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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 7  |  Issue : 3  |  Page : 212-218

Clinical profile of patients of ASD device closure with special reference to short and intermediate term complications


1 Department of Cardiology, Sahayog Hospital, Maharastra, India
2 Department of Cardiology, U.N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India
3 Department of Research, U.N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India
4 Department of Radiology, GMC, Gondia, Maharashtra, India

Date of Submission06-May-2021
Date of Decision20-May-2021
Date of Acceptance05-Nov-2021
Date of Web Publication14-Dec-2021

Correspondence Address:
Benny Jose Panakkal
Interventional Cardiologist, Jupiter Hospital, Pune
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpcs.jpcs_30_21

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  Abstract 


Background: Device closure of atrial septal defect (ASD) is a treatment of choice in selected patients with a suitable defect. We aimed to evaluate short- and intermediate-term outcomes with device closure in special reference to complications in Western Indian population. Materials and Methods: The present prospective observational study enrolled 184 patients with ASD who underwent Device closure. All patients were followed at 15–30 days (short) and 3–12 months (intermediate). Results: Device closure of ASD was done successfully in 180 (97.83%) patients. Systolic (P = 0.02), diastolic (P = 0.007), and mean PA (P = 0.0001) pressure were significantly decreased at postprocedure. Residual defect was resolved in 94.2% of patients by 6 months. Preprocedural Pulmonary artery hypertension was found in 36 (19.56%) patients and was reduced in 15 (8.15%) patients postprocedure and in 10 (5.43%) patients at 1 year. Residual shunt was reported in 34% of patients which was resolved in all by 6 months. At postprocedure and follow–up, patients were developed minor complications included (0.5%) moderate MR, 1 (0.5%) lower respiratory tract infection, and 3 (1.6%) local site hematoma. Eleven (5.98%) major complications involved arrythmia (2.17%), infective endocarditis (0.54%), LAA perforation (0.54%), cardioembolic shock (0.54%), device embolization (0.54%), sudden cardiac arrest (0.54%), intraprocedural acute coronary syndrome (0.54%), and cardiac tamponade (0.54%). Conclusion: Device closure appears to be best available option at the present time. Careful attention to the details of the technique is mandatory to achieve a successful outcome in order to avoid complication related to procedure. Patients of all ages experience reduction in pulmonary artery pressure after percutaneous device closure of ASD.

Keywords: Amplatzer device, atrial septum defect, device closure


How to cite this article:
Gaidhane P, Prajapati J, Patel IV, Bhutada B, Yadav C, Yadav K, Panakkal BJ. Clinical profile of patients of ASD device closure with special reference to short and intermediate term complications. J Pract Cardiovasc Sci 2021;7:212-8

How to cite this URL:
Gaidhane P, Prajapati J, Patel IV, Bhutada B, Yadav C, Yadav K, Panakkal BJ. Clinical profile of patients of ASD device closure with special reference to short and intermediate term complications. J Pract Cardiovasc Sci [serial online] 2021 [cited 2022 Jan 17];7:212-8. Available from: https://www.j-pcs.org/text.asp?2021/7/3/212/332487




  Introduction Top


Atrial septal defect (ASD) is common congenital anomaly, accounts for 6%–10% of congenital heart lesions at birth, and the second most common congenital heart defect (CHD) detected in adults.[1] The incidence of ASD is approximately 1 per 1500 live births and accounts for 30%–40% of CHD presenting in adulthood.[2]

Spontaneous closure is unusual in adults, and most of them develop symptoms such as fatigue, dyspnea, or paradoxical embolization in the course of time.[3] For many decades, surgical intervention for ASD has been accepted as the standard of care treatment. However, surgical treatment is safe; it is associated with complications such as morbidity, discomfort, infection, and thoracotomy scars.[4] The percutaneous approach has been evolved to be the preferred treatment option in patients with secundum ASD due to less invasive nature and high success rate, whereas traditional thoracotomy surgery has been reserved for the minority of patients with unfavorable morphologic features.[5] Although nonsurgical closure of ASD is becoming popular due to well-established benefits, technical complications with occasional deaths have also been reported. The complications reported include cardiac perforations, device malposition or embolization, residual shunts, vascular trauma, thrombus formation, atrioventricular valve regurgitation, atrial arrhythmias, infective endocarditis, and sudden death.[5] Malposition or embolization is the most commonest reason for emergency surgical intervention.[6]

