1
2 STRUCTURAL HEART DISEASE Percutaneous Device Closure of Patent Ductus Arteriosus with Pulmonary Artery Hypertension: Long‐Term Results Dr. H.S. Natraj Setty, MD,DM Dr. I.B. Vijayalakshmi MD.DM, Dr. Chitra Narasimhan MD, Dr.C.N. Manjunath MD,DM 7th International Congress of Cardiology, Shangai, China Nothing to disclose
3 Ductus Arteriousus Most of the blood from right ventricle bypass the fluid filled fetal lungs via vascular connection between pulmonary arteries and Aortic arch DA is significantly narrowed in hrs and disappears by three weeks. Release of bradykinin, maternal prostaglandin levels and fetal oxygenation are some of important factors Symptomatic PDA can be treated both surgically and non-surgically PGE2 Plays an important role in maintenance of DA, hence some NSAIDs have inhibitory action on patency of DA Journal of Interventional Cardiology – Vol.-27, No.6, 2014
4 Introduction This study aimed to know the challenges of percutaneous device closure in PDA with severe PAH and assess the medium to long term results PDA accounts for 10-15% of congenital heart disease, incidence 1:2000 term live births Paucity of data on technical considerations, patient selection, acute complication and long term follow up in patients undergoing device closure Device closure though widely considered as treatment of choice, is a challenge in PDA with PAH due to artery obstruction or increased risk of device embolization
5 Material and methods Period PAH Severity AnalysisPeriod of study: January 2005 to July 2014 Total of 1325 cases of PDA underwent trans-catheter device closure PAH 246 (18.6%) had various grades of Pulmonary artery hypertension (PAH) ie Pulmonary artery pressure (PAP) of more than 25 mm of Hg or pulmonary artery systolic pressure (PASP) more than 50 % of systemic systolic pressure Severity Mild PAH: mm of hg Moderate PAH: mm of hg Severe PAH > 45 mm of hg Associated shunt lesions, complex congenital heart disease requiring surgery were excluded. Analysis Statistical analysis was performed with SPSS Quantative data was expressed as mean +/- SD
6 Assessment of feasibility for device closureFirst 100% oxygen using face mask for 10 minutes was administered and hemodynamic measurements were repeated to note the significant reduction in PAP Balloon obstruction of PDA was done to measure size of PDA and also note the reduction in PAP Chosen DO used to occlude PDA for 10 minutes without oxygen inhalation. Then the PAP recorded from the side port of Y connector
7 Procedure All patients received SBE prophylaxisProcedure was done under caudal anesthesia with mild sedation in pts with body wt. less than 10 Kg. Else local anesthesia with IV sedation was used Amplatzer duct occlude/ Amplatzer muscular VSD occlude II / Amplatzer duct occluder II were used Occluder size >2-3 mm larger than minimal diameter of PDA was selected except in some infants where the risk of aortic obstruction was prevalent All patients received SBE prophylaxis Aspirin was advised at dose of 5mg/kg/day for 3 Months Journal of Interventional Cardiology – Vol.-27, No.6, 2014
8 Baseline characteristicsFemales 165 (67.1%) Males 81 (32.9%) Weight 12.7 Kg SD 8.7 (2.2-50Kg) Age 2 Years IQR 5.1 Follow-up 3.6 years IQR 2.7 PDA Size (mm) 5.8 (3.2-20) SD 2.2 MPAP (mmHg) PSAP (mmHg) 40.3 (25-110) SD 15.5 59.3 (30-143) SD 20.8
9 Distribution of study populationAge Mean PAP (mm Hg) No. of patients Average PDA size (mm) Complications Device embolism Other < 1 year 25-35 37 (41.6%) 4.5 (3 -8.7) NIL Vascular complications: 4 LPA obstruction: 1 35-45 25 (28.1%) 4.9 (3 – 8.6) >45 27 (30.3%) 5.4 (3 – 8.0) 1 89 1- 5 years 39 (56.5%) 5.2 ( ) 14 (20.3%) 5.5 (3 - 7) 16 (23.2%) 6.2 (3 – 9.2) 2 69 > 5 years 31 (40.8%) 6.1 ( ) 17 (22.4%) 6.9 (3 – 10.4) 28 (36.8%) 9.1 (5 - 20) 4 76
