Relationship of Annular Sizing Using Multidetector Computed Tomographic Imaging and Clinical Outcomes After Self-Expanding CoreValve Transcatheter Aortic Valve Replacement

Jeffrey J Popma; Thomas G Gleason; Steven J Yakubov; J Kevin Harrison; John K Forrest; Brijeshwar Maini; Carlos E Ruiz; Duane S Pinto; Marco Costa; Jon Resar; John Conte; Juan Crestanello; Yanping Chang; Jae K Oh; Michael J Reardon; David H Adams

doi:10.1161/CIRCINTERVENTIONS.115.003282

Relationship of Annular Sizing Using Multidetector Computed Tomographic Imaging and Clinical Outcomes After Self-Expanding CoreValve Transcatheter Aortic Valve Replacement

Circ Cardiovasc Interv. 2016 Jul;9(7):e003282. doi: 10.1161/CIRCINTERVENTIONS.115.003282.

Authors

Affiliations

¹ From the Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery) of the Beth Israel Deaconess Medical Center, Boston, MA (J.J.P., D.S.P.); Division of Cardiac Surgery, University of Pittsburgh Medical Center, PA (T.G.G.); Riverside Medical Center, Columbus, OH (S.J.Y.); Duke University Medical Center, Durham, NC (J.K.H.); Yale University Medical Center, New Haven, CT (J.K.F.); Pinnacle Health Care, Harrisburg, PA (B.M.); Lenox Hill Medical Center, New York, NY (C.E.R.); Department of Medicine-Cardiovascular Medicine, Case Western Reserve, Cleveland, OH (M.C.); Departments of Medicine (J.R.) and Surgery (J. Conte), Johns Hopkins Medical Center, Baltimore, MD; Division of Cardiac Surgery, Ohio State University, Columbus (J. Crestanello); Statistical Services, Medtronic, Inc, Minneapolis, MN (Y.C.); Department of Cardiovascular Diseases, Mayo Clinic Medical Center, Rochester, MN (J.K.O.); Houston Methodist DeBakey Heart & Vascular Center, TX (M.J.R.); and Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York (D.H.A.). jpopma@bidmc.harvard.edu.
² From the Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery) of the Beth Israel Deaconess Medical Center, Boston, MA (J.J.P., D.S.P.); Division of Cardiac Surgery, University of Pittsburgh Medical Center, PA (T.G.G.); Riverside Medical Center, Columbus, OH (S.J.Y.); Duke University Medical Center, Durham, NC (J.K.H.); Yale University Medical Center, New Haven, CT (J.K.F.); Pinnacle Health Care, Harrisburg, PA (B.M.); Lenox Hill Medical Center, New York, NY (C.E.R.); Department of Medicine-Cardiovascular Medicine, Case Western Reserve, Cleveland, OH (M.C.); Departments of Medicine (J.R.) and Surgery (J. Conte), Johns Hopkins Medical Center, Baltimore, MD; Division of Cardiac Surgery, Ohio State University, Columbus (J. Crestanello); Statistical Services, Medtronic, Inc, Minneapolis, MN (Y.C.); Department of Cardiovascular Diseases, Mayo Clinic Medical Center, Rochester, MN (J.K.O.); Houston Methodist DeBakey Heart & Vascular Center, TX (M.J.R.); and Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York (D.H.A.).

PMID: 27369803
DOI: 10.1161/CIRCINTERVENTIONS.115.003282

Abstract

Background: Multidetector computed tomography is useful for determining the appropriate transcatheter heart valve (THV) size in patients with severe aortic stenosis who are suboptimal surgical candidates. The relationship between adherence to the recommended CoreValve sizing algorithm and clinical outcomes is not known.

Methods and results: We evaluated 1023 patients with severe aortic stenosis deemed high or extreme risk for surgery treated with the CoreValve THV. All patients underwent preprocedural multidetector computed tomography, and the scans were reviewed at a central analysis center using standardized software. Compliance to a recommended sizing algorithm was used to identify patients with below-range, in-range, and above-range THV sizing. A device annular sizing ratio (DAR) was also calculated based on the native annulus perimeter and perimeter of the selected THV. Clinical end points included the presence of paravalvular aortic regurgitation evaluated by an independent echocardiographic laboratory. Adherence to the sizing algorithm was highest with a 31-mm THV (92.6%) and lowest with the 23-mm THV (38.5%). Below-range sizing was associated with a higher rate of moderate or severe paravalvular aortic regurgitation (15.3%) than in-range (6.5%) or above-range (10.0%; P<0.001) sizing. Higher DARs were associated with lower rates of moderate or severe paravalvular aortic regurgitation: DAR ≤10%, 17.6%; DAR 10% to 15%, 9.9%; DAR 15% to 20%, 6.3%; and DAR >20%, 4.9%; P<0.001. There was no increase in clinical events associated with higher DARs.

Conclusions: Adherence to a sizing algorithm guided by multidetector computed tomography resulted in lower rates of paravalvular aortic regurgitation after self-expanding transcatheter valve replacement without an increase in complications.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Keywords: annular geometry; aortic regurgitation; aortic stenosis; multidetector CT imaging; transcatheter aortic valve; valvular heart disease.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Algorithms
Aortic Valve / diagnostic imaging*
Aortic Valve / physiopathology
Aortic Valve / surgery*
Aortic Valve Insufficiency / diagnostic imaging
Aortic Valve Insufficiency / etiology
Aortic Valve Stenosis / diagnostic imaging*
Aortic Valve Stenosis / physiopathology
Aortic Valve Stenosis / surgery
Clinical Decision-Making
Decision Support Techniques
Female
Guideline Adherence
Heart Valve Prosthesis* / standards
Humans
Male
Multidetector Computed Tomography*
Patient Selection
Practice Guidelines as Topic
Predictive Value of Tests
Prosthesis Design* / standards
Risk Factors
Severity of Illness Index
Transcatheter Aortic Valve Replacement / adverse effects
Transcatheter Aortic Valve Replacement / instrumentation*
Transcatheter Aortic Valve Replacement / standards
Treatment Outcome
United States

Associated data

ClinicalTrials.gov/NCT01240902