© 2014, Wiley Periodicals, Inc. DOI: 10.1111/joic.12156
STRUCTURAL HEART DISEASE Percutaneous Device Closure of Patent Ductus Arteriosus with Pulmonary Artery Hypertension: Long‐Term Results ISHWARAPPA BALEKUNDRI VIJAYALAKSHMI, M.D., NATRAJ SETTY, M.D., CHITRA NARASIMHAN, M.D., VIVEK SINGLA, M.D., and CHOLENAHALLI NANJAPPA MANJUNATH, M.D. From the Sri Jayadeva Institute of Cardiovascular Sciences and Research Bengaluru, Bangalore, Karnataka, India
Device closure of patent ductus arteriosus (PDA) is treatment of choice. But device closure in presence of pulmonary artery hypertension (PAH) remains a challenge. Data on patient selection, technical considerations, and complications are limited. Aim: To know the challenges and efficacy of device closure of PDA with PAH. Materials and Results: Out of 1,325 cases of device closure of PDA, 246 (18.6%) with PAH formed the study material. To test the feasibility, chosen device is used to occlude PDA for ten minutes without oxygen inhalation. The device is released only if PAH reduced. PAH decreased in all except in 1 patient after closure with muscular ventricular septal occluder (MVSDO), pulmonary artery pressure (PAP) transiently increased (became supra‐ systemic), without significant reduction in aortic pressure. Device embolized in 8 patients (3.3%). Percutaneous retrieval was done in 4 (by snare in 2 and by fixing the cable to device in 2) and replaced with bigger devices. The surgical removal of the embolized MVSDO and ligation was done in 4 cases. All patients were on oral sildenafil and bosentan until PAP regressed to normal. Follow up was from 6 months to 9 years. No residual shunt in any patient on follow‐up. The PAP regressed to normal in all except 5 cases (2.03%) of Down’s syndrome with systemic PAP. Conclusions: Device closure of PDA with PAH is feasible, safe in all age groups. Temporary PDA occlusion with device is effective and time saving for evaluating pulmonary vascular reactivity. Device embolization in aorta is higher with severe PAH. Novel method of retrieval is effective. (J Interven Cardiol 2014;27:563–569)
Introduction Patent ductus arteriosus is seen in approximately 1 in 2000 of term live births accounting for 10–15% of congenital heart disease.1 Percutaneous device closure is widely considered as the treatment of choice for patients diagnosed with PDA.2,3 However, in patients with severe (PAH), device closure of PDA remains a challenge. The closure of large PDA with PAH is difficult due to increased risk of device embolization and pulmonary artery or aortic obstruction, due to the oversized large device. In neonates and infants, the PAH is most often reversible but in older Disclosure statement: The authors report no financial relationships or conflicts of interest regarding the content herein. Address for reprints: Natraj Setty, M.D., Sri Jayadeva Institute of Cardiovascular Sciences and Research Bengaluru, 493, 4th Cross, 7th Main, JP Nagar 3rd Phase, Bangalore 560 069, Karnataka, India. Fax: þ918026534477; e‐mail: [email protected]
Vol. 27, No. 6, 2014
patients the resolution of PAH is variable depending on the reversibility of pulmonary vascular resistance. Although advances in transcatheter techniques and devices have made closure of large PDAs technically feasible, there is a paucity of data on patient selection, technical considerations, acute complications, and long‐term problems related to this subset of patients.4–6 Many fear that the device closure of PDA with PAH, will convert into severe PAH. The aim of our study is to know the challenges of percutaneous device closure in PDA with severe PAH and assess the medium to long‐ term results.
Material and Methods From January 2005 to July 2014, totally 1,325 cases of PDA underwent transcatheter device closure. Out of which 246 (18.6%) had various grades of PAH. The
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VIJAYALAKSHMI, ET AL.
patients with either mean PAP of >25 mmHg or pulmonary artery systolic pressure more than 50% of the systemic pressure measured during catheterization were included in the study. All the patients with associated shunt lesions (except 2 cases in whom simultaneous closure of VSD was done), complex congenital heart diseases requiring surgery, were excluded. For the purpose of the study, the patients were further divided into 3 groups based upon the mean PAP (i) Mild PAH (26–35 mmHg), (ii) moderate PAH (36–45 mmHg), and (iii) severe PAH (>45 mmHg). All the patients underwent procedure after informed written consent from the guardian/patient.
