Device Closure Of Patent Foramen Ovale Research Articles

A matching-adjusted indirect comparison of results from REDUCE and RESPECT—two randomized trials on patent foramen ovale closure devices to prevent recurrent cryptogenic stroke

Aims Two randomized clinical trials, REDUCE and RESPECT, demonstrated that patent foramen ovale (PFO) closure in combination with antithrombotic therapy was more effective for the prevention of recurrent ischemic stroke compared with antithrombotic therapy alone. The aim of this study was to determine the relative efficacy and safety of the PFO closure devices used in REDUCE (HELEX and CARDIOFORM Septal Occluders) compared with the device used in RESPECT (Amplatzer PFO Occluder). Methods An unanchored matching-adjusted indirect comparison (MAIC) of the PFO closure arms of the REDUCE and RESPECT trials was performed using patient-level data from REDUCE weighted to match baseline characteristics from RESPECT. Comparisons of the following outcomes were made between the devices assessed in the trials: risk of recurrent ischemic stroke; recurrent ischemic stroke one year after randomization; any serious adverse event (SAE) related to the procedure or device; and atrial fibrillation or atrial flutter as an SAE related to the procedure or device. Results After conducting the MAIC, baseline characteristics were well-matched between the two trials. Compared to RESPECT, PFO closure using the devices from REDUCE resulted in a hazard ratio of 0.46 (95% confidence interval [CI] 0.15–1.43; p = 0.17) for the risk of recurrent stroke. For the recurrence of stroke after one year, SAE related to the procedure or device, and atrial fibrillation or atrial flutter as SAE related to the procedure or device, the MAIC resulted in a rate difference of −0.68 (95%CI −2.06 to 0.70; p = .34), −1.29 (95%CI −3.82 to 1.25; p = .32), and −0.19 (95%CI −1.16 to 0.78; p = .71), respectively. These findings were consistent across scenario analyses. Conclusions This MAIC analysis found no statistically significant differences in efficacy and safety outcomes between PFO closure with the HELEX and CARDIOFORM Septal Occluders versus the Amplatzer PFO Occluder, as used in the REDUCE and RESPECT trials.

Incidence of Atrial Fibrillation or Arrhythmias After Patent Foramen Ovale Closure

BackgroundPatients with a patent foramen ovale (PFO) who undergo percutaneous PFO closure are at a greater risk of developing atrial fibrillation (AF) compared with patients whose PFOs are managed medically. Postclosure AF appears to be well tolerated if treated but may increase the risk for stroke. Postclosure AF is reported to occur in 3.7% to 7.4% of patients; however, incidence across devices remains uncertain. This study aims to evaluate the frequency of postclosure AF, atrial flutter, and arrhythmias in 6 PFO closure devices. MethodsFour hundred forty-five patients underwent percutaneous PFO closure with appropriate follow-up between 2001 and 2021. The procedure was performed using Abbott Amplatzer PFO, Amplatzer ASD, Amplatzer Cribriform, NMT CardioSEAL, Gore Helex, or Gore Cardioform devices. Incidence of AF, atrial flutter, and arrhythmias were assessed by electrocardiogram within 6 months from closure. Multivariate logistic regression evaluated potential predictors of postclosure AF or atrial flutter. ResultsPostclosure AF or atrial flutter occurred in 30 patients (6.7%) within 6 months, and its incidence was significantly different across devices. Gore Cardioform had the greatest frequency of postclosure AF or atrial flutter events (16.8%) compared with other devices. The Gore Cardioform device, larger device sizes, and male sex were associated with greater risk of postclosure AF or atrial flutter. ConclusionsPostclosure AF or atrial flutter was more likely to occur in the Gore Cardioform device, in males, and in patients who underwent PFO closure with larger devices. Although it is more effective for complete closure, the Gore Cardioform device was shown to be an independent predictor of postclosure AF or atrial flutter.

Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence.

