title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Durand
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Bogdan
authors.initials: B
authors.lastname: Borz
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Godin
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Tron
authors.affiliation: Department of Cardiac Surgery, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Litzler
authors.affiliation: Department of Cardiac Surgery, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Bessou
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Karim
authors.initials: K
authors.lastname: Bejar
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Chiara
authors.initials: C
authors.lastname: Fraccaro
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Carlos
authors.initials: C
authors.lastname: Sanchez-Giron
authors.affiliation: Department of Radiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Jean-Nicolas
authors.initials: JN
authors.lastname: Dacher
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Bauer
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cribier
authors.affiliation: Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr.
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000772:Anesthesia, Local; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality / Q000628:therapy; D016009:Chi-Square Distribution; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery; D005471:Fluoroscopy; D005602:France; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality / Q000628:therapy; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D015641:Radiography, Interventional / Q000379:methods; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome