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【2007ESC年会】ZAHARA研究：先天性心脏病妊娠会有意想不到的心血管并发症

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Pregnancy in women with congenital heart disease: ZAHARA study finds unexpected rate of cardiovascular complications

Dr Els Pieper

There is relatively little known about pregnancy in women with congenital heart disease. Dr Els Pieper, from the University Medical Centre in Groningen, the Netherlands, reviews the Dutch ZAHARA study and the new diseasespecific information it includes

THE ADULT POPULATION of patients with congenital heart disease (CHD) is growing rapidly as a result of progress in cardiologic and surgical interventions. At least a million women with CHD are alive in the western world and many of them wish to become pregnant. During pregnancy, plasma volume and cardiac output increase by 30-50%, while systemic vascular resistance is reduced. Thus, the circulatory burden of pregnancy may not be well tolerated in women with CHD. Relatively little data on this subject are available in the literature, although several have presented data at this Congress.

Previous research has indicated that women with CHD have an increased risk of cardiac complications – mainly arrhythmias and heart failure. Their offspring has a greater risk for premature delivery, intrauterine growth restriction and recurrence of congenital heart disease. Predictors of increased maternal risk are pre-pregnancy NYHA-class, cyanosis, left-sided obstructive heart disease, systemic ventricular ejection fraction <40%, heart failure, transient ischaemic attack/cerebrovascular accident or arrhythmia.

Predictors of an increased foetal risk are maternal NYHA-class and cyanosis, left-sided obstructive heart disease, smoking during pregnancy, use of anticoagulation, and multiple pregnancy (Siu SC, Circulation 2001). Pulmonary hypertension is also associated with an increased maternal and foetal risk, as the Buenos Aires group of Professor Vazquez Blanco described in their poster presentation on Sunday (P506).

Cardiac contraindications to pregnancy are severe pulmonary hypertension, severe obstructive lesions, class III/IV congestive heart failure and Marfan syndrome with aortic root >40 mm.

Recently the Dutch ZAHARA study (pregnancy in CHD study) has added a significant amount of disease-specific information to the literature. This study used the nationwide registry of patients with CHD in the Netherlands, called CONCOR. Unexpected findings from the study were the high cardiovascular complication rate (40%) in women with atrioventricular septal defects (in part attributable to worsening of left atrioventricular valve regurgitation) and the high incidence of pre-eclampsia in some patient groups. High miscarriage rates, high numbers of premature deliveries and of small for gestational age children, and high fetal/neonatal mortality were not restricted to complex CHD but also occurred in simple CHD. Fetal/neonatal mortality was related to premature delivery and to recurrence of CHD. At this Congress, several investigators have reported maternal mortality rates of 0-2% (R.Brooks, V. Stangl, L.Hudsmith).

On Sunday a Dutch study (FP 1092) reported the pooled data of 1302 completed (>20 weeks) pregnancies in 1802 women from the ZAHARA study, the largest series ever. In addition to the previously noted predictors for maternal complications, several others were identified: valvular regurgitation, use of cardiac medication, and presence of a mechanical prosthetic valve.

Valvular regurgitation

Because of the fall in systemic vascular resistance, valvular regurgitation has been regarded as relatively harmless for the mother. So it was surprising that in the ZAHARA study atrioventricular valve regurgitation predicted maternal cardiac complications, with a predictive power comparable to NYHA-class. However, left-sided obstructive valvular lesions are a more powerful predictor for cardiac complications in the ZAHARA study, and this is also illustrated in the presentation of Dr Stangl.

Fig.1: In women with simple atrial septal defect (ASD), pregnancy is usually well tolerated, but cardiac and neonatal complications occur more frequently than in healthy women. The outcome of 243 pregnancies in women with ASD was presented to the Congress by Dr S.C. Yap on behalf of the ZAHARA investigators. Illustration: J.P.M. Hamer

Thromboembolic complications

Pregnancy results in a hypercoagulable state. In our recent literature review of 2491 pregnancies, thromboembolic complications occurred in one out of every 50 pregnancies of women with CHD (normal rate is 1 per 1000-2000 pregnancies).

