Surgical removal of an embolised patent ductus arteriosus. Mohammad hamid, muneer amanullah, surgical removal of an embolised patent ductus arteriosus amplatzer occluding device in a 4yearold. Although the study involved the offlabel use of a duct occluder, the preliminary result was satisfactory. To determine the safety and efficacy of the amplatzer duct occluder and the amplatzer duct occluder ii in different types of arterial ducts, and to determine in which types of ducts the use of.
Amplatzer duct occluder ii device with a 6 mm device length and 4 mm waist shown deployed a and expanded b to display the two retention discs separated by a waist. Article information, pdf download for successful percutaneous. Note the 86 amplatzer duct occluder device embolized in. The amplatzer duct occluder is a selfexpandable device made from a nitinol wire mesh. Fda reports serious erosion events with amplatzer septal occluder. Ductal closure using the amplatzer duct occluder type two. It is mushroomshaped with a low profile and consists of a flat retention disk and a cylindrical main. It is a wire mesh unit made using nitinol and interwoven polyester for remote promotion of tissue growth. This report presents 5 patients aged 3 to 73 years with large pavfs who underwent successful transcatheter closure with the amplatzer duct occluder ado, designed for the occlusion of patent duct. The amplatzer pfo occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale pfo to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical. Dec 31, 2007 closure of patent ductus arteriosus with the amplatzer duct occluder the amplatzer duct occluder the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A righttoleft shunt through a displaced amplatzer septal occluder was detected.
Live 3d image overlay for arterial duct closure with amplatzer duct occluder ii additional size volume 26 issue 3 sebstian goreczny, gareth j. Aim of our study is to assess the feasibility, efficacy, and complications of transcatheter closure of congenital gerbode defects with amplatzer duct occluder ii. Prior to use, reference the instructions for use, inside the product carton when available or online for more detailed information on indications, contraindications, warnings, precautions and adverse events. Amplatzer duct occluder ii clinical study full text view.
Tavr performs as well as surgery in lowrisk patients. The pfo occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale pfo, and then traveled to the brain. Nickel allergy induced systemic reaction to an intracardiac. There are few case reports and small series of acquired and congenital gerbode defects, closed with various types of devices. An account our experience using this new device for transcatheter occlusion follows. An intraoperative perventricular procedure is a good option for closing apical mvsds in small children with or without associated cardiac anomalies. Because the use of percutaneous intervention is increasing for the closure of the patent ductus arteriosus, the procedurerelated complications are also on rise, with migration of the device being. They were traditionally closed by surgery in the past. Backed by a 20year track record of performance, 1 the amplatzer duct occluder can accommodate large pdas with a single devicewhich can aid in minimizing the complexity of the procedure. A total of 192 subjects from 6 months to less than 18 years of. Endobronchial closure of bronchopleural fistulae using.
Polyester fabric is sewn into the occluder with polyester thread. Ten patients with 11 bpfs eight men and two women, aged. In this procedure, we must confirm the ado position in pda by aortogram from the arterial line. Offlabel use of duct occluder in transcatheter closure of. The medical device amplatzer duct occluder is realized by aga medical corporation. Background transcatheter closure of small to moderate sized pdas is an established procedure. Are the amplatzer duct occluder ii additional sizes.
The original amplatzer duct occluder ado ii, ce marked in 2008, can be introduced via pulmonary or aortic approach. Jun 20, 2016 the amplatzer duct occluder ii offers a feasible method for further reducing mitral regurgitation after a mitraclip procedure, a small case series suggests. Hybrid technique for ventricular septal defect closure in a. A patients guide to transcatheter closure of a patent ductus. Are the amplatzer duct occluder ii additional sizes devices dedicated only for. Food and drug administration today approved the amplatzer pfo occluder device. A 2yearold boy underwent surgery to remove part of an amplatzer occluder after patent ductus arteriosus pda device embolization in the thoracic aorta. The fda reported in a rare safety communication that the device may cause lifethreatening tissue erosion inside the heart. A new use for the amplatzer duct occluder device case report we report a case in which the amplatzer device for percutaneous occlusion of ductus arteriosus was successfully used for occluding a large systemicpulmonary collateral vessel in a patient who had previously undergone surgery for correction of pulmonary atresia and ventri. Amplatzer piccolo occluder device for patent ductus. The amplatzer duct occluder ii additional sizes is a good therapeutic option for the closure of different types of pda particularly types c, d, and e, as was observed in our group of 103 treated patients. Use of an amplatzer duct occluder device to treat a recurrent arteriovenous fistula following endovenous laser treatment. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. We have developed a novel, minimally invasive method of central bpf closure using amplatzer devices ads that were originally designed for the transcatheter closure of cardiac defects.
