Patent Foramen Ovale Closure Research Articles

The RISE Study: Retrospective Registry for the International Safety and Efficacy Results of Patent Foramen Ovale Closure with Figulla Flex Il PFO and UNI Occluders.

Background: Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. Methods: We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. Results: 527 patients were included. Mean age was 48.9 (±13.8) years. The procedure was under transthoracic, transesophageal or intracardiac echocardiography in 185 (35.1%), 193 (36.6%) and 149 (28.3%) cases, respectively, and under general anesthesia in 191 patients (36.2%). The FFP and FFU were used in 408 (77.4%) and 119 (22.6%) cases, respectively. The success rate was 99.1%. Median follow-up was 1.1 (0.5-2.5) years. A new atrial fibrillation/flutter within six months occurred in 14 (2.7%) cases, with no difference between devices. One device embolization in the pulmonary artery was identified two years post-procedure. Residual shunts occurred in 18 (6.9%) cases at 1 year, with TIA in three (16.6%) patients. Out of 437 patients with stroke/TIA, 260 (59%) were followed more than one year after closure. Median follow-up was 2.1 (1.17-3.1) years, with four recurrent strokes/TIA. Conclusions: The FFP and FFU devices are safe and effective for PFO closure, with very few atrial fibrillation/flutter and neurologic events, except in cases with a residual shunt.

Patent foramen ovale closure versus drug therapy in patients over 60 years and a follow-up of 5 years.

The advantages of patent foramen ovale (PFO) closure as protection from a recurrence of stroke remains controversial compared to drug therapy, especially in patients over 60 years. The aim of the study is to compare recurrence of stroke in patients over 60 years old with PFO closure versus drug therapy alone. We included 342 patients over 60 years who suffered a crytopgenic stroke, and were also accepted for a PFO closure. 199 patients refused a PFO closure and were treated with medical therapy alone, whereas 143 patients underwent a PFO closure procedure. The mean follow up time was 5.5 ± 1.5 years. All patients in Group B showed persistent shunt in the follow-up period (n = 199, 100%). In Group A, seven patients were diagnosed with residual shunt during echocardiography examination (5%). A new onset of atrial fibrillation occurred in seven patients in Group A (5%) and six patients in Group B (3%), p = .117. Recurrent stroke occurred in 3 patients in Group A (2%) and 11 patients in Group B (6%), p = .021. One patient died of unknown reason (1%) and two patients were lost due to neurological death (1%) in Group B, whereas no patients in Group A died during the follow-up period. Our results show that strict exclusion of patients over 60 years from PFO closure should be reconsidered. As life expectancies are increasing, patients should be considered for same treatment as younger patients, since the outcomes are improved compared to patients treated with medical therapy alone.

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.

Assessment of the Characteristics of Patent Foramen Ovale Associated with Cryptogenic Stroke.

This study aims to comprehensively assess the characteristics of patent foramen ovale (PFO) in relation to Cryptogenic Strok (CS) by utilizing transesophageal echocardiography (TEE) and contrast transthoracic echocardiography (c-TTE) and to identify high-risk factors associated with PFO-related CS. Transcatheter PFO closure has demonstrated its effectiveness in preventing PFO-related CS. Therefore, understanding the specific structural attributes of PFO associated with CS is imperative. Enrollment comprised 113 test patients who experienced CS in conjunction with PFO and 117 control patients diagnosed with migraine with PFO but without a history of stroke. The characteristics of the PFO were observed by TEE and c-TTE. A comparative analysis was undertaken to assess the variations in PFO characteristics between the test patients and controls, and to uncover the independent factors relevant to CS. The patients in the test group were older than the controls. Both the height and length of the PFO during Valsalva exhibited greater dimensions in the test group when contrasted with controls. Notably, the test group presented higher incidence rates of low-angle PFO (defined as an angle between the inferior vena cava (IVC) and PFO ≤ 10°) and atrial septal aneurysm (ASA) as contrasted with the control group. Right-to-left shunt (RLS) III during Valsalva demonstrated a significantly elevated occurrence within the test group as opposed to the controls. Conversely, RLS II during Valsalva exhibited a significantly higher frequency in the controls in contrast to the tests. No significant disparities were observed between the two groups with respect to RLS I during Valsalva and all grades of RLS at rest. Multivariate analysis revealed that the length of the PFO during Valsalva, the presence of ASA, RLS III during Valsalva and low-angle PFO were independent relevant factors associated with CS. The length of the PFO tunnel, low-angle PFO, RLS III during Valsalva and the presence of ASA were independent risk factors for CS. The combined utilization of TEE and c-TTE may prove valuable in identifying PFO patients at a heightened risk of CS and in facilitating the screening process for transcatheter PFO closure.</p>.

