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Transplant and pregnancy

Transplant and pregnancy. Divya Gupta, MD Emory University Center for Heart Failure Therapy and Transplantation. Organ Transplantation. Since 1988 577,738 Organ transplants to date 222,125 in women 106,211 in women 18-49 years of age.

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Transplant and pregnancy

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  1. Transplant and pregnancy Divya Gupta, MD Emory University Center for Heart Failure Therapy and Transplantation

  2. Organ Transplantation • Since 1988 • 577,738 Organ transplants to date • 222,125 in women • 106,211 in women 18-49 years of age http://optn.transplant.hrsa.gov/latestData/rptData.asp

  3. have you managed a pregnant transplant patient?

  4. Pregnancy and transplant • Organ transplantation for a more ‘normal’ life • >50% of pregnancies are unplanned • >70% successful live birth rate • 30-50% of live births have complications • Pregnancy • Our program • We do not encourage pregnancy • Provide thorough information • Appropriate support Transplantation Proceedings, 36, 1999–2000 (2004)

  5. national perspective Collecting Data since 1991 • Women and men • Outcomes in offspring http://www.ntpr.giftoflifeinstitute.org/

  6. TRAnsplant conceptions -

  7. Transplant conceptions -

  8. International perspective 14,000 births worldwide • Majority in kidney transplant recipients European Renal Association-European Dialysis and Transplant Association United Kingdom Transplant Pregnancy Registry • http://www.era-edta.org/index.php N Engl J Med 2006;354:1281-93

  9. Transplant and conception • Hormonal imbalances prior to transplant • Kidney, Heart, and Liver failure • Pregnancy difficult • Hypothalamc-gonadal dysfunction in a majority NOT ALL • Do not ovulate regularly • Amenorrhea • Recovery of hormonal function after transplant • 1 to 6 months N Engl J Med 2006;354:1281-93 Am J Kidney Dis 1997;29:685-90 Int J Cardiol 2005;98:379-87 Gut 1990;31:337-8

  10. Hormonal irregularities can lead to unpredictable patterns Strongly encourage contraception Use caution!!

  11. Contraception • >50% of pregnancies are unplanned • CDC recommendations accepted by the AST • Categorized pts • Complicated • Acute or chronic graft failure • Rejection • Cardiac allograft vasculopathy • Uncomplicated http://newsletter.myast.org/newsletter/may_june11/ www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm

  12. contraception • Categorized methods • 1 - no restrictions • 2 - advantages generally outweigh the theoretical or proven risks • 3 - theoretical or proven risks generally outweigh the advantages • 4 - unacceptable health risk if the method is used

  13. Estrogen-containing • Pills, patch, and ring • Uncomplicated transplants • Benefit outweighs risk (category 2) • Complicated transplants • Unacceptable health risk (category 4)

  14. Progesterone only • Depot medroxyprogesterone acetate (DMPA), etonogestrel implant, progestin-only pills • Uncomplicated and complicated • Benefits outweigh risks (category 2)

  15. IUD • Copper and progesterone coated • One of the most effective methods in general population • Not as effective in transplants • Works 2’ inflammation • Based on 2 cases • Infection risk

  16. IUD • Uncomplicated • Benefits outweigh risks (category 2) • Complicated • If continuing the method: benefit outweigh risk (cat 2) • Do not remove for rejection, organ failure, cardiac vasculopathy • Initiating method – risk outweighs benefit (category 3)

  17. Other forms • Emergency contraception • All methods • Uncomplicated and complicated • No restrictions (category 1) • Barrier Method • No restrictions (category 1) • 2% fail rate • Sterilization

  18. Planning for pregnancy….

  19. Preconception Counseling • Possible fertility issues • Frank discussion with recipient and spouse • Issues with deterioration of health of female recipient • Issues with child’s health • Decreased lifespan compared to age matched controls http://emedicine.medscape.com/article/429932-overview#a1

