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Abstract:

Introduction: half-year data on results of using new domestic NanoMed devices for closing atrial septal defects (ASD) were obtained. The occluder is a nitinol self-expanding and self-centering double disc device with a polyester membrane.

Aim: was to evaluate the safety and efficacy of a new domestic occluder for closing of atrial septal defect in a small group of patients over a 6-month follow-up period.

Material and methods: four pediatric patients underwent closure of atrial septal defects with domestic NanoMed occluders. Clinical examination and transthoracic echocardiography were performed at 24 hours, 1, 3, and 6 months. Endpoints included technical success of intervention, efficacy and safety of the procedure at follow-up instrumentation and physical examination.

Results: the average age of patients was 5,2 years (range 4 to 7 years). Mean ASD diameters and device waist sizes were 11,9 ± 1,2 mm and 13,7 ± 1,2 mm and 13,7 ± 1,2 mm, respectively. Technical and procedural success achieved in 100% of cases. During the six-month follow-up, no adverse events and residual flows were identified.

Conclusion: initial half-year data on the absence of adverse events and residual flows indicate the safety and effectiveness of the use of NanoMed occluders.


References

1.     Stout K, Daniels C, Aboulhosn J, et al. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019; 73(12): 1494-1563.

https://doi.org/10.1016/j.jacc.2018.08.1028

2.     Pettersen MD, Du W, Skeens ME, Humes RA. Regression equations for calculation of z scores of cardiac structures in a large cohort of healthy infants, children, and adolescents: an echocardiographic study. Journal of the American Society of Echocardiography. 2008; 21(8): 922-934.

https://doi.org/10.1016/j.echo.2008.02.006

3.     Gillespie MJ, Javois AJ, Moore P, et al. Use of the GORE CARDIOFORM septal occluder for percutaneous closure of secundum atrial septal defects: results of the multicenter U.S. IDE trial. Catheterization and Cardiovascular Interventions. 2020; 95(7): 1296-1304.

https://doi.org/10.1002/ccd.28814

4.     Sharifi M, Burks J. Efficacy of clopidogrel in the treatment of post-ASD closure migraines. Catheter Cardiovasc Interv. 2004; 63: 255.

https://doi.org/10.1002/ccd.20144

 

Abstract:

Currently, endovascular correction has become the method of choice in most cases of secondary atrial septal defects.

The obvious superiority lies in low trauma, a decrease in the incidence of early complications, atrial flutter and fibrillation, systemic thromboembolism, ischemic stroke, and all-cause mortality.

We present the initial experience of using new occluders for ASD closure.

 

References

1.     Warnes CA, Williams RG, Bashore TM, et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: a report of the American College of Cardiology/American heart association task force on practice guidelines (Writing committee to develop guidelines on the management of adults with congenital heart disease). Developed in collaboration with the American society of echocardiography, heart rhythm society, international society for adult congenital heart disease, society for cardiovascular angiography and interventions, and society of thoracic surgeons. J Am Coll Cardiol. 2008; 52: 143-263.

2.     King TD, Thompson SL, Steiner C, et al. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA. 1976; 235: 2506-2509.

3.     Alexi-Meskishvili VV, Konstantinov IE. Surgery for atrial septal defect: from the first experiments to clinical practice. Ann Thorac Surg. 2003; 76: 322-327.

4.     Nassif М, Abdelghani М, Bouma J, et al. Historical developments of atrial septal defect closure devices: what we learn from the past. Expert Review of Medical Devices. 2016; 13(6).

5.     Регистрационное удостоверение на медицинское изделие от 30 марта 2020 года № РЗН 2020/9850: «Окклюдер кардиологический «NanoMed» по НАЕФ.942511.015 ТУ.

Registration certificate for medical device, March 30, 2020 No. RZN 2020/9850: «NanoMed cardiological occluder» ac. to NAEF.942511.015 [In Russ].

