Day: 09/24/2012

Placenta accreta associated with submucosal fibroid polyp.

Posted by

0


  1. Papa Dasari

+ Author Affiliations

1.      JIPMER, Puducherry, India
  1. Correspondence to Papa Dasari, dasaripapa@gmail.com

Summary

A 35-year-old para 1, whose child birth was 5 years ago, was on barrier contraception and safe period. She was diagnosed to have a small submucosal posterior wall fibroid when she planned for her second child now. She conceived spontaneously during the next cycle after consultation. Her first trimester ultrasonography revealed placental implantation on the fibroid. She developed severe pre-eclampsia at 32 weeks of pregnancy and suffered from uncontrolled hypertension. and pulmonary oedema. Pregnancy was terminated at 33+4 weeks by elective lower segment caesarean section (LSCS) because of severe pre-eclampsia, pulmonary oedema and unfavourable cervix. At LSCS, placenta was found to be adherent to the pedunculated fibroid polyp which was removed by clamping, cutting and ligating the pedicle. Histopathological examination revealed placenta accreta and hyaline change of leiomyomatous polyp. Fetus was preterm, weighed 2.1 kg and survived.

Background

Complications are greater in cases of submucosal pedunculated intrauterine fibroid polyps associated with pregnancy. Adherent placenta is to be expected in cases of submucosal fibroid of uterus when placenta is seen anterior to it on ultrasonogram. Posterior wall fibroids may not be visualised in advanced pregnancy.

It is easy to remove the fibroid polyp at lower segment caesarean section (LSCS) and prevent the complications of postpartum haemorrhage and inversion which may result in case of vaginal birth.

Case presentation

A 35-year-old para 1 whose child birth was 5 years ago consulted for planning for second pregnancy. The couple were using male condom and safe period for contraception till she came for consultation. She gave history of menorrhagia (which did not make her anaemic) for the past 6 months . She was found to have a posterior wall fibroid of 3×2 cm size which appeared as submucosal in location on transvaginal ultrasound. She was advised to take folic acid tablet and was asked to return after 3 months if conception does not occur.

She conceived the following month after consultation. Her first trimester ultrasound showed posterior implantation with a single live fetus. The placenta was implanted posteriorly overlying the fibroid but there was an anechoic space between the placenta and the fibroid which was visualised up to second trimester (18 weeks scan) of pregnancy (figure 1). At 32 weeks, she developed severe pre-eclampsia and was hospitalised for the same at 32+3 days as her blood pressure (BP) was not controlled with tablet, –methyl Dopa given 500 mg 8 hourly on outpatient basis. She had severe pedal oedema extending up to knee joints. It was planned to manage her conservatively till 34 weeks of pregnancy and inj. Dexamethasone 6 mg was given intramuscularly 12 hourly for two doses for fetal lung maturity. She was also started on antioxidants, viz, vitamin A, vitamin C and vitamin E, along with sedatives. Five days after admission, that is, at 33+1 day she developed cough and difficulty in breathing. Respiratory system examination revealed fine crepitations. BP was within 150/100 mm of Hg. She was given injection Morphine and tab. Lasix 40 mg 8 hourly with which she had partial relief from dyspnoea. After 2 days the BP was on the rise >160/100 mm Hg and her output started decreasing and a decision to terminate pregnancy was taken. She was decided for elective LSCS in view of pulmonary oedema and unfavourable cervix at 33+4 weeks of gestation. On the operation table, her BP was 170/105 mm of Hg and there were bilateral crepitations. Oxygen saturation was 89%, hence LSCS was done under general anaesthesia with careful fluid administration, and injection magnesium sulphate was started prophylactically soon after the surgery. At surgery, the lower segment was not well formed and the fetal head was high floating and hence delivered with the help of forceps. The liquor was meconium stained and the placenta could not be removed by controlled cord traction though signs of placental separation were present. On intrauterine examination, the placenta was found to be adherent to the posterior wall and hence it was attempted to remove manually. When it was being removed, the upper part of the placenta was found to be attached to the posterior uterine wall by a pedunculated firm structure which was clamped cut and ligated with No-1 vicryl. After removal it was recognised to be the fibroid polyp of 3×4 cm on which the placenta was implanted. Placenta along with polyp was sent for histopathological examination. Uterine incision was closed in two layers with No-1 vicryl, and tubectomy was performed as per the patient’s wish. Fetus was preterm, alive with an Apgar of 6/10 at 1 min and 8/10 at 5 min and weighed 2.1 kg.

