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Thrombolysis and Invasive Treatments for Massive Pregnancy-related PE: The MAPP registry
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Thrombolysis and Invasive Treatments for Massive Pregnancy-related Pulmonary embolism: The MAPP Registry

 

♦ Data Entry ♦

 

 Description Abstract:

Pulmonary embolism (PE) occurs in about 1 in 1000-3000 pregnancies, and is one of the most common cause of maternal mortality in Europe and North America [1]. Whereas the treatment of hemodynamically stable PE during pregnancy is well documented, that of hemodynamically unstable (“massive”) PE, comprising about 5% of all PE, is not. In a recent systematic review, we collected 127 cases of massive and submassive PE during pregnancy and the postpartum period, published between 1967 and 2016 [2]. With thrombolysis (n=83), maternal and fetal survivals were high (94% and 88%). Major bleeding occurred in 17% in the antepartum but was very common (58%) in the postpartum. However, the inference from such data is tempered by the heterogeneity of cases and the risk of publication bias, with a greater likelihood of publication of positive cases with good outcomes. Further, we identified only 3 cases of massive PE treated with extracorporeal membrane oxygenation (ECMO) and 7 cases treated with percutaneous thrombectomy without thrombolytics.

Given this lack of strong evidence, current guidelines consider pregnancy as a relative contraindication to the use of thrombolytics [3] and advise to best reserve thrombolytic therapy for life-threatening maternal thromboembolism [4]. The use of ECMO and percutaneous thrombectomy is not discussed. Clinicians are therefore faced with uncertainty while taking care of pregnant and postpartum women with massive PE.

The objective of this international registry is to explore the maternal effectiveness and maternal/obstetrical safety of thrombolysis, mechanical thrombectomy and ECMO for massive PE in women during pregnancy and the postpartum period (6 weeks). Such data would help inform the care of these very ill patients and future guidelines.

 

Design and Methodology (Data expected to collect, sample size and statistical analysis):

The proposed design is an online registry of massive PE and their treatment during pregnancy and the postpartum period, in English, sponsored by the International Society on Thrombosis and Haemostasis.

The following data will be collected for each reported case, anonymously for the patient.

  • Date, hospital and name/email address of reporting clinician
  • Maternal characteristics: age, weight, BMI, history of VTE
  • Obstetrical characteristics: gravidity/parity, gestational age (at diagnosis of PE), other pregnancy complication ; if postpartum: date of delivery, type of delivery
  • PE characteristics: diagnostic imaging type, hemodynamic instability, cardiac arrest, use of vasopressors, RV dilation, concomitant DVT
  • Treatment options (several modalities are possible) and order of use

o   Thrombolytics: drug (alteplase, reteplase, tenecteplase, monteplase, streptokinase, urokinase), dose, duration of administration, method of administration (iv, pulmonary artery)

o   ECMO: type (a-v, v-v), duration.

o   Percutaneous thrombectomy: type (aspiration, catheter fragmentation, rheolytic devices)

o   Anticoagulation: drug (unfractionated heparin, LMWH, other)

  • Maternal outcomes

o   Hemodynamic improvement within 12h of treatment

o   Necessity for further invasive treatment

o   Survival at 7d and 30d.

o   Major bleeding (ISTH definition), location, timing.

  • Obstetrical outcomes (if treatment during pregnancy)

o   Fetal survival at 7d and until delivery

o   Fetal bleeding, location and timing.

o   Premature delivery

  • Neonatal outcomes

o   Survival at 30d post-delivery

o   Any concomitant neonatal medical problem

 

Study Population

Inclusion criteria: women during pregnancy or the postpartum period (6 weeks), with:

  • An objectively diagnosed PE: chest angio-CT, ventilation/perfusion lung scintigraphy or tomo-scintigraphy, pulmonary angiography, objectively diagnosed proximal DVT with a clinical PE, echocardiography with RV dilation and clinical PE, and
  • Criteria for massive PE, as defined by a SBP <90mmHg, an acute drop of blood pressure >40mmHg, the need for inotropic support or cardiac arrest, and
  • Treatment with percutaneous or i.v. thrombolysis, percutaneous thrombectomy, and/or ECMO.

 

If you have taken care of a woman with a massive pulmonary embolism during pregnancy or the postpartum period, or if you want to know more, please visit the MAPP registry or contact Dr. Marc Blondon at marc.blondon@hcuge.ch.

 

 

 

 

References

1   Sultan AA, Tata LJ, West J, Fiaschi L, Fleming KM, Nelson-Piercy C, Grainge MJ. Risk factors for first venous thromboembolism around pregnancy: a population-based cohort study from the United Kingdom. Blood 2013; 121: 3953–61.

2   Martillotti G, Boehlen F, Robert-Ebadi H, Jastrow N, Righini M, Blondon M. Treatment options for severe pulmonary embolism during pregnancy and the postpartum period: a systematic review. J Thromb Haemost 2017; 15: 1942–50.

3   Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic Therapy for VTE Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141: e419S–e494S.

4   Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos A-M, Vandvik PO, American College of Chest Physicians. 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. pp. e691S–736S. 

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