Procedure The procedure was done under caudal epidural anesthesia and with mild intravenous sedation in infants and patients 2–3 mm larger than the measured minimal diameter of the narrowest portion of the PDA. In some infants, over‐ sizing of the device was not possible, as this would have caused aortic obstruction. Hence, in such a subset of patients, the device chosen was of the same size or just 1 mm bigger than the measurement of the PDA. Previously large PDAs were closed with the modified Amplatzer duct occluder with a single layer of polyester or with custom made angled devices that had no polyester material.7,8 Recently after the availability of ADO II, device without polyester material, we are using them for long tubular PDA especially in infants and in the presence of PAH. The patients with severe PAH or supra‐systemic PAH were evaluated for feasibility of device closure using the following methods. 1. First 100% oxygen using a facemask for 10 minutes was administered and hemodynamic
564
measurements were repeated, to note the significant reduction in PAP. 2. In the earlier part of our study, balloon obstruction of PDA was done to measure the size of PDA and also to note the reduction in the PAP. In this group of patients another venous access was used for recording the PAP. The balloon obstruction of PDA is done for 2 purposes (i) to assess the reduction in PAP and (ii) when descending aortic angiogram fails to delineate the borders of the PDA clearly, to measure the precise size of the ductus (width) as S1 and length of the ductus as S2 (Fig. 1A and B). 3. More recently the chosen duct occluder is being used to occlude PDA for 10 minutes without oxygen inhalation. Then the PAP is recorded from the side port of the Y connector. The device is released only if all of the following criteria were fulfilled: (a) PAP either decreased or did not elevate. (b) Increase in aortic pressure or no fall in the aortic pressure and, (c) no bradycardia or worsening of hemodynamics occurred. After the procedure the patients were monitored in the post catheterization ward until the patients were completely awake and without any complications. All patients received SBE prophylaxis routinely. The aspirin was advised at a dose of 5 mg/kg/day for 3 months. All the patients were evaluated with the transthoracic echocardiogram and chest X‐ray after the procedure and at 3, 6, and 12 months follow‐up. Those patients in whom the PAH did not regress were followed twice in a year. Statistical analysis was performed with statistical software (SPSS 16.0 for Windows). Quantitative data are expressed as mean SD and median.
Figure 1. (A) The descending aortic angiogram shows large PDA (black arrow) without the definite delineation of the borders. (B) Balloon occlusion of PDA done to assess the reduction in PA pressure at the same time size of the duct is measured as S1 and length of the duct is measured as S2. AO, aorta; L, length; PA, pulmonary artery.
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DEVICE CLOSURE OF PDA WITH PAH
Results A total of 246 patients of PDA with PAH underwent percutaneous device closure during the study period. The baseline characteristics of the study population are summarized in Table 1. Out of 246 cases, 165 (67.1%) were females with female‐to‐male ratio of 2.1:1. The median age of the study population was 2 years with an interquartile range (IQR) of 5.1 and the median weight was 10 kg with an IQR of 9 respectively. Only 3 patients were adults (20, 24, and 32 years old). Of the 246 patients, 94 (38.2%) were infants and 63 (25.6%) had 6 kg body weight (Table 2). The youngest patient was 9 days old baby (2.2 kg body weight), who had chest retractions and biventricular dysfunction (LV ejection fraction 35%); additional complete heart block Table 1. Baseline Characteristics (n ¼ 246) Females Males Weight (kg)
165 (67.1%) 81 (32.9%) 12.7 kg SD 8.7 (2.2–50 kg) Median: 2 kg IQR: 5.1 Median: 3.6 years IQR: 2.7 years 5.8 mm SD 2.2 (3.2–20 mm) 40.3 SD 15.5 mmHg (25–110) 59.3 SD 20.8 mmHg (30–143 mmHg)
Age Follow‐up PDA size (mm) MPAP (mmHg) PASP (mmHg)
MPAP, mean pulmonary artery pressure; PASA, pulmonary artery systolic pressure; PDA, patent ductus arteriousos.