The hypercoagulable state poses an extra problem in women with a mechanical valve prosthesis. In the ZAHARA study, mechanical valve prosthesis predicted both maternal and neonatal complications. The literature reports maternal mortality of 3-4% in women with mechanical prosthetic valves. Continued use of oral anticoagulants throughout pregnancy is the safest regimen for the mother but has a high risk of fetal loss (±35%) and embryopathy (±6%, dose-dependent). Therefore, oral coagulants are often replaced by heparin from 6-12 weeks of pregnancy, but this results in a significantly increased number of (sometimes fatal) thromboembolic complications both with unfractionated and low-molecular-weight heparin.

Cardiac medication

The use of cardiac medication predicts a poorer outcome of pregnancy, both for the mother and the foetus. This is probably related more to a worse pre-pregnancy condition of the mother than to direct negative effects of the medication. Many cardiac medications are relatively safe for the fetus (diuretics, beta-blocking agents, digoxin); other medications must be avoided (ACE inhibitors). Both pre-pregnancy counselling and management of pregnant women with CHD continue to be a challenge to cardiologists and obstetricians. Prospective studies are needed to improve risk stratification and to elucidate the mechanisms responsible for maternal,obstetric and foetal/neonatal complications.

http://www.escardio.org/congresses/esc_congress/esc2007/news/pregnancy-women-congenital-heart-disease.htm

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Pregnancy in women with congenital heart disease: ZAHARA study finds unexpected rate of cardiovascular complications

先天性心脏病孕妇： ZAHARA研究发现心血管并发症发生率超出预料

There is relatively little known about pregnancy in women with congenital heart disease. Dr Els Pieper, from the University Medical Centre in Groningen, the Netherlands, reviews the Dutch ZAHARA study and the new diseasespecific information it includes

目前对先天性心脏病妇女伴有妊娠的了解相对较少。荷兰格罗宁根大学医学中心的Els Pieper医生回顾了荷兰ZAHARA研究和一些新的疾病谱信息。

THE ADULT POPULATION of patients with congenital heart disease (CHD) is growing rapidly as a result of progress in cardiologic and surgical interventions. At least a million women with CHD are alive in the western world and many of them wish to become pregnant. During pregnancy, plasma volume and cardiac output increase by 30-50%, while systemic vascular resistance is reduced. Thus, the circulatory burden of pregnancy may not be well tolerated in women with CHD. Relatively little data on this subject are available in the literature, although several have presented data at this Congress.

由于心脏病学和外科手术的发展，先天性心脏病 (CHD)的成年患者越来越多。在西方至少有100万CHD妇女存活，且她们当中的很多人都希望自己能怀孕。妊娠期间，血容量和心输出量增加30-50%，而全身血管阻力下降。因此，CHD妇女很难承受怀孕期间的循环负担。虽然本次会议上公布了一些数据，但文献当中关于这些患者的资料非常少。

Previous research has indicated that women with CHD have an increased risk of cardiac complications – mainly arrhythmias and heart failure. Their offspring has a greater risk for premature delivery, intrauterine growth restriction and recurrence of congenital heart disease. Predictors of increased maternal risk are pre-pregnancy NYHA-class, cyanosis, left-sided obstructive heart disease, systemic ventricular ejection fraction <40%, heart failure, transient ischaemic attack/cerebrovascular accident or arrhythmia.

以前的研究表明，CHD妇女发生心脏并发症的风险增高——主要是心律失常和心力衰竭。她们的孩子有较高的早产、宫内发育迟缓和先天性心脏病风险。与母体风险增加有关的预测因素有：孕前NYHA分级、紫绀、左侧梗阻性心脏病、射血分数<40%、心力衰竭、短暂性脑缺血发作/脑血管意外，或心律失常。

Predictors of an increased foetal risk are maternal NYHA-class and cyanosis, left-sided obstructive heart disease, smoking during pregnancy, use of anticoagulation, and multiple pregnancy (Siu SC, Circulation 2001). Pulmonary hypertension is also associated with an increased maternal and foetal risk, as the Buenos Aires group of Professor Vazquez Blanco described in their poster presentation on Sunday (P506).

