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Original Investigation |

Comparison of Balloon-Expandable vs Self-expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement:  The CHOICE Randomized Clinical Trial

Mohamed Abdel-Wahab, MD1; Julinda Mehilli, MD2; Christian Frerker, MD3; Franz-Josef Neumann, MD4; Thomas Kurz, MD5; Ralph Tölg, MD1; Dirk Zachow, MD6; Elena Guerra, MD7; Steffen Massberg, MD2; Ulrich Schäfer, MD3,8; Mohamed El-Mawardy, MD1; Gert Richardt, MD1 ; for the CHOICE investigators
[+] Author Affiliations
1Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
2Munich University Clinic, Munich, Germany
3Cardiology Department, Asklepios Clinic St Georg, Hamburg, Germany
4University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany
5Cardiology Department, Lübeck University Hospital, Lübeck, Germany
6Radiology Department, Segeberger Kliniken, Bad Segeberg, Germany
7Intracoronary Stenting and Antithrombosis Research Center, Munich, Germany
8Cardiology Department, University Hospital Hamburg-Eppendorf, Hamburg, Germany
JAMA. 2014;311(15):1503-1514. doi:10.1001/jama.2014.3316.
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Importance  Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed.

Objective  To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device.

Design, Setting, and Patients  The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany.

Interventions  Transfemoral TAVR with a balloon-expandable or self-expandable device.

Main Outcomes and Measures  The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications.

Results  Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk [RR], 1.24, 95% CI, 1.12-1.37, P < .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1% vs 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P < .001) and the less frequent need for implanting more than 1 valve (0.8% vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3% in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expandable valve group (RR, 0.79; 95% CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs 37.6%, P = .001).

Conclusions and Relevance  Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve.

Trial Registration  clinicaltrials.gov Identifier: NCT01645202

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Figure 1.
Study Flow Chart
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Figure 2.
Subgroup Analyses for Device Success

Subgroup analyses are shown for the primary end point of device success among patients who were randomly assigned to undergo transfemoral transcatheter aortic valve replacement with either a self-expandable or balloon-expandable prosthesis. The P value for interaction represents the likelihood of interaction between the variable and the relative treatment effect. Risk ratios are for the balloon-expandable vs self-expandable valve. CT indicates computed tomography; LVOT, left ventricular outflow tract. Aortic cusp (leaflet) and LVOT calcifications have been graded as described in Table 2.

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