6.     Базылев В.В., Шматков М.Г., Пьянзин А.И., Морозов З.А. «Отдаленные результаты применения отечественных коронарных стентов с биоинертным углеродным покрытием «Наномед». Журнал Диагностическая и интервенционная радиология. 2020; 14(1); 47-54.

Bazylev VV, Shmatkov MG, Pianzin AI, Morozov ZA. Long-term results of using domestic coronary stents with bioinert carbon coating, «Nanomed». Journal Diagnostic & interventional radiology. 2020; 14(1); 47-54 [In Russ].

https://doi.org/10.25512/DIR.2020.14.1.05

7.     Базылев В.В., Шматков М.Г., Морозов З.А. «Сравнительные результаты использования коронарных стентов с лекарственным покрытием «НаноМед» и Orsiro. Журнал Диагностическая и интервенционная радиология. 2019; 13(4); 21-26.

Bazylev VV, Shmatkov MG, Morozov ZA. Comparison of results of the use of coronary stents with drug eluting, «Nanomed» and Orsiro. Journal Diagnostic & interventional radiology. 2019; 13(4); 21-26 [In Russ].

https://doi.org/10.25512/DIR.2019.13.4.02

8.     Majunke N, Sievert H. ASD/PFO devices: what is in the pipeline? J Interv Cardiol. 2007; 20: 517-523.

9.     Aytemir K, Oto A, Ozkutlu S, et al. Early-midterm follow-up results of percutaneous closure of the interatrial septal defects with occlutech figulla devices: a single center experience. J Interv Cardiol. 2012; 25: 375-381.

10.   Haas NA, Happel CM, Soetemann DB, et al. Optimal septum alignment of the Figulla(R) Flex occluder to the atrial septum in patients with secundum atrial septal defects. EuroIntervention. 2016: 11(10):1153-60.

https://doi.org/10.4244/EIJY14M12_09

11.   Roymanee S, Promphan W, Tonklang N, et al. Comparison of the Occlutech (R) Figulla (R) septal occluder and Amplatzer (R) septal occluder for atrial septal defect device closure. Pediatr Cardiol. 2015; 36: 935-941.

12.   Sharifi M, Burks J. Efficacy of clopidogrel in the treatment of post-ASD closure migraines. Catheter Cardiovasc Interv. 2004; 63: 255.

 

Abstract:

Background: atrial septal defect (ASD) is characterized by a progressive increase in pulmonary vascular resistance and, accordingly, pressure in small circulation circle. It is noteworthy that these hemodynamic changes go in parallel with morphofunctional changes in small vessels of pulmonary artery system. At the same time, changes in hemodynamics of small circulatory circulation after endovascular closure in this category of patients and reversibility of pulmonary hypertension are not fully studied.

Aim: was to assess clinical course, indicators of cardiac chamber geometry and hemodynamics of small circulation circle after transcatheter closure of secondary ASD in adult patients with moderate and significant pulmonary hypertension in immediate and long-term periods.

Material and methods: from 2009 to 2020, 103 patients (mean age 48,3 ± 15,3 years) with secondary ASD underwent endovascular transcatheter closure of the defect. 60 (58,3%) patients had pulmonary hypertension. Depending on systolic pulmonary arterial pressure (SPAP), patients were divided into 3 groups: the first group consisted of 41 (68,3%) patients with mild PH (from 40 to 49 mm Hg); the second group included 10 (16,6%) patients with moderate PH (50 to 59 Hg); and the third group consisted of 9 (15%) patients with high SPAP (? 60 mm Hg). Average pulmonary artery systolic pressure in groups was: 43,6 ± 2,9 mm Hg; 52,1 ± 2,5 mm Hg; 64,4 ± 5,2 mm Hg, respectively. Average sizes of ASD (according to Pre-TEE data) were 18,7 + 6,1 mm; 22,1 ± 7,5 mm and 21,3 ± 5,3 mm, respectively. In all cases, echocardiographic signs of the right heart volume overload were detected. Follow-up was performed on an outpatient basis with an assessment of the clinical status and TTE in the long-term period.

