Morgan Recher

Transcatheter closure of atrial septal defect with the Figulla® ASD Occluder: A comparative study with the Amplatzer® Septal Occluder

BACKGROUND Single-centre experience in transcatheter closure of atrial septal defect (ASD) using the Figulla(®) ASD Occluder (FSO; Occlutech GmbH, Jena, Germany) and the Amplatzer(®) Septal Occluder (ASO; Saint-Jude Medical, Zaventem, Belgium) has been reported. AIM To perform a retrospective comparison of the two occluders. METHODS From September 2009 to December 2012, 131 consecutive patients underwent percutaneous ASD occlusion: One hundred with the ASO device; 31 with the FSO device. RESULTS There were no significant differences between the two groups regarding patient characteristics, stretched diameter, age and device size. In the ASO group, implantation succeeded in all but two patients because of deficient rim. Another patient had device embolization in the aorta retrieved percutaneously. During follow-up, 86 patients had no residual shunt and nine patients had a residual shunt (small in seven; moderate in two). Two other patients had persistent interatrial small shunt caused by an adjacent ASD close to the device. In the FSO group, implantation succeeded in all but two patients: one because of deficient posterior rim; and one because of complete atrioventricular block that resolved after device extraction. During follow-up, no shunt was observed in all but one patient. At late follow-up (up to 36months), full occlusion was observed in 88 (88.0%) patients in the ASO group and 28 (90.3%) patients in the FSO group (with no significant difference between groups). CONCLUSION Transcatheter closure of ASD with the FSO is feasible and safe. FSO results compare favorably with ASO results. However, additional long-term studies that include more patients are mandatory.

Enhance quality care performance: Determination of the variables for establishing a common database in French paediatric critical care units

Abstract Selected variables for the French Paediatric Intensive Care registry. Rationale, aims, and objectives Providing quality care requires follow‐up in regard to clinical and economic activities. Over the past decade, medical databases and patient registries have expanded considerably, particularly in paediatric critical care medicine (eg, the Paediatric Intensive Care Audit Network (PICANet) in the UK, the Australian and New Zealand Paediatric Intensive Care (ANZPIC) Registry in Australia and New Zealand, and the Virtual Paediatric Intensive Care Unit Performance System (VPS) in the USA). Such a registry is not yet available in France. The aim of this study was to determine variables that ought to be included in a French paediatric critical care registry. Methods Variables, items, and subitems from 3 foreign registries and 2 French local databases were used. Items described each variable, and subitems described items. The Delphi method was used to evaluate and rate 65 variables, 90 items, and 17 subitems taking into account importance or relevance based on input from 28 French physicians affiliated with the French Paediatric Critical Care Group. Two ratings were used between January and May 2013. Results Fifteen files from 10 paediatric intensive care units were included. Out of 65 potential variables, 48 (74%) were considered to be indispensable, 16 (25%) were considered to be optional, and 1 (2%) was considered to be irrelevant. Out of 90 potential items, 62 (69%) were considered to be relevant, 23 (26%) were considered to be of little relevance, and 5 (6%) were considered to be irrelevant. Out of 17 potential subitems, 9 (53%) were considered to be relevant, 6 (35%) were considered to be of little relevance, and 2 (12%) were considered to be irrelevant. Conclusions The necessary variables that ought to be included in a French paediatric critical care registry were identified. The challenge now is to develop the French registry for paediatric intensive care units.

0398: Transcatheter closure of traumatic induced VSD

Traumatic induced VSD is a rare but serious disease because of the acute hemodynamic changes. We reported one center experience in the interventional catheterization closure of traumatic induced VSD during the last ten years. We had 3 patients with four VSD. Mean age was 60 (40-71) years. VSD was muscular secondary to external trauma in one patient, and to transapical transcatheter replacement of both of the aortic and mitral valves in the second. Last patient had membranous and muscular VSD post Ross-Konno intervention. All patients had acute congestive heart failure. All procedures were performed under general anesthesia and transesophageal echocardiography control. Arteriovenous loop was always used to introduce the delivery sheath to the left ventricle. VSDs diameter was evaluated by echography and ranged from 9 to 13mm. Device diameter was chosen 1 to 2mm over the echo-graphic measures. Multiple devices were used (Amplatzer® septal occluder, Amplatzer® muscular VSD occluder, Occlutech® Figulla septal occluder). Mean procedures time was 113 (100-145) min, and mean irradiation dose was 160 (103-203) Gycm2. Non significant residual shunt was observed in all patients, but the heart failure was resolved in all. Complications were registered in three procedures: transient hemolytic anemia, severe bradycardia, tricuspid cordage rupture and groin hematoma. Conclusion Traumatic VSD closure is required because of the acute hemo-dynamic changes. Trancatheter closure is effective. Complications are frequents because of the critical clinical status.