10 Youngest Patient Youngest Patient was 9 days old baby (2.2 Kg weight)With chest retraction and biventricular dysfunction (LVEF=35%) and PAH (PAP = 52/20 mean 31 mm of Hg) Underwent successful PDA closure using 3 X 4 ADO II device PAP dropped to 28/16 mean 20 mm of Hg immediately after the procedure. Clinically significant improvement, on follow-up gained weight and normal LV function by 3 months Journal of Interventional Cardiology – Vol.-27, No.6, 2014
11 Results: Disease and DevicesA total of 246 patients of PDA with PAH underwent percutaneous device closure during study In 218 patients regular ducts of various sizes (14X12, 12X10, 10X8) were used MVSDO in 10 cases with Large PDA and severe PAH were used In 18 infants with severe PAH ADO II devices were used Largest device used were 26X24 DO and 22 mm MVSDO
12 Results: outcome The PAP dropped significantly in all patients immediately after the device closure The mean PAP at the time of discharge was / mm of Hg Despite significant drop in PAP, 20 out of 62 patients with severe PAH had mean PAP more than 45 mm of Hg Patients were discharged with pulmonary vasodialators like Sidenafil and Bosentan and closely followed up After mean follow up of 9 months PAP dropped to mild PAH in all except 5 patients with Down’s Syndrome
13 Results Journal of Interventional Cardiology – Vol.-27, No.6, 2014Two patients underwent VSD closure simultaneously with PDA closure Residual Shunt was noted in 3 out of 18 patients where ADO II was used, at the time of discharge but closed on follow up at 3 months In infant post- procedural weight gain was noted as 2.15 Kg +/- 400g at 3 months follow up Journal of Interventional Cardiology – Vol.-27, No.6, 2014
14 Complications Left Ventricular Dysfunction: 4 patients(1.6%) developed LV dysfunction as evident on echocardiography and were subsequently treated with ACEI and diuretics till recovery 4 (1.6%) Patients had loss of pulse at the site of puncture were successfully treated with Heparin and Streptokinase Device Embolization: Seen in 8 cases, 3 in Aorta, 5 in pulmonary artery. All with severe PAH In one infant LPA stenosis occurred with MVSDO with pull back gradient of 10 mm of Hg. The patient is under follow up and asymptomatic with gradient reduced to 6 mm of Hg
15 Device retrieval Device retrieval was done successfully in 4 casesIn 2 cases device was snared with appropriate sized goose-neck snare In 2 cases devise was retrieved using novel method of fastening the screw to the device with in the vessel In 3 cases retrieval was not tried to prevent damage to intima where device has embolized to the pulmonary artery. Referred for surgical removal The patients were followed from 3 months to 9 years
16 Video 1. Check descending aortic angiogram in left lateral position illustrates the perfect position of the duct occluder with no residual shunt.
17 Video 2. The screw of the cable into the socket (like docking of the space ship to space station) is fastened and the device is seen being pulled down.
18 Figure: (A) Seven years male with large 18mmPDA on angiogramFigure: (A) Seven years male with large 18mmPDA on angiogram. (B) The PDA closed with 2mmMVSDOas PAP dropped from 88/61m70 to 68/30m 43 mmHg. (C) Device embolized to PA after 1 hour. Surgical extraction of device and PDA closure was done with Bhati’s technique.
