Occluder Device Research Articles

Transcatheter closure of a large aortopulmonary window using a Lifetech™ Konar-MF occluder device.

Aortopulmonary window is a rare CHD, which comprises a communication between the ascending aorta and the pulmonary artery. The standard treatment of aortopulmonary window is surgical; however, few cases are amenable to closure via percutaneous intervention. We present a case of aortopulmonary window closure using Lifetech™ Konar-MF occluder device (Lifetech Scientific Co. Ltd., Shenzhen).

TIPS, a Trick for Transcaval TEVAR Access.

We described an alternative access for thoracic endovascular aortic repair (TEVAR) deployment using a transjugular intrahepatic portosystemic shunt (TIPS) needle for gaining transcaval access to the abdominal aorta. A 63-year-old man presented with a penetrating atherosclerotic ulcer in the descending aorta. Traditional transfemoral and transaxillary access were not possible. A transcaval access was established using a TIPS needle to puncture from the caval vein to the aorta. Next, the access was gradually upsized until a 22 french large-bore transcaval access was achieved. Afterwards the thoracic endograft was positioned and deployed accustomed. The infrarenal aortocaval fistula was closed with a covered stent. When classic TEVAR access is not possible, transcaval access is a valuable and minimally invasive alternative access. We prefer the use of a TIPS needle for gaining access and use a covered stent for closing the aortic access site when possible instead of using electrified wires nor a transseptal occluder device. Preoperative planning remains key. We discribe a transcaval access with a TIPS needle and closing of the aortocaval fistula with a covered stent. We are one of fiew reports of transcaval puncturing instead of using an electrified wire and the first using a TIPS needle for gaining transcaval access. We hope this case and our comments help other surgeons, radiologists and patients when they are in need of a transcaval access and contribute to a successful procedure.

Abstract 4131630: Comparative Outcomes of Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients with a Lower Stroke Risk

Introduction: Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA 2 DS 2 -VASc score ≥ 2 for stroke prevention. Left atrial appendage occlusion (LAAO) devices serve as alternatives to reduce stroke risk in select AF patients that are unable to tolerate long-term oral anticoagulation. However, Centers for Medicare&Medicaid Services reimburses left atrial appendage occlusion (LAAO) for patients with CHA 2 DS 2 -VASc score ≥ 3. Objective: To evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA 2 DS 2 -VASc score of ≥ 3 versus < 3. Methods: National Inpatient Sample and International Classification of Diseases, 10th Revision codes were used to identify AF patients who underwent LAAO device implantation in the U.S. from 2016−2020. The study population was stratified by stroke risk into two groups, CHA 2 DS 2 -VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization. A multivariable logistic regression model was used to assess the independent association of CHA 2 DS 2 -VASc score with study outcomes. Results: A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA 2 DS 2 -VASc ≥ 3 and < 3, respectively. Compared to patients with CHA 2 DS 2 -VASc score of ≥ 3, patients with CHA 2 DS 2 -VASc < 3 had lower overall (6.9% vs 9.9%, P< 0.01) and major (4.5% vs 6.2%, P< 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA 2 DS 2 -VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 – 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99). Conclusions: Patients with CHA 2 DS 2 -VASc < 3 had lower complications and hospitalization costs after LAAO device implantation than patients with CHA 2 DS 2 -VASc ≥ 3 . These data, if redemonstrated in a large randomized trial can have important clinical implications for stroke prevention in AF patients.

