Occluder Implantation Research Articles

Experimental validation of coronary stenosis severity and development of ischemic myocardium

The current study aimed to evaluate the causal association between hemodynamically significant stenosis and the occurrence of ischemic myocardium using an experimental animal model of coronary artery stenosis. In Yorkshire swine (n = 10), coronary stenosis in the left anterior descending artery was induced using a customized vascular occluder to create varying degrees of occlusion severity (40%-99%). Serial changes in coronary pressure and flow velocity were measured in the left anterior descending artery before and after the implantation of the vascular occluder. At 1 month, 13N-ammonia positron emission tomography (PET) was performed, followed by the collection of isolated hearts for 2,3,5-Triphenyltetrazolium chloride (TTC) staining to quantify the percent area of necrotic myocardium. Three animals in the control group were evaluated using the same protocols, but without the implantation of a vascular occluder Results: The median diameter stenosis after vascular occluder implantation was 61.3% (Q1-Q3: 55.9%-72.3%). Significant differences were observed in hyperemic stenosis resistance, fractional flow reserve (FFR), stress perfusion defect and reversibility in PET, as well as in necrotic myocardium in TTC staining based on stenosis severity (control group: < 50%, 50%-70%, 70%-90%, and > 90%) (all P < .010). Animals with FFR < 0.75 at 1 month exhibited a significantly higher area of stress perfusion defect (30.7 ± 3.1% vs 6.0 ± 4.2%, P < .001), reversibility in PET (11.0 ± 4.0% vs 0.0 ± 0.0%, P = .006), and necrotic myocardium in TTC staining (15.8 ± 6.4% vs 0.0 ± 0.0%, P < .001) than those with FFR ≥ 0.75. In a porcine model, the induction of hemodynamically significant stenosis with FFR < 0.75 was associated with the development of stress perfusion defects and reversibility in PET, as well as necrotic myocardium identified by pathology.

Tailored extracellular matrix-mimetic coating facilitates reendothelialization and tissue healing of cardiac occluders

Minimally invasive transcatheter interventional therapy utilizing cardiac occluders represents the primary approach for addressing congenital heart defects and left atrial appendage (LAA) thrombosis. However, incomplete endothelialization and delayed tissue healing after occluder implantation collectively compromise clinical efficacy. In this study, we have customized a recombinant humanized collagen type I (rhCol I) and developed an rhCol I-based extracellular matrix (ECM)-mimetic coating. The innovative coating integrates metal-phenolic networks with anticoagulation and anti-inflammatory functions as a weak cross-linker, combining them with specifically engineered rhCol I that exhibits high cell adhesion activity and elicits a low inflammatory response. The amalgamation, driven by multiple forces, effectively serves to functionalize implantable materials, thereby responding positively to the microenvironment following occluder implantation. Experimental findings substantiate the coating's ability to sustain a prolonged anticoagulant effect, enhance the functionality of endothelial cells and cardiomyocyte, and modulate inflammatory responses by polarizing inflammatory cells into an anti-inflammatory phenotype. Notably, occluder implantation in a canine model confirms that the coating expedites reendothelialization process and promotes tissue healing. Collectively, this tailored ECM-mimetic coating presents a promising surface modification strategy for improving the clinical efficacy of cardiac occluders.

Dynamics of residual shunt closure within one year after endovascular patent foramen ovale closure: a clinical study

Aim. To study 12-month dynamics of residual shunt (RS) closure after endovascular patent foramen ovale (PFO) closure.Material and methods. We analyzed the data of 80 patients who underwent endovascular PFO closure at the Chazov National Medical Research Center for Cardiovascular Diseases in the period 2018-2023. All patients underwent a full range of examinations in accordance with current clinical guidelines. The severity of RS immediately after occluder implantation, as well as after 1, 6 and 12 months post-intervention assessment was based on transesophageal echocardiogram bubble study at the control visit.Results. In the postoperative period, RS was visualized in 17,5% (n=14) of patients. Discharge was significant in 7,5% (n=6) of patients. One month after the intervention, residual significant discharge persisted in 10,0% (n=8) of patients. After 6 months, RS was visualized in 2,5% (n=2) of patients, and after 12 months, only in one patient (1,3%). The proportion of patients with RS 1 month after the intervention decreased to 42,9%, after 6 months to 85,7%, and after 12 months to 92,9% (p&lt;0,05).Conclusion. Most patients with RS after endovascular intervention for PFO are characterized by complete endocardialization of the occluder and PFO closure within the first year.

