Anatomical Characteristics of Patent Ductus Arteriosus and Choice of Transcatheter Occluder Devices. (2024)

Byline: Saima Rafique, Sana Imtiaz, Khurram Akhtar, Amjad Mehmood, Andaleeb Ara, Abdul Wahab, Abubakar Sadiq and Javeria Kamran

Keywords: Device occlusion, Embolization, Krichenko classification, Patent ductus arteriosus, Transcatheter occluder device.

INTRODUCTION

Patent Ductus Arteriosus (PDA) is a clinical condition in which the duct between proximal left pulmonary artery and the descending aorta fails to close after birth, that results in left-to-right shunt from the aorta to the pulmonary artery and increasing Left Ventricular (LV) preload.1 It is one of the most common congenital heart defects.2 with an incidence of 5%-10% of all congenital heart disease in infants which can be as high as 1 in 500 births in preterm babies.3 Echocardiography is the diagnostic investigation of choice. It can present in many ways, however, the natural history depends upon its size.4,5 Hemody-namically significant PDA leads to Left Ventricle (LV) volume overload and remodeling, finally resulting in severe complications, such as congestive heart failure, Eisenmenger syndrome, atrial arrhythmias and endarteritis.1,5

Untreated PDA can result in numerous cardiac and pulmonary problems. Transcatheter closure of PDA is the established method for closing the majority of PDAs.6 Pulmonary vascular disease and increased pulmonary flow are both prevented by this treatment. Endarteritis and endocarditis are both reduced with the closure of defect. Closure time depends upon both the severity of symptoms and the size of the defect.7 Asym-ptomatic newborns are managed conservatively and monitored for spontaneous closure.4 Patients with large PDA presenting with congestive heart failure require immediate attention for the closure of the defect.5 When a percutaneous method is not feasible, such as in the case of congestive heart failure in new-borns or pulmonary hypertension, surgical closure remains the only treatment option.2

PDA closure is now the preferred technique for PDA closure in infants and is one of the safest interventional cardiac procedures with a 95% success rate. Several devices have been authorized for PDA closure which are safe and successful.8 Literature has reported success rate of 97% to 99% after PDA closure via ranscatheter route6 with lower morbidity and mortality (0.2%) in patients undergoing ranscatheter PDA occlusion.9 According to Khan et al., in 51 consecutive cases over a year, PDA device closure was successful in 100% of cases.6 The morphology of a PDA is crucial in determining the appropriate device for occ-lusion. Tubular PDAs present a significant difficulty for interventional cardiologists. The Amplatzer Duct Occluder-II (ADO-II) device was designed to address these issues.10

Risks associated with PDA device closure (including device embolization, residual leak, iatrogenic coarctation, left pulmonary artery (LPA) stenosis, thromboembolism, cardiac perforations and vascular injuries) are minimal and depends upon the operator as well as the cardiac facility in which the procedure is done. Limited studies have been published in Pakistan regarding type of device used based upon anatomical classification. Our objective was to share our experience of a tertiary paediatric cardiac care center in Pakistan regarding the PDA closure, mor-phological types of ductus closed, choice of device depending upon morphology, procedural details and associated complications.

METHODOLOGY

This Analytical Cross-sectional study was conducted at Paediatric Department of AFIC/NIHD, Rawalpindi, Pakistan. Data was collected from January to July 2023 after the ethical approval from Institutional Ethical Review Board (Ltr. # 9/2/RandD/2024/295).

Sample size was calculated using the WHO sample size calculator, considering 6% prevalence of Patent Ductus Arteriosus (PDA) 11, 95% confidence level and 5% margin of error. The calculated sample size was found to be n=87. However, data was collected from total n=90 patients using universal sampling.

Inclusion criteria: Patients regardless of age and gender presenting with PDA, who underwent device closure were enrolled in this study.

Exclusion criteria: Patients who had other congenital heart diseases with duct dependent pulmonary circulation and severe pulmonary hypertension were excluded.

