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.

Outcomes After Successful Debridement, Antibiotic, and Implant Retention Therapy for Periprosthetic Joint Infection in Total Knee Arthroplasty.

BACKGROUND: Controversy surrounds debridement, antibiotic and implant retention (DAIR) for treatment of acute periprosthetic joint infection (PJI). Data regarding DAIR's rate of infection resolution is variable with little investigation of functional outcomes. METHODS: We identified 191 DAIR cases at a single institution from 2008 to 2020. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) and Patient Reported Outcome Measurement Information System-10 (PROMIS) scores were collected. Patient Reported Outcome Scores were obtained from 60 cases. Median follow-up (IQR) was 4.5 (2.1 to 7.6) versus 3.0 (1.2 to 5.3) years for the control group. Mean scores were compared to a cohort of uncomplicated total knee arthroplasties matched by age, body mass index, and sex using generalized linear models adjusted for follow-up duration. Kaplan-Meier survivorship curves for PJI were constructed. RESULTS: Mean Patient Reported Outcome Scores for the DAIR cohort were 57.2 ± 19.7 for KOOS-JR, 41.6 ± 7.1 for PROMIS physical health (PH), and 46.6 ± 8.7 for PROMIS mental health (MH). Mean control group values were 65.8 ± 21.0 for KOOS-JR, 44.6 ± 8.4 for PROMIS PH, and 49.2 ± 9.2 for PROMIS MH. No difference was observed in KOOS-JR (P = .83) or PROMIS MH (P = .11). PROMIS PH was lower in the DAIR cohort compared to the control group (P = .048). Median follow-up (years) for all 191 cases was 5.9 (range, 0.5 to 13.1). Survivorship (years) without subsequent operation for infection was 84% at 1, 82% at 2, and 79% at 5. CONCLUSION: Knee and MH outcomes in successful DAIR procedures were similar to uncomplicated total knee arthroplasty. DAIR's success rate was 79% in treating acute PJI at 5 years. LEVEL OF EVIDENCE: Level III.

Correlation between measured and predicted mismatch with valve hemodynamics in transcatheter aortic valve replacement: A sex-based analysis.

BACKGROUND: Data regarding the reliability of predicted effective orifice area indexed (pEOAi) is scarce in transcatheter aortic valve replacement (TAVR). AIMS: To assess the validity of the pEOAi in TAVR by correlating its value with echocardiography-derived hemodynamic data. METHODS: A single-center retrospective cohort study of TAVR patients from 2012 to 2021 with available echocardiograms was conducted. Patient-prosthesis mismatch (PPM) was defined based on the Valve Academic Research Consortium 3 criteria. The main endpoints were the congruence of measured effective orifice area indexed (EOAi) and pEOAi with the hemodynamic data obtained by echocardiography. The secondary endpoint included a correlation of predicted PPM (pPPM) and measured PPM (mPPM) with postoperative New York Heart Association (NYHA) status. RESULTS: A total of 318 patients were included. pPPM was more frequent than mPPM (54 [17%]; all moderate PPM vs. 39 [12.3%]: 32 moderate and 7 severe PPM). Predicted and measured EOAi were statistically correlated with postprocedural transvalvular mean gradient and Doppler velocity index (all p < 0.001), including in both sex-based subgroups. The positive predictive value and negative predictive value (NPV) of pPPM for postprocedural transvalvular mean gradient ≥ 20 mmHg were 16% and 97%, respectively. Only pPPM was significantly more prevalent in the group in which NYHA failed to improve than in those with symptom improvement (30.1% vs. 16%, p = 0.027). CONCLUSION: Predicted PPM has an excellent NPV for postprocedural transvalvular mean gradient ≥ 20 mmHg and seems to be a good predictor of NYHA status evolution as opposed to measured PPM. Predicted EOAi can be used in procedural planning to reduce the risk of PPM in both TAVR male and female patients.

Teprasiran, a Small Interfering RNA, for the Prevention of Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Randomized Clinical Study.

