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Introduction: Obstetric venous thromboembolism
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Available online at www.sciencedirect.com
Seminars in Perinatology www.seminperinat.com
Introduction: Obstetric venous thromboembolism Alexander M. Friedman Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, 622 West 168th Street, PH 16-66, New York, NY 10032, United States
A R T I C L E I N F O
AB STR ACT
Keywords:
How to best reduce maternal risk from obstetric venous thromboembolism (VTE) is a rela-
Maternal safety
tively controversial topic. In comparison, for other leading causes of maternal mortality
Obstetric quality
and severe morbidity such as obstetric hemorrhage and hypertension, there is general
Obstetric thromboembolism
agreement on recommendations. While obstetric VTE poses a unique epidemiological and
Maternal outcomes
public health challenge, a number of recommendations related to care improvement and patient safety can be made. This edition of Seminars in Perinatology focuses on (i) overview of clinical research and epidemiology that can serve as a basis for informed decision making regarding VTE prophylaxis strategies, (ii) VTE prophylaxis implementation from a leadership perspective, (iii) future directions for research on obstetric VTE, and (iv) critical care management of obstetric VTE. Ó 2019 Elsevier Inc. All rights reserved.
Introduction How to best reduce maternal risk from obstetric venous thromboembolism (VTE) is a relatively controversial topic.1-5 In comparison, for other leading causes of maternal mortality and severe morbidity such as obstetric hemorrhage and hypertension, there is general agreement on recommendations. Obstetric VTE poses a unique epidemiological and public health challenge. While most experts agree that outcomes are most likely to be improved by optimizing prevention (although appropriate diagnosis and treatment are also important), major disagreements exist regarding who should receive VTE prophylaxis, what type, and for how long.5-8 In comparison to medical and surgical scenarios where risk is particularly high for short hospitalizations or post-operative periods, increased obstetric VTE risk is broadly distributed both across the population with many risk factors being relatively common and temporally with risk extending through pregnancy to the postpartum period.9,10 Guidelines largely align regarding the
Conflicts of Interest: None. E-mail address: [email protected] https://doi.org/10.1053/j.semperi.2019.03.001 0146-0005/Ó 2019 Elsevier Inc. All rights reserved.
highest risk patients those with prior VTE events and highrisk thrombophilias with recommendations supporting pharmacologic prophylaxis with low molecular weight (LMWH) or unfractionated heparin (UFH) antenatally and postpartum.4-8 For patients with multiple lesser risk factors, including during the immediate postpartum period when risk is highest, recommendations support a range of management including observation versus mechanical versus pharmacologic prophylaxis for greater or lesser proportions of the obstetric population. Optimal prophylaxis for postpartum patients with multiple lesser risk factors will only become a more pressing clinical issue; cesarean delivery, hypertensive diseases of pregnancy, obesity, major obstetric hemorrhage, and other conditions are all associated with increased likelihood of obstetric VTE and have all increased on a population basis over recent decades.5 It is unlikely that population-level risk based on demographic, medical, and obstetric risk factors will decrease anytime soon. While resolving disagreements regarding best practices is beyond the scope of this edition of Seminars in Perinatology, a
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number of recommendations related to leadership and implementation can be made. Providers, hospital leadership, hospital systems, and state collaboratives all have a role in reducing VTE risk by deciding on an appropriate prophylaxis strategy, implementing it, and then following up to ensure that patients are receiving expected care. Four review articles in this edition of Seminars focus on implementation from a leadership perspective. Angela Burgess and Steven Clark review opportunities for hospitals, hospital systems, and leadership to improve obstetric VTE prophylaxis strategies. Doug Montgomery reviews VTE prophylaxis protocol implementation on a hospital-system level based on the experience of Kaiser Permanente Southern California. Mary D’Alton reviews how state maternal safety collaboratives can provide resources and support to hospital leadership based on the experience of the American College of Obstetricians and Gynecologists (ACOG) District II’s New York State Safe Motherhood Initiative. Richard Smiley reviews recommendations from major anesthesia societies (the Society for Obstetric Anesthesia and Perinatology and the American Society of Regional Anesthesia and Pain Medicine) related to neuraxial anesthesia among obstetric patients receiving anticoagulation that have major bearing on VTE prophylaxis strategies. This edition of Seminars also seeks to provide a succinct overview of clinical research and epidemiology that can serve as a basis for informed decision making regarding prophylaxis strategies. From the Centers of Disease Control and Prevention, Karon Abe, Elena Kuklina, Craig Hooper, and William Callaghan present data on VTE as a cause of severe maternal morbidity and mortality in the United States. Christy Lamont, Christopher McDermott, Andrew Thomson and Ian Greer present data on the evidence and rationale for society prophylaxis recommendations from United Kingdom. Cassandra Duffy provides an overview of clinical and epidemiological research evidence that serves as a basis for major society guideline recommendations. Joshua Rosenbloom and George Macones look forward at future research directions for prevention and treatment of obstetric thromboembolism and on what basis differences in recommendations may eventually be aligned. Finally, one clinically focused review is included. While obstetric providers may be familiar with treatment and management of VTE among stable patients, critical care management is less well characterized; Roxane Handal-Orefice and Leslie Moroz review treatment of thromboembolism with a focus on critically ill pregnant patients.
