- Email: [email protected]
Pulmonary pressure, telemedicine, and heart failure therapy
Comment
Pulmonary pressure, telemedicine, and heart failure therapy access period. In all, 347 patients from the original CHAMPION trial completed the randomised access period and transitioned to the open access period (177 in the former treatment group and 170 in the former control group). The results of the follow-up study are highly interesting and corroborate those published in 2011. First, the superiority of the treatment group over the control group was maintained to the end of the randomised access period, with a significant 33% reduction in heart failure-related admissions to hospital (HR 0·67 [95% CI 0·55–0·80]; p<0·0001) and a 16% reduction in all-cause admissions to hospital (HR 0·84 [95% CI 0·76–0·94]; p=0·0017). Second, the positive results in the treatment group were maintained during the open access period, during which no increase in hospital admissions was noted. Third, and most importantly, heart failure-related hospital admissions and all-cause hospital admissions in the former control group were reduced significantly by 48% and 21%, respectively, after pulmonary artery pressure information became available to guide therapy during the open access period. The more frequent medication changes in the treatment group suggest that these outcome differences were, indeed, a result of tailored therapy facilitated by the pressure data transmission. Thus, Abraham and colleagues provide convincing data for the benefit of telemedicine to improve heart failure therapy. However, it is not always easy to put technologies and workflow optimally together to gain benefits for patients with heart failure, such as reduced hospital admissions
www.thelancet.com Published online November 8, 2015 http://dx.doi.org/10.1016/S0140-6736(15)00808-9
Published Online November 8, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)00808-9 See Online/Articles http://dx.doi.org/10.1016/ S0140-6736(15)00723-0
Elizabeth Flores/ZUMA Press/Corbis
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
1
Comment
or mortality. Several recent trials using cardiac implantbased remote monitoring or classic telemonitoring of weight and symptoms failed to show such benefits,4,5 whereas other trials have a beneficial effect on outcome.6 We believe that both measurement of the right parameter and use of the optimal pathway for data transmission plus advanced, prespecified workflow for patient management is most likely to make the difference in outcome of patients with heart failure provided with telemedicine support. This perspective had previously been convincingly outlined by Desai and Stevenson.7 The importance of technology and workflow is further supported by recent analysis of big data, showing that in patients with pacemakers, defibrillators, or cardiac resynchronisation devices, a graded relationship of survival with the level of adherence to remote monitoring exists.8 Similar results were produced by a recent meta-analysis of randomised trials on the effects of remote monitoring in patients with an implanted defibrillator. Although no effects on total mortality, cardiovascular mortality, and hospital admissions were reported for the overall study analysis, a significant effect on total mortality was noted for devices with specific technical features and daily automatic data transmission.9 The effect on mortality was most pronounced in the IN-TIME trial.6 In this study, daily automatic transmission of several parameters, central data monitoring, and prespecified workflow in case of an event were believed to be key in explaining the substantial benefit reported. Notably, the CHAMPION trial2 had a comparable setup, which included daily data transmission and strict prespecified actions in case of significant pulmonary artery pressure changes. Indeed, for the initial phase of the trial, there have been concerns of potential for bias because of the intense monitoring by the nursing staff and the sponsor. The study shows sustained and substantial beneficial effects of pulmonary artery pressure monitoring—most importantly also in the open access phase when the funder had no influence on treatment pathways. However, the effects observed in the open access phase of the trial cannot be seen independently from the main trial, as the workflows would have been quite well established during the randomised trial phase, and simply extended in the open trial phase. Thus, whether comparable clinical benefits can be gained using the technology in a routine setting remains to be proven. Despite the growing and credible evidence for telemonitoring-associated benefits, these methods 2
