A review of half a million cases from the National Cardiovascular Data Registry finds that almost all acute percutaneous coronary interventions meet "acceptable" guidelines, but showed that only half of elective PCIs toed the line.
The report, presented this week at the American College of Cardiology’s annual conference, was based on data from 500,000 NCDR cases in 900 hospitals from July 2009 to June 2010. Its authors ranked the cases as "appropriate," "inappropriate" or "of uncertain value" according to guidelines set in 2009.
More than a two-thirds of the cases that could be ranked were acute and only 1.1 percent of the acute cases were deemed inappropriate (about 11 percent were of uncertain value according to the guidelines). When it came to elective cases, however, 11.6 percent were classed as inappropriate and only half were appropriate (38 percent were of uncertain value). And nearly three-quarters of the inappropriate, elective cases were "low-risk" and about two-thirds were asymptomatic to mildly symptomatic.
Overall, about 420,000 of the cases in the study were appropriate, about 4 percent inappropriate and 11.2 percent were uncertain.
Mixed results for CVRx Rheos BP device
The Rheos hypertension treatment device reduced blood pressure by 33 points in a small study, but failed to meet several other criteria, according to study results presented at the conference. The pacemaker-shaped device is designed to fool the brain into lowering blood pressure by stimulating nerves on the carotid arteries.
The device needs another round of clinical trials, according to the study’s authors, before a run at FDA approval stands a chance. The Rheos system is made by Minneapolis-based CVRx.
"The device works extremely well and there is a large group of patients who would benefit from this therapy, but we need to go back and identify this group more clearly," said lead investigator Dr. John Bisognano of the University of Rochester Medical Center. "This outcome is not uncommon. While the initial results are not as crisp as we would expect, it is clear from looking at the data that there are therapeutic benefits to pursue."
The pivotal trial included 265 patients with resistant hypertension treated at 40 medical centers in the U.S. and two in Europe. A sub-analysis of the trial found that the Rheos device helped change the structure and function of the heart for the better, reversing the thickening and enlargement caused by persistent high blood pressure.
"The device lowers blood pressure in a way that actually benefits patients beyond changing their numbers — it improves the structure of the heart, which in turn improves overall cardiac function" Bisognano said.
Study: ICD batteries need to last longer
A study of 1,764 patients showed that the typical patient implanted with a cardiac defibrillator lives more than seven years with the device, prompting its lead author to call on the device industry to make batteries that last longer than four to six hours.
"Because these patients are living this long, it has significant implications for how long the devices need to last,"said Dr. Robert Hauser of the Minneapolis Heart Institute. "Typically, (defibrillators) last between four to six years, but these findings indicate that the devices require long-lived batteries."
"I think they haven’t developed them because it isn’t convenient financially," Hauser added. "The replacement market is a very good market, so companies look at that and say, ‘Why would we do (rechargeable batteries) until we have to?’"
Medtronic Inc. (NYSE:MDT) and Boston Scientific (NYSE:BSX) spokespersons cited development challenges such as the bulk of rechargeable batteries, how frequently they’d need to be re-charged and whether patients or providers should be responsible for the re-charging.
