TRANSCATHETER PDA CLOSURE USING THE

AMPLATZER DUCT OCCLUDER

BY:BY:

JAMEEL AL-ATA, MDJAMEEL AL-ATA, MD

ASSISTANT PROFESSOR ASSISTANT PROFESSOR andand CONSULTANT PEDIATRIC CONSULTANT PEDIATRIC

CARDIOLOGISTCARDIOLOGIST

INTRO:

Transcatheter closure of the small Transcatheter closure of the small to moderate patent ductus to moderate patent ductus arteriosus utilizing coils is an arteriosus utilizing coils is an accepted treatment (…Hijazi, accepted treatment (…Hijazi, Galal Int cardGalal Int card). ).

Addressing the larger PDA using Addressing the larger PDA using multiple coils was shown to be multiple coils was shown to be feasible, but not without feasible, but not without problems (Hizji, > 4mm PDA, problems (Hizji, > 4mm PDA, Galal Zeitschrift kardiologie).Galal Zeitschrift kardiologie).

INTRO:

The large PDA remained the The large PDA remained the domain of surgery for a while. domain of surgery for a while. Only recently the Amplatzer duct Only recently the Amplatzer duct occlude (ADO) has been occlude (ADO) has been introduced as an alternative introduced as an alternative (Masura) ( Saliba) (Masura) ( Saliba)

Especially in the younger age Especially in the younger age and weight group there are still and weight group there are still relatively few reports relatively few reports describing the experience with describing the experience with this device (Alwi JACC 2001)this device (Alwi JACC 2001)

The aim of this study:

To present our experience with To present our experience with the ADO to close large PDA in a the ADO to close large PDA in a relatively young patients relatively young patients population. population.

Special attention was taken to Special attention was taken to focus on the selection of the focus on the selection of the optimum sized device as well optimum sized device as well as the problems and as the problems and complications which can be complications which can be encountered while using this encountered while using this device.device.

METHODS:

In a clinical study, all 43 patients In a clinical study, all 43 patients (29/43 females, 14/43 males) who (29/43 females, 14/43 males) who underwent attempt of transcatheter underwent attempt of transcatheter closure of their patent ductus closure of their patent ductus arteriosus using an Amplatzer duct arteriosus using an Amplatzer duct occlud between July 2001 and occlud between July 2001 and October 2003 were reviewedOctober 2003 were reviewed. .

Inclusion criteria:

All patients who had a PDA, which All patients who had a PDA, which was judged angiographically to be was judged angiographically to be too large for a single coil too large for a single coil implantation ( > 3 mm narrowest implantation ( > 3 mm narrowest diameter) were included in this diameter) were included in this study. study.

Exclusion criteria:

Patients who underwent Patients who underwent transcatheter closure in which transcatheter closure in which coils were utilized.coils were utilized.

Had other cardiac anomelies. Had other cardiac anomelies.

Clinical Examination and Echocardiographic

Evaluation:

All patients underwent complete All patients underwent complete cardiac evaluation; including cardiac evaluation; including physical examination, twelve lead physical examination, twelve lead ECG, and a radiogram of the ECG, and a radiogram of the chest.chest.

Detailed echocardiograms Detailed echocardiograms were performed at baseline were performed at baseline using Hewlett Packard Sonos using Hewlett Packard Sonos 5500. 5500.

Cont.:

CONT:

The narrowest diameter of the The narrowest diameter of the PDA was measured in the PDA was measured in the ductal view using color Doppler ductal view using color Doppler and electronic calipers. and electronic calipers.

Cont.:

Routine M-mode echo tracings Routine M-mode echo tracings were obtained in the parasternal were obtained in the parasternal long axis view as recommended by long axis view as recommended by the American Association for the American Association for ECHO.ECHO.

Cont.:

Follow-up echocardiograms Follow-up echocardiograms were performed in most before were performed in most before discharge, one month and then discharge, one month and then 6 months after closing the 6 months after closing the ductus arteriosus.ductus arteriosus.

Cardiac Catheterization procedure:

In all patients signed consent In all patients signed consent was obtained from their parents. was obtained from their parents. Patients were sedated with Patients were sedated with ketamine and midazolam during ketamine and midazolam during the procedure. the procedure.

