Comparison of Patent Ductus Arteriosus Stent and Blalock-Taussig Shunt as Palliation for Neonates with Sole Source Ductal-Dependent Pulmonary Blood Flow: Results from the Congenital Catheterization Research Collaborative.

2021

2021 Sep 15

1432-1971

<p>Patent ductus arteriosus (PDA) stenting is an accepted method for securing pulmonary blood flow in cyanotic neonates. In neonates with pulmonary atresia and single source ductal-dependent pulmonary blood flow (SSPBF), PDA stenting remains controversial. We sought to evaluate outcomes in neonates with SSPBF, comparing PDA stenting and surgical Blalock-Taussig shunt (BTS). Neonates with SSPBF who underwent PDA stenting or BTS at the four centers of the Congenital Catheterization Research Collaborative from January 2008 to December 2015 were retrospectively reviewed. Reintervention on the BTS or PDA stent prior to planned surgical repair served as the primary endpoint. Additional analyses of peri-procedural complications, interventions, and pulmonary artery growth were performed. A propensity score was utilized to adjust for differences in factors. Thirty-five patients with PDA stents and 156 patients with BTS were included. The cohorts had similar baseline characteristics, procedural complications, and mortality. Interstage reintervention rates were higher in the PDA stent cohort (48.6% vs. 15.4%, p &lt; 0.001).</p>

10.1007/s00246-021-02699-7

Pediatr Cardiol

34524483

Comparison of Management Strategies for Neonates With Symptomatic Tetralogy of Fallot.

2021

1093-1106

2021 Mar 02

1558-3597

<p><strong>BACKGROUND: </strong>Neonates with tetralogy of Fallot and symptomatic cyanosis (sTOF) require early intervention.</p>

<p><strong>OBJECTIVES: </strong>This study sought to perform a balanced multicenter comparison of staged repair (SR) (initial palliation [IP] and subsequent complete repair [CR]) versus primary repair (PR) treatment strategies.</p>

<p><strong>METHODS: </strong>Consecutive neonates with sTOF who underwent IP or PR at&nbsp;≤30&nbsp;days of age from 2005 to 2017 were retrospectively reviewed from the Congenital Cardiac Research Collaborative. The primary outcome was death. Secondary outcomes included component (IP, CR, PR) and cumulative (SR): hospital and intensive care unit lengths of stay; durations of cardiopulmonary bypass, anesthesia, ventilation, and inotrope use; and complication and reintervention rates. Outcomes were compared using propensity score adjustment.</p>

<p><strong>RESULTS: </strong>The cohort consisted of 342 patients who underwent SR (IP: surgical, n&nbsp;=&nbsp;256; transcatheter, n&nbsp;=&nbsp;86) and 230 patients who underwent PR. Pre-procedural ventilation, prematurity, DiGeorge syndrome, and pulmonary atresia were more common in the SR group (p&nbsp;≤0.01). The observed risk of death was not different between the groups (10.2% vs 7.4%; p&nbsp;=&nbsp;0.25) at median 4.3 years. After adjustment, the hazard of death remained similar between groups (hazard ratio: 0.82; 95% confidence interval: 0.49 to 1.38; p&nbsp;=&nbsp;0.456), but it favored SR during early follow-up (&lt;4&nbsp;months; p&nbsp;=&nbsp;0.041). Secondary outcomes favored the SR group in component analysis, whereas they largely favored PR in cumulative analysis. Reintervention risk was higher in the SR group (p&nbsp;=&nbsp;0.002).</p>

<p><strong>CONCLUSIONS: </strong>In this multicenter comparison of SR or PR for management of neonates with sTOF, adjusted for patient-related factors, early mortality and neonatal morbidity were lower in the SR group, but cumulative morbidity and reinterventions favored the PR group, findings suggesting potential benefits to each strategy.</p>

10.1016/j.jacc.2020.12.048

J Am Coll Cardiol

33632484

Impact of Treatment Strategy on Outcomes in Isolated Pulmonary Artery of Ductal Origin.

