PFO Device Complications: Literature Review and Possible Implications for Echocardiographic Follow-Up.

INTRODUCTION: Transthoracic (TTE) follow up guidelines after PFO device closure are vague. The primary goal of this study was to perform a literature search to characterize the timing of complications that occur after PFO device placement to determine the utility of long-term routine TTE. METHODS: A search was performed in Medline (PubMed) with English language and publication date (2000-2023) filters were applied. Studies were included if they reported on patients who underwent a PFO device closure. Studies were excluded if they only reported on ASD device closure patients, were meta-analysis or review papers, or did not report any outcomes for the PFO device procedure. RESULTS: A total of 305 articles met the criteria (observational cohort study, n = 196; case study, n = 99; and randomized control study, n = 10). Age at the time of PFO device closure was 47.5 ± 9.3 years. The incidence of complications was 6.9% (3358/48 348). Maximum range of follow-up was 0-17 years. The plurality of complications was due to arrhythmias (46.3%, 1554/3358), followed by residual shunts (29.7%, 999/3358). The majority of complications occurred ≤6 months post-device placement (57.8%, 1941/3358). Only 0.8% (27/3358) of complications took place >5 years. All patients with complications >5 years of device placement were presented with clinical symptoms related to their complications. CONCLUSION: The incidence of patients presenting with PFO-reported complications beyond 5 years post-procedure diminished. The utility of routine TTE beyond 5 years post-PFO after device placement should be further assessed.

Successful occluder removal and reocclusion of an atrial septal defect after occluder immigration to aortic arch: a case report.

BACKGROUND: Atrial septal defect (ASD) is a common congenital heart disease, and currently, transcatheter intervention is the most common clinical treatment method. However, certain complications still occur during the percutaneous process, among which occluder loss and displacement are rare but serious complication. Although the probability of occluder loss and displacement is low, severe cases can endanger life. CASE PRESENTATION: Here, we report the case of a patient who underwent ASD closure in which the occluder fell off into the aortic arch, the detached occluder was recovered through catheter intervention, and the patient underwent ASD closure again. CONCLUSIONS: In this case report, we highlight that although percutaneous closure of an ASD is regarded as a routine procedure, clinicians should remember the possibility of complications, especially occluder loss and displacement. Therefore, interventionist should carefully evaluate the situation before intervention closure, establish standardized interventional treatment procedures, and provide timely treatment follow-up.

Snare device retrieval of occluder embolized in patent foramen ovale closure: A case report.

RATIONALE: Transcatheter interventional closure therapy is the main treatment method for patent foramen ovale (PFO). However, occluder abscission is a serious complication in PFO interventional therapy. Thus, timely and effective management of the occluder detachment is crucial for improving patient prognosis. PATIENT CONCERNS: A 52-year-old female patient was admitted to the Department of Neurology mainly due to "right upper limb weakness for two days, which aggravated for eight hours." The patient had no history of any other diseases. DIAGNOSES: The patient was diagnosed with an atrial septal defect (foramen ovale type) and cerebral infarction. INTERVENTIONS AND OUTCOMES: The occluder abscission was successfully removed after several attempts with the help of the snare device. LESSONS: When the PFO occlusion device is detached, interventional treatment would lead to minimal trauma, fast postoperative recovery, and a definite therapeutic effect. Based on mastering the indications and standardizing the operational process, this is a safe and effective minimally invasive treatment method.

Determinants of adverse outcomes following patent foramen ovale closure in elderly patients.

BACKGROUND: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly. AIMS: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events. METHODS: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted. RESULTS: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF. CONCLUSIONS: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

Deceptive Anteroseptal ST-segment Elevation and Brugada Pattern Caused by Isolated Conus Artery Occlusion. / Elevação Enganosa do Segmento ST Ântero-Septal e Padrão de Brugada Causado por Oclusão Isolada da Artéria do Cone.

The conus artery (CA) supplies the right ventricular outflow tract (RVOT). ST-segment elevation in leads V1-3, which can resemble Brugada electrocardiogram (EKG) patterns, has been reported due to occlusion of the CA. A 68-year-old male was admitted to the hospital with a diagnosis of non-ST-elevation myocardial infarction. A coronary angiogram revealed a dissection in the conus artery, most likely caused by the catheter. Due to the small caliber of the CA, medical therapy was chosen as the course of action. However, after the procedure, an EKG showed changes consistent with features of both type-1 and type-2 Brugada patterns, with ST-segment elevations in leads V1-4. Subsequent coronary imaging revealed that the CA had progressed to total occlusion. Despite multiple attempts to gain reentry into the true lumen, they were unsuccessful. Based on the risk-benefit ratio, the decision was made to continue with medical therapy. This is the first reported case of CA occlusion induced by catheter dissection, which manifested as anteroseptal ST-segment elevation. The patient did not report any anginal symptoms or arrhythmic events, which contrasts with conventional knowledge. Not all CA obstructions or RVOT infarcts cause Brugada-like patterns. When they do, ST elevations tend to be less than those in true Brugada syndrome.

