Percutaneous Patent Foramen Ovale Research Articles

Percutaneous Patent Foramen Ovale Closure: Stroke and Beyond.

Over 750,000 individuals suffer from stroke annually in the United States, with 87% of these strokes being ischemic in nature. Roughly 40% of ischemic strokes occur in individuals 60 years of age or under. A quarter of all ischemic strokes have no identifiable cause despite extensive workup and are deemed cryptogenic in nature. Patent Foramen Ovales (PFO) has been postulated in stroke causation by either paradoxical embolization or platelet activation in the tunnel of the defect. The incidence of PFO is reported to be 15-25% in the general population but rises to 40% in patients with cryptogenic stroke. While the initial trials evaluating PFO closures were non-revealing, subsequent long-term follow-ups, as well as recent trials evaluating PFO closures in cryptogenic stroke patients 60 years of age or under, demonstrated the superiority of percutaneous closure compared to medical therapy alone, leading to FDA approval of PFO closure devices. In this review, we review the diagnosis of PFO, postulated stroke mechanisms, literature supporting PFO closure, patient selection for percutaneous closure, procedural considerations, and associated procedural complications.

Recurrent decompression sickness in experienced divers treated with percutaneous patent foramen ovale closure.

Recurrent decompression sickness in experienced divers treated with percutaneous patent foramen ovale closure.

A very rare and unusual complication after a percutaneous patent foramen ovale closure.

A very rare and unusual complication after a percutaneous patent foramen ovale closure.

Microtransesophageal echocardiographic guidance of patent foramen ovale percutaneous closure

Abstract Introduction The important growth in the number of percutaneous patent foramen ovale (PFO) closure procedures requires to find alternatives to conventional guidance by transesophageal echocardiography (TEE) with general anesthesia (GA). The micro-TEE monitoring, with local anesthesia, could allow a reliable guidance with a reduced procedural length, without the need for GA. The objective of this study is to evaluate the effectiveness and safety of PFO closure guided by micro-TEE compared to conventional TEE under GA. Methods This retrospective single-center observational study included all consecutive patients admitted to our hospital, from January 2019 to June 2021 for PFO closure. The type of guidance was based on PFO’s morphological characteristics and patient’s choice. The primary endpoint was the successful implantation of at least one prosthesis without significant residual shunting (≤ grade 1). Key secondary endpoints were the procedure duration and periprocedural complications. Results A total of 237 patients (44% of female, mean age: 50 ± 14 years) were included, with TEE and micro-TEE guidance in 174 (73%) and 63 (27%) cases, respectively. Smaller devices were more frequently implanted among patients with micro-TEE compared to TEE guidance, with 59% vs. 44% respectively (p=0.04), reflecting cases selection on the basis of prior TEE. Overall, there was no case of procedural failure and the primary endpoint was obtained in 158 (91%) and 60 (95%) patients with TEE and micro-TEE guidance, respectively (p=0.27). Procedural duration was shorter with micro-TEE guidance (median time 8 (7-11)min versus 21 (16-27)min, p=0.01). The rate of peri-procedural complications was low (1.3% overall) and limited to periprocedural atrial arrhythmia, without significant differences in both groups (p>0.99). Conclusions Micro-TEE guidance may result in safe and shorter PFO percutaneous closure compared to TEE guidance with GA.These results obtained on selected patients must be confirmed on larger cohorts.

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.

TCT-579 The Incidence of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure Detected by Implantable Loop Recorders

TCT-579 The Incidence of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure Detected by Implantable Loop Recorders

Comparison of three echo-guidance techniques in percutaneous patent foramen ovale closure for stroke prevention: Conventional transoesophageal, microprobe transoesophageal and intracardiac echocardiography

BackgroundRecent randomized trials have demonstrated a consistent reduction in recurrent stroke after percutaneous transcatheter patent foramen ovale closure versus medical therapy in patients with recent cryptogenic stroke. AimTo compare the safety and efficacy of intracardiac echocardiography-guided and microprobe transoesophageal echocardiography-guided patent foramen ovale closure under local anaesthesia with transoesophageal echocardiography-guided patent foramen ovale closure under general anaesthesia. MethodsThis prospective observational single-centre study included 194 consecutive patients scheduled for patent foramen ovale closure for secondary prevention of stroke from February 2018 to December 2019. Patients were asked to choose between an intracardiac echocardiography-guided, microprobe transoesophageal echocardiography-guided or transoesophageal echocardiography-guided procedure. The primary endpoint was the rate of successful closure at 6 months, defined as correct positioning of the device without severe shunt on 6-month contrast echocardiography. ResultsSuccessful closure was high and did not differ between groups: 97.8% (95% confidence interval 88.5–99.9%) in the intracardiac echocardiography-guided group versus 96.9% (95% confidence interval 83.8–99.9%) in the microprobe transoesophageal echocardiography-guided group and 99.1% (95% confidence interval 95.3–99.9%) in the transoesophageal echocardiography-guided group (P=0.63). Adverse events related to patent foramen ovale closure were low and did not differ between groups. ConclusionOur preliminary real-world experience suggests good efficacy and safety with intracardiac echocardiography and microprobe transoesophageal echocardiography guidance compared with conventional transoesophageal echocardiography guidance for percutaneous transcatheter patent foramen ovale closure in recurrent stroke prevention.