BACKGROUND: Acute kidney injury (AKI) affects up to 30% of patients undergoing cardiac surgery, leading to increased in-hospital and long-term morbidity and mortality. Teprasiran is a novel small interfering RNA that temporarily inhibits p53-mediated cell death that underlies AKI. METHODS: This prospective, multicenter, double-blind, randomized, controlled phase 2 trial evaluated the efficacy and safety of a single 10 mg/kg dose of teprasiran versus placebo (1:1), in reducing the incidence, severity, and duration of AKI after cardiac surgery in high-risk patients. The primary end point was the proportion of patients who developed AKI determined by serum creatinine by postoperative day 5. Other end points included AKI severity and duration using various prespecified criteria. To inform future clinical development, a composite end point of major adverse kidney events at day 90, including death, renal replacement therapy, and ≥25% reduction of estimated glomerular filtration rate was assessed. Both serum creatinine and serum cystatin-C were used for estimated glomerular filtration rate assessments. RESULTS: A total of 360 patients were randomly assigned in 41 centers; 341 dosed patients were 73±7.5 years of age (mean±SD), 72% were men, and median European System for Cardiac Operative Risk Evaluation score was 2.6%. Demographics and surgical parameters were similar between groups. AKI incidence was 37% for teprasiran- versus 50% for placebo-treated patients, a 12.8% absolute risk reduction, P=0.02; odds ratio, 0.58 (95% CI, 0.37-0.92). AKI severity and duration were also improved with teprasiran: 2.5% of teprasiran- versus 6.7% of placebo-treated patients had grade 3 AKI; 7% teprasiran- versus 13% placebo-treated patients had AKI lasting for 5 days. No significant difference was observed for the major adverse kidney events at day 90 composite in the overall population. No safety issues were identified with teprasiran treatment. CONCLUSIONS: The incidence, severity, and duration of early AKI in high-risk patients undergoing cardiac surgery were significantly reduced after teprasiran administration. A phase 3 study with a major adverse kidney event at day 90 primary outcome that has recently completed enrollment was designed on the basis of these findings (NCT03510897). Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02610283.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Are Morbidly Obese Patients Equally Benefitting From Care Improvements in Total Hip Arthroplasty?

BACKGROUND: Morbidly obese patients have increased rates of complications following primary total hip arthroplasty (THA) and it is not clear whether improvements in THA care pathways are equally benefitting these patients. The purpose of this study is to assess if reductions in complications have similarly improved for both morbidly obese and non-morbidly obese patients after THA. METHODS: Patients undergoing primary THA between 2011 and 2019 were identified in the American College of Surgeons National Surgical Quality Improvement Program database. Patients were stratified by body mass index (BMI) <40 and ≥40 kg/m2. Thirty-day rates of infectious complications, readmissions, reoperation, and any complication were assessed. Trends in complications were compared utilizing odds ratios and multivariate analyses. RESULTS: In total, 234,334 patients underwent THA and 16,979 (7.8%) had BMI ≥40 kg/m2. Patients with BMI ≥40 kg/m2 were at significantly higher odds for readmission, reoperation, and infectious complications. Odds for any complication were lower for morbidly obese patients in 2011, not different from 2012 to 2014, and higher from 2015 to 2019 compared to lower BMI patients. Odds for any non-transfusion complication were higher for morbidly obese patients and there was no improvement for either group over the study period. There were improvements in rates of readmission and reoperation for patients with BMI <40 kg/m2 and readmission for BMI >40 kg/m2. CONCLUSION: Odds for readmission and reoperation for non-morbidly obese patients and readmission for morbidly obese patients improved from 2011 to 2019. Reductions in transfusions are largely responsible for improvements in overall complication rates. Although morbidly obese patients remain at higher risk for complications, there does not appear to be a growing disparity in outcomes between morbidly obese and non-morbidly obese patients.

Evaluation of point-of-care thumb-size bispectral electroencephalography device to quantify delirium severity and predict mortality.

