Advances in interventional occlusion of persistent ductus arteriosus: comparison of results using different occlusion devices

This report describes our results with transcatheter closure of patent ductus arteriosus between March 1993 and May 2000 including our early experience with the Amplatzer duct occluder. One hundred and sixty-six consecutive procedures were performed in 160 patients. The mean age was 6.8 years (range 0.8 to 26.2), mean weight 24.3 kg (range 7.7 to 84.0). Single or multiple coils were implanted successfully in 114 cases, a Rashind double umbrella in 35 patients, and an Amplatzer duct occluder in 16 patients. After failure to implant coils in one patient, a second attempt with a Rashkind double umbrella was successful. Complete closure of the patent ductus arteriosus was achieved in a total of 148 patients (92.5%), mean fluoroscopy time was 13.7 min (range 3.1 to 126 min). In 144 patients (90.0%), occlusion without residual shunting was achieved by the first interventional approach. Angiography showed immediate closure in 44%, echocardiography within 48 h revealed complete closure in additional 28%. In a further 18%, a residual shunt disappeared spontaneously in the following months. In five patients a second procedure was performed to terminate residual shunting after placement of a Rashkind occluder system by coils. In three patients, the residual shunt resolved. In 12 patients (7.5%) echocardiography showed a residual shunt 2-1259 days after interventional approach. Occlusion rates of the different devices were 83% for the Rashkind occluder, 92% for detachable coils, and 100% for the Amplatzer duct occluder. Coil embolisation into the pulmonary artery occurred in two patients, interventional removal was successful in one of them. There were no further complications. According to our experience interventional occlusion of patent ductus arteriosus is highly effective and associated with a low complication rate. Transcatheter closure using the Amplatzer duct occluder seems to be safe and effective also in small children with a body weight of 8 kg and a large ductus diameter. Compared to the total group of patients, the occlusion rate of the Amplatzer duct occluder was significantly higher (p = 0.005), and of the Rashkind occluder system significantly lower (p = 0.026). Therefore, we recommend the use of detachable coils in patients with small ductus (diameter < or = 2 mm) and the Amplatzer duct occluder in those with a larger ductus. Transcatheter closure of the patent ductus arteriosus according to this regimen should achieve occlusion rates above 95%.     

Transcatheter closure of congenital muscular ventricular septal defect

The success with occlusion devices for the closure of atrial septal defects and patent ductus arteriosus prompted the transcatheter closure of single and multiple muscular ventricular septal defects (VSD). The procedure for VSD was first attempted by Lock et al. in 1988 and devices originally designed for the closure of other intracardiac defects (Rashkind umbrella device, Lock clamshell, Cardioseal, coils, Sideris buttoned device etc.) were used with a variable success rate and a residual shunt. Recently, specially designed Amplatzer muscular VSD occluder and Sideris device are in use. The Amplatzer muscular VSD occluder has been undergoing clinical trial since 1998 after the animal experiments had shown 100% occlusion and complete endothelization at 3 months. The procedure was first attempted in August 1995 using the Rashkind umbrella device and since April 1998 only the Amplatzer muscular VSD occluder has been used. Of the149 patients who underwent transcatheter closure of VSD, 50 had muscular trabecular defects in various locations: mid-muscular, anterior, posterior, or apical. All cases were selected by detailed transthoracic and/or transesophageal echocardiography (TTE) and aneurysm of the muscular septum was observed in three of them. The age range was 3-28 years and the diameter of VSD was 4-11 mm. In all but one patient, the device was deployed from the venous side. Simultaneous TTE was done for proper positioning of the device and continuous electrocardiographic monitoring was also done for any arrhythmia/conduction defects. All patients were followed up every 3 months and received 3-5 mg/kg aspirin for 6 months. The procedure was successful in all patients. The Rashkind umbrella device (17 mm) was used in two and Amplatzer muscular VSD occluder (6-14 mm) in 48 patients. Forty-four devices were delivered by antegrade transvenous approach and six by the transjugular route. None had residual shunt, new aortic regurgitation, or tricuspid regurgitation. Transient complete heart block after 24 hours was noticed in one patient. On a follow-up of 2-90 months, the device was in position in all patients. There was no embolization of the device, and no late-conduction defects, infective endocarditis, or hemolysis. Transcatheter closure of muscular VSD is safe and efficacious, and should be considered as a procedure of choice as an alternative to surgery that avoids cardiopulmonary bypass.     

