Outcomes of a Multidisciplinary Vascular Practice: 12-Month Amputation-Free Survival and Beyond in Patients With Chronic Limb-Threatening Ischemia.

OBJECTIVE: There is great variability in the treatment of chronic limb-threatening ischemia, including the practice paradigm, vascular provider specialty, devices utilized, and experience with advanced open and/or endovascular treatments, among other factors. Our unique practice consists of patient-centered, clinically oriented Interventional Radiologists and Vascular Surgeons, with treatments being performed in Office Interventional Suites (OIS), Ambulatory surgery center (ASC), and hospital inpatient/outpatient settings. We evaluate our results, centered on major amputation rates while comparing case complexity and rates with previously published data. METHODS: A retrospective review was performed of all Rutherford 4, 5, and 6 patients who underwent treatment in our practice from 2015 to 2021. Baseline patient characteristics, complexity of lesions, and major amputation rates were collected. Patients with more complex diseases or requiring re-interventions were openly discussed in multidisciplinary fashion to determine the group's approach to revascularization. Limb salvage, clinically driven target lesion revascularization (TLR), repeat interventions, length of follow-up, and mortality were assessed. RESULTS: Treatment was performed in 829 limbs in 351 females and 478 males, with chronic limb-threatening ischemia. Of the 829 cases, 541 cases had at least 1 chronic total occlusion (CTO), including 115 limbs with 2 CTOs and 24 limbs with 3 CTOs with 63.5% of cases requiring multilevel intervention. One year mortality rate was 6.2% with a major lower extremity amputation rate of 2.3% with a mean length of follow-up of 22.3 months. One-year freedom from clinically driven TLR rate was 78.7% with repeat intervention in 163 cases within 12 months. Over the course of the study, within the femoropopliteal stent subset, there was a significant increase in time to reintervention when newer stent technologies were utilized such as woven nitinol and drug-eluting technology (p=0.03). The overall 1-year amputation-free survival (AFS) was 91.5. CONCLUSIONS: Multidisciplinary approach with surgical and endovascular treatment may provide patients with the best chance of AFS. CLINICAL IMPACT: Real world practice of critical limb-threatening ischemia in a multidisciplinary practice demonstrates favorable outcomes for patients with the best reported one year major amputation free survival in a population this large. A strong clinical practice based on close routine follow up and arterial duplex monitoring is a major contributing factor, as well as utilization of the latest technology in drug eluting stents and drug coated balloons for best patient outcomes. We hope this study provides other practices with a guideline for establishing or modifying their practice to attain the best procedural and clinical outcomes.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Hepatocellular carcinoma likelihood on MRI exams: evaluation of a standardized categorization system.

PURPOSE: Evaluate the reliability and validity of a standardized reporting system designed to improve communication between the clinician and radiologist regarding likelihood of hepatocellular carcinoma (HCC). MATERIALS AND METHODS: The system assigns liver lesions into 1 of 5 categories of estimated likelihood of HCC: 1, <5%; 2, 5%-20%; 3, 21%-70%; 4, 71%-95%; 5, >95%. Six American Board of Radiology-certified radiologists reviewed 100 abdominal MRI studies (performed between September 2009 and June 2010 for HCC surveillance) blinded to the official reports and clinical information. Each reader recorded the highest category (1-5) assigned to any lesion per study. Reliability between readers was calculated by the Shrout-Fliess random sets intraclass correlation (ICC). To examine validity, original pretransplant reports from January 2009 to December 2010 were compared to pathology reports on liver explants. Sensitivities, specificities, predictive values, and receiver operating characteristic (ROC) curves were then produced. RESULTS: The ICC for retrospective readings was 0.80, indicating very good reliability. Of 45 pathologically proven cases, 16 category 1 or 2 cases were all free of HCC (negative predictive value 100%). Five of nine category 3 cases contained HCC. Six of eight category 4 cases contained HCC (PPV 75%). All 12 category 5 cases contained HCC (positive predictive value 100%). The area underneath the ROC curve was 0.949. If categories 1 and 2 are considered negative and categories 3-5 considered positive, this achieves 100% sensitivity with 73% specificity. CONCLUSION: This standardized system for reporting likelihood of HCC, which is a forerunner of the recently introduced Liver Imaging Reporting and Data System, produces strong reliability and validity, while aiming to improve the clarity of clinical magnetic resonance imaging reports.

Single-center comparison of three chemoembolization regimens for hepatocellular carcinoma.