Abstract 4138449: High Output Heart Failure from an Aortocaval Fistula

Introduction: High output heart failure (HOHF) due to a post-traumatic aortocaval fistula is a rare entity. This case seeks to explore the presentation as well as complexities of management of these patients. Case Presentation: A 50-year-old male with a prior right abdominal stab wound requiring exploratory laparotomy 20 years ago presented with worsening dyspnea on exertion and palpitations. Physical examination was remarkable for jugular venous distention, lower extremity edema, and a pulsatile mass in the right abdomen with an audible bruit. A 12-lead ECG showed rapid atrial flutter. A transthoracic echocardiogram (TTE) showed a reduced left ventricular ejection fraction (LVEF) of 30-35%, severely dilated atria and inferior vena cava (IVC) with high velocity flow. Abdominal computed tomography venogram showed dilation of the IVC up to 8cm and an aortocaval fistula at the level of the right renal vessels, resulting in an atrophic right kidney. Cardiac catheterization was notable for a cardiac output (CO) of 12L/min, cardiac index (CI) of 7L/min/m2 and reduced systemic vascular resistance (SVR). He was managed with beta blockers and diuretics, followed by TEE-guided cardioversion for atrial flutter to restore sinus rhythm. Vascular surgery performed a successful, first of its kind endovascular repair of the abdominal aorta with stenting of the right common iliac artery and placement of a 20mm Amplatzer Septal Occluder device in the right renal artery. He tolerated the procedure well, and post-operative TTE showed a recovered LVEF of 55-60% and CO of 6L/min. Discussion: HOHF is defined by a CO more than 8L/min or CI more than 4L/min/m2 along with clinical symptoms. Decreased SVR leads to sympathetic activation and stimulation of the renin-angiotensin-aldosterone system, leading to fluid retention, cardiac remodeling, and exacerbation of symptoms. Challenges present in the management of HOHF and the use of vasodilatory agents should be avoided, as they can exacerbate the problem. In our case, limitations were also faced in the use of many traditional HF therapies due to renal dysfunction as a result of the fistula. Therefore, repair was the only viable long-term solution. Conclusion: This case displays an uncommon etiology of HOHF, emphasizing the need for meticulous evaluation to ensure proper management. Early detection of aortocaval fistulas is crucial to prevent worsening cardiac dysfunction, with symptoms resolving rapidly post-repair.

Abstract 4141461: Zonal Coating Application System for Left Atrial Appendage Occlusion Devices: A Novel Approach to Reduce Peri-Device Leakage and Device Related Thrombus.

Introduction: Left atrial appendage occlusion (LAAO) is an effective method of stroke prevention in patients with atrial fibrillation (AF). However, peri-device leakage (PDL) and device related thrombus (DRT) are common limitations of LAAO. Notably, PDL is associated with an increased risk of thromboembolic events. In order to minimize DRT, the Watchman FLX Pro is coated with PVDF-HFP. We aim to minimize both DRT and PDL with our novel zonal coating application system (ZCAS). ZCAS integrates a two-part thromboresistant and endothelialization promoting coating onto LAAO devices (Figure 1). In order to determine the optimal coating for the endothelialization promoting zone of ZCAS, we validated coating candidates in an in vitro model of LAAO device endothelialization (Figure 2). Hypothesis: We hypothesized that polyethylene terephthalate (PET) mesh coated with collagen type IV, fibronectin + VEGF, or poly-L-lysine would improve endothelial cell viability and proliferation. Methods: Human umbilical vein endothelial cells (HUVEC) were cultured in DMEM/F12 supplemented with ATCC’s Endothelial Cell Growth Kit and antibiotics. For the cell viability and proliferation assay, HUVEC cells were cultured in DMEM/F12 supplemented with 2% FBS, 10 mM L-glutamine, and antibiotics. A 96 well plate with PET inserts was coated with three coating candidates. Each coating was applied in three concentrations ([1x], [10x], and [100x]) with triplicates for each concentration. The coatings included collagen type IV ([1x]: 1 ug/cm2), fibronectin ([1x]: 1 ug/cm2) + VEGF ([1x]: 10 ng/cm2), and poly-L-lysine ([1x]: 4 ug/cm2). An MTS assay was performed at 48 hours after plating to assess cell viability and proliferation. Results: MTS absorbance relative to the uncoated control (MTS absorbance coated well/MTS absorbance uncoated well) for collagen type IV at [1x], [10x], and [100x] was 0.81, 1.29, and 0.84 respectively (Table 1). Fibronectin + VEGF at [1x], [10x], and [100x] was 1.31, 1.62, and 0.96. Finally, poly-L-lysine at [1x], [10x], and [100x] was 0.69, 0.90, and 0.91 respectively. Conclusion(s): Among the coating candidates, fibronectin (1 ug/cm2) + VEGF (100 ng/cm2) had the greatest increase in cell viability and proliferation compared to the uncoated PET control. The significance of this finding lies in the potential for ZCAS to improve the endothelial seal between the LAAO device and LAA orifice, which may significantly reduce PDL post-implantation.

