Percutaneous Patent Foramen Ovale Research Articles

Predictors of Residual Right to Left Shunt in Patients Undergoing Percutaneous Transcatheter Patent Foramen Ovale Closure: A New Clue “Inferior Vena Cava-Patent Foramen Ovale Angle”

Background: Many different devices are currently used for percutaneous patent foramen ovale (PFO) closure (pPFOc), aiming to achieve complete occlusion to prevent recurrent embolism. We aimed to reveal the association between residual right-to-left shunt (RLS) after pPFOc and baseline structural features of the PFO determined using transoesophageal echocardiography (TEE) before the procedure. Methods: This is a single-center cross-sectional study. A total of 123 patients who underwent pPFOc for cryptogenic stroke (CS) were screened, consecutively. Patients were compared based on the presence of residual RLS. The association of structural features of the PFO with residual RLS was evaluated using logistic regression analysis. Results: The procedure was successfully completed in a total of 103 patients included in the study after exclusion and 21% had significant residual RLS. During a median follow-up of 18 months, one patient died at 25 months due to malignancy, recurrent CS were observed in 5 (5%) patients, and atrial fibrillation was detected in 3 (3%) patients. No significant difference was observed in the baseline clinical characteristics and laboratory parameters among the patients. In addition to atrial septal aneurysm (ASA), aortic rim, tunnel width and length; inferior vena cava (IVC)-PFO tunnel angle was associated with residual RLS with a cut-off 11.3 (AUC: 0.786, 64% sensitivity, 87% specificity, p < 0.001). In individuals with residual RLS, longer and wider tunnel size, rudimentary aortic rim, acute IVC-PFO tunnel angle, and decreased tunnel length-left disc ratio were observed. Conclusions: IVC-PFO tunnel angle is a novel parameter and provides benefit to detect significant RLS in pPFOc patients.

Incidence, determinants, and impact of in-hospital complications during percutaneous patent foramen ovale closure

Abstract Introduction The incidence, types, determinants, and clinical impact of in-hospital complications after contemporary patent foramen ovale (PFO) percutaneous closure is unclear. Purpose To describe the incidence, types, determinants, and clinical impact of in-hospital complications after percutaneous PFO closure. Methods This study included consecutive patients undergoing PFO percutaneous closure for any indication in 18 centers in France and Italy from the ongoing AIR-FORCE registry. Periprocedural complications were collected, including death, bleeding, myocardial infarction (MI), supraventricular arrhythmia, pericardial effusion or tamponade, cardiac perforation, device embolization, intracardiac thrombus, venous thrombosis, atrioventricular block, brachial paraesthesia, oesophageal hematoma, and veno-arterial fistula. Determinants of periprocedural complications were evaluated using a logistic multivariate model. The clinical impact of periprocedural complications on cardiovascular events after discharge measured by the composite endpoint of death, stroke, transient ischemic attack, MI atrial arrhythmia, pulmonary embolism, deep veinous thrombosis, BARC ≥2 bleeding, or percutaneous or surgical re-intervention on the PFO) at longest follow-up was evaluated using a Cox model adjusted on age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and shunt severity prior to closure. Results We analyzed a total of 2,799 patients undergoing PFO closure with median age 50.7 [41.7-58.6] years and 57.9% male. A total of 109 (3.9% 95%CI 3.2%-4.7%) patients presented at least one in-hospital complication, the most frequent being supraventricular arrhythmia in 39 (1.4% 95%CI 1.0-1.9%) patients and BARC bleeding type ≥2 in 26 (0.9% 95%CI 0.6-1.4%) patients. Determinants of in-hospital complications were older age (per on year aOR 1.02 95%CI 1.01-1.04), diabetes mellitus (aOR 2.58 95%CI 1.36-4.89) and PFO closure for secondary prevention of an arterial embolic event (aOR 2.12 95%CI 1.18-3.82). With a median follow-up of 1.1 [0.3-3.1] years, the occurrence of an in-hospital complication was associated with an increased risk of cardiovascular events after discharge (aHR 1.90 95%CI 1.26-2.89) (Figure 1). Conclusions Although relatively rare, the occurrence of in-hospital complication during PFO percutaneous closure is associated with an increased risk of cardiovascular events in the year following the procedure.

Prevalence, determinants, and impact of significant shunt after percutaneous patent foramen ovale closure

Abstract Introduction Percutaneous closure of patent foramen ovale closure is increasingly performed for secondary prevention of PFO-related arterial embolic event. The clinical significance of postclosure residual right-to-left significant shunt remains unclear. Purpose To describe the prevalence, determinants, and clinical impact of a significant post-closure. Methods The AIR-FORCE is an ongoing prospective international registry of patients undergoing PFO closure from 19 centers in France, Canada and Italy. Only patients undergoing PFO for secondary prevention of an arterial embolic event with at least one available post-closure contrast transthoracic echocardiography (TTE) with agitated saline injection and Valsalva maneuvers were analyzed. Residual shunt was categorized according to the number of bubbles in the left atrial within 3 cardiac cycles at the first available contrast TTE as small (<10), moderate (10-20) or severe (> 20). Determinants of the presence of moderate or severe shunt were evaluated with multivariate logistic regression and its impact on the primary outcome (stroke, transient ischemic attack or peripheral arterial emboly) was evaluated with Cox model adjusted on age and sex. Results A total of 2413 patients, with a median age of 49.3 [40.4-57.4] years, 56% male, undergoing PFO closure between 2001 and 2023 were included. The first contrast TTE, which was performed after a median delay of 3.4 [0.9-5.8] months, reported the presence of moderate or severe residual shunt in 214 (8.9% 95%CI 7.8-10.1) patients. Determinants of the presence of moderate or severe residual shunt at the first contrast TTE were decreased body mass index (per 1kg/m², aOR 0.96 95%CI 0.93-0.99), severe shunt prior to PFO closure (aOR 3.54 95%CI 2.25-5.55) and increased device left disc diameter (per 1mm, aOR 1.08 95%CI 1.05-1.12). With a median follow-up of 2.2 [0.9-4.9] years, a total of 60 events were reported and the presence of moderate or severe residual shunt was associated with an increased risk of the primary outcome (aHR 2.46 95%CI 1.15-5.24) (Figure 1). Conclusions A moderate to severe residual right-to-left intracardiac shunt is not uncommon after PFO percutaneous closure and seems to be associated with an increased risk of arterial emboly recurrence.

Influence of procedural timing on the preventive yield of percutaneous patent foramen ovale closure

BackgroundThe benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC...

Persistence of residual shunt at 6 and 12 months after transoesophageal echocardiography-guided percutaneous closure of a patent foramen ovale for cryptogenic stroke

BackgroundYoung patients suffering from cryptogenic stroke alongside a patent foramen ovale (PFO) are often considered for percutaneous device closure to reduce the risk of stroke recurrence. Residual right-to-left shunt after...

Shortened Duration of Dual Anti-Platelet Therapy After Percutaneous Patent Foramen Ovale and Atrial Septal Defect Closure

Shortened Duration of Dual Anti-Platelet Therapy After Percutaneous Patent Foramen Ovale and Atrial Septal Defect Closure

Transesophageal echocardiography guidance for percutaneous closure of PFO and a new method to improve the diagnosis and safety during the procedures.