She was monitored in RICU (respiratory intensive care unit) and was on continuous oxygen by mask. She developed hypertensive crisis which was controlled by inj. Labetalol for 24 h. Magnesium sulphate was discontinued after 24 h. She was shifted out of RICU after 36 h when she maintained Sp O2 of 96% with room air. She was started on tab. Amlodepine 5 mg twice daily after the Physician’s opinion. She was discharged on the 8th postoperative day along with the baby and advised to continue the antihypertensives for 2 weeks.

Investigations

Her complete haemogram performed after admission at 33 weeks of gestation was normal except for low platelet counts of 156 000/mm3. Renal function, liver function tests and glucose tolerance test were normal. Fundus examination showed grade I hypertensive changes. Ultrasonography (USG) at 32+4 weeks showed biometry corresponding to 31 weeks with estimated fetal weight of 1.8 kg. Placenta was posterior and the fibroid could not be visualised properly at this time. Amniotic fluid index was 16 cm.

The histopathological examination of placenta with polyp was reported as leiomyomatous polyp with hyaline change and placenta accreta

Treatment

  • ▶ Injection Dexamethasone for fetal lung maturity.
  • ▶ Antihypertensives for pre-eclampsia.
  • ▶ Prophylactic magnesium sulphate for imminent eclampsia.
  • ▶ Inj. Morphine and Lasix for pulmonary oedema.
  • ▶ LSCS polypectomy with bilateral tubectomy.

Outcome and follow-up

Normal at 6weeks.

Discussion

Fibroids are diagnosed in 4–5% of women undergoing prenatal ultrasound. Submucosal fibroids are the least common type of uterine fibroids (5%) and the pedunculated type account for only 2.5%.1 Uterine fibroid polyps (pedunculated submucous fibroids) can interfere with implantation causing infertility or they can cause miscarriage or preterm labour. The outcome of a pregnancy in a case of submucosal posterior wall fibroid is reported here.

The symptoms of submucous fibroids include abnormal uterine bleeding (most often menorrhagia, less commonly metrorrhagia), pain lower abdomen, dysmenorrhoea and increased vaginal discharge. Rarely they prolapse out of cervix into the vagina and occasionally cause inversion of uterus. This case was, however, asymptomatic except for mild menorrhagia (which did not make her anaemic). Hysteroscopic myomectomy is feasible and effective for submucous fibroids and it should be considered in women with intracavitary submucous fibroids suffering from infertility, pregnancy loss and abnormal uterine bleeding.2 But hysteroscopic myomectomy is associated with significant complications like bleeding, perforation, burns, electrolyte imbalance, possibility of hysterectomy and even death. Data describing the fertility and pregnancy outcomes following hysteroscopic myomectomy is limited.3 A pregnancy rate of 60% was reported in patients with infertility after hysteroscopic myomectomy.4 In this case, hysteroscopic resection was not considered as she was asymptomatic. A prospective study which assessed the positional affect of fibroids on pregnancy rates revealed 43.3% pregnancy rate in patients with submucosal fibroids who underwent myomectomy compared to 27.2% in those who did not undergo surgery.5 The affect of submucosal fibroids may not be purely positional as it was found that polyps and leiomyomas produce excess glycodelin, a glycoprotein, in the uterus which impairs fertilisation and implantation.6

Pregnancy has a variable and unpredictable effect on myoma growth, majority do not increase and in those that grow, the greatest growth usually occurs before 10 weeks of gestation.7 The pregnancy outcome differs from those who do not have fibroid only in the rate of caesarean section, which was significantly higher in those with fibroid uterus.8 Although most pregnancies are unaffected by fibroids, large submucosal and retroplacental fibroids seem to impart greater risk for complications including degeneration, abruptio placentae, preterm labour and delivery.9 This case did not suffer from abruptio placentae despite pre-eclampsia, and the fibroid polyp underwent degeneration without significant growth. However, adherent placenta was the result because of its implantation on the fibroid polyp. Submucosal fibroids have long been recognised as one of the causes for placenta accreta as mentioned by Fox.10 Both hyaline degeneration and placenta accreta were evident in this case.