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

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. 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. 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. PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

Antithrombotic Therapy Following Structural Heart Disease Interventions: Current Status and Future Directions.

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it's crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations.

Same-day discharge after elective percutaneous closure of patent foramen ovale.

Percutaneous closure of the patent foramen ovale (PFO) is increasingly performed in specific patients with cryptogenic stroke or clinical evidence of a paradoxical embolism. This study was performed to determine the safety of same-day discharge (SDD) following such procedures. This is a prospective, observational study of patients undergoing elective percutaneous PFO closure in a single tertiary center in Portugal between January 2020 and July 2023. AmplatzerTM devices (St. Jude Medical, St. Paul, MN, USA) and NobblestichTM EL (HeartStitch, Inc., Fountain Valley, CA, USA) were used. After 6 months, the following events were looked at: post-procedural paroxysmal atrial fibrillation, stroke, unplanned cardiac re-hospitalization, urgent cardiac surgery, major vascular complications, pericardial effusions, device embolization, and death. We studied 122 consecutive patients (52% female, 68; 48±12 years old) who had elective percutaneous closure with success and no complications. Forty-nine (40%) had SDD. AmplatzerTM devices were used more frequently in the SDD group, while NobblestichTM EL was more common in the overnight group. During the overnight group's follow-up period, there was one non-cardiovascular death; there were no further events. SDD after elective percutaneous closure of PFO was shown to be a safe and successful patient management method, including NobblestichTM, which we describe for the first time. Our results prove the safety of this same-day discharge strategy. We hypothesize that in the near future, in selected cases, PFO closure might become an ambulatory procedure.

Unusual Cause of Acute Stroke in a Young Woman with Patent Foramen Ovale - Duplicated Inferior Vena Cava and May-Thurner Syndrome.

The etiology of acute ischemic stroke (AIS) may often remain uncertain despite diligent work-up, especially in young people. Although patent foramen ovale (PFO) is a frequent association during such work-up, the actual source of thromboembolism, like deep vein thrombosis (DVT), may not be found. Such associative pathology makes it challenging to prescribe anticoagulation for secondary stroke prevention. We describe a young woman with a known history of PFO who presented with AIS and underwent endovascular reperfusion therapy. Post-thrombectomy, she developed hypoxic respiratory failure due to pulmonary embolism. Initiation of therapeutic anticoagulation was complicated by a retroperitoneal bleed necessitating imaging studies for etiological work-up. Computed tomographic angiography and venogram showed no active contrast extravasation but demonstrated duplication of the inferior vena cava with DVT in the right iliofemoral vein (RIFV). The proximity of the right common iliac artery compressing RIFV against the pelvic inlet is described as May-Thurner syndrome (MTS). Afterward, the patient was successfully treated with anticoagulation and PFO closure. MTS is a rare and underdiagnosed cause of iliofemoral DVT. In patients with known PFO, MTS is a possible cause that needs consideration. Hence, appropriate diagnostic tests are necessary to initiate appropriate management and to prevent AIS recurrence.

Abstract 92: Impacts of a Multidisciplinary Brain Heart Team on Patent Foramen Ovale Closure in Patients With Cryptogenic Stroke

