Word of caution: silent late device embolisation after perimembranous ventricular septal defect closure in a 6-Kg infant.

We report on a 6-month-old infant (6 Kg/ 64 cm) with perimembranous ventricular septal defect (absent sub-aortic rim, 10 mm left ventricular entry, and 4 and 6 mm right ventricular exists) and successful retrograde closure using an 8x6 mm KONAR-MF™ VSD occluder (Lifetech, China). Immediate and 48 hours post-procedure ultrasounds showed an accurately positioned device and two jets of mild-to-moderate residual shunts. At the 2-week follow-up, the device did not change position and the shunt was stable and intra-prosthetic. The scheduled 3-month follow-up was skipped for familial reasons. The patient came back without alarming symptoms for the regular 6-month follow-up, and the device was found embolised to the left pulmonary artery. The device was retrieved surgically, and the defect was patch-closed with excellent outcomes. There was a pseudoaneurysm involving the tricuspid valve chordae and the device was endothelialized partially on one edge suggesting that embolization occurred somewhere between 3 months and 6 months post-operative. Defects with compromised anatomies should be closed surgically to avoid suboptimal results, especially in small infants.

Cerebral embolic protection during transcatheter stent expansion of restrictive extra-cardiac Fontan conduit.

We report a 20-year-old female patient (76 Kg/164 cm) with an extra-cardiac Fontan circulation who was referred to our institution for exertional dyspnoea and desaturation. The patient was diagnosed with a large calcified thrombus at the level of the Fontan fenestration, protruding inside the lumen of the conduit and reducing the diameter by half with a 3 mmHg pressure gradient. Transcatheter stent expansion of the obstructed extra-cardiac conduit was done with a 48 mm long XXL PTFE-covered Optimus-CVS® under temporary cerebral embolic protection with a TriGUARD-3™ deflection filter device (Keystone Heart). There was no procedural complication and the 3 months clinical outcomes are good.

A word of caution: Early failure of Magmaris® bioresorbable stent after pulmonary artery stenting.

Bioresorbable scaffolds (BRS) have been advocated as the fourth revolution in interventional cardiology medical devices with promising technology to improve the treatment of coronary artery disease with an event-free future. We describe the first reported use and early collapse of the Magmaris® Resorbable Magnesium Scaffold (RMS) stent (BIOTRONIK AG, Switzerland) to relieve left pulmonary artery severe stenosis in a newborn after the Norwood procedure. The stent collapse was detected 2 weeks after implantation and urgently treated with a balloon-expandable stent. This complication raises the alarm about the need to keep implanted RMS under scrutiny. The possibility of faster scaffold resorption in small babies or lack of sufficient radial force of RMS to resist acute vessel recoil has led to ineffective relief of branch pulmonary artery stenosis and failure to enable a safe short-term bridge to Stage II palliation.

Transvenous retrograde thoracic duct embolization for effective treatment of recurrent plastic bronchitis after fontan palliation.

We report the case of a 5.5-year-old patient (16 kg/105 cm) who presented with plastic bronchitis (PB) refractory to conservative treatment 3 months after completion of Fontan palliation. Bi-inguinal transnodal fluoroscopy-guided lymphangiogram confirmed the chylous leak originating from the thoracic duct (TD) into the chest and did not opacify any central lymphatic vessel for direct transabdominal puncture. Retrograde transfemoral approach was adopted to catheterize the TD and selectively embolize its caudal portion using microcoils and liquid embolic adhesive. Recurrence of symptoms after 2 months indicated a redo catheterization to occlude the TD entirely using the same technique. The procedure was successful and the patient was discharged after 2 days with sustained clinical improvement at 24 months postoperative. In the context of refractory PB, end-to-end transvenous retrograde embolization of the TD appears to be an interesting alternative to more complex interventions such as transabdominal puncture, decompression, or surgical ligation of the TD.

Early spontaneous closure of large arterial ducts in two term neonates with Ebstein anomaly after failed attempts of transcatheter closure.