All patients underwent detailed pre-procedure assessment including history, detailed physical examination, ECG, Chest X-ray, complete blood count, quantitative CRP and detailed trans thoracic echo-cardiography (2-D, color and continuous wave Doppler) to assess size of the PDA, left ventricular dimensions, function and pulmonary artery pressures. Diameter of narrowest portion of ductus was recorded. Left ventricular ejection fraction was quantified. After getting an informed written consent, patient was taken to Cath lab. Procedure was performed under general or local anesthesia depending upon patient's age and ability to cooperate. Vascular access was obtained in right femoral artery and vein using anatomic landmarks. Aortogram was performed in true lateral projection to determine size (diameter at aortic end, pulmonary end and length of PDA) shape and narrowest diameter of PDA.

Krichenko et al. angiographically classified duct into five types: type A ''conical'' ductus, with ampulla at aorta and narrow point at the pulmonary end. Type B ''window'' ductus, with no ampulla and narrow end. Type C, ''tubular'' ductus. Type D, ''complex'' ductus, with several narrowing. Type E,''elongated'' ductus, with narrowing away from the anterior edge of the trachea.11 Ductus was classified morphologically as one of the Types A to E or F (having a tortuous morphology that does not fit in the Krichenko classi-fication). Duct was then crossed with Judkin's right heart catheter over 0.035 exchange length 260 cm wire antegradely from pulmonary side into descending aorta and exchanged with a delivery sheath.

Device was selected appropriate to the size and morphology of ductus on angiogram (correlation of the echocardiographic size of the PDA with the angio-graphic measurement was done to avoid under-sizing the device when PDA spasm occurs during the catheterization) and was passed through delivery sheath into descending aorta and aortic end was deployed. Entire assembly consisting of device and sheath were pulled back as a single unit and remaining device was uncovered within the duct making sure that pulmonary end of the device was flared appropriately inside the pulmonary artery. Post deployment aorto-gram was performed to confirm device position, residual leak or any obstruction. Device was released after confirming acceptable deployment. After the procedure, monitoring of patient was done including vital signs, prick site and peripheral pulses.

Data was analyzed using Statistical Package for the Social Sciences version-28.00. Continuous variables were expressed as Mean+-SD. Categorical variables were expressed as frequency (%). Chi-square test and Fischer Exact test were applied to find association between categorical variables. p<0.05 was considered as statistically significant.

RESULTS

In this study, n=90 patients were included. Out of these, 34(37.8%) were males and 56(62.2%) were females. Age of the patients ranged from 01 month to 32 years with median age of 1(IQR=0.6-4.25) years.

Median weight of the patients was 7.5(IQR=5.5-13.25) kg (Table-1). Mean duration of hospital stay was 22.76+-2.54 hours. Mean fluoroscopy time was 8.4(IQR=7.2-12.07) minutes The most common ductus types treated were Krichenko type-A 70(76.7%). VSD devices (MFO, Amplatzer muscular VSD Occluder) to occlude PDA was used in 15(16.7%) patients, Amplatzer duct Occluder - II was used in only 6(6.7%) patients and remaining 69(76.7%) patients' underwent device closure with conventional duct occluder (Amplatzer duct Occluder-I or similar design from different manufacturers Occlutech duct occluder, Lifetech duct occluder, SHSMA duct occluder). Descriptive statistics are summarized in Table-I.

The PDA's morphology plays a critical role in selecting the right device for occlusion. Figure-1 showed type of PDA devices used to obstruct the Ductal Arteriosus.

Echocardiography done before discharge, confirmed that all devices were in place. The overall success rate was observed in 88(97.7%) patients. Complications occurred in 2(2.2%) patients in the form of device embolization. In 1(1.1%) patient, embolized device was retrieved in the Cath lab while, in other patient it could not be retrieved and was referred for surgical retrieval and ligation of the ductus. No substantial gradient or obstruction was found in the descending aorta or left pulmonary artery during the final follow-up of all patients.

Table-I: Demographic and Clinical Parameters of Study Participants (n=90)

###Frequency

Study Variables###(%)

Age (years) {median (IQR)}###1(0.6-4.25)

Hospital stay (hours) (mean +- SD)###22.76+-2.54

Fluoroscopy time (minutes) {median (IQR)}###8.4(7.2-12.07)

Weight (kg) {median (IQR)}###7.5(5.5-13.25)

Gender###Male###34(37.8)

###Female###56(62.2)

Patient###Stable###89(98.9)

condition###Critical###1(1.1)

Mode of###General###86(95.6)

anesthesia###Local###4(4.4)

###Venous only###2(2.2)

Access###Arterial only###1(1.1)

###Both arterial and venous###87(96.7)

###RFA###70(77.8)

Site of arterial###LFA###18(20.0)

puncture###None###2(2.2)

###RFV###82(91.1)

Site of venous###LFV###7(7.8)

puncture###None###1(1.1)

###SHASMA###29(32.2)

Name of###Occlutech###4(4.4)

device###Amplatzer###8(8.9)

Manufacturer###Lifetech MFO###5(5.6)

###Lifetech PDA###44(48.9)

###A###70(76.7)

###B###4(4.4)

Krichenko###C###9(10.)

