PDA device closure is a relatively safe procedure barring from its rare complications of device embolization, hemolysis, and encroachment on surrounding structures including the left pulmonary artery and descending aorta [6]. Most of the studies report a high incidence of success rates, with successful device closure seen in 97–100% of the cases [7, 8]. However, as the procedure is increasingly being used in younger infants and neonates, there is a growing concern for procedure-related complications especially access site vascular injury which can have devastating consequences [9]. The use of smaller sheaths and catheters in this regard has shown to reduce the incidence of arterial thrombosis; however, the risk is not totally eliminated till arterial cannulation is used for the procedure [10]. This observational study was aimed to assess the feasibility of isolated venous access in children requiring PDA device closure, when compared to the traditional method of using both arterial and venous routes.
Arterial access during PDA device closure assists in angiographic profiling of the size and anatomy of PDA. After deployment of the device, it helps in assessing the residual shunt and any significant gradient across the aorta. Arterial access may also be required in cases of hemodynamic collapse, device embolization, and patients with pulmonary hypertension. Various studies however have reported a high incidence of vascular complications which includes arterial thrombosis, retroperitoneal bleeding, vessel tear, and dissection ranging from 2.5 to 3.8% with arterial access in pediatric catheterizations [4]. This risk is even higher for young children undergoing prolonged interventional procedures and is seen in up to 16% of infants on Doppler imaging [3].
Although the use of a single venous approach has been observed to produce successful outcomes, one of the main concerns remains that the crossing of PDA for initial sizing may induce ductal spasm and consequent undersizing of the device [11)]. Lack of precise size and morphological assessment can make the procedure difficult with frequent requirement of upsizing of devices. Careful preprocedural echocardiography thus becomes a prerequisite before embarking on only venous approach. Isolated venous access may also preclude from recognizing the iatrogenic coarctation of the aorta and measuring aortic gradient in large devices. Large PDA may similarly require arterial access for continuous pressure monitoring. Hence, previous studies also report the use of a successful venous approach in patients with careful preprocedure screening, although simultaneous arterial access may be required at different stages during the procedure [12, 13].
In a retrospective analysis by Gaurav et al., PDA device closure via the isolated venous approach could be successfully performed in 84% (151/179) of the patients without any vascular complications [12]. Liu et al. [14] similarly demonstrated successful PDA closure via only venous approach. No vascular complications were encountered, and the procedure was deemed safe for larger use including in infants.
We could successfully use the venous technique in 88% of the assigned patients as 7 patients required additional arterial access after initial attempt at isolated venous access.
The presentation of iatrogenic vascular complication immediately postprocedure includes acute limb ischemia or excessive bleeding, while long-term implications can lead to claudication and shortened length of the affected limb [14]. In the arterial access group (group II) in our study, access site complications were observed in 7.2% (n = 6, in 83 patients) vs none in the venous access group (group I). All these patients were less than 1 year of age with weight < 8 kg. Complications included common femoral artery thrombosis requiring intravenous heparin alone or thrombolysis in cases of a threatened limb.
The mainstay of treatment of acute limb ischemia involves parenteral anticoagulation, where heparin infusion alone is shown to be effective in 40% of the patients and, combined with streptokinase, complete revascularization can be achieved in 90% the cases [15]. Surgery can be offered in resistant cases for removal of the thrombus. We could successfully restore the blood flow by the use of heparin and/or streptokinase in all the patients within 24 h. All the patients had resolution of thrombus on follow-up ultrasound. Although rare, the use of fibrinolytics may be associated with fatal intracranial or gastrointestinal bleeding [16]; however, no excessive bleed was observed in any of the patient. One patient in our study developed hemolysis along with residual shunt and underwent surgical device retrieval. This is in accordance with previous studies such as by Jang et al. where major complications of hemolysis, infective endocarditis, and embolization were seen in 3.4%, and minor complications in 5.1% of the children undergoing PDA device occlusion [17].
In a randomized controlled trial by Thanopoulas et al. [18], in young children 2–24 months of age, 112 children were randomized for either venous only or standard access approach. Arterial complications were observed in 16% of the cases undergoing device closure via standard technique. The higher rates of arterial complications were probably secondary to younger population included in this study. We had 22 (16%) patients with weight < 6 kg. While 13 of them underwent PDA device closure by only venous access, the remaining 9 underwent the standard procedure. No significant complications were encountered in this population, and we could perform the device placement successfully for all the patients.
On subgroup analysis, fluoroscopy time and radiation dose were significantly reduced in group I in our study within cases of a single operator. This was likely as we had relied more on echocardiographic images to rule out aortic obstruction and residual shunts. The isolated venous approach may also facilitate early discharges due to less number of vascular complications. Previous studies have also demonstrated shorter procedural and fluoroscopic time due to a restricted number of cine angiograms [5]. Baykan et al. found increased fluoroscopic time in their cohort of patients since they used the return phase of the contrast angiography to see for adequacy of ductal closure [19].
The long-term complete occlusion with ADO devices is excellent with immediate closure rates of 66% and up to 97% at 1 month [20]. In Cocoon devices, long-term closure rates have been reported to be around 91.3% [21]. In our study, in majority of cases, Cocoon (45%) and ADO I (38%) devices were used and 80% of the children achieved immediate closure. None of the patients had residual shunt at 1 month of follow-up.
It was a single-center prospective experience where the decision to undergo only venous vs standard approach was decided by the primary operator. Due to state finance insurance schemes, devices used for PDA closure varied for different patients. Although the fluoroscopic time and radiation dose were reduced in only the venous approach, it can be secondary to less complicated cases chosen for the same.
