New findings from the Medtronic CoreValve ADVANCE study for one-year survival and health-related quality of life (HRQoL) with the CoreValve transcatheter aortic valve replacement system for the treatment of severe aortic stenosis, have been presented at the Transcatheter Cardiovascular Therapeutics Meeting 2012, which is being held from 22nd to 26th October, in Miami, FL. The results revealed that patients experienced high survival rates, with one-year survival at 82.1 per cent and one-year cardiovascular survival at 88.2 per cent.
The ADVANCE study is one of the largest multicentre transcatheter aortic valve implantation (TAVI) trials to date, with 996 patients consecutively treated at 44 experienced TAVI centres in 12 countries. Clinical endpoints were calculated according to Valve Academic Research Consortium standardised definitions. All data were independently monitored, all adverse events related to the primary endpoints were adjudicated by an independent Clinical Events Committee consisting of 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.
On the SF-12 scale at six months, patients' health scores significantly improved by 6.92 points from baseline for the physical component summary score (p<0.001), and significantly improved by 3.80 points from baseline for the mental component summary score (p<0.001, based on the SF-12 scale from zero to 100 with a higher score reflecting a better HRQoL). On the EQ-5D scale from zero (death) to one (perfect health), patients' health scores significantly increased by 0.10 points at both one and six months from baseline, (p<0.001). All differences reported were statistically significant.
In the study, even the highest-risk patients experienced significant improvements in HRQoL after TAVI: 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 six months (EQ-5D p<0.001). Additionally, patients who were implanted with the CoreValve system via direct aortic and subclavian access routes demonstrated similar HRQoL improvements, as measured by EQ-5D, as those undergoing transfemoral implantation. The CoreValve System can be implanted via three different delivery routes.
QoL was measured at baseline, one month and six 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; one-year results will be reported next year.
Since receiving the CE mark in 2007, the CoreValve system has been implanted in more than 30,000 patients in more than 60 countries outside of the US. CoreValve is available in four valve sizes (23, 26, 29 and 31mm), each deliverable via transfemoral, subclavian and direct aortic access through a low-profile, 18Fr delivery catheter.