Saint Luke’s Mid America Heart Institute cardiologists are participating in a clinical trial investigating a new minimally invasive cardiac implant that may offer hope for patients who’ve survived a heart attack but now have severe heart failure.
Heart enlargement after a heart attack
After a heart attack, some patients experience enlargement of the left chamber of the heart. In addition, the apex of the heart can become dysfunctional, which causes blood to settle in the bottom of the heart. This results in such heart failure symptoms as fatigue and shortness of breath.
Over time, the healthy portion of the heart not affected by the heart attack can become overloaded as it tries to compensate for this damage and loss in output.
Eventually, injured heart muscle tissue damaged by the heart attack will become stiff scar tissue. This process, called fibrosis, causes the heart to become inflexible and unable to contract and pump blood efficiently.
Traditionally, this condition has been treated with medications. In severe cases, patients may have even required open heart surgery to cut out the enlarged nonfunctioning tip of the heart.
Alternative treatment option
As part of the PARACHUTE-HF trial, Saint Luke’s interventional cardiologists will implant the Parachute Ventricular Partitioning Device in the left ventricle. The device closes off the non-functional portion of the heart from the healthy, functioning portion.
The device, which resembles a small inverted umbrella, is ultimately covered by the body’s own tissue and becomes a permanent implant.
The clinical trial will study the Parachute implant to determine whether the device can:
- Slow the progression of heart failure
- Decrease repeat hospitalizations
- Improve survival
- Improve quality of life
"The Parachute device is an exciting new option for patients who develop heart failure after a heart attack,” said Andrew Kao, MD., heart failure and transplant cardiologist and principal investigator of the PARACHUTE-HF trial. “In the past, this type of treatment would have been possible only through open heart surgery. To be able to offer patients a minimally invasive treatment that takes less than 75 minutes to complete as opposed to major surgery is a significant advance.”
About the Parachute
The PARACHUTE-HF trial is designed to evaluate the safety and effectiveness of the Parachute device in patients with moderate to severe heart failure due to ischemic heart disease. The device is implanted through catheters placed in the groin. The procedure is being conducted as part of a randomized clinical trial in which half of the patients will receive the device and the other half will remain on maximal medical therapy.
“Access to these potentially groundbreaking treatments and clinical trials is a tremendous benefit for our heart failure patients,” said Adnan Chhatriwalla, M.D., interventional cardiologist and medical director of the Structural Heart Disease Program at Saint Luke’s Mid America Heart Institute. “Especially for severe heart failure patients who are not ideal surgical candidates, this procedure offers a treatment option where previously there was none.”
The trial requires the expertise of interventional cardiologists, physicians who are technically adept at catheter procedures for treatment of heart disease. Saint Luke’s Mid America Heart Institute boasts a long history of internationally recognized expertise in interventional cardiology. The program is among the world’s largest and frequently hosts workshops to educate cardiologists worldwide in cutting-edge procedures.
Currently, Saint Luke’s Mid America Heart Institute is the only center in the greater Kansas City area offering this experimental procedure.
The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the United States, the Parachute system is an investigational device limited by federal law to investigational use only.
Find our more about clinical trials.
Kimberlyn Behnke, R.N.
Heart Failure Clinical Research Nurse