Clinical outcomes of high-risk cutaneous squamous cell carcinomas treated with Mohs surgery alone: An analysis of local recurrence, regional nodal metastases, progression-free survival, and disease-specific death.

BACKGROUND: The incidence of cutaneous squamous cell carcinoma (cSCC) continues to increase, and it is now predicted that the number of deaths from cSCC will surpass that of melanoma within the next 5 years. Although most cSCCs are successfully treated, there exists an important subset of high-risk tumors that have the highest propensity for local recurrence (LR), nodal metastasis (NM), and disease-specific death (DSD). OBJECTIVE: We investigated the clinical outcomes of high-risk cSCCs treated with Mohs surgery (MS) alone, analyzing LR, NM, distant metastasis, and DSD. In addition, we analyzed progression-free survival and DSD in patients who underwent salvage head/neck dissection for regional NMs. METHODS: Retrospective review of all high-risk cSCC treated in our clinics between January 1, 2000, and January 1, 2020, with follow-up through April 1, 2020. SETTING: Two university-affiliated, private-practice MS referral centers. RESULTS: In total, 581 high-risk primary cSCCs were identified in 527 patients, of which follow-up data were obtained for 579 tumors. The 5-year disease-specific survival was 95.7%, with a mean survival time of 18.6 years. The 5-year LR-free survival was 96.9%, the regional NM-free survival was 93.8%, and the distant metastasis-free survival was 97.3%. The 5- and 10-year progression-free survival rates from metastatic disease were 92.6 and 90.0%, respectively. In patients who experienced regional NMs and underwent salvage head and neck dissection with or without radiation, the 2-year disease-specific survival was 90.5%. CONCLUSION: Our cohort, which is the largest high-risk cSCC cohort treated with MS to date, experienced lower rates of LR, NM, and DSD than those reported with historical reference controls using both the Brigham and Women's Hospital and American Joint Committee on Cancer, Eighth Edition, staging systems. We demonstrated that MS confers a disease-specific survival advantage over historical wide local excision for high-risk tumors. Moreover, by improving local tumor control, MS appears to reduce the frequency of regional metastatic disease and may confer a survival advantage even for patients who develop regional metastases.

Mohs surgery for early-stage Merkel cell carcinoma (MCC) achieves local control better than wide local excision ± radiation therapy with no increase in MCC-specific death.

BACKGROUND: Merkel cell carcinoma (MCC) of the skin is most commonly treated with wide local excision (WLE) with or without adjuvant radiation therapy (RT). Mohs micrographic surgery (MMS) as monotherapy may offer an alternative treatment modality. The purpose of this study is to describe outcomes of patients with primary Stage I/II MCC treated with MMS alone and no RT. METHODS: A retrospectively collected sample of 56 MCCs treated with MMS was studied over an 18-year period. Tumor and treatment characteristics were described, and follow-up was assessed. RESULTS: A total of 56 primary Stage I/II MCCs in 53 patients were treated with MMS as monotherapy from April 2001 through July 2019. Patients were followed for an average of 4.6 years (median 2.7 years, range 0.8 to 16.9 years), of which 19 (33.9%) had follow-up of 5 years or more. There were no local recurrences due to inadequate excision. The 5-year Kaplan-Meier MCC-specific survival for AJCC8 Stage I and AJCC8 Stage IIA were 91.2% and 68.6%, respectively. CONCLUSION: In comparison to historical controls, Mohs surgery offers a survival that is at least as good as WLE +/- RT, with the added benefits of no need for adjuvant RT or the need for further surgery for treatment of local recurrence.

Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes.

BACKGROUND AND PURPOSE: To investigate the effects of adding virtual activity groups to a multicomponent ambulatory activity monitoring intervention in managing chronic conditions such as obesity and type 2 diabetes. METHODS: We randomized 120 subjects with type 2 diabetes to receive an activity monitor with or without placement into virtual activity groups. We monitored subjects over six months and collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data. RESULTS: All subjects lost significant weight over the course of the study (p = 0.005); however, there was no statistically significant difference in mean weight loss between two groups (p = 0.520). HbA1c decreased in both groups, but was not statistically significant (p = 0.084). Daily step counts were similar between groups (p = 0.633), but both groups did decrease significantly over time (p = 0.004). There was no linear correlation between daily step count and HbA1c (p = 0.609), but there was between daily step count and weight (p = 0.016) although this only accounted for 5.6% of weight loss. There were no significant differences found for blood pressure and Rand SF36 measures between groups or times, or group-time interactions with two exceptions. The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001). Compliance remained high, with 93.8% of subjects actively participating at the conclusion of the study. CONCLUSIONS: Activity monitoring with in-person goal-setting and scripted feedback over six months was associated with significant weight loss with or without virtual support groups.

