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

doi:10.1016/j.jacc.2011.07.040

Journal of the American College of Cardiology

Volume 58, Issue 21, 15 November 2011, Pages 2248-2256

https://doi.org/10.1016/j.jacc.2011.07.040 Get rights and content

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Objectives

The purpose of this study was to evaluate the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis.

Background

Transcatheter pulmonary valve replacement is evolving, but to date, experience has been limited to the Melody valve (Medtronic Inc., Minneapolis, Minnesota).

Methods

Eligible patients with dysfunctional right ventricle-to-pulmonary artery conduits were screened if body weight was ≥35 kg and the in situ conduit diameter was ≥16 mm and ≤24 mm. Standardized implantation and follow-up protocols were used.

Results

Thirty-six patients from 4 centers were recruited between April 2008 and May 2010. Mean body weight was 73.4 ± 22.9 kg. Successful valve deployment was achieved in 33 of 34 attempts (97.1%). Valve migration occurred in 3 patients, with 2 requiring surgical retrieval; however, 1 patient underwent successful perventricular valve implantation. Further intraprocedure complications included pulmonary hemorrhage (n = 2), ventricular fibrillation (n = 1), and stent migration (n = 1). Pullback gradient across the conduit decreased from 26.8 ± 18.4 mm Hg to 11.7 ± 8.0 mm Hg (p < 0.001). The right ventricular/aortic pressure ratio decreased from 0.6 ± 0.2 to 0.4 ± 0.1 (p < 0.001). Peak Doppler gradient across the right ventricular outflow tract decreased from 41.9 ± 27.9 mm Hg to 19.1 ± 13.3 mm Hg (p < 0.001). At 6-month follow-up, all patients were alive. The number of patients with New York Heart Association functional class I increased from 5 at baseline to 27 at follow-up. Pulmonary regurgitation was ≤2+ in 97% of patients. Freedom from reintervention was 97% with 1 patient undergoing elective placement of a second valve due to conduit-induced distortion of the initial implant.

Conclusions

Transcatheter pulmonary valve replacement using the Edwards SAPIEN transcatheter heart valve is safe and effective in patients with dysfunctional right ventricle-to-pulmonary artery conduits.

Key Words

conduit

pulmonary valve replacement

SAPIEN

stent

transcatheter

Abbreviations and Acronyms

computed tomography

MRI

magnetic resonance imaging

NYHA

New York Heart Association

RV-PA

right ventricle to pulmonary artery

THV

transcatheter heart valve

tPVR

transcatheter pulmonary valve replacement

TTE

transthoracic echocardiogram

Cited by (0)

: The trial was sponsored and funded through Edwards Lifesciences LLC. Dr. Hijazi is a consultant to Edwards Lifesciences. Dr. Kar has received research grants from Abbott Vascular; and has received honoraria from and is a consultant for Medtronic. Dr. Mullen is a proctor for Edwards Lifesciences. Dr. Makkar has received consultancy fees, grant support, and lecture fees from Abbott, Medtronic, and Lilly; and grant support from Johnson & Johnson and St. Jude Medical. Dr. Shirali is a consultant to, recipient of research grants from, and a member of the advisory board of Philips Medical Systems; and has received research grants from Edwards Lifesciences. Dr. Fogel has received grants from Edwards Lifesciences for the COMPASSION study; has received grants from Siemens; and payment as medical monitor for Kereos. Christopher Cain was an employee of Edwards Lifesciences during the trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.