The 3-year follow-up of a fully biodegradable implantable device closure for perimembranous ventricular septal defects in children using echocardiography.

The aim of this study was to investigate the morphologic changes of a novel fully biodegradable implantable device after closing a perimembranous ventricular septal defect (Pm-VSD) and to evaluate the effect of the occluder on the myocardial function in patients during a 3-year follow-up period. One-year, 2-year, and 3-year follow-ups were carried out after implantation with a total of 30 Pm-VSD patients who had successful closure by the fully biodegradable occluder. In total, 30 healthy children were enrolled as controls. At discharge and at every follow-up visit, the lengths of the left and right discs of the novel device were measured in the apical three- and four-chamber as well as short-axis views. At the end of the follow-up, using three-dimensional speckle-tracking conditions, the values of myocardial deformation, including global longitudinal strain, global circumferential strain, and global area strain, were acquired. The fully bioabsorbable double-disc occluder gradually decreased over time and was eventually invisible under echocardiographic scanning during the follow-up (p < 0.05). At the end of the third year, there were no significant differences in the myocardial deformation parameters between the cases implanted with the novel devices and the controls; no significant differences were found between the basal segments of the ventricle septa and that of the left ventricle (LV) free wall among the patients who completed the Pm-VSD closure using the fully biodegradable occluder (p > 0.05). The novel fully biodegradable occluder is a safe, effective, and perfect alternative for the treatment of VSD. Echocardiography plays a crucial role in the follow-up of this new type of occluder implantation.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study

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

Airway and anesthesia management in tracheoesophageal fistula closure implantation: a single-centre retrospective study

ObjectiveTo review and analyze the airway and anesthesia management methods for patients who underwent endoscopic closure of tracheoesophageal fistula (TEF) and to summarize the experience of intraoperative airway management.MethodWe searched the anesthesia information system of the First Affiliated Hospital of Nanjing Medical University for anesthesia cases of TEF from July 2020 to July 2023 and obtained a total of 34 anesthesia records for endoscopic TEF occlusion. The intraoperative airway management methods and vital signs were recorded, and the patients’ disease course and follow-up records were analyzed and summarized.ResultsThe airway management strategies used for TEF occlusion patients included nasal catheter oxygen (NCO, n = 5), high-flow nasal cannula oxygen therapy (HFNC, n = 4) and tracheal intubation (TI, n = 25). The patients who underwent tracheal intubation with an inner diameter of 5.5 mm had stable hemodynamics and oxygenation status during surgery, while intravenous anesthesia without intubation could not effectively inhibit the stress response caused by occluder implantation, which could easily cause hemodynamic fluctuations, hypoxemia, and carbon dioxide accumulation. Compared with those in the TI group, the NCO group and the HFNC group had significantly longer surgical times, and the satisfaction score of the endoscopists was significantly lower. In addition, two patients in the NCO group experienced postoperative hypoxemia.ConclusionDuring the anesthesia process for TEF occlusions, a tracheal catheter with an inner diameter of 5.5 mm can provide a safe and effective airway management method.

THORACOSCOPIC LEFT ATRIAL APPENDAGE AMPUTATION CAN BE AN ALTERNATIVE TO ENDOVASCULAR OCCLUSION

HighlightsWe present a clinical case of a patient with atrial fibrillation and a high bleeding risk according to HAS-BLED bleeding risk score who underwent thoracoscopic left atrial appendage (LAA) occluder implantation due to lack of endovascular access. Thoracoscopic amputation of LAA also can be performed in cases where an endovascular access cannot be achieved due to occlusion of the inferior vena cava or thrombosis of LAA. However, it is necessary to monitor the condition of the stump when conducting thoracoscopic amputation of LAA, and stop anticoagulation therapy only in case of non-embologenic stump. AbstractAtrial fibrillation is the most common rhythm disorder that can be conservatively treated using antiarrhythmic therapy, and anticoagulants can be used to prevent thromboembolic complications. However, prolonged use of anticoagulants is complicated by the risk of bleeding. Left atrial appendage (LAA) occluder implantation is an alternative way of preventing of thromboembolic and hemorrhagic complications. The article presents a clinical case of thoracoscopic LAA amputation after unsuccessful endovascular LAA occluder implantation in the patient with the inferior vena cava occlusion.

