Percutaneous Patent Foramen Ovale Closure Research Articles

Are we there yet with patent foramen ovale closure for secondary prevention in cryptogenic stroke? A systematic review and meta-analysis of randomized trials.

Background:We performed a meta-analysis to evaluate the benefit of patent foramen ovale closure in stroke prevention.Methods:We searched Medline/PubMed, EMBASE, Web of Science and Cochrane central database for randomized control trials assessing the incidence of recurrent stroke after patent foramen ovale closure when compared to medical therapy. Pooled odds ratio and 95% confidence intervals were calculated using a random effects model. The heterogeneity among studies was tested using the χ2 test and inconsistency was quantified using the I2 statistic.Results:Our search strategy yielded 71 articles. We included five studies with a total of 3440 patients. Median age in the device group was 45 (43, 5.5) years and in the medical group was 45 (44.5, 46) years; 52% were male, 27.7% of patients had an atrial septal aneurysm, 25% had hypertension, and 20.5% had diabetes mellitus. The median follow-up time was 44 (34.5–50) months. The pooled odds ratio of recurrent stroke, transient ischemic attack and composite end point of stroke + transient ischemic attack + peripheral embolism in the patent foramen ovale closure versus medical therapy group were 0.4 (95% confidence interval 0.25–0.63, I2 = 57.5%), 0.93 (95% confidence interval 0.61–1.42, I2 = 0%), and 0.6 (95% confidence interval 0.44–0.82, I2 = 0%), respectively. The incidence of atrial fibrillation was found to be significantly higher in the patent foramen ovale closure group with odds ratio of 6 (95% confidence interval 3.13–11.4, I2 = 33.5%). On subgroup analysis, patent foramen ovale closure appeared to benefit males and patients with a large shunt. Number needed to treat to prevent one recurrent stroke with patent foramen ovale closure is 42. Number needed to harm to cause one atrial fibrillation with patent foramen ovale closure is 39.Conclusion:This meta-analysis of randomized trials concludes that percutaneous patent foramen ovale closure is effective in recurrent stroke prevention especially in males and in those with a large shunt.

Sensitivity of contrast-enhanced transthoracic echocardiography for the detection of residual shunts after percutaneous patent foramen ovale closure.

The objective of this study is to investigate the sensitivity of contrast-enhanced transthoracic echocardiography (c-TTE) versus transesophageal echocardiography (TEE) to detect a residual right-to-left shunt (RLS) following a transcatheter patent foramen ovale (PFO) closure.A self-controlled study was conducted in a tertiary referral hospital. 57 patients with PFO who had experienced migraines underwent percutaneous PFO closure. c-TTE, TEE, and contrast-enhanced transcranial Doppler (c-TCD) at resting and Valsalva maneuver were performed during the 3-month follow-up after the closure.The closure devices were successfully implanted in all patients without complications. Three months after closure, TEE did not detect residual Valsalva shunts in any of the 57 patients; residual valsalva shunts were found via c-TTE in 15 of the 57 patients and were also observed via c-TCD. When c-TTE and/or c-TCD were used, the rate of residual RLSs detected in patients who underwent PFO closure was 26.32%, which was significantly different than the rate detected using TEE (P < .05)c-TTE and c-TCD showed equivalent sensitivity in evaluating transcatheter closure of a PFO. c-TTE could be a more cost-effective and reliable method to detect the residual shunt after PFO closure.

Patent Foramen Ovale and Hypoxemia.

Patent foramen ovale (PFO), an embryonic remnant of the fetal circulation, is present in 20-25% of adults. Although recent observational studies and clinical trials have established the link between PFO-mediated right-to-left shunting with cryptogenic stroke and migraine with aura, the role of a PFO in exacerbating hypoxemic medical conditions (ie, sleep apnea, chronic obstructive pulmonary disease, pulmonary hypertension, platypnea-orthodeoxia, pulmonary arteriovenous malformation, high-altitude pulmonary edema, and exercise desaturation) remains less understood. PFO-mediated hypoxemia occurs when deoxygenated venous blood from the right atrium enters and mixes with oxygenated arterial blood in the left atrium. Patients with an intracardiac right-to-left shunt may have profound hypoxemia out of proportion to underlying primary lung disease, even in the presence of normal right-sided pressures. The presence of right-to-left cardiac shunting can exacerbate the degree of hypoxemia in patients with underlying pulmonary disorders. In a subset of these patients, percutaneous PFO closure may result in marked improvement in dyspnea and hypoxemia. This review discusses the association between PFO-mediated right-to-left shunting with medical conditions associated with hypoxemia and explores the role of percutaneous PFO closure in alleviating the hypoxemia.

