附錄 L — 附錄 L: Ch07 OpenEvidence 一問一答

本附錄為 Ch07 章節的 OpenEvidence 實證驗證紀錄(12 題)。每題含:

  • Q:原設計問題(針對手冊特定敘述設計)
  • A:OE 綜合回答(整合多篇原始文獻)
  • Verdict:🟢 支持 / 🟡 修正 / 🟠 部分 / 🔴 推翻
  • Article ID:OpenEvidence session 識別碼
  • Top citations:Top 5 原始文獻(含 DOI 與 chip 代碼;📄 本機 PDF 由 chip drawer 開啟)

驗證日期:2026-04-22 狀態:12 / 12 完成(6 🟢 小修正 · 4 🟡 修正 · 2 🔴 推翻)

完整 metadata 見 qa/oe_papers_library/Ch07_ecmo/Ch07_citations.json


L.1 驗證記錄

L.1.1 Q50 [High] Ch07:77 ECMO flow 40-50% CO (2-2.5 L/min) vs full-flow

Q: In intraoperative VA-ECMO during lung transplantation, does controlled flow 40-50% of cardiac output (2-2.5 L/min) vs full-flow ECMO reduce PGD3 at 72h?

A (OE 綜合): 沒有 RCT 或 cohort 直接比較 partial vs full flow。文獻集中在 ECMO vs no-ECMO / CPB。Villavicencio 2026 多中心 RCT interim(首次 RCT 證據):VA-ECMO 13.6% vs off-pump 19.4% PGD3(P=0.506)— 整體無差異。Loor 2022 ELS Registry(852 txs):intraop ECMO 28.9% PGD3 vs off-pump 12.1% vs CPB 42.7%。Vienna Hoetzenecker 2018:常規 ECMO 1 年 91% vs 82%。AATS 2022 Consensus(Class 2a):「planned MCS for controlled reperfusion may reduce PGD」。Marczin 2021 Intl Consensus:「permissive systemic hypotension + low PAP for first 10 min reperfusion」支持控制性再灌流概念,但未指定流速。ECMOToP(Messika 2024)正在比較 systematic vs on-demand VA-ECMO,不是 partial vs full。Vienna/Leuven 流速目標 2-2.5 L/min = 中心經驗,未經 RCT 驗證。

Verdict: 🟡 Operational(保留但加註:「基於 Vienna/Leuven 中心經驗;尚無 RCT 直接驗證 partial vs full flow」)

Article ID: 63dc4e65-d17c-4253-b1b0-521bfc0676c4

Top citations: 1. Villavicencio 2026 JTCVS doi:10.1016/j.jtcvs.2025.12.021 [OE-Villavicencio-2026-VAECMO-RCT] 2. Loor 2022 JTCVS doi:10.1016/j.jtcvs.2021.10.076 (REUSE) 3. Hoetzenecker 2018 JTCVS doi:10.1016/j.jtcvs.2017.10.144 [OE-Hoetzenecker-2018-ViennaRoutineECMO] 4. AATS 2022 JTCVS doi:10.1016/j.jtcvs.2022.06.024 (REUSE) 5. Marczin 2021 JHLT doi:10.1016/j.healun.2021.07.012 (REUSE) 6. Messika 2024 BMJ Open doi:10.1136/bmjopen-2023-077770 [OE-Messika-2024-ECMOToP]

L.1.2 Q51 [Med] Ch07:79 PaO2 60-150, avoid hyperoxia

Q: Does maintaining PaO2 60-150 mmHg vs >200 mmHg reduce reperfusion injury, PGD, and mortality?