Current guidelines recommend that all patients with hemodynamically significant ASD should undergo ASD closure, regardless of symptoms, in order to prevent long-term complications such as atrial arrhythmias, pulmonary hypertension, and/or paradoxical embolism.[7]

The present study aims to discuss the clinical profile of ASD device closure patients and illustrate the safety and efficacy of percutaneous device closure of secundum ASD with special reference to short- and intermediate-term complications.


  Materials and Methods Top


Study design

The present study was a prospective, observational, and cohort design included patients who underwent ASD intervention at the Department of Cardiology, U. N. Mehta Institute of Cardiology, Ahmedabad, from August 2015 to December 2018 and were followed from the day of intervention and followed at 3, 6, and 12 months. The study was approved by the institutional ethics committee (UNMICRC/CARDIO/2015/80). Written informed consent was obtained from every patient before the procedure. All the patients were thoroughly reviewed for any immediate complications before the discharge. After that, patients underwent regular follow-up at 15–30 days (short) and 3–12 months (intermediate).

Study criteria

The indications for closing the ASDs were

  1. Sizable defects with shunt (Qp/Qs) >1.5/1
  2. Right heart volume overload
  3. Development of symptoms.


The patient selection for percutaneous closure was based on the morphology of the defect as well as the presence of a sufficient rim around it, particularly in the inferior and posterior parts of the defect. The assessment was performed using a transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE).

Inclusion criteria

  1. The presence of an ostium secundum ASD in patients with a minimum body weight of 10 kg and above
  2. Left to right shunting across the ASD
  3. Maximal ASD diameter of ≤38 mm
  4. Secundum type ASD with adequate rims
  5. Dilation of the right ventricle with evidence of right ventricular volume overload.


Exclusion criteria

  1. Patient with other associated defects which is not suitable for transcatheter closure
  2. Patient with Eisenmenger
  3. Patient with heart failure.


Preprocedure evaluation

Absent or deficient aortic rim was not considered as an exclusion criterion. All these cases were evaluated thoroughly by chest X-ray (CXR), 12-lead ECG, and transthoracic echocardiography before enrollment in the device closure group. Before cardiac catheterization, normal precatheterization evaluation and blood tests were performed in all cases (CBC, Urea, Creatinine, HIV, HBsAg, CRP). Preprocedural transesophageal echo was performed in all cases.

Procedure and implantation technique

All the cases were done under local anesthesia in the femoral region with 1% lignocaine. Sedation was given in un-cooperative adults and patients <18 years of age. General anesthesia was given only if required. All the children were sedated with injection Midazolam, injection Ketamine, injection Phenobarbitone, and injection Propofol either alone or as a cocktail.

All the patients were heparinized with 100 Units/kg heparin during procedure. Activated clotting time was kept above 200. Injection cefazolin 50 mg/kg body weight was pushed in IV drip during the procedure and continued up to 48 h. Aspirin 5 mg/kg was advised for all patients up to 6 months unless contraindicated. All patients were observed for 24 h in a postcatheterization observation room with monitoring of ECG and all vital signs in overhead monitor. Twelve-lead ECG was performed immediately the postprocedure and at 8 and 24 h after procedure. Pressure bandage was removed after 6–8 h. and CXR, and echocardiography was performed immediately after the procedure and before discharge if required.

The devices were selected arbitrarily 2–4 mm larger in defects with adequate rim and 4–6 mm larger in defects with floppy or deficient rims. After making a complete hemodynamic evaluation, a Judkins Right/multipurpose catheter was placed in either left or right upper pulmonary vein followed by stiff wire exchange. The device was then advanced through a long sheath to the left atrium by pushing the delivery cable. The device was then deployed, first left atrial disc followed by right atrial disc under fluoroscopic and TEE guidance. A secure and stable position of the occluder within the defect was checked by a push-pull maneuver the “Minnesota wiggle.” The device and adjacent structures were re-examined by TEE and TTE to ensure that there was no encroachment of the device on the atrioventricular valves or the right pulmonary veins or any significant residual shunt.

