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

TCT 2016, TCT.16, main arena, late breaking trials
Feature | Cath Lab| September 28, 2016
September 28, 2016 — The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 fi
4Tech, TriCinch TTVR, transcather tricuspid valve repair device, first implant
News | Heart Valve Technology| September 22, 2016
4Tech Inc. announced that its TriCinch device has been used in the world’s first-ever successful transcatheter...
Transesophageal Echo, TEE. Interventional echocardiography, interventional echo, Philips, CX50

Transesophageal echo (TEE) has become an essential part of the new transcatheter structrual heart therapies, giving rise to a new sub-speciality of interventional echocardiography.  

Feature | Cath Lab Navigation Aids| September 21, 2016 | Dave Fornell
The rapid growth of transcatheter structural heart procedures and the need for increased use of echocardiography as a
Claret Medical, Sentinal CPS, cerebral protection system, FDA marketing application, TAVR, embolic protection
News | Embolic Protection Devices| September 20, 2016
Claret Medical announced its filing of a marketing application with the U.S. Food and Drug Administration (FDA) for...
Edwards sapien, intermediate risk patients, CE mark
News | Heart Valve Technology| September 20, 2016
September 19, 2016 — Edwards Lifesciences received European CE mark to expand use of the Edwards Sapien 3 transcathet
Lotus Edge Valve, CE mark, boston scientific, TAVR, TAVI

The Lotus Edge system in its deployed position. The Lotus valve expands outward as it is compressed and buckled in the deployment position. It also has a skirt to help eliminate paravalvular leaks.

News | Heart Valve Technology| September 19, 2016
September 19, 2016 — Boston Scientific received European CE mark approval for its Lotus Edge Valve System, the compan
Valtech Cardio, Cardioband Tricuspid, Cardioband Mitral, PCR London Valves 2016, study data
News | Heart Valve Technology| September 19, 2016
Valtech Cardio Ltd. announced that it will present the first-in-man data for its Cardioband Tricuspid (TR) system at...
Xeltis bioabsorbable aortic conduit, endogenous tissue restoration, ETR, preclinical data, ISACB 2016
News | Heart Valve Technology| September 09, 2016
Six-month preclinical data from trials of a Xeltis bioabsorbable aortic conduit were presented at the 2016 scientific...
Pradaxa, dabigatran, GLORIA-AF registry, ESC Congress 2016, NVAF
News | Antiplatelet and Anticoagulation Therapies| September 01, 2016
First outcome results from the GLORIA-AF Registry show that treatment with Pradaxa (dabigatran etexilate mesylate) was...
Edwards Intuity aortic valve, surgical aortic valve replacement, PinnacleHealth, first U.S. implants
News | Heart Valve Technology| August 26, 2016
This week, PinnacleHealth, Harrisburg, Pa., became the first hospital in the country to implant the Edwards Intuity...
Overlay Init