00 (2019) 1
2
Clinical recommendations for obstetric VTE prophylaxis will continue to evolve based on experience and research evidence. The most recent iteration of the UK Confidential Enquiries noted that the complexity of the recommended risk assessment represented an obstacle to appropriate prophylaxis is some cases. Proposals in the US have ranged from waiting for more data to expanding pharmacologic prophylaxis to widespread use of pharmacologic anticoagulation.1,2 What can be understood from the best available evidence is that VTE is a major cause of morbidity and mortality among pregnant women, this risk isn’t going away, and that leadership at all levels have an opportunity to improve clinical outcomes.
R E F E R E N C E S
1. Sibai BM, Rouse DJ. Pharmacologic thromboprophylaxis in obstetrics: broader use demands better data. Obstet Gynecol. 2016;128:681–684. 2. Macones GA. Patient safety in obstetrics: more evidence, less emotion. Obstet Gynecol. 2017;130:257–259. 3. Kotaska A. Postpartum venous thromboembolism prophylaxis may cause more harm than benefit: a critical analysis of international guidelines through an evidence-based lens. BJOG. 2018;125:1109–1116. 4. D’Alton ME, Friedman AM, Smiley RM, et al. National partnership for maternal safety: consensus bundle on venous thromboembolism. Obstet Gynecol. 2016;128:688–698. 5. The Royal College of Obstetricians and Gynaecologists. Thrombosis and embolism during pregnancy and the puerperium, reducing the risk. Green-top guideline no. 37a. 2015. 6. ACOG Practice Bulletin No. 196. Thromboembolism in pregnancy: correction. Obstet Gynecol. 2018;132:1068. 7. Bates SM, 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;2:3317–3359. 8. Bates SM, Greer IA, Middeldorp S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: antithrombotic therapy and prevention of thrombosis, 9th ed.: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141:e691S–e736S. 9. Bernstein PS, Martin JN Jr., Barton JR, et al. National partnership for maternal safety: consensus bundle on severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;130:347–357. 10. Main EK, Goffman D, Scavone BM, et al. National partnership for maternal safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015;121:142–148.
E M I N A R S
I N
P
E R I N A T O L O G Y
000 (2019) 1
2
Available online at www.sciencedirect.com
Seminars in Perinatology www.seminperinat.com
Introduction: Obstetric venous thromboembolism Alexander M. Friedman Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, 622 West 168th Street, PH 16-66, New York, NY 10032, United States
A R T I C L E I N F O
AB STR ACT
Keywords:
How to best reduce maternal risk from obstetric venous thromboembolism (VTE) is a rela-
Maternal safety
tively controversial topic. In comparison, for other leading causes of maternal mortality
Obstetric quality
and severe morbidity such as obstetric hemorrhage and hypertension, there is general
Obstetric thromboembolism
agreement on recommendations. While obstetric VTE poses a unique epidemiological and
Maternal outcomes
public health challenge, a number of recommendations related to care improvement and patient safety can be made. This edition of Seminars in Perinatology focuses on (i) overview of clinical research and epidemiology that can serve as a basis for informed decision making regarding VTE prophylaxis strategies, (ii) VTE prophylaxis implementation from a leadership perspective, (iii) future directions for research on obstetric VTE, and (iv) critical care management of obstetric VTE. Ó 2019 Elsevier Inc. All rights reserved.
Introduction How to best reduce maternal risk from obstetric venous thromboembolism (VTE) is a relatively controversial topic.1-5 In comparison, for other leading causes of maternal mortality and severe morbidity such as obstetric hemorrhage and hypertension, there is general agreement on recommendations. Obstetric VTE poses a unique epidemiological and public health challenge. While most experts agree that outcomes are most likely to be improved by optimizing prevention (although appropriate diagnosis and treatment are also important), major disagreements exist regarding who should receive VTE prophylaxis, what type, and for how long.5-8 In comparison to medical and surgical scenarios where risk is particularly high for short hospitalizations or post-operative periods, increased obstetric VTE risk is broadly distributed both across the population with many risk factors being relatively common and temporally with risk extending through pregnancy to the postpartum period.9,10 Guidelines largely align regarding the
Conflicts of Interest: None. E-mail address: [email protected] https://doi.org/10.1053/j.semperi.2019.03.001 0146-0005/Ó 2019 Elsevier Inc. All rights reserved.
