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.
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As reported in the Daily Briefing, improving prevention measures and treatment helped reduce death rates from coronary heart disease (CHD) by 35% from 1994 to 2005 for one study population, according to new findings in JAMA.
Researchers from Toronto-based Sunnybrook Health Sciences Center analyzed patients in eight mutually exclusive CHD subgroups ages 25 to 84 in Ontario. The researchers reported that the decline in deaths from CHD between 1994 and 2005 translated to delaying 7,585 deaths in 2005, or from 191 deaths per 100,000 residents to 125 per 100,000. MedPage Today notes that there were 10,060 actual coronary deaths that year.
The study attributed 48% of the decline to improvements in cardiovascular risk factors. Researchers also noted that 43% of the decline was caused by improvements in medical and surgery treatments that translated to roughly 3,280 deaths prevented or delayed during the study period.
Management of patients with chronic stable coronary artery disease led to "substantial contributions," with 1,305 fewer deaths, or 17% of the decline. For example, just 8% of patients with chronic stable coronary artery disease used statins in 1994, compared with 78% in 2005, an increase that accounted for 725 deaths--9% of the total--prevented or delayed. Additionally, improved management of heart failure patients--due in large part to greater use of beta-blockers--accounted for a 10% decrease in coronary deaths, or 750 fewer deaths.
According to American Heart Association data, the death rate from CHD in the U.S. has declined by almost 37% between 1996 and 2006, HealthDay reports.
Researchers noted, however, that rising diabetes and obesity rates may temper their findings. Specifically, a 1% rise in diabetes corresponds with a 6% increase in mortality, the study's author said (Wijeysundera et al., JAMA, 5/12 [subscription required]; Neale, MedPage Today, 5/11; Edelson, HealthDay, 5/11).
The Center for Medicare & Medicaid Services (CMS) has released a technical correction to the 2010 Physician Fee Schedule that will increase reimbursement for myocardial perfusion imaging (MPI)--both planar and SPECT--cardiac CTs and cardiac catheterizations. All corrections are retroactive to January 1, 2010.
The changes made to MPI and cardiac CT codes address errors made in determining practice expenses associated with offering these services. Codes affected include: CPT codes 75571-75574 and 78451-78454. Increases in reimbursement ranged from a 16 percent increase for SPECT MPI with multiple studies (CPT code 78452-G) to a 161 percent increase for Planar MPI, multiple (CPT code 78454-TC). The new payments for the procedures mentioed are $439.65 and $318.47, respectively. A more detailed summary of the nuclear cardiology payment changes is provided by the American Society of Nuclear Cardiology.
CMS has also made changes to malpractice RVUs for cardiac catheterizations to reflect the higher risk associated with invasive procedures. Increases in the professional component for cardiac catheterizations range from 6 to 8 percent. For example, reimbursement associated with the professional component of a left heart catheterization (CPT codes 93510-26) has increased from $235 to $253. For more details on how reimbursement for cardiac catheterizations will be affected, please see the ACC's crosswalk.
While this is an important victory for the ACC, the American Society of Nuclear Cardiology and other advocacy groups, Jack Lewin, the CEO of the ACC, makes it very clear that this correction alone is not enough to address the dramatic cuts in reimbursement cardiologists have experienced. As such, ACC is going to continue to pressure CMS to phase-in bundled nuclear codes and increase reimbursement echos and other services through increased adherence to appropriate use criteria.
For more information on CMS's correction, please click on the following links: www.acc.org and www.acsn.org.
Dr. Ian Gilchrist presented research at the 2010 SCAI Scientific Sessions indicating that transradial access for PCI may enable patients to be discharged the same day as the procedure who would otherwise not meet same-day discharge criteria. Notably, the patients who are suitable under radial access include diabetics, older patients, as well as those who live a significant distance from the hospital.
These patients are typically excluded from same-day discharge under the ACC guidelines for outpatient PCI. Investigators note these patients are typically not considered candidates for same-day discharge due to the assumption PCI is performed via the femoral artery. While the majority of PCIs in the United States are performed via the femoral artery, radial access is very common internationally.
Radial access may facilitate same-day discharge for these typically overnight patients due to the low incidences of bleeding with radial access. Given the small size of the radial artery compared to the femoral, serious bleeding incidences are very rare and overnight monitoring is typically not needed.
Investigators found that none of the 100 patients studied reported complications or hospital readmissions following same-day discharge. More information on the study is available here.
As reported in today's Daily Briefing, heart failure (HF) patients who have follow-up visits with a health care professional within seven days of hospital discharge have a 15% lower 30-day readmission rate than patients who do not have such a visit, a study in JAMA finds.
For the study, researchers from Duke University School of Medicine assessed data on 30,136 Medicare patients with HF treated at 225 hospitals between January 2003 and December 2006. Overall, rates of physician follow-up within one week after discharge were low and varied across hospitals.
Specifically, the researchers found that although nearly 94% of HF patients were scheduled for a follow-up, an average of just 38.3% of patients actually had a visit within a week after discharge. The majority of patients who received early follow-up care were seen by a general internist, while only 7.5% of these patients were seen by a cardiologist. Overall, approximately 21% of HF patients were readmitted within 30 days.
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Though many have voiced concerns over the need for CTA in many cases and the potentially unnecessary cost burden, a recent study published in the American Journal of Cardiology reports that physicians found 98% of CTA exams helpful in treating patients. The research was conducted at Massachusetts General Hospital by Ron Blankstein, MD, who reviewed 108 patients who received computed tomographic angiography (CTA) to assess coronary artery disease (CAD) and whose referring physicians completed surveys to gauge the impact of the results. Referring physicians were predominately cardiologists (79%), while 19% were primary care physicians.
Survey respondents reported that 98% of the scans were helpful, with a mean usefulness score of 8.9 +/- 1.5 on a scale of 1 to 10, with 10 being "extremely helpful." Test results prompted physicians to reclassify the patient's CAD risk in more than half of patients and change medical therapy in 35% of patients, suggesting the value of the results in refining patient care.
Also interesting was the physicians' reports regarding their choices were CTA not an option. Almost half of respondents said they would have ordered invasive angiography (46%), especially in symptomatic patients, suggesting that providing the option for CTA may prevent the need for more expensive, invasive testing.