Rouen Experience Supports Safety of TAVR Using Local Anesthesia
May 9, 2012—In an expedited publication online in the Journal of the American College of Cardiology: Cardiovascular Interventions, Eric Durand, MD, et al reported findings on the feasibility and 30-day outcomes of transcatheter aortic valve replacement (TAVR) with the Edwards Sapien and Edwards Sapien XT prostheses (Edwards Lifesciences, Irvine, CA) implanted exclusively using local anesthesia and fluoroscopic guidance.
The investigators concluded that the study showed the feasibility and safety of simplified transfemoral TAVR when performed in high-surgical-risk patients with severe aortic stenosis. The single-center, prospective registry was conducted at the Charles Nicolle Hospital at the University of Rouen in Rouen, France. One of the investigators, Alain G. Cribier, MD, performed the first-in-man percutaneous valve implantation at the Rouen center in 2002.
According to the investigators, transfemoral TAVR is often managed with general anesthesia, but a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population.
As detailed in the Journal of the American College of Cardiology: Cardiovascular Interventions, 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, periprocedural myocardial infarction, major vascular complications, and repeat procedures for valve-related dysfunction at 30 days.
The transarterial femoral approach was surgical in all Sapien procedures and percutaneous in 97.3% with the Sapien XT using the Prostar vascular closure device (Abbott Vascular, Santa Clara, CA), and it was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (Sapien cases) due to complications, and vasopressors were required in 5.5%. The procedural success rate was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2%), life-threatening bleeding (7.9%), stage 3 acute kidney injury (0.7%), periprocedural myocardial infarction (1.3%), major vascular complications (7.9%), and repeat procedures for valve-related dysfunction (2%) at 30 days. A permanent pacemaker was required in 5.3%, reported the investigators.
In a commentary that was also published online in the Journal of the American College of Cardiology: Cardiovascular Interventions, interventional cardiologists Danny Dvir, MD, and Rajiv Jhaveri, MD, and anesthesiologist Augusto D. Pichard, MD, of the Washington Hospital Center in Washington, DC, discuss the study’s implications for adopting a minimalist approach for TAVR in high-risk patients in the United States, where most TAVR procedures are performed with general anesthesia. They cite a survey indicating that 5% of 61 North American centers regularly employ conscious sedation compared with 68% of centers in Europe that use conscious sedation during TAVR.
They noted that a minimalist approach of local anesthesia and conscious sedation is obviously attractive in frail, elderly, high-risk patients. However, they advised that the results from this study come from an experienced team and might not be reproducible for other groups, especially at the beginning of their learning curve. Additionally, all other available data come from nonrandomized trials. Therefore, they concluded, this study should be viewed as “hypothesis generating” only. They recommended the need for a critical evaluation of anesthetic techniques to guide the anesthesiologists who care for these patients.
The commentators stated, “We support the message coming from Rouen and encourage TAVR centers to collect anesthesia-related data to help us make an educated choice when selecting the optimal anesthetic approach for each of the patient subgroups undergoing these procedures.”