Welcome to Thesis
Presentation
TITLE
COMPARISON OF EARLY OUTCOMES BETWEEN
SURGICAL AND TRANSCATHETER DEVICE CLOSURE
OF SECUMDUM TYPE ATRIAL SEPTAL DEFECT
Investigator
Dr. Md. Mahmudur Rahman
Master of Surgery (Cardiovascular & Thoracic Surgery)
Phase B Resident
E-Registration: 16122291410
Roll: 0229-003
Session: March 2018
Bangabandhu Sheikh Mujib Medical University, Dhaka
Department of Cardiac Surgery
National Institute of Cardiovascular Diseases (NICVD)
Sher-E-Bangla Nagar, Dhaka-1207, Bangladesh
October, 2023
In affiliation with BSMMU, Shahbagh, Dhaka
GUIDE
Prof. Dr. Md. Kamrul Hasan
MBBS (Dhaka), MS (Cardiovascular and Thoracic Surgery),
FRCS (England)
Professor
Department of Cardiac Surgery,
National Institute of Cardiovascular diseases (NICVD),
Sher-E-Bangla Nagar, Dhaka, Bangladesh.
CO-GUIDE
Dr. Md. Zahidul Islam
MBBS, MS (Cardiovascular & Thoracic Surgery)
Assistant Professor,
Department of Paediatric Cardiac Surgery,
National Institute of Cardiovascular Disease (NICVD),
Sher-E- Bangla Nagar, Dhaka, Bangladesh
LETTER OF ACCEPTANCE
This thesis is submitted to Bangabandhu Sheikh Mujib Medical
University (BSMMU) in partial fulfillment of the requirements of
the degree for Master of Surgery (Cardiovascular and Thoracic
Surgery). The study was carried out in the Department of Cardiac
Surgery and Paediatric Cardiology Department, NICVD, Dhaka,
from August 2018 to July 2020. Acceptance of the thesis has
been approved by a board of examiners. The board consists of-
DECLARATION
I hereby humbly declare that this thesis entitled “Comparison of
early outcomes between surgical and transcatheter device closure
of secumdum type atrial septal defect” is based on the work
carried out by me from August 2018 to July 2020.at Department of
Cardiac Surgery and Paediatric Cardiology Department, NICVD
under the guidance of Prof. Dr. Md. Kamrul Hasan, Professor,
Department of Cardiac Surgery, NICVD, Dhaka, Bangladesh. No
portion of the research work has been submitted in support of an
application for another degree or any other institution of learning.
………………
…………………………....….………
Date
Dr. Md. Mahmudur Rahman
FORWARDING OF GUIDE
This is to certify that Dr. Md. Mahmudur Rahman, Phase-B, Resident, MS
(Cardiovascular and Thoracic surgery) of the Department of Cardiac Surgery,
National Institute of Cardiovascular Diseases (NICVD), Sher-E-Bangla Nagar,
Dhaka, Bangladesh, under Bangabandhu Sheikh Mujib Medical University
(BSMMU) has carried out this research titled “Comparison of early
outcomes between surgical and transcatheter device closure of secundum
type atrial septal defect” and prepared this thesis under my direct
supervision and guidance. I have found the thesis work satisfactory for the
requirements of the phase B examination of Master of Surgery
(Cardiovascular and Thoracic Surgery).
GUIDE:
Professor Dr. Md. Kamrul Hasan
MBBS, MS (Cardiovascular and Thoracic Surgery),
FRCS (England)
Professor
Department of Cardiac surgery,
National Institute of Cardiovascular Diseases (NICVD),
Sher-E-Bangla Nagar, Dhaka, Bangladesh.
ACKNOWLEDGEMENT
In the name of Allah, the most beneficent, the most merciful. He
gives wisdom to whom He wills, and whoever has been given
wisdom has certainly been given much good.
It’s a great pleasure to acknowledge my profound gratitude to
Prof. Dr. Md. Kamrul Hasan, Professor, Department of Cardiac
surgery, NICVD for his kind permission to select this topic for my
research and for his constant and careful guidance and valuable
advice which helped me to accomplish the task successfully. I am
deeply grateful to my co-guide Dr. Zahidul Islam, Assistant
Professor, Department of Paediatric Cardiac Surgery, NICVD
without whose constant and eager cooperation my thesis would
not have come to light.
I am grateful to Prof. Dr. Mir Jamal Uddin, Director, NICVD for his
kind approval to carry out the study in this institute.
I would like to express my special thanks of gratitude to the
Department of Paediatric Cardiology and Department of
Cardiology in NICVD, Sher-E-Bangla Nagar, Dhaka for their
generous cooperation in doing Echocardiography to conduct this
study. I would like to thank the nurses and staff in the operating
room, ICU and wards for their cooperation in carrying out the
study.
It wouldn’t have been possible to accomplish this journey
without the endless blessings, utmost patience and selfless
sacrifice of my beloved mother to whom I will remain forever
indebted. I fondly remember the loving memories of my late
father and pray for the eternal peace of his soul. Last but not
least, my heartfelt thanks go to all the patients and their legal
guardians for their kind consent and cooperation which helped
me in the completion of this thesis.
Date:
Dr. Md. Mahmudur Rahman
LIST OF CONTENTS
Chapter no.
Chapter I
1.1
1.2
1.3
1.4
Chapter II
Content
Declaration
Forwarding of guide
Acknowledgment
List of contents
List of tables
List of abbreviations
Abstract
Introduction
Introduction
Rationale
Hypothesis
Objectives
Literature review
Page
iv
v
vi
vii
ix
x
xi
1
5
6
7
8
LIST OF CONTENTS
Chapter III
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
Materials and methods
Study design
Place of study
Period of study
Study population
Study sample
Ethical clearance
Selection criteria
Study groups
Sampling technique
Determination of sample size
Study variables
Study procedure
Data collection technique
Data processing and analysis
14
14
14
14
14
14
15
16
16
16
17
18
20
20
LIST OF CONTENTS
3.15
Workflow chart
21
3.16
Research tools
22
3.17
Ethical aspects
22
3.18
Operational definitions
23
Chapter IV
Results
26
Chapter V
Discussion
38
Chapter VI
Conclusion
42
Chapter VII
Study limitations
43
Chapter VIII
Recommendations
44
Chapter IX
References
45
LIST OF CONTENTS
Annexures
Appendices Content
Page no.
Appendix A Work schedule
xiv
Appendix B Approval from ethical review committee
xv
Appendix C
Consent form in English
xvi
Appendix D Consent form in Bangla
xvii
Appendix E
Questionnaire
xviii
Appendix F
Checklist
xxi
LIST OF TABLES
Table
Table I
Table II
Table III
Table IV
Table V
Table VI
Table
VII
Title
Page
Comparison of patients by age between two
26
groups
Comparison of patients by gender between two
27
groups
Comparison of preintervention NYHA functional 28
class between two groups
Comparison of preintervention chest X-ray 29
features between two groups
Comparison of preintervention transesophageal 30
echocardiogram features between two groups
Comparison of associated comorbidities between 31
two groups
Comparison of per-operative attributes between
32
two groups
LIST OF TABLES
Table
Table
VIII
Table IX
Title
Page
Comparison of postoperative attributes between 33
two groups
Comparison of postoperative echocardiogram 34
findings on follow-up at 6 months following
discharge between two groups
Table X Comparison of postoperative NYHA functional
35
class on follow-up at 6 months following
discharge between two groups
Table XI Comparison of pre- and post-intervention NYHA 36
and PASP values in surgical and device closure
patients
Table
Comparison of pre- and post-intervention 37
XII
pulmonary arterial systolic pressure (PASP) values
in surgical and device closure patients
LIST OF ABBREVIATIONS
ASD
Atrial Septal Defects
BMI
Body Mass Index
CCU
Coronary Care Unit
CHD
Congenital Heart Disease
CPB
Cardiopulmonary Bypass
ICU
Intensive Care Unit
NICVD
National Institute of Cardiovascular Diseases
NYHA
New York Heart Association
LIST OF ABBREVIATIONS
OS
Ostium Secundum
PAH
Pulmonary Arterial Hypertension
PASP
Pulmonary Artery Systolic Pressure
Qp
Pulmonary Flow
Qs
Systemic Flow
SD
Standard Deviation
SPSS
Statistical Package for The Social Science
ABSTRACT
Background:
Atrial Septal Defects (ASDs) are prevalent congenital heart
defects in Bangladesh. Among the different types of ASDs,
ostium secundum is notable for its central, oval-shaped opening
in the upper part of the atrial septum, closely adjacent to the
fossa ovalis, which facilitates communication between the right
and left atria. The management of secundum-type ASDs
primarily involves two approaches: surgical closure and
transcatheter device closure. However, comprehensive research
comparing the early outcomes of these two methods within the
context of Bangladesh's healthcare system is notably lacking. The
purpose of this study was to compare the early postprocedural
outcomes between surgical and transcatheter device closure
methods for secundum-type atrial septal defects.
ABSTRACT
Methods:
After obtaining ethical clearance, this cross-sectional study was
conducted in the Department of Cardiac Surgery and Paediatric
Cardiology Department, National Institute of Cardiovascular
Diseases (NICVD), Sher-E-Bangla Nagar, Dhaka, involving a total
of 72 patients aged between 4 and 16 years undergoing
intervention for secundum ASD without other concomitant
congenital cardiac anomalies and decompensated congestive
heart failure. Patients were divided into two groups based on the
intervention method: Group A (n=42) underwent surgical
closure, while Group B (n=30) underwent transcatheter device
closure. The choice of intervention method was determined by a
multidisciplinary team based on clinical criteria, patient-specific
factors, anatomical characteristics and patient preferences, with
informed consent obtained. Data were collected using a semistructured questionnaire from face-to-face interviews and a
review of medical records.
Results:
The distribution of patients in the surgical closure group skewed
towards those aged 4 to 10 years, while the transcatheter device
closure group had a majority in the 11-16 years age range. Group
B had a significantly higher average age than Group A
(12.03±2.75 vs. 10.38±3.29 years, respectively, p=0.028).
Although the size of the secundum ASD tended to be slightly
larger in Group A, this difference was not statistically significant
(p>0.05). Surgical closure procedures had longer durations
compared to transcatheter device closure (121.14±20.92 vs.
40.69±8.11 minutes; p<0.001), with cardiopulmonary bypass
times in Group A being significantly higher than fluoroscopy
times in Group B (p<0.001). Group A also had longer stays in the
ICU/CCU and overall hospital stays compared to Group B
(p<0.001).
