New ‘Rapid Recommendations’ Tackle TAVR in Patients at Low-to-Intermediate Risk
With the goal of incorporating important trial results into clinical practice as quickly as possible and shortening the time it takes to revise guidelines, a group of guideline developers and the BMJ have collaborated to launch “rapid recommendations,” starting with guidance on the treatment of patients with severe symptomatic aortic stenosis and low-to-intermediate surgical risk.
Narrowly focused, the guidelines contain age-stratified recommendations to help guide clinicians. For patients younger than 75, there is a strong recommendation for surgery over transfemoral TAVR below age 65 and a weak recommendation for surgery between ages 65 and 74. For patients 75 and older, there is a strong recommendation for transfemoral TAVR over surgery in the oldest age group (85 years and above) and a weak recommendation for transfemoral TAVR between ages 75 and 84.
If transfemoral TAVR is not possible, surgery is preferred to transapical TAVR, according to the guidance, which was published online September 28, 2016, ahead of print in the BMJ. That publication date is less than 6 months after the PARTNER 2A trial showed that TAVR was noninferior to surgery in patients with intermediate risk, with a significant advantage for transfemoral TAVR specifically, and less than 2 months after the US Food and Drug Administration approved TAVR in intermediate-risk patients.
“We hope these recommendations will be picked up and adapted by different countries and organizations,” lead author Per Vandvik, MD, PhD (University of Oslo, Norway), told TCTMD, pointing out that there are typically a lot of duplicated efforts when it comes to various organizations crafting guidelines. Vandvik is a founder and board member of the Norwegian nonprofit organization MAGIC, which works to improve the development and dissemination of clinical practice guidelines and associated evidence summaries and decision aids.
“I think there will be many organizations that will still continue to duplicate efforts, do their own systematic reviews, create their own recommendations,” he said. “We don’t think this will entirely change the way guideline developers work. To us, it’s more of a model to show that it’s possible to do this the right way and rapidly.”
Speeding Guideline Creation
What impact the rapid recommendations will have either on clinical practice or on the ongoing revision of the American Heart Association/American College of Cardiology (AHA/ACC) valvular heart disease guidelines remains unclear.
Catherine Otto, MD (University of Washington, Seattle), who is on the panel that developed the new recommendations and is the co-chair of the AHA/ACC guidelines, said to TCTMD: “The AHA/ACC and the [European Society of Cardiology] guidelines obviously provide a very important role and they provide a great overview . . . for an entire topic like valvular heart disease, which is a huge topic. But the way those guidelines are developed is fairly time consuming and it’s not very responsive to change in a rapid way.”
Whereas the major guideline-writing committees are typically made up solely of content experts, Otto said, the panels for the rapid recommendations—which will be an ongoing effort across multiple subject areas—will consist of content experts, research methodologists, and communication experts. The methodologists are key, she said, because they can quickly provide in-depth systematic reviews and meta-analyses to ease the creation of evidence-based recommendations in a shorter timeframe.
Otto said that she has kept her roles with the rapid recommendations and the AHA/ACC effort separate, but added that she thinks they can be complementary. The larger guidelines give a broad overview, indications for who should have an aortic valve replacement, and “fairly general” recommendations for choosing between surgery and TAVR, she said, whereas the deeper dive into this one specific issue in the rapid recommendations can be used to give clinicians more detailed information to help make the choice with their patients.
On top of that, the new recommendations are presented as an interactive infographic, both on the BMJ site and through MAGIC’s web-based platform, MAGICapp. Through those sources, clinicians can click through to get more information about any aspect of the recommendations and to access decision aids for patient discussions.
“I think it’s going to be useful for patients as well as clinicians to really be able to see the data,” Otto said, noting that even though the 2014 AHA/ACC valve guidelines were designed to be more accessible electronically, that hasn’t happened yet.
‘A Shot Across the Bow’
Commenting on the recommendations for TCTMD, Chandan Devireddy, MD (Emory University, Atlanta, GA), said, “The intention here is a good one in that with our current rapid dissemination of evidence, the digital tools we have at our disposal, and our desire to standardize clinical practices not just across a health system but across the world, we want guideline statements to be issued as quickly as [possible].”
There is a question about whether guidelines as they are crafted now can keep up with how fast a field like TAVR is developing, he said, noting that clinicians can get frustrated when there is a lag between the publication of important findings and guideline revisions.
As for these specific recommendations, Devireddy said they would be a good resource for patients and general practitioners or general cardiologists who may not be very familiar with TAVR.
But “for someone like me where we’re in the trenches making decisions about sending patients either to surgery or TAVR, this is a little bit more generalized than what we would use as far as decision-making,” he said.
He also said he was concerned by the grouping together of patients at low risk and intermediate risk because the evidence is much more robust in the intermediate-risk population.
Nonetheless, Devireddy said, “A nice thing about this is it does issue a little bit of a shot across the bow, if you will, to many of the societies that are involved with guideline drafting to say, ‘Hey, maybe we do need to come up with something that is a little bit more streamlined.’”
Vandvik PO, Otto CM, Siemieniuk RA, et al. Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline. BMJ. 2016;Epub ahead of print.
- Vandvik reports no relevant conflicts of interest.
- Otto reports being the valvular heart disease editor for UpToDate.
- Devireddy reports serving on the scientific advisory board for Medtronic. His center is an enrolling site for TAVR trials conducted by multiple companies, including Edwards Lifesciences, Medtronic, and Boston Scientific.