Classification###E###5(5.6)

###F###2(2.2)

###ADO I###69(76.7)

Type of Device###VSD###15(16.7)

used###ADO II###6(6.7)

###Tiny###1(1.1)

###Small###46(51.1)

Echo size###Moderate###37(41.1)

###Large###6(6.7)

###Absence of pulse after 2###12(13.3)

Complications###hour

###Device embolization###2(2.2)

Success rate###88(97.7)

Table-II: Comparison of Krichenko Classification with Type of Devices and Weight of Study Participants (n=90)

###Krichenko Classification

###Type-A###Type-B###Type-C###Type-E###Type-F

Variables###n=70###n=4###n=9###n=5###n=2###p-value

###Frequency###Frequency###Frequency###Frequency###Frequency

###(%)###(%)###(%)###(%)###(%)

###ADO-I###66(94.3)###1(25.0)###2(22.2)###--###--

Device used###VSD###4(5.7)###3(75.0)###4(44.4)###4(80.0)###--###<0.001

###ADO-II###--###--###3(33.3)###1(20.0)###2(100)

###a%0$?5###12 (17.1)###--###6(66.7)###--###2(100)###5###58(82.9)###4(100)###3(33.3)###5(100)###--

ADO-I device was used in 66(94.3%) patients with PDA type-A while Type-C was occluded by VSD device in 4(44.4%) patients. Moreover, 6(6.67%) patients underwent closure with ADO-II device, out of which 2(33.3%) were Type-F and 3(50.0%) were Type-C PDAs. Statistically significant relationship was observed between anatomical type (Krichenko classification) of PDA with type of device used and weight of study participants (p5 kg while ADO-II device was implanted in 2(33.3%).

Table-III: Comparison of Type of Devices Used and Weight of Study Participants (n=90)

###Device used

###ADO I###VSD###ADO II

Weight(kg)###n=69###n=15###n=6###p- value

###Frequency###Frequency Frequency

###(%)###(%)###(%)

a%0$?5 Kg###13 (18.8)###3(20.0)###4(66.6)###0.04

>5 Kg###56(81.2)###12(80.0)###2 (33.3)

DISCUSSION

PDA is a common congenital heart disease with an incidence of 5%-10% of all congenital heart defects.2

The success rate after PDA device closure depends on the PDA anatomy and appropriate device size selection.6 Our study reported a success rate of 88(97.7%) with 2(2.2%) complication rate. Aortic angiogram revealed that the most common ductus type treated was Krichenko type-A 70(76.7%), mean duration of hospital stay was 22.76+-2.54 hours. Conventional duct occluder device by various manufacturers was most commonly used 69(76.7%) among the study population, followed by VSD 15(16.7%) and ADO-II 6(6.7%) devices. Statistically significant relationship was observed between anatomical type (Krichenko classification) of PDA with type of device used (p<0.001) and weight of patients (p<0.001). In addition to that, significant results were observed between devices used and weight of the patients (p=0.04).

Most of the cases in our study were females 56(62.2%) which outnumbered males as reported in previous literature. Khan et al., reported the majority of females with PDA (64.7%) in their study.6 Likewise, Mehmmood et al., reported male to female ratio of 1:2 in a Pakistani population with PDA.12 The mean hospital stay after PDA device closure reported by our study was 22.76+-2.54 hours comparable to a local study by Khan et al., that reported 22 hours of hospital stay.6 However Zulqarnain et al., reported a relatively prolonged hospital stay which was 37.9 hours.13

