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Transcatheter closure of arterial duct (AD) remains challenging in low-weight patients and using Amplatzer Duct Occluder devices is still considered off-label in infants < 6 kg. This study aimed to report a large, single-center experience of percutaneous AD closure in infants < 6 kg as well as to compare the most frequently used devices, Amplatzer Duct Occluder type I (ADO I) and Amplatzer Duct Occluder type II Additional Sizes devices (ADO II-AS) (St. Jude Medical Corp, St. Paul, MN, USA). From March 2000 to March 2017, among the 762 patients submitted to percutaneous closure of AD at our Institution, 33 were infants < 6 kg (age 4.8 ± 2.1 months; weight 5.0 ± 0.9 kg). Fourteen patients (45%) underwent ADO I (Group I) and 19 patients ADO II-AS (Group II) device implantation. AD diameter was 2.6 ± 0.8 (range 1.5-4.0) mm resulting in QP/QS of 2.6 ± 0.0.9 (range 1.1-4.5). Successful device deployment was achieved in all patients without procedural morbidity or mortality. Procedural and fluoroscopy times were not significantly different between the groups. However, total X-ray absorbed dose was significantly higher in Group I (121 ± 69 vs 29 ± 16 mGy/cm 2 , p < 0.01). Immediate, 24 h, and mid-term (46 ± 37 months, median 39) complete occlusion were recorded in 72.7, 90.9, and 97% of patients, respectively without significant difference between the groups. In conclusion, transcatheter closure of AD with Amplatzer Duct Occluder devices is feasible, safe, and effective also in infants less than 6 kg, without significant difference between the most commonly used devices, namely, ADO I and ADO II-AS.

Significant and balanced PA growth following arterial duct (AD) stenting has already been consistently reported in literature. However, to date, no data are available about the role of this approach as palliation of congenital heart disease with a duct-dependent discontinuous pulmonary artery (dPA). The aim of this study was to evaluate the fate of a dPA of ductal origin following trans-catheter AD stabilization. Angiographic PA evaluation was performed in seven patients submitted to neonatal AD stenting as palliative recruitment of dPA. Five patients showed discontinuity of one PA, while two patients had both PAs served by bilateral ducts. PA growth was evaluated as per the Nakata index, McGoon ratio as well as dPA (n = 9) versus heart-dependent PA (hPA; n = 5) size and z-score changes. AD stabilization was performed using coronary stents dilated to 3.2 ± 0.3 mm (median 3.4), with significant increase of O 2 saturation (from 83 ± 11 to 95 ± 5%, p < 0.02). Control angiography was performed 5.1 ± 2.8 months (median 6 months) after duct stenting, showing significant growth of the dPA (from 3.7 ± 1.0 to 7.6 ± 2.7 mm, p < 0.001; z-score from -0.7 ± 1.4 to 1.7 ± 2.2, p < 0.01). A trend toward better growth of the dPA as compared with the hPA was found (117 ± 87 vs. 54 ± 34%, p = NS). The final vessel size was still significantly different between the groups (dPA 7.6 ± 2.7 vs. hPA 11.9 ± 3.4 mm, p = 0.02), although the final z-score value did not significantly differ (dPA 1.7 ± 2.2 vs. hPA 3.8 ± 0.9 mm, p = NS). In conclusion, percutaneous AD stenting is effective in promoting a significant catch-up growth of duct-dependent dPA, being, therefore, advisable as a reliable alternative to surgical palliation.

Objectives: This study aimed to report a large, single-center experience of percutaneous arterial duct (AD) closure using Amplatzer Duct Occluder II Additional Sizes device (ADO II-AS)(St. Jude Medical Corp, St. Paul, MN, USA)., Background: Transcatheter closure of AD remains challenging in low body weight patients and those who have a persisting shunt following a previous attempt at interventional closure. Recent technical advances in device design may address these issues., Methods: From May 2011 to April 2016, 109 patients underwent attempted percutaneous closure of AD with ADO II-AS at our Institution. Mean age and weight were 4.8 ± 8.1 years (range 0-48) and 21.4 ± 20.6 kg (range 3-93), respectively. Fifteen patients (13.8%) were ≤6 kg (age 3.5 ± 2.0 months; weight 4.7 ± 1.1 kg). Arterial duct morphology was type A in 62 (57%), type B in 1 (1%), type C in 32 (29%), type D in 7 (6%) and type E in 6 patients (6%), respectively. Arterial approach was used to negotiate and deploy the occluding device in 103 patients (94.5%)., Results: AD diameter was 2.2 ± 0.6 (range 1.5-4.5) resulting in QP/QS of 1.9 ± 0.7 (range 1-3.3). Mean pulmonary artery pressure and PA/aortic pressure ratio were 19.3 ± 5.0 mm Hg (range 12-38) and 0.34 ± 0.14 (range 0.14-0.95), respectively. Successful device deployment was achieved in 107 patients (98.2%). Neither procedural morbidity nor mortality was recorded. Immediate, 24h and mid-term (30 ± 17 months) complete occlusion was recorded in 71%, 98.1%, and 100% of patients, respectively., Conclusion: In our experience, trans-catheter closure of AD of different sizes and morphologies using ADO II-AS is highly feasible, safe and effective also in challenging anatomic/clinical settings. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

