Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Assessment of Open Surgery Suturing Skill: Image-based Metrics Using Computer Vision.

OBJECTIVE: This paper presents a computer vision algorithm for extraction of image-based metrics for suturing skill assessment and the corresponding results from an experimental study of resident and attending surgeons. DESIGN: A suturing simulator that adapts the radial suturing task from the Fundamentals of Vascular Surgery (FVS) skills assessment is used to collect data. The simulator includes a camera positioned under the suturing membrane, which records needle and thread movement during the suturing task. A computer vision algorithm processes the video data and extracts objective metrics inspired by expert surgeons' recommended best practice, to "follow the curvature of the needle." PARTICIPANTS AND RESULTS: Experimental data from a study involving subjects with various levels of suturing expertise (attending surgeons and surgery residents) are presented. Analysis shows that attendings and residents had statistically different performance on 6 of 9 image-based metrics, including the four new metrics introduced in this paper: Needle Tip Path Length, Needle Swept Area, Needle Tip Area and Needle Sway Length. CONCLUSION AND SIGNIFICANCE: These image-based process metrics may be represented graphically in a manner conducive to training. The results demonstrate the potential of image-based metrics for assessment and training of suturing skill in open surgery.

Prosthetic outcomes after amputation and the impact of mobility level on survival.

OBJECTIVE: Lower extremity amputation continues to be necessary in a significant number of patients with peripheral vascular disease. The 5-year survival following lower limb loss is markedly reduced. Many of these patients are never fitted with a prosthesis, and there is a dearth of knowledge regarding the barriers to prosthetic attainment. The goal of this study was to identify the risk factors for not receiving a prosthesis and the effect of mobility level on survival following major amputation. METHODS: This was a retrospective analysis of all patients that underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to December 31, 2019. Abstracted data included: age, sex, race, body mass index, comorbidities, American Society of Anesthesiologists score, statin use, level of amputation, stump revision, fitting for prosthesis, type of prosthesis, and the United States' Medicare Functional Classification Level, also called K level. Survival was determined using a combination of sources, including the Social Security Death Master File, searches of multiple genealogic registries, and general internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis attainment. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: A total of 464 patients were included in this study. The mean age was 65 years, and mean body mass index was 27 kg/m2. The majority of patients were male (68%), White (56%), diabetic (62%), and hypertensive (76%), and underwent below-the-knee amputation (69%). Prosthetic attainment occurred in 185 (40%). On multivariable analysis, age >81 years and current tobacco use were associated with no prosthetic fitting. Overall 5-year survival was 41.9% (95% confidence interval [CI], 37.6%-46.6%) (below-the-knee amputation, 47.7% [95% CI, 42.5%-53.5%]; above-the-knee amputation, 28.7% [95% CI, 22.1%-37.2%]). On multivariable analysis, age >60 years, congestive heart failure, above-the-knee amputation, and no prosthetic attainment were associated with decreased survival. Increasing K level was incrementally associated with improved survival. CONCLUSIONS: This study has identified several patient factors associated with prosthetic attainment, as well as multiple factors predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. The Medicare Functional Classification Level K level predicts survival. More research is needed to determine the barriers to prosthetic attainment and if improving a patients K level will improve survival.

A toolkit for individualizing interventions to mitigate second-victim syndrome in a diverse surgery community.

Adverse outcomes are an inevitable consequence of surgical care. The term "second victim" was introduced by Wu to describe the emotional trauma experienced by a clinician who feels responsibility for an adverse clinical outcome. Second victims may feel shame, guilt, sadness, and a crisis of confidence. Surgeons rarely seek professional support following an adverse event but are more likely to confide in colleagues. Surgeons who represent groups traditionally underrepresented in medicine may be less likely to seek assistance following an adverse clinical outcome. There is a need for surgeons to have sufficient training to provide peer-to-peer support for wounded colleagues. The PEARLS Toolkit provides a blueprint toward this end.

Measuring hand movement for suturing skill assessment: A simulation-based study.

BACKGROUND: To maximize patient safety, surgical skills education is increasingly adopting simulation-based curricula for formative skills assessment and training. However, many standardized assessment tools rely on human raters for performance assessment, which is resource-intensive and subjective. Simulators that provide automated and objective metrics from sensor data can address this limitation. We present an instrumented bench suturing simulator, patterned after the clock face radial suturing model from the Fundamentals of Vascular Surgery, for automated and objective assessment of open suturing skills. METHODS: For this study, 97 participants (35 attending surgeons, 32 residents, and 30 novices) were recruited at national vascular conferences. Automated hand motion metrics, especially focusing on rotational motion analysis, were developed from the inertial measurement unit attached to participants' hands, and the proposed suite of metrics was used to differentiate between the skill levels of the 3 groups. RESULTS: Attendings' and residents' performances were found to be significantly different from novices for all metrics. Moreover, most of our novel metrics could successfully distinguish between finer skill differences between attending and resident groups. In contrast, traditional operative skill metrics, such as time and path length, were unable to distinguish attendings from residents. CONCLUSION: This study provides evidence for the effectiveness of rotational motion analysis in assessing suturing skills. The suite of inertial measurement unit-based hand motion metrics introduced in this study allows for the incorporation of hand movement data for suturing skill assessment.

