Comment
In summary, Xie and colleagues’ systematic review4 provides strong evidence that intensive blood pressure reduction is more beneficial than less intensive blood pressure reduction. This finding will pave the way for the treatment of a large number of additional patients compared with the number treated at present. About a third of all excess cardiovascular mortality attributable to increased blood pressure is within the normotensive range.8 Hence, with the numbers needed to treat presented by Xie and colleagues (94 for high-risk patients and 186 for all other included patients), this finding will be of great interest from the point of view of public health, and probably beneficial from a health economic perspective. The results of this review will probably be supported further by forthcoming results from the Systolic Blood Pressure Intervention Trial (SPRINT).9 SPRINT had a similar design to the trials included in Xie and colleagues’ meta-analysis,4 with the addition of around 9000 more patients, with moderately raised blood pressure (systolic blood pressure >130 mm Hg) and increased cardiovascular risk, to the 44 989 analysed here. Although the evidence seems to be convincing, including studies from different populations in a meta-analysis does not mean that the overall results can be applied to all included populations. In particular, it is not yet obvious that patients with diabetes mellitus, or very elderly patients, will benefit from lower treatment targets than the recommended goal of lower than 140/90 mm Hg. Thus, the definition of
new blood pressure treatment targets will not be an easy task, in terms of comorbidity and a specific mm Hg target. Mattias Brunström, *Bo Carlberg Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University, SE-901 85 Umeå, Sweden [email protected] We declare no competing interests. 1
2
3
4
5
6 7
8 9
Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2013; 31: 1281–357. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the eighth Joint National Committee (JNC 8). JAMA 2014; 311: 507–20. Cushman WC, Evans GW, Byington RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010; 362: 1575–85. Xie X, Atkins E, Lv J, et al. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet 2015; published online Nov 6. http://dx.doi. org/10.1016/S0140-6736(15)00805-3. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure lowering on outcome incidence in hypertension: 2. Effects at different baseline and achieved blood pressure levels—overview and meta-analyses of randomized trials. J Hypertens 2014; 32: 2296–304. American Diabetes Association. Cardiovascular disease and risk management. Diabetes Care 2015; 38 (suppl): S49–57. Stearne MR, Palmer SL, Hammersley MS, et al. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703–13. Stamler J, Stamler R, Neaton JD. Blood pressure, systolic and diastolic, and cardiovascular risk. Arch Intern Med 1993; 153: 598–615. US National Heart, Lung, and Blood Institute. Landmark NIH study shows intensive blood pressure management may save lives. Sept 11, 2015. http://www.nhlbi.nih.gov/news/press-releases/2015/landmark-nih-studyshows-intensive-blood-pressure-management-may-save-lives (accessed Nov 2, 2015).
Late preterm rupture of membranes: it pays to wait Published Online November 9, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)00809-0 See Articles page 444
406
In contrast to previous assumptions, there is increasing evidence that being born in the late preterm period— between 34 and 36 weeks gestation—is associated with important long-term adverse effects. Several adverse outcomes have been reported, including cerebral palsy, more hospital admissions in early childhood, lower childhood height, asthma, limiting long-term illness, and poorer educational attainment.1–3 Findings from studies show a gradient of health outcomes with decreasing gestation.1 An estimated 4–5% of infants are born at 34–36 weeks,2,3 and 30% of preterm births follow prelabour rupture of the membranes.4 Because of the potential risks of fetal and neonatal infection—although with limited evidence to support this assumption— present guidance favours planned early delivery in women
presenting with ruptured membranes at 34–36 weeks.5,6 With the emerging evidence of differences in long-term outcomes between late preterm and term infants, robust assessment of the risks and benefits of this strategy is essential, because a small increase in gestation at birth is likely to be beneficial to the infant. In The Lancet, Jonathan Morris and colleagues7 present the results of a pragmatic randomised controlled trial of planned immediate delivery versus expectant management in women presenting with pre-labour ruptured membranes at 34–36 weeks. Findings from this trial advance substantially the evidence on the optimum management strategy in these women. 1839 women in whom there was no indication for urgent delivery were randomly assigned to immediate delivery (n=924) or www.thelancet.com Vol 387 January 30, 2016
