Surgical Adverse Events Research Articles

Primary Tumor Resection in Synchronous Metastatic Colorectal Cancer Patients Treated with Upfront Chemotherapy plus Bevacizumab: A Pooled Analysis of TRIBE and TRIBE2 Studies.

The decision to resect or not the primary tumor in asymptomatic patients with synchronous metastatic colorectal cancer (mCRC) is a complex and challenging issue for oncologists, especially when an antiangiogenic-based therapy is planned. Patients enrolled in the phase III TRIBE and TRIBE2 studies that compared upfront FOLFOXIRI + bevacizumab to FOLFIRI or FOLFOX + bevacizumab, respectively, were included. We assessed the association of primary tumor resection (PTR) with progression-free survival (PFS), overall survival (OS), response rate (ORR), rate of grade > 2 adverse events (AEs), and serious gastrointestinal and surgical AEs in the overall population and according to the treatment arm. Of the 999 patients included, 513 (51%) underwent PTR at baseline. Longer PFS and OS were observed in resected patients compared to those with unresected primary tumors: 11.2 vs. 10.0 months (p < 0.001) and 26.6 vs. 22.5 (p < 0.001), respectively. In multivariate models, PTR was confirmed as an independent prognostic factor for better PFS (p = 0.032) and OS (p = 0.018). Patients with PTR experienced a higher incidence of grade 3 or 4 diarrhea (p = 0.055) and lower incidence of anemia (p = 0.053), perforation (p = 0.015), and serious gastrointestinal and surgical AEs (p < 0.001). No statistically significant differences were noted in incidence of bleeding (p = 0.39). The benefit of FOLFOXIRI + bevacizumab in terms of PFS (p for interaction: 0.46), OS (p for interaction: 0.80), ORR (p for interaction: 0.36), and incidence of grade 3 or 4 AEs was independent of PTR. PTR at baseline was independently associated with good prognosis in synchronous mCRC patients and with lower incidence of serious gastrointestinal and surgical AEs during upfront chemotherapy plus bevacizumab. The benefit and toxicity profile of FOLFOXIRI plus bevacizumab was independent of PTR.

Efficacy and outcome analysis: Combination of Endostar and chemotherapy as a neoadjuvant treatment of stageIIIA/IIIB squamous cell lung cancer.

Patients with stage IIIA/IIIB squamous non-small cell lung cancer (SqCLC) are particularly challenging to treat with a poor 5-year survival rate and new treatment strategies are needed. In the present study, a retrospective, single-center study was conducted to explore the efficacy and safety of Endostar combined with chemotherapy as the neoadjuvant treatment in patients with stage IIIA/IIIB SqCLC. A total of 27 patients with locally advanced SqCLC treated with Endostar combined with chemotherapy as neoadjuvant therapy from January 1, 2017 to December 31, 2019 at the Zhejiang Cancer Hospital (Hangzhou, China) were included. Short-term efficacy, rate of surgical resection, long-term outcome and adverse events were analyzed. After treatment with Endostar combined with chemotherapy, 37% of the patients underwent surgery and the radical resection rate was 90%. The objective response rate was 63% for the total population and 80% for patients who received surgery. Of note, 100% of the patients achieved disease control after treatment with Endostar combined with chemotherapy. In patients who underwent surgical resection, postoperative pathology showed that 100% of the patients achieved pathological downstaging. Furthermore, 1 (10%) patient showed a pathological complete response after surgery. The median progression-free survival was 13.5 months and overall survival was 27.9 months for the total cohort. The most common adverse events (AEs) were anemia (69.4% of patients), followed by hypertension (29.6% of patients). Most of the AEs were grade 1-2 and only 4 patients (14.8%) developed grade 3-4 AEs. Endostar combined with chemotherapy was well-tolerated and showed promising efficacy in patients with stage IIIA/IIIB SqCLC. Further prospective studies are warranted to explore its value as a neoadjuvant therapy.