A (OE 綜合): 支持。Diamond 2013 (10-center, 1,255 recipients): reperfusion FiO2 每升 10% → PGD3 OR 1.1 (P=0.01)。Diamond 2016:F2-isoprostane 氧化損傷標誌在 PGD 中升高,reperfusion FiO2>40% 加劇。Shaver 2018:cell-free Hb + FiO2>=0.40 → PGD OR 3.41。Ellman 2005 ex vivo 兔肺:hyperoxia 加劇再灌流損傷但無氧合益處。ECMO 通用文獻:Gu 2024 meta(13 studies, 17,766 pts)PaO2>=200 → 28-d mortality OR 1.43;>=150 OR 1.51。Zeng 2025 meta(17,529 pts)hyperoxia OR 1.41,VA-ECMO/ECPR 最顯。Munshi 2017 ELSO VV-ECMO 765 pts:moderate hyperoxia (101-300 @24h) → mortality OR 1.66。Burrell 2024 EXCEL RCT(300 VA-ECMO)SaO2 92-96 vs 97-100% 無差異但 trend 支持保守。AATS 2023 + Marczin 2021 共識:再灌流 PaO2 60-100 mmHg,避免 hyperoxia。PaO2 60-150 目標有充分間接證據支持。

Verdict: 🟢 Keep(evidence-based,不需修訂)

Article ID: 843d03ed-912d-4220-ae62-91517f282e4c

Top citations: 1. Diamond 2013 AJRCCM doi:10.1164/rccm.201210-1865oc [OE-Diamond-2013-FiO2-PGD] 2. Diamond 2016 JHLT doi:10.1016/j.healun.2015.12.012 [OE-Diamond-2016-F2iso-PGD] 3. Shaver 2018 JCI Insight doi:10.1172/jci.insight.98546 [OE-Shaver-2018-cfHb-PGD] 4. Gu 2024 Anesth Analg doi:10.1213/ane.0000000000007348 [OE-Gu-2024-Hyperoxia-ECMO-Meta] 5. Zeng 2025 J Crit Care doi:10.1016/j.jcrc.2025.155338 [OE-Zeng-2025-Hyperoxia-Meta] 6. Munshi 2017 CCM doi:10.1097/ccm.0000000000002643 [OE-Munshi-2017-ELSO-VV-O2] 7. Burrell 2024 ICM doi:10.1007/s00134-024-07564-8 [OE-Burrell-2024-EXCEL-VAECMO-O2] 8. Ellman 2005 JTCVS doi:10.1016/j.jtcvs.2005.06.037 [OE-Ellman-2005-Hyperoxic-Rabbit]

L.1.3 Q52 [Med] Ch07:99-101 Prolongation trigger P/F <100 or mPAP/mABP >2/3

Q: 這兩個 threshold 是否為 validated trigger?

A (OE 綜合): NO validated thresholds。AATS 2022 + Marczin 2021 只說「臨床判斷 + graft dysfunction」,不給 numeric threshold。P/F >100 是 WEANING 的 threshold(非 prolongation 觸發)。Vienna Hoetzenecker 2018/2020:「whenever graft function does not meet certain quality criteria」,exact numeric criteria 未發表。Kawashima 2025(Japan PAH):所有 PAH 常規 extended central VA-ECMO — 不看 P/F。Hannover/Leuven/Toronto 無發表 numeric criteria。TSGH P/F<100(weaning 的反向)plausible;mPAP/mABP>2/3 無發表依據

Verdict: 🟡 Operational — 保留 P/F<100 threshold 加註「TSGH operational derived from weaning criterion inverse」;mPAP/mABP>2/3 建議改為「PA pressure elevated + hemodynamic instability」敘述式

Article ID: 9735c11a-9560-4c59-bfe9-acb650361cbe

Top citations: 1. Hoetzenecker 2020 JTCVS doi:10.1016/j.jtcvs.2019.10.155 [OE-Hoetzenecker-2020-ViennaPGD24h] 2. Hoetzenecker 2018 JTCVS (REUSE) 3. AATS 2022 JTCVS (REUSE) 4. Marczin 2021 JHLT (REUSE) 5. Bernhardt 2023 J Card Fail (REUSE) 6. Kawashima 2025 EJCTS (REUSE)

L.1.4 Q53 [Med] Ch07:137 Prolongation duration 1-3 days mean 30±12 hr

Q: 最佳 ECMO prolongation duration?是 1-3 d 或 30±12 h?

