- Email: [email protected]
Paramedic direct admission of heart-attack patients to coronary care unit
CORRESPONDENCE
occurrence of NSAID-induced peptic ulcers. These opposite conclusions from two studies create considerable confusion as to the best policy to adopt in the protection of H pylori-infected patients who need to take NSAIDs. In the attempt to reconcile these conflicting findings, difference in patient selection was held responsible for the opposite results.1 In fact, Hawkey and colleagues recruited H pylori-positive patients with current or previous peptic ulceration, dyspepsia, or both, who continued to use NSAIDs. By contrast, Chan and colleagues investigated patients positive for H pylori with no history of ulcer disease or dyspeptic symptoms before they started NSAIDs. From a practical point of view, however, patients on chronic therapy NSAID are only a small part of the population who takes this kind of medication. Most NSAID users need intermittent treatment for exacerbation of osteoarthritis or for episodic pain attacks of the musculoskeletal system due to various causes.5 Because not all patients can be treated, we wonder what is the best protection in those subsets of patients who are at higher risk of developing gastrointestinal complications, especially elderly patients and those who have already had an ulcer in the past. Is it more advisable to eradicate H pylori infection or to maintain the infectious condition to increase the benefit of acidsuppressant drugs in patients who need only short-term intermittent treatment with NSAIDs? *Vincenzo Savarino, Sergio Vigneri, Guido Celle *Dipartimento di Medicina Interna e Specialità Mediche, Università di Genova, 16132 Genova, Italy; and Istituto di Medicina Interna e Geriatria, Università di Palermo 1
2
3
4
5
Hawkey CJ, Tulassay Z, Szczepanski L, et al. Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Lancet 1998; 352: 106–21. Yeomans ND, Tulassay Z, Juhász L, et al. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: 719–26. Hawkey CJ, Jarrasch JA, Szczepanski L, et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: 727–34. Chan FKL, Sung JJY, Sydney Chung SC, et al. Randomised trial of eradication of Helicobacter pylori before non-steroidal antiinflammatory drug therapy to prevent peptic ulcers. Lancet 1997; 350: 975–79. Jones AC, Berman P, Doherty M. Non-steroidal anti-inflammatory drug usage and requirement in elderly acute hospital admissions. Br J Rheumatol 1992; 31: 45–48.
THE LANCET • Vol 352 • December 19/26, 1998
Author’s reply Sir—Francis Chan and Joseph Sung are right to emphasise that there is very little relation between dyspepsia and ulceration in NSAID users, but we did not regard dyspepsia as a risk factor for ulceration. As we stated, we recruited patients with significant dyspepsia, and those at high risk of ulceration because we believed (wrongly as it turned out) that H pylori eradication would improve dyspepsia but would not prevent ulcer recurrence. Francis Chan questions statistical power, but this is a difficulty for studies with negative results rather than positive results; the difference was so robust that it was detected with small numbers. Chan and colleagues found that curing H pylori with bismuth triple therapy did not impair the healing of complicated gastric or duodenal ulcers. Unfortunately, the abstract they cite does not contain these data so we don’t know whether endoscopy at 8 weeks might have missed a difference, or whether the results might be different after bismuth triple therapy. The primary objective of our study was to investigate the effect of H pylori eradication over 6 months. Chan’s failure to find evidence of a protective effect of H pylori eradication in patients with bleeding peptic ulcer validates our endoscopic approach. Thus, a sterile debate of whether treatments may affect ulcer complications differently to endoscopic ulcers can be avoided. We disagree with Manfred Stolte that endoscopy is an imprecise way to diagnose ulcers, since most of modern gastroenterology is based on it. He raises a false dichotomy in suggesting that some ulcers of H pylori-infected NSAID-users are due to H pylori and others to the NSAID; the evidence is that ulcers in this group have rather homogenous and predictable patterns of behaviour that are different both from pure NSAID ulcers and pure H pylori ulcers. We also disagree that NSAID ulcers are generally only oneoff ulcers. Vincenzo Saverino and co-workers raise a good question that is difficult to answer because there is no direct evidence. NSAID use in elderly patients is not intermittent as they suggest,1 but if they wish to use acid suppression to protect high-risk patients on NSAIDs they should not eradicate H pylori since this will reduce effectiveness. The effects of H pylori in other areas of health are unlikely to be relevant to NSAID users. There is no longer believed to be a causal association between H pylori and coronary disease. Whereas H pylori
predisposes to gastric cancer, NSAIDs abolish this risk.2 The most important point from our study is that the simple finding of H pylori is not an indication for eradication. Some disorders are improved by eradication, others are not. *C J Hawkey, on behalf of the HELP NSAID Study Group Division of Gastroenterology, University Hospital, Queen’s Medical Centre, Nottingham NG7 2UH, UK 1
2
Cullen DJE, for Nottingham NSAID 2000 Intervention Group, University Nottingham. Non-steroidal, anti-inflammatory drug exposure in the elderly: effect of treatment length and patient compliance. Gastroenterology 1994; 106: A6. Thun MJ. NSAID use and decreased risk of gastrointestinal cancers. Gastroenterol Clin North Am 1996; 25: 333–48.
Paramedic direct admission of heart-attack patients to coronary care unit Sir—David Sandler (Oct 10, p 1198)1 compares the time delays involved in different routes to thrombolysis. The time between onset of symptoms and the start of thrombolysis in the paramedic route is impressive. However, we are concerned about several issues that arise from this report. Only 278 (56%) patients admitted to the coronary care unit with confirmed myocardial infarction received thrombolysis. This proportion seems rather low. What contraindications prevailed in the patients who did not receive thombolysis? The absence of indicators of variations (SD) and arithmetical error make interpretation difficult. For example, in the figure, Sandler shows that the mean time for medical admissions unit patients between arrival in hospital and diagnosis is 118 min, whereas from the numerical data (time from arrival to thrombolysis [148 min] minus time between diagnosis and thrombolysis [25 min]) is 123 min, an inconsistency too large to be explained by any rounding of the time points involved, which number only three. Of the different components of the total time for the sequence from call to ambulance to thrombolysis, it is the time between arrival to hospital and diagnosis that is most different between the routes. Although this time is only 14 min for the family physician route and 18 min for the paramedic route, it is much higher (42 min) for patients seen in accident and emergency, and reaches an astonishing 118 (or 123?) min for
2017
CORRESPONDENCE
patients seen in the medical admissions unit. It is unfortunate for people with chest pain (and subsequently proven myocardial infarction) to wait and average of 2 h between arrival at hospital and diagnosis of acute myocardial infarction, and ironic that this diagnostic delay is five to six times longer when patients are admitted to a unit specifically designed to diagnose and treat medical emergencies. The only obvious explanation for this delay is that unlike the other routes, many of the patients in a medical admission unit would have presented without classic clinical features of myocardial infarction (such as chest pain) and hence an electrocardiogram (ECG) was done only after clinical suspicion was raised during the physician’s assessment. If this is the case, then the comparison of time to diagnosis between the different routes is invalid. If this is not the case—which would imply a mean 2 h wait in hospital for an ECG in patients with chest pain—then clearly the correct course of action is to improve staff numbers or training in the medical admissions unit. Furthermore, 347 (78%) of the 446 patients in Sandler’s report presented to the medical admissions unit or accident and emergency. Consequently, we infer from this study that an increase in resources in these areas would be most cost-effective. *L Ceri Davies, Darrel P Francis, Andrew J S Coats Department of Cardiology, Royal Brompton Hospital and Imperial College of Science, Technology and Medicine, London SW3 6NP, UK (email: [email protected]) 1
Sandler D. Paramedic direct admission of heart-attack patients to a coronary-care unit. 1998; 352: 1198.
Sir—David Sandler1 shows that paramedic direct admission of heartattack patients to a coronary-care unit (CCU) produced the shortest time between the call for an ambulance and thrombolysis (mean 95 min). There are several points that merit further discussion. We note that paramedic direct admission to the CCU was associated with an 11 min delay before arrival at hospital, compared with immediate transfer to the accident and emergency department. In the early phase of an evolving myocardial infarction, there is a high risk of developing arrhythmias, and, therefore, it would be pertinent to know the rate of adverse out-of-hospital events in these patients, compared with the group transported directly to hospital.
2018
A mean door to needle time of 39 min for paramedic direct admissions to the CCU is commendable, but direct comparison of this time with that for patients who attended the medical assessment unit is not appropriate. The paramedics have the opportunity to select out the easy cases. By contrast, patients who are handed on to the medical admissions unit may be those with less obvious ECG changes or a more complicated presentation, and 30–40% of patients who present with acute myocardial infarction are likely to fall into this category.2,3 It cannot be concluded from this data that direct admission to the CCU would reduce the mean door to needle time over the entire population, or would prevent a substantial number of deaths. We audited the provision of thrombolysis in Sheffield in 1996–97, and found that the shortest call to thrombolysis times occurred when patients attended the accident and emergency department and underwent thrombolysis there (mean 82 min). By contrast, patients admitted directly to the CCU by paramedics had much longer call to thrombolysis times (mean 125 min). Every effort needs to be made to shorten treatment delays for patients with acute myocardial infarction. There is no universal strategy that will deliver thrombolysis safely and efficiently in all populations, since facilities, expertise, and local conditions vary. As our comparative figures show, a system that works efficiently in one locality may not be the best system in another. Detailed audit of the provision of thrombolysis is essential if solutions are to be found at a local level. *June Edhouse, J Wardrope, F P Morris Accident and Emergency Medicine, Northern General Hospital NHS Trust, Sheffield S5 7AU, UK 1
2
3
Sandler DA. Paramedic direct admission of heart-attack patients to a coronary-care unit. Lancet 1998; 352: 1198. More R, Moore K, Quinn E, et al. Delay times in the administration of thrombolytic therapy: the Brighton experience. Int J Cardiol; 1995; 49: S39–46. Pell ACH, Miller HC, Robertson CE, Fox KAA. Effect of ‘fast-track’ admission for acute myocardial infarction on delay to thrombolysis. BMJ 1992; 304: 83–87.
Author’s reply Sir—Although L Ceri Davies and colleagues thought our thrombolysis rate of 56% “rather low”, it compares favourably with the European Secondary Prevention Study Group’s1 report of rates between 13% and 52% (median 36%; maximum 55%) in 4035 patients across 11 European countries.
Number of patients Thrombolysis not indicated Symptoms >12 h only No diagnostic ECG changes only Symptoms >12 h plus no ECG change
153 (70%) 23 85 45
Thrombolysis contraindicated Active bleeding Previous haemorrhagic CVA Stroke within 6 months Major trauma within 6 weeks Active gastrointestinal bleeding <6 months Suspected aortic dissection Active peptic ulcer symptoms Lengthy cardiopulmonary resuscitation Taking oral anticoagulants Diabetic retinopathy
58 (27%) 9 18 2 7 9
Number with good reason not to thrombolyse
211 (97%)
2 1 6 2 2
Reason for no thrombolytic therapy in 217 patients with proven acute myocardial infarction
In our study we decided not to use thrombolysis in 211 (97%) of the 217 patients with acute myocardial infarction because there was a good reason (table), and thus only six eligible patients were not thrombolysed. The apparent long delay to diagnosis of acute myocardial infarction in those patients admitted to the medical assessment unit was not caused by inadequate numbers of staffing or poor training. This delay was because these patients did not have clear-cut acute myocardial infarction when they presented with chest pains but without ECG changes. The diagnosis in these patients was made after observation, and repeated ECG and blood enzyme testing at the medical assessment unit. Surely we are not the only hospital to see a large number of such patients? However, the time to thrombolysis once the diagnosis was confirmed in these patients (25 min) compared favourably with the 21 min for paramedic patients. Thus, once the medical staff had made the diagnosis, there was little further delay over and above paramedic admissions. Naturally, the patients brought by the paramedics had an unequivocal diagnosis of acute myocardial infarction, but are those not indeed the patients that should be channelled rapidly towards thrombolysis? I accept that there were no arithmetical indicators to the numbers in the paper, but this study was merely an observational audit of an innovative new development. The calculations for the figure and for the numerical data were from different segments of the database interrogated, which may account for any differences in mean times. June Edhouse is concerned about the 11 min difference in mean time
THE LANCET • Vol 352 • December 19/26, 1998
occurrence of NSAID-induced peptic ulcers. These opposite conclusions from two studies create considerable confusion as to the best policy to adopt in the protection of H pylori-infected patients who need to take NSAIDs. In the attempt to reconcile these conflicting findings, difference in patient selection was held responsible for the opposite results.1 In fact, Hawkey and colleagues recruited H pylori-positive patients with current or previous peptic ulceration, dyspepsia, or both, who continued to use NSAIDs. By contrast, Chan and colleagues investigated patients positive for H pylori with no history of ulcer disease or dyspeptic symptoms before they started NSAIDs. From a practical point of view, however, patients on chronic therapy NSAID are only a small part of the population who takes this kind of medication. Most NSAID users need intermittent treatment for exacerbation of osteoarthritis or for episodic pain attacks of the musculoskeletal system due to various causes.5 Because not all patients can be treated, we wonder what is the best protection in those subsets of patients who are at higher risk of developing gastrointestinal complications, especially elderly patients and those who have already had an ulcer in the past. Is it more advisable to eradicate H pylori infection or to maintain the infectious condition to increase the benefit of acidsuppressant drugs in patients who need only short-term intermittent treatment with NSAIDs? *Vincenzo Savarino, Sergio Vigneri, Guido Celle *Dipartimento di Medicina Interna e Specialità Mediche, Università di Genova, 16132 Genova, Italy; and Istituto di Medicina Interna e Geriatria, Università di Palermo 1
2
3
4
5
Hawkey CJ, Tulassay Z, Szczepanski L, et al. Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Lancet 1998; 352: 106–21. Yeomans ND, Tulassay Z, Juhász L, et al. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: 719–26. Hawkey CJ, Jarrasch JA, Szczepanski L, et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: 727–34. Chan FKL, Sung JJY, Sydney Chung SC, et al. Randomised trial of eradication of Helicobacter pylori before non-steroidal antiinflammatory drug therapy to prevent peptic ulcers. Lancet 1997; 350: 975–79. Jones AC, Berman P, Doherty M. Non-steroidal anti-inflammatory drug usage and requirement in elderly acute hospital admissions. Br J Rheumatol 1992; 31: 45–48.
THE LANCET • Vol 352 • December 19/26, 1998
Author’s reply Sir—Francis Chan and Joseph Sung are right to emphasise that there is very little relation between dyspepsia and ulceration in NSAID users, but we did not regard dyspepsia as a risk factor for ulceration. As we stated, we recruited patients with significant dyspepsia, and those at high risk of ulceration because we believed (wrongly as it turned out) that H pylori eradication would improve dyspepsia but would not prevent ulcer recurrence. Francis Chan questions statistical power, but this is a difficulty for studies with negative results rather than positive results; the difference was so robust that it was detected with small numbers. Chan and colleagues found that curing H pylori with bismuth triple therapy did not impair the healing of complicated gastric or duodenal ulcers. Unfortunately, the abstract they cite does not contain these data so we don’t know whether endoscopy at 8 weeks might have missed a difference, or whether the results might be different after bismuth triple therapy. The primary objective of our study was to investigate the effect of H pylori eradication over 6 months. Chan’s failure to find evidence of a protective effect of H pylori eradication in patients with bleeding peptic ulcer validates our endoscopic approach. Thus, a sterile debate of whether treatments may affect ulcer complications differently to endoscopic ulcers can be avoided. We disagree with Manfred Stolte that endoscopy is an imprecise way to diagnose ulcers, since most of modern gastroenterology is based on it. He raises a false dichotomy in suggesting that some ulcers of H pylori-infected NSAID-users are due to H pylori and others to the NSAID; the evidence is that ulcers in this group have rather homogenous and predictable patterns of behaviour that are different both from pure NSAID ulcers and pure H pylori ulcers. We also disagree that NSAID ulcers are generally only oneoff ulcers. Vincenzo Saverino and co-workers raise a good question that is difficult to answer because there is no direct evidence. NSAID use in elderly patients is not intermittent as they suggest,1 but if they wish to use acid suppression to protect high-risk patients on NSAIDs they should not eradicate H pylori since this will reduce effectiveness. The effects of H pylori in other areas of health are unlikely to be relevant to NSAID users. There is no longer believed to be a causal association between H pylori and coronary disease. Whereas H pylori
predisposes to gastric cancer, NSAIDs abolish this risk.2 The most important point from our study is that the simple finding of H pylori is not an indication for eradication. Some disorders are improved by eradication, others are not. *C J Hawkey, on behalf of the HELP NSAID Study Group Division of Gastroenterology, University Hospital, Queen’s Medical Centre, Nottingham NG7 2UH, UK 1
2
Cullen DJE, for Nottingham NSAID 2000 Intervention Group, University Nottingham. Non-steroidal, anti-inflammatory drug exposure in the elderly: effect of treatment length and patient compliance. Gastroenterology 1994; 106: A6. Thun MJ. NSAID use and decreased risk of gastrointestinal cancers. Gastroenterol Clin North Am 1996; 25: 333–48.
Paramedic direct admission of heart-attack patients to coronary care unit Sir—David Sandler (Oct 10, p 1198)1 compares the time delays involved in different routes to thrombolysis. The time between onset of symptoms and the start of thrombolysis in the paramedic route is impressive. However, we are concerned about several issues that arise from this report. Only 278 (56%) patients admitted to the coronary care unit with confirmed myocardial infarction received thrombolysis. This proportion seems rather low. What contraindications prevailed in the patients who did not receive thombolysis? The absence of indicators of variations (SD) and arithmetical error make interpretation difficult. For example, in the figure, Sandler shows that the mean time for medical admissions unit patients between arrival in hospital and diagnosis is 118 min, whereas from the numerical data (time from arrival to thrombolysis [148 min] minus time between diagnosis and thrombolysis [25 min]) is 123 min, an inconsistency too large to be explained by any rounding of the time points involved, which number only three. Of the different components of the total time for the sequence from call to ambulance to thrombolysis, it is the time between arrival to hospital and diagnosis that is most different between the routes. Although this time is only 14 min for the family physician route and 18 min for the paramedic route, it is much higher (42 min) for patients seen in accident and emergency, and reaches an astonishing 118 (or 123?) min for
2017
CORRESPONDENCE
patients seen in the medical admissions unit. It is unfortunate for people with chest pain (and subsequently proven myocardial infarction) to wait and average of 2 h between arrival at hospital and diagnosis of acute myocardial infarction, and ironic that this diagnostic delay is five to six times longer when patients are admitted to a unit specifically designed to diagnose and treat medical emergencies. The only obvious explanation for this delay is that unlike the other routes, many of the patients in a medical admission unit would have presented without classic clinical features of myocardial infarction (such as chest pain) and hence an electrocardiogram (ECG) was done only after clinical suspicion was raised during the physician’s assessment. If this is the case, then the comparison of time to diagnosis between the different routes is invalid. If this is not the case—which would imply a mean 2 h wait in hospital for an ECG in patients with chest pain—then clearly the correct course of action is to improve staff numbers or training in the medical admissions unit. Furthermore, 347 (78%) of the 446 patients in Sandler’s report presented to the medical admissions unit or accident and emergency. Consequently, we infer from this study that an increase in resources in these areas would be most cost-effective. *L Ceri Davies, Darrel P Francis, Andrew J S Coats Department of Cardiology, Royal Brompton Hospital and Imperial College of Science, Technology and Medicine, London SW3 6NP, UK (email: [email protected]) 1
Sandler D. Paramedic direct admission of heart-attack patients to a coronary-care unit. 1998; 352: 1198.
Sir—David Sandler1 shows that paramedic direct admission of heartattack patients to a coronary-care unit (CCU) produced the shortest time between the call for an ambulance and thrombolysis (mean 95 min). There are several points that merit further discussion. We note that paramedic direct admission to the CCU was associated with an 11 min delay before arrival at hospital, compared with immediate transfer to the accident and emergency department. In the early phase of an evolving myocardial infarction, there is a high risk of developing arrhythmias, and, therefore, it would be pertinent to know the rate of adverse out-of-hospital events in these patients, compared with the group transported directly to hospital.
2018
A mean door to needle time of 39 min for paramedic direct admissions to the CCU is commendable, but direct comparison of this time with that for patients who attended the medical assessment unit is not appropriate. The paramedics have the opportunity to select out the easy cases. By contrast, patients who are handed on to the medical admissions unit may be those with less obvious ECG changes or a more complicated presentation, and 30–40% of patients who present with acute myocardial infarction are likely to fall into this category.2,3 It cannot be concluded from this data that direct admission to the CCU would reduce the mean door to needle time over the entire population, or would prevent a substantial number of deaths. We audited the provision of thrombolysis in Sheffield in 1996–97, and found that the shortest call to thrombolysis times occurred when patients attended the accident and emergency department and underwent thrombolysis there (mean 82 min). By contrast, patients admitted directly to the CCU by paramedics had much longer call to thrombolysis times (mean 125 min). Every effort needs to be made to shorten treatment delays for patients with acute myocardial infarction. There is no universal strategy that will deliver thrombolysis safely and efficiently in all populations, since facilities, expertise, and local conditions vary. As our comparative figures show, a system that works efficiently in one locality may not be the best system in another. Detailed audit of the provision of thrombolysis is essential if solutions are to be found at a local level. *June Edhouse, J Wardrope, F P Morris Accident and Emergency Medicine, Northern General Hospital NHS Trust, Sheffield S5 7AU, UK 1
2
3
Sandler DA. Paramedic direct admission of heart-attack patients to a coronary-care unit. Lancet 1998; 352: 1198. More R, Moore K, Quinn E, et al. Delay times in the administration of thrombolytic therapy: the Brighton experience. Int J Cardiol; 1995; 49: S39–46. Pell ACH, Miller HC, Robertson CE, Fox KAA. Effect of ‘fast-track’ admission for acute myocardial infarction on delay to thrombolysis. BMJ 1992; 304: 83–87.
Author’s reply Sir—Although L Ceri Davies and colleagues thought our thrombolysis rate of 56% “rather low”, it compares favourably with the European Secondary Prevention Study Group’s1 report of rates between 13% and 52% (median 36%; maximum 55%) in 4035 patients across 11 European countries.
Number of patients Thrombolysis not indicated Symptoms >12 h only No diagnostic ECG changes only Symptoms >12 h plus no ECG change
153 (70%) 23 85 45
Thrombolysis contraindicated Active bleeding Previous haemorrhagic CVA Stroke within 6 months Major trauma within 6 weeks Active gastrointestinal bleeding <6 months Suspected aortic dissection Active peptic ulcer symptoms Lengthy cardiopulmonary resuscitation Taking oral anticoagulants Diabetic retinopathy
58 (27%) 9 18 2 7 9
Number with good reason not to thrombolyse
211 (97%)
2 1 6 2 2
Reason for no thrombolytic therapy in 217 patients with proven acute myocardial infarction
In our study we decided not to use thrombolysis in 211 (97%) of the 217 patients with acute myocardial infarction because there was a good reason (table), and thus only six eligible patients were not thrombolysed. The apparent long delay to diagnosis of acute myocardial infarction in those patients admitted to the medical assessment unit was not caused by inadequate numbers of staffing or poor training. This delay was because these patients did not have clear-cut acute myocardial infarction when they presented with chest pains but without ECG changes. The diagnosis in these patients was made after observation, and repeated ECG and blood enzyme testing at the medical assessment unit. Surely we are not the only hospital to see a large number of such patients? However, the time to thrombolysis once the diagnosis was confirmed in these patients (25 min) compared favourably with the 21 min for paramedic patients. Thus, once the medical staff had made the diagnosis, there was little further delay over and above paramedic admissions. Naturally, the patients brought by the paramedics had an unequivocal diagnosis of acute myocardial infarction, but are those not indeed the patients that should be channelled rapidly towards thrombolysis? I accept that there were no arithmetical indicators to the numbers in the paper, but this study was merely an observational audit of an innovative new development. The calculations for the figure and for the numerical data were from different segments of the database interrogated, which may account for any differences in mean times. June Edhouse is concerned about the 11 min difference in mean time
THE LANCET • Vol 352 • December 19/26, 1998