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• W4309339957 abstract "Prophylactic anticoagulation is indicated during pregnancy for patients with a history of venous thromboembolism (VTE), high-risk thrombophilia, and obstetrical antiphospholipid syndrome.1Heit J.A. Kobbervig C.E. James A.H. Petterson T.M. Bailey K.R. Melton 3rd, L.J. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study.Ann Intern Med. 2005; 143: 697-706Crossref PubMed Scopus (990) Google Scholar,2James A.H. Venous thromboembolism in pregnancy.Arterioscler Thromb Vasc Biol. 2009; 29: 326-331Crossref PubMed Scopus (189) Google Scholar Other pregnant patients necessitate maintaining long-term therapeutic anticoagulation (eg, for atrial fibrillation, congenital cardiopathies, or recurrent VTE).3Middeldorp S. Ganzevoort W. How I treat venous thromboembolism in pregnancy.Blood. 2020; 136: 2133-2142Crossref PubMed Google Scholar,4Bates S.M. Rajasekhar A. Middeldorp S. et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy.Blood Adv. 2018; 2: 3317-3359Crossref PubMed Scopus (265) Google Scholar The drugs of choice are usually low-molecular-weight heparins (LMWHs) as they do not cross the placenta or have teratogenic effects and have stable pharmacokinetics, together with a large body of data supporting their favorable risk-benefit balance.3Middeldorp S. Ganzevoort W. How I treat venous thromboembolism in pregnancy.Blood. 2020; 136: 2133-2142Crossref PubMed Google Scholar,4Bates S.M. Rajasekhar A. Middeldorp S. et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy.Blood Adv. 2018; 2: 3317-3359Crossref PubMed Scopus (265) Google Scholar Continuous intravenous infusion of unfractionated heparin (UFH) might represent an alternative for the inpatient setting (prophylactic or therapeutic indications), although subcutaneous UFH administration is sometimes substituted for prophylactic LMWHs. Various scientific societies have issued guidelines on the management of anticoagulation in pregnancy, notably around the time of labor and for the use of epidural anesthesia,4Bates S.M. Rajasekhar A. Middeldorp S. et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy.Blood Adv. 2018; 2: 3317-3359Crossref PubMed Scopus (265) Google Scholar, 5Leffert L. Butwick A. Carvalho B. et al.The Society for Obstetric Anesthesia and Perinatology consensus statement on the anesthetic management of pregnant and postpartum women receiving thromboprophylaxis or higher dose anticoagulants.Anesth Analg. 2018; 126: 928-944Crossref PubMed Scopus (125) Google Scholar, 6Horlocker T.T. Wedel D.J. Rowlingson J.C. et al.Regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition).Reg Anesth Pain Med. 2010; 35: 64-101Crossref PubMed Scopus (990) Google Scholar, 7Gogarten W. Vandermeulen E. Van Aken H. et al.Regional anaesthesia and antithrombotic agents: recommendations of the European Society of Anaesthesiology.Eur J Anaesthesiol. 2010; 27: 999-1015Crossref PubMed Scopus (407) Google Scholar, 8Royal College of Obstetricians & GynaecologistsReducing the risk of venous thromboembolism during pregnancy and the puerperium: Green-top Guideline 37a. 2015.https://www.rcog.org.uk/media/qejfhcaj/gtg-37a.pdfDate: 2015Google Scholar which is the favored mode of pain management with an enhanced safety profile.9Osterman M.J. Martin J.A. Epidural and spinal anesthesia use during labor: 27-state reporting area, 2008.Natl Vital Stat Rep. 2011; 59 (1–13, 16)Google Scholar The guidelines uniformly recommend waiting 24 hours for “epidural” catheter placement since the last administration of therapeutic-dose LMWH (regardless of whether it is administered once or twice daily), although a 12-hour delay is deemed sufficient in case of prophylactic dosage. We hereby propose a collection of arguments to reduce this delay to 12 hours for twice-daily therapeutic dosage, similar to prophylactic doses, therefore allowing quicker access to adequate pain management for these patients. Except for the Society for Obstetric Anesthesia and Perinatology,5Leffert L. Butwick A. Carvalho B. et al.The Society for Obstetric Anesthesia and Perinatology consensus statement on the anesthetic management of pregnant and postpartum women receiving thromboprophylaxis or higher dose anticoagulants.Anesth Analg. 