Medtronic Presents Baseline Data of Extreme Risk Patients in the CoreValve US Pivotal Trial

June 14, 2013—Medtronic, Inc. (Minneapolis, MN) announced that baseline characteristics of patients enrolled in the Extreme Risk Study of the Medtronic CoreValve United States pivotal trial were presented at the TVT 2013: Transcatheter Valve Therapies conference in Vancouver, Canada. The study was designed to evaluate the outcomes of patients unsuitable for conventional aortic valve surgery who underwent treatment with the company's CoreValve transcatheter aortic valve replacement.

According to Medtronic, the Extreme Risk Study enrolled 487 elderly patients who underwent extensive demographic evaluation, including assessment of comorbidities, frailty, and disability, and identified a very ill group of patients who were unsuitable for conventional surgery. To be included in the study, patients were required to have a diagnosis of severe symptomatic aortic stenosis measured by hemodynamic assessments and New York Heart Association Class assignment, and a predicted mortality or irreversible morbidity ≥ 50% at 30 days.

The company advised that surgical risk was assessed by the clinical site heart teams (composed of interventional cardiologists and cardiac surgeons) at 40 clinical sites and confirmed by a national committee of cardiac surgeons and interventional cardiologists.

The study reported that patients treated with transcatheter aortic valve replacement using an iliofemoral approach had a high frequency of medical comorbidities, including coronary artery disease (82.1%), peripheral vascular disease (35.7%), previous myocardial infarction (31.2%), and severe Society of Thoracic Surgery-defined chronic lung disease (24.6%). In addition, the patients in the Extreme Risk Study were extremely frail, as assessed by severe (Score 5) Charlson Score Comorbidity index (58.3%), and had a low body mass index (7.4%, < 21 kg/m²), poor grip strength (67.4%), and dependence on home oxygen (30.8%).

Patients in the Extreme Risk Study will be evaluated against a performance goal derived from contemporary studies. The primary endpoint data from the Extreme Risk Study will be presented at the TCT 2013: Transcatheter Cardiovascular Therapeutics scientific meeting, to be held October 27–November 1 in San Francisco, California, noted Medtronic.