与胎儿风险增加有关的预测因素有：母体NYHA分级、紫绀、左侧梗阻性心脏病、孕期吸烟史、使用抗凝药以及多次妊娠 (Siu SC, Circulation 2001)。肺动脉高压也会增加母体和胎儿风险， Vazquez Blanco 教授的布宜诺斯艾利斯小组已经在星期六进行了阐述。(P506)

Cardiac contraindications to pregnancy are severe pulmonary hypertension, severe obstructive lesions, class III/IV congestive heart failure and Marfan syndrome with aortic root >40 mm.

怀孕的心脏禁忌症包括严重肺动脉高压、严重梗阻性病变、心功能III/IV级的先天性心脏病和主动脉根部>40 mm的马凡氏综合征。

Recently the Dutch ZAHARA study (pregnancy in CHD study) has added a significant amount of disease-specific information to the literature. This study used the nationwide registry of patients with CHD in the Netherlands, called CONCOR. Unexpected findings from the study were the high cardiovascular complication rate (40%) in women with atrioventricular septal defects (in part attributable to worsening of left atrioventricular valve regurgitation) and the high incidence of pre-eclampsia in some patient groups. High miscarriage rates, high numbers of premature deliveries and of small for gestational age children, and high fetal/neonatal mortality were not restricted to complex CHD but also occurred in simple CHD. Fetal/neonatal mortality was related to premature delivery and to recurrence of CHD. At this Congress, several investigators have reported maternal mortality rates of 0-2% (R.Brooks, V. Stangl, L.Hudsmith).

最近荷兰 ZAHARA研究（CHD妊娠研究）在CHD妇女妊娠方面增加了大量疾病特异性资料。该研究纳入了荷兰CHD患者国家登记册，称为 CONCOR。研究结果出人意料，房室间隔缺损的女性患者心血管并发症的发生率高达40%（部分原因是左侧房室瓣反流加重），一些患者先兆子痫的发生率增加。高流产率、大量早产和小于胎龄儿、高胎儿/新生儿死亡率不仅限于复杂CHD，也可见于简单的CHD。胎儿/新生儿死亡率与早产和CHD再发有关。在本次大会上，几位研究者报道的产妇死亡率为0-2%。(R.Brooks, V. Stangl, L.Hudsmith).

On Sunday a Dutch study (FP 1092) reported the pooled data of 1302 completed (>20 weeks) pregnancies in 1802 women from the ZAHARA study, the largest series ever. In addition to the previously noted predictors for maternal complications, several others were identified: valvular regurgitation, use of cardiac medication, and presence of a mechanical prosthetic valve.

周六荷兰研究报道了最大的连续性研究即ZAHARA研究1802位妇女中1302位完成妊娠（>20周）的数据。除了强调以前研究认同的母体并发症预测因素外，又发现几个新的预测因素：瓣膜反流、使用心脏病药物、植入人工机械瓣。

Valvular regurgitation

瓣膜反流

Because of the fall in systemic vascular resistance, valvular regurgitation has been regarded as relatively harmless for the mother. So it was surprising that in the ZAHARA study atrioventricular valve regurgitation predicted maternal cardiac complications, with a predictive power comparable to NYHA-class. However, left-sided obstructive valvular lesions are a more powerful predictor for cardiac complications in the ZAHARA study, and this is also illustrated in the presentation of Dr Stangl.

由于全身血管阻力下降，瓣膜反流一直被认为对母体相对无害。因此，当 ZAHARA研究显示房室瓣反流可以预测母体心脏并发症，且预测力与NYHA分级相当时，令人非常震惊。然而，在 ZAHARA研究中，左侧梗阻性瓣膜病是更有力的心血管并发症预测因素，这也证明了Stangl博士的报告。

Fig.1: In women with simple atrial septal defect (ASD), pregnancy is usually well tolerated, but cardiac and neonatal complications occur more frequently than in healthy women. The outcome of 243 pregnancies in women with ASD was presented to the Congress by Dr S.C. Yap on behalf of the ZAHARA investigators. Illustration: J.P.M. Hamer

