Closure Device Research Articles

Haemostatic biomaterial based on expired platelets for medical applications

Blood loss has been a concern especially in surgery and bleeding control and a number of haemostatic agents and tissue sealants have been developed and applied in various surgical disciplines. The first steps to stop bleeding due to a vascular lesion, limit blood loss and allow healing are ensured by platelets that play an essential role in forming the primary haemostatic plug. After this, the clot is consolidated by the formation of a fibrin network organized around platelet aggregates. In this study we tested for the treatment of external haemorrhagic lesions a new biomaterial based on expired platelets from blood banks immobilized on a collagen support. These platelets are no longer used for transfusions, are safe (tested for viral and bacterial contamination) and still have local haemostatic activity. Collagen is non-toxic, non-antigenic and promotes cell adhesion. Platelets bind to the collagen support and subsequently form clots through the intrinsic coagulation pathway.

Outcomes of vascular closure devices for femoral venous hemostasis following catheter ablation of atrial fibrillation.

Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking. Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation). After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005). Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

Hold-and-drag suturing using a new closure device.

Hold-and-drag suturing using a new closure device.

Updates on Patent Foramen Ovale (PFO) Closure.

Patent foramen ovale (PFO) has been previously linked to left circulation thromboembolism and stroke. This review article aims to discuss the latest evidence, updated societal guidelines, diagnostic algorithms and novel therapeutic devices for PFO closure. PFO closure for cryptogenic stroke and systemic embolization is supported by a large body of evidence and has a strong societal recommendation. Limited data are available for platypnea-orthodeoxia syndrome, although closure appears to be beneficial. Current data do not support routine closure for migraines and decompression Illness. Development of heart-brain teams can improve identification of patients most likely to benefit from closure, utilizing a combination of imaging test and risk score algorithms. Multiple novel devices aiming at reducing complications and improving the long-term impact of current available devices are being evaluated. PFO closure has significantly progressed over the last years, with new data supporting its superiority in reducing risk of recurrent embolic stroke in patients with PFO-related stroke. Additional clinical data are required to provide further refinements on patient selection and guidance on treatment of specific subgroups.

Percutaneous Closure of Post-myocardial Infarction Ventricular Septal Rupture-experience From a Resource-limited Setup From Eastern Part of India

Background: Post-infarction ventricular septal rupture (VSR) is a rare but lethal mechanical complication of an acute myocardial infarction (AMI). It results in 90% - 95% mortality within two months of diagnosis without any kind of intervention. Given high surgical mortality, transcatheter closure has emerged as a potential strategy as an alternative to high-risk surgical closure. Indian data on percutaneous device closure of post-AMI-VSR is limited hence we report our resource-limited single-centre experience with different kinds of occluder devices for closure of post-AMI VSR. Methods and results: In this single-centre, retrospective, cohort study, patients who underwent transcatheter closure of post-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 (ASO, PostMI VSD device, Konar MFO) were used to close VSR. Successful closure was performed in 9 patients (81%) with minimal residual shunt in 2 patients. Out of 9 cases 3 patients expired, one was lost to follow up and the rest are doing well at 30 days follow-up. Conclusion: Transcatheter closure of PMIVSRs can be performed with different kinds of devices with high technical success, relatively low procedural complication rates, and 30 days survival even in a resource-limited setup as an alternative to high-risk surgical closure.

Transition from WATCHMAN generation-2.5 device to WATCHMAN FLX device for percutaneous left atrial appendage closure: Incidence and predictors of device-related thrombosis and short- to mid-term outcomes.