Hospital spending and length of stay attributable to perioperative adverse events for inpatient hip, knee, and spine surgery: a retrospective cohort study

BackgroundThe incremental hospital cost and length of stay (LOS) associated with adverse events (AEs) has not been well characterized for planned and unplanned inpatient spine, hip, and knee surgeries.MethodsRetrospective cohort study of hip, knee, and spine surgeries at an academic hospital in 2011–2012. Adverse events were prospectively collected for 3,063 inpatient cases using the Orthopaedic Surgical AdVerse Event Severity (OrthoSAVES) reporting tool. Case costs were retrospectively obtained and inflated to equivalent 2021 CAD values. Propensity score methodology was used to assess the cost and LOS attributable to AEs, controlling for a variety of patient and procedure factors.ResultsThe sample was 55% female and average age was 64; 79% of admissions were planned. 30% of cases had one or more AEs (82% had low-severity AEs at worst). The incremental cost and LOS attributable to AEs were $8,500 (95% confidence interval [CI]: 5100–11,800) and 4.7 days (95% CI: 3.4–5.9) per admission. This corresponded to a cumulative $7.8 M (14% of total cohort cost) and 4,290 bed-days (19% of cohort bed-days) attributable to AEs. Incremental estimates varied substantially by (1) admission type (planned: $4,700/2.4 days; unplanned: $20,700/11.5 days), (2) AE severity (low: $4,000/3.1 days; high: $29,500/11.9 days), and (3) anatomical region (spine: $19,800/9 days; hip: $4,900/3.8 days; knee: $1,900/1.5 days). Despite only 21% of admissions being unplanned, adverse events in these admissions cumulatively accounted for 59% of costs and 62% of bed-days attributable to AEs.ConclusionsThis study comprehensively demonstrates the considerable cost and LOS attributable to AEs in orthopaedic and spine admissions. In particular, the incremental cost and LOS attributable to AEs per admission were almost five times as high among unplanned admissions compared to planned admissions. Mitigation strategies focused on unplanned surgeries may result in significant quality improvement and cost savings in the healthcare system.

Overcoming Underpowering in the Outcome Analysis of Repaired-Tetralogy of Fallot: A Multicenter Database from the CMR/CT Working Group of the Italian Pediatric Cardiology Society (SICPed).

Background: Managing repaired tetralogy of Fallot (TOF) patients is still challenging despite the fact that published studies identified prognostic clinical or imaging data with rather good negative predictive accuracy but weak positive predictive accuracy. Heterogeneity of the initial anatomy, the surgical approach, and the complexity of the mechanism leading to dilation and ventricular dysfunction explain the challenge of predicting the adverse event in this population. Therefore, risk stratification and management of this population remain poorly standardized. Design: The CMR/CT WG of the Italian Pediatric Cardiology Society set up a multicenter observational clinical database of repaired TOF evaluations. This registry will enroll patients retrospectively and prospectively assessed by CMR for clinical indication in many congenital heart diseases (CHD) Italian centers. Data collection in a dedicated platform will include surgical history, clinical data, imaging data, and adverse cardiac events at 6 years of follow-up. Summary: The multicenter repaired TOF clinical database will collect data on patients evaluated by CMR in many CHD centers in Italy. The registry has been set up to allow future research studies in this population to improve clinical/surgical management and risk stratification of this population.

Accuracy of autonomous robotic surgery for dental implant placement in fully edentulous patients: A retrospective case series study.

This study evaluated the accuracy of dental implant placement using the robotic computer-assisted implant surgery (r-CAIS) technology in fully edentulous patients. Fully edentulous and terminal dentition patients were enrolled for r-CAIS technology. Based on the cone-beam computed tomography (CBCT) examination, a customized positioning marker and a preoperative surgical plan were created before surgery. During the implant surgery, the implant osteotomy and placement were automatically performed using an autonomous robotic surgery system under the surgeon's supervision. A postoperative CBCT scan was used to determine the discrepancies between the planned and placed implants. Ten patients with 59 implants underwent autonomous robotic surgery. No adverse surgical events occurred. The deviations of global coronal, global apical, and angular were 0.67 ± 0.37 mm (95% CI: 0.58-0.77 mm), 0.69 ± 0.37 mm (95% CI: 0.59-0.78 mm), and 1.27° ± 0.59° (95% CI: 1.42°-1.11°), respectively. The autonomous r-CAIS technology proved an accurate surgical approach for implant placement in fully edentulous patients due to the control of the angular deviation. Autonomous robotic surgery seems promising as an accurate technology for treating fully edentulous patients. However, further trials are required to provide more hard clinical evidence.

