Feature | May 02, 2014

Medtronic Reveals Positive Outcomes for CoreValve Patients Treated Via Alternative Access Routes

AATS late-breaking data show strong clinical results in complex patient population


May 2, 2014 — Medtronic Inc. revealed new data demonstrating positive outcomes for extreme risk patients with severe aortic stenosis who were treated with the CoreValve system via alternative access approaches. The data were unveiled during a late-breaking clinical session at the 94th American Association for Thoracic Surgery (AATS) annual meeting.

The study evaluated 150 patients from the CoreValve U.S. pivotal trial (23 percent of the extreme risk patient group) who were not suitable for traditional transcatheter aortic valve replacement (TAVR) through the femoral artery, and therefore were treated via subclavian or direct aortic approaches. These patients were more ill and frail than patients treated transfemorally, with higher rates of peripheral vascular disease (61.3 percent of alternate access patients versus 35.2 percent of transfemoral patients, p=0.001). These patients also had significant rates of severe lung disease (39.3 percent of alternate access patients versus 23.5 percent of transfemoral patients, p<0.001) and home oxygen therapy (44.0 percent of alternate access patients versus 29.9 percent of transfemoral patients, p=0.002).

The rate of all-cause mortality or major stroke for these patients was 39.4 percent at 12 months (compared to 26 percent in patients treated transfemorally), an acceptable rate given the higher risk nature of these patients. Rates of moderate or severe aortic regurgitation were low (2.4 percent at one year) and 85.7 percent of these patients improved at one year.

Upon the completion of the extreme risk study, 339 additional patients were treated via a subclavian or direct aortic approach in the continued access study. The mortality rate in the pivotal alternate access patients was 11.3 percent, and in the continued access study this rate improved to 9.5 percent (both at 30 days).

Also in the continued access study compared to the pivotal trial, rates of major stroke at 30 days (3 percent vs. 7.5 percent, p=0.03) and major vascular complications (4.2 percent vs. 8.7 percent, p=0.04) were significantly reduced.

“The data presented demonstrate that multiple implant approaches with the CoreValve system provide positive alternatives for very sick patients who have no other options. These data show that more patients can safely and successfully be treated,” said Michael Reardon, M.D., professor of cardiothoracic surgery at the Methodist DeBakey Heart and Vascular Center in Houston.

The CoreValve system was designed specifically to serve a broad range of TAVR patients. The device has a small 18 French profile for all valve sizes, which minimizes trauma at implant and allows physicians to treat patients with small or calcified vasculature. Its nitinol frame is designed to prevent unwanted leakage and optimize blood flow. In addition, the CoreValve system is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.

The Medtronic CoreValve U.S. pivotal trial’s extreme risk study evaluated the self-expanding device in patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery. In the rigorous study, all patients were monitored by independent core labs and evaluated against a pre-approved performance goal. Physician “heart teams” were comprised of leading cardiac surgeons and interventional cardiologists in accordance with the U.S. Food and Drug Administration (FDA)-approved protocol.

For more information: www.medtronic.com


Related Content

News | Heart Valve Technology

January 4, 2024 — Findings from a published case series research letter by the Henry Ford Health Structural Heart ...

Home January 04, 2024
Home
News | Heart Valve Technology

December 22, 2023 — TRiCares SAS (“TRiCares”), a privately held pioneer in the field of minimally invasive treatment of ...

Home December 22, 2023
Home
News | Heart Valve Technology

December 18, 2023 — Death rates related to infective endocarditis declined in most adults across the U.S. within the ...

Home December 18, 2023
Home
News | Heart Valve Technology

December 12, 2023 — Patients who received the anticoagulant drug warfarin after bioprosthetic aortic valve replacement ...

Home December 12, 2023
Home
News | Heart Valve Technology

November 20, 2023 — Abbott announced new late-breaking data that show advanced heart failure patients living with its ...

Home November 20, 2023
Home
News | Heart Valve Technology

October 24, 2023 — Abiomed, part of Johnson & Johnson MedTech[1], announced that novel data from seven research studies ...

Home October 24, 2023
Home
News | Heart Valve Technology

October 17, 2023 — The Patel Children's Heart Institute at St. Joseph's Children's Hospital achieved a milestone ...

Home October 17, 2023
Home
News | Heart Valve Technology

August 2, 2023 — Foldax, Inc., a leader in the development of innovative, polymer heart valves, today announced that the ...

Home August 02, 2023
Home
News | Heart Valve Technology

July 31, 2023 — Today, the U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 ...

Home July 31, 2023
Home
Subscribe Now