6,527 results on '"Septal occluder device"'
Search Results
2. Simultaneous Transcatheter Closure of a Ventricular Septal Defect and Pulmonary Valvuloplasty: A Case Report.
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Alghalyini, Baraa, Zia Zaidi, Abdul Rehman, Bin Shuiel, Hadeel Khalid, Alyabis, Nouf Abdullah, Bin Shuayl, Mohammed Khalid, and Suliman, Ihab
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- *
VENTRICULAR septal defects , *PULMONARY stenosis , *CONGENITAL heart disease , *PERCUTANEOUS balloon valvuloplasty , *CARDIAC surgery , *HUMAN abnormalities - Abstract
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]
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- 2024
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3. The skinny on post‐patent foramen ovale closure atrial fibrillation
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Mojadidi, Mohammad K and Tobis, Jonathan M
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Atrial Fibrillation ,Cardiac Catheterization ,Foramen Ovale ,Patent ,Humans ,Septal Occluder Device ,Stroke ,Treatment Outcome ,CERE-cerebrovascular disease ,PFO-patent foramen ovale/atrial septal defect ,STR-stroke ,CHDA-congenital heart disease in adults ,STR- stroke ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Published
- 2022
4. Prevention and interventional treatment of neurological diseases related to patent foramen ovale
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ZHANG Wei, YANG Shi⁃juan, WANG Qiang, and GUO Zhi⁃gang
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foramen ovale, patent ,nervous system diseases ,septal occluder device ,review ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
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.
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- 2024
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5. Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system: Post-approval study results.
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Hascoet, Sebastien, Baruteau, Alban-Elouen, Jalal, Zakaria, Demkow, Marcin, de Winter, Robbert, Gaio, Gianpiero, Clerc, Jean-Michel, Sabiniewicz, Robert, Eberli, Franz, Santoro, Giuseppe, Dauphin, Claire, Schubert, Stephan, Smolka, Grzegorz, Lutz, Matthias, Moreno, Raul, Pan, Manuel, Gutierrez-Larraya, Federico, Godart, Francois, Carminati, Mario, and Ovaert, Caroline
- Abstract
[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]
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- 2023
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6. Racial Disparities in In-Hospital Adverse Events Among Patients With Atrial Fibrillation Implanted With a Watchman Left Atrial Appendage Occlusion Device: A US National Perspective.
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Khan, Muhammad Zia, Munir, Muhammad Bilal, Darden, Douglas, Pasupula, Deepak Kumar, Balla, Sudarshan, Han, Frederick T, Reeves, Ryan, and Hsu, Jonathan C
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Humans ,Atrial Fibrillation ,Treatment Outcome ,Hospitalization ,Length of Stay ,Risk Assessment ,Risk Factors ,Comorbidity ,Time Factors ,Databases ,Factual ,Aged ,Aged ,80 and over ,Inpatients ,United States ,Female ,Male ,Health Status Disparities ,Septal Occluder Device ,Cardiac Catheterization ,Race Factors ,Hispanic or Latino ,White People ,Black or African American ,atrial fibrillation ,comorbidity ,continental population groups ,obesity ,prevalence ,Cardiovascular ,African Americans ,Whites ,Cardiorespiratory Medicine and Haematology ,Clinical Sciences ,Medical Physiology ,Cardiovascular System & Hematology - Abstract
[Figure: see text].
- Published
- 2021
7. Pooled Analysis of PFO Occluder Device Trials in Patients With PFO and Migraine
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Mojadidi, Mohammad K, Kumar, Preetham, Mahmoud, Ahmed N, Elgendy, Islam Y, Shapiro, Hilary, West, Brian, Charles, Andrew C, Mattle, Heinrich P, Sorensen, Sherman, Meier, Bernhard, Silberstein, Stephen D, and Tobis, Jonathan M
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Biomedical and Clinical Sciences ,Clinical Sciences ,Neurosciences ,Cardiovascular ,Clinical Trials and Supportive Activities ,Headaches ,Migraines ,Chronic Pain ,Pain Research ,Clinical Research ,Foramen Ovale ,Patent ,Humans ,Migraine Disorders ,Randomized Controlled Trials as Topic ,Septal Occluder Device ,migraine headache with aura ,patent foramen ovale ,PFO occluder ,PREMIUM trial ,PRIMA trial ,Cardiorespiratory Medicine and Haematology ,Public Health and Health Services ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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
- Published
- 2021
8. A comparison of methods to determine patent foramen ovale size
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Kumar, Preetham, Rusheen, Joshua, and Tobis, Jonathan M
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Biomedical and Clinical Sciences ,Clinical Sciences ,Cardiovascular ,Cardiac Catheterization ,Coronary Circulation ,Echocardiography ,Transesophageal ,Foramen Ovale ,Patent ,Hemodynamics ,Humans ,Observer Variation ,Predictive Value of Tests ,Prosthesis Design ,Reproducibility of Results ,Retrospective Studies ,Septal Occluder Device ,Severity of Illness Index ,patent foramen ovale ,intracardiac echocardiogram ,sizing balloon ,transcranial Doppler ,right-to-left shunt ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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
- Published
- 2020
9. Two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder
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Kumar, Preetham, Orford, James L, and Tobis, Jonathan M
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Biomedical and Clinical Sciences ,Clinical Sciences ,Cardiovascular ,Heart Disease ,Adult ,Cardiac Catheterization ,Cardiac Tamponade ,Device Removal ,Female ,Foramen Ovale ,Patent ,Heart Atria ,Heart Injuries ,Humans ,Middle Aged ,Prosthesis Design ,Prosthesis Failure ,Septal Occluder Device ,Treatment Outcome ,ASD ,PDA ,PFO ,CLAS-closure ,CONA-congential heart disease ,adults ,PERI-pericardium ,SHDI-structural heart disease intervention ,ASD/PDA/PFO ,CONA-congential heart disease ,adults ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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.
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- 2020
10. 单纯食道超声心动图引导下经腋下小切口 儿童动脉导管未闭的封堵治疗.
- Author
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伊寒露, 叶赞凯, 朱耀斌, 丁楠, 沈磊, 郭健, and 李志强
- Abstract
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]
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- 2023
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11. Neglected Partial Anomalous Pulmonary Venous Return during Atrial Septal Defect Device Closure.