Lung perfusion studies after detachable coil occlusion of persistent arterial duct

OBJECTIVE: To evaluate relative lung perfusion following complete occlusion of persistent arterial duct with detachable Cook coils. METHODS: Ductal occlusion using detachable coils was performed in 35 patients (median age 3.9 years, range 0.5 to 16; 32 native ducts, three patients with previous devices). If the duct could be crossed with a 0.035 inch guidewire and a 4 F catheter after coil implantation, a further coil was implanted. Between one and seven coils were used (median two). RESULTS: Complete ductal occlusion was confirmed by echocardiography 24 hours after the procedure in all patients. Lung perfusion scans were performed three months after the procedure in 33 of 35 patients (two older patients with a single coil each did not attend). Decreased perfusion to the left lung (defined as < 40% of total lung flow) was observed in only one patient, who had previously had a 17 mm Rashkind umbrella implanted. There was no correlation between left lung perfusion and peak left pulmonary artery Doppler velocities (r = 0.27 and p = 0.125 for the entire group; r = 0.29 and p = 0.124 after excluding patients with previous devices). CONCLUSIONS: Coil occlusion is effective in achieving complete closure of the duct. An aggressive approach using multiple coils did not compromise perfusion to the left lung.     

经导管封堵动脉导管未闭介入治疗后残余分流

目的探讨经导管封堵动脉导管未闭(PDA)介入治疗后残余分流的可行性和临床疗效。方法自1997年3月至2001年8月16例PDA介入治疗后残余分流的患者,其中男4例,女12例,平均年龄5.9±2.4岁(2～9岁),平均体重17.7±5.4kg(9～28kg),应用不同介入方法经动脉或静脉途径封堵残余分流,首次介入治疗与再次介入治疗的时间间隔平均为1.5±1.1年(1天～3.5年)。结果残余分流直径平均为2.7±0.9mm(1.2～5.0mm)。15例成功完成残余分流封堵术,1例失败,技术成功率为94%(15/16)。单纯应用Cook可控弹簧圈9例(其中双弹簧圈2例),Rashkind双面伞2例,Sidris纽扣式补片1例,Amplatzer蘑菇伞2例,同时应用Cook可控弹簧圈和Sidris纽扣式补片1例。封堵术后即刻造影,3例仍有少量残余分流,完全闭合率为80%(12/15)。平均手术时间为75.0±22.8min(45～120min),平均X线透视时间为10.4±3.9min(5～20min)。股动脉并发症1例,其余无并发症出现。封堵术后24h复查超声心动图,所有残余分流均完全闭合(100%),在平均2年随访中未出现残余分流再通、封堵器移位和左右肺动脉狭窄。结论经导管封堵PDA介入治疗后残余分流安全、疗效确切、创伤小,可作为外科手术治疗PDA介入治疗后残余分流的一种替代方法。     

Transcatheter closure of moderate to large patent ductus arteriosus with the Amplatzer duct occluder.