In neonatal Ebstein's anomaly of the tricuspid valve, prolonged ductal patency in patients without anatomic pulmonary valve atresia can be deleterious. Circular shunts may develop in patients with different degrees of pulmonary and tricuspid insufficiency. Closure of the arterial duct may result in haemodynamic improvement in particular scenarios. The transcatheter approach is a valuable closure alternative despite some technical difficulties in large-sized arterial ducts and low birth weight neonates. Herein, we report on two consecutive term newborns with Ebstein's anomaly and large arterial ducts in whom mechanical stimulus of the arterial duct during failed attempts of transcatheter closure led after two days to definitive closure followed by good clinical outcomes.

Failure to post-dilate BeSmooth peripheral stents to adult vessel size diameters during benchside tests.

BACKGROUND: Low-profile stent implantation remains a rescue treatment for aortic coarctation and branch pulmonary arteries stenosis in small children. Stent re-expansion to cope with vascular growth remains problematic. OBJECTIVES: To evaluate ex vivo feasibility and mechanical behaviour of over-dilating BeSmooth peripheral stents (Bentley InnoMed, Germany). METHODS: Three BeSmooth peripheral stents in diameters of 7, 8, and 10 mm were dilated to nominal pressure and then 13 atm. BeSmooth Ø7 × 23 mm was sequentially post-dilated using 12, 14, and 16 mm high-pressure balloons. BeSmooth Ø10 × 57 mm was post-dilated with a 14 mm balloon and then with a 48 mm bare-metal Optimus XXL stent hand-mounted on a 14 mm balloon (stent-in-stent). BeSmooth Ø8 × 57 mm was directly post-dilated with a 48 mm bare-metal Optimus XXL stent hand-mounted on a 16 mm balloon (stent-in-stent). The stents' diameter and length were measured. Digital inflation pressure was noted. Balloon rupture and stent fracture patterns were closely evaluated. RESULTS: At 20atm pressure, BeSmooth Ø7 × 23 mm shortened to 2 mm forming a 12 mm diameter solid ring circle and the woven balloon ruptured radially. At 10 atm pressure, BeSmooth Ø10 × 57 mm fractured longitudinally in various dispatched breaking points at a diameter of 13 mm without shortening and ruptured the balloon with multiple pinholes. At 10 atm pressure, BeSmooth Ø8 × 57 mm fractured centrally at three different points at a diameter of 11.5 mm without shortening and the balloon broke radially in half. CONCLUSIONS: In our benchmark tests, extreme shortening, severe balloon rupture, or unpredictable stent fracture patterns at small balloon diameters limits safe post-dilation of BeSmooth stents beyond 13 mm. BeSmooth stents are not ideal candidates for off-label stent interventions in smaller patients.

Improvised bespoke technique for atrial septostomy in the shortage of atrioseptostomy balloon catheters.

Atrioseptostomy balloon catheter is an essential item to have on our shelves. However, the recall and shortage in production of the commonly used balloon atrioseptostomy catheters posed an imminent threat to our patients. Herein, we present the case of a newborn with a post-natal diagnosis of simple transposition of great arteries and restrictive atrial communication where repeated static balloon atrial septostomy using a 9 mm x 20 mm Sterling balloon failed to improve his status. We had to improvise per-operatively a new bespoke technique to perform a vital pull-through balloon atrial septostomy. The distal third of a 10 mm x 20 mm semi-compliant Cristal balloon was exteriorised out the tip of a 6-Fr 55 cm Cook Flexor sheath in the left atrium, and both were simultaneously pulled back to the right atrium to create an 8 mm septal defect. The procedure was successful without any complications. The baby was weaned off prostaglandin on day 3 and surgically repaired on day 5 with excellent results.

Modified safety techniques for transcatheter repair of superior sinus venosus defects with partial anomalous pulmonary venous drainage using a 100-mm Optimus-CVS® covered XXL stent.