Surgical Safety Does Not Happen By Accident: Learning From Perioperative Near Miss Case Studies

Adverse surgical events cause negative patient health outcomes and harm that can often overshadow the safe and effective patient care provided daily by nurses as members of interprofessional healthcare teams. Near misses occur far more frequently than adverse events and are less visible to nurse leaders because patient harm is avoided due to chance, prevention, or mitigation. However, near misses have comparable root causes to adverse events and exhibit the same underlying patterns of failure. Reviewing near misses provides nurses with learning opportunities to identify patient care weaknesses and build appropriate solutions to enhance care. As the operating room is one of the most complex work settings in healthcare, identifying potential weaknesses or sources for errors is vital to reduce healthcare-associated risks for patients and staff. The purpose of this manuscript is to educate, inform, and stimulate critical thinking by discussing perioperative near miss case studies and the underlying factors that lead to errors. Our authors discuss 15 near miss case studies occurring across the perioperative patient experience of care and discuss barriers to near miss reporting. Nurse leaders can use our case studies to stimulate discussion among perioperative and perianesthesia nurses in their hospitals to inform comprehensive risk reduction programs.

Baseline characteristics of a European patient population with difficult-to-treat depression (RESTORE-LIFE) treated with adjunctive vagus nerve stimulation

BackgroundMajor depressive disorder is a complex heterogeneous disorder. Treatment is especially challenging for patients with “difficult-to-treat depression” (DTD): a less stigmatizing and more clinically relevant framework defining depression that continues to cause significant burden despite usual treatment efforts. MethodsRESTORE-LIFE is a prospective, observational, multicenter, post-market study being conducted in Europe and is designed to reflect real-world clinical application of adjunctive Vagus Nerve Stimulation Therapy (VNS) for DTD. Baseline characteristics of RESTORE-LIFE patients were analyzed and compared to published treatment-resistant depression (TRD) trials. ResultsThis analysis includes the initial 98 RESTORE-LIFE patients who commenced treatment with VNS. Patients had a mean of 11.4 failed anti-depressant treatments, 1.1 suicide attempts, 87 % had prior electroconvulsive therapy, and 36 % had an endocrine/metabolic comorbidity. On average, disease severity was comparable to that in TRD trials (n = 15,463). However, RESTORE-LIFE patients appear to have been experiencing DTD for a longer duration and their DTD was characterized by a lack of positive mental health and meaningfulness of life, to a greater degree than by excess of negative mood. Despite high comorbidity rates in RESTORE-LIFE, VNS implantation was performed safely with no discontinuations due to surgical adverse events. LimitationsRESTORE-LIFE enrolls any patient receiving adjunctive VNS for DTD. Prescription of VNS may be biased by differences in practices amongst sites and countries. ConclusionsThe present analysis offers insight into contemporary real-world use of VNS Therapy for DTD in Europe representing a comprehensive characterization of DTD and how this population may differ from those in the TRD literature.

Implementation of a Brief Evidence-Based Intraoperative Coping Curriculum

Recent research has called for further resident training in coping with errors and adverse events in the operating room. To the best of our knowledge, there currently exists no evidence-based curriculum or training on this topic. Synthesizing three prior studies on how experienced surgeons react to errors and adverse events, we developed the STOPS framework for handling surgical errors and adverse events (Stop, Talk to your team, Obtain help, Plan, Succeed). This material was presented to residents in two teaching sessions. In this paper, we describe the presentation of, and the uniformly positive resident reaction to, the STOPS framework: an empirically based psychological tool for surgeons who experience operative errors or adverse events.

