The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

INTERVENTIONS FOR VALVULAR DISEASE AND HEART FAILURE

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system

EuroIntervention 2019;14:1378-1385 published online November 2018. DOI: 10.4244/EIJ-D-18-01035

1. Hôpital Marie Lannelongue, Le Plessis Robinson, France; 2. Department of Pediatric Cardiology and Pediatric Intensive Care, LMU München, Munich, Germany; 3. Leeds Teaching Hospitals NHS Trust, Yorkshire Heart Centre, Leeds, United Kingdom; 4. St. Paul’s Hospital, Vancouver, Canada; 5. Centre for Congenital Heart Defects, Heart and Diabetes Centre Bad Oeynhausen, Ruhr University Bochum, Bad Oeynhausen, Germany; 6. Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Centre Munich, Technical University Munich, Munich, Germany; 7. The Cardinal Stefan Wyszyński Institute of Cardiology, Warsaw, Poland; 8. University Children’s Hospital Zurich and University Hospital Zurich, Zurich, Switzerland; 9. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany; 10. Edwards Lifesciences, Prague, Czech Republic; 11. Edwards Lifesciences, Nyon, Switzerland

Aims: Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation (PPVI) using the SAPIEN 3 (S3) transcatheter heart valve. The aim of this study was to explore the short-term safety, feasibility, and haemodynamic outcomes of PPVI using the S3 transcatheter heart valve.

Methods and results: Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) were obtained. The most common underlying diagnosis was tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy; 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without the need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0%, and NYHA ≥II from 86.0% to 15.2%. During follow-up, valve thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years.

Conclusions: PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes. ClinicalTrials.gov Identifier: NCT02777892

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A modified procedure for percutaneous pulmonary valve implantation of the Edwards SAPIEN 3 valve