0076: Transcatheter closure of the arterial duct with the Occlutech PDA occluder

Purpose Transcatheter closure of the arterial duct using the Occlutech PDA occluder. Methods and results From March 2013 to April 2015, 16 patients underwent percutaneous arterial duct closure with the new Occlutech PDA occluder. There were 10 females and 6 males. All patients had significant L-to-R shunt with enlarged left ventricle. At implantation, the mean age was 87 months (median 35 months) and mean weight was 16±11kg (7.2 to 54kg). The procedure was realized under local anaesthesia. Size of the duct was 2.96±0.94mm (range 1.7 to 5.5mm) on angiography. According to Krichenko classification of PDA, ducts were: type A (n=14), Type B (n=1) and type E (n=1). The systolic pulmonary artery pressure was 43±17mmHg (range 24 to 91mmHg). Implantation succeeded in all. Closure was performed by the standard 4/6mm occluder (n=8), the standard 6/8mm occluder (n=3), the standard 5/7mm occluder (n=3), the standard 3.5/ 5mm (n=1) and the standard 8/10mm occluder (n=1) using a 6 or 7 F delivery sheath. After implantation, trivial shunt was noticed on angiography in 12 patients, 4 had no shunt. The fluoroscopic time was 6.5±8.7 minutes and radiation dose 6.0±4 Gycm2. After closure, femoral thrombosis was noticed in 2 patients but resolved completely under heparin therapy. On control Doppler echocardiography (1 to 18 months), duct was closed in all patients but one with only one month follow-up. No obstruction of the left pulmonary artery or isthmic stenosis was noticed. Conclusions Percutaneous closure of PDA with the new Occlutech PDA occluder is safe and effective. The device is easy to handle and there is no learning curve for operators using the classic Amplatzer duct occluder. Further studies with longer follow-up are necessary to confirm these good results.

0323: Mid-term follow-up and quality of life in patients after Fontan surgery

Background The Fontan procedure (atriopulmonary Fontan) and total cavo-pulmonary connection are designed to treat univentricular heart. Whereas peri-operative mortality has declined, the current challenge is long-term outcome. Objective To evaluate the outcome and quality of life of survivors with Fontan circulation. Methods This retrospective monocentric study aimed patients who had follow-up after Fontan surgery at the University Hospital of Lille. Data were collected on medical records. The quality of life was evaluated between June and October 2014 by two scales: Paediatric Quality of Life Inventory TM (PedsQL) before 26 years of age and Medical Outcome Study Short Form 36 (MOS SF 36) after 26 years. Results Among 96 patients who underwent Fontan procedure, median follow-up was 9.6 (6.1-12.5) years after the last intervention. Nine-year global survival was 93%. 95% of patients had total cavo-pulmonary connection and 5% had atrio-pulmonary connection. Arrhythmia occurred in 27.1%, single ventricle dysfunction in 87.4%, leak of the atrio-ventricular valve in 58.9%. Protein-losing enteropathy affected 4.2% of patients and thromboembolic events appeared in 17.7%. Total score of quality of life was 66.5% according to the PedsQL and 62.5% to the MOS SF36. Conclusion This French cohort of survivors with Fontan circulation has the same initial characteristics than which described in the literature. The level of quality of life was comparable to general population. The question of global rehabilitation of these patients must be raised.

0152: Is amiodarone a safe and effective alternative drug in persistant fetal tachycardias?