The sonographic appearance of myomas is generally characteristic but as they can undergo various kinds of degeneration, the sonographic appearance can vary mimicking other cystic conditions. MRI is more accurate and specific in diagnosing the various changes that occur in a fibroid.11 The fibroid could not be visualised during the later half of pregnancy by USG in this case because of its posterior location and it’s small size and most probably because of hyaline degenerative change reported on histopathological examination. MRI would have been useful in delineating the fibroid in such a situation.

The pedicle could be easily felt on the posterior wall of the uppersegment and clamped and ligated at LSCS in this case. If she had a vaginal delivery, retained placenta with primary postpartum haemorrhage (PPH) would have been the result as there is partial adherence of placenta, that is, on the polyp, and attempts at manual removal would not be successful because of pedunculated polyp and she would have required a laparotomy for the same. A case of pedunculated submucosal myoma that prolapsed during 26 weeks of pregnancy causing preterm labour was reported to be successfully managed by vaginal myomectomy.12 Postnatal complications of pedunculated uterine polyp include PPH, infection, necrosis, prolapse of the polyp and inversion of uterus if the polyp is large. A case of pedunculated submucosal fibroid of lower segment causing PPH is recently reported13 and two cases of infection and necrosis and prolapse were reported in older literature.14

This case illustrates the outcome of pregnancy when the placenta is implanted on the submucosal pedunculated fibroid polyp. Placenta accreta and hyaline change of the fibroid polyp were the outcome. Postpartum haemorrhage and inversion of uterus were prevented in this case because of recognition and prompt action in removing the adherent placenta along with fibroid polyp at LSCS.

Learning points

  • ▶ Placenta can get implanted on the pedunculated submucosal fibroid and can become morbidly adherent.
  • ▶ Fibroid polyp can undergo degenerative change during pregnancy.
  • ▶ Posterior submucous fibroids may not be visualised during late pregnancy.
  • ▶ Pedunculated submucosal fibroids can safely be removed at caesarean section.
  • Competing interests None.
  • Patient consent Obtained.

Footnotes

References

  1. ↵
    1. Panageas E,
    2. Kier R,
    3. McCauley TR,
    4. et al

. Submucosal uterine leiomyomas: diagnosis of prolapse into the cervix and vagina based on MR imaging. AJR Am J Roentgenol 1992;:555–8.

[Abstract/FREE Full text]

  1. ↵
    1. Lefebvre G,
    2. Vilos G,
    3. Allaire C,
    4. et al

. The management of uterine leiomyomas. SOGC clinical practice guidelines. No. 128. J Obstet Gynaecol Can 2003;:396–405.

[Medline]

  1. ↵
    1. Goldenberg M,
    2. Sivan E,
    3. Sharabi Z,
    4. et al

. Outcome of hysteroscopic resection of submucous myomas for infertility. Fertil Steril 1995;:714–16.

[Medline][Web of Science]

  1. ↵
    1. Ubaldi F,
    2. Tournaye H,
    3. Camus M,
    4. et al

. Fertility after hysteroscopic myomectomy. Hum Reprod Update 1995;:81–90.

[Abstract/FREE Full text]

  1. ↵
    1. Casini ML,
    2. Rossi F,
    3. Agostini R,
    4. et al

. Effects of the position of fibroids on fertility. Gynecol Endocrinol 2006;:106–9.

[CrossRef][Medline][Web of Science]

  1. ↵
    1. Richlin SS,
    2. Ramachandran S,
    3. Shanti A,
    4. et al

. Glycodelin levels in uterine flushings and in plasma of patients with leiomyomas and polyps: implications for implantation. Hum Reprod 2002;:2742–7.

[Abstract/FREE Full text]

  1. ↵
    1. Rosatti P,
    2. Exacoustous C,
    3. Mancuso S

. Longitudinal evaluation of myoma growth during pregnancy. A sonographic study. J Ultrasound Med 1992;:511–15.

