Medtronic's CoreValve Data Presented at EuroPCR

May 20, 2011—Medtronic, Inc. (Minneapolis, MN) announced that data presented at the EuroPCR 2011 conference in Paris confirmed positive outcomes in patients receiving the company's CoreValve system across seven international clinical registries. In a late-breaking presentation about transcatheter aortic valve implantation (TAVI), the meta-analysis summarized European data from 2,156 patients treated with the CoreValve system for severe aortic stenosis.

"Our weighted analysis of early and late clinical outcomes after CoreValve implantation demonstrates that this transcatheter self-expandable valve prosthesis provides a safe treatment alternative to patients who are at high risk or unable to undergo surgical aortic valve replacement," commented Carlos E. Ruiz, MD. "There has been some variability in reported early and late outcomes with TAVI systems from individual country registries, which we believe can be attributed to limited sample sizes and different experience levels among physicians."

The results demonstrate positive patient outcomes based on a procedural success rate of 97.8%, a vascular complication rate of 2.9%, a 1-month stroke rate of 1.9%, a 1-month survival rate of 93.8%, and a 1-year all-cause mortality rate of 17.1% from five registries. The meta-analysis included findings from Australia, Belgium, France, Germany, New Zealand, Spain, and the United Kingdom. 

Medtronic, which provided financial support for the study, noted that limitations of the meta-analysis included use of nonstandard definitions by independent registries and independent reporting of clinical outcomes.

The company also announced that in a May 17 presentation at the EuroPCR conference, new clinical data demonstrated immediate and long-term health-related quality-of-life (HRQoL) benefits for patients receiving the Medtronic CoreValve system. The company stated that the favorable 2-year results from the 18-F CoreValve multicenter prospective study are the largest set of CoreValve HRQoL data and the longest-term HRQoL data available for a TAVI system.

“Together with positive 2-year performance and durability data presented at EuroPCR 2010, these results offer clear, mounting evidence that CoreValve is a truly transformational therapy for many patients with severe aortic stenosis, resulting in sustained clinical benefits and improved quality of life,” commented Raoul Bonan, MD.

According to Medtronic, the study included 126 patients who were implanted with the CoreValve system at nine centers in Europe and Canada. Investigators reported the following HRQoL outcomes based on patient completion of the EuroQoL (EQ-5D) questionnaire and Visual Analog Scale at baseline and 3, 6, 12, and 24 months after the procedure:

• Mean health utility scores (range, 0–1). By 12 months, CoreValve patients reached the normal range of health utility scores (relative to United Kingdom general population norms for this age group) and this was sustained for 24 months. They improved from 0.6 at baseline to 0.71 at 3 months, 0.73 at 12 months, and 0.76 at 24 months (P < .05).
• Visual analog scores (range, 0–100). Reflecting patients' improved perceptions of their health, these scores increased from 53.1% at baseline to 64.4% at 3 months, 67.3% at 12 months, and 69.1% at 24 months (P < .0001).
• Pain/discomfort and anxiety/depression. For individual patients, significant improvements were observed in these domains at 3 months and were maintained through 12 months (P < .05).

The CoreValve system is designed to provide a nonsurgical, minimally invasive treatment option for patients with symptomatic, severe aortic stenosis who are at high risk or are ineligible for open heart surgery. The company advised that in the United States, the Medtronic CoreValve system is currently limited to investigational use.