British Thoracic Society guidelines for the management of suspected acute pulmonary embolism

doi:10.1136/thorax.58.6.470

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British Thoracic Society guidelines for the management of suspected acute pulmonary embolism

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Evidence-Based Thrombolysis with Alteplase in Massive Pulmonary Embolism
Michael T Henry
Published on: 29 April 2016
Reply: Clinical validity of negative CTPA
Andrew C Miller
Published on: 29 April 2016
Anticoagulation in suspected pulmonary embolism and negative Computed Computed tomographic pulmonary
Jaime Latour-Perez
Published on: 29 April 2016
Validation of the BTS pre-test probability score
A C Miller
Published on: 29 April 2016
Re: Surgical Pulmonary Embolectomy
Andrew C Miller
Published on: 29 April 2016
Validation of the BTS pre-test probability score
Christopher W.H. Davies
Published on: 29 April 2016
Surgical Pulmonary Embolectomy
Holger Klaus Eltzschig
Published on: 29 April 2016

Published on: 29 April 2016
Evidence-Based Thrombolysis with Alteplase in Massive Pulmonary Embolism
- Michael T Henry, Consultant Respiratory Physician
- Other Contributors:
  Toby Capstick, Pharmacy Department, Leeds General Infirmary, Leeds LS1 3EX
Dear Editor
We read with interest the guidelines for the management of suspected acute pulmonary embolism by the British Thoracic Society.[1] However, we were somewhat concerned about the recommendation of administering a 50mg intravenous bolus of alteplase for the treatment of patients with massive PE [grade C recommendation]. We believe that this recommendation is misleading as this advice is based on a case ser...
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Dear Editor
We read with interest the guidelines for the management of suspected acute pulmonary embolism by the British Thoracic Society.[1] However, we were somewhat concerned about the recommendation of administering a 50mg intravenous bolus of alteplase for the treatment of patients with massive PE [grade C recommendation]. We believe that this recommendation is misleading as this advice is based on a case series of just 6 patients, of whom 2 died.[2] There is also a paucity of data on the safety and efficacy of bolus dose alteplase compared to placebo and to other thrombolytic regimens.
There are only two small studies comparing bolus dose and standard infusions of alteplase,[3,4] neither of which were large enough to detect any significant difference in terms of thrombolytic efficacy or safety. There was, however, a slightly higher all cause mortality rate and death due to recurrent PE and major bleeding episodes in the bolus dose group in one study.[3]
We have reviewed the data on the safety and efficacy of bolus dose alteplase in comparison to standard alteplase infusions and have produced some worrying data on thrombolytic efficacy, safety and the Number Needed to Harm (NNH) if bolus dose alteplase is used in preference to standard infusions.
Standard alteplase infusions produce a statistically significantly greater rate of objectively measured thrombolysis compared to bolus dose regimens (67% of patients vs. 33% respectively, p=0.0007) corresponding to a NNH = 3 if practice was changed according to the BTS guidance. The resultant death rate due to the initial PE is consequently greater in patients receiving bolus dose alteplase (3.2% vs. 0.5%, p=0.01), equivalent to a NNH = 37. Bolus dose alteplase is also associated with a trend towards statistically significantly greater all cause mortality, deaths due to major bleeding events and recurrent PE and also a worse side effect profile (major bleeding episodes and recurrent PE).
The implications for practice from our review are that on the current available evidence, standard alteplase infusions are more effective and safer than bolus dose regimens. Thrombolytic treatment of massive PEs should continue to utilise the licensed alteplase infusion regimen rather than the bolus dose method recommended in the recent BTS guidance.
References
(1) British Thoracic Society Standards of Care Committee Pulmonary Embolism Guideline Development Group. British Thoracic Society guidelines for the management of suspected acute pulmonary embolism. Thorax 2003; 58: 470-484.
(2) Ruiz-Bailén M, Aguayo-de-Hoyos E, Seerano-Corcoles MC, et al. Thrombolysis with recombinant tissue plasminogen activator during cardiopulmonary resuscitation in fulminant pulmonary embolism: A case series. Resuscitation. 2001; 51: 97-101.
(3) Goldhaber SZ, Agnelli G, Levine MN, on behalf of the Bolus Alteplase Pulmonary Embolism Group. Reduced dose bolus alteplase versus conventional alteplase infusion for pulmonary embolism thrombolysis: An international multicenter randomized trial. Chest. 1994; 106: 718-724.
(4) Sors H, Pacouret G, Azarian R, et al. Hemodynamic effects of bolus versus 2-hr infusion of alteplase in acute massive pulmonary embolism: A randomized controlled multicenter trial. Chest. 1994; 106: 712-717.
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Conflict of Interest:
None declared.
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Published on: 29 April 2016
Reply: Clinical validity of negative CTPA
- Andrew C Miller, Consultant Physician
Dear Editor
Dr Latour-Perez's concerns[1] are anticipated on page 474 of our article, which summarises the results of three good quality studies using CTPA (not multi-slice) as the only imaging modality (references 187-189). Just after going to press we became aware of a recent excellent large multicentre study [2] with similar results. Combining these four of similar design (well conducted, CTPA only, no anticoagul...
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Dear Editor
Dr Latour-Perez's concerns[1] are anticipated on page 474 of our article, which summarises the results of three good quality studies using CTPA (not multi-slice) as the only imaging modality (references 187-189). Just after going to press we became aware of a recent excellent large multicentre study [2] with similar results. Combining these four of similar design (well conducted, CTPA only, no anticoagulation if PE excluded), the PE rate at 3 months is only 0.9% (10/1100). So, even though CTPA will miss some small PEs (also true of conventional pulmonary angiography) this possibility needn't worry clinicians.
References
(1) Latour-Perez J. Anticoagulation in suspected pulmonary embolism and negative Computed Computed tomographic pulmonary [electonic response to BTS Guidelines: British Thoracic Society guidelines for the management of suspected acute pulmonary embolism] thoraxjnl.com 2003 http://thorax.bmjjournals.com/cgi/eletters/58/6/470#87
(2) Van Strijen MJ, et al. Single-detector helical computed tomography as the primary diagnostic test in suspected pulmonary embolism: a multicenter clinical management study of 510 patients. Ann Intern Med 2003;138:307-314.
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Conflict of Interest:
None declared.
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Published on: 29 April 2016
Anticoagulation in suspected pulmonary embolism and negative Computed Computed tomographic pulmonary
- Jaime Latour-Perez, Staff Physician
Dear Editor
I would like to express my concern about the recent British Thoracic Society guidelines for the management of suspected acute pulmonary embolism,[1] which suggest that “Patients with a good quality negative CTPA do not require further investigation or treatment for PE.” [grade A recommendation]:
1. According to a recent well designed study,[2] the negative likelihood ratio of CTPA f...
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Dear Editor
I would like to express my concern about the recent British Thoracic Society guidelines for the management of suspected acute pulmonary embolism,[1] which suggest that “Patients with a good quality negative CTPA do not require further investigation or treatment for PE.” [grade A recommendation]:
1. According to a recent well designed study,[2] the negative likelihood ratio of CTPA for the diagnosis of pulmonary embolism is about 0.33. If we assume a pre-test probability is 78% (Well’s high clinical probability),[3] the probability of pulmonary embolism after a negative CTPA is about 54%. This figure looks too high to suspend the anticoagulant treatment.
2. The empirical evidence that supports the safety of withholding anticoagulant treatment in patients with negative CTPA is of poor quality:
- Most of the studies (cohort restrospective studies), do not exclude the possibility that the patients that were anticoagulated despite a negative CTPA (and consequently excluded from the studies) were more prone to recurrent thromboembolic events than patients in which anticoagulant treatment was stopped.
- In some patients, the diagnostic workup included other diagnostic tools to exclude deep venous thrombosis, besides CTPA.
- The magnitude of the loses to follow-up is often substantial, so we cannot confidently exclude the occurrence of thromboembolic events in these patients.
3. Probably the best evidence that supports the safety of stopping the anticoagulation comes from the study of Swensen et al.[4], a retrospective study based upon 1010 patients, with a low percent of loses to follow up and a low prevalence of anticoagulated patients. However, this study is based on a last generation multi-slice electron beam scanner, and its results cannot be extrapolated to the typical clinical environment.
Taking these points altogether, I consider that there are sound doubts about the safety of withholding anticoagulant treatment after negative CTPA findings, at least in patients with a high clinical probability of PE and with the usual radiologic environment. Probably, these conclusions should be revised according the new technological improvements.
References
(1) British Thoracic Society Standards of Care Committee Pulmonary Embolism Guideline Development Group. British Thoracic Society guidelines for the management of suspected acute pulmonary embolism. Thorax 2003;58:470–484
(2) Perrier A, Howarth N, Didier D, Loubeyre P, Unger PF, de Moerloose P, Slosman D, Junod A, Bounameaux H. Performance of Helical Computed Tomography in unselected outpatients with suspected pulmonary embolism. Ann Intern Med 2001;135:88-97.
