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Objective: Congenital defects/diseases Background: Congenital heart diseases (CHDs) are the most common form of birth defects, affecting the structure and function of neonatal hearts. Pulmonary valve stenosis (PVS) and ventricular septal defects (VSD) are 2 of the more prevalent forms, both of which can lead to significant morbidity if left untreated. The emergence of transcatheter techniques has revolutionized the therapeutic landscape, presenting minimally invasive yet effective alternatives to open-heart surgery and significantly reducing associated patient morbidity and recovery time. Case Report: The presented case details the management of a 19-year-old man with complex CHDs, highlighting the nuanced decision-making process that led to a transcatheter approach. The patient's clinical presentation, marked by symptoms reflective of significant cardiac compromise, demanded a tailored approach that utilized the latest advancements in non-surgical intervention. The successful closure of the VSD with an Amplatzer device and the resolution of PVS via balloon valvuloplasty were achieved without complications, showcasing the potential of these techniques in managing similar cases. The post-intervention period was marked by a noteworthy recovery, confirming the procedural efficacy and enhancing the patient's quality of life. Conclusions: The favorable outcome of this case highlights the pivotal role of transcatheter interventions in treating complex CHDs and suggests a shift towards less invasive approaches in cardiac care. This case contributes valuable insights to the existing body of evidence, reinforcing the potential of transcatheter techniques to become the preferred treatment modality. With promising immediate and short-term results, these techniques highlight the need for continued research into their long-term efficacy and application across diverse patient demographics. [ABSTRACT FROM AUTHOR]

Patent foramen ovale (PFO) is closely related to neurological diseases such as stroke, migraine, obstructive sleep apnea syndrome (OSAS) and decompression sickness (DCS). It has been suggested that PFO closure could be effectively prevent and treat these neurological diseases. This article focus on exploration of the pathogenesis, epidemiology and clinical characteristics of neurological diseases related to PFO, and to discuss the potential complexity and future development of PFO closure for the treatment of these diseases. The aim is to provide guidance for the diagnosis and treatment of neurological diseases related to PFO.

[Display omitted] • The Trevisio DS flexible tip improves occluder position assessment before release. • Trevisio PAS studied the Trevisio DS during transcatheter closure of PFO and ASD. • 251 patients (144 PFO and 107 ASD) were enrolled at 22 European sites. • The Trevisio DS exhibited a high rate of technical success and excellent safety. The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged < 18 years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect. [ABSTRACT FROM AUTHOR]

[Figure: see text].

BackgroundAlthough observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine, randomized clinical trials have not met their primary efficacy endpoints.ObjectivesThe authors report the results of a pooled analysis of individual participant data from the 2 randomized trials using the Amplatzer PFO Occluder to assess the efficacy and safety of percutaneous device closure as a therapy for episodic migraine with or without aura.MethodsThe authors analyzed individual patient-level data from 2 randomized migraine trials (the PRIMA [Percutaneous Closure of Patent Foramen Ovale in Migraine With Aura] and PREMIUM [Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migraine and PFO Using the Amplatzer PFO Occluder Compared to Medical Management] studies). Efficacy endpoints were mean reduction in monthly migraine days, responder rate (defined as ≥50% reduction in monthly migraine attacks), mean reduction in monthly migraine attacks, and percentage of patients who experienced complete cessation of migraine. The safety endpoint was major procedure- and device-related adverse events.ResultsAmong 337 subjects, 176 were randomized by blocks to device closure and 161 to medical treatment only. At 12-month follow-up, the analysis met 3 of the 4 efficacy endpoints: mean reduction of monthly migraine days (-3.1 days vs. -1.9 days; p = 0.02), mean reduction of monthly migraine attacks (-2.0 vs. -1.4; p = 0.01), and number of subjects who experienced complete cessation of migraine (14 [9%] vs. 1 [0.7%]; p

Objective To explore the safety, effectiveness and feasibility of patent ductus arteriosus ( PDA) occlusion in children under the guidance of transesophageal echocardiography (TEE) via a small left axillary incision. Methods Clinical data were retrospectively reviewed for 40 PDA children between March 2018 and December 2021. There were 13 boys and 27 girls with an age range of 1. 09 ( 0. 60 - 1. 75) years and a body weight of 9 ( 7. 20 - 10. 50) kg. Simple esophageal heart ultrasound-guided small incision was performed in left axilla for PDA closure. Return to the intensive care unit after the operation for symptomatic treatment and, if necessary, cardiotonic and diuretic treatment. Both echocardiogram and electrocardiogram were examined immediately, Month 1 post-operation and Month 3 - 6 post-operation for evaluating the treatment outcomes. Results The occluder was successfully implanted in all children. At Month 3 post-operation, occluder was displaced in one child without any obvious discomfort. The occluder was removed, arterial catheter withdrawn and skin sutured. In the remainders, follow-up cardiac color Doppler ultrasound and electrocardiogram indicated that the position of occluder was excellent and internal diameter of each atrium was basically normal. There were no complications such as residual shunt, pericardial effusion or arrhythmia. Conclusion It is safe and effective to occlude PDA with a small left axillary incision under the sole guidance of esophageal echocardiography in children. Such an approach is also suitable for young and underweight children with thick PDA. It offers the advantages of minimal trauma, faster recovery and fewer complications. [ABSTRACT FROM AUTHOR]

Partial anomalous pulmonary venous return (PAPVR) is a rare congenital heart malformation in which 1 or more pulmonary veins drain into the systemic venous circulation or directly into the right atrium instead of the left atrium. It may occur alongside other congenital heart defects, including atrial septal defect (ASD). All patients with newly diagnosed ASD must be evaluated thoroughly for the likelihood of PAPVR to select surgical or percutaneous procedures. Here, we describe a 10-year-old girl with PAPVR who underwent percutaneous device closure of her secundum ASD with her PAPVR neglected at 3 years of age. We had to correct the anomalous venous connection by removing the device during an intricate procedure. The typical connection of the pulmonary veins to the left atrium was reported on her postoperative echocardiography 1 day after surgery. The patient was discharged without complications, and her first follow-up visit 7 days after discharge was unremarkable. While the most accurate diagnostic tools for PAPVR are cardiovascular magnetic resonance imaging and computed tomographic angiography, a careful examination of the pulmonary veins during pulmonary angiography or transesophageal echocardiography in children helps identify PAPVR in patients with ASD. [ABSTRACT FROM AUTHOR]