: A 56-year-old patient was referred because of refractory heart failure and mild haemolysis caused by multiple, severe paravalvular leaks of a Starr-Edwards valve implanted in mitral position 23 years before. Owing to perceived high risk of surgical re-valving, percutaneous paravalvular leak occlusion was performed by implantation of multiple, simultaneously deployed Amplatzer Vascular Plugs.

Objective: Significant and balanced pulmonary artery (PA) growth following arterial duct (AD) stenting has already been reported in literature. However, no data are so far available about the role of this percutaneous approach in promoting PA growth in the case of congenital heart disease (CHD) with completely duct-dependent pulmonary blood flow (CDD-PBF). Aim of this study was to evaluate the effect of AD stenting in this pathophysiological setting., Methods: PA growth was evaluated as Nakata index and McGoon ratio as well as individual PA z-score changes in 49 patients submitted to neonatal AD stenting according to their pathophysiology (CDD-PBF (n=15) versus multiple PBF sources (n=34))., Results: Control angiography was performed 7.2±6.4 months (range 1-8, median 6) after AD stenting. In the whole population, significant and balanced PA growth was recorded (Nakata index+122±117%; left pulmonary artery (LPA) z-score +84±52%; right pulmonary artery (RPA) z-score +92±53% versus preprocedure, p<0.0001 for all comparisons). Percentage increase of global and branch vessel size was not significantly different in patients with CDD-PBF compared with those with multiple PBF sources (Nakata index 89±90% vs 144±124%; LPA z-score 63±40% vs 89±58%; RPA z-score 74±35% vs 100±57%, p=NS for all comparisons) as was final absolute PA size (Nakata index 237±90 vs 289±80 mm(2)/m(2), p=NS)., Conclusions: Percutaneous AD stenting was associated with significant and balanced PA growth in CHD with completely duct-dependent pulmonary circulation over a short-term follow-up. Thus, it may be considered as an alternative to surgical palliation in this subset of patients., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objectives: This study sought to evaluate the impact of arterial duct (AD) stenting in promoting catch-up growth of hypoplastic pulmonary artery (PA) tree in congenital heart disease with duct-dependent pulmonary circulation (CHD-DPC)., Background: Significant and balanced PA growth following AD stenting has already been consistently reported in the literature. However, no data are so far available about the role of this approach in severe PA hypoplasia, which significantly impacts the risk of surgical repair., Methods: Pre-surgical angiographic PA evaluation was performed in 45 patients with confluent PAs submitted to neonatal AD stenting as palliation of CHD-DPC. PA growth was evaluated as Nakata Index and McGoon ratio as well as individual PA z-score changes, both in the whole population and according to the original vessel size (Nakata Index <100 mm(2)/m(2), Group I [n = 15] vs. Nakata Index >100 mm(2)/m(2), Group II [n = 30])., Results: Control angiography was performed 7.5 ± 6.5 months (median 6 months) after duct stenting, showing significant and balanced PA growth. The Nakata Index increased from 143 ± 73 mm(2)/m(2) to 270 ± 88 mm(2)/m(2) (124 ± 118%, p < 0.0001); left PA z-score from -0.7 ± 1.7 to 1.0 ± 1.4; right PA z-score from -0.6 ± 1.3 to 1.2 ± 1.3 (p < 0.0001 for both comparisons). Group I showed a greater increase of global PA growth (Nakata Index increase 227 ± 141% vs. 72 ± 57%, p < 0.001) as compared with Group II. Final PA size did not significantly differ between the groups (246 ± 105 mm(2)/m(2) vs. 282 ± 78 mm(2)/m(2), p = NS)., Conclusions: Percutaneous AD stenting is highly effective in promoting a significant and balanced catch-up growth of diminutive PAs, being therefore advisable in this subset of patients as a reliable alternative to surgical palliation., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate early results, learning-curve changes, and mid-term outcome of arterial duct (AD) stenting in congenital heart disease with duct-dependent pulmonary circulation (CHD-DPC) in a high-volume, tertiary referral center., Background: In spite of wide acceptance as cost-effective alternative to surgical palliation, AD stenting indications, results and mid-term outcome still largely depend on small series, experiences in particular subsets of patients or multicenter series with different approaches and interventional philosophy., Methods: Between April 2003 and December 2013, 119 patients underwent AD stenting as lower-risk palliation of CHD-DPC at our Institution. Procedural and mid-term follow-up data of these patients are reported., Results: The procedure was successfully completed in 93.3% of cases, with a complication rate and in-hospital mortality of 17.6% and 3.6%, respectively. No patient underwent rescue surgical shunt but elective Blalock-Taussig shunt was needed in 15 patients (13.5%). Over time, favorable trends toward higher feasibility and efficacy in complex ductal anatomy as well as lower procedural risk were recorded. Presurgical cardiac catheterization (n = 36) showed significant and balanced pulmonary artery (PA) growth (Nakata Index +113 ± 101%; left PA z-score +87 ± 52%; right PA z-score +97 ± 53%, P < 0.001 for all comparisons), without significant changes of left-to-right PA diameter ratio. PA growth was significantly better in patients with severely hypoplastic PAs at the time of duct stabilization (Nakata Index increase 194 ± 115 vs. 75 ± 61%, P < 0.001)., Conclusions: AD stenting is feasible and effective at low-risk in a high percentage of patients with CHD-DPC, promoting significant and balanced PA growth mainly in patients with hypoplastic main PAs at duct stabilization., (© 2015 Wiley Periodicals, Inc.)

