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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:

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.

 

Reference

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14.   Carlson K.M., Justino H., O'Brien R.E.,Dimas V.V., Leonard G.T., Pignatelli R.H.,Mullins C.E., Smith E.O., Grifka R.G.Transcatheter atrial septal defect closure:modified balloon sizing technique to avoid     18.overstretching the defect and oversizing theAmplatzer septal occluder. Catheter.Cardiovasc. Interv. 2005; 66 (3): 390-396.

15.   Chen C.Y., Lee C.H., Yang M.W., Chung H.T., Hsieh I.C., Ho A.C. Usefulness of transesophageal echocardiography for transcatheter closure of ostium secundum atrial septum defect with the amplatzer septal occluder. Chang. Gung. Med.J. 2005; 28 (12): 837-845.

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18.   Radhakrishnan S., Marwah A., Shrivastava S. Non surgical closure of atrial septal defect using the Amplatzer septal occluder in children-feasibility and early results. Indian Pediatr. 2000; 37 (11): 1181-1187.

 

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.

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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.

 

References

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