Predicting Septic Arthritis in the Setting of Crystalline Arthropathy in the Native Joint Using Laboratory Data.

Background: Septic arthritis is an orthopedic emergency. Diagnosis is difficult in patients with concomitant crystalline arthropathy (gout or pseudogout). The symptomatology of crystal arthritis mimics septic arthritis, clouding clinical diagnosis. Arthrocentesis and synovial fluid analysis are the standard diagnostic tests for both pathologies. Crystals on microscopy are diagnostic of crystal arthritis, however their presence does not rule out septic arthritis. Septic arthritis is diagnosed by positive microbiology culture. Though septic arthritis is associated with elevated synovial total nucleated count (TNC), TNC elevations can also occur with gout. The literature suggests that a TNC count of > 50,000 cells in a crystal-positive joint should raise suspicion for concurrent septic arthritis, however data is limited. Further diagnostic indicators are needed to help clinicians promptly identify crystal positive septic arthritis as the treatments and prognoses are different. Methods: Patients were retrospectively identified who had arthrocentesis of a native joint positive for monosodium urate (MSU) and/or (CPPD) crystals. Laboratory data was collected including synovial fluid cultures, total nucleated cell count (TNC), percent polymorphic neutrophils (%PMN), and crystal analysis; and serum CRP, ESR, and white blood cell count (WBC). Statistical analysis performed using Spearman correlation, Univariate-Fischer's exact and Wilcoxon tests, and multivariate analysis. Results: 442 joints identified with positive CPPD and/or MSU crystals, 31% female, 69% male. Of 442 aspirates, 58 had positive cultures. Patients were more likely to have positive cultures if synovial TNC > 50,000 (odds ratio 7.7), CRP > 10 mg/dL (OR 3.2), PMN > 90% (OR 2.17), and if the patient was female (OR 1.9), all were statistically significant with p < 0.05. There were 55 patients who underwent irrigation and debridement based on clinical suspicion or a positive gram stain, 37 of these ultimately had a positive culture (67%), the remaining 18 had negative cultures. Conclusion: Results are consistent with the literature, a TNC > 50,000 warrants a high suspicion for concurrent septic arthritis and should prompt providers to critically evaluate other patient laboratory data. Results further suggests that a patient with positive crystals, synovial TNC > 50,000 cells, PMN > 90%, and serum CRP > 10mg/dL is at high risk for having a concurrent septic arthritis and may warrant urgent irrigation and debridement and antibiotic therapy. This data serves as a supporting to develop an infection risk calculator for crystal positive septic arthritis. Level of Evidence: III.

Utility of Debridement, Antibiotics, and Implant Retention for Acute Periprosthetic Joint Infection in Revision Total Knee Arthroplasty.

Background: Periprosthetic joint infection (PJI) in revision arthroplasty presents as a challenging complication that is difficult to manage. Debridement, antibiotics, and implant retention (DAIR) is a recognized treatment option, although few studies have investigated success rates in addition to eventual amputation rates for failed cases. Methods: A retrospective review of 365 DAIR cases was performed at a single institution from 2008-2020. Patient records were thoroughly reviewed for inclusion and exclusion criteria by multiple members of the research team, discovering 45 cases met criteria for the study cohort. Demographic information, medical history, culture data, and surgical history, were recorded. DAIR's overall survivorship was evaluated with a Kaplan-Meier (KM) survival curve. Additional KM curves were constructed to compare acute postoperative versus acute hematogenous infections as well as DAIR survivorship relative to infecting organism. Results: DAIR's success rate in revision TKA was 77% at 0.5 years, 56% at 2 years and 46% at 5 years. No significant difference was noted in survivorship when comparing acute postoperative and acute hematogenous cases at 5 years (29 vs 51%, P=0.64). No significance differences in survivorship were noted according to infecting organism (P =0.30). Median follow up duration was significantly lower in the failed DAIR cohort with a median time of 0.5 years in comparison to 1.7 years for the successful DAIR group (P =0.012). There were 20 DAIR cases that failed, 10 of which resulted in eventual amputation. Conclusion: DAIR's success rate for managing acute PJI in revision arthroplasty cases was 46% at 5 years. Of the 20 failed DAIR cases, 10 resulted in eventual amputation. DAIRs utility in managing these complicated PJI cases in the setting of revision arthroplasty is concerning with low success rates and high rates of amputation in failed cases. Level of Evidence: III.

Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial.

BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared to intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis-when 75% of anticipated participants had completed follow up-the Data and Safety Monitoring Board recommended to terminate the trial, and upon unblinding, the Operations Committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group and in 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5%; 95% CI, -0.9 to 0.03; P = .07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3%; 95% CI, 5.2 to 11.5; P = .007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared to the intravenous group was 8.2% (95% CI, 3.4 to 12.9). CONCLUSIONS: Among patients having cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared to intravenous tranexamic acid.

Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation.

BACKGROUND: Postoperative atrial fibrillation (POAF) is associated with increased morbidity and mortality. Epicardial injection of botulinum toxin may suppress POAF. OBJECTIVES: This study sought to assess the safety and efficacy of AGN-151607 for the prevention of POAF after cardiac surgery. METHODS: This phase 2, randomized, placebo-controlled trial assessed the safety and efficacy of AGN-151607, 125 U and 250 U vs placebo (1:1:1), for the prevention of POAF after cardiac surgery. Randomization was stratified by age (<65, ≥65 years) and type of surgery (nonvalvular/valve surgery). The primary endpoint was the occurrence of continuous AF ≥30 seconds. RESULTS: Among 312 modified intention-to-treat participants (placebo, n = 102; 125 U, n = 104; and 250 U, n = 106), the mean age was 66.9 ± 6.8 years; 17% were female; and 64% had coronary artery bypass graft (CABG) only, 12% had CABG + valve, and 24% had valve surgery. The primary endpoint occurred in 46.1% of the placebo group, 36.5% of the 125-U group (relative risk [RR] vs placebo: 0.80; 95% CI: 0.58-1.10; P = 0.16), and 47.2% of the 250-U group (RR vs placebo: 1.04; 95% CI: 0.79-1.37; P = 0.78). The primary endpoint was reduced in the 125-U group in those ≥65 years of age (RR: 0.64; 95% CI: 0.43-0.94; P = 0.02) with a greater reduction in CABG-only participants ≥65 years of age (RR: 0.49; 95% CI: 0.27-0.87; P = 0.01). Rehospitalization and rates of adverse events were similar across the 3 groups. CONCLUSIONS: There were no significant differences in the rate of POAF with either dose compared with placebo; however, there was a lower rate of POAF in participants ≥65 years undergoing CABG only and receiving 125 U of AGN-151607. These hypothesis-generating findings require investigation in a larger, adequately powered randomized clinical trial. (Botulinum Toxin Type A [AGN-151607] for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery [NOVA]; NCT03779841); A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A [AGN 151607] Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery; 2017-004399-68).

Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population / Impacto dos Balões de Eluição de Paclitaxel Comparados a Stents Farmacológicos de Segunda Geração para Reestenose Intra-Stent em uma População com Síndrome Coronária Aguda Primária

Abstract Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.