Patent foramen ovale (PFO) is frequently identified in young patients with ischemic stroke. Randomized controlled trials provide robust evidence supporting PFO closure in selected patients with cryptogenic ischemic stroke; however, several questions remain unanswered. This report summarizes current knowledge on the epidemiology of PFO-associated stroke, the role of PFO as a cause of stroke, and anatomic high-risk features. We also comment on breakthrough developments in patient selection algorithms for PFO closure in relation to the PFO-associated stroke causal likelihood risk stratification system. We further highlight areas for future research in PFO-associated stroke including the efficacy and safety of PFO closure in the elderly population, incidence, and long-term consequences of atrial fibrillation post-PFO closure, generalizability of the results of clinical trials in the real world, and the need for assessing the effect of neurocardiology teams on adherence to international recommendations. Other important knowledge gaps such as sex, race/ethnicity, and regional disparities in access to diagnostic technologies, PFO closure devices, and clinical outcomes in the real world are also discussed as priority research topics.

Timing on patent foramen ovale closure: early versus delayed closure

Abstract Introduction Pivotal randomized clinical trials showed benefit in patent foramen ovale closure (PFOC) up to 9 months after a cryptogenic stroke or transient ischemic attack (TIA) [1-4]. It might be sensible to indicate PFOC also in non-recent cryptogenic strokes, but evidence is lacking. Purpose We aimed to compare the effectiveness of PFOC according to the time elapsed from the patient’s last episode of cryptogenic cerebrovascular event (CVE) or systemic embolism (SE). Methods A retrospective, international, multicentre, cohort study was performed to compare the outcomes of an early closure (EC, <9 months) or delayed closure (DC, ≥9 months) of patent foramen ovale (PFO) as secondary prevention after the index event. The primary end-point was recurrence of CVE or SE after PFOC. Results A total of 325 and 171 patients were classified in the EC and DC groups, with a median time to PFOC of 3.4 (IQR 1.9-5.5) and 17.5 (IQR 12.2-33.4) months, respectively. No significant differences were observed regarding the type of event indicating PFOC (stroke was the most frequent (77.8% in EC group vs 79.0% in DC group), followed by TIA (19.4% vs 18.7%)); neither about neuroanatomic localization of the lesions, nor contrast transcranial Doppler patterns, nor Risk of Paradoxical Embolism (RoPE) score (7 (IQR 5-8) vs 6 (IQR 5-7), p=0.077). Echocardiographic PFO characteristics of both groups were similar, except for a larger defect size (tunnel width) in the DC group (6 (IQR 4-14) vs 12 (IQR 6-16) mm, p=0.005)). PFOC device, procedural success (99.4 in EC vs 98.8% in DC group) and periprocedural complications (2.1 vs 0.8%) were comparable in both groups. Median follow-up was 2.0 (IQR 1.3-3.8) years in the EC group and 2.2 (IQR 1.2-4.9) in the DC group (p=0.721). No significant differences were observed concerning recurrence of stroke, TIA or SE (3.9% vs 2.6%, p=0.443), time from PFOC to recurrence (0.9 (IQR 0-2.1) vs 6.1 (2.5-8.8) years, p=0.090), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment during follow-up (Figure 1). Moreover, a subanalysis considering those patients with a very delayed PFOC (≥24 months) after the index event also showed no differences in recurrence rate during follow-up compared to the earlier procedures (4.2% in the <24-month group vs 3.4% ≥24-month group, p=0.770). Conclusions No differences were observed regarding recurrences of CVE/SE in patients undergoing PFOC before and after 9 months from the index event. Despite the absence of evidence from randomized trials, this study suggests that the preventive benefit of PFOC after a cryptogenic CVE/SE may be extended beyond 9 months after the last event.Figure 1:Incidence of recurre

Reporting quality of randomized controlled trials of percutaneous patent foramen ovale closure for the treatment of migraine based on the CONSORT statement

Abstract Background Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine. Purpose The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist. Methods Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement. Results The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF>30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score. Conclusions Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.

Abstract 17951: Infective Endocarditis of an Amplatzer PFO Occluder: A Rare and Devastating Complication

