A sub-study of the POISE-3 randomized trial examined effects of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury.

In this pre-specified sub-study of the POISE-3 trial, we examined the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of postoperative acute kidney injury (AKI). Altogether,7307 patients were included from 110 hospitals in 22 countries. Patients were 45 years and older, had or were at risk of atherosclerotic disease, took at least one antihypertensive medication, and were scheduled for noncardiac surgery. Hypotension-avoidance strategy: (i) target intraoperative mean arterial pressure (MAP) 80 mm Hg or over, (ii) on day of surgery and for two days after, hold renin-angiotensin-aldosterone system inhibitors and use other antihypertensives in stepwise fashion if systolic blood pressure (SBP) 130 mm Hg or more. Hypertension-avoidance strategy: (i) target intraoperative MAP 60 mm Hg or more, (ii) continue all antihypertensives before and after surgery. Primary outcome: postoperative AKI, an increase in serum creatinine concentration of either 26.5 µmol/L or more (0.3 mg/dL or more) within 48 hours of randomization or 50% or more within seven days of randomization. The hypotension-avoidance group (3654 patients) used fewer antihypertensive medications than the hypertension-avoidance group (3653 patients); specifically, 6% vs. 38% used an ACEI or ARB on the day of surgery, and 6% vs. 47% and 7% vs. 50% one and two days after surgery, respectively. Patients also spent about half as much intraoperative time with a MAP under 80 mm Hg (27 vs 60 minutes, respectively), but had little difference in average BP before or after surgery. There was no significant difference in AKI risk (15.1% vs. 14.4%). Results were consistent with other definitions of AKI and in patients with preexisting chronic kidney disease. Thus, a hypotension-avoidance strategy targeting a MAP greater than 80 mm Hg in the operating room and discontinued blood pressure medication during the perioperative period did not confer a lower risk of AKI compared to a hypertension avoidance strategy.

Mortality, perioperative complications and surgical timelines in hip fracture patients: Comparison of the Spanish with the non-Spanish Cohort of the HIP ATTACK-1 trial.

BACKGROUND: Hip fractures carry a substantial risk of complications and death. This study aimed to report the 90-day incidence of mortality, major perioperative complications and in-hospital timelines after a hip fracture in the Spanish HIP ATTACK-1 trial cohort, comparing with the non-Spanish cohort. METHODS: Prospective cohort study of Spanish patients nested in the HIP ATTACK-1 trial. The HIP ATTACK-1 was an international, randomized, controlled trial (17 countries, 69 hospitals, 7 in Spain, highest recruiting country). Patients were randomized to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. Participants were ≥45 years of age who presented with a low-energy hip fracture requiring surgery. RESULTS: Among 534 patients in the Spanish cohort, 69 (12.9 %) patients died at 90 days follow-up, compared to 225 (9.2 %) in the non-Spanish cohort (p = 0.009), mostly due to higher nonvascular related mortality. A composite of major postoperative complication occurred in 126 patients (23.6 %). The most common perioperative complications were myocardial injury (189 patients, 35.4 %), infection with no sepsis (86 patients, 16.1 %) and perioperative delirium (84 patients, 15.7 %); all these complication rates in Spain were significantly higher than the non-Spanish patients (29.2 % p = 0.005; 11.9 % p = 0.008 and 9.2 % p < 0.0001, respectively). Spanish cohort patients were older and had more comorbidities than the non-Spanish cohort, evidencing their greater frailty at baseline. Among Spanish patients, the median time from hip fracture diagnosis to surgery was 30.0 h (IQR 21.1-53.9) in the standard-care group, with 68.8 % of patients receiving surgery within 48 h of diagnosis. This median time was lower in the non-Spanish cohort (22.8 h, IQR 9.5-37.0), where 82.1 % of patients were operated within 48 h. CONCLUSIONS: In the HIP ATTACK-1 trial, 1 in 8 patients died 90 days after a hip fracture in Spain. The most common complication after a hip fracture was myocardial injury, followed by infection and delirium. Spanish patients had worse outcomes than non-Spanish patients. Research needs to focus on new interventions such as accelerated surgery and perioperative troponin measurement with the appropriate investment of resources, to prevent and identify early these complications with a goal of improving mortality for this high-risk population. LEVEL OF EVIDENCE: II.