Intravenous (IV) Cefazolin (1 g) was given to prevent bacterial endocarditis, and aspirin was prescribed at a dose of 5 mg/kg daily for 6 months to avoid thromboembolic events. Cefazolin was given 30 min before procedure and followed by 1 g IV every 8 h for an additional 2 doses.

Follow-up protocol

The patients received aspirin 5 mg/kg for 6 months until full endothelization of the device unless contraindicated. Before discharge at 24 h, patients underwent clinical examination, ECG, chest X-ray, and routine echocardiographic examinations. The same procedures were performed at 15–30 days, 3–12 months after the implantation at all follow-up.

Devices used

Two different devices were used: Amplatzer septal occluder (ASO) in 166 patients and Life Tech cera in 17 patients.

Statistical analysis

All statistical studies were carried out using SPSS program version 20. Quantitative variables were expressed as the mean ± standard deviation, and qualitative variables were expressed as percentage (%). A comparison of parametric values between two groups was performed using the independent sample t-test. Categorical variables were compared using the Chi-square test. A nominal significance was taken as a two-tailed P < 0.05.


  Results Top


Various presenting chief complaints of patients such as dyspnea, chest pain, palpitations, fatigue, and others (cardioembolic stroke) were compared in different age groups (children ≤12 years, adolescent = 12–18 years, young adult = 19–40 years, and adult ≥40 years) tabulated in [Table 1]. In all age groups, the most common presenting complaint was dyspnea, followed by chest pain. In adolescent (42.1%) and young adults (29.6%), it was followed by palpitations; however, in children (29.6%) and adults (40%), fatigue was more common than palpitation. Apart from abovementioned presenting complaints, one adolescent patient presented with cardioembolic stroke. Further, all patients of different age groups were classified according to WHO/NYHA classification. In children and adolescent groups, maximum patients were found under Class I, followed by Class II. However, in the young adults, majority of patients presented with Class I/II. In adults, majority patients were in Class II followed by Class III.
Table 1: Distribution of Baseline variables in different Age groups:

Click here to view


[Table 2] represents the pre and postprocedural pressure. Systolic (P = 0.002), diastolic (P = 0.007), and mean (P = 0.0001) PA pressures were significantly reduced at postprocedure; however, there was no significant change found in pre- and post-procedural systolic and diastolic aortic pressure.
Table 2: Pre and post procedure Pulmonary artery (PA) pressure

Click here to view


[Table 3] presents the number of patients with residual defect resolved at different time intervals. 65.74% of patients were found no residual defect on their 1st visit, while another 33.69% of patients were found to have mild (23.91%), moderate (1.09%), and trivial (8.69%) residual defect. The residual defect was resolved in all patients by 6-months follow-up.
Table 3: Post-procedure residual defect resolved at different time interval.

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Pre- and post–procedure PAH comparison has shown in [Table 4]. Postprocedure PAH was found in 21 (11.48%) patients, however, in comparison to preprocedure evaluation, PAH was regressed in nearly 15 (8%) patients. Furthermore, the severity of PAH reduced on postprocedure evaluation as 12 patients with severe preprocedure PAH regressed to mild in 6 and moderate in 6 patients. Further, out of 16 patients with preprocedure moderate PAH, on postprocedure, it regressed to mild in nine patients and was normalized in seven patients. At 1-year follow-up, only 12 (6.67%) patients had PAH, of which 3 were young adults and 9 fell in the adult group.
Table 4: Comparison of pre and post procedural pulmonary artery hypertension (PAH)

Click here to view


[Table 5] presents the different complications at 1 year in different age groups. In the present study, one death (related to the procedure), 11 major complications, and four minor complications occurred immediate postprocedure. Three major complications occurred at short-term follow-up (two at 15 days and one at 3 months), while one minor complication occurred at 6-month follow-up.
Table 5: Complications in different age group

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[Table 6] shows major and minor complications at different time interval.
Table 6: Various major and minor complications at different time interval.