Intrasaccular Device Occlusion and Location Scale IDOL - a Novel Grading Scale For Cerebral Aneurysms Treated with Intrasaccular Devices

Intrasaccular Device Occlusion and Location Scale IDOL - a Novel Grading Scale For Cerebral Aneurysms Treated with Intrasaccular Devices

Percutaneous Closure of Postmyocardial Infarction Ventricular Septal Rupture – A Single Center Experience from the Eastern Part of India

Abstract Background: Postinfarction ventricular septal rupture (VSR) is a rare but lethal mechanical complication of an acute myocardial infarction (AMI). It results in 90%–95% mortality within 2 months of diagnosis without any kind of intervention. Given high surgical mortality, transcatheter closure has emerged as a potential strategy and as an alternative to high-risk surgical closure. Indian data on percutaneous device closure of post-AMI VSR are limited; hence, we report our resource-limited single-center experience with different kinds of occluder devices for closure of post-AMI VSR. Methods and Results: In this single-center, retrospective cohort study, patients who underwent transcatheter closure of postmyocardial infarction (MI) VSR between 2018 and 2024 at Health World Hospitals in Durgapur, West Bengal, were included. The primary outcome was a mortality rate of 30 days. The study population was eleven primary cases of post-MI VSR. The mean age of the population was 61 years. The majority of the patients had anterior wall MI (54.5%), and the remaining had inferior wall MI. Different kinds of devices (Amplatzer atrial septal occlude, post-MI VSD device, and Konar-Multifunctional Occluder) were used to close VSR. Successful closure was performed in 9 patients (81%) with minimal residual shunt in 2 patients. Of 9 cases, 3 patients expired; one was lost to follow-up, and the rest are doing well at 30-day follow-up. Conclusion: Transcatheter closure of PMI VSRs can be performed with different kinds of devices with high technical success, relatively low procedural complication rates, and a good 30-day survival even in a setup outside the metropolis with limited availability of devices, as an alternative to very high-risk surgical closure.

Strategy Optimization for a Combined Procedure in Patients With Atrial Fibrillation

The optimal strategy of combining left atrial appendage occlusion (LAAO) with catheter ablation (CA) in patients with atrial fibrillation (AF) during a single procedure remains unclear. To determine the effects of ablation-first vs occlusion-first strategies on long-term clinical outcomes among patients with atrial fibrillation undergoing a combined LAAO and CA procedure. The prospective, multicenter COMBINATION randomized clinical trial was conducted in 14 high-volume centers in China. Enrollment of patients with nonvalvular AF referred for the combined procedure began on July 24, 2020, and concluded on January 20, 2022. Patients were randomly assigned to either the ablation-first group or the occlusion-first group. Outcomes of LAAO using an occlusion device and CA using a contact force-sensing catheter following different combination strategies during long-term follow-up were evaluated. The primary end point was a composite of thromboembolic events including stroke or transient ischemic attack, device-related thrombus (DRT), clinically relevant bleeding, and cardiovascular rehospitalization or death. Freedom from AF or atrial tachyarrhythmia (ATA) after a single procedure without antiarrhythmic drugs, at both 1 year and long-term follow-up, was also evaluated. Of the 202 patients enrolled, 194 (96.0%) completed the trial (97 in the ablation-first group and 97 in the occlusion-first group). The mean (SD) age of the cohort was 67.3 (9.2) years, and 110 patients (56.7%) were male. All procedures achieved acute successful LAAO and restoration of sinus rhythm, with similar incidences of periprocedural complications. Compared with the ablation-first group, the occlusion-first group exhibited significantly higher event-free survival of the primary end point (83.5% vs 71.1%; hazard ratio [HR], 0.53 [95% CI, 0.29-0.95]; log-rank P = .04) during the median 2.5 (IQR, 2.3-2.8) years of follow-up. Subgroup analysis indicated that male patients and those with higher CHA2DS2-VASc scores (a composite of factors associated with stroke risk; higher scores indicate higher risk) were at lower risk of thromboembolic events. Rates of long-term freedom from AF (77.3% vs 63.5%; HR, 0.58 [95% CI, 0.34-0.97]; log-rank P = .04) and from ATA (70.1% vs 55.7%; HR, 0.62 [95% CI, 0.39-0.99]; log-rank P = .04) were higher in the occlusion-first group vs the ablation-first group. Additionally, a higher incidence of chronic peridevice leak (15 [15.5%] vs 5 [5.2%]; P = .03) and DRT (8 [8.2%] vs 1 [1.0%]; P = .04) was observed in the ablation-first group vs the occlusion-first group. In this randomized clinical trial, the occlusion-first approach was superior due to its higher event-free survival of the primary end point and long-term freedom from ATA. These findings suggest that the occlusion-first approach should be recommended for combined procedures with plug-like device implantation. Chinese Clinical Trial Registry Identifier: ChiCTR2000031486.