Predictors of outcomes after internal fixation of periprosthetic femoral hip fractures Subgroup analysis of the peri-implant and peri-prosthetic fractures Spanish registry (PIPPAS).

PURPOSE: To identify risk factors predisposing patients to poor outcomes after fixation of periprosthetic hip fractures around femoral stems. METHODS: Prospective multicentre cohort study of fractures around a hip replacement stem managed by internal fixation. The primary outcome was one-year mortality, while secondary outcomes were local complications and healthcare burden-related outcomes (nursing facility utilization and hospital length of stay). RESULTS: One-year mortality was 16.2%. Age-adjusted Charlson Comorbidity Index score (OR=1.17; 95%CI=1.03-1.33)), Pfeiffer Short Portable Mental Status Questionnaire (SPMSQ) score (OR=1.16; 1.06-1.28), prosthetic dysfunction (OR=1.90; 1.00-3.61), and postoperative medical complications (OR=1.97; 1.06-3.68) were predictors of mortality. Patients with prior prosthetic dysfunction, lower Pfeiffer SPMSQ scores, Vancouver A fractures, and fractures fixed only using cerclages were at higher risk of local complications, which occurred in 9.3% of cases. Medical (OR=1.81; 1.05-3.13) and local complications (OR=5.56; 2.42-3.13) emerged as consistent risk factors for new institutionalization. Average hospitalization time was 13.9±9.2 days. Each day of fixation delay led to an average 1.4-day increase in total hospitalization. CONCLUSION: Frail periprosthetic hip-fracture patients with poorer functional status, dysfunctional replacements, and postoperative complications are at increased risk of mortality. Postoperative complications are more common in patients with dysfunctional arthroplasties, Vancouver A fractures, and fixation using cerclages alone. Postoperative complications were the most consistent predictor of higher healthcare resource utilization.

Is immediate weight bearing safe for subtrochanteric femur fractures in elderly patients treated by cephalomedullary nailing? A multicentric study in one hundred eighty-two patients.

PURPOSE: Biomechanical superiority of intramedullary nails over extramedullary implants has been proved for subtrochanteric fractures. Nevertheless, postoperative management of these patients has not changed, with high rates of protected weight-bearing after intramedullary nailing. The purpose of this study is to determine the mechanical complications of immediate postoperative full weigh-bearing for subtrochanteric femur fractures in elderly patients treated with a cephalomedullary nail. METHODS: We performed a retrospective case series study from patients treated with a cephalomedullary nail for subtrochanteric fractures (AO/OTA 31A.3 and 32A-32C) over a nine-year period. Patients in the immediate full weight-bearing (IFWB) group received orders for immediate full weight bear as tolerated on postoperative 48 h. Patients in the non- or limited- weight-bearing (NLWB) group received orders not to full weight bear in the immediate postoperative. RESULTS: There were five (2.7%) cases of implant failure including four cutouts and one nail breakage that needed a reoperation. Of them, one (2.2%) followed the NLWB protocol and four (2.9%) followed the IFWB protocol. Mean length of stay was 7.9 days (median 8, range 3-21) in the NLWB group and 10.7 days (median 8, range 2-60) in the IWBAT group. The NLWB group observed a 2.8-day shorter postoperative length of stay when compared to the IFWB, but the median remained equal. CONCLUSION: This study suggests that geriatric patients with subtrochanteric fractures treated by intramedullary nailing and in which a good fracture reduction was achieved, may be able to tolerate immediate postoperative full weight-bearing, not increasing reoperation rates due to implant failure.

Differences in Colorectal Cancer Survival Based on Primary Tumor Location: Retrospective Study from a Single Institution.