Modified Battlefield Acupuncture Does Not Reduce Pain or Improve Quality of Life in Patients with Lower Extremity Surgery.

INTRODUCTION: This study seeks to determine if modified Battlefield Acupuncture is more effective at relieving acute extremity pain, reducing medication use, and improving quality of life than placebo acupuncture or standard care after lower extremity surgery. METHODS: We conducted a multi-site 3-arm randomized, double-blind controlled trial of standard care alone versus standard care + placebo auricular acupuncture with semi-permanent needles versus standard care + modified battlefield acupuncture with semi-permanent needles for lower extremity surgery at two Air Force hospitals. Subjects reported pain level immediately after acupuncture, 24, 48, 168, and 720 hours later to a blinded research associate. Additionally, subjects completed a PIQ-6 30 days post-operatively, and opioid use was tracked for 30 days post-operatively. RESULTS: Two hundred thiry-three subjects >18 years old (92 females and 141 males) with a mean age of 44.5 years were randomized with 81 randomized to modified BFA, 74 randomized to placebo acupuncture, and 78 randomized to standard care. Overall pain levels were unchanged at each time point between groups. Outcomes showed unchanged pain, opioid and quality of life between groups. CONCLUSION: The use of modified battlefield acupuncture protocol does not change pain opioid use or quality of life in those with lower extremity surgery.

Left Ventricular Compressions Improve Hemodynamics in a Swine Model of Out-of-Hospital Cardiac Arrest.

INTRODUCTION: We hypothesized that chest compressions located directly over the left ventricle (LV) would improve hemodynamics, including coronary perfusion pressure (CPP), and return of spontaneous circulation (ROSC) in a swine model of cardiac arrest. METHODS: Transthoracic echocardiography (echo) was used to mark the location of the aortic root and the center of the left ventricle on animals (n = 26) which were randomized to receive chest compressions in one of the two locations. After a period of ten minutes of ventricular fibrillation, basic life support (BLS) with mechanical cardiopulmonary resuscitation (CPR) was initiated and performed for ten minutes followed by advanced cardiac life support (ACLS) for an additional ten minutes. During BLS the area of maximal compression was verified using transesophageal echo. CPP and other hemodynamic variables were averaged every two minutes. RESULTS: Mean CPP was not significantly higher in the LV group during all time intervals of resuscitation; mean CPP was significantly higher in the LV group during the 12-14 minute interval of BLS and during minutes 22-30 of ACLS (p < 0.05). Aortic systolic and diastolic pressures, right atrial systolic pressures, and end-tidal CO2 (ETCO2) were higher in the LV group during all time intervals of resuscitation (p < 0.05). Nine of the left ventricle group (69%) achieved ROSC and survived to 60 minutes compared to zero of the aortic root group (p < 0.001). CONCLUSIONS: In our swine model of cardiac arrest, chest compressions over the left ventricle improved hemodynamics and resulted in a greater proportion of animals with ROSC and survival to 60 minutes.

Assessment of the effeCt of lIfestyle iNtervention plus water-soluble ciNnAMon extract On loweriNg blood glucose in pre-diabetics, a randomized, double-blind, multicenter, placebo controlled trial: study protocol for a randomized controlled trial.

BACKGROUND: The World Health Organization predicts that by 2030 diabetes will be the seventh leading cause of death in the world. Multiple studies have tried to determine if cinnamon is an effective treatment for diabetes. Cinnamon extract is an insulin sensitizer, protects mesangial cells, decreases inflammatory markers, and lowers glucose, lipids, and blood pressure in patients with type 2 diabetes, so we developed a protocol to study whether ingestion of water-soluble cinnamon extract prevents progression from pre-diabetes to diabetes. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled trial comparing cinnamon extract versus placebo in subjects with pre-diabetes who have committed to participate in a lifestyle change program. The trial will be conducted at five sites and will include 428 subjects who take cinnamon extract or placebo for 1 year. Follow-up for these subjects will be for a total of 2 years (nine study visits). The primary outcomes to be assessed are 1) conversion of patients from pre-diabetes to diabetes and 2) impact of water-soluble cinnamon extract on hepatic transaminases, renal function, and QT interval on electrocardiogram. Secondary outcomes include changes in HbA1c, lipids, waist circumference, weight, blood pressure, and fasting plasma glucose. The trial protocol has been approved by the Institutional Review Board of the US Air Force 59th Medical Wing, Wilford Hall Ambulatory Surgical Center (Protocol FWH20110035H). Investigator-sponsored Investigational New Drug status (114078) was granted by the US Food and Drug Administration. DISCUSSION: This study will provide high-quality evidence of the efficacy of water-soluble cinnamon extract in conjunction with lifestyle intervention for preventing patients with pre-diabetes from converting to diabetes. Additionally, it will provide important safety information about water-soluble cinnamon extract. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01301521 , 18 February 2011.