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Radmehr, Elahe, Radmehr, Hassan, Shahidi, Mohsen, and Zanjani, Keyhan Sayadpour
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ECHOCARDIOGRAPHY , *CONGENITAL heart disease , *MAGNETIC resonance imaging , *PULMONARY veins - Abstract
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]
- Published
- 2023
12. Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale
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Fleming, Rubine Gevorgyan, Kumar, Preetham, West, Brian, Noureddin, Nabil, Rusheen, Joshua, Aboulhosn, Jamil, and Tobis, Jonathan M
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Assistive Technology ,Neurosciences ,Bioengineering ,Heart Disease ,Clinical Research ,Brain Disorders ,Cardiovascular ,6.3 Medical devices ,Evaluation of treatments and therapeutic interventions ,Adult ,Aged ,Atrial Fibrillation ,Cardiac Catheterization ,Female ,Foramen Ovale ,Patent ,Hemodynamics ,Humans ,Male ,Middle Aged ,Prevalence ,Prosthesis Design ,Recurrence ,Retrospective Studies ,Risk Factors ,Septal Occluder Device ,Stroke ,Time Factors ,Treatment Outcome ,United States ,complications ,patent foramen ovale ,patent foramen ovale closure ,PFO closure device ,residual shunt rate ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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.
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- 2020
13. New-onset atrial fibrillation following percutaneous patent foramen ovale closure: a systematic review and meta-analysis of randomised trials.
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Elgendy, Akram Y, Elgendy, Islam Y, Mojadidi, Mohammad K, Mahmoud, Ahmed N, Barry, Julia S, Jneid, Hani, Wayangankar, Siddharth A, Tobis, Jonathan M, and Meier, Bernhard
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Biomedical and Clinical Sciences ,Clinical Sciences ,Atrial Fibrillation ,Foramen Ovale ,Patent ,Humans ,Randomized Controlled Trials as Topic ,Septal Occluder Device ,Stroke ,Statistics ,Cardiovascular medicine and haematology - Published
- 2019
14. Endoscopic Management of a Chronic Gastrocutaneous Fistula after Bariatric Revisional Surgery Using a Novel Cardiac Septal Occluder
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Mariana Kumaira Fonseca, Nelson Heitor Vieira Coelho, João Luiz Langer Manica, Rafael Ramos Ramblo, Ingrid Elisa Spier, and Artur Pacheco Seabra
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bariatric surgery ,gastric fistula ,endoscopy ,gastrointestinal ,septal occluder device ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
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.
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- 2022
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15. 食管超声引导下经肋间超微切口封堵小儿膜周部和高位室间隔缺损的对比研究.
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傅行鹏, 叶菁菁, 俞劲, 张泽伟, 尤海容, and 谈林华
- Abstract
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]
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- 2023
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16. Developing a random forest algorithm to identify patent foramen ovale and atrial septal defects in Ontario administrative databases
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Laura Oliva, Eric Horlick, Bo Wang, Ella Huszti, Ruth Hall, and Lusine Abrahamyan
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Foramen ovale ,Patent ,Machine learning ,Septal occluder device ,Septal defects ,Atrial ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
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.
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- 2022
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17. [Transcatheter closure of patent ductus arteriosus in an extremely low birth weight preterm infant].
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Liu JH, Sun Y, Luo G, and Pan SL
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- Humans, Infant, Newborn, Male, Cardiac Catheterization methods, Infant, Premature, Septal Occluder Device, Treatment Outcome, Gestational Age, Ductus Arteriosus, Patent therapy, Ductus Arteriosus, Patent surgery, Infant, Extremely Low Birth Weight
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- 2025
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18. Percutaneous Transcatheter Closure of Post Myocardial Infarct Ventricular Septal Rupture After Surgical Patch Dehiscence.
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Varma P, Ferrari C, Gennari M, and De Marco F
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- Humans, Treatment Outcome, Male, Intra-Aortic Balloon Pumping, Septal Occluder Device, Surgical Wound Dehiscence etiology, Surgical Wound Dehiscence diagnostic imaging, Aged, Myocardial Infarction etiology, Myocardial Infarction diagnostic imaging, Myocardial Infarction therapy, Cardiac Surgical Procedures adverse effects, Ventricular Septal Rupture etiology, Ventricular Septal Rupture diagnostic imaging, Ventricular Septal Rupture surgery, Ventricular Septal Rupture therapy, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects
- Abstract
Post myocardial infarction ventricular septal rupture (MI-VSR) is a dreaded complication, closure of which is extremely challenging. We here describe a case which was surgically closed after 10 days but had a failure needing continuous intra-aortic balloon pump (IABP) support and was subsequently closed percutaneously with a Post MI-VSR device., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
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- 2025
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19. Atrial septal defect closure via a partial lower ministernotomy.
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Konstantinov IE, Bocchetta N, and Fricke TA
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- Humans, Minimally Invasive Surgical Procedures methods, Female, Cardiac Surgical Procedures methods, Septal Occluder Device, Treatment Outcome, Male, Adult, Heart Septal Defects, Atrial surgery, Sternotomy methods
- Abstract
Patients with secundum atrial septal defects preferentially undergo device closure; however, this procedure is not always feasible. Instead, patients can safely undergo surgical closure. At a time when minimally invasive surgery can now be utilized with improved cosmetic results and the same excellent outcomes as a conventional sternotomy for an atrial septal defect closure, we propose the partial lower ministernotomy as the new standard for surgical atrial septal defect closure. We present a surgical case demonstrating this technique., (© The Author 2025. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2025
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20. Enhanced Endothelialization Using Resveratrol-Loaded Polylactic Acid-Coated Left Atrial Appendage Occluders in a Canine Model.
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Hu L, Zhang K, Zhang H, Dong X, Ding L, Qi Y, and Tang M
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- Animals, Dogs, Materials Testing, Particle Size, Male, Coated Materials, Biocompatible chemistry, Coated Materials, Biocompatible pharmacology, Septal Occluder Device, Atrial Fibrillation drug therapy, Resveratrol pharmacology, Resveratrol chemistry, Resveratrol administration & dosage, Atrial Appendage diagnostic imaging, Polyesters chemistry
- Abstract
Left atrial appendage occlusion (LAAO) is a well-established alternative to anticoagulation therapy for patients with atrial fibrillation who have a high bleeding risk. After occluder implantation, anticoagulation therapy is still required for at least 45 days until complete LAAO is achieved by neoendocardial coverage of the device. We applied a polylactic acid-resveratrol coating to the LAAO membrane to enhance endothelialization with the goal of shortening the anticoagulation therapy duration. Eighteen dogs were randomly divided into the experimental group (coated occluders) or the control group (noncoated occluders). The dogs were sacrificed in cohorts at days 14, 28, and 90 for anatomical and pathological examination to evaluate endothelialization and thrombus formation. Transesophageal echocardiography (TEE) was performed before sacrifice to evaluate device-related adverse events. According to the anatomical and pathological examinations, all except one LAAO cover exhibited larger or thicker tissue or neoendocardial coverage in the experimental group compared with the control group at the same sacrifice time points. All connection hubs were densely covered by endothelial cells at 90 days and completely covered at 28 days in the experimental group, while all connection hubs were thinly covered at 90 days and two connection hubs were exposed at 28 days in the control group. Pathological examination revealed no thrombus formation in the experimental group, while a small amount of thrombus was observed in one dog at 90 days and in two dogs at 28 days in the control group. Finally, TEE showed no peri-device leakage (PDL) in the experimental group, whereas a small amount of PDL was detected in one dog (3.2 mm) at 28 days and in one dog (3.7 mm) at 14 days in the control group. The resveratrol-loaded polylactic acid-covered LAAO device enhanced endothelialization and reduced thrombus formation and PDL. This effect could possibly reduce the anticoagulation therapy duration.