are underused in clinical practice, as recently shown for cardiovascular electronic devices in a survey of the European Heart Rhythm Association.10 There are several reasons for this, but probably a crucial one is the high workload imposed on the personnel by use of these novel technologies, of which the burden is insufficiently recognised and inadequately reimbursed by the healthcare system in most countries.11 Overall, the results reported by Abraham and colleagues provide further strong evidence that telemonitoring can be successfully applied to manage disease in patients with heart failure. However, widespread and meaningful applications of these technologies will require coordinated efforts of all involved parties, as well as proper recognition of their function by the health-care system. Nikolaos Dagres, *Gerhard Hindricks Department of Electrophysiology, Herzzentrum Leipzig, 04289 Leipzig, Germany [email protected] ND reports personal fees from Boston Scientific outside of the submitted work. GH reports grants from Boston Scientific, St Jude Medical, and Biotronik outside of the submitted work. 1
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Dagres N, Hindricks G. Risk stratification after myocardial infarction: is left ventricular ejection fraction enough to prevent sudden cardiac death? Eur Heart J 2013; 34: 1964–71. Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB, for the CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet 2015; published online Nov 8. http://dx.doi.org/10.1016/ S0140-6736(15)00723-0. Abraham WT, Adamson PB, Bourge RC, et al, for the CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 2011; 377: 658–66. Böhm M. Effect of implanted device-based impedance monitoring with telemedicine alerts on mortality and morbidity in heart failure (OptiLink HF). 2015 European Society of Cardiology Congress; London; Aug 29–Sept 2, 2015. http://www.escardio.org/static_file/Escardio/Press-media/Press%20 releases/2015/Congress/OptiLink-HF_Bohm.pdf (accessed Oct 4, 2015). Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in patients with heart failure. N Engl J Med 2010; 363: 2301–09. Hindricks G, Taborsky M, Glikson M, et al, for the IN-TIME study group. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014; 384: 583–90. Desai AS, Stevenson LW. Connecting the circle from home to heart-failure disease management. N Engl J Med 2010; 363: 2364–67. Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J Am Coll Cardiol 2015; 65: 2601–10. Parthiban N, Esterman A, Mahajan R, et al. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J Am Coll Cardiol 2015; 65: 2591–600. Hernández-Madrid A, Lewalter T, Proclemer A, Pison L, Lip GY, Blomstrom-Lundqvist C, for the Scientific Initiatives Committee, European Heart Rhythm Association. Remote monitoring of cardiac implantable electronic devices in Europe: results of the European Heart Rhythm Association survey. Europace 2014; 16: 129–32. Mairesse GH, Braunschweig F, Klersy K, Cowie MR, Leyva F. Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association. Europace 2015; 17: 814–18.
www.thelancet.com Published online November 8, 2015 http://dx.doi.org/10.1016/S0140-6736(15)00808-9
Pulmonary pressure, telemedicine, and heart failure therapy access period. In all, 347 patients from the original CHAMPION trial completed the randomised access period and transitioned to the open access period (177 in the former treatment group and 170 in the former control group). The results of the follow-up study are highly interesting and corroborate those published in 2011. First, the superiority of the treatment group over the control group was maintained to the end of the randomised access period, with a significant 33% reduction in heart failure-related admissions to hospital (HR 0·67 [95% CI 0·55–0·80]; p<0·0001) and a 16% reduction in all-cause admissions to hospital (HR 0·84 [95% CI 0·76–0·94]; p=0·0017). Second, the positive results in the treatment group were maintained during the open access period, during which no increase in hospital admissions was noted. Third, and most importantly, heart failure-related hospital admissions and all-cause hospital admissions in the former control group were reduced significantly by 48% and 21%, respectively, after pulmonary artery pressure information became available to guide therapy during the open access period. The more frequent medication changes in the treatment group suggest that these outcome differences were, indeed, a result of tailored therapy facilitated by the pressure data transmission. Thus, Abraham and colleagues provide convincing data for the benefit of telemedicine to improve heart failure therapy. However, it is not always easy to put technologies and workflow optimally together to gain benefits for patients with heart failure, such as reduced hospital admissions
www.thelancet.com Published online November 8, 2015 http://dx.doi.org/10.1016/S0140-6736(15)00808-9
Published Online November 8, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)00808-9 See Online/Articles http://dx.doi.org/10.1016/ S0140-6736(15)00723-0
Elizabeth Flores/ZUMA Press/Corbis
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
1
Comment