The Role of Feral Swine in Human Aortic Infection With Brucella Species.

Brucellosis is one of the most common zoonotic infections in the world. Human infections are the result of direct exposure to infected animals or ingestion of unprocessed dairy products. While Brucella sp. infection has largely been eliminated from commercial cattle and swine with aggressive vaccination, there is a significant prevalence of Brucella sp. infection in the expanding population of feral swine in the US. We report the surgical treatment of a ruptured mycotic aneurysm of the abdominal aorta due to Brucella suis in a woman living in a rural community with a large population of feral swine. Vascular surgeons should be aware that brucellosis can result in arterial infection and should be considered in the differential diagnosis in patients with a history of exposure to feral swine or the ingestion of unprocessed dairy products.

Changing Management of Type B Aortic Dissections.

The purpose of this manuscript is to review recent trends in the management of acute type B aortic dissection. Due to its efficacy and low morbidity, thoracic endografting has rapidly been adopted as the treatment of choice for most patients with malperfusion or rupture as a consequence of acute aortic dissection. This technology is increasingly applied to patients without rupture or malperfusion, so-called "uncomplicated" dissections, to reduce the incidence of late aneurysmal degeneration in the ungrafted segments of the thoracoabdominal aorta. A variety of techniques have been proposed, including intentional rupture of the dissection membrane to obliterate the false lumen as well as the candy-plug technique to eliminate retrograde flow in the false lumen.

How I do it: The neoaortoiliac system for treatment of aortoduodenal fistula after endovascular aortic repair.

The term neoaortoiliac system (NAIS) was coined by Clagett in 1993 to describe the use of the deep veins in the thigh to replace the aorta and iliac arteries in the setting of graft infection. Since that time, the NAIS procedure has been used to treat a wide array of both infectious and noninfectious conditions affecting the aortoiliac segment. In this article, we present a 10-step description of the NAIS procedure to treat an aortoduodenal fistula in a patient with an infected endovascular aneurysm repair.

Assessment of open surgery suturing skill: Simulator platform, force-based, and motion-based metrics.

Objective: This paper focuses on simulator-based assessment of open surgery suturing skill. We introduce a new surgical simulator designed to collect synchronized force, motion, video and touch data during a radial suturing task adapted from the Fundamentals of Vascular Surgery (FVS) skill assessment. The synchronized data is analyzed to extract objective metrics for suturing skill assessment. Methods: The simulator has a camera positioned underneath the suturing membrane, enabling visual tracking of the needle during suturing. Needle tracking data enables extraction of meaningful metrics related to both the process and the product of the suturing task. To better simulate surgical conditions, the height of the system and the depth of the membrane are both adjustable. Metrics for assessment of suturing skill based on force/torque, motion, and physical contact are presented. Experimental data are presented from a study comparing attending surgeons and surgery residents. Results: Analysis shows force metrics (absolute maximum force/torque in z-direction), motion metrics (yaw, pitch, roll), physical contact metric, and image-enabled force metrics (orthogonal and tangential forces) are found to be statistically significant in differentiating suturing skill between attendings and residents. Conclusion and significance: The results suggest that this simulator and accompanying metrics could serve as a useful tool for assessing and teaching open surgery suturing skill.

Iatrogenic Arteriovenous Fistula Secondary to Percutaneous Coronary Intervention Causing Severe Decompensated Heart Failure.

Congestive heart failure has long been a well-known cause of both morbidity and mortality for thousands of people worldwide. Consequences of decompensated heart failure are systemic and widespread, including but not limited to pulmonary edema, dyspnea, hypoxia, peripheral edema, and end-organ hypoperfusion. Common etiologies of congestive heart failure include systemic hypertension, coronary artery disease, longstanding alcohol abuse, valvular dysfunctions, and myocarditis. While the vast majority of congestive heart failure cases are secondary to one of these common etiologies, there is a subset of cases that cannot be traced to any of these causes and are most often grouped under the category of idiopathic. One rarely seen etiology of decompensated heart failure is an arteriovenous fistula, whether naturally occurring or iatrogenic. We report a case of an iatrogenic AV fistula secondary to percutaneous coronary intervention causing severe decompensated heart failure that was successfully treated with surgical ligation.