Objective: The location of the primary tumor in colorectal cancer (CRC) could be a prognostic factor related to survival. However, its usefulness has not been sufficiently analyzed. The results in patients with tumors in initial stages are very limited, and there are descriptive parameters of survival that have not been analyzed in detail. In this study, the relationship between primary tumor location and survival in CRC patients was analyzed. Materials And Methods: This was a retrospective observational study. All patients treated consecutively for CRC between January 2005 and December 2019 in the same hospital center were included. Overall survival (OS), cancer-related survival (CRS), time to recurrence (TTR), relapse-free survival (RFS) and postrecurrence survival (PRS) were analyzed, and the results were classified by tumor stage. The results were compared among patients with right colon (RS), left colon (LS) and rectal tumors. Results: In the entire cohort, patients with RS tumors had lower OS and lower CRS at 60 months after diagnosis than did patients with LS or rectal tumors. In the regression analysis, the localization of the primary tumor was an independent prognostic indicator for OS and CRS. Analysis by tumor stage showed that patients with RS stage III tumors had lower OS and lower CRS at 60 months than did patients with LS and rectal tumors (42%, 59% and 53%, respectively, p = 0.006; and 48%, 63% and 57%, respectively, p = 0.025). Additionally, patients with RS Stage IV tumors had lower OS and lower CRS at 36 months than did patients with LS and rectal tumors (9%, 24%, 24%, respectively, p < 0.001; and 10%, 24% and 24%, respectively, p < 0.001). No differences were found in TTR and RFS among patients with stage I and II RS, LS, and rectal tumors. In contrast, patients with stage RS III tumors had significantly poorer PRS (9% for RS tumors, 13% for LS tumors, and 22% for rectal tumors) (p < 0.001). Conclusion: The location of the primary tumor in patients with CRC is related to survival. The effect of laterality is more marked in patients with stage III and IV tumors. Patients with RS tumors had lower OS and CRS due to the lower survival of patients with stage IV RS tumors and lower PRS for patients with stage III tumors.

Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.

BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. CONCLUSION: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

AO/OTA type C3 distal humeral fractures in patients aged 75 years and older: Is ORIF with double precontoured anatomical locking plates a reliable treatment?

INTRODUCTION: The incidence of osteoporotic distal humeral fractures (DHF) is on the rise. Their operative management is demanding. Fixation with non-locking reconstruction plates was associate with a high number of complications. Elbow arthroplasty (total or hemi) has been proposed as an alternative treatment, in spite of lifetime activity restrictions, and risk of complications, unknown implant survival and problematic revision surgery. Precontoured anatomical locking plates have increased the strength of the fixation in complex fractures. HYPOTHESIS: double plating ORIF with precontoured anatomical locking plates is a safe and reliable treatment option for the management of AO/OTA type C3 DHF in patients aged 75 and older. PATIENTS AND METHODS: A retrospective case series study of patients aged 75 years old and older with an AO/OTA type C3 DHF treated with ORIF with double precontoured anatomical locking plates between 2007 and 2021. Pathologic fractures were excluded. Patients' demographic, surgical, clinical, and radiological data were reviewed. RESULTS: A total of 27 women and 3 men, mean age of 80.1 years (range 75-93 years), were included. Mean Charlson index was 5 (range 3-8). Out of 30 patients, 19 had already died. Mean survival time after the surgical treatment was 72.3 months. Mean Mayo elbow performance score was 88.9 (range 60-100); 23 patients scored excellent or good. All fractures healed with no cases of delay union or non-union, hardware failure or loss of reduction. No patient needed a revision surgery to arthroplasty. The total number of complications was 12 (40%), mainly ulnar neuropathy (5) and cerclage removal (4). CONCLUSION: ORIF with double pre-contoured locking plates may be a safe and reliable treatment for type C3 DHF in patients aged 75 years and older, with a good functional outcome. Complications are expected but not related to loss of reduction, fixation failure or revision to elbow arthroplasty.

Tranexamic Acid in Patients Undergoing Noncardiac Surgery.

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).

Impact of subtrochanteric fractures in the geriatric population: better pre-fracture condition but poorer outcome than pertrochanteric fractures: evidence from the Spanish Hip Fracture Registry.

