CDU

NEW ORLEANS Cream and sugar, Martin and Lewis, coughs and colds are well-known pairings. An innovative combination coronary stenting teamed with additional partners was reported on in a poster session during November's annual scientific sessions of the American Heart Association (Dallas) at the Ernest N. Morial Convention Center alongside the Mississippi River downtown.

Belgian researchers said that stented angioplasty combined with robotically assisted "keyhole" bypass surgery to treat different parts of the coronary vasculature is safe and may benefit patients with cardiovascular disease who also have difficult-to-treat vascular conditions or related co-morbidities.

Bernard De Bruyne, MD, PhD, study co-author and head of the catheterization laboratory at the Cardiovascular Center (Aalst, Belgium), described in a clinical trial abstract this combination strategy used to treat 12 patients, calling it "the first hybrid bypass performed without opening the chest and on a beating heart." He termed the combination approach "the best of both worlds."

De Bruyne acknowledged the small number of patients in this pilot study, but said that the technique "might be applied to many similar patients. We had absolutely no complications with this approach."

All of the patients involved in the study had presented primarily with angina pain, as well as the other co-morbid conditions, Grievisu Dovidavicus, MD, who worked with De Bruyne on the study, told Cardiovascular Device Update.

The researchers said that larger-trial confirmation could especially benefit patients with more complex problems, such as those with both coronary heart disease and diabetes and patients whose narrowed arteries include chronic obstruction of the left anterior descendant (LAD) artery. In this trial, all had fatty deposits narrowing the heart's three main arteries, including obstructions in the LAD that precluded angioplasty.

Eleven patients were first treated with angioplasty in the right coronary artery or left circumflex artery an average of 41 days prior to their bypass operation. The 12th patient underwent angioplasty three days after surgery. A combination of bare-metal stents and the Taxus stent from Boston Scientific (Natick, Massachusetts) were used, Dovidavicus said.

The keyhole surgery described as robotically enhanced, minimally invasive direct coronary artery bypass [MIDCAB], used in only a few centers worldwide uses a robotic system to harvest from the chest one or both internal mammary arteries.

Doctors then sutured them to the obstructed coronary arteries through a left keyhole mini-thoracotomy, about 2 inches wide, to supply blood below the obstruction.

The harvesting is done by cutting two small holes in the chest, in addition to a larger hole (the mini-thoracotomy). The surgeon inserts a small light into the chest through one hole and a camera through the other.

The computer-controlled surgical instruments are inserted through the larger hole, with the surgeon viewing the procedure on a monitor. Computer control enables reduction in the tremors of the surgeon's hand to reduce operative risk, and the keyhole approach enables faster recovery for the patient.

Frank Van Praet, MD, senior author of the report and affiliated with the department of cardiovascular and thoracic surgery at the OLV Clinic (Aalst), noted that the keyhole approach avoids opening the chest "and without arresting the heart, offers patients the best post-operative comfort level and aesthetic results."

De Brunye pointed especially to the benefit for the trial group and the patient population it represents: "Patients with diabetes often have long lesions in their LAD that are difficult to treat with angioplasty but can be helped with bypass surgery," he said. "They also have a greater risk of infection if you open the chest and are more likely to have a long period of healing; therefore, avoiding opening the chest might be particularly beneficial in these patients."

The bypass grafts and stented segments of arteries were found patent with the use of follow-up angio- grams, and the researchers reported that all 12 patients remain free of angina-like chest pain. At six-week and six-month follow-up, all 12 were alive and none had heart attacks or required additional procedures to reopen arteries.

Dovidavicus said that the current trial would be expanded to 50 patients in order to further test the hybrid approach.

Tech offering wide on exhibit floor

Vasomedical's (Westbury, New York) electropulsation system could not help but draw attention on the exhibit floor, given live young humans lying on what appeared to be padded examination tables, and slightly bouncing up and down so as to recall scenes from The Exorcist. Being "exorcised" in this demonstration, however, were no demons, but rather the pain of angina and the heart-constricting inability to perform common everyday tasks such as negotiating a flight of stairs.

Being demonstrated was the Lumenair System, the latest generation of Vasomedical's enhanced external counterpulsation therapy (EECP), receiving first commercial roll-out at the AHA meeting. Lumenair is the fourth version of the company's EECP system and now its "premier product," Marketing Director Brian Weber told Cardiovascular Device Update, because of important advances over the initial product that was FDA-cleared and introduced in 1999. That product, the MC-2, featured a flat bed with multiple control units in what Weber characterized as a too-many-pieces configuration.