Resumo Fundamento: O papel de balões farmacológicos (BFs) no tratamento de reestenose intra-stent (RIS) não está bem definido, particularmente em na síndrome coronária aguda (SCA). Objetivo: Comparar desfechos clínicos do uso de BF com stents farmacológicos (SFs) de segunda geração no tratamento de RIS em uma população real com alta prevalência de SCA. Métodos: Foi realizada uma análise retrospectiva de pacientes consecutivos com RIS tratados com um BF comparados a pacientes tratados com SF de segunda geração. O desfecho primário incluiu eventos cardiovasculares adversos importantes (morte por todas as causas, infarto do miocárdio não fatal, e revascularização da lesão alvo). As comparações foram realizadas pelo modelo proporcional de riscos de Cox ajustado e análise de Kaplan-Meier com log-rank. Resultados: A coorte incluiu 91 pacientes tratados com BF e 89 pacientes tratados com um SF (75% com SCA). O tempo mediano de acompanhamento foi de 26 meses. Eventos cardiovasculares adversos importantes ocorreram em 33 pacientes (36%) no grupo BF, e em 17 (19%) no grupo SF (p log-rank = 0,02). Após ajuste multivariado, não houve diferença significativa entre os grupos (HR para BF = 1,45 [IC95%: 0,75-2,83]; p = 0,27). As taxas de mortalidade de 1 ano foram 11% com BF, e 3% com SF (p = 0,04; HR ajustado = 2,85 [IC95%: 0,98-8,32; p = 0,06). Conclusão: Em uma população com alta prevalência de SCA, observou-se um aumento não significativo nas taxas de eventos cardiovasculares adversos importantes com o uso de BF comparado ao uso de SF de segunda geração para o tratamento de RIS, principalmente pelo aumento na taxa de mortalidade. É necessário um ensaio clínico controlado, randomizado, com poder estatístico adequado para confirmar esses achados.

Conversion after off-pump coronary artery bypass grafting: the CORONARY trial experience

OBJECTIVES: Emergent and late conversions form OFF-to-ON pump coronary artery bypass grafting (CABG) have been associated with worse outcomes, however, it remains unclear as to which risk factors are associated with conversion and how to prevent them. METHODS: Among 4718 patients who randomly underwent off- or on-pump CABG, the incidence of off-pump to on-pump cross-over, or 'OFF-to-ON conversion', was 7.9% (186/2356). The primary outcome was a composite of death, stroke, myocardial infarction, or new renal failure requiring dialysis. We assessed the risk factors and outcomes of converted patients. RESULTS: Emergent OFF-to-ON conversions, defined as conversions for hypotension or ischaemia, were required for 3.2% of patients ( n  = 75), while most elective conversions were due to small or intramuscular coronaries ( n  = 83). OFF-to-ON converted patients required increased surgery time, blood transfusions, intensive care unit stay, and presented a higher incidence at 1 year of the composite outcome compared with non-converted off-pump patients (all P < 0.01), especially if the conversion was emergent. Conversely, elective conversions outcomes were no different compared with non-converted off-pump patients ( P  = 0.35). Independent predictors of emergent conversions included higher heart rate or chronic atrial fibrillation, urgent surgery, more grafts planned and surgeon experience with off-pump CABG...

Five-year outcomes after off-pump or on-pump coronary-artery bypass grafting

BACKGROUND: We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial). METHODS: A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG. For this report, we analyzed a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization (either CABG or percutaneous coronary intervention). The mean follow-up period was 4.8 years. RESULTS: There were no significant differences between the off-pump group and the on-pump group in the rate of the composite outcome (23.1% and 23.6%, respectively; hazard ratio with off-pump CABG, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72) or in the rates of the components of the outcome, including repeat coronary revascularization, which was performed in 2.8% of the patients in the off-pump group and in 2.3% of the patients in the on-pump group (hazard ratio, 1.21; 95% CI, 0.85 to 1.73; P=0.29)...

Rationale and design of the steroids in cardiac surgery trial

Background Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonarybypass (CBP). There is a need for a large randomized controlled trial to clarify the effect of steroids in such patients.Methods We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation whoare undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo. The first coprimary outcome is 30-day allcausemortality, and the most second coprimary outcome is a composite of death, MI, stroke, renal failure, or respiratory failurewithin 30 days. Other outcomes include a composite of MI or mortality at 30 days, new onset atrial fibrillation, bleeding andtransfusion requirements, length of intensive care unit stay and hospital stay, infection, stroke, wound complications,gastrointestinal complications, delirium, postoperative insulin use and peak blood glucose, and all-cause mortality at 6 months.Results As of October 22, 2013, 7,034 patients have been recruited into SIRS in 82 centers from 18 countries. Patient’smean age is 67.3 years, and 60.4% are male. The average European System for Cardiac Operative Risk Evaluation is 7.0with 22.1% having an isolated coronary artery bypass graft procedure, and 66.1% having a valve procedure.Conclusions SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiacsurgery requiring CBP. (Am Heart J 2014;167:660-5.)BackgroundWorldwide, N2 million patients undergo cardiacsurgery annually. Most cardiac surgeries use cardiopulmonarybypass (CPB). Although CPB serves an importantrole, it.

