BACKGROUND:Patients with femoropopliteal (FP) chronic total occlusions (CTOs) presenting with intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) differ in disease severity and lesion complexity. We performed a subgroup analysis of the prospective, multicenter RESTOR-1 trial to evaluate the safety and effectiveness of the Santreva™-ATK Endovascular Revascularization Catheter in these patient populations. OBJECTIVES:Compare procedural and short-term clinical course outcomes of the Santreva™-ATK catheter in patients with IC and CLTI enrolled in RESTOR-1 pivotal trial. METHODS:74 patients with Rutherford class (RC) 2-5 peripheral artery disease and de novo FP CTOs were stratified into IC (RC 2-3, n=48) and CLTI (RC 4-5, n=26). The primary endpoint was clinical success, defined as successful device-facilitated guidewire placement into the distal true lumen without device-related major adverse events (MAEs). Secondary endpoints included procedural success, intravascular (IVUS)-determined crossing trajectory, and 30-day clinical outcomes. RESULTS:Clinical success was achieved in 89.6% of patients with IC and 84.6% of patients with CLTI, with similarly high technical and procedural success rates between groups. IVUS evaluation was performed in 85.4% (41/48) of patients with IC and 76.9% (20/26) of patients with CLTI. Among patients with documented crossing trajectory, 86.9% (53/61) demonstrated intraplaque crossing and 13.1% (8/61) demonstrated extraplaque crossing. Although patients with CLTI had a numerically higher prevalence of diabetes mellitus and heavily calcified lesions, these differences were not statistically significant, and crossing performance remained comparable between groups. CONCLUSION:Santreva™-ATK catheter demonstrated high clinical success and an excellent safety profile across the spectrum of FP CTO disease, supporting its use in both IC and CLTI patients.
There are unresolved questions regarding indications and outcomes of endovascular below-the-knee (BTK) interventions in patients with symptomatic peripheral artery disease (PAD) in real-world clinical practice. We analyzed 884 patients from the multicenter XLPAD registry between 2006 and 2023 with nonstent BTK PAD interventions. Primary outcome: freedom from major adverse limb events (MALE) at 1 year, a composite of all-cause death, major amputation, or clinically driven revascularization. Majority (62.8%) of the BTK interventions were performed for chronic limb threatening ischemia (CLTI), while remaining (37.2%) in patients with intermittent claudication (IC), performed together with an inflow femoropopliteal artery intervention in 58% or involving complex lesion crossings (11.8%). Nearly, 74% were men, mean age 68.0 ± 10.7 years. Mean Rutherford class was 4.65 in CLTI and 2.71 in IC groups. Moderate to severe calcification was present in 25% of cases. Significantly greater number of lesions were treated in the CLTI group (1.84 ± 1.52 vs 2.08 ± 1.61; p = 0.029). Lesion lengths (CLTI: 129.3 ± 85.1 mm vs IC: 115.5 ± 82.5; p = 0.075) were comparable. Nearly, 92% of lesions were treated with balloon angioplasty. Drug-coated balloon use was higher in IC (5% vs 15%, p <0.001), whereas atherectomy use was high in both groups (CLTI: 45.4% vs IC: 49.9%; p = 0.201). Procedural success was similar (CLTI: 92% vs IC: 88.8%; p = 0.098), however 1-year MALE was significantly higher in CLTI patients (30.5% vs 15.8% vs; p <0.0.001), driven by higher all-cause mortality (5.6% vs 2.1% vs; p = 0.014) and major amputations (14% vs 3.7%; p <0.001). Endovascular treatment for BTK PAD is more often performed in patients with CLTI compared with IC, where it is often combined with an inflow artery intervention or complex lesion crossings. Despite similar procedural success, 1-year MALE is significantly higher in CLTI, driven mainly by over a 2-fold increase in all-cause mortality and major amputations.
