BALLOON ATRIAL SEPTOSTOMY: IS BEDSIDE PROCEDURE SAFE AND EFFECTIVE UNDER TRANSTHORACIC ECHOCARDIOGRAPHIC GUIDANCE?
Objective: To evaluate the safety and efficacy of balloon atrial septostomy under transthoracic Echocardiographic guidance in ward setting in patients with transposition of great arteries.
Study Design: Comparative cross-sectional study.
Place and Duration of Study: Armed Forces Institute of Cardiology Rawalpindi from Jan 2012 to Dec 2014.
Material and Method: It was a comparative cross-sectional study of all consecutive young infants with transposition of the great arteries that underwent balloon atrial septostomy for restrictive inter-atrial communication and cyanosis from January 2012 to December 2014. In group 1, balloon atrial septostomy was performed under local anesthesia in ward setting successfully. The cases who were shifted to catheterization lab for completion of procedure assigned as group 2 (procedure started in ward but couldn't be completed).
Results: A total of 49 patients with transposition of the great arteries underwent balloon atrial septostomy during study period, 77.6% (n=38) of these were male and 22.4% (n=11) were female. A total of 44.8% (n=22) patients presented in 1st week with significant p-value <0.05. Balloon atrial septostomy was successfully performed in ward in 42 cases (group 1), while seven cases (group 2) were shifted to cath lab for completion of procedure. There was significant improvement in Oxygen satura tion post-procedure with p-value of <0.05 in both groups and there was positive correlation between post-procedural Patent foramen ovale size and post-procedural oxygen saturation. Independent t-test was applied to compare both groups and there was no significant statistical difference between two groups.
Conclusion: Balloon atrial septostomy was found to be safely performed in ward setting under transthoracic guidance, provided expertise of technique are available. However facilities of catheterization lab should also be available for backup.
Keywords: Balloon atrial septostomy, Transposition of great vessels.
Congenital heart diseases occur in approximately 6 in 1,000 live births and transposition of the great arteries (TGA) is the most commonly diagnosed cyanotic congenital heart disease presenting in the neonatal period1,2. In TGA, the aorta and pulmonary arteries do not arise from their respective ventricles, resulting in ventriculo-arterial discordance and thus parallel pulmonary and systemic circulation. In the patients with un-repaired TGA, delivery of oxygen to tissues, including the brain, is dependent on mixing between the systemic and pulmonary circulations. An adequate inter-atrial communication along with prostaglandin infusion to keep patent ductus arteriosus open, are the two very important components of initial stabilization of young infants with unrepaired TGA3.
Balloon atrial septostomy (BAS) was introduced by Rashkind and Miller in 1966 and is an effective palliative procedure in children with transposition of the great arteries and poor inter-circulatory mixing4. The non-restrictive atrial communication improves systemic oxygen saturations and helps in preoperative stabilization prior to definitive arterial switch operation (ASO)5-7. BAS can be performed in catheterization lab as conventional manner or can be done in intensive care/ward settings under transthoracic echocardiography guidance. In fluoroscopic guided cardiac catheterization, there is exposure to radiation8 and involves shifting of young infants to cath lab which may increases the risks of destabilization and hypothermia. Moreover as a bedside procedure it is cost effective too. We are reporting our three years' experience of BAS in young infants done in ward setting under transthoracic guidance in department of paediatric cardiology.
MATERIAL AND METHODS
It was a comparative cross-sectional study of all consecutive young infants with transposition of the great arteries that underwent BAS for restrictive inter-atrial communication, from January 2012 to December 2014 Armed Forces Institute of Cardiology Rawalpindi. Balloon septostomy was performed under local anesthesia in ward setting successfully, allotted as group 1. Those who failed in ward were taken to catheterization lab and assigned as group 2. A detailed proforma was filled for each patient. Detailed maternal, patient history and examination including gender, gestational age, birth weight, postnatal age of admission, oxygen saturation levels before and after procedure, presenting complaints and complications were recorded. Baseline investigations including complete blood count, infective markers and biochemistry were also recorded. Pre-procedural echocardiographic findings were also recorded.
Informed consent was taken before procedure. Neonates were kept warm throughout the procedure by warmers. Femoral vein was preferred mode of access in both groups. After establishing venous line (confirmed by transthoracic echo by visualizing wire in IVC or by injecting saline in IVC), 1.8 ml septostomy balloon advanced from IVC to right atrium across the PFO to left atrium. The standard subcostal view was mainly used to delineate the inter-atrial septum and to guide the balloon catheter. In all cases, 6F short sheaths were used. After confirming position in left atrium, balloon inflated and pulled back to right atrium with quick yet precise force to create an adequate inter-atrial communication. Procedure repeated till desired results achieved. In group 2, we could not cross the PFO with echo guidance and thus shifted to cath lab and procedure was completed under fluoroscopy guidance.
