Author + information
- Received October 5, 2016
- Revision received February 10, 2017
- Accepted February 13, 2017
- Published online April 17, 2017.
- Philipp Blanke, MDa,
- Philippe Pibarot, DVMb,
- Rebecca Hahn, MDc,
- Neil Weissman, MDd,
- Susheel Kodali, MDc,
- Vinod Thourani, MDe,
- Rupa Parvataneni, MScf,
- Danny Dvir, MDa,
- Christopher Naoum, MBBSa,
- Bjarne L. Nørgaard, MD, PhDg,
- Pamela Douglas, MDh,
- Wael Jaber, MDi,
- Omar K. Khalique, MDc,
- Hasan Jilaihawi, MDj,
- Michael Mack, MDk,
- Craig Smith, MDc,
- Martin Leon, MDc,
- John Webb, MDa and
- Jonathon Leipsic, MDa,∗ ()
- aCentre for Heart Valve Innovation and Department of Radiology and Division of Cardiology, St Paul Hospital & University of British Columbia, Vancouver, Canada
- bDivision of Cardiology, Québec Heart & Lung Institute, Laval University, Québec, Canada
- cDivision of Cardiology, Columbia University Medical Center/NY Presbyterian Hospital, New York, New York
- dDivision of Cardiology, Medstar Health Research Institute and Georgetown University, Washington, DC
- eDepartment of Cardiac Surgery, Emory University School of Medicine, Atlanta, Georgia
- fCardiovascular Research Foundation, New York, New York
- gDivision of Cardiology, Aarhus University, Aarhus, Denmark
- hDivision of Cardiology, Duke Clinical Research Institute, Durham, North Carolina
- iDivision of Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio
- jDivision of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California and NYU Langone Medical Center, New York, New York
- kDepartment of Surgery, Baylor Scott and White Health, Plano, Texas
- ↵∗Address for correspondence:
Dr. Jonathon Leipsic, UBC Department of Medical Imaging, Centre for Heart Valve Innovation, St Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Objectives The aim of the study was to investigate the influence of the extent of computed tomography (CT)–based area and perimeter oversizing on the incidence and severity of paravalvular aortic regurgitation (PAR) for the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) device, using CT data and echocardiographic outcome data of the PARTNER II (Placement of AoRTic TraNscathetER Valves Trial II) SAPIEN 3 intermediate-risk cohort.
Background Transcatheter heart valve (THV) sizing algorithms are device specific, requiring refinements for new valve designs.
Methods A total of 835 intermediate-risk patients with severe, symptomatic aortic stenosis enrolled in a multicenter, nonrandomized registry at 57 sites in the United States and Canada with available systolic CT data and echocardiographic follow-up were included in this analysis. THV size selection was primarily CT guided based on annular area. Area-based and perimeter-based oversizing was calculated using systolic annular CT dimensions and nominal dimensions of the implanted THV size. PAR was assessed at 30 days according to a 5-class scheme.
Results Mean oversizing by area was 7.7 ± 9.4% and mean oversizing by perimeter was 1.7 ± 4.4%. An inverse proportional relationship between degree of oversizing and frequency and severity of PAR was observed for both area and perimeter oversizing. Perimeter and area oversizing confer similar predictive capacity in regard to the occurrence of PAR after THV implantation (area under the curve: 0.78 [95% confidence interval: 0.70 to 0.85] vs. area under the curve: 0.78 [95% confidence interval: 0.72 to 0.85]; p < 0.0001). No aortic root ruptures were observed.
Conclusions For the SAPIEN 3 THV, the frequency and extent of PAR is inversely related to the degree of oversizing with acceptable rates of PAR being achieved at lower degrees of oversizing. Perimeter and area oversizing confer similar predictive capacity in regard to the occurrence of PAR after implantation of the SAPIEN 3 THV. Therefore, the SAPIEN 3 THV may offer the opportunity to reduce the risk of annular rupture associated with more significant degrees of oversizing in borderline annular anatomy. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves [PARTNER II]; NCT01314313)
- aortic stenosis
- aortic regurgitation
- computed tomography
- paravalvular regurgitation
- transcatheter aortic valve replacement
- transcatheter heart valve
Dr. Blanke has served as a consultant for Edwards Lifecsciences, Circle CVI, Neovasc, and Tendyne Holdings; and has provided computed tomography Core Lab services for Edwards Lifesciences, Medtronic, Neovasc, GDS, and Tendyne Holdings. Dr. Pibarot has Core Lab contracts with Edwards Lifesciences; and has served as a speaker for St. Jude Medical. Dr. Hahn has an institutional Core Lab contract with Edwards Lifesciences for which she receives no direct compensation and is a speaker for Philips Healthcare, St. Jude Medical, and Boston Scientific. Dr. Weissman has Core Lab contracts with Edwards Lifesciences, St. Jude Medical, Boston Scientific, Medtronic, Biostable, Sorin, Abbott Vascular, Direct Flow, and Mitralign; and has received research grant support from Boston Scientific, Edwards Lifesciences, Medtronic, St. Jude Medical, and Abbott Vascular. Dr. Kodali is on the Steering Committee for Edwards Lifesciences; is a consultant for Medtronic and Claret Medical; and is on the scientific advisory board for Thubrikar Aortic Valve Inc. Dr. Thourani has served as a consultant for Edwards Lifesciences and Abbott Medical; and has received research grant support from Edwards Lifesciences. Ms. Parvataneni is a consultant with Jazz Pharmaceuticals. Dr. Dvir has served as a consultant for Edwards Lifesciences. Dr. Nørgaard has received unrestricted institutional research grant support from Edwards Lifesciences and Siemens. Dr. Douglas has received research grant support from Edwards Lifesciences. Dr. Jaber has performed Echocore LAB work for the PARTNER trial. Dr. Khalique has served as on the Speakers Bureau for Edwards Lifesciences and Boston Scientific; and as a reader for a Core Lab that has contracts with Edwards Lifesciences. Dr. Jilaihawi has served as a consultant for Edwards Lifesciences and Venus Medtech. Dr. Webb has served as a consultant for Edwards Lifesciences. Dr. Leipsic has served as a consultant for Edwards Lifesciences and Circle CVI; and has provided computed tomography Core Lab services for Edwards Lifesciences, Medtronic, Neovasc, GDS, and Tendyne Holdings. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 5, 2016.
- Revision received February 10, 2017.
- Accepted February 13, 2017.
- 2017 American College of Cardiology Foundation