OBJECTIVES: To investigate the acute and follow-up results of transcatheter closure of moderate to large patent ductus arteriosus (PDA) with the Amplatzer duct occluder. METHODS: Between April 2000 and June 2005, 237 patients underwent attempted transcatheter closure of PDA, of whom Amplatzer duct occluder was used in 68 patients with moderate-to-large-sized PDA (45 females, with ages ranging from 56 days to 75 years, median 3.3 years). Moderate to large PDA is defined as ductus diameter > or =2.5 mm (> or =3 mm in early phase of this study) in infants and young children, or > or =4 mm in adolescents and adults. The size of device selected was generally at least 1-2 mm larger than ductus diameter. RESULTS: The ductus diameter ranged from 2.5 to 8.5 mm (4.1 +/- 1.3 mm). Amplatzer duct occluder was successfully deployed in 66 out of 68 patients. The size of device deployed ranged from 4 to 12 mm (6.3 +/- 1.6 mm). The causes of failure in the 2 patients included calcification of ductus resulting, in failure in advancing a sheath to descending aorta in 1 and kinking of a Cook sheath in the other. Distal embolization of the device occurred several hours later in one. After the device was retrieved percutaneously, the patient was sent to surgery. No other significant complications occurred. In the 3-month follow-up, complete occlusion was achieved in all patients. No patient had left pulmonary artery stenosis. CONCLUSIONS: Transcatheter closure of moderate-to-large-sized ductus with Amplatzer ductus occluder is effective and safe.     

Clinical evaluation of the new Amplatzer duct occluder II for patent arterial duct occlusion

Background: Several devices such as coils and Amplatzer duct occluder (ADO) are used for catheter closure of patent arterial ducts (PDA). These carry a high success rate but residual shunts, suboptimal device orientation, and technical problems are encountered. The Amplatzer duct occluder II (ADO II) is designed to address these limitations. Objectives: To evaluate the technical features of the new ADO II device for PDA closure and document the immediate/early closure rate, complications and device behavior during implantation. Methods: Prospective, two center study from February 2008 to January 2009. Twenty‐seven patients (18 females) received the ADO II. The median age was 22 months (range: 7 months–68 years) and the median weight was 11.7 kg (range: 6.9–108). The median PDA diameter was 2.6 mm (range: 1–4.4). The approach was arterial in 13 and venous in 14 patients. Follow‐up included echocardiography at 1 day and 1 month postimplantation. Results: All implantations were technically successful with immediate complete angiographic closure in 21 and trivial contrast flow in six patients. The median procedure time was 43 min (range: 15–82) and the fluoroscopy time was 6 min (range: 2.2–26.5). Echocardiography confirmed no residual shunts on the following day. There were no complications. Conclusion: The new ADO II is a versatile and very effective device for closure of PDAs of various shapes, lengths, and up to diameters of 5.5 mm. The disc articulations, high early closure rate, arterial or venous approach options, and small diameter delivery catheter are all beneficial features. © 2009 Wiley‐Liss, Inc.     

Transcatheter closure of persistent ductus arteriosus in infants using the Amplatzer duct occluder

AIM—To evaluate whether transcatheter closure with the Amplatzer duct occluder offers an alternative to surgical treatment in infants with a persistent ductus arteriosus.
METHODS—12 patients under 1 year of age (age 1-11 months, body weight 2.6-8.7 kg) with clinical and echocardiographic findings of a significant duct were considered for transcatheter closure with the Amplatzer occluder. The device is made of a Nitinol and polyester fabric mesh and provides occlusion by stenting the duct. Measured angiographically, the narrowest diameter of the ducts ranged from 1.5-5 mm; in six patients pulmonary hypertension was also present.
RESULTS—The devices were implanted and complete duct occlusion was demonstrated during follow up in 10 patients. Procedure related difficulties occurred in nine of the 12 cases and led to relatively long procedure and fluoroscopy times (procedure time 50-180 minutes, median 80 minutes; fluoroscopy time 4.9-49 minutes, median 16 minutes). In two infants transcatheter closure could not be achieved and surgical duct ligation had to be carried out.
CONCLUSIONS—In small infants with a persistent ductus arteriosus the Amplatzer duct occluder offers an alternative to surgical treatment, but further improvement of the implantation system is necessary before the procedure can be recommended as the treatment of choice.