Introduction: Patent foramen ovale (PFO) closure is indicated for secondary prevention of ischemic strokes in select patients. PFO closure devices are rarely complicated by infective endocarditis (IE). We present the case of a patient with a closure device infected by Methicillin-sensitive Staphylococcus Aureus (MSSA). Case: A 60-year-old woman with a history of ischemic stroke status post transcatheter PFO closure with a 25 mm Amplatzer occluder eight months prior to presentation was admitted for a two week history of lower back pain, bilateral lower extremity weakness, and urinary incontinence. She denied dental procedures following device implantation. MRI of the spine revealed L3-L4 osteomyelitis with an adjacent epidural abscess which was immediately drained. Blood and intra-operative cultures revealed MSSA. There was no evidence of endocarditis on transthoracic echocardiogram (TTE). Given persistent bacteremia, a transesophageal echocardiogram (TEE) was performed, revealing large, highly mobile vegetations measuring up to 3 cm in length, attached to both the left and right atrial surfaces of the Amplatzer occluder. Urgent surgical removal of the Amplatzer occluder and PFO closure was performed. She received a 4-week course of Cefazolin. Discussion: Despite periprocedural antibiotics and prophylaxis for dental procedures for six months after implantation, IE of PFO occluders can rarely occur days to years after implantation. In patients with PFO occluders and persistent bacteremia or fevers, TEE is the diagnostic modality of choice as TTE are often negative. Management consists of urgent surgical excision and long-term antibiotics.

Performance, safety, and biocompatibility of a novel PFO closure device in a long-term porcine model

BackgroundAs the catheter-based device closure of the patent foramen ovale (PFO) is expanding, novel devices aim to address the limitations of first-generation occluders (e.g. bulk, erosion, dislodgment). The second-generation device from Encore Medical (Eagan, MN, USA) features an articulating frame structure which allows the device to better conform to atrial anatomies, has lower disc thickness and metal mass/surface area, and is fully retrievable at any point in the procedure. The aim of the study was to evaluate the feasibility and safety of a novel low-profile, fully retrievable, Encore PFO closure device in the animal model. MethodsSix swine underwent implantation of the novel PFO occluder under fluoroscopic and intra-cardiac echocardiography guidance and survived for 140 days. Interim transthoracic echocardiography (TTE) was conducted on Day 29. Following terminal angiography and TTE at 140 days, the hearts were subjected to gross and histopathologic analysis. ResultsAll animals were successfully implanted and survived for 140 days. Interim TTE revealed proper device retention with no blood flow across the septum or thrombus in any of the animals. X-ray and pathology results showed preserved implant integrity with no fractures, and complete integration of the devices into the septum with complete re-endothelialization and nearly complete coverage by a mature, relatively thin neoendocardium. No surface fibrin deposition or thrombosis was reported. ConclusionsIn the standard porcine model, device retention and biocompatibility remained favorable following structural and functional device modifications exemplified by the second-generation PFO occluder from Encore Medical, including marked reduction of metal mass.

World Stroke Organization Brain & hEart globAl iniTiative Program

Introduction: The World Stroke Organization (WSO) Brain & Heart Task Force developed the Brain & hEart globAl iniTiative (BEAT), a pilot feasibility implementation program to establish clinical collaborations between cardiologists and stroke physicians who work at large healthcare facilities. Methods: The WSO BEAT pilot project focused on atrial fibrillation (AF) and patent foramen ovale (PFO) detection and management, and poststroke cardiovascular complications known as the stroke-heart syndrome. The program included 10 sites from 8 countries: Brazil, China, Egypt, Germany, Japan, Mexico, Romania, and the USA The primary composite feasibility outcome was the achievement of the following 3 implementation metrics (1) developing site-specific clinical pathways for the diagnosis and management of AF, PFO, and the stroke-heart syndrome; (2) establishing regular Neurocardiology rounds (e.g., monthly); and (3) incorporating a cardiologist to the stroke team. The secondary objectives were (1) to identify implementation challenges to guide a larger program and (2) to describe qualitative improvements. Results: The WSO BEAT pilot feasibility program achieved the prespecified primary composite outcome in 9 of 10 (90%) sites. The most common challenges were the limited access to specific medications (e.g., direct oral anticoagulants) and diagnostic (e.g., prolonged cardiac monitoring) or therapeutic (e.g., PFO closure devices) technologies. The most relevant qualitative improvement was the achievement of a more homogeneous diagnostic and therapeutic approach. Conclusion: The WSO BEAT pilot program suggests that developing neurocardiology collaborations is feasible. The long-term sustainability of the WSO BEAT program and its impact on quality of stroke care and clinical outcomes needs to be tested in a larger and longer duration program.