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- 2025
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21. Surgery for chronic pyothorax after failed amplatzer closure of bronchopleural fistula.
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Vincent Y, Lenzini A, Hanna A, Leymarie N, Le Picault B, and Fadel E
- Subjects
- Humans, Adult, Male, Chronic Disease, Treatment Failure, Thoracostomy methods, Bronchial Fistula surgery, Bronchial Fistula etiology, Pleural Diseases surgery, Pleural Diseases etiology, Pneumonectomy adverse effects, Empyema, Pleural surgery, Septal Occluder Device
- Abstract
Background: Post-pneumonectomy bronchopleural fistula (BPF) is a life-threatening event whose treatment is not standardized., Case Presentation: We report the management of a 28-year-old patient with a 3-year history of BPF complicating right pneumonectomy for congenital emphysema. Despite closure by an Amplatzer device, the patient had chronic pyothorax and severely deteriorated general health and quality of life. An attempt at Amplatzer device removal through an open window thoracostomy failed. A median sternotomy was performed, the carina was resected, and the left main bronchus was anastomosed to the trachea. The thoracostomy was closed using fasciocutaneous pedicled flaps. At 9 months, the patient was doing well., Conclusion: The utilisation of an Amplatzer device to close a broncho-pleural fistula can have adverse effects and potentially result in fatal sepsis in those cases where it is unsuccessful. The endoscopic treatment of BPF should be reserved for expert centers, considering the location, size, and stability of the fistula when choosing the treatment strategy. The surgical management of failed Amplatzer closure may be extremely complex, requiring a highly experienced team., Competing Interests: Declarations. Ethics approval and consent to participate: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Because this is an observational work, institutional review board approval was not necessary. Written patient consent for this retrospective analysis was obtained to include their information in this publication. Consent for publication: Written patient consent for this retrospective analysis was obtained to include their information in this publication. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)
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- 2025
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22. Secundum atrial septal defect closure in adults in the UK.
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English KM, Espuny-Pujol F, Franklin RC, Crowe S, and Pagel C
- Subjects
- Humans, Female, Male, Adult, Middle Aged, Retrospective Studies, England epidemiology, Wales epidemiology, Treatment Outcome, Cardiac Surgical Procedures methods, Hospital Mortality trends, Follow-Up Studies, Septal Occluder Device, Survival Rate trends, Risk Factors, Registries, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial epidemiology, Cardiac Catheterization
- Abstract
Aims: To examine determinants of access to treatment, outcomes, and hospital utilization in patients undergoing secundum atrial septal defect (ASD) closure in adulthood in England and Wales., Methods and Results: Large retrospective cohort study of all adult patients undergoing secundum ASD closures in England and Wales between 2000/01 and 2016/17. Data were from population-based official data sets covering congenital heart disease procedures, hospital episodes, and death registries. Out of 6541 index closures, 79.4% were transcatheter [median age 47 years, interquartile range (IQR) 34-61] and 20.6% were surgical (40 years, 28-52). The study cohort was predominantly female (66%), with socioethnic profile similar to the general population. Mortality in hospital was 0.2% and at 1 year 1.0% [95% confidence interval (CI) 0.8-1.2%]. Risk of death was lower for transcatheter repairs, adjusting for age, sex, year of procedure, comorbidities, and cardiac risk factors [in-hospital adjusted odds ratio 0.09, 95% CI 0.02-0.46; 1-year adjusted hazard ratio 0.5, 95% CI 0.3-0.9]. There was excess mortality 1 year after ASD closure compared with matched population data. Median (IQR) peri-procedural length of stay was 1.8 (1.4-2.5) and 7.3 (6.2-9.2) days for transcatheter and surgical closures, respectively. Hospital resource use for cardiac reasons started the year before repair (median two inpatient and two outpatient-only days) and decreased post-repair (zero inpatient and one outpatient days during the first 2 years)., Conclusion: This national study confirms that ASD closure in adults, by surgical or transcatheter methods, is provided independently of ethnic or socioeconomic differences, it is low (but not no) risk, and appears to reduce future cardiac hospitalization even in older ages., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2025
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23. Percutaneous Patent Ductus Arteriosus Closure in a Conjoined Twin: Case Report.
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Calamita PC, Lombardi JG, Barreto MRP, Barbosa OC, Prudente ML, Hamu ZC, and Gardenghi G
- Subjects
- Humans, Infant, Newborn, Treatment Outcome, Cardiac Catheterization methods, Female, Male, Ductus Arteriosus, Patent surgery, Ductus Arteriosus, Patent diagnostic imaging, Twins, Conjoined surgery, Septal Occluder Device
- Abstract
Conjoined twin patients with patent ductus arteriosus and hemodynamic repercussions have a worse prognosis. In the present case report, we demonstrate the first successful percutaneous closure of the ductus arteriosus with the Piccolo© device (Abbot Structural Heart, Plymouth, MN, USA) in this type of clinical situation.
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- 2025
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24. WATCHMAN versus LACbes® device for percutaneous left atrial appendage closure: a single-center, propensity-matched study.
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Zhang S, Xiong S, Zhang S, Chen K, Wang H, Li K, Xu X, Zhao X, Zhu N, Huang X, Qin Y, Guo Z, and Bai Y
- Subjects
- Humans, Female, Male, Aged, Treatment Outcome, Time Factors, Retrospective Studies, Risk Factors, Aged, 80 and over, Risk Assessment, Ischemic Stroke prevention & control, Ischemic Stroke etiology, Middle Aged, Septal Occluder Device, Stroke prevention & control, Stroke etiology, Left Atrial Appendage Closure, Atrial Appendage physiopathology, Atrial Appendage surgery, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Atrial Fibrillation therapy, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Propensity Score, Prosthesis Design
- Abstract
Background: Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC., Methods: Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed., Results: After PSM, 184 patients were included in each group. The mean CHA
2 DS2 -VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18-0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11-0.33)., Conclusion: The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device., Competing Interests: Declarations. Ethics approval and consent to participate: This analysis was approved by the institutional review board (Changhai Hospital) and adheres to the relevant guidelines of the Declaration of Helsinki. We also received informed and signed consent from the included participants. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)- Published
- 2025
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25. Evaluation of endothelialization of an occluder device with cardiac computed tomography and assessment of the pathological validation.
