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��ࡱ�>��	`b����]^_�����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������[�	���bjbj����	4&ΐΐ�O,�������((kkkkk����8�$�gL�Z9OOO��~D�$�K�K�K�K�K�K�K$�N�#QD�KQk������KkkOO7!L�'�'�'�8kOkO�K�'��K�'�'�z1h�2O����ࠢ��j�%��1�K7L0gL�1�gQ&�gQ �2�2tgQk*El���'������K�K�'���gL������������������������������������������������������������������������gQ���������(	1:	Title:
Predictors for Left ventricular systolic dysfunction and its outcome after Patent Ductus Arteriosus (PDA) closure by device.
Authors: Hussain Bux Korejo1, Abdul Sattar Shaikh1, Arshad Sohail1, Naresh Kumar Chohan1, Veena Kumari1, Muhammad Asif Khan1, Najma Patel1.

ARTICLE TYPE:   Original Article.

Correspondence:
Dr. Abdul Sattar Shaikh. 
Assistant Professor Paediatric Cardiology.
Department of Paediatric Cardiology
National Institute of Cardiovascular Diseases Karachi, Pakistan
Rafiqi (H.J) Shaheed Road 75510 
Cell # 00923033334994,  00923333434981.
e-mail:HYPERLINK "mailto:sattar1979@hotmail.com"sattar1979@hotmail.com.

Authors�:
Hussain Bux Korejo, FCPS, fellow Paediatric Cardiology NICVD Karachi,    
    HYPERLINK "mailto:drhussain76@yahoo.com"drhussain76@yahoo.com. Cell #00923352742800.
Abdul Sattar Shaikh, FCPS, Assistant Professor Paediatric Cardiology NICVD Karachi, HYPERLINK "mailto:sattar1979@hotmail.com"sattar1979@hotmail.com, Cell# 00923033334994.
Arshad Sohail, FCPS, fellow Paediatric Cardiology NICVD Karachi, HYPERLINK "mailto:arshadsohail03@gmail.com"arshadsohail03@gmail.com,  Cell#00923339016758.    
Naresh Kumar, FCPS, fellow Paediatric Cardiology NICVD Karachi, HYPERLINK "mailto:drnchohan84@hotmail.com"drnchohan84@hotmail.com. 00923352555344.
Veena Kumari. FCPS, fellow Paediatric Cardiology NICVD Karachi, HYPERLINK "mailto:veenakumari77@yahoo.com"veenakumari77@yahoo.com. Cell#00923002238510.
Muhammad Asif khan. FCPS fellow paediatric cardiology NICVD Karachi,
HYPERLINK "mailto:drkhan9508@yahoo.com"drkhan9508@yahoo.com, 00923332748230
Najma Patel. FCPS,FSCAI, Professor and Head of the Department, Paediatric Cardiology, NICVD Karachi. HYPERLINK "mailto:najmapatel@yahoo.com"najmapatel@yahoo.com. Cell# 00923009238163.

Abstract:
Objective: To evaluate the predictors of left ventricle (LV) systolic dysfunction after PDA closure by device.
Back ground: LV dysfunction is very common in patients after PDA closure by device. There are certain predictors leading to it. 
Methods: 63 patients of isolated PDA. Patients were admitted in paediatric cardiology department of National Institute of Cardiovascular Disease Karachi, Pakistan. Baseline echocardiography was performed. Hemodynamics were done during cardiac catheterization, pulmonary blood flow/systemic blood flow (QP/QS) and pulmonary vascular resistance calculated. After successful device closure echocardiography was repeated on day 1, after one, three and six months. All subjects were divided into two groups on the basis of post closure LV ejection fraction. All the parameters which include age, gender, weight, LVEDD z-score, QP, PDA size, left ventricle end diastolic pressure and pulmonary artery pressure compared in both groups.
Results:  41 patients (65.1%) developed LV systolic dysfunction. Coil was used in only 3(4.8%) patients and two of them developed dysfunction. All patients recovered within six months except two had dysfunction beyond six months. 30 patients (47.6%) patients had weight Z�score < - 3 SD and 29 of them developed dysfunction. Weight, base line LVEDD Z �score, QP, LVEDP and PDA size has significant impact on LV function with p-value <0.05.
Conclusion:  Haemodynamic effects of PDA, changes in LV dimensions and function caused by it are reversible after transcatheter closure of PDA. Large PDA size, high QP/QS are potential risk factors leading to LV dysfunction after device closure. 
Keywords: Patent Ductus Arteriosus, Echocardiography, Cardiac Catheterization, Ventricular Dysfunction, Congenital Heart Disease.
	


