[Abstract]

  1. ↵
    1. Qidwai GI,
    2. Caughey AB,
    3. Jacoby AF

. Obstetric outcomes in women with sonographically identified uterine leiomyomata. Obstet Gynecol 2006;:376–82.

[Medline][Web of Science]

  1. ↵
    1. Ouyanq DW,
    2. Economy KE,
    3. Norwitz ER

. Obstetric complications of fibroids. Obstet Gynecol Clin North Am 2006;:153–69.

[CrossRef][Medline][Web of Science]

  1. ↵
    1. Fox H

. Placenta accreta- review. Obstet Gynecol Survey 1972;:475.

Search Google Scholar

  1. ↵
    1. Reddy NM,
    2. Jain KA,
    3. Gerscovich EO

. A degenerating cystic uterine fibroid mimicking an endometrioma on sonography. J Ultrasound Med 2003;:973–6.

[FREE Full text]

  1. ↵
    1. Demirci F,
    2. Somunkiran A,
    3. Safak AA,
    4. et al

. Vaginal removal of prolapsed pedunculated submucosal myoma during pregnancy. Adv Ther 2007;:903–6.

[CrossRef][Medline][Web of Science]

  1. ↵
    1. Adaji SE,
    2. Shittu SO,
    3. Ageda BR

. A huge polypoid uterine myoma causing severe post-partum haemorrhage. A report of one case. Niger J Surg Res 2005;:220–1.

Search Google Scholar

  1. ↵
    1. Buckle AE

. The dangerous submucous uterine myoma. Postgrad Med J 1965;:146–8.

[FREE Full text]

Source: BMJ

 

Risk of preterm birth after treatment for cervical intraepithelial neoplasia among women attending colposcopy in England: retrospective-prospective cohort study.

Posted by

0


Abstract

Objective To explore the association between preterm delivery and treatment at colposcopy.

Design Retrospective-prospective cohort study using record linkage.

Setting 12 National Health Service hospitals in England.

Participants Women who had a cervical histology sample taken between 1987 and 2009. These women were linked by hospital episode statistics to hospital obstetric records between 1998 and 2009 for the whole of England to identify singleton live births between 20-43 gestational weeks before or after cervical histology.

Main outcome measures Proportion of preterm births (<37 weeks); the relative risk for the strength of association between preterm births and treatment for cervical intraepithelial neoplasia.

Results 18 441 singleton births occurred: 4176 before histology and 14 265 after histology. Of the singleton births after histology, 9.0% (n=1284) were preterm compared with 6.7% of all births in England over the same period (excess risk 2.3 per 100 births, 95% confidence interval 1.8% to 2.8%). Among first births after histology, the adjusted relative risk associated with previous treatment was 1.19 (95% confidence interval 1.01 to 1.41); among first births before histology the relative risk associated with subsequent treatment was 1.47 (1.05 to 2.05). Combining these, the relative risk associated with treatment adjusted for timing relative to histology was 0.91 (0.66 to 1.26) corresponding to an absolute difference of −0.25 (−2.61 to 2.11) per 100 singleton births. Among 372 women who gave birth both before and after treatment, there were 30 preterm births after treatment and 32 before treatment (relative risk 0.94, 0.62 to 1.43).

Conclusion The risk of preterm delivery in women treated by colposcopy in England was substantially less than that in many other studies, predominantly from Nordic countries. The increased risk may be a consequence of confounding and not caused by treatment. Although this study is reassuring for large loop excision of the transformation zone overall, it is possible that deep conisation or repeated treatment leads to an increased risk of preterm delivery.

Source: BMJ.

 

 

Do not forget about HELLP.

Posted by

0


Summary

A 32-year-old female para 4 gravi 3, who was 21 weeks pregnant, presented to the emergency department (ED) with a 2-day history of abdominal pain, headache, blurred vision and vomiting. On arrival, she was agitated and confused with a blood pressure 162/106 mm Hg, pulse rate 107, respiratory rate 18, temperature 37 degrees Celsius, point of care blood glucose 6.2 and her Glasgow coma scale was 13/15 M6V4E3. Paramedics witnessed seizure-like activity lasting <1 min during transport. A diagnosis of eclampsia complicated by the HELLP syndrome (haemolysis, elevated liver enzymes, low platelets count) was made. She was commenced on magnesium and labetalol intravenously for blood pressure control. Initial blood test results were consistent with the HELLP syndrome. Recognition of the HELLP syndrome with prompt management of blood pressure and clotting abnormalities is essential in the ED setting. An aggressive multidisciplinary approach is a key to optimise the prognosis for mother and fetus.