BACKGROUND: We have developed the bispectral electroencephalography (BSEEG) method for detection of delirium and prediction of poor outcomes. AIMS: To improve the BSEEG method by introducing a new EEG device. METHOD: In a prospective cohort study, EEG data were obtained and BSEEG scores were calculated. BSEEG scores were filtered on the basis of standard deviation (s.d.) values to exclude signals with high noise. Both non-filtered and s.d.-filtered BSEEG scores were analysed. BSEEG scores were compared with the results of three delirium screening scales: the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), the Delirium Rating Scale-Revised-98 (DRS) and the Delirium Observation Screening Scale (DOSS). Additionally, the 365-day mortalities and the length of stay (LOS) in the hospital were analysed. RESULTS: We enrolled 279 elderly participants and obtained 620 BSEEG recordings; 142 participants were categorised as BSEEG-positive, reflecting slower EEG activity. BSEEG scores were higher in the CAM-ICU-positive group than in the CAM-ICU-negative group. There were significant correlations between BSEEG scores and scores on the DRS and the DOSS. The mortality rate of the BSEEG-positive group was significantly higher than that of the BSEEG-negative group. The LOS of the BSEEG-positive group was longer compared with that of the BSEEG-negative group. BSEEG scores after s.d. filtering showed stronger correlations with delirium screening scores and more significant prediction of mortality. CONCLUSIONS: We confirmed the usefulness of the BSEEG method for detection of delirium and of delirium severity, and prediction of patient outcomes with a new EEG device.

Daytime Variation of Clinical Outcome in Cardiac Surgery: A Propensity-Matched Cohort Study.

OBJECTIVE: The purpose of the present study was to investigate the hypothesis of a nychthemeral variation in the tolerance to ischemia and reperfusion injury in adult cardiac surgeries. DESIGN: Retrospective cohort study. SETTING: A single academic center. PARTICIPANTS: All patients undergoing nonemergent aortic valve replacement (AVR) ± coronary artery bypass graft between January 2012 and May 2018 were included. They were divided into two groups (morning and afternoon) according to the time of the day at the beginning of surgery. Propensity score matching estimated by multivariate logistic regression with a 1:1 matching ratio was performed to ensure that the two groups were comparable. This allowed obtaining 269 pairs, for a total of 538 patients. INTERVENTION: The objective of the study was to assess whether there were differences in perioperative and postoperative outcomes between the morning and the afternoon groups. RESULTS: There was no between-group difference in the primary composite endpoints, namely the occurrence of death, myocardial infarction, low cardiac output, and stroke during the 30 days following the surgery. Regarding cardiac biomarkers, there were no between-group differences for both postoperative evolution of troponin T plasma levels and the maximum postoperative troponin T plasma level. CONCLUSION: These results did not support the hypothesis that the timing of the surgery could influence the tolerance to ischemia and reperfusion injury, at least in patients undergoing nonemergent AVR or a combined AVR with coronary artery bypass graft.

Routine Radiographs After Total Joint Arthroplasty: Is There Clinical Value?

BACKGROUND: Routine radiographs have historically been obtained during routine care after total joint arthroplasty (TJA). However, substantial improvements in surgical technique, biomaterials, and changes in payment models placing greater emphasis on value have occurred. Recently, there has been interest in a transition to performing follow-up visits virtually. The purpose of this study was to assess how frequently patients attend postoperative appointments and the clinical utility of routine radiographs after TJA. METHODS: Patients undergoing primary total hip arthroplasty and total knee arthroplasty at a single tertiary institution in 2018 were included. Patients attending scheduled follow-up at 6 to 12 weeks and 1 year were assessed. Retrospective chart review was conducted to determine whether abnormalities were noted on routine radiographic surveillance by the orthopedic surgeons or radiologist and if any radiographic findings altered clinical management. RESULTS: A total of 938 TJAs were performed, and 885 met inclusion criteria, with 423 (47.8%) total hip arthroplasties and 462 (52.2%) total knee arthroplasties. Eight hundred sixty-five (97.7%) patients attended a follow-up visit at 6 or 12 weeks and 589 (66.6%) attended at 1 year postoperatively. A single radiographic abnormality was detected, occurring at the 6- to 12-week period by the radiologist and interpreted as being an artifact by the surgeon. No additional radiographic abnormalities were detected at 1 year. Information from radiographs did not change clinical management for any patients. CONCLUSION: In a large cohort of patients, routine radiographic surveillance did not detect any true abnormalities during the first year after primary TJA. For patients without symptoms attributable to the TJA prosthesis, conducting virtual care visits without routine radiographs may be considered.

