Flying high?-Exploring the effect of red bull on blood pressure after microsurgical breast reconstruction in a randomized controlled trial.

BACKGROUND: A sufficiently high blood pressure (BP) is essential for flap perfusion after microsurgical breast reconstruction. However, postoperative hypotension is common after these procedures. Perioperative volume overload may increase flap-related complications, and postoperative vasopressor use may be limited depending on institutions. Red Bull has been shown to increase BP in several studies. We aimed to evaluate the effect of Red Bull on perfusion-related variables after microsurgical breast reconstruction. METHODS: We conducted a multicenter, prospective, randomized controlled trial. Female patients undergoing unilateral microsurgical breast reconstruction from June 2020 to October 2022 were randomly assigned to the intervention or control groups. The intervention group received 250 ml of Red Bull 2 h after surgery and twice on postoperative day (POD) 1. The control group received 250 ml still water at the respective intervals. BP was measured using a 24-hour monitoring device. Vasopressor use, fluid balance, and flap outcomes were compared. RESULTS: One hundred patients were included in the study. Both groups were comparable concerning age, body mass index, and caffeine consumption. Mean arterial and diastolic BP were significantly higher in the Red Bull group after the second drink in the morning of POD1 (p-value = 0.03 and 0.03, respectively). Vasopressor use was similar, with a tendency for less postoperative etilefrine in the Red Bull group (p-value = 0.08). No flap loss was observed. CONCLUSIONS: We observed increased mean arterial and diastolic BP in the Red Bull group after the second drink. Red Bull may be a useful adjunct after microsurgical breast reconstruction. LEVEL OF EVIDENCE: I, therapeutic.

Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial.

BACKGROUND: Maintaining a sufficiently high systolic blood pressure is essential for free flap perfusion after microsurgical breast reconstruction. Yet, many women undergoing these procedures have low postoperative systolic blood pressure. Intravenous volume administration or vasopressors may be needed to maintain systolic blood pressure above a predefined threshold. However, excessive volume administration may lead to volume overload and flap stasis, and the postoperative use of vasopressors may be limited depending on institutional standards. Additional nonpharmacological measures to raise blood pressure might be beneficial. Evidence suggests that the Red Bull energy drink could raise blood pressure. It has been shown to increase systolic and diastolic blood pressure in healthy volunteers and athletes. OBJECTIVE: The primary objective of this study is to determine the difference in systolic blood pressure between an intervention group receiving Red Bull and a control group receiving still water after microsurgical breast reconstruction. Secondary objectives include postoperative heart rate, 24-hour fluid balance, pain level, or necessity for revision surgery due to flap complications. METHODS: The Red Bull study is a prospective, multicenter randomized controlled trial comparing the effect of postoperative ingestion of Red Bull energy drink against still water in female patients undergoing unilateral microsurgical breast reconstruction. A total of 250 mL of Red Bull (intervention group) or 250 mL of still water (control group) will be administered to the study participants 2 hours postoperatively as well as for breakfast and lunch on postoperative day 1, amounting to a total volume of 750 mL per 24 hours. Female patients between 18 and 70 years of age undergoing unilateral microsurgical breast reconstruction will be included. Exclusion criteria are a history of arterial hypertension, cardiac rhythm disorder, diabetes mellitus, gastric or duodenal ulcer, thyroid disease, and current use of antihypertensive or antiarrhythmic drugs or thyroid hormones, as well as intolerance to Red Bull. RESULTS: Recruitment for the study started in June 2020 and was completed in December 2022. There is evidence that the Red Bull energy drink increases blood pressure in healthy volunteers and athletes. We hypothesize that postoperative ingestion of Red Bull will increase systolic blood pressure in women after microsurgical breast reconstruction. Red Bull could hence be used as a nonpharmacological adjunct to vasopressors or volume administration in women with hypotensive blood pressure after microsurgical breast reconstruction. CONCLUSIONS: This paper describes the Red Bull study trial protocol and analysis plan. The information will increase the transparency of the data analysis for the Red Bull study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04397419; https://clinicaltrials.gov/ct2/show/NCT04397419. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38487.