Objectives: To evaluate feasibility and results of arterial duct (AD) stenting in low-weight newborns with congenital heart disease and duct-dependent pulmonary circulation (CHD-DPC)., Background: AD stenting is nowadays considered a cost-effective alternative to surgical shunt in CHD-DPC. This option might be even more advisable in low-weight neonates (<2.5 kg), who are at higher surgical risk and in whom stent redilation might adapt shunt magnitude to patient's growth., Methods: Between April 2003 and September 2010, 76 neonates with CHD-DPC underwent AD stenting at our institution, as lower-risk palliation with respect to surgical shunt. Procedural and follow-up data of the 15 low-weight newborns (2.0 ± 0.3 kg, median 2.2) (group I) were compared with the remaining normal-weight newborns (3.5 ± 0.7 kg, median 3.2) (group II)., Results: Feasibility, complication rate, and need for surgical shunt did not significantly differ between groups. Global X-ray exposure was significantly higher in the low-weight group (82 ± 108 vs. 30 ± 33 Gray/cm(2) , P < 0.002), which maybe due to a longer angiographic presenting work-up. In-hospital mortality rate was 14.3% (vs. 1.9% in the group II, P = NS), although none of the fatalities was procedure-related. During follow-up, five patients (35.7% vs. 15.7% in the group II, P = NS) underwent stent redilation before surgical repair. At control angiography, the Nakata and McGoon indexes had significantly increased (P < 0.05 for both comparisons), without any significant difference with the group II (162 ± 52% vs. 144 ± 158% and 40 ± 17% vs. 42 ± 38%, P = NS)., Conclusions: AD stenting is also feasible and effective in low-weight newborns with CHD-DPC, supporting the spontaneous improvement process or promoting a significant pulmonary artery growth., (Copyright © 2011 Wiley-Liss, Inc.)

Background: Despite current trends toward primary repair, surgical systemic-to-pulmonary shunt is still an invaluable palliative option in some patients with congenital heart defects and duct-dependent pulmonary circulation. However, arterial duct stabilization with a high-flexibility coronary stent could be an effective alternative in high-risk surgical candidates or whenever short-term pulmonary blood flow support is anticipated., Methods and Results: On the basis of ductal origin and morphology, the stenting procedure can be performed from an arterial or venous route. Following arterial duct angiographic imaging, the stabilizing stent is chosen to completely cover the entire ductal length and dilated slightly less than the proposed surgical shunt. Procedural failure depends mainly on ductal tortuosity and ranges around 10% of cases. Morbidity and mortality are 8-11% and less than 1%, respectively. Mid-term fate of the stented duct is spontaneous, slow and progressive closure within a few months. Compared with a Blalock-Taussig shunt, stented ducts result in similar but more uniform pulmonary artery growth over a mid-term follow-up., Conclusion: Arterial duct stenting is a technically feasible, well tolerated and effective palliation in congenital heart disease with duct-dependent pulmonary circulation. It is advisable either in high-risk neonates or whenever a short-term pulmonary blood flow support is anticipated. The stented duct appears less durable than a conventional surgical shunt although it is highly effective in promoting a global and uniform pulmonary artery growth.

A young woman, submitted to aortic coarctation repair in early infancy, was referred with clinical and echocardiographic signs of severe recoarctation. Spiral CT scan confirmed the aortic isthmus obstruction but imaged also a huge aneurysm distal to the coarctation site, from which arose a large aberrant right subclavian artery. In cardiac catheterization, this vessel showed an upper-to-lower flow direction and its closure was deemed mandatory to abolish a major feeding source to the aneurysmal sack. Thus, this anomalous vessel was occluded with an Amplatzer Duct Occluder device and multiple covered Cheatham-Platinum stents were telescopically implanted into the thoracic aorta to dilate the coarctation and exclude the aneurysm. In conclusion, percutaneous transcatheter treatment is feasible, safe, and cost-effective even in aortic arch obstructions with complex anatomic arrangement., ((c) 2010 Wiley-Liss, Inc.)