Anatomic location of infrainguinal peripheral arteries has continually challenged endovascular revascularization strategies based on the use of stent vs. nonstent strategies. The objective of our study is to compare stent vs. nonstent outcomes of patients enrolled in the multicenter, core laboratory adjudicated XLPAD registry (NCT01904851) between 2005 and 2023. We analyzed 12-month cumulative incidence of major adverse cardiac and vascular events (MACVE), a composite outcome of all-cause death, nonfatal myocardial infarction, stroke, lower limb revascularization and any amputation in patients treated with clinically indicated stent or nonstent interventions, analyzed within a competing risk framework; group differences assessed using the Gray's test. To minimize confounding bias, we also implemented propensity score matching. About 5,067 patients (5,876 lesions), mean age 67.2 ± 10.3 years, underwent stent (n = 2,571) or nonstent (n = 2,496) predominantly femoropopliteal artery (68%) interventions. 42.8% were current smokers, 57.3% diabetic; 17% had chronic kidney disease and 56.5% coronary artery disease. 50.7% presented with Rutherford class (II-III) symptoms, with mean ankle-brachial index 0.64 ± 0.24. 61% lesions in stent group and 38.6% in the nonstent group had chronic total occlusions (p <0.001). Significantly greater calcified (36.6% vs. 33%; p = 0.004) and longer lesions (142.9 ± 96.5 mm vs. 115.8 ± 91.3 mm; p <0.001) were treated in the stented group. Drug-coated balloon and atherectomy use were 18% and 34.2%, respectively. Procedural success was higher in the stent group (96.9% vs. 89.5%; p <0.001). Peri-procedural period flow-limiting dissections were higher in the stent (2.7% vs. 0.3%; p <0.001), and any amputation in the nonstent (3.0% vs. 4.4%; p = 0.008). 12-month MACVE was higher in the stent group (22.2% vs. 19.2%, p = 0.009) mainly driven by greater need for repeat endovascular revascularization (13.1% vs. 10.4%, p = 0.003), and this was consistent even after adjusting for chronic limb threatening ischemia presentation (adjusted odds ratio [OR], 1.193; 95% confidence interval [CI], 1.039 to 1.370; p = 0.013). The stented group had 29.6% increased odds of MACVE compared to nonstent (adjusted OR, 1.296, 95% CI: 1.115 to 1.506, p = 0.001), even after adjusting for residual confounders with propensity matching. Stent-based interventions are used to treat more complex infrainguinal PAD, with greater procedural success, but higher 12-month MACVE compared with nonstent interventions.
Background: Contemporary treatments of acute aortic dissection, including medical, surgical, and endovascular options, are remarkably effective at the management of malperfusion and rupture. Unfortunately, long-term studies indicate that 30%-50% of patients need secondary procedures to treat progressive aneurysmal enlargement of the untreated aorta. The Stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique was introduced to improve long-term outcomes. Purpose: This study aims to investigate the results of the STABILISE technique in patients with aortic dissection. Methods: This is a single-center, retrospective review of all patients treated with the STABILISE technique. There were 12 de novo type B aortic dissection (TBAD) and 7 residual TBAD following type A aortic dissection (TAAD) repair. Results: There was disruption of the dissection membrane and relamination in all or part of the bare metal stent segment in 100% of cases. The average percent attainment of a uni-luminal aorta in comparison to the length with persistent false lumen was 91 +/- 12%. Conclusion: Midterm results suggest that the STABILISE technique may improve aortic remodeling after endovascular treatment of acute dissection.
Aortic dissection is the most common of the acute aortic syndromes. Acute aortic dissection remains a highly morbid and potentially lethal condition despite contemporary advances in medical and surgical care. Type B aortic dissection (TBAD) is classified as uncomplicated, uncomplicated with high-risk features, and complicated. The role of thoracic endovascular aortic repair (TEVAR) in uncomplicated TBAD remains uncertain and is the topic of ongoing clinical trials. In most complicated cases, TEVAR is effective at restoring visceral and extremity blood flow. TEVAR has also been shown to arrest hemorrhage in the setting of thoracic aortic rupture. TEVAR has been demonstrated to induce satisfactory remodeling in the covered segment of the thoracic aorta, but progressive enlargement of the visceral aorta has led to a variety of techniques designed to promote remodeling in the uncovered aortic segment. There is a need to better define high-risk features so that treatment can be tailored to specific clinical conditions.
ObjectiveThis 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.DesignA 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 ResultsExperimental 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 SignificanceThese 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.
Although there are established high-risk features in acute type B aortic dissection (TBAD), its management is variable. This study characterizes complicated, uncomplicated, and high-risk TBAD in addition to their management and outcomes to gain insight into the actual significance of these high-risk features and the reality of real-world practice in managing TBAD. A retrospective review of 62 patients was conducted. Patient demographics, management, and outcomes were characterized and evaluated with Pearson's χ2 test, Fisher's exact test, or analysis of variance. Of the 32 high-risk TBADs, 66% (n = 21) received endovascular repair, 31% (n = 10) were medically managed, and 3% (n = 1) received hybrid (open and endovascular) repair. Refractory hypertension and pain (52%, n = 11) were the most common high-risk features in patients with high-risk TBAD who received endovascular repair. A maximum aortic diameter of >40 mm (67%, n = 6) was the most common high-risk feature in patients who received medical management. The most prevalent high-risk feature for all treatment groups in the high-risk TBADs was an aortic diameter of >40 mm (n = 16; 50%). Adverse postoperative outcomes were highest in the high-risk and complicated groups with endoleak as the most common adverse outcome (high-risk 12.9%, complicated 13.6%). Of the 62 patients, 47% (n = 26) had follow-up since their admission with an average follow-up time of 69 ± 166 days. The significance of high-risk features in the management of high-risk TBAD remains unclear. This single-center experience with managing acute TBAD reveals the reality of inadequate follow-up that may be specific to this disease process. This highlights a need to direct more efforts to assess long-term outcomes after treatment.
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.