Our data revealed that 6(6.7%) patients underwent closure with ADO-II device, out of which 2(33.3%) were Type-F and 3(50.0%) were Type-C PDAs, with 97.7% success rate. Sultan et al., reported success rate of 98.2%.9 A recent article by Maksymenko et al., reported an overall success rate of 97.2%.16 Yildiz K et al, reported a success rate of 94.2% after transcatheter PDA closure, which is consistent with previous studies14,17, and a success rate of 94.6% was reported by a study from Tukey.18 Yildiz et al., suggested that the ADO devices provide an effective and reliable method for transcatheter PDA closure having a success rate of 100%.14 In a recent study from Turkey by Osman et al., ADO II achieved a success rate of 98.7%, which was higher than other devices.15

Similarly, according to El-Saiedi et al., tubular PDAs with a diameter 0.05) and reported that higher event rates were more likely to occur with younger and low body weight patients (10% vs 2%;p < 0.001).8,17 In our study, we used devices in all the patients which could be the reason of a lower complication rate. The rate of embolisation can be reduced by the persistent endeavours of researchers to enhance the effectiveness and safety of device deployment. A multivariate study revealed that low body weight, raised pulmonary artery pressure (hypertensive PDA), procedural time, fluoroscopy time, and device size are all independent risk factors associated with a greater likelihood of complications.8

LIMITATIONS OF STUDY

This study was limited to single-center with relatively small sample size. Scarce resources and insufficient access to diverse devices on shelf was another constraint. Further studies are required to validate our findings to establish the relationship of PDA anatomy and choice of device

CONCLUSION

PDA transcatheter closure for occlusion of ductus of varied morphologies with a variety of devices is safe and effective procedure, and has high success rate with lower morbidity and mortality.

ACKNOWLEDGEMENT

I am grateful to my supervisor for his guidance, technical advice and support in completing my research project. I also extend my gratitude to Comdt Exec Dir Armed Forces Institute of Cardiology/ National Institute of Heart Diseases (AFIC/NIHD) and RandD dept for their support and contribution in completion of this research work.

Conflict of Interest: None

Authors' Contribution

Following authors have made substantial contributions to the manuscript:

SR and SI: Concept, drafting the manuscript, critical review, approval of the final version to be published

KA and AM: Study design, critical review, approval of the final version to be published

AA and AW: Data acquisition, data analysis, data interpretation, approval of the final version to be published

AS and JK: Data acquisition, critical review, approval of the final version to be published

Authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

REFERENCES

1. Hwang HJ, Yoon KL, Sohn IS. Transient severe left ventricular dysfunction following percutaneous patent ductus arteriosus closure in an adult with bicuspid aortic valve: A case report. Exp Ther Med. 2016; 11(3): 969-72. https//doi.org: 10.3892/etm.2015.3014

2. Abdel-Bary M, Abdel-Baseer KA, Abdel-Latif AF, Abdel-Naser MA, Nafie M, Eisa KM. Left ventricular dysfunction postsurgical patent ductus arteriosus ligation in children: predictor factors analysis. J Cardiothorac Surg. 2019; 14(1): 168. https//doi.org: 10.1186/s13019-019-1025-8

3. Dice JE, Bhatia J. Patent ductus arteriosus: an overview. J Pediatr Pharmacol Ther. 2007; 12(3): 138-46. https//doi.org: 10.5863/1551-6776-12.3.138

4. Agha HM, Hamza HS, Kotby A, Ganzoury MEL, Soliman N. Predictors of transient left ventricular dysfunction following transcatheter patent ductus arteriosus closure in pediatric age. J Saudi Heart Assoc. 2017; 29(4): 244-51. https//doi.org: 10.1016/j.jsha.2016.12.001

5. Hou M, Qian W, Wang B, Zhou W, Zhang J, Ding Y, et al. Echocardiographic Prediction of Left Ventricular Dysfunction After Transcatheter Patent Ductus Arteriosus Closure in Children. Front Pediatr. 2019; 7: 409. https//doi.org: 10.3389/fped.2019.00409

6. Khan AM, Ullah Z, Ilyas S, Wazir HD, Rehman Y, Hussain I, et al. The Outcome of Transcatheter Closure of Patent Ductus Arteriosus: A Single-Center Experience. Cureus. 2022; 14(1): e21577. https//doi.org: 10.7759/cureus.21577

7. Ezzeldin D, Wahba S, El Sayed M, Roushdy A. Immediate-and Short-Term Effect of Percutaneous Patent Ductus Arteriosus Closure on Left Ventricular Function: A Speckle Tracking Echocardiographic Study. Journal of The Indian Academy of Echocardiography and Cardiovascular Imaging. 2020; 4(2). https//doi.org: 10.4103/jiae.jiae_35_19