Weight-Based Aspirin Dosing May Further Reduce the Incidence of Venous Thromboembolism Following Primary Total Joint Arthroplasty.

BACKGROUND: Obesity poses a challenge to thromboembolic prophylaxis following total joint arthroplasty (TJA). The purpose of this study is to evaluate a weight-based aspirin dosing regimen for prevention of venous thromboembolism (VTE) following TJA. METHODS: This is a retrospective observational study of 2403 patients who underwent primary total hip or knee arthroplasty at one institution. A weight-based aspirin dosing regimen for VTE prophylaxis was administered to 1247 patients: patients weighing ≥120 kg received 325 mg aspirin twice daily (BID) and those weighing <120 kg received 81 mg aspirin BID for 4 weeks. In total, 1156 patients in the comparison cohort received 81 mg aspirin BID. VTE and gastrointestinal bleeding events were identified through chart review at 42 days and 6 months postoperatively. A multivariable logistic regression was performed to adjust for covariates. RESULTS: The weight-based aspirin cohort had a significantly lesser incidence of VTE at 42 days (P = .03, relative risk [RR] 0.31, 95% confidence interval 0.12-0.82) and 6 months (P = .03, RR 0.38, 95% confidence interval 0.18-0.80). There was no difference in VTE incidence between total hip arthroplasty and total knee arthroplasty cases (P = .8). There was no difference in gastrointestinal bleeding events between the cohorts at 42 days (P = .69) or 6 months (P = .92). Subanalysis of patients weighing ≥120 kg demonstrated a significant difference between the cohorts with a VTE incidence of 3.48% and 0% in the 81 mg and weight-based cohorts, respectively (P = .02). CONCLUSION: Patients prescribed a weight-based aspirin regimen had significantly fewer VTEs after TJA compared to historical controls with an RR reduction of 69% at 6 weeks and 62% at 6 months postoperatively. This suggests the need to factor patient weight when determining postoperative VTE prophylaxis with aspirin.

Resilience and Depression Influence Clinical Outcomes Following Primary Total Joint Arthroplasty.

BACKGROUND: Resilience and depression may impact clinical outcomes following primary total joint arthroplasty (TJA). This study aimed to quantify baseline resilience and depression prevalence in patients undergoing primary TJA and evaluate their influence on patient-reported clinical outcomes. METHODS: We prospectively enrolled 98 patients undergoing primary TJA. Exclusion criteria included patients under 18 years of age, undergoing surgery for fracture, or who underwent additional surgery during the study period. Patients completed the Brief Resilience Scale to measure resilience, Patient Health Questionnaire-9 to measure depression, and Patient-Reported Outcomes Measurement Information System-10 to measure global physical and mental health preoperatively and 1 year postoperatively. RESULTS: Preoperatively, 22% and 15% of patients demonstrated major and mild depression, respectively. High resilience was identified in 34% of patients, normal resilience in 55%, and low resilience in 11%. Preoperative depression correlated with lower resilience, global physical health, and global mental health scores preoperatively as well as at 1 year after surgery (P < .001). Higher levels of preoperative resilience correlated with higher global physical and mental health scores preoperatively and at 1 year postoperatively (P < .001). CONCLUSION: Depression symptoms are common among patients undergoing primary TJA and are associated with worse patient-reported outcomes. Patients with higher levels of resilience have higher global physical and mental health scores before and after TJA. Psychological traits and depression impact clinical outcomes following TJA.

Do Extended Oral Postoperative Antibiotics Prevent Early Periprosthetic Joint Infection in Morbidly Obese Patients Undergoing Primary Total Joint Arthroplasty?

