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Heart & Vascular Health | Heart News | Tests and Treatments | Valve Disorders
Cardiac Research Studies

New Trials for Heart Valve Replacement Underway

Surgeons look to trials to improve on current successes

Aortic valve replacement is a life-saving option for many when medication and repair don’t solve the problem of stiffened, narrowed or leaky aortic valves that interfere with normal blood supply to the body.

Two studies are building on the proven success and effectiveness of current technology and techniques in aortic valve surgery to see if improvements can be made.

TRANSFORM study focus

Joseph F. Sabik III, MD, Chairman of the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic, is the principal investigator for the TRANSFORM study on the Intuity Valve.

“…we are always looking to improve the outcomes in our patients.”

Dr. Sabik explains, “Though outcomes are excellent, surgeons and researchers continue to look into new technology and techniques to improve the outcomes and durability of biologic valve replacements.”

The TRANSFORM study looks at the design of the Intuity pericardial aortic valve. Dr. Sabik says, “This newer technology will allow for a minimally invasive, or small incision, surgery. This ability could theoretically decrease the length of time it takes to place the valve and decrease the time the patient is required to be on a heart lung machine. The hope for this is better hospital outcomes for the patient.”

Researchers will follow the progress of patients enrolled in the study for up to five years. Among other issues, they will collect and analyze data involving:

  • Effectiveness of the valve
  • Durability
  • Side effects
  • Leaks or other complications
  • Need for additional surgery
  • Overall survival

COMMENCE GLX study

The COMMENCE GLX study looks at an existing valve (currently used in valve replacement surgery) that is prepared (tissue processing, sterilization and packaging) in a different way.

The GLX process (a non-liquid process, which eliminates the need for rinsing and environmentally responsible disposal of storage solution) could possibly result in longer-lasting biologic valves.

Lars Svensson, MD, Director of the Aorta Center in the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic, is the principal investigator in this study. He states, “Younger patients are reluctant to take blood thinners for mechanical valves and if this new technology holds up as well as it has in animal studies, the possibility will be that this new biological valve will be used in younger patients with better long term durability.”

Researchers will follow study participants for up to five years, collecting and then analyzing data about the safety and effectiveness of the new valve preparation. Among other issues, researchers will look at:

  • Improvement in patient health
  • Rate of complications, including infection and leaking of the valves
  • Need for follow-up surgery
  • Survival rates

Dr. Sabik sums up the aim of both studies. “The goal is to improve hospital outcomes and long-term outcomes in these studies. Even though we have success with aortic valve replacement, we are always looking to improve the outcomes in our patients.”

Tags: aortic valve replacement, heart and vascular institute, heart surgery, innovation, outcomes, research
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