Sanjay Sinha1, Jamil Aboulhosn1,2, Jeremy Asnes3, Martin Bocks4, Evan Zahn5, Bryan H Goldstein6, Jeffrey Zampi7, William Hellenbrand3, Morris Salem8, Daniel Levi1,2. 1. Department of Pediatrics, Division of Cardiology, UCLA Mattel Children's Hospital, Los Angeles, California. 2. Department of Medicine, Ahmanson Adult Congenital Heart Disease Center, David Geffen School of Medicine at UCLA, Los Angeles, California. 3. Department of Pediatrics, Division of Cardiology, Yale Medical Center, New Haven, Connecticut. 4. Department of Pediatrics, Division of Pediatric Cardiology, UH Rainbow Babies and Children's Hospital, Cleveland, Ohio. 5. Guerin Family Congenital Heart Program, The Heart Institute and Department of Pediatrics Cedars-Sinai Medical Center, Los Angeles, California. 6. Department of Pediatrics, Division of Cardiology, Cincinnati Children's Hospital, Cincinnati, Ohio. 7. Department of Pediatrics, Division of Cardiology, University of Michigan, Ann Arbor, Michigan. 8. Department of Pediatrics, Division of Cardiology, Kaiser Permanente, Los Angeles, California.
Abstract
OBJECTIVES: To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. BACKGROUND: Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. METHODS: A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results. RESULTS: A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into "native RVOTs", measuring 24-32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1-9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). CONCLUSIONS: TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short-term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.
OBJECTIVES: To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. BACKGROUND: Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. METHODS: A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results. RESULTS: A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into "native RVOTs", measuring 24-32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1-9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). CONCLUSIONS: TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short-term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.
Authors: Abhay A Divekar; Yousef M Arar; Stephen Clark; Animesh Tandon; Thomas M Zellers; Surendranath R Veeram Reddy Journal: Children (Basel) Date: 2022-04-02