Patients with nonvalvular atrial fibrillation (AF) not suitable for long-term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC) using the WATCHMAN device. The safety and efficacy of WATCHMAN-FLX (WM-FLX) compared with WATCHMAN-2.5 (WM-2.5), particularly in Asian populations, is unknown. We evaluated the background, procedure, and clinical outcomes of 199 patients who underwent LAAC between September 2019 and December 2022 and compared WM-2.5 (72 patients) with WM-FLX (127 patients). The mean age was 76 years, with 128 men, and 100 had nonparoxysmal AF (non-PAF). The mean CHA2DS2-VASc, and HAS-BLED were 5.1, and 3.2 points, respectively. WM-FLX group demonstrated a shorter procedure time than WM-2.5 group (50 vs. 42 min, p = 0.001). The WM-FLX group demonstrated no procedural-related acute cardiac tamponade, which was significantly low (5.6% vs. 0%, p = 0.02), and a significantly higher rate of complete seal at 45-day (63% vs. 80%, p = 0.04). WM-FLX group had a significantly higher cumulative 1-year incidence of device-related thrombosis (DRT) than WM-2.5 group (3.4% vs. 7.0%, Log-rank p = 0.01). Univariate analysis identified two DRT risk factors in the WM-FLX group: non-PAF (odds ratio [OR] 7.72; 95% confidence interval [CI] 1.20-48.7; p = 0.04), and 35-mm device (OR 5.13; 95% CI 1.31-19.8; p = 0.02). WM-FLX significantly improved the procedural quality and safety of LAAC. However, DRT remains an important issue even in the novel LAAC device, being a hazard for patients with high DRT risk, such as having non-PAF and using 35-mm devices.

Laparoscopic repair for a recurrent epigastric incisional hernia following xiphoidectomy: A case report

Introduction: Xiphodynia is a rare musculoskeletal disorder characterized by epigastric or anterior chest pain, for which xiphoidectomy is considered as a definitive treatment. This procedure and its complications are not well researched, particularly within Australasian populations. We describe the novel laparoscopic incisional hernia repair from a xiphoidectomy complicated by recurrent epigastric hernias. Case Report: A 49-year-old female presented with chronic epigastric pain post-xiphoidectomy for xiphoidynia. The patient previously underwent open mesh repair for an incisional epigastric hernia, complicated by infection and subsequent removal of the mesh. A vacuum-assisted closure device was then utilized, followed by delayed primary closure. However, she experienced ongoing pain, a recurrent mass, and hypertrophic scarring, confirmed by abdominal computed tomography (CT) scan. Our laparoscopic approach involved a standard supine position with three ports and preperitoneal dissection similar to transabdominal preperitoneal (TAPP) hernia repair. The defect was 5 × 8 cm in size. A simple prolene mesh (9 × 12 cm) was secured with AsorbaTack and Glubran 2, followed by peritoneal closure with a 3/0 V-Loc suture. At two months follow-up, the patient had no evidence of recurrent hernia, no ongoing pain, and satisfactory wound healing. Conclusion: Laparoscopic surgical repair using a TAPP approach is a safe alternative to open repair of an incisional recurrent epigastric hernia post-xiphoidectomy.

4D intravital imaging studies identify platelets as the predominant cellular procoagulant surface in a mouse hemostasis model

AbstractInterplay between platelets, coagulation factors, endothelial cells (ECs), and fibrinolytic factors is necessary for effective hemostatic plug formation. This study describes a 4-dimensional (4D) imaging platform to visualize and quantify hemostatic plug components in mice with high spatiotemporal resolution. Fibrin accumulation after laser-induced vascular injury was observed at the platelet plug–EC interface, controlled by the antagonistic balance between fibrin generation and breakdown. We observed less fibrin accumulation in mice expressing low levels of tissue factor or F12−/−mice compared with controls, whereas increased fibrin accumulation, including on the vasculature adjacent to the platelet plug, was observed in plasminogen-deficient mice or wild-type mice treated with tranexamic acid. Phosphatidylserine (PS), a membrane lipid critical for the assembly of coagulation factors, was first detected at the platelet plug–EC interface, followed by exposure across the endothelium. Impaired PS exposure resulted in a significant reduction in fibrin accumulation in cyclophilin D−/−mice. Adoptive transfer studies demonstrated a key role for PS exposure on platelets, and to a lesser degree on ECs, in fibrin accumulation during hemostatic plug formation. Together, these studies suggest that (1) platelets are the functionally dominant procoagulant cellular surface, and (2) plasmin is critical for limiting fibrin accumulation at the site of a forming hemostatic plug.