Evaluating the efficacy of single-shot versus prolonged antibiotic prophylaxis in alveolar cleft osteoplasty – A retrospective cohort study

This retrospective cohort study aimed to compare the outcomes of alveolar cleft osteoplasty using single-shot antibiotic prophylaxis versus a prolonged antibiotic regimen. The primary endpoints assessed were the incidence of infection, failure of surgical correction, and antibiotic-related side effects. Patients with orofacial clefts affecting the alveolar ridge who underwent alveolar cleft osteoplasty at a tertiary care center between 2015 and 2021 were included. The prolonged antibiotic group received extended antibiotic treatment, while the single-shot group received preoperative antibiotics only. Among 83 patients (mean age 12.8 years), 51 interventions were performed under prolonged antibiotic prophylaxis (mean duration 5.82 days) whereas in 40 interventions only single-shot prophylaxis was administered. There were no significant differences in infection frequency, surgical correction failure, implant loss, or adverse events between the groups. However, after single-shot antibiotic regimen, patients had significantly shorter hospital stays, being discharged on average one day earlier. The study suggests that single-shot antibiotic prophylaxis does not have drawbacks compared to prolonged antibiotic treatment in alveolar cleft osteoplasty. Considering increasing antibiotic resistance and potential side effects, omitting prolonged antibiotic prophylaxis is recommended for patients undergoing alveolar cleft osteoplasty.

The Limited Use Of Dexmedetomidine For Subarachnoid Blocks In Pakistan.

Respected Madam, Dexmedetomidine is a selective alpha-2 adrenoceptor agonist. It acts by binding to the presynaptic alpha-2 adrenoceptors and inhibits the release of norepinephrine. Thereafter, it causes a decrease in the sympathetic tone and terminates the propagation of pain signals. As a result, the haemodynamic and the endocrine stress responses of the body to surgery and anesthesia are attenuated, the blood pressure and heart rate are decreased, and the requirement for other anaesthetic agents is reduced. These effects have meant that dexmedetomidine has been widely used prior to endotracheal intubation to optimize the patients and prevent the likelihood of hemodynamic adverse effects (1). In addition to its use in general anesthesia, peri-operative physicians worldwide are now becoming increasingly aware of the dexmedetomidine’s potential usefor subarachnoid blocks. A few studies have documented the efficacy of intravenous (IV) dexmedetomidine in prolonging the duration of sensory and motor blockade induced by agents such as bupivacaine, prilocaine, and ropivacaine up to 4 hours (2), (3). Recent studies have found that intrathecal administration of dexmedetomidine in combination with the local anesthetic agent yields similar benefits (4). This has been attributed to the activation of presynaptic alpha2-A receptors at locus ceruleus and the termination of pain signal propagation via the medullospinal noradrenergic pathway (4). Therefore, it is no surprise that the use of dexmedetomidine in conjunction with local anesthetics for the subarachnoid block is common practice in peri-operative physicians throughout the globe. While Pakistani peri-operative physicians are aware of the benefits of dexmedetomidine prior to endotracheal intubation (5), the same cannot be said for subarachnoid blocks induced in Pakistan. Peri-operative physicians in Pakistan are either yet to realize the potential benefits the use of dexmedetomidine can provide for subarachnoid blocks or still adhere to conventional spinal anesthesia practices. Since the effects of a conventional subarachnoid block last from 2 to 3 hours, in any case of a surgical adverse event that prolongs the surgery, severe pain, nausea, vomiting, and derangement of the hemodynamic status have been noted in patients. Often times, this results in a shift towards general anesthesia midway through the procedure. Ultimately, the postoperative stay is prolonged which directly impacts the clinical outcome and the quality of life for these patients. ---Continue

Clinical Efficacy and Safety of a Novel Stent for Fistula Management Following Sleeve Gastrectomy