Percutaneous patent foramen ovale closure during live case demonstrations.

Live case demonstrations serve as an educational tool for interventional techniques in cardiology. The aim of this study was to assess the safety and technical success of percutaneous patent foramen ovale (PFO) closure during live case demonstrations. All patients who had undergone percutaneous PFO closure with Amplatzer devices during live case demonstrations at our institution were consecutively included in this retrospective analysis. Procedure related events were compared with summary event rates derived from the eight randomized controlled trials (RCTs) investigating PFO closure, as well as with a propensity matched cohort of patients treated under usual conditions. From April 2004 to June 2015, 142 patients underwent percutaneous PFO closure during live demonstrations, mainly for secondary prevention of cryptogenic cerebrovascular events. The interventions were fluoroscopy guided and successful in all but three cases (2%). Minor adverse events occurred in nine patients (6%). Contrast TEE performed at about 6 months showed complete closure in 84%. No significant differences with regard to technical success and major complications rate were found compared to RCTs, except for an increased rate of minor bleeding observed during live case demonstrations (P for difference < 0.001), mainly attributable to concomitant arterial access for incidental coronary angiography performed in 70% of patients. Except for slightly longer procedure duration, no difference was found compared to a matched population treated under usual conditions. Percutaneous PFO closure can be performed during live case demonstrations with the same high technical success as during routine cases.

Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up.

To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long-term follow-up (FU). The Occlutech device has been proven safe and effective six-months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient-years of FU. All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right-to-left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe. In total, 250 patients (mean age 53.5 ± 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 ± 1.8 years, a total of 1,345 patient-years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one-year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1-year FU (four TIA, one stroke) and in 7.4% at long-term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient-year of FU, with a stroke rate of 0.01%. The Occlutech device appears to be safe at long-term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1-year FU.

Identification of candidates for PFO closure in the echocardiography laboratory.

A patent foramen ovale (PFO) is implicated in several pathologic processes, including that of cryptogenic stroke (cCVA). Recent trials identify "high-risk" PFOs in patients with cCVA as likely to benefit from percutaneous closure. The younger the patient (<60years old) the more likely a PFO may be attributable to the cCVA. The RoPE Score index helps determine the likelihood that an existing PFO is related to a cCVA. This may help guide the clinician and patient when contemplating percutaneous PFO closure. When evaluating a patient for possible percutaneous closure, one should identify the CVA as a typical ischemic type stroke. In order to "rule-out" other causes of CVA, imaging of the intracranial arteries, cervical, and aortic arch vessels should be performed. Small vessel disease or a lacunar-type infarct should be excluded. To rule out atrial fibrillation, prolonged monitoring should be performed. An index has been developed to determine the probability that a PFO is the causative etiology and calculates the risk of recurrence. This may help guide the clinician and patient in the decision for PFO closure. In addition, one should consider a work-up for a hypercoagulable state. We will obtain an ultrasound of the lower extremities or consider deep pelvic vein thrombosis (prolonged sitting or malignancy). If the closure is to be performed, the Food and Drug Administration (FDA) has approved the Amplatzer PFO Occluder and the GORE Cardioform Septal Occluder for percutaneous closure. These devices are both approved in patients predominately between ages 18 and 60years with a cCVA due to presumed paradoxical embolism as verified by a neurologist and cardiologist and when other causes of ischemic CVA have been excluded. "High-risk" PFOs appear to achieve the most potential benefit from percutaneous closure.

Work-up in a patient with embolic stroke of unknown source – clinical case

А 33-year-old man without risk factors was admitted to Cardiology Department with history of embolic stroke of unknown source (ESUS). The physical examination, laboratory tests, Holter ECG, and transthoracic echocardiography (TTE) were unremarkable. For further evaluation, he underwent transcranial contrast Doppler sonography (TCD) and transesophageal echocardiography (TEE), which showed atrial septal aneurism and patent foramen ovale (PFO) with significant right-to-left shunt. After screening for thrombophilia, the patient was scheduled for percutaneous closure of PFO. After the procedure he was discharged in a satisfactory condition with following anticoagulant therapy for a year. Conducting further clinical testing in young patients with ESUS is important for the assessment of etiology, further treatment, and secondary stroke prevention .

