CD&D Washington Editor

As the saying goes, sometimes no decision is a decision, and such was the case in last week's announcement by the Centers for Medicare & Medicaid Services to make no change to its current payment policy for computerized tomography for angiography (CTA).

In the March 12 announcement, CMS stated "that no national coverage determination on the use of cardiac computed tomography angiography for coronary artery disease is appropriate at this time." CMS was considering covering such scans only for trials intended to develop evidence to support those uses.

Medicare imaging has been the source of ire for the Medicare Payment Advisory Commission (MedPAC), and CMS unilaterally undertook a review of CTA to establish whether it is money well spent. The outcome of the entire exercise is that CMS will continue to default to local Medicare carriers to decide on reimbursement for CTA in assessment of coronary artery disease (CAD), with angina serving as the index symptom.

CMS said the use of CTA "has increased due to advances in technology and rapid diffusion of machines outside the hospital," and that "proponents have claimed that CTA may reduce the need for invasive coronary angiography." Critics of such uses point to "the lack of evidence on outcomes and the limitations to the technology including unin-terpretable/unassessable [arterial] segments and the health risks from the considerable radiation exposure."

CMS's statement noted that the Agency for Healthcare Research and Quality commissioned a technology assessment in 2006 that drew on 29 studies of CTAs of 16-slice machines or better. AHRQ concluded that "there is limited evidence regarding test performance ... for identifying, quantifying, or otherwise characterizing coronary artery stenoses." AHRQ also concluded, "future work will need to examine these tests in larger, less selected populations representing" real-world clinical settings.

The agency acknowledged the "uncertainty regarding any potential health benefits or patient management alterations from including coronary CTA in the diagnostic workup," adding that "no adequately powered study has established that improved health outcomes can be causally attributed to coronary CTA for any well-defined clinical indication." However, while the force of opinion of the relevant medical societies "did not dispel the uncertainty of the test's clinical utility, they did strongly favor maintaining the local coverage policies for CTA.

"In light of this, CMS has decided to make no change in the current NCD," CMS stated, while warning: "We believe that current guidelines are inadequate to provide appropriate guidance to patients and providers as to the appropriate inclusion of CTA into the diagnostic milieu." CMS said it was "concerned that providers are using CTA as an additional test rather than thoughtfully considering the appropriate mix of these tests," and encouraged "the specialty societies to quickly develop this type of guidance."

Laurel Sweeney, senior director of reimbursement for Philips Medical Systems (Malvern, Pennsylvania), told Cardiovascular Devices & Drugs that the CMS non-decision makes sense for patients and deficit hawks. Regarding data that depicts the cost of high rates of imaging of Medicare patients, she said "that data will not show the [cost of] cardiac catheterization" that CTA replaces.

Sweeney said that one reason the agency is unlikely to issue an NCD approving payment seemingly supported by the fact that local carriers in all 50 states are willing to pay is that "there's a lot of data that's pending" on 64-slice CT, and because much of the extant data is from 16-slice equipment.

Local carriers are fans of the 64-slice configuration "because you can take the scan a lot faster," which eliminates the problem of patients having to hold their breath for longer than is comfortable, Sweeney said. "The newer technologies also allow you to set the [radiation] dose to the patient's weight," which gives clinicians "better images so you don't have to retake them."

Speaking for both industry and the medical societies, Sweeney said that CMS's decision to scrutinize CTA was "a surprise to all of us," partly because referral data for CTA do not suggest the physician self-referral problem that has MedPAC up in arms over mounting Medicare imaging costs. She said "the number of self-referrals [for CTA] is not contributing at all," and that "most of overall imaging referrals are referred by primary care doctors," not by specialists.

Andrew Whitman, VP of the Medical Imaging & Technology Alliance (Rosslyn, Virginia), said in a statement that the association "applauds CMS for following through on its commitment to conduct a comprehensive evaluation of all the data before issuing its final coverage decision." On the question of whether CMS should simply issue an NCD for coverage, he told CD&D. "I think CMS made the correct decisions to leave it with the local carriers" because the CED process "is used in instances where the evidence is not always 100% there, and here it was evident that the data support" the use of this technology for CTA.

