Transcatheter closure of tubular PDA with amplatzer plug 4 in preterm infants weighing between 900 and 3,400†g: the pros and cons.

Objective: To our knowledge, no prior study has focused on the outcome of PDA occlusion using an Amplatzer™ Vascular Plug 4 (AP4) in ill preterm infants. This study aims to highlight the pros and cons of AP4 in this cohort. Methods: Between 2020 and 2022, 26 ill preterm infants underwent PDA closure in our centre. The median age, weight, and gestational age were 60 days (11-180 days), 1,900g (900-3,400 g), and 25 weeks (22-33 weeks), respectively. The indication of the intervention was hemodynamically significant PDA. A medical trial with non-steroid medication failed to close the ducts in all patients. Follow-up using echocardiography was done 24, 48, and 72 h after the intervention. Results: Of 26 ducts, 21 were successfully closed with AP4. Five ducts shorter than 7 mm were unsuitable for AP4 and were closed with the Amplatzer Piccolo device. The median radiation time was 4 min (3-9 min). No early plug-related complications or deaths were documented. Plug-related jailing of the left pulmonary artery as a late complication was 9.5%, and LPA reintervention was required. All ducts were closed after 48 h. Conclusion: Implantation of the AP4 using a 4 F 0.38 guide wire-compatible catheter without inserting a long sheath makes the closure of tubular ducts with this device feasible and uncomplicated with a short intervention time. However, the limited sizes with fixed lengths of the AP4 make it unsuitable for ducts wider than 4.5 mm and shorter than the chosen device length, which can increase the risk of significant left pulmonary stenosis. A wide range of plug diameters and lengths is required to accommodate the large and short ducts.

New insights learned from the pulmonary to systemic blood flow ratio to predict the outcome in patients with hypoplastic left heart syndrome in the pre-Glenn stage: a single-center study.

Background: To the best of our knowledge, no study has been made until now to determine whether the ratio between pulmonary and systemic blood flow (Qp/Qs) in the pre-stage II (PS2) or pre-Glenn stage can predict the outcome in patients with hypoplastic left heart syndrome (HLHS) who underwent Norwood (NW) palliation. Patients and methods: From January 2016 to August 2022, 80 cardiac catheterizations in 69 patients with HLHS in NW palliation stage with modified Blalock-Taussig shunt (MBTS) were retrospectively recruited. The Qp/Qs was measured under stable conditions using the Fick formula. None of the patients were intubated. Patients were divided into two groups: Group 1 included patients who underwent planned cardiac catheterization (n = 56), and Group 2 had unplanned examination (n = 13), in which the indication for cardiac catheterization was desaturation in 11 patients and pulmonary over-circulation in two. The composite primary outcome was defined as accomplishing the planned operations (Glenn and Fontan) with freedom from death and reoperation, referring to palliative therapy or heart transplantation. The secondary outcome was freedom from transcatheter intervention in MBTS or pulmonary arteries. Results: The median follow-up was 48 months (range 6-72 months). The median value of Qp/Qs in Group 1 was 1.75 (range 1.5-2.2). In Group 2, the 11 patients with desaturation, the median value of Qp/Qs was 1.25 (range 0.9-1.45). The two patients with suspected pulmonary overcalculation showed Qp/Qs of 2.3 and 2.5, respectively; a reduction of the shunt size was required. Approximately 96.4% of patients in Group 1 achieved the primary outcome compared with only 30.7% in Group 2. The need for reintervention was 1.8% in Group 1 compared with 61.3% in Group 2. There is a significant relationship between Qp/Qs and the impaired outcome (death, palliative therapy, or heart transplantation) with a p-value of 0.001, a relative risk factor of 3.1, and a 95% confidence interval of 1.4-7.1. No significant relationship between the Qp/Qs and the size of MBTS (p-value of 0.073) was noted. Conclusion: The Qp/Qs in PS2 can predict outcomes in patients with HLHS in Norwood stage with MBTS. The Qp/Qs between 1.5 and 2.2 with a median of 1.75 seems to be optimal in the patients in PS2. Qp/Qs of <1.5 is associated with pulmonary stenosis, shunt stenosis, and pulmonary hypertension.

Echocardiogram-Guided Stenting of a Critical Aortic Coarctation in an Extremely Low Weight Preterm Infant.

We report a case of critical aortic coarctation in an extremely low birth weight preterm infant weighing 600 g that was successfully treated with interventional stent implantation. The intervention was guided by echocardiography without using contrast agent due to associated renal failure. (Level of Difficulty: Intermediate.).