Results: technical success of endovascular defect closure was 100%. Average size of the occluder was 26,3 + 6,96 (from 12 to 40) mm. Immediately after implantation of device, complete closure of ASD was observed in 55 (91,7%) cases. Residual flow (<3 mm) was observed in 5 cases (2 cases in the first group, 1 case in second group, and 2 cases in third group, (p >0,05)). In the vast majority of cases - 54 (90%) hospital period proceeded smoothly. All patients were examined in the long-term period (on average 12,5 + 6,5 months). The survival rate in groups was 100%. In the long- term follow-up remodeling of the right heart was observed in all patients. In the first group the size of RA decreased from 6,0 ± 0,5 cm to 3,3 ± 0,4 cm, RV size decreased from 4,7 ± 0,5 to 3,1 ± 0,4 cm; in the second group RA from 5,7 ± 0,7 cm to 3,8 ± 0,5 cm, RV - from 4,7 ± 0,9 to 3,8 ± 0,6 cm; in the third group RA - from 5,5 ± 0,6 cm and 4,2 ± 0,5 cm, the size of RV decreased from 4,5 ± 0,6 4,0 ± 0,5 cm, respectively. In all patients, significant decrease in SPAP was observed, in some cases up to normalization. In the first group, SPAP decreased from 43,7 ± 2,9 to 32,1 ± 2,6 mmHg, in the second group - from 52,1 ± 2,5 to 34,3 ± 2,6 mmHg; in the third group - from 64,4 ± 5,2 to 50,3 ± 4,8 mmHg. The most expressed decrease of pressure occurred in the second group of patients. At the same time, in the third group, dynamics of pressure reduction was significantly less expressed in comparison with the other two groups. At the same time in two patients of third group high PH remained in the long-term period, despite the successful closure of the defect.

Conclusion: results show that in case of left-right shunt in the absence of hypoxemia, transcatheter closure of ASD in adult patients with moderate and significant pulmonary hypertension is a pathophysiologically and clinically justified, is a highly effective treatment method that allows achieving significant improvement of both clinical manifestations and intracardiac and systemic hemodynamics. In patients with a significant degree of pulmonary hypertension and a high probability of the latter, the following tactical approaches may be considered:

1. primary closure of defect with further drug therapy;

2. primary drug therapy aimed on regulating of the anatomic-functional state of the arterial bed of the small circulation and hence reducing pulmonary vascular resistance followed by endovascular ASD-closure;

3. closure of the defect with a fenestrated occluder (in case of a negative test for temporary balloon occlusion), followed by drug therapy. This assumption can be considered in future research.

 

References

1.     Jain S, Dalvi B. Atrial septal defect with pulmonary hypertension: when/how can we consider closure? J Thorac Dis. 2018; 10(24): 2890-2898.

2.     Fraisse, et al. Atrial Septal Defect Closure: Indications and Contra-Indications. J Thorac Dis. 2018; 10(24): 2874-2881.

3.     Akagi T. Current concept of transcatheter closure of atrial septal defect in adults. J Cardiol. 2015; 65(1): 17-25.

4.     Kefer J. Percutaneous Transcatheter Closure of Interatrial Septal Defect in Adults: Procedural Outcome and Long-Term Results. Catheter Cardiovasc Interv. 2012; 79(2): 322-30.

5.     Gruner C, Akkaya E, Kretschmar O, et al. Pharmacologic preconditioning therapy prior to atrial septal defect closure in patients at high risk for acute pulmonary edema. J Interv Cardiol. 2012; 25: 505-12.

6.     Abaci A, Unlu S, Alsancak Y, et al. Short- and long-term complications of device closure of atrial septal defect and patent foramen ovale: metaanalysis of 28,142 patients from 203 studies. Catheter Cardiovasc Interv. 2013; 82(7): 1123-1138.

7.     Humenberger M, Rosenhek R, Gabriel H, et al. Benefit of atrial septal defect closure in adults: impact of age. Eur Heart J. 2011; 32: 553-560.

