Medical Device Daily Washington Editor
The abdominal aortic aneurysm (AAA) is still a very deadly circulatory system condition and device makers in the U.S. are still hot on the trail of a better percutaneous repair approach, as a recent announcement by Cordis (Bridgewater, New Jersey) makes clear (Medical Device Daily, April 12, 2010). An article that debuted yesterday in the New England Journal of Medicine offers the classic good news/bad news scenario on the topic. While the article, based on a study of patients in the UK, asserted that percutaneous repair was no better in the long haul than conventional surgical repairs of the aorta, it also made clear that a device maker that can improve long-term outcomes has a substantial opportunity.
The bad news for makers of the percutaneous class of devices is that the cost differential is liable to drive a lot of coverage decisions because surgery was said to be less expensive than the percutaneous approach.
The authors of the article, including the principal investigator of the trial, Roger Greenhalgh, MD of the Imperial College London, state that the EVAR 1 (Endovascular Aneurysm Repair 1) study randomized slightly more than 1,250 patients between 1999 and 2004 evenly between the two arms, although the authors do not name the percutaneously delivered device(s) used in the study. Operative mortality in the study group at 30 days was, not unexpectedly, lower in the study arm (1.8% compared to 4.3%) than in the surgical arm, but the authors note that the early benefit regarding operative mortality “was lost by the end of the study, at least partially because of fatal endograft ruptures.“ By the end of follow-up, which averaged six years, survival was at 93% for both procedures, and was 54% for all causes in both arms of the study.
The authors also pulled out cost data for the two arms, which may be where the decisive data are as far as UK health authorities are concerned. According to the study data, the average cost of the surgical procedure was a bit less than $18,000 whereas the percutaneous approach is said to have averaged a cost of almost $19,700. The cost of readmissions further favored conventional surgery over the percutaneous approach, $669 vs. more than $3,400. The authors acknowledge that both of these patient groups may have generated further costs not captured by the study, but offers no attempt to assess the potential additional costs. The total cost difference came to roughly $4,400 per patient.
Patients in the study arm experienced substantially more complications at all time frames, including six months (132 to 45), between six months to four years (114 to 18), and beyond four years (36 to 15). Reinterventions were also higher in the percutaneous arm in each phase, although the difference varied. The difference in reinterventions during the first six months was 66 to 40 (percutaneous vs. surgical), and tallied 55 to six in favor of surgery between six months and four years. Thereafter, the gap narrowed, 24 to nine, again favoring surgery.
NIH says apnea boosts risk of stroke
As if anyone needs another reason to lose sleep, the National Institutes of Health released a statement recently indicating that those who suffer from obstructive sleep apnea (OSA) are at greater risk for stroke than those whose sleep is undisturbed by night-time breathing issues.
According to the April 8 statement by the National Heart, Lung and Blood Institute, OSA “more than doubles the risk of stroke in men“ and the effect holds even for mild cases of OSA. Still, men with moderate to severe OSA “were nearly three times more likely“ to suffer a stroke than their counterparts with mild OSA or no such issues at all. According to the NHLBI data, the risk runs independently of other factors, such as weight problems, hypertension, smoking and diabetes. However, researchers are also seeing for the first time a definitive link between OSA and stroke in women.
The statement notes that the underlying study, which was reviewed recently in the American Journal of Respiratory and Critical Care Medicine, drew data from more than 5,400 participants who were followed for nine months. Of that number, 193 (108 women out of more than 2,900 and 85 men out of more than 2,400) sustained a stroke. The higher rate of stroke in men is thought to be related to a typically earlier onset of the condition, which presumably translates to more damage sustained over time.
Susan Shurin, MD, acting director of NHLBI, said in the statement that the data suggest that “the time is right for researchers to study whether treating sleep apnea could prevent or delay stroke in some individuals.“ Whether this will prompt action in the private sector remains to be seen.
NIH says that more than 12 million American adults may suffer from OSA and that most of them have not been diagnosed and treated. Weight loss can cut down on the severity of OSA, but treatments are typically mechanical in nature, including continuous positive airway pressure devices, a treatment that is notorious for being the subject of an extraordinary degree of non-compliance on the part of the patient.
CMS eyes oxygen for cluster headaches
Anyone with recurring headaches of any kind can appreciate the burden this class of conditions imposes, but the pain suffered by those with cluster headaches – headaches that are sometimes described as suicide headaches – is said to be in a class by itself. Thanks to the ongoing development of evidence and a little urging from two medical societies, the Centers for Medicare & Medicaid Services recently announced it will undertake a national coverage analysis to establish whether the use of oxygen is sufficiently reasonable and necessary to cover for these patients.
CMS formally announced the review yesterday, an effort taken up at the behest of Fred Sheftell, MD, president of the American Headache Society (Mount Royal, New Jersey) and Robert Griggs, MD, president of the American Academy of Neurology (St. Paul, Minnesota). The agency indicates it will take public comments until May 9 and will propose a coverage decision by October 9. The final decision should be in by next January.
Cluster headaches were the subject of a study that was published late last year in the Journal of the American Medical Association, which concluded that 78% of the patients on oxygen had experienced at least some reduction in pain vs. 20% on a placebo of straight air. The study was led by Anna Cohen, PhD, of the National Hospital for Neurology and Neurosurgery in the UK, and is in the Dec. 9, 2009 edition of JAMA.
CMS adds clinics to list for bariatric, CAS
CMS also reported yesterday that it had added one hospital to its list of approved centers for bariatric surgery and two for carotid artery stenting (CAS).
Winning approval for bariatric surgery was Carteret General (Moorehead, North Carolina), while Marshall Medical Center North (Guntersville, Alabama) was accredited for CAS. Also joining Marshall on the list for CAS is Oklahoma Heart Hospital (Oklahoma City, Oklahoma), both of which were certified or recertified on April 2.
Mark McCarty, 703-268-5690