Results:
Among device closure patients, 1 experienced device embolism, 2
developed device endocarditis, 2 were deferred for surgical
intervention, and 1 required re-intervention. Surgical closure
achieved a 100.0% immediate procedural success rate, while the
device closure group had a success rate of 90.0%. Six months
post-discharge, residual ASD (≥2mm) was observed in 3 device
closure patients. Both surgical and device closure groups showed
a significant reduction in post-intervention NYHA scores and PASP
values compared to their pre-procedure values (p<0.05).
Conclusion:
Both surgical and transcatheter device closure approaches offer
favorable early outcomes for closure of secundum atrial septal
defects. Surgical closure offers advantages such as complete
closure and fewer device-related complications, while
transcatheter device closure is associated with shorter
procedure times and hospital stays. This finding suggests that the
patient's age, procedural preferences and possible complications
of secundum ASD closure should be considered when choosing
between surgical and implant-assisted closure methods.
INTRODUCTION
1.1 Background:
Congenital heart disease (CHD) refers to structural or functional
heart abnormalities present at birth (Stout et al., 2018). CHD is a
common birth defect and a major cause of child death. The
reported prevalence of CHD ranges from 4 to 50 per 1000 live
births (Ma et al., 2023). Atrial septal defects (ASDs) represent the
third most prevalent form of congenital heart disease, facilitating a
direct communication between atrial chambers, allowing shunting
of blood between the systemic and pulmonary circulation (Geva et
al., 2014).
INTRODUCTION
1.1 Background:
In the Indian population, ASD accounts for 19–21% of congenital
heart diseases, and a significant portion of operative and
interventional volume (Biswas, 2023). Notably, atrial septal defects
were found to encompass 25% of the entire spectrum of congenital
heart diseases in Bangladesh (Khan et al., 2022). Recent strides in
ASD care encompass enhanced diagnostic techniques, procedural
planning, prompt closure following early diagnosis, and refined
intervention approaches, culminating in improved clinical
outcomes and overall prognosis (Brida et al., 2022). Five to ten
percent of infants are born with an ostium secundum atrial septal
defect, and this defect is also seen in thirty percent of adults with
CHD (Vida et al., 2006). Unrepaired large atrial septal defects,
characterized by persistent left-to-right shunting, initiate a cascade
of worsening clinical outcomes.
INTRODUCTION
1.1 Background:
Exercise intolerance arises due to disrupted blood circulation,
limiting physical activity, while the right side of the heart,
particularly the right ventricle, contends with increased blood
volume, potentially leading to right-sided heart failure.
Concurrently, irregular heart rhythms, or atrial arrhythmias,
often coexist, causing palpitations, dizziness, and fainting. The
abnormal blood flow caused by ASD can elevate pulmonary
artery pressure, known as flow-related pulmonary artery
hypertension, resulting in further cardiac and pulmonary
complications over time. Due to gradual symptom development,
diagnosing ASDs is challenging, often leading to delayed
diagnosis in adulthood. This underscores the importance of
proactive assessment and intervention to prevent worsening
clinical outcomes related to untreated large ASDs (Djer et al.,
2013).
INTRODUCTION
1.1 Background:
The ideal age for ASD closure is preschool age between 4 and 5
years old. It may be undetected until adolescence or adulthood
(Djer et al., 2013). Patients with isolated atrial septal defects will
have good outcomes. The size of the defect and relative diastolic
filling properties of the right ventricle should be considered in
every case (Webb and Gatzoulis, 2006).
As the defect may lead to right ventricular volume overload,
increased pulmonary pressure, atrial arrhythmia, and
paradoxical emboli in later decades and symptoms are worsen
with increasing age and according to an age effect of the
patients’ ventricular compliance. The ideal remedy has been to
eliminate the left-to right-shunt before it develops its
complications (Vijarnsorn et al., 2012).
INTRODUCTION
1.1 Background:
In the year 2008, the collaborative efforts of the American
College of Cardiology and American Heart Association ushered in
a pivotal update to their guidelines pertaining to adults afflicted
by congenital heart disease. Notably, a Class I recommendation is
endorsed for ASD closure, irrespective of the presence of
symptomatic history, in instances characterized by the cooccurrence of right atrial and right ventricular enlargement. The
guidance emphasizes that closure may be accomplished through
either percutaneous or surgical modalities, underpinning the
importance of preemptive intervention to avert the potential for
deleterious outcomes (Fentanes and Wisenbaugh, 2013).
INTRODUCTION
1.1 Background:
The treatment of ASDs becomes imperative under circumstances
where there is a significant discrepancy between pulmonary flow
(Qp) and systemic flow (Qs), denoted as Qp:Qs ratio, exceeding
1.5:1. This marked imbalance signals a hemodynamic defect
wherein the volume of blood shunting from the left side of the
heart to the right side surpasses the normal physiological range.
This alteration in flow dynamics is often accompanied by
increased dimensions of the right ventricle, as discerned through
echocardiography, a non-invasive imaging technique that employs
sound waves to visualize the heart's structures (Costa et al.,
2013).
INTRODUCTION
1.1 Background:
For over 45 years, the conventional approach to treating atrial
septal defects has been surgical closure via median sternotomy
with cardiopulmonary bypass, regarded as the gold standard.
However, recent advancements in interventional cardiology have
introduced a transformative alternative, transcatheter device
closure. This less invasive technique was first pioneered by King
and Mills in 1976, marking a pivotal moment in ASD treatment
(Quek et al., 2010a).
Transcatheter closure offers numerous advantages, including
reduced procedural complications, shorter hospital stays, and a
less invasive approach compared to traditional surgery. Notably,
about 80% of secundum-type ASDs can be effectively closed using
the available transcatheter devices, rendering this approach
increasingly prevalent in medical institutions (Kotowycz et al.,
2013).
INTRODUCTION
1.1 Background:
While surgical closure has maintained its position as a highly
effective and nearly 100% efficacious option, the advent of
transcatheter closure has added a new dimension to ASD
treatment. This technique has become a viable alternative,
particularly for patients with suitable anatomy. Its utility, however,
should be judiciously evaluated for younger patients given the
procedure's failure rate and safety concerns (Vijarnsorn et al.,
2012).
INTRODUCTION
1.1 Background:
Surgical ASD closure demonstrates its efficacy through very low
mortality rates (below 1%) in patients without significant
comorbidities, particularly in those under 25 years of age and
lacking pulmonary arterial hypertension (Hardman and Zacharias,
2023, Roos-Hesselink et al., 2003). Similarly, transcatheter device
closure has emerged as the preferred option for patients with
amenable secundum ASD anatomy, delivering comparable efficacy
and hemodynamic benefits when compared to surgery, along with
reduced complications and shorter hospital stays (Du et al., 2002,
Ooi et al., 2016, Rosas et al., 2007).
INTRODUCTION
1.1 Background:
The novel transcatheter technique presents its own set of challenges
and complications. Early complications following transcatheter
occlusion of secundum ASD may include issues such as device
embolization, cardiac perforation, or erosion. These can result in the
need for surgical retrieval or repair. Late complications might involve
device infection leading to endocarditis, nickel allergy, thrombus
formation, or the occurrence of residual or recurrent defects
following closure (Chessa et al., 2002, Tadros and Asgar, 2016a).
Therefore, this study aimed to bridge existing knowledge gaps
through assessment of early outcomes associated with surgical and
transcatheter device closure methods for secundum-type atrial
septal defects (ASDs) in a tertiary hospital of Bangladesh. By
scrutinizing early complications and results, the study sought to
provide insights into the relative effectiveness and safety of these
approaches in managing secundum ASDs.
INTRODUCTION
1.1 Rationale
Secundum atrial septal defect (ASD) is one of the most common
congenital heart diseases. A substantial number of affected
children exhibit an absence of significant symptoms associated
with secundum ASD. In accordance with current guidelines, the
method of closure, whether surgical or through transcatheter
devices, assumes paramount importance. This consensus
underscores the necessity of ASD closure, regardless of
symptomatology, unless the defect is exceptionally small. This
proactive strategy aligns with the overarching goal of mitigating
long-term complications, notably atrial arrhythmias, pulmonary
hypertension, and paradoxical embolism. The choice between
surgical and device closure of secundum ASD depends on various
factors, including patient characteristics, clinical context,
available resources, and procedural expertise.
INTRODUCTION
1.1 Rationale
Surgical closure though requires a thoracotomy or sternotomy,
involving a more invasive procedure, has a long-standing history
of success. It achieves immediate closure, eliminating the risk of
residual shunting post-procedure and also enables concurrent
management of any associated cardiac anomalies. Conversely,
transcatheter device closure is minimally invasive in nature that
generally fosters expedited patient recuperation and improved
cosmetic outcomes. But this method requires constant
monitoring and the possibility of device migration, embolism, or
erosion necessitating re-intervention.
INTRODUCTION
1.1 Rationale
Therefore, this study aimed to compare the early outcomes
between surgical and transcatheter device closure for
secundum-type atrial septal defects. The findings of this study
can enhance patient satisfaction, overall quality of life, and the
likelihood of successful treatment outcomes. This, in turn, can
result in streamlined healthcare delivery, and potentially
reduced healthcare expenditures over the long term.
INTRODUCTION
1.3 Hypothesis
1.3.1 Research hypothesis:
Surgical closure of secundum type atrial septal defect is better in
early outcomes than transcatheter device closure.
• 1.3.2 Statistical hypothesis:
• Null Hypothesis (H0):
• There is no significant difference in early outcomes between
surgical closure and transcatheter device closure of secundum
type atrial septal defect.
• Alternative Hypothesis (H1):
• Surgical closure of secundum type atrial septal defect is
associated with better early outcomes compared to
transcatheter device closure.
INTRODUCTION
1.4 Objectives
1.4.1 General Objective:
To compare early postprocedural outcomes between surgical
and transcatheter device closure methods for secundum type
atrial septal defects
1.4.2 Specific Objectives:
1. To evaluate perioperative outcomes, including duration of
surgery, occurrence of hematoma events, device embolism,
and aortic cross clamp time/fluoroscopy time between surgical
and transcatheter device closure methods.
2. To determine the need for ICU/CCU stay in hours, the
occurrence
of
complications
(cardiac
arrhythmias,
pneumothorax, pleural effusion, and the need for
reintervention), and total length of hospital stay for patients
undergoing surgical occlusion or transcatheter device occlusion
undergo.
INTRODUCTION
3. To compare the presence of residual shunt and pre- and
post-procedural pulmonary artery systolic pressure (PASP)
measurements by color Doppler echocardiography between
the surgical and transcatheter device closure techniques for
secundum-type atrial septal defects.
4. To assess New York Heart Association (NYHA) functional class
symptoms pre-procedure and at 6 months after discharge for
patients undergoing both surgical and transcatheter closure.