Background: The AHA/ASA 2021 Secondary Stroke Prevention Guideline recommends a joint decision by neurology and cardiology for patent foramen ovale (PFO) closure. The impact of a Brain Heart Team (BHT) consisting of interventional cardiologists and vascular neurologists to evaluate PFO closure is unclear. We analyzed whether a BHT implementation led to more guideline recommended PFO closures based on Risk of Paradoxical Embolism (RoPE) score and PASCAL categories across a 15-hospital system. Methods: Data were collected retrospectively between 1/2016 - 2/2023. Baseline demographics, risk factors, method of shunt identification, high-risk shunt features, post PFO atrial fibrillation and stroke rates, RoPE score and PASCAL categorization were abstracted. Non-BHT was defined as absence of vascular neurology involvement. Appropriate PFO closure was defined as RoPE score &gt; 7 and/or PASCAL categories of possible/probable. Chi-squared and t-test were used. Results: Of 174 patients, 108 (62%) were identified as BHT and 66 (38%) as non-BHT. There were no differences in baseline risk factors between BHT and non-BHT besides hyperlipidemia (28.7% vs 53% p &lt; .002) and smoking history (12% vs 31.8% p &lt; .003). BHT patients were younger at age of diagnosis and PFO closure (44.8 yrs ±1.7 vs 56 yrs ±1.2 p=0.003 and 44.7 yrs ±1.9 vs. 56 yrs ±1.3 p=0.004 respectively). There were differences in race/ethnicity (Table 1). More BHT patients had possible/probable PASCAL vs non-BHT (101 [93.5%] vs 44 [66.7%], p &lt;0.001). Patients in BHT had higher mean RoPe scores (7.34 ± 1.55 vs 6.06 ± 2.02 p &lt;0.001). More patients in BHT had a RoPE score &gt; 7 (77 [71.3%] vs 26 [39.4%] p &lt;0.001). There were no differences in atrial fibrillation (5 [4.6%] vs 5 [7.6%] p = 0.635) or stroke after PFO closure (2 [1.9%] vs 2 [3%] p = 1). Conclusion: Implementing a multi-disciplinary approach with a Brain Heart Team leads to more guideline based PFO closures in cryptogenic strokes based on PASCAL and RoPE scores.

Abstract TP265: Comparison of Medical Therapies on Outcomes From Index Vascular Event to PFO Closure

Introduction: Recent trials have shown the benefit of PFO closure in recurrent stroke prevention. The literature has shown the benefit of PFO closure plus medical therapy versus medical therapy alone. In subgroup analyses of prior studies, recurrent stroke events between medical therapy only groups found decreased stroke recurrence in the anticoagulation (AC) group when compared to the antiplatelet (AP) group. The timeline of investigation was also notably over multiple years. There is no standardized practice to dictate appropriate AC/AP therapy in the setting of stroke secondary to PFO prior to closure. This study aims to compare recurrent stroke risk of AC versus AP therapy in the interim from index stroke/TIA to PFO closure in a more limited timeline. Methods: The study design was a retrospective cohort study, including patients discussed at an institution’s multi-disciplinary PFO committee meetings between September 2019 and October 2022. Chart review yielded key features of the patient’s stroke/TIA presentation, treatment and PFO characteristics. A total of 90 patient charts were reviewed, of which 26 underwent PFO closure and were analyzed for the primary outcome. The primary outcome was recurrent stroke/TIA events that occurred between the Index event and PFO closure. Results: The average time between index event and closure was 472 days. Of the 26 patients who underwent closure, 16 were in the AP group and 10. Primary outcome occurred in 2 patients within the AP group prior to closure versus 0 in the AC group, 12.5% v. 0% respectively. Conclusions: This outcomes analysis favors the use of AC therapy in the interim between the PFO index event and PFO closure. The results should be considered for AC/AP decisions, while appreciating that the average interim timeline was likely prolonged due to the COVID-19 pandemic with delayed elective procedures. The analysis was not powered to achieve significance due to sample size, however it did display some important trends.

Abstract WMP39: Incorporation of Automated Robotic Transcranial Doppler to Screen for Patent Foramen Ovale and Quantify Right to Left Shunt Severity in the Evaluation of Ischemic Stroke Patients for Stroke Etiology at a Comprehensive Stroke Center