Right disc thrombosis of the new Gore Cardioform ASD Occluder.

The GCA is a well performing device in terms of efficacy despite complex anatomies (aortic rim <5 mm and ASD diameter >17 mm) with a good safety profile. To evaluate atrial septal defect (ASD) features impacting on right disc device thrombosis in patients who underwent Gore Cardioform ASD Occluder (GCA) implantation. A total of 44 consecutive patients undergoing percutaneous ASD with GCA device from January 2020 to September 2022 at our tertiary care Center were evaluated. The minimum follow-up was 6 months. The patients were stratified in two groups according to a cut-off value of ASD diameter equal to 20 mm at sizing balloon, derived from ROC analysis (AUC = 0.894; p = 0.024). Baseline characteristics were comparable between groups in terms of age, sex, weight, height, and interatrial septum dimensions. Patients with ASD > 20 mm (n = 9) had a higher ASD/device dimension ratio, both at echocardiography (p = 0.009) and at sizing balloon (p = 0.001), longer fluoroscopic time (p = 0.022), and higher incidence of device thrombosis (0.006). Right disc thrombosis was observed in three patients of the ASD > 20 mm group, always in the inferior portion of the right disc. On univariate analysis, ASD diameter at sizing balloon (OR 1.360; p = 0.036) was the only positive predictor of device thrombosis. Right disc thrombosis of the GCA device may be under-recognized at follow-up, hence deserving clinical attention, especially in those patients with larger ASD diameters.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7days or hospital discharge (whichever is later). Major adverse events through 45days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45days (2.3% vs 1.5%; P = 0.012). The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of theAmulet occluder in the real-world setting. More experienced operators had improved implant success and fewerPEs,suggesting a learning curve effect implanting this dual occlusive mechanism device.

Atrial function after percutaneous occluder device and suture-mediated patent fossa ovalis closure.

Suture-mediated patent fossa ovalis (PFO) closure is a recent technique, achieving closure by means of a simple suture. The differences between traditional occluders and suture might have different impacts on atrial function. The aim of this study was to evaluate atrial function after PFO closure by direct suture and traditional occluders. We prospectively studied 40 patients, 20 undergoing PFO closure by occluder and 20 by suture. Trans-thoracic echocardiography was carried out the day before and 1 year after the procedure. Left atrial (LA) and right atrial (RA) function was evaluated by using speckle-tracking analysis assessing the strain values of the reservoir (st-RES), conduit (st-CD), and contraction phase (st-CT). Compared with values baseline PFO closure, at 1-year follow-up, patients with occluder implantation had significantly worse indices of LA and RA reservoir (LA st-RES P < 0.001; RA st-RES P < 0.001), conduit (LA st-CD P < 0.001; RA st-CD P < 0.001), and contraction function (LA st-CT P < 0.05; RA st-CT P < 0.05). In patients with suture-mediated PFO closure, no significant differences were observed in the same indices of reservoir (LA st-RES P = 0.848; RA st-RES P = 0.183), conduit (LA st-CD P = 0.156; RA st-CD P = 0.419), and contraction function (LA st-CT P = 0.193; RA st-CT P = 0.375). Suture-mediated PFO closure does not alter atrial function. Conversely, PFO closure by metallic occluders is associated with a deterioration of atrial function. This detrimental effect on atrial function could favour the development of atrial arrhythmias.

Clinical outcome and intraprocedural characteristics of left atrial appendage occlusion: a comparison between single-occlusive plug-type and dual-occlusive disc-type devices.