LITERATURE REVIEW
2.1 Anatomy of ASD
Atrium septal defect (ASD) refers to a direct link between the
heart's atrial chambers, enabling blood to flow between the
systemic and pulmonary circulation. A notable aspect of ASD is its
gradual development, often without symptoms in children and
young adults, leading to delayed detection. As a result, ASD is the
predominant congenital heart condition identified in adulthood,
constituting around 25-30% of newly diagnosed cases. Traditionally,
it has been viewed as a heart issue primarily affecting the right
side, largely due to complications that develop over time, such as
arrhythmias, right heart failure, thromboembolism, and, in some
cases, pulmonary arterial hypertension (PAH). Simultaneously, the
way atrial-level shunts impact the left side of the heart is also
significant, as it results in reduced volume and affects the
interaction between the two ventricles.
LITERATURE REVIEW
2.1 Anatomy of ASD
In many patients, closing the ASD leads to positive changes in
the right ventricle's structure, particularly when considering
patient age, resulting in improved functional status, better
cardiac output, and enhanced exercise capacity irrespective of
age.
Atrial septal defect (ASD) is a common form of congenital heart
disease, accounting for about 10% of all congenital heart defects
in children with a prevalence estimated to affect 100 of 100,000
live births. ASDs are classified according to location, the most
frequent being secundum ASD (75%–80%), primum ASD (15%–
20%), sinus venosus (5%–10%), and the less common defect,
coronary sinus (< 1%). These defects frequently result in left-toright shunting.
LITERATURE REVIEW
2.1 Anatomy of ASD
Current indications for closure, according to American and
European guidelines, are a ratio of pulmonary over systemic flow
> 1.5 and enlargement of the right-sided chambers with or
without symptoms, in the absence of significant pulmonary
hypertension. Closure may also be considered if the pulmonary
vascular resistance is less than two-thirds of the systemic
resistance or if the pulmonary arterial pressure is less than twothirds of the systemic pressure at baseline or responsive to
pulmonary vasodilators (TADROS and ASGAR, 2016b).
LITERATURE REVIEW
A.
B.
Figure-1: Semi-diagrammatic illustrations modified after Patten
showing the embryological development of the atrial septum.
The septum primum has almost reached the endocardial cushion
and the ostium secundum has appeared.
A later stage illustrating how the septum primum forms the valve
of the foramen ovale (Lewis et al., 1955).
Secundum type ASDs are the most common form of all ASDs,
approximately 80%. Survival to the age of 18 years for secundum
atrial septal defect is 97.0% (90.0% to 99.0%). If atrial septal
defects (ASD) left untreated, lead to chronic right sided volume
overload and right-sided chamber enlargement. Therefore, all
patients with hemodynamically significant ASD should undergo
ASD closure, in order to prevent long-term complications (Askari
et al., 2018). 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 (Kotowycz et al.,
2013).
Techniques of ASD closure included surgical closure and device
closure. When dealing with significant cases of secundum ASDs,
surgical closure is typically essential to alleviate symptoms like
fatigue, arrhythmias, and congestive heart failure (King and Milk,
1974). Surgical closure has been for many years, the gold
standard treatment for patients with ASDs (Siddiqui et al., 2014).
ASD surgery has been done for more than 60 years and has
gotten better over time. On the other hand, using devices to
close ASDs was first done as a different method in 1976. This
device method is less invasive, meaning it doesn't involve as
much cutting, and it comes with fewer problems after the
procedure. It's also safer when it comes to anesthesia, and
people don't need to stay in the hospital for as long. This device
method has become very popular in recent times (Askari et al.,
2018).
In 1976, doctors named Mills and King did the first non-surgical
closure of a certain heart problem called secundum atrial septal
defect (ASD). Since then, this non-surgical method has improved
and is used more often nowadays. Another way to fix this heart
issue is with surgery, and it's better than just using medicine for
some types of defects. Surgery works well with certain types of
patients, like older ones, and has good results. In recent years,
there have been big improvements in how we find and treat this
heart problem in both kids and adults, including better ways to
look inside the heart and using devices to fix it without surgery.
But still, many adults with this heart issue don't know they have
it, which can lead to more problems later on, like issues with the
lungs and heart rhythm. This technique has become widely
accessible for appropriate cases, and despite the growing usage
of transcatheter closures, there is limited data comparing its
efficacy, expenses, and potential complications to traditional
surgical approaches (Siddiqui et al., 2014, Thomson et al., 2002).
Surgical closure of atrial septal defect (ASD) was performed for
the first time in 1953. This technique provides good early
postoperative and long-term results. Surgical repair has been
proven to be superior to medical treatment in middle-aged and
elderly patients (Butera et al., 2006).
Kotowycz et al. in their study reported that surgery to close ASDs
shows impressive outcomes over a long period. For those with
the most frequent type of ASD (secundum ASD), there's also an
option to close it using a special method called transcatheter
closure. This method is much less invasive than surgery, comes
with fewer issues right after the procedure, and means a shorter
time spent in the hospital. Around 80% of secundum ASDs can
be closed with the devices currently used, and in many places,
this transcatheter method has become the main way of doing it
(Kotowycz et al., 2013).
2.2 Related previous work:
After using catheter by King and Mills in 1976, various devices
have been utilized, altered, or discontinued. Among the many
devices available today, the Amplatzer septal occluder has been
extensively used to close ASDs and is now recognized as one of
the established devices globally for non-surgical ASD treatment
due to its safety record. In recent times, improvements in
minimally invasive surgical techniques and devices delivered
through catheters have made these procedures a preferable
option over traditional surgery. In fact, they are rapidly
becoming a more common choice than open heart surgery,
particularly in instances where ASD closure is concerned (Quek
et al., 2010b).
2.2 Related previous work:
There were controversies regarding hospital costs and achieving
full closure. In contrast, surgery to close ASDs is relatively
straightforward and doesn't need specialized long-term
monitoring. However, the success of using devices for closure
depends on the doctor's experience, and after using devices to
close the defect, patients need to be watched closely over time
to catch any serious problems that might develop later on
(Askari et al., 2018, Kotowycz et al., 2013).
2.2 Related previous work:
There is an increasing interest in studies that compare how well
different treatments work in real-life medical settings. In 2010,
the Patient Protection and Affordable Care Act made it
important to research how effective different treatments are
for improving healthcare. While not everyone agrees on the
value of measuring cost-effectiveness as much as how well a
treatment works, it's still important, especially for expensive
procedures. Since the use of transcatheter closure for ASDs has
become so common, it's a good idea to see if it's cost-effective
compared to other methods as part of a broader comparison
(Mylotte et al., 2014).
2.2 Related previous work:
Butera et al. reported the complications associated with surgery
of Secundum Atrial Septal defect and categorized in to major and
minor. The minor complications were transient arrhythmias or
arrhythmias interrupted by drugs, respiratory tract infections,
pericardial effusion or pneumothorax not requiring mechanical
drainage, mild anemia not requiring transfusion, others; we
defined this as mild a complication that could be completely
treated by drugs and gave no hemodynamic abnormalities. The
major complications were heart failure, transient AV block
needing a temporary pacemaker, severe bleeding requiring
reoperation, cardiac tamponade, arrhythmias responsible for
hemodynamic decompensation requiring immediate electrical
cardioversion, surgical drainage of a pericardial or pleural effusion
or of a pneumothorax, reoperation, severe anemia requiring
blood transfusion, thrombus formation on the atriotomy treated
by heparin (Butera et al., 2006).
2.2 Related previous work:
Chessa et al. categorized the complications associated with
transcatheter occlusion of Secundum Atrial Septal defect into
major and minor group. Major complications included all events
leading to one of the following: 1) death; 2) life-threatening
hemodynamic decompensation requiring immediate therapy; 3)
need for surgical intervention; and 4) significant permanent
anatomic or functional lesion resulting from catheterization,
device embolization/malposition needing surgical retrieval and
surgical closure of the ASD, thrombus formation on the device
treated by heparin, vascular injury of the femoral vessels
requiring vascular surgery repair, pericardial effusion with or
without cardiac tamponade due to perforation of the left atrial
and aortic wall by the device. Minor complications were defined
as events that were transient and resolved with specific
treatment such as groin hematoma (Butera et al., 2006, Chessa
et al., 2002).
Tadros and Asgar reported that, transcatheter closure of ASDs has
progressed because of the development of the first stainless steel
devices covered by Dacron and is now the gold standard for the
treatment of secundum ASDs. Patients with defects amenable to
transcatheter closure can be divided into simple secundum
defects (< 26 mm in diameter) and more complex secundum
ASDs, which are larger and may have concomitant rim deficiency.
Patients with defects > 40 mm, or those with multiple deficient
rims or coexistent pulmonary venous anomalies, are usually
referred for surgical closure (TADROS and ASGAR, 2016b).
Historically, surgical closure (SC) had been considered the
standard of care with excellent long-term results. Over the past
few decades, the popularity of transcatheter device closure (TCC)
has increased as studies have demonstrated its safety and
efficacy (Villablanca et al., 2017).
Helmy et al in their study revealed that subjects who underwent
surgical procedures had significantly more complications than
subjects who underwent transcatheter closure procedure. Hospital
stays were significantly longer for surgical patients than for
transcatheter closure patients. In addition, all surgical subjects
required intensive care. Transcatheter closure had a mean total
cost of 52.7 (SD 6.7) million Rupiahs while the mean cost of surgery
was 47 (SD 9.2) million Rupiahs (P<0.0001). Since the ASO device
cost represented 58% of the total cost of transcatheter closure, the
mean cost of transcatheter closure procedure without the device
itself was less costly than surgery. Transcatheter closure using ASO
has a similar efficacy to that of surgical closure procedure.
However, individuals who received transcatheter closure
experience reduced rates of complications and spend less time in
the hospital compared to those who underwent surgery.
However, it's important to note that the expenses associated with
transcatheter closure are higher in comparison to the surgical
procedure (Helmy et al., 2013).
Some small studies in the past have shown that using
transcatheter methods to close ASDs might be less expensive
during the hospital stay and the procedure compared to surgery.
In order to gain a genuine comprehension of the cost efficiency of
a new medical approach, it's imperative to examine its influence
on the entire cohort of potential recipients of the treatment.
Additionally, it's crucial to evaluate its efficacy over both the short
and extended durations.
There are few studies comparing SC to TCC, and no clear
superiority of one technique over the other is known. This study
could help to assess the efficacy and safety with direct
comparisons between TCC and SC approaches for ASD closure.
3. MATERIALS AND METHODS
Study design:
This study was a comparative cross-sectional study.