For endovascular treatment of below-the-knee (BTK) peripheral artery disease (PAD), independently adjudicated real-world outcomes comparing non-stent-based balloon angioplasty (percutaneous transluminal angioplasty) and adjunctive treatments with or without a concomitant ipsilateral femoropopliteal (FP) artery intervention are scarce. A total of 1,060 patients from the multicenter XLPAD registry who underwent non-stent-based BTK PAD intervention between 2006 and 2021 were included. The primary outcome was the 1-year incidence of major adverse limb events (MALEs), a composite of all-cause death, any amputation, or clinically driven repeat revascularization. A total of 566 patients underwent BTK and 494 BTK + FP interventions; 72% were men, with a mean age of 68.4 ± 10.9 years. Diabetes mellitus was more prevalent in the BTK-only group (76.5% vs 69%, p = 0.006). Mean Rutherford class was 4.2 ± 1.18; chronic limb-threatening ischemia was more frequent in the BTK group (55.3% vs 49%, p = 0.040). Moderate to severe calcification was more frequent in the BTK + FP group (21.2% vs 27.1%, p = 0.024), as was lesion length (110.6 ± 77.3 vs 135.4 ± 86.3 mm, p <0.001). Nearly 81% of lesions were treated with percutaneous transluminal angioplasty. Drug-coated balloon (1.6% vs 14%, p <0.001) and atherectomy (38% vs 58.5%, p <0.001) use was more frequent in the BTK + FP group. The rate of procedural success was higher in the BTK + FP group (86% vs 91%, p = 0.009), with amputation being the most common complication at 3.3% within 30 days after the procedure. The rates of 1-year MALE (21.2% vs 22.3%, p = 0.675) and mortality (4.6% vs 3.4%, p = 0.3) were similar between the BTK and BTK + FP groups. Nonstent treatment for BTK PAD with concomitant FP intervention leads to high procedural success and similar rates of 1-year MALE compared with isolated BTK intervention. Condensed Abstract: The vast majority of below-the-knee (BTK) peripheral artery disease (PAD) interventions are performed with balloon angioplasty. Presence of inflow femoropopliteal PAD in patients who undergo BTK interventions can affect the outcome of the procedure. This report explores immediate procedural success and major adverse limb events at 1 year after balloon angioplasty treatment for isolated BTK PAD and in patients who underwent an additional femoropopliteal PAD intervention.
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.
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.
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.
Background: Optimal management of intramural hematoma (IMH) remains controversial. Previous studies offer conflicting information on how outcomes differ between patients with acute aortic dissection (AAD) and IMH. Methods: Patients enrolled in the International Registry of Acute Aortic Dissection (IRAD) between 1996 and 2023 were stratified by AAD and IMH. True IMH, defined as the presence of intramural hematoma in the absence of both double lumen and intimal flap, was noted in 605 patients (7.7%). Results: IMH was more common in Type B patients (12.7% IMH versus 5.1% with Type A). In both groups, IMH patients were older (mean age 70.4 vs. 61.3 years, p<0.001) and less frequently male (51.4% vs. 67.2%, p<0.001). Marfan Syndrome was less common with IMH (1.1% vs. 4.0%, p<0.001).For both dissection types, IMH patients less frequently demonstrated presenting mesenteric ischemia (Type A: 0.8% vs. 4.3%, p=0.003; Type B: 0.7% vs. 6.3%, p<0.001) or limb ischemia (Type A: 3.2% vs. 12.3%, p<0.001; Type B: 2.7% vs. 9.3%, p<0.001). Tamponade at presentation was more common in Type A IMH (17.9% vs. 11.6%, p=0.005). Type B IMH patients had less presenting renal failure (7.5% vs. 16.9%, p<0.001). Medical management alone was more commonly employed as a treatment strategy for IMH versus AAD, both in Type A (18.8% vs. 8.7%, p<0.001) and Type B (78.7% vs. 56.9%, p<0.0001). Correspondingly, Type B IMH patients had less endovascular management (15.6% vs. 29.3%, p<0.001). Surgery was delayed beyond 48 hours of diagnosis in almost twice as many surgical Type A IMH patients (14.9% vs. 8.4%, p=0.009). Additionally, medically managed type A IMH patients had lower mortality than those with AAD (33.3% vs. 58.0%, p=0.001), although medical mortality was still higher than that of surgical patients with IMH (33.3% vs. 12.0%, p<0.001). Kaplan-Meier analyses of 1-year post-discharge death, late intervention, and aortic growth were similar between groups. Conclusions: Intervention was less common among patients with IMH for both Type A and Type B. While a select subset of non-operative IMH patients had more favorable in-hospital outcomes compared to those with AAD, this mortality was still higher than for those IMH patients receiving surgery.
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.
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.
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.
ObjectiveThis 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.MethodsThe 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.ResultsAnalysis 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 significanceThe results suggest that this simulator and accompanying metrics could serve as a useful tool for assessing and teaching open surgery suturing skill.