ThROmbolytIc TherApy of Prosthetic Heart Valve Thrombosis in PREGnancy with Low Dose Slow Infusion of t-pa (TROIA-PREG)

Transcription

1 ThROmbolytIc TherApy of Prosthetic Heart Valve Thrombosis in PREGnancy with Low Dose Slow Infusion of t-pa (TROIA-PREG) Beytullah ÇAKAL, MD Koşuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey ESC Congress 2012, Munich, Germany

2 Disclosure: None

3 Introduction Pregnancy is associated with increased risk of prosthetic heart valve thrombosis (PHVT) Elkayam U at al, J Cardiovasc Pharmacol Ther 2004 Still debate about how to treat this lifethreatening complication PHVT during pregnancy requires urgent therapy including thrombolytic therapy (TT) or surgical therapy

4 Surgical therapy during pregnancy : Maternal mortality, morbidity 6%, 24% Fetal mortality and morbidity 9%, 30% Weiss BM at al, Am J Obstet Gynecol,1998 Expert view: Surgical therapy using cardiopulmonary bypass exposes mother and fetus to a greater risk than TT does. Alpert JS, J Am Coll Cardiol, 2003

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6 Purpose Experience concerning TT during pregnancy is lacking and data is limited to case reports / case series Leonhardt G, at al. Thrombosis and Thrombolysis, 2006 Safety and efficacy of administration of t-pa for PHVT during pregnancy was evaluated in this study

7 Methods 22 patients with PHVT in 27 different episodes All the pts were mechanical MVR Mean Age: 29 ±6 Obstructive thrombus :15 Non-obstructive thrombus:12

8 Methods Transesophageal echocardiography guided TT t-pa 25 mg, 6-hours without bolus, repetitive if needed was administered Anticoagulation with i.v unfractioned heparin was withheld during TT Ozkan M et al, TROIA Trial, JACC Imaging, under review

9 Criteria for success A) Obstructive thrombus: Methods In the absence of fatal or nonfatal major complications; 1. Doppler documentation of the resolution of increased gradient and decreased valve area. 2. Clinical improvement in symptoms. 3. Reduction by 75% in major diameter and/or area of the thrombus. Complete success was defined when all 3 criteria were met Partial success was defined as less than 3. Ozkan et al, TROIA Trial,JACC Imaging,( under review)

10 Methods B) Non-obstructive thrombus: - In the absence of fatal or nonfatal major complications; 1. Complete success: 75% reduction in thrombus area and/or length. 2. Partial success: 50%-75% reduction in thrombus area and/or length Ozkan M, TROIA Trial, JACC Imaging, (under review)

11 Methods Ultrasound evaluation of the fetus was done by an obstetrician during hospitalization The study received ethical approval from the local ethics committee

12 Results TT was associated with a higher success rate of 100 % when compared with 85.5 % success rate reported by our previous study and from literature Ozkan et al, TROIA Trial, JACC Imaging,2012 (under review) Tong et al, PROTEE Registry, JACC, 2003 Average dose of t-pa : 45 ±22 mg One preterm live birth occured at 30th week due to plasental hemorrhage

13 Results The spontaneous abortion rate in our study (n:4,14.8%) is comparable to that (19.1%) observed in pregnants with prosthetic heart valve Suri V at al, European Journal of Obstetrics,Gynecology and Reproductive Biology,2011 None of live births suffered permanent deficit All abortions were occured in first trimester

14 Conclusion This is the first very large-scaled study to date conducted in pregnant patients with prosthetic heart valve thrombosis who underwent TT High success rate in our study may be related to age of thrombus occuring during pregnancy which may easily respond to thrombolysis.

15 Low dose, slow infusion of t-pa with repetition as needed without bolus provides effective and safe thrombolysis in both mother and fetus Our data suggest that TT can be considered as a first-line therapy in pregnants complicated with PHVT, and this may call for a change in current guidelines.

16 CASE 42 year old, 30 weeks of pregnancy Mechanical MVR (St.Jude) 11 years ago Dyspnea (NYHA Class IV) No sound of closing of mechanical valve INR: 1.2 on admission, MVA: 0.6 cm2 ; Grad: 29mmHg(mean) Özkan M et al. Circulation 2009

17 Huge obstructive mitral mechanical prosthetic valve thrombosis before tpa Özkan M et al. Circulation 2009 Total lysis after 75 mg

18 CASE 2 27 year old, 17 weeks of gestation Dyspnea, NYHA Class II-III Mechanical MVR (Carbomedics) 4 Years ago INR :1,4 MVA:2.1 cm2,mean Grad: 6 mmhg

19 After 25 mg tpa,6 hours,2 times

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