A (OE 綜合): No RCT。Duration 是 criteria-based。Vienna Hoetzenecker 2018 + Moser 2018(PAH cohort 103 pts):median 2.5 days (range 1-40),1 年生存 90.2%,5 年 87.4%。Kawashima 2025(Japan PAH):median 4 d (IQR 2-4), 100% 1-yr survival。AATS 2022:「until lung function recovers」。Rescue PGD(Harano 2021):mean 5.0±10.6 d, 84.6% decannulation。Takahashi 2023:PGD3 VV-ECMO 96% 30-d survival vs VA-ECMO 54%,VV preferred。Luu 2023 + Minqiang 2021:delayed withdrawal HR 1.99 早期死亡風險 vs early OR 拔除。TSGH 30±12 hr 低於 Vienna median 2.5 d 與 Kawashima 4 d。

Verdict: 🟡 Revise — 將「30±12 hr」改為「typical median 2-3 days(Vienna PAH 2.5 d / Kawashima 4 d),依 Marczin 2021 weaning criteria 個別化」

Article ID: a6942f1d-2b0d-4113-85aa-9adc4f627532

Top citations: 1. Hoetzenecker 2018 JTCVS (REUSE) 2. Moser 2018 EJCTS (REUSE, 驗證 Vienna PAH 2.5-d median) 3. Kawashima 2025 EJCTS (REUSE) 4. Harano 2021 ASAIO J doi:10.1097/mat.0000000000001350 [OE-Harano-2021-RescueECMO-PGD] 5. Takahashi 2023 Ann Thorac Surg doi:10.1016/j.athoracsur.2022.12.038 [OE-Takahashi-2023-PGD3-VV-VA] 6. Luu 2023 J Thorac Dis doi:10.21037/jtd-22-1387 [OE-Luu-2023-ECMOManagement-LTx] 7. Minqiang 2021 Transplantation doi:10.1097/tp.0000000000003290 [OE-Minqiang-2021-LTx-ECMO]

L.1.5 Q54 [High] Ch07:138 Ultra-protective TV <=4 mL/kg on ECMO (EOLIA)

Q: 4 mL/kg vs conventional 4-6 mL/kg 是否減少 VILI?

A (OE 綜合): 證據不支持 ultra-protective <=4 mL/kg 勝過 conventional。EOLIA ventilation strategy 是 6 mL/kg PBW, Pplat <=24, PEEP >10。Guervilly 2022 RCT(39 severe ARDS VV-ECMO)TV 1-2 mL/kg + prone vs EOLIA:biotrauma markers 無差異,60-d mortality 趨勢上升 45% vs 17% (p=0.06),trial 提早終止 for futility。Schmidt 2019 multicenter cohort 350 pts: ECMO 前 2 天 ventilator settings 與 6 月生存 無關;higher TV + lower DP during course → better outcome(反映 compliance 恢復)。Rozencwajg 2019 減 biomarkers 但無 clinical endpoint。AATS 2022 推薦早期 ECMO 避免 Pplat>30 + FiO2>60%;VV-ECMO 優於 VA-ECMO(Noda 2024: 96% vs 62% 30-d survival)。TSGH 4 mL/kg 可保留為 operational,但無 outcome 優勢

Verdict: 🟡 Operational — 保留但註記「tidal volume 4-6 mL/kg PBW per EOLIA/conventional; <=4 mL/kg ultra-protective 操作選項但無臨床 endpoint 優勢(Guervilly 2022 RCT 提早終止)」