2018; 126: 928-944Crossref PubMed Scopus (125) Google Scholar these recommendations indiscriminately apply to all patients, although the obstetrical population represents a distinct demographic subgroup of younger and otherwise healthy individuals. Outside of rare, well-recognized conditions, such as preeclampsia in which renal function may deteriorate rapidly and patients with chronic renal insufficiency, the risk of LMWH accumulation is exceedingly uncommon in pregnant patients. Furthermore, minimal residual anticoagulant activity might be compensated by a pregnancy-associated hypercoagulable state.10Brenner B. Haemostatic changes in pregnancy.Thromb Res. 2004; 114: 409-414Abstract Full Text Full Text PDF PubMed Scopus (464) Google Scholar The incidence of spinal or “epidural” hematoma with neuraxial anesthesia has been shown to be 5 to 10 times lower in the obstetrical population (with an estimated incidence of 3:1,000,000 to 4:1,000,000) than in the general population.5Leffert L. Butwick A. Carvalho B. et al.The Society for Obstetric Anesthesia and Perinatology consensus statement on the anesthetic management of pregnant and postpartum women receiving thromboprophylaxis or higher dose anticoagulants.Anesth Analg. 2018; 126: 928-944Crossref PubMed Scopus (125) Google Scholar,11D’Angelo R. Smiley R.M. Riley E.T. Segal S. Serious complications related to obstetric anesthesia: the serious complication repository project of the Society for Obstetric Anesthesia and Perinatology.Anesthesiology. 2014; 120: 1505-1512Crossref PubMed Scopus (202) Google Scholar, 12Moen V. Dahlgren N. Irestedt L. Severe neurological complications after central neuraxial blockades in Sweden 1990-1999.Anesthesiology. 2004; 101: 950-959Crossref PubMed Scopus (751) Google Scholar, 13Ehrenfeld J.M. Agarwal A.K. Henneman J.P. Sandberg W.S. Estimating the incidence of suspected epidural hematoma and the hidden imaging cost of epidural catheterization: a retrospective review of 43,200 cases.Reg Anesth Pain Med. 2013; 38: 409-414Crossref PubMed Scopus (37) Google Scholar, 14Rosero E.B. Joshi G.P. Nationwide incidence of serious complications of epidural analgesia in the United States.Acta Anaesthesiol Scand. 2016; 60: 810-820Crossref PubMed Scopus (56) Google Scholar Furthermore, given that 1 large study reported no complication in the obstetrical subgroup, the aforementioned cumulative incidence is likely overestimated.15Bateman B.T. Mhyre J.M. Ehrenfeld J. et al.The risk and outcomes of epidural hematomas after perioperative and obstetric epidural catheterization: a report from the Multicenter Perioperative Outcomes Group Research Consortium.Anesth Analg. 2013; 116: 1380-1385Crossref PubMed Scopus (108) Google Scholar General anesthesia usually represents a valid alternative to “epidural” anesthesia in most clinical situations. However, it poses specific maternal and fetal risks (difficult airway management, aspiration risk, and exposure of the fetus to anesthetic agents, among others). In addition, it hampers the initial fetomaternal interaction (reduced immediate postdelivery skin-to-skin bonding and breastfeeding initiation with decreased likelihood of exclusive breastfeeding).16Smith J. Plaat F. Fisk N.M. The natural caesarean: a woman-centred technique.BJOG. 2008; 115: 1037-1042Crossref PubMed Scopus (77) Google Scholar,17Moore E.R. Anderson G.C. Bergman N. Dowswell T. Early skin-to-skin contact for mothers and their healthy newborn infants.Cochrane Database Syst Rev. 2016; 5 (CD003519)Google Scholar Depriving a pregnant patient of adequate management of labor pain (with “epidural” if wished) is equally unacceptable. Most guidelines