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.
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.
Authors: Molly Szerlip; Deborah Tabachnick; Mohanad Hamandi; LuAnn Caras; Allison T Lanfear; John J Squiers; Katherine Harrington; Srinivasa P Potluri; J Michael DiMaio; Jordan Wooley; Benjamin Pollock; Justin M Schaffer; William T Brinkman; David L Brown; Michael J Mack Journal: Proc (Bayl Univ Med Cent) Date: 2020-09-23
Authors: Peter Stachon; Klaus Kaier; Andreas Zirlik; Jochen Reinöhl; Timo Heidt; Wolfgang Bothe; Philip Hehn; Manfred Zehender; Christoph Bode; Constantin von Zur Mühlen Journal: Clin Res Cardiol Date: 2018-04-13 Impact factor: 5.460
Authors: Albert Markus Kasel; Salvatore Cassese; Thomas Ischinger; Alexander Leber; Diethmar Antoni; Gotthard Riess; Jayshree Vogel; Adnan Kastrati; Walter Eichinger; Ellen Hoffmann Journal: Am J Cardiovasc Dis Date: 2014-06-28