2021

2021 Jan 04

1432-1971

<p>Isolated pulmonary artery (PA) of ductal origin (IPADO) is a rare cardiac defect which requires surgical repair, with or without preceding palliation. We sought to determine the impact of treatment strategy on outcomes. Retrospective study of consecutive patients with IPADO that underwent staged or primary repair from 1/05 to 9/16 at 6 Congenital Cardiac Research Collaborative centers. Patients with single ventricle physiology, major aortopulmonary collaterals, or bilateral IPADO were excluded. Primary outcome was isolated PA z-score at late follow-up. Secondary outcomes included PA symmetry index (isolated:confluent PA diameter) and reintervention burden. Propensity score adjustment was used to account for baseline differences. Of 60 patients in the study cohort, 26 (43%) underwent staged and 34 (57%) primary repair. The staged and primary repair groups differed in weight at diagnosis and presence of other heart disease but not in baseline PA dimensions. Staged patients underwent ductal stent (n = 16) or surgical shunt (n = 10) placement followed by repair at 210 vs. 21 days in the primary repair group (p &lt; 0.001). At median follow-up of 4.5 years post-repair, after adjustment, isolated PA z-score (- 0.74 [- 1.75, - 0.26] vs. - 1.95 [- 2.91, - 1.59], p = 0.012) and PA symmetry index (0.81 [0.49, 1.0] vs. 0.55 [0.48, 0.69], p = 0.042) significantly favored the staged repair group. Freedom from PA reintervention was not different between groups (adjusted HR 0.78 [0.41, 1.48]; p = 0.445). A staged approach to repair of IPADO is associated with superior isolated PA size and symmetry at late follow-up. Consideration should be given to initial palliation in IPADO patients, when feasible.</p>

10.1007/s00246-020-02511-y

Pediatr Cardiol

33394118

Impact of Palliation Strategy on Interstage Feeding and Somatic Growth for Infants With Ductal-Dependent Pulmonary Blood Flow: Results from the Congenital Catheterization Research Collaborative.

2020

e013807

2020 Jan 07

2047-9980

<p><strong>Background</strong> In infants with ductal-dependent pulmonary blood flow, the impact of palliation strategy on interstage growth and feeding regimen is unknown.</p>

<p><strong>Methods and Results</strong> This was a retrospective multicenter study of infants with ductal-dependent pulmonary blood flow palliated with patent ductus arteriosus (PDA) stent or Blalock-Taussig shunt (BTS) from 2008 to 2015. Subjects with a defined interstage, the time between initial palliation and subsequent palliation or repair, were included. Primary outcome was change in weight-for-age -score. Secondary outcomes included % of patients on: all oral feeds, feeding-related medications, higher calorie feeds, and feeding-related readmission. Propensity score was used to account for baseline differences. Subgroup analysis was performed in 1- (1V) and 2-ventricle (2V) groups. The cohort included 66 PDA stent (43.9% 1V) and 195 BTS (54.4% 1V) subjects. Prematurity was more common in the PDA stent group (=0.051). After adjustment, change in weight-for-age -score did not differ between groups over the entire interstage. However, change in weight-for-age -score favored PDA stent during the inpatient interstage (=0.005) and BTS during the outpatient interstage (=0.032). At initial hospital discharge, PDA stent treatment was associated with all oral feeds (&lt;0.001) and absence of feeding-related medications (=0.002). Subgroup analysis revealed that 2V but not 1V patients demonstrated significant increase in weight-for-age -score. In the 2V cohort, feeding-related readmissions were more common in the BTS group (=0.008).</p>

<p><strong>Conclusions </strong>In infants with ductal-dependent pulmonary blood flow who underwent palliation with PDA stent or BTS, there was no difference in interstage growth. PDA stent was associated with a simpler feeding regimen and fewer feeding-related readmissions.</p>