图1：单纯房间隔缺损（ASD）的女性通常对妊娠耐受良好，但心脏和新生儿并发症明显高于健康女性。 S.C. Yap博士代表 ZAHARA 研究的研究者在大会上报告了243名ASD妊娠妇女的研究结果。

Thromboembolic complications

血栓栓塞并发症

Pregnancy results in a hypercoagulable state. In our recent literature review of 2491 pregnancies, thromboembolic complications occurred in one out of every 50 pregnancies of women with CHD (normal rate is 1 per 1000-2000 pregnancies).

妊娠导致血液呈高凝状态。我们对2491位孕妇进行文献复习，血栓栓塞并发症在CHD孕妇中的发生率为1/50（正常孕妇的发生率为1/1000-2000）

The hypercoagulable state poses an extra problem in women with a mechanical valve prosthesis. In the ZAHARA study, mechanical valve prosthesis predicted both maternal and neonatal complications. The literature reports maternal mortality of 3-4% in women with mechanical prosthetic valves. Continued use of oral anticoagulants throughout pregnancy is the safest regimen for the mother but has a high risk of fetal loss (±35%) and embryopathy (±6%, dose-dependent). Therefore, oral coagulants are often replaced by heparin from 6-12 weeks of pregnancy, but this results in a significantly increased number of (sometimes fatal) thromboembolic complications both with unfractionated and low-molecular-weight heparin.

高凝状态给机械瓣膜妇女带来了麻烦。 ZAHARA 研究中，机械瓣对产妇和新生儿并发症均有预测价值。文献报道，机械瓣产妇的死亡率为3-4%。孕期持续使用口服抗凝药对母亲是最安全的策略，但会增加胎儿缺陷(±35%)和胚胎病(±6%，剂量依赖）的风险。因此，口服抗凝药通常在妊娠6-12周时被肝素替代，但肝素和低分子肝素都会使血栓栓塞并发症（有些是致命的）显著增加。

Cardiac medication

心脏病药物

The use of cardiac medication predicts a poorer outcome of pregnancy, both for the mother and the foetus. This is probably related more to a worse pre-pregnancy condition of the mother than to direct negative effects of the medication. Many cardiac medications are relatively safe for the fetus (diuretics, beta-blocking agents, digoxin); other medications must be avoided (ACE inhibitors). Both pre-pregnancy counselling and management of pregnant women with CHD continue to be a challenge to cardiologists and obstetricians. Prospective studies are needed to improve risk stratification and to elucidate the mechanisms responsible for maternal,obstetric and foetal/neonatal complications.

心脏病药物的使用预示着一个较差的妊娠结果，对母亲和胎儿都是如此。与药物副作用相比，这可能与母亲孕前状态较差更有关。许多心脏病药物对胎儿相对安全（利尿剂、beta阻滞剂、地高辛）；其他一些药物必须避免使用（ACE抑制剂）。CHD妇女的孕前咨询和孕期管理对心脏病医生和产科医生来说仍然是一个挑战。目前还需要前瞻性的研究来改善风险分层，阐明产妇和胎儿/新生儿并发症的机制。

编译：

ZAHARA研究：先天性心脏病孕妇的心血管并发症发生率超出预料

Dr Els Pieper

目前对先天性心脏病妇女伴有妊娠的了解相对较少。荷兰格罗宁根大学医学中心的Els Pieper医生回顾了荷兰ZAHARA研究和一些新的疾病谱信息。

由于心脏病学和外科手术的发展，先天性心脏病 (CHD)的成年患者越来越多。在西方至少有100万CHD妇女存活，且她们当中的很多人都希望自己能怀孕。妊娠期间，血容量和心输出量增加30-50%，而全身血管阻力下降。因此，CHD妇女很难承受怀孕期间的循环负担。虽然本次会议上公布了一些数据，但文献当中关于这些患者的资料非常少。

