Author + information
- Received May 11, 2015
- Revision received June 2, 2015
- Accepted June 6, 2015
- Published online August 18, 2015.
- Mohamed Abdel-Wahab, MD∗∗ (, )
- Franz-Josef Neumann, MD†,
- Julinda Mehilli, MD‡,
- Christian Frerker, MD§,
- Doreen Richardt, MD‖,
- Martin Landt, MD∗,
- John Jose, MD∗,
- Ralph Toelg, MD∗,
- Karl-Heinz Kuck, MD§,
- Steffen Massberg, MD‡,
- Derek R. Robinson, DPhil¶,
- Mohamed El-Mawardy, MD∗,
- Gert Richardt, MD∗,
- CHOICE Investigators
- ∗Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- †University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany
- ‡Munich University Clinic, Munich, Germany
- §Cardiology Department, Asklepios Clinic St. Georg, Hamburg, Germany
- ‖Cardiosurgery Department, Lübeck University Hospital, Lübeck, Germany
- ¶Mathematics Department, University of Sussex, Brighton, United Kingdom
- ↵∗Reprint requests and correspondence:
Dr. Mohamed Abdel-Wahab, Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel, Lübeck and Hamburg, Am Kurpark 1, 23795 Bad Segeberg, Germany.
Background The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve.
Objectives The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up.
Methods The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function.
Results At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p = 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p = 0.005).
Conclusions Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial; NCT01645202)
This study was funded by the Heart Center, Segeberger Kliniken GmbH (Bad Segeberg, Germany). Drs. Abdel-Wahab and Richardt have received an institutional research grant from Biotronik and St. Jude Medical. Dr. Abdel-Wahab is a proctor for Boston Scientific. Dr. Neumann has received institutional research grants and speaking honoraria from Edwards Lifesciences and Medtronic. Dr. Mehilli has received personal fees from Boston Scientific and Edwards Lifesciences. Dr. Frerker has received speaking honoraria from Edwards Lifesciences. Dr. Richardt is an advisory board member for Abbott Vascular and Boston Scientific; and has received lecture fees from Abbott Vascular, Biotronik, Boston Scientific, and Edwards Lifesciences. Dr. Kuck has received grants and personal fees from St. Jude Medical, Biosense Webster, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 11, 2015.
- Revision received June 2, 2015.
- Accepted June 6, 2015.
- 2015 American College of Cardiology Foundation