8.     Ioseliani DG, Kovalchuk IA, Rafaeli TR, et al. Simultaneous Percutaneous Coronary Intervention and Endovascular Closure of Atrial Septal Defect in Adults. Kardiologia. 2019; 59(2): 56-60 [In Russ].

9.     Correction to: 2018 AHA/ACC Guideline for the Management of Adults with Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019; 139(14): 833-834.

10.   Gali? N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016; 37(1): 67-119.

11.   Haas NA, Soetemann DB, Ates I, et al. Closure of secundum atrial septal defects by using the occlutech occluder devices in more than 1300 patients: the IRFACODE project: a retrospective case series. Catheter Cardiovasc Interv. 2016; 88: 71-81.

12.   Nakahawa K, Akagi T, Taniguchi M, et al. Transcatheter closure of atrial septal defect in a geriatric population. Catheter Cardiovasc Interv. 2012.

13.   Marwick TH, Gillebert TC, Aurigemma G, et al. Recommendations on the Use of Echocardiography in Adult Hypertension: A Report from the European Association of Cardiovascular Imaging (EACVI) and the American Society of Echocardiography (ASE). J Am Soc Echocardiogr. 2015; 28(7): 727-754.

14.   Galderisi M, Cosyns B, Edvardsen T, et al. Standardization of adult transthoracic echocardiography reporting in agreement with recent chamber quantification, diastolic function, and heart valve disease recommendations: an expert consensus document of the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2017; 18(12): 1301-1310.

15.   Bossone E, D'Andrea A, D'Alto M, et al. Echocardiography in pulmonary arterial hypertension: from diagnosis to prognosis. J Am Soc Echocardiogr. 2013; 26(1): 1-14.

16.   Miranda WR, Hagler DJ, Reeder GS, et al. Temporary balloon occlusion of atrial septal defects in suspected or documented left ventricular diastolic dysfunction: Hemodynamic and clinical findings. Catheter Cardiovasc Interv. 2019; 93(6): 1069-1075.

17.   Shin C, Kim J, Kim J-Y, et al. Determinants of serial left ventricular diastolic functional change after device closure of atrial septal defect. JACC. 2020; 75(11).

18.   Martin-Garcia AC, Dimopoulos K, Boutsikou M, et al. Tricuspid regurgitation severity after atrial septal defect closure or pulmonic valve replacement. Heart. 2020; 106(6): 455-461.

19.   Zwijnenburg RD, Baggen VJM, Witsenburg M, et al. Risk Factors for Pulmonary Hypertension in Adults After Atrial Septal Defect Closure. Am J Cardiol. 2019; 123(8): 1336-1342.

 

Abstract:

Introduction: pulmonary arterial hypertension (PAH) is a pathophysiological syndrome that can occur in a variety of clinical conditions. Percutaneous balloon dilatation and stent implantation are methods for creating or expanding atrial communication in a variety of conditions to improve cardiac output. It should be kept in mind that creation of an inadequate size of the shunt leads to an excess of right-left shunt, worsening of pulmonary blood flow, severe hypoxemia, and acute left ventricular failure. Possibility of a calculated determination of required size of shunt in the interatrial septum will increase the effectiveness and safety of atrioseptostomy, which is especially important in this severe category of patients.

Aim: to substantiate a method of determining of optimal diameter of the atrial communication during atrioseptostomy in patients with PAH for increase of exercise tolerance, prevention of syncope and reducing the risk of sudden death.

Materials and methods: the choice of the diameter of the interatrial communication during atrioseptostomy operation in patients with PAH is as follows: before the operation, patient undergoes an invasive measurement of pressure in right and left atrium and determination of stroke volume of left ventricle. Then calculation the diameter of the interatrial communication according to the formula is performed. We performed calculation according to presented formula in 4 patients with PAH. In 2 patients, a fenestrated occluder was implanted, in 1 patient atrial septum stenting was performed, and 1 patient underwent open atrioseptostomy.

