Double-disk Device Research Articles

Applicability of Percutaneous Occlusion with Double Disc Prosthesis for Correction of Patent Foramen Ovale

Objective: To discuss the applicability of percutaneous occlusion with a double-disk prosthesis to correct patent foramen ovale. Methodology: Integrative review of the literature carried out in the Virtual Health Library (VHL), Google Scholar and PubMed databases, using the Health Sciences (DeCS) descriptors: “Prosthesis design”, “Patent foramen ovale” and “Cardiac catheterization ” combined with each other by the Boolean operator AND. Results: Patent foramen ovale (PFO) is a congenital condition characterized by non-healing of the foramen ovale after birth, which can lead to complications such as paradoxical embolism and cerebrovascular accidents. Percutaneous occlusion rates with double-disc prostheses have accompanied this increase in PFO detection, while the technique, which involves inserting a double-disc device into the foramen ovale to close it, has proven effective in preventing embolic events in patients with a history of cryptogenic stroke or other PFO-related manifestations. The approach of percutaneous occlusion with a double-disk prosthesis for PFO correction is, therefore, a valuable tool in the therapeutic arsenal to reduce the risk of embolic events in high-risk patients. Conclusion: Percutaneous occlusion with a double disc prosthesis is an effective approach to preventing embolic events in patients with patent foramen ovale. Its growth reflects technological advances and understanding of the risks of FOP.

Stent Implantation Across the Atrial Flow Regulator Device.

The Atrial Flow Regulator (AFR) is a self-expandable double-disc device with a central fenestration, intended to maintain a calibrated communication across the interatrial septum. We reported for the first time a stent implantation across an AFR device in an adolescent born with complex congenital heart disease with duct-dependent systemic circulation and severe combined pulmonary hypertension.

Management of PDA device closure complicated by severe hemolysis by transcatheter retrieval and deployment of new device

BackgroundHemolysis after Patent ductus arteriosus (PDA) device closure is rare. Although in most cases, hemolysis settles on its own; however, in some cases it may not settle spontaneously and may require additional procedures like putting additional coils, gel foam or thrombin instillation, balloon occlusion, or removing it surgically. We report a case of adult PDA device closure who persisted with hemolysis and was managed by transcatheter retrieval.Case presentationA 52-year-old gentleman presented to us with a diagnosis of large PDA with operable hemodynamics. Descending thoracic aortic Angio showed a large 11 mm PDA. Transcatheter device closure was done in the same sitting with a 16 × 14 Amplatzer Ductal Occluder I(ADO) device,;however, after device release, the aortic end of the device was not fully formed and there was residual flow. The next morning patient started with gross hematuria with persistent residual flow. We tried to manage with conservative means including hydration, and blood transfusion; however, residual flow persisted for 10 days and his hemoglobin dropped from 13 gm/dl preprocedural to 7 gm/dl, creatinine increased from 0.5 mg/dl to 1.9 mg/dl, bilirubin increased to 3.5 mg/dl & urine showed hemoglobinuria. As the patient continued to deteriorate it was planned to retrieve the device by transcatheter approach. 10 French amplatzer sheath was parked in the pulmonary artery near the ductus. We tried with a combination of multiple catheters and Gooseneck snare (10 mm) and finally, we successfully retrieved with a combination of Multipurpose (MP) catheter and 10 mm Gooseneck snare. After that, we closed the defect successfully with a double disk device (muscular Ventricular septal defect 14 mm Amplatzer). The patient’s hematuria settled and was discharged after 2 days with normal hemoglobin and creatinine.ConclusionsPatent ductus arteriosus ADO 1 device should not be released if the aortic end of the disk is not fully formed Patient should be carefully monitored for hemolysis if evidence of residual shunt and given supportive treatment. If conservative treatment fails, residual flow needs to be eliminated. Transcatheter retrieval although technically challenging is a feasible treatment. A muscular VSD device is a good alternative to the usual PDA device to close PDA, especially in adults.

Versatility of Atrial Flow Regulator Device in Congenital Heart Disease: A Case Series.

