title: NuMED Covered Cheatham-Platinum Stent™ for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement.
abstract: OBJECTIVE
  Retrospectively assess the frequency of right ventricular outflow tract (RVOT) conduit disruption during transcatheter pulmonary valve replacement (TPVR) and the effectiveness and safety of NuMED Covered Cheatham-Platinum Stents™ (CCPS) for its prevention or treatment.
  
  
  BACKGROUND
  There have been no published reports to date describing the safety and effectiveness of covered stents to prevent or treat RVOT conduit disruption during TPVR.
  
  
  METHODS
  Data regarding 251 TPVR procedures performed at multiple US investigational sites were retrospectively reviewed to explore the incidence and potential predictors of conduit disruption. In addition, data on the use of 69 CCPS implanted in 50 patients during TPVR was reviewed.
  
  
  RESULTS
  The overall incidence of conduit disruption requiring intervention was 6%. The only predictor identified was a very elevated RVOT conduit systolic pressure gradient. A pre-existing conduit tear was present in nine, while 31 developed tears after conduit dilation and three, after TPVR. The CCPS was used prophylactically in seven. Conduit tears were prevented or repaired in 49/50 patients. No CCPS-related acute complications were reported. At 6-month follow-up, no patient had more than mild pulmonary regurgitation and the mean Doppler RVOT gradient (12.7 ± 5.8 mm Hg) comparing favorably with that reported in the Melody TPV® IDE trial (20.0 ± 8.6 mm Hg).
  
  
  CONCLUSIONS
  CCPS implantation can successfully treat RVOT conduit disruption without negative impact on the TPV function. This retrospective analysis suggests high RVOT conduit systolic pressure gradient is a risk factor for conduit tears during TPVR.
authors.affiliation: Division of Pediatric Cardiology, Johns Hopkins School of Medicine, Bloomberg Children's Center Baltimore, Maryland.
authors.forename: Ram N
authors.initials: RN
authors.lastname: Bishnoi
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Jones
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Kreutzer
authors.forename: Richard E
authors.initials: RE
authors.lastname: Ringel
mesh_terms: D000293:Adolescent; D000328:Adult; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002648:Child; D020099:Coated Materials, Biocompatible; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010984:Platinum; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000503:physiopathology / Q000601:surgery*; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014694:Ventricular Outflow Obstruction / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control* / Q000628:therapy*; D055815:Young Adult
chemical_list: D020099:Coated Materials, Biocompatible; D010984:Platinum
keywords: covered cheatham-platinum stent; melody TPV®; right ventricular outflow tract conduit; transcatheter pulmonary valve replacement