P51 PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE IN CHILDREN :SINGLE CENTER EXPERIENCE

Abstract Background Transcatheter patent foramen ovale (PFO) closure is a validated strategy to prevent recurrent cerebral events in adult patients; limited data are available for children. Methods This is a retrospective analysis including pediatric population underwent to percutaneous treatment of PFO in our center. Results From 2006 to 2021, 21 transcatheter PFO closures have been performed in children (mean age: 14 +3 years; female: 58%, weight: 59 + 20 kg). Indications for the closure of PFO consisted in the occurrence of cryptogenic ischemic events for 18 patients (86%), in disabling migraine symptoms for 2 patients (9,5%) and in prophylactic measure to prevent paradoxical embolism in high risk abdominal surgery for 1 patient (4,5%). Transcatheter PFO closure was performed under general anesthesia with transesophageal ultrasound guidance. Complex anatomies of PFO included atrial septal aneurysm in 4 cases (with accessory fenestration of atrial membrane in 2 of these cases) and long and stiff PFO tunnel in one case. Single device was used in 20 procedures. ASD closure device was required for 5 cases because of anatomic characteristics of PFO. In one case of large multifenestrated atrial septal aneurysm, percutaneous treatment was performed using both PFO closure device and ASD closure device. No peri and/or post procedural complications have been reported . All patients were treated with Acetylsalicylic acid and Clopidogrel for the first six months after the procedure. Conclusions Transcatheter PFO closure is a safe procedure in pediatric patients in high volume center that should be used for preventing recurrent cerebral events also in children.

The Risk of Heart Failure Progression in Patients With Patent Foramen Ovale: Differential Risk Associated With Device Closure

A patent foramen ovale (PFO) can unload left atrial pressure via an interatrial shunt. We investigated whether device closure of PFO is associated with a subsequent risk of heart failure (HF), particularly in patients with structural heart disease or atrial fibrillation (AF). We enrolled 4,804 consecutive patients who underwent transesophageal echocardiography at tertiary medical centers in Korea between 2007 and 2019. The primary outcome was the 4-year risk of HF hospitalization. Underlying structural heart disease was determined by echocardiography. A PFO was observed in 981 (20.4%) patients, where 161 underwent device closure. During follow-up (median, 3.5 [1.4-6.4] years), the primary outcome was lower in patients with PFO than in those without (2.6% vs 4.0%; adjusted hazard ratio [aHR], 0.65; 95% CI, 0.45-0.94; P=.021). Among the patients with PFO, the primary outcome was higher in the device closure group than in the no-closure group (5.5% vs 1.2%; aHR, 5.59; 95% CI, 4.26-7.34; P<.001). A consistent result was found in patients with structural heart disease or AF (9.6% vs 3.9%; aHR, 2.55; 95% CI, 1.95-3.33; P<.001), demonstrating an increased risk of the primary outcome proportionate to the number of combined structural abnormalities. However, no significant association was observed between the primary outcome and PFO closure in those without structural heart disease or AF (1.7% vs 1.5%; aHR, 1.22; 95% CI, 0.99-1.50; P=.054). Patients with underlying structural heart disease or AF may be predisposed to symptomatic HF progression after PFO closure. Therefore, careful medical surveillance with optimal risk management is needed in these patients.

Outcomes of Patent Foramen Ovale Transcatheter Closure: Should a Short Aortic Rim Preclude Closure?

BackgroundThe risk of erosion of an atrial septal closure device, in particular the Amplatzer Septal Occluder, has been described as higher in patients with a short aortic rim. Similar concern has been applied to patent foramen ovale (PFO) closure devices, but there are only rare reported cases of erosion. It may be that smaller devices are chosen due to fear of device erosion in PFO patients when this is not necessarily an issue. ObjectivesThe authors aimed to assess outcomes after PFO closure with the Amplatzer PFO device in patients with a short (<9 mm) aortic rim. MethodsWe performed a retrospective analysis of PFO closure for any indication, between 2006 and 2017 at a quaternary center. Preprocedural transesophageal echocardiographic parameters including the aortic rim were remeasured. Long-term outcomes were obtained by linkage to provincial administrative databases. ResultsOver the study period, 324 patients underwent PFO closure with the Amplatzer PFO device, with a mean age of 49.8 years; 61% had a short aortic rim (<9 mm). The most common indication was cryptogenic stroke (72%); those with longer aortic distance were more likely to have a non-stroke indication for closure, diabetes (15% vs 6.5%, P = 0.04), and heart failure (15.7% vs 4%, P < 0.001). Over a median 7 years of follow-up, there were no cases of device erosion or embolization requiring cardiac surgery. ConclusionsIn a large cohort with long-term administrative follow-up (1,394 patient-years), implantation of an Amplatzer PFO device was performed safely even in patients with a short aortic rim.