expectant management (n=915). There was no difference in the primary outcome of definite or probable neonatal sepsis between neonates in the immediate birth and expectant management groups (23 [2%] of 923 vs 29 [3%] of 912; relative risk [RR] 0·8, 95% CI 0·5–1·3). Additionally, there was no difference between groups in a secondary composite neonatal outcome of sepsis, ventilation for 24 h or more, or death (73 [8%] of 923 in the immediate delivery group vs 61 [7%] of 911 in the expectant management group; RR 1·2, 95% CI 0·9–1·6). Infants of women assigned to planned immediate delivery had a significantly higher risk of respiratory distress syndrome (76 [8%] of 919 vs 47 [5%] of 910; RR 1·6, 95% CI 1·1–2·3) and mechanical ventilation (114 [12%] of 923 vs 83 [9%] of 912; 1·4, 1·0–1·8) compared with those whose mothers were assigned to expectant management. These infants also had a significantly longer stay in a special care nursery or neonatal intensive care unit (median 4·0 days, IQR 0·0–10·0 vs 2·0 days, 0·0–7·0) and a longer total hospital stay (6·0 days, 3·0–10·0 vs 4·0 days, 3·0–8·0). However, in contrast to their infants, mothers in the expectant management group had a longer hospital stay than mothers who were assigned to planned immediate delivery (median 6·0 days, IQR 4·0–9·0 vs 5·0 days, 3·0–7·0), owing to the fact that most women in the expectant group were managed in hospital and were not discharged home to await the onset of labour. Almost 90% of women randomly assigned to expectant management received antibiotics before delivery, but this was not universal despite clear evidence of benefit.8 Also, a planned subgroup analysis of women who had group B streptococcus cultured from a vaginal swab showed no difference in the primary outcome of neonatal sepsis between the groups (RR 0·9, 95% CI 0·2–4·5). The main strength of Morris and colleagues’ study7 is its size; previous meta-analyses included a total of only 1230 infants.9,10 However, a concern associated with the present study is the time taken to recruit sufficient women—10 years. Patterns of obstetric care are unlikely to have changed sufficiently over that time to have a major effect on the study’s results, but preferences for antibiotic use will have changed in view of the findings of the ORACLE II trial11 and the association identified between maternal co-amoxiclav and necrotising enterocolitis.8 Morris and colleagues’ trial7 adopted a pragmatic approach to management within the expectant group, www.thelancet.com Vol 387 January 30, 2016
ERproductions Ltd/Blend Images/Corbis
Comment
allowing women to be cared for according to the usual practice of the recruiting centre. Therefore, management was varied, as shown by the fact that some women were treated at home, and laboratory testing and antibiotic prescription were not universal. This variation might have affected outcomes, but one could argue that it enhanced the generalisability of the results. However, women were recruited at 65 centres in 11 countries, and major differences in the respective maternity care systems should be considered when interpreting the results for practice in individual countries. What then do we still need to know? The investigators speculate that their findings will be associated with economic as well as health benefits,7 but in view of the reciprocity of length of stay data between mothers and infants in the two groups, this clearly needs formal assessment. Any economic benefit will be affected by variation in home versus hospital expectant management, the relative risks and benefits of which are unclear.12 The prolongation of pregnancy achieved with expectant delivery was small—will this translate into longer-term health and educational benefits for infants? Even small differences are likely to be important on a population basis, but still should be robustly examined. Additionally, to enhance the safety of expectant management, research must continue to be done to understand the effects of the inflammatory process on the fetal brain and on improving the detection of chorioamnionitis. The prevailing orthodoxy in obstetric practice, despite the emerging evidence on long-term outcomes, is to 407
Comment
have a low threshold for delivery in the face of obstetric problems between 34 and 36 weeks, on the basis that neonatal outcome is uncompromised. Morris and colleagues’ trial7 fundamentally challenges this thinking in the area of late preterm pre-labour rupture of membranes, and, even with the caveats noted, this new evidence suggests an urgent need for reassessment of present recommendations regarding immediate delivery of women with ruptured membranes close to term.