or mortality. Several recent trials using cardiac implantbased remote monitoring or classic telemonitoring of weight and symptoms failed to show such benefits,4,5 whereas other trials have a beneficial effect on outcome.6 We believe that both measurement of the right parameter and use of the optimal pathway for data transmission plus advanced, prespecified workflow for patient management is most likely to make the difference in outcome of patients with heart failure provided with telemedicine support. This perspective had previously been convincingly outlined by Desai and Stevenson.7 The importance of technology and workflow is further supported by recent analysis of big data, showing that in patients with pacemakers, defibrillators, or cardiac resynchronisation devices, a graded relationship of survival with the level of adherence to remote monitoring exists.8 Similar results were produced by a recent meta-analysis of randomised trials on the effects of remote monitoring in patients with an implanted defibrillator. Although no effects on total mortality, cardiovascular mortality, and hospital admissions were reported for the overall study analysis, a significant effect on total mortality was noted for devices with specific technical features and daily automatic data transmission.9 The effect on mortality was most pronounced in the IN-TIME trial.6 In this study, daily automatic transmission of several parameters, central data monitoring, and prespecified workflow in case of an event were believed to be key in explaining the substantial benefit reported. Notably, the CHAMPION trial2 had a comparable setup, which included daily data transmission and strict prespecified actions in case of significant pulmonary artery pressure changes. Indeed, for the initial phase of the trial, there have been concerns of potential for bias because of the intense monitoring by the nursing staff and the sponsor. The study shows sustained and substantial beneficial effects of pulmonary artery pressure monitoring—most importantly also in the open access phase when the funder had no influence on treatment pathways. However, the effects observed in the open access phase of the trial cannot be seen independently from the main trial, as the workflows would have been quite well established during the randomised trial phase, and simply extended in the open trial phase. Thus, whether comparable clinical benefits can be gained using the technology in a routine setting remains to be proven. Despite the growing and credible evidence for telemonitoring-associated benefits, these methods 2
are underused in clinical practice, as recently shown for cardiovascular electronic devices in a survey of the European Heart Rhythm Association.10 There are several reasons for this, but probably a crucial one is the high workload imposed on the personnel by use of these novel technologies, of which the burden is insufficiently recognised and inadequately reimbursed by the healthcare system in most countries.11 Overall, the results reported by Abraham and colleagues provide further strong evidence that telemonitoring can be successfully applied to manage disease in patients with heart failure. However, widespread and meaningful applications of these technologies will require coordinated efforts of all involved parties, as well as proper recognition of their function by the health-care system. Nikolaos Dagres, *Gerhard Hindricks Department of Electrophysiology, Herzzentrum Leipzig, 04289 Leipzig, Germany [email protected] ND reports personal fees from Boston Scientific outside of the submitted work. GH reports grants from Boston Scientific, St Jude Medical, and Biotronik outside of the submitted work. 1
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Dagres N, Hindricks G. Risk stratification after myocardial infarction: is left ventricular ejection fraction enough to prevent sudden cardiac death? Eur Heart J 2013; 34: 1964–71. Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB, for the CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet 2015; published online Nov 8. http://dx.doi.org/10.1016/ S0140-6736(15)00723-0. Abraham WT, Adamson PB, Bourge RC, et al, for the CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 2011; 377: 658–66. Böhm M. Effect of implanted device-based impedance monitoring with telemedicine alerts on mortality and morbidity in heart failure (OptiLink HF). 2015 European Society of Cardiology Congress; London; Aug 29–Sept 2, 2015. http://www.escardio.org/static_file/Escardio/Press-media/Press%20 releases/2015/Congress/OptiLink-HF_Bohm.pdf (accessed Oct 4, 2015). Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in patients with heart failure. N Engl J Med 2010; 363: 2301–09. Hindricks G, Taborsky M, Glikson M, et al, for the IN-TIME study group. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014; 384: 583–90. Desai AS, Stevenson LW. Connecting the circle from home to heart-failure disease management. N Engl J Med 2010; 363: 2364–67. Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J Am Coll Cardiol 2015; 65: 2601–10. Parthiban N, Esterman A, Mahajan R, et al. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J Am Coll Cardiol 2015; 65: 2591–600. Hernández-Madrid A, Lewalter T, Proclemer A, Pison L, Lip GY, Blomstrom-Lundqvist C, for the Scientific Initiatives Committee, European Heart Rhythm Association. Remote monitoring of cardiac implantable electronic devices in Europe: results of the European Heart Rhythm Association survey. Europace 2014; 16: 129–32. Mairesse GH, Braunschweig F, Klersy K, Cowie MR, Leyva F. Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association. Europace 2015; 17: 814–18.
www.thelancet.com Published online November 8, 2015 http://dx.doi.org/10.1016/S0140-6736(15)00808-9