Association of artificial intelligence-powered and manual quantification of programmed death-ligand 1 (PD-L1) expression with outcomes in patients treated with nivolumab ± ipilimumab.

Assessment of programmed death ligand 1 (PD-L1) expression by immunohistochemistry (IHC) has emerged as an important predictive biomarker across multiple tumor types. However, manual quantitation of PD-L1 positivity can be difficult and leads to substantial inter-observer variability. Although the development of artificial intelligence (AI) algorithms may mitigate some of the challenges associated with manual assessment and improve the accuracy of PD-L1 expression scoring, use of AI-based approaches to oncology biomarker scoring and drug development has been sparse, primarily due to the lack of large-scale clinical validation studies across multiple cohorts and tumor types. We developed AI-powered algorithms to evaluate PD-L1 expression on tumor cells by IHC and compared it with manual IHC scoring in urothelial carcinoma, non-small cell lung cancer, melanoma, and squamous cell carcinoma of the head and neck (prospectively determined during the phase II and III CheckMate clinical trials). 1,746 slides were retrospectively analyzed, the largest investigation of digital pathology algorithms on clinical trial datasets performed to date. AI-powered quantification of PD-L1 expression on tumor cells identified more PD-L1-positive samples compared with manual scoring at cutoffs of ≥1% and ≥5% in most tumor types. Additionally, similar improvements in response and survival were observed in patients identified as PD-L1-positive compared with PD-L1-negative using both AI-powered and manual methods, while improved associations with survival were observed in patients with certain tumor types identified as PD-L1-positive using AI-powered scoring only. Our study demonstrates the potential for implementation of digital pathology-based methods in future clinical practice to identify more patients who would benefit from treatment with immuno-oncology therapy compared with current guidelines using manual assessment.

New Technologies to Image Tumors.

The premise of this book is the importance of the tumor microenvironment (TME). Until recently, most research on and clinical attention to cancer biology, diagnosis, and prognosis were focused on the malignant (or premalignant) cellular compartment that could be readily appreciated using standard morphology-based imaging.

Practice guidelines for the supervising professional: intraoperative neurophysiological monitoring.

The American Society of Neurophysiological Monitoring (ASNM) was founded in 1989 as the American Society of Evoked Potential Monitoring. From the beginning, the Society has been made up of physicians, doctoral degree holders, Technologists, and all those interested in furthering the profession. The Society changed its name to the ASNM and held its first Annual Meeting in 1990. It remains the largest worldwide organization dedicated solely to the scientifically-based advancement of intraoperative neurophysiology. The primary goal of the ASNM is to assure the quality of patient care during procedures monitoring the nervous system. This goal is accomplished primarily through programs in education, advocacy of basic and clinical research, and publication of guidelines, among other endeavors. The ASNM is committed to the development of medically sound and clinically relevant guidelines for the performance of intraoperative neurophysiology. Guidelines are formulated based on exhaustive literature review, recruitment of expert opinion, and broad consensus among ASNM membership. Input is likewise sought from sister societies and related constituencies. Adherence to a literature-based, formalized process characterizes the construction of all ASNM guidelines. The guidelines covering the Professional Practice of intraoperative neurophysiological monitoring were initially published January 24th, 2013, and subsequently that document has undergone review and revision to accommodate broad inter- and intra-societal feedback. This current version of the ASNM Professional Practice Guideline was fully approved for publication according to ASNM bylaws on February 22nd, 2018, and thus overwrites and supersedes the initial guideline.

Advances in the computational and molecular understanding of the prostate cancer cell nucleus.