Background Persistant fetal tachycardias, especially when complicated with hydrops, are associated with a poor prognosis. Digoxin and flecaine are usually used but not always effective. Amiodarone remains frequently a last choice of treatment because of its known complications. Aims In this retrospective study, we reviewed the use of amiodarone in patients with resistant fetal tachycardia, to determine the safety of this drug and its efficiency. Methods Between 1986 and 2012, sixteen pregnancies admitted for fetal tachycardia were treated with amiodarone. Four had atrial flutter and twelve had supra-ventricular tachycardia. The fetuses were severe: ten fetuses (63%) had hydrops. Amiodarone was never used as a first line therapy, but as a second line therapy in 6 fetuses and as a third line therapy in 6 fetuses. Results Amiodarone was effective in 10 of the 16 (63%) patients and despite the presence of hydrops (efficiency was obtained in 4/6 fetuses of the non hydropic group versus 6/10 of the hydrops group, p=NS). Among mothers, two complications were noticed: mild hypothyroidism and hepatic cytolysis. Hypothyroidism was present in three patients who did not need any substitutive treatment. Hepatic cytolysis was also present in three patients but never above three times normal level. Fetuses were born at 35.8±3.2 WA, weighed 2805±579g, and five of them required oral intubation at birth. One fetal death occured (sinusal rhythm was obtained but hydrops with ventricular dysfunction persisted and a ventricular thrombus appeared). Hypothyroidism was present in six patients: three had transient hypothyroidism that resolved in two weeks, two were treated for six months and one is still treated. All children had normal neurological development. Conclusion Persistant tachycardias complicated with hydrops remain a medical challenge. Amiodarone seems to be a safe and efficient alternative drug in this indication.

0355: Complications after transcatheter ASD closure with the amplatzer septal occluder

The aim of this study is to report complications of transcatheter ASD closure using the Amplatzer Septal Occluder (ASO) (St Jude Medical). From December 1999 to October 2013 (April 2014), 760 patients underwent ASD closure with the ASO. Closure was mostly performed under general anaesthesia and transoesophageal echocardiography control. Choice of the device diameter was established after balloon sizing and measurement of the stretched diameter. Mean age of the patients was 31.9±22 years (0.5 month - 84 years). The stretched diameter was 22.5±6.6 mm (5-40mm) and device dimension 22±6.7mm (4-40mm). Duration of the procedure was 41±15 minutes (10-120 minutes) and fluoroscopic time 7.63±6.65 minutes (1-92 minutes). Dose of radiation was 18.7±22 Gy.cm2 (median 12 Gy.cm2). Implantation succeeded in 96.3% of pts and failure was mainly related to deficient rim. No device related death was noticed. Embolization occurred in 4 pts (0.5%): 1 in the aorta, 1 in the left ventricle, and 2 in the pulmonary artery. All but one underwent surgical extraction and ASD closure. The patient with aortic embolization had percutaneous device extraction and underwent subsequently successful implantation with a larger device. No patient required blood transfusion for any groin hematoma. One patient without aortic rim had hemopericardium one month after implantation; this was corrected by drainage with no recurrence and ASD full occlusion was noticed on colour Doppler control. No late complication was observed. The rate of full occlusion on Doppler control is more than 90%, and the remainings have trivial shunt. Transcatheter ASD occlusion with the Amplatzer Septal Occluder is a safe and effective procedure. The rate of immediate complication is very low and need for immediate surgery following the implantation is rare (

CO 3 Effects and risks of beta-blocker in infantile haemangioma: A retrospective analysis

Introduction Infantile haemangioma (IH) is a very common vascular tumour that affects up to 10% of newborns. Since 2008, oral propranolol is used to treat complicated IH, like haemangioma that obstruct vital structures or ulcerated haemangioma. Objective The aim of this study was to investigate, by a retrospective review, the therapeutic results and effects of propranolol on cardiovascular and biological parameters in infants treated for complicated infantile haemangioma and to assess its safety. Results All paediatric patients with complicated IH who started systemic propranolol from February 2009 to December 2014 were included. 218 patients (155 girls and 63 boys) were treated by propranolol. The mean weight was 6780g (2115g to 20000g). Median age at beginning of treatment was 4.7 months (10 days to 6 years). The most frequent localisation of IH was facial (63 patients), palpebral (52 patients), perineal (20 patients), labial (14 patients), airway obstruction (8 patients) and 1 PHACE syndrome. Median length of therapy was 7.5 months for facial IH, 6 months for palpebral, 5.6 months for perineal IH and 7 months for subglottic localisation. Adverse events were observed: hypoglycemia (n=11 patients aged less 6 months), arterial hypotension (n=103 patients, especially at the second and third dose with dose titration), bradycardia (n=120). Transthoracic echocardiography was realised in 158 patients: 19 pathologies were found (8 PDA, 4 ASD, 4 mitral regurgitations, 2 VSD and 1 coarctation). Other adverse events occurred in 49 patients (wheezing, acrocyanosis, diarrhoea, sleep disturbance) leading to modification in management. Complete response was observed for all but 11 (partial or no response). Conclusion In appropriated patients, propranolol therapy is effective for severe or complicated IH. We must be aware of frequent adverse events under beta-blocker in these patients.