The Atrial Flow Regulator (AFR) is a self-expandable double-disk device with a central fenestration, intended to maintain a calibrated communication across the interatrial septum. Only case reports and small case series have been published about its use in the pediatric and congenital heart disease (CHD) population. We described AFR implantation in three congenital patients with different anatomies and indications. In the first case, the AFR was deployed to create a stable fenestration in a Fontan conduit, while in the second, it was used to reduce a Fontan fenestration. In the third case, we implanted an AFR to decompress the left atrium of an adolescent with complex CHD in natural history, with complete mixing, ductal-dependent systemic circulation and combined pulmonary hypertension. This case series demonstrates the great potential of the AFR device in the CHD field, showing versatility, efficacy, and safety in establishing a calibrated and stable shunt, with promising hemodynamic and symptomatic benefits.

Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.

The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

Mid-Term Preliminary Results for Safety and Patency of the Occlutech Atrial Flow Regulator in an Animal Model

Objective: The Atrial Flow Regulator (AFR) is a double disc device made of self-expanding Nitinol wire mesh, structured around a central lumen. Once deployed via the transfemoral route, the device stents the atrial septum leaving a preselected fixed diameter atrial communication. We sought to evaluate the mid-term performance of the AFR by implanting the device in 5 healthy porcine hearts to assess safety and patency of the device fenestration over a period of 150 days. Method: Five AFR devices were implanted in 5 female Yucatan adult minipigs. The animals were survived to 150 days with periodic assessments at days +3, +30, +60, +90, +120, and +150. These assessments consisted of transesophageal echocardiography and fluoroscopic evaluation. The animals were sacrificed at day +150. Histological and pathological assessments were carried out to characterize neointimal tissue growth, inflammation, thrombus formation, endothelial coverage, endothelial maturity, and the presence of any luminal thrombus. Result: There were no unscheduled deaths. Patency was maintained in all 5 animals across the 150-day study. There was no statistically significant difference in the lumen diameter over the study duration. Neointimal growth was mild to moderate in all specimens and occurred mostly on the surfaces of the device in direct contact with the atrial septum. There was no evidence of any significant inflammatory response on routine blood work or by imaging or histological assessment. Scanning electron microscope (SEM) examination showed nearly complete surface coverage with endothelial tissue. The animals were in a healthy condition for the duration of the study with no attributable pathology and no adverse effects noted on distant organs in any of the 5 animals. Conclusion: As a continuation of our earlier work, this 150-day midterm animal study provides important safety and feasibility information. Our preliminary results show that the AFR is both safe and effective in maintaining a sustainable atrial level communication for the duration of the study.

Transcatheter creation of a Potts shunt with the Occlutech Atrial Flow Regulator: Feasibility in a pig model

BackgroundCreation of a Potts shunt, a connection between the left pulmonary artery (LPA) and descending aorta (DAo), improves functional status and survival in drug-refractory suprasystemic pulmonary arterial hypertension. We investigated a new approach to transcatheter Potts shunt creation in pigs. Methods and resultsIn six pigs, a steerable SureFlex sheath was used to optimize the trajectory of perforation from the DAo into LPA using a 0.035″ radiofrequency wire. The combination of a larger perforation, stiffer radiofrequency wire and smooth dilator-to-sheath transition allowed sheath entry into the LPA without requiring an arterio-venous wire circuit. The Occlutech Atrial Flow Regulator (AFR), a double-disc device with a central fenestration, was deployed through this sheath with apposition of the distal disc to the posterior LPA wall and the proximal disc to the anterior DAo wall. The AFR is compliant and crumpling of the central fenestration was resolved by balloon dilation. It was feasible to implant a stent within the fenestration (n = 3). Aortography confirmed a left-to-right shunt through the AFR without contrast extravasation. Autopsy demonstrated anchoring of both discs against the vessel walls, patency of the fenestration and secure placement of the stent with no intra-thoracic bleeding. ConclusionsIn an acute pig model, we have demonstrated the feasibility of creating a transcatheter Potts shunt with a simplified technique using a steerable sheath, a double-disc device with a central fenestration that acts as the shunt channel and optional stenting of the fenestration.