Background

HELLP (haemolysis, elevated liver enzymes, low platelets count) syndrome is a multisystem disease that is characterised by microangiopathic haemolytic anaemia, hepatic dysfunction and thrombocytopenia. It was first described by Weinstein in 1982.1 It has a high maternal and perinatal morbidity and mortality. Its incidence is reported as 0.2%–0.6% of all pregnancies, and 10%–20% of women with co-morbid pre-eclampsia. HELLP usually begins during the third trimester, and usually in Caucasian women over the age of 25.2 Prompt recognition of HELLP syndrome and timely initiation of therapy are vital to ensure the best outcome for mother and fetus.

Case presentation

A 32-year-old female para 4 gravi 3, who was 21 weeks pregnant, presented to the emergency department (ED) with a 2-day history of abdominal pain, headache, blurred vision and vomiting. Her mother stated that earlier in the day she had an episode consistent with seizure-like activity. Medical and family history was unremarkable.

On arrival, she was agitated and confused with a blood pressure 162/106, pulse rate 107, respiratory rate 18, temperature 37 degrees Celsius, point of care blood glucose 6.2 and her Glasgow coma scale was 13/15 M6V4E3. Paramedics witnessed seizure-like activity lasting <1 min during transport. Primary survey revealed that her chest was clear, heart sounds normal and abdomen was soft and non-tender with a palpable uterus rising just below the umbilicus. She had no per vaginal bleeding. She was icteric and had evidence of tongue biting. A urine dipstick revealed protein 4+.

An initial working diagnosis of eclampsia complicated by the HELLP syndrome was made. She was commenced on magnesium and labetalol intravenously for blood pressure control. Initial blood test results were consistent with the HELLP syndrome (table 1).

View this table:

Table 1

Initial blood test results

She was transfused two pools of platelets and transferred to an obstetric centre. She was treated conservatively for 24 h; unfortunately she miscarried the following day. Day 1 post spontaneous abortion, the labetalol and magnesium were discontinued.

Discussion

HELLP syndrome is a multisystem disease that is characterised by microangiopathic haemolytic anaemia, hepatic dysfunction and thrombocytopenia. It was first described by Weinstein in 1982.1 It has a high maternal and perinatal morbidity and mortality. Its incidence is reported as 0.2%–0.6% of all pregnancies, and 10%–20% of women with co-morbid pre-eclampsia. HELLP usually begins during the third trimester, and usually in Caucasian women over the age of 25.2

The aetiology and pathogenesis of HELLP syndrome remains unclear. Van Beek et al postulate that abnormal placentation results in placental ischaemia and the production of a circulating toxin that causes endothelial cell injury.3 The injury is believed to cause vascular constriction within multiple organ systems, activation of the coagulation system, increased capillary permeability and platelet activation with platelet consumption in the microvasculature, all resulting in hypertension, proteinuria, oedema and thrombocytopaenia.

Prompt recognition of HELLP syndrome and timely initiation of therapy are vital to ensure the best outcome for mother and fetus. When the syndrome was first described, prompt delivery was recommended.4 Recent research suggests that morbidity and mortality do not increase when patients with HELLP are treated conservatively. Patients with HELLP syndrome may be eligible for conservative management if hypertension is controlled at less than 160/110 mm Hg, oliguria responds to fluid management and elevated liver function values are not associated with right upper quadrant or epigastric pain. One study found that pregnancy was prolonged by an average of 15 days when conservative management (i.e., bed rest, fluids and close observation) was used in patients who were at less than 32 weeks of gestation.4 Maternal morbidity was not increased. For infants, the prolongation of pregnancy translated into less time in the neonatal intensive care unit, a decreased incidence of necrotising enterocolitis and a decreased incidence of respiratory distress syndrome.4 Females treated conservatively should be managed in a tertiary care centre that has a neonatal intensive care unit and a perinatologist available for consultation. Patients with HELLP syndrome should be treated prophylactically with magnesium sulphate to prevent seizures, whether hypertension is present or not. A bolus of 4 to 6 g of magnesium sulphate as a 20 percent solution is given initially. This dose is followed by a maintenance infusion of 2 g per h. The infusion should be titrated to urine output and magnesium level. Patients should be observed for signs and symptoms of magnesium toxicity. If toxicity occurs, 10 to 20 ml of 10 percent calcium gluconate should be given intravenously.