Interventional Management of a Rare Case of Complex Congenital Heart Disease in an Adult Patient: A Case Report

Congenital heart disease (CHD), which accounts for about one-third of all congenital defects and affects approximately 1% of all live births worldwide, has maintained a stable incidence rate while experiencing a decrease in mortality rates since 1990. Despite advancements in fetal cardiac ultrasound examinations and routine pulse oximetry screening of newborns, a significant proportion of CHD patients may still be undiagnosed until adulthood. This oversight can lead to considerable morbidity and mortality due to physical limitations and reduced quality of life. In this case report, we describe a 29-year-old woman who was initially misdiagnosed as having an inoperable case of CHD and was referred to our center with symptoms of palpitations and exertional dyspnea. During her evaluation, she was diagnosed with severe pulmonary hypertension associated with patent ductus arteriosus (PDA), pre-ductal aortic coarctation, ventricular septal defect (VSD), and bicuspid aortic valve, all of which had been overlooked since infancy. Following initial medical treatment for pulmonary hypertension, a simultaneous transcatheter approach was employed, during which the PDA was closed using an occluder device, and the coarctation was repaired concurrently with a self-expanding stent. Eight months later, her VSD was successfully closed using a muscular VSD occluder device through an interventional technique. This case underscores the importance of adult CHD fellowship training, which enables cardiologists specializing in this field to accurately diagnose and treat complex cases of CHD that may have been missed during infancy and early childhood. This timely intervention ultimately led to the complete relief of her symptoms and prevented progression to Eisenmenger syndrome.

Late complete atrioventricular block after transcatheter perimembranous ventricular septal defect closure with the KONAR-MF™ VSD occluder: a case report and systematic review.

The soft nitinol KONAR-MF™ ventricular septal defect (VSD) Multifunctional Occluder (MFO) device is increasingly used for transcatheter perimembranous ventricular septal defect closure. We report for the first time a case of delayed complete atrioventricular block with pacemaker implantation 20 months post-procedure. Through a systematic review, the overall rate of persistent complete atrioventricular block was 0.6% with this device, but follow-up duration was limited.

Safety and efficacy of perventricular device closure of ventricular septal defects in children

Abstract Objectives To evaluate safety and efficacy of perventricular device closure techniques for the closure of ventricular septal defects (VSD) in children in United Arab Emirates. Methods In the year 2023-24, 13 children underwent per-ventricular device closures of VSD under the guidance of transesophageal echocardiography without cardiopulmonary bypass(CPB). The mean age at operation was 3.76 years (range 3 months-14 years). The ventricular septal defect sizes ranged from 2.7-6 mm. The device sizes ranged from 5-12mm. All patients except two required symmetrical device. Eight defects were peri membranous, 3 were sub-aortic and 2 were muscular. Ventricular septal defect occlusion device (Memoport, Beijing, China) were used through a 3-cm skin incision in the lower third of the sternum. Results All patients underwent VSD device closure successfully. The mean procedural duration was 42 minutes. None of the patients required CPB. The mean ventilation time and ICU stay was 3 hrs. and 24 hrs. respectively. None of the patients required inotropic support or blood transfusions. There were no residual shunt (except small shunt through the device), arrhythmias including heart block post operatively. At follow up, (3 months-7 months) there were no residual shunts, conduction disturbances, device dislodgement or major aortic or tricuspid valve complications. There was no mortality. Conclusions Perventricular device closure of VSD is highly successful, less invasive, safe and effective. It is associated with quick recovery, short length of stay and better cosmetic incision. Moreover, it avoids CPB.