BackgroundPatent foramen ovale (PFO) is implicated in the pathogenesis of clinical conditions such as cryptogenic stroke and migraine with aura. This study evaluated the challenges of sizing a PFO with different contemporary imaging modalities and assessed the relationship between PFO size and severity of the right-to-left shunt (RLS).MethodsPatients who were referred to interventional cardiology with the diagnosis of a PFO and had undergone intra-procedural balloon sizing (n = 147), transesophageal echocardiogram (TEE) imaging (n = 67), or intracardiac echocardiogram (ICE) imaging (n = 73) at the time of workup were included in this study. TEE and ICE were used to obtain PFO length and height during normal respiration. A sizing balloon was used to obtain PFO width and height after the septum primum was opened with balloon inflation.ResultsThe mean PFO length measured by TEE and ICE differed significantly (n = 27, 13.0 ± 4.1 vs. 9.9 ± 3.2 mm, p = .001). The mean PFO height measured by TEE and ICE (n = 27, 1.4 ± 0.6 vs. 1.7 ± 0.6 mm, p = .04), TEE and sizing balloon (n = 56, 1.5 ± 1.2 vs. 10.5 ± 4.2 mm, p

Percutaneous patent foramen ovale (PFO) closure is recommended for secondary prevention of paradoxical embolism through a PFO. In the United States, two Food and Drug Administration-approved PFO closure devices are currently available, and the choice depends on operator preference and PFO anatomy. Although these devices are easy to implant, there are several potential complications. As opposed to the Amplatzer PFO Occluder, there has been no published case of atrial erosion with Gore closure devices. This report describes two cases of pericardial tamponade due to perforation of the atrial wall induced by a wire frame fracture of the Gore Helex and Cardioform devices.

ObjectivesTo compare residual shunt rate and complications associated with six different devices used for PFO closure.BackgroundTranscutaneous PFO closure is an effective treatment for preventing recurrent stroke in patients with a history of cryptogenic stroke. The rate of residual shunt is one metric by which the technical success of PFO closure can be measured.MethodsPatients who underwent PFO closure at a single center between February 2001 and July 2019 were retrospectively enrolled in the study. Right-to-left shunt at baseline and during follow-up was assessed using transcranial Doppler (TCD) or transthoracic echocardiography (TTE). Periprocedural and device-related complications, including atrial fibrillation, were also assessed.ResultsOf 467 PFO closures performed during this period, 320 patients received quantitative assessment of right-to-left shunting both before and after percutaneous closure. The highest effective closure was achieved with the Cardioform device (100%, n = 104), followed by the Amplatzer Cribriform (93%, n = 14), Helex (90%, n = 137), Amplatzer ASO (88%, n = 17), CardioSEAL (86%, n = 14), and Amplatzer PFO (85%, n = 33) devices. The most common significant adverse event was atrial fibrillation, which was more common with the Cardioform device (13%) than the Helex (4%) or the Amplatzer PFO (4%) devices.ConclusionsThe Gore Cardioform Septal Occluder provides more robust closure of a PFO when compared to other devices but its effectiveness is offset by the higher prevalence of transient atrial fibrillation.

Introduction: Endoscopic techniques are now considered the first-line approach for the management of bariatric surgery-related fistulas. The off-label use of cardiac septal defect occluders (CSDO) is an emerging technique that has demonstrated favorable outcomes for the closure of extravascular defects, including gastrointestinal (GI) disruptions. Previous case reports have reported similar results with the CSDO Amplatzer™ for the management of GI disruptions following bariatric surgery. However, the use of similar alternative devices for this purpose has not yet been described. Case Presentation: This case report presents the first reported use of the Occlutech® CSDO for the treatment of a chronic gastrocutaneous fistula after bariatric revisional surgery. Despite apparent initial success – no extravasation of contrast material through the device in the contrast study after the CSDO placement – fistula closure failed due to partial dislodgement of the device. The placement of a second device between the discs of the former one ultimately sealed the fistulous orifice. Discussion: In chronic GI fistulas, the mature tract is often not liable to the application of standard endoscopic methods, leading to failed closure attempts. A new application of Occlutech® CSDO can obviate the clinical burden of a high-risk laparotomy in these cases. Appropriate endoscopic equipment as well as the involvement of a multidisciplinary team are prime conditions to ensure successful patient outcomes.

