Anatomic Staging Research Articles

Amputation-Free Survival, WIfI Stage, and GLASS Classifications in Distal Crural or Pedal Bypass for Chronic Limb-Threatening Ischemia

Background: Chronic limb-threatening ischemia (CLTI) is a severe condition with high risks of amputation and mortality, especially in patients with distal crural or pedal artery disease. Despite advances in endovascular techniques, bypass surgery remains crucial for patients with CLTI. This study aimed to investigate amputation-free survival, Wound, Ischemia, and foot Infection (WIfI) staging, and Global Limb Anatomic Staging System (GLASS) classifications in patients undergoing distal crural or pedal bypass for CLTI. Methods: This retrospective study analyzed all patients who underwent distal crural or pedal bypass for CLTI in a tertiary vascular centre from January 2010 to December 2019. The data were collected from hospital records and preoperative imaging. WIfI stages and GLASS classifications were determined for each patient, and the primary endpoint was amputation-free survival. Secondary outcomes included bypass patency, 30-day morbidity, and mortality. Results: We identified 31 bypasses performed on 29 patients with a median age of 67 years (79% male). Preoperatively, 94% of limbs were staged GLASS III and 55% were classified WIfI stage 4. Failed endovascular revascularization preceded bypass surgery in 65% of the cases. Thirty-day mortality was 3% (n = 1) and 30-day major amputation rate was 10%. Primary patency was 87%, and secondary patency was 94% at 30 days. Median duration of follow-up for survival was 59 months with a mean follow-up index (FUI) of 0.99 ± 0.05, and for major amputation and bypass patency 54 months (mean FUI 0.9 ± 0.19 and 0.85 ± 0.28, respectively). At one year, amputation-free survival was 58%, decreasing to 45% at two years, 39% at three years, and 32% at five years. Most major amputations occurred in WIfI stage 4 patients, but 53% of WIfI stage 4 and 80% of WIfI stage 3 patients were alive without major amputation after one year. Conclusions: Distal crural and pedal bypasses are essential for limb salvage in high-risk CLTI patients, particularly those with failed prior revascularization. However, the procedure is associated with limited long-term amputation-free survival. WIfI and GLASS classifications are useful for stratifying risk and guiding treatment, but outcomes suggest the need for individualized care strategies. Further research into perioperative management and alternative interventions is warranted to improve long-term outcomes in this population.

Duplex-ultrasound as a single imaging test for Global Limb Anatomic Staging System (GLASS) assignment stage and comparison with intraoperative arteriography

Obtaining a prognostic and predictive classification based on the risk of amputation is crucial in ischemic pathology of the lower limbs. Accurate anatomical characterization of arterial lesions is essential for optimal clinical decision-making. The Global Limb Anatomic Staging System (GLASS) provides a comprehensive anatomy assessment of the femoropopliteal and infrapopliteal arterial system. GLASS introduces concepts such as the target arterial path (TAP) and estimated limb-based patency (LBP), crucial for determining the best arterial route to restore blood flow. A prospective study conducted from May to December 2022 involved 66 patients undergoing revascularization surgery for Critical Limb-Threatening Ischemia (CLTI). Preoperative arterial mapping (PAM) using duplex ultrasonography was the sole imaging modality. The TAP was defined in each patient, and GLASS staging was determined. Intraoperative arteriography (IA) was used on the day of surgery for comparison. Agreement between PAM and IA was assessed using Cohen's kappa coefficient, and diagnostic metrics were compared using ROC curves. Doppler ultrasound demonstrated a sensitivity of 98%, specificity and PPV of 100%, and NPV of 94.7% in the femoropopliteal sector, with a Kappa coefficient of 0.98. For the infrapopliteal sector, sensitivity was 95%, specificity 96.5%, PPV 97.3%, and NPV 93.3%, with a Kappa coefficient of 0.89. Combining both sectors, the overall GLASS stage showed a 93.9% concordance with a Kappa coefficient of 0.91. ROC curves revealed no significant differences between ultrasound and arteriography in terms of staging. This study demonstrates that Doppler Ultrasound can serve as the exclusive imaging modality for determining the preoperative GLASS stage.

Exploring the Other Side of the River: Early and Midterm Outcomes of Endovascular Pedal Arch Revascularization in Patients with Chronic Limb-Threatening Ischemia.

