title: Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon.
abstract: OBJECTIVE
  Calcific coronary lesions impose a rigid obstacle to optimal balloon and stent expansion and the 20 to 30 atm limit that non-compliant (NC) balloons reach can be insufficient. The aim of our study was to evaluate the safety and efficacy of a new dedicated super high-pressure NC balloon (OPN NC®; SIS Medical AG, Winterthur, Switzerland).
  
  
  RESULTS
  We retrospectively evaluated a consecutive series of 91 lesions in which conventional NC balloons at maximal pressure failed to achieve an adequate post-dilatation luminal gain and were therefore treated with an OPN NC balloon up to 40 atm. Angiographic success was defined as residual angiographic diameter stenosis <30%. MLD and %DS were measured at baseline, after NC balloon, OPN NC balloon and stent implantation. Angiographic success was achieved in 84 lesions (92.3%). All of the remaining lesions received rotational atherectomy with the exception of two cases in which rotational atherectomy was not attempted because of small vessel size and excessive tortuosity. MLD and acute gain were significantly greater and %DS was significantly lower post OPN NC balloon compared with conventional NC balloon inflation (p<0.001). No coronary perforations occurred. No acute or 30-day follow-up MACE was reported.
  
  
  CONCLUSIONS
  When conventional NC balloons fail, the new OPN NC dedicated high-pressure balloon provides an effective and safe alternative strategy for the dilatation of resistant coronary lesions.
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.
authors.forename: Gioel Gabrio
authors.initials: GG
authors.lastname: Secco
authors.forename: Matteo
authors.initials: M
authors.lastname: Ghione
authors.forename: Alessio
authors.initials: A
authors.lastname: Mattesini
authors.forename: Gianni
authors.initials: G
authors.lastname: Dall'Ara
authors.forename: Liviu
authors.initials: L
authors.lastname: Ghilencea
authors.forename: Kadriye
authors.initials: K
authors.lastname: Kilickesmez
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Luca
authors.forename: Rossella
authors.initials: R
authors.lastname: Fattori
authors.forename: Rosario
authors.initials: R
authors.lastname: Parisi
authors.forename: Paolo Nicola
authors.initials: PN
authors.lastname: Marino
authors.forename: Alessandro
authors.initials: A
authors.lastname: Lupi
authors.forename: Nicolas
authors.initials: N
authors.lastname: Foin
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D017225:Atherectomy, Coronary / Q000379:methods; D006348:Cardiac Surgical Procedures / Q000379:methods; D017023:Coronary Angiography / Q000379:methods; D003327:Coronary Disease / Q000628:therapy*; D004106:Dilatation / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D012189:Retrospective Studies; D016896:Treatment Outcome