Objective To explore the characteristics and prognoses of perimembranous and high ventricular septal defects (VSD) closure via a ultra-minimal trans-intercostal incision (i.e.left parasternal intercostal ultra-minimal incision≤1 cm) in children guided by transesophageal echocardiography (TEE) and provide references for such mini-invasive surgery. Methods From January 2015 to December 2021, 344 cases of VSD closure via a left parasternal ultra-minimal trans-intercostal incision in children guided by TEE.According to the location of VSD, they were divided into two groups of perimembranous VSD (239/344, 69.5%) and high VSD (outflow tract & high membrane)(105/344, 30.5%). Operative procedures, operative duration, postoperative complications, prognoses and other relevant data of two groups were compared. Results Among them, 229 cases (229/239, 95.8%) of perimembranous VSD and 100 cases (100/105, 95.2%) of high VSD were successfully occluded.No significant difference existed in success rate (P>0.05). However, operative duration of perimembranous VSD was longer than that of high VSD (P<0.05). In both groups, diameter of VSD was correlated positively with diameter of occluder, but not with operative duration.Among 239 cases of perimembranous VSD and 105 cases of high VSD, 12 cases (12/239, 5.0%) and 5 cases (5/105, 4.8%) were successfully re-occluded after adjusting or replacing occluder.No significant inter-group difference existed in success rate of re-occlusion (P>0.05). A total of 10 children in perimembranous VSD group failed to occlude, including 7 cases (7/239, 2.9%) in which guide wire could not pass through VSD, 2 cases (2/239, 0.8%) in which occluder slipped off and 1 case of ventricular fibrillation.There were 5 cases of occlusion failure in high VSD group, including 1 case in which guide wire could not pass through VSD during operation (1/105, 1.0%), 1 case with occluder displacement during operation and 1 case post-operation (2/105, 1.9%), 1 case with aggravation of aortic regurgitation and 1 case with marked decrease in blood pressure.There was no significant inter-group difference in failure rate when guide wire could not pass through VSD and occluder slipped off or shifted(P>0.05). During a follow-up period of (1-4) days in perimembranous VSD group, there were 1 case of mild mitral regurgitation and 4 cases of mild-to-moderate tricuspid regurgitation.No change occurred during 6-month follow-ups.During a follow-up period of (1-4) days in high VSD group, one case developed right ventricular outflow tract obstruction and flow velocity declined during 6-month follow-ups.There were residual slight shunt (n=19), pericardial effusion (n=19) and pleural effusion (n=4) in two groups.They were self-cured during 6-month follow-ups. Conclusion Through a ultra-minimal trans-intercostal incision guided by TEE, perimembranous and high VSD closure offers a high success rate and an excellent postoperative recovery in children.Although operative duration of high VSD is shorter, diameter of VSD is not a sole influencing factor of operative duration. [ABSTRACT FROM AUTHOR]

Abstract Purpose Routinely collected administrative data is widely used for population-based research. However, although clinically very different, atrial septal defects (ASD) and patent foramen ovale (PFO) share a single diagnostic code (ICD-9: 745.5, ICD-10: Q21.1). Using machine-learning based approaches, we developed and validated an algorithm to differentiate between PFO and ASD patient populations within healthcare administrative data. Methods Using data housed at ICES, we identified patients who underwent transcatheter closure in Ontario between October 2002 and December 2017 using a Canadian Classification of Interventions code (1HN80GPFL, N = 4680). A novel random forest model was developed using demographic and clinical information to differentiate those who underwent transcatheter closure for PFO or ASD. Those patients who had undergone transcatheter closure and had records in the CorHealth Ontario cardiac procedure registry (N = 1482) were used as the reference standard. Several algorithms were tested and evaluated for accuracy, sensitivity, and specificity. Variable importance was examined via mean decrease in Gini index. Results We tested 7 models in total. The final model included 24 variables, including demographic, comorbidity, and procedural information. After hyperparameter tuning, the final model achieved 0.76 accuracy, 0.76 sensitivity, and 0.75 specificity. Patient age group had the greatest influence on node impurity, and thus ranked highest in variable importance. Conclusions Our random forest classification method achieved reasonable accuracy in identifying PFO and ASD closure in administrative data. The algorithm can now be applied to evaluate long term PFO and ASD closure outcomes in Ontario, pending future external validation studies to further test the algorithm.

BackgroundMigraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood.ObjectivesThis study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura.MethodsThe PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura.ResultsOf 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (-3.4 vs. -2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01).ConclusionsPFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056).

When treating perimembranous ventricular septal defect, median sternotomy leads to unsightly scar, right subaxillary thoracotomy requires cardiopulmonary bypass, and transcatheter device closure constrained by vascular condition. Using small left intercostal incision, we employed transthoracic device closure to get around these issues. During this study, right subaxillary thoracotomy was used for surgical repair in 117 patients (Surgical group), whereas small left intercostal incision was used for transthoracic device closure in 131 patients (Device group). Retrospective data collection and analysis were conducted. The success rate was comparable (117/117 vs. 130/131, P = 1.000). The device group experienced notably reduced operating time, mechanical ventilation duration, ICU stay, and postoperative hospital stay (All P < 0.001). Given that the device group's incision was much smaller than the surgical group's (1.1 ± 0.3 vs. 6.8 ± 1.6 cm, P < 0.001), blood transfusion or drainage tube was not needed. The device group observed a lower frequency of complications, with the exception of small residual shunt. It is feasible and safe to perform transthoracic device closure in children with perimembranous ventricular septal defects via small left intercostal incision. It can be a good minimally invasive substitute for surgical closure when utilized properly., (© 2024. The Author(s).)

Percutaneous PFO closure is a well-established medical procedure to mitigate paradoxic embolism and the future risk of stroke in a well-selected patient clientele. When it comes to procedural guidance during PFO closure, various modalities exist, each with its own advantages and disadvantages. Guidance by transesophageal echocardiography (in combination with fluoroscopy) offers high-resolution 2D/3D imaging, however, it requires the presence of a peri-interventional imager and conscious sedation (or endotracheal intubation). Intracardiac echocardiography and fluoroscopy guidance can be performed by a single operator and omits the need for conscious sedation (or endotracheal intubation)., Competing Interests: Disclosure H. Sievert has received study honoraria to institution, travel expenses and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, Celonova, Contego, Coramaze, Croivalve, CSL Behring LLC, CVRx, Dinova, Edwards, Endobar, Endologix, Endomatic, Esperion Therapeutics, Inc, Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and Whiteswell., (Copyright © 2024 Elsevier Inc. All rights reserved.)

A 63-year-old man presented with delayed inferior ST-elevation myocardial infarction complicated with ventricular septal rupture (VSR). He developed cardiogenic shock and respiratory failure requiring intubation and Impella (Abiomed) support.

