scholarly journals Preliminary Experience With the New Amplatzer™ Trevisio™ Delivery System in Transcatheter Atrial Septal Defect Closures in Children

2021 ◽  
Vol 9 ◽  
Author(s):  
Raymond N. Haddad ◽  
Diala Khraiche ◽  
Damien Bonnet ◽  
Mathilde Meot ◽  
Sophie Malekzadeh-Milani

Objectives: To evaluate safety, efficacy, and technical advantages of Amplatzer™ Trevisio™ intravascular delivery system (ATIDS) in percutaneous atrial septal defect (ASD) closure in children.Background: The Trevisio™ is a novel delivery system designed for accurate and facilitated implantation of Amplatzer™ devices. There are no published clinical reports so far.Methods: During September 2020, 9 children with anatomically challenging ASDs underwent attempted transcatheter closure using ATIDS to deliver Amplatzer™ Septal occluders (ASO). All interventions were performed under general anesthesia, trans-esophageal echocardiography (TOE), and fluoroscopic guidance. Standard safety, immediate, and 60-days outcomes were prospectively assessed.Results: The median age was 8.1 (5.1–16.9) years and the median bodyweight was 30 (18–63) kg. Six patients had isolated secundum-type ASDs with absent anterosuperior rims including one with an aneurysmal septum. Three patients had unclassical defects associated with complex congenital heart anomalies. Eight devices were delivered from the femoral vein and the jugular vein was accessed in one patient with interrupted inferior caval vein and azygos continuation. All implantations were successful. The shape, position, and orientation of the ASO were identical before and after release on TOE and fluoroscopy. There was no device embolization or serious complication following closure. Complete shunt closure was confirmed on follow-up.Conclusions: We report the first clinical experience with ATIDS in transcatheter ASD pediatric closures. Safety and efficacy were witnessed in our case-series. The major advantage of reduced-tension deployment and reliable precision in device positioning is highly beneficial in challenging anatomies and unusual access.

2020 ◽  
Vol 29 (158) ◽  
pp. 200099
Author(s):  
Selai Akseer ◽  
Eric Horlick ◽  
Varnita Vishwanath ◽  
Benjamin Hobbes ◽  
Ella Huszti ◽  
...  

BackgroundAtrial septal defect (ASD) is a common form of congenital heart disease. Significant shunts may increase the risk of developing pulmonary hypertension (PH). We aimed to describe current PH definitions, evaluate PH prevalence and the effect of PH on outcomes in patients undergoing percutaneous ASD closure.MethodsEMBASE, MEDLINE and Cochrane databases were systematically searched. Studies reporting PH prevalence or mean systolic pulmonary arterial pressure (sPAP) before and after percutaneous ASD closure in adults were included. We conducted meta-analyses to obtain summary estimates for PH prevalence and mean sPAP.Results15 articles with a total of 1073 patients met the eligibility criteria. Studies applied variable PH definitions. PH prevalence and mean sPAP levels decreased in all studies after closure. The pooled PH prevalence decreased from 44% (95% CI 29–60%) to 18% (95% CI 8–27%). The overall standardised mean difference in sPAP was 1.12 (95% CI 0.81–1.44) and 1.62 (95% CI 1.00–2.23) in cohort and case-series studies respectively indicating a large decrease. The pooled standard mean difference among the younger and older patients were different, 1.25 (95% CI 0.78–1.71) and 0.91 (95% CI 0.56–1.27), respectively. A high degree of between-study heterogeneity was noted.ConclusionsBoth PH prevalence and mean sPAP decrease after ASD closure. Larger, prospective studies with consistent PH definitions using the recommended measurement modality are warranted.


2020 ◽  
Vol 2020 ◽  
pp. 1-5
Author(s):  
R. J. R. Snijder ◽  
L. E. Renes ◽  
D. Bosshardt ◽  
M. J. Suttorp ◽  
J. M. ten Berg ◽  
...  