  20. Preconception counseling • High Risk • Multidisplinary team to manage • High risk OB • Frequent transplant MD visits during and several months after delivery (every 2-4 weeks) • Neonatologist/perinatologist • Delivery • C-section only for OB reasons N Engl J Med 2006;354:1281-93

  21. Timing of pregnancy • Good health 1-2 years post-transplant • No graft rejection in last year • Adequate and stable graft function • No current infections that might affect fetus • Immunosuppression at stable doses • Normal blood pressure or blood pressure well controlled with one medication • Normal allograft ultrasonography results • Compliance N Engl J Med 2006;354:1281-93 Cardiol Clin 30 (2012) 441–452

  22. Factors that affect recommendations • Maternal age • Rejection in the last year • Med noncompliance • Comorbid factors that affect pregnancy and graft function Cardiol Clin 30 (2012) 441–452

  23. Factors that may lead to poor pregnancy Outcomes • Etiology of original disease • risk of recurrence • Inherited diseases in mother or father • Chronic allograft dysfunction • Renal insufficiency • Cardiopulmonary diseases • Hypertension • Diabetes mellitus • Obesity • Maternal infection with HBV, HCV, or CMV Cardiol Clin 30 (2012) 441–452

  24. Maternal factors – General population • Hypertension -most common medical problem • 2-3% of all pregnancies • Diabetes – race/ethnicity based • 2%-17% of pregnancies • Preeclampsia • 5% of all pregnancies • 10% of first pregnancies • 20-25% in women with chronic HTN Obstet Gynecol Clin North Am. 2007 June; 34(2): 173–vii http://emedicine.medscape.com/article/261435-overview

  25. NTPR data up to 2012 Pregnancies by transplanted organ Kidney, Liver, and Heart

  26. Kidney transplants – Maternal Factors • 1,576 pregnancies in 904 kidney transplant recipients • Lower rejection risk if creatinine <1.5 mg/dL at conception

  27. Kidney transplant-outcomes • Spontaneous abortions • 10-20% of pregnancies in gen pop • Ectopic pregnancies • 1-2.5% in gen pop • Stillbirths • 1% in gen pop

  28. Kidney transplant-birth outcomes • Premature • 12% in gen pop • Low birth weight • 10% in gen pop

  29. Liver transplant-maternal factors • 357 pregnancies in 198 liver transplant recipients • Hypertension • 40% with cyclosporine • 19% with tacrolimus • Preeclampsia • 20% in all CI • Diabetes • 2% with cyclosporine • 15% with tacrolimus

  30. Liver transplant-maternal factors • Rejection • 11% with cyclosporine • 1-3% with CsA (modified) and tacrolimus • Graft loss within 2 years of delivery • 3-7%

  31. Liver transplant-outcomes • Spontaneous abortions • 15-22% • Ectopic pregnancies • 0-1% • Stillbirths • 0-3% • Live births • 70-80% Are these similar to the general population? YES

  32. Liver transplant-live births • Premature birth • 30-40% • Low birth weight • 30-35% Are these comparable to births in the general population? NO

  33. Heart transplants-maternal factors • 116 pregnancies in 67 heart transplant recipients • Hypertension • 50% with cyclosporine • 30% with tacrolimus • Preeclampsia • 10% with cyclosporine • 23-29% with CsA(modified) and tacrolimus • Diabetes • 2-5%

  34. Heart transplant-maternal factors • Rejection during pregnancy • 21% with CsA • 2-4% with CsA (modified) and tacrolimus • Graft loss within 2 years of delivery • 0% with CsA • 2-4% with CsA (modified) and tacrolimus

  35. Heart transplant- outcomes • Spontaneous abortions • 19% CsA • 35-40% with CsA (modified) and tacrolimus • Ectopic • Up to 2% • Stillbirth • Up to 4% • Live birth • 50-70% • CsA with highest percentage Are these similar to the general population? NO

