Early Concerning Outcomes for the Edwards Inspiris Resilia Bioprosthesis in the Pulmonary Position

Sameh M. Said, Gurumurthy Hiremath, Varun Aggarwal, John L Bass, Sandeep Sainathan, Mahmoud I. Salem, Shanti Narasimhan

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Inspiris Resilia (Edwards Lifesciences LLC, Irvine, CA) bioprosthesis has gained widespread use in the aortic position; however no robust data are available about its use in the pulmonary position. Methods: We reviewed our outcomes for the Inspiris Resilia in the pulmonary position between August 2019 and October 2021. Results: Twenty-seven patients (15 female patients [56%]; mean age, 22.26 ± 14.99 years) were included. The most common original pathology was tetralogy of Fallot (13 patients, 48%). Five patients (18.5%) had prior transcatheter interventions. The mean right ventricular end-diastolic volume index was 164.25 ± 45.1 mL/m2. Sternotomy or repeat sternotomy was the most common approach (21 patients, 77.8%). The standard technique for pulmonary valve replacement was used in 22 patients (81.5%), whereas the prosthesis was implanted as a conduit in the remaining 5 (18.5%). Trivial to mild prosthetic regurgitation was present in 6 patients (22.2%) at the time of discharge. There was no early mortality. Follow-up was complete in all patients (mean, 16 ± 8 months), with no late mortality or late reoperations. New prosthetic regurgitation developed in 13 patients (48%), all of whom underwent replacement with the standard surgical technique. No regurgitation occurred in the conduit cases. This progressed to moderate regurgitation in 6 patients (22%) and severe in 3 (11%). Three patients (11%) underwent transcatheter valve-in-valve after their surgical pulmonary valve replacement. Conclusions: The early data regarding the Inspiris Resilia bioprosthesis use in the pulmonary position is concerning. The prosthesis design may not be suitable for low-pressure circulation, or modification of its implantation technique may be needed.

Original languageEnglish (US)
JournalAnnals of Thoracic Surgery
DOIs
StateAccepted/In press - 2022

Bibliographical note

Funding Information:
The authors have no funding sources to disclose. Sameh M. Said reports a relationship with Artivion, Inc that includes consulting or advisory and speaking and lecture fees, a relationship with Abbott that includes consulting or advisory, and a relationship with Stryker that includes consulting or advisory and speaking and lecture fees. All other authors declare that they have no conflicts of interest.

Publisher Copyright:
© 2022 The Society of Thoracic Surgeons

PubMed: MeSH publication types

  • Journal Article

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