and PAH (PAP 52/20 mean 31 mmHg; aortic pressure 62/37 mmHg). The patient underwent successful PDA closure using 3 4 ADO II device. Immediately after the procedure the PAP dropped to 28/16 mean 20 mmHg and the patient improved symptomatically. On follow‐up the patient gained weight and the LV function normalized by the 3 months follow‐up. The mean PDA size (at narrowest point) as measured during catheterization was 5.8 mm SD 2.2 (3.2–20 mm), and 37 patients (15.04%) had 8 mm PDA. The average mean PAP was 40.3 SD 15.5 mmHg (range: 25– 110 mmHg) and 62 patients (25.2%) had severe PAH (mean PAP more than 45 mmHg). In 218 patients, the various sizes (14 12, 12 10, 10 8) of regular duct occluders were used. Ten cases with large PDAs with severe PAH were closed with MVSDO (Fig. 2A and B) and in 18 infants with severe PAH, ADO II devices were used. The largest devices used were 26 24 duct occluder and 22 mm MVSDO. Most frequently used devices were 12 10 and 10 8. The PAP dropped significantly in all patients immediately after device closure. The mean PAP at the time of discharge was 32.4 13.7 mmHg. Despite significant drop in PAP, 20 (32.3%) of the 62 patients with severe PAH had mean PAP more than 45 mmHg at the time of discharge. These patients were discharged on pulmonary vasodilators like sildenafil and bosentan and they were closely followed. After mean follow‐up of 9 months the PAP dropped to mild PAH in all except 5 patients with Down’s syndrome. Two patients underwent VSD device closure simultaneously with the PDA closure. The residual shunt was noted at the time of discharge, in 3 out of 18 cases where ADO II was deployed, which
Table 2. Distribution of Study Population According to Age, Mean Pulmonary Artery Pressure Complications Mean PAP (mmHg)
No. of Patients
45
1–5 years
25–35 36–45 >45
>5 years
25–35 36–45 >45
45 (47.9%) 25 (26.6%) 24 (25.5%) 94 45 (60.0%) 17 (22.7%) 13 (17.3%) 75 33 (42.9%) 19 (24.7%) 25 (32.4%) 77
Age
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Average PDA Size (mm)
Device Embolization
Other
4.5 (2.8–8.7) 5.1 (3.7–8.6) 5.6 (3.0–8.0)
NIL 1 1
Vascular complications: 4 LPA obstruction: 1
4.8 (2.2–8.0) 5.3 (3.0–7.0) 5.7 (3.0–9.2)
1 1
NIL
6.2 (2.5–11.0) 6.7 (3.0–10.4) 9.4 (5.0–20.0)
NIL NIL 4
NIL
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Figure 2. (A) The descending aortic angiogram in 10 years old girl shows 20 mm large PDA. (B) Closed with 20 mm MVSDO. Post procedure PAP dropped from 120/80 m 93 to 78/57 m 60 mm of Hg. SaO2 pre procedure: UL, 92%; LL, 84%. On follow‐up 3 months after procedure PASP was 50 mmHg and after 1 year PASP is 30 mm of Hg, SaO2—98%. AO, aorta; MPA, main pulmonary artery; PDA, patent ductus arteriosus.
closed on follow‐up after 3 months. There was no evidence of hemolysis in any of the patients. In infants, the post procedure average weight gain after 3 months was 2.15 kg 400 g.