This study investigated the effect of patency of the pedal arch (PA) on wound healing rate and time, amputation-free survival (AFS), limb salvage, and limb-based patency (LBP) in chronic limb-threatening ischemia (CLTI) patients undergoing endovascular revascularization of infrainguinal arterial lesions. This prospective study included all CLTI patients presenting with wound, ischemia, and foot infection (WIfI) stages 2 to 4 (WIfI ischemia grades 2-3) who underwent endovascular revascularization of infrainguinal arterial disease between April 2019 and April 2021. Pedal angioplasty was attempted in all patients with significant steno-occlusive pedal artery disease. Patients were stratified according to Kawarada PA types. Successful PA revascularization (PAR) was counted when at least 1 pedal vessel is patent. Wound healing rate and time and Kaplan-Meier estimate of AFS and LBP at 2 years were evaluated and compared among the patient groups. A total of 120 patients were categorized according to PA type into type 1 (n = 34; 28.3%), type 2 (n = 64; 53.3%), and type 3 (n = 22; 18.3%). Pedal angioplasty was attempted in 97 patients and was technically successful in 75 patients (77.3%). Successful PAR (with or without pedal angioplasty) was achieved in 98 patients (81.7%). During the follow-up, successful PAR resulted in a better wound healing rate (86.7% vs 59.1%; P = 0.007), major amputation rates (5.1% vs 40.9%; P ≤ 0.001), and AFS (92.9% vs 72.7%; P = 0.018) compared with unsuccessful PAR. There were no significant differences between the 2 groups in wound healing time (3.76 ± 1.99 months vs 3.64 ± 1.94 months; P = 0.798, respectively) or LBP (80.6% vs 72.7%; P = 0.594, respectively). Global Limb Anatomic Staging System (GLASS) stage (odds ratio [OR] = 6.84; 95% CI, 1.30-36.03; P = 0.023) and unsuccessful PAR (OR = 21.64; 95% CI, 4.01-116.69; P ≤ 0.001) were independently associated with failure of wound healing, whereas site of wound lesion (OR = 5.52; 95% CI, 1.15-26.48; P = 0.033), GLASS stage (OR = 24.93; 95% CI, 2.84-218.69; P = 0.004), and unsuccessful PAR (OR = 22.44; 95% CI, 3.53-142.67; P = 0.001) were significant predictors of major amputation. Successful PAR is important for improving clinical outcomes of endovascular revascularization of CLTI patients such as wound healing, amputation-free survival, and limb salvage. Predictors of limb salvage were site of foot lesion, GLASS stage, and successful PAR, whereas GLASS stage and successful PAR were independently associated with improved wound healing. Pedal arch patency positively influences clinical outcomes in patients with chronic limb-threatening ischemia who have ischemic wounds undergoing endovascular revascularization. This study demonstrated that successful pedal arch revascularization (PAR) significantly improved wound healing, amputation-free survival, and limb salvage rates when compared to patients who did not achieve successful PAR. Additionally, the study identified the predictors of limb salvage as the site of foot lesions, GLASS staging, and successful PAR, while both GLASS staging and successful PAR were found to be independently associated with improved wound healing.

Technique and early results of endovenous laser ablation in morphologically complex varicose vein recurrence after small saphenous vein surgery.

Recurrences after varicose vein treatment occur frequently and represent a significant health and economic problem. In contrast to primary treatments of superficial truncal venous insufficiency, their management is often more difficult. Here we assessed the technical feasibility and early results of endovenous laser ablation (EVLA) for recurrences with stumps or subfascial meandering varices after small saphenous vein (SSV) surgery. This single-center retrospective study included 45 consecutive EVLA procedures from July 2019 to December 2021 in 40 patients (19 male, 21 female, mean age 62.8 ± 12.7 years). Patients had clinically relevant recurrent varicose veins after SSV surgery, with clinical, etiologic, anatomic and pathophysiologic (CEAP) classification stage of C2S or higher. We categorized the recurrences morphologically according to duplex sonographic criteria. Ablations were done with a 1470 nanometers laser and dual ring radial fibers and aimed at thermal closure as proximal as possible to the upper inflow. Analyses were performed by descriptive statistics and the Kaplan-Meier method. The primary outcome analyzed was the technical success, defined by thermal occlusion not requiring re-intervention during the observation period. The secondary outcome was the occurrence of postoperative complications. A complex morphology with residual stumps or tortuous venous connections to the popliteal vein was present in 35 cases (77.8%). Immediate technical success at the first postoperative visit after a median of 11 days (interquartile range 8-13 days) was 97.8%. During the follow-up period (median 77 days, interquartile range 13-256 days), 6 limbs (13.3%) required redo EVLA due to symptomatic persistent or newly presenting reflux. The median freedom from re-recurrence was 791 days. Otherwise, no medical or surgical complications requiring specific treatment were observed, particularly no endothermal heat-induced thrombosis (EHIT) or other thrombotic complications, and no nerve damage. According to our pilot data, EVLA is technically feasible for complex popliteal variceal recurrence, although the success rate appears substantially lower than for primary treatment of truncal venous insufficiency.