10.1161/JAHA.119.013807

J Am Heart Assoc

31852418

Comparison of Outcomes at Time of Superior Cavopulmonary Connection Between Single Ventricle Patients With Ductal-Dependent Pulmonary Blood Flow Initially Palliated With Either Blalock-Taussig Shunt or Ductus Arteriosus Stent

2019

e008110

2019 Oct

1941-7632

<p><strong>BACKGROUND: </strong>Patients with single ventricle anatomy and ductal-dependent pulmonary blood flow may be initially palliated with either modified Blalock-Taussig shunt (BTS) or ductus arteriosus stent (DAS). Comparisons of outcomes during the interstage period and at the time of superior cavopulmonary connection (SCPC) are lacking and may differ between palliation strategies.</p>

<p><strong>METHODS: </strong>Infants with single ventricle anatomy and ductal-dependent pulmonary blood flow palliated with either DAS or BTS from 2008 to 2015 were reviewed across 4 centers. Interstage outcomes, and for those who had SCPC, anatomy, hemodynamics, and perioperative clinical outcomes were compared. Thirty-five patients with DAS and 136 patients with BTS were included.</p>

<p><strong>RESULTS: </strong>At initial palliation, demographic, clinical variables, and pulmonary artery size were similar. Interstage death, transplant, or unplanned reintervention to treat cyanosis occurred in 25.7% of DAS and 35.8% of BTS, =0.27. Reintervention was more common with DAS (48.6% versus 2.2%; &lt;0.001). Twenty-three DAS patients and 111 BTS patients underwent SCPC. Preoperative hemodynamics and overall pulmonary atresia growth were similar, although right pulmonary artery growth was better with DAS (change in -score: 1.57 versus 0.65, =0.026). SCPC intraoperative and postoperative courses were similar.</p>

<p><strong>CONCLUSIONS: </strong>In patients with single-ventricle anatomy and ductal-dependent pulmonary blood flow, interstage outcomes, hemodynamics before SCPC, and acute postoperative outcomes were similar. Overall reintervention was more common in the DAS group, driven by more frequent planned reintervention. Unplanned reintervention, death, and transplant were similar. Both groups demonstrated good pulmonary atresia growth. DAS is a reasonable initial palliative alternative to BTS in select patients.</p>

10.1161/CIRCINTERVENTIONS.119.008110

Circ Cardiovasc Interv

31607156

Differences in Cost of Care by Palliation Strategy for Infants With Ductal-Dependent Pulmonary Blood Flow.

2019

e007232

2019 Apr

1941-7632

<p><strong>BACKGROUND: </strong>In infants with ductal-dependent pulmonary blood flow, initial palliation with patent ductus arteriosus (PDA) stent or modified Blalock-Taussig (BT) shunt have comparable mortality but discrepant length of stay, procedural complication rates and reintervention burdens, which may influence cost. The relative economic impact of these palliation strategies is unknown.</p>

<p><strong>METHODS AND RESULTS: </strong>Retrospective study of infants with ductal-dependent pulmonary blood flow palliated with PDA stent (n=104) or BT shunt (n=251) from 2008 to 2015 at 4 centers of the Congenital Catheterization Research Collaborative. Inflation-adjusted inpatient hospital costs were calculated for first year of life using Pediatric Health Information System data. Costs derived from outpatient catheterizations not in Pediatric Health Information System were imputed. Costs were compared using propensity score-adjusted multivariable models, to account for baseline differences between groups. After propensity score adjustment, first year of life costs were significantly lower in PDA stent ($215 825 [190 644-244 333]) than BT shunt ($249 855 [230 693-270 609]) patients ( P=0.05). After addition of imputed costs, first year of life costs were not significantly different between PDA stent ($226 403 [200 274-255 941]) and BT shunt ($252 072 [232 955-272 759]) groups ( P=0.15). Patient characteristics associated with higher costs included: younger gestational age, genetic syndrome, noncardiac diagnoses, procedural complications, extracorporeal membrane oxygenation, duration of ventilation, intensive care unit and hospital length of stay and reintervention ( P≤0.02 for all).</p>

