MitraClip Update: Abbott Announces Encouraging Safety Data
March 19th, 2010Since I first heard about the MitraClip several years ago, I have been fascinated by the evolution of this new, non-invasive technology used to treat mitral regurgitation without open heart surgery. (You might recall, Elizabeth Taylor underwent the MitraClip procedure last October.)
That said, I was excited to learn that Abbott Laboratories, the manufacturer of the MitraClip, just announced some encouraging safety findings from its clinical trials. In this very unique research, the MitraClip – which is delivered to the heart via a catheter through a blood vessel in the leg – was compared against traditional, open heart surgery for mitral regurgitation treatment.
The MitraClip By Abbot Laboratories
The primary safety goal of the study compared the number of adverse events (stroke, re-operation of mitral valve, urgent cardiovascular surgery, heart attack, kidney failure, major bleeding, and death) 30 days after the procedure.
The highlights of this research were:
- Among patients who received the MitraClip, 9.6 percent suffered major adverse events compared with 57 percent in the surgery group, a difference considered to be statistically significant. In the surgery group, 42 of the 55 adverse events were major bleeding.
- Interestingly… The MitraClip proved effective in 72.4 percent of patients compared with 87.8 percent in the surgery group, falling within pre-specified parameters of non-inferiority, researchers said.
- There were no deaths, heart attacks or major strokes among MitraClip patients in the study.
- The average hospital stay for a surgery patient is about three times that for the MitraClip procedure and recovery times are much shorter.
Dr. Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in suburban Chicago and one of the studies lead investigators, called it one of the best safety results he had ever seen in a heart procedure trial.
Dr. Ted Felman, NorthShore University HealthSystem
It is estimated that mitral regurgitation – which affects more than 8 million people in the United States and Europe – is marked by a faulty mitral valve that does not close tightly enough, allowing blood to flow backward in the heart, also known as a leaky heart valve. It can be a debilitating condition in which the heart’s ability to function deteriorates over time, and can lead to serious heart problems and death.
“This is a stunning difference in safety for an acceptable trade-off in efficacy for many patients,” said Feldman, who presented the data at the American College of Cardiology scientific meeting in Atlanta. “If a patient does not have success with the (device), he can still have surgery. The real take-home message from this is that this procedure gives patients another option,” Feldman said, adding that the clip procedure could especially benefit eldery patients unable or unwilling to endure surgery.
At one year, patients with significant mitral regurgitation who received the MitraClip demonstrated improvements in heart function, quality of life, and normal physical activity. The repair device, which Abbott added to its portfolio with its acquisition of Evalve last year, works by clipping together the leaflets of the mitral valve, one of four valves in the heart.
Although analysts believe the device could win U.S. approval next year and become a $1 billion a year product for Abbott, some believe that the MitraClip is not the panacea for mitral regurgitation treatment.
Interventional cardiologists, the same doctors who install artery-opening heart stents, perform MitraClip procedures. That said, this technology could add to a long-running rivalry between these doctors and traditional open-heart surgeons over the best treatment methods, The Wall Street Journal reports.
“It will be a bit of a debate,” said Larry Dean, an interventional cardiologist who directs the University of Washington’s Regional Heart Center in Seattle, and is not involved with Abbott or this study. “There are a group of patients who are not well-suited for surgery where this may be beneficial,” he added.
Regardless of who wins the debate, I will continue to monitor the MitraClip as more data is created and released. Ultimately, for us – the patients – this device provides one more surgical option to consider.
Keep on tickin!
 |
| About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient's Guide To Heart Valve Surgery. This unique book integrates clinical research with the personal experiences of 135 former patients to help future patients and their caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here. |
 |
