Author + information
- Nageswara Rao Koneti, MD⁎ (, )
- Narayanswami Sreeram, MD,
- Raghava Raju Penumatsa, MD,
- Srinivas K. Arramraj, MD,
- Vadlamudi Karunakar, MD and
- Uwe Trieschmann, MD
- ↵⁎Department of Pediatric Cardiology, CARE Hospital, The Institute of Medical Sciences, Road Number 1, Banjara Hills, Hyderabad 500 034, India
To the Editor:
Transcatheter closure of perimembranous ventricular septal defects (pmVSD) is a well-established procedure but is associated with an unacceptable incidence of complete heart block (CHB) (1,2). We describe retrograde single catheter closure of pmVSDs by an off-label use of the Amplatzer duct occluder II (ADO II) device (St. Jude Medical, St. Paul, Minnesota).
All children between 1 and 15 years with pmVSD were included in the initial assessment. The decision to use the ADO II device was based primarily on reduction of the cost of the procedure ($1,500 for device closure) and the need to close symptomatic VSDs in young patients.
Clinical inclusion criteria
At least 3 of the following had to be present:
Overt heart failure, not improving with medications
Failure to thrive, predominantly due to hemodynamic effects of the VSD
Recurrent respiratory infections (defined as >6 events in the preceding 12 months)
Mid-diastolic flow rumble at the apex on auscultation
Electrocardiogram showing left atrial enlargement and left ventricular hypertrophy with standard criteria for children
Cardiothoracic ratio on chest x-ray of >0.55
Left atrial to aortic diameter ratio on long-axis echocardiogram >1.5
Left ventricular end-diastolic z-score on echocardiogram, indexed to body surface area of >2.0
Estimated pulmonary to systemic blood flow ratio >1.5 at cardiac catheterization
Morphologic inclusion criteria
VSD size <6.5 mm
Upper margin of VSD to aortic valve distance ≥ 3 mm
Morphologic exclusion criteria:
VSD size >6.5 mm
Perimembranous VSD with bidirectional or predominantly right to left shunt through the VSD on color Doppler echocardiography
Perimembranous VSD associated with other structural heart defects requiring surgery
Cardiac catheterization was performed under general anesthesia (n = 12) or intravenous sedation (n = 51), after informed consent was obtained. Intravenous heparin (100 U/kg) was given after femoral arterial access was obtained. Procedures were monitored by transthoracic echocardiography. The diameter of the device is chosen to be either equal to (±0.5 mm) or 1 mm greater than the smallest VSD diameter. A 5-F (internal diameter 0.061 inch) or 6-F (internal diameter 0.070 inch) right coronary artery guiding catheter with side holes (Launcher, Medtronic, Minneapolis, Minnesota; or Cordis, Cordis, Miami Lakes, Florida) was used as the delivery catheter, via the femoral artery. A 0.035-inch or 0.032-inch angulated hydrophilic guidewire (Terumo Corporation, Tokyo, Japan) was used to cross the VSD. The guide catheter was then advanced over the wire into the right ventricle. In a few cases where the delivery catheter took a tortuous course, it was stabilized in the right ventricle by the use of a 0.014-inch “buddy wire” (Galeo Extra Support, Biotronik, Berlin, Germany; or Road Runner, Cook, Inc., Bloomington, Indiana). Where multiple openings were present at >6 mm distance from one another, the procedure was either abandoned (n = 2) or an additional device was used (n = 1) (Fig. 1). All children were given aspirin 3 to 5 mg/kg and clopidogrel 1 mg/kg for 6 months.
Of 63 patients initially assessed (31 male), 57 were eligible for the procedure after left ventricular angiography. Their age ranged from 0.7 to 14.5 years (median 3.7 years), and weight ranged from 7.0 to 31 kg (median 12.5 kg). Median fluoroscopic time was 8.8 (4.0 to 36) min. The median VSD diameter was 5 (3.4 to 6.5) mm. Devices used (device diameter/length in mm) were 4/4 (n = 3), 5/4 (n = 21), 5/6 (n = 3), 6/4 (n = 29), and 6/6 (n = 1). The complete VSD closure rate was 78% immediately after the procedure as documented by left ventricular angiography and transthoracic echocardiography, 92% at 24 h, and 94% at last follow-up. There was 1 device embolization to the pulmonary artery (6/4 mm device), 2 h after the procedure. The device was successfully retrieved, and the defect was successfully closed with a 10-mm Amplatzer muscular VSD occluder. There was no incidence of femoral pulse loss. Fifteen children had tricuspid regurgitation (TR) before the procedure. A reduction of pre-existing TR by at least 2 grades was seen in 11 children after VSD closure; in the other 4 children it was converted to a normotensive (normal calculated RV systolic pressure) TR. Two children developed new trivial aortic regurgitation (AR). One boy who had pre-existing AR associated with valve cusp prolapse underwent device closure with abolition of AR. There was no incidence of left bundle branch block, P-Q prolongation, or CHB during the follow-up evaluation. Most children (n = 46) were underweight before the procedure (less than the third centile for age and sex) and demonstrated appropriate weight gain (with 38 of 45 children—who were followed up for longer than 6 months after VSD closure—reaching weights >10th centile) at follow-up.
Most procedure-related complications have occurred in patients of <6 years of age and/ or weighing <15 kg (3). Post-procedure CHB has been reported to occur in up to 18% of patients undergoing transcatheter closure of a pmVSD under the age of 3 years (4). The longer central waist of the ADO II might avoid mechanical compression of the peri-nodal tissue. The VSDs larger than 6.5 mm diameter cannot be closed with the ADO II. Because the retention discs are symmetrical, a minimum distance of 3 mm is required between the upper margin of the VSD and the aortic valve. The ADO II device is cheap and effective for closing pmVSDs. Availability of larger-sized ADO II devices might increase its applicability, allowing percutaneous closure of a wider range of VSDs.
Please note: The authors thank the Nimmagadda Foundation, Hyderabad, India, for their financial support in helping to pay for the devices. All authors report that they have no relationships relevant to the contents of this paper to disclose.
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