3 4 5
6 7
8
*Marian Knight, David Churchill National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK (MK); and New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK (DC) [email protected] We declare no competing interests. 1
2
Boyle EM, Poulsen G, Field DJ, et al. Effects of gestational age at birth on health outcomes at 3 and 5 years of age: population based cohort study. BMJ 2012; 344: e896. Chan E, Quigley MA. School performance at age 7 years in late preterm and early term birth: a cohort study. Arch Dis Child Fetal Neonatal Ed 2014; 99: F451–57.
9
10
11
12
Moster D, Lie RT, Markestad T. Long-term medical and social consequences of preterm birth. N Engl J Med 2008; 359: 262–73. Goldenberg RL, Rouse DJ. Prevention of premature birth. N Engl J Med 1998; 339: 313–20. American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Obstetrics. Practice bulletins no. 139: premature rupture of membranes. Obstet Gynecol 2013; 122: 918–30. Carroll S. Preterm prelabour rupture of membranes (green-top guideline no. 44). London: Royal College of Obstetricians and Gynaecologists, 2010. Morris JM, Roberts CL, Bowen JR, et al, on behalf of the PPROMT Collaboration. Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial. Lancet 2015; published online Nov 9. http://dx.doi.org/10.1016/S0140-6736(15)00724-2. Kenyon S, Boulvain M, Neilson JP. Antibiotics for preterm rupture of membranes. Cochrane Database Syst Rev 2013; 12: CD001058. van der Ham DP, Vijgen SM, Nijhuis JG, et al. Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial. PLoS Med 2012; 9: e1001208. Buchanan SL, Crowther CA, Levett KM, Middleton P, Morris J. Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks’ gestation for improving pregnancy outcome. Cochrane Database Syst Rev 2010; 3: CD004735. Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008; 372: 1319–27. Abou El Senoun G, Dowswell T, Mousa HA. Planned home versus hospital care for preterm prelabour rupture of the membranes (PPROM) prior to 37 weeks’ gestation. Cochrane Database Syst Rev 2014; 4: CD008053.
Pulmonary pressure, telemedicine, and heart failure therapy Published Online November 8, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)00808-9 See Articles page 453
408
Heart failure is a leading cause of hospital admissions in patients with cardiac diseases and poses a huge burden for patients and societies. In recent years, major advances have been made with the introduction of new drugs and novel interventional approaches such as cardiac resynchronisation therapy. However, there is a need for further improvement, especially considering the projection for increases in heart failure prevalence caused by ageing of the population. Longer survival of patients with cardiac diseases, an effect of modern life-extending treatments, such as primary angioplasty for myocardial infarction and implantable defibrillators for prevention of sudden cardiac death, also contributes to the need for more effective therapies for heart failure.1 In this issue of The Lancet, William T Abraham and colleagues2 report the extended results of the CHAMPION trial. This was a multicentre, randomised trial investigating the efficacy of wireless pulmonary artery haemodynamic monitoring, achieved with an implanted pressure sensor, in patients with chronic heart failure. The trial population consisted of 550 patients with moderate (New York Heart Association functional class III) heart failure, irrespective of left ventricular ejection fraction or cause, who had
had a hospital admission for heart failure within the past 12 months.3 The trial had an interesting design: all patients underwent implantation of the pressure sensor and were randomly assigned into either the treatment group (n=270) or the control group (n=280). Patients received drug and device treatment according to standard care. In addition, patients in the treatment group had pulmonary artery pressure measurements transmitted daily, which were used to guide medication adaptation according to clear protocol instructions. After completion of the randomised access period, with a mean follow-up of 18 months, an open access period, with a mean followup of 13 months, was initiated, during which pulmonary artery pressure information became available to guide therapy for all patients including those of the previous control group. In 2011, the investigators published initial results of the randomised access period showing that at 6 months there were significantly less heart failure-related admissions to hospital in the treatment group than in the control group.3 Now, the investigators report the results of the entire randomised access period, as well as those of the open access period. In all, 347 patients from the original www.thelancet.com Vol 387 January 30, 2016