3.2 Place of study:
The study was conducted at the Department of Cardiac Surgery
and Paediatric Cardiology, National Institute of Cardiovascular
Diseases (NICVD), Sher-e-Bangla Nagar, Dhaka, Bangladesh.
3.3 Period of study:
From August 2018 to July 2020.
3. MATERIALS AND METHODS
3.4 Study population:
The study population was the patients aged 4-16 years with type
II or secundum type atrial septal defects admitted in the
Department of Cardiac Surgery and Paediatric Cardiology
Department, NICVD Dhaka.
3.5 Study sample:
Patients who were admitted for intervention, either surgical or
transcatheter device closure, for secundum ASDs after fulfilling
the inclusion criteria in the Department of Cardiac Surgery and
Pediatric Cardiology Department, NICVD Dhaka.
3. MATERIALS AND METHODS
3.6 Ethical clearance:
Ethical clearance for the study was obtained from Ethical
Review Committee of NICVD, Sher-e-Bangla Nagar, Dhaka
before the commencement of this study.
3.7 Selection criteria
3.7.1 Inclusion criteria:
Patients aged between 4 to 16 years.
Diagnosed patients of isolated secundum atrial septal defects
thorough color doppler echocardiography with left-to-right
shunt causing right ventricular volume overload, as evidenced
by a Qp/Qs ratio of ≥1.5:1, who were indicated for
intervention.
3. MATERIALS AND METHODS
Transcatheter device closer group:
Patients with secundum ASD diameter up to 38 mm
Presence of 5 mm distance from the margins of the ASD to the
coronary sinus, atrio-ventricular valves and right upper
pulmonary vein as measured by echocardiography.
Surgical closure group:
Patients with secundum ASD of any diameter.
3. MATERIALS AND METHODS
3.7.2 Exclusion criteria:
Presence of associated congenital cardiac anomalies (ventricular
septal defect, tetralogy of Fallot, pulmonary stenosis etc.) requiring
surgical repair
Pulmonary vascular resistance ≥ 7 woods per units
Right-to-left shunt at the atrial level with a peripheral arterial
saturation ≤ 94%
Decompensated congestive cardiac failure.
3.8 Study groups:
After enrolment, the study subjects were purposively distributed
into the following two groups –
3. MATERIALS AND METHODS
Group A: Patients who had undergone surgical closure for
secundum ASD.
Group B: Patients who had undergone transcatheter device closure
for secundum ASD.
3.9 Sampling technique:
Purposive sampling was done according to the surgeon’s choice
who fulfilled the selection criteria.
3. MATERIALS AND METHODS
3.10 Determination of sample size:
Sample size was calculated using analysis of difference between two
proportion:
(Islam, 2022)
Where,
n = sample size
P1 = Proportion of patients developing adverse outcome in group-A
= 63% =0.63
P2 = Proportion of patients developing adverse outcome in group-B
= 33% = 0.33
3. MATERIALS AND METHODS
3.10 Determination of sample size:
[Values were taken from the study by (Kotowycz et al., 2013)]
Zα = Z-value (two tail) at a definite level of significance
= 1.96 (at 5% level of significance)
Zβ = The lower one tailed Z value related to the alternate
hypothesis
= 0.85 (at 80% power, when β=0.1)
3. MATERIALS AND METHODS
Therefore,
3.58640862
=
0.09
= 39.848984666666666666666666666667
≈ 40
So, the calculated sample size was, n = 40 (in each group).
Due to limitations of time and economic constraints, and
availability of the patients within the time period a total of 72
patients with secundum ASD were included in the study fulfilling
the selection criteria (surgical patients = 42, device patients =
30).
3.11 Study variables:
• Independent variables:
• Demographic variables:
• Age (in years)
• Sex (M/F)
• Body mass index (kg/m2)
• Clinical variables:
• NYHA functional class
•
•
•
•
•
Pre-operative investigation:
Chest X-ray (P/A view) :
Cardiomegaly
Prominent pulmonary conus
Increased pulmonary vascularity.
• Echocardiography :
• Primary ASD size (mm).
• PASP
B. Dependent variables:
a. Per-operative outcome:
• Fluoroscopy time (minutes)
• Device embolism
• Aortic cross-clamp time (min)
• Cardiopulmonary bypass time (min)
• Procedural time (minutes)
b. Post-operative outcome:
• ICU/CCU stay in hours.
• Uses of inotropic agents
• Cardiac arrhythmias
• Bleeding / Hematoma
• Pleural / Pericardial effusion
• Need of reintervention
• Any residual shunt
• Endocarditis
• Length of hospital stay (days).
3.12 Study procedure:
After obtaining approval from the Ethical Review Committee of
NICVD, Dhaka this prospective observational study has been
conducted in the Department of Cardiac Surgery and Paediatric
Cardiology, National Institute of Cardiovascular Diseases from
August 2018 to July 2020.
3.12 Study procedure:
Informed written consent from all patients was obtained for this
study. Cases were selected purposively. The study population
were patients admitted in the Department of Cardiac Surgery and
also in the Department of Paediatric Cardiology, NICVD, Sher-EBangla Nagar, Dhaka for secundum ASD closure in the study
period. A total number of 72 patients were selected from the
study population according to the inclusion and exclusion criteria.
The study subjects who underwent surgical closure for secundum
ASD under general anesthesia with endotracheal intubation were
categorized into Group A (n = 42) and the rest of the participants
were enrolled in Group B (n = 30) who underwent transcatheter
device closure under local anesthesia with or without continuous
transesophageal echocardiographic (TEE) monitoring, which were
appropriate for the patients. Each participant underwent
echocardiography to assess pre- operative PASP and size of the
secundum ASD , post operative PASP and residual shunt.
After percutaneous entry of the femoral vein, a complete
hemodynamic evaluation was performed in each Group B patient.
This was followed by an angiogram in the right upper pulmonary
vein in the hepato-clavicular projection to further delineate the
atrial septum.
The sheath was usually positioned over the guide wire inside the
left upper pulmonary vein or in the middle of the left atrium.
Under fluoroscopic and TEE guidance, both discs of the device were
deployed across the defect (Amplatzer ASD Occluder). Once the
device has been deployed and released, repeat TEE and angiogram
were performed in Group B patients to assess the result of closure.
A dose of an appropriate antibiotic was given during the procedure
and two doses at 8h interval was given after. Patients were usually
observed overnight. All patients were instructed about infective
endocarditis prophylaxis for a total of six months after device
placement. Aspirin 3–5 mg/kg was initiated 48h before closure and
continued for six months after.
For patients who underwent surgical closure (Group A), standard
ASD repair under general endotracheal anesthesia was
performed. The chest was opened by sternotomy. After the
establishment of CPB, the right atrium was opened. The ASD was
closed either by direct suture or by using a glutaraldehyde
treated pericardial patch. After closing the right atrium, weaning
from CPB and securing all the bleeding points, the sternum and
surgical wounds were closed in layers. Then the patient was then
transferred to intensive care unit and then to step down. On
stabilization patients were discharged with advice.
Data was collected before the procedure, during the procedure,
post- procedural hospital stay in ICU/CCU and 6 months after
discharge from the hospital in all the patients. All the patients
clinical outcomes including the procedural complications were
evaluated and managed accordingly. For each and every subject
a separate data collection sheet was prepared. There were no
dropouts. Collected data were analyzed and compared between
the two interventions group using Microsoft Excel and the latest
version of SPSS software (v27.0). A comparative analysis was
performed between the two groups to ascertain any discernible
differences between their respective outcomes.
3.13 Data collection technique:
Every subject fulfilling the inclusion criteria was selected until
the required sample size was achieved. The demographic
information, relevant history, examination findings and
investigation reports and outcome of treatment of all the study
subjects were recorded in the data collection sheet. Patients
were evaluated for any post-intervention adverse effects. The
data sheet was filled up from documents from the patients and
report of laboratory.
3.14 Statistical analysis:
After completion of data collection, the data were checked and
edited manually and verified before tabulation. Data were
coded, entered, and analyzed on a computer. The statistical
analysis was conducted using IBM SPSS (statistical package for
social science) Windows version 27.0 statistical software. After
compilation, the data were presented in the form of tables and
figures as necessary. Data were expressed as means, median,
range and standard deviations for continuous variables and as
frequency and percentage for categorical variables. For statistical
analysis, The Chi-Square Test and Fisher’s exact test were applied
to compare categorical data. Student’s unpaired t-test and
paired sample t-test (for normally distributed numerical data)
were done to compare continuous data between two groups. P
value <0.05 was considered statistically significant.
3.15 Schematic presentation of the study procedure
and data processing:
3.15 Schematic presentation of the study procedure
and data processing:
3.16 Research tools:
Patient’s treatment records and investigations report.
Consent form (appendix III-IV).
Data collection sheet (appendix V).
3.17 Ethical aspects:
Permission for the study was taken from the Department of
Cardiac Surgery and Department of Cardiology, NICVD, Sher-eBangla Nagar, Dhaka. Ethical clearance for the study was taken
from the Ethical Review Committee of NICVD prior to the
commencement of this study.
The aim and objectives of the study along with its procedure, risks
and benefits of this study was explained to the study subjects in an
easily understandable local language. Total study process and
public health benefits also were elaborately described. Study risk,
time and cardiac preventive measures about the disease was
clearly defined to the subjects. A written informed consent was
taken from all the study subjects without exploiting any of their
weakness. Participants were assured of adequate treatment of any
complications developed in relation to the purpose of the study. All
the study subjects were assured about their confidentiality and
freedom to withdraw themselves from the study at any time.
Patients had the freedom of not to participate in the study. Normal
treatment preceded as per the general treatment protocol of the
hospital, even if patient did not participate in the research.
3.18 Operational definitions:
Intensive care unit (ICU) stay:
Defined as the duration of ICU stay needed after operation
including the potential need for additional stay after
readmission.
Prolong intensive care unit (ICU) stay:
Defined as the duration of ICU stay more than 48 hours (Perrea
et al., 2011)
Prolonged ventilation:
Prolonged postoperative mechanical ventilator support for more
than 48 hours (Bojar, 2021).
Early post operative period:
The early postoperative was defined as the time from awakening
after surgery till 6 months after discharge from hospital (Meyer
et al., 2016).
Hospital stays:
Defined as the duration of post-operative stay at NICVD,
including ICU, post-ICU, post-operative ward.
Postoperative hospital stays:
Defined as the duration of postoperative stay of patient in ICU
and ward. Normally it is ≤7 days. However, if there is indication
for discharge on or before 7th day, yet the patient prefers to
prolong his/her stay for personal convenience then it will not be
considered as a prolonged hospital stay (Bojar, 2021).