Three‐dimensional transesophageal echocardiography measurements of ASD sizing parameters in comparison to balloon sizing method in percutaneous ASD closure

AbstractBackgroundBalloon sizing (BS) has been used for device size selection in percutaneous atrial septal defect (ASD) closure. Due to its limitations, alternative imaging techniques like three‐dimensional transesophageal echocardiography (3D‐TEE) are valuable for guiding ASD device size selection during ASD closure procedures. The purpose of this study was to compare ASD sizing using measurements obtained from 3D–TEE to those utilizing the standard balloon sizing method.MethodsWe identified 53 patients with single secundum type ASD without PFO who underwent percutaneous closure at the Tehran Heart Center between 2019 and 2022. Balloon sizing was performed in all patients with the stop‐flow technique, and the choice of device size was determined based on the sizing derived from BS. 3D‐TEE imaging was performed before the intervention, and the ASD shape and quality of ASD rims were assessed.ResultsAmong the 53 patients who underwent single ASD device closure, multiple 3D TEE measurements significantly correlated with balloon sizing results. This included defect area, perimeter, and diameter obtained from 3D‐TEE images multi‐planar reconstruction. ASD perimeter detected by 3D TEE had the best correlation with BS results. When divided by the shape of ASD, there was no significant difference between our 3D‐images data and BS in round or oval‐shaped ASDs.ConclusionThe 3D‐TEE study is reliable for assessing ASD configurational characteristics in percutaneous device closure candidates. 3D‐TEE has the potential to accurately determine the appropriate device size and reduce complications, costs, and procedural duration. Further research is needed to validate these findings and establish the role of 3D‐TEE measurements in guiding the best treatment decisions for ASD closure.

Effectiveness of Various Sternal Closure Devices Post Adult Cardiac Surgery

Effectiveness of Various Sternal Closure Devices Post Adult Cardiac Surgery

Device Closure or Antithrombotic Therapy After Cryptogenic Stroke in Elderly Patients With a High-Risk Patent Foramen Ovale.

In young patients (aged 18-60 years) with patent foramen ovale (PFO)-associated stroke, percutaneous closure has been found to be useful for preventing recurrent ischemic stroke or transient ischemic attack (TIA). However, it remains unknown whether PFO closure is also beneficial in older patients. Patients aged ≥60 years who had a cryptogenic stroke and PFO from ten hospitals in South Korea were included. The effect of PFO closure plus medical therapy over medical therapy alone was assessed by a propensity-score matching method in the overall cohort and in those with a high-risk PFO, characterized by the presence of an atrial septal aneurysm or a large shunt. Out of the 437 patients (mean age, 68.1), 303 (69%) had a high-risk PFO and 161 (37%) patients underwent PFO closure. Over a median follow-up of 3.9 years, recurrent ischemic stroke or TIA developed in 64 (14.6%) patients. In the propensity score-matched cohort of the overall patients (130 pairs), PFO closure was associated with a significantly lower risk of a composite of ischemic stroke or TIA (hazard ratio [HR]: 0.45; 95% confidence interval [CI]: 0.24-0.84; P=0.012), but not for ischemic stroke. In a subgroup analysis of confined to the high-risk PFO patients (116 pairs), PFO closure was associated with significantly lower risks of both the composite of ischemic stroke or TIA (HR: 0.40; 95% CI: 0.21-0.77; P=0.006) and ischemic stroke (HR: 0.47; 95% CI: 0.23-0.95; P=0.035). Elderly patients with cryptogenic stroke and PFO have a high recurrence rate of ischemic stroke or TIA, which may be significantly reduced by device closure.