BACKGROUND: Clinical management in orthogeriatric units and outcome indicators are similar for extracapsular fragility hip fractures, without discriminating between subtrochanteric and pertrochanteric fractures. HYPOTHESIS: Geriatric patients, 75 years or older, with subtrochanteric fractures have worse clinical and functional outcomes than those with pertrochanteric fractures. MATERIALS AND METHODS: Retrospective observational study of data prospectively collected by the Spanish Hip Fracture Registry including patients 75 years or older, admitted for extracapsular hip fractures from January 2017 to June 2019. Demographic and baseline status, pre-operative, post-operative and 30-day follow-up data were included. RESULTS: A total of 13,939 patients with extracapsular hip fractures were registered: 12,199 (87.5%) pertrochanteric and 1740 (12.5%) subtrochanteric. At admission, patients with subtrochanteric fractures were younger (86.5 ± 5.8 versus 87.1 ± 5.6 years old), had better pre-fracture mobility (3.7 ± 2.7 versus 3.9 ± 2.8) (1-to-10 scale, 1 being independent) and were more likely to be living at home; those with pertrochanteric fractures had worse cognitive function (Pfeiffer 3.3 ± 3.3 versus 3.8 ± 3.5). The subtrochanteric fracture group showed worse post-fracture mobility (7.3 ± 2.7 versus 6.7 ± 2.7) and greater deterioration of mobility (3.7 ± 3.0 versus 2.9 ± 2.7). Among individuals living at home at baseline, those with subtrochanteric fractures were more likely to remain in an assisted facility at 30-day follow-up. In-hospital mortality during acute admission was higher for the subtrochanteric group (5.6% versus 4.5%) (p = 0.028). To our knowledge, this is the first paper highlighting the differences between these two fracture groups in the geriatric population. CONCLUSIONS: Subtrochanteric fractures in the older population are a different and worse entity, with greater morbimortality and functional decline than pertrochanteric fractures. Despite being younger and fitter at admission, older patients with subtrochanteric fractures have a higher risk of remaining non-weight bearing and undergoing re-operation and institutionalization. Orthogeriatric units should be aware of this and manage subtrochanteric fractures accordingly. LEVEL OF EVIDENCE: IV.

Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery.

BACKGROUND: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. METHODS: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. DISCUSSION: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.

Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial.

BACKGROUND: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. OBJECTIVE: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. DESIGN: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). INTERVENTION: If the presurgery systolic blood pressure (SBP) is <130 mmHg, all antihypertensive medications are withheld on the morning of surgery. If the SBP is ≥130 mmHg, some medications (but not angiotensin receptor blockers [ACEIs], angiotensin receptor blockers [ARBs], or renin inhibitors) may be continued in a stepwise manner. During surgery, the patients' mean arterial pressure (MAP) is maintained at ≥80 mmHg. During the first 48 hours after surgery, some antihypertensive medications (but not ACEIs, ARBs, or renin inhibitors) may be restarted in a stepwise manner if the SBP is ≥130 mmHg. CONTROL: Patients receive their usual antihypertensive medications before and after surgery. The patients' MAP is maintained at ≥60 mmHg from anesthetic induction until the end of surgery. SETTING: Recruitment from 108 centers in 22 countries from 2018 to 2021. PATIENTS: Patients (~6800) aged ≥45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications. MEASUREMENTS: The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ≥26.5 µmol/L (≥0.3 mg/dL) within 48 hours of randomization or ≥50% within 7 days of randomization. METHODS: The primary analysis (intention-to-treat) will examine the relative risk and 95% confidence interval of acute kidney injury in the intervention versus control group. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by preexisting chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate <60 mL/min/1.73 m2. RESULTS: Substudy results will be analyzed in 2022. LIMITATIONS: It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury. CONCLUSIONS: This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury.