Article ID: 9a10eb28-d9a7-46cf-8f0a-3d80cc27c80f

Top citations: 1. Guervilly 2022 Crit Care doi:10.1186/s13054-022-04272-x [OE-Guervilly-2022-UltraProtective] 2. Rozencwajg 2019 CCM doi:10.1097/ccm.0000000000003894 [OE-Rozencwajg-2019-UltraProtective] 3. Schmidt 2019 AJRCCM doi:10.1164/rccm.201806-1094oc [OE-Schmidt-2019-EOLIA-MechanicalPower] 4. Noda 2024 Clin Transplant doi:10.1111/ctr.70029 [OE-Noda-2024-VV-PGD] 5. Christie 2024 NEJM doi:10.1056/nejmra2401039 [OE-Christie-2024-PGD-NEJM]

L.1.6 Q55 [Med] Ch07:151 Enoxaparin 0.5 mg/kg SC BID on ECMO (Vienna)

Q: Enoxaparin 0.5 mg/kg SC BID on ECMO 是否安全有效?

A (OE 綜合): SUPPORTED。Gratz 2020(Vienna LTx 102 pts perioperative ECMO, 80 LMWH vs 22 UFH):serious bleeding 無差異(12.5% vs 22.7%, p=0.31);thromboembolic events LMWH 顯著少(20% vs 50%, p=0.01),校正後仍存在。Wiegele 2022(Vienna COVID ECMO 62 enoxaparin vs 36 UFH):所有 HR 支持 enoxaparin — thromboembolic HR 3.43, hemorrhagic HR 2.58, composite HR 2.86;anti-Xa median 0.45 IU/mL confirmed therapeutic。Piwowarczyk 2021(Nadroparin vs UFH VV-ECMO)outcomes 相當。Krueger 2017:61 VV-ECMO prophylactic enoxaparin 40 mg SC daily — 5-d 內無 circuit exchange,5% thrombosis >5 d。TSGH 0.5 mg/kg BID 低於標準 therapeutic 1 mg/kg BID — intermediate intensity,anti-Xa 監測必要(0.3-0.7)。

Verdict: 🟢 Keep — Vienna practice 已充分發表;加 Gratz 2020 + Wiegele 2022 作為引用;強調 anti-Xa 監測

Article ID: 224440f1-265a-45dc-bdb6-f2d90bf1afdd

Top citations: 1. Gratz 2020 Artif Organs doi:10.1111/aor.13642 [OE-Gratz-2020-ViennaLMWH] 2. Wiegele 2022 Front Med doi:10.3389/fmed.2022.879425 [OE-Wiegele-2022-EnoxaparinCOVID-ECMO] 3. Piwowarczyk 2021 ASAIO J doi:10.1097/mat.0000000000001166 [OE-Piwowarczyk-2021-Nadroparin-VV] 4. Krueger 2017 Artif Organs doi:10.1111/aor.12737 [OE-Krueger-2017-Enoxaparin-VV] 5. Seelhammer 2024 Cochrane doi:10.1002/14651858.cd015685 [OE-Seelhammer-2024-CochraneECMO-Anticoag]

L.1.7 Q56 [Med] Ch07:162-165 UFH bolus 50-100 IU/kg; ACT 180-220; anti-Xa 0.3-0.7

Q: ACT 180-220 s vs anti-Xa 0.3-0.7 IU/mL 監測目標哪個較佳?

A (OE 綜合): Both 是 ELSO 認可 option,無 RCT 證明某一者 definitely superior。Lorusso 2021 Post-Cardiotomy ELS Consensus (STS/EACTS/ELSO/AATS):ACT 180-200 s,引用 ELSO Anticoagulation Guideline ACT 180-220;承認 anticoagulation management 未 standardized。Sun 2023 meta (26 studies, 1,684 pts):anti-Xa 較穩定 + 較好 correlation with heparin dose,但小型 retro。Figueroa Villalba 2020 pediatric (152 runs):ACT→anti-Xa 轉換 減 circuit change 75%、bleeding 69%→51% (p=0.03)。Al-Jazairi 2021 + Ranucci 2020:anti-Xa 預測 circuit thrombosis;aPTT 預測 bleeding 較佳;multi-modal 最佳。Martucci 2024 AJRCCM PROTECMO (652 VV-ECMO):aPTT HR 1.07 per 20s 預測 bleeding。TSGH 雙目標可行(ACT 180-220 + anti-Xa 0.3-0.7)。

