Tae-Hyun Yang1, John G Webb2, Philipp Blanke2, Danny Dvir2, Nicolaj C Hansson3, Bjarne L Nørgaard3, Christopher R Thompson2, Martyn Thomas4, Olaf Wendler5, Alec Vahanian6, Dominique Himbert6, Susheel K Kodali7, Rebecca T Hahn7, Vinod H Thourani8, Gerhard Schymik9, Bruce Precious2, Adam Berger2, David A Wood2, Philippe Pibarot10, Josep Rodés-Cabau10, Wael A Jaber11, Martin B Leon7, Thomas Walther12, Jonathon Leipsic13. 1. Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada; Inje University Busan Paik Hospital, Busan, South Korea. 2. Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 3. Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. 4. Department of Cardiology, St. Thomas's Hospital, London, United Kingdom. 5. Department of Surgery, King's College Hospital/King's Health Partners, London, United Kingdom. 6. Department of Cardiology, Bichat Hospital, Paris, France. 7. Department of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York. 8. Department of Surgery, Emory University School of Medicine, Atlanta, Georgia. 9. Department of Cardiology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany. 10. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. 11. Cleveland Clinic, Cleveland, Ohio. 12. Department of Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany. 13. Department of Medical Imaging and Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: JLeipsic@providencehealth.bc.ca.
Abstract
OBJECTIVES: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform. BACKGROUND: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known. METHODS: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography. RESULTS: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR. CONCLUSIONS: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.
OBJECTIVES: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform. BACKGROUND: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known. METHODS: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography. RESULTS: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR. CONCLUSIONS: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.
Authors: Beth Ripley; Tatiana Kelil; Michael K Cheezum; Alexandra Goncalves; Marcelo F Di Carli; Frank J Rybicki; Mike Steigner; Dimitrios Mitsouras; Ron Blankstein Journal: J Cardiovasc Comput Tomogr Date: 2015-12-12