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. 2021 Nov 1;98(5):990-999.
doi: 10.1002/ccd.29862. Epub 2021 Jul 6.

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry

Robin Le Ruz  1 , Julien Plessis  1 , Ali Houeijeh  2   3 , Alban-Elouen Baruteau  1   4   5   6 , Laurianne Le Gloan  1 , Karine Warin Fresse  1 , Clément Karsenty  3   7 , Jérôme Petit  3 , François Godart  2 , Sébastien Hascoët  3   8 , Patrice Guérin  1
Affiliations

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry

Robin Le Ruz et al. Catheter Cardiovasc Interv. .

Abstract

Objectives: This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve.

Background: The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported.

Methods: From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively.

Results: The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35.

Conclusions: This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Keywords: adults; congential heart disease; heart disease intervention; percutaneous intervention; percutaneous valve therapy; pulmonary valve disease; stent design; structural; transcatheter valve implantation.

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References

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