New-onset atrial fibrillation after percutaneous patent foramen ovale closure: a meta-analysis

BackgroundThe exact incidence and predictors of new-onset atrial fibrillation (AF) after percutaneous closure of patent foramen ovale (PFO) are unknown.ObjectiveWe sought to find post-procedural AF incidence rates and differences due to different screening strategies and devices.MethodsA systematic search was conducted in Cochrane, MEDLINE and EMBASE. Controlled trials fulfilling the inclusion criteria were included into this meta-analysis. The incidence of new-onset AF was the primary outcome. Further parameters were surveillance strategy, device type, AF treatment and neurological events. New AF was determined as early onset within one month after implantation and late thereafter.Results8 controlled trials and 16 cohort studies were eligible for quantitative analysis. 7643 patients received percutaneous PFO closure after cryptogenic stroke or transient ischaemic attack, 117 with other indications, whereas 1792 patients formed the control group. Meta-analysis of controlled trials showed an AF incidence of 5.1% in the interventional and 1.6% in the conservative arm, respectively (OR 3.17, 95% CI 1.46–6.86, P = 0.03, I2 = 55%). 4.7% received high-quality surveillance strategy with Holter-ECG or Loop recorder whereby AF incidence was overall higher compared to the low-quality group with 12-lead ECG only (3.3–15% vs. 0.2–4.3%). Heterogeneous results on time of AF onset were found, limited by different follow-up strategies. CardioSEAL and Starflex seemed to have higher AF incidences in early and late onset with 4.5% and 4.2%, respectively.ConclusionPercutaneous PFO closure led to higher AF post-procedural incidence compared to the conservative strategy. Heterogeneity in surveillance and follow-up strategy limited the generalizability.Trial RegistrationRegistered on PROSPERO (CRD42022359945).Graphical abstract

Antiplatelet Therapy May Be Insufficient to Prevent Stroke Recurrence Before Percutaneous Patent Foramen Ovale Closure.

Antiplatelet Therapy May Be Insufficient to Prevent Stroke Recurrence Before Percutaneous Patent Foramen Ovale Closure.

Microtransesophageal echocardiographic guidance of patent foramen ovale percutaneous closure

The important growth in the number of percutaneous patent foramen ovale (PFO) closure procedures requires to find alternatives to conventional guidance by transesophageal echocardiography (TEE) with general anesthesia (GA). The micro-TEE monitoring, with local anesthesia, could allow a reliable guidance with a reduced procedural length, without the need for GA. The objective of this study is to evaluate the effectiveness and safety of PFO closure guided by micro-TEE compared to conventional TEE under GA. This retrospective single-center observational study included all consecutive patients admitted to the Pitié-Salpêtrière hospital, from January 2019 to June 2021 for PFO closure. The type of guidance was based on PFO's morphological characteristics and patient's choice. The primary endpoint was the successful implantation of at least one prosthesis without significant residual shunting (≤ grade 1). Key secondary endpoints were the procedure duration and periprocedural complications. A total of 237 patients (44% of female, mean age: 50 ± 14 years) were included, with TEE and micro-TEE guidance in 174 (73%) and 63 (27%) cases, respectively. Smaller devices (i.e. Amplatzer PFO occluder™ 18/25 or Occlutech Figulla Flex II 23/25™) were more frequently implanted among patients with micro-TEE compared to TEE guidance, with 59% vs. 44% respectively (P = 0.04). Overall, there was no case of procedural failure and the primary endpoint was obtained in 158 (91%) and 60 (95%) patients with TEE and micro-TEE guidance, respectively (P = 0.27). Procedural duration was shorter with micro-TEE guidance [median time 8 (7–11)min versus 21 (16–27)min, P = 0.01]. The rate of periprocedural complications was low (1.3% overall) and limited to periprocedural atrial arrythmia, without significant differences in both groups (P > 0.99). Micro-TEE guidance may result in safe and shorter PFO percutaneous closure compared to TEE guidance with GA. These results must be confirmed on larger cohorts. TEE and micro-TEE durations (Fig. 1).