Patent Foramen Ovale and Cryptogenic Stroke: Integrated Management

Patent foramen ovale (PFO) is a common cardiac abnormality with a prevalence of 25% in the general population. PFO has been associated with the paradoxical embolism causing cryptogenic stroke and systemic embolization. Results from clinical trials, meta-analyses, and position papers support percutaneous PFO device closure (PPFOC), especially if interatrial septal aneurysms coexist and in the presence of large shunts in young patients. Remarkably, accurately evaluating patients to refer to the closure strategy is extremely important. However, the selection of patients for PFO closure is still not so clear. The aim of this review is to update and clarify which patients should be considered for closure treatment.

378 VERY-LATE THROMBUS-RELATED STROKE AFTER PERCUTANEOUS PFO CLOSURE: MEDICAL MANAGEMENT OF A RARE COMPLICATION

Abstract In May 2020, a 45-years-old woman was admitted to the Emergency Department due to transient ischemic attack. The thrombophilia screening showed hemizygous prothrombin gene mutation (Factor II) and homozygous MTHFR mutation. The transthoracic echocardiography was normal, with a left ventricular ejection fraction of 60% and no morphological or functional valve disease. The 24-h Holter ECG and the past medical history did not show any specific cause of the neurologic manifestations. In the absence of a specific and plausible cause of the transient ischemic attack, a diagnosis of cryptogenic stroke was made. The patient then underwent transcranial Doppler, which showed a high-grade shunt (curtain effect), and transesophageal echocardiography with bubble test, which showed the presence of a massive right-to-left shunt through a patent foramen ovale (PFO) during the Valsalva maneuver. A therapy with warfarin (achieving a target INR between 2 and 3) was therefore started, and the indication for a percutaneous PFO closure was given. In January 2021 the patient underwent successful percutaneous PFO closure with the Gore Cardioform Septal Occluder 25/25 mm (W.L. Gore and Associates, Inc.) through intracardiac echocardiographic guidance with no complication and without any residual shunt. The patient was discharged on dual antiplatelet therapy with aspirin 100 mg daily plus clopidogrel 75 mg daily for six months, and pantoprazole 20 mg daily, followed by aspirin 100 mg daily chronically. After 6 months the patient underwent transcranial Doppler, which was negative for shunt. 12 months after the implantation the patient stopped aspirin by her own initiative. In August 2022, due to the diagnosis of an ovarian cyst, the gynecologist prescribed estro-progestogen pill: in that occasion, the patient did not mention her thrombophilia. After 10 days, sudden onset of weakness of the right upper limb and aphasia. The patient was then admitted to the Emergency Department, were the computer tomography showed two acute lesions on the left cerebral hemisphere. Therefore, the patient underwent intravenous thrombolysis, with complete regression of the neurological symptoms: a diagnosis of stroke was then formulated. To understand the origin of such stroke, the neurologist gave indication to cardiological evaluation. The patient did not have any palpitation in the previous months and the electrocardiogram showed normal sinus rhythm. However, the transthoracic echocardiographic evaluation showed a dubious image of a mass attached to the interatrial septum, for which the patient underwent transesophageal echocardiography, which showed a 10×9 mm fluctuating thrombus attached to the left side of the previously implanted PFO closure device. Therefore, an oral anticoagulation therapy with warfarin plus a subcutaneous therapy with enoxaparin 6000 UI twice daily (as bridge to obtain the desired INR between 2 and 3) was started. After ten days, the patient underwent a new transesophageal echocardiography, which showed a substantial reduction in the dimensions of the thrombus (4×3 mm). The patient was then discharged in warfarin therapy with no residual neurological symptoms.

Antithrombotic Therapy Duration after Patent Foramen Ovale Closure for Stroke Prevention: Impact on Long-Term Outcome.