Keywords: persistent ductus arteriosus; transcatheter closure; infants; Amplatzer duct occluder     

Comparison of percutaneous closure of large patent ductus arteriosus by multiple coils versus the Amplatzer duct occluder device

This study compared the efficacy and costs of the most used approaches for percutaneous closure of large patent ductus arteriosus, that is, multiple coils and the Amplatzer duct occluder (ADO) device. From April 2000 to September 2003, 47 patients underwent closure of large, symptomatic patent ductus arteriosus (diameter 4.6 +/- 3.0 mm/m(2); QP/QS 2.1 +/- 1.9) with multiple Cook detachable coils (n = 19) or the ADO device (n = 28). The multiple coil approach was significantly cheaper (1,389 +/- 168 vs 3,811 +/- 38, p <0.0001) but as effective as the ADO device over a mid-term follow-up (occlusion rate 89.5% vs 96.4%, p = NS).     

Percutaneous closure of congenital and acquired ventricular septal defects--considerations on selection of the occlusion device

Nonsurgical closure of congenital and acquired ventricular septal defects (VSD) has become increasingly acceptable with the availability of various occlusion systems that allow percutaneous treatment of muscular and membranous defects. This study describes a series of 12 patients (0.2-74-years-old) who underwent defect closure with six different occlusion systems. Device selection according to anatomy and outcome is highlighted. Seven VSDs were located in the membranous part of the septum, five in the mid-muscular septum. Complex heart lesions were present in five postmyocardial infarction VSD in one and residual postsurgical defects in three patients. The size of the VSD ranged from 2.6 to 10 mm. The applied devices were: Amplatzer muscular VSD occluder (n=4), Amplatzer septal occluder (n=2), Amplatzer duct occluder (n=1), Amplatzer membranous VSD occluder (n=2), Nit-Occlud coil (n=2), and Cook PDA coil (n=1). The devices were implanted successfully in nine patients. There was complete VSD closure in eight patients within the first 24 hours. In one patient, a trivial residual shunt disappeared at 6 months follow-up. Because of device instability, two occluders were removed during catheterization. In two other cases, tricuspid valve tissue was entrapped in the occluder and had to be removed surgically, one of them during the consecutive Rastelli operation. Neither significant arrhythmia, nor thromboembolism or hemolysis occurred in out patients during follow-up. Transcatheter closure of VSD is an attractive alternative to surgery. In complex congenital heart disease, surgical-interventional hybrid therapy may improve morbidity and total outcome. The recently developed Amplatzer VSD devices allow closure of muscular and membranous VSDs. Implantation and short-term follow-up are superior to the formerly used devices. Long-term effects have to be evaluated in further studies.     

Safety and feasibility of transcatheter closure of large patent ductus arteriosus measuring >or=4 mm in patients weighing

Kothandam Sivakumar  Edwin Francis  Prasad Krishnan 《Journal of interventional cardiology》2008,21(2):196-203

Transcatheter occlusion of the patent ductus arteriosus with a single device technique: comparison between the Cook detachable coil and the Rashkind umbrella device

Transcatheter coil occlusion of the patent ductus arteriosus (PDA) has become the interventional treatment option of choice. Immediate occlusion of any residual shunting results in excellent closure rates, but frequently requires multiple coil deployment. Aims: To assess the efficacy and limitations of single Cook detachable coil PDA closure compared to a preceding series of Rashkind umbrella procedures. Methods and results: Between 1990 and 1999, transcatheter occlusion of a small (<2 mm; n=45) or moderate-sized (2-4 mm; n=47) PDA was successfully attempted in 90/92 consecutive patients (mean age 6+/-4.8 years) with a coil (39/41) or Rashkind device (51/51). Immediate angiographic closure rates for both devices were low, although better for small (54-68%) than moderate ducts (7-22%, P<0.01). A 2-year echocardiographic closure rate of small ducts increased to 92% for the coil group versus 95% for the Rashkind group. By that time, moderate-sized ducts were only occluded in 64% with the coil and 54% with the Rashkind device. A visible residual shunt at post-implant angiography in moderate ducts was associated with a high incidence (59%) of long-term echocardiographic shunt patency and a need for repeat interventions for audible residual shunts (32%). Conclusions: Single coil transcatheter occlusion is the treatment of choice for the small duct as most residual shunts will resolve spontaneously. However, long-term shunt persistence after single coil deployment in moderate sized ducts is as frequent as with the Rashkind device. A primary multiple coil approach is advocated if the postcoil aortogram shows residual ductal shunting and if there is persistence of a ductal murmur on auscultation.     

