By Will Boggs MD
NEW YORK (Reuters Health) - Migraine patients who have no residual interatrial shunt following transcatheter closure of patent foramen ovale (PFO) have significantly higher odds of reducing their migraine burden, according to a retrospective study.
"Although the connection between PFO and migraine is complex, there is a subpopulation that will benefit from PFO closure - studying this entity will allow us to better understand the pathophysiology connecting these syndromes and will allow us to find the population that will benefit from PFO closure," Dr. Eyal Ben-Assa of Massachusetts General Hospital, in Boston, told Reuters Health by email.
Patients with PFO have a much higher prevalence of migraine, compared with the general population. Although several studies have reported improvement in migraine symptoms after transcatheter PFO closure, three randomized trials that followed patients for six to 12 months failed to demonstrate a benefit.
Dr. Ben-Assa, also at Tel Aviv University, in Israel, and colleagues evaluated outcomes from 110 patients who underwent transcatheter PFO closure for cryptogenic stroke or for platypnea-orthodexia (breathlessness alleviated when lying down and exacerbated when sitting or standing up) and who also had migraines and long-term follow-up of at least 12 months.
PFO closure was completed successfully in all patients, but 69 (64%) had residual right-to-left shunt at rest (mild in 75%, moderate in 21%, and large in 4%).
During 3.2 years' median follow-up after PFO closure, there was a significant decrease in all symptoms for the overall migraine population, with 87% experiencing a reduction in migraine burden by at least 50% and 48% seeing their migraine symptoms eliminated.
In multivariable analysis, the presence of aura was independently associated with 4.30 times greater odds of abolishment of migraine (P=0.006), but aura was not associated with the likelihood of achieving >50% reduction in migraine burden, the researchers report in JACC: Cardiovascular Interventions.
At six months after PFO closure, 29 patients (26%) had persistent residual right-to-left shunt of any severity.
Absence of right-to-left shunt at six months was associated with 4.60 (P=0.017) times greater odds of achieving >50% reduction in migraine burden, but with similar odds of migraine abolishment, after adjusting for clinically relevant covariates.
"This is a retrospective analysis with its inherent limitation and should be treated as such - nevertheless, it sets the stage for a large randomized clinical trial (RCT) examining the correlation of PFO closure with migraine symptoms improvement," Dr. Ben-Assa said. "Learning from our data, patient with aura should be targeted as well, striving for complete closure."
"For my own practice, I think I can now tell my patients who are about to get their PFO closed for cryptogenic stroke and who happen to have migraine that they have high chance to improve their migraine symptoms, especially if they have aura and if we are able to completely close the shunt," he said.
Dr. Stephane Noble of University Hospital of Geneva, who wrote an accompanying editorial, told Reuters Health by email, "As for stroke prevention, but even more for migraine, residual shunt should be as minimal as possible. The Starflex device used in the MIST study had the highest rate of residual shunt. Technical aspects of the procedure (echo guidance: transesophageal echocardiography or intracardiac echocardiography is important), selection of the device, and sizing are very important points with respect to the procedure."
"There are migraineurs without PFO and PFO without migraine," he said. "There are still many questions that should be addressed in the migraine population in collaboration with neurologists. The abolishment of migraine symptoms seems repeatedly more frequent in patients with aura, as shown again in this report."
Dr. Jonathan M. Tobis of David Geffen School of Medicine at the University of California, Los Angeles, who has also researched the association between PFO and migraine, told Reuters Health by email, "This report corroborates all the other observational studies that show a benefit of migraine reduction with PFO closure. The question is why are the findings from observational studies different than the RCTs PREMIUM and PRIMA? I believe the answer is that the observational studies were done primarily on people with mild or infrequent migraine, whereas the RCTs require severe, debilitating migraine that is unresponsive to 2 drugs."
"The additional information from this study is that those people who had a residual shunt had less benefit," said Dr. Tobis, who was not involved in the new work. "This is important and makes physiological sense. Future trials will need devices that are very effective in closing the PFO. The RELIEF trial will use the Cardioform device which we have shown is 100% effective in obtaining complete closure."
The report includes no funding information. Two of Dr. Ben-Assa's coauthors report ties to device makers.
SOURCE: https://bit.ly/3bt4Lw3 and https://bit.ly/2ShljiP JACC: Cardiovascular Interventions, February 10, 2020.