Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial)
Graphical abstract
Section snippets
Methods
This prospective, single-arm, multicenter study (NCT02744677) was conducted at 11 sites in the United States between July 5, 2016 and July 17, 2018. The study aimed to determine the safety and effectiveness of the SAPIEN 3 THV in the treatment of patients with a dysfunctional RVOT conduit or surgical valve in the pulmonic position, with a clinical indication for intervention. The research protocol complied with the Declaration of Helsinki and was approved by institutional review boards at each
Results
A total of 67 patients were screened, and 58 were enrolled (Figure 2). A total of 2 patients did not have an attempted implant because of the difficulty of accessing the conduit or valve before the insertion of the eSheath. Implants were successful in 100% of those attempted (VI population; n = 56). There were no instances of coronary artery compression under angiographic balloon sizing.
The most common original congenital heart defect diagnoses were the tetralogy of Fallot (55.2%), pulmonary
Discussion
The COMPASSION S3 study demonstrated the safety and effectiveness of the third-generation SAPIEN 3 THV in a select patient population with dysfunctional RVOT conduits and surgical bioprosthetic pulmonary valves. These findings are consistent with the earlier COMPASSION trial, which found excellent valve function and clinical outcomes up to 3 years after the index procedure with the first-generation SAPIEN THV—similarly developed for transcatheter aortic valve replacement and successfully used
Acknowledgment
The authors thank the following trial investigators for their contributions: Robert Gray, MD of Intermountain Healthcare, Salt Lake City, Utah; Vaikom Mahadevan, MD and Phillip Moore, MD of the University of California, San Francisco Medical Center, San Francisco, California; Wilson Szeto, MD and Matthew Gillespie, MD of the University of Pennsylvania, Philadelphia, Pennsylvania; Thomas Jones, MD of Seattle Children's Hospital, Seattle, Washington; Dean Kereiakes, MD and Andrew Leventhal, MD of
Disclosures
Drs. Lim and DSL and Shirali report that their institutions receive grant funding from Edwards Lifesciences. Drs. Aboulhosn, Levi, Torres, and Babaliaros report receiving consultancy/proctoring fees from Edwards Lifesciences. Dr. Zhao is an employee of Edwards Lifesciences. The remaining authors have no conflicts of interest to declare.
References (9)
Self-expanding pulmonary valves for large diameter right ventricular outflow tracts
Interv Cardiol Clin
(2019)- et al.
Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: Early phase 1 results from an international multicenter clinical trial
J Am Coll Cardiol
(2011) - et al.
Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the U.S. Clinical trial
J Am Coll Cardiol
(2009) - et al.
The Melody® valve and Ensemble® delivery system for transcatheter pulmonary valve replacement
Ann N Y Acad Sci
(2013)
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Funding: Edwards Lifesciences, Inc, Irvine, California funded this study.