Results: in all patients after atrioseptostomy, an improvement in quality of life was observed: decreased dyspnea, increased exercise tolerance, decreased edema of lower limbs, and the absence of syncopal conditions. Thus, after the operation, there was a positive dynamics in clinical status of patients, indicators of test with a six-minute walk, as well as changes in echocardiographic indicators: a decrease in the size of the right ventricle and square area of right atrium, an increase in the end-diastolic size of the left ventricle, which indicates an improvement in function of both ventricles.

Conclusion: a mathematical model based on principles of intracardiac hemodynamics, demonstrates the importance of choosing of size of foramen to create a certain Qp/Qs. Size of foramen, depending on the pressure in atrium, in conditions of high pulmonary hypertension has a small range of values (from 6 to 8 mm). Therefore, the use of the 7 mm size, previously obtained empirically by other authors, is physically justified. Our first experience testifies to applicability of the developed model, but due to the small number of observations associated with the rarity of the pathology, it requires further research.

  

Referenses 

1.     Micheletti A, Hislop AA, Lammers A, et al. Role of atrial septostomy in the treatment of children with pulmonary arterial hypertension. Heart. 2006; 92: 969-72.

http://doi.org/10.1136/hrt.2005.077669

2.     Baglini R, Scardulla C., Reduction of a previous atrial septostomy in a patient with end-stage pulmonary hypertension by a manually fenestrated device. Cardiovasc Revasc Med. 2010; 11(4).

http://doi.org/10.1016/j.carrev.2009.11.005

3.     St?mper O, Gewillig M, Vettukattil J, et al. Modified technique of stent fenestration of the atrial septum. Heart. 2003; 89: 1227-30.

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7.     Alekyan BG, Gorbachevskiy SV, Pursanov MG, et al. Atrial septal stenting with idiopathic pulmonary hypertension. AN Bakulev National Medical Research Center of Cardiovascular Surgery. Thoracic and Cardiovascular Surgery. 2016; 58(5): 258-314 [In Russ].

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11.   Lammers AE, Derrick G, Haworth SG, et al. Efficacy and long-term patency of fenestrated Amplatzer devices in children. Cathet. Cardiovasc. Interv. 2007; 70(4): 578-84.

http://doi.org/10.1002/ccd.21216

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14.   Hirsch R, Bagby MC, Zussman ME. Fenestrated ASD closure in a child with idiopathic pulmonary hypertension and exercise desaturation. Congenit Heart Dis. 2011; 6(2): 162-166.

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http://doi.org/10.1378/chest.06-1227

16.   Patel MB, Samuel BP, Girgis RE, et al. Implantable atrial flow regulator for severe, irreversible pulmonary arterial hypertension. EuroIntervention. 2015; 11(6): 706-709.

http://doi.org/10.4244/EIJY15M07_08

17.   Kapoor A, Khanna R, Batra A, et al. Inoue balloon atrial septostomy in severe persistent pulmonary hypertension following surgical ASD closure. J Cardiol Cases. 2012; 6(1): 1-3.

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http://doi.org/10.1002/ccd.27233

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http://doi.org/10.1016/j.carrev.2009.11.005

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Abstract:

The aim of the study was to assess the powers of complex ultrasonography in different stages of endovascular closure of atrial septal defects (ASD). 31 patients 13-56 years old (mean age 23,65 ±5,2 years) with septal defects were included into the study. Ultrasound (US) monitoring performed during the procedure of endovascular closure, and as a follow-up. There were prevalence (35,4%) of the patients with central ASD with rims of 5 mm and more. Abcence of anterio-superior or aortic rim, or its deficiency, noted in 19,2% of cases. Patent foramen ovale (PFO) registered in 25,81% of patients. Incidence of multiple ASDs and ASD in aneurysm occurred to be similar and was as high as 9,67%. In 2 cases of multiple ASDs, and 2 cases of PFO, transseptal puncture was used as an approach to left atrium, for the reason of complex anatomy of the septum. After the closure, transthoracic US showed reliable decrease of the right atrium, right ventricle, and pulmonary artery (PA) size. The majority of patients (64%) showed normalization of PA pressure and left ventricle enlargement in a week after the procedure. Two-dimensional echocardiography (EchoCG) with color Doppler mapping (CDM) is the key method for ASD imaging and assessing its suitability for endovascular closure. Transesophageal EchoCG can help in verification of the ASD anatomy and refinement of the ASD rims. Ultrasound guidance during the procedure of endovascular closure allows optimal positioning of the device, immediate assessment of the homodynamic effects, and timely diagnosis of complications.