Introduction:
PDA is a common congenital heart anomaly seen in pediatric practice forming 5 -10% of all congenital heart defects. It is nearly two times more common in female than in male [1].
Most of the PDA s can be safely closed by using Amplatzer duct occluder I, coils, vascular plugs, Amplatzer VSD device and Nit-Occluders [1, 2]. Procedure is safe, cost-effective and offers considerable advantages over surgical ligation and has largely replaced surgical ligation in different age groups [3]. 
Little is known; however, of the degree and timing of changes in LV size and function after percutaneous PDA closure [4]. Studies have reported an immediate decrease in LV performance followed by recovery within a few months after successful transcatheter closure of PDAs in children [5]. 
Hemodynamically significant PDA leads to a LV volume overload and remodeling alters the systolic and diastolic function of the LV. These changes are expected to improve after PDA closure but some patients develop LV systolic dysfunction [6]. A good explanation could not be found for this observation, but a possible mechanism is Starling�s effect resulting from changes in preload and afterload subsequent to closure [2]. Hemodynamically significant PDA, once closed, decreases the preload to the LV by removing left to right shunt and increases the afterload by isolating the low resistance pulmonary circulation from LV outflow circulation [6]. This simultaneous reduction in LV preload and increase in afterload leads to LV systolic dysfunction. Despite of similar hemodynamic changes in patients with pre and post PDA device closure, LV systolic dysfunction does not occur in all of patients after device closure. The predictors of LV systolic dysfunction after PDA closure have been studied  recently which includes left ventricular internal diastolic dimension (LVIDD), PDA size, QP/QS ratio, but  more work is needed to indentify other risk factors like left ventricular end diastolic pressure (LVEDP), age and weight of patients [6,7,8]. Echocardiography is the most commonly used method for evaluating LV function; such studies include 2-dimensional, Motion mode, conventional Doppler, and tissue Doppler technology [4, 5]. We have no available data of our Pakistani population regarding incidence, predictors and outcome of LV systolic dysfunction after percutaneous transcatheter PDA closure by device. So this study will help in future to identify patients at risk of dysfunction so can   intervene earlier.
Material and methods;
Prospective, case series and observational study conducted at Paediatric cardiology department of National Institute of Cardiovascular disease (NICVD) Karachi Pakistan from July 2015 to December 2016. Total 63 cases of PDA device closure through non probability consecutive sampling technique included in study. Inclusion criteria were age > 6 months, Weight 6 kg and above, Isolated PDA suitable for device closure. 
Those excluded from study were having pulmonary vascular resistant index (PVRI) >7 WU/m2, QP/QS ratio <1.5:1, PDA morphology not suitable for device closure, base line LVEF <55% and any associated cardiac lesion like ventricular septal defect, aortic stenosis, aortopulmonary window.
Data collection and procedure; All subjects enrolled in study were admitted and written consent obtained. Data including age, weight, sex and height was recorded in pre designed proforma. Base line echocardiography was done for PDA presence, end diastolic velocity of PDA, LVEDD, ejection fraction, PA pressure and for other associated congenital heart defects.    Z-score of LVEDD calculated with normal range of -2 to +2. Ejection fraction 55% and above was taken as normal.
 Patients kept nil per oral according to age. All procedures done under conscious sedation with midazolam /or diazepam and nelbuphine. After complete sterilization of both groins, Site of puncture infiltrated with 2% xylocain injection. Both arterial and venous access done with seldinger technique and appropriate size sheath passed. Multipurpose for venous and Pigtail catheter for arterial catheterization used to obtained base line saturations of right atrium (RA), right ventricle (RV), PA, superior vena cava (SVC), LV and descending aorta.  QP/QS and PVRI calculated. Mean PA pressure<20 mmHg considered normal and >55 mmHg severe hypertension. PDA size and suitability of device closure was decided by descending aortogram with pigtail catheter using non ionic contrast, 1-1.5 ml per kg, at left lateral 90 degree and RAO 35 degree by cine method and other projections when necessary. Narrowest point of PDA measured. PDA measuring 2 mm and above were closed by Amplatzer duct occluder 1(ADO-1) (AGA Medical Corporation, Golden Valley, MN)) and <2 mm closed by with flipper PDA closure detachable coil (cook medical Bloomington [7, 9].
ADO -1 used  atleast 2mm larger than the narrowest diameter of duct and coil double the size of narrowest diameter of duct were selected. Procedure performed according to described procedure after device deployment, ascending and descending aorta pressure recorded for any gradient in descending aorta. PA pressure and LVEDP also recorded. Patient kept under close observation for atleast 24 hours for vitals, pulses of lower limb, change in temperature and color of lower limb and other complications. Chest X-ray routinely was done in all patients for device position. After successful device closure all patients were put on heart failure treatment for three to six months. Echocardiography done within 24 hours to assess for EF, residual shunt and device position. Before discharge next follow-up plan given at 1, 3 and 6 months. At every follow up visit echo was done to assess LVEF [10].
Data Analysis; 
Statistical Package for the Social Sciences�Software (SPSS, version 21) is used for analysis. Qualitative variables as gender, EF, ADO-1, Coil were presented in terms of frequency and percentages. Quantitative variables as age, weight, LVIDD z-score, PDA size, QP/QS ratio, PVR, LVEDP, PA mean were presented in terms of mean and standard deviation. Mean differences of quantitative variables analyzed by t-test which have only two categories. Post stratification chi square test was also applied considering pd"0.05 as significant. T-test was applied to analyze  the statistical difference in mean age, weight,  pre closure LVEDD , PDA size, mean PVR, pre closure  LVEDP ,QP and  mean PA pressure between two groups.
RESULTS: Demographic data shown in [Table-I]. Total numbers of patients included in study were sixty three. Out of them 26 (41.3%) were males and 37(58.7%) females. Age was 8.47�7.26 years.Weight17.06 kg �12.4. All patients had successful PDA closure without significant complications. After PDA device closure EF decreased in 41(65.1%) patients, while EF was normal in 22(34.9%).Coil was used in only 3(4.8%) patients and two of them developed systolic dysfunction. Out of 63 patients 30 (47.6%) had weight Z�score <-3 SD and 29 of them developed dysfunction and was statistically very significant with p-value <0.001. 
Base line variables in both groups shown in [Table II]. Pre closure LVEDD,QP/QS, weight, PDA size, LVEDP have significant impact on EF after device closure of PDA with p-value <0.05, while age and mean PA pressure did not have  any statistically significant deference. All patients followed till six months after device closure and out of 41 who developed dysfunction, 39 recovered completely within six months, (majority in first month) and heart failure treatment stopped in these patients. Graph I shows percentages and frequency of EF at base line and post device closure during follow ups.





