  36. Heart transplant-live births • Premature • 40-50% with CsA and tacrolimus • 15% with CsA (modified) • Low birth weight • 38% across the board Are these similar to outcomes in live births in the general population? NO

  37. Summary – maternal factors • Hypertension • Preeclampsia • Diabetes • Significantly higher prevalence in transplant recipients • Higher than typical pregnancy, but similar to prevalence in pts with chronic htn • Similar to general population

  38. Summary-maternal factors • Graft loss • Highest in liver on CsA • Up to 8% in kidney • Up to 4% in heart • Did not correlate with rejection

  39. Summary-outcomes • Spontaneous abortions • Up to twice the occurrence • Ectopics and stillbirths • Similar to gen pop

  40. Summary-live births • Premature • 5x greater risk • Low birth weight • 4x the occurrence of gen pop

  41. Immunosuppression in pregnancy

  42. Pregnancy safety categories • Category A • Adequate human studies failed to demonstrate a risk to the fetus • Category B • Animal studies show no risk to the fetus and no adequate studies in pregnant women OR animal studies have shown an adverse effect, but studies in pregnant women failed to demonstrate a risk to the fetus • Category C • Animal studies show adverse effect to fetus and no adequate studies in humans, BUT potential benefits may outweigh potential risks • Category D • Evidence of human fetal risk but potential benefits may warrant use of the drug despite potential risks. • Category X • Studies in animals or humans have demonstrated fetal abnormalities and/or there is evidence of fetal risk, and the risks clearly outweigh potential benefits

  43. Prednisone (category c) • Maternal effects • Associated with premature rupture of membranes • Crosses placenta • 10:1 ratio • Prenatal exposure • Fetal growth restriction • Low birth weight • Safe in breastfeeding

  44. Mycophenolic acid products (category d) • Prenatal exposure • >20% risk of congenital malformation • Unknown safety in breastfeeding • Stop drug >6 wks prior to conception and throughout pregnancy

  45. Azathioprine(category d) • Crosses placenta • Prenatal exposure • Protected from toxicity 2’ lack of enzyme to convert to active form • Growth restriction • Myelosuppression • Leukopenia avoided if maternal WBC >7500 • Fetal malformations (4-9%) • 3-5% seen in gen pop • No known associated congenital malformation • Avoid breastfeeding

  46. Sirolimus (category c) • Maternal effects • May inhibit myometrial hyperplasia required in early gestation • Paternal effects • Decreased fertility in men • Prenatal exposure • Decreased fetal weight • Delayed skeletal ossification • Unknown safety with breastfeeding

  47. Cyclosporine (category c) • Maternal effects • Increased metabolism in pregnancy • Requires higher doses • Crosses placenta • 30-60% of what is in maternal blood • Prenatal exposure • Growth restriction • Premature birth • Low birth weight • Avoid breastfeeding

  48. Tacrolimus (category c) • Maternal effects • Possible miscarriage • Frequent monitoring drug levels (q 2-4 wks) • Crosses placenta • Prenatal exposure • Transient perinatal hyperkalemia • Increased incidence of diabetes • Avoid breastfeeding

  49. Pregnancy safety categories • Category A • Adequate human studies failed to demonstrate a risk to the fetus • Category B • Animal studies show no risk to the fetus and no adequate studies in pregnant women OR animal studies have shown an adverse effect, but studies in pregnant women failed to demonstrate a risk to the fetus • Category C • Animal studies show adverse effect to fetus and no adequate studies in humans, BUT potential benefits may outweigh potential risks • Category D • Evidence of human fetal risk but potential benefits may warrant use of the drug despite potential risks. • Category X • Studies in animals or humans have demonstrated fetal abnormalities and/or there is evidence of fetal risk, and the risks clearly outweigh potential benefits

  50. Prednisone (category c) • Maternal effects • Associated with premature rupture of membranes • Crosses placenta • 10:1 ratio • Prenatal exposure • Fetal growth restriction • Low birth weight • Safe in breastfeeding

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