Persistent foramen ovale closure in divers with ahistory of decompression sickness.

ObjectiveTo study the effect of percutaneous patent foramen ovale (PFO) closure in divers with a history of decompression sickness (DCS).Study design(1) Retrospective study of patient records and (2) telephonic follow-up. Patients with unexplained decompression sickness, who were referred to a cardiologist with a focus on diving medicine between 2000 and 2017, were included in the studyResultsA total of 62 divers with DCS were included. In all cases transoesophageal echocardiography (TEE) was performed, showing 29 PFOs and 6 atrial septum defects (ASDs) in total n = 35 (56%). The highest prevalence was found in divers with cutaneous and vestibular DCS. At follow-up (mean follow-up duration 6.8 years), 21 PFOs/ASDs were closed using a percutaneous procedure. One diver was lost to follow-up. One diver quit diving. The remaining divers were able to resume unrestricted diving; there was no recurrence of major DCS. Of the divers with an open PFO or ASD, 14 were included of whom 7 are currently diving. All (except one diver with a small PFO) divers are using a conservative diving profile to reduce nitrogen load and the appearance of venous nitrogen bubbles. There was no recurrence of major DCS in this group.ConclusionPercutaneous PFO closure may be an effective and safe treatment for divers who have suffered a major DCS to return to unrestricted diving. Alternatively, conservative treatment seems safe when divers refrain from unrestricted diving and use a conservative technique in order to reduce nitrogen load.

Closure versus Medical Therapy for Patent Foramen Ovale in Patients with Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Controlled Trials

BackgroundDebate continues about whether percutaneous closure of patent foramen ovale (PFO) is a better strategy for the treatment of patients with cryptogenic stroke in comparison with medical therapy alone. We performed an updated meta-analysis of 6 randomized controlled trials (RCTs) to assess the effectiveness and safety of percutaneous closure of PFO as secondary prevention for patients with previous cryptogenic stroke compared to medical therapy. Materials and MethodsMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and Internet-based resources were retrieved in March 2018 for eligible RCTs. The primary effectiveness outcome was recurrent strokes. ResultsSix studies meeting our selection criteria were identified. Among 3560 participants, 1889 patients were assigned to PFO closure and 1671 patients to medical therapy. There were no significant differences among the baseline characteristics. The pooled incidence of recurrent strokes was 1.96% in the PFO closure group and 4.60% in the medical therapy group (Relative risk [RR] .39, 95% confidence interval [CI] .18-.82, P = .01). Newly detected atrial fibrillation occurred in 77 of 1844 (4.18%) patients in the PFO closure group and in 12 of 1667 (.72%) patients in the medical therapy group (RR 4.56, 95% CI 2.21-9.41, P <.0001). There was no difference in terms of serious adverse events, total mortality or bleeding between 2 groups. ConclusionsOur updated meta-analysis suggests that in patients with PFO and cryptogenic stroke, the rate of recurrent stroke is significantly reduced with percutaneous closure of PFO compared to the medical therapy.

PMD24 - Cost Effectiveness Analysis of Percutaneous Patent Foramen Ovale (PFO) Closure in Patients with a History of Cryptogenic Stroke in Korea