 

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Abstract:

199 patients with ASD were included in the study. In 102 cases ASD was closed with Amplatzer system and in 97 cases cardiac surgery was performed. Analysis and comparison of ASD correction results (both short- and long-term) have been done, according to patient's age and type of ASD.

 

 

Reference 

 

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2.     Мутафьян О.А. Врожденные пороки сердца удетей. Санкт-Петербург: «Невский диалект». 2002; 331.

3.     Бокерия Л.А. Минимально инвазивная хирургия сердца: состояние проблемы и возможные перспективы. Мат. всероссийской конференции «Минимально инвазивная хирургия сердца и сосудов». 1997.

4.     Алекян Б.Г., Машура И., Пурсанов М.Г. и др. Первый в России опыт закрытия дефектов межпредсердной перегородки с использоанием «Amplatzer Septal Occluder». Мат. международного симпозиума. «Минимально инвазивная хирургия сердца и сосудов». 1998; 23.

5.     Бураковский В.П., Бухарин В.А., Подзолков В.П. и др. Врожденные пороки сердца. В кн.: Сердечно сосудистая хирургия. Под ред. В.И. Бураковского, Л.А. Бокерия. М.: Медицина. 1996; 768.

6.     Усупбаева Д.А. и др. Ремоделирование сердца после транскатетерного закрытия вторичного межпредсердного дефекта системой Amplatzer. Терапевтический архив. 2006; 6.

7.     Усупбаева Д.А. и др. Двухмерная эхокардиоскопия в транскатетерном закрытии вторичного межпредсердного дефекта окклюдером Амплатца. Ультразвуковая и функциональная диагностика. 2005; 4: 74-81.

8.     Chan К.С, Godman MJ. Morphologic a variations of fossa ovalis atrial septal defects (secundum): feasibility for transcutaneous closure with the clamshell device. Br. Heart J. 1993; 69 (1): 52-55.

 

 

 

Abstract:

This case report is about endovascular treatment of pulmonary arteriovenous malformations accompanied by severe arterial hypoxemia in the newborn. The peculiarity of this case is the extreme rarity of manifestation and successful treatment of the pathology in infancy The second feature was the use of vascular occlude devices. Currently due to the sporadic clinical observations in newborn, we consider to appropriate description of this case, focusing on the technical aspects of the intervention. 

 

References

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15.   Белозеров Ю.М., Детская кардиология. М.: Медпрессинформ. 2004;167-180. Belozerov Ju. M., Detskaja kardiologija [Pediatrics cardiology]. M.: Med-pressinform. 2004;167-180 [In Russ]. 

 

 

Abstract:

Endovascular correction of atrial septal defect (ASD) has become the «gold standard» of treatment, both in children and adults. In case of complicated anatomy of the defect (multiple defects, its large size, lack of edges, aneurysm of atrial septum), experts often chose surgical correction of such pathology Accumulated experience of interventional cardiology and appearance of specialized tools allow to perform a successful intervention in a non-standart situation.

Article describes cases of a successful endovascular correction of ASD in a two year child and adult patient with complicated anatomy factors. In both cases, during echocardiography, we diagnosed multiple ASD with aneurysm of atrial septum, accompanied by clinical symptoms. During multidisciplinary discussions, we identified indication for endovascular correction of the defect.

We performed successfull correction of ASD with occluder for closure of patent foramen ovale, and complete termination of left-to-right shunt on the operating table.

 

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