highest risk patients those with prior VTE events and highrisk thrombophilias with recommendations supporting pharmacologic prophylaxis with low molecular weight (LMWH) or unfractionated heparin (UFH) antenatally and postpartum.4-8 For patients with multiple lesser risk factors, including during the immediate postpartum period when risk is highest, recommendations support a range of management including observation versus mechanical versus pharmacologic prophylaxis for greater or lesser proportions of the obstetric population. Optimal prophylaxis for postpartum patients with multiple lesser risk factors will only become a more pressing clinical issue; cesarean delivery, hypertensive diseases of pregnancy, obesity, major obstetric hemorrhage, and other conditions are all associated with increased likelihood of obstetric VTE and have all increased on a population basis over recent decades.5 It is unlikely that population-level risk based on demographic, medical, and obstetric risk factors will decrease anytime soon. While resolving disagreements regarding best practices is beyond the scope of this edition of Seminars in Perinatology, a
ARTICLE IN PRESS 2
S
E M I N A R S
I N
P
E R I N A T O L O G Y
number of recommendations related to leadership and implementation can be made. Providers, hospital leadership, hospital systems, and state collaboratives all have a role in reducing VTE risk by deciding on an appropriate prophylaxis strategy, implementing it, and then following up to ensure that patients are receiving expected care. Four review articles in this edition of Seminars focus on implementation from a leadership perspective. Angela Burgess and Steven Clark review opportunities for hospitals, hospital systems, and leadership to improve obstetric VTE prophylaxis strategies. Doug Montgomery reviews VTE prophylaxis protocol implementation on a hospital-system level based on the experience of Kaiser Permanente Southern California. Mary D’Alton reviews how state maternal safety collaboratives can provide resources and support to hospital leadership based on the experience of the American College of Obstetricians and Gynecologists (ACOG) District II’s New York State Safe Motherhood Initiative. Richard Smiley reviews recommendations from major anesthesia societies (the Society for Obstetric Anesthesia and Perinatology and the American Society of Regional Anesthesia and Pain Medicine) related to neuraxial anesthesia among obstetric patients receiving anticoagulation that have major bearing on VTE prophylaxis strategies. This edition of Seminars also seeks to provide a succinct overview of clinical research and epidemiology that can serve as a basis for informed decision making regarding prophylaxis strategies. From the Centers of Disease Control and Prevention, Karon Abe, Elena Kuklina, Craig Hooper, and William Callaghan present data on VTE as a cause of severe maternal morbidity and mortality in the United States. Christy Lamont, Christopher McDermott, Andrew Thomson and Ian Greer present data on the evidence and rationale for society prophylaxis recommendations from United Kingdom. Cassandra Duffy provides an overview of clinical and epidemiological research evidence that serves as a basis for major society guideline recommendations. Joshua Rosenbloom and George Macones look forward at future research directions for prevention and treatment of obstetric thromboembolism and on what basis differences in recommendations may eventually be aligned. Finally, one clinically focused review is included. While obstetric providers may be familiar with treatment and management of VTE among stable patients, critical care management is less well characterized; Roxane Handal-Orefice and Leslie Moroz review treatment of thromboembolism with a focus on critically ill pregnant patients.
00 (2019) 1
2
Clinical recommendations for obstetric VTE prophylaxis will continue to evolve based on experience and research evidence. The most recent iteration of the UK Confidential Enquiries noted that the complexity of the recommended risk assessment represented an obstacle to appropriate prophylaxis is some cases. Proposals in the US have ranged from waiting for more data to expanding pharmacologic prophylaxis to widespread use of pharmacologic anticoagulation.1,2 What can be understood from the best available evidence is that VTE is a major cause of morbidity and mortality among pregnant women, this risk isn’t going away, and that leadership at all levels have an opportunity to improve clinical outcomes.
R E F E R E N C E S
1. Sibai BM, Rouse DJ. Pharmacologic thromboprophylaxis in obstetrics: broader use demands better data. Obstet Gynecol. 2016;128:681–684. 2. Macones GA. Patient safety in obstetrics: more evidence, less emotion. Obstet Gynecol. 2017;130:257–259. 3. Kotaska A. Postpartum venous thromboembolism prophylaxis may cause more harm than benefit: a critical analysis of international guidelines through an evidence-based lens. BJOG. 2018;125:1109–1116. 4. D’Alton ME, Friedman AM, Smiley RM, et al. National partnership for maternal safety: consensus bundle on venous thromboembolism. Obstet Gynecol. 2016;128:688–698. 5. The Royal College of Obstetricians and Gynaecologists. Thrombosis and embolism during pregnancy and the puerperium, reducing the risk. Green-top guideline no. 37a. 2015. 6. ACOG Practice Bulletin No. 196. Thromboembolism in pregnancy: correction. Obstet Gynecol. 2018;132:1068. 7. Bates SM, 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;2:3317–3359. 8. Bates SM, Greer IA, Middeldorp S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: antithrombotic therapy and prevention of thrombosis, 9th ed.: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141:e691S–e736S. 9. Bernstein PS, Martin JN Jr., Barton JR, et al. National partnership for maternal safety: consensus bundle on severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;130:347–357. 10. Main EK, Goffman D, Scavone BM, et al. National partnership for maternal safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015;121:142–148.