Feasibility, efficacy and safety of PFO closure under local anesthesia with transoesophageal echocardiography microprobe: A single-center study of 383 patients

Percutaneous patent foramen ovale (PFO) closure is usually performed under general anesthesia (GA) with guidance by transesophageal echocardiograpy (TEE). Microrobe makes this procedure possible under local anesthesia (LA). Our study aimed to assess the feasibility, efficacy and safety of PFO closure under LA with microprobe guidance. The aim was to evaluate the rate of PFO closure failure in patients who underwent a procedure under LA with a TEE microprobe (micro-LA group) vs. under GA with a conventional probe (conventional-GA group). The primary endpoint was the persistence of inter-atrial shunt (> 10 microbubbles) 6 months after procedure, screened by contrast transthoracic ultrasound. The secondary objectives were: identification of risk markers for the persistence of inter-atrial shunt at 6 months, post-procedure complication rates and major cardiovascular events rate. Three hundred and eighty three patients were included: 303 (79%) in the conventional-GA group, 79 (21%) in the micro-AL group. The median follow-up was 28.0 (14.0–49.0) months. The average age was 49.9 ± 12.6 years, 61.9% of men. There was no failure of PFO closure under AL. Six months after PFO closure, there was no difference in persistence of inter-atrial shunt between the conventional-GA group and the micro-AL group (29.3% vs. 25.5%, P = 0.583). There was no difference in the occurrence of complications related to the procedure between the 2 groups. In multivariate analysis, the presence of interatrial septal aneurysm [OR 1.88 (95% CI 1.07–3.31), P = 0.029], ROPE score > 6 [OR 1.22 (1.04–1.43), P = 0.015] and the occurrence of stroke following the procedure [OR 4.48 (1.12–17.87), P = 0.034] were independently associated with the presence of a residual inter-atrial shunt at 6 months. Our study identified that PFO closure under LA with TEE microprobe is feasible and safe. There was no difference in efficacy of 6-month FOP closure, regardless of conventional-GA or micro-AL method.

Analysis of Risk Factors Related to the Efficacy of Foramen Ovale Closure as a Therapy for Migraine.

This study aimed to monitor the incidence of migraine non-remission after percutaneous patent foramen ovale (PFO) closure and to discuss relevant risk factors. Recently, evidence of a relationship between the presence of PFO and migraines has been found, and PFO closure has been pointed out as a possible treatment for migraineurs.A retrospective analysis was conducted, which involved 139 patients diagnosed with PFO and associated migraine who underwent percutaneous PFO closure in The First Affiliated Hospital of Zhengzhou University from October 2019 to April 2021. All the considered patients were evaluated using the Headache Impact Test (HIT-6™) and classified with a score higher than 55 points before closure. The HIT-6™ score was re-evaluated 1-6 months after the intervention. HIT-6™ ≤ 55 was defined as headache remission (n = 93) and > 55 as headache non-remission (n = 46). A logistic regression model was developed to identify the risk factors of headache non-remission after PFO closure.The incidence of headache non-remission after PFO closure was 33.09%. Statistically significant differences were observed between the two groups as regards age and serum phosphorus level (P < 0.05). History of smoking, atrial fibrillation, absolute lymphocyte count, platelet-to-lymphocyte ratio, and interventricular septal thickness were identified as independent risk factors for headache non-remission following PFO closure, which were statistically significant (P < 0.05).

Falência do Dispositivo Noblestitch após Encerramento Percutâneo de Foramen Ovale Patente em um Caso de Síndrome de Platipneia-Ortodeoxia: Será Este Dispositivo para Todos os Doentes?

O forame oval patente (FOP) é uma lesão cardíaca congênita comum, correspondendo a uma comunicação interatrial fetal normal que tipicamente fecha com a fusão do septum primum ao septum secundum após o nascimento. Quando persiste, o forame oval geralmente é assintomático e benigno, sem necessidade de tratamento. Em casos raros, pode ter implicação na patogênese de algumas doenças como a síndrome de platipneia-ortodeóxia (SPO). Nesse contexto, pode ser indicado o fechamento do FOP. Vários dispositivos de oclusão tradicionalmente baseados em disco duplo demonstraram que o fechamento percutâneo do FOP é possível. Apesar da eficácia comprovada, o uso destes dispositivos não é tecnicamente viável para alguns pacientes. Além disso, eles têm o potencial de causar algumas complicações. NobleStitch EL (NS) é uma técnica alternativa de fechamento percutâneo do FOP disponível na Europa, com marcação comissão europeia (CE) para sutura cardiovascular e fechamento de FOP, e nos EUA, com liberação da Food and Drug Administration (FDA) para sutura vascular e cardiovascular. Consiste em um sistema “sem dispositivos” com dois cateteres dedicados para colocação de sutura. , Até o momento, a experiência com o dispositivo NS é limitada e ainda faltam informações sobre determinantes de falha, o que ajudaria na seleção de pacientes.