<p><strong>CONCLUSIONS: </strong>In this first multicenter comparative cost study of PDA stent or BT shunt as palliation for infants with ductal-dependent pulmonary blood flow, adjusted for baseline differences, PDA stent was associated with lower to equivalent costs over the first year of life. Combined with previous evidence suggesting clinical noninferiority, these findings suggest that PDA stent provides competitive health care value.</p>

10.1161/CIRCINTERVENTIONS.118.007232

Circ Cardiovasc Interv

30998390

Classification scheme for ductal morphology in cyanotic patients with ductal dependent pulmonary blood flow and association with outcomes of patent ductus arteriosus stenting.

2019

2019 Feb 21

1522-726X

<p><strong>OBJECTIVES: </strong>To devise a classification scheme for ductal morphology in patients with ductal dependent pulmonary blood flow (PBF) that can be used to assess outcomes.</p>

<p><strong>BACKGROUND: </strong>The impact of ductal morphology on outcomes following patent ductus arteriosus (PDA) stenting is not well defined.</p>

<p><strong>METHODS: </strong>Patients &lt;1 year of age who underwent PDA stenting for ductal dependent PBF at the four centers comprising the Congenital Catheterization Research Collaborative (CCRC) were included. A classification scheme for PDA morphology was devised based on a tortuosity index (TI)-Type I (straight), Type II (one turn), and Type III (multiple turns). A subtype classification was used based upon the ductal origin.</p>

<p><strong>RESULTS: </strong>One hundred and five patients underwent PDA stenting. TI was Type I in 58, Type II in 24, and Type III in 23 PDAs, respectively. There was a significant association between ductal origin and vascular access site (p &lt; 0.001). Procedure times and need for &gt;1 stent did not differ based on TI. Greater TI was associated with pulmonary artery (PA) jailing (p = 0.003). Twelve (11.4%) patients underwent unplanned reintervention, more commonly with greater TI (p = 0.022) and PA jailing (p &lt; 0.001). At the time of subsequent surgical repair/palliative staging, PA arterioplasty was performed in 32 patients, more commonly when a PA was jailed (p = 0.048). PA jailing did not affect PA size at follow up.</p>

<p><strong>CONCLUSIONS: </strong>The proposed qualitative and quantitative PDA morphology classification scheme may be helpful in anticipating outcomes in patients with ductal dependent PBF undergoing PDA stenting.</p>

10.1002/ccd.28125

Catheter Cardiovasc Interv

30790426

Technical factors are associated with complications and repeat intervention in neonates undergoing transcatheter right ventricular decompression for pulmonary atresia and intact ventricular septum:

2018

1042-1049

2018 Aug

1467-1107

<p><strong>BACKGROUND: </strong>Transcatheter right ventricle decompression in neonates with pulmonary atresia and intact ventricular septum is technically challenging, with risk of cardiac perforation and death. Further, despite successful right ventricle decompression, re-intervention on the pulmonary valve is common. The association between technical factors during right ventricle decompression and the risks of complications and re-intervention are not well described.</p>

<p><strong>METHODS: </strong>This is a multicentre retrospective study among the participating centres of the Congenital Catheterization Research Collaborative. Between 2005 and 2015, all neonates with pulmonary atresia and intact ventricular septum and attempted transcatheter right ventricle decompression were included. Technical factors evaluated included the use and characteristics of radiofrequency energy, maximal balloon-to-pulmonary valve annulus ratio, infundibular diameter, and right ventricle systolic pressure pre- and post-valvuloplasty (BPV). The primary end point was cardiac perforation or death; the secondary end point was re-intervention.</p>