Off-pump or on-pump coronary-arterybypass grafting at 30 days

BackgroundThe relative benefits and risks of performing coronary-artery bypass grafting (CABG) with a beating-heart technique (off-pump CABG), as compared with cardiopulmonarybypass (on-pump CABG), are not clearly established.MethodsAt 79 centers in 19 countries, we randomly assigned 4752 patients in whom CABG was planned to undergo the procedure off-pump or on-pump. The first coprimary outcome was a composite of death, nonfatal stroke, nonfatal myocardial infarction, or new renal failure requiring dialysis at 30 days after randomization.ResultsThere was no significant difference in the rate of the primary composite outcomebetween off-pump and on-pump CABG (9.8% vs. 10.3%; hazard ratio for the offpump group, 0.95; 95% confidence interval [CI], 0.79 to 1.14; P = 0.59) or in any of its individual components. The use of off-pump CABG, as compared with on-pump CABG, significantly reduced the rates of blood-product transfusion (50.7% vs. 63.3%; relative risk, 0.80; 95% CI, 0.75 to 0.85; P<0.001), reoperation for perioperative bleeding(1.4% vs. 2.4%; relative risk, 0.61; 95% CI, 0.40 to 0.93; P = 0.02), acute kidney injury (28.0% vs. 32.1%; relative risk, 0.87; 95% CI, 0.80 to 0.96; P = 0.01), and respiratorycomplications (5.9% vs. 7.5%; relative risk, 0.79; 95% CI, 0.63 to 0.98; P = 0.03) but increased the rate of early repeat revascularizations (0.7% vs. 0.2%; hazard ratio, 4.01; 95% CI, 1.34 to 12.0; P = 0.01).ConclusionsThere was no significant difference between off-pump and on-pump CABG with respect to the 30-day rate of death, myocardial infarction, stroke, or renal failure requiring dialysis. The use of off-pump CABG resulted in reduced rates of transfusion, reoperation for erioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization. (Funded by theCanadian Institutes of Health Research; CORONARY ClinicalTrials.gov number,NCT00463294.)

Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery

Background Uncertainty remains regarding the benefits and risks of the technique of operating on a beating heart(off pump) for coronary artery bypass grafting (CABG) surgery versus on-pump CABG. Prior trials had few events and relativelyshort follow-up. There is a need for a large randomized, controlled trial with long-term follow-up to inform both the short- andlong-term impact of the 2 approaches to CABG.Methods We plan to randomize 4,700 patients in whom CABG is planned to undergo the procedure on pump or offpump. The coprimary outcomes are a composite of total mortality, myocardial infarction (MI), stroke, and renal failure at30 days and a composite of total mortality, MI, stroke, renal failure, and repeat revascularization at 5 years. We will alsoundertake a cost-effectiveness analysis at 30 days and 5 years after CABG surgery. Other outcomes include neurocognitivedysfunction, recurrence of angina, cardiovascular mortality, blood transfusions, and quality of life.Results As of May 3, 2011, CORONARY has recruited N3,884 patients from 79 centers in 19 countries. Currently,patient's mean age is 67.6 years, 80.7% are men, 47.0% have a history of diabetes, 51.4% have a history of smoking, and34.4% had a previous MI. In addition, 20.9% of patients have a left main disease, and 96.6% have double or triplevessel disease.Conclusions CORONARY is the largest trial yet conducted comparing off-pump CABG to on-pump CABG. Its resultswill lead to a better understanding of the safety and efficacy of off-pump CABG. (Am Heart J 2012;163:1-6.)