Purpose. The Occlutech Figulla occluder has been proven safe and effective at midterm follow-up after percutaneous atrial septal defect (ASD) closure. We describe the safety and efficacy at long-term follow-up in adults. Methods. All consecutive adult patients that underwent ASD closure between 2008 and 2015 were included. All complications were registered. Residual left-to-right shunt (LRS) was diagnosed using color-Doppler transthoracic echocardiography (TTE). Right-to-left shunting was diagnosed using contrast TTE. Successful closure was defined as no LRS at follow-up. Results. In total, 166 patients (mean age 56.7 ± 16.1 years; 62% female) underwent percutaneous ASD closure using the Occlutech Flex I (70%) or Flex II (30%) device (diameter 24 mm; range 10–40 mm) under general anaesthesia and transoesophageal echocardiographic guidance. Long-term follow-up data were available for 144 patients (87%) with a mean follow-up of 5.9 ± 2.6 years, a total of 814 patient-years. During hospitalization, device embolization occurred in three patients (1.8%) with successful extraction in all. During the long-term follow-up, 15 patients (9.8%) suffered new-onset atrial fibrillation and stroke occurred in 2.1%. There was no residual LRS at 12-month follow-up. No device embolization occurred during the long-term follow-up. Conclusion. Percutaneous ASD closure using the Occlutech device appears to be safe at long-term follow-up with a high successful closure rate at one year.


2013 ◽  
Vol 16 (5) ◽  
pp. E274-E275
Author(s):  
Hakan Vural ◽  
Tahsin Bozat ◽  
Derih Ay ◽  
M. Çağdaş Çayir ◽  
Arif Gücü ◽  
...  

Atrial septal defect (ASD) closure using a percutaneous transcatheter device is used as an alternative to surgery. Various devices are increasingly used in clinical practice, and various types and models of septal occluder devices are available. The Amplatzer device (Amplatzer Medical, Golden Valley, MN, USA) is one with increasing popularity.We report a case of attempted percutaneous transcatheter closure of a large ASD in a 14-year-old girl, complicated by total device embolization to the right ventricle necessitating emergency surgery.


2005 ◽  
Vol 8 (2) ◽  
pp. 96 ◽  
Author(s):  
Osman Tansel Dar�in ◽  
Alper Sami Kunt ◽  
Mehmet Halit Andac

Background: Although various synthetic materials and pericardium have been used for atrial septal defect (ASD) closure, investigators are continuing to search for an ideal material for this procedure. We report and evaluate a case in which autologous right atrial wall tissue was used for ASD closure. Case: In this case, we closed a secundum ASD of a 22-year-old woman who also had right atrial enlargement due to the defect. After establishing standard bicaval cannulation and total cardiopulmonary bypass, we opened the right atrium with an oblique incision in a superior position to a standard incision. After examining the secundum ASD, we created a flap on the inferior rim of the atrial wall. A stay suture was stitched between the tip of the flap and the superior rim of the defect, and suturing was continued in a clockwise direction thereafter. Considering the size and shape of the defect, we incised the inferior attachment of the flap, and suturing was completed. Remnants of the flap on the inferior rim were resected, and the right atrium was closed in a similar fashion. Results: During an echocardiographic examination, neither a residual shunt nor perigraft thrombosis was seen on the interatrial septum. The patient was discharged with complete recovery. Conclusion: Autologous right atrial patch is an ideal material for ASD closure, especially in patients having a large right atrium. A complete coaptation was achieved because of the muscular nature of the right atrial tissue and its thickness, which is a closer match to the atrial septum than other materials.


2016 ◽  
Vol 19 (3) ◽  
pp. 145 ◽  
Author(s):  
Young Hwa Kong ◽  
Jinyoung Song ◽  
Kyung Hee Kim ◽  
June Huh ◽  
I-Seok Kang

<strong>Background:</strong> Acute changes in left ventricular diastolic function shortly after ASD closure in elderly patients have not been well known. We aimed to investigate acute changes in left ventricular end diastolic pressure (LVEDP) in elderly patients following transcatheter closure of atrial septal defect (ASD). <br /><strong>Methods:</strong> All 19 adults with ASDs who underwent transcatheter closure between June 2013 and December 2014 were enrolled. LVEDP was measured prior to device closure and compared with that immediately following device closure and 15 minutes after device closure. <br /><strong>Results:</strong> The median age of the patients was 48 years old. The baseline E/e’ and LVEDP values were 8.3 ± 2.8 and 13 ± 3 mmHg. The LVEDP value immediately following closure was 19 ± 4 mmHg, and 15 minutes after closure was 16 ± 4 mmHg. The median increase in the LVEDP value immediately following closure was 6 mmHg, which significantly differed from that prior to closure. The LVEDP 15 minutes after closure decreased but remained significantly higher than the value observed immediately after closure. No significant changes were observed with regard to E/e’ at either 1 day or 3 months following closure. The LVEDP value <br />15 minutes after device closure was significantly correlated with those observed before closure and immediately following closure; however, no significant correlations were observed with regard to patient age, Qp/Qs, E/e’ before closure, or E/e’ 3 months after device closure.<br /><strong>Conclusion:</strong> LVEDP in adults with ASDs significantly increases following device closure. LVEDP before closure predicts LVEDP following device closure.