Background and AimsManagement of fistulas after bariatric surgery has shifted from a surgical to a primarily endoscopic approach. We aimed to determine the efficacy of a novel stent for the closure of fistulas and stent-related adverse events in patients with fistulas after sleeve gastrectomy (SG). MethodsFifteen patients who developed fistulas following SG between July 2016 and December 2020 and managed at a tertiary care hospital by a primarily endoscopic approach were retrospectively evaluated. The technical and clinical success of a novel stent for the exclusion and definitive closure of fistulas and the need for endoscopic and surgical reinterventions and adverse events were analyzed. ResultsFifteen patients with median age of 47 (20-61) years, 11 (73%) females, were included. Fistulas were located at the cardia in 12 (80%) patients, with a median diameter of 4 (2-15) mm. Concomitant stricture of the gastric tube was detected in 8 (53%) patients. A single stent was placed in 13 (87%) patients. Endoscopic reinterventions were required in 5 (33%), and a surgical toilette was needed for 3 (20%) patients. After a median stent implantation duration of 6 (3-21) weeks, fistula closure was documented in all 15 (100%) patients. The concomitant stricture of the gastric tube that occurred in 8 (53%) patients was also successfully managed. Adverse events related to stent placement or removal occurred in 5 (33%) patients and were managed endoscopically. Stent dysfunction occurred in 1 (7%) patient. One patient died due to bleeding from an aortoesophageal fistula 3 cm above the proximal edge of the stent. ConclusionThe novel stent is effective in closing fistulas after SG. The unique stent design is associated with a low risk of migration, allows for the management of concomitant strictures in the gastric tube, and facilitates stent removal.

Prophylactic Uterine Artery Embolization in Placenta Accreta Spectrum—An Active Intervention to Reduce Morbidity and Promote Uterine Preservation

PurposeTo evaluate the feasibility and safety of early and proactive involvement of interventional radiology (IR) in the management of placenta accreta spectrum (PAS) by performing the cesarean operation and prophylactic uterine artery embolization in the IR angiography suite as a combined procedure. Materials and MethodsThis study evaluated the effectiveness and safety of prophylactic uterine artery embolization prior to placental separation in cases of antenatally proven or suspected abnormal placentation. Over a 5-year period, 16 consecutive patients with PAS underwent combined IR and obstetric intervention. In all cases, cesarean delivery was performed in the IR angiography suite. Vascular access was obtained prior to surgery with balloon placement into both internal iliac arteries. These balloons were inflated after delivery, followed by uterine artery embolization (14 of 16) if there was evidence of active postpartum bleeding or inability to deliver the placenta. ResultsThere was no fetal or maternal mortality and no significant IR or surgical adverse events. Mean blood loss was 1900 mL. Seven patients (44%) underwent hysterectomy. ConclusionsIn patients with PAS, cesarean section in the angiography suite preceded by prophylactic balloon placement and followed by uterine artery embolization was feasible, safe, and effective in preventing massive blood loss, with a 56% uterine sparing rate.

Incidence and Risk Factors of Postoperative Complications After Rhinoplasty: A Multi-Institutional ACS-NSQIP Analysis.

Despite the popularity of rhinoplasty, outcome research has been mainly limited to single-surgeon or single-institution reports. Therefore, we performed a multi-institutional analysis to present a broader portrait of the postoperative outcomes and risk factors for adverse events after rhinoplasty surgery. We reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2009-2019) to identify patients who underwent rhinoplasty. The postoperative outcomes of interest included 30-day mortality, reoperation, readmission, and surgical and medical complications. We also analyzed risk factors for complication occurrence, including patient comorbidities and preoperative laboratory values. We identified 835 patients, 72% (n=602) of whom underwent a primary, 21% (n=175) a secondary, and 6.7% (n=58) a cleft nasal deformity procedure. The average patient age was 41±17 years, with most patients being female (n=472; 57%) and white (n=643; 77%). Complications rates were generally low, with reoperation (n=19; 2.3%) and superficial incisional infection (n=9; 1.1%) account for the most common general and surgical adverse event, respectively. Multivariable analysis revealed male sex (P=0.04) and higher ASA scores (P<0.0001) as risk factors for complications. Low serum albumin (P=0.04) and hematocrit (P=0.003) levels were associated with the occurrence of any complication, whereas low serum albumin (P=0.02) also correlated with the incidence of surgical adverse events. Complication rates after rhinoplasty were overall low and seemed to correlate with male sex and ASA scores. We identified preoperative albumin and hematocrit as predictive biomarkers of adverse events. Preoperative nutritional optimization and management of low hematocrit may improve postoperative outcomes.