PURPOSE: Transarterial chemoembolization regimens for hepatocellular carcinoma (HCC) vary, without a gold-standard method. The present study was performed to evaluate outcomes in patients with HCC treated with doxorubicin/ethiodized oil (DE), cisplatin/doxorubicin/mitomycin-c/ethiodized oil (CDM), or doxorubicin drug-eluting beads (DEBs). MATERIALS AND METHODS: Patients received the same regimen at all visits, without crossover. Groups were compared based on Child-Pugh disease status, tumor/node/metastasis stage, and Barcelona Clinic Liver Cancer stage. Imaging outcomes were assessed based on modified Response Evaluation Criteria in Solid Tumors to calculate tumor response (ie, sum of complete and partial response), progressive disease (PD), and time to progression (TTP). RESULTS: A total of 228 infusions were performed in 122 patients: 59 with DE, 30 with CDM, and 33 with DEBs. The groups had similar Child-Pugh status (P = .45), tumor/node/metastasis stages (P = .5), and Barcelona Clinic Liver Cancer scores (P = .22). Follow-up duration was similar among groups (P = .24). Patients treated with DE underwent significantly more treatments (2.3 ± 1.4) than those treated with CDM (1.6 ± 0.7; P = .004) or DEBs (1.4 ± 0.6; P<.0001). Compared with DE (51%), tumor response was significantly more common with CDM (84%; P = .003) or DEBs (82%; P = .004). PD was significantly more likely with DE (37%) than with CDM (13%; P = .02) or DEBs (9%; P = .004). TTP was similar between groups (P = .07). CDM and DEBs were similar in regard to disease progression (P = .6) and response (P = .83). CONCLUSIONS: During a similar follow-up period, patients treated with CDM or DEB chemoembolization showed a significantly higher response rate and a lower incidence of tumor progression, with fewer required treatment sessions, than those treated with DE chemoembolization.

Safety of uterine artery embolization in patients with preexisting hydrosalpinx.

PURPOSE: To determine (i) if preexisting hydrosalpinx poses a risk for development of pyosalpinx following uterine artery embolization (UAE) and (ii) the effect of UAE on fallopian tube diameter. MATERIALS AND METHODS: Between 2005 and 2011, 429 women underwent UAE for treatment of symptomatic leiomyomas. Magnetic resonance (MR) imaging before UAE revealed 16 (3.7%) premenopausal women (median age, 47 y; range, 40-52 y) with preexisting hydrosalpinx. Bilateral UAE was performed by using 500-700-µm tris-acryl microspheres with the administration of routine prophylactic antibiotics. Pre- and post-UAE MR images were used to measure fallopian tube diameter. Fallopian tube diameters were classified as normal (1-4 mm) or mildly (< 10 mm), moderately (10-20 mm), or severely enlarged (> 20 mm). A diameter change ≥ 3 mm was considered significant. Resolution of hydrosalpinx was defined by the inability to identify fallopian tubes on post-UAE MR imaging or a normal fallopian tube diameter. Radiology and hospital records were reviewed to determine clinical outcomes. RESULTS: All 16 patients underwent successful bilateral UAE. Clinical follow-up ranged from 14 to 1,531 days (median, 106 d). There was no clinical evidence of pyosalpinx after UAE. Two patients experienced minor complications unrelated to fallopian tube dilation. Post-UAE MR images were available in 13 of 16 patients (81.3%). There were no MR findings to suggest pyosalpinx after UAE. Resolution or improvement was noted in four of 15 hydrosalpinges (26.7%) for patients with follow-up imaging. CONCLUSIONS: The results of the present study suggest that UAE is safe for patients with preexisting hydrosalpinx.

Recent trends in soft-tissue infection imaging.

This article discusses the current techniques and future directions of infection imaging with particular attention to respiratory, central nervous system, abdominal, and postoperative infections. The agents currently in use localize to areas of infection and inflammation. An infection-specific imaging agent would greatly improve the utility of scintigraphy in imaging occult infections. The superior spatial resolution of (18)F-fluorodeoxyglucose positron emission tomography ((18)F-FDG-PET) and its lack of reliance on a functional immune system, gives this agent certain advantages over the other radiopharmaceuticals. In respiratory tract infection imaging, an important advancement would be the ability to quantitatively delineate lung inflammation, allowing one to monitor the therapeutic response in a variety of conditions. Current studies suggest PET should be considered the most accurate quantitative method. Scintigraphy has much to offer in localizing abdominal infection as well as inflammation. We may begin to see a gradual increase in the usage of (18)F-FDG-PET in detecting occult abdominal infections. Commonly used modalities for imaging inflammatory bowel disease are scintigraphy with (111)In-oxine/(99m)Tc-HMPAO labeled autologous white blood cells. The literature on central nervous system infection imaging is relatively scarce. Few clinical studies have been performed and numerous new agents have been developed for this use with varying results. Further studies are needed to more clearly delineate the future direction of this field. In evaluating the postoperative spine, (99m)Tc-ciprofloxacin single-photon emission computed tomography (SPECT) was reported to be >80% sensitive in patients more than 6 months after surgery. FDG-PET has also been suggested for this purpose and may play a larger role than originally thought. It appears PET/computed tomography (CT) is gaining support, especially in imaging those with fever of unknown origin or nonfunctional immune systems. Although an infection-specific agent is lacking, the development of one would greatly advance our ability to detect, localize, and quantify infections. Overall, imaging such an agent via SPECT/CT or PET/CT will pave the way for greater clinical reliability in the localization of infection.