In summary, Xie and colleagues’ systematic review4 provides strong evidence that intensive blood pressure reduction is more beneficial than less intensive blood pressure reduction. This finding will pave the way for the treatment of a large number of additional patients compared with the number treated at present. About a third of all excess cardiovascular mortality attributable to increased blood pressure is within the normotensive range.8 Hence, with the numbers needed to treat presented by Xie and colleagues (94 for high-risk patients and 186 for all other included patients), this finding will be of great interest from the point of view of public health, and probably beneficial from a health economic perspective. The results of this review will probably be supported further by forthcoming results from the Systolic Blood Pressure Intervention Trial (SPRINT).9 SPRINT had a similar design to the trials included in Xie and colleagues’ meta-analysis,4 with the addition of around 9000 more patients, with moderately raised blood pressure (systolic blood pressure >130 mm Hg) and increased cardiovascular risk, to the 44 989 analysed here. Although the evidence seems to be convincing, including studies from different populations in a meta-analysis does not mean that the overall results can be applied to all included populations. In particular, it is not yet obvious that patients with diabetes mellitus, or very elderly patients, will benefit from lower treatment targets than the recommended goal of lower than 140/90 mm Hg. Thus, the definition of
new blood pressure treatment targets will not be an easy task, in terms of comorbidity and a specific mm Hg target. Mattias Brunström, *Bo Carlberg Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University, SE-901 85 Umeå, Sweden [email protected] We declare no competing interests. 1
2
3
4
5
6 7
8 9
Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2013; 31: 1281–357. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the eighth Joint National Committee (JNC 8). JAMA 2014; 311: 507–20. Cushman WC, Evans GW, Byington RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010; 362: 1575–85. Xie X, Atkins E, Lv J, et al. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet 2015; published online Nov 6. http://dx.doi. org/10.1016/S0140-6736(15)00805-3. Thomopoulos C, Parati G, Zanchetti A. Effects of blood pressure lowering on outcome incidence in hypertension: 2. Effects at different baseline and achieved blood pressure levels—overview and meta-analyses of randomized trials. J Hypertens 2014; 32: 2296–304. American Diabetes Association. Cardiovascular disease and risk management. Diabetes Care 2015; 38 (suppl): S49–57. Stearne MR, Palmer SL, Hammersley MS, et al. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703–13. Stamler J, Stamler R, Neaton JD. Blood pressure, systolic and diastolic, and cardiovascular risk. Arch Intern Med 1993; 153: 598–615. US National Heart, Lung, and Blood Institute. Landmark NIH study shows intensive blood pressure management may save lives. Sept 11, 2015. http://www.nhlbi.nih.gov/news/press-releases/2015/landmark-nih-studyshows-intensive-blood-pressure-management-may-save-lives (accessed Nov 2, 2015).
Late preterm rupture of membranes: it pays to wait Published Online November 9, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)00809-0 See Articles page 444
406
In contrast to previous assumptions, there is increasing evidence that being born in the late preterm period— between 34 and 36 weeks gestation—is associated with important long-term adverse effects. Several adverse outcomes have been reported, including cerebral palsy, more hospital admissions in early childhood, lower childhood height, asthma, limiting long-term illness, and poorer educational attainment.1–3 Findings from studies show a gradient of health outcomes with decreasing gestation.1 An estimated 4–5% of infants are born at 34–36 weeks,2,3 and 30% of preterm births follow prelabour rupture of the membranes.4 Because of the potential risks of fetal and neonatal infection—although with limited evidence to support this assumption— present guidance favours planned early delivery in women
presenting with ruptured membranes at 34–36 weeks.5,6 With the emerging evidence of differences in long-term outcomes between late preterm and term infants, robust assessment of the risks and benefits of this strategy is essential, because a small increase in gestation at birth is likely to be beneficial to the infant. In The Lancet, Jonathan Morris and colleagues7 present the results of a pragmatic randomised controlled trial of planned immediate delivery versus expectant management in women presenting with pre-labour ruptured membranes at 34–36 weeks. Findings from this trial advance substantially the evidence on the optimum management strategy in these women. 1839 women in whom there was no indication for urgent delivery were randomly assigned to immediate delivery (n=924) or www.thelancet.com Vol 387 January 30, 2016
