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

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.

A modified approach in the repair of type I and II truncus arteriosus to promote branch pulmonary arterial growth and limit early reoperation

“… 1 , 19 , 20 By extending the time to reoperation and allowing the branch PAs to grow, the placement of a larger-sized conduit (≥20 mm) at the time of the first reoperation allows for future catheter-based valve reintervention. 21 , 22 Children repaired using the modified approach, based on conduit longevity and subsequent catheter reintervention, may not require a third operation until their fifth or sixth decade.…”

2024 Statement from Asia expert operators on transcatheter pulmonary valve replacement

“…Other risk factors include previous implantation of valved conduits, previous history of endocarditis, previous implantation of bovine jugular vein valves, no prophylactic use of antibiotics, dental and other invasive procedures, bacteremia (skin, nail infection), and so on. [55][56][57] To reduce the incidence of infective endocarditis after TPVR, prophylactic antibiotics should be used in strict accordance with the recommendations of the guidelines for the prevention of infective endocarditis after TPVR. Once this complication occurs, antiinfective treatment should be given first, but some patients may still require surgical valve removal and replacement.…”

“…However, recent studies suggest that the risk of endocarditis after TPVR is always present, 54 and multivariate analysis suggests that the high‐pressure gradient in the RVOT and young age are independent predictors of endocarditis after TPVR. Other risk factors include previous implantation of valved conduits, previous history of endocarditis, previous implantation of bovine jugular vein valves, no prophylactic use of antibiotics, dental and other invasive procedures, bacteremia (skin, nail infection), and so on 55–57 . To reduce the incidence of infective endocarditis after TPVR, prophylactic antibiotics should be used in strict accordance with the recommendations of the guidelines for the prevention of infective endocarditis after TPVR.…”

“…* Core Viewpoint 8: Following TPVR, patients should actively prevent the occurrence of infective endocarditis, that is, strict adherence to the recommendations of the guidelines for the prevention of infective endocarditis of bioprosthetic valves, and use antibiotics prophylactically under the conditions of invasive operation and exposure to high‐risk factors 54–58 (COR I, LOE C).…”

Pulmonary Valve Stenosis: From Diagnosis to Current Management Techniques and Future Prospects

“… 76 About the long-term outcomes of the XT valve, in the study of Le Ruz et al, the primary efficacy outcome (freedom from valve-reintervention) 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%). 77 The ongoing COMPASSION S3 (ClinicalTrials.gov Identifier: NCT02744677) aims to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.…”