Clinical Outcomes After Distal Bypass in Patients With Chronic Limb-Threatening Ischemia due to Connective Tissue Disease.

Chronic limb-threatening ischemia (CLTI) is mostly caused by arteriosclerosis, but is sometimes due to connective tissue disease. However, there is a limited knowledge of clinical outcomes of patients with CLTI with connective tissue disease. The objective of the study was to assess outcomes after distal bypass in these patients using global vascular guidelines. Data from distal bypasses performed for CLTI at a single center from 2014 to 2023 were evaluated retrospectively. Clinical outcomes after distal bypass were compared for patients with CLTI with arteriosclerosis (AS group) and those with connective tissue disease (CD group). The primary endpoints were limb salvage and wound healing. Of the 282 distal bypasses performed for 222 patients with CLTI, 22 were conducted for 21 patients with connective tissue disease (CD group). The connective tissue disease was progressive systemic scleroderma (n = 11 patients), pemphigoid diseases (n = 2), polyarteritis nodosa (n = 2), rheumatoid arthritis (n = 2), and others (n = 4). Compared with the AS group, the CD group included more females (P = .007) and had greater oral steroid use (P < .001) and a higher Global Limb Anatomical Staging System (GLASS) inframalleolar (IM) modifier P2 (P < .001). The mean follow-up period of the whole cohort was 27 ± 22 months with no significant difference between the groups (P = .25), and 22 limbs required major amputation during this period. The 2-year limb salvage rate was significantly lower in the CD group compared to the AS group (75% vs 94%, P = .020). Wound healing was achieved in 220 (78%) limbs, and the 12-month wound healing rate was significantly lower in the CD group (52% vs 86%, P = .006). The low 2-year limb salvage and 12-month wound healing rates in patients with CLTI with connective tissue disease indicate that distal bypass may be challenging in these patients.

The prognostic value of the 8th American Joint Committee on cancer anatomic and prognostic stage groups for penile cancer: A multicenter collaboration study

ObjectiveThe aim of this study was to investigate the value of 8th American Joint Committee on Cancer (AJCC) anatomic and prognostic stage groups for penile cancer patients and explore whether there is room for improvement. MethodsThe clinical and histopathologic data from 16 centers between 2000 and 2021 were assessed according to the 8th AJCC anatomic and prognostic stage groups. Kaplan–Meier plots were used to estimate the disease-specific survival (DSS) of the patients. The accuracy of the staging systems was investigated using the Harrell's concordance index (C-index). ResultsThe 5-year DSS rates for patients with stages 0is/a, I, IIA, IIB, IIIA, IIIB, and IV (stage 0 to stage IV) disease were 100 %, 98.9 %, 85.5 %, 81.1 %, 65.8 %, 34.4 %, and 23.2 %, respectively (p0is/a–I=0.798, pI–IIA<0.001, pIIA–IIB=0.486, pIIB–IIIA<0.001, pIIIA–IIIB<0.001, pIIIB–IV=0.004, ptotal<0.001). According to the modified model 1 system, the 5-year DSS rates without survivorship overlap for patients with stages 0is/a, I, II, IIIA, IIIB, and IV disease were 100 %, 98.9 %, 87.8 %, 65.8 %, 34.4 %, and 23.2 %, respectively (p0is/a–I=0.798, pI–II<0.001, pII–IIIA=0.002, pIIIA–IIIB<0.001, pIIIB–IV=0.004, ptotal<0.001). Similarly, according to the modified model 2 system, the 5-year DSS rates without survivorship overlap for patients with stages 0is/a, I, II, IIIA, IIIB, and IV disease were 100 %, 99.0 %, 85.8 %, 65.8 %, 34.4 %, and 23.2 %, respectively (p0is/a–I=0.757, pI–II<0.001, pII–IIIA=0.008, pIIIA–IIIB<0.001, pIIIB–IV=0.004, ptotal<0.001). The C-index of the simple modified staging systems were not inferior to those of the AJCC anatomic and prognostic stage groups. These results were confirmed by the bootstrap internal validation. ConclusionThere is still room for improvement about 8th AJCC anatomic and prognostic stage groups. The improved models, which are more concise and convenient, had a similar predictive value.