Post procedural care included intravenous fluids, two doses of antibiotics and keeping baby dry and warm. Post-procedural echo was done for size of PFO and for ventricular functions and pericardial effusion. Post procedural saturations were recorded. Data was analyzed in SPSS 16.
Descriptive statistics including means, standard deviations and percentages for variables like degree of hypoxia, complications and outcome were calculated. A p-values calculated for quantitative analysis. Group 1 and group 2 were compared by independent t-test.
Table-I: Parameters of both groups are compared as follows
Parameter###Group 1 (mean +- SD)###Group 2 (mean +- SD)
Weight (kilogram)###3.05 +- 0.32###3.2 +- 0.39
Length (cm)###52.4 +- 2.5###52 +- 3.3
Mean age of presentation (days)###15.2 +- 17.65###21.28 +- 31.3
Pre-procedural saturation %###56.2 +- 8.59###51 +- 6
Post-procedural saturation %###79.19 +- 3.9###77 +- 3.69
Pre-procedural PFO (mm)###1.96 +- 0.26###1.81 +- 0.36
Post-procedural PFO (mm)###4.7 +- 0.54###4.7 +- 0.68
Time of Procedure (minutes)###42.93 +- 14.17###58.57 +- 21.54
Table-II: Comparison of safety parameter between two groups
###No. of patients###No. of patients
###Group 1###Group 2
Cross over rate###7###0
A total of 49 patients with TGA underwent BAS during study period, 77.6% (n=38) of these were male and 22.4% (n=11) were female (fig-I). A total of 44.8% (n=22) patients presented in 1st week with significant p-value<0.05 and 37% patients were severely cyanosed with oxygen saturation <50%. In 83.7% (n=41) cases via right femoral vein, 14.3% (n=7) via left femoral vein and in 2% (n=1) cases umbilical vein was utilized as mentioned in fig 2. Balloon atrial septostomy was successfully performed in ward in 42 (86%) cases (group 1), while seven (14%) cases (group 2) were shifted to cath lab for completion of procedure as shown in table-I. In group 2, mean fluoroscopy time was 2.2 +- 1.4 minutes. One patient had respiratory arrest which was managed with positive pressure ventilation and another one developed minimal pericardial effusion in group 1 which was managed conservatively and dissolved itself over next two days as mentioned in table-II.
There was significant improvement in Oxygen saturation postprocedure with p-value of <0.05 in both groups. There was positive correlation (r=+0.613, p-value 0.00) between post-procedural PFO size and post-procedural oxygen saturation. Independent t-test was applied to compare both groups and there was no significant statistical difference between two group.
TGA is the most common cyanotic congenital heart disease in neonatal period and mostly presents in first week of life9,10. In developing country like ours, presentation of these cases can be delayed due to lack of adequate health facilities and early recognition. In our study population only 44.8% presented during first week of life. TGA is more common in males as reported by many studies, and in accordance 77.6% of our study population was male11. To maintain adequate oxygen saturations, it's mandatory to have some form of free mixing between systemic and pulmonary circulation. It can be either achieved at atrial level or by having unrestricted large VSD or PDA. In neonates with small restrictive inter atrial communications, even presence of VSD/PDA may not allow adequate mixing of blood, thus necessitating creation of ASD with the help of balloon atrial septostomy. Rashkind and Miller, in 1966 gave description of the BAS and thus open door for interventional cardiology12,13.
BAS is of established value in the management of many congenital heart diseases in the neonatal period and most important of all is TGA. BAS can be performed in cath lab under fluoroscopic monitoring, ITC or in paediatric wards under echocardiographic control at bedside14. In ward, it is easy to maintain body temperature of young infant and also avoids potential destabilization while shifting the baby to cath lab and moreover we can prevent child from undue exposure of radiations.
We offered BAS in ward setting to 49 patients and were completely done in ward in 85.7% of the patient. However, in only 14.2% septostomy balloon could not be advanced to left atrium under echo guidance and procedure was completed under fluoroscopy guidance. In almost all patients (98%) percutaneous femoral vein was used to access central line which carry lowest post-op complications as discussed in another study by Porter et al15 There was significant improvement in Oxygen saturation postprocedure with p-value of <0.05 in both groups. The diameter of the foramen ovale was the most important factor influencing arterial oxygenation16,17. We found no statistical difference when both groups were compared. In many centers, with trained specialists, it is performed at bedside and considered safe and cost-effective18.
Bedside BAS was found and effective procedure and also helped in prevention risk of radiation exposure without a change in efficacy. However facilities of catheterization lab should be available as a standby.
CONFLICT OF INTEREST
This study has no conflict of interest to declare by any author.
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