Left atrial appendage occlusion simulation based on three-dimensional printing: new insights into outcome and technique.

The aim of this study was to assess the predictive value of simulation based on 3D-printed models before left atrial appendage occlusion (LAAO) for peri-device leaks (PDL) and the impact on procedural outcomes compared to conventional imaging. Seventy-six patients referred for LAAO with double disc device underwent construction of a 3D-printed LA model using flexible photopolymer resin. An implant simulation was performed retrospectively in Group 1 (55 patients), blinded to implanted device size, and prospectively in Group 2 (21 patients). In Group 1, an off-axis device position occurred in 14 patients (25%) and the incidence of PDL was 27% (15 patients); mismatch between model and device size was the best predictor (area under the curve 0.88, CI: 0.77-0.99). When using 3D simulation prospectively, mean prosthesis number per patient (1.05±0.21 vs. 1.20±0.52, p=0.04) and incidence of leaks (5% vs. 27%, p<0.01) were reduced compared to conventional imaging alone, as well as fluoroscopy time (19 mins [13.4-23] vs. 13.5 mins [11.1-15], p=0.012) and total fluoroscopy dose (7,291 [1,811-12,734] vs. 1,978 (1,548-4,800) mGy·cm2, p=0.029). 3D-printed patient-specific adaptive and flexible LA models improve LAAO double disc device sizing. This can potentially reduce procedure time and the number of prostheses employed per patient.

Multicenter midterm follow-up results using the gore septal occluder for atrial septal defect closure in pediatric patients.

To assess the safety and efficacy of the Gore Septal Occluder (GSO) used for device-closure of significant secundum-type atrial septal defects (ASD II) focusing on pediatric patients. The GSO is a patch-like double disc device. Due to its design, it is assumed to be safe, even when implanted in ASDs with deficient retro-aortic rims. Multicenter retrospective analysis of consecutive children and adolescents with a GSO in situ for at least 12 months according to a 1- to 4-year midterm follow-up. Hundred and seventy three pediatric patients were enrolled. At implantation, median age was 6 years (range 0.7-17.9), median body weight and length were 21 kg (6.4-95) and 119 cm (65-193). Median follow-up period was 20 months (range 12-51). ASD anatomy was comprised of single defects in 131 patients (76%), multi-fenestrated defects in 42 (24%), and deficient retro-aortic rims in 33 (19%). Follow-up confirmed an overall closure-rate of 95.4%. Small residual shunts were reported in eight patients (4.6%) without need for any re-intervention. Complications were classified as minor events both during the initial procedure (9 patients, 5.2%) and on follow-up (another 9 patients), including transient AV block II in three patients (1.8%) and four snare-retrievals (2.4%) during the initial procedure. Periprocedural and midterm follow-up data have shown the GSO to be effective and safe for ASD device closure in children and adolescents. GSO may be considered the first-choice device in deficient retro-aortic rims and multi-fenestrated defects, when covering most of the atrial septum is necessary. © 2016 Wiley Periodicals, Inc.

TCT-31 Title: Immediate and One Year U.S. IDE Trial Results of the New GORE® CARDIOFORM Septal Occluder for Transcatheter Closure of Secundum Atrial Septal Defects

The GORE® CARDIOFORM Septal Occluder (studied as GORE® Septal Occluder) was recently FDA approved for the transcatheter treatment of ostium secundum atrial septal defects. It is a low profile double disc device composed of a nitinol 5-wire frame, and covered with expanded polytetrafluoroethylene.

