title: Symetis Acurate Transapical Aortic Valve: the initial experience with a second generation of transcatheter aortic valve replacement device.
abstract: BACKGROUND
  Transcatheter aortic valve replacement (TAVR) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high risk and surgically in operable patients who suffer from severe symptomatic aortic stenosis. However, a significant number of complications, associated with both the learning curve and device specificity, have required attention and subsequent improvement. The Symetis transapical TAVR system is a self-positioning bioprosthesis composed of a non-coronary leaflet of surgical quality porcine tissue valve sewn into a self-expanding nitinol stent that iscovered with a PET-skirt.
  
  
  METHODS
  From June to September 2013 six patients have been operated on severe aortic stenosis using the new TAVR device. All patients have undergone critical assessment of a local Heart Team and have been disqualified from conventional AVR. Five were woman. Mean age was 82.3 ± 2.0 (mean LogEuroScore 23.9 ± 14.3). Four patients suffered from coronary artery disease - two had history of previous percutaneous coronary intervention with intracoronary stents, while the next two had history of coronary artery bypass grafting. Diabetes was frequent (n = 3) as well as chronic obstructive pulmonary disease (n = 4). Carotid artery disease was encountered in three patients similarly to atrial fibrillation. Mean left ventricular ejection fraction (LVEF) was 51.5 ± 11.8%, but one patient had suffered from low-flow-low-gradient aortic stenosis with LVEF of 29%.
  
  
  RESULTS
  The procedure was carried out successfully in all six cases. Two patients have received the valve sized L, three - M and one - S. Mean procedure time was 180 ± 19 min, mean cine 7.2 ± 1.2 min. Mean X-ray dose 930 ± 439 mGy, while mean volume of contrast given was 135 ± 61 mL. In all patients but one perivalvular leak (PVL) was not present. One patient had trace of PVL. Also, good LVEF was noted in all patients. Similar findings were obtained 30 days post procedure. No strokes, transient ischaemic attack or other cerebrovascular incidents were observed.
  
  
  CONCLUSIONS
  This brief clinical communication reports the first Polish experience with the second generation of TAVR device - the Symetis Acurate Transapical Aortic Valve. While it lacks large patient population and longer follow-up, it reveals that TAVR procedure can be performed safely, with minimal X-ray exposure time and contrast given and successfully - with almost nonexistent PVL and no cerebrovascular incidents or heart rhythm disturbances. Heart Team approach is vital, and transapical access should not be treated inferiorly, but rather as an equally appealing TAVR option.
authors.affiliation: Department of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases, Zabrze, Poland. m.zembala.jr@sccs.pl.
authors.forename: Michał Oskar
authors.initials: MO
authors.lastname: Zembala
authors.forename: Jacek
authors.initials: J
authors.lastname: Piegza
authors.forename: Jacek
authors.initials: J
authors.lastname: Wacławski
authors.forename: Michał
authors.initials: M
authors.lastname: Hawranek
authors.forename: Michael
authors.initials: M
authors.lastname: Hilker
authors.forename: Tomasz
authors.initials: T
authors.lastname: Niklewski
authors.forename: Jan
authors.initials: J
authors.lastname: Głowacki
authors.forename: Monika
authors.initials: M
authors.lastname: Parys
authors.forename: Paweł
authors.initials: P
authors.lastname: Nadziakiewicz
authors.forename: Piotr
authors.initials: P
authors.lastname: Chodór
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Wilczek
authors.forename: Roman
authors.initials: R
authors.lastname: Przybylski
authors.forename: Mariusz
authors.initials: M
authors.lastname: Gąsior
authors.forename: Marian
authors.initials: M
authors.lastname: Zembala
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011044:Poland; D013552:Swine