Table 2.
Shunt study descriptions.
| Author | Year | N | Age Rangea | Procedure | Study Type | Anticoagulationb | Complications (hemorrhagic and/or TE) | Comments |
|---|---|---|---|---|---|---|---|---|
| Januszewska | 2011 | 236 | 2–82 days | Norwood with RV-PA shunt | R | Heparin 5–10 U/kg/hour “if no bleeding” ASA 2–5 mg/kg/day until second stage |
2.5% shunt occlusion | Shunt-related complications after Norwood |
| Ohman | 2012 | 28 | 3–35 days | mBTT, central, or Sano shunt | P | ASA 5 mg/kg/day Warfarin (N = 1) ASA+ Warfarin (N = 2) |
29% Shunt narrowing | SpO2 monitoring at home |
| Manlhiote | 2012 | 195 | 3–74 days | All three stages of SV palliation (Stage I N = 145) | CSS | 66% Enoxaparin (anti-Xa 0.5–1 U/mL) 30% no prophylaxis 2% ASA+ enoxaparin 2% ASA |
49% Arterial/cardiac thromboses 9% Stroke/PE 51% Venous thrombosis |
Thrombotic complications across all three stages of SV palliation; Multiple TE in some patients |
| Tzanetose | 2012 | 16 | Mean 4.6 days (Norwood) | All three stages of SV palliation (Stage I Norwood N = 5) | P | Heparin 10 U/kg/hour ASA starting postoperative day 1–2 |
31% thrombus on prospective imaging (3 of 5 had Norwood done previously) | TE in SV patients associated with lower ATIII levels, higher tPA antigen levels, longer bypass time, cardiac dysfunction on preoperative echo |
| Guzzetta | 2013 | 207 | Mean 20 days | mBTT | R | Heparin 10 U/kg/hour ASA 40 mg/day |
6.8% Shunt occlusion | In-hospital shunt thrombosis in mBTT |
| Romlin | 2013 | 14 | 3–100 days | mBTT/Sano, Norwood | P | Heparin 250 U/kg/day ASA 3–5 mg/kg/day |
None reported | Observational study of impedance aggregometry |
| Wessel | 2013 | 906 | 0–92 days | Systemic-PA shunts | RCT | Clopidogrel 0.2 mg/kg/day versus placebo plus usual care 87.9% ASA |
Shunt thrombosis: 5.8% of clopidogrel, 4.8% placebo 3.8% major bleeds |
Bleeding was most commonly gastrointestinal |
| Bao | 2014 | 110 | 1–228 months | Central shunt | R | Heparin 0.25 mg/kg infusion every 6 hours x3 days Aspirin 3–5 mg/kg/day |
1.8% Shunt thrombosis | None |
| Emanid,e | 2014 | 95 | <18 years | 15% Stage I/ mBTT | P | Heparin ASA (20.25, 40.5, 81 mg/d) – median dose 6.5 mg/kg/day |
7.5% TE (more common in non-responders – 1.2% versus 60%) | ASA unresponsiveness using VerifyNow-ASA™ Thrombotic events not described by specific procedures |
| Horer | 2014 | 13 | Not reported | Systemic-PA shunt | P | Heparin 5000 U/m2/day ASA 3–5 mg/kg/day |
7.7% VTE (no shunt thrombosis | Histopathologic study of explanted shunts |
| Mir | 2015 | 20 | 4–75 days | Norwood/Sano, mBTT | P | ASA 20 mg/day; if resistance +, dose increased to 40 mg/day | no bleeding or thrombotic complications | 80% ASA resistance in SV patients |
| Kucuk | 2016 | 44 | 1 day–20 months | mBTT | R | Heparin ASA 3–5 mg/kg/day |
9.1% shunt thrombosis | Risk for adverse outcomes after mBTT |
| Anderson | 2017 | 80 | Not reported | Systemic-PA shunt +/− Norwood/DKS | R | ASA 20 mg/day | 15% shunt thrombosis; (6.3% within 24 h) | Hematocrit was risk for shunt thrombosis |
| Chittithavorn | 2017 | 85 | 1–123 days | mBTT | R | Heparin 10 u/kg/h “if no bleeding” ASA 2–5 mg/kg/day |
14% Shunt thrombosis | <3 mg was risk factor for in-hospital shunt thrombosis after mBTT |
| Ramachandran | 2017 | 932 | Median 5 days (IQR 4–8) | Stage I and II patients – 932 stage I only here (56% Norwood/RV-PA, 41% Norwood/ mBTT, 3% central/other) |
R (MCR) | 93.8% aspirin (87% solidary), 4% no anticoagulants | 0.3% shunt thrombosis 0.2% with stroke (clopidogrel or enoxaparin only) |
Variation in antithrombotic therapy in SV patients across sites |