We report the first use of a single 100-mm long custom-made version of the Optimus-CVS® balloon-expandable PTFE-covered XXL (15-Zig) stent (AndraTec, GmbH) to eliminate sinus venosus defect left-to-right shunt and redirect anomalous right pulmonary veins blood flow through a new walled channel to the left atrium. Anatomical feasibility and strategy decision were guided by ex-vivo procedure simulation on the patient-specific 3D printed heart model and in-vivo balloon interrogation. Modified procedural and implantation techniques are detailed. Immediate and one-month follow-up showed excellent outcomes.

Embolization of vascular abnormalities in children with congenital heart diseases using medtronic micro vascular plugs.

This study aimed at evaluating our experience with Micro Vascular Plug (MVP) for embolization of vascular abnormalities in children with congenital heart diseases (CHDs). MVP is one of the most recent additions to the armamentarium for peripheral embolization. Data on its use in congenital cardiology are scarce. Medical records of children with CHDs who had embolizations with MVPs between April 2015 and September 2020 were reviewed. Immediate and follow-up data were assessed. A total of 153 patients underwent 172 procedures during which 240 embolizations using 259 MVPs were attempted. Median age and weight were 34.9 months (IQR, 4-75 months) and 12.5 kg (IQR, 4.8-19.4 kg), respectively. Targets were abnormal systemic arteries (n = 163), patent arterial ducts (n = 26), venous (n = 45), and coronary-cameral fistulas (n = 6). Median vessel diameter was 3.3 mm (IQR, 2.5-4 mm). Veins were larger than arteries (2.3 mm > 2.1 mm, p < 0.01). MVPs were implanted in narrower diameters compared to manufacturer's recommendations. Compared to veins, solitary implanted MVPs in arteries were additionally oversized at 12.4%, 5.1%, and 7.9% for MVP-3Q, 5Q, and 7Q, respectively. Additional occlusion material (16.7%) and 2 MVPs (5.8%) were needed at the same site for complete closure. Implantation and procedure success rates were 99.2% and 96.7%, respectively. Five complications were treated percutaneously (n = 4) and surgically (n = 1). Efficacy of vascular embolization using MVPs was demonstrated in the largest cohort of children with CHDs and a variety of clinical settings. Immediate and stable closure is obtained with a single device in most cases. Detailed device selection chart according to vessel type and diameter is proposed to achieve intended outcomes.

Word of caution: Severe aortic valve injury linked to retrograde closure of perimembranous ventricular septal defects.

Retrograde device closure of perimembranous ventricular septal defects (pmVSDs) is an interesting procedure with several technical advantages and encouraging follow-up results. Nevertheless, aortic valve injuries may occur and require sufficient attention. Herein, we report the first two cases of severe aortic regurgitation that we have linked to the retrograde pmVSD closure with the KONAR-MF™ VSD occluder. We detail the technical aspects, comprehensively discuss procedural errors and conclude with important learning points.

Three centers experience with device closure of congenital Gerbode-type perimembranous ventricular septal defects.

OBJECTIVES: We aim to evaluate our experience with interventional closure of Gerbode-type perimembranous ventricular septal defects (pmVSDs). METHODS: We performed three-center retrospective data review of patients with congenital indirect Gerbode-type pmVSDs treated percutaneously between August 2017 and May 2021. Standard safety and latest follow-up outcomes were assessed. RESULTS: Ten patients (six females) were identified with a median age of 6.8 years (range: 2.5-54) and a median weight of 26.5 kg (range: 12-88). The median left ventricular defect size was 10 mm (range: 3-15.5). On baseline ultrasound, 6 patients had absent subaortic rim , 6 patients had trivial aortic regurgitation, and 3 patients had tear-drop-type (small) aortic cusp prolapse. The tricuspid regurgitation was graded II (n = 5) and III (n = 5). Five Lifetech Konar-Multifunctional occluders, four Amplatzer duct occluders II and one Amplatzer duct occluder I were implanted. The median fluoroscopy time was 10.4 min (range: 4.3-20.2). Pre-existing aortic regurgitations remained identical. One new aortic regurgitation was identified before discharge and remained trivial after 48 months of follow-up. No heart block or tricuspid stenosis was observed on a median follow-up of 17 months (range: 3-48). All patients are symptom-free with complete shunt closure and significant regression or resolution of tricuspid regurgitation. CONCLUSIONS: Despite anatomical challenges, interventional closure of congenital indirect Gerbode-type pmVSD appears to be feasible, safe, and most importantly clinically effective using different commercially available devices. Amplatzer duct occluder II and Lifetech Konar-Multifunctional occluder offer interesting specifications to retrogradely target this specific defect with success.

