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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