A decision made last month by the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) means another 90,000 patients a year will qualify for reimbursement coverage to receive implantable cardioverter defibrillators (ICDs), but the coverage guidelines fall short for another 200,000 people researchers say would benefit from the devices. The expanded coverage should be in effect in about six months, CMS said in June. The coverage decision brings to an end a year of lobbying efforts to win the additional coverage but the extent of the coverage is unlikely to end the scientific and economic debate over the issue. Medicare paid for the placement of 45,000 ICDs last year, which cost about $35,000 each to buy and implant, and the expanded coverage represents the most expensive single addition to the agency's list of covered benefits since 1999, CMS said.

CMS's decision is not based on published observations or peer review, Michael Cain, MD, professor of medicine and director of the cardiovascular division at Washington University School of Medicine and Barnes-Jewish Hospital (St. Louis, Missouri) told Cardiovascular Device Update. Cain is the president of the North American Society of Pacing and Electrophysiology (NASPE)/Heart Rhythm Society (Natick, Massachusetts). "We are delighted the decision was a national one and not at the discretion of local carriers, but disappointed that it restricted a subset of the MADIT II participants," Cain said. The decision limits implants to only those patients fitting a new indication category whose ECG shows an abnormally wide QRS duration greater than 120 milliseconds, he explained.

CMS expanded its coverage for patients with coronary artery disease with prior myocardial infarction (heart attack), left ventricular ejection fraction less than or equal to 0.35, and inducible, sustained ventricular tachycardia or ventricular fibrillation at electrophysiological study. Coverage was also approved for patients with a prior myocardial infarction and left ventricular ejection fraction less than or equal to 0.30 and an electrical conduction abnormality in the heart QRS duration greater than 120 milliseconds.

The coverage decision goes against a CMS advisory committee's recommendation. In February, CMS convened its Medicare Coverage Advisory Committee, an expert and impartial panel, to review the clinical trial results of the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). The committee voted unanimously that the evidence was adequate to apply the findings of MADIT II to all Medicare patients who meet the trial's inclusion and exclusion criteria.

Fred McCoy, president of cardiac rhythm management at Guidant (Indianapolis, Indiana) which sponsored MADIT II and its predecessor, MADIT I acknowledged that the decision extends Medicare ICD coverage to many MADIT II patients, "thereby expanding the number of people who will receive the life-saving benefits of ICDs and providing for sustainable growth of ICD therapy." But he said that the "best medical science and evidence-based medicine signal us that this coverage stops short of that which is warranted." He said the scientific data "convincingly demonstrate that, in patients who meet the MADIT II criteria, implantable defibrillators offer life-saving benefits." McCoy added: "We encourage CMS to follow through on its stated commitment to evaluate national coverage in the remainder of the MADIT II population as additional data becomes available."

MADIT II was a prospective, randomized, multicenter intention-to-treat study that enrolled 1,232 patients at 71 centers in the U.S. and five outside the U.S. The trial was halted in November 2001 by an independent monitoring board because it demonstrated a 31% decrease in mortality for those patients with an ICD compared to those with drug therapy alone. The FDA approved the expanded indication for ICDs in July of 2002.

"CMS's limited coverage decision is inconsistent with the findings of the MADIT II trial, which demonstrated a significant reduction in the risk of death for all patients who received ICD therapy," said Arthur Moss, MD, professor of medicine and director of the heart research follow-up program at the University of Rochester Medical Center (Rochester, New York). Moss was the primary investigator in the MADIT II trial.

CMS said it will reevaluate its decision when the results of the National Heart, Lung and Blood Institute's (NHLBI; Bethesda, Maryland) Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) becomes available early next year. SCD-HeFT also is evaluating the benefits of ICDs in patients with heart disease, and some of the patients are similar to those treated in the MADIT II trial, according to CMS.

Needed: Pediatric bedside blood monitoring

In hospitals nationwide, three out of four infants who die after undergoing high-risk congenital heart surgery could survive if doctors monitored blood at the bedside and rapidly detected and corrected life-threatening oxygen deficiencies, according to data presented at the 4th World Congress on Pediatric Intensive Care. The results, reported by Miami Children's Hospital (Miami, Florida), were based on survival outcomes in infants whose blood was rapidly tested hourly following surgery, with a point-of-care, hand-held device that tests two drops of blood in two minutes. Compared to national averages, the data showed a 74% decline in deaths in babies at highest risk, and a 63% drop in deaths overall.

"The ability to use a tiny blood sample to accurately test lactate levels, a sensitive marker of oxygen debt, in two minutes at the bedside of an infant and then immediately adjust therapy is a major advance in our ability to make life-saving treatment decisions," said Anthony Rossi, MD, director of cardiac intensive care at Miami Children's. "These are definitive and clinically significant findings that, for the first time, show how technological advances in blood testing directly and dramatically improve even the most fragile infant's chance of survival."

The highest-risk infants who undergo heart surgery normally have a one-in-three chance of dying (29.6%) often because post-surgical deficiency of oxygen cannot be diagnosed quickly enough. Steven Melnick, MD, medical director of pathology at the hospital, said central laboratory samples often take more blood than infants can spare, and time delays are inevitable when transporting specimens to and from the intensive care unit, leading to delays in clinical decision-making. "Our ability to bring the lab to the patient gives the lab a much greater role in effecting patient survival," he said. "The use of point-of-care testing in infants means that we can test specimens and doctors can react within a five-minute window to correct the onset of oxygen deficiency. We know of no other way to test for lactate and adjust therapy all within five minutes."

To determine if treatment should be escalated, diminished or unchanged, the point-of-care testing system from i-STAT (East Windsor, New Jersey) was used at the bedside every hour for the first four hours after surgery, and then at four- to six-hour intervals, with immediate therapy changes if necessary.

Type 1 diabetes: Tight control pays off

New research unveiled at last month's annual meeting of the American Diabetes Association (ADA; Alexandria, Virginia) in New Orleans, Louisiana, indicates that tight control of Type 1 diabetes pays off in reduced atherosclerosis and other complications years later even if control has subsequently become less intense due to mechanisms beyond blood glucose levels alone.

The Diabetes Control and Complications Trial (DCCT) was launched 20 years ago and involved 1,441 people in a comparison of intensive vs. conventional control. The initial results, reported in 1993, demonstrated a 39% to 76% reduction in development of microvascular complications, including retinopathy, neuropathy, and nephropathy. Most participants were then enrolled in the Epidemiology of Diabetes Interventions and Complications (EDIC) observation study, involving an annual assessment over eight years and serving as the basis of the report at the ADA meeting.

John Lachin, ScD, professor of biostatistics at George Washington University (Washington) and principal investigator of the DCCT/EDIC Coordinating Center, "Intensive control, bringing blood glucose levels as close to normal as possible for an average of six and one-half years, yielded reduced atherosclerosis even after eight years of less effective control, compared to those who never achieved tight control." The researchers acknowledged that the mechanism of such benefits is unknown, but they theorized it could be the result of a cascade of metabolic effects triggered by high glucose levels or, alternatively, a result of "imprinted" metabolic memory. David Nathan, MD, professor of medicine at Harvard Medical School (Boston, Massachusetts) and co-chair of the DCCT/EDIC study, said that the key message of the research "is that good glucose control should be implemented as early as possible."

A poster presentation showed that those previously on intensive control had significantly less calcification in their coronary arteries than those on conventional control, as evidenced by CT scans. Further, those formerly on intensive therapy continued to display a markedly reduced progression of microvascular disease.