CONTEXTE: La plupart des patients qui prennent des médicaments antihypertenseurs continuent de les prendre le matin d'une intervention chirurgicale et pendant la période périopératoire. De plus en plus de preuves suggèrent que cette pratique pourrait entraîner l'hypotension périopératoire et augmenter le risque de complications. Ce protocole décrit une sous-étude sur l'insuffisance rénale aiguë (IRA) découlant de l'essai Perioperative Ischemic Evaluation-3 (POISE-3). Cet essai teste l'effet d'une stratégie d'évitement de l'hypotension périopératoire par rapport à une stratégie d'évitement de l'hypertension chez des patients qui subissent une chirurgie non cardiaque. OBJECTIFS: Cette sous-étude de l'essai POISE-3 vise à déterminer si une stratégie d'évitement de l'hypotension périopératoire réduit le risque d'IRA comparativement à la stratégie d'évitement de l'hypertension. TYPE D'ÉTUDE: Essai clinique randomisé à répartition 1:1 au groupe intervention (stratégie d'évitement de l'hypotension périopératoire) ou au groupe témoin (stratégie d'évitement de l'hypertension). GROUPE INTERVENTION: Si la pression artérielle systolique (PAS) avant l'opération est <130 mmHg, tous les médicaments antihypertenseurs sont suspendus le matin de la chirurgie. Si la PAS est ≥130 mmHg, certains médicaments (excluant les inhibiteurs de l'enzyme de conversion de l'angiotensine [IECA], les antagonistes du récepteur de l'angiotensine [ARA] ou les inhibiteurs de la rénine) peuvent être poursuivis de façon graduelle. Pendant la chirurgie, la pression artérielle moyenne (PAM) du patient est maintenue à ≥80 mmHg. Dans les 48 heures suivant l'intervention chirurgicale, certains médicaments antihypertenseurs (excluant les IECA, les ARA ou les inhibiteurs de la rénine) peuvent être réintroduits par étapes si la PAS est ≥130 mmHg. GROUPE TÉMOIN: Les patients reçoivent leurs médicaments antihypertenseurs habituels avant et après la chirurgie. La PAM du patient est maintenue à ≥60 mmHg de l'induction de l'anesthésie à la fin de l'intervention chirurgicale. CADRE: Recrutement à partir de 108 centres dans 22 pays entre 2018 à 2021. SUJETS: Des patients (~6 800) âgés de 45 ans et plus atteints d'athérosclérose, ou présentant un risque de l'être, devant subir une chirurgie non cardiaque et prenant des médicaments antihypertenseurs sur une base régulière. MESURES: Le principal critère d'évaluation de cette sous-étude est une IRA postopératoire définie par une hausse d'au moins 26,5 µmol/L (≥0,3 mg/dL) de la créatinine sérique dans les 48 heures suivant la randomisation ou d'au moins 50 % dans les 7 jours suivant la randomisation. MÉTHODOLOGIE: L'analyse primaire (par intention de traiter) examinera le risque relatif d'une IRA et l'intervalle de confiance à 95 % dans le groupe intervention par rapport au groupe témoin. Nous répéterons l'analyse primaire en utilisant d'autres définitions de l'IRA et nous examinerons la modification de l'effet en présence d'une insuffisance rénale préexistante (définie par un DFGe prérandomisation <60 ml/min/1,73 m2). RÉSULTATS: Les résultats de cette sous-étude seront analysés en 2022. LIMITES: Il n'est pas possible de procéder à l'insu des patients ou des prestataires de soins pour cette intervention; des mesures objectives seront toutefois utilisées pour évaluer l'IRA. CONCLUSION: Cette sous-étude fournira des estimations généralisables de l'effet d'une stratégie visant à éviter l'hypotension périopératoire sur le risque d'insuffisance rénale aiguë.

Custom IMU-Based Wearable System for Robust 2.4 GHz Wireless Human Body Parts Orientation Tracking and 3D Movement Visualization on an Avatar.

