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Questions about Extracellular Matrix and Heart Tissue Repair

 

What are these first-ever new valve repair and remodeling procedures?
St. Francis Heart Center director of cardiothoracic surgery Marc Gerdisch, M.D., has successfully performed the first-ever surgeries to repair or remodel internal heart structures, such as valves, using a unique bio-scaffold “patch,” that enables patients to naturally re-grow their own cardiovascular tissue. Known as Extracellular Matrix (ECM)™, this unique patch is sutured to the patient’s heart tissue during surgery. Once implanted, the ECM serves as a bio-scaffold, allowing the patient’s own cardiovascular tissue to naturally re-grow over a period ranging from six weeks to several months. Over time, the ECM is replaced by the patients’ own tissue.

What is ECM?
Extracellular Matrix (ECM) is a unique bio-scaffold “patch” that harnesses the body’s innate ability to repair and repopulate damaged cardiovascular tissue.

What is the benefit of using the ECM?
The new treatment protocol offers significant healing advantages and quality of life benefits to patients after surgery because the successful implantation of the ECM eliminates the need for life-long, anti-rejection medications required with the use of animal tissue implants or artificial heart valves.

Animal tissue implants are subject to calcium deposition and hardening, due to the body’s ability to recognize them as foreign. Synthetic material lacks the performance characteristics of tissue and causes an inflammatory response by the body, avoided only by the patient taking anti-rejection medication for the rest of his or her life. ECM, however, leads to the growth of new, functional cardiovascular tissue.

Even stem cell therapy where donor stem cells are injected into the surgery site is not as successful as ECM. Most injected donor stem cells die instead of regenerate because there’s not a healthy matrix on which they can grow.

What is the ECM made of?
The ECM is derived from the small intestine of a pig and is processed in a way that removes all cells, leaving the structural matrix, made of collagen, intact. It is a fibrous paper-like substance that is exceptionally strong, but very pliable and thin. To learn more, visit the CorMatrix Web site.

How does it work?
The cells in our bodies can only grow and multiply if they have some type of structure to which they can attach. This structural “bio-scaffold” within our bodies supports and encourages cell growth, which ultimately forms different types of tissue. The ECM serves as that bio-scaffold for patients requiring complex valve repair or replacement surgery.

Once the ECM is surgically implanted, the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanisms to repair tissue at the site of implantation. During the tissue repair process, the matrix is rapidly degraded and resorbed, leaving the remodeled functional tissue instead of scar tissue or injured tissue.

How is the ECM used?
The ECM “patch” is cut to the appropriate size by Dr. Marc Gerdisch, hydrated in water, and then sutured over the heart valve or other internal heart structure during surgery. The ECM serves as an interim bio-scaffold over the site of the incision.

After implantation, the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanisms to repair tissue at the site of implantation. During the tissue repair process, the matrix is rapidly degraded and resorbed, leaving the remodeled functional tissue instead of scar tissue or injured tissue.

When did Dr. Marc Gerdisch perform his groundbreaking surgeries?
Dr. Gerdisch performed the first-of-its kind surgery using the CorMatrix ECM to repair a congenital defect in August 2007. Dr. Gerdisch was also the first to use ECM to enlarge the space needed for valve implantation and to repair an infected valve in 2008.

Why is this new procedure being announced now when the surgeries were performed one to two years ago?
Because the use of ECM is a revolutionary procedure and the St. Francis Heart Center is first and foremost committed to patient health and healing, Dr. Gerdisch and the St. Francis wanted an appropriate amount of time to evaluate patient outcomes.

For how many patients has Dr. Gerdisch performed this procedure?
Since August 2007, Dr. Gerdisch has helped 27 patients reconstruct their damaged heart tissue with this surgical procedure, which allows for natural tissue re-growth.

Why did Dr. Gerdisch explore this new procedure?
In order to avoid leaving patients with a foreign body inside their hearts, such as a synthetic valve, Dr. Gerdisch uses this remarkable bio-scaffold in various configurations to augment and repair the heart and its valves. The surgery using the ECM, coupled with the body’s innate ability to repair damaged heart tissue, offers significant healing advantages and quality of life benefits to patients after surgery.

Why is this material and procedure so important?
Each year, millions of people are diagnosed with valve disease or a valve disorder. Valve disease occurs when the heart’s valves do not work correctly, causing the heart muscle to work harder to circulate the right amount of blood through the body. Surgery to repair or replace the valve(s) has proven to be the most effective way to treat this life-threatening disease. Using the ECM for valve repair and remodeling not only allows for the patient’s valve to be repaired, but enables the patient to re-grow his or her own cardiovascular tissue, eliminating the need for anti-rejection medication or blood thinners.

When was the ECM first introduced and what was it used for?
First introduced in 2006, the ECM was originally used to repair the pericardium, the protective “sac” that surrounds the heart, after open heart surgery. Prior to that, most surgeons did not close the pericardium after open heart surgery because of the risk of scar tissue buildup, causing problems with heart function. With the ECM, patients naturally regrow their own cardiovascular tissue to close the pericardial incision, without scarring.

How many people have received a ECM implant?
An estimated 500,000 patients worldwide have received a ECM implant, but Dr. Gerdisch and the St. Francis Heart Center were the first to use the ECM to repair and rebuild heart structures, such as valves.

Who is a candidate for this surgical procedure?
The ECM valve surgery, like other heart valve repair or replacement surgery options, is one treatment option for patients with heart valve disease. The St. Francis Heart Center recommends patients consult with their primary care or cardiovascular physicians to gain more information about the various cardiovascular and valve repair surgery treatments.

Who is Dr. Marc Gerdisch?
Marc Gerdisch, M.D., is the director of cardiothoracic surgery at the St. Francis Heart Center located at St. Francis Hospital & Health Centers in Indianapolis, Ind. He is also the co-director of the St. Francis Midwest Heart Valve Center. Dr. Gerdisch has specialized in complex heart valve surgeries for much of his surgical carer 

Is Dr. Gerdisch available for interviews?
Dr. Gerdisch is available for interviews to discuss this revolutionary procedure. Please e-mail Joe Stuteville with St. Francis Hospital & Health Centers or call (317) 782-7986 office; (317) 946-9930 cell; or (317) 906-0079 pager.

Are audiovisual materials available?
This Web site provides a variety of downloadable resources, including b-roll, animation and still photography of valve surgery using the ECM.