麻豆传媒

This article is a collaboration between 麻豆传媒 and:

Intra-aortic balloon pumps (IABPs) not only fail to improve outcomes, but may contribute to mortality, a Japanese registry study suggested.

IABP treatment was associated with a among patients getting percutaneous coronary intervention (PCI) in the acute or non-acute setting, compared with 0.9% for PCI without a balloon pump.

"This unfavorable association was consistent across clinical settings and was more pronounced as the indications for IABP use became less established," , of Keio University School of Medicine in Tokyo, Japan, and colleagues reported in JAMA Internal Medicine.

The researchers concluded that "it is time to reconsider the appropriate use of IABP therapy, a potentially life-saving but extremely costly and high-risk intervention for patients."

A meta-analysis published earlier this year also showed that balloon pump use does . Nonetheless, Inohara's group emphasized that a causal relationship between IABP use and in-hospital mortality remains to be proven.

In their study, IABP therapy was received by 6.7% of the 13,253 total patients included from 2008 through 2014. This group had a worse baseline risk profile, with more serious heart failure, cardiogenic shock, and cerebrovascular disease. They also received more multivessel PCI and were more likely to present with ST-elevation myocardial infarction (STEMI) rather than stable or unstable angina.

Following risk adjustment, use of IABP remained an independent predictor of in-hospital mortality (OR 3.87, 95% CI 2.71-5.52, P<0.001). The risk persisted across patient subgroups, and was especially prominent for those with unstable angina, three-vessel disease, and non-STEMI.

But study co-author , also of Keio University told 麻豆传媒 in an email that "there may be limits to how far we can adjust statistically, but harm of IABP in less-established indications seems to be real."

"The bottom line is that we shouldn't interpret the study to mean that the balloon pump makes people worse," agreed , chief of medicine at California's VA Long Beach Healthcare System.

But "if you are using IABP to support patients in the worst conditions, it's not your best support device," Kern, who was not involved in the study, told 麻豆传媒.

In such cases, the Impella left ventricular assist device (LVAD) may be "the better device," he said, emphasizing that "LVADs should be considered when we decide to balloon pump or not to balloon pump."

He doesn't appear to be alone in that opinion, as U.S. interest in IABPs has been eclipsed by the rise of percutaneous ventricular assist devices (PVADs), especially Impella. A recent study revealed that between 2007 and 2012, while use of IABPs fell by 7.5% over the same period.

However, the procedure continues to be popular in other countries. "IABP is used very heavily in Japan" despite the "negative results" in recent clinical trials such as , Kohsaka noted.

Yet "not all Japanese institutions have direct access to LVADs," Kohsaka pointed out. Rather than abandoning IABP, his team will still consider it for some patients, especially "those with mechanical complications."

In an editorial accompanying the paper, , and , both of the University of California San Francisco, wrote that the study confirms that IABPs "are being increasingly used in patients without indications for their use." They suggested that "misaligned financial incentives might have a role" in "such excessive use" of IABPs and PVADs. "Furthermore, continued use of IABPs may be due to established routines or treatment protocols, with commission bias tending toward action rather than inaction," they added.

For certain groups getting PCI, such as the critically ill, "it may seem reasonable to use mechanical circulatory support devices as salvage therapy," Deedwania and Acharya conceded, concluding, however, that "perhaps less is more" in the use of such devices.