Medtronic's CoreValve Shows High Rates of Survival and Improved QoL at 1 Year in Postmarket ADVANCE Study

October 22, 2012—Medtronic, Inc. (Minneapolis, MN) announced new findings from the Medtronic CoreValve ADVANCE international postmarket study for 1-year survival and health-related quality of life (HRQoL). The findings were presented this week at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

According to Medtronic's announcement, initial 1-year results of the ADVANCE study revealed that patients experienced high survival rates, with 1-year survival at 82.1% and 1-year cardiovascular survival at 88.2%. HRQoL measures for patients in the ADVANCE study improved significantly at 1 and 6 months, compared with their status before receiving the Medtronic CoreValve system.

Quality of life was measured at baseline, 1 month, and 6 months using two general validated questionnaires (the EQ-5D and the SF-12 physical and mental), and health status was self-reported by patients. The ADVANCE study will continue to measure HRQoL benefits over time; 1-year results will be reported next year, stated Medtronic.

On the SF-12 scale from 0 to 100, with a higher score reflecting a better HRQoL, the patients' health scores at 6 months significantly improved by 6.92 points from baseline for the physical component summary score (P < .001), and significantly improved by 3.80 points from baseline for the mental component summary score (P < .001).

On the EQ-5D scale from 0 (death) to 1 (perfect health), patients' health scores significantly increased by 0.1 points at both 1 month and 6 months from baseline (P < .001). All differences reported are statistically significant.

Medtronic noted that in the study, even the highest risk patients experienced significant improvements in HRQoL after transcatheter aortic valve replacement. When evaluating these improvements by patient risk, patients with higher risk profiles (EuroSCORE > 20) had significantly worse baseline HRQoL than patients with lower risk profiles but still demonstrated significant improvements out to 6 months (EQ-5D, P < .001).

Additionally, patients who received the CoreValve system via direct aortic and subclavian access routes demonstrated similar HRQoL improvements (as measured by EQ-5D) as those undergoing transfemoral implantation.

In Medtronic's press release, Prof. Johan Bosmans, MD, of the University Hospital of Antwerp in Belgium commented on the findings.

“TAVI already has been shown to improve survival compared with standard therapy, but quality of life can be at least as important as survival in elderly patients, especially since TAVI patients can be frail with multiple comorbidities,” stated Prof. Bosmans. “We are extremely proud of this data which confirms that the benefits of transcatheter aortic therapy extend beyond survival even in this challenging patient population.”

In the ADVANCE study, 996 patients were consecutively treated at 44 experienced TAVI centers in 12 countries. Clinical endpoints were calculated according to Valve Academic Research Consortium standardized definitions. All data were independently monitored, all adverse events related to the primary endpoints were adjudicated by an independent Clinical Events Committee composed of experienced cardiac surgeons and interventional cardiologists, and all cerebrovascular events (including stroke and other events) were adjudicated by an independent neurologist using neuroimaging and systematic National Institutes of Health Stroke Scale assessments.

The CoreValve system received CE Mark approval in 2007. In markets that recognize CE Mark approval, the CoreValve system is available in four valve sizes (23 mm, 26 mm, 29 mm, and 31 mm), each deliverable via transfemoral, subclavian, and direct aortic access through a low-profile, 18-F delivery catheter. The CoreValve System is currently limited to investigational use in the United States, advised Medtronic.