A artéria do cone (AC) irriga a via de saída do ventrículo direito (VSVD). A elevação do segmento ST nas derivações V1-3, que pode assemelhar-se aos padrões de eletrocardiograma (ECG) de Brugada, foi relatada devido à oclusão da AC. Um paciente do sexo masculino, 68 anos de idade, foi internado no hospital com diagnóstico de infarto do miocárdio sem supradesnivelamento do segmento ST. Uma angiografia coronária revelou uma dissecção na AC, provavelmente causada pelo cateter. Devido ao pequeno calibre da AC, a terapia medicamentosa foi escolhida como curso de ação. No entanto, após o procedimento, um ECG mostrou alterações consistentes com características dos padrões de Brugada tipo 1 e tipo 2, com elevações do segmento ST nas derivações V1-4. A imagem coronariana subsequente revelou que a AC havia progredido para oclusão total. Apesar das diversas tentativas de obter a reentrada no lúmen verdadeiro, não houve êxito. Com base na relação risco-benefício, foi tomada a decisão de continuar com a terapia medicamentosa. Este é o primeiro caso relatado de oclusão da AC induzida por dissecção por cateter, que se manifesta como elevação ântero-septal do segmento ST. O paciente não relatou sintomas anginosos ou eventos arrítmicos, o que contrasta com o conhecimento convencional. Nem todas as obstruções da AC ou infartos da VSVD causam padrões semelhantes aos de Brugada. Quando isso ocorre, as elevações de ST tendem a ser menores do que as da verdadeira síndrome de Brugada.

Challenges and advances in device-related thrombus in left atrial appendage occlusion.

Oral anticoagulation therapy (OAC) is a mainstay for mitigating stroke and other embolic events in patients with atrial fibrillation (AF). Despite the demonstrated efficacy of OAC in reducing events, many patients are unable to tolerate OAC due to bleeding risks. Left atrial appendage occlusion (LAAO) devices were developed as implantable technologies to moderate stroke risk in patients with intolerance to OAC. Despite clinical data supporting near-comparable protection against thromboembolic events with OAC, device-related thrombus formation has emerged as a critical complication following LAAO that remains a potential limitation to the safety and efficacy of LAAO. Improved biocompatibility of LAAO devices with fluoropolymers, a well-established stent-coating technology used to reduce thrombus formation and promote endothelialization, may optimize outcomes after LAAO.

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Real-World Patent Foramen Ovale (PFO) Closure in Japan　- 30-Day Clinical Outcomes From the AmplatzerTM PFO Occluder Japan Post-Marketing Surveillance Study.

BACKGROUND: The AmplatzerTM PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients. METHODS AND RESULTS: PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the AmplatzerTM PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure. CONCLUSIONS: In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the AmplatzerTM PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.

Embolization of Patent Foramen Ovale Closure Device-Rare Complication and Unique Management Approach.

Percutaneous closure of the patent foramen ovale (PFO) is generally regarded as a safe and effective procedure, indicated in patients with a prior PFO-associated stroke. While it is highly safe, rarely, it could be accompanied by a migration of the device, mainly caused by the interplay of a specific PFO morphology and inappropriate device sizing. Herein, we outline a seldom-observed complication of an unintentional detachment of the PFO closure device during implantation, leading to its migration into the abdominal aorta, and a unique management approach. Due to the inability to recapture the occluder with a snare, which is considered to be a mainstay of endovascular retrieval methods, two coronary guidewires were maneuvered through the mesh of the occluder and then captured with a snare proximally to the occluder. This innovative dual-wire-snare system was carefully pulled to the common femoral artery, a position deemed suitable for surgical extraction via arteriotomy, which was achieved successfully.

Atrial Fibrillation After Patent Foramen Ovale Closure: Incidence, Pathophysiology, and Management.

This comprehensive review explores the incidence, pathophysiology, and management of atrial fibrillation (AF) following percutaneous closure of patent foramen ovale (PFO). Although AF is considered a common adverse event post PFO closure, its incidence, estimated at <5%, varies based on monitoring methods. The review delves into the challenging task of precisely estimating AF incidence, given subclinical AF and diverse diagnostic approaches. Notably, a temporal pattern emerges, with peak incidence around the 14th day after closure and a subsequent decline after the 45th day, mimicking general population AF trends. The pathophysiological mechanisms behind post PFO closure AF remain elusive, with proposed factors including local irritation, device-related interference, tissue stretch, and nickel hypersensitivity. Management considerations encompass rhythm control, with flecainide showing promise, and anticoagulation tailored to individual risk profiles. The authors advocate for a personalized approach, weighing factors like age, comorbidities, and device characteristics. Notably, postclosure AF is generally considered benign, often resolving spontaneously within 45 days, minimizing thromboembolic risks. Further studies are required to refine understanding and provide evidence-based guidelines.

