title: Valvuloplasty with a paclitaxel-eluting balloon prevents restenosis in an experimental animal model of aortic stenosis.
abstract: OBJECTIVE
  Restenosis occurs invariably within 12 months following balloon valvuloplasty (BAV) in calcific aortic valve disease (CAVD), and is a limiting factor of this treatment. Cellular proliferation secondary to balloon injury is thought to play a pivotal role in the mechanism of restenosis. The study aim was to investigate the potential role of a paclitaxel-eluting valvuloplasty balloon to mitigate the progression of restenosis in an animal model of CAVD.
  
  
  METHODS
  Fifty-three rabbits were fed with an aortic stenosis (AS)-inducing diet (cholesterol 0.5% plus vitamin D3 50,000 IU/day) for three months. The surviving animals (n = 40) underwent echocardiographic and invasive assessments, followed by valvuloplasty, randomly using either a paclitaxel-coated (3 μg/mm2) or a plain balloon. At one month after BAV, the surviving animals (n = 28) underwent repeat assessments, followed by histology and micro-computed tomography (MicroCT) analysis of the aortic valve.
  
  
  RESULTS
  The baseline and post-BAV transvalvular gradients, aortic valve area (AVA), left ventricular stroke work loss (SWL) and aortic valve resistance (AVR) were similar between the groups (14 rabbits were assigned to paclitaxel-eluting, and 14 to plain balloon). Significant differences between the groups were observed at one-month post-BAV, which was suggestive of diminished restenosis in the paclitaxel-balloon group (mean maximum transvalvular pressure gradient 7.7 ± 7.7 versus 3.6 ± 3.7 mmHg, p = 0.08; AVA 0.91 ± 0.59 versus 0.55 ± 0.22 cm2, p = 0.04; SWL 3.5 ± 4.0 versus 8.6 ± 8.0%, p = 0.047; AVR 86 ± 71 versus 177 ± 137 dynes/s/cm(-5), p = 0.039). Histology demonstrated decreased leaflet thickness (0.60 ± 0.15 versus 0.71 ± 0.17 mm, p = 0.03), proliferating cell nuclear antigen (PCNA) staining (grade 1.53 ± 0.04 versus 2.24 ± 0.55, p = 0.049), and calcification in the paclitaxel-balloon group.
  
  
  CONCLUSIONS
  Use of a paclitaxel-eluting valvuloplasty balloon in an animal model of AS resulted in attenuated restenosis, secondary to decrease in valve proliferation and calcification.
authors: Konstantinos
authors: K
authors: Spargias
authors: Mariann
authors: M
authors: Gyöngyösi
authors: Rayyan
authors: R
authors: Hemetsberger
authors: Aniko
authors: A
authors: Posa
authors: Noemi
authors: N
authors: Pavo
authors: Imre J
authors: IJ
authors: Pavo
authors: Kurt
authors: K
authors: Huber
authors: Zsolt
authors: Z
authors: Petrasi
authors: Ors
authors: O
authors: Petnehazy
authors: Rembert Pogge
authors: RP
authors: von Strandmann
authors: Jeffrey
authors: J
authors: Park
authors: Dietmar
authors: D
authors: Glogar
authors: Gerald
authors: G
authors: Maurer
authors: Nalini M
authors: NM
authors: Rajamannan
mesh_terms: D000818:Animals; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D050197:Atherosclerosis / Q000473:pathology; D063126:Balloon Valvuloplasty / Q000295:instrumentation* / Q000379:methods; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D002118:Calcium / Q000032:analysis; D004195:Disease Models, Animal; D017239:Paclitaxel; D018809:Proliferating Cell Nuclear Antigen / Q000032:analysis; D011817:Rabbits; D011897:Random Allocation; D012008:Recurrence; D014463:Ultrasonography; D055114:X-Ray Microtomography
chemical_list: D018809:Proliferating Cell Nuclear Antigen; D017239:Paclitaxel; D002118:Calcium