Transcatheter closure of an acquired post-operative aorta to right ventricle shunt in a child with complex univentricular heart.

KONAR-MultifunctionalTM VSD Occluder (Lifetech, Shenzhen, China) is one of the most recent additions to the armamentarium of device closure interventions offering special features to tackle complex cardiac anatomies. Herein, we report the first use of the KONAR-MFO in an 8.5-year-old female patient (27 kg/129 cm) with stage III palliated univentricular heart to close an acquired post-operative tunnel-like communication (5 mm long × 2.6 mm large) between the right anterior non-coronary aortic sinus and the rudimentary right ventricular cavity. The shunt was diagnosed two and a half years after bulboventricular foramen surgical enlargement. The 5× 3 mm KONAR-MFO was retrogradely implanted under ultrasound and biplane fluoroscopic guidance. Immediate and 12-month follow-up confirmed successful outcomes with complete shunt closure and preserved aortic valve competence.

Off-label use limitation of the Super Arrow-Flex® sheath introducer in congenital heart disease interventions.

Many interventionists are infatuated by the recent resurgence of the coilwire design with the Super Arrow-Flex® sheath (Teleflex, Inc., NC, United States of America). This exclusive sheath is a highly flexible, durable, conduit intended for use in diagnostic and interventional procedures with several advantages and maximum effectiveness in challenging cases. We report failure to easily advance memory shape occluders through Super Arrow-Flex® sheaths larger than the recommended implant French size. We detail the technical reasons behind this non-previously reported drawback and describe benchside tests as possible solutions.

Transcatheter closure of extracardiac Fontan conduit fenestration using new promising materials.

Fenestration transcatheter closure is widely considered to eliminate persistent right-to-left shunt after Fontan surgeries. Three consecutive children with stage III-palliated univentricular hearts recently underwent successful endovascular fenestration closure using 43 mm/Large Optimus-CVS™ that were implanted using the new Altosa-XL™ PTA balloon catheters (AndraTec GmbH). The procedure was fast with no complication and patients were discharged the following day with complete shunt closure. One-month follow-up confirmed excellent outcomes. This report aims to highlight and discuss the competitive advantages of these promising new materials in this particular intervention.

Transcatheter closure of congenital Gerbode-type ventricular septal defect using the new multifunctional occluder device.

The KONAR-Multifunctional™ VSD Occluder (MFO) (Lifetech) is one of the most recent additions to the armamentarium of transcatheter therapies. The device offers superior technical features and experienced interventionists having been using it in risky and complex anatomies. Herein, we report the first use of the MFO device to close a congenital Gerbode-type perimembranous ventricular septal defect in an 18-year-old girl. The device was retrogradely implanted into proper position under ultrasound and fluoroscopic guidance. Immediate and 12-month-follow-up confirmed successful outcomes with complete shunt closure and resolution of tricuspid regurgitation.

Sudden cardiac arrest in an epicardial paced-dependent child: watch out, it's a pitfall!

Coronary artery compression by epicardial leads is a rare complication in children and can be difficult to identify with potentially lethal outcomes. Herein, we report the case of a previously asymptomatic paced-dependant 5-year-old girl who presented to our institution with resuscitated cardiac arrest. We describe the atypical sequence of clinical findings misleading initial diagnosis. Hardware failure and the commonly occurring lead fracture were incriminated in the mechanism of cardiac arrest, precipitating implantation of a new pacing system while concealing dynamic compression of the left anterior descending coronary artery.

