A Japanese study of intra-aortic balloon pumps appears to indicate the devices do little to improve outcomes for patients with acute cases and may increase the chances of death.
In the registry study published in JAMA Internal Medicine, the treatment using the devices was associated with a 15.1% rate of in-hospital mortality among patients receiving percutaneous coronary intervention in the acute or nonacute environment versus 0.9% for PCI without a balloon pump.
The devices, called IABPs, are typically inserted through the aorta and threaded to the heart to help it pump blood and stabilize a patient suffering from acute mital valve regurgitation or severe heart failure.
"It is time to reconsider the appropriate use of IABP therapy, a potentially life-saving but extremely costly and high-risk intervention for patients," the researchers, led by Dr. Taku Inohara of the Keio University School of Medicine in Tokyo, said in the conclusion of their study.
In the study, 6.7% of the 13,253 patients studied between 2008 and 2014 received IABP therapy, and were considered to have the worst baseline risk profile with more serious heart failure, cardiogenic shock and cerebrovascular disease.
A meta-analysis published in JAMA Internal Medicine in June indicated that IABPs don't improve survival for acute myocardial infarction.
Still, the authors of the Japanese study said that a casual relationship between IABP use and in-hospital mortality remains to be proven.
"The bottom line is that we shouldn't interpret the study to mean that the balloon pump makes people worse," Dr. Morton Kern, chief of medicine at California's VA Long Beach Healthcare System, told MedPage Today. However, Kern, who wasn't involved in the study, added, "if you are using IABP to support patients in the worst conditions, it's not your best support device."
|Maquet's intra-aortic balloon pump--Courtesy of Maquet|
In those cases, he suggested, the Impella left ventricular assist device (LVAD) may prove to be the better option. They "should be considered when we decide to balloon pump or not to balloon pump."
Abiomed ($ABMD), the maker of the Impella heart pump, reported last week first-quarter global sales of the device were $71.7 million, which was a 53% jump from $46.9 million for the same period last year.
Maquet, the German devicemaker, produces a line of IABPs. They were the subject of a severe Class 1 recall in 2014 after the firm received 106 reports of device malfunction.
Unrelated to the study, Maquet was hit with a permanent injunction by the U.S. Justice Department earlier this year and recalled more than 4,000 of its TigerPaw left atrial appendage occlusion devices designed to prevent strokes.
Special Report: Four key medical device recalls of 2015 - Questionable regulation leads to recall of all units of troubled Maquet's cardiology implant