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Liu A, Duan X, Wang K, Fan H, Li L, and Yan C
- Subjects
- Humans, Female, Male, Middle Aged, Retrospective Studies, Adult, Septal Occluder Device, Coronary Angiography, Contrast Media, Tomography, X-Ray Computed methods, Computed Tomography Angiography methods
- Abstract
Background: Assessing the endothelialization of occlusive devices noninvasively remains a challenge. Cardiac computed tomography angiography (CTA) can be employed to evaluate device endothelialization based on contrast uptake within the occluder., Objective: This study examined device endothelialization using cardiac CTA and investigated the pathological associations., Methods: From January 2010 to May 2022, we retrospectively analyzed 25 patients (age: 50.00 [17.00, 52.00] years; 12 Female) who underwent surgical device removal within 1 month after cardiac CTA examination (implantation period: 29.00[0.50, 108.00] months). The contrast uptake within the occluder was determined using cardiac CTA. The relationship between contrast uptake within the occluder and the endothelialization status with pathology was analyzed., Results: Contrast uptake within the occluder was identified in 76.00% of patients. Pathological examination confirmed incomplete coverage of fibrotic tissue and superposed neoendothelium on the surface of all devices exhibiting contrast uptake. This included no coverage in 47.37% of patients and partial coverage in the remaining cases. On the surface of all devices without contrast uptake, a complete range of fibrotic tissue was observed, with an incomplete range of superposed neoendothelium in 66.67% of patients. On the surface of devices with an implantation period > 6 months, 71.43% of patients had incomplete coverage of fibrotic tissue and superposed neoendothelium on the left disc, 42.86% of patients occurred the same on the right disc., Conclusions: Contrast uptake within the occluder indicated incomplete endothelialization, as confirmed by pathological validation. Late endothelialization of the device occurs frequently, and further research is required to investigate related mechanisms., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2025 Liu 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.)
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- 2025
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26. Delayed occluder displacement following patent ductus arteriosus closure successfully managed with thoracic endovascular aortic repair: a case report and literature review.
- Author
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Pan D, Yu A, Li C, Chen L, Ni C, and Zhao H
- Subjects
- Humans, Female, Young Adult, Cardiac Catheterization methods, Endovascular Aneurysm Repair, Ductus Arteriosus, Patent surgery, Septal Occluder Device, Endovascular Procedures methods, Aorta, Thoracic surgery
- Abstract
Interventional occlusion of Patent ductus arteriosus (PDA) is generally efficacious and complications such as delayed occluder displacement are infrequent. Herein, we report a case of 24-year-old female with a history of unsuccessful PDA closures, who subsequently experienced delayed occluder displacement into the left main pulmonary artery. Despite numerous unsuccessful catheter-based interventions, thoracic endovascular aortic repair (TEVAR) was successfully executed. This procedure effectively resolved the PDA without any postprocedural complications. This case highlights the efficacy and safety of TEVAR as a viable alternative for managing complex PDA cases involving occluder displacement., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: none declared. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2025
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27. Managing Congenital Heart Defects in Elderly: The Platypnea-Orthodeoxia Syndrome in Underestimated Patent Foramen Ovale.
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Verdoia M, Viola O, Marenna B, Marrara F, Bertola B, Brancati MF, Gioscia R, Soldà PL, and Rognoni A
- Subjects
- Humans, Syndrome, Female, Aged, Treatment Outcome, Septal Occluder Device, Posture, Male, Cardiac Catheterization, Platypnea Orthodeoxia Syndrome, Foramen Ovale, Patent complications, Foramen Ovale, Patent diagnostic imaging, Dyspnea etiology, Hypoxia etiology, Hypoxia complications
- Abstract
The platypnea-orthodeoxia syndrome (POS) is a rare and often suboptimally managed condition with a complex diagnostic workup, conversely displaying an easy treatment and a good recovery of symptoms, especially if consequent to an intracardiac shunt. However, its identification is challenging, due to the several clinical manifestations, the multiple etiologies, representing often the delayed presentation of a congenital heart disease. We present a case report and review of available literature on patients with the POS secondary to a patent foramen ovale successfully treated with its closure., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2025
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28. Left atrial appendage occlusion devices vs direct oral anticoagulants for atrial fibrillation: An updated systematic review and meta-analysis.
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Fernandes JM, Pinheiro RPS, Serpa F, de Andrade NM, Pereira V, Sbardelotto ÂEE, and Gomes WF
- Subjects
- Humans, Administration, Oral, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Thromboembolism prevention & control, Thromboembolism etiology, Thromboembolism epidemiology, Hemorrhage chemically induced, Hemorrhage epidemiology, Septal Occluder Device, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Atrial Appendage surgery, Anticoagulants therapeutic use, Anticoagulants administration & dosage
- Abstract
Background: Direct Oral Anticoagulants (DOACs) are the first line anticoagulation for patients with non-valvular atrial fibrillation (NVAF). Percutaneous Left Atrial Appendage Occlusion (LAAO) has emerged as a new therapy and its safety and effectiveness compared with DOACs are still controversial., Methods: A systematic review of randomized controlled trials and observational studies was conducted, focusing on patients with NVAF. Outcomes analyzed included: (1) all-cause mortality; (2) cardiovascular (CV) mortality; (3) thromboembolic events; (4) stroke or transient ischemic attack (TIA); (5) bleeding events; and a (6) composite of death, hemorrhagic, and thromboembolic events. We performed a subgroup analysis of major bleeding according to different definitions: (1) Bleeding Academic Research Consortium (BARC); (2) International Society on Thrombosis and Haemostasis (ISTH); and (3) other definitions., Results: Ten studies involving 18,507 patients were included, with 42.35 % undergoing LAAO. In pooled analysis, LAAO was associated with lower rates of all-cause mortality (HR 0.63; 95 % CI 0.50-0.80), cardiovascular mortality (HR 0.56; 95 % CI 0.45-0.70), and of the composite outcome (HR 0.73; 95 % CI 0.58-0.92). A trend towards lower stroke/TIA events was observed but not statistically significant. Overall bleeding events did not significantly differ between groups; using the ISTH definition, LAAO showed significantly lower incidence of bleeding events (HR 0.63; 95 % CI 0.43-0.91). No difference was found in thromboembolic events., Conclusion: LAAO was associated with a significantly lower all-cause mortality and cardiovascular mortality, as well as the composite of death, hemorrhagic or thromboembolic events, as compared with DOACs., Competing Interests: Declaration of competing interest The authors 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.)
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- 2025
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29. Rescue Transcatheter Native Aortic Valve Closure to Treat Severe Aortic Regurgitation in a Patient With Single Ventricular Physiology and Decompensated Heart Failure.