Recent studies confirm the applicability of Inertial Measurement Unit (IMU)-based systems for human motion analysis. Notwithstanding, high-end IMU-based commercial solutions are yet too expensive and complex to democratize their use among a wide range of potential users. Less featured entry-level commercial solutions are being introduced in the market, trying to fill this gap, but still present some limitations that need to be overcome. At the same time, there is a growing number of scientific papers using not commercial, but custom do-it-yourself IMU-based systems in medical and sports applications. Even though these solutions can help to popularize the use of this technology, they have more limited features and the description on how to design and build them from scratch is yet too scarce in the literature. The aim of this work is two-fold: (1) Proving the feasibility of building an affordable custom solution aimed at simultaneous multiple body parts orientation tracking; while providing a detailed bottom-up description of the required hardware, tools, and mathematical operations to estimate and represent 3D movement in real-time. (2) Showing how the introduction of a custom 2.4 GHz communication protocol including a channel hopping strategy can address some of the current communication limitations of entry-level commercial solutions. The proposed system can be used for wireless real-time human body parts orientation tracking with up to 10 custom sensors, at least at 50 Hz. In addition, it provides a more reliable motion data acquisition in Bluetooth and Wi-Fi crowded environments, where the use of entry-level commercial solutions might be unfeasible. This system can be used as a groundwork for developing affordable human motion analysis solutions that do not require an accurate kinematic analysis.

Patient Satisfaction Using a Home-Based Rehabilitation Protocol for the Non-Surgical Treatment of Proximal Humeral Fractures: A Prospective Longitudinal Cohort Study.

Supervised, center-based, daily physiotherapy presents limitations: transport, need for an accompanying person, or risk of infection. Home-based rehabilitation protocols (HBRP) can be effective alternatives. We use a HBRP for the non-surgically treated proximal humeral fractures (PHF) in older patients. OBJECTIVES: To assess patient satisfaction and preferences of using a booklet, videos, or an app to guide physiotherapy. PATIENTS AND METHODS: Prospective, single-center observational study of patients ≥55 years old who sustained a non-surgically treated PHF. The HBRP consisted of immediate mobilization, followed by 5 physiotherapist-guided, weekly sessions of rehabilitation and standard physiotherapy after 3 months, if needed. A booklet with images, videos, or a smartphone application were offered to guide the patients. RESULTS: Mean degree of satisfaction (1-5) was 4.66 ± .9: 84 patients (82.4%) were very satisfied, 11 patients (10.8%) were satisfied, and 5 patients (4.9%) were not satisfied at all. Mean Oxford Shoulder Score achieved was 40.5 ± 6.6. 59.8% patients preferred the booklet and 29.4% the videos. Exercise compliance was considered very high in 87.3% of patients, while 4% hardly never followed the HBRP. Only 17.7% patients needed center-based physiotherapy after the HBRP. DISCUSSION: Reasons for satisfaction were good final functional outcome, no need for transportation, being away from hospital, immediate rehabilitation availability and being capable of maintaining independence. Adherence is a major concern. Videos are more didactic explaining the exercises. CONCLUSION: If standard physiotherapy is not available, the HBRP can be a valid treatment option for PHF management in older patients, with a high degree of patient satisfaction. Older patients preferred the booklet to guide physiotherapy.

MIPO helical pre-contoured plates in diaphyseal humeral fractures with proximal extension. Surgical technique and results.

INTRODUCTION: The aim of this study was to determine the feasibility of applying the MIPO technique with a helical-shaped plate in the treatment of humeral shaft fractures with proximal extension. PATIENTS AND METHODS: We present an observational prospective study of patients with a humeral shaft fracture involving the proximal humerus fixed with a long proximal humerus polyaxial locking plate with an anterior curvature and helical shape (ALPS® Zimmerbiomet, Warsaw, Indianapolis, USA), using a MIPO technique. Between January 2017 and July 2020, 15 patients were treated at our institution. Proximally a 4-5 cm anterolateral transdeltoid approach was made. And distally, a 5-7 cm incision was made 4 cm proximal to the elbow crease. At each follow-up, radiographs were taken to evaluate fracture healing. Funtional scales were applied to evaluate clinical results. RESULTS: Ten women and five men were included, with a mean age of 62 yo (range 26-86). All but one fracture healed uneventfully. The mean time to union was 28 weeks (range 12-48 weeks). Two out of 15 patients presented complications (an atrophic nonunion and a peri­implant distal fracture). None of the patients had a nerve palsy prior neither after the surgery. No other complications, including infection, were registered during follow-up. Shoulder range of motion showed the following means: abduction of 147° (range 50°-180°), anterior flexion of 144° (range 80°-180°), external rotation of 77,5 ° (range 70°-80°) and internal rotation of 54.5° (range 45°-60°). All patients recovered their pre-fracture elbow range of motion. All patients presented less than 10° of angular deviation in varus/valgus or ante/recurvatum after the surgical procedure. At the end of the follow-up, all final functional scores were "good" or "excellent": mean Constant-Murley score was 72 ± 13 (range 38-91), ASES score was 73 ± 12 (range 41-88), UCLA shoulder scale was 30 ± 3,5 (range 10-35), and Q-DASH score was 16.5 ± 0,11 (range 4-57). CONCLUSION: When applied correctly, the treatment of diaphyseal humeral fractures involving the proximal humerus using a polyaxial locking helical plate with a MIPO technique is a reliable treatment method. It has high union rates with low complications.