The Impact of Obesity on Perioperative Outcomes for Children Undergoing Appendectomy for Acute Appendicitis: A Systematic Review.

Today, the prevalence of obesity in the pediatric population has increased dramatically. Acute appendicitis (AA) is the most common surgical condition among pediatric patients. We aimed to investigate the impact of obesity on postoperative outcomes in terms of operative time (OT), length of stay (LOS), surgical site infection (SSI), overall complications, adverse events, and mortality in children undergoing appendectomy for acute appendicitis. An extensive search of the literature in PubMed and Google Scholar was conducted to evaluate the outcomes of normal weight (NW), overweight (OW), and obese (OB) children who underwent appendectomy. Although no statistically significant differences were noted in perioperative outcomes and overall postoperative complications between OW/OB and NW children in the majority of the included studies, prolonged OT and LOS and SSI were found in some studies. Moreover, no differences in terms of readmissions and ED visits were recorded. We conclude that the impact of obesity on postoperative outcomes for children undergoing appendectomy for AA is unclear, and, therefore, no safe conclusions can be drawn with the currently available data. Due to the lack of high-quality studies, further research is required to optimize the surgical approach and prevent unwarranted complications.

The efficacy of a visiting surgical service versus that of a hospital-based surgical service in providing endoscopic endonasal surgery to remove nonfunctioning pituitary adenomas in rural communities.

To satisfy the increasing demand for endoscopic endonasal approach (EEA) to treat pituitary tumors, especially in rural areas, the "mobile EEA" system, a visiting surgical service, has been established We report this unique system for maintaining community healthcare and evaluate the surgical results of mobile EEA. A retrospectively acquired database of 225 consecutive cases of EEA at Shinshu University Hospital (i.e., "home EEA") and its affiliated hospitals (i.e., "away EEA") between May 2018 and May 2022 was reviewed. A total of 105 consecutive patients who fulfilled the criterion of a diagnosis of new-onset nonfunctioning pituitary adenoma (PA) were included. Clinical characteristics and postoperative clinical outcomes were statistically compared between the home EEA and away EEA groups to assess the presence of a home advantage and/or an away disadvantage. Patients were stratified into two cohorts: patients treated at our hospital (home EEA: n = 41 [39.0%]) and those treated in the visiting surgical service at an affiliated hospital (away EEA: n = 64 [61.0%]). Postoperative clinical outcomes, such as the extent of tumor resection (p = 0.39), operation time (p = 0.80), visual function (p = 0.54), and occurrence of surgical complications (p = 0.53), were comparable between the groups. There were no visiting surgical service-related adverse events or accidents caused by physicians' driving to away hospitals. Pituitary surgeries performed via the mobile EEA system for nonfunctioning PAs may help maintain local community healthcare. Furthermore, this system can also contribute to the efficient training of surgeons by the same experienced pituitary surgeon using the same protocol.

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery.

