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Chair of the SCAI's writing group for their 2022 guidelines on management of patent foramen ovale, Dr. Clifford Kavinsky, sits down with Practical Cardiology to take part in a Q&A on the guideline's recommendations and the writing process for the SCAI's first PFO guidance.
The Society for Cardiovascular Angiography and Interventions (SCAI) 2022 Scientific Sessions hit the ground running with the organization’s release of their first comprehensive guideline for management of patent foramen ovale (PFO).
Published in the Journal of the Society for Cardiovascular angiography and Interventions on May 19, the 15-page document outlines 13 recommendations formulated by a multidisciplinary guideline panel to address 5 PFO clinical scenarios.
“This document represents the first truly rigorous guideline document put forth by the SCAI to lend clarity to a field surrounded by controversy and aid in physician decision making for PFO associated conditions,” said Clifford J. Kavinsky, MD, PhD, MSCAI, chair of the writing group and chief of the Section of Structural and Interventional Cardiology at Rush University Medical Center, in a statement.
With an interest in learning more about the guideline writing process and recommendations made within the SCAI’s guideline on management for PFO, Practical Cardiology reached out to Kavinsky and a transcript of that conversation can be found below.
Practical Cardiology: What was it like for you to lead the process of creating this historic guideline?
Kavinsky: For a long time, the SCAI has put themselves forward as the voice of interventional medicine. Yet, they have never published a single guideline document about any interventional procedure. So, for them, this is the first time that they are putting forth a rigidly adjudicated guideline document. So, you know, this is very satisfying to me and represents, like 2 years of work leading to this moment.
Practical Cardiology: Can you summarize the top points of this document for our audience?
Kavinsky: So, the purpose of this document was to help clinicians, to help third-party payers, and to help policymakers in gaining some clarity around the procedureof PFO closure. Many of the patients who clinicians are actually treating don't fall within the very narrow scope of the large randomized clinical trials. So, the hope of this document was to address many patient selection issues, including some of the more controversial ones.
Now, what are the controversial patient group who may have had PFO-mediated events, but not a stroke? That means patients with refractory migraines, patients who have extensive shunting across their PFO, the so-called orthodeoxia platypnea syndrome patients, patients with thrombophilia, patients who have had a DVT or they may have had a pulmonary embolism, but they've never had a PFO stroke. Also, patients who have had a systemic embolism mediated by a PFL, but not a stroke. All of these are patient populations that were addressed.
Practical Cardiology: Can you discuss the 5 specific clinical situations highlighted in the early portions of the document?
Kavinsky: The first one is largely centered around patient subsets who have a PFO and a PFO event but not a stroke. So, patients who have a systemic embolism without a stroke, patients who have like a TIA, patients who have had a DVT or pulmonary embolism, patients with refractory migraine. Those are all patient populations that are not included in a randomized clinical trial.
The second question is the population of patients that really aligns itself with the patients included in the randomized clinical trial. Those are the patients who have a PFO and an ischemic stroke for which no other cause can be found between the ages of 18-60 years. That aligns itself most closely with the FDA labeling and the strong evidence to support PFO closure in these patients. Then, the document goes further and addresses patients over older than 60 years, because randomized clinical trials really only enrolled people up to the age of 60. Well, the panel also supports closing patients over the age of 60. You have had a presumptive PFO-mediated stroke.
There was a lot of controversy centered around patients who have had a presumably PFO-mediated stroke, but it may have occurred years ago. That remains an issue that is unresolved.
The next two questions centered around anticoagulation. Is anticoagulation a reasonable therapeutic option for a patient who's had a PFO stroke, is it a reasonable option is an alternative to PFO device closure?
Although, therapeutically, it may be a reasonable alternative to PFO device closure, it was the recommendation of the panel that these patients should have be a device closure rather than anticoagulation. For the main reason that anticoagulation is tricky. There's a large degree of noncompliance, and we see physicians and patients discontinue their anticoagulation for surgical procedures and other indications. So, you can't ensure uninterrupted anticoagulation and, for that reason, the panel recommended PFO as an alternative rather than anticoagulation.
Then, the next question is patients who have had a PFO-mediated stroke but have a requirement for lifelong anticoagulation for other reasons, such as recurrent pulmonary embolism, recurrent DVT, or thrombophilia. Once again, the panel supports PFO device closure plus anticoagulation, rather than anticoagulation alone, for the same reasons that I've just recited: the issues of noncompliance and interruption of therapy. So, these are sort of the real-life issues that are encountered by the clinician. Many of the patients we get asked to treat do not fall within the narrow scope of inclusion criteria for the randomized clinical trials. So, we try to place some clarity on these other patient populations, and these others their therapies like anticoagulation.
Practical Cardiology: In your position, how hard is it to really try to put together and put your personal stamp on recommendations that haven't really been examined in clinical trials?
Kavinsky: This is why we do make the recommendations. So, for patients who have had a PFO-mediated stroke, for example, the panel recommends full closure rather than anticoagulation. We do get out there and give the guidance, but we have to be honest to say that the supporting data for it is not strong. Therefore, the recommendation is conditional and the conditions of the recommendation are clearly stated.
Practical Cardiology: What are some of the most immediate areas in need of further research related to PFO?
Kavinsky: So, the migraine issue remains a hot controversial topic. There is strong observational data to suggest that PFO closure in these patients ameliorate survivors’ headaches. Yet, the randomized clinical trials to date have been negative. There are ongoing clinical trials and I am hopeful that those will answer this question.
Secondly, the issue of scuba divers with decompression illness. Among these patients, there seems to have beneficial effects of therapy that has not been studied in a randomized trial and everyone could use a randomized trial to clarify.
Then another is patients who have had a PFO-mediated stroke, but it happened to them years earlier. What should we do with those people? Should they and can they be studied in some sort of randomized clinical trial?
Lastly, the issue of how do we treat patients after their PFO closure with medication. There's really no data out there. There's not enough data to even make a conditional recommendation. So that area needs to be studied as well.