Nuclear alterations are a hallmark of many types of cancers, including prostate cancer (PCa). Recent evidence shows that subvisual changes, ones that may not be visually perceptible to a pathologist, to the nucleus and its ultrastructural components can precede visual histopathological recognition of cancer. Alterations to nuclear features, such as nuclear size and shape, texture, and spatial architecture, reflect the complex molecular-level changes that occur during oncogenesis. Quantitative nuclear morphometry, a field that uses computational approaches to identify and quantify malignancy-induced nuclear changes, can enable a detailed and objective analysis of the PCa cell nucleus. Recent advances in machine learning-based approaches can now automatically mine data related to these changes to aid in the diagnosis, decision making, and prediction of PCa prognoses. In this review, we use PCa as a case study to connect the molecular-level mechanisms that underlie these nuclear changes to the machine learning computational approaches, bridging the gap between the clinical and computational understanding of PCa. First, we will discuss recent developments to our understanding of the molecular events that drive nuclear alterations in the context of PCa: the role of the nuclear matrix and lamina in size and shape changes, the role of 3-dimensional chromatin organization and epigenetic modifications in textural changes, and the role of the tumor microenvironment in altering nuclear spatial topology. We will then discuss the advances in the applications of machine learning algorithms to automatically segment nuclei in prostate histopathological images, extract nuclear features to aid in diagnostic decision making, and predict potential outcomes, such as biochemical recurrence and survival. Finally, we will discuss the challenges and opportunities associated with translation of the quantitative nuclear morphometry methodology into the clinical space. Ultimately, accurate identification and quantification of nuclear alterations can contribute to the field of nucleomics and has applications for computationally driven precision oncologic patient care.

Dimensionality reduction-based fusion approaches for imaging and non-imaging biomedical data: concepts, workflow, and use-cases.

BACKGROUND: With a wide array of multi-modal, multi-protocol, and multi-scale biomedical data being routinely acquired for disease characterization, there is a pressing need for quantitative tools to combine these varied channels of information. The goal of these integrated predictors is to combine these varied sources of information, while improving on the predictive ability of any individual modality. A number of application-specific data fusion methods have been previously proposed in the literature which have attempted to reconcile the differences in dimensionalities and length scales across different modalities. Our objective in this paper was to help identify metholodological choices that need to be made in order to build a data fusion technique, as it is not always clear which strategy is optimal for a particular problem. As a comprehensive review of all possible data fusion methods was outside the scope of this paper, we have focused on fusion approaches that employ dimensionality reduction (DR). METHODS: In this work, we quantitatively evaluate 4 non-overlapping existing instantiations of DR-based data fusion, within 3 different biomedical applications comprising over 100 studies. These instantiations utilized different knowledge representation and knowledge fusion methods, allowing us to examine the interplay of these modules in the context of data fusion. The use cases considered in this work involve the integration of (a) radiomics features from T2w MRI with peak area features from MR spectroscopy for identification of prostate cancer in vivo, (b) histomorphometric features (quantitative features extracted from histopathology) with protein mass spectrometry features for predicting 5 year biochemical recurrence in prostate cancer patients, and (c) volumetric measurements on T1w MRI with protein expression features to discriminate between patients with and without Alzheimers' Disease. RESULTS AND CONCLUSIONS: Our preliminary results in these specific use cases indicated that the use of kernel representations in conjunction with DR-based fusion may be most effective, as a weighted multi-kernel-based DR approach resulted in the highest area under the ROC curve of over 0.8. By contrast non-optimized DR-based representation and fusion methods yielded the worst predictive performance across all 3 applications. Our results suggest that when the individual modalities demonstrate relatively poor discriminability, many of the data fusion methods may not yield accurate, discriminatory representations either. In summary, to outperform the predictive ability of individual modalities, methodological choices for data fusion must explicitly account for the sparsity of and noise in the feature space.

Recall and patient perceptions of hip precautions 6 weeks after total hip arthroplasty.

Background and purpose - There is a lack of evidence to support the role of hip precautions in preventing dislocation following total hip arthroplasty (THA). We report an exploratory study which assesses recall, adherence, and the impact of precautions on activities of daily living in the first 6 weeks postoperatively. Patients and methods - We designed a new questionnaire based on the education patients receive and refined by professionals within our multidisciplinary team. 129 patients underwent primary elective THA during the study period and received the questionnaire at 6 weeks postoperatively. Results - 97 (75%) patients responded before the 8th week postoperatively. Most of these (83 patients) could remember all the precautions. Of the 97 who responded only 22 claimed to adhere to all of the precautions. 48 admitted to putting their own underwear on without the use of aids or assistance, and 38 had started walking without an aid. Due to the precautions 67 avoided leaving the house at some point and 63 were unable to perform desired activities. 84 stated that their sleep was affected. There were no dislocations among the 97 patients who responded; however, there was 1 dislocation among the 32 non-responders. Interpretation - We found that most patients did not adhere to hip precaution advice. Precautions have a detrimental effect on patient activity and sleep. In view of the limited efficacy in reducing dislocation rate, we question the use of precautions in the primary arthroplasty setting.