Patent Foramen Ovale (PFO) is a congenital defect that constitutes a hole between the right and left upper chambers of the heart. It may contribute to the risk of ischemic stroke so the closure is considered as a secondary prevention in patients who had a cryptogenic stroke. The objective of this study is to examine cost effectiveness of PFO closure in the context of Korean healthcare system. A Markov model consisting of 4 health states (stable, post-minor recurrent stroke, post-moderate recurrent stroke, death) similar to Tirschwell et al. (HTAi 2017) was developed to assess cost effectiveness in patients selected for PFO closure based on RESPECT trial extended follow-up. The intervention cost and medication costs were obtained from the current fee schedule, drug prices, and statistical yearbook in the National Health Insurance (NHI). Severity distribution of recurrent stroke was set by expert opinion. Using these data, a cost effectiveness analyses of (1) PFO closure with antiplatelet therapy (intervention) versus (2) medical therapy alone (control) was assessed at 20 years post the intervention. Univariate sensitivity analyses and probabilistic sensitivity analysis (PSA) were performed. The analysis showed that the intervention has 3.2 million KRW more cost with 1.2 higher utility which corresponds to an ICER of 2.7 million KRW per QALY which is below the implicit Korean threshold of 25 million KRW. A sensitivity analysis on time horizon showed that discounted ICER reach the threshold in 4 years, i.e. net monetary benefit of intervention exceeds control in 4 years. The PSA result showed acceptability of intervention at the threshold was 96.4% compared to control. Though there might be uncertainties from foreign modeling, the current study suggests a careful selection of patients with cryptogenic stroke history and application of PFO closure may benefit the patients and the public payer in Korea.

TCT-243 Are Percutaneous Patent Foramen Ovale Closure Devices effective? A Comprehensive Meta-Analysis Assessing their Long Term Outcomes

TCT-243 Are Percutaneous Patent Foramen Ovale Closure Devices effective? A Comprehensive Meta-Analysis Assessing their Long Term Outcomes

TCT-244 Percutaneous suture-mediated patent foramen ovale (PFO) closure with the NobleStitch EL system: center experience effect

Suture-based percutaneous closure of patent foramen ovale (PFO) with the NobleStitch EL (Heartstitch, Fountain Valley, CA) system was shown to provide safe and effective closure of PFO. This approach appeared to be more technically demanding than typical occluder implantation. Whether this

TCT-822 Patent Foramen Ovale (PFO) closure compared to medical therapy for prevention of stroke recurrence in cryptogenic stroke population: Systematic Review and Meta-Analysis

Background Closure of a Patent Foramen Ovale(PFO), may play a role in reducing the risk of recurrent strokes in the cryptogenic stroke population. With recent new evidence published, we aimed to conduct a review of currently available randomised controlled trials(RCT) in order to evaluate the utility of percutaneous device closure of PFO compared to medical therapy in prevention of recurrent strokes. Our aim was to compare the incidence of recurrent stroke between the 2 approaches and also to compare the incidence of transient ischaemic attacks(TIA) and major bleeding between the 2 approaches. Methods A comprehensive search of major databases was performed. We included comparative RCTs, where outcomes of percutaneous PFO closure with medical therapy were available in patients with cryptogenic stroke and a PFO. Results Six studies were included with total of 3560 patients. Incidence of recurrent stroke was significantly less in the PFO closure group compared to medical therapy (2.86% vs. 5.09%, OR 0.49, 95% CI 0.35 – 0.70, p < 0.0001). Incidence of TIA was not significantly different in both PFO closure group compared to medical therapy (2.75% vs. 3.83%, OR 0.79, 95% CI 0.54 – 1.15, p = 0.22). Major bleeding was shown to not be significantly different in PFO closure group compared to medical therapy (1.64% vs. 1.76%, OR 0.90, 95% CI 0.54 – 1.49, p = 0.68) either. Sub group analysis of patients with ASA, comparing PFO closure group to medical therapy showed significant benefit in terms of stroke prevention in the PFO closure group (3.02% vs. 7.99%, OR 0.39, 95% CI 0.21 – 0.72, p = 0.002). Sub group analysis of large intra-atrial shunt similarly showed significant benefit in terms of stroke prevention in the PFO closure group (1.43% vs. 5.40%, OR 0.26, 95% CI 0.13 – 0.51, p < 0.0001). Download : Download high-res image (119KB)Download : Download full-size image Conclusion When combining all trials published so far, our analysis demonstrates a net beneficial effect of PFO closure overall. Our study also highlights the need of a dedicated RCT to explore PFO closure compared to oral anticoagulation to reduce the likelihood of bias in the future.