19 No Residual Defect
20 Percutaneous Device ClosureUntil recently the patients of PDA with PAH underwent surgical closure Though surgical ligation is the oldest and safe modality of treatment with mortality close to zero, it still is associated with high morbidity Recent studies have shown feasibility and safety of percutaneous device closure in infant < 6 Kg Important dilemma is whether to close or not to close the PDA owing to risk of progressive pulmonary disease Grey zone is when PVR index is in between 6-9 Woods unit/ m2
21 Percutaneous Device ClosureAuthors recommend careful assessment of Pulmonary artery and aortic pressure during device closure and regular monitoring after discharge Authors found that PDA occlusion with suitable device for 10 minutes without oxygen inhalation is better and less cumbersome than balloon occlusion. Area of major concern is the risk of device embolization, in this study it was seen in 3.3% of the patients, though all were managed successfully either by percutaneous or surgical removal Journal of Interventional Cardiology – Vol.-27, No.6, 2014
22 Percutaneous device closureThe results of present studies are comparable with available studies and showed that the closure of the PDA with PAH is feasible, safe and efficacious in all age group with marginal risk of device embolization Study No. of patients Age (yrs) Weight (Kg) PDA (mm) PASP (mmHg) Device used Embolisation Thanopolis [13] (Greece) 2002 7 8.9 31.7 9.8 106 MVSDO NIL Yan [6] (China) 2007 20 34.2 54.6 10.4 104.9 ADO, MVSDO Zabal[14] (Mexico) 2010 168 10.3 NA 6.4 63.5 ADO, MVSDO, ASO 5(2.97 %) Zang [15] (China) 2012 29 32 12.5 Duct occluder (Lifetech) Bhalgat [4] (India) 2012 65 9.1 14 8.1 66.9 Duct occluder (Amplatzer, Lifetech, Cocoon), MVSDO Vijayalakshmi (India) 2013 234 4.5 12.6 6.9 66.8 ADO, ADO II, Lifetech, MVSDO 7 (2.9 %) ADO – Amplatzer duct occluder: ASO – Amplatzerseptaloccluder; MVSDO – muscular ventricular septal defect occluder
23 Down’s Syndrome Authors found that PAP dropped in all the patient after device closure but was delayed and relatively less in patients with Down’s syndrome Children with Down’s Syndrome probably have multiple factors contributing to PAH Chronic upper airway obstruction Abnormal pulmonary vasculature growth Alveolar hypoventilation Pulmonary tissue damage Recurrent pulmonary infection Thinner media of pulmonary arterioles Diminished number of Alveoli
24 Conclusions In infants ADO II is an important adjunct.Though Duct occlude works well in most cases sometimes MVSDO has to be used Device embolization is a serious complication in PDA with severe PAH Retrieval of large MVSDO at times may be difficult and requires surgery Timely device closure with vasodialators can decrease PAP immediately and continue to do so on follow ups.
25 Limitations This is a single center studyPulmonary pressure at follow up were measured only by echo cardiography which is an indirect measure Journal of Interventional Cardiology – Vol.-27, No.6, 2014
26 References Bilkis AA, Alwi M, Hasri S, Haifa AL, Geetha K, Rehman MA, Hasanah I. The Amplatzer duct occluder: experience in 209 patients. J Am CollCardiol 2001; 37: 258–261 Bhalgat PS, Pinto R, Dalvi BV. Transcatheter closure of large patent ductusarteriosus with severe pulmonaryarterial hypertension: Short and intermediate term results. Ann PediatrCardiol. 2012;5:135–140 Yang SW, Zhou YJ, Hu DY, Liu YY, Shi DM, Guo YH, Cheng WJ, Nie XM, Wang JL.Feasibility and safety of transcatheter intervention for complex patent ductusarteriosus. Angiology 2010;61: Yan C, Zhao S, Jiang S, Xu Z, Huang L, Zheng H, Ling J, Wang C, Wu W, Hu H, Zhang G, Ye Z, Wang H. Transcatheter closure of patent ductusarteriosus with severe pulmonary arterial hypertension in adults. Heart 2007;93: Vijayalakshmi IB, Chitra N, Rajasri R, Prabhudeva AN. Amplatzer angled duct occluder for closure of patent ductusarteriosus larger than the aorta in an infant. PediatrCardiol. 2005;26:480–483. Zabal C, García-Montes JA, Buendía-Hernández A, Calderón-Colmenero J, Patiño-Bahena E, Juanico- Enriquez A, Attie F. Percutaneous closure of hypertensive ductusarteriosus. Heart.2010 ;96:625-9. Zhang CJ, Huang YG, Huang XS, Huang T, Huang WH, Xia CL, Mo YJ.Transcatheter closure of large patent ductusarteriosus with severe pulmonary arterial hypertension in adults: immediate and two-year follow-up results. Chin Med J 2012;125:
27 Thank You