A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial

NATALEE assessed efficacy and tolerability of 3 years of adjuvant ribociclib plus NSAI compared with a nonsteroidal aromatase inhibitor (NSAI) alone in a broad population of patients with HR+/HER2- early breast cancer, including a select group without nodal involvement. This is the final preplanned analysis of invasive disease-free survival (iDFS). Premenopausal/postmenopausal women and men were randomized 1:1 to ribociclib (n=2549; 400 mg/day, 3 weeks on/1 week off for 36 months) plus NSAI (letrozole 2.5 mg/day or anastrozole 1 mg/day for 60 months) or NSAI alone (n=2552). Men and premenopausal women also received goserelin (3.6 mg once every 28 days). Patients had anatomical stage IIA (N0 with additional risk factors or N1), IIB, or III disease. The primary endpoint was iDFS. Secondary efficacy endpoints were recurrence-free survival (RFS), distant DFS (DDFS), and overall survival (OS). This final iDFS analysis was planned after ≈500 events. At data cutoff (21 July 2023), ribociclib was stopped for 1996 patients (78.3%); 1091 (42.8%) completed 3 years of ribociclib, and ribociclib treatment was ongoing for 528 (20.7%). Median follow-up for iDFS was 33.3 months. Overall, 226 and 283 iDFS events occurred with ribociclib plus NSAI vs NSAI alone, respectively. Ribociclib plus NSAI demonstrated significant iDFS benefit over NSAI alone (Hazard Ratio 0.749, 95% Confidence Interval [CI] 0.628-0.892; P=0.0012). The 3-year iDFS rates were 90.7% (95% CI 89.3%-91.8%) vs 87.6% (95% CI 86.1%-88.9%). A consistent benefit was observed across prespecified subgroups, including stage (II/III) and nodal status (+/-). DDFS and RFS favored ribociclib plus NSAI. OS data were immature. No new safety signals were observed. With longer follow-up and most patients off ribociclib, NATALEE continues to demonstrate iDFS benefit with ribociclib plus NSAI over NSAI alone in the overall population and across key subgroups. Observed adverse events remained stable.

Evaluation of global vascular guidelines strategy in infra-inguinal occlusive disease: Revisited using global limb anatomic staging system.

Evaluation of global vascular guidelines strategy in infra-inguinal occlusive disease: Revisited using global limb anatomic staging system.

Survival Outcomes and Prognostic Staging in Locally Advanced Breast Cancer Patients Receiving Radiotherapy: A Single Center Experience

The American Joint Committee on Cancer (AJCC) 8th edition prognostic staging was introduced to improve breast cancer staging by incorporating factors like hormone receptor status and human epidermal growth factor receptor-2 (HER2) expression. This study assesses its effectiveness in locally advanced breast cancer (LABC). A total of 557 patients with locally advanced breast cancer (Stage III) were re-evaluated using prognostic staging. Overall survival (OS), disease-free survival (DFS), and distant metastasis free survival (DMFS) rates were evaluated using the Kaplan-Meier method, and the log-rank test was employed to compare outcomes between anatomic and prognostic staging. According to restaging 34.5% of patients remained in the same stage, while 55.8% were downstaged, and 9.7% were upstaged. When patients reassigned using prognostic staging patients classified as stage IIA showed improved OS rates compared to those in stages IIIA, IIIB, and IIIC (p&lt; 0.001 for each). Patients with prognostic stage IIA had better DFS compared to IIIA, IIIB (p= 0.003, and p&lt; 0.001, respectively). Both anatomic and prognostic staging were found to significantly impact OS in patients with Luminal-A tumors (p= 0.008 and p= 0.001, respectively), whereas neither anatomic nor prognostic stage had any impact on triple negative subgroup. When stage IIIA patients restaged, downstaged individuals showed better OS than those who stayed at the same stage or were upstaged (p= 0.01 and p= 0.02, respectively). This study highlights the prognostic staging system’s superiority over anatomic staging in predicting survival outcomes for LABC, and the use of the prognostic staging system for more personalized treatment strategies. Keywords: Breast cancer, Radiotherapy, Anatomic staging, Prognostic staging