Cardiopulmonary Bypass (CPB):
Cardiopulmonary bypass is a process by which systemic venous
blood is taken from the patient, transferred to a pump
oxygenator and delivered back to the arterial circulation of the
patient (Bojar, 2021).
Body Mass Index (BMI):
Weight in Kg/(Height in meter)2.
Left atrial index:
Left atrial volume (ml) / Body surface area (m2)
Pulmonary Artery Systolic Pressure (PASP):
Normal pulmonary artery systolic pressure at rest is 18 to 25 mm
Hg, with a mean pulmonary pressure ranging from 12 to 16 mm
Hg (Nauser and Stites, 2001).
Significant arrythmia:
Atrial fibrillation
Ventricular tachycardia
Ventricular fibrillation
High degree AV block / 3rd degree or complete heart block
Second degree heart block
Atrial fibrillation (AF):
AF arrhythmia characterized by both abnormal automatic firing
and the presence of multiple interacting re-entry circuits looping
around the atria. Episodes of atrial fibrillation are initiated by
rapid bursts of ectopic beats arising from conducting tissue in the
pulmonary veins or from diseased atrial tissue. AF becomes
sustained because of re-entrant conduction within the atria or
sometimes because of continuous ectopic firing (Davidson, 2014).
Reintervention:
May be defined as graft or device– related reoperation either
during the index admission period or later (Hwang 2017).
Re-exploration of bleeding:
It is defined as bleeding that required surgical reoperation after
initial departure from operating theatre.
Congestive Cardiac Failure–Killip Classification: (Killip and
Kimball, 1967)
Class I: Absence of crackles / rales over the lung fields and S3
Class II: Crackles / rales over 50% or less the lung fields and
presence of S3 gallop
Class III: Crackles / rales over 50% the lung fields and presence of
S3 gallop
Class IV: Cardiogenic shock
NYHA functional class:
Class
Symptoms
I
Cardiac disease, but no symptoms and no limitation in
ordinary physical activity, e.g., shortness of breath when
walking, climbing stairs etc.
II
Mild symptoms (mild shortness of breath and/or angina)
and slight limitation during ordinary activity.
III
Marked limitation in activity due to symptoms, even
during less-than-ordinary activity, e.g., walking short
distance(20–100m).
Comfortable only at rest.
IV
Severe limitations. Experiences symptoms even while at
rest. Mostly bedbound patients.
RESULTS
4.1 Age distribution:
Table I shows, 4-10 years of age patients mostly (71.9%)
underwent surgical closure followed by 11-16 years old patients
(47.5%). Over half (52.5%) of 11-16 years old patients with
secundum ASD underwent device closure (group B) followed by
4-10 years old participants who accounted for 28.1%. The mean
age of group A patients were 10.38±3.29 years compared to
12.03±2.75 years in group B. Both the differences in distributions
of respondents were statistically significant (p<0.05).
Table I: Comparison of patients by age between two groups (group
A = 42, group B = 30)
Age (years)
Group A
f (%)
Group B
f (%)
Total
f (%)
4 – 10
23 (71.9)
9 (28.1)
32 (100.0)
11 – 16
19 (47.5)
21 (52.5)
40 (100.0)
p-value
a0.037s
b0.028s
Mean ± SD 10.38 ± 3.29 12.03 ± 2.75
Data were presented as frequency (f) and percentage (%), mean ±SD.
Figures in the parentheses denote corresponding percentage (%).
aStatistical analysis was done by Chi-square (ꭓ2) test.
bIndependent sample t-test was done to compare the mean between
two groups.
p-value <0.05 was considered as significant.
s = significant
4.2 Gender distribution:
Table II illustrates, the male patients were predominant (60.7%)
in group A and females (43.2%) in group B. Male female ratio
was 0.7:1 in group A and 0.6:1 in group B. But there was no
significant difference between the two groups in respect of
gender distribution (p = 0.739).
Table II: Comparison of patients by gender between two groups
(group A = 42, group B = 30)
Group A
Group B
Total
Gender
p value
f (%)
f (%)
f (%)
Male
17 (60.7)
11 (39.3)
28 (100)
Female
25 (56.8)
19 (43.2)
44 (100)
Male: Female
0.7:1
0.6:1
0.8:1
Data were presented as frequency (f) and percentage (%).
Figures in the parentheses denote corresponding percentage (%).
aStatistical analysis was done by Chi-square (ꭓ2) test.
p-value <0.05 was considered as significant.
ns = Not significant
a0.744ns
4.3 Comparison of clinical features:
The mean New York Heart Association (NYHA) functional score
was 1.76±0.75 in group A patients and 1.53±0.78 in group B
patients (p = 0.216). The majority of the patients (72.7%) who
underwent surgery preoperatively had class II symptoms. Over
half (51.4%) of patients in group B had class I symptoms,
followed by class III symptoms (38.5%). However, the functional
class distribution of study participants between two groups was
not statistically significant (p>0.05).
Table III: Comparison of pre-intervention NYHA functional class
between two groups (group A = 42, group B = 30)
Functional Class
(NYHA)
Group A
Group B
Total
f (%)
f (%)
f (%)
Class I
18 (48.6)
p value
19 (51.4) 37 (100.0)
Class II
16 (72.7)
6 (27.3) 22 (100.0) c0.187ns
Class III
8 (61.5)
5 (38.5) 13 (100.0)
b0.216ns
Mean ± SD
1.76 ± 0.75 1.53 ± 0.78
Data were presented as frequency (f) and percentage (%), mean ± SD.
Figures in the parentheses denote corresponding percentage (%).
cFisher’s exact test was done to compare frequency and percentage
between two groups.
bIndependent sample t-test was done to compare mean between two
groups.
p-value <0.05 was considered as significant.
ns = Not significant
4.4 Comparison of preoperative chest X-ray features:
Table IV demonstrates that cardiomegaly was observed in chest
X-ray in 60.0% of group A patients, followed by prominent
pulmonary coning occurred in 57.1% of participants. Increased
pulmonary vascularity was observed in 43.8% of Group B
respondents, followed by prominent pulmonary conus (42.9%).
However, none of these differences in distributions between the
two groups were found statistically significant (p>0.05).
Table IV: Comparison of preintervention chest X-ray features
between two groups (group A = 42, group B = 30)
X-ray findings
Cardiomegaly
Prominent pulmonary
conus
Increased pulmonary
vascularity
Group A
f (%)
3 (60.0)
Group B Total
f (%)
f (%)
2 (40.0) 5 (100.0)
14
8 (57.1)
6 (42.9)
(100.0)
32
18 (56.3) 14 (43.8)
(100.0)
p-value
a0.643ns
a0.920ns
a0.748ns
Data were expressed as mean and standard deviation (SD).
aStatistical analysis was done by Chi-square (ꭓ2) test.
p value <0.05 was considered as significant.
ns = not significant
4.5 Comparison of preoperative echocardiography features:
Table V exhibits, the mean (±SD) secundum ASD size was
19.60±5.54 mm in group A patient compared to 17.30±5.17 mm
in group B participants. The pre-procedure pulmonary artery
systolic pressure (PASP) was 26.48±5.47mm Hg in group A
respondents compared to 24.20±5.01 mm Hg in group B study
subjects. None of these mean differences between the two
groups were statistically significant (p>0.05).
Table V: Comparison of preintervention transesophageal
echocardiogram (TEE) features between two groups (group A =
40, group B = 32)
Group A
Mean ± SD
Group B
Mean ± SD
p-value
ASD size (mm)
19.60 ± 5.54
17.30 ± 5.17
b0.079ns
PASP (mmHg)
26.48 ± 5.47
24.23 ± 5.01
b0.076ns
Parameters
Data were expressed as mean and standard deviation (SD).
bIndependent sample t-test was done to compare the mean
between two groups.
p value <0.05 was considered as significant.
ns = not significant
4.6 Comparison of early outcome attributes:
Table VI shows that arrhythmias were present in 55.6% of the
group A patients compared to over two-fifths (44.4%) in group B
participants. This difference in distribution of the respondents
were statistically not significant between the two groups (p >
0.05).
Table VI: Comparison of associated comorbidities between two
groups (group A = 42, group B = 30)
Risk factors
Group A
f (%)
Group B
f (%)
Total
f (%)
Arrythmias
5 (55.6)
4 (44.4)
9 (100.0)
pvalue
c1.000n
s
Data were expressed as frequency (f) and percentage (%).
Figures in the parentheses denote corresponding percentage (%).
cFisher’s exact test was done to compare frequency and
percentage between two groups.
aStatistical analysis was done by Chi-square (ꭓ2) test.
p value <0.05 was considered as significant.
ns = not significant
4.7 Comparison of per-operative attributes:
Table VII shows that the average time for surgical closure of the
secundum ASD was 121.14±20.92 minutes, compared to the
procedure time for transcatheter device placement at
40.69±8.11 minutes (p <0.001). Mean cardiopulmonary bypass
time in group A patients was 40.96±1.26 minutes, and the
average fluoroscopy time was 13.02±3.27 minutes in group B
participants. The aortic cross clamp time in group A respondents
was 31.89±4.12 minutes. Only one patient in group B had a
device embolism. On the table deferred for surgery was
observed in only 2 patients in group B.
Table VII: Comparison of per-operative attributes between two
groups (group A = 42, group B = 30)
Groups
Per-operative attribute
Duration of surgery/
procedure time (minutes)
Cardiopulmonary bypass
time (min)
Fluoroscopy time (minutes)
Aortic cross clamp time
(minutes)
Device embolism
On table deferred for
surgery
Group A
Group B
Mean ± SD
Mean ± SD
p value
121.14 ± 20.92 40.69 ± 8.11 b<0.001s
40.96 ± 1.26
-
-
13.02 ± 3.27
31.89 ± 4.12
-
-
1/30 (0.33)
-
2/30 (6.67)
Table VII: Comparison of per-operative attributes between two
groups (group A = 42, group B = 30)
Data were expressed as mean ± SD.
bIndependent sample t-test was done to compare the mean
between two groups.
Figures in the parentheses denote corresponding percentage (%).
p value <0.05 was considered as significant.
s = significant
ns = not significant
4.8 Comparison of postoperative early clinical outcome:
Patients in group A had significantly longer duration of ICU stay
(3.31±0.56 days vs. 2.07±0.45 days; p < 0.001), longer use of
inotropes (38.36±3.88 hours vs. 12.27±2.13 hours; p < 0.001),
and longer length of postoperative hospital stay (8.52±1.13 days
vs. 2.93±1.08 days; p < 0.001) compared to group B patients. No
significant difference was found between the two groups
regarding postoperative bleeding/hematoma, pleural/pericardial
effusion, reintervention and device endocarditis (p>0.05).