Percutaneous closure of the left atrial appendage may be indicated in patients with contraindications to anticoagulation therapy, for example, after recurrent gastrointestinal bleeding. It is an effective and safe procedure but is not without complications. We present a patient who presented with severe aortic insufficiency due to migration of the left atrial appendage closure device, which required urgent cardiac surgery for its removal., Competing Interests: Declarations Competing interests The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Objectives: This study aimed to explore the endothelialization process and assess the potential association between endothelialization and peri-device leak (PDL) following Watchman implantation via a quantitative method., Methods: This is a single-center retrospective study of consecutive patients undergoing LAAO between December 2015 and November 2021. Device endothelialization, compared between PDL and non-PDL group, were quantitatively analyzed based on hypoattenuated thickening in cardiac computed tomography angiography (CCTA). Advancement in endothelialization over time were explored using the Cochran-Armitage test and generalized estimating equation approach. Potential risk factors of delayed endothelialization were analyzed using the Cox proportional-hazards model., Results: A total of 172 patients (mean age, 68 years ± 10 [standard deviation], 114 men) were finally included. The average endothelialization ratio of the study population was 89.8 ± 7.2 percent. In the follow-up period of postprocedural 3 months to more than 12 months, an incremental trend of endothelialization over time was observed with the ratio of 85.8 ± 8.0, 89.6 ± 7.6, 92.2 ± 4.5, 94.3 ± 2.9 percent, respectively (p < 0.0001). Notably, patients without PDL exhibited a swifter advancement in endothelialization compared to those with PDL, irrespective of device size. The multivariable Cox regression model showed that PDL (HR = 2.113, 95%CI: 1.300-3.435, p = 0.003), DSP (HR = 1.717, 95%CI: 1.113-2.647, p = 0.014) were independent risk factors of delayed endothelialization., Conclusion: CCTA holds promise as an effective means of quantitatively assessing device endothelialization. Endothelialization advanced gradually over time, with PDL potentially impeding device endothelialization., Clinical Relevance Statement: A comprehensive understanding of the correlation between endothelialization ratio, time, and residual shunt can establish a more dependable foundation for determining the appropriate anticoagulation treatment following left atrial appendage closure., Key Points: Current recommendations for postleft atrial appendage occlusion anti-platelet and anticoagulation therapy are based on animal studies. Cardiac computed tomography angiography (CCTA) combined with the UNet neural network model enables the quantitative assessment of device endothelialization. This technique will allow for additional studies to better understand device endothelialization to optimize treatments in this population., (© 2024. The Author(s), under exclusive licence to European Society of Radiology.)

Background: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device., Objective: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study., Methods: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported., Results: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group., Conclusion: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The 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 in non-recent cryptogenic strokes., Aims: The objective of the study was to evaluate the effectiveness of PFOC in relation to the time since the patient's most recent cryptogenic cerebrovascular event (CVE) or systemic embolism (SE)., Methods: We conducted a multicentre, retrospective cohort study with international participation, to assess the results of an early closure (EC, <9 months) for secondary prevention versus a delayed closure (DC, ≥9 months). Recurrence of CVE/SE following PFOC was evaluated as the primary endpoint., Results: 496 patients were included (65% in the EC and 35% in the DC group). With the exception of a larger defect size in the DC group (tunnel width 6 (4-14) vs 12 (6-16) mm, p=0.005), similar clinical and echocardiographic baseline features were observed between the groups. No differences were observed regarding the type of devices used for PFOC, procedural success rate (99.4 in EC vs 98.8% DC group) and periprocedural complications (2.1% vs 0.8%). Median follow-up was 2.0 (1.2-4.2) years in the whole study population. Recurrence of CVE/SE (3.9% vs 2.6%, p=0.443), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment strategy were comparable in both groups during follow-up. A subanalysis comparing very delayed PFOC (≥24 months) also showed no differences in recurrence (4.2% in the <24-month vs 3.4% in the ≥24-month group, p=0.770)., Conclusion: Patients undergoing PFOC before and after 9 months after the index event had a comparable recurrence rate of CVE/SE. These findings suggest that PFOC might be recommended in cryptogenic CVE/SE which are more remote than 9 months., Competing Interests: Competing interests: PS declares speaker fees from Abbott and Gore., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure., Objectives: This study sought to report the combined pivotal and continued access cohorts of the ASSURED (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs) trial results through 36 months., Methods: This prospective, multicenter, single-arm trial evaluated procedural and clinical outcomes of ASD closure with the GCA. The primary endpoints were 6-month closure success following device implantation and composite clinical success (deployment/retention of device, safety, and closure). Technical and procedure success, safety, clinically significant new arrhythmia (CSNA) secondary endpoints, and wire frame fracture (WFF, with fluoroscopy) at 6 and 36 months were evaluated., Results: Of 569 patients (median age of 10.4 years and median weight of 35.0 kg) who underwent attempted secundum ASD closure, 526 were technical successes. The mean stop-flow ASD diameter was 17.6 ± 5.3 mm. All 478 patients with 6-month imaging achieved closure success. Composite clinical success at 6 and 36 months was achieved in 87.6% (468/534) and 84.0% (351/418) of patients, respectively. Technical failure occurred in 8.1% (43/548), 30-day device- or procedure-related serious adverse event in 3.9% (21/534), and 6-month device events in 2.8% (15/534) of patients. At 30 days, 21 of 569 patients (3.7%) had CSNA. At 6 months, 138 of 436 (31.7%) patients had WFFs and 105 of 185 (56.8%) at 36 months (without sequelae)., Conclusions: In this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae. The unique features, size range, and safety profile expand the options for secundum ASD closure. (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs [ASSURED]; NCT02985684)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by W. L. Gore & Associates. Dr Qureshi is a consultant for W. L. Gore & Associates, Medtronic, and B. Braun. Dr Sommer has received institutional funding from W. L. Gore & Associates for working on their national PFO and ASD trials; and serves on the Advisory Board for Conformal Medical. Dr Morgan is a consultant/proctor for W. L. Gore & Associates. Dr Paolillo is a consultant, proctor, and preceptor for W. L. Gore & Associates. Dr Goldstein is a consultant for Medtronic, W. L. Gore & Associates, Edwards Lifesciences, and Mezzion Pharmaceuticals. Dr Sugeng serves on the Speakers Bureau for Philips Healthcare; and is a consultant for Siemens Healthineers and Yale Echo Corelab YCRG. Dr Gillespie is a consultant for W. L. Gore & Associates and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of the longest diameter. Research on percutaneous closure of oval-shaped ASDs is limited, with no known reports of non-fluoroscopic closure for this population., Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs., Methods: This single-center retrospective study evaluates patients undergoing non-fluoroscopic percutaneous closure of oval-shaped ASDs, defined by the shortest to longest diameter ratio < 0.75, a circular index of 1.33, or ultrasound visualization of an oval shape. Device size was chosen to be 0-4 mm larger than the defect's longest diameter, based on transthoracic and transesophageal ultrasound measurements., Results: We identified 78 patients (33.3% children, 20.5% males) with a mean age of 27.4 ± 16.3 years and a mean weight of 46.8 ± 19.8 kg. The mean longest diameter and mean shortest diameter of ASDs were 23.3 ± 6.8 mm and 15.8 ± 5 mm, respectively. The mean ratio of the shortest to longest diameter was 0.7 ± 0.1. Percutaneous closure was not attempted in 7/78 (9%) patients. Three out of 71 (4.2%) procedures were fluoroscopy-guided upfront due to technical difficulties, and 5/71 (7%) were converted to fluoroscopy-guided closure. Overall procedural success rate was 98.6% (70/71) including 63/71 (88.7%) performed with zero fluoroscopy. Mean device size was 26.5 ± 7.1 mm. Mean procedural time was 45.3 ± 22.6 min. Eleven intraprocedural complications occurred including 6 arrhythmias, 3 pericardial effusions, and 2 device dislodgements., Conclusion: Transcatheter closure of oval-shaped ASD is safe and feasible. Echocardiography is adequate for adequate operative guidance., (© 2024. The Author(s).)