Complete Percutaneous Retrieval of Migrated VSD Occluder Device from the Pulmonary Artery: Management of a Catastrophic Complication.

Transcatheter closure of muscular ventricular septal defects (VSD) remains a safe and effective method with low complication rates. However, device migration can pose a significant challenge to interventional cardiologists due to potential mortal consequences. A 21-year-old female presented to our clinic with exertional dyspnea and was diagnosed with a muscular VSD. The defect was percutaneously closed using an Amplatzer occluder device. On the first post-procedural day, the patient experienced repeated episodes of coughing and mild hemoptysis. Imaging revealed migration of the VSD occluder device to the right pulmonary artery (PA). Percutaneous retrieval of the device was then decided upon. The right PA was accessed using a hydrophilic guidewire and a pigtail catheter. This catheter was exchanged for an 8-Fr sheathless guide catheter, and a 6-Fr Judkins right catheter was advanced into the right PA through the sheathless guide catheter using the mother-and-child technique. Multiple attempts using a snare were made to retrieve the migrated device. Eventually, the proximal marker point, the hub of the device, was grasped and pulled back from the PA, then externalized through the sheath without the need for surgical cutdown. Our report represents a case of complete percutaneous retrieval of an embolized VSD occluder device from the PA.

A device-related fistula between coronary artery and left atrial appendage following left atrial appendage closure: Case presentation.

INTRODUCTION: Left atrial appendage (LAA) closure (LAAC) is considered a viable alternative to anticoagulation therapy for stroke prevention in nonvalvular atrial fibrillation, we report a case with a less common shunt resulting from a device-related coronary artery-appendage fistula (CAAF) following LAAC. METHODS AND RESULTS: A 67-year-old male with a history of LAAC was referred to our emergency room with recurrent chest pain and palpitations and was diagnosed with ischemic angina pectoris. Subsequent coronary angiography (CAG) revealed 70% in-stent restenosis and an abnormal shunt of contrast originating from the left circumflex artery (LCA) to the LAA tip which did not exist before. The restenosis was successfully dilated using a drug-coated balloon, the procedure was safely completed without pericardial effusion. The patient had been implanted with a LAmbre occluder (Lifetech Scientific Corp.) in the previous LAAC procedure. This occluder had a lobe-disk design, and the distal umbrella was not fully opened after release, particularly in the lower portion. This could make the hooks embedded on the umbrella contact the LAA wall more tightly, possibly resulting in microperforation and coincidental impingement of the LCA. The epicardial adipose and hyperplastic tissue then chronically wrapped the perforated site, prevented blood outflow into the epicardium, and ultimately formed a CAAF. CONCLUSION: CAAF is a rare complication after LAAC but may be underestimated, especially for lobe-disk designed occluders. Therefore, CAG is perhaps necessary to detect this complication.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

OBJECTIVES: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. METHODS: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. RESULTS: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. CONCLUSIONS: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

Risk Factors of Long-Term Sequelae After Transcatheter Closure of Perimembranous Ventricular Septal Defect in Young Children.

BACKGROUND: Complications arising from transcatheter closure of perimembranous ventricular septal defects (pmVSD) in children, such as residual shunts and aortic regurgitation (AR), have been observed. However, the associated risk factors remain unclear. This study identified risk factors linked with residual shunts and AR following transcatheter closure of pmVSD in children aged 2-12 years. METHODS AND RESULTS: The medical records of 63 children with pmVSD and a pulmonary-to-systemic blood flow ratio <2.0 who underwent transcatheter closure between 2011 and 2018 were analyzed with a minimum 3-year follow-up. The success rate of transcatheter closure was 98.4%, with no emergency surgery, permanent high-degree atrioventricular block, or mortality. Defects ≥4.5 mm had significantly higher odds of persistent residual shunt (odds ratio [OR] 6.85; P=0.03). The use of an oversize device (≥1.5 mm) showed a trend towards reducing residual shunts (OR 0.23; P=0.06). Age <4 years (OR 27.38; 95% confidence interval [CI] 2.33-321.68) and perimembranous outlet-type VSD (OR 11.94, 95% CI 1.10-129.81) were independent risk factors for AR progression after closure. CONCLUSIONS: Careful attention is crucial for pmVSDs ≥4.5 mm to prevent persistent residual shunts in transcatheter closure. Assessing AR risk, particularly in children aged <4 years, is essential while considering the benefits of pmVSD closure.