Picometer-scale OAM interferometry using an adaptive polar transform algorithm.

A phase demodulation algorithm based on an adaptive polar transform is proposed that can achieve picometer-scale measurements in orbital angular momentum (OAM) interferometry. The proposed algorithm converts the rotational movement in a petal-shaped interference pattern into translational movement of the grayscale projection curves, so that can be easily measured using correlation operations to determine the pixel displacement in determining the rotation angle. Displacements ranging from -120 nm to 120 nm have been measured for various topological charges, with a minimum average deviation of 0.07 nm. Furthermore, we have studied the effects of piezoelectric transducer alignment, various binary threshold values, fringe occlusion, and charge-coupled device (CCD) camera resolutions on displacement measurement. Comparative experiments indicate that the proposed algorithm can effectively manage the local measurement challenges in traditional OAM interferometers, demonstrating better measurement accuracy and robustness than several existing phase demodulation algorithms.

A high-fidelity personalised 3d printed simulator for the left atrial appendage occlusion procedure

Purpose This study aims to develop a realistic 3D printing-based simulator for the training and planning of the left atrial appendage occlusion (LAAO) to be used in the cath lab. Design/methodology/approach Starting from a pre-operative computed tomography dataset of a patient already treated with LAAO, the model was obtained, consisting in the right and left heart, opportunely assembled to replicate the position and orientation of the patient's anatomy while lying on the cath lab table. Different 3D printing techniques and materials were used to mimic the interaction between the cardiac tissue and the clinical instrumentation. The simulator was tested in the cath lab under proper image guidance by three LAAO expert operators. The clinicians were required to assign a score in terms of realism to each material used to fabricate the fossa ovalis and the LAA. Findings The simulated interventions were successfully performed by the operators, who were able to navigate in the system and release the occluder device as during a real procedure. The intraoperative images acquired during the simulations were highly comparable with data from a real intervention, with a mean percentage difference below 10%. Originality/value This study demonstrated the feasibility of the proposed simulator to faithfully replicate the LAAO procedure and its potentiality to be used for multiple purposes, including the training of the young clinicians, the evaluation of the most complicated cases and the design of novel occluder devices, in a fully realistic setting.

Transfabric Leaks After Percutaneous Left Atrial Appendage Occlusion Procedures with the WATCHMAN FLX Device

BackgroundCardiac computed tomography imaging with contrast is being used increasingly to image left atrial appendage occlusion (LAAO) devices. Contrast flow across a device, also known as a transfabric leak (TFL), may indicate a lack of complete LAAO-device endothelialization. The data on the rate, predictors, and clinical events associated with TFL are limited. MethodsAll patients who underwent an LAAO-device implantation with a WATCHMAN FLX device and received a postimplantation computed tomography scan were included in this single-centre retrospective cohort study. Patients were classified as either having or not having a TFL, according to 3 currently proposed definitions of TFL. Clinical and procedural differences between the 2 groups were determined. An exploratory univariate logistic regression model to evaluate predictors of TFL was constructed. ResultsA total of 56 individuals were included in the cohort. The rate of TFL varied from 27% to 52%, depending on the radiographic definition employed. No clinically important patient or procedural characteristics were noted between the groups with vs without TFL. No predictors of TFL were identified. Six deaths and one stroke occurred during a median follow-up period of 673 days. ConclusionsTFLs occur commonly post–LAAO procedures, suggesting that complete endothelialization of LAAO devices in humans may not be similar to that reported in animal models. Additional study into the best imaging approach to identify TFLs, and clinical events associated with TFLs, is necessary to clarify the significance of TFLs.

Effectiveness and safety of a novel crosslinked hyaluronate canalicular gel occlusive device for dry eye.