Introduction: Delivery systems are crucially important for the implantation of medical devices in patients with congenital heart disease. However, very little data is available comparing the advantages and disadvantages of the various delivery systems., Areas Covered: This article describes the delivery systems and methods used for delivery of atrial septal occluder devices, ventricular septal occluder devices, devices to occlude patent arterial ducts, and transcatheter pulmonary valves. Delivery systems are compared relating to prepping and loading, positioning of the delivery sheath/catheter, deployment, ability to recapture and reposition, as well as device release., Expert Opinion: For most ASD/VSD/PDA occluder devices, the basic delivery mechanism has changed very little over the preceding 20 years. Future modifications may focus on meaningful modifications to the cable systems that reduce stiffness and improve angulation at the connection to the device. Over the next 5-10 years, it is expected to see significant changes to delivery systems used for transcatheter pulmonary valve implantation, that result in improvements in the ability to recapture and reposition self-expandable transcatheter valves during the deployment process, combined with kink resistant sheaths that facilitate easy tracking across often complex right ventricular outflow tracts.

Percutaneous left atrial appendage closure (LAAC) is a valid alternative to oral anticoagulation to prevent ischemic stroke in patients with atrial fibrillation.The devices approved in Europe and United States for percutaneous LAAC contain metal and temporary antithrombotic therapy is strongly recommended following implantation to prevent thrombus formation on the atrial device surface. There is still uncertainty regarding to the optimal antithrombotic drug regimen after device implantation for several reasons. Thus, this review aims at summarizing the available evidence and the remaining challenges related to the management of antithrombotic therapy in the context of LAAC procedure., Competing Interests: Disclosures R. Galea reports no relationships relevant to the contents of this paper to disclose. L. Raber reports research grants to institution by Abbott Vascular, United States, Boston-Scientific, Biotronik, Germany, InfraRedx, United States, HeartFlow, United States, Sanofi, United States, Regeneron and Swiss National Science Foundation. He reports speaker/consultation fees by Abbott-Vascular, Amgen, AstraZeneca, Canon, Novo Nordisk, Medtronic, Occlutech, Sanofi., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Atrial fibrillation (AF) is the most common rhythm disorder with a high risk for cardioembolic strokes. Interventional occlusion of the left atrial appendage (LAA) is an alternative to the widely established stroke prevention with oral anticoagulation. Complications through LAA closure (LAAC) are rare and usually occur periinterventional. We present a case of an 87-year-old patient who presents for elective LAAC. After placement of the LAA occluder (Amplatzer Amulet device 25 mm) in the LAA and partial resheathing, the patient developed a pericardial effusion (PE), became hemodynamically unstable and went into cardiac arrest with the need for cardiopulmonary resuscitation (CPR). After drainage of the PE, we closed the causative LAA-perforation using a persistent foramen ovale (PFO)-occluder device (Amplatzer Talisman, 25 mm). Thereby we were able to successfully seal the perforation and stabilize the patient. The patient was monitored at our intensive care unit for 2 days and left the hospital in good condition a few days after. Procedural complications during interventional LAAC are rare but can be serious. The most common complication, PE, requires percutaneous drainage and often cardiac surgery. We present a case in which a perforation and following PE with hemodynamic relevance and need for CPR was resolved with an interventional strategy through implantation of a PFO-occluder into the perforation. With this approach we were able to show that in the right setting even serious complications can be treated by interventional measures, thereby not only saving the patient's life, but also avoiding cardiac surgery., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: New and refined catheter based left atrial appendage (LAA) closure devices have been introduced in the past decade. The procedure can be performed using either an endocardial occlusion device or an epicardial loop stitch. We aimed to analyzed recent procedural safety., Methods: Catheter based LAA closures were identified in a complete nationwide German dataset via ICD and OPS codes from 2016 to 2020., Results: From 2016 to 2020, 28,039 endocardial and 213 epicardial occlusions were performed. Numbers of endocardial procedures increased from 5259 in 2016 to 5917 in 2020 (p = 0.020) in 387 centers with shifting of patients' characteristics towards older age (β = 0.29, p < 0.001), more heart failure (β = 1.01, p < 0.001) and renal disease (β = 0.67, p = 0.001) and without a significant trend for in-hospital safety except more bleeding (β = 0.12, p = 0.05). In-hospital major adverse cardiac and cerebrovascular events (MACCE) or pericardial puncture were independent on center procedure numbers. The loop stitch procedure was performed in 15 centers. Patients were younger (76.17 ± 8.16 vs. 73.16 ± 8.99, p < 0.001) and had a lower comorbidity index (2.29 ± 1.93 vs. 1.92 ± 1.64, p = 0.005). Adjusted risk difference for pericardial effusion (8.04%; 95% CI 3.01-13.08%; p = 0.002) and pericardial puncture (6.60%; 95% CI 3.85-9.35%; p < 0.001) was higher for the loop stitch procedure, while risk of bleeding (- 1.85%; 95% CI - 3.01 to - 0.69%; p = 0.002), intracerebral bleeding (- 0.37%; 95% CI - 0.59 to - 0.15%; p = 0.001) and shock (- 1.41%; 95% CI - 2.44 to - 0.39%; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE., Conclusions: Endocardial occlusion was the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 to 2020. In-hospital MACCE was independent on endocardial LAAC center volumes. Conclusions on the comparison between the two procedure types must be made cautious as the LAA loop stitch occlusion was utilized limited in a minor number of centers., (© 2023. The Author(s).)