BACKGROUND: Extended oral antibiotic prophylaxis after primary total knee arthroplasty (TKA) and total hip arthroplasty (THA) in patients with body mass index (BMI) ≥40 kg/m2 may reduce the rate of early periprosthetic joint infection (PJI); however, existing data are limited. The purpose of this study was to examine rates of wound complications and PJI in patients with BMI ≥40 kg/m2 treated with and without extended oral antibiotic prophylaxis after surgery. METHODS: We retrospectively identified all primary THA and TKA performed since 2015 in patients with a BMI ≥40 kg/m2 at a single institution. Extended oral antibiotic prophylaxis for 7-14 days after surgery was prescribed at the discretion of each surgeon. Wound complications and PJI were examined at 90 days postoperatively. RESULTS: In total, 650 cases (205 THA and 445 TKA) were analyzed. Mean age was 58 years and 62% were women. Mean BMI was 44 kg/m2. Extended oral antibiotic prophylaxis was prescribed in 177 cases (27%). At 90 days, there was no difference between prophylaxis and nonprophylaxis groups in rate of wound complications (11% vs 8%; P = .41) or PJI (1.7% vs 0.6%; P = .35). The univariate analysis demonstrated increased operative time (odds ratio (OR) 1.01; 95% confidence interval (95% CI) 1.01-1.02) and diabetes mellitus (OR 1.88; 95% CI 1.03-3.46) to be associated with increased risk of 90-day wound complications. No patient factors were associated with increased risk of PJI at 90 days postoperatively. CONCLUSION: Extended oral antibiotic prophylaxis after primary THA and TKA did not reduce rates of wound complications or early PJI in a morbidly obese patient population.

What is the Clinical Utility of Synovial Alpha Defensin Testing of Antibiotic Spacers Before Reimplantation?

BACKGROUND: The purpose of this study was to evaluate the diagnostic performance of standalone alpha defensin (AD) testing of antibiotic spacers during two stage exchange and to determine if the addition of AD testing to other commonly used laboratory tests improves the ability to detect persistent infection in an antibiotic spacer. METHODS: Cases of two-stage exchange for periprosthetic joint infection from 2016 to 2019 at a single institution were retrospectively reviewed. Cases were classified as persistently infected or not infected in accordance with 2014 and 2018 Musculoskeletal Infection Society criteria to determine if AD provided any clinical utility beyond the other commonly used tests that make up both criteria. Delphi Consensus criteria at 1 year were used as the gold standard for determining recurrent periprosthetic joint infection. RESULTS: Fifty-two spacers (25 hips and 27 knees) in 51 patients were included for analysis. Five spacers were persistently infected based on Musculoskeletal Infection Society criteria. One spacer underwent reresection and the remaining 4 underwent reimplantation with no subsequent infectious complications. All 48 patients who were categorized as not infected underwent reimplantation; at 1 year postoperatively, 7 (13%) had failed due to infection. Three spacers (6%) had a positive AD test. Two spacers with positive AD tests underwent reimplantation, neither had failed at 1 year postoperatively. Sensitivity of standalone AD testing was 0%, and specificity was 96%. CONCLUSION: Standalone AD testing for the purpose of predicting repeat infection after two-stage exchange arthroplasty exhibits sensitivity of 0% and low predictive value. Addition of synovial AD testing did not increase the diagnostic performance of commonly used synovial and serologic markers of infection. LEVEL OF EVIDENCE: IV-retrospective cohort study.

Changes in outcomes over time in intermediate-risk patients treated for severe aortic stenosis.

BACKGROUND: The advent of transcatheter aortic valve replacement (TAVR) has changed the practice of treating patients with severe aortic stenosis (AS). Heart-Teams have improved their decision-making process to refer patients to the best and safest treatment. The evidence allowed centers to increase funding and TAVR volume and extend indications to different risk categories of patients. This study evaluates the outcomes of intermediate-risk patients treated for severe AS in an academic center. METHODS: Between 2012 and 2019, 812 patients with AS underwent TAVR or surgical aortic valve replacement (SAVR). A propensity score-matching analytic strategy was used to balance groups and adjust for time periods. Outcomes were recorded according to the Society of Thoracic Surgeons Guidelines; the primary outcome being 30-day mortality and the secondary outcomes being perioperative course and complications. RESULTS: No difference in mortality was seen but complications differed: more postoperative transient ischemic attacks, permanent pacemaker implantations, and perivalvular leaks in the transcatheter group, while more acute kidney injuries, atrial fibrillation, delirium, postoperative infections and bleeding, tamponade and need for reoperation in the surgical group as well as a longer hospital length-of-stay. However, over the years, morbidities/mortality decreased for all patients treated for AS. CONCLUSIONS: Data showed an improvement in morbidities/mortality for intermediate-risk patients treated with SAVR or TAVR. Increased funding allowed for a higher TAVR volume by increasing access to this technology. Also, the difference in complications could impact healthcare costs. By incorporating important metrics such as length-of-stay, readmission rates, and complications into decision-making, the Heart-Team can improve clinical outcomes, healthcare economics, and resource utilization.