(3) Wells PS, Ginsberg JS, Anderson DR, et al. Use of a clinical model for safe management of patients with suspected pulmonary embolism. Ann Intern Med 1998;129:997–1005.
(4) Swensen SJ, Sheedy PF, Ryu JH et al. Outcomes after withholding anticoagulation from patients with suspected acute pulmonary embolism and negative computed tomographic findings: a cohort study. Mayo Clin Proc 2002;77:130-138.
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Conflict of Interest:
None declared.
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Published on: 29 April 2016
Validation of the BTS pre-test probability score
- A C Miller, consultant physician
Dear Editor
British Thoracic Society guidelines for the management of suspected acute pulmonary embolism
It is indeed unsatisfactory to make such recommendations in the absence of prospective studies; three have now been published.[1-3] Although differing in the way clinical probability was evaluated and in the D-dimer assays used, all found that in combination many patients with suspected pulmonary embo...
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Dear Editor
British Thoracic Society guidelines for the management of suspected acute pulmonary embolism
It is indeed unsatisfactory to make such recommendations in the absence of prospective studies; three have now been published.[1-3] Although differing in the way clinical probability was evaluated and in the D-dimer assays used, all found that in combination many patients with suspected pulmonary embolism (PE) could safely be managed without further imaging or anticoagulation. These encouraging results suggest that the same is true with our simpler clinical model, originally conceived by extrapolation from the deep vein thrombosis study of Wells’s group and subsequently corroborated by them for PE.[4,5] A multi-centre study of patients seen by middle-grade doctors in district general hospitals is certainly very desirable.
A similar dilemma occurs in suspected subarachnoid haemorrhage (SAH), another potentially fatal condition with a wide differential diagnosis. Perhaps here too all should have an urgent CT scan, but in practice clinicians use clinical pointers to decide when this is unnecessary. Therefore, when updating our guidelines for PE (far commoner than SAH), we decided to continue with a promising (albeit unproven) suggestion because the two alternatives were less satisfactory. The first is that clinicians continue to make decisions based on either no or inadequate imaging, which should now be considered indefensible both medically and legally. The second is that all patients with suspected pulmonary embolism should undergo appropriate imaging, with major resource implications in a situation where the diagnosis will only be confirmed in 15-30% of cases. Although not yet irrefutable, evidence is growing that being selective in requesting such tests is possible and safe.
References
(1) M Rodger, Wells P, Makropoulos D, et al. The bedside investigation of pulmonary embolism diagnosis (BIOPED) study. Acad Emerg Med 2003;10:502.
(2) MG Leclercq, Lutisan JG, van Marwijk Kooy M, et al. Ruling out clinically suspected pulmonary embolism by assessment of clinical probability and D-dimer levels: a management study. Thromb Haemost 2003;89:97-103.
(3) JA Kline, Webb WB, Jones AE, et al. Impact of a clinical decision rule and a D-dimer plus alveolar deadspace measurement to rule out pulmonary embolism in an urban emergency department. Acad Emerg Med 2003;10:502.
(4) P Wells, Hirsh J, Anderson D, et al. Accuracy of clinical assessment of deep-vein thrombosis. Lancet 1995;345:1326-30.
(5) PS Wells, Ginsberg JS, Anderson DR, et al. Use of a clinical model for safe management of patients with suspected pulmonary embolism. Ann Intern Med 1998;129:997-1005.
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Conflict of Interest:
None declared.
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Published on: 29 April 2016
Re: Surgical Pulmonary Embolectomy
- Andrew C Miller, consultant physician
Dear Editor
The letter from Dr Eltzschig [1] refers to their paper showing that surgical embolectomy remains an option in severe pulmonary embolism. Firstly, this required "a multidisciplinary evaluation team with a widespread reputation for 24-hour availability, 7 days per week" (and over half of their patients had surgery during the weekend); there must be very few centres in the world who can offer such a service,...
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Dear Editor
The letter from Dr Eltzschig [1] refers to their paper showing that surgical embolectomy remains an option in severe pulmonary embolism. Firstly, this required "a multidisciplinary evaluation team with a widespread reputation for 24-hour availability, 7 days per week" (and over half of their patients had surgery during the weekend); there must be very few centres in the world who can offer such a service, and few patients would be able to reach them in time.