Verdict: 🟢 Keep — 現有 dual-target 監測符合 ELSO/Lorusso 2021;加註 anti-Xa 為 LMWH 時必要

Article ID: 46031e6a-c726-4f32-bda0-9411ca40dedc

Top citations: 1. Lorusso 2021 JTCVS doi:10.1016/j.jtcvs.2020.09.045 (REUSE if in drawer else add) 2. Sun 2023 Heart Lung doi:10.1016/j.hrtlng.2023.05.003 [OE-Sun-2023-AntiXa-Systematic] 3. Figueroa Villalba 2020 CCM doi:10.1097/ccm.0000000000004615 [OE-FigueroaVillalba-2020-ACTtoAntiXa] 4. Al-Jazairi 2021 Ann Pharmacother doi:10.1177/1060028020960409 [OE-AlJazairi-2021-ECMOmonitoring] 5. Ranucci 2020 Semin Thromb Hemost doi:10.1055/s-0039-1697950 [OE-Ranucci-2020-AntiXaECMO] 6. Martucci 2024 AJRCCM doi:10.1164/rccm.202305-0896oc [OE-Martucci-2024-PROTECMO-AJRCCM] 7. Kanji 2022 Thromb Haemost doi:10.1055/a-1508-8230 [OE-Kanji-2022-Optimal]

L.1.8 Q57 [High] Ch07:199 Bivalirudin bolus 0.05-0.5 mg/kg, infusion 0.03-0.1 mg/kg/hr

Q: Bivalirudin vs UFH 是否減 bleeding/thrombosis/mortality?

A (OE 綜合): Bivalirudin 減 circuit thrombosis,可能降 mortality;但無 RCT(2022-2025 全部 observational meta)。Thrombosis: Hu 2025 (11 studies) OR 0.52 (p<0.0001); Chen 2023 network meta (2,522 pts) OR 0.51; Liu 2022 OR 0.44; Lofy 2026 retro 30.2% vs 43.4% (p=0.017) + TTR 70% vs 55.5% (p<0.001)。Bleeding MIXED: Li 2022 RR 0.32 favor;Liu 2022 OR 0.36 favor;但 Chen 2023 OR 0.54 NS;Ma 2022 OR 0.87 NS。Mortality: Hu 2025 OR 0.74 (p=0.04);Li 2022 RR 0.82;Liu 2022 OR 0.78;Chen 2023 OR 0.75 NS。Kartika 2024 VV-ECMO 專門:thrombosis HR 0.14, circuit 16 vs 10 d。Saura 2025:heparin 仍 mainstay,bivalirudin emerging。ELSO 2023-2024 尚未 formal guidance。TSGH 劑量(0.05-0.5 mg/kg bolus + 0.03-0.1 mg/kg/hr)符合 published protocols。

Verdict: 🟢 Keep — 作為 HIT 或 UFH-refractory 替代。加「ELSO 2024 尚無 formal guidance; all meta observational, RCT pending」

Article ID: 90855fc8-c383-4b3c-81e5-0b7ad2059965

Top citations: 1. Hu 2025 Medicine doi:10.1097/md.0000000000042696 [OE-Hu-2025-Bivalirudin-Meta] 2. Chen 2023 Pharmacotherapy doi:10.1002/phar.2859 [OE-Chen-2023-NetworkMeta] 3. Liu 2022 Pharmacol Res doi:10.1016/j.phrs.2022.106089 [OE-Liu-2022-Bivalirudin] 4. Li 2022 Br J Clin Pharmacol doi:10.1111/bcp.15251 [OE-Li-2022-Bivalirudin] 5. Kartika 2024 Eur J Haematol doi:10.1111/ejh.14146 [OE-Kartika-2024-Bivalirudin-VV] 6. Lofy 2026 Ann Pharmacother doi:10.1177/10600280251371081 [OE-Lofy-2026-Bivalirudin-Retro] 7. Saura 2025 Curr Opin Anaesthesiol doi:10.1097/aco.0000000000001603 [OE-Saura-2025-ECMO-Anticoag]

L.1.9 Q58 [Med] Ch07:210-213 Hct >35-40%, Plt >80-100k, Fib >100-150 on ECMO

Q: Hct>35% vs restrictive 是否改善 survival?

