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Residual Shunt After PFO Closure Increases Stroke Risk
Significant risk seen with moderate and large shunts
Study Authors: Wenjun Deng, Shanye Yin, et al.; William G. Kussmaul
Target Audience and Goal Statement: Cardiologists, neurologists
The goal of this study was to evaluate the long-term association of residual shunt after percutaneous patent foramen ovale (PFO) closure with the incidence of recurrent neurologic events.
Question Addressed:
PFO is a remnant of fetal circulation, commonly found in adult populations, with a prevalence of 27% in autopsy studies. This channel-like communication between the atria exists in everyone before birth, but most often closes shortly after being born.
As an obvious substrate for right-to-left shunting,
PFO has been implicated in many pathologies, including cryptogenic
stroke. The mechanism presumably involves venous thromboemboli crossing
from the right to the left atria.
Several studies have shown the efficacy of PFO closure in preventing recurrent stroke, especially in patients with a large shunt. In the absence of another obvious cause of stroke, PFO closure is considered to be a reasonable treatment, especially in young patients.
However, residual shunting has been observed in up to 25% of patients after PFO closure, and nearly 10% showed moderate to large residual shunting, with unclear significance.
In a prospective cohort study, MingMing Ning, MD, MMSc, of Massachusetts General Hospital and Harvard Medical School, and colleagues found that the presence of residual shunt after PFO closure was associated with an elevated risk of stroke or TIA recurrence years after the procedure. Their findings were published in the Annals of Internal Medicine.
Ning and team analyzed single-center data collected from 2015 to 2017 from consecutive patients with PFO-attributable cryptogenic stroke who were eligible for percutaneous PFO closure. In total, 1,078 patients (mean age 49.3 years) had PFO closure with successful device placement and were followed for up to 11 years, with an average duration of 3.7 years and a total observation period of 3,988 patient-years.
At discharge, all patients received antiplatelet treatment (aspirin, clopidogrel, or both) and short- or long-term anticoagulation therapy, depending on their hypercoagulable status.
Following transcatheter closure, each patient had a transthoracic echocardiogram (TTE) with intravenous saline injection. This is the standard procedure for detecting intracardiac right-to-left shunting. TTEs were performed at 24 hours, at 1 and 6 months, and annually.
The maximum number of bubbles appearing in the left atrium within three cardiac cycles after agitated saline injection was used to determine the shunt size. No bubbles meant no shunt, one to 10 bubbles referred to a small shunt, 10 to 30 bubbles described a moderate shunt, and more than 30 bubbles referred to a large shunt.
The prespecified primary outcome was the composite of first recurrent ischemic stroke or TIA after PFO closure. Etiology or cause of recurrent stroke was determined by two independent vascular neurologists on the basis of TOAST criteria.
In keeping with findings from previous trials, the researchers observed effective closure (no or small residual shunt) in 985 patients (91.4%). No shunt was seen in 835 patients (77.5%). Residual shunt was observed in 243 patients (22.5%), with a small shunt in 150 patients (13.9%) and a moderate or large shunt in 93 patients (8.6%), according to the team.
The primary outcome occurred in 18 patients in the shunt group (2.32 per 100 patient-years) and 24 patients in the no-shunt group (0.75 per 100 patient-years). The elevated risk persisted after adjustment for factors associated with PFO closure, traditional stroke risk factors, high-risk PFO features, and medication use (adjusted HR 3.01, 95% CI 1.59-5.69).
For patients with and without residual shunt, the cumulative probability of recurrent stroke or TIA 5 years after closure was 9.3% and 2.5%, respectively.
A higher incidence of recurrent stroke or TIA was observed for patients with a moderate or large shunt compared with patients with no shunt (HR 4.50, 95% CI 2.20-9.20, P<0.001). Small residual shunts were not significantly associated with increased risk (HR 2.02, 95% CI 0.87-4.69, P=0.102).
People with moderate or large shunts were older (52.2 vs 47.1 years with small shunt, P=0.009) and had higher rates of atrial septal aneurysm, hypertension, hyperlipidemia, and diabetes. After these confounders were included for covariate adjustment, larger shunt size was still associated with a higher rate of stroke or TIA recurrence.