Comparing complications and perioperative teams in microsurgical breast reconstruction: retrospective cohort study.

Background: Subspecialization with dedicated perioperative teams has become common practice in some surgical disciplines. While surgeon experience, the number of surgeons involved, and enhanced recovery after surgery (ERAS) pathways are known factors affecting the outcome after microsurgical breast reconstruction, the impact of the perioperative team has not been studied. Methods: We conducted a retrospective cohort study consisting of a chart review of all patients who underwent microsurgical breast reconstruction from January 2019-April 2020. Surgery was performed by three microsurgeons at two institutions with different perioperative teams-one being a small clinic [private clinic (PC), 33 beds] and the other being a larger hospital [corporate hospital (CH), 335 beds]. Patients were grouped into two cohorts according to the institution where surgery was performed. The primary outcomes studied were frequency of revision surgery, flap loss and patient length-of-stay (LOS). Results: One hundred and fifty microsurgical breast reconstructions were performed in 125 patients. Demographic data [age, body mass index (BMI), current tobacco use, donor site] was found statistically comparable between both cohorts. In the PC cohort with fewer perioperative care providers, lower rates of revision surgery and flap loss were observed (P value =0.009 and 0.04, respectively). LOS was not significantly different between the two cohorts (P value =0.44). Conclusions: The outcome of microsurgical breast reconstruction depends on multiple factors. In this study, fewer flap complications occurred at the small clinic. One reason among others might be the lower number of perioperative care providers involved and hence higher likelihood of sharing microsurgical cases, which facilitates routine and ensures less variability in care. The value of perioperative team subspecialization in microsurgical breast reconstruction needs to be assessed in prospective studies.

Prospective Evaluation of Residual Breast Tissue After Skin- or Nipple-Sparing Mastectomy: Results of the SKINI-Trial.

OBJECTIVE: This study was designed to investigate the presence of residual breast tissue (RBT) after skin-sparing mastectomy (SSM) and nipple-sparing mastectomy (NSM) and to analyse patient- and therapy-related factors associated with RBT. Skin-sparing mastectomy and NSM are increasingly used surgical procedures. Prospective data on the completeness of breast tissue resection is lacking. However, such data are crucial for assessing oncologic safety of risk-reducing and curative mastectomies. METHODS: Between April 2016 and August 2017, 99 SSM and 61 NSM were performed according to the SKINI-trial protocol, under either curative (n = 109) or risk-reducing (n = 51) indication. After breast removal, biopsies from the skin envelope (10 biopsies per SSM, 14 biopsies per NSM) were taken in predefined radial localizations and assessed histologically for the presence of RBT and of residual disease. RESULTS: Residual breast tissue was detected in 82 (51.3%) mastectomies. The median RBT percentage per breast was 7.1%. Of all factors considered, only type of surgery (40.4% for SSM vs. 68.9% for NSM; P < 0.001) and surgeon (P < 0.001) were significantly associated with RBT. None of the remaining factors, e.g., skin flap necrosis, was associated significantly with RBT. Residual disease was detected in three biopsies. CONCLUSIONS: Residual breast tissue is commonly observed after SSM and NSM. In contrast, invasive or in situ carcinomas are rarely found in the skin envelope. Radicality of mastectomy in this trial is not associated with increased incidence of skin flap necrosis. ClinicalTrials.gov Identifier NCT03470909.

The use of tranexamic acid in microsurgery-is it safe?

BACKGROUND: An appropriate and adequate blood flow and oxygen delivery is paramount to free flap viability and success. The perioperative use of tranexamic acid (TXA) is associated with less risk for blood loss and blood transfusion in trauma, gynaecology, ear nose and throat (ENT) and orthopaedic surgery. As an antifibrinolytic drug, TXA has generally been avoided in microsurgery. The aim of this study is to evaluate the safety and benefit of using TXA in microsurgery. METHODS: We performed a retrospective single centre cohort study at the Pyramid Clinic, Zurich, Switzerland, including 98 free tissue transfers for breast reconstruction from 2011 to 2013. According to the estimated blood loss, up to 3 g TXA were administered intravenously in 63 free flaps perioperatively. RESULTS: No thrombosis (0%) of micro-anastomosis and 5 haematomas (10.0%) occurred after administration of TXA. In the control group, 1 thrombosis (3.0%) of a flap-vein and 6 haematomas (18.2%) occurred. Blood loss was significant lower (P<0.001) after administration of TXA. CONCLUSIONS: In this study, administration of TXA did not increase thrombosis in free tissue transfer and showed a reduced haematoma rate and significant reduction of blood loss. TXA is supposed to be safe and a reasonable adjunct for patients with anaemia and a higher intraoperative or postoperative blood loss.