<p><strong>RESULTS: </strong>A total of 99 neonates underwent transcatheter right ventricle decompression at a median of 3 days (IQR 2-5) of age, including 63 patients by radiofrequency and 32 by wire perforation of the pulmonary valve. There were 32 complications including 10 (10.5%) cardiac perforations, of which two resulted in death. Cardiac perforation was associated with the use of radiofrequency (p=0.047), longer radiofrequency duration (3.5 versus 2.0 seconds, p=0.02), and higher maximal radiofrequency energy (7.5 versus 5.0 J, p&lt;0.01) but not with patient weight (p=0.09), pulmonary valve diameter (p=0.23), or infundibular diameter (p=0.57). Re-intervention was performed in 36 patients and was associated with higher post-intervention right ventricle pressure (median 60 versus 50 mmHg, p=0.041) and residual valve gradient (median 15 versus 10 mmHg, p=0.046), but not with balloon-to-pulmonary valve annulus ratio, atmospheric pressure used during BPV, or the presence of a residual balloon waist during BPV. Re-intervention was not associated with any right ventricle anatomic characteristics, including pulmonary valve diameter.</p>

<p><strong>CONCLUSION: </strong>Technical factors surrounding transcatheter right ventricle decompression in pulmonary atresia and intact ventricular septum influence the risk of procedural complications but not the risk of future re-intervention. Cardiac perforation is associated with the use of radiofrequency energy, as well as radiofrequency application characteristics. Re-intervention after right ventricle decompression for pulmonary atresia and intact ventricular septum is common and relates to haemodynamic measures surrounding initial BPV.</p>

10.1017/S1047951118000756

Cardiol Young

29909817

A Comparison Between Patent Ductus Arteriosus Stent and Modified Blalock-Taussig Shunt as Palliation for Infants with Ductal-Dependent Pulmonary Blood Flow: Insights From the Congenital Catheterization Research Collaborative.

2018

589-601

2018 Feb 6

1524-4539

<p>Background -Infants with ductal-dependent pulmonary blood flow may undergo palliation with either a patent ductus arteriosus (PDA) stent or modified Blalock-Taussig (BT) shunt. A balanced multi-center comparison of these two approaches is lacking. Methods -Infants with ductal-dependent pulmonary blood flow, palliated with either PDA stent or BT shunt from 1/08 to 11/15, were reviewed from the four member centers of the Congenital Catheterization Research Collaborative. Outcomes were compared using propensity score adjustment to account for baseline differences between groups. Results -106 PDA stent and 251 BT shunt patients were included. The groups differed in underlying anatomy (expected two-ventricle circulation in 60% of PDA stents v. 45% of BT shunts, p=0.001), and presence of antegrade pulmonary blood flow (61% of PDA stents v. 38% of BT shunts, p&lt;0.001). After propensity score adjustment, there was no difference in the hazard of the primary composite outcome of death or unplanned reintervention to treat cyanosis [HR=0.8 (95% CI: 0.52 - 1.23), p=0.31]. Other reinterventions were more common in the PDA stent group [HR=29.8 (95% CI: 9.8 - 91.1, p&lt;0.001]. However, the PDA stent group had a lower adjusted ICU length of stay [5.3 (95% CI 4.2 - 6.7) v. 9.19 (95% CI 7.9 - 10.6) days, p&lt;0.001], a lower risk of diuretic use at discharge [OR=0.4 (95% CI: 0.25 - 0.64), p&lt;0.001] and procedural complications [OR=0.4 (95% CI: 0.2 - 0.77), p=0.006], and larger [152 (95% CI: 132 - 176) v. 125 (95% CI: 113 - 138) mm(2)/m(2), p=0.029] and more symmetric [symmetry index 0.84 (95% CI: 0.8 - 0.89) v. 0.77 (95% CI: 0.75 - 0.8), p=0.008] pulmonary arteries at the time of subsequent surgical repair or last follow-up. Conclusions -In this multi-center comparison of palliative PDA stent and BT shunt for infants with ductal-dependent pulmonary blood flow, adjusted for differences in patient factors, there was no difference in the primary endpoint, death or unplanned reintervention to treat cyanosis. However, other markers of morbidity and pulmonary artery size favored the PDA stent group, supporting PDA stent as a reasonable alternative to BT shunt in select patients.</p>

10.1161/CIRCULATIONAHA.117.029987

Circulation

29042354