nitinol and Foramen-Ovale--Patent

Allergic reaction to nitinol is rarely reported, and its incidence, symptoms, and course have not been clearly defined. We report an occurrence of severe progressive generalized exanthema 3 days after the implantation of an Amplatzer occluder for a patent foramen ovale, with symptoms disappearing immediately after surgical removal of the device 3 months later. The risks and possible prevention of allergic reaction to nickel and especially to titanium are discussed.

Topics: Adult; Alloys; Cardiac Catheterization; Dermatitis, Allergic Contact; Device Removal; Equipment Failure; Female; Follow-Up Studies; Foramen Ovale, Patent; Humans; Rare Diseases; Septal Occluder Device; Severity of Illness Index; Treatment Outcome; Ultrasonography

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.

Topics: Adult; Aged; Alloys; Atrial Fibrillation; Cardiac Catheterization; Ceramics; Chi-Square Distribution; Coated Materials, Biocompatible; Echocardiography, Transesophageal; Female; Foramen Ovale, Patent; France; Germany; Hemodynamics; Humans; Male; Middle Aged; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Septal Occluder Device; Time Factors; Treatment Outcome; Valsalva Maneuver

We investigated the safety, feasibility and usefulness for closure of PFO with the new nitinol meshwire PFO-occluder device (Occlutech Figulla-single layer occluder) with an unique braiding technology which allows a 50% reduction of meshwork material on the left atrial side in combination with a greater flexibility as compared to the Amplatzer occluder device.. The retention discs of the new PFO Occlutech Figulla single layer device (23/25 mm) are connected by a 3 mm waist in the centre with only one right atrial side hub. The left atrial disc is a single flat layer covered by an ultrathin polyethylene terephthalate (PET) patch. We investigated the safety, feasibility and usefulness for closure of PFO in a multicenter clinical trial. Indications for closure included cryptogenic stroke with evidence of a patent foramen ovale in transesophageal echocardiography (PFO max. diameter 13 mm according to sizing balloon). The device was implanted in 36 patients (mean age 57, 18-80 years) by means of fluoroscopy and transesophageal echocardiography (TEE) using a 9 French delivery sheath and employing a femoral vein approach. Both acetylsalicylacid 100 mg/d (6 months) and clopidogrel 75 mg/d (3 months) were administered post interventional. A transthoracal (TTE) and transesophageal echocardiography follow-up examination was performed after 1, 2 and 6 months (TTE day 30 and 180; TEE day 60).. The device was successfully implanted in 36 pts. In one patient PFO implantations was attempted but not crossed with a guide wire. Perioperativly there were no major in-hospital-adverse events or complications thromboembolism, occluder dislodgement, infection or myocardial infarction. One patient had transient atrial fibrillation 2 h after implantation, which terminated medically after 12 h. TEE studies in the remaining 35 pts (one pt was unwilling to further participate) showed a residual shunt in 8.6% (3/35) after 60 days and a left-to-right shunt in 2.6% (1/35) of pts. After 180 days one pt with severe arteriosclerotic heart disease and A.carotic stenosis revealed a stroke without evidence of cardioembolic origin or devices thrombosis.. The novel Occlutech Figulla PFO N single layer device appears to be safe, feasible and useful for PFO closure despite a 50% reduction of the meshwire, no distal hub and an improved flexibility of the left atrial disc.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Aspirin; Balloon Occlusion; Cardiac Catheterization; Clopidogrel; Echocardiography, Transesophageal; Female; Femoral Vein; Fluoroscopy; Follow-Up Studies; Foramen Ovale, Patent; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Prostheses and Implants; Ticlopidine; Young Adult

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.

Topics: Alloys; Cardiac Catheterization; Chi-Square Distribution; Female; Foramen Ovale, Patent; Humans; Male; Middle Aged; Polytetrafluoroethylene; Postoperative Complications; Prostheses and Implants; Statistics, Nonparametric; Treatment Outcome

Although currently used devices for interventional closure of patent foramen ovale (PFO) are widely used due to the minimally invasive nature of this technique and high success rate, there is still a need to look for new materials and designs in order to improve the treatment outcomes.. To evaluate the safety, biocompatibility, temporal healing patterns, and coverage dynamics of the new Polish PFO occluder (Balton, Warsaw, Poland) in a swine model - an observation that may assist the decision with regard to its first-in-human use and duration of anticoagulation therapy.. In total, 12 pigs were scheduled for 28-day (n = 6) and 90-day follow-up (n = 6). In each animal, using a standard femoral venous approach, one PFO occluder was implanted and subsequently, in order to verify device position stability, the Minnesota manoeuvre was performed. At follow-up, all devices underwent a comprehensive evaluation with the use of high-resolution radiography (Faxitron MX-20 system), scanning electron microscopy (SEM), and standard histopathological techniques.. All PFO occluders were implanted successfully with no complications. The Faxitron revealed that all nitinol portions of the frame appeared intact and breaks were not detected at both studied time points. Overall, the device appeared to be well deployed in the atrial septum. At 28 days the average neointimal coverage of the right side of the PFO occluder by SEM was 92%; while in contrast the left side had less coverage, at 63%. At 90 days, the coverage of the right side of the occluder was 96.8%, while the left side of the PFO occluder improved and had similar coverage of 93.3%. By histology the endothelialisation process was virtually complete at 90 days. At the early time-point the overall inflammatory infiltrate was moderate and subsequently it diminished and was only mild or occasionally moderate at 90-day follow-up. At both time points the inflammatory reaction was limited to the neointimal tissue surrounding the device.. Our study confirmed safety and good overall biocompatibility of the new Polish PFO occluder, which is comparable to other devices available on the market - an observation that supports the decision with regard to its first-in-human application. Neoendothelialisation was virtually completed at 90 days, suggesting that similarly to other widely used devices a minimum of three to six months of anticoagulation therapy should be recommended.