Use of a proactive duplex ultrasound protocol for hemodialysis access.

OBJECTIVE: Arteriovenous fistula (AVF) creation is the preferred approach for hemodialysis access; however, the maturation of AVFs is known to be poor. We established a proactive early duplex ultrasound (DUS) surveillance protocol for evaluating AVFs before attempted access. This study determined the effect of this protocol related to improving AVF maturation. METHODS: From 2008 to 2013, 153 patients received new upper extremity AVFs and an early DUS surveillance protocol at a single academic institution. The protocol involved an early DUS evaluation before hemodialysis cannulation of the AVF at 4 to 8 weeks after AVF creation. A positive DUS result was identified as a peak systolic velocity of >375 cm/s or a >50% stenosis on gray scale imaging, along with decreased velocity in the outflow vein. Patients with positive DUS findings underwent prophylactic endovascular or open intervention to assist with AVF maturation. Nature of secondary interventions, as well as AVF patency and maturation, were assessed. Overall clinical outcomes and fistula patency were investigated. RESULTS: During the study period, 183 upper extremity AVFs were created in 153 patients, including 82 radiocephalic, 63 brachiocephalic, and 38 brachiobasilic AVFs. A mortality rate of 43% (n = 66) was observed in a median follow-up period of 34.5 months (interquartile range, 19.6-46.9). A total of 164 early DUS were performed at a median of 6 weeks (interquartile range, 3.4-9.6 weeks) after the initial creation. Early DUS showed nine AVFs were occluded and were excluded from further analysis. Hemodynamically significant lesions were found in 62 AVFs (40%); however, only 17 (11%) were associated with an abnormal physical examination. Positive DUS finding prompted a secondary intervention in 81% of the patients. Among those with positive early DUS findings, AVF maturation was 70% in those undergoing a secondary intervention compared with 25% in those not undergoing a prophylactic intervention (P = .011). Primary-assisted patency for AVFs with early positive and negative DUS findings were 83% and 96% at 6 months, 64% and 89% at 1 year, and 52% and 82% at 2 years, respectively (P < .001). CONCLUSIONS: Early DUS surveillance of AVFs before initial access is reasonable to identify problematic AVFs that may not be reliably detected on clinical examination. Although DUS criteria for AVFs have yet to be universally accepted, proactive early postoperative DUS interrogation assists in the early detection of dysfunctional AVFs and improvement of fistula maturation. Despite improved patency in those with positive DUS findings who undergo prophylactic secondary intervention, overall patency remains inferior to those without an abnormality detected on early DUS imaging.

SPY technology as an adjunctive measure for lower extremity perfusion.

OBJECTIVE: Lack of a reliable outcome measure often leads to excessive or insufficient interventions for critical limb ischemia (CLI). SPY technology (Novadaq Technologies Inc, Bonita Springs, Fla), widely adapted by plastic and general surgeons, uses laser-assisted fluorescence angiography (LAFA) to assess tissue perfusion. We sought to determine the role of SPY as an alternative, perhaps more reliable outcome measure for vascular interventions. METHODS: All patients undergoing elective or urgent revascularization for claudication and CLI were prospectively recruited from June 2012 to August 2014. LAFA using SPY technology was performed before and after revascularization procedures under a standard Institutional Review Board-approved protocol. Quantitative measures of perfusion at plantar surfaces were analyzed and compared with ankle-brachial index. RESULTS: A total of 93 patients with claudication or CLI underwent LAFA before and after a revascularization procedure in the study period. The mean preoperative ankle-brachial index increased from 0.60 to 0.84 (P < .001) after a revascularization procedure. Plantar perfusion as measured by LAFA also improved significantly after intervention. Ingress, defined as the rate at which fluorescence intensity increases on the plantar surface during LAFA, increased from 7.1 to 12.4 units/s (P < .001). Peak perfusion, defined as the difference between the baseline and the peak of fluorescence intensity, increased from 97.1 and 143.9 units (P < .001). Egress, defined as the rate at which intensity diminishes after reaching peak perfusion, increased from 1.0 to 1.9 units/s (P = .035). Procedure-related digital embolization was also observed in several patients despite lack of an angiographic finding. CONCLUSIONS: This is the largest prospective study evaluating SPY technology in peripheral vascular interventions. Our study shows that SPY is a valuable tool in visualizing real-time procedural outcomes and providing additionally useful information on regional tissue perfusion. Further investigation is warranted to standardize outpatient use and to determine threshold values that predict wound healing.