Elastin-Like Recombinamer Hydrogels for Improved Skeletal Muscle Healing Through Modulation of Macrophage Polarization.

Large skeletal muscle injuries, such as a volumetric muscle loss (VML), often result in an incomplete regeneration due to the formation of a non-contractile fibrotic scar tissue. This is, in part, due to the outbreak of an inflammatory response, which is not resolved over time, meaning that type-1 macrophages (M1, pro-inflammatory) involved in the initial stages of the process are not replaced by pro-regenerative type-2 macrophages (M2). Therefore, biomaterials that promote the shift from M1 to M2 are needed to achieve optimal regeneration in VML injuries. In this work, we used elastin-like recombinamers (ELRs) as biomaterials for the formation of non- (physical) and covalently (chemical) crosslinked bioactive and biodegradable hydrogels to fill the VML created in the tibialis anterior (TA) muscles of rats. These hydrogels promoted a higher infiltration of M2 within the site of injury in comparison to the non-treated control after 2 weeks (p<0.0001), indicating that the inflammatory response resolves faster in the presence of both types of ELR-based hydrogels. Moreover, there were not significant differences in the amount of collagen deposition between the samples treated with the chemical ELR hydrogel at 2 and 5 weeks, and this same result was found upon comparison of these samples with healthy tissue after 5 weeks, which implies that this treatment prevents fibrosis. The macrophage modulation also translated into the formation of myofibers that were morphologically more similar to those present in healthy muscle. Altogether, these results highlight that ELR hydrogels provide a friendly niche for infiltrating cells that biodegrades over time, leaving space to new muscle tissue. In addition, they orchestrate the shift of macrophage population toward M2, which resulted in the prevention of fibrosis in the case of the chemical hydrogel treatment and in a more healthy-like myofiber phenotype for both types of hydrogels. Further studies should focus in the assessment of the regeneration of skeletal muscle in larger animal models, where a more critical defect can be created and additional methods can be used to evaluate the functional recovery of skeletal muscle.

Does an early mobilization and immediate home-based self-therapy exercise program displace proximal humeral fractures in conservative treatment? Observational study.

BACKGROUND: Nonoperative management of proximal humeral fractures (PHFs) is the most common treatment, but its functional outcome may improve with early mobilization. In frail osteoporotic patients, quick recovery of prefracture independency is mandatory. This study assessed fracture displacement in PHFs managed with conservative treatment after early mobilization and a home-based self-exercise program. METHODS: We retrospectively analyzed the radiologic displacement of fracture fragments of PHFs treated conservatively with early mobilization and a home-based self-exercise program. RESULTS: Included were 99 patients with 26 one-part, 32 two-part, 32 three-part, and 9 four-part PHFs managed conservatively, followed by early mobilization and a home-based self-exercise program. In the x-ray examinations, the head displaced from varus into valgus 55° ± 23° to 42° ± 22°, in the normal range of anatomic values. The medial hinge displaced from medial to the diaphysis (+1 ± 6 mm) to lateral to the head (-0.6 ± 6 mm). The greater tuberosity displaced cranially from -1 ± 7 mm to 2 ± 5 mm. The Constant score at the 1-year follow-up was 79.69 ± 16.3. DISCUSSION AND CONCLUSIONS: The home-based self-exercise program for conservative treatment of PHFs displaces the head-diaphysis angle and the medial hinge toward anatomic reduction, but there is a risk of greater tuberosity cranial displacement. Functional results are fairly good, allowing frail patients to keep on with their independency and life style. Because a large number of patients might need further physiotherapy, the quality of the home-based self-exercises should be supervised.

Minimally invasive polyaxial locking plate osteosynthesis for 3-4 part proximal humeral fractures: our institutional experience.

INTRODUCTION: The objectives of this study were to describe the surgical technique of fixation of 3-4 part proximal humeral fractures with polyaxial locking plates utilising a minimally invasive approach and to evaluate the accuracy of reduction and stability of fixation. PATIENTS AND METHODS: We retrospectively reviewed 90 patients. Fractures were classified according to the Neer classification system. Different radiological parameters were measured to assess the quality of reduction and the stability of fixation. Complications and clinical outcomes were evaluated after one year of minimum follow up. RESULTS: There were 76 women and 14 men, with a mean age of 67.4years ±13 (range, 29-85). There were 60 3-part and 30 4-part fractures. Frozen cancellous allograft was used in 30 cases (33.3%). All fractures progressed to union and at one year follow up, the mean Constant score was 79.6±12(range, 62-100). Mean forward flexion, abduction, external rotation and internal rotation were 155°, 148°, 39° and vertebra Dorsal 8, respectively. Complications were noted in seven patients while the postoperative "head-diaphysis angle", "greater tuberosity height" and "medial metaphysis reconstruction" were close to the anatomical parameters; no significant differences were noted at one year radiological follow up. CONCLUSION: Reliable and stable fixation can be expected with the use of polyaxial locking plate through a minimally invasive approach for the treatment of 3-4 part proximal humeral fractures. Satisfactory functional results for this procedure can be obtained.

Scoliosis after median sternotomy in children with congenital heart disease.

STUDY DESIGN: A retrospective review of spinal deformity in patients with congenital heart disease surgically treated through a median sternotomy before the age of 8 years. Assessment was done on chest roentgenograms at skeletal maturity. OBJECTIVES: To determine if patients surgically treated through a median sternotomy present a higher prevalence of spinal deformity. SUMMARY OF BACKGROUND DATA: Congenital heart disease is associated with a higher prevalence of scoliosis. The etiology of scoliosis in this group of patients is unknown. Thoracotomy causes scoliosis, but median sternotomy has not been identified as a causal agent in these patients. METHODS: Chest roentgenograms were done after skeletal maturity in 128 patients to assess for the presence of a spinal deformity in the sagittal or coronal plane as a result of a median sternotomy for treatment of congenital heart disease before the age of 8 years in patients without any prior radiographic evidence of spinal or costal deformity before surgery. RESULTS: Forty-four (34.3%) of these patients had scoliosis greater than 10 degrees , 16 of them (12.5%) had curves greater than 20 degrees , and 33 (25.8%) had thoracic kyphosis lesser than 20 degrees . Patients operated before the age of 18 months had a significantly increased risk of developing scoliosis than those operated at a later age (odds ratio = 3.5; confidence interval = 1.3-9.6; P = 0.016). The presence of scoliosis was not related to the type of congenital heart disease. CONCLUSIONS: There is a high prevalence of scoliosis in patients with congenital heart disease surgically treated through a median sternotomy. The prevalence of scoliosis increases in patients operated at an earlier age.

Metaizeau's technique for displaced metatarsal neck fractures.

Metaizeau's technique can be applied to reduce the displaced metatarsal head distally from the fracture in an easier way and to keep the fracture site closed, as compared with retrograde Kirschner wires. We present seven fractures treated anterograde with progressive weight-bearing after 2 weeks. Open reduction was unnecessary in all cases. This technique permitted correct control of the distal fracture fragment, obtained good reduction of the metatarsal heads without opening the fracture site, and with no lesion of the capsulo-ligamentosus metatarsophalangeal joint structures. We obtained the radiographic healing of all and showed correct alignment. Metaizeau's technique is a valid alternative to retrograde Kirschner wires fixation in the treatment of displaced metatarsal neck fractures.