Hybrid approach to surgical correction of tetralogy of Fallot in all patients with functioning Blalock Taussig shunts.

BACKGROUND: In total surgical correction of tetralogy of Fallot (TOF) with functioning Blalock Taussig shunts (BTS), shunt take down increased surgical time, bleeding, and might injure phrenic and recurrent laryngeal nerve and thoracic duct. OBJECTIVES: A routine hybrid approach using transcatheter BTS closure immediately before total surgical correction of TOF in all patients might reduce these problems. We analyze the safety and feasibility of this approach. METHODS: Transcatheter BTS closure was achieved using single or multiple stainless steel embolization coils, Amplatzer vascular plugs, or duct occluders. When coils were released without control by bioptome forceps, coil migration in larger shunts was prevented by proximal or distal balloon occlusion. RESULTS: This routine hybrid strategy was followed in 22 consecutive patients aged 1-13 years over 4-year-period and 21 procedures were successful. Among the 16 patients attempted with coils, 13 had successful closure, 2 needed Amplatzer duct occluder devices, and 1 sent for surgical shunt takedown due to acute angulation of the shunt. New Amplatzer vascular plugs were used in six patients. Bioptome was used in six patients and proximal or distal balloon occlusion of flow was used in three patients. Four patients had closure of associated aortopulmonary or chest wall collaterals. CONCLUSION: Hybrid approach using routine transcatheter closure of all BTS immediately before surgical correction of TOF shunts with coils/plugs/devices is safe, feasible, and reproducible.     

Coil Occlusion of the Arterial Duct

In 1976 Poretmann introduced a catheter-mediated method of closure of the arterial duct. The first device to achieve widespread use was the Rashkind double umbrella. Closure rates were of the order of 80% with one device. The method was expensive and occlusion with Gianturco coils was shown to be as effective in small ducts. More recently, controlled release coils have proved to be as effective and have considerable popularity because they appear to carry a lower risk of embolization from the duct, and closure rates with one or more coils implanted at one procedure are in excess of 95%. Coil occlusion is safe and effective. However, large ducts still need other types of devices or must be closed surgically.     

Transcatheter closure of patent ductus arteriosus in adults using the Amplatzer duct occluder: initial results and follow-up

BACKGROUND: Surgical closure of patent ductus arteriosus in adult patients may be problematic. Transcatheter closure of patent ductus arteriosus is an established procedure. Recently, transcatheter closure of patent ductus arteriosus using the Amplatzer duct occluder has been shown to be safe and efficacious. We present our experience with this device in adults. METHODS AND RESULTS: Between January 2000 and January 2002,41 adult patients (31 females and 10 males) with a patent ductus arteriosus were referred for closure with the Amplatzer duct occluder. The median age was 35.6 years (range 18-70.7 years) and the median weight was 65.8 kg (range 32.7-164.5 kg). Of these 41 patients, 37 underwent attempted closure of the patent ductus arteriosus using the Amplatzer duct occluder. The device was successfully deployed in all patients except 1. Complete angiographic closure was seen Immediately after device deployment in 29 out of 36 patients (81%). Complete echocardiographic closure was demonstrated within 24 hours post-procedure in 34 out of 36 patients (94%), and at 6-month follow-up in 35 out of 36 patients (97%). No complications related to device implantation occurred in any patient. CONCLUSIONS: Closure of patent ductus arteriosus using the Amplatzer duct occluder is safe and effective in adults.     

