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

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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.

Reference

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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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Abstract:

Palliative surgery plays a major role as a stage of congenitalheart disease treatment.Palliative endovascular interventions are safe n neonates. Such treatment can stabilize patients and adequately prepare them for radical operation and in some cases it is an alternative to classic bypass methodic.

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Abstract:

Purpose. Was to investigate the radiodiagnostic features of ASD in different age groups and to evaluate the role of chest X-rays in diagnostics of this disease.

Materials and methods. 48 patients with ASD were studied (aged 15–71 yaers, mean 47,2 ± 15), including 16 men and 32 women. We have diagnosed ostium primum defect (3 pts), ostium secundum defect (42 pts), sinus venosus defect, combined with PAPVD (3 pts). All of them underwent chest x-rays, echocardiography and cardiac MRI (with phase-contrast sequences). Patients were divided into two groups: 1st group – older than 40 years (30 pts) and 2nd group – less than 40 years (18 pts).

Results. In the 1st group, heart failure, valve regurgitations and atypical radiographic findings were more common than in the 2nd group. The size of both atria, pulmonary arteries' diameter and systolic PAP levels were also greater in patients older than 40 yaers. Groups did not differ by the volume of intracardiac shunt and the size of the defect. 6 pts with small defects had no radiographical signs of CHD. 11 patients from the 1st group had signs of hypervolemic CHD, but significant heart chambers’ enlargement impeded more accurate diagnostics. Patients with marked pulmonary arterial hypertension differed significantly from patients with lower PAP levels by radiographical signs.

Conclusions. Specificity of chest x-rays in diagnostics of ASD is lower in patients of 2nd group. Chest x-rays is an effective screening method to reveal abnormalities of pulmonary circulation, such as pulmonary venous hypertension and pulmonary plethora.

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Abstract:

Aim: was to estimate possibilities of two-dimensional and three-dimensional transesophageal echocardiography (TEE) in the diagnosis of atrial septal defects (ASD).

Material and methods: 52 patients with atrial septal defect underwent TEE. In 32 cases - 3D TEE, 20-2D TEE. 44 patients further underwent endovascular closure of ASD, 8 underwent cardiac surgical correction of ASD with extracorporeal circulation.

Results: 3D TEE allows to make more accurately and correctly measure of ASD, to determine its location, shape, and number of defects and to quantify all edges, including top, and to measure the length of the partition in three standard areas and additional-caval from lower to upper edge.

Conclusions: 3D TEE gives the most correct estimation of localization, shape and size of the defect, as well as contributes the proper determination of the optimal tactics of surgical correction of the defect.

References

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2.     Klinicheskaja kardiologija: diagnostika i lechenie v treh tomah [Clinical cardiology: diagnostics and treatment in 3 volumes. Under edition of L.A. Bokeria, E.Z.Golukhov]. T 1. ( pod redakciej L.A. Bokerija., E.Z. Goluhova) M.: NCSSH im. A.N. Bakuleva RAMN. 2011; 518-52[ In Russ].

3.    Narcyssova G.P., Malahova O.Ju., Osiev A.G. Ul'trazvukovye kriterii otbora pacientov s defektom mezhpredserdnoj peregorodki na jendovaskuljarnuju korrekciju sistemoj AMPLATZER i ocenku rezul'tatov - medicinskaja tehnologija. [Ultrasound criteria for selection of patients with atrial septal defect for endovascular correction with AMPLATZER system and the evaluation of results.] Novosibirsk. 2012; 10-11 [In Russ]

4.    Prakticheskaja jehokardiografija[Practical echocardiography (under edition Frank A. Flaksamph, translation from germany - V.A. Sandrikova] (pod red. Franka A. Flaksampfa perevod s nem. pod obshhej red. V.A. Sandrikova) M.MED-press-inform. 2013; 224-234 [In Russ].

5.    Tkacheva A.V. Diagnostika i jendovaskuljarnoe zakrytie vtorichnogo defekta mezhpredserdnoj peregorodki ustrojstvom «AMPLATZER» [Diagnosis and endovascular closure of secondary atrial septal defect with «AMPLATZER» device] Avtoreferat. Diss. kand. med. nauk. M. 2008; 24 [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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