The feasibility, safety and efficacy of prehabilitation in adult patients awaiting elective cardiac surgery are unknown. A total of 180 participants undergoing elective cardiac surgery were allocated randomly to receive either standard pre-operative care or prehabilitation, consisting of pre-operative exercise and inspiratory muscle training. The primary outcome was change in six-minute walk test distance from baseline to pre-operative assessment. Secondary outcomes included change in inspiratory muscle strength (maximal inspiratory pressure); sarcopenia (handgrip strength); quality of life and compliance. Safety outcomes were pre-specified surgical and pulmonary complications and adverse events. All outcomes were assessed at baseline; at pre-operative assessment; and 6 and 12 weeks following surgery. Mean (SD) age was 64.7 (10.2) years; 33/180 (18%) were women. In total, 65/91 (71.4%) participants who were allocated to prehabilitation attended at least four of eight supervised in-hospital exercise classes; participants aged > 50 years were more likely than younger participants to attend (odds ratio (95%CI) of 4.6 (1.0-25.1)). Six-minute walk test was not significantly different between groups (mean difference (95%CI) -7.8 m (-30.6-15.0), p = 0.503) in the intention-to-treat analysis. Subgroup analyses based on tests for interaction indicated improvements in six-minute walk test distance were larger amongst sarcopenic patients in the prehabilitation group (p = 0.004). Change in maximal inspiratory pressure from baseline to all time-points was significantly greater in the prehabilitation group, with the greatest mean difference (95%CI) observed 12 weeks after surgery (10.6 cmH2 O (4.6-16.6) cmH2 O, p < 0.001). There were no differences in handgrip strength or quality of life up to 12 weeks after surgery. There was no significant difference in postoperative mortality (one death in each group), surgical or pulmonary complications. Of 71 pre-operative adverse events, six (8.5%) were related to prehabilitation. The combination of exercise and inspiratory muscle training in a prehabilitation intervention before cardiac surgery was not superior to standard care in improving functional exercise capacity measured by six-minute walk test distance pre-operatively. Future trials should target patients living with sarcopenia and include inspiratory muscle strength training.

Poster 313: More Severe Adverse Events are Associated with Worse Patient Reported Outcome Measures following Anterior Cruciate Ligament Reconstruction with and without Lateral Extra- articular Tenodesis Augmentation – Results from the Stability Randomized Trial

Objectives: Investigate how the severity of adverse events encountered during the follow up period of the Stability Study were associated with patient reported outcomes at two years post-operative. Methods: Stability is a pragmatic, multicenter, randomized clinical trial comparing single-bundle hamstring tendon ACLR with combined ACLR + LET. Patients aged 14-25 years with an ACL deficient knee were included (n = 618). Participants completed PROMs (KOOS, IKDC, ACL-QOL), and adverse events were documented pre-operatively and at 3, 6, 12 and 24 months postoperatively. Adverse events were categorized into four groups: none (no adverse event), minor medical (resolved spontaneously or with minimum medical management), minor surgical (event such as meniscus tear or stiffness that required surgical intervention but is not a graft rupture), contralateral ACL rupture, and graft rupture. A generalized linear model was used to compare mean PROM scores with the different levels of adverse events. Results: The rate of minor medical adverse events (11.2%), minor surgical adverse events (7.4%), and ipsilateral (7%) or contralateral (3%) ACL tears at 24 months post-operative were low considering the high-risk patient profile. There was no difference in the proportion of minor medical events, minor surgical events, or contralateral ACL ruptures between the ACLR only and ACLR + LET groups (p&gt;0.05). The ACLR only group had a significantly higher rate of graft rupture (11 vs 4%, p&lt;0.01). Increasing severity of adverse events were associated with lower PROM scores at 24 months post-operative. Patients who experienced any adverse event within the two-year follow up had significantly lower outcome scores than those with no events. When only adverse events in the first year post-operative were included, the influence of minor medical and minor surgical events was largely washed out suggesting the effect on outcomes may be due to recency rather than severity. However, graft tears and contralateral ACL tears within the first year led to significantly lower scores at two-years post-operative in all outcomes (p&lt;0.01). Conclusions: Increasing severity of adverse events were associated with lower patient reported outcome measures at 2 years post-operative. Recent minor medical and minor surgical events worsened PROM scores, but this effect was largely eliminated within a year of the event. Patients who experience a graft rupture or contralateral ACL tear appear to have a significantly lower PROMs at 2 years post- operative, regardless of the time at which the tear occurs. Therefore, the benefit of the LET procedure reducing graft rupture outweighs the potential for less severe events such as hardware irritation/removal which will likely be less detrimental to patient-important outcomes.

