Aortic Transfemoral Valve Replacement using Edwards SAPIEN and Edwards SAPIEN XT Prosthesis, Local Anesthesia.

Reference: Durand E. et al (JACC CV interventions 2012 in press)1

When percutaneous aortic valve replacement (AVR) first began the procedure required a large-bore sheath (22-24 F), being the most frequent surgical strategy when using general anesthesia. Continuous technological advances achieved the miniaturization of devices which allow the procedure to be performed with a much smaller caliber (18-19 F) by femoral punctures under local anesthesia. In turn, echocardiography use has been essential in the management of valvular heart disease. Furthermore, this method has been widely used to guide percutaneous procedures (mitral and aortic valve replacement, closure of cardiac communications, etc.). Recent advances in 3-D technology have stimulated the use of transesophageal echocardiography (TEE) during aortic valve replacement, AVR. However, the appropriate use of imaging is essential to reduce costs.

In 2002 Dr. Alain Cribier, (Rouen, France), performed the first AVR. This time, the actual group of Rouen demonstrated the feasibility of performing AVR with a minimalist strategy that consisted of a procedure without general anesthesia, being performed under local anesthesia and sedation, guided only by fluoroscopy and completely percutaneous. After an initial experience with 78 patients where the Edwards 24F valve was implanted, surgical approach and conscious sedation, the Rouen group presented their experience with 73 patients, (age 82.7 ± 6.9 years, logistic EuroSCORE 17.4 ± 10.0), that received Edwards XT valve implant, (18 F, Edwards Lifesciences, Irvine, California), by percutaneous femoral puncture, (ProStar XL).

Procedure success with the minimalist strategy was 95%. 30-day mortality was 5.5%, combined with an endpoint of safety at 30 days (death, severe bleeding, major stroke, acute renal failure, major vascular complications and need for new process due to valvular dysfunction) of 13.3%. Only one patient required conversion to general anesthesia due to a rupture of the annulus. The authors concluded that the minimalist approach for AVR using the Edwards XT valve is feasible and safe.

Comment: In this single-center observational study the use of conscious sedation during the AVR was feasible, requiring conversion to general anesthesia in only one patient. Clearly, the findings of this study are very encouraging, as the avoidance of endotracheal intubation is particularly attractive in patients referred for AVR due to its fragility. Unlike general anesthesia, conscious sedation allows you to monitor the presence of pain and the neurological status during the procedure. Despite its advantages, such practice varies by region, being widely used in Europe (68.4%) but far less in the United States (5%). This important variation in the practice of anesthesia is part of the excitement about the superiority of sedation over general anesthesia. Use of transesophageal echocardiogram (TEE) during the RVA is not mandatory and varies from center to center. It is not uncommon for the anesthesiologist to decide upon the combined use of general anesthesia and TEE but general anesthesia is not required for this procedure. Authors of this study demonstrate that it is feasible to perform effectively a RVA under fluoroscopy without the use of TEE, simplifying the procedure. Finally, the realization of a purely percutaneous procedure promises that no doubts are present with conscious sedation.

References:

1. Durand E, Borz B, Godin M, Tron C, Litzler PY, Bessou JP, Bejar K, Fraccaro C, Sanchez-Giron C, Dacher JN, Bauer F, Cribier A, Eltchaninoff H. Transfemoral aortic valve replacement with the edwards sapien and edwards sapien xt prosthesis using exclusively local anesthesia and fluoroscopic guidance: Feasibility and 30-day outcomes. JACC Cardiovasc Interv. 2012;5:461-467.

2. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607.

3. Goncalves A, Marcos-Alberca P, Zamorano JL. Echocardiography: Guidance during valve implantation. EuroIntervention. 2010;6 Suppl G:G14-19.

4. Jabbour A, Ismail TF, Moat N, Gulati A, Roussin I, Alpendurada F, Park B, Okoroafor F, Asgar A, Barker S, Davies S, Prasad SK, Rubens M, Mohiaddin RH. Multimodality imaging in transcatheter aortic valve implantation and post-procedural aortic regurgitation: Comparison among cardiovascular magnetic resonance, cardiac computed tomography, and echocardiography. J Am Coll Cardiol. 2011;58:2165-2173.

5. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: First human case description. Circulation. 2002;106:3006-3008.

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