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 Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
Neovasc, Tiara, transcatheter mitral valve, TMVR

The Neovasc Tiara transcatheter mitral valve is currently being tested in U.S. and international clinical trials. 

Feature | Heart Valve Repair| November 12, 2015 | Dave Fornell
The advent of transcatheter valve repair and replacement technologies is one of those rare instances where there is a
SALUS trial, Direct Flow Medical TAVR device, Medtronic CoreValve, PinnacleHealth CardioVascular Institute

Image courtesy of Direct Flow Medical

News | Heart Valve Repair| November 10, 2015
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a randomized trial studying a new...
Sponsored Content | Videos | TCT| November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
aortic valve replacment, AVR, severe aortic stenosis, CURRENT AS registry, TCT 2015
News | Heart Valve Repair| October 27, 2015
A large observational registry found that initial aortic valve replacement (AVR) in asymptomatic patients with severe...
Medtronic CoreValve, real-world clinical outcomes, STS/ACC TVT Registry, TCT 2015

Image courtesy of Medtronic

News | Heart Valve Repair| October 22, 2015
Medtronic plc released the first CoreValve transcatheter aortic valve replacement (TAVR) system outcomes data using...
Direct Flow Medical TAVR System, DISCOVER post-market study, real-world results, TCT 2015

Image courtesy of Direct Flow Medical Inc.

News | Heart Valve Repair| October 22, 2015
Direct Flow Medical Inc. announced one-year outcomes from the DISCOVER post-market study that demonstrate excellent...
BRAVO 3 trial results, bivalirudin, heparin, anticoagulation, TAVR, TCT 2015
Feature | Antiplatelet and Anticoagulation Therapies| October 20, 2015
Results from the BRAVO 3 trial found that bivalirudin did not significantly reduce major bleeding rates at 48 hours or...
Amaranth Fortitute Bioresorbable stent

The Amaranth Fortitute bioresorbable stent was among several fully bioresorbing platforms discussed in sessions, late breaking trial data presentations and on the expo floor at TCT 2015.

Feature | TCT| October 19, 2015 | Tom Watson, BS, RCVT, Clinical Analyst, MD Buyline
There were several overarching technology trends seen at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) ann
Claret embolic protection, TAVR, cerebral protection

The Claret TAVR embolic protection system as seen in the aortic arch under angiography. The loops contain embolic filters they protect the ostium of vessles leading to the brain.

Feature | Heart Valve Repair| October 16, 2015
October 14, 2015 — Claret Medical, an innovator in cardiovascular cerebral protection, Data presented this week at Tr
Overlay Init