Amplatzer duct occluder ii additional sizes cedarssinai. A novel use of amplatzer duct occluder request pdf. The hybrid perventricular closure of apical muscular. Download scientific diagram flouroscopy image showing the amplatzer duct. Data showing more than 98% complete occlusion at 6 and 12 months 2. The closest point to the aorta measured 11mm and the most stenotic one, after the angulation site, 4. Amplatzer pfo occluder for the prevention of recurrent ischemic stroke may 24, 2016 st. Amplatzer septal occluder device early embolization to left ventricular outflow tract in asymptomatic patient. Surgical removal of an embolised patent ductus arteriosus amplatzer occluding device in a 4yearold girl. Transcatheter procedure for residual mitral regurgitation. The amplatz canine duct occluder acdo is a nitinol mesh device with a. Amplatzer duct occluder 512 46 57 device length 58 mm amplatzer duct occluder ii 36 6 45 double disc device in 4 or 6 mm length occlutech pda occluder 3.
Join us for free and access thousands of articles from eurointervention, as well as presentations, videos, cases. The physician deploys the occluder discs on either side of the defect, closing off the hole. He exhibited moderate to severe obstruction with erosion of the intimal. Nov 22, 2011 few data exist regarding the efficacy and safety of the amplatzer ductal occluder ado type 1 device in the asian region.
Jude medical launches pediatric trial for amplatzer. Timely management is necessary to prevent complications. The amplatzer duct occluder ii offers a feasible method for further reducing mitral regurgitation after a mitraclip procedure, a small case series suggests. Whether the rare but serious adverse event of erosion with amplatzer septal occluder devices should give interventionalists pause before using them is the subject of debate. Contraindications the amplatzer duct occluder ii is contraindicated for the. Flouroscopy image showing the amplatzer duct occluder ado ii. When can we release the amplatzer ductal occluder ado safely. Jude amplatzer atrial septal occluder aso, a transcatheter device used to seal congenital holes in the atrial septum. Are the amplatzer duct occluder ii additional sizes devices. The amplatzer duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of patent ductus arteriosus pda. The amplatzer pfo occluder s unique design is a primary reason for its safety and efficacy. Aortic root angiogram obtained after the procedure demonstrating the optimal placement of the amplatzer vascular plug ii and amplatzer duct occluder i and minimal patency of the fistula and better opacification of the coronary arteries. In addition, the occluder s capability to be fully recaptured and fully repositioned allows physicians to confirm proper placement prior to final release of the device. Jan 01, 2001 objectives the aim of the study was to assess the safety and efficacy of the amplatzer ductal occluder ado in transcatheter occlusion of patent ductus arteriosus pda.
Percutaneous forceps retrieval of an embolized amplatzer duct. Closure of patent ductus arteriosus with the amplatzer duct. Description of the device the amplatzer duct occluder is wire mesh made out of nickel and titanium nitinol. A cone shape that can help conform to tapering ducts. Amplatzer pfo occluder centennial heart cardiovascular. It can be delivered through a lowprofile catheterwhile also achieving a very high occlusion rate. Percutaneous forceps retrieval of an embolized amplatzer. Jude medical launches pediatric trial for amplatzer duct. To our knowledge, this is the first report to investigate the offlabel use of a duct occluder in the transcatheter closure of an asd with no rpv rim. Follow up at 3 years showed good positioning of the device with no residual shunt. Using four chamber view, measure the distance from the rim of the defect to the rim of. Further experience with transcatheter closure of the patent ductus arteriosus using the amplatzer. Amplatzer duct occluder ii sizing chart intended use the amplatzer duct occluder ii is a percutaneous transcatheter occlusion device intended for the nonsurgical closure of patent ductus arteriosus.
The amplatz canine duct occluder acdo is a nitinol mesh device with a short. It is mushroomshaped with a low profile and consists of a flat retention disk and a cylindrical main body, into which polyester fibers are sewn. Pda occlusion in dogs with the acdo is straightforward and extremely. Listing a study does not mean it has been evaluated by the u. Successful percutaneous treatment of an embolized patent ductus. To our knowledge, the delayed dysfunction of an amplatzer septal occluder has not been reported. Oct 28, 20 the amplatzer ductal occluder ado is recommended for pdas with sizes larger than 2 mm. As a stroke prevention device for patients with atrial fibrillation, the amplatzer amulet left atrial appendage laa occluder is part of the industryleading amplatzer line of structural intervention occluders. The ado is a selfexpandable device with a number of salutary features, notably its retrievability, ease of delivery via. During the deployment of an amplatzer duct occluder device, it was. Amplatzer device was advanced through the sheath with no difficulty as far as the narrowing point. The amplatzer pfo occluder is authorized by federal law for the nonsurgical closure of a patent foramen ovale pfo in patients with recurrent cryptogenic stroke1 due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy2.
However, there is a risk of device embolization after deployment. Rating is available when the video has been rented. Amplatzer duct occluder ii for closure of congenital. The amulet laa occluder is a part of abbotts broad structural heart portfolio. Pulmonary hypertension and resultant right ventricular failure and right atrial dilation could have contributed to the persistent shunting and paradoxical embolism. The amplatzer duct occluder aga medical corporation, golden valley, mn is a selfexpanding and selfcentering device, made from 0.
