Are Full, Formal Guidelines Still Useful in the Rapidly Changing TAVR Field?

WASHINGTON, DC—Comprehensive clinical guidelines have been central to the practice of evidence-based medicine for decades, but some experts are questioning whether the standard process for developing them—which can slow the integration of important new research—can keep up with developments in transcatheter valve therapies.

“I think that [guidelines] are very important, and I do support them, but I think we all agree they’ve got some limitations,” Catherine Otto, MD (University of Washington, Seattle), said during a session on TAVR indications here at TCT 2016.

Otto, who is co-chair of the American Heart Association/American College of Cardiology (AHA/ACC) valvular heart disease guidelines, pointed to the slowness of the process required to develop them, the lack of an adequately rigorous analysis of data, the failure to include discussion of practical issues, and the challenges of using recommendations in daily practice because of the length and number of the documents.

While showing a picture of a sinking ship meant to symbolize traditional guidelines, Otto questioned whether they are currently meeting the needs of clinicians, patients, or society.

As part of a debate following Otto’s presentation, John Webb, MD (St. Paul’s Hospital, Vancouver, Canada), presented a bit of a conflicted view on the subject. He stated that “guidelines do have limited value in rapidly evolving transcatheter therapies,” adding shortly after, however, that he believes guidelines indeed do serve a purpose.

The problem, he said, is that in the transcatheter field there are rapid improvements in technology, techniques, expertise, programs, and patient selection accompanied by reductions in mortality, stroke, vascular complications, bleeding, morbidity, and cost.

Thus, indications are changing quickly and patients who could benefit from a transcatheter procedure are dying while the guidelines slowly adapt to newly available information, Webb said.

WikiRecs to the Rescue?

If guidelines from the major professional societies are a floundering ship, perhaps a new effort called WikiRecs is the lifeboat, Otto said, highlighting a new initiative aimed at dramatically shortening the time to develop recommendations following publication of practice-changing research. The first such effort—announced last month—came in the form of “rapid recommendations” for the treatment of patients with severe symptomatic aortic stenosis and low-to-intermediate surgical risk developed in collaboration with the BMJ.

WikiRecs are designed to not just shorten the time from publication of results to integration into clinical practice, but to make the recommendations more user-friendly at the point of care with a more visual presentation and more concise summaries of the evidence.

“We need platforms for guideline development that allow digitally structured data, dynamic updating and publication, and rapid responses,” Otto said, underscoring the importance of adding experts in research methodology and communication to writing committees.

No ‘Knockout Experiment’ Needed

On the other side of the debate, Patrick O’Gara, MD (Brigham and Women’s Hospital, Boston, MA), a past president of the ACC, argued that guidelines should remain the standard for clinical practice, albeit with some changes.

On the plus side, clinical practice guidelines are evidenced-based, expert, collaborative, transparent, rigorous, peer-reviewed, and balanced, he said. In addition, they provide the foundation for the development of performance measures and appropriate use criteria and have been shown to improve patient care.

But, he acknowledged, there are also challenges associated with guidelines in that they can be cumbersome to develop. Randomized evidence is lacking for many aspects of valvular heart disease, O’Gara said, and there is increasing scrutiny of relationships with industry among members of writing committees. Moreover, he said, “sometimes guidelines get in the way of clinical judgment. They obfuscate the individualization of care that we need to provide.”

Nevertheless, a “knockout experiment” in which guidelines are discarded is not the answer, he said: “There is absolutely no public tolerance for a lack of rigorous analysis, collaboration, and peer review.” And, he asserted, guidelines will be important during the transition from volume-based to value-based medicine.

Recognizing the need for change, however, O’Gara concluded that the process of developing guidelines can be improved by reducing turnover time, condensing content, easing dissemination at the point of care, developing meaningful derivatives, and harmonizing recommendations across societies.