Background: Anatomic variations of the patent foramen ovale (PFO) are commonly observed, yet limited research has investigated their impact on clinical outcomes following transcatheter closure. We aimed to explore the association between PFO morphology and clinical outcomes., Methods: Consecutive patients with cryptogenic stroke who underwent PFO closure were prospectively enrolled at a single center from September 2019 to April 2023. Patients were categorized into simple and complex groups based on PFO morphology. Composite events were compared between the two groups during a median follow-up of 24 months, including all-cause mortality, recurrent stroke, residual moderate or severe shunt, and symptomatic atrial fibrillation., Results: A total of 247 patients were enrolled, with a mean age of 41.9 ± 13.0 years and 45.3% males. Ninety-one (36.8%) patients had complex PFO. These individuals were older (45.4 ± 12.5 years vs. 39.9 ± 12.9 years; P = 0.001), more males (56.0% vs. 39.1%; P = 0.010), had longer procedure times (54 ± 32 min vs 46 ± 29 min; P = 0.044), and had a higher rate of using delivery sheath-assisted crossing of the PFO (22.0% vs 12.8%; P = 0.040) than those with simple PFO. The estimated event rates were 27.9% and 11.3% (P = 0.006) in the complex and simple PFO groups, respectively (12.9 events and 5.2 events per 100 person-years; P = 0.001). After adjusting for age, sex, hypertension, diabetes, smoking, device type, and left atrial diameters, complex PFO remained independently associated with composite events (HR 2.10, 95%CI 1.06-4.17, P = 0.034)., Conclusions: Patients with complex PFO may suffer from a higher risk of adverse events following transcatheter PFO closure., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Left atrial appendage (LAA) closure can prevent stroke in high-risk patients with atrial fibrillation.A bioabsorbable LAA occluder made of degradable polymer materials, such as polydioxanone (PDO) and poly-L-lactic acid (PLA), and nitinol wire was used. Occluders were successfully implanted in 18 Chinese rural dogs, 2 of which died within 48 hours after operation due to pericardial tamponade and hemorrhage, respectively. Follow-up observation was performed after transcatheter LAA closure. New tissue was found on the surface of the occluder 2 months after operation. No adjacent structures such as the mitral valve and the left superior pulmonary vein were affected by the occluder discs. Hematoxylin and eosin (HE) staining was performed at 3 months after operation, which showed intact intimal structure on the occluder surface, and unabsorbed PDO and PLA were observed. Scanning electron microscopy showed irregular arrangement of endothelial cells. New endothelial tissue was observed to completely cover the occluder at 6 months after operation. Most PDOs were replaced by fibrous connective tissue, and scanning electron microscopy showed regularly arranged endothelial cells. Pathological examination at 12 months showed only a small remnant of PDO. The gross specimens of the liver, spleen, and kidneys and pathological examination did not indicate thromboembolism.The bioabsorbable LAA occluder made of PDO, PLA, and nitinol wire was safe and effective for the occlusion of LAA in dogs. The surface of the occluder was endothelialized half a year after operation. The absorbable materials of the occluder were degraded after 1 year.

BACKGROUND Migraine, a prevalent primary headache disorder, often disrupts daily life, particularly when accompanied by visual auras. While the etiology of migraines remains elusive, emerging evidence suggests a correlation with cardiovascular anomalies. CASE REPORT This case involves a 35-year-old woman experiencing migraine with aura. Imaging studies, including MRI/A, revealed small-vessel ischemic damage in the right frontal region and historical microbleeds in the right occipital area. The patient's RoPE score was a high 9 out of 10, and a grade 4 (severe) PFO was diagnosed following a TEE+bubble test. A transfemoral PFO closure was successfully performed using a 25-mm Amplatzer PFO occluder device via an antegrade transvenous approach without fluoroscopy. The patient was discharged in stable condition, with no migraine episodes reported at 5-month follow-up. The detection of PFO in young migraineurs, particularly those with aura, is crucial and warrants thorough investigation during their assessment and treatment. CONCLUSIONS This case underscores the importance of incorporating cardiac evaluations in the diagnostic regimen for young individuals presenting with migraine and aura to uncover and rectify potential contributory structural heart defects like PFO. After PFO closure, this patient's significant improvement, evidenced by the absence of migraine recurrence, highlights the potential therapeutic benefit of addressing cardiac anomalies in such patients. It is important to note that current evidence does not support PFO closure as a treatment for migraines unless there are findings suggestive of ischemic stroke.