How Has COVID-19 Affected Our Orthopedic Implant Industry Partners? Implications for the Surgeon-Industry Relationship in 2020 and Beyond.

BACKGROUND: The COVID-19 pandemic has had far-reaching societal and financial consequences. The purpose of this study was to evaluate how COVID-19 has affected AAHKS industry partners and the surgeon-industry relationship, emphasizing education, resource allocation, and strategic direction for the second half of 2020. METHODS: AAHKS industry partners were contacted to participate in a blinded survey and optional interview with the AAHKS Industry Relations Committee. Based on the results, a group of AAHKS member surgeons with disparate practice types were asked to postulate on how the COVID-19 pandemic has and will affect their practice and relationship with Industry. RESULTS: AAHKS industry partner responses indicated decreased resource allocation for regional, "other national," and AAHKS annual meetings (67%, 55%, and 30%, respectively). Web-based educational content was expected to increase in 2020 and will likely remain a point of emphasis in 2021 (100% and 70% of responders). For Q3/Q4 2020, a significant emphasis was placed on site of service/outpatient TJA and COVID-19-related safety measures (70% and 90% of responders), as well as increased availability of instrumentation and implants (40% and 60%, respectively). CONCLUSION: The COVID-19 pandemic has altered the orthopedic landscape for the foreseeable future. Survey responses by AAHKS industry partners demonstrate a continued commitment to surgeon education with an increasing shift to a web-based platform. Increased resource allocation for outpatient TJA and COVID-19-related safety measures were significant. Articulating optimal mechanisms to aid industry in supporting surgeons with different practice models to meet demand during the second half of fiscal year 2020 will be critical.

Malnutrition and Mortality in Frail and Non-Frail Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be determined. METHODS: The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. RESULTS: There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01-1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001-1.12). CONCLUSIONS: Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.

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). The secondary outcome for the overall period of the trial - the mean cost in U.S. dollars per patient - also did not differ significantly between the off-pump group and the on-pump group ($15,107 and $14,992, respectively; between-group difference, $115; 95% CI, -$697 to $927). There were no significant between-group differences in quality-of-life measures. CONCLUSIONS: In our trial, the rate of the composite outcome of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 years of follow-up was similar among patients who underwent off-pump CABG and those who underwent on-pump CABG. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294 .).

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS: In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).

Effect of methylprednisolone on acute kidney injury in patients undergoing cardiac surgery with a cardiopulmonary bypass pump: a randomized controlled trial.

BACKGROUND: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 µmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS: Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION: Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388.

Restrictive Opioid Prescribing Protocols Following Total Hip Arthroplasty and Total Knee Arthroplasty Are Safe and Effective.

BACKGROUND: Orthopedic surgeons may overprescribe opioids postoperatively. Literature examining opioid prescribing guidelines following total joint arthroplasty (TJA) is limited. METHODS: Retrospective review was conducted of primary TJAs from June 2017 to February 2018, with 3-month follow-up. Patients were divided into those who underwent surgery before (historical cohort) and after (restrictive cohort) implementation of a strict postoperative opioid prescribing protocol. RESULTS: Three hundred ninety-nine total patients were included (282 in historical cohort, 117 in restrictive cohort). There was no significant difference in preoperative, perioperative, and postoperative inpatient opioid use. Historical cohort was given significantly larger initial prescriptions, received significantly more refills, and received significantly greater total quantity of opioids per patient. There were significantly fewer call-ins in the restrictive cohort. Clinical outcomes were not significantly different. CONCLUSION: Drastic reductions in opioid prescriptions following TJA are possible without an increase in refills, call-ins, or adverse clinical effects.