Expensive equipment used in cardiac surgery can pose a danger: research

Dennis Thompson
Health Day Reporter

Monday, November 18, 2019 (HealthDay News)-Two new studies show that expensive tech pumps that maintain blood flow during heart surgery can be more dangerous to patients than their low-tech predecessors. It has become clear.

The Impella device is associated with an increased risk of death, bleeding, and stroke in patients who undergo angioplasty and reopen a blocked artery, two separate research teams meet in Philadelphia on Sunday. It concludes with a presentation at the annual meeting of the American Heart Association.

Researchers report that using this device also increases costs, adding about $ 15,000 to the average hospital price.

“The relevant clinical outcomes showed no substantial improvement, but hospitalization costs increased,” said Dr. Amitamine, a senior researcher on one of the two teams and an assistant professor at the University of Washington School of Medicine in St. Louis. It was.

Physicians may want to use the impeller more wisely until further studies reveal these concerns, said Dr. Rainya Sweis, a cardiologist at Northwestern University’s Fineberg School of Medicine, who commented on the two studies. It was.

“Don’t jump to the impeller just because it’s new and cool,” Sways said.

However, device manufacturer Abiomed argued that the safety of the impeller has been proven by repeating the clinical trials required for both FDA approval and post-approval follow-up trials.

“We have demonstrated the safety and efficacy of Impella against the FDA using data from extensive research,” said Dr. Seth Bilazarian, Chief Medical Officer at Abiomed.

How to use

Patients undergoing angioplasty have a weak heart and may need mechanical support to maintain blood flow to the rest of the body.

Before Impella was approved by the FDA in 2008, doctors relied on small balloons placed in the aorta, one of the large arteries that extend from the heart. Balloons maintain blood flow by expanding and contracting in response to a person’s heartbeat.

Impella devices work by passing a small tube through a blood vessel through the heart itself. According to the manufacturer Abiomed, this small pump draws blood from inside the heart and pushes it into the aorta.

Impella has become a widely used option in angioplasty and is currently used in about one-third of patients who require blood flow support during the procedure, Amin’s research team reported.

However, two new studies point to some nasty trends about Impella.

One team focused on angioplasty patients suffering from cardiogenic shock. Cardiogenic shock is a condition in which the heart suddenly cannot pump enough blood to meet the needs of the body. In such cases, blood flow support is needed to keep the patient alive while the blocked artery is reopening.

About 10% of patients with a heart attack suffer from cardiogenic shock, said Dr. Sanket Dhruva, an assistant professor of cardiology at the University of California, San Francisco School of Medicine, who is the leader of the research team.

Approximately 45% of these patients died during procedures involving impellers, compared to 34% of patients whose blood flow was supported by an intra-aortic balloon, Dhruva said.

Impella also increased the risk of bleeding. Dhruva’s team found that approximately 31% of patients with cardiogenic shock treated with this device had major bleeding, compared with 16% of those treated with balloons.

Cause and effect unknown

Amin’s team showed similar findings, reporting that the impeller increased the risk of death by 24% and the risk of stroke by 34% compared to intra-aortic balloons.

Amin and his colleagues analyzed the health data of more than 48,000 patients who underwent angioplasty with mechanical blood flow support in 432 hospitals between 2004 and 2016 in the impeller and intra-aorta. We investigated the cost and effectiveness of balloons.

Researchers warned that these results were not from clinical trials and therefore may have been influenced by other factors.

For example, doctors may have used Impella devices more often in procedures involving patients with poor prognosis, Amin said.

“Sometimes more sick patients are used for impeller-like treatments,” Amin said. “It’s very hard to guess if this is the effect of confounding.”

According to Bilazarian, the new findings go against a recently published clinical trial showing that Impella reduced serious heart complications by 29% compared to balloon pumps.

Bilazarian added that another recent study, the National Cardiogenic Shock Initiative, found Impella increased survival rates for patients suffering from cardiogenic shock by 72 percent and improved by 22 percentage points.

It’s not time to recall

Sweis agreed that given all the inconsistent data, the results presented on Sunday were not strong enough to demand Impella’s withdrawal from the market.

“It’s too early to say Impella is complete because there’s no good explanation for why the device itself increases mortality,” Sweis said.

All that is needed is more clinical trial data on the device and how it compares to balloon pumps, Sweis said.

Dr. Spencer King, a former president of the American College of Cardiology, said these studies should lead to further studies that will help physicians use impeller devices in the most beneficial ways for their patients.


In the United States, one-quarter of deaths are caused by heart disease.
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“This kind of observation is very important to raise questions and to hypothesize that we are not using these things at the right time or in the right patients,” he said, having a good experience, primarily with impellers. The intervention cardiologist King said.

“The challenge is for people to know when to use and when not to use it,” King continued.

Amine’s study was also published in the journal on November 17th. circulation..

For more information

The American Heart Association has more about angioplasty.

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Source: Associate Professor of Medicine, Washington University in St. Louis, Ph.D. in Amitamine Medicine. Ranya Sweis, MD, Cardiologist, Northwestern University School of Medicine, Fineberg School of Medicine; Doctor of Medicine, Seth Virazarian, Chief Medical Officer of Aviomed. Sanket Dhruva, MD, Associate Professor of Cardiology, University of California, San Francisco School of Medicine. Doctor of Medicine Spencer King, Former President of the American College of Cardiology. November 17, 2019, circulationNovember 17, 2019, Presentation, American Heart Association Annual Meeting, Philadelphia

Expensive equipment used in cardiac surgery can pose a danger: research

Source link Expensive equipment used in cardiac surgery can pose a danger: research

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