Left atrial appendage occlusion devices (LAAO) are a feasible alternative for non-valvular atrial fibrillation (AF) patients at high risk of thromboembolic stroke and contraindication to antithrombotic therapies. However, optimal LAAO device configurations (i.e., size, type, location) remain unstandardized due to the large anatomical variability of the left atrial appendage (LAA) morphology, leading to a 4-6% incidence of device-related thrombus (DRT). In-silico simulations have the potential to assess DRT risk and identify the key factors, such as suboptimal device positioning. This work presents fluid simulation results computed on 20 patient-specific left atrial geometries, analysing different commercially available LAAO occluders, including plug-type and pacifier-type devices. In addition, we explored two distinct device positions: 1) the real post-LAAO intervention configuration derived from follow-up imaging; and 2) one covering the pulmonary ridge if it was not achieved during the implantation (13 out of 20). In total, 33 different configurations were analysed. In-silico indices indicating high risk of DRT (e.g., low blood flow velocities and flow complexity around the device) were combined with particle deposition analysis based on a discrete phase model. The obtained results revealed that covering the pulmonary ridge with the LAAO device may be one of the key factors to prevent DRT, resulting in higher velocities and reduced flow recirculations (e.g., mean velocities of 0.183 ± 0.12 m/s and 0.236 ± 0.16 m/s for uncovered versus covered positions in DRT patients). Moreover, disk-based devices exhibited enhanced adaptability to various LAA morphologies and, generally, demonstrated a lower risk of abnormal events after LAAO implantation., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Albors et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Young 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 device closure may persist in approximately a quarter of the patients at 6 months, and some may close at a later time point. This study aimed to assess the prevalence and persistence of residual right-to-left shunt after percutaneous PFO closure., Methods: Consecutive patients undergoing transoesophageal echocardiography-guided PFO closure for cryptogenic stroke between 2006 and 2021, with echocardiographic follow-up including contrast bubble study and Valsalva manoeuvre, were enrolled. Follow-up transthoracic echocardiography was performed at 6 months and repeated at 12 months in case of residual right-to-left shunt. Primary outcomes included the prevalence and grade of residual right-to-left shunt at 6 and 12 months after percutaneous PFO closure., Results: 227 patients were included with a mean age of 43±11 years and 50.2% were women. At 6-month follow-up, 72.7% had no residual right-to-left shunt, 12.3% small residual right-to-left shunt, 6.6% moderate residual right-to-left shunt and 8.4% large residual right-to-left shunt. At 12-month follow-up, the presence of residual right-to-left shunt in all patients was 12.3%, of whom 6.6% had small residual right-to-left shunt, 2.6% had moderate residual right-to-left shunt and 3.1% had large residual right-to-left shunt., Conclusions: Residual right-to-left shunts are common at 6 months after percutaneous closure of PFO. However, the majority are small and two-thirds of residual right-to-left shunts achieve complete closure between 6 and 12 months., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The foramen ovale remains patent in about 25% of the adult population. In adult life, thrombi form in the venous circulation and can cross the interatrial septum and trigger an ischemic stroke - called paradoxical embolism. The treatment can be performed through percutaneous closure of the patent foramen ovale (PFO), but still rarely performed in Brazil because it is not available in the public health care., Objectives: To evaluate the reproducibility of clinical trial results in real-life studies due to the low number of records published about the topic., Methods: This study is a retrospective cohort study including 121 patients who underwent percutaneous PFO closure for secondary prophylaxis of ischemic stroke between January 2012 and June 2022., Results: We observed a mean age of 50.3 years and most females . Severe interatrial shunt was observed in 82.6% and the presence of atrial septal aneurysm in 84.2%. After 6 months of the procedure, no patient still had a residual shunt. There were no serious bleeding or vascular complications. Recurrence of a new cerebrovascular event occurred in 1.6% of patients., Conclusion: We observed a low recurrence of new ischemic neurological events and lack major complications related to the procedure.

An 81-year-old patient was referred for left atrial appendage closure. Anatomical LAA analysis by CT scan showed an inverted chicken wing morphology. The procedure was performed through i an infero-anterior transseptal puncture and led to "sandwich" closure strategy using an AMPLATZER AMULET 25 mm device. Despite successful deployment of the occluder, a hemopericardium soon developed related to an iatrogenic LAA perforation/partial rupture and leading to major hemodynamic instability. After pericardocentesis, it was decided to inject activated thrombin into the pericardial sac to achieve in situ hemostasis. This strategy enabled coagulation of the hemopericardium and cessation of active bleeding, without recourse to surgical treatment., Competing Interests: Déclaration de liens d'intérêts Nicolas Amabile a reçu des honoraires de consultant et de proctor de Abbott Medical et Boston Scientific., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

A 73-year-old man with a history of hypertension, hyperlipidemia, and obesity presented for cardiovascular evaluation. He was experiencing mild fatigue and dyspnea on exertion. Transthoracic echocardiogram (TTE) showed right ventricular dilation, which was otherwise unremarkable.

Competing Interests: Declaration of competing interest The author declares no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Gastro-tracheal fistula (GTF) is one of the most serious complications after esophagogastrostomy and radiotherapy, with very high disability and mortality rates. To evaluate the effectiveness and safety of ventricular septal occluder devices (VSOD) for the treatment of Gastro-tracheal fistula (GTF)., Methods: From January 2020 to May 2022, 14 patients with GTF underwent VSOD under real-time fluoroscopy. The technical success, complications, quality of life (QoL), Eastern Cooperative Oncology Group (ECOG) score, Karnofsky score, and median overall survival (mOS) were recorded and analyzed., Results: Technical success, and major complication rates were 71.4%, and 14.3%, respectively. Both the ECOG and the Karnofsky score showed significant improvement at the 2-month evaluation compared with the pretreatment value (p<0.05). For QoL, general health, physical function, vitality, role physical, and social function all improved at the 2-month evaluation (p<0.05), but bodily pain, role emotion, and mental health showed no significant difference (P>0.05). During the mean follow-up of 9.6 months, eight patients were alive, and the mOS was 11.4 months (95% CI, 8.5-14.3)., Conclusions: VSOD is a simple and safe technique for GTF treatment, but long-term observation is needed at multiple centers to confirm our findings., (Copyright © 2024. Published by Elsevier Ltd.)