TCT-821 Patent Foramen Ovale Closure in Patients with Cryptogenic Stroke: Meta-analysis of Randomized Controlled Trials

Patent foramen ovale (PFO) with atrial septal aneurysm (ASA) is a potential source for cryptogenic strokes. Percutaneous PFO closure to reduce recurrence of stroke compared to medical therapy (MT) has been intensely debated. The aim of this study is to evaluate the efficacy and safety of PFO closure

Endovascular Retrieval of an Embolized Atrial Septal Occluder Device From the Abdominal Aorta

Patent foramen ovale (PFO) is a common heart condition in adults. Closure with a septal occluder device is a safe, well-established treatment option with excellent clinical outcomes. One rare complication of percutaneous PFO closure is embolization of the device to the heart chambers or distal vasculature. Most device migrations are recognized during or shortly after implantation. While many endovascular retrievals of migrated devices are successful, there are still a high percentage of surgical interventions performed. We report a case of a septal occluder device that embolized to the abdominal aorta and was discovered 7 days after implantation. Endovascular techniques with a snare and endobronchial forceps were used to retrieve the device safely.

Implications of detection of foramen ovale patent after cryptogenic ischemic stroke

Therapeutic uncertainty is inherent in decisions in patients with patent foramen ovale (PFO) and cryptogenic stroke. We aimed to determine clinical implications of PFO identification in transesophageal echocardiography (TEE) after a cryptogenic ischemic stroke. Consecutive TEE done between 2011 and 2015 in patients with previous cryptogenic stroke was evaluated. Clinical implications of PFO identification (closure and/or medical therapy) were retrieved from the medical records and discharge summaries. Adverse events related to therapy, stroke recurrence and death were analyzed during follow-up. Three-hundred one patients (mean age 59 ± 11years; 61% male) underwent a TEE, of which 77 (26%) patients had a diagnosis of PFO. Patients with PFO were younger (56 ± 13 versus 60 ± 14, p = 0.03). Of those with PFO, 23 (30%) underwent percutaneous closure of PFO and these patients had more frequently complex or large PFO (p < 0.001 and p = 0.004, respectively). The remaining 54 (70%) were treated with medical therapy: 30 (39%) with antiplatelet therapy and 24 (31%) with oral anticoagulation. During follow-up (44 ± 17months), only two patients had another stroke (both referred for PFO closure, while they were waiting for the procedure) and two patients, on whom PFO closure was not performed, died (not for cardiovascular causes). PFO's (size and complexity) and patients' characteristics influenced clinical decision when PFO was detected on TEE. The risk for recurrent stroke was not increased in patients who did not undergo PFO closure; although two patients waiting for PFO closure had recurrent stroke, demonstrating its importance.

Meta-analysis of randomized trials on percutaneous patent foramen ovale closure for prevention of migraine

Background: The role of percutaneous patent foramen ovale (PFO) closure for prevention of migraine is controversial.Methods: We performed a computerised search of MEDLINE, EMBASE and COCHRANE databases through December 2017 for randomised trials evaluating PFO closure versus control in patients with migraine headaches (with or without aura). The main study outcome was the reduction in monthly migraine attacks after PFO closure compared with the control group.Results: The final analysis included three randomised trials with a total of 484 patients. Reduction in monthly migraine attacks was higher in PFO closure compared with the control group (standardised mean difference-SMD = 0.25; 95% CI: 0.06–0.43; p = .01). There was higher reduction of monthly migraine days in PFO closure group compared with control group (SMD = 0.30; 95% CI: 0.08–0.53; p = .01). There was no statistically significant difference in complete resolution of migraine attacks (OR: 3.67; 95% CI: 0.66–20.41; p = .14) and in responders’ rate (OR: 1.92; 95% CI: 0.76–4.85; p = .17) between PFO closure and control groups. In patients whose majority of migraine attacks are with aura, there was an observed reduction in migraine attacks in PFO closure compared with control groups (SMD = 0.86; 95% CI: 0.07–1.65; p = .03).Conclusion: PFO closure might be beneficial in migraine patients by reducing migraine attacks and migraine days, especially in patients whose majority of migraine attacks are with aura. However, those benefits were not associated with an improvement in responders’ rate or complete resolution of migraine; raising concerns on the magnitude of clinical benefit of PFO closure in migraine prevention.

Percutaneous patent foramen ovale closure for secondary stroke prevention: Network meta-analysis.

