少见的介入瓣膜手术肺动脉瓣.pptVIP

Pulmonary Regurgitation (RVOT dysfunction) Need for intervention in RVOT dysfunction following congenital heart disease repair is increasing Long standing pulmonary regurgitation leads to decreased exercise tolerance, RV dysfunction and arrhythmia (atrial/ventricular) Earlier correction of PR may preserve RV function Indications for Intervention Regurgitation Fraction 30% and RVOT peak velocity on continuous Doppler wave 3 m/s RV dysfunction Reduced exercise capacity Documented atrial and/or ventricular arrhythmias Melody Trans-catheter Valve World Wide Experience Melody: Patient Characteristics Hemodynamic Effects (n=121) Hemodynamic Effects (n=121) Hemodynamic Effects (n=121) Learning Curve Learning Curve Melody? TPV US IDE Study US FDA IDE Study – Current Status Initial Cohort of 30 patients / 3 Centers ? Prospective, non-randomized ? January 2007 – first implant ? September 2007 – enrollment completed ? August 2008 – submission to FDA for HDE approval Continued Access at 5 Centers ? 120 total patients approved by FDA for enrollment ? All patients will be followed for 5 years Patients to Date ? 76 / 120 study patients ? 16 Compassionate / Emergency Use patients Inclusion Criteria Age ≥ 5 years Weight ≥30 kg Conduit 16 mm Conduit dysfunction Study Inclusion Criteria NYHA II,III,IV Mean RVOT gradient ≥ 35 mmHg, or Moderate or Severe PR NYHA I Mean RVOT gradient ≥ 40 mmHg, or Severe PR with RV dilation* or dysfunction** *RV dilatation defined as z-score for tricuspid annular diameter ≥2.0 **RV dysfunction defined as RV fractional area change 40% Patient Characteristics Procedural Data N = 30 attempted, 29 stented Procedure time 182 minutes (76 - 448) Fluoroscopy time 45 minutes (9-87) Vascular approach Femoral vein – 29 Jugular vein – 1 Size Narrowest diameter 12.8 (8-19) Balloon sizing 28/30 Balloon minimal waist 16.8 (14-20) Procedural Results 93% procedural success 1 homograft rupture 1 had post-implant trans-conduit gradient of 37 mm Hg 3 subjects (10%) h