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Emphasizing safety and effectiveness of a new heart procedure, a news release misses key risks and limitations

Transcatheter aortic valve replacement is safe, effective for very elderly patients

Our Review Summary

heart surgeryThe release describes a study which found that transcatheter aortic valve replacement (TAVR) surgery in patients who are 90 years old or older can improve quality of life for patients and does not pose a significant increase in health risks. More specifically, the release describes TAVR surgeries as “safe” for “very elderly patients.” However, much hinges on how one defines “safe” — since the paper reports that more than 30 percent of patients suffered “major adverse events” within 30 days of having a TAVR procedure. In addition, some 13% of patients receiving one of the procedures likely died as a result of complications — context that would have been helpful for readers evaluating the study.

 

Why This Matters

Aortic stenosis — or the narrowing of the aortic heart valve — increases with age and for many years the only treatment was a surgical procedure to replace the valve. For many individuals with other health issues associated with aging, surgery is not a reasonable option. Therefore, there has been a long search for alternatives for those deemed too high risk for surgery. Prior treatments such as balloon procedures to open up the narrowed valve didn’t work well and could make things worse. The advent of the TAVR procedures as a less invasive alternative to surgical replacement represents a scientific breakthrough for individuals who faced a poor quality of life and shortened life expectancy. The current study seeks to extend work showing benefit to an extremely old population – those who are in their 90’s. The release highlights some improvement in symptoms and quality of life after two different TAVR procedures — transfemoral TAVR (TF-TAVR), which is the traditional approach performed via the groin, and transapical TAVR (TA-TAVR).  The challenge is that since patients were not randomly assigned to treatment and there is no comparison to surgical or conservatively treated patients, it is difficult to definitively state, as this release does, that this represents a safe and effective procedure in this population. The rates of complications and death are not negligible, especially for the TA-TAVR procedure. Any patient considering such a procedure should be given the results of this study so that they can make a personalized decision.

Criteria

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

Not Satisfactory

The release does not mention cost or that this requires hospitalization. The article highlights that patients spent on average 5 days in the hospital.

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

Not Satisfactory

The release tells readers that within six months of having a TAVR procedure, patients had quality-of-life measurements that were “considerably better” than they had been before the surgery. Unfortunately, the release doesn’t offer any specific information about how much the quality-of-life measurements improved or which quality-of-life metrics were being used. The release would have been stronger if it had backed up qualitative terms like “considerably better” with quantitative information. Given the risks associated with the procedure, one would be interested in demonstrating that this procedure improved quality of life in individuals who, given their age, have limited life expectancy.

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

Not Satisfactory

This is a close one. The release (and related study) looks at both TF-TAVR and TA-TAVR patients. It notes the frequency of adverse health outcomes associated with the two procedures. For example 30-day stroke risk for TF-TAVR was 3.6 percent, and 35 percent of TF-TAVR patients had “major complications, such as bleeding or vascular issues.” Stroke risk for TA-TAVR was 2.0 percent and 32 percent of TA-TAVR patients had major complications.

That’s useful information, but the release neglects to mention the higher mortality rate observed in the TA-TAVR group compared with TF-TAVR — a difference that was not trivial. Overall, 4.6% of patients in the TF-TAVR died within 30 days or as a complication of the procedure. Among the TA-TAVR, the rate was 13%.

Overall, we think the lack of any mention of death rates related to the procedure unbalances the discussion of harms. We also think it’s problematic that the headline of the release describes TAVR as “safe,” when the second half of the release makes clear that there are substantial health risks associated with the procedures. Since the patients in this study were not randomly assigned to the valve treatment or conservative care, it is difficult to know for sure how the risks compare. The release could have done more to highlight that these patients are at high risk based upon age and their valve disease, and that it isn’t clear whether the complications and deaths associated with these procedures are greater than what would be expected with conservative care.

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

Not Satisfactory

This is another close one. The release describes the size of the study and sketches the study design in broad strokes, but it doesn’t give readers many details, is silent on important limitations of the study, and leaves out some key nuggets of information. The main thrust of the release is that the procedures can be done without excessively high death/complication rates. However, the release could have been clear about the fact that the study did not randomize treatment and thus one cannot be sure that these outcomes are better than what could be expected from conservative care. Similarly, the study emphasizes apparent benefits on quality of life, but gives a misleading portrait on other important outcomes. The higher death rate with TA-TAVR is one omitted finding that we mentioned above under the Harms criterion. It’s also worth looking at the release’s characterization of discharge status — it says that “more than 80% of patients were discharged home after the procedure,” but that’s only true for the TF-TAVR group. For the TA-TAVR group, only 58% were discharged home and some 42% were discharged to an extended care facility.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here.

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

Not Satisfactory

The release does not mention funding sources or conflicts of interest. This is particularly problematic for a release that leads with a statement that valve replacement surgery should be an option for older patients — given that the relevant journal article makes clear that six of the study authors have financial relationships with companies who have a vested interest in valve replacement surgeries.

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

Satisfactory

The release notes that TAVR is primarily a treatment option for patients who would be at high risk for “open” surgery. The release also mentions that there are other ways to perform TAVR in addition to the ones studied here.

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

Not Satisfactory

Based on the language in the release, it is not possible to tell whether TF-TAVR and/or TA-TAVR are widely available, if they are available only at specialized medical centers, or if these treatment options are still undergoing review for use outside of clinical trials. It is implied that this is an available procedure, but it could have been stated more clearly.

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

Satisfactory

The release notes that this study is “the largest series published to date.” However, the release would have been better if it had added a little bit of additional context. Does this work expand on an already robust literature in the field? Or is it relatively new?

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

Satisfactory

In medical care, and certainly in surgical care, doctors and patients need to make informed decisions that balance risks and potential benefits. If there is a strong likelihood that a procedure will significantly enhance a patient’s quality of life, a patient may opt to pursue a procedure regardless of potential risks. But that cannot be assumed. And therein lies the problem with this release. If one includes the headline, the release uses the words “safe” and “effective” three times each by the time the reader has reached the third paragraph. However, any mention of potential harms associated with the procedures doesn’t come until the reader reaches paragraphs eight and nine. The word “safe” can easily be construed as meaning “free from risk” — and that’s clearly not the case here.

Since we’ve already called attention to this problem above under the Harms criterion, we’ll give the story a pass here. We’d add that including information about the outcomes if nothing is done would be helpful in highlighting that the risks of this procedure may be worth it. But fundamentally, the individual undergoing this procedure is taking a short-term risk to improve symptoms and prolong life. For some individuals this risk may be worth taking, but others may be willing to accept their current state. It is notable that three-year mortality was around 50% among these patients — so while it may have relatively low short-term risks, it is not postponing death, often from other issues in this aged population.

Total Score: 4 of 10 Satisfactory

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