Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

Physician impact on use of fluoroscopy during endovascular procedures to improve radiation safety.

OBJECTIVE: To determine whether differences exist in fluoroscopy time and radiation exposure during lower extremity endovascular procedures performed by fellowship trained vascular surgeons vs general surgeons, to minimize radiation exposure to operating room staff. METHODS: A retrospective review of all lower extremity endovascular procedures was performed from August 1, 2014, to January 29, 2016. The procedures were performed by the surgical department's four surgeons with endovascular privileges: two vascular surgeons and two general surgeons. Only procedures involving lower extremity arterial angiograms with balloon angioplasty, stenting, or atherectomy were included. The operative records were reviewed for each case. The total fluoroscopy time and total radiation dose for each procedure were recorded. Procedures were grouped according to the number of endovascular interventions as one to two interventions, three to four interventions, and five or more interventions performed. Statistical analysis was performed with a P value of less than .05 considered significant. RESULTS: About 271 lower extremity endovascular procedures were performed during the study period by 4 surgeons. The average age of the patient population was 70 years. The total number of procedures performed over the study period were 112, 45, 91, and 25 for surgeons 1 through 4, respectively. On average, 3.24 interventions were performed during each procedure. Vascular surgeons were found to have shorter fluoroscopy time for procedures involving one to two (7.8 vs 30.1; P < .01), three to four (9.3 vs 34.2; P < .01), and five or more (11.5 vs 51.9; P < .01) interventions. Vascular surgeons were also found to have less radiation exposure compared with general surgeons in procedures with one to two (1.69 vs 3.53; P = .001) and five or more (2.3 vs 5.4; P = .003) interventions. There was no significant difference in radiation exposure between vascular and general surgeons for procedures with three to four interventions (5.86 vs 5.59; P = .95). CONCLUSIONS: In this small series at our institution, lower extremity endovascular procedures performed by specialty trained vascular surgeons were associated with both decreased operative fluoroscopy time and decreased radiation exposure when compared with general surgeons.

Ruptured abdominal aortic aneurysm after endovascular aortic aneurysm repair thrombosis.

Background Complete thrombosis of an aortic endograft after an endovascular aortic aneurysm repair is a rare complication. The majority of thrombotic events occur in the iliac limbs. Case presentation We present the case of a patient who presented with acute limb ischemia as the result of a thrombosed infra-renal aortic endograft. After restoration of blood flow to the lower extremities with an axillary to bi-femoral artery bypass, the patient was lost to follow-up. The patient returned two years later with a ruptured abdominal aortic aneurysm due to a type 1A endoleak. Discussion We propose that all patients after endovascular aortic aneurysm repair, including those with a thrombosed aortic endograft, continue to undergo regular graft surveillance. This case report highlights the importance of continued surveillance of the aortic sac, even after total thrombosis of the endovascular aortic aneurysm repair.

Treatment of upper extremity venous aneurysms with a polytetrafluoroethylene-covered stent.

Background Venous aneurysms of the upper torso are uncommon in contrast to the abdomen and lower extremities. Mostly silent, they can cause significant morbidity. Large or symptomatic venous aneurysms are generally treated with open resection. To our knowledge, there are no documented cases of head and neck venous aneurysms treated by a hybrid endovascular and open approach. Case Presentation A 56-year-old female presented with the complaint of pain and increasing size of a supraclavicular mass. Imaging revealed a large saccular aneurysm of the subclavian vein with the presence of a large intramural thrombus on computed tomography scan with contrast. A covered stent was deployed in order to exclude the aneurysm from circulation. Three weeks later, the symptoms continued, and an aneurysmorrhaphy was performed to excise the stent and aneurysm resection. Discussion A combined endovascular and open approach to resection of symptomatic subclavian vein aneurysms is a viable method with minimal morbidity.

Initiating advance care planning at admission: a brief intervention to increase goals of care discussions in geriatric trauma patients in an urban level I trauma center.

Objectives: The burden of geriatric trauma continues to rise. Older trauma patients experience higher morbidity and mortality and thus benefit from early goals of care (GOC) discussions and advance care planning (ACP). The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP) recommends holding a family meeting within 72 hours of admission when treating geriatric trauma patients. At our level I trauma center, we sought to increase early GOC discussions by implementing a new history and physical (H&P) note template for geriatric trauma patients. Methods: Patients (aged >65 years) admitted to the trauma surgery service (≥24 hours) were included in the study. The intervention was a change in the H&P note template to include confirmation of code status or previous ACP and identification of a healthcare proxy. Primary outcomes were the rates of recognizing a pre-existing Do-Not-Resuscitate (DNR) status/advanced directives at admission and of documentation of a GOC discussion within 72 hours. Outcomes from a 3-month period (March-May) during the pre-intervention (2021) and post-intervention (2022) periods were compared. Results: The pre-intervention and post-intervention groups had 107 and 150 patients, respectively. We observed an increase in recognition of pre-existing DNR code status at time of admission from 50% to 95% (p=0.003) and documentation of a GOC discussion within 72 hours from 17% to 83% (p<0.0001). We also observed a trend showing that new DNR orders were placed more frequently in the post-intervention period (9% vs 17%, p=0.098). The in-hospital mortality was not significantly different. Conclusions: The importance of GOC discussions and ACP documentation for geriatric trauma patients is evident, but its completion can be challenging. Our intervention of a new H&P note template increased GOC discussions, and this implementation may be feasible in other trauma centers to comply with the ACS-TQIP Geriatric Trauma Management Guidelines. Level of evidence: Level III.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.

Importance: In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs. Objective: To assess the use and safety of outpatient management of acute appendicitis. Design, Setting, and Participants: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020. Exposures: Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively. Main Outcomes and Measures: Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared. Results: Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores. Conclusions and Relevance: These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.

IMPORTANCE: Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making. OBJECTIVE: To assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021. EXPOSURES: Appendectomy vs antibiotics. MAIN OUTCOMES AND MEASURES: Conditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons. RESULTS: Of 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91). CONCLUSIONS AND RELEVANCE: This cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.

Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial.

Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials. Objective: To examine the association between patients' baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial. Design, Setting, and Participants: This was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis. Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful. Main Outcomes and Measures: Three outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors. Results: Of the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13-percentage point lower risk of appendectomy (aRD, -13.49; 95% CI, -24.57 to -2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was -5.68 (95% CI, -16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, -15.72; 95% CI, -29.71 to -1.72), with directionally similar results for the completely successful group (aRD, -15.14; 95% CI, -30.56 to 0.28). Conclusions and Relevance: Positive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Clinical correlation of success and acute thrombotic complications of lower extremity endovenous thermal ablation.

OBJECTIVE: Endovenous thermal ablation has become the primary modality of treatment for patients with venous insufficiency. Previous literature has provided reviews of radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) that mostly focus on the great saphenous vein (GSV) and small saphenous vein (SSV). Data with an extended review including the anterior accessory saphenous vein (ASV) and perforator veins (PVs) have been limited. This study examines the treatment of venous insufficiency with RFA and EVLA of these multiple veins to identify clinical and demographic predictors of both the early success and thrombotic complications of endovenous thermal ablation. METHODS: A retrospective analysis of patients who underwent either RFA or EVLA of the GSV, SSV, ASV, or PVs was performed from March 2012 through February 2014. The PVs were treated only using RFA. The success and complication rates of each method were compared. Procedure results were determined by duplex ultrasound examination at the next office visit. Obliteration of the target vein was defined as a success. A complication was defined as thrombosis of any vein proximal to the target vein or acute thrombosis of any tributaries. RESULTS: A total of 808 patients were treated with either RFA or EVLA (2057 procedures); 47 patients were excluded because of incomplete records. In total, 1811 procedures were included with an average of 2.4 procedures per patient. Excluding the PVs, the success rate of RFA was 98.4%, equivalent to EVLA at 98.1% (P = .66). The success rates of thermal ablation for each vein were as follows: GSV, 98.5%; SSV, 98.2%; ASV, 97.2%; and PVs, 82.4%. The overall thrombotic complication rate was 10.5%. The thrombotic complications include endovenous heat-induced thrombosis (EHIT; 5.9%) and acute superficial venous thrombosis (4.6%). However, when EHIT class 1 was excluded, the true EHIT rate was 1.16%. The rate of a thrombotic complication for each vein was as follows: GSV, 11.8%; SSV, 5.5%; ASV, 6.5%; and PVs, 2.4%. The thrombotic complication rate was 7.7% for RFA and 11.4% for EVLA (P = .007). Age, gender, laterality, presenting symptoms (based on Clinical, Etiology, Anatomy, and Pathophysiology class), and vein type and diameter have no effect on successful ablation. Increased vein diameter (P < .001) and type of vein (P < .0001) were significant predictors of acute thrombotic complications; however, on multivariable analysis, only type of vein was an independent statistically significant predictor when nested for within-person correlation. CONCLUSIONS: There were no statistical difference in successful closure rates between RFA and EVLA. The type of procedure (EVLA), larger vein diameters, and treatment of the GSV were associated with a greater thrombotic complication rate, but type of vein was the most significant independent predictor.