Residual shunting after percutaneous PFO closure: How to manage and how to close

Initial transcatheter Percutaneous patent foramen ovale (PFO) closure attempt may be incomplete and result in persistent residual shunting. The optimal treatment strategy for these patients remains unknown. Twenty-seven patients were diagnosed to have a moderate-large residual shunt at least 12 months after initial PFO closure associated or not to a recurrent ischemic event and underwent a second procedure. Residual shunt characteristics were classified in two types: Type I: tunnel-like or between the disk defect (11 patients); Type II: accessory defect next to a device rim or accessory defect (16 patients). Fourteen subjects had a recurrent transient ischemic attack/stroke (52%). Median time between the first and the second PFO closure procedure was 17 months (range 12-60 months). Deployment of a second device was successful in 92% (25/27) patients. A Type I defect was closed by using a coil or Amplatzer Vascular Plugs. In two patients a surgical option was chosen as a first option. A Type II defect was closed by using a double disc device. At a median follow-up of 36 months (range 12-60 months), two subjects showed significant residual shunting between the two disks of the device (Type I) at 12 months follow-up and were sent to surgery. Significant residual shunts can be successfully closed by using a second device. Care is required to select an optimal device depending on anatomy and original device. In some subjects, lack of endothelial covering account for the persistence of a significant residual shunting.

Safety and performance of the spider™ patent foramen ovale occluder

The aim of this clinical trial was to assess safety, efficacy, and technical handling of a novel ceramic-coated double-disc patent foramen ovale (PFO) occluder. Though percutaneous PFO closure is performed with increasing frequency worldwide, certain risks such as thrombus formation and incomplete endothelialization remain. The Spider™ PFO occluder was designed to minimize these risks. The Spider™ PFO occluder is a self-expandable double-disc device with a ceramic coated nitinol wire mesh and an integrated expanded polytetrafluoroethylene (ePTFE) membrane on the right atrial side and ceramic coated nitinol anchors and ePTFE patch on the left atrial side. Study patient assessments were conducted at baseline, periprocedure, and discharge and at 1-, 6- and 12-month follow-up. Fifty-one patients (mean age 52 ± 14 years; 63% male) were enrolled in the prospective, multicenter clinical trial. Implantation was successful in all patients. Mean procedural time was 30.0 ± 8.6 min. No periprocedural or in-hospital complications occurred. Four patients (8%) had paroxysmal atrial fibrillation (AF) at 1-month follow-up. Otherwise, no procedure or device related adverse events occurred. Importantly, there were no recurrent embolic events. At 1-month follow-up 63% (32/51) of patients had no residual shunt with contrast transesophageal echocardiography during Valsalva maneuver. Of all patients who underwent 6-month echo follow-up to date, 78% (39/50) had no residual shunt during Valsalva maneuver. Initial results with the novel Spider™ PFO occluder show that the device is safe and easy to use for percutaneous closure of PFO. The overall complication rate was low. The rate of AF needs further investigation.

Study on Precision Grinding of Involute Cams on a Double-Disc Device

The involute cam is used for generating tooth form of an involute gear in gear grinder with involute cam-link stopper, and its profile error is one of the factors which decide the tooth form precision of gear. The conventional processing means of involute cams can't achieve a sufficient accuracy. In this paper, a double-disc mode grinding device is introduced. Based on analysis of grinding principle, the device's structure and working process are described, and the main sources of grinding profile errors are analyzed. It is confirmed that the introduced device has the ability of accomplishing a highly precise grinding of involute cams.

In utero management of fetal lower urinary tract obstruction with a novel shunt: A landmark development in fetal therapy

Objective. Fetal lower urinary tract obstruction occurs in ∼1:3000 pregnancies. Standard vesicoamniotic shunting is fraught with malfunctioning in upto 60% of cases. We hereby report the development and application of a novel and reliable shunt.Materials and methods. Patients with lower urinary tract obstruction were offered the novel shunt among other standard management options. Shunting involved the placement of a double disk device with a standard double pig-tail catheter. All patients signed informed consent.Results. Four patients have been treated with the novel shunt. In three patients, shunting was conducted between the bladder and amniotic cavity. In one patient (dichorionic-discordant twins) with a prior dislodged shunt causing urinary ascites, shunting was conducted between the peritoneal and amniotic cavities (‘bridge shunt’). In all cases, correct and stable shunt placement was confirmed endoscopically and sonographically and in all patients, the fetal bladder remains effectively drained.Conclusion. Reliable and effective vesico or peritoneoamniotic shunting can be achieved with the novel shunt. This shunt cannot become dislodged into the peritoneal cavity or the amniotic cavity, and cannot be pulled out by the fetus. Further experience is necessary to determine the risks and benefits of this novel treatment for fetal lower urinary tract obstruction.

