Author + information
- Received June 18, 2018
- Revision received July 25, 2018
- Accepted July 31, 2018
- Published online November 28, 2018.
- Mohammad Abdelghani, MDa,b,∗ (, )
- Nader Mankerious, MDa,
- Abdelhakim Allali, MDa,
- Martin Landt, MDa,
- Jatinderjit Kaur, MDa,
- Dmitriy S. Sulimov, MDa,
- Constanze Merten, MDa,
- Susanne Sachse SCa,
- Julinda Mehilli, MDc,
- Franz-Josef Neumann, MDd,
- Christian Frerker, MDe,
- Thomas Kurz, MDf,
- Mohamed El-Mawardy, MDg,
- Gert Richardt, MDa and
- Mohamed Abdel-Wahab, MDa,h
- aThe Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany
- bCardiology Department, The Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- cMunich University Center, Ludwig-Maximilians University, and German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany
- dHeart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany
- eCardiology Department, Asklepios Clinic St. Georg, Hamburg, Germany
- fCardiology Department, Lübeck University Hospital, Lübeck, Germany
- gCardiology Department, Vivantes Wenckebach Hospital, Berlin, Germany
- hCardiology Department, Heart Center Leipzig – University Hospital, Leipzig, Germany
- ↵∗Address for correspondence:
Dr. Mohamed Abdel-Wahab, Heart Center Leipzig – University Hospital, Strümpellstraße 39, 04289 Leipzig, Germany.
Objectives The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli.
Background The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs.
Methods Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli.
Results THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR.
Conclusions Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.
- aortic stenosis
- hemodynamic performance
- magnetic resonance imaging
- paravalvular leak
- transcatheter aortic valve
Drs. Richardt and Abdel-Wahab have received institutional research grants from St. Jude Medical, Biotronik, and Medtronic. Dr. Abdel-Wahab is a proctor for Boston Scientific. Dr. Mehilli has received lecture fees from Abbott Vascular, Biotronik, and Edwards Lifesciences; and has received institutional grants from Abbott Vascular and Edwards Lifesciences. Dr. Neumann has received institutional research grants from Edwards Lifesciences, Biotronik, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 18, 2018.
- Revision received July 25, 2018.
- Accepted July 31, 2018.
- 2018 American College of Cardiology Foundation
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