By contrast, the Luminair offers an ergonomically designed padded bed and a touch-screen control at the side, with a simple writing table beneath, to provide a much-reduced footprint. The "all-in-one" configuration also includes a combined plethysmographic/Sp0₂ probe, with the resultant data stored by AutoData software for printout and analysis.

The Lumenair's task remains the same as previous generations of the product: to offer improved cardio function and pain relief for patients who have run out of drug and surgical therapeutic options, Weber said. To do this, cuffs are placed around the patients' legs and hips, with pulsating air sequentially pumped into them, creating a wave-like but painless action along the body.

Vasomedical says this "retrograde pressure wave serves to improve coronary perfusion" and produces "increased endothelial shear stress [which] releases growth factors," and improved endothelial function in general. The therapy is "incredibly safe," Weber says, with patients reporting the ability to walk further and perform everyday tasks that were impossible before.

Vasomedical in October reported completion of a 2,500-patient registry as a follow-on to a Phase I 5,000-patient registry focused on identifying the results of EECP therapies for patients having various co-morbidities, with reports on this registry to come in the future, the company says.

The significantly higher-tech device sector was represented by a report from Stereotaxis (St. Louis) on a new clinical trial of its magnetically guided, percutaneous navigation system. Researchers reported on 21 patients who underwent 31 magnetic-assisted coronary interventional procedures at the Methodist DeBakey Heart Center (Houston), "leading to a high success rate," they said.

The system consists of two permanent magnets that generate a magnetic field over the heart and a magnet-tipped coronary guidewire. The navigation procedure involves interaction between the magnetic field of specified direction and magnitude, positioned externally to the patient, and a tiny magnet in the tip of the interventional device. An automatic system controls the catheter advancement and retraction.

Neal Kleiman, MD, director of cardiac catheterization at Methodist DeBakey, reported 28 of 31 lesions (90%) successfully crossed. He said the Stereotaxis system has the potential to allow coronary interventions to be done more quickly than conventional guidewire techniques, with its major advantage the ability to treat extremely tortuous vessels.

"About 20% of patients treated with the magnetic system were poor candidates for standard angioplasty or had already failed the standard procedure," Kleiman said. "These are the patients who can benefit from the magnetic navigation system." He did note that the system is not usable for every case.

"Just how broad a niche this technique will occupy is not yet clear," he said. And he acknowledged a steep learning curve for the system, likely to be reduced via software upgrades and further experience.

On the information technology front, Gateway Medical Management Systems (GEMMS; Indianapolis), a developer of electronic clinical information systems, is featuring its MyRecord system.

MyRecord is a credit card-sized disc containing an individual's medical history and playable, the company says, on any computer. The patient carries the MyRecord, and his or her physician can use it to gain access to that record at the point of care.

The disc, GEMMS says, "can contain everything from written descriptions of doctor visits to in-depth reports and diagnostic images." It also offers patient education information specific to diagnoses, treatments and medications.

GEMMS was founded in 1999 to market a medical management system developed by a large cardiology practice, called the ECIS system. The company reports ECIS installations in practices in 23 states and that in those practices, all of the participating physicians use the system, a claim that it says other electronic medical record systems cannot make.

Again on the low-tech side, Italian researchers reported that the use of "flight socks" below-the-knee elastic stockings worn by "at-risk" individuals during long-haul air travel reduced the occurrence of deep vein thrombosis (DVT) and leg clots.
Below-knee DVTs were experienced by just 1.1% of the flight socks wearers, compared to 4.6% in a group that did not wear them, and superficial blood clots were found in 3.4% of that control group.

Disease management costs questioned

Surprises and contrarian conclusions aren't really expected from the AHA scientific sessions. Exercise more, eat less (and better), monitor your weight, cholesterol and other vital signs carefully and you've got the underlying mantra of these sessions. But late-breaking clinical trials sessions, kicking off activities on the opening day of the AHA meeting, offered some surprises, with one study in particular likely to jump-start a certain amount of controversy or ought to. That controversy will concern the value of disease management (DM) of severe heart disease, and perhaps have larger implications for management of chronic disease in general.