Cont.:

None of the patients received None of the patients received general anesthesia or general anesthesia or intubation. intubation.

Heparin in a dose of 100 IU/kg Heparin in a dose of 100 IU/kg was administeredwas administered

CONT:

Aortograms performed in straight Aortograms performed in straight lateral position were reviewed to lateral position were reviewed to determine the PDA diameter and determine the PDA diameter and the type of the ductus was the type of the ductus was described according to the described according to the classification of Krichenko. classification of Krichenko.

Cont.:

The narrowest diameter of the The narrowest diameter of the PDA, the aortic diameter of the PDA, the aortic diameter of the ampulla, the length of the ampulla ampulla, the length of the ampulla and the mid diameter of the and the mid diameter of the ampulla were measured. ampulla were measured.

CONT.:

Amplatzer duct occlud of the Amplatzer duct occlud of the PDA was performed through PDA was performed through anterograde approach anterograde approach

Study group:

The procedure proved successful in 42 The procedure proved successful in 42 patients (97.5%). patients (97.5%).

We used a device of size 6/4 in 21 of the We used a device of size 6/4 in 21 of the patients (50%), using the 8/6 device in 10 patients (50%), using the 8/6 device in 10 (24%), the 10/8 device in 7 (16.5%), and (24%), the 10/8 device in 7 (16.5%), and the 12/10 device in 4 (9.5%) of the the 12/10 device in 4 (9.5%) of the patients.patients.

Cont.:

In all patients who underwent In all patients who underwent implantation of devices, implantation of devices, cefuroxime (30 mg/kg) was cefuroxime (30 mg/kg) was administered intravenously administered intravenously during the procedure. during the procedure.

Two more doses were given Two more doses were given with the next 24 hours.with the next 24 hours.

Selection criteria of the ADO:

The duct occluder is offered in The duct occluder is offered in five different sizes. The first five different sizes. The first number mentioned on the number mentioned on the package of the device belongs to package of the device belongs to the larger diameter of the device, the larger diameter of the device, which is 2 mm larger than the which is 2 mm larger than the smaller diameter given on the smaller diameter given on the packagepackage..

Cont.:

The larger diameter is usually The larger diameter is usually positioned in the aortic end of positioned in the aortic end of the ductul ampulla, while the the ductul ampulla, while the smaller diameter is positioned at smaller diameter is positioned at the pulmonary end. the pulmonary end.

Cont.:

In the first two patients, we In the first two patients, we followed the recommendation followed the recommendation suggesting to use a duct suggesting to use a duct occluder in which its smaller occluder in which its smaller diameter (pulmonary end) is 1-diameter (pulmonary end) is 1-2 mm larger than the 2 mm larger than the narrowest diameter of the narrowest diameter of the specific duct. specific duct.

Cont.:

In view of the problems we In view of the problems we encountered with positioning of encountered with positioning of the second device, we tried to the second device, we tried to put all the measurements of the put all the measurements of the PDA into consideration, while PDA into consideration, while selecting adequate ADO. selecting adequate ADO.

Cont.:

In this specific case,though the In this specific case,though the Recommendation was followed, Recommendation was followed, because of a mismatch between because of a mismatch between the skirt of the device and aortic the skirt of the device and aortic end of the duct, the skirt of the end of the duct, the skirt of the device protruded into the device protruded into the descending aorta.descending aorta.

Cont.:

We therefore measured the We therefore measured the narrowest diameter of the duct, its narrowest diameter of the duct, its length, & the largest diameter for length, & the largest diameter for the aortic end, the aortic end,

Cont.:

Since it has to accommodate the Since it has to accommodate the skirt of the device, which is 4 mm skirt of the device, which is 4 mm larger than the number given for larger than the number given for the larger (aortic) end of the the larger (aortic) end of the ADO. ADO.

Cont.:

The mid ductul diameter was The mid ductul diameter was also measured, so to make also measured, so to make sure in case the duct is too sure in case the duct is too long, that the larger part of the long, that the larger part of the ADO will fit.ADO will fit.