Table VIII: Comparison of postoperative attributes between
two groups (group A = 42, group B = 30)
Postoperative outcome
ICU/CCU stay (days)
Use of inotropes (hours)
Arrythmias
Bleeding or hematoma
Pleural or pericardial effusion
Reopening
Device endocarditis
Duration hospital stay (days)
Group A
Mean ± SD
3.31 ± 0.56
38.36 ± 3.88
5 (55.6)
3 (60.0)
1 (33.3)
0 (0.0)
0 (0.0)
8.52 ± 1.13
Group B
Mean ± SD
2.07 ± 0.45
12.27 ± 2.13
4 (44.4)
2 (40.0)
2 (66.7)
1 (100.0)
2 (100.0)
2.93 ± 1.08
p value
b<0.001s
b<0.001s
c1.000ns
c1.000ns
c0.567ns
c0.417ns
c0.170ns
b<0.001s
Table VIII: Comparison of postoperative attributes between two
groups (group A = 42, group B = 30)
Data were expressed as mean ± SD.
bIndependent sample t-test was done to compare the mean
between two groups.
cFisher’s exact test was done to compare frequency and
percentage between two groups.
Figures in the parentheses denote corresponding percentage (%).
p value <0.05 was considered as significant.
s = significant
ns = not significant
4.9 Comparison of postoperative echocardiography findings on
follow-up:
Table IX reveals that immediate procedure success was observed
in all patients undergoing surgery compared to 90.0% in device
closure group. There was no residual ASD (≥2 mm) after surgery,
whereas it was present in 3 patients after transcatheter device
closure and this difference in distribution was found statistically
not significant (p = 0.068). Regarding postoperative PASP, there
was no statistically significant difference between the two
groups (group A: 22.1±2.23 vs. group B: 22.5±4.06 mmHg; pvalue = 0.589).
Table IX: Comparison of postoperative echocardiogram findings
on follow-up at 6 months following discharge between two
groups (group A = 42, group B = 30)
Parameters
Immediate
procedure success
Residual ASD
(≥2mm)
Pulmonary arterial
systolic pressure
(mmHg)
Group A
Group B
Mean ± SD
Mean ± SD
42/42 (100.0)
27/30 (90.0)
-
0 (0.0)
3 (100.0)
c0.068ns
22.10 ± 2.23
22.50 ± 4.06
b0.589ns
p-value
Table IX: Comparison of postoperative echocardiogram findings
on follow-up at 6 months following discharge between two
groups (group A = 42, group B = 30)
Data were expressed as mean and standard deviation (SD).
bIndependent sample t-test was done to compare the mean
between two groups.
cFisher’s exact test was done to compare frequency and
percentage between two groups.
p value <0.05 was considered as significant.
ns = not significant
4.10 Comparison of NYHA functional score at discharge:
Table X shows that post-operative NYHA class II in 60.0%
respondents following surgical closure of secundum ASD,
whereas class I symptoms were observed more (42.1%) than
class II (40.0%) in group B participants (p>0.05). The difference
between the mean NYHA score was also statistically not
significant between the two groups (p=0.851).
Table X: Comparison of postoperative NYHA functional class on
follow-up at 6 months following discharge between two groups
(group A = 42, group B = 30)
Functional Class Group A
Group B
Total
p value
(NYHA)
f (%)
f (%)
f (%)
Class I
33 (57.9) 24 (42.1) 57 (100.0) a
0.883ns
Class II
9 (60.0)
6 (40.0) 15 (100.0)
b0.885ns
Mean ± SD
1.21 ± 0.42 1.20 ± 0.41
Data were presented as frequency (f) and percentage (%), mean ±
SD.
Figures in the parentheses denote corresponding percentage (%).
aStatistical analysis was done by Chi-square (ꭓ2) test.
bIndependent sample t-test was done to compare mean between
two groups.
p-value <0.05 was considered as significant.
ns = Not significant
4.11 Comparison of pre- and post-interventions clinical
outcome based on NYHA classification:
Table XI presents a comparative analysis of the distribution of
patients in different New York Heart Association (N In the device
closure group, all the patients who were in NYHA Class I before
the procedure remained in Class I after the procedure. Among
patients with preoperative Class III symptoms, 40.0% improved
to Class I, while 60.0% improved to Class II post-device closure.
In the surgical closure group, all patients who were initially in
NYHA Class I remained in Class I after the surgery. Among
patients with preoperative Class III symptoms, a significant
proportion (75.0%) improved to Class I, while 25.0% improved to
Class II following surgical closure.
Statistical analysis demonstrated that these differences in
patient distribution among NYHA classes were statistically
significant (p<0.05).
Table XI: Comparison of pre- and post-intervention NYHA
and PASP values in surgical and device closure patients
(group A = 42, group B = 30)
Postoperative stages in
Preoperative
follow-up at 6 months
stages at
Total
(NYHA classification)
n (%)
admission
I
II
(NYHA class.)
n (%)
n (%)
Device closure (n=30)
I
19 (100)
0 (0)
19 (100.0)
II
5 (83.3)
1 (16.7)
6 (100.0)
III
2 (40.0)
3 (60.0)
5 (100.0)
Surgical closure (n=42)
I
18 (100.0)
0 (0.0)
18 (100.0)
II
11 (68.8)
5 (31.3)
16 (100.0)
III
6 (75.0)
2 (25.0)
8 (100.0)
P-value
c0.045s
c0.017s
Table XI: Comparison of pre- and post-intervention NYHA and
PASP values in surgical and device closure patients (group A =
42, group B = 30)
Data were presented as frequency (f) and percentage (%).
Figures in the parentheses denote corresponding percentage
(%).
cFisher’s exact test was done to compare frequency and
percentage between two groups.
p-value <0.05 was considered as significant.
s = significant
4.12 Comparison of pre- and post-interventions pulmonary
arterial systolic pressure (PASP):
Table XI shows that after both interventions, e.g., surgical closure
and transcatheter device closure of secundum ASDs, there was a
significant decrease in PASP (p < 0.05). After surgery, the average
reduction in PASP was 4.38±2.32 mmHg. After device closure,
the average reduction in PASP was 1.73±1.06 mmHg.
Table XI: Comparison of pre- and post-intervention pulmonary
arterial systolic pressure (PASP) values in surgical and device
closure patients (group A = 42, group B = 30)
Preprocedura
l value
Parameters
Mean ± SD
Surgical closure (n=42)
PASP
26.48 ± 5.47
(mmHg)
Device closure (n=32)
PASP
24.23 ± 5.01
(mmHg)
Postprocedu
Difference
p
ral value
95% CI
value
Mean ± SD Mean ±SD
4.38 ± 2.32 2.72-6.04 d<0.0
22.10 ± 2.23
01s
1.73 ± 1.06 1.14-2.35 d<0.0
22.50 ± 4.06
01s
Table XI: Comparison of pre- and post-intervention pulmonary
arterial systolic pressure (PASP) values in surgical and device
closure patients (group A = 42, group B = 30)
Data were presented as mean ± SD.
bIndependent sample t-test was done to compare mean
between two groups.
p-value <0.05 was considered as significant.
s = not significant
5.0 Discussion:
The major finding of the present study, which included 72
patients aged between 4- and 16 years undergoing intervention
for secundum atrial septal defects at the Department of Cardiac
Surgery and Paediatric Cardiology, NICVD, Dhaka, was that both
transcatheter devices and surgical procedures were good
methods for successful secundum ASD closure. The benefits of
transcatheter closure of ASD with Amplatzer septal occluder
devices included a shorter procedure time and a shorter stay in
the coronary care unit after the procedure, as well as an overall
shorter length of hospital stay for patients, whereas surgical
secundum ASD closure had fewer complications and good overall
success rates.
In this study, patients were divided into two groups depending
on the type of intervention. Forty-two patients who underwent
surgical closure with large defect or inadequate tissue rims from
the defects to important surrounding structures assessed by
echocardiography were assigned to group A, and the remaining
thirty patients who underwent transcatheter device closure for
secundum ASD greater than 5mm with signs of RV dilatation and
adequate rims of interatrial septal tissue between the defect and
adjacent structures on echocardiogram were included in group
B. Though the majority of patients in the surgical (23/42)
belonged to the age group between 4 and 10 years and device
closure (21/30) group belonged to the age group between 11
and 16 years, with the patients in group B were older than those
in group A (12.03±2.75 vs. 10.38±3.29 years, respectively, pvalue = 0.028).
Males were predominant in group A whereas females in group B.
But the distribution of patients according to age gender was not
significantly different between the two groups (p = 0.744). These
demographic characteristics were consistent with various studies
around the world (Askari et al., 2018, Butera et al., 2006) which
also reported a relatively lower age in the surgical closure group
compared to the device closure group, with no differences in the
gender distribution of respondents between the corresponding
groups.
In this study, 72.7% of patients in group A had New York Heart
Association functional class II symptoms preoperatively, whereas
class I symptoms were more common in group B in the
preintervention stage (51.4%). The average NYHA score in group
A was slightly higher preoperatively (1.76±0.75) compared to the
preprocedural value of patients in group B (1.53±0.78), but these
differences were statistically not significant (p>0.05). There were
significant differences between the preprocedural mean NYHA
score and postprocedural mean NYHA at follow-up on 6 months
after discharged in surgical closure group and transcatheter
device closure group. This finding is consistent with
(Schneeberger et al., 2017, Thilén and Persson, 2006), who also
observed
improvements
in
NYHA
functional
class
postoperatively.
In the present study, there were no significant differences in the
distribution of respondents between the two intervention
groups with regard to their preoperative chest X-ray findings of
cardiomegaly (p=0.643), pronounced pulmonary cone (p=0.920),
and increased pulmonary vascularity (p=0.748). A study by
Helmy et al. also observed similar results (Helmy et al., 2013).
In this study, the ASD size in the surgical closure group was
relatively larger than that in the device closure group
(19.60±5.54 vs. 17.30±5.17 mm, respectively, p=0.079). This
finding was comparable with the study by Du et al. who
observed that the size of the primary ASD was 13.3±5.4 mm for
the device group and 14.2±6.3 mm for the surgery group (p =
0.099) (Du et al., 2002).
Pre-procedure PASP was 26.48±5.47 mm Hg in group A, which
was slightly higher than the group B respondents (24.23±5.01
mm Hg), but this difference between the two groups was
statistically not significant (p=0.076). After surgical closure of the
secundum ASD, the PASP level decreased significantly compared
to the pre-intervention period with a mean difference of
4.38±2.32 mmHg (p<0.001). Likewise, after device closure, there
was a postprocedural PASP reduction with a mean difference of
1.73±1.06 mmHg compared to preprocedural PASP (p < 0.001).