Study: pacemaker use seen as promoting tissue protein benefits

Scientists at Johns Hopkins (Baltimore) have reported an experiment in dogs using pacemakers to electrically retune a heart damaged by long bouts of a wobbling heartbeat, where one heart muscle wall is beating sooner than the other. They found that this leads to fast improvements in the tissue levels of more than a dozen proteins key to the organ's health,

The team's findings, published online in the journal Circulation, are believed to be the first detailed chemical analysis of the pacemaker's biological effects on the heart and could serve as the basis for more strategic use of combined device-plus-drug treatments for people with congestive heart failure.

"Our results really help explain how pacemakers act much like a drug, actually changing the biology of the heart, and also explain why people can feel so much better after just two to six months with the device," says study senior study investigator and cardiologist David Kass, MD, a professor at the Johns Hopkins University School of Medicine and its Heart Institute.

"We are learning that pacemaker therapy does profoundly more than just mechanically correct how the heart beats; in fact, it produces major chemical changes that benefit the muscle," says lead investigator Khalid Chakir, Ph.D., a postdoctoral cardiology research fellow at Hopkins.

"Now that we have found that resynchronization is doing more fundamental things to the heart muscle, we should be able to better combine these devices with drugs to maximize long-term survival and outcomes," says Kass.

Chakir says previous research has shown that a year after implantation, pacemaker resynchronization has been effective at reducing mortality in some heart failure patients by as much as 36%, but researchers have not until now really understood the biological effect of the devices beyond the physical mechanics of contraction.

In the current study, the Hopkins team determined the biological effects of pacemaker treatment on the hearts of 22 dogs with heart failure induced by making the heart beat faster.

A key nervelike, electrical pathway that normally assures the muscle's harmonious beat was also damaged, producing a wobbly, discoordinated contraction. The asymmetric heart failure condition was allowed to take its natural progressive course in half the dogs; the others had cardiac resynchronization therapy with implantation of a pacemaker.

Results from tissue analysis in these two groups of dogs were then compared to a third group of six dogs with healthy hearts.

In the heart failure groups, the scientists report major ups and downs in production or activity levels in 17 out of more than two dozen proteins known to be involved with heart cell stress, survival and death.

The alterations were especially notable in the group that did not have their hearts retuned. But tissue levels and activity of these proteins were restored toward normal in those with pacemakers that were tuned to reestablish an even, coordinated contraction, with both sides beating at the same time.

Among the stand-out proteins was one that prevents heart muscle cells from dying, an enzyme called phospho-BCL2 antagonist of cell death, or pBAD for short, which was found to be five times more active in the pacemaker-treated group than in the untreated group.

A second protein, p38 MAP kinase, known to stimulate fibrosis and cell death, was twice as active in late-contracting parts of failing hearts in untreated dogs, than in the same heart zone of dogs who underwent pacemaker resynchronization therapy.

Other proteins that lead to heart cell death and worsen contraction and were overexpressed in dogs with untreated heart failure included calcium-calmodulin-dependent kinase (CaMKII), which is linked to arrhythmia, and tumor necrosis factor-alpha (TNFa), which is also tied to damaging inflammation and cell death.

Researchers next plan to look at how pacemakers stimulate biological changes in the heart, with the aim of developing treatments that bring the heart back to a normal, healthy state.

Mayo research recommends revising over-80 ECG 'normal' range

In another report from Mayo, a team of its researchers have concluded that the established "normal" ranges for evaluating electrocardiograms for persons over 80 years old should be "revisited." The recommendation comes in a study published n the American Journal of Geriatric Cardiology.

After analyzing readings from more than 700 patients 80 or older, the researchers discovered that the average cutoffs (beginning and end points) for measuring all three ECG intervals – PR, QRS and QT – were greater than the current established norms.

The findings also showed that the intervals, while greater in general, were significantly higher in men. The intervals refer to the times between recorded peaks of the specific motions in a heartbeat as represented on an electrocardiogram.

"What is normal for a population of middle-aged individuals may not be the same for the steadily increasing elderly population in this country," says Latha Stead, M.D., lead author of the study and chair of the Division of Emergency Medicine Research at Mayo Clinic.

Researchers studied ECG results from 702 patients who came to Mayo Clinic for routine annual examinations. Forty-six percent, or 331, were men. Just under 18% of all patients had a history of cardiac disease.

Basing their reference ranges on the healthy subgroup – 578 patients who either had no history of heart disease or who were taking heart medication –the researchers established averages for each of the three ECG prolonged intervals, in men and women.

In all cases, the average interval cutoffs for women were higher than the standards set out in the current medical literature.