Background: Patent foramen ovale (PFO) as a source of right-left shunting (RLS) is a recognized risk factor for recurrent stroke in young patients. Current standard care for RLS diagnosis includes transthoracic echocardiography (TTE), transesophageal echocardiography (TEE) and manual transcranial Doppler (TCD) which have disadvantages. The purpose of this retrospective review is to evaluate incorporation of an automated robotic TCD (rTCD) into the standard evaluation for RLS as cause of stroke, as prior studies have indicated higher sensitivity and quantification of RLS size to direct cardiology referral for potential PFO closure. Methods: Between Dec 2021-Oct 2022, 200 stroke patients age &lt;65 were included in this retrospective review. Average age was 55.7 ± 11.1 yrs. All patients had standard TTE and an rTCD (NovaSignal) with saline bubble injection at rest and Valsalva strain for assessment of RLS performed by echo and ultrasound technicians. Neurologists read results, including RLS shunt severity using the Spencer Shunt Grading scale (0-5), where Grade 3-5 is considered large. Results: The rate of positive RLS shunt using rTCD was 55.5% (n=111), of which 23.5% (n=47) were Spencer grade 3+ or higher. No bone window rate was 8.5% (n=17), which is lower than reported manual TCD rates. There were no rTCD RLS shunt negative patients who had a positive TTE or TEE. Of patients who had positive rTCD (n=14) and TTE with bubble, only 5 TTE’s were positive (35.7% sensitivity). Of rTCD positive patients (n=23) who also had TEE with bubble, only 11 were positive (48% sensitivity). And of 15 rTCD Grade 3+ RLS, only 11 TEE with bubble were positive (73% sensitivity). Conclusion: We successfully replaced rTCD for TTE with bubble to screen for RLS on patients who were admitted with a stroke or TIA, with the following advantages. Non-TCD technicians could be trained to perform the tests with accuracy. rTCD was more sensitive in detecting RLS than TTE with bubble. Quantification of RLS severity identified stroke patients with potentially higher risk of recurrence, prioritized to more aggressive medical management and cardiology referral for TEE and potential PFO closure.

Migraine and endovascular closure of patent foramen ovale as a method of its treatment: a literature review

The literature review is devoted to the pathophysiology and clinical picture of migraine, targets of therapy and drugs used, and the connection between the pathogenesis of migraine with aura and patent foramen ovale is discussed. The results of clinical studies show a positive effect of endovascular patent foramen ovale closure on the course of migraine in the form of a decrease in the intensity, frequency of attacks and the number of headache-free days, as well as in some cases complete relief of the disease. Further study of the topic is promising, but requires careful study design and long-term follow-up of patients.

Relationship between patent foramen ovale anatomical features and residual shunt after patent foramen ovale closure.

Transcatheter closure of patent foramen ovale (PFO) is an effective strategy for preventing recurrence of paradoxical embolism. However, PFO closure is often associated with residual shunt, which is a risk of recurrent stroke. This study aimed to evaluate the relationship between the anatomical features of PFO and residual shunt. The degree of residual shunt and its relationship with the anatomical features of PFO were evaluated in 106 patients who underwent PFO closure at our institution between March 2011 and January 2022 and in whom contrast transthoracic echocardiography was performed 1year later. The mean PFO tunnel length was 9.3 ± 3.6mm and the mean PFO height was 3.2 ± 2.2mm. Atrial septal aneurysm (ASA) was found in 37 patients. After PFO closure, residual shunt was observed in 28 patients (grade 1, n = 8; grade 2, n = 16; grade 3, n = 3; grade 4, n = 1). Univariate logistic analysis identified ASA to be associated with residual shunt (odds ratio 2.78, 95% confidence interval 1.14 to 6.79; p = 0.024). There was no association of residual shunt with the size of the PFO, the length of PFO tunnel, or the size of the device used for closure. Two of four patients with a large residual shunt of grade 3 or grade 4 were found to have device size mismatch. Residual shunt after PFO closure was observed in a quarter of patients and was related to the presence of ASA. A few patients had a large residual shunt due to the device size mismatch.

Speckle tracking echocardiographic prediction of atrial fibrillation after patent foramen ovale closure: a challenging matter.

Speckle tracking echocardiographic prediction of atrial fibrillation after patent foramen ovale closure: a challenging matter.

