A pilot attempts to investigate the use of Abiomed's (NSDQ: ABMD) Impella Heart Pump as a treatment to reduce the severity of heart attack has met its primary safety and implementation endpoints, clearing the road for a central attempt, according to primary researcher Dr. Navin Kapur.
The results of the central, if successful, could "change the paradigm of cardiac arrest," Kapur MassDevice.com told in an interview.
Data from the pilot trial was announced today at AHA Scientific Sessions 2018 in Chicago.
"We have now demonstrated for the first time [left ventricle] unloading, using the ImpellaCP device with a 30 minute delay before the reperfusion is safe and feasible," said Kapur, commenting on the pilot attempt. "What we learned was that among patients like had a major heart attack, there was a significantly lower infarct size. "
More importantly, treatment can improve the outcomes for heart failure patients.
" If we can change infarct size by 5%, we think this will reduce the global burden of heart failure due to myocardial infarction and will also improve not only short-term mortality, but improve long-term mortality for patients who come into a heart attack. And that's really the central goal for both the pilot and the central attempt, "said Kapur.
For every 5% increase in cardiac injury after a heart attack, there is a relative 20% increase in heart failure in one year and a 20% increase in mortality, Kapur said.
"There is a significant need for public health to try to reduce heart attack size for patients who come in, despite using modern approaches," said Kapur.
Blocked arteries reduce the amount of oxygen delivered to the heart, said Kapur, so in normal treatment, opened the arteries to improve myocardial oxygenation has been a primary concern. But earlier research has suggested that instead of just recovering oxygen supply by opening arteries, myocardial oxygen needs can also be lowered through reperfusion, or reduce the work the heart has to do – with something like Abiomed's Impella pump.
In his own research, Kapur said that he has found that reperfusion works best with a 30-minute delay, so the device enters and works while the arteries are blocked before opening arteries.
"We have spent the last six to eight years understanding the mechanism of why delayed reperfusion in the setting of a unloading pump seems to work. And that's a number," said Kapur.
Captain and he and his team published research in the Journal of the American College of Cardiology in August as the explored mechanism and that the pilot study intended to explore the safety and feasibility of the technique.
In the pilot attempt, The Door two unload, researched researchers the mechanical benefit of delayed reperfusion in treating patients suffering from myocardial infarction. Researchers registered a total of 50 patients, half of whom received left ventricular discharge with Impella followed by immediate reperfusion, while the other half received a 30-minute delay for reperfusion, Kapur said. 19659004] Safety findings in the trial included an increase in major negative cardiovascular or cerebrovascular events and an increase in infarct size among the delayed reperfusion arm.
The results of the phase 1 safety and feasibility test indicated a 100% successful implant and release rate with Impella, Kapur.  Data showed no significant difference in the degree of major undesired cardiovascular or cerebrovascular events among arms, and found infarct size that was less than seen in previously published studies. Delayed reperfusion had no effect on infarct size either, said Kapur. Patients were examined in three to five days and thirty with cardiac magnetic resonance imaging, he added.
A further analysis as investigated patients who experienced major myocardial infarction showed that unloading and delayed reperfusion resulted in a statistically significant reduced infarct size, normalized to the risk area, compared with unloading and immediate reperfusion.
"And the reason this is important is that the purpose of the pilot was to inform the development of the central study," said Kapur.
The pivotal is slated to compare standard treatment, taking into account only door to balloon time, against patients treated with delayed reperfusion using the Impella pump.
Kapur said that he believes that the outcome of the experiment, if successful, can be disturbing as it may indicate that unloading of the Impella device is a therapy in itself.
Beyond the central, Kapur said he sees a lot of oppo rtunity to explore other angles, including other therapies or treatments to engage within 30 minutes of delay.
"What do you do in the 30 minutes? Do you give medications that may potentially be more beneficial to reduce infarct size?" Kapur said.
Earlier this month, Abiomed announced fiscal second quarter figures that wiped out the consensus forecast and increased their outlook for the rest of the year and sent share prices up today.
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