Percutaneous interventional left atrial appendage occlusion (LAAO) is a reliable, safe, and effective alternative for stroke prevention in selected patients with atrial fibrillation (AF). In a retrospective observational study, 149 patients underwent LAAO between 2016 and 2022 at the Department of Cardiology of the Charité-Universitätsmedizin Berlin, Campus Virchow, with AF for prevention of thromboembolic complications. We compared patient characteristics, intraoperative details and postoperative outcomes between single-occlusive plug-type (SOPT) and dual-occlusive disc-type (DODT) devices. In all patients, the device implantation was successful. 60 patients received a SOPT occluder, including Watchman (35%) and Watchman FLX Occluders (65%), while 89 patients received a DODT occluder, including Amplatzer Cardiac Plug (37.1%), the Amplatzer Amulet (25.8%), and the LAmbre occluder (37.1%) systems. Procedure duration was significantly longer for DODT occluder implantation (49 ± 33 vs. 41 ± 25 min, p = 0.018). There were no in-hospital deaths or thromboembolic events reported after LAAO in both groups. Beyond that, a low rate of bleeding or access-side-related complications and pericardial tamponades were observed. Anticoagulation at discharge varied. About 60.8% of patients received dual antiplatelet therapy at hospital discharge, and 33.1% received direct oral anticoagulants. A 6-month follow-up was obtained in 85% of the patients. All implanted devices were in the desired position. However, in 5.7% of the patients, a device-related thrombus formation was detected in the SOPT group, while no thrombus was seen in the DODT group (p = 0.11). Thromboembolic events were noticed in 3.1%, without any difference between the device types. There was a statistically non-significant trend for less residual device leaks after SOPT vs. DODT implantation (no leak in 71.7% vs. 62.2%, p = 0.07; minor leaks <5 mm, 9.4% vs. 20.3%, p = 0.1). In the SOPT group, less bleeding complications were reported after LAAO (11.3% vs. 17.6%, p = 0.1). Our data suggest the safety and efficiency of LAAO with a very high procedural implantation success rate irrespective of the used LAA device. Furthermore, no relevant procedural or device-related complication occurred during the 6-month follow-up in all patients.

Occlusion of functional high-volume intra-atrial shunts in older patients after embolic stroke of undetermined source.

Intra-atrial shunts are associated with an elevated risk of embolic stroke of undetermined source (ESUS). Percutaneous occluder implantation is recommended as secondary prevention in younger patients. This study aims to compare the outcome after shunt occlusion between younger and older patients with a history of presumed paradox embolism and to evaluate the impact of high-volume shunting in an elderly population. We conducted a single-center, retrospective, observational study, involving 187 patients who underwent interventional percutaneous PFO or ASD occlusion at our center between 2013 and 2023. The mean age of participants was 51.8 ± 11.8 years, with 76 patients aged ≤50 years and 111 patients aged >50 years. Older patients presented more cardiovascular risk factors. The presence of atrial septum aneurysm or large shunting was evenly distributed (ASA 26.3% vs. 28.8%, p = 0.833, mean shunt defect size 6.67 vs. 7.23 mm, p = 0.151). There were no significant differences in procedural or intrahospital complications. The event rate during the 6-month follow-up was low. Recurrence of arterial embolism occurred in 1.6% of the younger and 3.8% of the older patients (p = 0.817). Comparison of high-volume shunts (defect size ≥10 mm or passage ≥20 bubbles during bubble study) with low-volume shunts in this elderly cohort with a mean age ≥50 years showed no significant difference in outcomes. There was a statistically non-significant trend toward a higher rate of residual shunt at the end of the procedure in the high-volume shunt group (2.9% vs. 9.8%, p = 0.0894). This difference was not observed at the 6-month follow-up anymore (14.5 vs. 12.1%, p = 0.628). Two unsuccessful implantation attempts were reported in the high-volume shunt group, while none were observed in the low-volume shunt group (p = 0.372). No intervention-related deaths occurred in this patient cohort during follow-up. Occlusion of relevant, intra-atrial shunting is a safe and effective option for secondary prevention of cryptogenic embolism in patients over 50 years of age. The beneficial outcome was irrespective of a high-volume shunting before implantation.

