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Data-free announcement oversells “novel” heart monitoring device

First-in-Canada Implant of Novel Sensor Device for Heart Failure Patients

Our Review Summary

This news release covers the first implantation of a device called CardioMEMS in a Canadian heart failure patient. The wireless device includes a butterfly-like sensor, which sits inside the patient’s pulmonary artery and sends pressure readings to a secure website.

No other context or data are given. Although CardioMEMS is “novel” in Canada, the US has implanted the device in patients since 2007, and the US Food and Drug Administration (FDA) approved it for market in 2014.

We would have liked to have seen some outcome data from the CHAMPION trial, which followed 550 heart failure patients for around 15 months to see whether patients with CardioMEMS devices would require fewer heart failure-related hospitalizations. Instead, we are told that this one Canadian patient’s implantation procedure in March was “successful,” without any further information on how the patient is doing now and may do in the future.

Finally, the news release uses terms like “big game-changer” for the device and refers to heart failure as an “epidemic.” In these types of announcements, we like to see more neutral and cautious wording for medical stories, especially since the news release doesn’t mention the costs and harms associated with this device.

 

Why This Matters

Invasive procedures and surgery should be used as last resorts, after all other interventions — such as lifestyle changes and medications — have failed. The list of potential adverse effects associated with the implantation procedure is long, and patients should think long and hard and understand the risks before undergoing such treatments.

Although many media outlets like medical technology stories, news releases also have the responsibility to caution reporters and patients on the device’s harms, as well as any relevant data and information from clinical trials. The results (outlined in the benefits section) of the CHAMPION trial were clear, but it’s also important to note that all authors had some kind of financial interest or tie to CardioMEMS, as seen by the disclosures statement in the original journal article.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Although this implant was a first in Canada, the news release could have cited costs of existing alternatives and given a ballpark estimate of the new intervention.

For example, an implantable cardioverter defibrillator (ICD) is a battery-powered device placed under the skin to keep track of heart rate. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat. ICDs alone range from $25,000-$32,000, but costs vary widely depending on insurance or financial assistance. Procedure costs depend on the physician and medical facility.

Like ICDs, it’s probable that CardioMEMS will also cost tens of thousands of dollars for US patients. Since there is no discussion of costs in this news release, we give it a Not Satisfactory rating here.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

We only know that one heart failure patient in Canada underwent the implantation procedure. “The device…was successfully implanted by interventional cardiologists,” the news release states.

No other data were given. We don’t know how other patients have fared after the fact, including the one mentioned in the news release.

Although this is a first for Canada, the US has been treating heart failure patients with the CardioMEMS system since 2007. The US FDA approved CardioMEMS after reviewing results from the CHAMPION clinical trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients). Clinicians followed 550 heart failure patients and looked at heart failure-related hospitalizations in the treatment group versus the control group at 6 months. At this point in time, there was a 28 percent reduction in heart failure hospitalizations, with 84 hospitalizations in the treatment group, compared to 120 in the control group. Researchers also observed a 37 percent reduction in heart failure-related hospitalizations in the treatment group during the entire follow-up period of approximately 15 months.

Since none of this data were given, we rate this one Not Satisfactory.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

No intervention is risk-free, especially ones that are invasive. On page 9 of the CardioMEMS user’s manual, a slew of potential adverse effects is associated with this implantation procedure, including infection, bleeding, arrhythmias, blood clots, heart attacks, stroke and even death.

Since the news release doesn’t address harms, we give it a Not Satisfactory rating.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release presents this one heart failure patient as if it were evidence of the device’s benefits. Instead, this patient represents the only case in Canada to undergo this implantation procedure for CardioMEMS. Since the medical team implanted the device in March, we don’t know at this point whether the patient will have fewer heart failure-related hospitalizations in the future. As we mentioned above in the benefits section, the CHAMPION trial’s efficacy endpoint was at 6 months, with the average follow-up time being 15 months.

In an expert analysis by the American College of Cardiology, doctors write, “Little is revealed in the CHAMPION trial on potential side effects of aggressive diuresis or vasodilation that were used to reduce pulmonary artery pressures.” (Diuresis refers to excessive production of urine, and vasodilation refers to dilated blood vessels, subsequently lowering blood pressure.) This may be particularly relevant for elderly patients with heart failure in the real world, and it is unclear how this strategy applies to patients with more (or less) severe forms of heart failure, they add.

Detailing a single case or an anecdote is not real evidence, which is why we give the news release a Not Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in the news release per se, but the lead scientist refers to heart failure as an epidemic, which could give the wrong impression. However, this is addressed in the unjustifiable language section. We also wish the news release could have given us the sources for its heart failure numbers, as they vary widely across agencies.

We give the news release the benefit of the doubt and a Satisfactory rating.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

We found no conflicts of interest associated with this news release. The release discloses the fact that the CardioMEMS implantation procedure was funded by the Ted Rogers Centre for Heart Research.

We give the news release a Satisfactory rating here.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Heart failure is treated in a variety of ways and depends on the type and severity. Clinicians first treat its underlying cause, whether it be high blood pressure, coronary heart disease or diabetes. This may include lifestyle changes, such as increasing physical activity, reducing weight, quitting smoking and eating more heart-healthy foods.

Physicians may prescribe medications, such as ACE inhibitors, beta blockers and diuretics, so that the heart won’t work as hard and that fluid won’t build up in the lungs.

In severe cases, heart failure is treated with surgery, such as a heart transplant, or with the implantation of a device, such as a pacemaker, a left ventricular assist device or an implantable cardioverter defibrillator.

Since the news release doesn’t touch upon any of these alternatives, we give it a Not Satisfactory here.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release makes it clear that this device is not widely available in Canada, since it’s a “novel” sensor and not yet approved by Health Canada.

In the last sentence, it states that CardioMEMS was approved by the US FDA, implying that the implantation procedure is more widespread there.

We rate this one Satisfactory.

Does the news release establish the true novelty of the approach?

Satisfactory

CardioMEMS may be a novel procedure in Canada, but it’s been around in the US since September 2007, when patients were first enrolled in a clinical trial looking into the device’s effectiveness. In 2016 the Lancet published the results of the CHAMPION trial, which followed 550 heart failure patients. Participants were then randomized to receive CardioMEMS heart failure sensors or traditional heart failure therapies.

The news release points out that CardioMEMS was approved by the US FDA, but is awaiting approval by Health Canada.

We wish this information would have been higher up in the story, along with more context on the device’s history and clinical trial. The term “novel” in the headline may also be misleading to readers, since it refers to the novelty of CardioMEMS in Canada.

Despite this, we feel the news release did a good enough job for a Satisfactory rating here.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The leading quote includes terms such as “epidemic” and “big game-changer.” First of all, heart failure is not an infectious disease, and only one person has undergone this therapy at the Cardiac Centre.

The headline and leading sentence also talks about the device being a “first” in Canada without any mention of previous implantation procedures in other countries.

These word choices could be misleading and raise red flags in our eyes. Therefore, we give the news release a Not Satisfactory rating.

Total Score: 4 of 10 Satisfactory

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