The added value of 68Ga-PSMA PET/CT in anatomical staging of prostatic carcinoma in correlation with the histopathological zonal staging

BackgroundProstate cancer is well known as the commonest cancer in men and the second leading cause of cancer-related death. CT, MRI and bone scintigraphy are considered the commonly widely used imaging diagnostic tools for detection, staging and follow-up of prostate cancer. Prostate-specific membrane antigen (PSMA) is a membrane glycoprotein, that can be concentrated in prostate cancer cells up to 100 times higher than in normal cells. PSMA-targeted imaging modalities have now proven their efficacy in diagnosis, staging and follow-up of prostate cancer. The use of 68Ga PSMA PET-CT has efficiently improved the detection of loco-regional and metastatic disease. 68Ga PSMA PET-CT also has an effective role in the primary diagnosis, staging, and detecting biochemical recurrence after curative treatment and in metastasis-targeted therapy. This work aims to review the role of 68Ga PSMA PET-CT in anatomical staging of prostate cancer in correlation with histopathological staging.ResultsZonal correlation between 68Ga PSMA findings and biopsy results showed sensitivity ranging between 76.9 and 90.6% and specificity ranging from 85.7 to 100%. There was high significant correlation between the SUVmax uptake and the biopsy results, between the SUVmax uptake and the local staging as well as between the Gleason score and 68Ga PSMA PET/CT findings.Conclusions68Ga PSMA PET/CT is a highly promising imaging modality with an effective role in detection of prostate cancer showing high sensitivity and specificity in prediction of zonal histopathological results and loco-regional Gleason score staging with significant positive correlation between the SUV uptake results, Gleason score and the PSA levels.

Relationship between NLR and penile squamous cell carcinoma: a systematic review and meta-analysis

ObjectiveWe conducted this study to summarize the results of studies reporting the role of NLR (neutrophil to lymphocyte ratio) in PSCC (penile squamous cell carcinoma).MethodsThis meta-analysis was conducted using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria. A systematic search was conducted on PubMed, Scopus, and web of science up to March 10, 2023. Fourteen studies were included in the review. The NOS (Newcastle–Ottawa Scale) was used to determine the quality of the included studies. This meta-analysis was conducted on the studies reporting the relationship between NLR and survival using HR (hazard ratio) and 95% CI (confidence interval).ResultsThere was a significant association between NLR levels and the prognosis, nodal stage, and anatomical tumor stage of PSCC patients. In the meta-analysis of the association of NLR with survival, NLR level was significantly associated with lower cancer-specific survival (HR = 3.51, 95% CI = 2.07–5.98, p < 0.001) and lower disease-free survival (HR = 2.88, 95% CI = 1.60–5.20, p < 0.001). However, NLR was found to have no association with the stage, grade, location, and size of the tumor.ConclusionNLR has a significant diagnostic and prognostic value in PSCC.

Prospective Multi-Center Longitudinal Study to Validate Accuracy of the Global Anatomic Staging System (GLASS) Score in Predicting Major Acute Limb Events in Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention: The PROMOTE-GLASS Study Protocol.

Developed by the Global Vascular Guidelines committee, the Global Limb Anatomic Staging System (GLASS) is an angiographic scoring system used for quantifying infrainguinal disease extent and predicting treatment success with endovascular techniques (EVT). Currently, no other risk prediction model is available for patients with chronic limb threatening ischemia (CLTI) undergoing EVT. GLASS' validation and adoption outside academic institutions for research are limited. Thus, this longitudinal multicenter prospective study aims to examine GLASS' validity and reliability in predicting major acute limb events and overall survival (OS) in patients with CLTI undergoing EVT. This prospective, international, multicenter, observational study will include patients with CLTI undergoing EVT (PROMOTE-GLASS) (ClinicalTrials.gov; ID: NCT06186544) identified through routine clinical referrals and emergency visits to vascular units in participating centers. Only patients who are referred for EVT will be recruited. The primary outcomes are immediate technical success, immediate technical failure, and 1-year limb base patency. The secondary outcomes are major adverse limb events, major lower limb amputation, and OS in patients presenting with CLTI who undergo EVT up to 1 year after the procedure. Clinical and imaging data will be analyzed at the end of follow-up to validate risk prediction. This protocol outlines our approach for identifying cases, GLASS score calculation, outcome measures assessment, and a statistical analysis plan. PROMOTE-GLASS holds significant implications and can potentially revolutionize clinical decision-making by assisting clinicians in identifying patients who are likely to benefit from EVT. Ultimately, reduce the need for more invasive procedures and improve patient outcomes. Furthermore, PROMOTE-GLASS can provide useful information, including patient selection, for future randomized controlled trials (RCTs) investigating EVT for CLTI. PROMOTE-GLASS anticipated implications on the vascular community are rooted in its potential to improve patient care, inform future research, and address limitations in existing literature regarding CLTI treatment outcomes.

