One recent trial looked at the efficacy and safety of a new generation aortic valve – the LOTUS ™ device, and Baylor Hamilton Heart and Vascular Hospital was one of only 60 sites in the U. S., Canada, Western Europe and Australia approved to enroll patients in these trials.
Dr. Stoler and colleagues realize the value of publishing data on their own experiences. Published articles related to Baylor Hamilton Heart and Vascular Hospital’ s research and outcomes positions physicians on the institution’ s medical staff as industry thought-leaders.“ This helps us gain early access to new treatments, and allows patients often turned down at other institutions viable alternatives to open heart surgery,” Dr. Stoler says.
FY16 CLINICAL TRIALS
• REPRISE( Boston Scientific Lotus Valve) – Randomized to Lotus vs. Medtronic Evolut
– First trial to compare new valve to commercially available valve
• SURTAVI( Medtronic) – Intermediate risk patients( STS between > 3 % and < 8 %)
– Randomized to TAVR( Evolut or CoreValve) vs. open surgery
– New continued access – TAVR only
• Low Risk( Medtronic) – Low risk patients( STS < 3 %) – Randomized to TAVR( Evolut) vs. open surgery
• COAPT – Functional mitral regurgitation – EF > 20 % and < 50 % – High risk for surgical mitral valve repair – Randomized to MitraClip vs. medical therapy
• Tendyne
– Transcatheter mitral valve replacement( transapical route)
– High risk for surgical mitral valve replacement – Any type of severe mitral regurgitation – EF > 30 % – Multiple strict criteria
CoreValve ® Evolut™R CoreValve is a registered trademark of Medtronic CV Luxembourg S. a. r. l. Evolut is a registered trademark of Medtronic, Inc. * Image courtesy of Medtronic.
In early fiscal year 2016, Baylor Jack and Jane Hamilton Heart and Vascular Hospital added several“ firsts” to its long list of taking the lead in cardiovascular innovation by being the first in North Texas to commercially offer a“ next generation” valve: CoreValve ® Evolut™ R. The U. S. Food and Drug Administration( FDA) made this new heart valve readily available after 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 patients with smaller vessels in the groin for“ transfemoral” access route.
Also in fiscal year 2016, as a leader in treatment for mitral valve regurgitation, Baylor Hamilton Heart and Vascular Hospital was one of a few sites worldwide to offer Tendyne Bioprosthetic Mitral Valve System as an investigational device. This device is ideal for patients too frail to undergo open heart surgery.
Primary investigator for this trial is Paul Grayburn, MD, Medical Director, Non-Invasive Cardiology – Baylor Hamilton Heart and Vascular Hospital.
Tendyne Bioprosthetic Mitral Valve System * Image courtesy of Abbott
OUTCOMES 2016
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