The DM effort used in the study succeeded in lengthening the lives of heart failure patients - by an average of 76 days, compared to control, upon 18 months of follow-up but produced no reductions in healthcare costs, according to data from the South Texas Congestive Heart Failure Disease Management Project, the detailed report of the study now appearing on the web site of Circulation, the AHA journal. But while the study's DM program produced longer life, other measures of functional capacity among the patients in this trial were not improved.

Most pointedly, the study concluded: "Healthcare utilization was not reduced by DM [disease management], and it conferred no cost savings."

Presenting the results was Autumn Galbreath, MD, vice chairman for clinical programs at the University of Texas Health Sciences Center (San Antonio), who said that the study was launched to assess assumptions concerning the superiority of disease management programs, with the researchers' goals "to prove to ourselves whether or not that was true."

She noted that data on the issue has been "conflicting" and that earlier studies showing improved clinical results and lower costs "were often of short duration and /or had a small sample size."

The DM program employed included specialized cardiac training delivered to about 350 patients, average age 71, by registered nurse "disease managers," with these nurses making care recommendations to the patients' primary care doctors in accordance with American College of Cardiology (Bethesda, Maryland)/AHA guidelines for CHF, including recommendations regarding changes in medication. These patients were provided bathroom scales and an around-the-clock, toll-free number to call with questions regarding their case management.

The disease management program was primarily telephonic, with call frequency initially weekly, with a transition to monthly for the duration of the program.

A control group of about 360 patients received "usual care" without DM intervention.

Besides the additional average of 76 more days of life, patients with the most severe problems of systolic heart failure appeared to benefit most from DM, according to a subgroup analysis. But DM patients' scores on a six-minute walking test and their ejection fractions saw no improvement, according to Galbreath.

Besides clinical assessments, the researchers collected about 53,000 individual charges, and they said cost data was "equally distributed among the groups" and that "the lack of cost difference persisted even in patients with higher NYHA class, suggesting that the improved survival in sicker patients was not associated with cost savings."

In some categories, however, the report actually noted some costs higher in the experimental group than the control group.

Asked by reporters at the session concerning the major implications of the findings, Galbreath said that "a lot more thought needs to be given" to the provision of DM programs.

As broader context, she noted the DM demonstration programs recently rolled out by the Centers for Medicare & Medicaid Services (CMS; Baltimore) and, specifically, such programs for Medicare patients recently mandated by the State of Florida along with concurrent cost-cutting in those programs on the assumption of expected savings.

Findings concerning disease management were not the only unexpected results unveiled during the early going of the AHA sessions, however. Others took a closer analytical look at exercise as related to heart health.

While exercise is almost always assumed to be beneficial, it can sometimes work against cardiovascular health or at least too much might according to one report during the early sessions.

The study, by researchers at Brigham and Women's Hospital (Boston), found that frequent "vigorous exercise" was associated with "an increased risk of developing AF [atrial fibrillation]." In particular, "Men who jogged five to seven times per week had a 67% increased risk of developing AF, compared to men who did not exercise, after controlling for multiple CVD [cardiovascular disease] risk factors."

The study was based on an evaluation of 15,255 participants, with 8.4% of them reporting AF during a 14-year follow-up period.

Providing some good news with the not-so-good, the researchers said that the apparent increased risk of AF could be "balanced" by other health benefits and that further study is needed to discover a possible unknown factor associated with vigorous exercise that may elevate this risk.

In a somewhat mixed result concerning exercise among women, researchers at George Washington University (Washington) found that moderate/strenuous exercise reduced the risk of diabetes among white women but not among Hispanic, African-American and Asian women.

The findings, they said, need to be further explored with research "in larger populations of minority women or in randomized trials."

ICDs seen cost-effective

Results from the landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), presented during last March's annual meeting of the American College of Cardiology (Bethesda, Maryland) showed that implantable cardioverter defibrillators (ICDs) reduced death by 23% in people with moderate heart failure and poor heart pumping function, compared to those who did not receive them. New data presented at AHA demonstrate that ICDs are a cost-effective therapy for them as well. Study results reported during an AHA session indicate that the cost to add one year of life for these heart failure patients with an ICD is $33,192. The results of the cost-effectiveness analysis were consistent across predetermined patient subgroups. Medical therapies that add a patient year of life for $50,000 or less, such as primary coronary stenting, are generally considered to be cost-effective treatments.