Current guidelines report no benefit for patent foramen ovale (PFO) closure compared to medical treatment in patients with cryptogenic ischemic stroke (IS) or TIA. Two recent randomized controlled clinical trials have challenged these recommendations. We performed a systematic review and network meta-analysis of randomized controlled trials to estimate the safety and efficacy of closure compared to medical treatment, and to compare available devices. We conducted pairwise meta-analyses for closure vs medical therapy, irrespective of the device used, and for each device vs medical therapy. Our literature search highlighted 6 studies. PFO occlusion was associated with reduced risk of recurrent IS (risk ratio [RR] 0.42, 95% confidence interval [CI] 0.20-0.91) and IS/TIA (RR 0.65, 95% CI 0.48-0.88) but with increased risk of new-onset atrial fibrillation (AF) (RR 4.59, 95% CI 2.01-10.45) compared to medical treatment. In indirect analyses, both Amplatzer (AMP) and GORE devices were found to be associated with a lower risk of new-onset AF compared to STARFlex (SFX) (RR 0.25, 95% CI 0.10-0.65 and RR 0.28, 95% CI 0.08-0.95). Moreover, AMP was found to be associated with a lower risk of recurrent IS/TIA events compared to the SFX device (RR 0.35, 95% CI 0.14-0.91). In the clustered ranking plot on the risk of IS against new-onset AF, GORE was comparable to AMP; however, on the risk of IS/TIA against new-onset AF, AMP appeared to be superior to the GORE device. In both ranking plots, SFX was highlighted as the worst option. PFO closure is associated with reduced risk of recurrent IS or IS/TIA and with increased risk of new-onset AF.

Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry.

The aim of this study was to assess the efficacy of a novel percutaneous "deviceless" suture-mediated patent foramen ovale (PFO) closure system. Between June 2016 and October 2017, a prospective registry aimed at assessing the safety and efficacy of the NobleStitch EL (HeartStitch, Fountain Valley, CA, USA) suture-based PFO closure system was carried out at 12 sites in Italy. Among 200 consecutive patients evaluated, 192 were considered suitable for suture-mediated PFO closure (44±13 years, 114 female). Suture of the septum with the NobleStitch EL system was carried out successfully in 186 (96%) patients. Median fluoroscopy time was 16.1 (13.0-22.5) minutes and contrast volume 200 (150-270) ml. At 206±130 days follow-up, contrast transthoracic echocardiography with the Valsalva manoeuvre revealed no RLS (grade 0) in 139 (75%) patients and RLS grade ≤1 in 166 (89%) patients. Significant RLS was present in 20 (11%) patients (grade 2 and 3 in 11 and nine patients, respectively). There were no device-related complications. The early results of this first Italian registry indicate that the suture-mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, and provides an effective closure of PFO comparable to traditional devices with a good safety profile at medium-term follow-up.

Cost-effectiveness of percutaneous patent foramen ovale closure as secondary stroke prevention

Objective: Compared to medical therapy alone, percutaneous closure of patent foramen ovale (PFO) further reduces risk of recurrent ischemic strokes in carefully selected young to middle-aged patients with a recent cryptogenic ischemic stroke. The objective of this study was to evaluate the cost-effectiveness of this therapy in the context of the United Kingdom (UK) healthcare system.Methods: A Markov cohort model consisting of four health states (Stable after index stroke, Post-Minor Recurrent Stroke, Post-Moderate Recurrent Stroke, and Death) was developed to simulate the economic outcomes of device-based PFO closure compared to medical therapy. Recurrent stroke event rates were extracted from a randomized clinical trial (RESPECT) with a median of 5.9-year follow-up. Health utilities and costs were obtained from published sources. One-way and probabilistic sensitivity analyses (PSA) were performed to assess robustness. The model was discounted at 3.5% and reported in 2016 Pounds Sterling.Results: Compared with medical therapy alone and using a willingness-to-pay (WTP) threshold of £20,000, PFO closure reached cost-effectiveness at 4.2 years. Cost-effectiveness ratios (ICERs) at 4, 10, and 20 years were ₤20,951, ₤6,887, and ₤2,158, respectively. PFO closure was cost-effective for 89% of PSA iterations at year 10. Sensitivity analyses showed that the model was robust.Conclusions: Considering the UK healthcare system perspective, percutaneous PFO closure in cryptogenic ischemic stroke patients is a cost-effective stroke prevention strategy compared to medical therapy alone. Its cost-effectiveness was driven by substantial reduction in recurrent strokes and patients’ improved health-related quality-of-life.