8. Nour A, Abdelrazik Y, Huessin S, Kamel H. Safety and efficacy of percutaneous patent ductus arteriosus closure: a multicenter Egyptian experience. The Egyptian Heart Journal. 2022; 74(1): 1-

7. https//doi.org: 10.1016/j.ehj.2021.07.009

9. Sultan M, Ullah M, Sadiq N, Akhtar K, Akbar H. Transcatheter device closure of patent ductus arteriosus. J Coll Physicians Surg Pak. 2014; 24(10): 710-3. https//doi.org: 10.2014/JCPSP.710710

10. El-Saiedi SA, Zoair AM, Agha HM, El-Shedoudy S, Fattouh AM, Abu-Farag IM, et al. Tubular PDA versus other PDA types: Challenging device choice for transcatheter closure. Progress in pediatric Cardiology. 2022; 64: 101434. https//doi.org: 10.1016/j.ppedcard.2021.101434

11. Gruenstein DH, Ebeid M, Radtke W, Moore P, Holzer R, Justino H. Transcatheter closure of patent ductus arteriosus using the AMPLATZER duct occluder II (ADO II). Catheter Cardiovasc Interv. 2017; 89(6): 1118-28. https//doi.org: 10.1002/ccd.26856

12. Mehmmood K. To study the residual leak within 24 hours after Transcatheter closure of PDA with different types of duct occluder Asia Pac J Paediatr Child Health. 2021; 4. https//doi.org: 10.21203/rs.3.rs-922529/v1

13. Zulqarnain A, Younas M, Waqar T, Beg A, Asma T, Baig MAR. Comparison of effectiveness and cost of patent ductus arteriosus device occlusion versus surgical ligation of patent ductus arteriosus. Pakistan Journal of Medical Sciences. 2016; 32(4): 974. https//doi.org: 10.12669/pjms.324.10173

14. Yildiz Sr K, Kir M, Prencuva P, Genc HZ, Celiktepe V, Bozyer HE, et al. Transcatheter Patent Ductus Arteriosus Closure in Children With Different Devices and Long-Term Results. Cureus. 2023; 15(10). https//doi.org : 10.7759/cureus.11350

15. Baspinar O, Irdem A, Sivasli E, Sahin DA, Kilinc M. Comparison of the efficacy of different-sized Amplatzer duct occluders (I, II, and II AS) in children weighing less than 10 kg. Pediatric cardiology. 2013; 34: 88-94. https//doi.org: 10.1007/s00246-012-0411-7

16. Maksymenko AV, Kuzmenko YL, Dovhaliuk AA, Motrechko OO, Herrmann FE, Haas NA, et al. Percutaneous closure of patent ductus arteriosus with the Nit-OccludA(r) patent ductus arteriosus device in 268 consecutive cases. Annals of Pediatric Cardiology. 2019; 12(3): 206. https//doi.org: 10.4103/apc.APC_144_18

17. El-Said HG, Bratincsak A, Foerster SR, Murphy JJ, Vincent J, Holzer R, et al. Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience. Journal of the American Heart Association. 2013; 2(6): e000424 https//doi.org 10.1161/JAHA.113.000424

18. Atik SU, Saltik IL. Transcatheter coil occlusion of patent ductus arteriosus and follow-up results. Turk Kardiyoloji Dernegi arsivi: Turk Kardiyoloji Derneginin yayin organidir. 2019; 47(4): 265-72. https//doi.org 10.5543/tkda.2018.12756

19. Backes CH, Rivera BK, Bridge JA, Armstrong AK, Boe BA, Berman DP, et al. Percutaneous patent ductus arteriosus (PDA) closure during infancy: a meta-analysis. Pediatrics. 2017; 139(2). https//doi.org 10.1542/peds.2016-3338

20. Bruckheimer E, Steiner K, Barak-Corren Y, Slanovic L, Levinzon M, Lowenthal A, et al. The Amplatzer duct occluder (ADOII) and Piccolo devices for patent ductus arteriosus closure: a large single institution series. Frontiers in Cardiovascular Medicine. 2023; 10: 1158227. https//doi 10.3389/fcvm.2023.1158227