The optimal duration of antithrombotic therapy (ATT) after patent foramen ovale (PFO) closure remains under debate. This study sought to compare the clinical outcome of patients receiving antithrombotic agents for a short (6 months) versus extended (>6 months) period after the procedure. This was a retrospective cohort study using a propensity score matching analysis on 259 consecutive patients (131 males, 43 ± 10 years) undergoing PFO closure due to cryptogenic stroke, with complete follow-up (median duration of 10 [4-13] years). The outcome was compared between patients receiving short-term (Group short, N = 88) versus extended ATT (Group long, N = 171). The PFO closure device was successfully implanted in all cases, with 3% of minor complications. After propensity score matching, there were no differences between Groups short and long in the rate of stroke (0.3 vs. 0.4% patient-year, p=1.00), bleeding (2 vs. 2% patient-year, p=0.17), and device thrombosis (0.3 vs. 0.1% patient-year; p=0.60). Univariate analysis showed that short-term ATT was not associated with an increased risk of recurrent stroke (HR: 1.271 [95% CI: 0.247-6.551], p=0.775) or prosthesis thrombus (HR: 0.50 [95% CI: 0.070-3.548], p=0.72). Kaplan-Meier analysis revealed similar overall survival in Group short and long (100 vs. 99 ± 1%, respectively; p=0.25). Short-term (6 months) ATT after PFO closure did not impair the clinical outcome, with a preserved low rate of recurrent stroke (0.3% patient-year) and device thrombosis (0.2% patient-year) at 10-year follow-up.

Transcranial Doppler Screening for Patent Foramen Ovale Closure in Cryptogenic Strokes in Young: A Single Center Experience from South India.

Cryptogenic strokes are common in young adults. Patent foramen ovale (PFO) is an important cause of cryptogenic ischemic strokes. Transcranial Doppler (TCD) with bubble contrast is a noninvasive bedside tool in screening for PFO and other right to left shunt (R-L shunt). Percutaneous PFO closure in selected patients with a high risk for paradoxical emboli is beneficial. Data on PFO in young cryptogenic strokes from India are limited. To determine the utility of screening for R-L shunt using TCD in young patients with cryptogenic strokes and to identify clinical predictors of an R-L shunt. This was a hospital-based prospective study conducted between January 2013 and December 2019 in a tertiary hospital in South India. All consecutive patients with ischemic stroke and ages between 18 and 45 years were included. TCD with bubble contrast study was performed on all patients. Those who were TCD bubble contrast study positive and had features of an embolic stroke of undetermined source (ESUS) underwent transesophageal echocardiography (TEE) to confirm a PFO and to look for its high-risk features. Selected ESUS patients with PFO and associated high-risk features as identified on TEE underwent percutaneous PFO device closure. All patients were followed up in the stroke and cardiology clinics. During the study period, 6,197 patients with ischemic strokes were screened for eligibility of which 304 (4.9%) were between the age of 18 and 45 years. Of these, 300 patients with ischemic stroke in young underwent the TCD bubble contrast study. R-L shunt was found in 121 (40.3%) patients. Based on an extensive etiological evaluation, 72 patients were identified to have an ESUS and underwent TEE for confirming PFO. Of these, 65 patients had PFO, four were negative, and three were found to have extracardiac shunts. Based on clinical findings, imaging features, and high-risk features on TEE, 29 patients underwent PFO closure. Activity at the time of stroke onset equivalent to a Valsalva maneuver (p ≤ 0.01), isolated cortical infarction (p = 0.027), and posterior circulation involvement (p = 0.0135) were significantly associated with the presence of an R-L shunt. The patients who had a higher modified anatomical-functional risk of paradoxical embolism (AF-RoPE) score, a high-grade shunt on the TCD bubble contrast study had a longer length of the tunnel and had the presence of an interatrial septal aneurysm (p = 0.012) were referred for PFO device closure. R-L shunt is common in cryptogenic ischemic strokes in young. TCD with bubble contrast study is a noninvasive and feasible bedside tool to detect them. Applying the ESUS criteria in these cryptogenic strokes with a positive TCD bubble contrast study can be then used for selecting patients for more invasive tests like TEE. High-risk PFOs picked up with TEE can be then considered for PFO closure for secondary stroke prevention. The history of Valsalva maneuver-like activity (such as lifting heavy weights or straining) at the time of stroke onset can be a clinical predictor for the presence of an R-L shunt. In addition to isolated cortical infarction, the presence of posterior circulation infarct in ESUS can predict the presence of an R-L shunt.

IS THE PATENT FORAMEN OVALE AN INNOCENT BYSTANDER OR THE REAL CULPRIT? THE MILLION-DOLLAR QUESTION

IS THE PATENT FORAMEN OVALE AN INNOCENT BYSTANDER OR THE REAL CULPRIT? THE MILLION-DOLLAR QUESTION

Application of Transesophageal Echocardiography in Amplatzer Atrial Septal Defect Occluder for Percutaneous Closure of Large Patent Foramen Ovale.

