Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study - 04/02/19

Doi : 10.1016/S1470-2045(18)30781-2

Shelley Potter, PhD ^a,^b,^⁎ , Elizabeth J Conroy, MSc ^c, Ramsey I Cutress, ProfPhD ^e, Paula R Williamson, ProfPhD ^d, Lisa Whisker, MBChB ^f, Steven Thrush, MBBS ^g, Joanna Skillman, MA ^h, Nicola L P Barnes, MD ⁱ, Senthurun Mylvaganam, MA ^j, Elisabeth Teasdale ^k, Abhilash Jain, ProfPhD ^l,^m, Matthew D Gardiner, PhD ^l,^m, Jane M Blazeby, ProfMD ^a, Chris Holcombe, ProfMD ⁿ
on behalf of the
iBRA Steering Group^{^†}
All members of these groups are listed in the Supplementary Material E Teasdale is a patient representative

and the
Breast Reconstruction Research Collaborative^{^†}
All members of these groups are listed in the Supplementary Material E Teasdale is a patient representative

R Achuthan, I Adwan, S Aggarwal, M Ahmed, M Akelund, D Akolekar, O Al-Jibury, M Amanita, D Appleton, D Archampong, K Asgiersson, R Athwal, A Augusti, S Ayaani, S Bains, B Baker, E Baker, S Baldota, D Banerjee, S Barker, L Barr, P Barry, N Basu, S Bathla, N Bishop, G Boland, O A Branford, R Bright-Thomas, R Brindle, L Brock, V Brown, F Bux, G Byrne, H Cain, L Caldon, M Callaghan, A Carbone, R Carpenter, S Cawthorn, L Chagla, T Challoner, C Chalmers, R Chalmers, S Chambers, M Chana, N Chand, V Chandran, M Chandrashekar, H Charfare, J Chatterjee, S Chatterjee, R Chattopadhyay, A Chaudry, K Chin, K Chong, A Chouhan, C Choy, P Christopoulos, D Clarke, S Clarke, E Clayton, R Clifford, D Cocker, T Collin, N Collis, F Conroy, C Constantinou, A Conway, J Cook, N Coombs, K Cox, A Critchley, M Dakka, M Dani, R Daoud, L Darragh, S Darvesh, I Dash, S Datta, E Davies, S Dawson, E De Sousa, D Debnath, H Deol, H Devalia, R Di Micco, JR Dicks, J Dickson, N Dobner, G Dobson, N Dunne, D Egbeare, D El Sharief, D Elfadl, E Eltigani, D Enver, E Erel, A Evans, G Exarchos, E Fage, H Fatayer, C Fenn, D Ferguson, R Foulkes, J Franks, V Fung, M Galea, T Gandamihardja, A Gandhi, C Garnsey, C Gateley, J Gattuso, S Gawne, N Geerthan, A Ghattura, A Giaramadze, J Gill, AR Godden, S Goh, S Govindarajulu, S Goyal, T Graja, S Granger, M Green, K Grover, G Gui, R Gurung, E Gutteridge, A Hakim, A Halka, W Hamilton-Burke, I Hamo, C Harding-Mackean, A Hargreaves, S Harries, K Harris, P Harris, S Harrison, J Harvey, M Hashem, U Hassan, J Henderson, J Henton, S Hignett, K Hodgkins, K Horgan, S Horn, J Hu, A Hussain, J Iddon, A Iqbal, R Irri, T Irvine, G Irwin, A Iskender, A Ismail, C Ives, K James, R James, N Jiwa, M Jobson, S Joglekar, L Johnson, R Johnson, R Johnson, L Jones, M Ju Hwang, V Kalles, K Kanesalingam, I Karat, M Kaushik, K Kennedy, E Khalifa, H Khan, M Khanbhai, S Khawaja, H Khout, T Kiernan, B Kim, K Kirkpatrick, P Kiruparan, C Kirwan, M Kishore, P Kneeshaw, A Knight, S Kohlhardt, J Krupa, K Krupa, R Kuruvilla, C Laban, LM Lai, I Laidlaw, K Lambert, F Langlands, M Lansdown, N Laurence, S Laws, S Ledwidge, V Lefemine, H Lennon, R Linforth, K Little, A Luangsomboon, J Lund, J Maalo, L MacLennan, RD Macmillan, F MacNeil, TK Mahapatra, E Mallidis, P Mallon, N Manoloudakis, L Maraqa, S Marla, S Masood, J Massey, T Masudi, P Matey, F Mazari, S McCulley, K McEvoy, J Mcintosh, S McIntosh, S McKenzie, P McManus, J McNicholas, I Michalakis, N Mills, G Mitchell, S Monib, M Mullan, C Murphy, G Murphy, J Murphy, B Murthy, S Musa, G Nagra, R Nangalia, S Narayanan, R Nasr, C Navin, R Newton, S Nicholson, N Nuru, R O’Connell, J O’Donoghue, A Ogedegbe, OS Olayinka, S Olsen, G Osborn, C Osborne, H Osman, C Otieno, F Pakzad, A Park, S Parker, P Partlett, A Parvaiz, L Parvanta, G Patel, A Peel, L Peiris, M Pennick, A Peppe, D Perry, S Pilgrim, J Piper, S Poonawalla, E Popa, V Pope, P Pugh, D Rainsbury, K Ramsey, T Rasheed, R Rathinaezhil, T Rattay, D Ravichandran, M Reed, S Refsum, D Remoundos, K Rigby, S Robertson, A Robinson, J Robinson, N Roche, PJ Roy, M Runkel, J Rusby, S Saha, Z Saidan, M Salab, M Saleh, F Salem, A Sami, S Samlalsingh, N Sarfraz, R Shah, S Shaheed, Y Sharaiha, G Shetty, R Shotton, T Sircar, E Skene, S Sloan, B Smith, J Smith, L Soldanova, F Soliman, S Soumian, J Stevens, C Steventon, E Stewart-Parker, T Stringfellow, R Sutaria, R Sutton, H Sweetland, B Swiech, S Tadiparthi, H Tafazal, N Taheri, C Tait, M Tan, S Tang, A Tansley, S Tate, S Tayeh, A Taylor, J Taylor, P Thawdar, C Thomas, S Thomas, S Thomson, A Thorne, R Tillett, Z Tolkien, A Tomlins, A Topps, F Tsang, EJ Turner, P Turton, S Udayasankar, F Ugolini, E Vaughan Williams, R Vidya, B Vijaynagar, R Vinayagam, A Volleamere, V Voynov, S Waheed, T Walker, U Walsh, R Warner, R Waters, A Wilkins, K Williams, G Wilson, M Wiltsher, B Wooler, C Wright, M Wright, L Wyld, M Youssef, C Zabkiewicz, C Zammit, B Zeidan, D Zheng