Exploring the Role of Trial Occlusion Test in Patent Ductus Arteriosus (PDA) Closure: A Serial Case

Background: Patent ductus arteriosus occurs in around 1 in 2000 full-term live newborns, making up 10-15% of cases of congenital heart disease. Percutaneous device closure is largely regarded as the preferred therapy for people diagnosed with PDA. Nevertheless, the closure of the PDA with a device is still a difficult task in patients with severe PAH. The trial occlusion strategy is used to evaluate the response of patients with severe pulmonary hypertension after closing the defect by briefly blocking it. This test has the potential to serve as a reliable predictor of the future progression of pulmonary hypertension. Case Presentation: We provide a report on three instances that underwent percutaneous closure of patent ductus arteriosus (PDA) in the presence of pulmonary hypertension. A 24-year-old adult patient arrived at our hospital with symptoms of intermittent dyspnea, easy fatigability, and occasional non-productive cough. The examination detected a persistent murmur located at the upper left sternal boundary. The patient received a diagnosis of patent ductus aorta and pulmonary hypertension. Discussion: The condition was successfully treated with transcatheter closure, which included a trial occlusion test. In the second instance, a toddler aged 2 was diagnosed with patent ductus aorta and pulmonary hypertension. The procedure of percutaneous PDA closure was scheduled. Following the trial occlusion test using the device occluder, we observed an elevation in pulmonary pressure which persisted and led to a pulmonary crisis. Conclusion: The trial occlusion test aids in identifying individuals who are prone to experiencing long-term regression of pulmonary hypertension and those who may deteriorate due to progressive pulmonary vascular disease (PVD) and right heart failure, therefore determining their suitability for PDA closure.

Diagnostic Value of Femoral Vein Flow Pattern for Detecting Incidental Valve Ligation by Suture-Mediated Closure Device.

Diagnostic Value of Femoral Vein Flow Pattern for Detecting Incidental Valve Ligation by Suture-Mediated Closure Device.

A single institution experience of the Manta closure device in endovascular aortic repair.

Majority of EVAR procedures are performed with percutaneous arterial access, unless there is severe steno-occlusive disease in the common femoral arteries (CFA). We present our experience of using MANTA closure device with a retrospective evaluation of its safety and efficacy, in the elective setting, and in the emergent setting for ruptured aortic aneurysm. Between Feb 2021 and May 2023 a total of 75 EVAR procedures were closed with a Manta device. Data was collected prospectively and analysed retrospectively. In 75 patients, 128 CFAs were closed with a Manta closure device including 4 emergent ruptured aneurysms. 67 male and 8 female patients with a median age of 77 years had percutaneous EVAR using Manta as a closure device. 128 CFAs were closed with Manta closure device. 3% (4/128) had deployment failures, with three requiring surgical cut down and closure. In one patient, a second Manta device deployment achieved satisfactory haemostasis. Three deployments were complicated by pseudoaneurysms of the CFA, all requiring no further interventions/treatment. No death related to severe haemorrhage from device failure. The pre- and post-procedure CFA puncture site AP diameter was recorded in a total of 106 cases with appropriate follow-up. 66% of these (70/106) had no reduction in CFA diameter post Manta closure. 34% (36/106) had some reduction of vessel AP size CFA post EVAR. No adverse features or further treatment was required due to reduction of vessel diameter in these cases (ongoing yearly surveillance). Manta closure device is safe and easy to deploy with an overall success rate of 97%. There is a short learning curve. Ultrasound assessment and precise puncture at the healthy section of femoral artery are the key to achieve successful haemostasis with Manta closure device. Our findings suggest there is an association of non-clinically significant mild reduction in CFA vessel AP diameter post Manta closure device, which does not require further intervention.

Passive Approximator Vascular Closure Device Use in Patients with Shallow Femoral Artery Depth Increases Puncture-site Complications in Neuroendovascular Treatment

Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P= 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications. Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.