For men, the cutoffs were considerably higher -- in some cases more than twice as high. Based on the findings, the researchers suggest ECG standards be re-examined for both age and sex for the older population.

Psychosocial status shown as link to survival after 'arrhythmic event'

High anxiety obviously can provoke a heart attack, but state of mind and cardiovascular health may have a much broader association even than this, according to research published in March 2008 edition of the HeartRhythm Journal, the journal of the Heart Rhythm Society (Wahington).

The research found a direct connection between a recovering patient's psychosocial state and survival rate following an arrhythmic event. The study, led by Jonathan Steinberg, MD, of St. Luke's-Roosevelt Hospital Center (New York), is being billed asi the first to show how a patient's negative state of mind can have a direct impact on long-term survival after a cardiac event. In addition, the study found that in high-risk cardiac patients, psychosocial profiles can also independently predict death, separately from a physical assessment.

"In the days, months and years after a patient has experienced an arrhythmic event, the psychosocial state of that individual may have an impact on the longevity of life or likelihood of life-threatening arrhythmias," said Jonathan Steinberg, MD, lead author and chief of the Division of Cardiology, St. Luke's-Roosevelt Hospital Center.

"Our research shows that assessing a patient's mental well-being, and seeking counseling or therapy when needed, can be a critical factor in a successful recovery."

The study examined self-reported quality of life (QoL) questionnaires from Antiarrhythmics Versus Implantable Defibrillators (AVID) trial patients who had experienced cardiac arrest or life-threatening ventricular tachycardia (VT). Upon measuring the survival of patients three years after having an arrhythmic event, the study revealed a 40% death rate among the one half of patients with a poor psychosocial condition versus a 20% death rate among the other half of patients with a good, or better, psychosocial condition.

In AVID, several QoL instruments were used, including SF-36 Subscales (Physical and Mental Component Summaries), Patient Concerns Checklist and Quality of Life Index-Cardiac. The AVID trial enrolled 1,016 patients, 740 of whom had baseline data available from at least one of the QoL instruments.

CMS seeks evidence-based protocol for coverage of artificial hearts

The Centers for Medicare & Medicaid Services reopened its coverage policy last year on the use of artificial hearts and recently said it has opted to allow limited reimbursement as part of an evidence development effort, known as coverage with evidence development (CED). In its proposal memo, CMS said the available evidence fails to make a conclusive argument about the reasonableness and necessity of an artificial heart for New York Heart Association Class IV heart failure.

However, CMS said that it found the evidence nonetheless "promising" and that the agency "supports additional research" on the question. One of the several conditions for reimbursement is that a study could potentially show any "unique circumstances, such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes."

CMS said that it had issued a non-coverage decision for artificial hearts in 1986, but the September 2006 approval of a humanitarian device exemption for the Abiocor, manufactured by Abiomed (Danvers, Massachusetts), prompted a second look at coverage for both destination and bridge-to-transplant (BTT) uses. CMS noted that FDA granted the HDE despite the fact that the circulatory systems advisory committee recommended no HDE.

CMS said that FDA approved the Abiocor for patients who aren't candidates for transplantation, "who are near death from end-stage biventricular Class IV heart failure," and whose other treatment options have run out. As the CED label suggests, any such study will have to produce evidence that could be used in any future decisions on the coverage question.

It added that one of its "major concerns is the relatively few implanting hospitals and uneven distribution of patient experience among those hospitals" that have participated in previous studies. CMS also said it was concerned about the relatively few patients enrolled in the destination arm for the Abiocor and the lack of recent data on BTT patients for the Cardio West artificial heart from Syncardia (Tucson, Arizona). CMS concluded that the data from those studies "can[not] be extrapolated outside of the controlled, monitored" study conditions.

CMS expects to complete its analysis May 1.

Report cardio diagnostics put at $2.9 billlion in 2007

Rising costs of materials and growing complexity of procedures characterize the field of cardiology. according to a report from Global Industry Analysts (San Jose, California). It puts the U.S. market for cardiovascular disease diagnostics at $2.9 billion in 2007, not surprisinglly the largest in the world, with Japan the second largest.

The report puts the world cardiovascular in vivo diagnostics market at $ 4.1 billion for 2007. Increasing acceptance of computed tomography and magnetic resonance angiography is expected to modify cath-lab function.

The report titled "Cardiovascular Disease Diagnostics: A Global Strategic Business Report", categorizes the market into in vitro diagnostics and in vivo Diagnostics.