Antihypertensive therapy should be initiated if blood pressure is consistently greater than 160/110 mm Hg despite the use of magnesium sulphate. This reduces the risk of maternal cerebral haemorrhage, placental abruption and seizure. The goal is to maintain diastolic blood pressure between 90 and 100 mm Hg. Patients who have had HELLP syndrome should be counselled that they have a 19 to 27 per cent risk of developing the syndrome in subsequent pregnancies. They also have up to a 43 per cent risk of developing preeclampsia in another pregnancy.5

Recognition of the HELLP syndrome with prompt management of blood pressure and clotting abnormalities is essential in the ED setting. An aggressive multidisciplinary approach is a key to optimise the prognosis for mother and fetus. This case report highlights the need for vigilance regarding HELLP recognition in the ED setting.

Learning points

  • ▶ HELLP syndrome is a multisystem disease that is characterised by microangiopathic haemolytic anaemia, hepatic dysfunction and thrombocytopenia.
  • ▶ An aggressive multidisciplinary approach is a key to optimise the prognosis for mother and fetus.
  • ▶ Recognition of the HELLP syndrome with prompt management of blood pressure and clotting abnormalities is essential in the ED setting.
  • Competing interests None.
  • Patient consent Obtained.

Footnotes

References

  1. ↵
    1. Weinstein L

. Syndrome of hemolysis, elevated liver enzymes, and low platelet count: a severe consequence of hypertension in pregnancy. Am J Obstet Gynecol 1982;:159–67.

[Medline][Web of Science]

  1. ↵
    1. Sibai BM,
    2. Ramadan MK,
    3. Usta I,
    4. et al

. Maternal morbidity and mortality in 442 pregnancies with hemolysis, elevated liver enzymes, and low platelets (HELLP syndrome). Am J Obstet Gynecol 1993;:1000–6.

[Medline][Web of Science]

  1. ↵
    1. Van Beck E,
    2. Peeters LL

. Pathogenesis of preeclampsia: a comprehensive model. Obstet Gynecol Surv 1998;:233–9.

[CrossRef][Medline]

  1. ↵
    1. Visser W,
    2. Wallenburg HC

. Temporising management of severe pre-eclampsia with and without the HELLP syndrome. Br J Obstet Gynaecol 1995;:111–7.

[CrossRef][Medline]

  1. ↵
    1. Sibai BM,
    2. Taslimi MM,
    3. el-Nazer A,
    4. et al

. Maternal-perinatal outcome associated with the syndrome of hemolysis, elevated liver enzymes, and low platelets in severe preeclampsia-eclampsia. Am J Obstet Gynecol 1986;:501–9.

[Medline][Web of Science]

 

Source: BMJ

 

 

 

Sugar-Sweetened Soft Drinks Contribute Significantly to Weight Gain .

Posted by

0


Three New England Journal of Medicine studies on the consumption of sugar-sweetened beverages suggest that the drinks have an important role in the risk for obesity.

One study, in a large cohort of initially nonobese adults, looked at patterns of drink consumption and their relation to subjects’ genetic predisposition to obesity. Researchers found that incident obesity increased with increasing drink consumption within the same level of genetic risk; similarly, obesity increased with increasing genetic risk within the same level of consumption.

Two other studies examined the effects of replacing sugar-sweetened drinks with sugar-free drinks, one in normal-weight children and the other in adolescents who were overweight or obese. Among normal-weight children, those randomized to one masked sugar-free drink/day for 18 months gained significantly less weight and body fat, compared with those randomized to a sugar-containing drink. Among overweight adolescents, a 1-year intervention aimed at reducing sugary drink consumption lowered gains in BMI at 1 year, but not at 2 years, relative to controls.

