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Novel wireless device shows potential for detecting cardiovascular disease among childhood cancer survivors

25 min read

Saro H. Armenian

A wireless device designed to detect cardiovascular disease among childhood cancer survivors treated with anthracycline chemotherapy appeared accurate and displayed a low false-negative rate compared with cardiac MRI, according to researchers at City of Hope.

“The pediatric oncology community is becoming increasingly aware that there are new issues faced by many cancer survivors that may not manifest themselves until decades after their cancer treatment is complete,” Saro H. Armenian, DO, MPH, director of the Childhood Cancer Survivorship Clinic at City of Hope, said in a press release. “One of these issues is a higher burden for cardiovascular disease, which can result from exposure to anthracyclines as part of their cancer treatment.”

The handheld device — known as Vivio (Avicenna Medical Systems) — is not intended to take the place of echocardiogram or cardiac MRI.

“One possible implementation of Vivio could be for preliminary screening,” Armenian said. “If the patient’s heart function is below a specific threshold as measured by [the device], that patient could schedule an in-depth evaluation. This way, [the device] could keep these survivors engaged and help to reduce the burden of inconvenient tests for individuals with a normal heart function.”

HemOnc Today spoke with Armenian about the association between anthracycline chemotherapy treatment for children with cancer and risk for cardiac complications later in life, how Vivio differs from other methods of cardiovascular disease detection, and what must be confirmed in subsequent research.

Question: What is the association between anthracycline chemotherapy treatment for children with cancer and
subsequent
risk for cardiac complications?

Answer: Nearly half of all children treated for cancer in the United States receive anthracyclines as part of their curative treatment. Anthracyclines have been around for several decades and likely have contributed to improvements in survival for children with cancer. However, in the past 30 years or so, we have recognized a dose-dependent risk for cardiac disease associated with anthracyclines. Thankfully, this is a relatively rare occurrence among children, but when it does happen it is devastating. Many individuals will not develop heart failure until a decade or more after treatment.

Q: How was
Vivio
developed?

A: The device was initially developed with our partners at California Institute of Technology, not specifically for the cancer survivorship population but to evaluate cardiovascular function for all people. We chose to look at this device in our patient population because they are at high risk for heart failure or cardiac dysfunction. I reached out to our partners to see if we could examine the accuracy and utility of this device in this particular population, knowing that the findings could translate to people without cancer who are at risk for heart failure.

Q: How does it work?

A: The mechanism is placed against the carotid artery and, through the carotid pulse, a specific tracing is generated. This pulse has a specific waveform that is picked up by the device. The device measures the waveform of the pulse and, through the waveform, our partners at California Institute of Technology are able to measure how strong the heart is beating and how healthy the heart is.

Q: How does it differ from other methods of cardiovascular disease detection?

A: For one, it is handheld and is no larger than the size of an average thumb. This is different from the most widely used tool through which we assess heart function, the echocardiogram, which is essentially an ultrasound of the heart. It is a large machine that is quite expensive, and the patient has to be in a medical center or office to get those images done. Other alternatives include cardiac MRI, which requires very large, expensive machines that are not widely available. Both echocardiogram and cardiac MRI are dependent upon an individual coming to a medical center for the assessment. They do provide more detailed information but may not be readily accessible to everyone. This new device is handheld, portable and does not rely on imaging. Through the waveform, it is able to measure cardiac health, which would ultimately result in immediate generation of results. We are potentially taking a diagnostic tool that was limited in the context of the health care provider to the hands of the patient.

Q: What efficacy results have
you
observed with this approach? How do they compare with standard methods?

A: Our study — one of the first to assess the use of this device in this particular population — compared the device with echocardiogram and cardiac MRI. We showed the accuracy for detecting left ventricular ejection fraction was as good as what would have been detected or measured by cardiac MRI, considered the gold standard measurement. We did observe a difference between the device and echocardiogram in terms of the measurements, but there were also differences between echocardiogram and cardiac MRI. This allows us to believe that an echocardiogram and MRI reading may not be as comparable. This device in the context of this study performed just as well as cardiac MRI.

Q: What
must
be confirmed in subsequent research?

A: This is only the first step of many. First, we need to validate our findings in a much larger population. We also need to evaluate the device in a different population — not necessarily cancer survivors at risk for cardiac dysfunction, but other populations at risk for cardiac dysfunction — so we can speak to its generalizability. There are also questions about the optimal setting for use of this device — in the hands of patients or in the hands of primary care providers who may not necessarily have an echocardiogram or cardiac MRI at their disposal.

Q:
How likely is it
that this will become mainstream in the clinic and, if it does, what benefits will it offer?

A: I cannot speak to the likelihood as there are additional studies that need to be conducted, but I am very optimistic given our preliminary findings. If these findings hold up in future studies, this would be a tremendous leap forward in terms of how we monitor and diagnose patients at risk for cardiovascular disease, both in the general population and among patients at high risk due to exposure to toxic cancer treatments. It would be a very inexpensive tool at a fraction of the cost of cardiac MRI or echocardiogram so, in terms of a reduction of health care expenses, this would clearly be a major advance. – by Jennifer Southall

Reference:

Armenian SH, et al. Clin Cancer Res. 2018;doi:10.1158/1078-0432.CCR-17-3599.

For more information:

Saro H. Armenian, DO, MPH, can be reached at City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010; email: [email protected]

Disclosures: The study was sponsored by the Caltech and City of Hope Biomedical Research Initiative, as well as the Leukemia & Lymphoma Society Scholars in Clinical Research Award. Armenian reports no relevant financial disclosures.