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Intraprocedural complication was occurred in two patients. One female patient with 30 years of age had sudden cardiac arrest, and the condition was probably due to air embolism; later on, the patient was resuscitated and planned for surgical closure. Another 54-year-old female patient had an intraprocedural acute coronary syndrome that the patient had IWMI after device deployment and it was because air embolism on background of the critical RCA lesion with multivessel CAD.

Immediate complication was identified in six patients. LAA perforation was diagnosed in a 34-year-old female patient who had pericardial effusion with deficient aortic rim and had cardiac tamponade. Later on, pericardial drain and surgical ligation of LAA were done. 2:1 AV block was diagnosed in two female patients with the age of 26 and 12 years. In one patient, it was improved after 1 week of steroids, and in other patient, it was resolved with the steroids. Device embolization was occurred in a 19-year-old male patient immediately after deployment, and the patient underwent surgical closure of ASD. One patient had sudden cardiac arrest during procedure and resuscitated and planned for surgical closure of ASD. There was a 46-year-old female with the cardioembolic stroke immediate postprocedure.

Short-term complications were detected in three patients. Infective endocarditis was found in a 3-year-old female patient and was resolved with antibiotics. 2:1 AV block was occurred in a 59-year-old female patient, and it was persisted despite giving steroids. CHB was detected in a 24-year-old male patient; the patient was delayed for PPI, and later on developed severe biventricular dysfunction and then underwent PPI.

One female patient with age 22 years had cardiac tamponade at 6 months, and pericardiocentesis was performed and perforation was ruled out.

Minor complications were noted in total 2.7% of the population. Nearly 1.63% of the study population had vascular access site hematoma. One patient detected moderate MR at intermediate-term follow-up. Moreover, three patients at intermediate-term follow-up were detected with a local site hematoma in that one patient was on oral anticoagulant and two patients had hypertension.


  Discussion Top


Interventional procedure or nonsurgical intervention procedure for ASD has been recognized as an alternative to surgical closure in developed countries as well as in developing countries. Many countries in the world have reported it with favorable results.[7],[8] In most of developing countries with the inadequate recourses and funding, nonsurgical treatment options for ASD closure is safe and cost-effective procedure. In our study population, we found 11 (5.98%) patients with major complications, 5 (2.72%) patients with minor complications, and other 167 (90.77%) patients with uncomplicated procedure at intermediate and long term after device implantation.

Rao et al.[9] reported residual shunts in 45% of patients on color Doppler with a buttoned device, while worms et al. found residual shunt in 37% of patients with Rao et al. device.[10] The incidence of residual shunts was very low with ASO.[11],[12],[13],[14] A study by Kefer et al.[15] reported 98% of patients with resolution of residual shunts on follow-up. In the present study, residual shunt was noted in 34% of patients, which resolved in 100% by the end of 6 months.

In the present study, infective endocarditis was reported in 1 (0.54%) pediatric patient at 15 days, which is supported by previous studies on ASD device closure by Sadiq et al. and Sievert et al. reported complication related to infective endocarditis was 0.5% and 1%.[16],[17]

Perforation is the most feared complication after transvenous device closure.[18],[19] Cardiac perforations related to technique can occur during catheterization or typically before hospital discharge; the patient can present with hemopericardium, pericardial effusion, and cardiovascular collapse. There may be sudden death due to perforation.[6],[14],[19],[20] Divekar et al.[19] in a retrospective study reported that, from total 24 cardiac perforation patients, 20 patients with cardiac perforation were occurred in anterosuperior atrial wall and adjacent aorta. Amin et al.[21] have shown that oversized ASO may increase the risk which may lead to erosion of ASO and recommended ways to minimize the risk of perforation.[22] In the present study, out of three pericardial effusions, in one patient, LAA rupture was noted which was technique related. While in other 2 patients, perforation was ruled out with no objective evidence found in one patient, whereas in other patient, it was postulated to be secondary to viral pericarditis in background of anticoagulation.

