SAPIEN valve for percutaneous transcatheter pulmonary valve replacement without “pre‐stenting”: A multi‐institutional experience

• Published in: Catheterization and cardiovascular interventions Vol. 93; no. 2; pp. 324 - 329
• Main Authors: Morgan, Gareth J., Sadeghi, Soraya, Salem, Moris M., Wilson, Neil, Kay, Joseph, Rothman, Abraham, Galindo, Alvaro, Martin, Mary Hunt, Gray, Robert, Ross, Michael, Aboulhosn, Jamil A., Levi, Daniel Steven
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.02.2019; Wiley Subscription Services, Inc
• Subjects: Adolescent; Adult; Aged; Aorta; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Child; Child, Preschool; Chromium; Cobalt; Compression; Coronary artery disease; Embolization; Female; Fractures; Heart diseases; Heart Valve Diseases - diagnostic imaging; Heart Valve Diseases - physiopathology; Heart Valve Diseases - surgery; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Hemodynamics; Humans; Implants; Male; Middle Aged; percutaneous pulmonary valve replacement; Prosthesis Design; Pulmonary valve; Pulmonary Valve - diagnostic imaging; Pulmonary Valve - physiopathology; Pulmonary Valve - surgery; Recovery of Function; Regurgitation; Retrospective Studies; Rheumatic heart disease; right ventricular outflow tract stenting; stent fracture; Stents; Time Factors; Treatment Outcome; Tricuspid valve; United States; Ventricle; Ventricular Outflow Obstruction - diagnostic imaging; Ventricular Outflow Obstruction - physiopathology; Ventricular Outflow Obstruction - surgery; Young Adult; United States; stent fracture; right ventricular outflow tract stenting; percutaneous pulmonary valve replacement
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.27932

Objectives To describe a multicenter experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards SAPIEN S3 valve without the use of a prior stent (“pre‐stenting”). Background The SAPIEN S3 and XT valves have durable cobalt–chromium stent frames which may allow for TPVR in large diameter dysfunctional right ventricular outflow tracts (RVOTs) without pre‐stenting the landing zone. Methods A retrospective review was performed of all patients with Congenital Heart Disease and dysfunctional RVOT who underwent TPVR using the SAPIEN valve without the use of a pre‐stent. Imaging data, procedural elements, and clinical follow‐up data were collected to evaluate short and intermediate‐term results. Results Fifty‐seven patients underwent percutaneous placement of the SAPIEN valve in the pulmonary position without the use of pre‐stenting. The anatomical substrate varied: native RVOTs (n = 41), conduits (n = 10), and bioprosthetic valves (n = 6). There were no cases in which the valve could not be implanted and no cases of valve embolization or misplacement. On follow‐up (range 1 month to 2.2 years, median 5.3 months), no patients had significant obstruction or regurgitation around the valve. There were no frame fractures. There were no procedural deaths. Major complications included severe aortic compression (n = 1) requiring surgical explantation and tricuspid valve injury requiring surgical intervention (n = 2). Conclusions This limited multi‐institutional experience demonstrates that the SAPIEN valve can be used for TPVR without the use of a pre‐stent without medium‐term risk of frame fracture, paravalvar leak, or embolization. Longer term follow‐up is required to fully assess this method.