germont, 76031 Rouen Cedex, France
Objectives The authors report the feasibility and 30-day outcomes of transfemoral aortic valve replacement (TAVR), using the Edwards SAPIEN (Edwards Lifesciences, Irvine, California) and Edwards SAPIEN XT (Edwards Lifesciences) prosthesis, implanted using exclusively local anesthesia and fluoroscopic guidance.
Background Transfemoral TAVR is often managed with general anesthesia. However, a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population.
Methods Between May 2006 and January 2011, the authors prospectively evaluated 151 consecutive patients (logistic EuroSCORE: 22.8 ± 11.8%) who underwent TAVR (SAPIEN: n = 78, SAPIEN XT: n = 73) using only local anesthesia and fluoroscopic guidance. The primary endpoint was a combination of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), periprocedural myocardial infarction (MI), major vascular complication, and repeat procedure for valve-related dysfunction at 30 days.
Results Transarterial femoral approach was surgical in all SAPIEN procedures and percutaneous in 97.3% of SAPIEN XT, using the ProStar vascular closure device, and was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (SAPIEN cases) and was related to complications. Vasopressors were required in 5.5%. Procedural success was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), stage 3 AKI (0.7%), periprocedural MI (1.3%), major vascular complication (7.9%), and repeat procedure for valve-related dysfunction (2.0%) at 30 days. A permanent pacemaker was required in 5.3%.
Conclusions This single-center, prospective registry demonstrated the feasibility and safety of a simplified transfemoral TAVR performed using only local anesthesia and fluoroscopic guidance in high surgical risk patients with severe aortic stenosis.
Dr. Litzler received honorarium from Edwards Lifesciences. Dr. Cribier is a consultant for Edwards Lifesciences. Dr. Eltchaninoff is a proctor for and received lecture fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 11, 2011.
- Revision received December 14, 2011.
- Accepted January 5, 2012.
- 2012 American College of Cardiology Foundation