News | May 19, 2014

Minimally Invasive Valve Procedure Saves More Lives Than Open-Heart Surgery

Findings revealed to American College of Cardiology, The New England Journal of Medicine

May 19, 2014 — For the first time, a minimally invasive transcatheter valve — tested by Baylor Research Institute in Dallas (BRI) — has been shown to save more lives than open-heart surgery, according to new research revealed at the American College of Cardiology’s (ACC) 2014 Scientific Sessions and published in The New England Journal of Medicine.

The research is part of a clinical trial that studied the transcatheter aortic valve replacement (TAVR) procedure, which uses a wired catheter to implant a self-expanding valve device through a small incision in the leg. The procedure is used to treat patients with aortic stenosis, a condition that narrows the aortic valve, affecting blood flow.

As a principal investigator in the Medtronic CoreValve U.S. Pivotal Trial, Robert C. Stoler, M.D., FACC, FSCAI, led the study of patients at Baylor Heart and Vascular Hospital (BHVH). The hospital was one of 45 national trial sites and the only site in North Texas to participate in the research.

“This is the first time we’ve seen a transcatheter-based therapy do better than open-heart surgery patients,” Stoler said. “That really opens up a door for treating patients in the future with a far less invasive method of valve replacement.”

According to the study’s findings, patients with the TAVR CoreValve device experienced significantly improved survival ratings (85.8 percent vs. 80.9 percent) at one year, compared to participants who underwent invasive, open-heart surgery to implant replacement valves. Additionally, CoreValve patients showed better quality of life indicators at 30 days, compared with open-heart participants.

“And those results are just the tip of the iceberg,” said Stoler, adding that BRI is involved in several other studies exploring TAVR’s application to valve patients. “There are new generations of valves coming out from several different manufacturers, and we’re interested to see how those affect outcomes, including stroke.”

Future studies that will be open to patients at Baylor facilities will address those issues, in addition to exploring longevity-related questions about the valve device. Because of those continuing valve-related research efforts, Stoler said, the future is promising for aortic stenosis patients.

“If you’re a patient and you need an aortic valve replacement, you have more options now,” he said. “Transcatheter valve therapy is going to expand to a bigger patient population, and we’re seeing more patients who now have a chance to be treated with valve replacement. Plus, the new generations of valves are going to have smaller catheter sizes and fewer complications. They’re only getting better.”

In early 2014, the U.S. Food and Drug Administration (FDA) approved TAVR for treatment of patients in the extreme-risk, or inoperable, category. The successful findings of the new research presented at ACC may support FDA approval for TAVR application to high-risk patients.

For more information visit: www.BaylorScottandWhite.com

Related Content

Henry Ford Hospital First in Michigan to Perform Cardioband Mitral Valve Procedure

An angiography image showing the catheter-based implantation of the Cardioband annuloplasty ring using corkscrew shaped anchors.

News | Heart Valve Technology | June 13, 2018
Henry Ford Hospital is one of 17 U.S. trial sites using a catheter-based procedure approved in Europe to repair a leaky...
Abbott Portico transcatheter aortic valve replacement (TAVR) performed well PORTICO I real-world study. #EuroPCR
News | Heart Valve Technology | June 01, 2018
June 1, 2018 –  Use of the Abbott Portico transcatheter aortic valve replacement (TAVR) therapy was associated with e
Tendyne Transcatheter Mitral Valve Replacement Device Demonstrates Positive 30-Day Outcomes
News | Heart Valve Technology | May 25, 2018
Abbott announced favorable outcomes from the first 100 patients treated in a global study of its Tendyne Transcatheter...
A 3-D printed aortic root with an simulated implant of an Edwards Sapien TAVR valve. New clinical data points to length-of-stay as a new predictor of outcomes in TAVR patients. Image from Henry Ford Hospital.

A 3-D printed aortic root with an simulated implant of an Edwards Sapien TAVR valve. New clinical data points to length-of-stay as a new predictor of outcomes in TAVR patients. Image from Henry Ford Hospital. 

Feature | Heart Valve Technology | May 14, 2018
May 14, 2018 – A new study finds patients who stay in the hospital for more than 72 hours when undergoing trans-femor
The use of 3-D printed hearts from patients' pre-TAVR planning CT scans have improved outcomes of procedures at the University of Minnesota. Clearly identifying where calcium is located on the valves prior to TAVR device implantation has helped reduce the incidence of paravalvular leak.  #SCAI, #SCAI2018

The use of 3-D printed hearts from patients' pre-TAVR planning CT scans have improved outcomes of procedures at the University of Minnesota. Clearly identifying where calcium is located on the valves prior to TAVR device implantation has helped reduce the incidence of paravalvular leak.

News | Heart Valve Technology | May 14, 2018
May 14, 2018 – A new study examines the effectiveness of 3-D printing technology and computer modeling to predict par
First-Ever Risk Tool Helps Predict TAVR Readmission Rates in 2018 SCAI late-breaking study. #SCAI, #SCAI2018
News | Heart Valve Technology | May 11, 2018
A new study looked at the effectiveness of a novel risk tool to predict 30-day readmission rates in patients undergoing...
Medtronic Shares Two-Year Harmony Transcatheter Pulmonary Valve Results at SCAI 2018. #SCAI, #SCAI2018
News | Heart Valve Technology | May 11, 2018
Medtronic plc announced two-year outcomes for the Harmony Transcatheter Pulmonary Valve (TPV) from its early...
Colibri Heart Valve Continues Enrollment in TAVI Early Feasibility Study
News | Heart Valve Technology | May 07, 2018
Colibri Heart Valve LLC announced the Colibri transcatheter aortic valve implantation (TAVI) System has been used on an...
An 3D echo view of a Neovasc Tiara transcatheter mitral valve. This valve is currently in clinical trials and is ahead of most of the TMVR devices in development.

A 3-D echo view of a Neovasc Tiara transcatheter mitral valve. This valve is currently in clinical trials and is ahead of most of the TMVR devices in development.

Feature | Heart Valve Technology | May 04, 2018 | Dave Fornell, Editor
May 4, 2018 — Transcatheter val...
Edwards Granted CE Mark For First Transcatheter Tricuspid Therapy - Cardioband Tricuspid Valve Reconstruction System
News | Heart Valve Technology | May 01, 2018
Edwards Lifesciences Corp.announced that it received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction...
Overlay Init