recommend splitting therapeutic dosage to twice-daily dosing starting at 36 weeks of gestation. The aim is to reduce anti-activated factor X (anti-Xa) peak levels and consequently the associated bleeding risk during delivery. However, the twice-daily regimen prevents most patients going into spontaneous labor from benefiting from timely anesthesia. The median time from admission to delivery varies with parity and dilation at admission, approximately 12 to 20 hours,18Zhang J. Landy H.J. Ware Branch D. et al.Contemporary patterns of spontaneous labor with normal neonatal outcomes.Obstet Gynecol. 2010; 116: 1281-1287Crossref PubMed Scopus (521) Google Scholar noticeably less than the prescribed 24-hour safety interval. Some international or local guidelines suggest circumventing this issue with planned delivery (induction labor) for patients receiving therapeutic-dose LMWHs, allowing earlier discontinuation of anticoagulant therapy. However, this point remains controversial and supported by only low-level evidence.3Middeldorp S. Ganzevoort W. How I treat venous thromboembolism in pregnancy.Blood. 2020; 136: 2133-2142Crossref PubMed Google Scholar,4Bates S.M. Rajasekhar A. Middeldorp S. et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy.Blood Adv. 2018; 2: 3317-3359Crossref PubMed Scopus (265) Google Scholar The induction of labor is associated with prolonged duration of labor and bed rest in the peripartum, thus representing an additional prothrombotic factor for these high-risk patients.19Grobman W.A. Bailit J. Lai Y. et al.Defining failed induction of labor.Am J Obstet Gynecol. 2018; 218: 122.e1-122.e8Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar There are benefits to waiting for spontaneous labor, particularly for women with a strong wish to do so and to avoid induction of labor.20American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—ObstetricsACOG Practice Bulletin No. 196: thromboembolism in pregnancy.Obstet Gynecol. 2018; 132: e1-17Crossref PubMed Scopus (172) Google Scholar Reducing the prerequisite waiting delay between LMWH injection and “epidural” catheter placement would allow more patients to undergo safer natural labor. The dichotomous awaiting period proposed by the current guidelines does not fit with another specificity of the pregnant population, which is the wider array of dosing schemes, that is, fixed-dose classical prophylaxis, weight-adjusted prophylactic doses, intermediate strength prophylaxis, and weight-adjusted once- or twice-daily therapeutic usage (Table). Moreover, as pregnant patients come in all shapes, sizes, and body weights, the expected trough anti-Xa levels largely overlap, blurring the distinction among categories.TableAvailable low-molecular-weight heparin forms and dosage schemesSubstance (all subcutaneous administration route)ProphylacticIntermediateaSome scientific societies do not recognize the intermediate dosing category and consider any amount greater than prophylactic dosing as “therapeutic” for epidural placementTherapeutic (BID)Therapeutic (once daily)Enoxaparin30–40 mg once dailybProphylactic dosing may require modifications for extremes of body weight.0.5 mg/kg once daily60 mg once daily, increase as pregnancy progresses to 1 mg/kg once daily30–40 mg BID<1 mg/kg BID<1.5 mg/kg once daily1 mg/kg BID1.5 mg/kg once dailyDalteparin5000 U once daily>5000 U once daily and <120 U/kg BID or 200 U/kg once daily100–120 U/kg BID200 U/kg once dailyTinzaparin4500 U once daily50 UI/kg once daily175 U/kg once dailyNadroparin<5700 U once daily86 U/kg BID171 U/kg once dailyCertoparin3000 U once dailyReviparin1750 U once dailyBID, twice daily.Legardeur. Rethinking the timing of epidural anesthesia in anticoagulated obstetrical patients. Am J Obstet Gynecol 2023.a Some scientific societies do not recognize the intermediate dosing category and consider any amount greater than prophylactic dosing as “therapeutic” for epidural placementb Prophylactic dosing