- Author
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Kang SL, Deri A, Suliman M, and Bentham JR
- Subjects
- Humans, Treatment Outcome, Hypoplastic Left Heart Syndrome surgery, Hypoplastic Left Heart Syndrome physiopathology, Male, Recovery of Function, Prosthesis Design, Ventricular Function, Right, Ventricular Dysfunction, Right physiopathology, Ventricular Dysfunction, Right etiology, Ventricular Dysfunction, Right therapy, Ventricular Dysfunction, Right diagnostic imaging, Echocardiography, Doppler, Color, Hemodynamics, Aortic Valve Insufficiency physiopathology, Aortic Valve Insufficiency surgery, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency etiology, Cardiac Catheterization instrumentation, Heart Failure physiopathology, Heart Failure therapy, Heart Failure diagnosis, Heart Failure etiology, Severity of Illness Index, Aortic Valve physiopathology, Aortic Valve surgery, Aortic Valve diagnostic imaging, Septal Occluder Device
- Abstract
Semilunar valve regurgitation in single ventricular physiology is rare but portends a poor prognosis. Medical therapy is often ineffective particularly in the context of structural valve abnormality, and surgical valve repair or replacement can be associated with poor outcomes. We report an innovative use of a highly occlusive and conformable Gore Septal Occluder for transcatheter treatment of severe native aortic regurgitation in a symptomatic patient with hypoplastic left heart syndrome and severe systemic right ventricular dysfunction, resulting in safe and complete occlusion of the aortic regurgitant orifice and clinical benefit., (© 2024 Wiley Periodicals LLC.)
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- 2025
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30. Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders.
- Author
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Fang Y, Hou K, Lin D, Zhou D, Pan W, and Ge J
- Subjects
- Humans, Female, Male, Time Factors, Treatment Outcome, Adult, Young Adult, China, Adolescent, Middle Aged, Septal Occluder Device, Heart Septal Defects, Atrial diagnostic imaging, Heart Septal Defects, Atrial therapy, Computed Tomography Angiography, Prosthesis Design, Predictive Value of Tests, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects
- Abstract
Background: Complete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReAces) compared with traditional occluders 1 year post-implantation using computed tomography angiography (CTA)., Methods: Fifteen patients from each group in a randomized controlled trial comparing ReAces with traditional occluders were included at the 1-year follow-up at Zhongshan Hospital, Fudan University. Baseline characteristics and procedural data were recorded. CTA was performed to assess the device morphology and degree of endothelialization. Independent samples t-test and Fisher's exact test were primarily used to compare the above data., Results: Each patient received a single device and had no residual shunts. There were no differences in defect size (15.3 ± 4.0 mm vs. 15.3 ± 4.7 mm, p = 1.00) or occluder size (21.2 ± 4.4 mm vs. 21.5 ± 5.3 mm, p = 0.882) between the two groups. At the 1-year follow-up CTA, the central region thickness (4.2 mm ± 0.9 mm vs. 7.8 mm ± 2.4 mm, p < 0.0001), left atrial device-occupied volume (1863.3 mm
2 ± 404.4 mm2 vs. 4764.4 mm2 ± 2321.2 mm2 , p < 0.001), and device compression rates (10.1 ± 4.8% vs. 17.5 ± 5.6%, p = 0.001) were significantly lower in the experimental group. All occluders in the experimental group achieved complete endothelialization, whereas in the control group, 7 patients did not (100% vs. 53.3%, p = 0.006)., Conclusions: Compared with traditional occluders, ReAces presented a significantly greater complete endothelialization rate, lower central region thickness, lower left atrial device-occupied volume, and lower device compression rates at 1 year post-implantation by CTA., Trial Registration: Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022., Competing Interests: Declarations. Ethics approval and consent to participate: This study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University (No. B2021-339R) and adhered to the principles of the Declaration of Helsinki. Written informed consent was obtained from all the patients or their relatives before any study procedures were initiated. Consent for publication: Not applicable. Competing interests: This study was supported by Hanyu Medical Technology. W.P and D.Z. were consultants of Hanyu Medical Technology. All the other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024. The Author(s).)- Published
- 2024
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31. [Application of modified percutaneous closure in the treatment of ventricular septal rupture after acute myocardial infarction].
- Author
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Sun ZR, Han Y, Liu YH, Jiang JC, Han Y, Ben LL, Zhang J, and Gao CY
- Subjects
- Humans, Male, Retrospective Studies, Female, Aged, Treatment Outcome, Septal Occluder Device, Cardiac Tamponade etiology, Cardiac Tamponade surgery, Cardiac Tamponade therapy, Cardiac Catheterization methods, Ventricular Fibrillation, Operative Time, Ventricular Septal Rupture etiology, Ventricular Septal Rupture surgery, Myocardial Infarction complications, Myocardial Infarction surgery
- Abstract
Objective: To investigate the effect of modified percutaneous closure in the treatment of ventricular septal rupture. Methods: This study is a retrospective cohort study. Forty-four patients with ventricular septal rupture who underwent percutaneous closure at the Fuwai Central China Cardiovascular Hospital from December 2017 to October 2023 were included. According to the closure method, patients were divided into the modified group (11 cases) and the traditional group (33 cases). Surgical success was defined as successful placement of the occluder. The operation time, X-ray intake, sheath bending rate, incidence of ventricular fibrillation and pericardial tamponade, and postoperative residual shunt were compared between the two groups. Results: The age of the patients was (75.0±5.7) years, with 20 (45%) males. There were 3 cases of operation failure in the traditional group, while all patients in the modified group were successfully occluded. The procedure time in the modified group was shorter than that in the traditional group (40 (35, 45) min vs. 60 (50, 65)min, P <0.001); X-ray dose intake was lower ((442.43±73.26)mGy vs. (784.45±247.78)mGy, P <0.001). There was no occurrence of sheath bending in the modified group, while the incidence of sheath bending in the traditional surgery group was 46% (15/33), and the difference was statistically significant ( P =0.017). Intraoperative ventricular fibrillation and pericardial tamponade occurred in 7 cases (21%) and 2 cases (6%) in the traditional group respectively, while none occurred in the modified group, but the differences between the groups were not statistically significant (both P >0.05). There was no significant difference in residual shunt between the two groups (3.6 (2.5, 4.3) mm vs. 4.0 (3.5, 4.5) mm, P =0.506). Conclusion: The procedure of modified ventricular septal rupture closure is more simplified, with a lower incidence ofventricular fibrillation and pericardial tamponade.
- Published
- 2024
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32. Complete percutaneous repair of Tetralogy of Fallot in adult: a case report.