Noblestitch Failure After Percutaneous Patent Foramen Ovale Closure in a Case Of Platypnea-Orthodeoxia Syndrome: Is this Device Suitable for All Patients?

Noblestitch Failure After Percutaneous Patent Foramen Ovale Closure in a Case Of Platypnea-Orthodeoxia Syndrome: Is this Device Suitable for All Patients?

Correlation between percutaneous patent foramen ovale closure and recurrence of unexplained syncope.

The relationship between patent foramen ovale (PFO) and unexplained syncope remains to be illustrated. Therefore, this study aimed to explore the outcomes and prognostic factors for syncope recurrence after PFO closure. Patients with both large right-to-left shunting (RLS) PFO and unexplained syncope who visited the cardiovascular department of Xiangya Hospital Central South University from 1 January 2017 to 31 December 2021 were consecutively enrolled in our study. The recurrence rate of syncope was compared between the non-closure group (n = 20) and the closure group (n = 91). A total of 111 patients were finally included. After 31.11 ± 14.30 months of follow-up, only 11% of patients in the closure group had recurrent syncope, which was much lower than that of the non-closure group (11.0 vs. 35%, P = 0.018). We further investigated the possible prognostic factors for syncope recurrence in the closure group and found syncope occurring more than five times preoperatively, hypertension, and residual RLS at 12-month follow-up were significantly correlated with a higher number of recurrences. PFO closure reduced the recurrence rate of unexplained syncope. The efficacy of prevention was prognosticated by factors including the presence or absence of syncope induction, the frequency of syncope episodes, and the presence or absence of hypertension. Syncope recurrence was also related to residual shunts post closure.

Platypnea-Orthodeoxia Syndrome in an Elderly Patient Treated with Percutaneous Patent Foramen Ovale Closure: Report of a Case and Review of the Literature

Platypnea-Orthodeoxia Syndrome in an Elderly Patient Treated with Percutaneous Patent Foramen Ovale Closure: Report of a Case and Review of the Literature

Readmission in patients undergoing percutaneous patent foramen ovale closure in the United States

Current estimates suggest that a patent foramen ovale (PFO) may exist in up to 25% of the general population and is a potential risk factor for embolic, ischemic stroke. PFO closure complications include bleeding, need for procedure-related surgical intervention, pulmonary emboli, device malpositioning, new onset atrial arrhythmias, and transient atrioventricular block. Rates of PFO closure complications at a national level in the Unites States remain unknown. To address this, we performed a contemporary nationwide study using the 2016 and 2017 Nationwide Readmissions Database (NRD) to identify patterns of readmissions after percutaneous PFO closure. In conclusion, our study showed that following PFO closure, the most common complications were atrial fibrillation/atrial flutter followed by acute heart failure syndrome, supraventricular tachycardia and acute myocardial infarction.

TCT-316 Long Term Outcome of Percutaneous Patent Foramen Ovale Closure in Patients Above 60 Years Old

TCT-316 Long Term Outcome of Percutaneous Patent Foramen Ovale Closure in Patients Above 60 Years Old

Advances in Percutaneous Patent Foramen Ovale Closure: From the Procedure to the Echocardiographic Guidance.

Percutaneous patent foramen ovale (PFO) closure by traditional, double disc occluder devices was shown to be safe for patients with PFO, and more effective than prolonged medical therapy in preventing recurrent thromboembolic events. The novel suture-mediated “deviceless” PFO closure system overcomes most of the risks and limitations associated with the traditional PFO occluders, appearing to be feasible in most interatrial septum anatomies, even if data about its long-term effectiveness and safety are still lacking. The aim of the present review was to provide to the reader the state of the art about the traditional and newer techniques of PFO closure, focusing both on the procedural aspects and on the pivotal role of transesophageal echocardiography (TEE) in patient’s selection, peri-procedural guidance, and post-interventional follow-up.

Percutaneous Patent Foramen Ovale Closure in a Patient With Anomalous Aortic Origin of the Left Coronary Artery

Percutaneous Patent Foramen Ovale Closure in a Patient With Anomalous Aortic Origin of the Left Coronary Artery