Topics: Alloys; Animals; Biocompatible Materials; Foramen Ovale, Patent; Patient Safety; Prosthesis Design; Septal Occluder Device; Sus scrofa; Therapeutic Occlusion; Treatment Outcome

Topics: Adult; Alloys; Aorta, Thoracic; Cardiac Surgical Procedures; Female; Foramen Ovale, Patent; Humans; Prosthesis Failure; Septal Occluder Device

There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity. Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure.

Topics: Adult; Alloys; Cardiac Catheterization; Drug Hypersensitivity; Female; Fluoroscopy; Foramen Ovale, Patent; Humans; Male; Middle Aged; Nickel; Prosthesis Design; Septal Occluder Device; Treatment Outcome; Young Adult

A number of devices are available for percutaneous closure of a clinically significant patent foramen ovale (PFO). The new GORE(®) septal occluder (GSO) is a nonself-centering device consisting of an expanded polytetrafluoroethylene tube supported by a frame of nitinol wire conforming into a double disk. This study reports the first clinical GSO implantation experience.. GSO implantation in 20 consecutive patients is reported. Inclusion criteria were all patients referred with a significant PFO implicated in paradoxical embolism or transient right to left shunting causing desaturation. Procedures were performed under local anaesthesia and intracardiac echocardiography (ICE) in addition to fluoroscopy. Procedural data, acute and early closure rates were examined.. All patients underwent successful day-case device implantation. Eleven patients had previous stroke, five had transient ischemic attacks, two had a history suspicious of PFO-related desaturation, and two had a history suspicious of PFO-related peripheral thromboembolism. Acute closure rates on IVC injection bubble testing were 100% at implant and 100% (14/14) at 1 month. Average PFO balloon size was 8.0 ± 3.6(range 2.0-16.7) mm, mean fluoroscopic implantation time 3.0 ± 1.7(range 0.7-6.3) min, radiation dose 283 ± 340 (range 6-1,431) μGym(2), and total procedural time 34.8 ± 8.0 (range 22-53) min. 5 × 20 mm(2), 7 × 25 m(2), 8 × 30 mm(2) GSO devices were implanted, aiming for device size at least twice balloon PFO size. Cases included aneurysmal septums with up to 30 mm deviation and tunnels up to 12 mm long. Removal and repositioning of two devices was performed on two occasions after uncertainty about device locking. At 1 month follow-up, two patients had brief self-terminating episodes of suspected atrial fibrillation, all had normal resting ECGs. No thromboembolic/neurological events were reported.. The GSO can be implanted under local anaesthesia and ICE with low procedural and fluoroscopy times with high procedural success as a day case. No residual shunts were seen. This initial experience suggests that it is a safe and effective device for PFO closure.

Topics: Adult; Alloys; Anesthesia, Local; Atrial Fibrillation; Cardiac Catheterization; Device Removal; Female; Foramen Ovale, Patent; Humans; Male; Middle Aged; Polytetrafluoroethylene; Prosthesis Design; Prosthesis Failure; Radiography, Interventional; Septal Occluder Device; Time Factors; Treatment Outcome; Ultrasonography; Young Adult

We investigated the safety, feasibility and efficacy of the Occlutech devices for patent foramen ovale (PFO) and atrial septal defect (ASD) closure in a prospective trial.. The retention discs of the PFO device (23 x 25 mm, 27 x 30 mm) are connected by a 3 mm waist in the center with only one right atrial side central pin. The left atrial disc is produced either with a single or double flat layer, which allows a significant reduction of meshwork material. The ASD occluder (6-40 mm, 3 mm increments) has only one central pin on the right atrial side. Indications for closure included cryptogenic stroke with evidence of a PFO on transesophageal echocardiography (TEE) or an ASD II. The devices were implanted in 29 patients with PFO and in 12 patients with ASD II (fluoroscopy and TEE). An echocardiographic follow-up examination was performed after 1, 2 and 6 months.. The devices were successfully implanted in all 41 patients. There were no periprocedural complications. One patient with ASD II died of recurrent myocardial infarction without evidence of cardioembolic origin. TEE studies showed a residual shunt in 11.2% after 60 days in patients with PFO and a left-to-right shunt in 9.1% of the remaining patients with ASD II. After 180 days only 1 patient with PFO had a right-to-left shunt (3.7%). A residual shunt in the patients with ASD was not observed.. The novel Occlutech devices appear to be safe, feasible and effective for PFO and ASD closure, with a significant reduction of the meshwork and absence of left atrial central pin.

Topics: Adult; Aged; Alloys; Animals; Echocardiography; Echocardiography, Transesophageal; Equipment Failure Analysis; Equipment Safety; Feasibility Studies; Female; Foramen Ovale, Patent; Foreign-Body Reaction; Heart Septal Defects, Atrial; Humans; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Prosthesis Design; Septal Occluder Device; Swine; Swine, Miniature

Topics: Aged; Alloys; Echocardiography; Equipment Failure Analysis; Equipment Safety; Female; Foramen Ovale, Patent; Foreign-Body Reaction; Heart Septal Defects, Atrial; Humans; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Prosthesis Design; Septal Occluder Device