may require modifications for extremes of body weight. Open table in a new tab BID, twice daily. Legardeur. Rethinking the timing of epidural anesthesia in anticoagulated obstetrical patients. Am J Obstet Gynecol 2023. In pharmacokinetic studies, observed levels of anti-Xa activity after the administration of LMWHs in different populations are already substantially reduced after 12 hours, regardless of subcutaneous or intravenous administration.21Zufferey P.J. Dupont A. Lanoiselée J. et al.Pharmacokinetics of enoxaparin in COVID-19 critically ill patients.Thromb Res. 2021; 205: 120-127Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar, 22De Schryver N. Serck N. Eeckhoudt S. Laterre P.F. Wittebole X. Gérard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: a randomized controlled trial.J Crit Care. 2022; 70: 154029Crossref PubMed Scopus (1) Google Scholar, 23Febbraro S. Leal Martínez-Bujanda J. Nieto Magro C. Bettica P. Bioavailability study of enoxaparin sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults.Int J Clin Pharmacol Ther. 2021; 59: 734-744Crossref PubMed Scopus (1) Google Scholar This can be explained by the short half-life of LMWHs ranging from approximately 3 to 8 hours allowing the elimination of approximately 90% to 75% of the administrated dose (which is equivalent to 4 to 2 half-lives) within 12 hours in the general population.24Sanderink G.J. Guimart C.G. Ozoux M.L. Jariwala N.U. Shukla U.A. Boutouyrie B.X. Pharmacokinetics and pharmacodynamics of the prophylactic dose of enoxaparin once daily over 4 days in patients with renal impairment.Thromb Res. 2002; 105: 225-231Abstract Full Text Full Text PDF PubMed Scopus (197) Google Scholar,25Collignon F. Frydman A. Caplain H. et al.Comparison of the pharmacokinetic profiles of three low molecular mass heparins--dalteparin, enoxaparin and Nadroparin--administered subcutaneously in healthy volunteers (doses for prevention of thromboembolism).Thromb Haemost. 1995; 73: 630-640Crossref PubMed Scopus (171) Google Scholar The half-life of LMHWs is expected to be further reduced in pregnancy because the renal blood flow and glomerular filtration rate increase by 50%, as early as 14 weeks of gestation.26Costantine M.M. Physiologic and pharmacokinetic changes in pregnancy.Front Pharmacol. 2014; 5: 65Crossref PubMed Scopus (273) Google Scholar In addition, a pregnancy-related increase in blood volume is expected to expand Considerably the volume of distribution of LMWHs, decreasing their plasma levels.5Leffert L. Butwick A. Carvalho B. et al.The Society for Obstetric Anesthesia and Perinatology consensus statement on the anesthetic management of pregnant and postpartum women receiving thromboprophylaxis or higher dose anticoagulants.Anesth Analg. 2018; 126: 928-944Crossref PubMed Scopus (125) Google Scholar,27Casele H.L. Laifer S.A. Woelkers D.A. Venkataramanan R. Changes in the pharmacokinetics of the low-molecular-weight heparin enoxaparin sodium during pregnancy.Am J Obstet Gynecol. 1999; 181: 1113-1117Abstract Full Text Full Text PDF PubMed Scopus (213) Google Scholar,28Ansari J. Carvalho B. Shafer S.L. Flood P. Pharmacokinetics and pharmacodynamics of drugs commonly used in pregnancy and parturition.Anesth Analg. 2016; 122: 786-804Crossref PubMed Scopus (52) Google Scholar Some experts even recommend a dose adjustment in pregnancy to prevent infratherapeutic levels if using dosages developed for the general population.20American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—ObstetricsACOG Practice Bulletin No. 196: thromboembolism in pregnancy.Obstet Gynecol. 2018; 132: e1-17Crossref PubMed Scopus (172) Google Scholar Regrettably, there is currently no validated laboratory test to assess the individual bleeding risk from “epidural” anesthesia in patients receiving anticoagulants.5Leffert L. Butwick A. Carvalho B. et al.The Society for Obstetric Anesthesia and Perinatology consensus statement on the anesthetic management of pregnant and postpartum women receiving thromboprophylaxis or higher dose anticoagulants.Anesth Analg. 