expectant management (n=915). There was no difference in the primary outcome of definite or probable neonatal sepsis between neonates in the immediate birth and expectant management groups (23 [2%] of 923 vs 29 [3%] of 912; relative risk [RR] 0·8, 95% CI 0·5–1·3). Additionally, there was no difference between groups in a secondary composite neonatal outcome of sepsis, ventilation for 24 h or more, or death (73 [8%] of 923 in the immediate delivery group vs 61 [7%] of 911 in the expectant management group; RR 1·2, 95% CI 0·9–1·6). Infants of women assigned to planned immediate delivery had a significantly higher risk of respiratory distress syndrome (76 [8%] of 919 vs 47 [5%] of 910; RR 1·6, 95% CI 1·1–2·3) and mechanical ventilation (114 [12%] of 923 vs 83 [9%] of 912; 1·4, 1·0–1·8) compared with those whose mothers were assigned to expectant management. These infants also had a significantly longer stay in a special care nursery or neonatal intensive care unit (median 4·0 days, IQR 0·0–10·0 vs 2·0 days, 0·0–7·0) and a longer total hospital stay (6·0 days, 3·0–10·0 vs 4·0 days, 3·0–8·0). However, in contrast to their infants, mothers in the expectant management group had a longer hospital stay than mothers who were assigned to planned immediate delivery (median 6·0 days, IQR 4·0–9·0 vs 5·0 days, 3·0–7·0), owing to the fact that most women in the expectant group were managed in hospital and were not discharged home to await the onset of labour. Almost 90% of women randomly assigned to expectant management received antibiotics before delivery, but this was not universal despite clear evidence of benefit.8 Also, a planned subgroup analysis of women who had group B streptococcus cultured from a vaginal swab showed no difference in the primary outcome of neonatal sepsis between the groups (RR 0·9, 95% CI 0·2–4·5). The main strength of Morris and colleagues’ study7 is its size; previous meta-analyses included a total of only 1230 infants.9,10 However, a concern associated with the present study is the time taken to recruit sufficient women—10 years. Patterns of obstetric care are unlikely to have changed sufficiently over that time to have a major effect on the study’s results, but preferences for antibiotic use will have changed in view of the findings of the ORACLE II trial11 and the association identified between maternal co-amoxiclav and necrotising enterocolitis.8 Morris and colleagues’ trial7 adopted a pragmatic approach to management within the expectant group, www.thelancet.com Vol 387 January 30, 2016
ERproductions Ltd/Blend Images/Corbis
Comment
allowing women to be cared for according to the usual practice of the recruiting centre. Therefore, management was varied, as shown by the fact that some women were treated at home, and laboratory testing and antibiotic prescription were not universal. This variation might have affected outcomes, but one could argue that it enhanced the generalisability of the results. However, women were recruited at 65 centres in 11 countries, and major differences in the respective maternity care systems should be considered when interpreting the results for practice in individual countries. What then do we still need to know? The investigators speculate that their findings will be associated with economic as well as health benefits,7 but in view of the reciprocity of length of stay data between mothers and infants in the two groups, this clearly needs formal assessment. Any economic benefit will be affected by variation in home versus hospital expectant management, the relative risks and benefits of which are unclear.12 The prolongation of pregnancy achieved with expectant delivery was small—will this translate into longer-term health and educational benefits for infants? Even small differences are likely to be important on a population basis, but still should be robustly examined. Additionally, to enhance the safety of expectant management, research must continue to be done to understand the effects of the inflammatory process on the fetal brain and on improving the detection of chorioamnionitis. The prevailing orthodoxy in obstetric practice, despite the emerging evidence on long-term outcomes, is to 407
Comment
have a low threshold for delivery in the face of obstetric problems between 34 and 36 weeks, on the basis that neonatal outcome is uncompromised. Morris and colleagues’ trial7 fundamentally challenges this thinking in the area of late preterm pre-labour rupture of membranes, and, even with the caveats noted, this new evidence suggests an urgent need for reassessment of present recommendations regarding immediate delivery of women with ruptured membranes close to term.