Comparison of the Sideris and Amplatzer septal occlusion devices

The results of transcatheter atrial septal defect (ASD) occlusion with 2 different devices (Sideris adjustable buttoned device vs Amplatzer Septal Occluder) were compared in 2 consecutive series of patients. Comparative outcomes were assessed by whether a device was implanted or not, by complications and fluoroscopy time of implantation, and by the incidence of residual shunting on transthoracic echocardiography at follow-up. The patient and defect characteristics were similar in both groups. Twenty-eight of 33 Sideris devices and 37 of 39 Amplatzer devices were implanted. The fluoroscopy time for the Amplatzer implants was 13.4 minutes (range 8 to 41) compared with 23.7 minutes (range 11 to 60.6) for the Sideris implants (p <0.001). The complete occlusion rate for the Amplatzer device was 93% compared with 44% for the Sideris device at 1 year (p <0.001). In conclusion, the Amplatzer device produces higher occlusion rates of ASDs with shorter fluoroscopy times.     

Percutaneous closure of patent ductus arteriosus with the Amplatzer duct occluder

BACKGROUND AND METHODS: Percutaneous closure of a moderate-to-large sized patent ductus arteriosus using multiple coils or a Rashkind double-umbrella may be technically demanding and raises a significant rate of embolization and residual shunting. This is why we tried a new self-expandable device called Amplatzer Duct Occluder to close transvenously large ductuses in eighteen patients at a median age of 2.8 years (range: 0.7 to 34). They had a patent ductus arteriosus with a minimal diameter > 3 mm (mean: 5 +/- 2 mm). The device had a mean diameter of 9 +/- 2 mm and was delivered through a 6F venous sheath. Aortography was done 5 to 10 minutes after the release and follow-up evaluation was performed with color Doppler echocardiography within 24 h, 1 and 3 to 6 months after the procedure. RESULTS: Placement was successful in all but the first patient (95%). Complete closure was achieved immediately in 4/17 patients (24%) and in 13/17 (76%) 24 h later. Two patients were lost for follow-up. Complete closure was confirmed in 14 of the 15 (93%) reviewed patients at 1 and 3 months. In all patients with a ductal diameter < or = 7.5 mm the closure was complete at 1 month. Embolization occurred in one patient with a 9.7 mm duct and surgery was undertaken. A mild and transient hematuria was observed in one patient. No pulmonary artery stenosis nor aortic obstruction were observed on follow-up. CONCLUSION: The Amplatzer Duct Occluder device offers a safe and effective option to treat patients with a ductus arteriosus which minimal diameter is up to 7.5 mm.     

Immediate and early results of closure of moderate to large patent arterial ducts using the new Amplatzer device

OBJECTIVES: Our aim was to assess the immediate and short term results of closure of moderate and large patent arterial ducts using the self-expanding and repositionable Amplatzer device. METHOD: We attempted closure in 25 patients (10 Females and 15 males) using the Amplatzer occluder. Their median age was 48 months with a range from 8 months to 26 years and median weight of 14 kg with a range from 4.5 kg to 48 kg. The mean ductal diameter was 4.1 mm (S.D 1.51 mm). A 6F/7F long sheath was used to deliver the device. Follow up was performed with colour- flow mapping of the pulmonary trunk within 24 hours, at 3 months, and 6 months of closure. RESULTS: Of the 25 patients, the device was placed successfully in 23. Concurrent angiography showed immediate closure in 12 patients, while 8 had trivial shunting and 3 had mild shunting. Within 24 hours, Doppler examination revealed complete closure in all but three patients, who had a mild residual shunt. Two attempts were unsuccessful. Both these patients underwent successful surgical ligation. All except one patient were discharged on the next day. Of the 23 patients, 15 (65%) have been followed up for 3 months, while 8 (35%) have completed 6 months of follow-up. Of the three patients initially with mild residual flow, two had completely closed at 3 months The one remaining patient is yet to be seen at the 3 month follow-up. Thus, at 3 months, all patients studies had shown complete closure. CONCLUSION: Antegrade transcatheter closure using the Amplatzer duct occluder is an efficacious treatment for bigger patent arterial ducts. Long-term follow-up is necessary to show sustained benefits and confirm the absence of side effects.     