THE PROBLEM OF TRANSCATHETER CLOSURE OF MULTIPLE ATRIAL SEPTAL DEFECTS: INTERVENTIONAL APPROACHES AND RESULTS. LITERATURE REVIEW

HighlightsThe article presents a review of the literature and the results of endovascular correction of multiple atrial septal defects, methods of occluder implantation. Indications for transcatheter closure and possible complications of the procedure are given. AbstractOver the past few decades, the treatment strategy for the second atrial septal defect has changed significantly. Due to the improvement of device technology and procedural techniques, transcatheter closure of atrial septal defects is currently considered to be the method of choice in most patients with secondary types of defects. The latest generation devices provide a simple and safe implantation. The use of biocompatible occluder materials contributes to endothelization and reduction of traumatization of nearby structures. Most of the currently available devices demonstrate excellent efficiency and comparable results with their own advantages and disadvantages. In addition to improving the properties and performance of the device, there was a clear improvement in the procedural technique because of numerous experiments with closing of the device. A difficult problem for an endovascular surgeon is the procedure for closing multiple defects, due to their shapes, locations on the septum, the lack of a sufficient amount of tissue edge on the septum, as well as difficulties with choosing the type of device, their number and relative location.

Comprehensive multi-modality treatment of thoracic aorta pseudoaneurysms: a single-center experience

IntroductionThoracic aorta false aneurysms (TAFA) are unexplored complications after cardiac surgery associated with significant morbidity and mortality. Therefore, the purpose of this study was to examine the clinical profiles, surgical techniques, and operative outcomes, of patients treated for TAFA at a single institution.MethodsFrom 1996 to 2022, 112 patients were treated for aortic pseudoaneurysm (mean age 55 ± 14 years, 78 patients were male). In the majority of the patients (90%) TAFA developed after previous cardiovascular surgery, the most common diagnosis and surgical procedure preceding the TAFA development was an aortic dissection (52%) and Bentall procedure (47%). In the rest of the cohort, the leading cause was trauma.ResultsSixty-one percent of patients were indicated for reintervention (surgical reoperation, endoluminal graft implantation, septal occluder implantation, coil embolization, or a combination of procedures). Overall, 52 patients had undergone cardiac reoperation. TAFA was resected and the aorta was repaired in 55% or replaced in 45%. Operative mortality was 5.7%. In postoperative follow-up, a hypoechogenic lesion encircling aortic prosthesis was present in 94%, therefore it was determined as a negative prognostic factor. The mean follow-up was 13.2 ± 19.4 years.ConclusionAlthough there is no specific approach how to prevent TAFA development, maintaining normal blood pressure and regular follow-up should be applied. More frequent follow-ups should be performed in patients with a hypoechogenic lesion encircling and aortic prosthesis. Early detection during long-term postoperative follow-up, an individually tailored approach of a multidisciplinary team is necessary for favorable treatment outcomes.

Progress of biodegradable polymer application in cardiac occluders.

Cardiac septal defect is the most prevalent congenital heart disease and is typically treated with open-heart surgery under cardiopulmonary bypass. Since the 1990s, with the advancement of interventional techniques and minimally invasive transthoracic closure techniques, cardiac occluder implantation represented by the Amplazter products has been the preferred treatment option. Currently, most occlusion devices used in clinical settings are primarily composed of Nitinol as the skeleton. Nevertheless, long-term follow-up studies have revealed various complications related to metal skeletons, including hemolysis, thrombus, metal allergy, cardiac erosion, and even severe atrioventricular block. Thus, occlusion devices made of biodegradable materials have become the focus of research. Over the past two decades, several bioabsorbable cardiac occluders for ventricular septal defect and atrial septal defect have been designed and trialed on animals or humans. This review summarizes the research progress of bioabsorbable cardiac occluders, the advantages and disadvantages of different biodegradable polymers used to fabricate occluders, and discusses future research directions concerning the structures and materials of bioabsorbable cardiac occluders.

Thoracoscopic ablation of persistent atrial fibrillation after left atrial appendage occluder implantation: a case report

A clinical case of successful radiofrequency thoracoscopic ablation of persistent atrial fibrillation after implantation of an occluder in the left atrium appendage is presented.

Fenestration: Integrating Wings Into the Atrial Septal Occluder for Navigating a Challenging Terrain.

