title: Aortic valve replacement with a novel anti-calcification technology platform.
abstract: OBJECTIVE
  The primary cause of long-term failure of bioprosthetic valves is structural valve deterioration due to tissue calcification. A novel anti-calcification technology platform was developed that may irreversibly block calcium binding sites in bioprosthetic valves.
  
  
  METHODS
  Twenty patients with severe aortic stenosis underwent isolated aortic valve replacement using a bioprosthetic valve treated with the novel anti-calcification technology. Mean patient age and body mass index was 73.7 ± 4.8 years and 30.1 ± 5.8 kg/m², respectively. Females comprised 65% of the patient population, and 30% of the population was in New York Heart Association class III/IV. Other baseline characteristics included hypertension (90%), hyperlipidaemia (75%), diabetes (35%), renal failure (25%), pulmonary disease (10%), and myocardial infarction (10%). Patients were followed-up for up to one year. Haemodynamic performance was evaluated by echocardiography. All complications were recorded.
  
  
  RESULTS
  There was one early death on postoperative day five. No other complications were noted up to discharge. Follow-up at 3-6 months and at one year were both 100%. At one year, no valve-related mortality, structural valve deterioration, major paravalvular leak (> 2+), thromboembolic events, major bleeding, prosthetic valve endocarditis, or reoperation were observed. Mean effective orifice area increased from 1.0 ± 0.5 cm² at baseline to 1.8 ± 0.5 cm² at one year. Mean gradient decreased from 54.8 ± 21.2 mm Hg at baseline to 11.3 ± 3.4 mm Hg at one year.
  
  
  CONCLUSIONS
  This early clinical experience using an aortic bioprosthetic valve treated with a novel anti-calcification tissue processing technology demonstrated excellent valve performance, durability, and safety. No valve-related complications were noted. Longer-term follow-up is needed to verify these promising results.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Sadowski
authors.affiliation: Department of Cardiovascular Surgery and Transplantation, Jagiellonian University, John Paul II Hospital, Krakow, Poland. krzysztofbartus@gmail.com.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Bartuś
authors.forename: Bogusław
authors.initials: B
authors.lastname: Kapelak
authors.forename: Amy
authors.initials: A
authors.lastname: Chung
authors.forename: Maciej
authors.initials: M
authors.lastname: Stąpor
authors.forename: Maciej
authors.initials: M
authors.lastname: Bochenek
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002114:Calcinosis / Q000517:prevention & control*; D005260:Female; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure