Comment
by the nursing intervention or expected in this sample of chronically ill patients. Should mortality be a priority outcome for this type of nursing intervention in elderly patients with multiple comorbidities? The benefit of the SAFETY intervention can be seen when we consider the median number of days spent in hospital per admission: 2·8 days in the SAFETY intervention group and 3·6 days with standard management (p=0·035). In participants allocated to the SAFETY intervention, 50 fewer admissions were recorded and 653 fewer days were spent in hospital for cardiovascular-related care, compared with patients assigned to standard management. Furthermore, fewer admissions for new heart failure were reported among patients allocated to the SAFETY intervention group (n=18) compared with those assigned to standard management (n=28), although the difference was not significant. Also notable is that 16 days were spent in hospital for treatment of cerebrovascular disease by patients allocated to the SAFETY intervention compared with 237 days among individuals assigned to standard management; diabetesrelated care was needed for 11 days among patients assigned to the SAFETY intervention and for 173 days in those allocated to standard management. As the authors suggest, the higher number of admissions among patients assigned to the SAFETY intervention might have been attributable to increased surveillance. The nurse-led home-based management strategy might have detected clinical compromise early and averted events that would otherwise need prolonged treatment, thereby reducing length of stay. Patients with multiple chronic disorders face many challenges in terms of recognising clinical signs that need emergency care or assessment by a health-care provider.5–8 An evaluation of the green, amber, red delineation of risk and need (GARDIAN) method,9 which is used to monitor clinical status and self-care, was not reported specifically by the investigators. Further studies are important to identify the benefit of the GARDIAN approach for
surveillance and early intervention in populations similar to that included in Stewart and colleagues’ study. Additional research is needed to assess the effect of the SAFETY intervention and similar home-based strategies on outcomes such as self-care behaviours, symptom management, clinical status, receipt of guidelinedirected care, and health-care use in patients with atrial fibrillation and multiple comorbidities. Stewart and colleagues’ findings2 are a meaningful contribution to the evidence base for delivery of care to this rapidly growing population, and we look forward to subsequent studies that will build on this work. *Pamela J McCabe, Holli A DeVon Mayo College of Medicine, Rochester, MN 55905, USA (PJM); and University of Illinois at Chicago, College of Nursing, Chicago, IL, USA (HAD) [email protected] We declare no competing interests. 1
2
3
4
5
6
7
8 9
Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation 2014; 129: 837–47. Stewart S, Ball J, Horowitz JD, et al. Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial. Lancet 2014; published online Nov 17. http://dx.doi.org/10.1016/S01406736(14)61992-9. Takeda A, Taylor SJ, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev 2012; 9: CD002752. Inglis S, McLennan S, Dawson A, et al. A new solution for an old problem? Effects of a nurse-led multidisciplinary, home-based intervention on readmission and mortality in patients with chronic atrial fibrillation. J Cardiovasc Nurs 2004; 19: 118–27. Lam C, Smelzer SC. Patterns of symptom recognition, interpretation, and response in heart failure patients: an integrative review. J Cardiovasc Nurs 2013; 28: 348–59. Horne R, James D, Petrie JD, Weinman J, Vincent R. Patients’ interpretation of symptoms as a cause of delay in reaching hospital during acute myocardial infarction. Heart 2000; 83: 388–93. Brandt CL. Study of older adults’ use of self-regulation for COPD self-management informs an evidence-based patient teaching plan. Rehabil Nurs 2013; 38: 11–23. McCabe PJ, Rhudy L, DeVon HA. Patient experiences from symptom onset through initial treatment for atrial fibrillation. J Clin Nurs (in press). Carrington MJ, Kok S, Jansen K, Stewart S. The Green, Amber, Red Delineation of Risk and Need (GARDIAN) management system: a pragmatic approach to optimizing heart health from primary prevention to chronic disease management. Eur J Cardiovasc Nurs 2013; 12: 337–45.