Complications Out of 246 cases 4 patients (1.6%) with severe PAH developed left ventricular dysfunction with reduced ejection fraction on echocardiography soon after the procedure. They were treated with ACE inhibitor and diuretics till they recovered. The device embolization was seen in 8 cases (3.3%). The devices embolized into aorta in 3 cases and into the pulmonary artery in 5. All these cases had severe PAH. The transcatheter device retrieval was done successfully in 4 cases. In 2 cases the
device was snared with the appropriate sized goose‐ neck snare. In 2 cases the device was retrieved using a novel method of fastening the screw to the device within the vessel (Fig. 3A–C) and retrieving the device as being reloaded in the sheath.9 After device retrieval, ductus was successfully closed with bigger ADO device or ADO II in 3 cases. In 3 cases, where the large MVSDOs (16, 18, and 22 mm) had embolized into pulmonary artery (Fig. 4A–C), the attempt for transcatheter retrieval of the device was not done in order to prevent damage to the intima and the patients were directly referred for surgical removal of the device and multiple ligation. In one case the 6X6 ADO II device, which had embolized into LPA and could not be retrieved despite various maneuvers. Hence the patient was referred for surgical retrieval and ligation of the PDA. In 1 infant, LPA stenosis occurred with MVSDO, with a pullback gradient of 10 mmHg. The patient is under regular follow‐up and is asymptomatic and the gradient across LPA has reduced to 6 mmHg. The device moved toward aorta just after release causing obstruction in 3 infants. The device was gently pushed back with low‐pressure balloon dilatation. The devices were stable without aortic obstruction in 2 patients where as it slipped to descending aorta in 1 patient and was retrieved using novel technique of fastening the screw inside the vessel. The 4 patients (1.6%) who had loss of pulse at the site of puncture were successfully treated with heparin and streptokinase infusion. All the 4 patients were infants with large PDA requiring larger devices. The patients were followed up from 3 months to 9 years. Out of 62 (25.2%) patients with severe PAH, 5 patients (8.1%) continue to have moderate PAH despite the optimal drug therapy. Incidentally all 5 of them had Down’s syndrome. 48 (37.4%) patients have
Figure 3. (A) 8 6 ADO in situ in a 7‐year‐old child with systemic pulmonary artery pressure. (B) Arrow pointing to the embolized device in the aorta. (C) The embolized device retrieved through a novel method of fastening the screw inside the aorta before retrieving it successfully. AO, aorta.
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DEVICE CLOSURE OF PDA WITH PAH
Figure 4. (A) Seven years male with large 18 mm PDA on angiogram. (B) The PDA closed with 22 mm MVSDO as PAP dropped from 88/61 m 70 to 68/30 m 43 mmHg. (C) Device embolized to PA after 1 hour. Surgical extraction of device and PDA closure was done with Bhati’s technique. AO, aorta.
in infants including those
STRUCTURAL HEART DISEASE Percutaneous Device Closure of Patent Ductus Arteriosus with Pulmonary Artery Hypertension: Long‐Term Results ISHWARAPPA BALEKUNDRI VIJAYALAKSHMI, M.D., NATRAJ SETTY, M.D., CHITRA NARASIMHAN, M.D., VIVEK SINGLA, M.D., and CHOLENAHALLI NANJAPPA MANJUNATH, M.D. From the Sri Jayadeva Institute of Cardiovascular Sciences and Research Bengaluru, Bangalore, Karnataka, India
Device closure of patent ductus arteriosus (PDA) is treatment of choice. But device closure in presence of pulmonary artery hypertension (PAH) remains a challenge. Data on patient selection, technical considerations, and complications are limited. Aim: To know the challenges and efficacy of device closure of PDA with PAH. Materials and Results: Out of 1,325 cases of device closure of PDA, 246 (18.6%) with PAH formed the study material. To test the feasibility, chosen device is used to occlude PDA for ten minutes without oxygen inhalation. The device is released only if PAH reduced. PAH decreased in all except in 1 patient after closure with muscular ventricular septal occluder (MVSDO), pulmonary artery pressure (PAP) transiently increased (became supra‐ systemic), without significant reduction in aortic pressure. Device embolized in 8 patients (3.3%). Percutaneous retrieval was done in 4 (by snare in 2 and by fixing the cable to device in 2) and replaced with bigger devices. The surgical removal of the embolized MVSDO and ligation was done in 4 cases. All patients were on oral sildenafil and bosentan until PAP regressed to normal. Follow up was from 6 months to 9 years. No residual shunt in any patient on follow‐up. The PAP regressed to normal in all except 5 cases (2.03%) of Down’s syndrome with systemic PAP. Conclusions: Device closure of PDA with PAH is feasible, safe in all age groups. Temporary PDA occlusion with device is effective and time saving for evaluating pulmonary vascular reactivity. Device embolization in aorta is higher with severe PAH. Novel method of retrieval is effective. (J Interven Cardiol 2014;27:563–569)