Sex, age, and other barriers for prosthetic referral following amputation and the impact on survival.

BACKGROUND: Despite advances in peripheral vascular disease treatment, lower extremity amputation continues to be necessary in a significant number of patients. Up to 80% of amputees are not referred for prosthetic fitting. The factors contributing to referral decisions have not been adequately investigated, nor has the impact of prosthetic referral on survival. We characterized differences between patients who were successfully referred to our in-house prosthetists and those who were not, and identified factors associated with prosthetic referral and predictive of survival. METHODS: This was a retrospective analysis of all patients who underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to June 30, 2017. Data regarding age, sex, race, body mass index (BMI), diabetes, hypertension, hyperlipidemia, end-stage renal disease, prior coronary artery bypass graft surgery, congestive heart failure, tobacco use, American Society of Anesthesiologists (ASA) score, previous arterial procedure, chronic obstructive pulmonary disease, statin use, postoperative ambulatory status, level of amputation, stump revision, and referral for prosthesis were collected. Survival was determined from a combination of sources, including the Social Security Death Master Index, multiple genealogic registries, and internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis referral. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: There were 293 patients included in this study. Mean age was 66 years, and mean BMI 27 kg/m2. The majority of patients were male (69%), white (53%), with diabetes (65.4%) and hypertension (77.5%), and underwent below-the-knee amputation (BKA) (73%). Prosthetic referral occurred in 123 (42.0%). Overall 5-year survival was 61.7% (95% confidence interval [CI], 55.9%-68.1%) (BKA 64.7% [95% CI, 57.9%-72.3%]; above-the-knee amputation 53.8% [95% CI, 43.4%-66.6%]). On multivariate analysis, age >70 years, female sex, diabetes, ASA score 4 or 5, and current tobacco use were associated with no referral for prosthetic fitting. Patients with BMI 25 to 30, a previous arterial procedure, BKA, and history of stump revision were more likely to be referred. Factors associated with decreased survival were increasing age, higher ASA class, black race, and BMI; prosthetic referral was seen to be protective. CONCLUSIONS: We identified multiple patient factors associated with prosthetic referral, as well as several characteristics predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. Further research is needed to determine whether the factors identified as associated with nonreferral are markers for patient characteristics that make them clinically unsuitable for prosthetic fitting or if they are symptoms of unconscious bias or of the patient's access to care.

Ensuring equity, diversity, and inclusion in the Society for Vascular Surgery: A report of the Society for Vascular Surgery Task Force on Equity, Diversity, and Inclusion.

Diversity, equity, and inclusion represent interconnected goals meant to ensure that all individuals, regardless of their innate identity characteristics, feel welcomed and valued among their peers. Equity is achieved when all individuals have equal access to leadership and career advancement opportunities as well as fair compensation for their work. It is well-known that the unique backgrounds and perspectives contributed by a diverse workforce strengthen and improve medical organizations overall. The Society for Vascular Surgery (SVS) is committed to supporting the highest quality leadership, patient care, surgical education, and societal recommendations through promoting diversity, equity, and inclusion within the SVS. The overarching goal of this document is to provide specific context and guidance for enhancing diversity, equity, and inclusion within the SVS as well as setting the tone for conduct and processes beyond the SVS, within other national and regional vascular surgery organizations and practice settings.

Effects of radiation and MediPort placement on the development of thoracic outlet syndrome.

We present a patient who exemplifies the interplay of factors contributing to the development of venous-type thoracic outlet syndrome. The patient was treated with both radiation and chemotherapy for squamous cell carcinoma in the head and neck region; radiation and chemotherapy have been known to damage the vascular system. Multimodality treatment is necessary to achieve good long-term results in these complex patients.

Urgent need for individual mobile phone and institutional reporting of at home, hospitalized, and intensive care unit cases of SARS-CoV-2 (COVID-19) infection.