A (OE 綜合): NO — Hct>35-40% 不優於 restrictive。歷史 ELSO pre-2021 Hct>40% 目標已被揚棄。PROTECMO(Martucci 2023 Lancet Resp Med, 604 VV-ECMO 41 centers):mean Hb 9.1 g/dL;只有 Hb<7 與 ICU mortality 相關(HR 2.99);PRBC transfusion 只在 Hb<7 有益(HR 0.15)。Boscolo 2025 meta 5 studies 1,339 pts:restrictive Hb 7 g/dL 改善 28-d survival。Pratt 2024 (229 VV-ECMO): Hb<8 最低 hazard。Ng 2023: VV-ECMO 亞組 restrictive aOR 0.36 favor restrictive。Thao 2025 VA-ECMO target-trial emulation (534 pts):liberal Hb>=9 只在 VA-ECMO 前 2-3 d 有 modest 益處 (NNT 7-8),之後無益。JACC: VA-ECMO 8-10 g/dL。Platelets Raasveld 2023 PROTECMO:每 10x10^9/L Plt 降 +3.7% bleeding;Plt<100 增 bleeding + 減 6 月生存。Fibrinogen >150 實務目標但 prospective 未驗證

Verdict: 🔴 Revise — Hct>35-40% 過高。改為「VV-ECMO Hb 7-8 g/dL, VA-ECMO Hb 8-10 g/dL;Plt>=50-100k(bleeding 風險對應);Fibrinogen>=150 mg/dL 實務目標」

Article ID: 46bcea20-1e4a-45ea-b654-8aee4aab628f

Top citations: 1. Martucci 2023 Lancet Resp Med doi:10.1016/s2213-2600(22)00353-8 [OE-Martucci-2023-PROTECMO-Lancet] 2. Boscolo 2025 Artif Organs doi:10.1111/aor.70001 [OE-Boscolo-2025-TransfusionMeta] 3. Pratt 2024 Chest doi:10.1016/j.chest.2024.05.043 [OE-Pratt-2024-Hb-VV] 4. Ng 2023 Transfusion doi:10.1111/trf.17221 [OE-Ng-2023-RestrictiveECMO] 5. Thao 2025 Crit Care doi:10.1186/s13054-025-05606-1 [OE-Thao-2025-LiberalRestrictive] 6. Raasveld 2023 Crit Care doi:10.1186/s13054-023-04612-5 [OE-Raasveld-2023-Plt-PROTECMO]

L.1.10 Q59 [Low] Ch07:253-258 Weaning composite SvO2 >75, P/F >=100, PIP <=29, FiO2 60

Q: Composite criteria 是否優於 single criteria?

A (OE 綜合): 未直接比較。但 composite 明顯優於 single,為 consensus + 多個 cohort 一致結論。TSGH 組合與 Marczin 2021 Intl Consensus 完全一致:SvO2>75, P/F>100 + PaCO2<45, compliance/imaging 改善, PIP max 29, FiO2 60。Al-Fares 2021 Chest (VV-ECMO) 79% 成功率 multi-parametric。Gerhardinger 2024 CCM: ventilator settings (低 RR, 低 PaCO2) 預測最強。Hsu 2024 PLoS One: 高 TV, HR, VR, 食道 swings 預測失敗。Charbonneau 2022 + Broman 2018 (VA-ECMO): MAP>60 minimal vaso, lactate<2, SvO2>65-75, LVEF>20-25, LVOT VTI>10-12, AV 開。Greendyk 2025 Curr Opin: multi-parametric essential, LVOT VTI 最常單一指標但不足。Gannon 2021 + Shekar 2020 protocolized weaning 87.5% success。