- Author
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Das A, Lakhani G, Kar D, Mishra L, Mollah NN, and Tewary S
- Subjects
- Humans, Male, Adolescent, Septal Occluder Device, Cardiac Surgical Procedures methods, Balloon Valvuloplasty methods, Tetralogy of Fallot surgery, Cardiac Catheterization methods
- Abstract
Tetralogy of Fallot (TOF) is the most common congenital cyanotic heart disease and is characterized by an antero-superior deviation of the infundibular septum with a consequent large malaligned ventricular septal defect (VSD) and a pulmonary and sub-pulmonary (infundibular) stenosis. Surgical repair has been the cornerstone of treatment that is electively performed early in their lives between 3 and 6 months of age. With advancements in transcatheter interventions, the complete percutaneous repair of TOF, a complex disease with multiple treatable lesions, is becoming a conceivable possibility. Here, we report the case of total transcatheter correction of an 18-year-old boy with TOF, performed in two stages. The first stage involved addressing the right ventricular outflow tract (RVOT) obstruction with balloon pulmonary valvuloplasty (BPV) and occluding the conal artery using absolute alcohol and a coil. In the second stage, the VSD was closed with a Multifunctional Occluder (MFO) Konar device 14 -12 mm (Lifetech, China). While surgical treatment remains the gold standard for total correction of TOF, the transcatheter approach can also be considered for selected group of patients who are surgically turned-down., Competing Interests: Declarations. Disclosure: We have nothing to disclose. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2024
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33. A Challenging Interventional Procedure: Transcatheter Closure of Tubular Patent Ductus Arteriosus in Patients with Pulmonary Hypertension.
- Author
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Yucel IK, Epcacan S, Bulut MO, Demir IH, Surucu M, Yilmaz EH, Kardas M, Kanlioglu P, and Celebi A
- Subjects
- Humans, Female, Male, Infant, Child, Preschool, Retrospective Studies, Treatment Outcome, Child, Ductus Arteriosus, Patent surgery, Cardiac Catheterization methods, Septal Occluder Device, Hypertension, Pulmonary surgery
- Abstract
Transcatheter closure of the tubular ducts remains the most challenging procedure, with higher complication rates than other types. This study evaluates the characteristics of transcatheter closure of tubular ducts with pulmonary hypertension. 73 patients with tubular ducts who underwent cardiac catheterization for transcatheter PDA closure were analyzed. The mean age and weight were 1.93 ± 2.68 years and 8.83 ± 6.14 kg, respectively. Transcatheter closure was attempted in 72 patients. Four cases (5.5%) were referred to surgery, while the procedure was completed in the remaining (94.5%). Amplatzer duct occluder (ADO) I or Cardiofix duct occluder (CDO) was the most commonly used devices. However, the use of Amplatzer vascular plug (AVP) II raised in recent years. The most common concern was aortic protrusion/stenosis in ADO I/CDO devices, but most regressed during follow-up. Iatrogenic coarctation of the aorta was observed in two with ADO I/CDO. Embolization of the device to the pulmonary artery was observed in three with CDO, AVP II, and AVP I. Significant left pulmonary artery stenosis requiring stenting developed in one after closure with an MVSDO device. Tubular ducts are highly associated with pulmonary arterial hypertension, and transcatheter closure of them is still challenging despite the developing device armamentarium. Although ADO I or similar devices are widely used, off-label devices are usually needed at increasing rates. The AVP II device is unsuitable for short tubular ducts but seems the best option for long ones., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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34. Kissing-catheter technique in percutaneous transcatheter closure of patent ductus arteriosus: a snare-free approach.
- Author
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Zhang C, Chen L, and Gu H
- Subjects
- Humans, Female, Male, Retrospective Studies, Treatment Outcome, Child, Child, Preschool, Adult, Adolescent, Pulmonary Artery surgery, Pulmonary Artery diagnostic imaging, Ductus Arteriosus, Patent surgery, Ductus Arteriosus, Patent therapy, Cardiac Catheterization methods, Septal Occluder Device
- Abstract
Objectives: For percutaneous closure of the patent ductus arteriosus (PDA) with a mushroom-shaped occluder, the establishment of a guidewire rail with the antegrade venous approach may be difficult in some cases. The retrograde technique can be used instead; however, the use of a snare system may bring extra costs and risks. The aim of the study was to report on a new method that fulfills the retrograde technique without the use of a snare system in transcatheter closure of PDA., Methods: From May 2019 to January 2023, we attempted transcatheter closure using the kissing-catheter technique after failure of the conventional antegrade venous approach on 22 consecutive patients with PDA. This technique involves docking the distal ends of the antegrade catheter and retrograde catheter in the main pulmonary artery, and sending an exchange guidewire from one catheter, through the docking junction, and externalized from the proximal end of the other. Then an artery-PDA-vein guidewire loop was established for the delivery of the occluder. The results and operation time of this method were analyzed., Results: Successful establishment of the guidewire rail was achieved in all patients. The average time from attempting to dock the 2 catheters to successfully passing the guidewire was 26 ± 15 seconds. There were no complications during or after the procedures., Conclusions: The snare-free kissing-catheter technique is an efficient and reliable method for transcatheter closure of PDA in cases where the antegrade approach is difficult.
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- 2024
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35. Transcatheter closure of a right pulmonary artery to left atrium fistula using multi-modality image fusion guidance.
- Author
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Soszyn N, Gill EA, Zablah JE, and Morgan GJ
- Subjects
- Humans, Female, Middle Aged, Fistula surgery, Fistula diagnostic imaging, Fistula diagnosis, Septal Occluder Device, Multimodal Imaging, Echocardiography, Transesophageal methods, Vascular Fistula surgery, Vascular Fistula diagnostic imaging, Vascular Fistula diagnosis, Echocardiography, Pulmonary Artery abnormalities, Pulmonary Artery diagnostic imaging, Pulmonary Artery surgery, Heart Atria diagnostic imaging, Heart Atria abnormalities, Cardiac Catheterization methods
- Abstract
We present the case of 53-year-old woman with a late diagnosis of an right pulmonary artery-left atrium fistula who underwent transcatheter device closure using multi-modality imaging for pre-procedural planning and procedural guidance.
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- 2024
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36. Incomplete cor triatriatum dexter and percutaneous closure of atrial septal defects, a single-centre experience.
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Martín DG, Sánchez-Rubio Lezcano J, Fuertes Ferre G, Álvarez Roy L, López Ramón M, and Diarte De Miguel JA
- Subjects
- Humans, Middle Aged, Female, Male, Cardiac Catheterization methods, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnosis, Foramen Ovale, Patent complications, Foramen Ovale, Patent diagnostic imaging, Echocardiography, Three-Dimensional methods, Treatment Outcome, Fluoroscopy, Cor Triatriatum diagnosis, Cor Triatriatum surgery, Echocardiography, Transesophageal methods, Septal Occluder Device, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial diagnosis
- Abstract
Cor Triatriatum Dexter (CTD) is a rare congenital heart malformation, with an estimated incidence of 0.025%, characterised by a membrane dividing the right atrium (RA) into two chambers. A variant, incomplete CTD (CTDi), occurs when the right membrane extends partially into the interatrial septum without fully dividing the RA. CTDi can be associated with interatrial septal defects, found in 5% of patients with atrial septal defects or a patent foramen ovale (PFO). The study reports three adult patients (46-53 years old) with CTDi and a PFO, all presenting cryptogenic stroke and referred for PFO closure. Two cases underwent percutaneous closure with guidance from fluoroscopy and 2D/3D transesophageal echocardiography (TEE), and the last one utilised intracardiac echocardiography (ICE) for device placement. In patients referred for PFO closure, CTDi is common and can complicate visualisation, prolong procedure times, and reduce success rates. Difficulties in device deployment and the risk of residual shunt or embolisation have been reported. The authors highlight that using oversizing techniques, traction manoeuvres during device deployment, and preoperative planning with advanced imaging (such as ICE or 3D TEE) are crucial for successful percutaneous closure in cases with CTDi and PFO.