Saro H. Armenian

A wireless device designed to detect cardiovascular disease among childhood cancer survivors treated with anthracycline chemotherapy appeared accurate and displayed a low false-negative rate compared with cardiac MRI, according to researchers at City of Hope.

“The pediatric oncology community is becoming increasingly aware that there are new issues faced by many cancer survivors that may not manifest themselves until decades after their cancer treatment is complete,” Saro H. Armenian, DO, MPH, director of the Childhood Cancer Survivorship Clinic at City of Hope, said in a press release. “One of these issues is a higher burden for cardiovascular disease, which can result from exposure to anthracyclines as part of their cancer treatment.”

The handheld device — known as Vivio (Avicenna Medical Systems) — is not intended to take the place of echocardiogram or cardiac MRI.

“One possible implementation of Vivio could be for preliminary screening,” Armenian said. “If the patient’s heart function is below a specific threshold as measured by [the device], that patient could schedule an in-depth evaluation. This way, [the device] could keep these survivors engaged and help to reduce the burden of inconvenient tests for individuals with a normal heart function.”

HemOnc Today spoke with Armenian about the association between anthracycline chemotherapy treatment for children with cancer and risk for cardiac complications later in life, how Vivio differs from other methods of cardiovascular disease detection, and what must be confirmed in subsequent research.

Question: What is the association between anthracycline chemotherapy treatment for children with cancer and
subsequent
risk for cardiac complications?

Answer: Nearly half of all children treated for cancer in the United States receive anthracyclines as part of their curative treatment. Anthracyclines have been around for several decades and likely have contributed to improvements in survival for children with cancer. However, in the past 30 years or so, we have recognized a dose-dependent risk for cardiac disease associated with anthracyclines. Thankfully, this is a relatively rare occurrence among children, but when it does happen it is devastating. Many individuals will not develop heart failure until a decade or more after treatment.

Q: How was
Vivio
developed?

A: The device was initially developed with our partners at California Institute of Technology, not specifically for the cancer survivorship population but to evaluate cardiovascular function for all people. We chose to look at this device in our patient population because they are at high risk for heart failure or cardiac dysfunction. I reached out to our partners to see if we could examine the accuracy and utility of this device in this particular population, knowing that the findings could translate to people without cancer who are at risk for heart failure.

Q: How does it work?

A: The mechanism is placed against the carotid artery and, through the carotid pulse, a specific tracing is generated. This pulse has a specific waveform that is picked up by the device. The device measures the waveform of the pulse and, through the waveform, our partners at California Institute of Technology are able to measure how strong the heart is beating and how healthy the heart is.

PAGE BREAK

Q: How does it differ from other methods of cardiovascular disease detection?

A: For one, it is handheld and is no larger than the size of an average thumb. This is different from the most widely used tool through which we assess heart function, the echocardiogram, which is essentially an ultrasound of the heart. It is a large machine that is quite expensive, and the patient has to be in a medical center or office to get those images done. Other alternatives include cardiac MRI, which requires very large, expensive machines that are not widely available. Both echocardiogram and cardiac MRI are dependent upon an individual coming to a medical center for the assessment. They do provide more detailed information but may not be readily accessible to everyone. This new device is handheld, portable and does not rely on imaging. Through the waveform, it is able to measure cardiac health, which would ultimately result in immediate generation of results. We are potentially taking a diagnostic tool that was limited in the context of the health care provider to the hands of the patient.

Q: What efficacy results have
you
observed with this approach? How do they compare with standard methods?

A: Our study — one of the first to assess the use of this device in this particular population — compared the device with echocardiogram and cardiac MRI. We showed the accuracy for detecting left ventricular ejection fraction was as good as what would have been detected or measured by cardiac MRI, considered the gold standard measurement. We did observe a difference between the device and echocardiogram in terms of the measurements, but there were also differences between echocardiogram and cardiac MRI. This allows us to believe that an echocardiogram and MRI reading may not be as comparable. This device in the context of this study performed just as well as cardiac MRI.

Q: What
must
be confirmed in subsequent research?

A: This is only the first step of many. First, we need to validate our findings in a much larger population. We also need to evaluate the device in a different population — not necessarily cancer survivors at risk for cardiac dysfunction, but other populations at risk for cardiac dysfunction — so we can speak to its generalizability. There are also questions about the optimal setting for use of this device — in the hands of patients or in the hands of primary care providers who may not necessarily have an echocardiogram or cardiac MRI at their disposal.

Q:
How likely is it
that this will become mainstream in the clinic and, if it does, what benefits will it offer?

A: I cannot speak to the likelihood as there are additional studies that need to be conducted, but I am very optimistic given our preliminary findings. If these findings hold up in future studies, this would be a tremendous leap forward in terms of how we monitor and diagnose patients at risk for cardiovascular disease, both in the general population and among patients at high risk due to exposure to toxic cancer treatments. It would be a very inexpensive tool at a fraction of the cost of cardiac MRI or echocardiogram so, in terms of a reduction of health care expenses, this would clearly be a major advance. – by Jennifer Southall

Reference:

Armenian SH, et al. Clin Cancer Res. 2018;doi:10.1158/1078-0432.CCR-17-3599.

For more information:

Saro H. Armenian, DO, MPH, can be reached at City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010; email: [email protected]

Disclosures: The study was sponsored by the Caltech and City of Hope Biomedical Research Initiative, as well as the Leukemia & Lymphoma Society Scholars in Clinical Research Award. Armenian reports no relevant financial disclosures.

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