As reported in the Daily Briefing, in a finding that may affect a wide patient population, Abbott Laboratories on Tuesday said its MitraClip device may be as effective as surgery in treating mitral regurgitation (MR) after two years, Dow Jones/Wall Street Journal reports.
An individual with MR, which affects nearly eight million individuals in the United States and Europe, has a faulty mitral valve that allows blood to "leak backward" into the heart, Reuters reports. MitraClip is seen as an alternative to traditional open-heart surgery. The clip is inserted through blood vessels in a patient's leg and is threaded to the heart.
Abbott in March unveiled preliminary results of its MitraClip study, Everest II, which showed that it was safer than open-heart surgery after one month. Abbott presented longer-term data about the device on Tuesday at the EuroPCR cardiology conference in Paris.
According to the data, MitraClip is equally safe and effective when used to repair both degenerative MR and functional MR. Both patient groups showed improvement from baseline in heart function, symptoms and quality of life 12 months after receiving the device, Abbott said. The major adverse event rate--which measured 12 complications such as major stroke, urgent cardiovascular surgery and myocardial infarction--was 8.1% for degenerative MR patients and 8.2% of functional MR patients 30 days post procedure. Meanwhile, the adverse event rate for surgery patients was 42.6%. Patients who were treated with the clip were no more likely to require additional procedures than surgery patients after two years, reflecting a "durability of outcome," according to Abbott's vice president for medical devices.
According to Dow Jones/Journal, MitraClip currently is available in Europe and awaiting FDA approval in the U.S. Abbott said it expects FDA to review the MitraClip data in the second half of 2010 (Kamp, Dow Jones/Journal, 5/25 [subscription required]; Berkrot, Reuters, 5/25).
In an effort to improve and personalize the informed consent process, nine U.S. hospitals are piloting a Web-based program that taps into a national cardiovascular database to calculate individualized risks of death, bleeding or restenosis, American Medical News reports.
The hospitals are offering the new informed consent process to patients who need nonemergency cardiac catheterization and potential angioplasty procedures. The system--called Patient Refined Expectations for Deciding Invasive Cardiac Treatments (PREDICT)--allows physicians to access information from the American College of Cardiology's National Cardiovascular Data Registry. The registry contains more than 10 million catheter-laboratory patient records.
PREDICT incorporates a patient's age, comorbidities and other factors to estimate an individual's risk profile, which is displayed in an "easy-to-understand" bar chart, according to American Medical News. The system alerts cardiologists about alternative medical and procedural interventions that may reduce a patient's risks during angioplasty procedures.
The new informed consent process may pose legal problems separate from older forms, but it is unlikely to worsen overall liability concerns, according to the editor-in-chief of the American Journal of Bioethics. Physicians involved with PREDICT say the new tool's transparency will allow it to bypass any legal issues.
A clinical director of outcomes research at Saint Luke's Hospital in Kansas City, Mo., developed PREDICT using $5.6 million in grants from the American Heart Association and NIH. He said that PREDICT symbolizes a "major effort" to break down and provide more information about angioplasty procedures and to supply "realistic estimates about the risks and benefits for the patients undergoing this procedure" (O'Reilly, American Medical News, 5/17).
A new subcutaneous implantable cardioverter defibrillator (ICD) eliminates the need to implant transvenous leads to the heart and is as effective as traditional devices in restoring normal cardiac rhythm, according to an initial trial published in NEJM.
For a conventional ICD, leads are threaded through veins and implanted into the heart to jolt the muscle into normal rhythm. However, some ICDs recently were recalled or received new warning labels due to faulty wires, which are often difficult to implant and remove in certain patients and may break following prolonged use, according to Bloomberg.
Subcutaneous ICD May Be Safer Than Traditional Device, Study Finds