Capsular contracture in implant based breast reconstruction-the effect of porcine acellular dermal matrix.

BACKGROUND: Irradiation of implant-based breast reconstructions (BR) is known to increase capsular contracture (CC) rates on average by 4-fold over non-irradiated reconstructions. The use of acellular dermal matrix (ADM) has been associated with lower CC rates in non-irradiated reconstructions (0-3%). Experimental and clinical studies suggest that ADM may also reduce CC rates in irradiated breasts. The aim of this study was to evaluate CC rates in non-irradiated and irradiated one- and two-stage BRs performed with the assistance of porcine ADM (PADM). METHODS: A single centre, retrospective, cohort study was designed from December 2008 to October 2012. A total of 200 immediate implant-based BRs were performed using PADM for inferior pole reinforcement. We included non-irradiated BR with a minimum follow up of 6 month from primary surgery (one stage) or from explantation of expander and implantation of the definitive implant (two stage). Of the postoperatively irradiated BR we included patients with 1 year or more follow up time from termination of radiotherapy. CC was graded using the conventional Spear-Baker classification and modified version for irradiated BR. According to the literature Grade III and IV CC were defined as clinically significant CC. RESULTS: Of 200 BRs with PADM, 122 were included in this study (84 non-irradiated and 38 irradiated). Sixty-five BR were one stage and 57 were two stage BR. Grade III/IV CC was remarkable low in non-irradiated (6%) and irradiated BR (13%). There was a non-significant trend to increased Grade III and IV CC in irradiated BR vs. non-irradiated BR (13% vs. 6%, P=0.216). In this study follow up time (P<0.001) and the stage of ADM reconstruction (two vs. one stage, P=0.022) were significant risk factors for occurrence of grade III/IV CC on univariate analysis and remained significant for the follow up time (P=0.013) and remarkable for the stages (P=0.093) in multivariate analysis. CONCLUSIONS: Our data support the current clinical evidence that ADM use in implant-based BR is associated with a reduced risk of CC when compared to the standard submuscular techniques in literature. The reduced risk is maintained in the setting of radiotherapy. Two stage procedures in our study population showed increased grade III/IV CC compared to one stage procedures with or without exposure to radiation.

An evaluation of resource utilisation of single stage porcine acellular dermal matrix assisted breast reconstruction: A comparative study.

OBJECTIVES: To evaluate resource utilization of single stage porcine acellular dermal matrix (ADM) assisted breast reconstruction compared with tissue expander (TE), latissimus dorsi flap and implant (LD/I) and latissimus dorsi flap and TE (LD/TE) reconstructive techniques. MATERIALS AND METHODS: Clinical data was collected for length of stay, operative time, additional hospitalisations and operative procedures, and outpatient appointments for 101 patients undergoing unilateral implant based breast reconstruction. Resources utilised by ADM (Strattice Reconstructive Tissue Matrix™) patients were analysed and compared to the resource usage of traditional techniques. RESULTS: 25 patients undergoing single stage ADM (ADM/I) were compared with 27 having TE, 32 having LD/I and 17 having LD/TE reconstructions. Follow up was 24 months. Compared to TE, ADM/I had similar length of stay and operative time, lower rate and number of additional procedures, fewer, shorter re-admissions (p < 0.05) and fewer appointments (p < 0.05). Compared to LD/TE, ADM/I had shorter length of stay and operative time (p < 0.05), lower rate and number of additional procedures, fewer, shorter re-admissions (p < 0.05) and fewer appointments (p < 0.05). Compared to LD/I, ADM/I had shorter length of stay (p < 0.05) and operative time (p < 0.05), fewer appointments, similar rate and number of additional procedures but required more and longer re-admissions. CONCLUSION: In our experience, unilateral single stage ADM/I was associated with fewer resources utilised in comparison with two staged TE and LD/TE reconstructions in both complication-free and complicated settings over a 24-month period, despite requiring aesthetic revision in 60.9% of patients. Compared to LD/I, resource utilisation was commensurate in complication-free and complicated settings.