Background Atrial septal defect (ASD) closure with significant left-to-right shunt and concurrent comorbidities poses challenges for intervention. A fenestrated atrial septal defect (FASD) device is a viable option for patients who cannot undergo complete occlusion due to hemodynamic and medical reasons. This study explores the use of FASD occluders in patients with secundum ASD and associated comorbidities where complete occlusion is difficult. Methodology This retrospective study collected the details of patients recommended for FASD closure diagnosed with significant secundum ASD and who had additional comorbidities between July 2015 and July 2023 in a tertiary cardiac center in eastern India. Among this cohort, patients who underwent FASD device placement were subjected to a comprehensive analysis. Results In total, 16 patients diagnosed with secundum ASD, characterized by significant left-to-right shunt and concurrent comorbidities, were considered for FASD closure during the study period. Ultimately, 13 patients (first group) underwent fenestrated atrial septal occluder implantation. The average age was 45.07 years, with the majority being females (n = 9). Comorbidities among this cohort included substantial left ventricular diastolic dysfunction (n = 7), left ventricular diastolic dysfunction coupled with moderate pulmonary hypertension (n = 1), severe pulmonary hypertension (n = 1), severe pulmonary valvular stenosis with right ventricular diastolic dysfunction (n = 2), and systemic lupus erythematosus (SLE) (n = 2). From this cohort, three patients did not undergo the intervention. The second group consisted of an elderly patient with severe left ventricular diastolic dysfunction, a young adult with a history of left atrial arrhythmia, and achild with Duchenne muscular dystrophy (DMD). The average ASD size among patients who underwent the intervention was 26.38 mm, with a thick-to-thick dimension measuring 31.15 mm. The procedure was successful in all 13 patients, with the most frequently used device being a 34 mm occluder (range = 28-40 mm). All devices, excluding the initial one, were custom-made atrial septal occluders (Lifetech Scientific). Among the patients, 12 exhibited left-to-right fenestration flow, while one patient experienced fenestration constriction, likely due to occluder overcrowding. The first patient hada handmade 5 mm fenestration in a 40 mm Amplatzer septal occluder, which got closed off at the one-year follow-up. The procedure was well-tolerated hemodynamically in all patients, with no major complications during the peri-procedural period. Short-term follow-up indicated favorable patient progress. Conclusions FASD closure emerges as a pivotal alternative for intricate scenarios involving secundum ASD coupled with concurrent comorbidities, offeringindividualized tailored solutions. Alongside the conventional associated comorbidities, such as left ventricular diastolic dysfunction and pulmonary hypertension, FASD devices hold the potential to extend their benefits to patients grappling with other complexities, including severe pulmonary valvular stenosis, SLE, predisposition to left atrial arrhythmia, and conditions like DMD. Ensuring meticulous evaluation of patient suitability and providing ongoing vigilant care becomes paramount for achieving optimal outcomes. The validation of these findings and the broadening of the comprehension of this approach necessitate further comprehensive investigations.

The use of distal femoral venous access for pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation: randomized study design and preliminary results

Aim. This study aims to compare the results of the distal femoral access with the classic approach in patients undergoing pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation.Methods. The primary results of the 1:1 randomized single-center study are presented. The study group recruited 47 patients who underwent the catheter-based procedure using ultrasound-assisted distal femoral access. 38 patients with traditional ultrasound-guided proximal femoral access were involved in the control group.Results. Total 85 patients were included: 47 in the study group and 38 in the control group. The median age was 61 years, and pulmonary vein cryo-ablation was performed in 84%. 95% of patients were taking direct oral anticoagulants. In the study group, the most frequent topographic and anatomical variant was the location of the superficial femoral vein on the lateral side from the artery (81%), whereas in the control group it was on the medial side (81%). The median access time was 30 s in the study group for the right leg and 35 s for the left leg. In the control group, access time was 33 s and 39 s for the right and left leg respectively. Unintentional arterial puncture occurred more frequently in both groups when the vein was fully overlapped by the artery for both right and left legs, but the differences were statistical unsignificant (p&gt;0.05 and p=0.09 in the main group, p=0.24 and p=0.72 in the control group). In a correlation analysis, neither body mass index (p=0.19) nor femoral circumference (p=0.19 for right and p=0.06 for left legs) influenced the access time and did not increase the number of unintended arterial punctures. Two patients in the control group required additional manual hemostasis. There was no postprocedural venous thrombosis in both groups. Back pain was observed only in patients in the control group.Conclusion. The efficacy and safety of the distal femoral access approach are comparable to the traditional proximal approach. Earlier postprocedural activation of patients can help improve quality of life.

