During the study period, 52 premature infants underwent SL of the PDA and 74 underwent TCPC. The median gestational age was 24 weeks for both groups. The median age (4.9 vs 6.1 weeks) and weight (1.09 vs 1.38 kg) at the time of the procedure were significantly lower in the patient’s undergoing SL compared to TCPC. Gestational age, birth weight, gender, race, and ethnicity were comparable between the two groups. (Table 1)
Table 1. Demographic characteristics stratified by type of intervention.
Variable
|
Surgical PDA Ligation
(n=52)
|
Transcatheter PDA device closure
(n=74)
|
p-value
|
Gestational Age
(weeks)
|
24.8 (23.8 – 26.6)
|
24.7 (23.9 – 26.6)
|
0.84
|
Age at Procedure
(weeks)
|
4.9 (4 – 6.5)
|
6.1 (4.8 – 9.3)
|
<0.01
|
Birth Weight
(kg)
|
0.68 (0.63 – 0.82)
|
0.66 (0.57 – 0.8)
|
0.29
|
Weight at procedure (kg)
|
1.09 (0.9 – 1.47)
|
1.38 (1.02 – 1.91)
|
0.01
|
Sex
Male
Female
|
30 (57.7)
22 (42.3)
|
34 (45.9)
40 (54.1)
|
0.19
|
Race
White
African American
Asian
|
11 (21.2)
39 (75)
2 (3.8)
|
20 (27)
52 (70.3)
2 (2.7)
|
0.72
|
Ethnicity
Hispanic
Non-Hispanic
|
48 (92.3)
4 (7.7)
|
69 (93.2)
5 (6.8)
|
1
|
Median (interquartile range), analyzed by Mann-Whitney U test. N (%), analyzed by chi-square test.
Abbreviations: PDA = patent ductus arteriosus; kg = kilograms
Infants undergoing TCPC received significantly lower amounts of intra and post-procedural opioids. The median intra-procedural fentanyl dose was 5.99 µg/kg (IQR 3.28 – 13.33) in the SL group compared to 3.64 µg/kg (IQR 2.08 – 5.82) in the TCPC group, p=<0.001. The median cumulative post-procedural opioid dose (MME) was 0.28 mg/kg (IQR 0.14 – 0.78) in the SL group compared to 0.09 mg/kg (IQR 0.04 – 0.28) in the TCPC group, p=<0.001. The difference remained significant when comparing opioid utilization separately on post-procedure days 0 & 1. (Table 2.)
Table 2. Comparison of procedural and post-procedural opioid use stratified by type of intervention, unmatched cohort.
Outcome
|
N
|
Surgical PDA Ligation
|
N
|
Transcatheter PDA device closure
|
p-value
|
Procedural
Fentanyl (µg/Kg)
Day 0
MME (mg/Kg)
Day 1
MME (mg/Kg)
Cumulative Post-procedural MME
(mg/kg) b
|
52
45
38
48
|
5.99 (3.28 – 13.33)
0.18 (0.09 – 0.41)
0.17 (0.09 – 1.11)
0.28 (0.14 – 0.78)
|
74
41
30
45
|
3.64 (2.08 – 5.82)
0.05 (0.03 – 0.11)
0.09 (0.05 – 0.28)
0.09 (0.04 – 0.28)
|
<0.001
<0.001
0.016
<0.001
|
Abbreviations: MME = morphine milligram equivalent.
Median (Interquartile range), analyzed by Mann-Whitney U test.
Similar results were obtained upon repeating the analysis after propensity score matching. The median intra-procedural fentanyl dose was 5.99 µg/kg (IQR 3.28 – 13.33) in the SL group compared to 4.33 µg/kg (IQR 2.67 – 7.38) in the TCPC group, p=0.037. The median cumulative post-procedural opioid dose (MME) was 0.32 mg/kg (IQR 0.14 – 0.87) in the SL group compared to 0.09 mg/kg (IQR 0.04 – 0.28) in the TCPC group, p=<0.001. The difference remained significant when comparing opioid utilization separately on post-procedure days 0 & 1. (Table 3)
Table 3. Comparison of procedural and post-procedural use stratified by type of intervention in propensity-matched cohorts.
Outcome
|
N
|
Surgical PDA Ligation
|
N
|
Transcatheter PDA device closure
|
p-value
|
Procedural
Fentanyl (µg/Kg)
Day 0
MME (mg/Kg)
Day 1
MME (mg/Kg)
Cumulative Post-procedural MME
(mg/kg)
|
52
41
30
45
|
5.99 (3.28 – 13.33)
0.16 (0.09 – 0.35)
0.17 (0.09 – 0.48)
0.32 (0.14 – 0.87)
|
52
41
30
45
|
4.33 (2.67 – 7.38)
0.05 (0.03 – 0.11)
0.095 (0.05 – 0.28)
0.09 (0.04 – 0.28)
|
0.037
<0.001
0.038
<0.001
|
Abbreviations: MME = morphine milligram equivalent.
Median (Interquartile range), analyzed by Mann-Whitney U test.
A significantly lower proportion of infants undergoing TCPC received opioids for post-procedure pain management compared to those undergoing SL. On post-procedure day 0, 86.5% (45/52) of infants undergoing SL received opioids compared to 55.4% (41/74) in the TCPC group (mean difference 31.1%, 95% CI 16.4 – 45.8%). On post-procedure day 1, 73.1% (38/52) of infants in the SL group received opioids compared to 40.5% (30/74) in the TCPC group (mean difference 32.6%, 95% CI 16.2 – 49%). Overall, 92.3% (48/52) infants received opioids after SL compared to 60.8% (45/74) after TCPC (mean difference 31.5, 95% CI: 18.2 – 44.8%). (Figure 1)