Percutaneous patent foramen ovale (PFO) closure is becoming more and more common for the treatment or prevention of PFO-associated right-to-left shunt (RLS). This study aims to investigate the value of transesophageal echocardiography (TEE) in percutaneous PFO closure, and to explore a new method that can improve intraoperative diagnosis and surgical safety. Based on our inclusion and exclusion criteria, we enrolled 73 patients between 16 and 70 years old (average age 43.25 ± 14.87 years) who underwent percutaneous PFO closure at the Department of Cardiac Surgery, Zhongshan Hospital (Xiamen), Fudan University, from January 2022 to December 2023. Out of the 73 enrolled patients, there were 28 males (38.36%) and 45 females (61.64%), 29 migraine patients (39.73%), 14 patients (19.19%) with headache and dizziness, 14 patients (19.18%) with a history of cerebral infarction (CI), and 25 patients (34.25%) with CI, lacunar infarction or ischemic focus on magnetic resonance imaging (MRI). All patients received routine transthoracic echocardiography (TTE) and agitated saline contrast echocardiography (ASCE) before operations. Percutaneous closure of PFO was completed under the guidance of TEE. In 12 patients, the method of "injection of heparinized sterile saline through the delivery sheath" was used to observe their RLS, and the anatomical characteristics of the PFO according to the shunt path were monitored and evaluated. This method was also applied to some patients to guide the conveyor to pass through the foramen ovale (FO) channel safely and effectively, thereby improving the success rate of PFO closure. The application of TEE during the procedure of percutaneous PFO closure, including preoperative evaluation, intraoperative guidance, and postoperative reevaluation, can offer further details about the anatomical and shunt characteristics of PFO, improve the diagnosis rate, and confirm the safety of the surgical path. It ensures the safety and reliability of the whole operation, greatly improving the success rate and reducing postoperative complications. TEE guidance of percutaneous PFO closure has the advantages of minimal trauma, no radiation and real-time visualization, while injecting heparinized sterile saline through the delivery sheath is safer and more effective in improving the success rate and reducing postoperative complications.

Impact of Post-Procedural Atrial Fibrillation on Anti-Thrombotic Therapy After Percutaneous Patent Foramen Ovale Closure

Impact of Post-Procedural Atrial Fibrillation on Anti-Thrombotic Therapy After Percutaneous Patent Foramen Ovale Closure

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

BackgroundPatent foramen ovale (PFO) is seen in 25% of the general population but in up to 50% of patients ≤60 years old with cryptogenic strokes. Trials have shown that PFO closure vs medical therapy reduces the risk of future strokes. PFO closure may cause atrial fibrillation (AF), with prior trials reporting an incidence of 2% to 11.9%. However, the true incidence of AF after PFO closure is unknown due to limitations in prior studies for long-term monitoring. MethodsThis is a retrospective observational study at a single center. Patients who underwent PFO closure and had an implantable loop recorder prior to PFO closure were included. The final review included 38 patients who had at least 2 months of implantable loop recorder data post-PFO closure. ResultsTen out of 38 (26%) patients developed AF post-PFO closure. The median time to the first episode of AF was 3.95 weeks, with 40% having their first AF episode after 3 months. Median duration of AF episodes was 1 hour. One hundred percent had spontaneous termination of AF. Of the AF patients, 70% were started on oral anticoagulant therapy. ConclusionsOur review shows a higher incidence of AF post-PFO closure as compared with most reported prior studies. We recommend larger prospective studies to explore the true incidence of AF post-PFO closure, its clinical impact, and subsequent stroke risk.

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.

A Retrospective Analysis of Self-Limiting Fever following Percutaneous Patent Foramen Ovale and Atrial Septal Defect Closure.

While percutaneous closure of patent foramen ovale (PFO) and atrial septal defect (ASD) are generally well-tolerated procedures, the development of postprocedure fever has been observed at a higher frequency than reported in the initial device trials. We performed a retrospective analysis of 62 patients who underwent PFO or ASD closure from January 1, 2020, to December 31, 2022, at Mayo Clinic, Arizona. Eight patients out of 62 (12.9%) developed fever following PFO or ASD closure. In each of the fever cases, the Gore Cardioform devices (W.L. Gore and Associates, Flagstaff, AZ) were used. No association was found between clinical characteristics or procedural details and the development of fever. The reactions occurred 24 to 48 hours following device implantation and resolved spontaneously. No evidence of infection was found upon diagnostic evaluation. There was a higher incidence of self-limited atrial fibrillation (AF) in the fever patients (37.5% vs. 18.5%) which was not statistically significant. All patients who developed fever had successful closure with no other subsequent clinical events. We have found a high incidence of fever following PFO or ASD closure using the Gore family of devices that has not been observed in prior years. A unifying etiology or risk factor, such as infection or medication, for the fever could not be identified. Long-term device success was achieved in all fever patients. This small retrospective study suggests that the observed fever is benign and self-limiting but further investigation is warranted to determine its true incidence, mechanism, and prognosis.

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).