To evaluate the effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared with a commercially available hydrogel canalicular plug (Form Fit). 5 sites in the United States. Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug). Adults (≥22 years) with the Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was noninferiority of the mean within subject change from baseline to month 3 in Schirmer score for patients receiving filler compared with plugs. The key secondary effectiveness endpoint was noninferiority of the proportion of patients with filler achieving improvement from baseline to month 3 in OSDI by a minimal clinically important difference. Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear breakup time, and safety. 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was noninferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI. Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

Pulmonary Artery Injury Following Endocardial Left Atrial Appendage Occlusion: The Known and Unknown.

Left atrial appendage closure (LAAC) is frequent alternative for stroke prophylaxis in patients for whom oral anticoagulation is contraindicated. Pulmonary artery injury (PAI) is a feared yet rare complication of endocardial LAAC, but its surrounding literature is scarce. The aim of the current study was to review prior PAI published reports and the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to understand evidence and mechanisms of PAI after LAAC. A systematic review was conducted of the literature and MAUDE database for previously reported cases of PAI, and cases were reviewed for patient characteristics and outcomes. In addition, we identify risks and review our strategies to avoid this injury. Thirty-six cases (16 case reports and 20 MAUDE reports) of PAI were found. These patients had a mean age of 73.6 ± 8.2 years with a median CHA2DS2VASC score of 5 (quartile 1-quartile 3: 3-6). Most commonly, LAAC associated with PAI involved a dual-seal (75%) followed by lobular occlusive devices (19.4%); the device was unspecified in 2.8% of cases. PAI commonly presented postprocedurally, either within the first 24 hours (50%) or beyond (38.9%), with cardiac tamponade (61.1%) or cardiac arrest (19.4%). Overall, 52.8% required surgery with or without antecedent pericardiocentesis, and 16.7% were managed with pericardiocentesis. PAI was associated with a high mortality rate (ie,33.3%). Unfortunately, no specific cardiac imaging or procedural details to predict PAI were noted in the reports. Presentation of PAI after LAAC can occur immediately following the procedure or be delayed. Thus, the threshold for suspicion, especially with rapid and hemodynamically significant pericardial effusion, after LAAC should be low.

Resolution of Severe Ulcerative Colitis Secondary to Nickel Allergy Following Explantation of Amplatzer Septal Occluder Device: A Delayed Presentation.

Nickel is a component of nitinol, an alloy used in several medical devices. Allergy to nickel may place patients at a high risk for severe hypersensitivity reactions. We report a rare case of a patient who developed severe ulcerative colitis ten years following closure of an atrial septal defect with the Amplatzer Septal Occluder device.

Catheter ablation for atrial fibrillation in patients with prior left atrial appendage occlusion device.

The safety and efficacy of CA for AF and left-sided atrial arrhythmias (AA) in patients with left atrial appendage occlusion (LAAO) devices are lacking. This is a single-center retrospective registry that included all patients with prior LAAO who underwent catheter ablation for AF or left-sided atrial arrhythmia from January 2020-January 2023. The primary outcomes were procedure-related complications, device-related complications, AA recurrence, and stroke. A total of 30 patients with prior LAAO were included in the analysis (mean age 75.1 ± 7.1years old, 50% male, mean CHA2DS2-VASc score 4 ± 1.6, 46.7% paroxysmal AF, 73.3% had prior AF ablation, mean time to ablation 475 ± 365days). 93.3% (n = 28) and 6.6% (n = 2) patients had ablation for AF (46.7% paroxysmal, 36.7% persistent, 10% long-standing persistent) and left-sided atrial tachycardia, respectively. 16.7% (n = 5) patients underwent ablation along the left atrial appendage ostium, and 3.3% (n = 1) underwent Vein of Marshall alcohol ablation. There were 3 (10%) peri-procedural complications (1 access hematoma and two pericardial effusions requiring intervention-none related to left atrial appendage ostium or alcohol ablation). During the mean follow-up of 440 ± 379days, 40% (n = 12) patients had AA recurrence (91.6% AF, 8.3% atrial tachycardia), of which five patients needed repeat ablation, and two patients were readmitted for heart failure. There was no stroke or any device-related complications, including new peri-device leaks or device-related thrombosis in patients who had follow-up imaging studies (n = 11, 36.7%). Catheter ablation for AF (including VoM alcohol ablation) in patients with prior LAAO devices is feasible and safe with favorable outcomes.