Digit-Sparing Mohs Surgery for Melanoma.

BACKGROUND: Digital melanoma is commonly treated with amputation or wide local excision. Mohs micrographic surgery (MMS) may offer an alternative treatment modality. OBJECTIVE: To describe outcomes of digital melanomas treated with MMS over a 35-year period. METHODS: A retrospective series of digital melanomas treated with MMS was studied. Tumor and treatment characteristics were described and follow-up was assessed. RESULTS: Sixty-two digital (1.2%) tumors were identified from 4995 melanomas, of which 57 (91.9%) were primary and 5 (8.1%) were recurrent on enrollment. Melanocytic antigen recognized by cytotoxic T lymphocytes from melanoma patients (MART)-1 and HMB-45 immunostains were used in 34 (54.8%) and 14 (22.6%) cases, respectively. Five (8.2%) tumors recurred locally during the course of the study, none of which occurred with MART-1 use. Three (60.0%) local recurrences were salvaged with additional MMS. Local recurrence-free survival rates for primary melanomas at 5 and 10 years were 91.8% and 82.6%, respectively. Overall, 55 (96.5%) patients with primary digital melanomas avoided amputation. Five and 10-year melanoma-specific survival rates for all patients were 95.0% and 81.2%, respectively. LIMITATIONS: A formal comparison group was not studied. CONCLUSION: In the management of digital melanoma, MMS conserves function by avoiding amputation and offers a low local recurrence rate. Outcomes are improved with the use of MART-1.

Objective comparison of animal training versus artificial simulation for initial cricothyroidotomy training.

This manuscript aims to determine if there is a difference in performance outcomes after initial training with either animals or simulators. Volunteers without prior experience performing emergency procedures were randomly assigned to receive training in cricothyroidotomy on either a pig model or on an artificial simulator. Volunteers were given identical lectures and trained to proficiency. Two weeks after training, trainees were tested using human cadavers as to their performance with time, incision size, incision start location, initial placement attempt, and final accuracy. Overall success rate of the animal-trained group was 64 per cent and in the artificial simulator group, 73 per cent (P = 0.431). Median time to completion in the animal group and artificial simulator group was 143 s and 105 s (P = 0.482), and incision lengths 4.0 cm and 3.2 cm (P = 0.173), respectively. Accuracy of initially attempted incision placement and final cricothyroidotomy tube placement was also compared. Initially attempted site accuracy in the animal-trained group was 93 per cent and correct final position 79 per cent, and in the artificial group, 100 per cent (P = 0.452) and 88 per cent (P = 0.782), respectively. There was no statistically significant, objective difference in any metric between animal- and simulator-trained groups after cricothyroidotomy training. For initial training, there is no objective benefit of animal training.

Prospective evaluation of the correlation between torso height and aortic anatomy in respect of a fluoroscopy free aortic balloon occlusion system.

BACKGROUND: To report the lengths of key torso vascular and to develop regression models that will predict these lengths, based on an external measure of torso height (EMTH, sternum to pubis) in the development of a fluoroscopy-free balloon occlusion system for hemorrhage control. METHODS: We conducted a prospective, observational study at a Combat Support Hospital in Southern Afghanistan using adult male patients undergoing computed tomography (CT). EMTH was recorded using a tape measure and intra-arterial distance was derived from CT imaging. Regression models to predict distance from the common femoral artery (CFA) into the middle of aortic zone I (left subclavian artery to celiac trunk) and zone III (infrarenal aorta) were developed from a random 20% of the cohort and validated by the remaining 80%. RESULTS: Overall, 177 male patients were included with a median (interquartile range [IQR]) age of 23 (8) years. The median (IQR) lengths of aortic zone I and III were 222 (24), 31 (9), and 92 (15) mm. The mid-zone distance from the left and right CFA to zone I were 423 (27) and 418 (29) and for zone III 232 (21) and 228 (22). Linear regression models demonstrated an accuracy between 99.3% to 100% at predicting the insertion distance required to place a catheter within the middle of each aortic zone. CONCLUSION: This study demonstrates the use of morphometric analysis in the development of a fluoroscopy-free balloon occlusion system for torso hemorrhage control. Further study in a larger population of mixed gender is required to further validate insertion models.