2018; 126: 928-944Crossref PubMed Scopus (125) Google Scholar Pharmacokinetic-pharmacodynamic data correlating levels of anti-Xa activity and residual bleeding risk are lacking. The establishment of a “safe” anti-Xa cutoff allowing the administration of “epidural” anesthesia is unlikely for several factors. Applying data from other medical fields is of limited value as the relationship between “epidural” hematoma and bleeding complications, in general, has not been established. Furthermore, there are conditions where anti-Xa activity may underestimate the anticoagulant effect of LMWHs (antiphospholipid syndrome, hypertriglyceridemia, etc.). Moreover, the in vitro chromogenic anti-Xa activity assay, in platelet-poor plasma, only reflects LMWH concentration, which is distinct from LMWH in vivo activity. Finally, LMWH preparations vary in their composition and may, theoretically, have some residual direct thrombin inhibition not accounted for in the anti-Xa assay. “Thromboelastometry, with a short turnaround time and whole blood analysis, may represent an attractive option. However, in vivo data validating its use for LMWH therapeutic monitoring and for assessing the procoagulant state of late pregnancy are still preliminary.”29Pavoni V. Gianesello L. Conti D. et al.“In Less than No Time”: feasibility of rotational thromboelastometry to detect anticoagulant drugs activity and to guide reversal therapy.J Clin Med. 2022; 11: 1407Crossref PubMed Scopus (10) Google Scholar Therefore, to date, the precautious approach applied in the different guidelines is reasonable, and prespecified safety time intervals (reflecting the actual anticoagulant half-lives in the concerned population) remain the most practical management option. These elements constitute in the authors’ view a bundle of arguments in favor of rethinking the current approach to suggest a delay of 12 hours for prophylactic and intermediate strength prophylaxis and spliced, twice-daily, therapeutic dosage while keeping the 24-hour delay for the once-daily therapeutic dosage. In line with the 2018 American Society of Hematology Guidelines,4Bates S.M. Rajasekhar A. Middeldorp S. et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy.Blood Adv. 2018; 2: 3317-3359Crossref PubMed Scopus (265) Google Scholar we agree that a multidisciplinary, individualized approach should be used when decisions are made about delivery plans and anesthetic options for patients receiving anticoagulants. We go beyond and argue that pregnant patients’ specifics in terms of demographics, procoagulant state, and LMWH pharmacokinetics and the risks of general anesthesia for both mother and offspring warrant caution against overestimating the LMWH-associated bleeding, and we suggest that a 12-hour delay for twice-daily therapeutic LMWH dosage should be sufficiently safe. Regrettably, to date, there is insufficient experimental prospective data to validate definitively this attitude, as high-quality evidence in this distinct subpopulation is largely lacking. Therefore, prospective scrupulous clinicobiological documentation (laboratory values at the time of epidural anesthesia, including thromboelastography if available, and clinical outcome), preferably in a multicentric setting, is called for to gather additional knowledge and help inform the future updates of the guidelines. We believe that these data will be essential for (1) a tailored dosage of LMWH during pregnancy and (2) a refined definition of the secure conditions for “epidural” placement, both being equally relevant toward better, safer, patient-oriented obstetrical and perinatal care." @default.
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• W4309339957 title "Shall we rethink the timing of epidural anesthesia in anticoagulated obstetrical patients?" @default.
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