Temporal alterations in P-wave electrocardiographic metrics post patent foramen ovale closure: a retrospective study

Aims: This study aimed to analyze the electrocardiograms (ECG) of 69 patients before and after patent foramen ovale (PFO) closure, specifically investigating novel ECG parameters, over a 6-month post-procedure period. Methods: ECGs from 69 patients undergoing PFO closure were examined at three time points: before the procedure, and at 1st and 6th months post-procedure. A comprehensive set of ECG parameters, including P-wave (PW) maximum (PWmax), PW minimum (PWmin), PR interval, PW dispersion (PWdis), PW peak time in lead D2 (PWPTD2), PW peak time in lead V1(PWPTV1), P-axis, PW terminal force in the V1 (PWTF) and heart rate, were analyzed using a generalized linear mixed model (GLMM). Results: The GLMM analysis revealed significant changes in novel ECG parameters at 1-month post-procedure compared to baseline values. Parameters including PWmax (OR=8.898, 95% CI 7.521-10.275, p&amp;lt;0.001, PWmin (OR=6.579, 95% CI 5.611-7.548, p&amp;lt;0.001), PR (OR=4.159,95% CI 3.031-5.288, p&amp;lt;0.001), PWdis (OR=2.594, 95% CI 1.607-3.581, p&amp;lt;0.001), PWPTD2 (OR=4.261, 95% CI 2.928-5.593, p&amp;lt;0.001), PWPTV1 (OR=5.261, 95% CI 4.529-5.992, p&amp;lt;0.001), and PWTF (OR= 5.781, 95% CI 2.083-16.044, p&amp;lt;0.001) exhibited notable alterations, indicating a transient impact on cardiac conduction. However, these changes returned to baseline values by the 6-month follow-up. No statistically significant differences were observed in P-axis and heart rate across all time points. Conclusion: The analysis of ECG in patients undergoing PFO closure highlighted dynamic changes in novel ECG parameters in the early post-procedural period, with subsequent normalization by 6 months. Further research is warranted to elucidate the clinical implications of these dynamic electrocardiographic shifts and their potential association with long-term cardiovascular outcomes.

Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study.

Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown. The Assessment of Flecainide to Lower the PFO closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150mg per day in a single sustained-release (SR) dose) for 6 months (Group 1), Flecainide (150mg per day in a single SR dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analysed as a secondary objective of the study. AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure. NCT05213104 (clinicaltrials.gov).

The association between patent foramen ovale and unexplained syncope in pediatric patients

BackgroundPatent foramen ovale (PFO) is associated with transient ischemia attack (TIA) or stroke, paradoxical embolism, and migraines. PFO closure decreases the recurrent incidence of cerebral ischemic events and reduces the incidence of syncope in adults. However, whether PFO is associated with syncope in pediatric patients has not been investigated.Methods1001 pediatric patients (aged 4 to 17 years, mean age 10.31 ± 2.61 years, 519 males) who complained of unexplained syncope, palpitation, headache, dizziness and chest pain and were hospitalized in the Syncope Ward, The Second Xiangya Hospital, Central South University between January 2013 and April 2022 were recruited. Children with definite etiology of syncope, neurological, cardiogenic, psychological and other system diseases were excluded. PFO was measured by transthoracic echocardiography and right-heart contrast echocardiography was performed to identify the presence of right-to-left shunting. The demographic data and medical records were retrospectively reviewed and analyzed.Results276 cases were included in the simple syncope group, 379 cases in the headache/dizziness group, 265 cases in the chest pain group, and 81 cases in the palpitation group. The incidence of PFO between the four groups was insignificant (4.71%, 4.74%, 4.15%, 6.17%, respectively, P = 0.903). Multivariate Logistic regression demonstrated that PFO is not associated with the increased risk of syncope (P = 0.081).ConclusionPFO may not increase the risk of syncope in pediatric patients. Further study may include a large and multicenter sample to investigate the association between PFO and unexplained syncope.

Experimental study of the bilateral asymmetric single-rivet occluder device for transcatheter patent foramen ovale closure with reserved interatrial septal puncture area.

