Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial)

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Significant pulmonary regurgitation (PR) and pulmonary stenosis are common after surgical repair of some congenital heart defects. This prospective, single-arm, multicenter trial enrolled patients who underwent transcatheter heart valve (THV) implantation with a SAPIEN 3 valve to treat dysfunctional right ventricular outflow tract (RVOT) conduits or pulmonic surgical valves (≥ moderate PR and/or mean RVOT gradient ≥35 mm Hg). The primary end point was a nonhierarchical composite of THV dysfunction at 1 year comprising RVOT reintervention, ≥ moderate total PR, and mean RVOT gradient >40 mm Hg. A performance goal of <25% of upper confidence interval (CI) was prespecified for the primary end point, using a 95% exact binomial CI. Patients (n = 58) were enrolled between July 5, 2016 and July 17, 2018, with mean age of 32 years. Prestenting was performed in 53.4%. At discharge, the device success was 98.1% (single valve without explant, < moderate PR, gradient <35 mm Hg). At 30 days, there were no major adjudicated adverse clinical events. At 1 year, the primary end point composite was 4.3% (95% CI 0.5 to 14.5). The composite components were 0% (0 of 56) RVOT reintervention, 2.1% (1 of 47) ≥ moderate PR, and 2.1% (1 of 48) mean RVOT gradient >40 mm Hg. No mortality, endocarditis, thrombosis, or stent fracture were reported at 1 year. In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year.

Clinical trial registration: NCT02744677; https://clinicaltrials.gov/ct2/show/NCT02744677

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.

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Funding: Edwards Lifesciences, Inc, Irvine, California funded this study.

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