Introduction Patent ductus arteriosus is seen in approximately 1 in 2000 of term live births accounting for 10–15% of congenital heart disease.1 Percutaneous device closure is widely considered as the treatment of choice for patients diagnosed with PDA.2,3 However, in patients with severe (PAH), device closure of PDA remains a challenge. The closure of large PDA with PAH is difficult due to increased risk of device embolization and pulmonary artery or aortic obstruction, due to the oversized large device. In neonates and infants, the PAH is most often reversible but in older Disclosure statement: The authors report no financial relationships or conflicts of interest regarding the content herein. Address for reprints: Natraj Setty, M.D., Sri Jayadeva Institute of Cardiovascular Sciences and Research Bengaluru, 493, 4th Cross, 7th Main, JP Nagar 3rd Phase, Bangalore 560 069, Karnataka, India. Fax: þ918026534477; e‐mail: [email protected]
Vol. 27, No. 6, 2014
patients the resolution of PAH is variable depending on the reversibility of pulmonary vascular resistance. Although advances in transcatheter techniques and devices have made closure of large PDAs technically feasible, there is a paucity of data on patient selection, technical considerations, acute complications, and long‐term problems related to this subset of patients.4–6 Many fear that the device closure of PDA with PAH, will convert into severe PAH. The aim of our study is to know the challenges of percutaneous device closure in PDA with severe PAH and assess the medium to long‐ term results.
Material and Methods From January 2005 to July 2014, totally 1,325 cases of PDA underwent transcatheter device closure. Out of which 246 (18.6%) had various grades of PAH. The
Journal of Interventional Cardiology
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VIJAYALAKSHMI, ET AL.
patients with either mean PAP of >25 mmHg or pulmonary artery systolic pressure more than 50% of the systemic pressure measured during catheterization were included in the study. All the patients with associated shunt lesions (except 2 cases in whom simultaneous closure of VSD was done), complex congenital heart diseases requiring surgery, were excluded. For the purpose of the study, the patients were further divided into 3 groups based upon the mean PAP (i) Mild PAH (26–35 mmHg), (ii) moderate PAH (36–45 mmHg), and (iii) severe PAH (>45 mmHg). All the patients underwent procedure after informed written consent from the guardian/patient.
Procedure The procedure was done under caudal epidural anesthesia and with mild intravenous sedation in infants and patients 2–3 mm larger than the measured minimal diameter of the narrowest portion of the PDA. In some infants, over‐ sizing of the device was not possible, as this would have caused aortic obstruction. Hence, in such a subset of patients, the device chosen was of the same size or just 1 mm bigger than the measurement of the PDA. Previously large PDAs were closed with the modified Amplatzer duct occluder with a single layer of polyester or with custom made angled devices that had no polyester material.7,8 Recently after the availability of ADO II, device without polyester material, we are using them for long tubular PDA especially in infants and in the presence of PAH. The patients with severe PAH or supra‐systemic PAH were evaluated for feasibility of device closure using the following methods. 1. First 100% oxygen using a facemask for 10 minutes was administered and hemodynamic
564
measurements were repeated, to note the significant reduction in PAP. 2. In the earlier part of our study, balloon obstruction of PDA was done to measure the size of PDA and also to note the reduction in the PAP. In this group of patients another venous access was used for recording the PAP. The balloon obstruction of PDA is done for 2 purposes (i) to assess the reduction in PAP and (ii) when descending aortic angiogram fails to delineate the borders of the PDA clearly, to measure the precise size of the ductus (width) as S1 and length of the ductus as S2 (Fig. 1A and B). 3. More recently the chosen duct occluder is being used to occlude PDA for 10 minutes without oxygen inhalation. Then the PAP is recorded from the side port of the Y connector. The device is released only if all of the following criteria were fulfilled: (a) PAP either decreased or did not elevate. (b) Increase in aortic pressure or no fall in the aortic pressure and, (c) no bradycardia or worsening of hemodynamics occurred. After the procedure the patients were monitored in the post catheterization ward until the patients were completely awake and without any complications. All patients received SBE prophylaxis routinely. The aspirin was advised at a dose of 5 mg/kg/day for 3 months. All the patients were evaluated with the transthoracic echocardiogram and chest X‐ray after the procedure and at 3, 6, and 12 months follow‐up. Those patients in whom the PAH did not regress were followed twice in a year. Statistical analysis was performed with statistical software (SPSS 16.0 for Windows). Quantitative data are expressed as mean SD and median.