SIMPLEr not to test implantable cardioverter defibrillators? Substantial evidence exists that implantable cardioverter defibrillators (ICDs) are useful for the primary and secondary prevention of sudden cardiac death. Since the introduction of ICDs in the early 1980s, routine www.thelancet.com Vol 385 February 28, 2015
defibrillation threshold testing has been an accepted part of implantation. Testing involves induction of ventricular fibrillation after the implantation procedure, and assessment of the device’s ability to terminate
Published Online February 23, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60242-2 See Articles page 785
753
Comment
Dr P Marazzi/Science Photo Library
the arrhythmia. The primary objective of such tests has been to confirm the reliable sensing and detection of ventricular fibrillation by the ICD and efficacy of the delivered shock to terminate the arrhythmia. This objective is based on the premise that the shock delivered within the laboratory will, with an added safety margin, successfully terminate a life-threatening arrhythmia in a real-world situation. Despite this being an approved and commonly practised strategy, clinicians have always been concerned about the risk-to-benefit ratio and its questionable effect on long-term clinical outcomes. In The Lancet, Jeff Healey and colleagues1 report the results from their Shockless IMPLant Evaluation (SIMPLE) study that compared the efficacy and safety of ICD implantation with and without defibrillator testing. Understandably, in the early years of defibrillator therapy with initial generations of devices, the use of epicardial patches, and monophasic shocks, the risk of failing to defibrillate was a troubling issue. However, ICDs have been substantially refined, with the introduction of biphasic shocks and development of pectoral systems.2,3 These advances have substantially reduced the mean defibrillation thresholds. Additionally, ICDs now have the capability to reverse the polarity, change the vector, and modify defibrillation waveforms, which has greatly enhanced the success of defibrillation. Consequently, routine defibrillation testing for ICDs has been reduced.4 Many of these practice changes have been specific to individual countries and institutions. Notably, data from the US National Cardiovascular Data Registry in 2010 showed that about 70% of 64 227 initial ICD implants had defibrillation testing.4 Because these tests have the potential to cause harm (from either the procedural anaesthesia, the actual induction of ventricular fibrillation, or the delivered shock), and because induced and spontaneous arrhythmias are not correlated,5 whether routine testing is justified in the current era of ICDs is unclear. SIMPLE1 is the largest randomised clinical trial to address the role of routine defibrillation testing in patients receiving an ICD. In this multicentre, single-masked, noninferiority trial, 2500 eligible patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned to either defibrillation testing (n=1253) or no testing (n=1247) and followed up for a mean of 3·1 years. The investigators examined the composite outcome of arrhythmic death or failed appropriate 754
shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The investigators also examined safety of the testing during the implantation procedure. Patients in the study mostly received the ICD for primary prevention, but 27% of patients received the device for secondary prevention. The results of the study are compelling, showing that ICD implantation without defibrillation testing did not reduce long-term device efficacy. The no-testing approach was not inferior for the primary endpoint of failed appropriate shock or arrhythmic death compared with testing (90 [7% per year] patients vs 104 [8% per year] patients; hazard ratio [HR] 0·86, 95% CI 0·65–1·14; pnon-inferiority
by the nursing intervention or expected in this sample of chronically ill patients. Should mortality be a priority outcome for this type of nursing intervention in elderly patients with multiple comorbidities? The benefit of the SAFETY intervention can be seen when we consider the median number of days spent in hospital per admission: 2·8 days in the SAFETY intervention group and 3·6 days with standard management (p=0·035). In participants allocated to the SAFETY intervention, 50 fewer admissions were recorded and 653 fewer days were spent in hospital for cardiovascular-related care, compared with patients assigned to standard management. Furthermore, fewer admissions for new heart failure were reported among patients allocated to the SAFETY intervention group (n=18) compared with those assigned to standard management (n=28), although the difference was not significant. Also notable is that 16 days were spent in hospital for treatment of cerebrovascular disease by patients allocated to the SAFETY intervention compared with 237 days among individuals assigned to standard management; diabetesrelated care was needed for 11 days among patients assigned to the SAFETY intervention and for 173 days in those allocated to standard management. As the authors suggest, the higher number of admissions among patients assigned to the SAFETY intervention might have been attributable to increased surveillance. The nurse-led home-based management strategy might have detected clinical compromise early and averted events that would otherwise need prolonged treatment, thereby reducing length of stay. Patients with multiple chronic disorders face many challenges in terms of recognising clinical signs that need emergency care or assessment by a health-care provider.5–8 An evaluation of the green, amber, red delineation of risk and need (GARDIAN) method,9 which is used to monitor clinical status and self-care, was not reported specifically by the investigators. Further studies are important to identify the benefit of the GARDIAN approach for