Results:

Age (years) 3.79 ± 3.82 (0.45 - 13)

Sex 29 females, 14 males

Weight (kilograms) 

11.9 ± 8.91 (4.5 – 44) 

Height (centimeters)

83.6 ± 21.1 (59 – 154) 

Systolic pulmonary arterial pressure (millimeters of

mercury)

40 ± 17.8 (17-87) 

Systolic aortic pressure

 (millimetres of mercury)

88 ± 21.9 (59-115)

Ratio of pulmonary to systemic flows

2.43 ± 1.6 (1-7.6)

Index of pulmonary arteriolar resistance

(Wood units)

3.29 ± 1.91 (0.39-6.5)

Time required for fluoroscopy (minutes)

16.9 ± 7.8 (5.6-36.7) 

Overall procedural time (minutes)

102 ± 31.7 (46-169) 

Contrast used (milligrams per kilogram)

5.81 ± 4.1 (1.6-17.9) 

Narrowest diameter of duct(millimetres)

5.18 ± 1.9 (3.4-11.1) 

Largest diameter at the aortic ampulla

(millimetres)

13.6 ± 4.9 (8-21) 

Diameter at the mid-ampulla(millimetres)

10.2 ± 3.1 (5.9-15) 

Total length of the duct(millimetres)

12.9 ± 5.1 (6-21.8) 

Cont.:

All patients were done as a day All patients were done as a day case. case.

None had to be admitted over None had to be admitted over night.night.

Rate of occlusionRate of occlusion: : Immediate occlusion, confirmed angiographically, Immediate occlusion, confirmed angiographically,

was achieved in 25 (60%) patients. was achieved in 25 (60%) patients. In another 8 (19%), complete occlusion occurred In another 8 (19%), complete occlusion occurred

some hours after the procedure, as confirmed by some hours after the procedure, as confirmed by echocardiography. echocardiography.

In 33 (79%) of the patients, therefore, complete In 33 (79%) of the patients, therefore, complete occlusion was achieved on the day of the occlusion was achieved on the day of the procedure. procedure.

At a further follow-up, of between one At a further follow-up, of between one week and 6 months, complete occlusion had week and 6 months, complete occlusion had occurred in 6 more patients.occurred in 6 more patients.

At that time, 2 patients had trivial residual At that time, 2 patients had trivial residual shunting, while one had a significant shunting, while one had a significant residual leak.residual leak.

Issues pertinent to Procedure:

Mean number of angiographies Mean number of angiographies to visualize the PDA before to visualize the PDA before implantation was 1.8 injection implantation was 1.8 injection (range 1-7). (range 1-7).

PROBLEMS & COMPLICATIONS

There was no device There was no device embolization.embolization.

There was no loss of pulse.There was no loss of pulse. There was no mortalityThere was no mortality. .

Cont.:

Waist of coils 3 coils in one Waist of coils 3 coils in one

patientpatient Waiste of Amplatzer in two Waiste of Amplatzer in two

patients patients Pull through of device in three Pull through of device in three

patientspatients

Cont.:

Kinking of sheath and inability Kinking of sheath and inability to retrieve a too large device.to retrieve a too large device.

Excessive bleeding needing Excessive bleeding needing transfusion in one.transfusion in one.

Difficulty in visualizing the Difficulty in visualizing the large PDA.large PDA.

Conclusions:

Transcatheter occlusion of Transcatheter occlusion of PDA by the ADO has a high PDA by the ADO has a high complete occlusion rate and complete occlusion rate and is effective in PDA up to a is effective in PDA up to a narrowest diameter of 10 mm narrowest diameter of 10 mm and probably larger PDAsand probably larger PDAs. .

Cont.: Especially in the young age group, Especially in the young age group,

problems & complication rate of 30% problems & complication rate of 30% can be encountered in the learning can be encountered in the learning phase. phase.

The ADO diameter should not The ADO diameter should not exceed the largest ampulla diameter exceed the largest ampulla diameter of the PDA in order to avoid of the PDA in order to avoid descending aortic obstructiondescending aortic obstruction. .