Stenting of critical aortic coarctation in neonates between 600 and 1,350 g. Using a transfemoral artery approach. A single center experience.

Background: Stenting of aortic coarctation (CoA) in newborns with a very low bodyweight remains rare and challenging. In this study we aim to highlight on two points: first the feasibility of CoA stenting in such babies and second the importance of using echocardiogram for guiding the intervention without the need for contrast agent. Methods: Between 2020 and 2022 three preterm babies with very low (VLWB) and extremely low weight (ELWB) underwent CoA-stenting in our center. The weight of the patients at time of intervention was 1,350, 1,200, and 600 g, respectively. The femoral artery was chosen in all patients as vascular access. Transthoracic echocardiography, sonography of the femoral arteries and head ultrasound were applied for follow up. Results: All three interventions were successfully done, with no complications. Coronary stents were implanted. In one Patient (1,350 g) the stent was inserted without sheath. In two patients with renal failure, the stenting was performed under echocardiography-guidance without contrast agent. The follow up showed a preserved function of the left ventricle in all patients. No relevant gradient was reported and no stent re-intervention was required. Sonographic follow up showed a patent femoral artery in all patients. Two patients were operated 73 and 110 days after stenting, and the stents were successfully removed. In the third patient the intervention was performed 130 days ago and he is waiting for the operation. Conclusion: CoA-stenting in VLWB and ELWB is feasible and can bridge them to the next surgery without complications. Echocardiography-guided CoA-stenting in VLWB is a considerate option especially in patients with renal failure. Accessing the femoral artery by experienced doctors, using local anesthesia before the puncture and before removing the sheath might help to protect the vessel from stenosis or occlusion.

Duct Stenting vs. Modified Blalock-Taussig Shunt: New Insights Learned From High-Risk Patients With Duct-Dependent Pulmonary Circulation.

Background: As no data were available on the comparison of outcomes between modified Blalock-Taussig shunts (MBTs) vs. duct-stenting (DS) in patients with pulmonary atresia (PA) and an increased ductal tortuosity and in patients with pulmonary atresia and intact septum (PA-IVS) with right ventricle-dependent coronary circulation (RVDCC), we aimed to perform a single-center retrospective evaluation. Methods: Between 2010 and 2019, 127 patients with duct-dependent pulmonary circulation (DDPC) underwent either MBTs (without additional repairs) (n = 56) or DS (n = 71). The primary endpoint was defined as arriving at the next planned surgery (Glenn or biventricular repair) avoiding one of the following: (1) unplanned surgery or unplanned perforation of the pulmonary valve (PVP) with a stent, (2) procedure-related permanent complications, and (3) death. Two subgroups were considered: (1) patients who had a ductal curvature index (DCI) >0.45 (n = 32) and (2) patients with PA-IVS and RVDCC (n = 13). Ductal curvature index (DCI) was measured in all the patients to assess the tortuosity of the ducts. Patients with DCI >0.45 were considered as being in a high-risk group for the duct-stenting; a previous study showed that the patients with a DCI < 0.45 had a better outcome when compared with those with a DCI> 0.45. Results: The primary outcome was achieved equally in the two groups (77.5% in DS, 75% in MBTs). Hospital deaths, need for ECMO, and the occurrence of major complications was more frequent in the group with MBTs with an Odds Ratio (OR) of 5, 0.8, and 4, respectively, and a 95% Confidence Interval (CI) 1.1-22.6, 0.7-0.9, and 1.6-10.3, respectively, and a P-value < 0.05. For the two subgroups, the primary outcome was achieved in 64% of patients with a DCI >0.45 who received MBTs compared to 20% in those with DS (OR 3.5, 95% CI 1.2-10, P 0.005). While 74.1% of the patients with PA-IVS and RVDCC after DS had achieved the primary outcome, all patients with MBTs had an impaired outcome (OR 3.5, 95%CI 1-11.2, P 0.004). Conclusion: MBTs showed a better outcome in patients with tortuous ducts compared to DS. DS seems to be superior in patients with DDPC with DCI <0.45 and patients with PA-IVS with RVDCC.