Outcomes of revascularization of stenotic inframalleolar lesions in chronic limb-threatening ischemia.

For chronic limb-threatening ischemia, revascularization has been reported for occlusions but not for stenosis in the inframalleolar (IM) lesions. We investigated the clinical outcomes of balloon dilation for stenotic IM lesions distal to the treatment target in the infrapopliteal (IP) legion. We conducted a retrospective analysis of patients who had chronic limb-threatening ischemia and underwent revascularization of stenotic IM lesions distal to the target IP lesions between January 2015 and August 2022. The outcome measures were amputation-free survival, wound healing rate, and freedom from target IM reintervention. The 87 patients had a mean age of 72.7 ± 10.7 years and comprised 67.8% men, 74.7% with diabetes mellitus, 55.2% on dialysis, 33.3% who had Rutherford six classification. The amputation-free survival (AFS), wound healing, and freedom from target IM reintervention rates at 1 year were 82.9%, 53.3%, and 58.4%, respectively. On Cox proportional multivariate analysis, the predictors were Wound, Ischemia, and foot Infection (WIfI) ≥3 and diffuse stenosis in the target IM vessels for delayed wound healing and Global Limb Anatomic Staging System stage Ⅲ and ≥3 diseased IM vessels before endovascular therapy for target IM reintervention. At the time of reintervention, the lesion morphology had progressed from stenosis to occlusion in 50% of cases. In patients with chronic limb-threatening ischemia, revascularization of stenosis in IM lesions showed a high reintervention rate and progression of lesion morphology, although AFS and wound-healing rates were acceptable.

Acute limb ischemia and its predictive factors after revascularization: A single-center retrospective study from a resource-limited setting

Background: Patients with acute limb ischemia (ALI) are being treated using both open and endovascular procedures, with technological developments making treatments simpler and safer. However, the most significant improvements in outcomes for these patients will come from timely diagnosis, followed by quick and standardized therapy to reduce the likelihood of limb loss and subsequent sequels. The study sought to explore the clinical presentation and treatment outcome of open surgical revascularization for ALI in a resource-limited setting. Method: Between June 2019 and December 2022, a retrospective study including all patients presenting with ALI and treated with urgent revascularization at Al-Thora General Hospital, Sana’a, Yemen, was performed. All patients were classified using Rutherford’s ALI categorization. Demographic parameters, clinical data, treatment details, and outcomes were obtained from patient medical profiles. The main outcome was organ/patient survival and amputation 30 days following surgery. Secondary outcomes included factors associated with amputation. Result: Overall, 91 ALI patients were treated with urgent open revascularization during the study period. The mean age of patients was 55.9 ± 11.5 years, and most cases (61.5%) were male patients. The duration of symptoms was longer than 36 h in 29 cases (31.9%). Comorbidities such as ischemic heart disease, hypertension, diabetes mellitus, hyperlipidemia, cerebrovascular disease, congestive heart failure, renal impairment, atrial fibrillation, and history of malignancy were present in 61 (67.0%), 76 (83.5%), 56 (61.5%), 49 (53.8%), 11 (12.1%), 21 (23.1%), 25 (27.5%), 47 (51.6%), and 8 (8.8%) cases, respectively. Sensory impairment was seen in 30 (33.0%) cases. Thrombosis etiology was the most common ALI causes (80.2%). In laboratory results, high C-reactive protein (CRP) levels, low hemoglobin levels (anemia), and low albumin levels were present in 15 (16.5%), 15 (16.5%), and 8 (8.8%), respectively. Most ALI (85.7%) were occurred in lower extremity. Additionally, 61 (67.0%) cases were in the Rutherford IIb stages. All cases were undergoing open surgical revascularization and fasciotomy was made in 6 (6.6%) cases. The amputation-free survival rate was 76.9% at 30 days follow-up. The 30-day outcome was amputation in 21 (23.1%) cases and death in one case. In univariate analysis, current smoking, history of diabetes, hemodialysis, history of malignancy, atrial fibrillation, sensory impairment, prolonged symptoms duration (&gt;36 h), elevated CRP (&gt;5 mg/L), advanced ALI stage (Rutherford’s class IIb), fasciotomy, and thrombosis etiology were associated with revascularization failure and amputation and were statistically significant (all p-values &lt; 0.05). Conclusion: In this study, despite no endovascular treatment offered, the application of the standard treatment—open surgical revascularization—in patients with ALI represents the key to success for limb salvage with acceptable amputation rates even in a resource-limited setting. Additionally, independent risk factors for amputation were current smoking, history of diabetes, hemodialysis, history of malignancy, atrial fibrillation, sensory impairment, prolonged symptoms duration (&gt;36 h), elevated CRP (&gt;5 mg/L), advanced ALI stage, fasciotomy, and thrombosis etiology. Advanced tailoring revascularization strategy and timing for the proper patient and comorbidities treatment could potentially improve amputation-free survival in ALI patients. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision-making in ALI.