An editorialist says that the studies “provide a strong impetus to develop recommendations and policy decisions to limit consumption of sugar-sweetened beverages.”

Source: NEJM

Results from Novartis Phase III study show that RLX030 reduced deaths in patients with acute heart failure.

Posted by

0


  • RELAX-AHF study met one of its two primary endpoints in reducing dyspnea or shortness of breath, and showed RLX030 (serelaxin) was well tolerated[1]
  • Six-month study shows that investigational RLX030 reduced all-cause mortality in patients with acute heart failure (AHF)[1]
  • Results of single Phase III clinical trial to be discussed with health authorities worldwide
  • RELAX-AHF data will be presented at American Heart Association congress in November

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with acute heart failure (AHF)[1]. The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases[2].

 

The study had two primary endpoints using different scales to measure reduction in dyspnea, only one of which reached statistical significance[1]. Dyspnea, or shortness of breath, is the most common symptom of AHF[3]. RLX030 was well tolerated in the study[1].

 

RELAX-AHF was a Phase III clinical trial to investigate the efficacy and safety of RLX030 for the treatment of AHF. It was a randomized, double-blind, placebo-controlled study involving 1,161 patients in 11 countries[1]. In the study, RLX030 was given on admission to the hospital in the form of an intravenous infusion for up to 48 hours in addition to loop diuretics and other medicines and was compared to placebo on top of standard of care treatment for AHF[4],[5].

 

The study will be presented at the American Heart Association (AHA) congress in Los Angeles in November, 2012. Novartis will initiate discussions of the results of this single Phase III study with health authorities worldwide shortly.

 

Heart failure is a disease in which the heart is unable to supply enough blood to meet the body’s needs[6],[7]. Around half of all patients die within five years of diagnosis[8], particularly as a result of acute episodes in which their symptoms suddenly become worse and urgent hospital treatment is needed[6]. Acute heart failure (AHF) places an enormous burden on healthcare systems and accounts for around two million hospitalizations each year in the EU and US[9].

 

RLX030 is the first in a new class of medicines and is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women[10]. In women, levels of relaxin-2 rise to support important physiological changes during pregnancy[10]. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women[11].

References

1. Novartis Pharma AG. Data on file.

2. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke Statistics – 2011 Update. A Report From the American Heart Association. Circulation. 2011;123:e18-e209.

3. Goldberg RJ, Spencer FA, Szklo-Coxe M, et al. Symptom presentation in patients hospitalized with acute heart failure. Clin Cardiol. 2010;33:e73-80.

4. Clinicaltrials.gov: Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF). http://clinicaltrials.gov/ct2/show/NCT00520806; Accessed September 2012.

5. Ponikowski P, Metra M, Teerlink JR, et al. Design of the RELAXin in Acute Heart Failure Study. Am Heart J. 2012;163:149-55.

6. McMurray JJV, Adamopoulos S, Anker SD, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012;33:1787-1847.

7. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;53:e1-90.

8. Roger VL, Lloyd-Jones DM, Benjamin EJ, et al. Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation. 2012;125:e2-e220.

9. Opportunity Assessment for Relaxin in Acute Heart Failure, Decision Resources. Oct 2010.

10 Dschietzig T, Bartsch C, Baumann G, et al. Relaxin – a pleiotropic hormone and its emerging role for experimental and clinical therapeutics. Pharmacol Therap. 2006;112:38-56.

11. Conrad KP. Unveiling the vasodilatory actions and mechanisms of relaxin. Hypertension. 2010;56:2-9.

Source: Novartis Newsletter.

 

The misapplication of the term spinal cord injury without radiographic abnormality (SCIWORA) in adults.

Posted by

0


Como JJ et al. – Spinal cord injury without computed tomography evidence of trauma (SCIWOCTET) is mainly a disease of adults, and its subset Spinal cord injury without radiographic abnormality (SCIWORA), a disease of children, is much less common. Adults with this disease have computed tomographic (CT) scans showing canal stenosis and significant degenerative changes in the cervical spine; thus, it is not accurate to state that they have SCIWORA. The characteristics of this patient population are important as SCIWOCTET is the concern when clearing the cervical spines of trauma patients with a CT scan of the cervical spine negative for injury.

Source: Journal of Trauma