Large diameter Advanta V12 covered stent trial for coarctation of the aorta: COARC Study

BACKGROUND: Covered stent implantation for treatment of coarctation of the aorta (CoA) is effective and can prevent aortic wall injury. Prospective studies with long-term follow-up, including imaging, are lacking. We report the acute and long-term outcomes for use of the Large Diameter Advanta V12 covered stent for treatment of native and recurrent CoA. METHODS: A prospective, multicenter, nonrandomized study was performed including 70 patients (43 male), median age 17 years, median weight 57.4 kg with CoA who underwent implantation of the Large Diameter Advanta V12 covered stent. Annual follow-up for 5 years included Doppler echocardiography to calculate diastolic velocity: systolic velocity ratio. RESULTS: CoA diameter increased from 5.6±3.6 to 14.9±3.9 mm (P<0.0001) and the pressure gradient decreased from 35.8±16.2 to 5.6±7.9 mm Hg (P<0.0001). Preimplantation diastolic velocity: systolic velocity of 0.6±0.16 dropped to 0.34±0.13 (P<0.0001) and was maintained at 5 years. Computed tomography angiograms at 12 months post implantation demonstrated the stent: transverse arch diameter to be similar, 0.91±0.09 to post procedure 0.86±0.14. Major adverse vascular events at 30 days and 12 months were 1.4% and 4.3%, respectively. Significant adverse events included three patients who required stent implantation to treat infolding. There were no mortalities. CONCLUSIONS: The Large Diameter Advanta V12 covered stent is safe and effective for the treatment of CoA with an immediate and sustained reduction of the pressure gradient over 12 months and 5 years as assessed by preimplantation and post implantation Doppler echocardiography and 12-month computed tomography angiography.

Large Diameter Advanta V12 Covered Stent Trial for Coarctation of the Aorta: COARC Study.

BACKGROUND: Covered stent implantation for treatment of coarctation of the aorta (CoA) is effective and can prevent aortic wall injury. Prospective studies with long-term follow-up, including imaging, are lacking. We report the acute and long-term outcomes for use of the Large Diameter Advanta V12 covered stent for treatment of native and recurrent CoA. METHODS: A prospective, multicenter, nonrandomized study was performed including 70 patients (43 male), median age 17 years, median weight 57.4 kg with CoA who underwent implantation of the Large Diameter Advanta V12 covered stent. Annual follow-up for 5 years included Doppler echocardiography to calculate diastolic velocity: systolic velocity ratio. RESULTS: CoA diameter increased from 5.6±3.6 to 14.9±3.9 mm (P<0.0001) and the pressure gradient decreased from 35.8±16.2 to 5.6±7.9 mm Hg (P<0.0001). Preimplantation diastolic velocity:systolic velocity of 0.6±0.16 dropped to 0.34±0.13 (P<0.0001) and was maintained at 5 years. Computed tomography angiograms at 12 months postimplantation demonstrated the stent:transverse arch diameter to be similar, 0.91±0.09 to postprocedure 0.86±0.14. Major adverse vascular events at 30 days and 12 months were 1.4% and 4.3%, respectively. Significant adverse events included three patients who required stent implantation to treat infolding. There were no mortalities. CONCLUSIONS: The Large Diameter Advanta V12 covered stent is safe and effective for the treatment of CoA with an immediate and sustained reduction of the pressure gradient over 12 months and 5 years as assessed by preimplantation and postimplantation Doppler echocardiography and 12-month computed tomography angiography. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00978952. URL: http://www.anzctr.org.au; Unique identifier: ACTRN12612000013864.

Use of the ductal curvature index to assess the risk of ductal stenting in patients with duct-dependent pulmonary circulation.

BACKGROUND: To evaluate whether a quantitative curvature threshold can contribute to risk stratification of ductal stenting in patients with a duct-dependent pulmonary circulation (DDPC). METHODS: A single-center retrospective analysis was performed. The ductal curvature index (DCI) was calculated in 71 patients with DDPC. The ducts were divided into four classes based on quartile thresholds of DCI: class I (≤0.12), class II (0.13-0.33), class III (0.34-0.44), and class IV (≥0.45). The primary outcome of this study was defined as free from all of the following: (I) intervention related death, (II) need of unplanned surgery (III) need of unplanned pulmonary valve (PV) perforation with stent in right ventricular outflow tract (RVOT), and (IV) intervention related permanent complications. RESULTS: Eighty percent of patients in class IV (DCI ≥0.45) failed to achieve the primary outcome; odds ratio (OR) 9 and 95% confidence interval (CI): 3.7-21.4 compared to 26.6% in all classes with DCI <0.45. 66.7% of these patients needed unplanned surgery or PVP with RVOT stent; OR 12.4 (95% CI: 4-39). 80% of major complications were observed in class IV (P<0.01). Need of pulmonary arterioplasty was in class IV 53.3%; OR 3.3 (95% CI: 1.5-7.1). CONCLUSIONS: DCI can be useful to guide the clinical decision-making in patients with torqued ducts. Patients with a DCI ≥0.45 belong to a high-risk group, in which ductal stenting is associated with an elevated risk for early surgery or unplanned re-intervention.