A prospective evaluation of using IVUS during percutaneous superficial femoral artery interventions.

BACKGROUND: The outcomes of endovascular interventions of the superficial femoral artery (SFA) are variable. Completion angiography is typically performed to confirm satisfactory outcomes after SFA angioplasty and/or stenting. However, two-dimensional angiography may not accurately reflect the extent of residual stenosis. We sought to determine whether intravascular ultrasound (IVUS) can help with residual disease assessment and procedure outcome. METHODS: Patients with anticipated SFA disease were prospectively recruited to the study. Patients with primary SFA disease on diagnostic angiography were included. After SFA endovascular intervention with angioplasty and/or stenting, a completion angiogram was performed to confirm satisfactory results before IVUS evaluation. IVUS-detected maximal residual stenosis, maximal residual lesion volume, and number of nonconsecutive posttreatment SFA segments with >50% residual stenosis were evaluated. Periprocedural ankle-brachial indexes (ABIs), Short Form 36 (SF-36) surveys, and Walking Impairment Questionnaires were also collected. RESULTS: Fifty-nine patients were prospectively enrolled. Thirty-three received angioplasty only, and 26 received angioplasty and stenting. All patients were men, mean age was 67 years, and major comorbidities included coronary artery disease (53%), active smoking (56%), hypertension (88%), and diabetes (68%). The angioplasty-only cohort had more nonconsecutive areas of >50% residual stenosis (P = 0.004), greater residual stenosis (P = 0.03), and smaller minimal lumen diameters after treatment (P = 0.01) than the angioplasty and stenting cohort. However, there was no significant difference in ABI between the 2 groups and no difference in ABI improvement after intervention. Sixty-four percent of all patients demonstrated a >0.2 increase in postintervention ABI. Improvement in ABI at 1 month after procedure significantly correlated with postintervention SF-36 survey physical scores (r = 0.435, P = 0.007). CONCLUSIONS: IVUS evaluation provides more-accurate intraprocedural insight on the extent of residual stenosis after SFA interventions. Future studies are warranted to determine whether IVUS-guided postangioplasty and/or stenting can impact long-term interventional outcome.

Shuttering of the superior mesenteric artery during fenestrated endovascular aneurysm repair.

OBJECTIVE: Shuttering occurs when a scallop or fenestration does not align perfectly with the target vessel ostium and is potentially minimized by stenting. The current United States Food and Drug Administration-approved fenestrated endovascular aneurysm repair (f-EVAR) device is most commonly configured with an unstented superior mesenteric artery (SMA) scallop, thereby subjecting the SMA to risk of partial coverage. We aimed to describe the incidence, severity, and clinical effect of SMA shuttering during f-EVAR. METHODS: Patients undergoing f-EVAR using the commercially available Zenith (Cook Medical, Bloomington, Ind) fenestrated stent graft system containing an SMA scallop at our institution between September 2012 and January 2014 were included for analysis. Corrected multiplanar reformatted images on postoperative computed tomographic angiography were reviewed to measure SMA shuttering, defined as the percentage of scallop misalignment relative to the SMA ostial diameter. RESULTS: Of the 28 f-EVAR cases performed at our institution during the study period, 18 patients (78% male) had an SMA scallop and were included in this analysis. The median age was 78 years (interquartile range [IQR], 72-81 years), and the median abdominal aortic aneurysm size was 61 mm (IQR, 56-64 mm). Fifty-one vessels were targeted (18 SMA scallops, 32 renal fenestrations, 1 renal snorkel), with covered stents placed in all fenestrations. Target vessel catheterization and successful branch stent deployment was achieved in 100% of patients. SMA shuttering measured on postoperative computed tomographic angiography of any amount occurred in 50% of patients (range of SMA shuttering, 12%-40%). The severity of SMA shuttering varied: one patient had 11% to 20%, four had 21% to 30%, and four had 31 to 40%. When compared with patients without shuttering, patients with any SMA shuttering were noted to have a shorter infra-SMA neck length (17 vs. 25 mm; P = .007), higher volume of intraprocedural contrast administration (100 vs. 66 mL; P = .001), and had a trend toward longer procedural durations (240 vs. 188 minutes; P = .09). No association was found between SMA shuttering and the preoperative measured clock position of the visceral vessels, percentage of device oversizing, number of target vessels per patient, aortic diameter at the SMA or seal zone, aneurysm neck morphology, infrarenal neck length, scallop width, or SMA ostial diameter. No acute or chronic events of mesenteric ischemia were noted during a median clinical follow-up period of 11 months (IQR, 5-14 months). CONCLUSIONS: Even with the custom design of currently available fenestrated technology, shuttering of the SMA occurred in one-half of the patients in our cohort, although no clinical events were noted. Further details of the incidence, magnitude, and tolerance of SMA shuttering during f-EVAR are warranted to fully understand the clinical implication of this radiographic finding. Future design considerations for advanced EVAR should take into account SMA shuttering to further refine operative planning.