- Published
- 2024
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37. Discordance between the European and the United States guideline criteria for atrial septal defect closure in adult patients with pulmonary hypertension and its clinical impact.
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Tangcharoen T, Ngernsritrakul T, Chandavimol M, Kamsorn C, Apakuppakul S, and Yamwong S
- Subjects
- Humans, Female, Male, Retrospective Studies, Middle Aged, United States epidemiology, Adult, Europe epidemiology, Echocardiography methods, Treatment Outcome, Aged, Septal Occluder Device, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial complications, Heart Septal Defects, Atrial diagnosis, Hypertension, Pulmonary diagnosis, Practice Guidelines as Topic, Cardiac Catheterization methods
- Abstract
Background: The criteria for ASD closure in patients with PAH are different between the AHA/ACC and the ESC guidelines. We aimed to study the prevalence of patients with different guideline criteria for ASD closure and its impact on the clinical outcome after closure., Methods and Results: A retrospective cohort study recruiting patients who underwent ASD closure from 2011-2020 was conducted in a single university hospital. Patients were grouped into ASD closure recommended (class I, class IIa, and class IIb) and ASD closure not recommended groups (class III). The primary outcome was the prevalence of patients with discordant criteria and the clinical outcomes and echocardiographic parameters after ASD closure. A total of 17 of 66 ASD patients (25.8 %) were diagnosed with ASD with pulmonary hypertension. Two patients were excluded due to incomplete right heart catheterization data. 13 patients (86.7 %) were classified as ASD-closure recommended group by both guidelines. Two patients, classified as class IIb by ACC/AHA guidelines, were unsuitable for ASD closure by ESC guidelines. After ASD closure, all 15 patients reported functional class improvement and no significant difference in the echocardiography parameters. However, the number of patients with a low probability of PHT was higher in patients with ESC guideline-recommended closure., Conclusions: Most patients (86.7 %) are in concordant classification regarding ASD closure recommendations. The ESC guidelines are more restrictive than the AHA/ACC guidelines, allowing fewer patients for ASD closure. However, the clinical outcomes after ASD closure are not significantly different between these guidelines., Competing Interests: Declaration of competing interest The authors 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. Published by Elsevier Inc.)
- Published
- 2024
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38. Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine The PREMIUM Trial
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Tobis, Jonathan M, Charles, Andrew, Silberstein, Stephen D, Sorensen, Sherman, Maini, Brijeshwar, Horwitz, Phillip A, and Gurley, John C
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Neurosciences ,Clinical Research ,Pain Research ,Headaches ,Migraines ,Chronic Pain ,Cardiovascular ,Clinical Trials and Supportive Activities ,Brain Disorders ,Heart Disease ,Adult ,Cardiac Catheterization ,Double-Blind Method ,Echocardiography ,Doppler ,Female ,Foramen Ovale ,Patent ,Humans ,Male ,Middle Aged ,Migraine Disorders ,Pain Management ,Pain Measurement ,Prosthesis Implantation ,Septal Occluder Device ,Severity of Illness Index ,Treatment Outcome ,Amplatzer PFO Occluder device ,aura ,double-blind randomized clinical trial ,migraine ,patent foramen ovale ,Cardiorespiratory Medicine and Haematology ,Public Health and Health Services ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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).
- Published
- 2017
39. Transcatheter Patent Foramen Ovale Closure After Cryptogenic Stroke An Updated Meta-Analysis of Randomized Trials
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Mojadidi, Mohammad Khalid, Elgendy, Akram Y, Elgendy, Islam Y, Mahmoud, Ahmed N, Elbadawi, Ayman, Eshtehardi, Parham, Patel, Nimesh K, Wayangankar, Siddharth, Tobis, Jonathan M, and Meier, Bernhard
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Cardiac Catheterization ,Embolism ,Paradoxical ,Foramen Ovale ,Patent ,Humans ,Randomized Controlled Trials as Topic ,Risk Factors ,Septal Occluder Device ,Stroke ,Treatment Outcome ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Published
- 2017
40. Patent foramen ovale with right atrial septal pouch
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Kijima, Yasufumi, Bokhoor, Pooya, and Tobis, Jonathan M
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Heart Disease ,Cardiovascular ,Abnormalities ,Multiple ,Angiography ,Atrial Septum ,Cardiac Catheterization ,Cardiac Surgical Procedures ,Echocardiography ,Transesophageal ,Foramen Ovale ,Patent ,Heart Septal Defects ,Atrial ,Humans ,Male ,Middle Aged ,Septal Occluder Device ,CLAS-closure ,ASD/PDA/PFO ,CONA-congenital heart disease ,adults ,EMBP-embolic protection devices ,IAF-imaging ,angiographic/fluoroscopic ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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.
- Published
- 2017
41. Surgical Removal of Migrated Atrial Septal Defect Closure Device: A Case Report
- Author
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Sunjoo Kim and Sangil Min
- Subjects
device removal ,heart septal defects ,atrial ,septal occluder device ,foreign-body migration ,Diseases of the blood and blood-forming organs ,RC633-647.5 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
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.
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- 2022
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42. Case report of worsening of preexisting pericardial effusion after ASD device closure: is it calamitous?
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Zahra Khajali, Ata Firouzi, Hamidreza Pouraliakbar, Zahra Hosseini, and Fateme Jorfi
- Subjects
Atrial septal defects ,Congenital heart defect ,Septal occluder device ,Pericardial effusion ,Echocardiography ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
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.