A critical infant with unrestrictive ventricular septal defect and absence of the left pulmonary artery underwent transcatheter re-canalization of the occluded arterial duct-left pulmonary artery complex and surgical banding of the right pulmonary artery. After this hybrid approach, the baby was discharged under mild anticongestive therapy in view of a later surgical repair.

Objectives: The aim of this study was to assess the pulmonary artery (PA) growth following arterial duct (AD) stenting in neonates with congenital heart disease (CHD) with duct-dependent pulmonary circulation., Background: AD stenting is increasingly deemed as a reliable alternative to surgical shunt in CHD with duct-dependent pulmonary circulation. Allowing the stent to conform to the PA anatomy might avoid any unbalance of lung perfusion and promote a uniform growth of the main PAs., Methods: Of the 47 neonates and infants submitted to AD stenting as palliation of CHD with duct-dependent pulmonary circulation at our Institution, 15 underwent angiographic evaluation of the PA development before surgical repair due to progressive decrease of the systemic oxygen saturation. The Nakata and McGoon indexes as well as the left-to-right PA diameter ratio were considered as being indicative of global and balanced growth., Results: Ductal stabilization was achieved with coronary stents dilated to 3.3 + or - 0.4 mm (range 2.5-4). The control angiography was performed 7 + or - 3 months (range 3-13) after the stenting procedure. At that time, the Nakata and McGoon indexes had significantly increased from 132 + or - 67 to 287 + or - 94 mm/m(2) and from 1.6 + or - 0.3 to 2.1 + or - 0.2 mm/m(2), respectively (P < 0.0001 for both comparisons), due to uniform vascular growth (left PA z-score from -0.7 + or - 1.6 to 1.4 + or - 1.2; right PA from -0.8 + or - 1.4 to 1.4 + or - 1.2, P < 0.0001 for both comparisons; final left-to-right PA ratio 0.9 + or - 0.1)., Conclusions: Percutaneous AD stabilization with highly flexible coronary stents is effective in promoting a significant and balanced growth of the PAs in CHD with duct-dependent pulmonary circulation.

Bilateral arterial ducts feeding discontinuous pulmonary arteries are a very rare anatomic arrangement in complex heart malformations with pulmonary atresia. In this setting, neonatal ductal closure may result in abrupt pulmonary hypoperfusion and life-threatening systemic hypoxia. In high-risk patients, percutaneous arterial duct stenting might be an engaging and cost-effective alternative to surgery. This paper reports on a critical low-weight neonate with complex heart disease and discontinuous pulmonary arteries dependent on bilateral arterial ducts who underwent successful transcatheter ductal stenting as an alternative to a high-risk surgical palliation.

Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD). Surgical ASD closure relieves patient symptoms but often fails to revert cardiac volume overload findings. Transcatheter ASD closure might be an attractive alternative to surgery, also because of the possibility to study the amount and time-course of the electro-geometric modifications following shunt disappearance. Between March 2000 and December 2002, 24 patients (age 22.7 +16.8 years) underwent percutaneous closure of large ASD (stretched diameter >20 mm and/or QP/QS ratio >1.5:1). ASD closure was performed with the Amplatzer Septal Occluder device (mean 25 +/- 7 mm), achieving a complete occlusion in all patients at 1 month. In 6 patients, right ventricular (RV) monophasic action potential was recorded during the procedure. All patients underwent standard 12-lead electrocardiography and transthoracic echocardiography before and at 24 hours and 1 month after ASD closure. After the procedure, monophasic action potential length increased from 359 +/- 27 to 372 +/- 27 ms (p <0.0001). At 1 month, QT dispersion decreased from 54 +/- 25 to 41 +/- 17 ms (p <0.05), RV diastolic diameter decreased from 42 +/- 6 to 34 +/- 5 mm (p <0.00001), and left ventricular (LV) diastolic diameter increased from 39 +/- 5 to 44 +/- 5 mm (p <0.0001), resulting in a decrease in the RV/LV ratio from 1.11 +/- 0.22 to 0.79 +/- 0.11 (-28.8%, p <0.00001). Electrocardiographic changes, as well as the amount and time-course of RV overload relief, did not significantly differ between pediatric (<16 years of age; n = 11) and adult patients (n = 13). In conclusion, regardless of age at procedure, percutaneous ASD closure results in early striking electrical and geometric cardiac changes that may be beneficial during long-term follow-up.