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Balloon-Expandable vs Self-Expandable Valves: Does the CHOICE Matter?

Summary and Comment |
March 30, 2014

Balloon-Expandable vs Self-Expandable Valves: Does the CHOICE Matter?

  1. Howard C. Herrmann, MD

Procedural outcomes at 30 days after transcatheter aortic valve replacement favored the BE device, but longer and larger trials are needed to assess clinical outcomes.

  1. Howard C. Herrmann, MD

Both the balloon-expandable (BE) Sapien XT and the self-expandable (SE) CoreValve transcatheter heart valves are approved for use in the U.S. and Europe. In this German, five-center, open-label, randomized trial, 241 patients with severe aortic stenosis and at least intermediate surgical risk underwent transcatheter aortic valve replacement with one of the two devices. The primary endpoint was device success, a procedural composite endpoint described by the Valve Academic Research Consortium.

The device success rate was higher with the BE than with the SE device (96% vs. 76%; P<0.001), primarily because of less-frequent moderate or severe aortic regurgitation (4% vs. 18%; P<0.001) and need for a second valve (0.8% vs. 5.8%; P=0.03). No significant between-group differences were observed in procedural or 30-day mortality or in symptom improvement, but the rate of new permanent pacemaker implantation was higher with the SE device (38% vs. 17%; P=0.001), and the stroke rate was higher with the BE device (5.8% vs. 2.6%; P=0.33).

Comment

This is the first of what will likely be multiple randomized device-to-device comparisons in patients undergoing transcatheter aortic valve replacement. The primary endpoint of device success favored the balloon-expandable device, but the lack of significant between-group differences in mortality, symptom improvement, or stroke is inconclusive, since the study's small size and short duration leave it underpowered for these endpoints. Both the high rate of aortic regurgitation with the self-expandable device and the high rate of pacemaker implantation with both devices contrast with findings from larger registries and previous studies and emphasize the need for more and larger comparisons.

  • Disclosures for Howard C. Herrmann, MD at time of publication Consultant / Advisory board Gerson Lehrman Group; Siemens; St. Jude Medical Speaker's bureau American College of Cardiology Foundation; Cardiovascular Institute; Cardiovascular Research Foundation; Christiana Medical Center; Coastal Cardiovascular Society; Crozer-Chester Hospital; Mayo Clinic; New York Cardiology Society Equity Micro-Interventional Devices, Inc. Grant / research support Abbott Vascular; Edwards Lifesciences; Gore; Medtronic; St. Jude Medical Editorial boards Catheterization and Cardiovascular Interventions; Circulation-Cardiovascular Interventions; Journal of Interventional Cardiology; Journal of Invasive Cardiology

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