2012 ◽  
Vol 15 (2) ◽  
pp. 111 ◽  
Author(s):  
Yang Hyun Cho ◽  
Tae-Gook Jun ◽  
Ji-Hyuk Yang ◽  
Pyo Won Park ◽  
June Huh ◽  
...  

The aim of the study was to review our experience with atrial septal defect (ASD) closure with a fenestrated patch in patients with severe pulmonary hypertension. Between July 2004 and February 2009, 16 patients with isolated ASD underwent closure with a fenestrated patch. All patients had a secundum type ASD and severe pulmonary hypertension. Patients ranged in age from 6 to 57 years (mean � SD, 34.9 � 13.5 years). The follow-up period was 9 to 59 months (mean, 34.5 � 13.1 months). The ranges of preoperative systolic and pulmonary arterial pressures were 63 to 119 mm Hg (mean, 83.8 � 13.9 mm Hg) and 37 to 77 mm Hg (mean, 51.1 � 10.1 mm Hg). The ranges of preoperative values for the ratio of the pulmonary flow to the systemic flow and for pulmonary arterial resistance were 1.1 to 2.7 (mean, 1.95 � 0.5) and 3.9 to 16.7 Wood units (mean, 9.8 � 2.9 Wood units), respectively. There was no early or late mortality. Tricuspid annuloplasty was performed in 14 patients (87.5%). The peak tricuspid regurgitation gradient and the ratio of the systolic pulmonary artery pressure to the systemic arterial pressure were decreased in all patients. The New York Heart Association class and the grade of tricuspid regurgitation were improved in 13 patients (81.2%) and 15 patients (93.7%), respectively. ASD closure in patients with severe pulmonary hypertension can be performed safely if we create fenestration. Tricuspid annuloplasty and a Cox maze procedure may improve the clinical result. Close observation and follow-up will be needed to validate the long-term benefits.


Author(s):  
Yusuke Enta ◽  
Shunsuke Tatebe ◽  
Yoshikatsu Saiki ◽  
Norio Tada

Without the femoral venous approach, transcatheter closure of an atrial septal defect is challenging. We performed percutaneous closure via the left subclavian vein in a patient with absence of the inferior vena cava with azygos continuation. Considering that inferior vena cava anomalies are not extremely rare among those with congenital heart disease, the left subclavian vein approach can be an alternative to the femoral approach.


Author(s):  
Gerard M. Guiraudon ◽  
Douglas L. Jones ◽  
Daniel Bainbridge ◽  
John T. Moore ◽  
Chris Wedlake ◽  
...  

Objective Optimal atrial septal defect (ASD) closure should combine off-pump techniques with the effectiveness and versatility of open-heart techniques. We report our experience with off-pump ASD closure using the Universal Cardiac Introducer (UCI) in a porcine model. The goal was to create an ASD over the fossa ovale (FO) and position a patch over the ASD under ultrasound (US) imaging and augmented virtual reality guidance. Methods An US probe (tracked with a magnetic tracking system) was positioned into the esophagus (transesophageal echocardiographic probe) for real-time image-guidance. The right atrium (RA) of six pigs was exposed via a right lateral thoracotomy or medial sternotomy. The UCI was attached to the RA wall. A punching tool was introduced via the UCI, navigated and positioned, under US guidance, to create an ASD into the FO. A patch with its holder and a stapling device were introduced into the RA via the UCI. The patch was positioned on the ASD. Occlusion of the ASD was determined using US and Doppler imaging. Results The FO membrane was excised successfully in all animals. US image-guidance provided excellent visualization. The patch was positioned in all cases with complete occlusion of the ASD. The stapling device proved too bulky, impeding circumferential positioning. Conclusions Using the UCI, ASD closure was safe and feasible. US imaging, combined with virtual and augmented reality provided accurate navigating and positioning. This study also provided valuable information on the future design of anchoring devices for intracardiac procedures.


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