3 4 5
6 7
8
*Marian Knight, David Churchill National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK (MK); and New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK (DC) [email protected] We declare no competing interests. 1
2
Boyle EM, Poulsen G, Field DJ, et al. Effects of gestational age at birth on health outcomes at 3 and 5 years of age: population based cohort study. BMJ 2012; 344: e896. Chan E, Quigley MA. School performance at age 7 years in late preterm and early term birth: a cohort study. Arch Dis Child Fetal Neonatal Ed 2014; 99: F451–57.
9
10
11
12
Moster D, Lie RT, Markestad T. Long-term medical and social consequences of preterm birth. N Engl J Med 2008; 359: 262–73. Goldenberg RL, Rouse DJ. Prevention of premature birth. N Engl J Med 1998; 339: 313–20. American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Obstetrics. Practice bulletins no. 139: premature rupture of membranes. Obstet Gynecol 2013; 122: 918–30. Carroll S. Preterm prelabour rupture of membranes (green-top guideline no. 44). London: Royal College of Obstetricians and Gynaecologists, 2010. Morris JM, Roberts CL, Bowen JR, et al, on behalf of the PPROMT Collaboration. Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial. Lancet 2015; published online Nov 9. http://dx.doi.org/10.1016/S0140-6736(15)00724-2. Kenyon S, Boulvain M, Neilson JP. Antibiotics for preterm rupture of membranes. Cochrane Database Syst Rev 2013; 12: CD001058. van der Ham DP, Vijgen SM, Nijhuis JG, et al. Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial. PLoS Med 2012; 9: e1001208. Buchanan SL, Crowther CA, Levett KM, Middleton P, Morris J. Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks’ gestation for improving pregnancy outcome. Cochrane Database Syst Rev 2010; 3: CD004735. Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008; 372: 1319–27. Abou El Senoun G, Dowswell T, Mousa HA. Planned home versus hospital care for preterm prelabour rupture of the membranes (PPROM) prior to 37 weeks’ gestation. Cochrane Database Syst Rev 2014; 4: CD008053.
Pulmonary pressure, telemedicine, and heart failure therapy Published Online November 8, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)00808-9 See Articles page 453
408
Heart failure is a leading cause of hospital admissions in patients with cardiac diseases and poses a huge burden for patients and societies. In recent years, major advances have been made with the introduction of new drugs and novel interventional approaches such as cardiac resynchronisation therapy. However, there is a need for further improvement, especially considering the projection for increases in heart failure prevalence caused by ageing of the population. Longer survival of patients with cardiac diseases, an effect of modern life-extending treatments, such as primary angioplasty for myocardial infarction and implantable defibrillators for prevention of sudden cardiac death, also contributes to the need for more effective therapies for heart failure.1 In this issue of The Lancet, William T Abraham and colleagues2 report the extended results of the CHAMPION trial. This was a multicentre, randomised trial investigating the efficacy of wireless pulmonary artery haemodynamic monitoring, achieved with an implanted pressure sensor, in patients with chronic heart failure. The trial population consisted of 550 patients with moderate (New York Heart Association functional class III) heart failure, irrespective of left ventricular ejection fraction or cause, who had
had a hospital admission for heart failure within the past 12 months.3 The trial had an interesting design: all patients underwent implantation of the pressure sensor and were randomly assigned into either the treatment group (n=270) or the control group (n=280). Patients received drug and device treatment according to standard care. In addition, patients in the treatment group had pulmonary artery pressure measurements transmitted daily, which were used to guide medication adaptation according to clear protocol instructions. After completion of the randomised access period, with a mean follow-up of 18 months, an open access period, with a mean followup of 13 months, was initiated, during which pulmonary artery pressure information became available to guide therapy for all patients including those of the previous control group. In 2011, the investigators published initial results of the randomised access period showing that at 6 months there were significantly less heart failure-related admissions to hospital in the treatment group than in the control group.3 Now, the investigators report the results of the entire randomised access period, as well as those of the open access period. In all, 347 patients from the original www.thelancet.com Vol 387 January 30, 2016