Daniel Mark, MD, of Duke Clinical Research Institute (Durham, North Carolina), primary investigator for SCD-HeFT economics research, said, "The conclusion from this cost analysis is clear: Implantable defibrillators represent an economically attractive way to save lives in many people who have moderate, stable heart failure due to a damaged heart muscle."

Mark added: "It is highly unusual and very exciting that we have a therapy that provides such a significant impact on saving lives and does it efficiently from an economic standpoint."

Steve Mahle, president of Medtronic's (Minneapolis) Cardiac Rhythm Management business, said the SCD-HeFT study, which he characterized as "definitive," provides "conclusive evidence that defibrillation therapy is a highly cost-effective and lifesaving treatment for people with moderate heart failure and poor heart pumping function."

Medtronic helped fund the National Institutes of Health (Bethesda, Maryland)-sponsored study, along with Wyeth Pharmaceuticals (Madison, New Jersey).

Mahle said the cost-effectiveness analysis "demonstrates that ICD therapy, which comprises less than 1% of the Centers for Medicare & Medicaid Services [Baltimore] annual budget, is an appropriate and valuable use of healthcare dollars, and it is well worth the cost."

Now, he said, "it's a matter of getting this lifesaving therapy to all those who need it."

SCD-HeFT was a randomized, three-arm trial examining the use of ICD therapy and anti-arrhythmic drug therapy in 2,521 patients who have moderate heart failure (New York Heart Association Class II or III), plus impaired pumping function of the left ventricle, the heart's main pumping chamber. One-third of the patients enrolled in the study received an ICD provided by Medtronic. Another third received amiodarone, a Wyeth medication used to manage fast, life-threatening heart rhythms, and one-third received a placebo.

The economic analysis was performed by measuring the costs of all three treatment arms and calculating the extra costs associated with ICD therapy and amiodarone. Because amiodarone showed no improvement in survival over placebo, cost-effectiveness analysis involved only the ICD and placebo arms. The cost-effectiveness was based on the empirical data collected as part of the SCD-HeFT research effort, and statistical modeling was used to project survival and costs beyond the end of the study follow-up period.

In another study whose results were reported during the AHA meeting, a prospective, independent clinical trial showed a low incidence of repeat coronary procedures in insulin-dependent (IDDM) and non-insulin-dependent (non-IDDM) diabetic patients who received a Cypher sirolimus-eluting coronary stent made by the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey).

The study by Washington Hospital Center (Washington) compared diabetic patients to patients without diabetes who received a Cypher stent. Both IDDM and non-IDDM patients treated with the Cypher stent had extremely low rates of adverse events, Cordis said, defined as the need for retreatment, or the occurrence of heart attacks and death.

Specifically, the study found no statistical difference in clinical results between the two patient groups, revealing that diabetic patients fared as well statistically as did patients who did not have diabetes.

"Diabetics with heart disease can be challenging to treat with drug-eluting stents, especially insulin-dependent diabetics," said lead study author Ron Waksman, MD, associate director in the division of cardiology at Washington Hospital Center.

Waksman, who also is director of experimental angioplasty and emerging technology for the Cardiovascular Research Institute at the Washington Hospital Center, said: "This research is very encouraging based on the positive results realized in this study for diabetic patients treated with the Cypher stent. Across the board, the outcome measures were positive."

Some 1,407 patients were enrolled in the study, divided into three groups: insulin-dependent diabetics (11.3%, or 160 patients), non-insulin-dependent diabetics taking oral agents and/or on dietary control (23.6%, 332 patients) and patients who did not have diabetes (65%, or 915 patients). Follow-up evaluations were conducted for all groups following the procedure and at one month and six months post-procedure.

Waksman said six-month follow-up showed no significant differences with regard to mortality (4.5% in non-IDDM; 3.8% in IDDM and 2.3% for non diabetic); target lesion revascularization, also known as TLR (0.9% in non-IDDM; 0.4% in IDDM; and 1.5% in non-diabetic); and overall major adverse cardiac events (MACE) calculated with target vessel revascularization, also known as TVR (8% in non-IDDM; 7.9% in IDDM and 6.2% in non-diabetic).

Dennis Donohoe, MD, vice president of clinical and regulatory affairs at Cordis, said, "The data are compelling, and it is encouraging to see these low MACE rates when the Cypher stent is used in diabetic patients."