Understanding Diastolic Heart Failure
Diastolic Heart Failure occurs when the muscles of the heart are stiffer than normal and are not able to relax normally, and as a result, the left side of the heart may not fill as easily with blood. This means the pressure inside the left heart chambers and lungs increase. People with diastolic heart failure have difficulty breathing, in particular during activity, and often struggle with simple daily activities, drastically reducing their quality of life. Medicines that are effective for treating the other type of heart failure frequently do not work well for diastolic heart failure and treatment options are currently very limited.
What is the IASD® System II?
The IASD System II is an investigational, non-surgical medical device designed to reduce the pressure in the heart with an implant that allows blood to flow between the left and right atrium (the upper chambers of the heart), potentially reducing the elevated pressure in the left atrium, which contributes to the symptoms of diastolic heart failure.
The IASD System II is placed by an interventional cardiologist using a standard non-surgical procedure. During the procedure, a catheter is used to create a very small opening in the heart wall between the left and right atria to allow placement of the implant. The implant is then positioned in the opening to keep it open over time. The implant allows blood to flow from the high pressure left side to the low pressure right side, decreasing the pressure in the left atrium, which contributes to the symptoms of heart failure.
The IASD System II is an investigational device and is currently only available through clinical studies. Read more about the study and see if you may qualify. Learn about the risks and benefits of the IASD System II here.
Heart failure signs and symptoms may or may not improve. Potential benefits to people who are implanted with the investigational device may include the following:
- Reduction in shortness of breath
- Reduction in the number of hospitalizations and/or hospital days
- Reduction in the number of emergency room visits
- Reduction in medications
- Improved exercise tolerance
- Improved quality of life
The risks associated with this procedure may be similar to the risks of standard cardiac catheterization in which similar devices are permanently implanted on the atrial septal wall. These potential risks are uncommon. Interventional cardiologists and other cardiac catheterization laboratory staff are well trained to manage and reduce the likelihood of procedural risks. Potential implant procedural risks include the following:
- Adverse dye reaction
- Allergic reaction to implant
- Bleeding, with possible need for blood transfusion
- Blood clot
- Cardiac arrest
- Cardiac perforation from transeptal puncture
- Decreased cardiac output
- Device mal-position or need for unanticipated removal
- Device embolization, whole or partial
- Device fracture or loss of structural integrity
- Hematoma at access site
- Improper device placement or mal-deployment*
- Infection, including sepsis
- Nerve damage at femoral vein access site
- Pericardial tamponade
- Perforation of vessel or myocardium
- Pleural or pericardial effusion
- Pseudo aneurysm at access site
- Renal failure
- Systemic embolization (air, tissue or thrombus)
- Thrombosis or thrombus formation on device
- Worsening heart failure
* may require unanticipated device removal