GARY LUDWIG
During my younger days, I received an advertisement in the mail from my high school bookstore that would send the PETA (People for the Ethical Treatment of Animals) group running for the lawyers. In the envelope was a picture of a small beagle puppy, with those big sad, droopy eyes, looking straight at the reader. Against the head of the small puppy was the barrel of a huge .357 magnum. Captioned across the top of the advertisement in bold letters was, “Buy our stuff or else we’ll shoot this dog!”
In many ways, some fire departments are starting to feel the same way when the American Heart Association changed its Advanced Cardiac Life Support (ACLS) guidelines last August. One of the biggest changes is the recommended use of a drug called amiodarone. The new ACLS guidelines suggest amiodarone be administered for treating hemodynamically unstable ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) patients who do not respond to defibrillation.
The sole manufacturer of amiodarone is Philadelphia-based Wyeth-Ayerst Laboratories, a division of American Home Products Corp. of Madison, NJ. It is marketed under the brand name Caradone IV and the company holds an exclusive patent until 2002. Essentially, no other company can manufacture a generic version for a couple of more years. Therefore, when you are the only manufacturer and demand outstrips supply, the end result is usually an inflated price. A single dose of amiodarone for a cardiac arrest patient will cost a fire department approximately $130.
These new American Heart Association ACLS guidelines have created discussion and some controversy. The main reasons – the drug is very expensive and there has only been one study to validate its usage in a cardiac arrest. Thus, like having a gun to your head, you have to buy this drug if you want to meet the new ACLS guidelines.
But does this expensive drug work? That is a good question since the pharmaceutical committee of the American Heart Association based its decision on one study. The ARREST study (Kudenchuk P, et al: “Amiodarone for resuscitation after out of hospital cardiac arrest due to ventricular fibrillation.” New England Journal of Medicine. 871-878, September 1999) focused on out-of-hospital cardiac arrests managed by King County paramedics in Washington state. Through randomization, double-blind and placebo-controlled IV administration of amiodarone to 504 cardiac arrest patients, the study attempted to determine effectiveness of amiodarone in patients experiencing sudden cardiac arrest.
The ARREST study concluded that resuscitation into a stable heart rhythm was increased by 26% in people treated with intravenous amiodarone, as compared to those who received all other standard treatments for cardiac arrest. The authors also concluded that among people in whom defibrillation shocks alone could only temporarily maintain a stable heart beat, amiodarone improved their chances of “survival to admission” to the hospital.
The keys words here are “survival to admission” to the hospital. The study concluded that recipients of amiodarone were more likely to survive to be admitted to the hospital (44% vs. 34% of the placebo group). Critics of the study point out that the best measure of the study is not “survival to admission,” but “survival to discharge” from the hospital. Critics refer to the statistical data from the study which showed no significant difference in “survival to discharge” rates for patients who received amiodarone vs. the placebo group (13.4% vs. 13.2%).
Based on this data, one can conclude that 26% more patients in the amiodarone group were admitted to the hospital, significantly increasing costs without providing long-term benefits to patients.
Critics also point out that the study was conducted in the Seattle MedicOne EMS system, where emergency response times are much shorter, and consequently survival after cardiopulmonary resuscitation is much higher, than in most areas. They point out that replication of this study in areas with longer response times and lower survival rates would be even less likely to show any long-term benefit from amiodarone.
The major impact to fire departments with the new ACLS guidelines is that amiodarone is a very expensive drug. Medicare is already denying a record number of transport reimbursements and the new lower Medicare reimbursement rates are to roll out this spring. With a slowing economy bringing in fewer tax dollars and less money from reimbursements, many fire departments have to make the decision – do we stock our drug boxes with amiodarone?
Some fire department medical directors have opted not to place amiodarone into new paramedic cardiac arrest algorithms, pointing out that ACLS guidelines still provide options for the administration of Lidocaine during recurring ventricular fibrillation. Other fire department medical directors have opted to change guidelines and some departments are already administering amiodarone in the field.
Many advocate that the answer to survival with out-of-hospital cardiac arrest is not found in the drug administration, but is directly related to how quickly defibrillation is provided. Thus, one can conclude that time, money and effort should be more focused on finding ways to decrease the time to defibrillation.
Only time will tell whether this drug significantly changes patient outcomes in cardiac arrest. What is certain is that fire department budgets will be impacted.
Related:
Put A Gun To My Head: New ACLS Guidelines