Secondly, they acknowledge that their improved mortality was almost certainly due to including many patients with submassive PE, a group in whom it is not even universally agreed that thrombolysis is superior to heparin.
Thirdly, an alternative to thrombolysis that could be more widely and readily available, and which only requires one experienced radiologist, is catheter fragmentation (as referenced in our guidelines).
This first-class Boston group are well placed to consider a study in which patients are randomised to these different treatment groups, and may find that the less invasive options are at least as effective as well as being more applicable to non-specialist centres.
References
(1) Eltzschig HK, Rosenberger P. Surgical Pulmonary Embolectomy [electronic response to British Thoracic Society guidelines for the management of suspected acute pulmonary embolism] thoraxjnl.com 2003 http://thorax.bmjjournals.com/cgi/eletters/58/6/470#66
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Conflict of Interest:
None declared.
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Published on: 29 April 2016
Validation of the BTS pre-test probability score
- Christopher W.H. Davies, Consultant Physician
Dear Editor
I would be grateful if the PE Guidelines Development Committee could clarify the validity of the pre-test probability (PTP) score which was quoted in the 1997 guidelines for PE and which reappears in the latest PE guidelines.
In the 1997 guidelines it clearly states that the suggested PTP score had not been validated, but was derived from the works of others in particular Wells in Canada. Howe...
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Dear Editor
I would be grateful if the PE Guidelines Development Committee could clarify the validity of the pre-test probability (PTP) score which was quoted in the 1997 guidelines for PE and which reappears in the latest PE guidelines.
In the 1997 guidelines it clearly states that the suggested PTP score had not been validated, but was derived from the works of others in particular Wells in Canada. However, although the latest guideline still refers to the simple PTP from 1997, none of the quoted references supporting its use in this National guideline, have formally validated the criteria. As so much emphasis is placed on the low or intermediate PTP score, combined with the D-Dimer result, in many cases excluding patients from further tests for PE, I wonder if we should be recommending a PTP score which has not been validated in an unselected cohort of patients with suspected or possible PE.
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Conflict of Interest:
None declared.
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Published on: 29 April 2016
Surgical Pulmonary Embolectomy
- Holger Klaus Eltzschig, Anesthesiologist
- Other Contributors:
  Peter Rosenberger
Dear Editor
With great interest, we read the guidelines for the management of suspected acute pulmonary embolism (PE) by the British Thoracic Society (June issue 2003).[1] In the discussion of treatment options, the guidelines state that surgical embolectomy should only be considered in cases with absolute contraindications to thrombolysis, which is rarely an important consideration in a life-threatening situat...
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Dear Editor
With great interest, we read the guidelines for the management of suspected acute pulmonary embolism (PE) by the British Thoracic Society (June issue 2003).[1] In the discussion of treatment options, the guidelines state that surgical embolectomy should only be considered in cases with absolute contraindications to thrombolysis, which is rarely an important consideration in a life-threatening situation.
In contrast to the guidelines, a recent study of surgical pulmonary embolectomy with the use of normothermic cardiopulmonary bypass liberalized these criteria. Patients with anatomically extensive pulmonary embolism and concomitant right heart failure were included and demonstrated a 1-month mortality rate of only 11% following surgical intervention.[2] The improved survival rates in this case series as compared to previous reports [3,4] may be related to advances in surgical technique, patient selection and the experience of cardiac surgeons and cardiac anesthesiologists with this operation. However, this report no longer confines surgical pulmonary embolectomy to a treatment of last resort reserved for clinically desperate circumstances. In contrast, centers that are experienced in performing pulmonary embolectomy may consider utilizing this therapeutic intervention more liberal in order to improve morbidity and mortality of patients suffering from severe PE.
References
(1) British Thoracic Society guidelines for the management of suspected acute pulmonary embolism. Thorax 2003;58(6):470-483.
(2) Aklog L, Williams CS, Byrne JG, Goldhaber SZ. Acute Pulmonary Embolectomy: A Contemporary Approach. Circulation 2002;105(12):1416-1419.
(3) Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ, 3rd. Predictors of survival after deep vein thrombosis and pulmonary embolism: a population-based, cohort study. Arch Intern Med 1999;159(5):445-53.
(4) Doerge H, Schoendube FA, Voss M, Seipelt R, Messmer BJ. Surgical therapy of fulminant pulmonary embolism: early and late results. Thorac Cardiovasc Surg 1999;47(1):9-13.
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Conflict of Interest:
None declared.
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