Center for VALVE DISORDERS
MEASURING INNOVATION IN HEART AND VASCULAR CARE
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In conjunction with research, Baylor Hamilton Heart and Vascular Hospital realizes the value of publishing data on its experiences. Published articles related to Baylor Hamilton Heart and Vascular Hospital’ s research positions the physicians on the hospital’ s medical staff as industry thought-leaders.( A complete listing of fiscal year 2017 publications is included in this book.)
FY17 CLINICAL TRIALS
• Apollo( Medtronic) Intrepid TMVR – Transcatheter mitral valve replacement( transapical route) – High risk for surgical mitral valve replacement – Any type of severe mitral regurgitation – EF > 30 %
• COAPT – Closed for enrollment in fiscal year 2017 – Severe functional mitral regurgitation – Low EF: > 20 % and < 50 % – High risk for surgical mitral valve repair – Randomized to MitraClip ® vs. medical management
• COAPT / Continued Access – Open for enrollment in fiscal year 2017 – Severe functional mitral regurgitation – Low EF: > 20 % and < 50 % – High risk for surgical mitral valve repair
• CoreValve ® US Pivotal Trial – Closed for enrollment in fiscal year 2017 – High and extreme risk patients
• Intrepid 12 Study( Medtronic) – Severe mitral regurgitation – Enrollment began in late fiscal year 2017
• Low Risk( Medtronic) – Open for enrollment in fiscal year 2017 – Low risk patients( STS < 3 %) – Randomized to TAVR( Evolut or CoreValve) vs. open surgery
• REPRISE( Boston Scientific Lotus Trial) – High and intermediate risk patients; bi-cuspid valves – Placed on hold status mid-fiscal year 2017
• SURTAVI( Medtronic) – Intermediate risk patients( STS between > 3 % and < 8 %) – Randomized to TAVR( Evolut or CoreValve) vs. open surgery – Closed for enrollment in fiscal year 2017
• Tendyne( Abbott) – Transcatheter mitral valve replacement( transapical route) – High risk for surgical mitral valve replacement – Any type of severe mitral regurgitation – EF > 30 %
In early fiscal year 2017, the Center for Valve Disorders team at Baylor Hamilton Heart and Vascular Hospital added several“ firsts” to its long list of taking the lead in cardiovascular research and innovation by being the first in North Texas to commercially offer“ next generation” valves.
The team was the first in North Texas and one of the first in the U. S. to commercially offer CoreValve ® Evolut™R offered by Medtronic. The U. S. Food and Drug Administration( FDA) released this for commercial use in July 2016 for transcatheter aortic valve replacement( TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery. Due to the smaller size, this FDA-approved valve is a new option for the frail heart disease patient and for patients with smaller vessels in the groin or“ transfemoral” access route. When the interventional cardiologist performs the procedure by entering the transfemoral route, there is a minimized risk for major vascular complications in some patients.
CoreValve ® Evolut ™ Pro
Later in the year, the team had the first commercial placement in the state of Texas of the next generation Evolut™ valve – the Evolut™ Pro. This was also the first Evolut™ Pro valve placed in a failed bioprosthetic aortic valve in the United States, adding to a long list of“ firsts” in cardiovascular innovation at Baylor Hamilton Heart and Vascular Hospital because it was one of the first in the U. S. for a valve-in-valve case.
“ The Evolut Pro has a unique‘ skirt’ around the valve that helps minimize leakage; one of the greatest potential risks for TAVR patient outcomes,” says Dr. Stoler.“ In this procedure, the surgeon replaced an old surgically implanted bioprosthetic aortic valve using a minimally invasive approach, without open-heart surgery.”
CoreValve is a registered trademark of Medtronic CV Luxembourg S. a. r. l. Evolut is a registered trademark of Medtronic, Inc. Images courtesy of Medtronic