This is a brief news release about a device that, when implanted into the hearts of people with atrial fibrillation — irregular heartbeats — may prevent clots from forming. The study it’s based on is not a clinical trial, although it uses data from two completed clinical trials that compare the device and blood thinners.
Atrial fibrillation — an irregular heart rhythm that can cause palpitations and heart failure — affects about 2.2 million people in the United States each year, according to the National Heart, Lung, and Blood Institute, and that number is expected to double by 2020.
In addition to doubling a person’s risk of death, atrial fibrillation causes 15% to 20% of strokes and costs an estimated $6.4 billion to treat each year in the United States.
The chance that a person will get atrial fibrillation increases with age, and it affects an estimated 6% of Americans age 65 and older.
If a new device is more cost-effective than current treatment, cardiologists and their patients might want to know.
Side effects from blood thinners include bleeding, a concern in older people especially, because of their increased propensity for falls. This has been a concern with the device as well, which was finally approved last year by the FDA, with questions still being raised about its effectiveness.
The news release does not say how much the new device costs, nor does it say how it compares with the cost of warfarin or non-warfarin oral anticoagulants.
This is of concern, since the news release focuses on the cost-effectiveness of the device.
The news release says that “the device did appear to be more cost-effective in the larger, longer-term trial,” but it does not say what made it appear to be more cost-effective.
It then adds a quote from the lead author, Dr. James Freeman, in which he says longer-term results are needed to be certain of the device’s value in clinical practice. But, since it never quantifies the length of the results that were obtained, we do not know how long the longer-term data need to be.
Perhaps more importantly, it does not talk about the effectiveness of the product compared with the effectiveness of standard treatments.
The news release does not mention possible drawbacks to use of the Watchman device.
But federal regulators have made clear that they have concerns. In a letter dated March 13, 2015, the Food and Drug Administration told the manufacturer, Boston Scientific, that its approval was contingent upon the submission of periodic reports on the safety of the device.
“The primary safety endpoint is treatment of the patient without the occurrence of life-threatening events as determined by the Clinical Events Committee, which would include events such as device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion and any bleeding related to the device or procedure that necessitates an operation,” the letter says.
It also notes that the device maker agreed to carry out a study to assess “whether the rates of safety and effectiveness during the early commercialization of the WATCHMAN device in the United States are consistent with the premarket findings.”
The news release does not describe the quality of the evidence.
The news release does not engage in disease mongering. A brief description of how many people are affected by the condition might have added some useful context.
The news release does not say who paid for the work or whether any of those involved in the studies cited had conflicts of interest.
The news release does mention that the implantable device is intended to replace medication.
It goes further, stating that “It has been suggested that as treatment for atrial fibrillation, the Watchman device may be preferable to standard blood thinning medications, such as warfarin, which raise the risk of bleeding.”
However, the release does not cite data to support that suggestion, so it is impossible to make a meaningful comparison.
The news release does not say that the FDA approved the device last year, or how widely available it is.
The news release makes a very weak claim of novelty. It does suggest that the study “may provide more certainty in terms of cost-effectiveness” but quickly adds that longer term results are needed to be “completely certain of the device’s value in medical practice.”
The “may be” in the title is a big maybe, and given the data (of this study and the individual clinical trials) the results may be presented more optimistically than is warranted by the data.
By using the passive voice in the following sentence, the news release misses an opportunity to be clear: “It has been suggested that as treatment for atrial fibrillation, the Watchman device may be preferable to standard blood thinning medications, such as warfarin, which raise the risk of bleeding.”
Who has suggested this? The device maker? We are not told.