^a Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK

^b Bristol Breast Care Centre, North Bristol NHS Trust, Bristol, UK

^c Clinical Trials Research Centre, University of Liverpool, Liverpool, UK

^d North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK

^e Faculty of Medicine, Cancer Sciences Unit, University of Southampton, Somers Cancer Research Building, University Hospital Southampton, Southampton, UK

^f Nottingham Breast Institute, Nottingham University Hospitals NHS Trust, Nottingham, UK

^g Breast Unit, Worcester Royal Hospital, Worcester, UK

^h Department of Plastic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK

ⁱ Nightingale Breast Unit, Manchester University NHS Foundation Trust, Manchester, UK

^j New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK

^k Patient representative, Liverpool, UK

^l Department of Plastic Surgery, Imperial College London NHS Trust, London, UK

^m Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Oxford, UK

ⁿ Linda McCartney Centre, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK

^* Correspondence to: Dr Shelley Potter, Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, BS8 2PS, UK Bristol Centre for Surgical Research Population Health Sciences Bristol Medical School Bristol BS8 2PS UK

Summary

Background

Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction—breast reconstruction with implants or expanders at the time of mastectomy—but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques.

Methods

In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.

Findings

Between Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8–10) experienced implant loss, 372 (18%, 16–20) required re-admission to hospital, and 370 (18%, 16–20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23–27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection).

Interpretation

Complications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction.

Funding

National Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.

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Vol 20 - N° 2

P. 254-266 - février 2019 Retour au numéro

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Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study - 04/02/19

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