Comparison of self-efficacy and its improvement after artificial simulator or live animal model emergency procedure training.

The objective of this study is to compare post-training self-efficacy between artificial simulators and live animal training for the performance of emergency medical procedures. Volunteer airmen of the 81st Medical Group, without prior medical procedure training, were randomly assigned to two experimental arms consisting of identical lectures and training of diagnostic peritoneal lavage, thoracostomy (chest tube), and cricothyroidotomy on either the TraumaMan (Simulab Corp., Seattle, Washington) artificial simulator or a live pig (Sus scrofa domestica) model. Volunteers were given a postlecture and postskills training assessment of self-efficacy. Twenty-seven volunteers that initially performed artificial simulator training subsequently underwent live animal training and provided assessments comparing both modalities. The results were first, postskills training self-efficacy scores were significantly higher than postlecture scores for either training mode and for all procedures (p < 0.0001). Second, post-training self-efficacy scores were not statistically different between live animal and artificial simulator training for diagnostic peritoneal lavage (p = 0.555), chest tube (p = 0.486), and cricothyroidotomy (p = 0.329). Finally, volunteers undergoing both training modalities indicated preference for live animal training (p < 0.0001). We conclude that artificial simulator and live animal training produce equivalent levels of self-efficacy after initial training, but there is a preference in using a live animal model to achieve those skills.

Morphometric analysis of torso arterial anatomy with implications for resuscitative aortic occlusion.

BACKGROUND: Hemorrhage is a leading cause of death in military and civilian trauma. Despite the importance of the aorta as a site of hemorrhage control and resuscitative occlusion, detailed knowledge of its morphometry is lacking. The objective of this study was to characterize aortic morphometry in a trauma population, including quantification of distances as well as and diameters and definition of relevant aortic zones. METHODS: Center line measures were made (Volume Viewer) from contrast computed tomography (CT) scans of male trauma patients (18-45 years). Aortic zones were defined based on branch arteries. Zone I includes left subclavian to celiac; Zone II includes celiac to caudal renal; Zone III includes caudal renal to aortic bifurcation. Zone lengths were calculated and correlated to a novel external measure of torso extent (symphysis pubis to sternal notch). RESULTS: Eighty-eight males (mean [SD], 28 [4] years) had CT scans for the study. The median (interquartile range) lengths (mm) of Zones I, II, and III were 210 mm (202-223 mm), 33 mm (28-38 mm), and 97 mm (91-103 mm), respectively. Median aortic diameters at the left subclavian, celiac, and lowest renal arteries were 21 mm (20-23 mm), 18 mm (16-19 mm), and 15 mm (14-16 mm), respectively, and the terminal aortic diameter was 14 mm (13-15 mm). The correlation of determination for descending aortic length (all zones) against torso extend was r = 0.454. CONCLUSION: This study provides a morphometric analysis of the aorta in a male population, demonstrating consistency of length and diameter while defining distinct axial zones. Findings suggest that center line aortic distances correlate with a simple, external measure of torso extent. Morphometric study of the aorta using CT data may facilitate the development and implementation of occlusion techniques to manage noncompressible torso, pelvic, and junctional femoral hemorrhage.

Comparing fitness performance before and after breast reduction surgery.

BACKGROUND: Breast reduction is one of the most commonly performed surgeries by plastic surgeons. Patients may receive many benefits and overall complications are low allowing for breast reduction to be a popular procedure offered by plastic surgeons. Fitness improvement is a perceived benefit but has not been objectively demonstrated, which is the purpose of this study. METHODS: An IRB approved retrospective review of fitness performance scores before and after breast reduction for symptomatic macromastia in active duty women was performed. RESULTS: No improvement or statistically significant difference was demonstrate in overall fitness, push-ups, sit-ups, waist measurement, or 1.5-mile run time. All women reported relief of symptoms of macromastia and felt more comfortable exercising. CONCLUSIONS: Although comfort during exercise improves, actual fitness performance remains unchanged. Fitness requirements of active duty members allowed for this unique opportunity to study actual fitness performance in breast reduction patients.