To evaluate a noval bilateral asymmetric single-rivet occluder with reserved interatrial septal puncture area for treating patent foramen ovale (PFO). The study established a pig model of patent foramen ovale (PFO) by puncturing the oval fossa and then performing high-pressure balloon dilation. A specially designed bilateral asymmetric occluder for the reserved interatrial septal puncture area was then. used to close the PFO through catheter-based intervention. The pigs were kept for 3 months before undergoing a second catheter-based intervention, involving interatrial septal puncture using a newly developed occluder in the reserved interatrial septal puncture area. During 6 months, the experimental pigs underwent assessment using digital subtraction angiography (DSA), echocardiography, and histological evaluation. A patent foramen ovale (PFO) model was successfully established in 6 pigs using the puncture atrial septum high-pressure balloon dilation method. The diameter of the unclosed PFO was measured (3.56 ± 0.25 mm). Using the newly developed occluder device, all 6 pigs with unclosed PFO underwent successful catheter-based closure surgeries, with intraoperative and postoperative transesophageal echocardiography showing excellent device positioning and complete closure without residual shunting. After 3 months of implantation, the catheter-based interatrial septal puncture was performed through the reserved interatrial septal puncture area, and all procedures were successful. Immediately following euthanasia, a histological examination revealed intact and undamaged occluder devices with visible puncture holes in the reserved interatrial septal puncture area. No fracture of the nitinol wire was observed, and the surface of the occluder device showed coverage of endothelial and connective tissues. Utilizing a bilateral asymmetric single-rivet occluder device implanted through the reserved interatrial septal puncture area has proven effective in closing PFO. After implantation, the occluder device allows subsequent interatrial septal puncture procedures through the reserved area. The novel occluder device demonstrated excellent closure performance, biocompatibility, and puncturability in the experiment. This indicates the feasibility of conducting further catheter-based interventions on the interatrial septum.

Left main and three vessels spontaneous coronary artery dissection as an incidental finding in young man with history of Hodgkin’s lymphoma-a case report

BackgroundSpontaneous coronary artery dissection is a rare and important cause of myocardial infarction, especially in young women without other coronary artery disease. This arterial dissection can occur within or between any of the 3 layers.Its predisposing factors include connective tissue diseases (Marfone syndrome, Ehlers-Danlos syndrome), vasculitis (polyarteritis nodosa, systemic lupus erythematosus, and Kawasaki disease), atherosclerosis and fibromuscular dysplasia.Clinical presentations of spontaneous coronary artery dissection are wide spectrum from asymptomatic to acute coronary disease, sustained ventricular arrhythmia and sudden cardiac death.Case presentationWe describe A 33-year-old man with history of Hodgkin’s lymphoma five years earlier that became a candidate for Patent foramen ovale closure due to recurrent embolic cerebrovascular accident. Before the intervention, coronary angiography incidentally showed dissection in the left main and all major coronary arteries.ConclusionsBased on our hypothesis, chemoradiotherapy-induced arteriopathies could be consider as a predisposing factor for spontaneous coronary artery dissection.

Large regional variation in cardiac closure procedures to prevent ischemic stroke in Switzerland a population-based small area analysis.

Percutaneous closure of a patent foramen ovale (PFO) or the left atrial appendage (LAA) are controversial procedures to prevent stroke but often used in clinical practice. We assessed the regional variation of these interventions and explored potential determinants of such a variation. We conducted a population-based analysis using patient discharge data from all Swiss hospitals from 2013-2018. We derived hospital service areas (HSAs) using patient flows for PFO and LAA closure. We calculated age-standardized mean procedure rates and variation indices (extremal quotient [EQ] and systematic component of variation [SCV]). SCV values >5.4 indicate a high and >10 a very high variation. Because the evidence on the efficacy of PFO closure may differ in patients aged <60 years and ≥60 years, age-stratified analyses were performed. We assessed the influence of potential determinants of variation using multilevel regression models with incremental adjustment for demographics, cultural/socioeconomic, health, and supply factors. Overall, 2574 PFO and 2081 LAA closures from 10 HSAs were analyzed. The fully adjusted PFO and LAA closure rates varied from 3 to 8 and from 1 to 9 procedures per 100,000 persons per year across HSAs, respectively. The regional variation was high with respect to overall PFO closures (EQ 3.0, SCV 8.3) and very high in patients aged ≥60 years (EQ 4.0, SCV 12.3). The variation in LAA closures was very high (EQ 16.2, SCV 32.1). In multivariate analysis, women had a 28% lower PFO and a 59% lower LAA closure rate than men. French/Italian language areas had a 63% lower LAA closure rate than Swiss German speaking regions and areas with a higher proportion of privately insured patients had a 86% higher LAA closure rate. After full adjustment, 44.2% of the variance in PFO closure and 30.3% in LAA closure remained unexplained. We found a high to very high regional variation in PFO closure and LAA closure rates within Switzerland. Several factors, including sex, language area, and insurance status, were associated with procedure rates. Overall, 30-45% of the regional procedure variation remained unexplained and most probably represents differing physician practices.