以前的研究表明，CHD妇女发生心脏并发症的风险增高——主要是心律失常和心力衰竭。她们的孩子有较高的早产、宫内发育迟缓和先天性心脏病风险。与母体风险增加有关的预测因素有：孕前NYHA分级、紫绀、左侧梗阻性心脏病、射血分数<40%、心力衰竭、短暂性脑缺血发作/脑血管意外，或心律失常。与胎儿风险增加有关的预测因素有：母体NYHA分级、紫绀、左侧梗阻性心脏病、孕期吸烟史、使用抗凝药以及多次妊娠 (Siu SC, Circulation 2001)。肺动脉高压也会增加母体和胎儿风险， Vazquez Blanco 教授的布宜诺斯艾利斯小组已经在星期六进行了阐述(P506)。怀孕的心脏禁忌症包括严重肺动脉高压、严重梗阻性病变、心功能III/IV级的先天性心脏病和主动脉根部>40 mm的马凡氏综合征。

最近荷兰 ZAHARA研究（CHD妊娠研究）在CHD妇女妊娠方面增加了大量疾病特异性资料。该研究纳入了荷兰CHD患者国家登记册，称为 CONCOR。研究结果出人意料，房室间隔缺损的女性患者心血管并发症的发生率高达40%（部分原因是左侧房室瓣反流加重），一些患者先兆子痫的发生率增加。高流产率、大量早产和小于胎龄儿、高胎儿/新生儿死亡率不仅限于复杂CHD，也可见于简单的CHD。胎儿/新生儿死亡率与早产和CHD再发有关。在本次大会上，几位研究者报道的产妇死亡率为0-2%(R.Brooks, V. Stangl, L.Hudsmith)。

周六荷兰研究报道了最大的连续性研究即ZAHARA研究1802位妇女中1302位完成妊娠（>20周）的数据。除了强调以前研究认同的母体并发症预测因素外，又发现几个新的预测因素：瓣膜反流、使用心脏病药物、植入人工机械瓣。

瓣膜反流

由于全身血管阻力下降，瓣膜反流一直被认为对母体相对无害。因此，当 ZAHARA研究显示房室瓣反流可以预测母体心脏并发症，且预测力与NYHA分级相当时，令人非常震惊。然而，在 ZAHARA研究中，左侧梗阻性瓣膜病是更有力的心血管并发症预测因素，这也证明了Stangl博士的报告。

图1：单纯房间隔缺损（ASD）的女性通常对妊娠耐受良好，但心脏和新生儿并发症明显高于健康女性。 S.C. Yap博士代表 ZAHARA 研究的研究者在大会上报告了243名ASD妊娠妇女的研究结果。

血栓栓塞并发症

妊娠导致血液呈高凝状态。我们对2491位孕妇进行文献复习，血栓栓塞并发症在CHD孕妇中的发生率为1/50（正常孕妇的发生率为1/1000-2000）。

高凝状态给机械瓣膜妇女带来了麻烦。 ZAHARA 研究中，机械瓣对产妇和新生儿并发症均有预测价值。文献报道，机械瓣产妇的死亡率为3-4%。孕期持续使用口服抗凝药对母亲是最安全的策略，但会增加胎儿缺陷(±35%)和胚胎病(±6%，剂量依赖）的风险。因此，口服抗凝药通常在妊娠6-12周时被肝素替代，但肝素和低分子肝素都会使血栓栓塞并发症（有些是致命的）显著增加。

心脏病药物

心脏病药物的使用预示着一个较差的妊娠结果，对母亲和胎儿都是如此。与药物副作用相比，这可能与母亲孕前状态较差更有关。许多心脏病药物对胎儿相对安全（利尿剂、beta阻滞剂、地高辛）；其他一些药物必须避免使用（ACE抑制剂）。CHD妇女的孕前咨询和孕期管理对心脏病医生和产科医生来说仍然是一个挑战。目前还需要前瞻性的研究来改善风险分层，阐明产妇和胎儿/新生儿并发症的机制。

终于翻完了，这篇文章好长啊，希望版主多加点分哟！

2007-09-27 15:11

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moreline 编辑于 2007-09-27 15:20

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2016-01-23 20:41

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