Objectives To determine the feasibility and safety of pre-stenting with a bare metal stent (BMS) before percutaneous pulmonary valve implantation (PPVI), and to analyse whether this approach improves haemodynamic outcomes and impacts on the incidence of PPVI stent fractures.
Design Retrospective analysis of prospectively collected data.
Setting Tertiary paediatric and adult congenital heart cardiac centre.
Patients and interventions 108 consecutive patients with congenital heart disease underwent PPVI between September 2005 and June 2008 (54 with PPVI alone, 54 with BMS pre-stenting before PPVI).
Results There were no significant differences in procedural complication rates. Acutely, there was no difference in haemodynamic outcomes. Serial echocardiography revealed that in the subgroups of ‘moderate’ (26–40 mm Hg) and ‘severe’ (>40 mm Hg) right ventricular outflow tract (RVOT) obstruction, patients with pre-stenting showed a tendency towards lower peak RVOT velocities compared to patients after PPVI alone (p=0.01 and p=0.045, respectively). The incidence of PPVI stent fractures was not statistically different between treatment groups at 1 year (PPVI 31% vs BMS+PPVI 18%; p=0.16). However, pre-stenting with BMS was associated with a lower risk of developing PPVI stent fractures (HR 0.35, 95% CI 0.14 to 0.87, p=0.024). The probability of freedom from serious adverse follow-up events (death, device explantation, repeat PPVI) was not statistically different at 1 year (PPVI 92% vs BMS+PPVI 94%; p=0.44).
Conclusions Pre-stenting with BMS before PPVI is a feasible and safe modification of the established implantation protocol. Pre-stenting is associated with a reduced risk of developing PPVI stent fractures.
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Funding PL is funded by the European Union (Health e-child initiative, grant no. 027749). SS is funded by the Royal Academy of Engineering/EPSRC (RAEng/EPSRC grant no. 10216/79). AJ is funded by a Clinician Scientist Award from the UCL Institute of Child Health Biomedical Research Centre. AMT is funded by the UK National Institute of Health Research (NIHR, grant no. SRF/08/01/018) and supported by the British Heart Foundation (grant no. CI/05/010).
Competing interests JN, PL and AMT have received honoraria from Speakers Bureau (Medtronic, Inc.). SK and DBM are consultants to Medtronic, Inc. PB is consultant to Medtronic, Inc. and has ownership interests with Melody Valve.
Ethics approval The ethics committees at Great Ormond Street Hospital for Children, The Heart Hospital and Harley Street Clinic (all located in London, UK) approved the study protocol.
Provenance and peer review Not commissioned; externally peer reviewed.
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