Verdict: 🟢 Keep — TSGH composite 與 Intl Consensus 完全一致,最佳 practice

Article ID: 7df2c1c3-c1fb-4303-a228-dda65b34e332

Top citations: 1. Marczin 2021 JHLT (REUSE) 2. Lorusso 2021 JTCVS (REUSE) 3. Al-Fares 2021 Chest doi:10.1016/j.chest.2021.05.068 4. Gerhardinger 2024 CCM doi:10.1097/ccm.0000000000006041 5. Hsu 2024 PLoS One doi:10.1371/journal.pone.0310289 6. Charbonneau 2022 Crit Care doi:10.1186/s13054-022-04249-w 7. Broman 2018 J Thorac Dis doi:10.21037/jtd.2017.09.95

L.1.11 Q60 [Med] Ch07:366 ELSO BTT center ~45 cannulation threshold

Q: BTT-ECMO center volume threshold 45 vs 20 vs 100/yr?

A (OE 綜合): 45 CUMULATIVE BTT cannulations 是 ELSO registry-validated threshold。Young 2025 Ann Thorac Surg(ELSO 1,066 pts 2010-2022):center volume of BTT-ECMO protective (p<0.001); benefit observed after approximately 45 total BTT intent cannulations(cumulative,非 annual)。Halpern 2019 UNOS 20,976 LTx:overall BTT-ECMO HR 1.37 (1.14-1.64); centers >35 LTx/yr 消除 penalty。Hayes 2016 UNOS: high-volume (~34/yr) HR 0.853 NS;low-volume HR 1.968 (p=0.026)。Deitz 2023 UNOS 634 BTT:high-volume 24% 更高 survival to TX, 44% 低 waitlist mortality。Li 2025 OPTN: VV-ECMO 不差;VA-ECMO HR 1.36 inferior。Wisniewski 2025: composite allocation 降 BTT rate 5.8% vs 7.8%。TSGH 作為低量中心須考慮轉運至高量中心 pathway。

Verdict: 🟢 Keep — 45 cannulation 有 ELSO registry evidence (Young 2025);加「cumulative, 非 annual」

Article ID: c60571a9-17dd-47a6-9654-c01e53130711

Top citations: 1. Young 2025 Ann Thorac Surg doi:10.1016/j.athoracsur.2025.04.017 [OE-Young-2025-ELSO-BTT-Volume] (關鍵 45-cannulation threshold) 2. Halpern 2019 Ann Thorac Surg doi:10.1016/j.athoracsur.2019.03.057 [OE-Halpern-2019-BTT-Volume] 3. Hayes 2016 AJRCCM doi:10.1164/rccm.201511-2222oc 4. Deitz 2023 Ann Thorac Surg doi:10.1016/j.athoracsur.2023.02.062 [OE-Deitz-2023-BTT-Waitlist] 5. Wisniewski 2025 Ann Thorac Surg doi:10.1016/j.athoracsur.2024.12.011

L.1.12 Q61 [Low] Ch07:454 pfHb >100 mg/dL → change circuit

Q: pfHb>100 vs >50 mg/dL 作為 circuit change threshold?