Omitting transesophageal echocardiography before catheter ablation of atrial fibrillation or left sided atrial tachycardia in patients on oral anticoagulation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Catheter ablation (CA) is accepted as a safe and effective therapy for atrial Fibrillation AF and left sided atrial tachycardias (AT) and is a well-established standard of care. However, the procedure can lead to life-threatening complications, including thromboembolic cerebrovascular events (CVE). Transesophageal echocardiography (TOE) is the gold standard for screening for left atrial appendage thrombus (LAAT) and is performed in many cases prior to CA of AF. However, the guidelines are limited on the precise role of LA imaging for thrombus detection prior to CA. Purpose The aim of our retrospective analysis was to evaluate the safety of individualized TOE approach for patient undergoing CA of AF or left sided AT in the two participating centers. Methods Patients, undergone AF or left sided AT ablation between August 2018 and October 2022 at two centers were enrolled. Patients were scheduled to TOE when one of the following criteria was met: 1) prior history of either thromboembolic stroke or 2) LAAT, 3) inappropriate anticoagulation (OAK) regimen in 4 weeks prior to CA. Otherwise, no TOE prior to CA was performed. (Figure 1). TOE and CA outcomes were retrospectively analyzed. CVE incidence from the procedure onset to 24 hours post-procedure was evaluated. Results A total of 1156 Patients were analyzed. The median age of study population was 70 (IQR: 62-76) years. 675 patients (58.4%) were male, 555(48.1%) had a persistent AF/AT and 358 (31%) had already left atrial CA in prior history. The CHA2DS2-VASc score was ≥ 2 in 939 (81.2%) patients. 505 patients (43.7%) were on apixaban, 359(31.0%) on rivaroxaban, 22 (1,9%) on dabigatran, 103 (8.9%) on edoxaban, 94(8.13%) on VKA, 73(6.3%) had no OAK prior to ablation (6 patients due to previous LAA occluder implantation, in 1 patient due to LAA resection). The median left ventricular ejection fraction was 59% (IQR: 50-60%), median left atrial volume index was 43.6 (IQR: 28.8-55) ml/m2.TOE was performed in 261 (22.6%) of patients, in 93 due to stroke history, in 24 due to LAAT history, in 161 due to inappropriate OAK. No LAA Thrombi were detected. Total 4 out of 1156 (0.35%) experienced CVE (Table 1). In 2 of these cases TOE was performed prior to CA, and LAA thrombi were ruled out. In another 2 patients in heart computer tomography immediately after stroke LAAT were excluded. Even not statistically significant, the higher rate of the CVE among the patients with TOE performed (2 out of 261 patients, 0.76%) emphasizes the higher baseline risk of thromboembolic events in this category of patients as opposed to the patients with low stroke risk where TOE was omitted (2 out of 895 patients, 0.22%, p=0.22). Conclusions Individualized selective approach to TOE prior to CA of AF or left sided AT showed to be safe. The stroke incidence (0.35%) in this approach was not higher, than in large cohort studies. In patients with uninterrupted OAK and low stroke risk TOE prior to CA could be omitted.

Embolic myocardial infarction associated with patent foramen ovale: a case series

A patent foramen ovale (PFO) is a fairly common mild cardiac defect that causes a shunting across the atrial septum. PFO is also a known risk factor for cryptogenic stroke. Much less frequently, PFO is associated with non-cerebral systemic embolic events. The article describes a case series of paradoxical embolism of the coronary arteries (CA), which caused myocardial infarction (MI). The presence of PFO was confirmed by imaging techniques. Subsequently, the patients underwent successful endovascular closure of the PFO. Thus, paradoxical CA embolism is a rare and underdiagnosed cause of acute MI. It should be considered in patients with MI and a low risk of atherosclerotic coronary artery disease. However, in most cases, it is not possible to verify the source of the embolism. The significance of occluder implantation as one of the treatment tactics requires further clarification.