surveillance and early intervention in populations similar to that included in Stewart and colleagues’ study. Additional research is needed to assess the effect of the SAFETY intervention and similar home-based strategies on outcomes such as self-care behaviours, symptom management, clinical status, receipt of guidelinedirected care, and health-care use in patients with atrial fibrillation and multiple comorbidities. Stewart and colleagues’ findings2 are a meaningful contribution to the evidence base for delivery of care to this rapidly growing population, and we look forward to subsequent studies that will build on this work. *Pamela J McCabe, Holli A DeVon Mayo College of Medicine, Rochester, MN 55905, USA (PJM); and University of Illinois at Chicago, College of Nursing, Chicago, IL, USA (HAD) [email protected] We declare no competing interests. 1
2
3
4
5
6
7
8 9
Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation 2014; 129: 837–47. Stewart S, Ball J, Horowitz JD, et al. Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial. Lancet 2014; published online Nov 17. http://dx.doi.org/10.1016/S01406736(14)61992-9. Takeda A, Taylor SJ, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev 2012; 9: CD002752. Inglis S, McLennan S, Dawson A, et al. A new solution for an old problem? Effects of a nurse-led multidisciplinary, home-based intervention on readmission and mortality in patients with chronic atrial fibrillation. J Cardiovasc Nurs 2004; 19: 118–27. Lam C, Smelzer SC. Patterns of symptom recognition, interpretation, and response in heart failure patients: an integrative review. J Cardiovasc Nurs 2013; 28: 348–59. Horne R, James D, Petrie JD, Weinman J, Vincent R. Patients’ interpretation of symptoms as a cause of delay in reaching hospital during acute myocardial infarction. Heart 2000; 83: 388–93. Brandt CL. Study of older adults’ use of self-regulation for COPD self-management informs an evidence-based patient teaching plan. Rehabil Nurs 2013; 38: 11–23. McCabe PJ, Rhudy L, DeVon HA. Patient experiences from symptom onset through initial treatment for atrial fibrillation. J Clin Nurs (in press). Carrington MJ, Kok S, Jansen K, Stewart S. The Green, Amber, Red Delineation of Risk and Need (GARDIAN) management system: a pragmatic approach to optimizing heart health from primary prevention to chronic disease management. Eur J Cardiovasc Nurs 2013; 12: 337–45.
SIMPLEr not to test implantable cardioverter defibrillators? Substantial evidence exists that implantable cardioverter defibrillators (ICDs) are useful for the primary and secondary prevention of sudden cardiac death. Since the introduction of ICDs in the early 1980s, routine www.thelancet.com Vol 385 February 28, 2015
defibrillation threshold testing has been an accepted part of implantation. Testing involves induction of ventricular fibrillation after the implantation procedure, and assessment of the device’s ability to terminate
Published Online February 23, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60242-2 See Articles page 785
753
Comment
Dr P Marazzi/Science Photo Library
the arrhythmia. The primary objective of such tests has been to confirm the reliable sensing and detection of ventricular fibrillation by the ICD and efficacy of the delivered shock to terminate the arrhythmia. This objective is based on the premise that the shock delivered within the laboratory will, with an added safety margin, successfully terminate a life-threatening arrhythmia in a real-world situation. Despite this being an approved and commonly practised strategy, clinicians have always been concerned about the risk-to-benefit ratio and its questionable effect on long-term clinical outcomes. In The Lancet, Jeff Healey and colleagues1 report the results from their Shockless IMPLant Evaluation (SIMPLE) study that compared the efficacy and safety of ICD implantation with and without defibrillator testing. Understandably, in the early years of defibrillator therapy with initial generations of devices, the use of epicardial patches, and monophasic shocks, the risk of failing to defibrillate was a troubling issue. However, ICDs have been substantially refined, with the introduction of biphasic shocks and development of pectoral systems.2,3 These advances have substantially reduced the mean defibrillation thresholds. Additionally, ICDs now have the capability to reverse the polarity, change the vector, and modify defibrillation waveforms, which has greatly enhanced the success of defibrillation. Consequently, routine defibrillation testing for ICDs has been reduced.4 Many of these practice changes have been specific to individual countries and institutions. Notably, data from the US National Cardiovascular Data Registry in 2010 showed that about 70% of 64 227 initial ICD implants had defibrillation testing.4 Because these tests have the potential to cause harm (from either the procedural anaesthesia, the actual induction of ventricular fibrillation, or the delivered shock), and because induced and spontaneous arrhythmias are not correlated,5 whether routine testing is justified in the current era of ICDs is unclear. SIMPLE1 is the largest randomised clinical trial to address the role of routine defibrillation testing in patients receiving an ICD. In this multicentre, single-masked, noninferiority trial, 2500 eligible patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned to either defibrillation testing (n=1253) or no testing (n=1247) and followed up for a mean of 3·1 years. The investigators examined the composite outcome of arrhythmic death or failed appropriate 754
shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The investigators also examined safety of the testing during the implantation procedure. Patients in the study mostly received the ICD for primary prevention, but 27% of patients received the device for secondary prevention. The results of the study are compelling, showing that ICD implantation without defibrillation testing did not reduce long-term device efficacy. The no-testing approach was not inferior for the primary endpoint of failed appropriate shock or arrhythmic death compared with testing (90 [7% per year] patients vs 104 [8% per year] patients; hazard ratio [HR] 0·86, 95% CI 0·65–1·14; pnon-inferiority