Comparison of fenestrated endografts and the snorkel/chimney technique.

OBJECTIVE: Recent approval by the Food and Drug Administration of custom fenestrated endografts has increased endovascular options for patients with short-neck or juxtarenal abdominal aortic aneurysms (AAAs). We sought to compare the early learning curve at a single institution of fenestrated repair vs the snorkel technique. METHODS: From 2009 to 2013, we performed 57 consecutive snorkel procedures for juxtarenal AAAs in an Institutional Review Board-approved prospective cohort, and since the summer of 2012, we gained access to the Food and Drug Administration-approved custom fenestrated device. Patient demographics, imaging, and operative techniques were compared between the first 15 cases for each of the snorkel (sn-EVAR) and fenestrated (f-EVAR) endovascular aneurysm repair (EVAR) techniques. RESULTS: Patient demographics and AAA morphology on preoperative imaging were similar between the groups. Operative time tended to be similar in the 3- to 4-hour range, with more fluoroscopy time and less contrast material used in f-EVAR than in sn-EVAR (P < .05) because of differing strategies of renal premarking. Larger delivery systems for f-EVAR required a higher rate of iliac conduits (40% vs 0%). Perioperative complications, short-term renal patency rates, and evidence of acute kidney injury were similar. CONCLUSIONS: The early experience of f-EVAR was similar to that of sn-EVAR in terms of patient demographics, case selection, and procedural characteristics. A significant portion of the learning curve for both procedures, particularly for f-EVAR, lies in the preoperative planning of fenestrations and the cannulation of branch vessels. Similar short-term postoperative outcomes between these two particular techniques indicate that both will have utility in the treatment of high-risk patients with complex anatomy.

Intravascular ultrasound as a clinical adjunct for carotid plaque characterization.

OBJECTIVE: Virtual histology intravascular ultrasound (VH IVUS) is valuable for estimating minimal lumen diameter and plaque characterization. The clinical use of IVUS in carotid intervention is not well characterized. We aim to evaluate the role of IVUS in carotid plaque characterization and determine whether it could be predictive of procedure-related microemboli. METHODS: From July 2010, patients with severe carotid stenosis who underwent elective carotid stenting procedures were prospectively enrolled. IVUS evaluation was performed before stent placement. Patient demographics, comorbidities, and preoperative images were recorded. Comparison of pre- and postoperative diffusion-weighted magnetic resonance images was used to identify the number of procedure-related microemboli. IVUS-derived minimal lumen diameter and vessel wall plaque characteristics were collected. Univariate and multivariate logistic regressions were used to search for associations between IVUS-derived VH data and incidence of microemboli. RESULTS: A total of 38 high-risk patients receiving carotid stenting were enrolled. Among them, 25 patients had type I aortic arches and 17 of the patients were symptomatic (preoperative stroke or transient ischemic attack). VH IVUS data did not show strong associations with microemboli, however, a trend was found between the area of fibrous tissue and median or more incidence of microemboli (P = .099). IVUS-defined vessel diameter maximum was associated with median or more incidence of microemboli (P = .042). In addition, median or more incidence of microemboli showed trends with proximal common carotid artery calcification (P = .056) and with being over the age of 80 (P = .06). Contralateral carotid occlusion or high-grade stenosis was associated with postoperative contralateral microemboli (P = .036). CONCLUSIONS: We demonstrate that periprocedural carotid IVUS is clinically feasible. VH IVUS may be helpful in better understanding plaque morphology and determining optimal stent placement. However, its use in predicting microembolization remains limited.