Percutaneous closure of restrictive-type perimembranous ventricular septal defect using the new KONAR multifunctional occluder: Midterm outcomes of the first middle-eastern experience.

OBJECTIVES: To evaluate the safety, efficiency, and midterm outcomes of transcatheter perimembranous ventricular septal defect (pmVSD) closure using the new KONAR-MF™ VSD occluder. BACKGROUND: Off-label percutaneous pmVSD closure is a well-established procedure with promising results. Yet, interventionists are still searching for the ideal device. METHODS: Between June 2018 and March 2019, 20 patients with hemodynamically significant but restrictive-type pmVSD underwent an attempted transcatheter closure using the new KONAR-MF™. All implantations were performed retrogradely under general anesthesia, transoesophageal echocardiography, and fluoroscopic guidance. Prospective follow-up using transthoracic echocardiography and electrocardiogram was done until August 2019. RESULTS: The median age was 6.4 years (8 months to 43.4 years), and the median body weight was 17.3 (9-74) kg. The mean defect size on the left ventricular aspect was 11.7 ± 2.8 mm. All devices were successfully and rapidly implanted. One device embolized in the pulmonary artery, 24 hr after implantation and was percutaneously retrieved with no complication. Over a mean follow-up period of 8.2 ± 3.0 months, complete closure was achieved in 84.2% of patients. One new onset of mild aortic regurgitation was detected before discharge and remained stable. Tricuspid valve regurgitation, complete heart block, major complication, and death were not observed. CONCLUSIONS: Transcatheter pmVSD closure using the KONAR-MF™ can be successfully performed in adult and pediatric patients. It is a safe and promising device, designed to provide high conformability to septal defects with a lower risk of heart block. Retrograde implantation allows procedural flexibility, efficient deliverability, and control of valvular interferences.

Transhepatic atrial septal defect closure: simple way to achieve haemostasis in a patient with important co-morbidities.

Percutaneous closure is the gold standard treatment for atrial septal defects, but the procedure can be complex in case of femoral thrombosis. Although unusual for congenital interventionists, transhepatic atrial septal defect closure is an attractive alternative to the internal jugular vein, especially when approaching the interatrial septum. Herein, we report the case of an adult patient with significant co-morbidities who had successful transhepatic atrial septal defect closure after a failed transjugular attempt. We describe the use of an absorbable haemostatic gelatin sponge to efficiently and safely achieve haemostasis after the use of a large vascular sheath with combined anticoagulation and antiplatelet therapy.

Not just another large atrial septal defect: complex anatomy, challenging procedure, and an unusual complication.

We report the case of a 59-year-old patient with a complex atrial septal defect in whom a 40-mm Amplatzer™ septal occluder was surgically extracted 50 days following implantation. Deployment manoeuvres were challenging leading to an immediate pericardial effusion that was closely monitored and uneventfully drained after 11 days. A dry pericardium was documented until 4 weeks of outpatient routine follow-up. However, the device was surgically explanted 2 weeks later, when an urgent chest computed tomography performed for worrisome symptoms showed pericardial effusion recurrence with peripheral contrast enhancement. Surprisingly, the surgical view showed a well-positioned device and an intact pericardium. We discuss the atypical sequence of clinical findings misleading our clinical judgement and precipitating surgery.

Hybrid perventricular muscular ventricular septal defect closure using the new multi-functional occluder.

The hybrid perventricular approach for the closure of trabecular ventricular septal defects is an attractive treatment modality for small children. Worldwide experience has shown that procedure success is influenced by the defect anatomical accessibility, operators' expertise, and device technical features. In May 2018, a new promising device, the KONAR-Multi-functional™ ventricular septal defect occluder (Lifetech, Shenzhen, China), obtained CE-marking for septal defect transcatheter closure after the first-in-man implantation in 2013. Herein, this is the first report of successful perventricular closure of ventricular septal defect using this new device in a child with significant co-morbidities.