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Comparison of Balloon-Expandable vs Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: The CHOICE Randomized Clinical Trial
Study Questions:
What is the comparative performance of the balloon-expandable device versus the self-expandable device regarding overall device success for transcatheter aortic valve replacement (TAVR)?
Methods:
The CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis) 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 five centers in Germany, and underwent transfemoral TAVR with a balloon-expandable or self-expandable device. The primary endpoint was device success, which is a composite endpoint 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 one valve implanted in the proper anatomical location. Secondary endpoints included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety endpoint 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% confidence interval [CI], 1.12-1.37; p < 0.001). 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 < 0.001) and the less frequent need for implanting more than one valve (0.8% vs. 5.8%, p = 0.03) 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 = 0.99). Bleeding and vascular complications were not significantly different, and the combined safety endpoint 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 = 0.42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs. 37.6%, p = 0.001).
Conclusions:
The authors concluded that 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.
Perspective:
In this contemporary study involving patients who had undergone TAVR, clinical outcome at 30 days was excellent with both valves and with low and comparable mortality and major stroke rates. The primary endpoint of device success was higher with the balloon-expandable device, which was attributed to a lower frequency of more-than-mild paravalvular aortic regurgitation, and the less frequent need for implanting two devices to achieve an acceptable hemodynamic outcome. Longer-term follow-up of the CHOICE population is indicated to determine whether differences in initial device success will translate into a clinically relevant overall benefit for the balloon-expandable valve. The areas not studied in this trial where self-expandable valves may have benefit include valve in valve for small valves and patients with minimal calcification of the aortic valve with predominantly regurgitant lesions, and needs further study.
Keywords: Heart Valve Prosthesis, Stroke, Bioprosthesis, Cardiology, Calcinosis, Germany, Confidence Intervals, Hemodynamics
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