Elective EVAR in nonagenarians is safe in carefully selected patients.

BACKGROUND: Nonagenarians are typically considered poor operative candidates for major aortic intervention because of shorter life expectancy, multiple comorbidities, and increased perioperative morbidity and mortality. Endovascular abdominal aortic aneurysm repair (EVAR) has clearly been associated with a lower perioperative morbidity and mortality in most anatomically suitable patients. There have been many reports of the technical success of EVAR in octogenarians, but few documenting EVAR in nonagenarians. In this study, we sought to review our experience with elective EVAR in nonagenarians to determine outcomes, complications, and long-term survival after repair. METHODS: We retrospectively reviewed our prospectively maintained aneurysm database from 2000 to 2010 at an academic referral center. Fifteen patients ≥90 years old underwent elective EVAR. No symptomatic or ruptured abdominal aortic aneurysm patients >90 years old were treated. Comorbidities, preoperative and postoperative functional status, aneurysm size, and technical success rate were all recorded in accordance with Society for Vascular Surgery reporting guidelines. Follow-up was performed within 30 days, 6 months, and annually thereafter unless more frequent follow-up was indicated. RESULTS: Of the 749 EVAR procedures performed in the decade-long experience, 15 nonagenarians underwent repair (14 male, 93%; mean age, 90.3 ± 0.6 years). Mean aneurysm diameter was 6.4 ± 1.45 cm with a median diameter of 5.8 cm (range 4.5-8.8 cm). All patients were offered repair because of having good to excellent preoperative functional status with an average number of comorbidities per patient of 2.7. Immediate technical success rate was 100%. Median intensive care unit stay was 1 day (range 1-17 days). Mean length of stay was 4.6 ± 5.3 days with a median of 3.5 days. Thirty-day mortality was 0%. Mean follow-up was 35 months. Mean survival was 56 months. Overall survival estimated annually extending out to 5 years was 91.7%, 83.3%, 71.4%, 57.1%, and 38.1%, respectively. Thirty-day rate of any complication was 40%, with a 20% readmission rate, with many of the issues being related to wound complications. On follow-up imaging there were noted to be 4 (27%) type I, 9 (60%) type II, and no type III or type IV endoleaks identified. Overall reintervention rate was 27%. No ruptures were noted in the postoperative period or long-term follow-up, and there were no conversions to open surgery. CONCLUSIONS: We found a median survival of 56.2 months in this carefully selected cohort of EVAR in nonagenarians. As techniques and technology improve and evolve, and particularly as devices become lower profile, there is the potential to apply EVAR to the increasingly older population. If perioperative morbidity can be minimized and the patient has good functional status, EVAR can be a safe procedure and provide rupture-free survival.

Reentry device aided endovascular aneurysm repair in patients with abdominal aortic aneurysm and unilateral iliac artery occlusion.

