Migraine with aura and patent foramen ovale (PFO) are associated. The Percutaneous Closure of PFO in Migraine with Aura (PRIMA) trial is a multicentre, randomized trial to investigate the effect of ...percutaneous PFO closure in patients refractory to medical treatment.
Migraine with aura patients and PFO who were unresponsive to preventive medications were randomized to PFO closure or medical treatment. Both groups were given acetylsalicylic acid 75-100 mg/day for 6 months and clopidogrel 75 mg/day for 3 months. The primary endpoint was reduction in monthly migraine days during months 9-12 after randomization compared with a 3-month baseline phase before randomization. The committee reviewing the headache diaries were blinded to treatment assignment.
One hundred and seven patients were randomly allocated to treatment with an Amplatzer PFO Occluder (N = 53) or control with medical management (N = 54). The trial was terminated prematurely because of slow enrolment. Eighty-three patients (40 occluder, 43 control) completed 12-month follow-up. Mean migraine days at baseline were 8 (±4.7 SD) in the closure group and 8.3 (±2.4) in controls. The primary endpoint was negative with -2.9 days after PFO closure vs. -1.7 days in control group (P = 0.17). Patent foramen ovale closure caused five adverse events without permanent sequelae.
In patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.
Anatomic variations of the patent foramen ovale (PFO) are commonly observed, yet limited research has investigated their impact on clinical outcomes following transcatheter closure. We aimed to ...explore the association between PFO morphology and clinical outcomes.
Consecutive patients with cryptogenic stroke who underwent PFO closure were prospectively enrolled at a single center from September 2019 to April 2023. Patients were categorized into simple and complex groups based on PFO morphology. Composite events were compared between the two groups during a median follow-up of 24 months, including all-cause mortality, recurrent stroke, residual moderate or severe shunt, and symptomatic atrial fibrillation.
A total of 247 patients were enrolled, with a mean age of 41.9 ± 13.0 years and 45.3% males. Ninety-one (36.8%) patients had complex PFO. These individuals were older (45.4 ± 12.5 years vs. 39.9 ± 12.9 years; P = 0.001), more males (56.0% vs. 39.1%; P = 0.010), had longer procedure times (54 ± 32 min vs 46 ± 29 min; P = 0.044), and had a higher rate of using delivery sheath-assisted crossing of the PFO (22.0% vs 12.8%; P = 0.040) than those with simple PFO. The estimated event rates were 27.9% and 11.3% (P = 0.006) in the complex and simple PFO groups, respectively (12.9 events and 5.2 events per 100 person-years; P = 0.001). After adjusting for age, sex, hypertension, diabetes, smoking, device type, and left atrial diameters, complex PFO remained independently associated with composite events (HR 2.10, 95%CI 1.06–4.17, P = 0.034).
Patients with complex PFO may suffer from a higher risk of adverse events following transcatheter PFO closure.
Central illustration. Association between patent foramen ovale (PFO) morphology and clinical outcomes following transcatheter closure. This figure shows the morphology of a simple PFO (top left) and complex PFO (top right). The complex PFO group exhibited a longer procedural time (54 ± 32 min vs. 46 ± 29 min; P = 0.044; bottom left) and a higher proportion of using delivery sheath-assisted crossing PFO (87.2% vs. 78.0%, P = 0.040; bottom middle). The estimated event rates were higher in the complex PFO group than in the simple PFO group (27.9% vs. 11.3%, P = 0.006; bottom right). Display omitted
•The PFO morphology can be categorized into two types: simple and complex. Transcatheter closure procedure, which was widely employed to prevent recurrent stroke in patients with PFO-associated stroke, remains no disparity between the two types of PFO.•Patients with complex PFO underwent an intricate closure procedure and exhibited a higher incidence of composite events following PFO closure.•The evaluation prior to closure, procedural technique during closure, and medication treatment following closure may need to be specified in patients with complex PFO.
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing patent foramen ovale (PFO) closure, anticoagulation, and antiplatelet therapy to prevent stroke ...recurrence in patients with PFO-associated cryptogenic stroke.
We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios (RRs) were calculated in random-effects meta-analyses. PFO closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79; I
=59%). The effect of PFO closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt (RR=0.27, 95% CI, 0.11-0.70; I
=42%) compared with patients without these anatomical features (RR=0.80, 95% CI, 0.43-1.47; I
=12%). Major complications occurred in 2.40% (95% CI, 1.03-4.25; I
=77%) of procedures. New-onset atrial fibrillation was more frequent in patients randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI, 2.37-7.89; I
=14%). One RCT compared PFO closure versus anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2 RCTs compared PFO closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95% CI, 0.05-0.63; I
=12%). Three RCTs compared anticoagulation versus antiplatelet therapy, with none showing a significant difference.