The authors present a case of percutaneous closure of an incomplete surgical left atrial appendage (LAA) ligation with a new device LAmbre (Lifetech ScientificCo Ltd).

Background: Percutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in patients with atrial fibrillation (AF) at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain., Objective: The study aimed to compare risk of stroke in HCM-AF patients treated with LAAC with those treated with AC., Methods: By use of the TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were assigned to categories of treatment with LAAC and treatment solely with AC and observed for 3 years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity score matching was used to limit confounders., Results: Of 14,867 HCM-AF patients identified, 364 (2.5%) were treated with LAAC vs 14,503 (97.5%) treated with AC. HCM LAAC patients were older (72 vs 67 years; P < .001) and had more comorbidities and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs 18%; P < .001), compared with HCM patients treated solely with AC. After propensity score matching, there was no baseline difference between groups including prior bleeding events (P > .05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs 8%; hazard ratio, 1.9; P = .006) and systemic embolism (14% vs 9%; hazard ratio, 1.8; P = .006) but no difference in mortality compared with matched HCM patients receiving AC., Conclusion: These real-world data do not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy during long-term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC because of prohibitive bleeding risk., Competing Interests: Disclosures Martin S. Maron: consultant for Cytokinetics, iRhythm (with grant), Imbria Pharmaceuticals, Takeda Pharmaceuticals (with grant). Ethan J. Rowin: research funding from Pfizer, iRhythm. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

We report a patient with fever and cough for 2 months who was finally given a diagnosis of alveolar-pleural fistula due to aspergillus empyema. We successfully closed the alveolar-pleural fistula with a ventricular septal defect occluder through bronchoscopy. Endoscopic closure of an alveolar-pleural fistula with ventricular septal defect occluder is worth being explored., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Xiqian Xing reports article publishing charges was provided by Famous Doctors of High-level Talent Training Support Program of Yunnan Province. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: In patients with atrial fibrillation (AF) on vitamin K antagonist (VKA) therapy and therapeutic international normalized ratio (INR) range, the incidence of cardiac thromboembolism is not negligible, and the subgroup of patients who have a mechanical prosthetic mitral valve (PMV) has the highest risk. We aimed to assess the long-term effects of left atrial appendage closure (LAAC) in AF patients with a mechanical PMV who experienced a failure of VKA therapy., Methods: In this retrospective, multicentre study, patients underwent LAAC because of thrombotic events including transient ischemic attack and/or stroke, systemic embolism, and evidence of left atrial appendage thrombosis and/or sludge, despite VKA therapy, were enrolled. Patients with a mechanical PMV were included and compared with those affected by nonvalvular AF. The primary endpoint was the composite of all-cause death, major cardiovascular events, and major bleedings at follow-up. The feasibility and safety of LAAC also were assessed., Results: A total of 55 patients (42% female; mean age, 70 ± 9 years), including 12 with a mechanical PMV, were enrolled. The most-frequent indication to LAAC (71%) was LAA thrombosis or sludge. Procedural success was achieved in 96% of overall cases, and in 100% of patients with a PMV. In 35 patients, a cerebral protection device was used. During a median follow-up of 6.1 ± 4.3 years, 4 patients with a PMV, and 20 patients without a PMV, reported adverse events (hazard ratio 0.73 [95% confidence interval 0.25-2.16, P = 0.564])., Conclusions: LAAC seems to be a valuable alternative in patients with AF who have a mechanical PMV, with failure of VKA therapy. This off-label, real-world clinical practice indication deserves validation in further studies., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Percutaneous closure of atrial septal defects (ASDs) has emerged as an alternative to surgical treatment; however, several early and late complications have been reported. In this report, we present the case of a patient who underwent surgical removal of a migrated ‘Figulla Flex II’ ASD occlusion device at the aortic bifurcation 2 months after ASD occlusion.

Abstract Background Secundum-type atrial septal defects (ASD) constitute 8% to 10% of congenital heart defect. Secundum ASDs can be closed either percutaneously or surgically. However, ASD device closure has proven to be technically safe and feasible; it is not free of complications. These complications include device embolization/malposition which have been reported in 3.5% of cases, arrhythmia, and pericardial effusion in 2.6% and 0.5–1.5% respectively, device thrombus, residual shunting, and impingement of the device on the adjacent structures. Case presentation We introduce three patients with secundum ASD who had preexisting pericardial effusion, device closure was performed for them, and after the procedure, the effusion size progressed significantly. We used multimodality imaging to diagnose the cause of pericardial effusion (PE). Cardiac erosion was diagnosed in one of the patients that managed surgically. We did not found any specific procedure-related cause for worsening the pericardial effusion in the other two patients. Conclusion Several reasons include procedure-related complication and other systemic causes should be considered in patients who develop pericardial effusion after trans catheter closure of ASDs.

A patent foramen ovale (PFO) is a communication across the inter-atrial septum and a right atrial septal pouch (RASP) is an indentation of the atrial septum caused by an incomplete fusion of the septum primum and septum secundum with its base opening into the right atrium. A 63-year-old male who had a history of two strokes and episodes of transient neurological deficit was diagnosed to have a small right-to-left shunt. At the time of PFO closure, an angiogram of the atrial septum revealed a small PFO associated with a RASP. The small PFO was crossed with a straight-tipped guide wire and was closed using a 25-mm GORE CARDIOFORM Septal Occluder (W.L. Gore and Associates, AZ). It is hypothesized that stagnant blood in the RASP may generate a clot that can cross the PFO and cause an infarct. © 2015 Wiley Periodicals, Inc.

For secundum ASD, a deficient retro-aortic rim is common (40% of cases) However, the deficient retro-aortic rim had no effect on ASD device placement success or immediate outcome The IMPACT Registry does not track long-term outcome, so there is no information provided about long-term complications, such as erosion.