Figure 1. (A) The descending aortic angiogram shows large PDA (black arrow) without the definite delineation of the borders. (B) Balloon occlusion of PDA done to assess the reduction in PA pressure at the same time size of the duct is measured as S1 and length of the duct is measured as S2. AO, aorta; L, length; PA, pulmonary artery.
Journal of Interventional Cardiology
Vol. 27, No. 6, 2014
DEVICE CLOSURE OF PDA WITH PAH
Results A total of 246 patients of PDA with PAH underwent percutaneous device closure during the study period. The baseline characteristics of the study population are summarized in Table 1. Out of 246 cases, 165 (67.1%) were females with female‐to‐male ratio of 2.1:1. The median age of the study population was 2 years with an interquartile range (IQR) of 5.1 and the median weight was 10 kg with an IQR of 9 respectively. Only 3 patients were adults (20, 24, and 32 years old). Of the 246 patients, 94 (38.2%) were infants and 63 (25.6%) had 6 kg body weight (Table 2). The youngest patient was 9 days old baby (2.2 kg body weight), who had chest retractions and biventricular dysfunction (LV ejection fraction 35%); additional complete heart block Table 1. Baseline Characteristics (n ¼ 246) Females Males Weight (kg)
165 (67.1%) 81 (32.9%) 12.7 kg SD 8.7 (2.2–50 kg) Median: 2 kg IQR: 5.1 Median: 3.6 years IQR: 2.7 years 5.8 mm SD 2.2 (3.2–20 mm) 40.3 SD 15.5 mmHg (25–110) 59.3 SD 20.8 mmHg (30–143 mmHg)
Age Follow‐up PDA size (mm) MPAP (mmHg) PASP (mmHg)
MPAP, mean pulmonary artery pressure; PASA, pulmonary artery systolic pressure; PDA, patent ductus arteriousos.
and PAH (PAP 52/20 mean 31 mmHg; aortic pressure 62/37 mmHg). The patient underwent successful PDA closure using 3 4 ADO II device. Immediately after the procedure the PAP dropped to 28/16 mean 20 mmHg and the patient improved symptomatically. On follow‐up the patient gained weight and the LV function normalized by the 3 months follow‐up. The mean PDA size (at narrowest point) as measured during catheterization was 5.8 mm SD 2.2 (3.2–20 mm), and 37 patients (15.04%) had 8 mm PDA. The average mean PAP was 40.3 SD 15.5 mmHg (range: 25– 110 mmHg) and 62 patients (25.2%) had severe PAH (mean PAP more than 45 mmHg). In 218 patients, the various sizes (14 12, 12 10, 10 8) of regular duct occluders were used. Ten cases with large PDAs with severe PAH were closed with MVSDO (Fig. 2A and B) and in 18 infants with severe PAH, ADO II devices were used. The largest devices used were 26 24 duct occluder and 22 mm MVSDO. Most frequently used devices were 12 10 and 10 8. The PAP dropped significantly in all patients immediately after device closure. The mean PAP at the time of discharge was 32.4 13.7 mmHg. Despite significant drop in PAP, 20 (32.3%) of the 62 patients with severe PAH had mean PAP more than 45 mmHg at the time of discharge. These patients were discharged on pulmonary vasodilators like sildenafil and bosentan and they were closely followed. After mean follow‐up of 9 months the PAP dropped to mild PAH in all except 5 patients with Down’s syndrome. Two patients underwent VSD device closure simultaneously with the PDA closure. The residual shunt was noted at the time of discharge, in 3 out of 18 cases where ADO II was deployed, which
Table 2. Distribution of Study Population According to Age, Mean Pulmonary Artery Pressure Complications Mean PAP (mmHg)
No. of Patients
45
1–5 years
25–35 36–45 >45
>5 years
25–35 36–45 >45
45 (47.9%) 25 (26.6%) 24 (25.5%) 94 45 (60.0%) 17 (22.7%) 13 (17.3%) 75 33 (42.9%) 19 (24.7%) 25 (32.4%) 77
Age
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Average PDA Size (mm)
Device Embolization
Other
4.5 (2.8–8.7) 5.1 (3.7–8.6) 5.6 (3.0–8.0)
NIL 1 1
Vascular complications: 4 LPA obstruction: 1
4.8 (2.2–8.0) 5.3 (3.0–7.0) 5.7 (3.0–9.2)
1 1
NIL
6.2 (2.5–11.0) 6.7 (3.0–10.4) 9.4 (5.0–20.0)
NIL NIL 4
NIL
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VIJAYALAKSHMI, ET AL.
