Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort studyBACKGROUND: 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.
Hemostatic resuscitation is neither hemostatic nor resuscitative in trauma hemorrhageSirat Khan, Karim Brohi, Manik Chana et al.|The Journal of Trauma: Injury, Infection, and Critical Care|2014 BACKGROUND: Trauma hemorrhage continues to carry a high mortality rate despite changes in modern practice. Traditional approaches to the massively bleeding patient have been shown to result in persistent coagulopathy, bleeding, and poor outcomes. Hemostatic (or damage control) resuscitation developed from the discovery of acute traumatic coagulopathy and increased recognition of the negative consequences of dilutional coagulopathy. These strategies concentrate on early delivery of coagulation therapy combined with permissive hypotension. The efficacy of hemostatic resuscitation in correcting coagulopathy and restoring tissue perfusion during acute hemorrhage has not been studied. METHODS: This is a prospective cohort study of ROTEM and lactate measurements taken from trauma patients recruited to the multicenter Activation of Coagulation and Inflammation in Trauma (ACIT) study. A blood sample is taken on arrival and during the acute bleeding phase after administration of every 4 U of packed red blood cells (PRBCs), up to 12 U. The quantity of blood products administered within each interval is recorded. RESULTS: Of the 106 study patients receiving at least 4 U of PRBC, 27 received 8 U to 11 U of PRBC and 31 received more than 12 U of PRBC. Average admission lactate was 6.2 mEq/L. Patients with high lactate (≥5 mEq/L) on admission did not clear lactate until hemorrhage control was achieved, and no further PRBC units were required. On admission, 43% of the patients were coagulopathic (clot amplitude at 5 minutes ≤ 35 mm). This increased to 49% by PRBC 4; 62% by PRBC 8 and 68% at PRBC 12. The average fresh frozen plasma/PRBC ratio between intervals was 0.5 for 0 U to 4 U of PRBC, 0.9 for 5 U to 8 U of PRBC, 0.7 for 9 U to 12 U of PRBC. There was no improvement in any ROTEM parameter during ongoing bleeding. CONCLUSION: While hemostatic resuscitation offers several advantages over historical strategies, it still does not achieve correction of hypoperfusion or coagulopathy during the acute phase of trauma hemorrhage. Significant opportunities still exist to improve management and improve outcomes for bleeding trauma patients. LEVEL OF EVIDENCE: Epidemiologic study, level III.
A Practical Approach to Introducing Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), the Problems Encountered and Lessons LearnedManik Chana, Zane Perkins, Robbie Lendrum et al.|Journal of Endovascular Resuscitation and Trauma Management|2021 Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is an endovascular procedure which utilises a catheter- based balloon device to achieve aortic occlusion. The aim of this resuscitative measure is to improve blood pressure proximal to the occlusion site and therefore preserve cardiac and cerebral perfusion to prevent cardiac arrest. In addition, there is a relative reduction in arterial flow to the site of injury distal to the balloon. Endovascular techniques are gaining acceptance for the in-hospital management of haemorrhage; however, their use in pre-hospital care is still limited. This is due to several factors including the technical challenges, training and skill sets of pre-hospital care teams and the potential for harm of REBOA, particularly with extended balloon occlusion times. However, non-com pressible torso haemorrhage is associated with a mortality of approximately 50% and a significant proportion of these deaths occur in the pre-hospital phase of care. In the exsanguinating patient, resuscitative thoracotomy with direct aortic compression is often the only means to control haemorrhage. This resuscitative measure is now a more established pre-hospital intervention which has significantly improved outcomes in the context of penetrating trauma, particularly thoracic injury. However, in the context of blunt injury and subdiaphragmatic haemorrhage, the outcomes from pre-hospital resuscitative thoracotomy remain poor. We present our initial technique for successfully introducing REBOA for the pre-hospital management of exsanguinating pelvic or groin haemorrhage following trauma, our indications for REBOA and comments on the problems and limitations encountered, as well as the lessons learned.