Abstract
Background
Patients with congenital or acquired heart defects affecting the pulmonary valve and
right ventricular outflow tract (RVOT) commonly require multiple surgical interventions,
resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary
valve implantation (PPVI). Though studies have previously reported the safety and
efficacy of the early generation transcatheter heart valves (THVs), data on more recent
devices are severely lacking.
Methods and results
We performed a multinational, multicentre, retrospective, observational registry analysis
of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients
that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis
(58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural
success rate was high (93.5%), with a low frequency of periprocedural complications
and adverse events (6.5% and 10.9%, respectively). At 30 days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or
II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1%
at baseline to 5.0% at 30 days, and the calculated peak systolic gradient had decreased from 45.2 (SD ± 21.3) mm Hg to 16.4 (SD ± 8.0) mm Hg, with these values remaining low up to 2 years.
Conclusions
The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies
in patients with conduits, as well as those with native pulmonary valves or transannular
patches. Continued data collection is necessary to verify long-term findings.
Clinicaltrials.gov identifier
NCT02302131.
Keywords
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Article info
Publication history
Published online: October 06, 2017
Accepted:
October 3,
2017
Received in revised form:
June 14,
2017
Received:
November 22,
2016
Identification
Copyright
© 2017 Elsevier B.V. All rights reserved.