| Truonge | 2017 | 24 | 2–352 days | Norwood (/BT), BT/central, cavopulmonary | P | ASA 3–5 mg/kg/day | 8.3% TE (No shunt thrombosis) 20.8% major bleeds |
Suboptimal AA inhibition |
| Ambarsari | 2018 | 51 | 3–83 days | Heparin-bonded systemic-PA shunts 72.5% univentricular |
R | ASA 3 mg/kg until shunt takedown | 9.8% Shunt thrombosis | |
| Naird,e,f | 2018 | 792 | Median 0.33 years (IQR 0.03–2.37) | Variety of procedures, shunts not divided out | P | Heparin infusion protocol ASA Clopidogrel Tirofiban Warfarin Enoxaparin |
Risk ratio for TE 0.76 pre-intervention versus post (P = 0.55) “Clinically relevant” bleeding events: 4.14 events/100 PD pre-intervention versus 1.62 events /100 PD post-intervention No difference in major bleeds |
Protocol decreased bleeding but no change in TE |
| Oladunjoyed,e | 2018 | 202 | Median 0.4 years (IQR 0.1–2.3) | 9.4% after stage I palliation + other procedures | P | Heparin infusion protocol per Nair et al. Median dose 24 U/kg/hour (IQR, 20–32 U/kg/hour) 66.3% ASA |
9.4% TE (1.68 events/100 PD) Major bleeds: 14.2% (3.02 events/ 100 PD) |
aPTT > 150 s more predictive than Xa for bleeding |
| Saini | 2019 | 68 | Mean 0.31 months | mBTT | R | ASA dosing not described (<7 mg/kg/day low, ≥8 mg/kg/day high) |
16.2% Shunt thrombosis (15% in standard dose, 18% in high-dose, statistically similar) | Pre/post evaluation of different ASA doses |
| Leijserf | 2019 | 118 | 11–12 days | 30% SV 70% TGA |
P | Heparin 28 U/kg/hour (anti-Xa 0.35–0.75 U/mL) Enoxaparin 1.75 mg/kg every 12 h (anti-Xa 0.5–1 U/mL) ASA used 5–10 mg/kg/day (not universally used but few details) |
AIS: 10.8% TGA 17% SV SDH: 24% TGA 23% SV IVH: 6% TGA 2.8% SV Parenchymal stroke: 37% SV |
Focused on stroke prophylaxis (30% had AIS, 56% had TE preoperatively Increased risk postoperative stroke on anticoagulation in SV but not TGA New white matter changes seen more often in newborns with anticoagulation + AP (80%) vs anticoagulation only (29%) |
| Okamoto | 2020 | 41 | 5–68 days | systemic-PA shunt | R | Heparin (target aPTT 45– 50 seconds) ASA 3–5 mg/kg/day) |
1 death from shunt obstruction | Functional SV heart with extracardiac TAPVR |
| Erdem | 2021 | 103c | mean 56 ± SD 51 months | 18.4% systemic-PA shunt + mixed procedures | P | ASA 3–5 mg/kg/day up to 100 mg/day Six months treatment if repaired with synthetic patches, transcatheter devices, or stents |
36.9% ASA resistance; this group was more likely to have had a history of TE (34.2% versus 9.2%) | Platelet aggregation as measured by AggreGuide A-100 |
aPTT, activated partial thromboplastin time; AA, arachidonic acid; AIS, acute ischemic stroke; AP, antiplatelet therapy; ASA, aspirin/acetylsalicylic acid; ATIII, antithrombin III; CSS, cross-sectional study; DKS, Damus–Kaye–Stansel procedure; INR, international normalized ratio; IQR, interquartile range; IVH, intraventricular hemorrhage; mBTT, modified Blalock-Taussig-Thomas shunt; MCR, multicenter registry; P, prospective observation/intervention study, PA, pulmonary artery; PD, patient days; R, retrospective study; RV, right ventricle; SD, standard deviation, SDH, subdural hemorrhage; SV, single ventricle; TAPVR, Total anomalous pulmonary venous return; TE, thromboembolism; TGA, transposition of the great arteries; tPa, tissue plasminogen activator; U, unit.
a
Ages represent ranges unless otherwise specified.
b
Anticoagulation includes antiplatelet therapy as well as monitoring strategy and targets if described.
c
Only 19 were aorticopulmonary arterial shunts.
d
Study also included in Valve Table (Table 1).
e
Study also included in Conduit Table (Table 3).
f
Study also included in Other Procedures Table (Table 4).