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Reply to Jahangiri et al.

Reply to Jahangiri et al. Letters to the Editor / European Journal of Cardio-Thoracic Surgery 1021 alternatives’ in paragraph 90) to the patient and allowing the patient to invitation to them to see an operation and to discuss video images and tan- choose. To give further emphasis to the need to set out options, one of the gible materials. Leslie Hamilton’s commentary was separately commissioned judges (Lady Hale) added ‘it is not possible to consider a particular medical by the journal so we leave to him the matter of doctors’ duties to inform but procedure in isolation from its alternatives.’ (paragraph 109). in order to adequately inform patients, doctors themselves need to know In a recent lecture to a surgical audience, James Badenoch QC (Mrs what the operation entails so for the benefit of readers we will correct errors Montgomery’s Barrister in the Supreme Court) said, as part of the summary of of fact in the order in which they appear in the Jahangiri et al.’s letter. the doctor’s duty of disclosure, ‘Next, if in the doctor’s considered opinion 1. The diameter of the aorta at the level of leaflet apposition was 40–54 mm in there are any realistic, reasonable and potentially effective alternative treat- these patients, not <40 mm [2]. ments/procedures, describe them and their risks and benefits relative to the 2. There is published animal research for PEARS [3] and a further study is doctor’s proposed course (with an explanation if wished of why they are not accepted for publication. Where are the animal studies for other root the doctor’s first choice)’. operations? The discussion must be tailored to the individual patient so that they can be 3. PEARS had the support of industry from the outset (http://www.exstent.com). supported to make their own decision—even if it is one with which the 4. The Royal Brompton Hospital formally oversaw the introduction of the oper- surgeon does not agree. This will be hard for surgeons to accept as it goes ationinthe first 20 cases[4]. against the culture in which we have grown up. The UK Mental Capacity Act 5. NICE then conducted a Health Technology appraisal [5]. 2005 warns doctors that they must not allow the fact that the patient makes, 6. The mesh sleeve has a proximal hem, equivalent to an annuloplasty ring, what they feel is an unwise or unusual decision about their treatment, to influ- which is secured with sutures to the aorto-ventricular junction. This has not ence their view on whether the patient has capacity. The need to respect the failed to date. patient’s decision is emphasized in the recent guidance from the Royal 7. Thesingleinstanceofaorticregurgitation some yearsafter PEARSimplant- College of Surgeons of England [4]. ation was a result of the mesh being released anteriorly at emergency rester- All new procedures will, in the early stages, be open to the questions raised notomy, permitting continued local increase in diameter at the level of the in the thoughtful letter from Jahangiri and colleagues. At some point, a new commissures [5]. This the usual mechanism of aortic valve regurgitation in procedure will reach the stage of being included in the discussion. The chal- Marfan syndrome lenge in my Editorial Comment was to ask if PEARS could now be considered as a ‘realistic, reasonable and potentially effective alternative procedure?’ Any patient with Marfan syndrome may come back in need of a further op- Surgeons will have to make this difficult decision about new treatments. eration; that’s in the nature of a systemic disease. PEARS provides no absolute obstacles to further surgery and may present less of a problem than after root Conflict of interest: none declared. replacement [6]. With respect to the arithmetical calculations of case volume, as the number of surgeons adopting PEARS is increasing, the average number of cases per surgeon is likely to go down before it goes up: that’s just the way numbers work. The other concerns raised are understandable but we have REFERENCES too few words to address them all. They tend to be hypothetical, speculative, or expressions of fear of the unknown. Some of these unknowns are becoming 1 Jahangiri M, Leigh B, Cameron D. External aortic root support: a viable known from 341 patient years of follow-up in 92 patients to date. For the un- alternative treatment option? Consent and duty of candour. Eur J known unknowns, only time will tell. Cardiothorac Surg 2017;51:1020. The PEARS development team welcome enquiries about our work in 2 Hamilton L. When does an ‘emerging technology’ emerge into the thera- progress. peutic arena? Should we be offering personalized external aortic root sup- port? Eur J Cardiothorac Surg 2016;50:405. 3 Montgomery (Appellant) v Lanarkshire Health Board (Respondent) [2015] UKSC 11. REFERENCES 4 Consent: supported decision-making https://www.rcseng.ac.uk/library- and-publications/college-publications/docs/consent-good-practice-guide/ 1 Jahangiri M, Leigh B, Cameron D. External aortic root support: a viable (6 December 2016, date last accessed). alternative treatment option? Consent and duty of candour. Eur J Cardiothorac Surg 2017;51:1020. 2 Treasure T, Takkenberg JJ, Golesworthy T, Rega F, Petrou M, Rosendahl U *Corresponding author. Royal College of Surgeons, The Old Barn, Bridle Path, et al. Personalised external aortic root support (PEARS) in Marfan syn- Newcastle-upon-Tyne NE3 5EU, UK. Tel: þ44-191-2850052; e-mail: leslieha- drome: analysis of 1-9 year outcomes by intention-to-treat in a cohort of milton80@yahoo.co.uk (L. Hamilton). the first 30 consecutive patients to receive a novel tissue and valve- conserving procedure, compared with the published results of aortic root doi:10.1093/ejcts/ezw442 replacement. Heart 2014;100:969–75. Advance Access publication 16 March 2017 3 Verbrugghe P, Verbeken E, Pepper J, Treasure T, Meyns B, Meuris B et al. External aortic root support: a histological and mechanical study in sheep. Interact CardioVasc Thorac Surg 2013;17:334–9. 4 Treasure T, Crowe S, Chan KM, Ranasinghe A, Attia R, Lees B et al.A method for early evaluation of a recently introduced technology by deriv- ing a comparative group from existing clinical data: a case study in external support of the Marfan aortic root. BMJ Open 2012;2:e000725. 5 Treasure T, Pepper J, Golesworthy T, Mohiaddin R, Anderson RH. External a, b Tom Treasure *and John Pepper aortic root support: NICE guidance. Heart 2012;98:65–8. Clinical Operational Research Unit, Department of Mathematics, University 6 Treasure T, Petrou M, Rosendahl U, Austin C, Rega F, Pirk J et al. College London, London, UK Personalized external aortic root support: a review of the current status. Department of Cardiac Surgery, Royal Brompton Hospital, London, UK Eur J Cardiothorac Surg 2016;50:400–4. Received 16 December 2016 * Corresponding author. Clinical Operational Research Unit, University College Keywords: Marfan syndrome � Aortic root aneurysm � External aortic root of London, 4 Taviton Street, London, WC1H 0BT, UK. Tel: þ44-1233-740378; support fax: þ44-1233-740378; e-mail: tom.treasure@gmail.com (T. Treasure). Jahangiri and Cameron [1] have been fully informed about the personalised doi:10.1093/ejcts/ezx051 external aortic root support (PEARS) operation from the outset. We renew the Advance Access publication 16 March 2017 LETTERS TO THE EDITOR http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