The Enzen Trial: Analysis of EVAR Endoprosthesis Zenith and Endurant for Infrarenal Aortoiliac Aneurysms Regarding Outcomes, Endoleaks, and Reinterventions.

The main objective of this paper is to analyze the outcomes regarding endoleaks, reinterventions, and death related to aneurysm complications in patients submitted to endovascular repair (EVAR) for abdominal aortoiliac aneurysm (AAA) using Endurant II (Medtronic) and Zenith Flex (Cook) endografts. This was a prospective, consecutive cohort study of patients with AAA who underwent EVAR between January 2019 and December 2022. Two groups of patients were evaluated: Group Endurant (patients submitted to EVAR with the use of Endurant II) and Group Zenith (patients submitted to EVAR with the use of Zenith Flex). A total of 156 patients were evaluated. Group Zenith (67 patients, 42.9%) and Group Endurant (89 patients, 57.1%). The perioperative mortality was 5.1%, eight patients (six patients Group Zenith, and two patients Group Endurant, p=0.054). There were 28 patients (17.9%) submitted to urgent repair of the aneurysm (expansion or rupture), with no differences among the groups. There were 36 cases (23.1%) of later endoleak, with a higher incidence in Zenith group (23 patients, 34.3%) than Endurant group (13 patients, 14.6%, p=0.002), most of them Type II endoleak (21 patients, 13.4%). There were 12 cases of Type I endoleak, also with a higher prevalence in Zenith group (13.4%) than Endurant group (3.4%, p=0.002). Moreover, regarding limb graft occlusion (LGO), there were nine patients (5.8%), with a higher prevalence in Zenith group (9%) than Endurant group (3.4%, p=0.045). The overall survival in a Kaplan-Meier at 720 days was 82.3% in the Zenith group and 89.1% in the Endurant group, with no statistical significance among the groups (p=0.09). The freedom from reintervention rates in a Kaplan-Meier at 720 days was 82.8% in the Zenith group and 93.2% in the Endurant group (p=0.001). In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, LGO and reinterventions than patients submitted to Endurant II endografts. The linear regression analysis showed that the presence of endoleaks, type of endograft device (Zenith graft) and limb graft occlusion were related to higher reintervention rates. In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, limb graft occlusions and reinterventions than patients submitted to Endurant II endografts. The main impact and the innovation that this article provides is an opportunity to evaluate and choose the best endograft suitable for the patient with AAA during EVAR.

Platelet Adhesion and Activation in an ECMO Thrombosis-on-a-Chip Model.

Use of extracorporeal membrane oxygenation (ECMO) for cardiorespiratory failure remains complicated by blood clot formation (thrombosis), triggered by biomaterial surfaces and flow conditions. Thrombosis may result in ECMO circuit changes, cause red blood cell hemolysis, and thromboembolic events. Medical device thrombosis is potentiated by the interplay between biomaterial properties, hemodynamic flow conditions and patient pathology, however, the contribution and importance of these factors are poorly understood because many in vitro models lack the capability to customize material and flow conditions to investigate thrombosis under clinically relevant medical device conditions. Therefore, an ECMO thrombosis-on-a-chip model is developed that enables highly customizable biomaterial and flow combinations to evaluate ECMO thrombosis in real-time with low blood volume. It is observed that low flow rates, decelerating conditions, and flow stasis significantly increased platelet adhesion, correlating with clinical thrombus formation. For the first time, it is found that tubing material, polyvinyl chloride, caused increased platelet P-selectin activation compared to connector material, polycarbonate. This ECMO thrombosis-on-a-chip model can be used to guide ECMO operation, inform medical device design, investigate embolism, occlusion and platelet activation mechanisms, and develop anti-thrombotic biomaterials to ultimately reduce medical device thrombosis, anti-thrombotic drug use and therefore bleeding complications, leading to safer blood-contacting medical devices.