Thanks for your note. You are asking all the right questions.
The standard approach for patients with leaky mitral valves is surgical repair. The key long-term is to have a successful repair and try to avoid replacement. This leads to improved life expectancy, improved heart function and avoidance of blood thinners. For a repair to be successful there needs to be little or no residual leakage after surgery. Repair rates vary dramatically from hospital to hospital. The national average is about 50%, valve repair centers such as ours have rates well over 90%. The American Heart Association recommends referral to centers with special expertise in valve repair that can offer >90% repair rates.
Since your wife had previous surgery, surgery to repair her mitral valve will be a bit more difficult. There is scar tissue from the previous surgery and if she has bypass grafts, they have to be protected. That said, if she is in reasonable overall shape and her heart function is not too bad, she should have a successful outcome. If all she needs is repair of her mitral valve, it can be performed in a less invasive way through a small incision.
That brings us to the Mitraclip procedure. This is a new procedure that tries to repair the valve by threading a catheter through the heart and deploying a clip to attach the leaflets of the valve together. The device and procedure have not been approved by the FDA. It is being used at a limited number of centers under a clinical research protocol to see if it works. The results of the first study of the Mitraclip, Everest I, was recently published. The results in my opinion were underwhelming. Here are some highlights
· 107 patients underwent the procedure
· The clip detached in 9%
· 9% had a major adverse event
· 36% had significant residual leakage (rated 2 or greater on a scale of 0-4)
· At 1 year following the procedure, 34% of patients had either died, had to undergo open surgery or had moderate to severe residual leakage (rated 3 or greater)
With these less than stellar results it is very hard to justify the procedure in its current form except perhaps in severely ill patients in whom the risk of surgery is extremely high. There is a new research trial about to begin in which patients will be randomized to surgery or the Mitraclip. The FDA is not expected to consider approval of the device until that trial is completed.
I hope that helps. Good luck and feels free to contact me directly if you have any further questions.
Lishan Aklog, MD
Chair, The Cardiovascular Center
Chief of Cardiovascular Surgery
The Heart and Lung Institute
St. Joseph’s Hospital and Medical Center
500 W. Thomas Rd, Suite 500
Phoenix, AZ
602-406-2996 (Assitant Beth)
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Dear Jamie,
Thanks for your note. You are asking all the right questions.
The standard approach for patients with leaky mitral valves is surgical repair. The key long-term is to have a successful repair and try to avoid replacement. This leads to improved life expectancy, improved heart function and avoidance of blood thinners. For a repair to be successful there needs to be little or no residual leakage after surgery. Repair rates vary dramatically from hospital to hospital. The national average is about 50%, valve repair centers such as ours have rates well over 90%. The American Heart Association recommends referral to centers with special expertise in valve repair that can offer >90% repair rates.
Since your wife had previous surgery, surgery to repair her mitral valve will be a bit more difficult. There is scar tissue from the previous surgery and if she has bypass grafts, they have to be protected. That said, if she is in reasonable overall shape and her heart function is not too bad, she should have a successful outcome. If all she needs is repair of her mitral valve, it can be performed in a less invasive way through a small incision.
That brings us to the Mitraclip procedure. This is a new procedure that tries to repair the valve by threading a catheter through the heart and deploying a clip to attach the leaflets of the valve together. The device and procedure have not been approved by the FDA. It is being used at a limited number of centers under a clinical research protocol to see if it works. The results of the first study of the Mitraclip, Everest I, was recently published. The results in my opinion were underwhelming. Here are some highlights
· 107 patients underwent the procedure
· The clip detached in 9%
· 9% had a major adverse event
· 36% had significant residual leakage (rated 2 or greater on a scale of 0-4)
· At 1 year following the procedure, 34% of patients had either died, had to undergo open surgery or had moderate to severe residual leakage (rated 3 or greater)
With these less than stellar results it is very hard to justify the procedure in its current form except perhaps in severely ill patients in whom the risk of surgery is extremely high. There is a new research trial about to begin in which patients will be randomized to surgery or the Mitraclip. The FDA is not expected to consider approval of the device until that trial is completed.
I hope that helps. Good luck and feels free to contact me directly if you have any further questions.
Lishan Aklog, MD
October 9, 2009 - 11:24amChair, The Cardiovascular Center
Chief of Cardiovascular Surgery
The Heart and Lung Institute
St. Joseph’s Hospital and Medical Center
500 W. Thomas Rd, Suite 500
Phoenix, AZ
602-406-2996 (Assitant Beth)
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