The reported sites of embolization include right ventricle, pulmonary artery, left ventricle, arch of aorta, and peripheral vessels. In a study by Kazmi et al., embolization rate was 2% after ASD device closure,[22] while in the present study, we found device embolization to RV in postprocedure period in one adolescent patient (0.54%), which was associated with floppy IVC rim. In a study by Chessa et al., embolization/malposition was the most common complication noted in 3.5% of patients.[23] Overall, the reported rate of device embolization ranges from 0.55% to 1.7%.[24] Procedural characteristics that increase the rate of device embolization include smaller devices and insufficient septal rims. Embolization is usually apparent during the procedure, but delayed embolization also occurs.[24]

Arrhythmia is another common complication that occurred in 2.6% of patients, 6 of which developed atrial fibrillation that required cardioversion reported by Putra et al.[25] A report by Spies et al. revealed that 3.5% of patients with transcatheter closure of ASD had atrial fibrillation.[26] In the present study, preprocedure AF was noted in 5 (2.7%) study subjects (4 adults and 1 young adult), and in postprocedure, it was seen in 6 (3.2%) subjects (4 adults and 2 young adults). In the present study, we also found 2:1 AV block in 3 (1.63%) patients (1 children, 1 adolescent, and 1 adult) and CHB in one patient, thereby arrhythmias comprised 2.17% of the study population.

In a study by Knepp et al.,[27] 10% of adults developed a new arrhythmia post-ASO placement. All of these patients were older than 50 years at the time of device placement. This observation, however, may be independent of the ASO. The expected course of a dilated atrium is to develop arrhythmias.[28] One could then postulate that the development of atrial fibrillation in the adult subgroup was independent of the device being placed.

Thrombus formation is another important concern, and the incidence of thrombus formation was 1.2% in ASD patients in the previous study.[29] Postprocedure atrial fibrillation and persistent atrial septal aneurysm were significant predictors of thrombus formation. However, in few studies like that of Kazmi et al., none of the patients developed evidence of thrombus formation in immediate or late follow-up.[22] In a study by Sievert et al., 4.5% of patients had thrombus formation around the device.[17] In th present study, postprocedure thrombus formation at LA disc was observed complicating to cardioembolic stroke in one adult patient (0.54%), which resolved after anticoagulation without recurrent embolization.

In the present study, one patient had intraprocedural inferior wall MI due to air embolism, postdevice deployment, on the background of critical mid-RCA lesion which was diagnosed on angiography performed for same and managed by PAMI.

Another patient had sudden cardiac arrest due to air embolism while engaging pulmonary veins. These two air embolism-related cardiac complications are more technique related. In reviewing previous literature, we came across a study by Vijayvergiya and Shrivastava,[30] in which they postulated that right coronary air embolism is more common in supine position, as right coronary sinus is superior and anterior in supine position.

Comparison to previous literature having minor complications of 1.6%,[1] in the present study, minor complications were noted in 2.7% study population. Out of this local site, hematoma was 1.6%, so ignoring them, the actual relevant minor complications related to ASD device were only 1.1%. Complications previously reported such as metal fatigue fractures, structural failures[31] explant, device malposition, and allergic reactions were not noted in the present study.[32],[33] Overall major complications in the present study comprised 5.98%. This is in accordance with previous studies, like study by Bartakian et al.[34] who found 5.5% of major complication rate. Furthermore, in another study,[35] major adverse event rate was reported in 5.8%, much similar to the present study. The technical success rate in the present study was found in 97.8%, which was related to other previous studies reported 96% to 98%.[26],[36],[37],[38],[39]


  Conclusion Top


Overall, the present study supports the current practice of using transcatheter ASD closure and the decision to intervene on ASD with significant shunts before symptoms become evident. The data presented in the present study strongly suggest that it should also be considered the standard of care in middle-aged and elderly patients too. The volume of data from studies regarding percutaneous closure and their safety and efficacy has long surpassed the surgical data in these age groups.

Careful attention to the details of the technique is essential to achieve a successful outcome in order to avoid mentioning complications related to the procedure. And by doing so and removing the operator error, ASD device closure in properly evaluated patients becomes the flawless procedure of default choice as complications related to the device itself have grown up by the time and science.

Ethics clearance

The study was approved by institutional ethics committee (UNMICRC/CARDIO/2015/80).

Financial support and sponsorship

This study was financially supported by U. N. Mehta Institute of Cardiology and Research Center (affiliated to BJ medical college, Ahmedabad).

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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