Approximately 90 days of the SARS-CoV-2 (COVID-19) spreading originally from Wuhan, China, and across the globe has led to a widespread chain of events with imminent threats to the fragile relationship between community health and economic health. Despite near hourly reporting on this crisis, there has been no regular, updated, or accurate reporting of hospitalizations for COVID-19. It is known that many test-positive individuals may not develop symptoms or have a mild self-limited viral syndrome consisting of fever, malaise, dry cough, and constitutional symptoms. However some individuals develop a more fulminant syndrome including viral pneumonia, respiratory failure requiring oxygen, acute respiratory distress syndrome requiring mechanical ventilation, and in substantial fractions leading to death attributable to COVID-19. The pandemic is evolving in a clustered, non-inform fashion resulting in many hospitals with preparedness but few or no cases, and others that are completely overwhelmed. Thus, a considerable risk of spread when personal protection equipment becomes exhausted and a large fraction of mortality in those not offered mechanical ventilation are both attributable to a crisis due to maldistribution of resources. The pandemic is amenable to self-reporting through a mobile phone application that could obtain critical information on suspected cases and report on the results of self testing and actions taken. The only method to understand the clustering and the immediate hospital resource needs is mandatory, uniform, daily reporting of hospital censuses of COVID-19 cases admitted to hospital wards and intensive care units. Current reports of hospitalizations are delayed, uncertain, and wholly inadequate. This paper urges all the relevant stakeholders to take up self-reporting and reporting of hospitalizations of COVID-19 as an urgent task in combating this devastating pandemic.

Diaphragmatic fenestrations seen after peritoneal dialysis catheter placement: A rare cause of hydrothorax.

This case report summarizes the clinical course of a patient who developed diaphragmatic fenestrations leading to hydrothorax after the initiation of peritoneal dialysis. We will discuss the interesting disease process in the setting of patient presentation, diagnosis, treatment, and outcome.

Vascular surgery: taking the next steps toward autonomy.

The recognition of vascular surgery as an independent surgical specialty is inevitable, but the pathway to full autonomy remains uncertain. Vascular surgery emerged from general surgery in the mid-1950s with the advent of synthetic grafts and microvascular techniques. By the early 1980s, Accreditation Council for Graduate Medical Education-approved fellowships were established in most large academic medical centers. The American Board of Surgery recognized this additional specialty training by awarding vascular graduates a Certificate of Special Qualifications distinguishing them from general surgeons. The emergence of endovascular surgery radically changed the face of vascular surgery from a general surgery subspecialty to a unique surgical specialty with a growing array of minimally invasive tools. With the establishment of a primary Certificate in Vascular Surgery and the subsequent development of integrated residencies, vascular surgery moved ever closer to recognition as an independent surgical specialty. Despite the remarkable progress that has been observed over the past 50 years, there is a desire in the vascular community for formal recognition of the unique body of knowledge and surgical skills that serve as the foundation of contemporary vascular care.

Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training.

OBJECTIVE: Endovascular aneurysm repair has led to a significant reduction in vascular trainee experience in the surgical treatment of aortic aneurysms. We sought to evaluate whether the vascular training paradigm or the "endovascular first" approach to lower extremity vascular disease has had a similar effect on trainee experience with infrapopliteal endovascular therapy and vein bypass. METHODS: Deidentified data were provided by the Vascular Surgery Board on the number of procedures performed by each 2014 fellowship and residency (0 + 5) graduate during training. Data were analyzed using parametric and nonparametric methods, where appropriate. RESULTS: Of 125 trainees (109 fellows, 16 residents), 33 (27%) performed 10 or fewer infrapopliteal vein bypasses and 37 (29%) performed 10 or fewer infrapopliteal endovascular procedures during their training. Eleven trainees (9%) performed 10 or fewer of both procedures. There was a positive correlation between number of infrapopliteal vein bypass and endovascular procedures performed (r = 0.19; P = .03). There was no difference between fellows and residents in the mean number of bypass operations performed during training (17.3 vs 19.1; P = .50; range, 0-53). However, residents performed more infrapopliteal endovascular procedures than fellows did (median, 29 vs 16; P = .03; range, 0-128). CONCLUSIONS: More than one in four graduates of both training paradigms finish with a low number of infrapopliteal bypasses and endovascular interventions. The number of these procedures needed for proficiency is not known. Vascular surgery training programs should critically evaluate the number of infrapopliteal procedures required to achieve proficiency.

Con: Contrast-induced nephropathy-should we try to avoid contrast media in patients with chronic kidney disease?

The incidence of acute kidney injury (AKI) attributed to iodinated contrast has been over-estimated and this has led clinicians to withhold potentially life-saving diagnostic and therapeutic interventions. There is mounting evidence that iodinated contrast plays only a minor role in the development of AKI in comparison with more significant risk factors such as pre-existing renal dysfunction, hemodynamic instability and exposure to nephrotoxic drugs. We will present data which challenge the dogma of avoiding iodinated contrast in patients with reduced renal function. Based on a rational and individualized risk-benefit analysis, we believe it is preferable to utilize iodinated contrast if alternate diagnostic or therapeutic options are comparatively ineffective or hazardous.