Severe midaortic syndrome: a stepwise approach to treatment with drug-eluting balloons: a case report.

BACKGROUND: Severe forms of the midaortic syndrome cause persistent arterial hypertension and can lead to angina abdominalis. Untreated, morbidity, and mortality are significant. In addition to palliation through bypass surgery, few other therapeutic approaches lead to a long-term relief. Drug-eluting balloons (DEB) covered with paclitaxel, a cytostatic drug, have proven to be effective in bifurcational lesions and for in-stent stenoses in coronary arteries. CASE SUMMARY: In a 15-year-old girl with severe midaortic syndrome and multiple collateral arteries, four interventional balloon dilatations with DEB of increasing diameters resolved the stenosis within 8 months. After a procedure free interval of now 2.7 years, the anatomical and the physical condition of the patient remained unchanged. DISCUSSION: This stepwise approach, with a low procedural risk and a lasting result may justify further investigations into this combined treatment.

Transvascular closure of single and multiple muscular ventricular septal defects in neonates and infants < 20 kg.

PURPOSE: While surgical closure of ventricular septal defects (VSD) is still the gold standard, we review our experience with the interventional closure of single and multiple muscular VSD in newborns and infants under 20 kg. METHOD: Between 2004 and 2012 transcatheter closure of ten Swiss cheese VSD, six single muscular and one apical VSD was attempted in 17 patients between 10 days and 7.3 years of age and with a bodyweight ranging from 2.2 to 19 kg. Seven patients had had a significant shunt after cardiac surgery, five patients a shunt induced congestive heart failure and in five patients postponement of surgery was intended. RESULTS: A total of 20 devices was successfully implanted in 15 of 17 (88%) patients, reducing the interventricular shunt and improving the haemodynamic situation in 14 patients. An acute AV-block led to immediate removal of the device in a patient of 2.2 kg. One Amplatzer muscular VSD occluder could not be delivered due to the sharp bending of the delivery sheath in 2004. Three patients died during follow-up not related to the intervention. Re-intervention was necessary in one patient with Swiss cheese VSD. CONCLUSION: Interventional closure of muscular VSD is possible in newborns and infants and presents an eligible treatment option. New occlusion systems with miniaturized introducer sheaths of 4-6 French have extended the spectrum of treatable lesions. An individual and interdisciplinary risk-benefit stratification is required to choose from surgical, interventional, or combined strategies.

Implantation of stents as an alternative to reoperation in neonates and infants with acute complications after surgical creation of a systemic-to-pulmonary arterial shunt.

Creation of a systemic-to-pulmonary shunt is still the firstline treatment in neonates with duct-dependent pulmonary circulation, or in patients with hypoplastic left heart syndrome as a part of the first stage of the Norwood sequence. Acute complications after such surgery, such as stenosis, thrombosis, or kinking, are potentially lifethreatening. These complications require immediate revision or exchange of the shunt. In this report, we discuss interventional treatment as an alternative to surgery in 5 patients with acute stenosis or complete occlusion of a shunt. The age of the patients ranged from 12 to 62 days, with a median of 30 days, and their weights ranged between 2.2 and 4.6 kilogrammes, with a median of 3.2 kilogrammes. In 3 patients, the shunts were central or of modified Blalock-Taussig type, while the 2 patients with hypoplastic left heart syndrome had shunts from the right ventricle to the pulmonary arteries. We implanted 6 coronary arterial and 2 peripheral stent systems. The diameter of the balloon used for implantation had a ratio to the shunt of 0.9. to 1. All shunts were successfully reopened by stenting. During follow-up, 3 patients underwent further procedures on an elective basis. We have one patient on the waiting list for further surgical intervention, but one patient died of septicaemia unrelated to the interventional procedure one month after implantation. In our limited experience, implantation of stents is an effective and long-lasting treatment for complications of shunts in an emergency situation.

Treatment of severe renal artery stenosis by percutaneous transluminal renal angioplasty and stent implantation: review of the pediatric experience: apropos of two cases.

The clinical course of two children with mid-aortic syndrome and renal artery stenosis (RAS) who suffered from severe arterial hypertension is described. Hypertension was uncontrollable by antihypertensive medication and was managed by percutaneous transluminal renal angioplasty (PTRA) with stent implantation. The pediatric experience with PTRA is limited, and there are only few cases reported with additional stent implantation. Complications of these procedures are well known from experience with adult patients. However, since surgical revascularization may be technically difficult especially in small children, PTRA with or without stenting should be considered as a valuable treatment option in pediatric RAS.