Source References: Annals of Internal Medicine 2020; DOI: 10.7326/M19-3583
Editorial: Annals of Internal Medicine 2020; DOI: 10.7326/M20-1879
Target Audience and Goal Statement: Cardiologists, neurologists
The goal of this study was to evaluate the long-term association of residual shunt after percutaneous patent foramen ovale (PFO) closure with the incidence of recurrent neurologic events.
Question Addressed:
- What was the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA)?
PFO is a remnant of fetal circulation, commonly found in adult populations, with a prevalence of 27% in autopsy studies. This channel-like communication between the atria exists in everyone before birth, but most often closes shortly after being born.
Action Points
- The presence of residual shunt after percutaneous patent foramen ovale (PFO) closure was associated with an increased risk of recurrent stroke or transient ischemic attack, according to a single-center prospective cohort study.
- Note that small residual shunts were not significantly linked to increased risk, while moderate or large residual shunts were.
Several studies have shown the efficacy of PFO closure in preventing recurrent stroke, especially in patients with a large shunt. In the absence of another obvious cause of stroke, PFO closure is considered to be a reasonable treatment, especially in young patients.
However, residual shunting has been observed in up to 25% of patients after PFO closure, and nearly 10% showed moderate to large residual shunting, with unclear significance.
In a prospective cohort study, MingMing Ning, MD, MMSc, of Massachusetts General Hospital and Harvard Medical School, and colleagues found that the presence of residual shunt after PFO closure was associated with an elevated risk of stroke or TIA recurrence years after the procedure. Their findings were published in the Annals of Internal Medicine.
Ning and team analyzed single-center data collected from 2015 to 2017 from consecutive patients with PFO-attributable cryptogenic stroke who were eligible for percutaneous PFO closure. In total, 1,078 patients (mean age 49.3 years) had PFO closure with successful device placement and were followed for up to 11 years, with an average duration of 3.7 years and a total observation period of 3,988 patient-years.
At discharge, all patients received antiplatelet treatment (aspirin, clopidogrel, or both) and short- or long-term anticoagulation therapy, depending on their hypercoagulable status.
Following transcatheter closure, each patient had a transthoracic echocardiogram (TTE) with intravenous saline injection. This is the standard procedure for detecting intracardiac right-to-left shunting. TTEs were performed at 24 hours, at 1 and 6 months, and annually.
The maximum number of bubbles appearing in the left atrium within three cardiac cycles after agitated saline injection was used to determine the shunt size. No bubbles meant no shunt, one to 10 bubbles referred to a small shunt, 10 to 30 bubbles described a moderate shunt, and more than 30 bubbles referred to a large shunt.
The prespecified primary outcome was the composite of first recurrent ischemic stroke or TIA after PFO closure. Etiology or cause of recurrent stroke was determined by two independent vascular neurologists on the basis of TOAST criteria.
In keeping with findings from previous trials, the researchers observed effective closure (no or small residual shunt) in 985 patients (91.4%). No shunt was seen in 835 patients (77.5%). Residual shunt was observed in 243 patients (22.5%), with a small shunt in 150 patients (13.9%) and a moderate or large shunt in 93 patients (8.6%), according to the team.
The primary outcome occurred in 18 patients in the shunt group (2.32 per 100 patient-years) and 24 patients in the no-shunt group (0.75 per 100 patient-years). The elevated risk persisted after adjustment for factors associated with PFO closure, traditional stroke risk factors, high-risk PFO features, and medication use (adjusted HR 3.01, 95% CI 1.59-5.69).
For patients with and without residual shunt, the cumulative probability of recurrent stroke or TIA 5 years after closure was 9.3% and 2.5%, respectively.
A higher incidence of recurrent stroke or TIA was observed for patients with a moderate or large shunt compared with patients with no shunt (HR 4.50, 95% CI 2.20-9.20, P<0.001). Small residual shunts were not significantly associated with increased risk (HR 2.02, 95% CI 0.87-4.69, P=0.102).
People with moderate or large shunts were older (52.2 vs 47.1 years with small shunt, P=0.009) and had higher rates of atrial septal aneurysm, hypertension, hyperlipidemia, and diabetes. After these confounders were included for covariate adjustment, larger shunt size was still associated with a higher rate of stroke or TIA recurrence.
Source References: Annals of Internal Medicine 2020; DOI: 10.7326/M19-3583
Editorial: Annals of Internal Medicine 2020; DOI: 10.7326/M20-1879
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