title: Is high pressure postdilation safe in bioresorbable vascular scaffolds? Optical coherence tomography observations after noncompliant balloons inflated at more than 24 atmospheres.
abstract: OBJECTIVE
  Optical coherence tomography (OCT) was used to investigate integrity and expansion of bioresorbable drug-eluting scaffolds (BVS) after high-pressure postdilation (HPPD).
  
  
  BACKGROUND
  Because of concerns about the risk of BVS damage, postdilation was not recommended and applied in the existing randomized studies and most registries. Recent real world data suggest incomplete BVS expansion cause higher rates of thrombosis. In vivo confirmation of the safety of high pressure postdilation is of paramount importance.
  
  
  METHODS
  Data from final OCT examination of consecutive implanted BVS, postdilated with noncompliant (NC) balloons at pressure ≥24 atm were analyzed. The following stent performance indices were assessed with OCT: mean and minimal lumen and scaffold area, residual area stenosis (RAS), incomplete strut apposition (ISA), tissue prolapse, eccentricity index (EI), symmetry index (SI), strut fractures, and edge dissections.
  
  
  RESULTS
  Twenty-two BVS postdilated at high pressure were analyzed. The average maximal postdilation balloon inflation (maxPD) was 28 ± 3 atm. High pressure OPN NC Balloon (SIS Medical AG, Winterthur Switzerland) was used in 41% of postdilations with a maximal PD of 30 ± 4.7 atm. Final mean and minimal lumen area were 6.8 ± 1.4 and 5.5 ± 1.4 mm(2) , respectively. OCT showed low percentage of RAS (16 ± 9.6%), and low percentage of ISA (1.8 ± 2.4%). Mean EI was 0.86 ± 0.02 and SI 0.35 ± 0.14. OCT analysis showed one edge dissection and no scaffold fractures.
  
  
  CONCLUSIONS
  BVS deployment optimization using HPPD does not cause BVS disruption and is associated with a good BVS expansion, low rate of strut malapposition and edge dissections.
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.|Cardiovascular Department, Ospedali Riuniti and University of Trieste, Trieste, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Fabris
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Caiazzo
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.|Department of Cardiology, Pamukkale University, Denizli, Turkey.
authors.forename: Ismail Dogu
authors.initials: ID
authors.lastname: Kilic
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.
authors.forename: Roberta
authors.initials: R
authors.lastname: Serdoz
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.|Department of Clinical and Experimental Medicine, University of Eastern Piedmont, Novara, Italy.
authors.forename: Gioel Gabrio
authors.initials: GG
authors.lastname: Secco
authors.affiliation: Cardiovascular Department, Ospedali Riuniti and University of Trieste, Trieste, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Sinagra
authors.affiliation: National Heart Centre Singapore, Singapore.
authors.forename: Renick
authors.initials: R
authors.lastname: Lee
authors.affiliation: National Heart Centre Singapore, Singapore.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Foin
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011312:Pressure; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors; D013314:Stress, Mechanical; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible
keywords: bioresorbable vascular scaffolds; coronary angioplasty; noncompliant balloon; optical coherence tomography; struts apposition