These findings were in agreement with the study by Askari et al.
(2018) and Siddiqui et al. (2014), who also observed no
significant difference in preoperative ASD size. Harjula and
colleagues also found decreased mean pulmonary artery
pressure in all those who had preoperative hypertension (mean
25 mmHg vs. 33 mmHg) (Harjula et al., 1988).
The present study demonstrated insignificant variation in
preoperative comorbidities such as arrhythmias (p=1.000)
between the two groups. These results agree with the findings of
Askari et al. (2018) but differ from Mylotte et al. (2014) and
Schneeberger et al. (2017) who found that there was a
significant variation in the distribution of preoperative
comorbidities especially arrhythmias between the two study
groups.
The mean time for placement of the transcatheter device was
significantly shorter in the group (40.69±8.11 minutes) compared
to surgical closure of the Secundum ASD (121.14±20.92 minutes),
p<0.001. Likewise, cardiopulmonary bypass time (CPB) was
significantly longer in Group A patients, at 40.96±1.26 minutes, in
contrast to the significantly shorter fluoroscopy time (13.02±3.27
minutes) observed in Group B participants. The mean aortic cross
clamp time was 31.89±4.12 minutes in group A patients. The
findings of significantly shorter procedure times in the
transcatheter device group, reflecting their minimally invasive
nature and expedited interventions, are in alignment with the
observations made by Butera et al. (2006) and Siddiqui et al.
(2014), thereby demonstrating consistency with previous studies in
the field. In the present study, only one patient in group B had a
device embolism. On the table deferred for surgery was observed
in only 2 patients in group A. This finding was in concordance with
Butera et al. (2006) but differed with Kotowycz et al. (2013), who
observed 2 cases of pulmonary embolism leading to death in
patients during surgical closure.
Patients in group A had significantly longer duration of ICU stay
(3.31±0.56 days vs. 2.07±0.45 days; p < 0.001), longer use of
inotropes (38.45±2.16 hours vs. 12.27±2.13 hours; p < 0.001),
and longer length of postoperative hospital stay (8.52±1.13 days
vs. 2.93±1.08 days; p < 0.001) compared to group B patients. The
mortality rate in both groups was zero. However, the surgical
closure group was at a slightly higher risk for complications of
bleeding/hematoma or pleural/pericardial effusion. Moreover,
the study found that one patient in the transcatheter device
occlusion group required reoperation and two patients in the
same group developed device endocarditis. These differences
were statistically not significant (p>0.05). These correlates with
the previous study findings (Askari et al., 2018, Du et al., 2002,
Helmy et al., 2013, Hughes et al., 2002).
The immediate procedural success rate in surgical closure was
100.0% while in transcatheter device closure it was observed
90.0%. No patients in surgical closure group revealed residual
ASD on postoperative echocardiogram on follow-up at 6 months,
while 03 patients of group B had residual ASD >2mm. These
findings were in accordance with (Askari et al., 2018, Rosas et al.,
2007), who also observed ASD were successfully closed surgically
in all patients, and there was no mortality.
Therefore, this study provides valuable insight into the early
outcomes of surgical closure and transcatheter device closure in
secundum ASDs. While both surgical and transcatheter device
closure methods provide favorable results, it is important to
consider potential complications specific to each approach.
Surgical closure of secundum atrial septal defects offers
advantages such as complete closure, and suitability for complex
cases, ensuring long-term durability and precise customization.
This approach further reduces the risk of device-endocarditis,
residual shunts, device embolism, and the need for reintervention compared to transcatheter closure. However, device
closure tends to result in a shorter total length of CCU and
hospital stay.
In order to prevent complications in the closure of secundum
atrial septal defects it is recommended that health care
providers should select patients carefully, ensure procedural
expertise, provide patient education, conduct postprocedural
monitoring, administer appropriate anticoagulation agents,
promote multidisciplinary collaboration and adhere to
established clinical guidelines.
6.0 Conclusion
Both surgery and transcatheter device approaches offer
favorable early outcomes for secundum atrial septal defect
closure. Transcatheter device closure offers advantages in terms
of less invasive intervention, shorter procedure time and stay in
the coronary care unit, and shorter overall length of hospital
stay. In contrast, compared with transcatheter closure, surgical
closure of secundum atrial septal defects offers advantages such
as complete closure, suitability for complex cases, less chance of
residual shunt, lower risk of device-related complications (such
as endocarditis and device embolism), and lower likelihood of
requiring reintervention. This finding suggests that the choice
between surgical and device closure methods should take into
account the individual patient factors, procedural preferences
and possible complications of secundum ASD closure.
7.0 Study limitation:
This single-center study with a relatively small sample size may
restrict the generalizability of the findings to a broader
population.
The assignment of patients to intervention groups based on
clinical criteria and physician discretion could introduce selection
bias.
The study primarily concentrated on early outcomes, potentially
overlooking long-term consequences and complications.
8.0 Recommendations:
• Surgical correction of secundum atrial septal defects is
preferred over device closure due to its advantages, including
complete closure, customization for complex cases, lower risk
of device-related complications and reduced likelihood of reintervention.
• Efforts should be directed toward developing more clinical
expertise and educating patients about transcatheter device
occlusion in order to proactively anticipate and effectively
manage associated complications.
• Future research efforts should prioritize conducting
multicenter, randomized trials with larger samples to
comprehensively compare the long-term outcomes of surgical
and transcatheter closure methods for ostium secundum
atrial septal defects.
References:
• Askari, B., Soraya, H., Ayremlu, N. and Golmohammadi, M.
(2018). 'Short-term outcomes after surgical versus trans
catheter closure of atrial septal defects; a study from Iran'.
The Egyptian Heart Journal, vol.70, no.4, pp.249-253.
• Benali Zel, A. and Abdedaim, H. (2014). 'Chest trauma
revealed an ostium secundum atrial septal defect in
adulthood'. The Pan African Medical Journal, vol.17, pp.17-29.
• Biswas, I. (2023). 'Perioperative Echocardiographic
Assessment of Atrial Septal Defect: Key Learning Points for
Fellows/Residents in Training'. Journal of Perioperative
Echocardiography, vol.8, no.2, pp.26-39.
• Bojar, R.M. (2020). 'Manual of perioperative care in adult
cardiac surgery'. 6th ed. John Wiley & Sons, pp.1-944.
• Brida, M., Chessa, M., Celermajer, D., Li, W., Geva, T., Khairy, P., et
al. (2022). 'Atrial septal defect in adulthood: a new paradigm for
congenital heart disease'. European Heart Journal, vol.43, no.28,
pp.2660-2671.
• Butera, G., Carminati, M., Chessa, M., Youssef, R., Drago, M.,
Giamberti, A., et al. (2006). 'Percutaneous versus surgical closure
of secundum atrial septal defect: comparison of early results and
complications'. American heart journal, vol.151, no.1, pp.228234.
• Chessa, M., Carminati, M., Butera, G., Bini, R.M., Drago, M., Rosti,
L., et al. (2002). 'Early and late complications associated with
transcatheter occlusion of secundum atrial septal defect'. Journal
of the American College of Cardiology, vol.39, no.6, pp.10611065.
Costa, R.N.D., Ribeiro, M.S., Pereira, F.L., Pedra, S.R.F., Jatene,
M.B., Jatene, I.B., et al. (2013). 'Percutaneous versus surgical
closure of atrial septal defects in children and adolescents'.
Arquivos Brasileiros de Cardiologia, vol.100, pp.347-354
• Djer, M.M., Ramadhina, N.N., Idris, N.S., Wilson, D., Alwi, I.,
Yamin, M., et al. (2013). 'Transcatheter closure of atrial septal
defects in adolescents and adults: technique and difficulties'.
Acta Medica Indonesiana, vol.45, pp.180-186.
• Du, Z.-D., Koenig, P., Cao, Q.-L., Waight, D., Heitschmidt, M.
and Hijazi, Z.M. (2002). 'Comparison of transcatheter closure
of secundum atrial septal defect using the Amplatzer septal
occluder associated with deficient versus sufficient rims'. The
American Journal of Cardiology, vol.90, no.8, pp.865-869.
• Fentanes, E. and Wisenbaugh, T. (2013). 'Transcatheter
Closure of Secundum-Type Atrial Septal Defect After Failed
Surgical Intervention'. Military Medicine, vol.178, no.10,
pp.e1165-e1167.
•
• Geva, T., Martins, J.D. and Wald, R.M. (2014). 'Atrial septal
defects'. The Lancet, vol.383, no.9932, pp.1921-1932.
• Hardman, G. and Zacharias, J. (2023). 'Minimal-Access Atrial
Septal Defect (ASD) Closure'. Journal of Cardiovascular
Development and Disease, vol.10, no.5, pp.1-13.
• Harjula, A., Kupari, M., Kyösola, K., Ventilä, M., Härtel, G.,
Maamies, T., et al. (1988). 'Early and late results of surgery for
atrial septal defect in patients aged over 60 years'. The Journal
of Cardiovascular Surgery, vol.29, no.2, pp.134-139.
• Helmy, M., Djer, M.M., Pardede, S.O., Setyanto, D.B., Rundjan, L.
and Sjakti, H.A. (2013). 'Comparison of surgical vs. non-surgical
closure procedures for secundum atrial septal defect'.
Paediatrica Indonesiana, vol.53, no.2, pp.108-116.
• Hughes, M., Maskell, G., Goh, T. and Wilkinson, J. (2002).
'Prospective comparison of costs and short term health
outcomes of surgical versus device closure of atrial septal defect
in children'. Heart, vol.88, no.1, pp.67-70.
• Khan, M.M.H., Rahman, M.M. and Ali, M.M. (2022). 'The
Prevalence and Risk Factor of Congenital Heart Defects in
Bangladesh'. Scholars Journal of Applied Medical Sciences,
vol.11, pp.1903-1907.
• King, T.D. and Milk, N.L. (1974). 'Nonoperative closure of atrial
septal defects'. Surgery, vol.75, no.3, pp.383-388.
• Kotowycz, M.A., Therrien, J., Ionescu-Ittu, R., Owens, C.G.,
Pilote, L., Martucci, G., et al. (2013). 'Long-term outcomes
after surgical versus transcatheter closure of atrial septal
defects in adults'. JACC: Cardiovascular Interventions, vol.6,
no.5, pp.497-503.
• Lewis, F.J., Taufic, M., Varco, R.L. and Niazi, S. (1955). 'The
surgical anatomy of atrial septal defects: experiences with
repair under direct vision'. Annals of Surgery, vol.142, no.3,
pp.401.