Perforation of the aortic sinus after closure of atrial septal defects with the Atriasept occluder

Percutaneous atrial septal defect closure is routinely performed nowadays because of the ease of implantation as well as the low complication rate. The Atriasept ASD occluder is a low profile, double disc device; over the years several modifications have been made. We report two cases of aortic sinus perforation by the Atriasept ASD occluder (model 2007). Two asymptomatic patients, in whom the device was implanted, were noticed to have metal projecting into the aorta. Real-time fluoroscopy showed fractures of the outer metal ring with abnormal movement of one of the struts of the device. One patient is being conservatively managed and in the other the device was surgically removed due to the presence of a second ASD, which needed closure. Transesophageal echocardiography and fluoroscopy may be necessary to identify this potentially life-threatening complication of this device.

Two cases of late embolization of Amplatzer septal occluder devices to the pulmonary artery following closure of secundum atrial septal defects

The Amplatzer septal occluder (ASO; AGA Medical Corporation) is a self-expanding nitinol double-disk device that is being used for atrial septal defect closure with increasing frequency. The morbidity of the procedure is thought to be low, but complications are possible. We describe two cases of delayed embolization of the device to the right heart. Our patients both required surgical retrieval of the devices, which had migrated to the pulmonary artery.

Perventricular device closure of muscular ventricular septal defects on the beating heart: technique and results

Objective Both surgical management and percutaneous device closure of muscular ventricular septal defects have drawbacks and limitations. This report describes our initial experience with intraoperative device closure of muscular ventricular septal defects without cardiopulmonary bypass in 6 consecutive patients. Methods A median sternotomy or a subxiphoid minimally invasive incision was performed. Under continuous transesophageal echocardiographic guidance, the right ventricle free wall was punctured, and a wire was introduced across the largest defect. The Amplatzer (AGA Medical Corporation, Golden Valley, Minn) muscular ventricular septal defect occluding device (a self-expandable double-disk device) was used. An introducer sheath was fed over the wire, with the sheath tip positioned in the left ventricle cavity. The device was then advanced inside the sheath and deployed by retracting the sheath. Associated cardiac lesions, if any, can then be repaired during cardiopulmonary bypass. A similar technique can also be applied for periatrial closure of complex atrial septal defects. Results The initial 6 patients are presented. Cardiopulmonary bypass was not needed in any patient for placement of the device and needed in 4 patients for repair of concomitant malformations only (double-outlet right ventricle, aortic arch hypoplasia, pulmonary artery band removal). No complications from using this technique occurred. Discharge echocardiograms showed no significant shunting across the ventricular septum. Conclusions Perventricular closure of multiple muscular ventricular septal defects is safe and effective. We believe that this could become the treatment of choice for any infant with muscular ventricular septal defects or any child with muscular ventricular septal defect and associated cardiac defects.

Effect of catheter device closure of atrial septal defect on diastolic mitral annular motion

Atrial septal defect closure with the Amplatzer septal occluder has a negative effect on diastolic mitral annulus motion in terms of decreasing longitudinal septal annular motion and changing the relation between the annulus motion and mitral inflow.

Interventional catheterization.

Several investigations have been performed to evaluate the mid-term results of coil embolization for patent ductus arteriosus. Excellent results were obtained with coils if the minimum diameter of the ductus was less than 4 mm. Balloon dilation of native coarctation and recoarctation may be associated with complications such as aneurysm formation. Stent placement may solve some of the problems of balloon dilation, but the stents currently available are not perfect. Results of transcatheter closure of atrial septal defect using new devices have been were reported. The self-expanding nitinol double-disk device (Amplatzer septal occluder) (AGA Medical Corporation, Golden Valley, Minnesota) is becoming popular because it is easy to implant, is easy to retrieve before its release, can occlude a relatively large defect, and has a low rate of residual leak. Although the immediate results with this device were excellent, surgical closure is still the standard treatment and we need to see the long-term results of transcatheter closure.

Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience

OBJECTIVETo review the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of interatrial communications (atrial septal defects (ASD), fenestrated Fontan (FF), patent foramen ovale (PFO)).DESIGNProspective study following...