Total Hip Arthroplasty Outcomes in Patients Who Have a History of Prior Radiation

BackgroundThe purpose of this study was to assess the odds of developing medical and surgical adverse events following total hip arthroplasty (THA) in patients who have a history of radiation therapy (RT) for cancer. MethodsA retrospective cohort study was conducted using a national database to identify patients who underwent primary THA (Current Procedural Terminology code 27130) from 2002 to 2022. Patients who had a prior RT were identified by International Classification of Diseases, Tenth Revision, Clinical Modification codes Z51.0 (encounter for antineoplastic RT), Z92.3 (personal history of irradiation), or Current Procedural Terminology code 101843 (radiation oncology treatment). One-to-one propensity score matching was conducted to generate 3 pairs of cohorts: 1) THA with/without a history of RT; 2) THA with/without a history of cancer; and 3) THA patients who have a history of cancer treated with/without RT. Surgical and medical complications were assessed at the 30-day, 90-day, and 1-year postoperative periods. ResultsPatients who have a history of RT had higher odds of developing anemia, deep vein thrombosis, pneumonia, pulmonary embolism, and prosthetic joint infection at all intervals. When controlling for a history of cancer, RT was associated with an increased risk of pulmonary embolism, heterotrophic ossification, prosthetic joint infection, and periprosthetic fracture at all postoperative time points. There was additionally an increased risk of aseptic loosening at 1 year (odds ratio: 2.0, 95% confidence interval: 1.2 to 3.1). ConclusionThese findings suggest that patients who have a history of antineoplastic RT are at an increased risk of developing various surgical and medical complications following THA.

Five-Year Outcomes of Gastric Bypass in Young versus Older Diabetic Adults

Abstract Background Timely metabolic surgery improves glycemic control and reduces cardiovascular risk for patients with type 2 diabetes. Young age is a known predictor of metabolic success but RYGB is often delayed due to the reported vulnerability of young adults. Aims To compare diabetes remission, metabolic outcomes and surgical adverse events in young (18-35 years) and older (&amp;gt;35 years) adults in the first five years following Roux-en-Y gastric bypass (RYGB). Methods We analysed prospective registry data from a single center on young (29.4 years, [standard deviation (SD)=5]) and older (47.7 years, [SD=6.7]) non-insulin-dependent diabetic adults undergoing RYGB. Younger adults were matched one to two to their older counterparts for sex, body mass index, duration of preoperative diabetes and American Society of Anaesthesiologist score. The rate of diabetes remission and adverse events in both groups were compared. Results A total of 78.2% (43/55) of the young and 75.4% (86/114) of the older adults attended the five-year follow-up. Diabetes remission occurred significantly earlier in the young adults group with a hazard ratio of 0.57 [95% confidence interval (CI) 0.23-0.87] and a median time to remission of 12 months [95% CI 3.2-20.8] compared to 24 months [95% CI 10.5-37.4, p=0.031] for older adults. There were no significant differences in loss to follow-up, percent weight change, and all-cause adverse events. Conclusions Diabetes remission occurred earlier and more frequently in young adults within the first 5 years after RYGB. The risk of surgical complications, nutritional deficiency or failure to achieve successful weight loss did not increase in the investigated young adult group.

Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management

Fractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence. To compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS. This randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022. Surgical fixation with a Gamma3 IMN or an SHS. The primary outcome was health-related quality of life (HRQOL), measured by the EuroQol-5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score). In this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, -0.03 to 0.07 points; P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, -0.04 to 0.05; P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (β [SE] , 0.01 [0.05]; P = .82) or previous fracture (β [SE], 0.01 [0.10]; P = .88) and treatment group. This randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip. ClinicalTrials.gov Identifier: NCT01380444.