Device closure of residual aortopulmonary window using Konar-MF occluder device: an attractive new option.

We report a case of a residual aortopulmonary window where a new Konar-MF occluder device was used to close the defect. This device has a low profile and conforms to the anatomy of aortopulmonary window very nicely without unnecessary protrusion on either side. This report highlights the advantage of Konar-MF occluder device for closure of such defects.

Utilization of Percutaneous Closure Devices for Large Bore Arterial Access in Genetic Aortopathy Patients Does Not Result in Increased Rates of Femoral Cutdown or Access Site Complications

Utilization of Percutaneous Closure Devices for Large Bore Arterial Access in Genetic Aortopathy Patients Does Not Result in Increased Rates of Femoral Cutdown or Access Site Complications

Device Closure in Multiple Atrial Septal Defect Secundum Concomitant with Atrial Flutter

This study discusses the case of a 23-year-old male with multiple atrial septal defect (ASD) secundum and atrial flutter who underwent ASD closure using device closure with satisfactory results. The patient recovered successfully and was discharged in good condition. ASD is a congenital heart disease often encountered in adulthood, with various types based on the location of the defect. Device closure of ASDs is one method to address abnormal blood flow, which can also reduce the risk of atrial arrhythmias through a negative remodeling process in the atria and ventricles. ASD closure in cases with multiple ASDs requires special consideration regarding the size, morphology, and distance between defects. Atrial flutter in ASD patients can be resolved with transcatheter ablation. Other studies have shown that device closure of ASDs is associated with a reduced prevalence of atrial tachyarrhythmia in the short to medium term, although atrial flutter/fibrillation and other arrhythmias are common in patients undergoing transcatheter ASD closure. Arrhythmias and conduction disturbances are also associated with ASD.

PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE AFTER A FAILED DEVICE–CLOSURE ATTEMPT: A HIGH–VOLUME SINGLE CENTRE EXPERIENCE

Abstract Introduction Persistence of patent foramen ovale (PFO) has been associated with cryptogenic stroke due to a paradoxical systemic embolism. In these cases, a percutaneous closure allows to decrease the risk of redo cerebral ischemic events. However, the presence of a complex anatomy might prevent a correct device–deployment with a high–risk o residual shunt and/or device embolization. We describe our experience about alternative technique after a failed device closure attempt. Methods We reviewed six cases wherein the device was not able to close effectively the PFO. In these cases, alternative techniques and skills were adopted to close the PFO. Results From 2021 to 2023, 194 PFO were closed in the congenital catheterization laboratory of Monaldi Hospital (Naples). In the most of cases (188/194 pts, 96.9%) an effective device closure was obtained. However, in 6 cases (3.1%) the device failed to have a PFO closure. In these 6 patients, the PFO anatomy was characterized by: a severe hypertrophy of the septum secundum (2 cases, 33%), an aneurysmatic interatrial septum (3 cases, 50%), a long stiff tunnel (6 cases, 100%). In three cases a deviceless suture–mediated system (NoblestichTM) was effective to achieve a complete PFO closure; whereas, in two cases a combined approach (suture–mediated system followed by a device deployment) allowed to achieve a complete PFO closure. In a patient with Ebstein anomaly and significant cyanosis due to right–to–left PFO shunt, a partial PFO closure (with mild residual right–to–left shunt) was obtained after NoblestichTM deployment. In this setting, the partial PFO closure was effective to achieve a significant improvement of the patient’s arterial saturation and the procedure stopped without to complete the PFO closure with a device. Conclusion Trans–catheter device closure is often effective to achieve a complete PFO closure. However, in some circumstances, the device was unable to have an appropriate PFO closure. A suture–mediated system or a combined approach (suture–mediated system with concomitant device deployment) are effective to achieve the PFO closure in these complex scenarios.

Loss and recovery of percutaneous femoral access during transcatheter aortic valve replacement. A case report

Loss and recovery of percutaneous femoral access during transcatheter aortic valve replacement. A case report