Immediate breast reconstruction with acellular dermal matrix: factors affecting outcome.

BACKGROUND: The use of acellular dermal matrix (ADM) for coverage of the lower pole in immediate implant-based breast reconstruction has changed surgeons' practice. We present our experience using a porcine ADM (Strattice), focusing on short-term outcomes, patient selection, and technique adaptations that may influence outcome. METHODS: A two-center, retrospective, cohort study was performed from December 2008 to October 2012 at Guy's and St. Thomas' Hospitals, London, and Clinic Pyramide, Zürich. The study period was divided into two periods: Period 1 which spanned from December 2008 to October 2010 and Period 2 from January 2011 to October 2012 wherein technique adaptations were introduced. Short-term complications after reconstructive surgery were compared between Periods 1 and 2. RESULTS: A total of 149 patients underwent 200 reconstructions (110 one-stage and 90 two-stage) following oncologic (134 breasts) or prophylactic (66 breasts) mastectomy. The mean follow-up was 22.2 months. The total complication rate was 32.5%, including infection, 11.5%; hematoma, 5%; seroma, 10.5%; skin necrosis, 3.5%; and serious wound breakdowns with implant exposure, 1.5%. Complications resulted in 3% requiring an early exchange of implant/expander and in 12.5% requiring explantation. A significant reduction in total complications, infection, implant exposure, and implant loss were noted in Period 2. Multivariate analysis showed time period of surgery (Period 1), single-stage reconstruction, and patient characteristics (mastectomy weight>600 g, or body mass index (BMI)>30, or smoking) to be statistically significant risk factors for the development of postoperative complications. Neoadjuvant chemotherapy showed a trend towards higher complication rates. CONCLUSION: The high rate of early complications in this study was mostly related to patient characteristics and learning curves and highlights the importance of patient selection and technique principles in optimizing the outcome.

Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study.

OBJECTIVE: Vitamin D (D3) status is reported to correlate negatively with insulin production and insulin sensitivity in patients with type 2 diabetes mellitus (T2DM). However, few placebo-controlled intervention data are available. We aimed to assess the effect of large doses of parenteral D3 on glycosylated haemoglobin (HbA(1c)) and estimates of insulin action (homeostasis model assessment insulin resistance: HOMA-IR) in patients with stable T2DM. MATERIALS AND METHODS: We performed a prospective, randomised, double-blind, placebo-controlled pilot study at a single university care setting in Switzerland. Fifty-five patients of both genders with T2DM of more than 10 years were enrolled and randomised to either 300,000 IU D3 or placebo, intramuscularly. The primary endpoint was the intergroup difference in HbA(1c) levels. Secondary endpoints were: changes in insulin sensitivity, albuminuria, calcium/phosphate metabolism, activity of the renin-aldosterone axis and changes in 24-hour ambulatory blood pressure values. RESULTS: After 6 months of D3 supply, there was a significant intergroup difference in the change in HbA(1c) levels (relative change [mean ± standard deviation] +2.9% ± 1.5% in the D3 group vs +6.9% ± 2.1% the in placebo group, p = 0.041) as HOMA-IR decreased by 12.8% ± 5.6% in the D3 group and increased by 10% ± 5.4% in the placebo group (intergroup difference, p = 0.032). Twenty-four-hour urinary albumin excretion decreased in the D3 group from 200 ± 41 to 126 ± 39, p = 0.021). There was no significant intergroup difference for the other secondary endpoints. CONCLUSIONS: D3 improved insulin sensitivity (based on HOMA-IR) and affected the course of HbA(1c) positively compared with placebo in patients with T2DM.