The amplatzer duct occluder can accommodate large pdas with a single devicewhich can aid in minimizing the complexity of the procedure. This retrospective study, conducted between august 2001 and april 2011, attempted device placement for 231 patients 165 females and 66 males with a median age of 7. The disks are 6 mm larger than the central lobe and range from 912 mm in diameter. Amplatzer pfo occluder for the prevention of recurrent. Robert frankeldirector of the cardiac catheterization lab at maimonides medical centerexplains the use of the amplatzer septal occluder device in treating heart disease. The amplatzer duct occluder can accommodate large pdas with a single device which can aid in minimizing the complexity of the procedure.
The wire mesh is filled with polyester fabric to help close the defect. Surgical removal of duct occluder device under mild. We report the case of a 33yearold man in whom an embolized amplatzer device was retrieved from the right pulmonary artery by a percutaneous method. Following its introduction into clinical practice, the amplatzer duct occluder ado has achieved a definite place in the armamentarium of the interventional.
The aim of the study was to assess the safety and efficacy of the amplatzer ductal occluder ado in transcatheter occlusion of patent ductus. Amplatzer duct occluder ii additional sizes ado ii as clinical study irb no. In adults, pda closure is recommended if left atrial or left ventricular enlargement is attributable to the pda with lefttoright shunt, pulmonary artery systolic pressure less than 50% systemic, and pulmonary vascular resistance less than onethird systemic. It consists of a central lobe, which measures 36 mm in diameter, and two retention disks on either side of the lobe fig. When can we release the amplatzer ductal occluder ado.
Percutaneous forceps retrieval of an embolized amplatzer duct occluder. Catheter closure of moderate to largesized patent ductus arteriosus using the new amplatzer duct occluder. Amplatzer septal occluder failure resulting in paradoxical. Bronchopulmonary fistulae bpfs are a severe complication of lobectomy and pneumonectomy and are associated with high rates of morbidity and mortality. Stj said today that its launching a pediatric clinical trial of a version of its amplatzer cardiac implant for treating a congenital heart defect. Live 3d image overlay for arterial duct closure with. Jul 11, 2008 amplatzer duct occluder ii clinical study ado ii the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Early amplatzer occluder closure of a postinfarct ventricular.
September 5, 2017 abbott announced it has initiated a u. Percutaneous closure of left main coronary artery fistula. Objectives this study reports a novel transcatheter procedure for residual mitral regurgitation mr after mitraclip implantation using the amplatzer duct occluder ii ado ii. We evaluated the results of hybrid perventricular closure of apical mvsds performed using an amplatzer duct occluder ado. The amplatzer duct occluder type two device is made of a meshwork of selfexpandable nitinol wire. Transcatheter closure of patent ductus arteriosus with the amplatzer duct occluder shows excellent results.
Protrusion of the amplatzer duct occluder ado ii device into the aortic. Jan 17, 2020 iatrogenic aortic stenosis is a serious complication and potentially fatal due to erosion of the aortic wall. The amplatzer ductal occluder ado is recommended for pdas with sizes larger than 2 mm. Amplatzer septal occluder echocardiography step by step. Amplatzer duct occluder for treatment of displaced pda coil. Backed by a 15year track record of performance in the u. Variable patent ductus arteriosus pda morphology and the need to close pdas in small size patients has led physicians to use amplatzer vascular plugs avp and recently available amplatzer duct occluder ii. Surgical removal of part of an occluder to treat iatrogenic. The amplatzer septal occluder, ce marked since 1998, is intended for patients with an asd in the secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. Amplatzer duct occluder ii and delivery system sizes table 2. Grants restful api soap web service annotations api oai service bulk downloads developers forum. The occlutech duct occluder for patent ductus arteriosus. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. Food and drug administration fda issued a warning this week about safety issues encountered with the st.
University of arizona leads statewide study of congenital heart defects. The ado is a selfexpandable device with a number of salutary features, notably its retrievability, ease of delivery via small 5f. These products are intended for use by or under the direction of a physician. This brochure is intended to provide you with general information about nonsurgical closure of a patent.
For transcatheter closure, we deployed the amplatzer duct occluder ii 9pda20506, aga med. Amplatzer duct occluder for treatment of displaced pda coil induced late haemolysis. For patients who have had a cryptogenic stroke and have a patent foramen ovale pfo, clinical trials have shown that they can benefit from pfo closure. Amplatzer piccolo occluder is a peasized, minimally invasive, selfexpanding, percutaneous transcatheter occlusion device used for nonsurgical closure of pda in patients. Amplatzer duct occluders abbott structural heart solutions. If you have patients that you would feel could benefit please feel free to contact dr. Percutaneous closure of ventricular septal defects vsd has become a widely accepted alternative to surgical repair. Objectives the aim of the study was to assess the safety and efficacy of the amplatzer ductal occluder ado in transcatheter occlusion of patent ductus arteriosus pda. Background although the mitraclip procedure is a transcatheter treatment option for patients at high surgical risk with severe mr, management of significant residual mr after mitraclip implantation is still challenging. Use of amplatzer vascular plugs and amplatzer duct. The purpose of this study is to evaluate whether an.
1178 912 8 1535 1308 1227 311 612 620 303 371 934 116 301 911 409 280 743 973 644 614 372 276 1232 225 17 982 1309 790 1283