Table I
Demographic data
�N= 63 (%)Male26(41.3)Female37(58.7)Age ( year)8.47�7.26Weight (kg)17.06�12.49PDA Size(mm)3.82�1.55EF Post device�Normal (>55%)22(34.9)Decreased (<55%)41(65)Type of occlude deviceADO-160(95.2)Coil3(4.8)








Table II
Base line variables affecting the ejection fraction after percutaneous closure of PDA
VariablesGroup-I  (normal EF) Group-II                 (EF decreased )**P-valueAge (years)6.26�4.916.57  �  8.300.87Weight (kg)21.45  �  14.4514.70  �  10.770.04*Above -3SD1 (4.5%)29 (70.7%)<0.001*Below -3SD21 (95.5%)12 (29.3%)LVEDD (Z-score)1.83 �  1.243.39  �  2.180.001*PDA size(mm)3. 02 �  0.844.26  � 1.67<0.0001*PVR pre (WU)2.60  �  1.212.69 �  1.400.805QP/Qs2.37�0.533.09 �  0.83<0.0001*LVEDP Pre (mmHg)10.18� 1.6511.76 � 2.830.007*PA Mean pre (mmHg)24.77  �  9.0928.85 � 12.770.148*Statistically significant at 0.05 level of significance
**P-value of t-test for testing of mean difference and chi-square test for association








Graph I
The Graph representing  overall percentages and frequencies of  ejection fraction at base line, Post device within 24 hours, after one, three and at six month.