BACKGROUND: We report 2 cases of patients undergoing endovascular aneurysm repair (EVAR) using reentry devices to recanalize unilateral iliac artery occlusions and complete a bifurcated endovascular repair. METHODS: Patient 1 is a 70-year-old male with an enlarging 6.5-cm abdominal aortic aneurysm (AAA) and disabling left leg claudication with L external iliac occlusion with patent common and internal iliac arteries. Patient 2 is a 67-year-old male with an asymptomatic 4.0-cm AAA and L iliac chronic total occlusion (CTO) and disabling claudication. Both patients were poor operative candidates for open repair. RESULTS: Both patients underwent elective percutaneous EVAR along with left iliac artery revascularization. Initial angiography in both cases showed a blind ending of the left common iliac artery. Retrograde subintimal dissection through the occluded iliac segment was attempted but in both cases the wire was unable to traverse back into the true aortic lumen. Using either the Outback LTD or Pioneer reentry catheter, direct visualization of the true aortic lumen was obtained to re-enter the true lumen. The subintimal iliac tract was then predilated to facilitate routine EVAR in both cases. Both patients were discharged the following day and 1-year and 6-month follow-up imaging revealed aneurysm exclusion, no endoleak, and patent bilateral common iliac arteries with resolution of claudication symptoms and normal ankle-brachial indexes. The previously patent internal iliac artery was preserved. CONCLUSIONS: While not always technically possible, reentry device aided EVAR is safe, feasible, and durable in the mid-term and avoids the morbidity and mortality related to aortouniiliac/femoral-femoral bypass and open repair. This technique should be considered in patients with iliac artery CTO and concurrent AAA to allow total endovascular repair.

Evaluation of a Remote Patient Monitoring Program During the COVID-19 Pandemic: Retrospective Case Study With a Mixed Methods Explanatory Sequential Design.

BACKGROUND: Community health center (CHC) patients experience a disproportionately high prevalence of chronic conditions and barriers to accessing technologies that might support the management of these conditions. One such technology includes tools used for remote patient monitoring (RPM), the use of which surged during the COVID-19 pandemic. OBJECTIVE: The aim of this study was to assess how a CHC implemented an RPM program during the COVID-19 pandemic. METHODS: This retrospective case study used a mixed methods explanatory sequential design to evaluate a CHC's implementation of a suite of RPM tools during the COVID-19 pandemic. Analyses used electronic health record-extracted health outcomes data and semistructured interviews with the CHC's staff and patients participating in the RPM program. RESULTS: The CHC enrolled 147 patients in a hypertension RPM program. After 6 months of RPM use, mean systolic blood pressure (BP) was 13.4 mm Hg lower and mean diastolic BP 6.4 mm Hg lower, corresponding with an increase in hypertension control (BP<140/90 mm Hg) from 33.3% of patients to 81.5%. Considerable effort was dedicated to standing up the program, reinforced by organizational prioritization of chronic disease management, and by a clinician who championed program implementation. Noted barriers to implementation of the RPM program were limited initial training, lack of sustained support, and complexities related to the RPM device technology. CONCLUSIONS: While RPM technology holds promise for addressing chronic disease management, successful RPM program requires substantial investment in implementation support and technical assistance.

Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study.

OBJECTIVE: To evaluate the efficacy and safety of long-acting i.m. testosterone undecanoate (TU) in Malaysian men with testosterone deficiency (TD). PATIENTS AND METHODS: A total of 120 men, aged 40-70 years, with TD (serum total testosterone [TT] ≤ 12 nmol/L) were randomised to receive either i.m. TU (1000 mg) or placebo. In all, 58 and 56 men in the placebo and treatment arm, respectively, completed the study. Participants were seen six times in the 48-week period and the following data were collected: physical examination results, haemoglobin, haematocrit, TT, lipid profile, fasting blood glucose, sex hormone-binding globulin, liver function test, prostate- specific antigen (PSA) and adverse events. RESULTS: The mean (sd) age of the participants was 53.4 (7.6) years. A significant increase in serum TT (P < 0.001), PSA (P = 0.010), haematocrit (P < 0.001), haemoglobin (P < 0.001) and total bilirubin (P = 0.001) were seen in the treatment arm over the 48-week period. Two men in the placebo arm and one man in the treatment arm developed myocardial infarction. Common adverse events observed in the treatment arm included itching/swelling/pain at the site of injection, flushing and acne. Overall, TU injections were well tolerated. CONCLUSIONS: TU significantly increases serum testosterone in men with TD. PSA, haemoglobin and haematocrit were significantly elevated but were within clinically safe limits. There was no significant adverse reaction that led to the cessation of treatment.

Evaluating the morbidity and efficacy of reoperative surgery in the central compartment for persistent/recurrent papillary thyroid carcinoma.