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- 2021
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43. Atrio-aortic erosion caused by Amplatzer Atrial Septal Occluder – a case report
- Author
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Christine E. Kamla, Joscha Buech, Philipp M. Doldi, Christian Hagl, Gerd Juchem, and Alexey Dashkevich
- Subjects
Atrial septal defect ,Cardiac tamponade ,Septal Occluder device ,Case report ,Surgery ,RD1-811 ,Anesthesiology ,RD78.3-87.3 - Abstract
Abstract Background In specialized centers, percutaneous closure using specific occluders is the first-choice treatment in atrial septal defects (ASD). Late complications after this intervention, such as erosion of the aorta or the atria, are rare and have not been sufficiently approached and dealt with in literature. In our clinic we have been faced with the problematic situation of diagnosing and treating such cases. That is why, we have decided to share our experience with other colleagues. Case presentation We present two cases of severe late complications after percutaneous closure of atrial septal defects (ASD). In both cases, the atrial septal occluder (Amplatzer™ Atrial Septal Occluder Device, Abbott, Chicago USA) caused the erosion between the left atrium and the aortic root. The atrio-aortic erosion led to acute cardiac tamponade with upper venous congestion and shock. As the bleeding source remained undetectable for any imaging tools, a diagnostical sternotomy remained the only solution. The cause of the acute bleeding was discovered to be the erosion between the left atrium and the aortic root. The treatment consisted in the removal of the occluder, direct suturing of the perforated areas and the surgical closure of the remaining ASD. The patients fully recovered within the nine to fourteen days’ hospital stay. Six months after surgery both patients were well and able to recover their daily routine. Conclusions The atrio-aortic erosion after percutaneous closure of atrial septal defects is a surgical emergency. The more so, since it can be complicated by the absence of specific symptoms. A key-element in the diagnosis of this rare pathology remains the medical history of the patient, which the surgeon has to consider thoroughly and launch the diagnostic sternotomy without delay.
- Published
- 2021
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44. Addressing the needs of treating congenital heart disease: The influence of deficient retro‐aortic rim on technical success and early adverse events following device closure of secundum atrial septal defects: An analysis of the IMPACT registry®
- Author
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Tobis, Jonathan M
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Pediatric ,Cardiovascular ,Heart Disease ,Cardiac Catheterization ,Heart Septal Defects ,Atrial ,Humans ,Registries ,Septal Occluder Device ,Treatment Outcome ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
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.
- Published
- 2017
45. To close or not to close: contemporary indications for patent foramen ovale closure
- Author
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Zier, Lucas S, Sievert, Horst, and Mahadevan, Vaikom S
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Headaches ,Cardiovascular ,Stroke ,Pain Research ,Neurosciences ,Brain Disorders ,Rare Diseases ,Anticoagulants ,Cardiac Catheterization ,Foramen Ovale ,Patent ,Humans ,Meta-Analysis as Topic ,Platelet Aggregation Inhibitors ,Prosthesis Implantation ,Randomized Controlled Trials as Topic ,Septal Occluder Device ,Treatment Outcome ,Patent foramen ovale ,closure devices ,stroke ,transient ischemic attack ,migraine headache ,decompression sickness ,platypnea-orthodeoxia syndrome ,venous thromboembolism ,Cardiorespiratory Medicine and Haematology ,Public Health and Health Services ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
IntroductionPatent foramen ovale (PFO) is a common congenital cardiac abnormality and that has been associated with several disease processes including transient ischemic attacks (TIA), stroke, migraine headaches with aura, decompression sickness, platypnea-orthodeoxia syndrome, and shunt induced cyanosis. Controversy exists regarding closure of PFO as a therapeutic treatment modality for these disease processes. This review addresses the contemporary clinical indications for PFO closure. Areas covered: We conducted a comprehensive literature search of contemporary research studies focusing on randomized trials and meta-analyses comparing medical therapy and device closure of PFOs for the treatment of PFO associated clinical syndromes. We synthesized this literature into a review addressing indications for PFO closure in stroke, TIA, migraine headaches with aura, decompression sickness, platypnea-orthodeoxia syndrome, and shunt induced cyanosis. Expert commentary: Because in many PFO associated conditions it can be difficult to determine the degree to which the PFO is a causative factor in the disease process, we recommend a comprehensive diagnostic evaluation to exclude other obvious etiologies of PFO associated conditions before implicating the PFO and proceeding with closure. However in the properly selected patient population there is growing clinical experience and experimental evidence suggesting that closure of PFO is a safe and effective treatment modality.
- Published
- 2016
46. Developing a random forest algorithm to identify patent foramen ovale and atrial septal defects in Ontario administrative databases.
- Author
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Oliva, Laura, Horlick, Eric, Wang, Bo, Huszti, Ella, Hall, Ruth, and Abrahamyan, Lusine
- Subjects
ATRIAL septal defects ,PATENT foramen ovale ,RANDOM forest algorithms ,MEDICAL databases ,MACHINE learning - 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. [ABSTRACT FROM AUTHOR]- Published
- 2022
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47. Comparison of Embolization Coils and Patent Ductus Arteriosus Occluders for Coronary Artery Fistula Transcatheter Closure: A Single Centre Experience.
- Author
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Wei P, Li Y, Xu L, Wan J, Zhang F, Tse G, Chan JSK, Wang S, Ouyang W, Zhang G, Fang F, and Pan X
- Abstract
Background and Objectives: There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce., Methods: Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66)., Results: No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs. 62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59-32.64; p=0.01). In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342)., Conclusions: Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes., Competing Interests: The authors have no financial conflicts of interest., (Copyright © 2025. The Korean Society of Cardiology.)
- Published
- 2024
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48. Device closure via minimally invasive left intercostal incision in children with perimembranous ventricular septal defect.
- Author
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Xu F, Zeng X, Xie L, Huang Q, Shen Y, Liao Z, Liao D, and Fan CJ
- Subjects
- Humans, Female, Male, Child, Preschool, Retrospective Studies, Child, Infant, Treatment Outcome, Length of Stay, Septal Occluder Device, Adolescent, Operative Time, Heart Septal Defects, Ventricular surgery, Minimally Invasive Surgical Procedures methods, Thoracotomy methods
- Abstract
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).)
- Published
- 2024
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49. Fenestrated closure of an atrial septal defect for left ventricular diastolic dysfunction in an early infant with hypertrophic cardiomyopathy.
- Author
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Hayashi K, Hasegawa T, and Tanaka T
- Subjects
- Humans, Infant, Male, Diastole, Echocardiography, Septal Occluder Device, Cardiomyopathy, Hypertrophic complications, Cardiomyopathy, Hypertrophic surgery, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial complications, Ventricular Dysfunction, Left etiology, Ventricular Dysfunction, Left physiopathology
- Abstract
Left ventricular diastolic dysfunction is associated with poor prognosis in patients with hypertrophic cardiomyopathy and CHD. We report the case of an infant concomitant with hypertrophic cardiomyopathy, an atrial septal defect, and left ventricular diastolic dysfunction, who was successfully managed with fenestrated closure of the atrial septal defect.
- Published
- 2024
- Full Text
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50. Practical Aspects of Patent Foramen Ovale Closure: Ultrasound and Fluoroscopic Guidance.
- Author
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Piayda K, Bertog S, Mbai M, Sharma A, Veulemans V, and Sievert H
- Subjects
- Humans, Fluoroscopy methods, Septal Occluder Device, Stroke prevention & control, Stroke etiology, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnostic imaging, Foramen Ovale, Patent complications, Echocardiography, Transesophageal methods, Cardiac Catheterization methods, Ultrasonography, Interventional methods
- Abstract
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.)
- Published
- 2024
- Full Text
- View/download PDF
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