Discussion
Better immediate and long term outcome of transcatheter closure of PDA with minimum risk of mortality and morbidity have made the procedure of choice whenever indicated [3, 4]. LV dysfunction is due to sudden decrease in pre load and increase in after load by duct closure. Our study was planned to observe systolic performance of LV after duct closure by device and contribution of base line predictors leading to LV systolic dysfunction. All these parameters assessed by echocardiography and cardiac catheterization during procedure. We had 63 patients who underwent PDA closure percutaneously, out of them 60 were closed by ADO-1 and 3 by coil. All patients had successful closure without any significant complications and were discharge after 48 hours of hospital stay. Baseline parameters compared in Group-1 and Group-II 41(65%) patients developed LV systolic dysfunction and out of these 2 cases were of PDA closure by coil. All patients developed dysfunction immediately after device closure. No statistical deference was seen in gender and age but we observed that in dysfunction group age was higher.  Low weight for age was strong predictor of LV systolic dysfunction. In our study 30 patient had weight>-3 SD and 29 of them developed dysfunction. We have found that malnutrition is a strong predictor of post procedure LV dysfunction and to our knowledge this factor not has been evaluated. There is study by Hamid et al [10] where he mentioned weight less than 10 kilogram had more complications. In our study large PDA size was notable, in group-II with p-value of< 0.05.QP/QS ratio was 3:1 and above in group-II with p-value <0.0001.This explains that high QP/QS ratio leads to LV dimensional changes and  is strong predictor for post PDA closure LV systolic dysfunction and consistent with study by Yeo Hyang [5]. Study by Galal [11], showed that 60% of large PDA closed by device developed moderate to severe LV dysfunction and majority recovered within 3 to 6 months. This   is consistent with our study as 87.8% patients recovered within 3 months and 92.7% within 6 months and only 7.3% had mild dysfunction beyond 6 months. 
Other important predictor of LV systolic dysfunction was high LVEDD Z �score observed at base line in our study. In all group-II patients LVEDD Z-score was higher than +3 and was well correlated with post procedure LV dysfunction and in follow-ups it decreased as LV systolic function improved. This observation is consistent with study by Kim YH et al [5] and other studies by Agha et al [12]. LVEDP was high at base line in dysfunction group this indicates that they had some diastolic dysfunction as well and is due to increased preload. Gupta SK,et al [6] in his study concluded that those having LV systolic dysfunction also had LV diastolic dysfunction and recovery from diastolic dysfunction was delayed than systolic dysfunction.PA pressure more than two third of systemic pressure is one of predictor of LV dysfunction [7, 9], but device closure is reported in literature in these patients [13]. But none of our patient had PA pressure more than two third of systemic pressure. With appropriate patient and device selection transcatheter PDA closure is safe procedure [14]. Tilahun B also reported LV dysfunction in post PDA ligation patients that was resolved within 3 months [15]. 
Conclusion:  Sudden changes  LV volume and other haemodynamics after PDA  closure leads to LV dysfunction in significant number of patients within 24 hours which are mostly reversible but antifailure treatment  and regular  follow up  and monitoring for LV function is required .


Financial support: Nil
Conflicts of interest: None.

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Allen HD, Shaddy RE, Penny DJ 2016 Moss and Adam text book of Heart diseases in infants, children and adolescents (ninth edtn), Wolter Kluwer, China.
Tilahun B, Tefera E 2013 Transient left ventricular systolic dysfunction following surgical closure of large patent ductus arteriosus among children and adolescents operated at the cardiac centre, Ethiopia. Journal of Cardiothoracic Surgery 8:139.








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