A (OE 綜合): 無 RCT。ELSO 以 pfHb>50 mg/dL 為 serious hemolysis cutoff(非 100)。TSGH 100 mg/dL 是 ELSO 標準的 兩倍,可能延遲 circuit exchange。Omar 2015 (154 adult ECMO): pfHb>50 at 24h 獨立 mortality predictor OR 3.4 (p=0.011)。Lubnow 2014 / Lehle 2015 (318 VV-ECMO):survivors median pfHb 90 vs 148 mg/L (p<=0.001)。Graw 2022 (273 VV-ECMO ARDS): dose-response — pfHb 5-14 aOR 2.69 AKI; >=15 aOR 5.47 KDIGO-3。Lyu 2016 VA-ECMO: peak pfHb OR 1.052 per unit AKI 預測。Blum 2024 Crit Care: Regensburg 最新 pump 下 severe hemolysis 僅 1.7% measurements。Mechanism: haptoglobin 飽和 → 腎管細胞毒性 + 血管收縮。Pumphead thrombosis 是 primary indication 緊急換路,pump 替換 2 天內 pfHb 正常化。

Verdict: 🔴 Revise — TSGH 應將 circuit exchange threshold 由 pfHb>100 mg/dL 下修為 pfHb>50 mg/dL(ELSO 標準),並加「結合 LDH 上升趨勢 + circuit 參數變化 + AKI 惡化 綜合判斷」

Article ID: ce32b076-4483-4418-ac9b-38997ce4d3e8

Top citations: 1. Omar 2015 PLoS One doi:10.1371/journal.pone.0124034 [OE-Omar-2015-pfHb-ECMO] 2. Lehle 2015 PLoS One doi:10.1371/journal.pone.0143527 [OE-Lehle-2015-pfHb-VV] 3. Graw 2022 Crit Care doi:10.1186/s13054-022-03894-5 [OE-Graw-2022-pfHb-AKI] 4. Lyu 2016 JCVA doi:10.1053/j.jvca.2016.02.011 5. Lubnow 2014 PLoS One doi:10.1371/journal.pone.0112316 6. Blum 2024 Crit Care doi:10.1186/s13054-024-05121-9


L.2 批次總結

Verdict 數量 題號
🟢 Keep 6 Q51, Q55, Q56, Q57, Q59, Q60
🟡 Operational / Minor revise 4 Q50, Q52, Q53, Q54
🔴 Revise 2 Q58, Q61

手冊 Ch07 必要修訂: 1. Q58 Ch07:210-213 — Hct 目標從「>35-40%」下修為「VV-ECMO Hb 7-8 g/dL; VA-ECMO Hb 8-10 g/dL」;Plt>=50-100k;Fibrinogen>=150 mg/dL(實務目標,無 RCT) 2. Q61 Ch07:454 — circuit exchange threshold 由「pfHb>100 mg/dL」下修為 pfHb>50 mg/dL(ELSO 標準),結合 LDH + circuit 參數 + AKI 趨勢 3. Q53 Ch07:137 — prolongation duration 由「mean 30±12 hr」改為「typical median 2-3 days(Vienna PAH 2.5 d, Kawashima 4 d),criteria-based 個別化」 4. Q50 Ch07:77 — 加註「partial vs full flow 尚無 RCT;2-2.5 L/min 基於 Vienna/Leuven 中心經驗」 5. Q52 Ch07:99-101 — mPAP/mABP>2/3 改為敘述式「PA pressure elevated + hemodynamic instability」;P/F<100 加註「TSGH operational」 6. Q54 Ch07:138 — 改為「TV 4-6 mL/kg PBW (EOLIA); <=4 mL/kg ultra-protective 選項,無 outcome 優勢 (Guervilly 2022 RCT terminated)」 7. Q55 Ch07:151 — 保留 enoxaparin 0.5 mg/kg SC BID,加引用 Gratz 2020 + Wiegele 2022(Vienna 雙中心 published practice),強調 anti-Xa 0.3-0.7 IU/mL 監測 8. Q57 Ch07:199 — Bivalirudin 劑量保留,加「ELSO 2024 尚無 formal guidance;2022-2025 所有 meta 為 observational,RCT pending(Seelhammer 2024 Cochrane)」 9. Q60 Ch07:366 — 加註「45 cannulations 為 cumulative (Young 2025 ELSO),非 annual;低量中心應建立高量中心轉運 pathway」

新增引用(53 unique OE codes,排除已在 Ch03-06 drawer 的代碼)。