Short- and Mid-Term Results of Pulmonary Valve Replacement with the Inspiris Valve

Daniel K Ragheb; Elisabeth Martin; Ayush Jaggi; George K Lui; Shiraz A Maskatia; Michael Ma; Frank L Hanley; Doff B McElhinney

doi:10.1016/j.athoracsur.2023.07.049

Short- and Mid-Term Results of Pulmonary Valve Replacement with the Inspiris Valve

Ann Thorac Surg. 2023 Aug 23:S0003-4975(23)00854-8. doi: 10.1016/j.athoracsur.2023.07.049. Online ahead of print.

Authors

Daniel K Ragheb¹, Elisabeth Martin², Ayush Jaggi², George K Lui³, Shiraz A Maskatia⁴, Michael Ma², Frank L Hanley², Doff B McElhinney⁵

Affiliations

¹ Vanderbilt University School of Medicine, Nashville, Tennessee.
² Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, California.
³ Department of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto, California; Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
⁴ Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.
⁵ Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, California; Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California. Electronic address: doff@stanford.edu.

PMID: 37625611
DOI: 10.1016/j.athoracsur.2023.07.049

Abstract

Background: Various bioprosthetic valves are used off-label for pulmonary valve replacement (PVR), but there is no consensus on whether a particular valve is best for this application. Recently, the Inspiris Resilia valve (Edwards Lifesciences Inc) was approved for aortic valve replacement, and surgeons have begun using it for PVR. There is limited evidence on the performance of the Inspiris valve compared with other valves in the pulmonary position.

Methods: This study reviewed all patients who underwent PVR with a size 19- to 29-mm Inspiris valve or Mosaic valve (Medtronic Inc) from 2007 to 2022 at Lucile Packard Children's Hospital Stanford (Palo Alto, CA). Midterm outcomes included freedom from moderate or severe pulmonary regurgitation (PR), a maximum Doppler gradient ≥36 mm Hg, and freedom from reintervention.

Results: A total of 225 consecutive patients who underwent PVR with a size 19- to 29-mm Mosaic (n = 163) or Inspiris (n = 62) valve were included. There was no difference in baseline characteristics. Early postoperative gradients were low in both groups but higher in the Mosaic cohort, and neither group had more than mild PR on discharge. On univariable and multivariable analysis, Inspiris valves were significantly more likely to develop moderate or greater PR over time. There was no significant difference between the valves in freedom from reintervention or from a maximum gradient ≥36 mm Hg.

Conclusions: Early and short-term gradients were similar in patients undergoing PVR with Inspiris and Mosaic valves, but significant PR was more common in patients who received an Inspiris valve. These preliminary findings suggest that the durability of the Inspiris valve in the pulmonary position may not be superior to that of other bioprosthetic valves used for PVR.