PFO closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle-aged patients. PFO closure was associated with an increased risk of atrial fibrillation.
Patent foramen ovale (PFO) is present in a significant proportion of young patients with stroke of undetermined etiology, but is not always causal. Therefore, classifications (RoPE, PASCAL) have been ...developed to determine the probability that PFO is the stroke cause. However, the presence of an initial arterial occlusion as a prediction factor was not studied when these classifications were built. Our aim was to evaluate the presence of arterial occlusion in young patients with stroke of undetermined etiology with/without high-risk PFO.
From a prospectively-built monocentric database, we identified patients aged≥18 to<60-years with strokes of undetermined etiology and complete etiological work-up, including transesophageal echocardiography. We divided patients in two groups: (i) with high-risk PFO i.e. PFO with large interatrial shunt (>30 microbubbles) or associated with atrial septal aneurysm and (ii) with low-risk/without PFO. We recorded the presence of arterial occlusion and large vessel occlusion (LVO) in the acute phase.
We included 96 patients; 55 (57%) had high-risk PFO. Their median age was 48 (40–52) years, and 28 (29%) were women. The percentages of patients with arterial occlusion and with LVO were lower in the high-risk PFO group than in the low-risk/without PFO group: 11 (20%) versus 19 (46%) (P=0.008), and 5 (9%) versus 15 (37%) (P=0.002), respectively. There was no difference in the median RoPE score between groups (P=0.30).
The presence of LVO could represent a “red flag” of PFO causality in stroke of undetermined etiology, and could be implemented in future PFO-related stroke classifications.
Background: The morphology of a patent foramen ovale (PFO) with a high-risk for cryptogenic ischemic stroke (CS) is an important factor in the selection of patients for transcatheter closure, but the ...morphological features of PFO in older patients with a history of CS are less known because the most data are obtained from younger patients.Methods and Results: The study included 169 patients who had a history of CS and PFO. The prevalence of high-risk morphologies of PFO assessed by transesophageal echocardiography was compared between patients aged ≥60 years and patients aged <60 years. We also assessed the presence of septal malalignment of PFO on the aortic wall. The probability of CS due to PFO was evaluated using the PFO-Associated Stroke Causal Likelihood classification system. Patients aged ≥60 years had a significantly higher prevalence of atrial septal aneurysm than patients aged <60 years. The prevalence of large right-to-left shunt, long-tunnel of PFO, or Eustachian valve or Chiari’s network was similar between patients aged ≥60 years and <60 years. Septal malalignment was observed more frequently in patients aged ≥60 years than in those <60 years old. Nearly 90% of patients aged ≥60 years were classified as ‘possible’ in the PFO-Associated Stroke Causal Likelihood classification system.Conclusions: High-risk morphologies of PFO are common in older patients with a history of CS, as well as in younger patients.
Percutaneous closure of a patent foramen ovale (PFO), a common variation of interatrial septum anatomy, is a commonly performed procedure in the catheterization laboratory to reduce the risk of ...recurrent stroke in selected patients and to treat other PFO-related syndromes. In the last twenty years, disc-based devices have represented the armamentarium of the interventional cardiologist; recently, suture-based devices have become an attractive alternative, despite limited data regarding their long-term performance. The present review gives an overview of the current evidence regarding suture-based PFO closure, the device's characteristics, the echocardiographic evaluation of the PFO anatomy, and recommendations for patient selection. A detailed procedural guide is then provided, and potential complications and future developments in the field are discussed.
Paradoxical Embolism Windecker, Stephan, MD; Stortecky, Stefan, MD; Meier, Bernhard, MD
Journal of the American College of Cardiology,
07/2014, Letnik:
64, Številka:
4
Journal Article
Recenzirano
Odprti dostop
Abstract Paradoxical embolism is an important clinical entity among patients with venous thromboembolism in the presence of intracardiac or pulmonary shunts. The clinical presentation is diverse and ...potentially life-threatening. Although the serious nature and complications of paradoxical embolism are recognized, the disease entity is still rarely considered and remains under-reported. This paper provides an overview on the different clinical manifestations of paradoxical embolism, describes the diagnostic tools for the detection of intracardiac and pulmonary shunts, reviews therapeutic options, and summarizes guideline recommendations for the secondary prevention of paradoxical embolism.
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