Objective The Amplatzer patent foramen ovale (PFO) occluder is the most commonly used device for percutaneous closure of a large PFO. However, its use may predispose the patient to postoperative residual shunting. To reduce the incidence of residual shunting, we investigated the safety and effectiveness of the Amplatzer atrial septal defect (ASD) occluder for percutaneous closure of a large PFO measured by transesophageal echocardiography (TEE) and evaluated the value of TEE in this procedure. Methods Overall, 118 patients who were diagnosed with a large PFO (all with a ≥ 2 mm left atrial side height after the Valsalva maneuver (VM) excluding those with a small ASD) using contrast transthoracic echocardiography (c-TTE) and TEE underwent closure under TEE guidance at The First Affiliated Hospital of Xi'an Jiaotong University. An ASD device was used in 48 patients (group I) and a PFO device in 70 (group II). After the procedure, we verified the safety and efficacy of different devices using c-TTE, TTE, and TEE. Results In both groups, the preoperative TEE results showed a significantly increased left height of the PFO after VM compared with that at rest (all P < 0.01). Compared with the left height of the PFO measured using TEE after VM, the PFO-stretch diameter (SD) measured by TEE after the delivery sheath passed the PFO was higher (all P < 0.01). We selected the ASD occluder size according to this PFO-SD. In group II, most patients underwent the implantation of the larger PFO devices. Interventional treatment was successfully performed on all patients. The effective occlusion rate in group I at 12 months after the procedure was significantly higher than that in group II (93.7% vs. 78.6%, P < 0.05). The TEE results showed that 18 patients with a medium and large residual shunt at 12 months after the procedure exhibited an intradisc tunnel-like shunt. Conclusion The Amplatzer ASD device and Amplatzer PFO device are safe for large PFO closure, but the Amplatzer ASD device has a higher effective occlusion rate. TEE plays a crucial role in the use of the Amplatzer ASD occluder for percutaneous closure of a large PFO.

Suture-Mediated Patent Foramen Ovale Closure Using the NobleStitch EL: Results from a Hospital-Based HTA.

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies’ governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89–97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.

B-29 | Incidence of Atrial Fibrillation and Arrhythmias in Six Closure Devices for Patent Foramen Ovale

Patients with a patent foramen ovale (PFO) who undergo percutaneous PFO closure are at a greater risk of developing atrial fibrillation (AF) compared to patients whose PFOs are managed medically. Post-closure AF appears to be well tolerated if treated, but could theoretically increase the risk for stroke. Post-closure AF is reported to occur in 3.7% of patients, however, incidence across devices remains uncertain. This study aims to evaluate the frequency of post-closure AF and arrhythmias in 6 PFO closure devices.

Amplatzer Patent Foramen Ovale Occluder Device-Related Complications.

Patent foramen ovale (PFO) is a standard variant that is present in 25% of the whole adult population. In a certain population, PFO can lead to cerebrovascular accidents. Mechanism of cerebrovascular accidents can be by paradoxical embolization from the right circulation or in situ thrombosis. Diagnosis of a PFO-responsible cerebrovascular accident is based on a thorough work-up to exclude other possible etiologies and detect PFO on trans-thoracic or trans-esophageal echocardiography with bubble study and/or Doppler. Over the last few years, multiple studies have supported that percutaneous PFO closure is superior to medical therapy in the secondary prevention of cerebrovascular accidents. However, numerous adverse events have been linked to PFO closure devices in general compared to medical therapy as new-onset atrial fibrillation, residual shunt, device-related thrombus, bleeding, deep vein thrombosis, pulmonary embolism, and inter-atrial septal erosions. Amplatzer device is one of the PFO occluder devices approved by the FDA. Device-related adverse events have been addressed by comparing the Amplatzer device with other PFO occluder devices. Based on the new data, we expect to see more complications related to PFO closure in the coming few years. We reviewed different studies that looked at the PFO closure-related complications and the trials comparing adverse events in the Amplatzer PFO occluder device compared to other devices. Amplatzer PFO occluder device is either superior or non-statistically different from other PFO occluder devices related to new-onset atrial fibrillation and residual shunt. More studies are needed to address the other less common adverse events. Since many of the device-related complications appear many years after device placement, a long-term follow-up is recommended.