title: Clinical outcome and paravalvular leakage of the new balloon-expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement.
abstract: OBJECTIVE
  The aim of this study was to compare the 30-day procedural, clinical and echocardiographic outcome of the new balloon-expandable Edwards Sapien 3 (ES3) valve with the Edwards Sapien XT (ESXT).
  
  
  BACKGROUND
  Post-implant paravalvular leaks (PVL) after transfemoral aortic valve replacement (TAVR) resulting in residual aortic regurgitation (AR) are a major limitation for long term outcome. New TAVR-devices have to eliminate this problem.
  
  
  METHODS
  Transfemoral TAVR was performed in 209 consecutive intermediate-high-risk surgical patients (pts) with symptomatic aortic stenosis (ESXT n = 102, ES3 n = 107). Transthoracic echocardiography (TTE) and 3-dimensional computed tomography were used for valve size selection. Primary endpoint of the study was none/trace AR derived by TTE 30-days after TAVR.
  
  
  RESULTS
  All pts underwent successfully TAVR with a combined device success of 100/102 (99%) in ESXT and 107/107 (100%) in ES3 pts. Fluoroscopy time (ESXT 11.8 ± 0.5 min vs. ES3 10.0 ± 0.5 min, P = 0.003) and contrast (ESXT 188.9 ± 5.6 mL vs. ES3 170.4 ± 4.7 mL, P = 0.04) were significantly lower in ES3 patients. 30-day clinical events did not differ. Transvalvular mean pressure gradients were significantly reduced to 7.4 ± 0.8 mmHg after ESXT and to 10.1± 0.4 mmHg after ES3 implantation. After 30 days none/trace AR was found in 34.3% (n = 35) of all ESXT pts in contrast to 89.7% (n = 96) of all ES3 patients. Moderate-to-severe AR was found rarely (ESXT 2.9% vs. ES3 0%, P = 0.073).
  
  
  CONCLUSIONS
  Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany. Wolfgang.bocksch@sana.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Bocksch
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Benita
authors.initials: B
authors.lastname: Grossmann
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Geisler
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Steeg
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Michal
authors.initials: M
authors.lastname: Droppa
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Rezo
authors.initials: R
authors.lastname: Jorbenadze
authors.affiliation: Department of Medicine IV, Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Haap
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Meinrad
authors.initials: M
authors.lastname: Gawaz
authors.affiliation: Department of Medicine III (Cardiovascular Disease), Eberhard-Karls-Universitaet Tuebingen, Germany.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Fateh-Moghadam
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000209:etiology* / Q000401:mortality / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D004452:Echocardiography; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011677:Punctures; D015641:Radiography, Interventional; D012307:Risk Factors; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: aortic stenosis; balloon-expandable valve; paravalvular leakage; residual aortic regurgitation; transfemoral aortic valve replacement