Reply to Jahangiri et al.

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Oxford University Press
Copyright
© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
ISSN
1010-7940
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1873-734X
DOI
10.1093/ejcts/ezx051
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Abstract

Letters to the Editor / European Journal of Cardio-Thoracic Surgery 1021 alternatives’ in paragraph 90) to the patient and allowing the patient to invitation to them to see an operation and to discuss video images and tan- choose. To give further emphasis to the need to set out options, one of the gible materials. Leslie Hamilton’s commentary was separately commissioned judges (Lady Hale) added ‘it is not possible to consider a particular medical by the journal so we leave to him the matter of doctors’ duties to inform but procedure in isolation from its alternatives.’ (paragraph 109). in order to adequately inform patients, doctors themselves need to know In a recent lecture to a surgical audience, James Badenoch QC (Mrs what the operation entails so for the benefit of readers we will correct errors Montgomery’s Barrister in the Supreme Court) said, as part of the summary of of fact in the order in which they appear in the Jahangiri et al.’s letter. the doctor’s duty of disclosure, ‘Next, if in the doctor’s considered opinion 1. The diameter of the aorta at the level of leaflet apposition was 40–54 mm in there are any realistic, reasonable and potentially effective alternative treat- these patients, not <40 mm [2]. ments/procedures, describe them and their risks and benefits relative to the 2. There is published animal research for PEARS [3] and a further study is doctor’s proposed course (with an explanation if wished of why they are not accepted for publication. Where are the animal studies for other root the doctor’s first choice)’. operations? The discussion must be tailored to the individual patient so that they can be 3. PEARS had the support of industry from the outset (http://www.exstent.com). supported to make their own decision—even if it is one with which the 4. The Royal Brompton Hospital formally oversaw the introduction of the oper- surgeon does not agree. This will be hard for surgeons to accept as it goes ationinthe first 20 cases[4]. against the culture in which we have grown up. The UK Mental Capacity Act 5. NICE then conducted a Health Technology appraisal [5]. 2005 warns doctors that they must not allow the fact that the patient makes, 6. The mesh sleeve has a proximal hem, equivalent to an annuloplasty ring, what they feel is an unwise or unusual decision about their treatment, to influ- which is secured with sutures to the aorto-ventricular junction. This has not ence their view on whether the patient has capacity. The need to respect the failed to date. patient’s decision is emphasized in the recent guidance from the Royal 7. Thesingleinstanceofaorticregurgitation some yearsafter PEARSimplant- College of Surgeons of England [4]. ation was a result of the mesh being released anteriorly at emergency rester- All new procedures will, in the early stages, be open to the questions raised notomy, permitting continued local increase in diameter at the level of the in the thoughtful letter from Jahangiri and colleagues. At some point, a new commissures [5]. This the usual mechanism of aortic valve regurgitation in procedure will reach the stage of being included in the discussion. The chal- Marfan syndrome lenge in my Editorial Comment was to ask if PEARS could now be considered as a ‘realistic, reasonable and potentially effective alternative procedure?’ Any patient with Marfan syndrome may come back in need of a further op- Surgeons will have to make this difficult decision about new treatments. eration; that’s in the nature of a systemic disease. PEARS provides no absolute obstacles to further surgery and may present less of a problem than after root Conflict of interest: none declared. replacement [6]. With respect to the arithmetical calculations of case volume, as the number of surgeons adopting PEARS is increasing, the average number of cases per surgeon is likely to go down before it goes up: that’s just the way numbers work. The other concerns raised are understandable but we have REFERENCES too few words to address them all. They tend to be hypothetical, speculative, or expressions of fear of the unknown. Some of these unknowns are becoming 1 Jahangiri M, Leigh B, Cameron D. External aortic root support: a viable known from 341 patient years of follow-up in 92 patients to date. For the un- alternative treatment option? Consent and duty of candour. Eur J known unknowns, only time will tell. Cardiothorac Surg 2017;51:1020. The PEARS development team welcome enquiries about our work in 2 Hamilton L. When does an ‘emerging technology’ emerge into the thera- progress. peutic arena? Should we be offering personalized external aortic root sup- port? Eur J Cardiothorac Surg 2016;50:405. 3 Montgomery (Appellant) v Lanarkshire Health Board (Respondent) [2015] UKSC 11. REFERENCES 4 Consent: supported decision-making https://www.rcseng.ac.uk/library- and-publications/college-publications/docs/consent-good-practice-guide/ 1 Jahangiri M, Leigh B, Cameron D. External aortic root support: a viable (6 December 2016, date last accessed). alternative treatment option? Consent and duty of candour. Eur J Cardiothorac Surg 2017;51:1020. 2 Treasure T, Takkenberg JJ, Golesworthy T, Rega F, Petrou M, Rosendahl U *Corresponding author. Royal College of Surgeons, The Old Barn, Bridle Path, et al. Personalised external aortic root support (PEARS) in Marfan syn- Newcastle-upon-Tyne NE3 5EU, UK. Tel: þ44-191-2850052; e-mail: leslieha- drome: analysis of 1-9 year outcomes by intention-to-treat in a cohort of milton80@yahoo.co.uk (L. Hamilton). the first 30 consecutive patients to receive a novel tissue and valve- conserving procedure, compared with the published results of aortic root doi:10.1093/ejcts/ezw442 replacement. Heart 2014;100:969–75. Advance Access publication 16 March 2017 3 Verbrugghe P, Verbeken E, Pepper J, Treasure T, Meyns B, Meuris B et al. External aortic root support: a histological and mechanical study in sheep. Interact CardioVasc Thorac Surg 2013;17:334–9. 4 Treasure T, Crowe S, Chan KM, Ranasinghe A, Attia R, Lees B et al.A method for early evaluation of a recently introduced technology by deriv- ing a comparative group from existing clinical data: a case study in external support of the Marfan aortic root. BMJ Open 2012;2:e000725. 5 Treasure T, Pepper J, Golesworthy T, Mohiaddin R, Anderson RH. External a, b Tom Treasure *and John Pepper aortic root support: NICE guidance. Heart 2012;98:65–8. Clinical Operational Research Unit, Department of Mathematics, University 6 Treasure T, Petrou M, Rosendahl U, Austin C, Rega F, Pirk J et al. College London, London, UK Personalized external aortic root support: a review of the current status. Department of Cardiac Surgery, Royal Brompton Hospital, London, UK Eur J Cardiothorac Surg 2016;50:400–4. Received 16 December 2016 * Corresponding author. Clinical Operational Research Unit, University College Keywords: Marfan syndrome � Aortic root aneurysm � External aortic root of London, 4 Taviton Street, London, WC1H 0BT, UK. Tel: þ44-1233-740378; support fax: þ44-1233-740378; e-mail: tom.treasure@gmail.com (T. Treasure). Jahangiri and Cameron [1] have been fully informed about the personalised doi:10.1093/ejcts/ezx051 external aortic root support (PEARS) operation from the outset. We renew the Advance Access publication 16 March 2017 LETTERS TO THE EDITOR

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European Journal of Cardio-Thoracic Surgery – Oxford University Press

Published: May 1, 2017

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