Figure 2. (A) The descending aortic angiogram in 10 years old girl shows 20 mm large PDA. (B) Closed with 20 mm MVSDO. Post procedure PAP dropped from 120/80 m 93 to 78/57 m 60 mm of Hg. SaO2 pre procedure: UL, 92%; LL, 84%. On follow‐up 3 months after procedure PASP was 50 mmHg and after 1 year PASP is 30 mm of Hg, SaO2—98%. AO, aorta; MPA, main pulmonary artery; PDA, patent ductus arteriosus.
closed on follow‐up after 3 months. There was no evidence of hemolysis in any of the patients. In infants, the post procedure average weight gain after 3 months was 2.15 kg 400 g.
Complications Out of 246 cases 4 patients (1.6%) with severe PAH developed left ventricular dysfunction with reduced ejection fraction on echocardiography soon after the procedure. They were treated with ACE inhibitor and diuretics till they recovered. The device embolization was seen in 8 cases (3.3%). The devices embolized into aorta in 3 cases and into the pulmonary artery in 5. All these cases had severe PAH. The transcatheter device retrieval was done successfully in 4 cases. In 2 cases the
device was snared with the appropriate sized goose‐ neck snare. In 2 cases the device was retrieved using a novel method of fastening the screw to the device within the vessel (Fig. 3A–C) and retrieving the device as being reloaded in the sheath.9 After device retrieval, ductus was successfully closed with bigger ADO device or ADO II in 3 cases. In 3 cases, where the large MVSDOs (16, 18, and 22 mm) had embolized into pulmonary artery (Fig. 4A–C), the attempt for transcatheter retrieval of the device was not done in order to prevent damage to the intima and the patients were directly referred for surgical removal of the device and multiple ligation. In one case the 6X6 ADO II device, which had embolized into LPA and could not be retrieved despite various maneuvers. Hence the patient was referred for surgical retrieval and ligation of the PDA. In 1 infant, LPA stenosis occurred with MVSDO, with a pullback gradient of 10 mmHg. The patient is under regular follow‐up and is asymptomatic and the gradient across LPA has reduced to 6 mmHg. The device moved toward aorta just after release causing obstruction in 3 infants. The device was gently pushed back with low‐pressure balloon dilatation. The devices were stable without aortic obstruction in 2 patients where as it slipped to descending aorta in 1 patient and was retrieved using novel technique of fastening the screw inside the vessel. The 4 patients (1.6%) who had loss of pulse at the site of puncture were successfully treated with heparin and streptokinase infusion. All the 4 patients were infants with large PDA requiring larger devices. The patients were followed up from 3 months to 9 years. Out of 62 (25.2%) patients with severe PAH, 5 patients (8.1%) continue to have moderate PAH despite the optimal drug therapy. Incidentally all 5 of them had Down’s syndrome. 48 (37.4%) patients have
Figure 3. (A) 8 6 ADO in situ in a 7‐year‐old child with systemic pulmonary artery pressure. (B) Arrow pointing to the embolized device in the aorta. (C) The embolized device retrieved through a novel method of fastening the screw inside the aorta before retrieving it successfully. AO, aorta.
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DEVICE CLOSURE OF PDA WITH PAH
Figure 4. (A) Seven years male with large 18 mm PDA on angiogram. (B) The PDA closed with 22 mm MVSDO as PAP dropped from 88/61 m 70 to 68/30 m 43 mmHg. (C) Device embolized to PA after 1 hour. Surgical extraction of device and PDA closure was done with Bhati’s technique. AO, aorta.
in infants including those