Percutaneous closure of a giant coronary arteriovenous fistula using multiple devices in a 12-day-old neonate.

Coronary arteriovenous fistulas (CAVFs) are uncommon in children and are rarely reported in neonates. Larger fistulas usually require either surgical closure or percutaneous closure using a variety of different devices. Device closure of large fistulas in the immediate neonatal period has not been reported. We report the first case of a gigantic CAVF in a 12-day-old neonate (2.4 kg) where successful device closure was achieved in a staged approach using a 12 mm Amplatzer muscular VSD device, seven flipper coils, a 10/8 mm Amplatzer duct occluder device, as well as a 9 mm Gianturco Grifka vascular occlusion device. No complications were encountered and the patient was subsequently weaned off the ventilator.     

Transcatheter closure of patent ductus arteriosus with the Amplatzer duct occluder: short-term follow-up

BACKGROUND: Transcatheter closure of the patent ductus arteriosus is a well established procedure. The objective of this study was to assess the effectiveness and the safety of the Amplatzer duct occluder. METHODS AND RESULTS: Occlusion of the patent ductus arteriosus was attempted in 23 patients. The median weight was 11.7 Kg (range, 5 kg - 42.4 kg) with a mean ductus diameter of 3.7 mm (range, 1.6 - 7.2 mm). The immediate closure rate was 86% with a closure rate of 100% at 6 months, 1 year and 2 years following device placement. There was one device embolization that occurred immediately following device placement. No patient had aortic narrowing or pulmonary artery stenosis following the procedure. CONCLUSIONS: The Amplatzer duct occluder is safe and effective in the closure of a patent ductus arteriosus up to 7.2 mm in diameter. Selecting a device at least 12 mm larger than the minimal ductal diameter can minimize embolization.     

Safety and Feasibility of Transcatheter Closure of Large Patent Ductus Arteriosus Measuring ≥4 mm in Patients Weighing ≤6 kg

Objectives: The study aims to find safety of transcatheter closure of large patent ductus arteriosus (PDA) ≥4 mm in patients weighing ≤6 kg.
Background: Large PDA ≥4 mm in patients ≤6 kg challenge the interventionist due to need for large delivery sheath, kink of delivery sheath, and encroachment of aorta or pulmonary artery (PA) by the device. Many institutions refer them for surgery.
Methods: Preterm neonates and ducts with coarctation were excluded. All other patients were taken for catheter closure. Ducts with roomy ampulla were closed with multiple coils aided by bioptome, and others with Amplatzer duct occluders.
Results: Twenty-eight patients aged 2–18 months (median 5.5 months) and weighing 3.8–6 kg (median 4.7 kg) had large PDA (mean diameter 6.3 ± 2 mm) with hyperkinetic pulmonary hypertension. Four patients had bioptome-aided coil closure. Twenty-two other ducts were closed with devices. Two procedures failed due to sheath kink in one patient and device pulling through a duct in the other patient. Four infants needed blood transfusions. The mean procedural time was 42 ± 20 minutes. On a mean follow-up of 25.5 ± 14.8 months, there were no residual flows and no gradients across aorta or pulmonary artery.
Conclusions: Transcatheter closure of large ducts ≥4 mm might be considered safe and effective in infants weighing ≤6 kg also. Decision on coils versus devices depends on ductal morphology. On midterm follow-up with somatic growth, there was no occurrence of aortic or PA gradients.