Focused Issue: Transcatheter Valve Interventions
Expedited Publications
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

https://doi.org/10.1016/j.jcin.2012.01.018Get rights and content
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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.

Key Words

anesthesia
aortic stenosis
TAVR
Valve Academic Research Consortium (VARC)

Abbreviations and Acronyms

BAV
balloon aortic valvuloplasty
CT
computed tomography
MI
myocardial infarction
RVP
rapid ventricular pacing
TAVR
transfemoral aortic valve replacement
TEE
transesophageal echocardiography
TTE
transthoracic echocardiography
VARC
Valve Academic Research Consortium

Cited by (0)

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.