• Ma, D., Huang, J.L. and Xiong, T. (2023). 'Association between
congenital heart disease and autism spectrum disorders: A
protocol for a systematic review and meta-analysis'. Medicine
(Baltimore), vol.102, no.11, pp.e33247.
• Mansour, M.J., El Hage, E., Ismail, M., Aijaroudi, W., Ghanem,
G., El-Houwayek, E., et al. (2019). 'Ostium secundum atrial
septal defect in adults'. Lebanese Medical Journal, vol.67,
no.2, pp.63-69.
• Meyer, M.R., Kurz, D.J., Bernheim, A.M., Kretschmar, O. and
Eberli, F.R. (2016). 'Efficacy and safety of transcatheter closure
in adults with large or small atrial septal defects'.
Springerplus, vol.5, no.1, pp.1-8.
• Moysidis, D.V., Gemousakakis, E., Liatsos, A., Tsagkaris, C. and
Papazoglou, A.S. (2023). 'Atrial Septal Defect'. In: Clinical and
Surgical Aspects of Congenital Heart Diseases: Text and Study
Guide, 1st edn. Springer, Cham, pp.25-36.
• Mylotte, D., Quenneville, S.P., Kotowycz, M.A., Xie, X., Brophy,
J.M., Ionescu-Ittu, R., et al. (2014). 'Long-term costeffectiveness of transcatheter versus surgical closure of
secundum atrial septal defect in adults'. International journal
of cardiology, vol.172, no.1, pp.109-114.
• Ooi, Y.K., Kelleman, M., Ehrlich, A., Glanville, M., Porter, A.,
Kim, D., et al. (2016). 'Transcatheter versus surgical closure of
atrial septal defects in children: a value comparison'. Journal
of the American College of Cardiology: Cardiovascular
Interventions, vol.9, no.1, pp.79-86.
• Perrea, D.N., Ekmektzoglou, K.A., Vlachos, I.S., Tsitsilonis, S.,
Koudouna, E., Stroumpoulis, K., et al. (2011). 'A formula for
the stratified selection of patients with paroxysmal atrial
fibrillation in the emergency setting: a retrospective pilot
study'. The Journal of Emergency Medicine, vol.40, no.4,
pp.374-379.
• Quek, S.C., Hota, S., Tai, B.C., Mujumdar, S. and Tok, M.Y.
(2010a). 'Comparison of clinical outcomes and cost between
surgical and transcatheter device closure of atrial septal
defects in Singapore children'. Annals of the Academy of
Medicine, Singapore, vol.39, no.8, pp.629-633.
• Quek, S.C., Hota, S., Tai, B.C., Mujumdar, S. and Tok, M.Y.
(2010b). 'Comparison of clinical outcomes and cost between
surgical and transcatheter device closure of atrial septal
defects in Singapore children'. Annals Academy of Medicine
Singapore, vol.39, no.8, pp.629.
• Roos-Hesselink, J., Meijboom, F., Spitaels, S., Van Domburg, R.,
Van Rijen, E., Utens, E., et al. (2003). 'Excellent survival and low
incidence of arrhythmias, stroke and heart failure long-term
after surgical ASD closure at young age: a prospective follow-up
study of 21–33 years'. European Heart Journal, vol.24, no.2,
pp.190-197.
• Rosas, M., Zabal, C., Garcia‐Montes, J., Buendia, A., Webb, G.
and Attie, F. (2007). 'Transcatheter versus surgical closure of
secundum atrial septal defect in adults: impact of age at
intervention. A concurrent matched comparative study'.
Congenital heart Disease, vol.2, no.3, pp.148-155.
• Schneeberger, Y., Schaefer, A., Conradi, L., Brickwedel, J.,
Reichenspurner, H., Kozlik-Feldmann, R., et al. (2017).
'Minimally invasive endoscopic surgery versus catheter-based
device occlusion for atrial septal defects in adults:
reconsideration of the standard of care'. Interactive
CardioVascular and Thoracic Surgery, vol.24, no.4, pp.603-608.
• Siddiqui, W.T., Usman, T., Atiq, M. and Amanullah, M.M.
(2014). 'Transcatheter versus surgical closure of atrial septum
defect: a debate from a developing country'. Journal of
Cardiovascular and Thoracic Research, vol.6, no.4, pp.205.
• Stout, K., Daniels, C., Aboulhosn, J., Bozkurt, B., Broberg, C.,
Colman, J., et al. (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, vol.139, pp.e698-800.
• Tadros, B.V.-X. and Asgar, A.W. (2016a). 'Transcatheter closure
of atrial septal defects'. Cardiac Interventions Today, vol.10,
pp.56-60.
• Tadros, B.V.-X. and Asgar, A.W. (2016b). 'Transcatheter Closure
of Atrial Septal Defects'. Cardiac Interventions Today, vol.10,
no.2, pp.56-60.
• Thilén, U. and Persson, S. (2006). 'Closure of atrial septal
defect in the adult. Cardiac remodeling is an early event'.
International Journal of Cardiology, vol.108, no.3, pp.370-375.
• Thomson, J.D., Aburawi, E., Watterson, K., Van Doorn, C. and
Gibbs, J. (2002). 'Surgical and transcatheter (Amplatzer)
closure of atrial septal defects: a prospective comparison of
results and cost'. Heart, vol.87, no.5, pp.466-469.
• Vida, V.L., Barnoya, J., O’connell, M., Leon-Wyss, J., Larrazabal,
L.A. and Castañeda, A.R. (2006). 'Surgical versus percutaneous
occlusion of ostium secundum atrial septal defects: results
and cost-effective considerations in a low-income country'.
Journal of the American College of Cardiology, vol.47, no.2,
pp.326-331.
• Vijarnsorn, C., Durongpisitkul, K., Chanthong, P.,
Chungsomprasong, P., Soongswang, J., Loahaprasitiporn, D., et
al. (2012). 'Transcatheter closure of atrial septal defects in
children, middle-aged adults, and older adults: failure rates,
early complications; and balloon sizing effects'. Cardiology
Research and Practice, vol.2012.
• Villablanca, P.A., Briston, D.A., Rodés-Cabau, J., Briceno, D.F.,
Rao, G., Aljoudi, M., et al. (2017). 'Treatment options for the
closure of secundum atrial septal defects: a systematic review
and meta-analysis'. International Journal of Cardiology,
vol.241, pp.149-155.
• Webb, G. and Gatzoulis, M.A. (2006). 'Atrial septal defects in
the adult: recent progress and overview'. Circulation, vol.114,
no.15, pp.1645-1653.
APPENDIX A
Work schedule
APPENDIX B
Ethical Clearance Certificate
APPENDIX C
Consent Form
After being fully informed about the objectives, consequence of the
study and my right to withdraw myself from the study at any time for any
purpose, what so ever,
I am, ………………………….., / on
behalf of my patient ………………………… hereby giving consent to
participate in the study titled as “Comparison of early outcomes
between surgical and transcatheter device closure of secumdum type
atrial septal defect” conducted by Dr. Md. Mahmudur Rahman, MS
(Cardiovascular and Thoracic Surgery), Phase-B resident, National
Institute of Cardiovascular Diseases (NICVD), Dhaka. I fully recognize that
my / my patient’s participation in this study will generate valuable
medical information that might be used for the interest of patients in the
future. Hospital authority, Doctor and any other staff will not be
responsible for any adverse consequence during the study. I shall try my
best to comply with the instructions given by the investigator throughout
the whole period of study.
Signature/thumb impression of the
participant/guardian………………………………….
Date ……………………………..……………………………..
Signature of the investigator………………………………………………………………..
Date……………………………………………………………….
APPENDIX D
গবেষণার সম্মতিপত্র
Avwg................................................................................. Aby‡gv`b
KiwQ †h, Wv: †gv: gvngy`yi ingvb, GB nvmcvZv‡ji
KvwW©qvK mvR©vix wefv‡M Zvi †dR-we dvBbvj cixÿvi Rb¨
“Comparison of Early Outcomes Between Surgical and
Transcatheter Device Closure of Secundum type Atrial Septal
Defects M‡elYvi welqvejx m¤ú‡K© we¯ÍvwiZfv‡e e¨vL¨v Kiv
nBqv‡Q| Avwg mg¨K fv‡e ÁvZ AvwQ †h, Avgvi mieivnK…Z
Z_¨ †Mvcb Kiv nB‡e Ges M‡elYvj× Z_¨vw` fwel¨‡Z Ab¨
†ivMx‡`i wPwKrmvi Kv‡R e¨envi Kiv n‡e| Avwg †¯^”QvB Ges
mÁv‡b D³ M‡elYvi AšÍf©~³ nB‡Z m¤§Z AvwQ| D³ M‡elYv‡q
AšÍf‚©w³i d‡j †Kvb iKg RwUjZv nB‡j Wv³vi/nvmcvZvj KZ©„cÿ
`vqx _vK‡e bv|
M‡elYv Kv‡j M‡elK I Zvi mn‡hvMx‡`i c~Y© mn‡hvwMZv w`‡Z
Avwg ivwR AvwQ|
Appendix: E
Group0
DATA COLLECTION FORM
Patient
Department of Cardiac Surgery, NICVD, Dhaka.
No.
Name of the study:
“Comparison of Early Outcomes Between Surgical and
Transcatheter Device Closure of Secundum Type Atrial Septal
Defects’’
Patient’s Name
Age
Bed
Year
Ward
Sex
Operation
Date
Male
Female
Appendix: E
Address
Contact No.
Symptoms Class/Grade :
Symptoms
Preoperative
Postoperative at 6
Months
NYHA
1
2
3
4
1
2
3
4
Pre-operative Investigations :
Chest X ray P/A view :
Cardiomegaly
Prominent pulmonary Conus
Increased Pulmonary
Vascularity
Appendix: E
Echocardiography :
Variables
PASP
Primary ASD
Diameter
Pt’s Value
Procedural Variables :
Procedural Time (mins)0
Cardiopulmonary Bypass Time (mins)
Fluoroscopy Time (mins)
Aortic Cross Clamp Time (mins)
Device Embolism
Units
mmHg
mm
Appendix: E
Post-operatives Variables :
ICU / CCU stay in Hospital
Uses of Inotropes (Hours)
Arrhythmias
Bleeding or Hematoma (ml)
Pleural / Pericardial Effusion
Need of reintervention
Residual shunt
Endocarditis
Hospital stay (Days)
Date : ………………………
Signature :
…………………..
Appendix: E
Follow up ( 6 Months after Discharge) :
Echocardiography Findings :
PASP
Residual Shunt
NYHA Class/ Grade
Date : ………………………
Signature :
…………………..