BACKGROUND: Although reoperative surgery in the central compartment (RCND) is indicated for bulky or progressive persistent/recurrent papillary thyroid carcinoma (PTC), its associated morbidity and disease outcomes remain unclear. We evaluated RCND outcomes by comparing them with those of patients who underwent primary central neck dissection (CND). METHODS: After matching for age, sex, tumor size, and initial tumor stage, the morbidity and outcomes of 50 consecutive patients who underwent RCND were compared with data from 75 patients who underwent primary therapeutic CND during the same period. Matching was performed blind to the morbidity and disease outcome of each patient. A stimulated thyroglobulin (sTg) <2 ng/ml was considered undetectable. RESULTS: Relative to primary CND, the incidence of extranodal extension (p = 0.010) and size of metastatic lymph nodes (p < 0.001) were significantly greater in the RCND group. Postoperative hypoparathyroidism and vocal cord palsy rates were comparable in the groups. There were two esophageal injuries in the RCND group and none in the primary CND group. The secondary CND group achieved a significantly lower undetectable postablation sTg rate (12.0 vs. 52.0 %, p = 0.001) and worse 10-year disease-free survival (35.6 vs. 91.8 %, p = 0.001) and cancer-specific survival (82.0 vs. 98.5 %, p = 0.001) than the primary CND group. CONCLUSIONS: Although RCND for persistent/recurrent PTC was performed with morbidity comparable to that seen with primary CND, it was associated with some serious complications. Short- and long-term disease control appeared moderate with approximately one-tenth of patients having an undetectable sTg level 6 months after ablation and one-third remaining clinically disease-free after 10 years.

Acute Carpal Tunnel Syndrome: Early Nerve Decompression and Surgical Stabilization for Bony Wrist Trauma.

We undertook this study to investigate the outcomes of surgical treatment for acute carpal tunnel syndrome following our protocol for concurrent nerve decompression and skeletal stabilization for bony wrist trauma to be undertaken within 48 hours. Methods: We identified all patients treated at our trauma center following this protocol between January 1, 2014 and December 31, 2019. All patients were clinically reviewed at least 12 months after surgery and assessed using the Brief Michigan Hand Outcomes Questionnaire, the Boston Carpal Tunnel Questionnaire, and sensory assessment with Semmes-Weinstein monofilament testing. Results: The study group was made up of 35 patients. Thirty-three patients were treated within 36 hours. Patients treated with our unit protocol for early surgery comprising nerve decompression and bony stabilization within 36 hours report excellent outcomes at medium term follow-up. Conclusions: We propose that nerve decompression and bony surgical stabilization should be undertaken as soon as practically possible once the diagnosis is made. This is emergent treatment to protect and preserve nerve function. In our experience, the vast majority of patients were treated within 24 hours; however, where a short period of observation was required, excellent results were generally achieved when treatment was completed within 36 hours.

Long-Term Follow-up (14 to 25 Years) Following Closed Reduction and Early Movement for Simple Dislocation of the Elbow.

BACKGROUND: We have previously reported on the midterm outcomes after a nonoperative protocol to treat simple dislocations of the elbow that included a short period of splinting followed by early movement. We have now performed extended follow-up of the original patient group from the prior study to determine whether the excellent results that previously had been reported were maintained in the long term and also to determine the rate of and need for any late surgical intervention. METHODS: We attempted to contact all of the patients from the original study group. We requested that they complete the Oxford Elbow Score (OES) survey, the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, and a validated patient satisfaction questionnaire. Patients also were requested to attend a face-to-face assessment to have a clinical examination that included neurovascular, range-of-motion, and ligamentous stability assessments. RESULTS: Seventy-one patients from the original patient group agreed to participate in the new study. The mean duration of follow-up was 19.3 years. At the time of the final follow-up, patients reported excellent functional outcome scores and a preserved functional range of movement in the injured elbow. The mean OES was 91.6 points, the mean DASH score was 5.22 points, and the mean satisfaction score was 90.9 points. None of the patients had undergone delayed or secondary surgery for instability during the interval period. CONCLUSIONS: This study demonstrated that the original excellent outcomes following treatment with a protocol of a short period of splinting and early movement remained excellent and were maintained into the very long term. LEVEL OF EVIDENCE: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.