History of the Surveillance, Epidemiology, and End Results (SEER) Program.

The Surveillance, Epidemiology, and End Results (SEER) Program established in 1973 was the first laboratory for experimenting with new methods for cancer data collection and translating the data into population-based cancer statistics. The SEER Program staff have been instrumental in the development of the International Classification of Disease-Oncology and successfully implemented the routine collection of anatomic and prognostic cancer stage at diagnosis. Currently the program consists of 21 central registries that generate cancer statistics covering more than 48% of the US population and an additional 10 research support registries contributing to certain research projects, such as the National Childhood Cancer Registry. In parallel with the geographical expansion, the program built an architecture of methods and tools for population-based cancer statistics, with SEER*Explorer as the most recent online tool for descriptive statistics. In addition, SEER releases annual updates for a comprehensive data product line, which includes SEER*Stat databases with an annual caseload of more than 800 000 incident cases. Furthermore, the program developed a full suite of analytical applications for population-based cancer statistics that include Joinpoint (regression-based trend analysis), DevCan (risk of diagnosis and death), CanSurv (survival models), and ComPrev and PrejPrev (cancer prevalence), among others. The future of the SEER Program is closely aligned to the overall goals of the "war on cancer." The program aims to release longitudinal treatment data coupled with a comprehensive genomic characterization of cancers with a declared goal of decreasing the cancer burden and disparities across a wide spectrum of diseases and communities.

The impact of angiographic pedal circulation status on wound healing in chronic limb-threatening ischemia after bypass surgery

ObjectiveIn the treatment of chronic limb-threatening ischemia (CLTI), complete wound healing is an important goal. Although foot perfusion status seems to be important for wound healing, the Global Limb Anatomic Staging System (GLASS) of the Global Vascular Guidelines does not include pedal artery status for the staging process due to the lack of sufficient evidence of its importance. This study aimed to clarify the importance of pedal perfusion status after bypass surgery. MethodsAmong the 153 CLTI cases that underwent bypass distal to popliteal arteries from 2014 to 2018, 117 CLTI limbs with wounds and with sufficient pedal angiographic data were enrolled. They were classified into two groups, based on the wound status 6 months postoperatively; early wound healing group (EWG; n = 78), which achieved complete wound healing within 6 months postoperatively, and prolonged healing or unhealed wounds group (PWG; n = 39), which failed to achieve wound healing within 6 months. Various factors associated with wound healing, including the wound, ischemia, and foot infection (WIfI) classification, intraoperative graft flow, and pedal angiographic data, were analyzed. Regarding pedal angiographic data, in addition to the GLASS inframalleolar/pedal disease descriptor (IPD), newly formed classification system of the pedal circulation status in association with the location of wounds was included: pedal circulation status was classified into two groups as visualized arterial perfusion towards wounds (visualized perfusion) and non-visualized arterial perfusion towards wounds (non-visualized perfusion). ResultsUnivariate analysis showed preoperative albumin (Odds ratio [OR], 0.47; 95% confidence interval [CI], 0.24-0.94; P = .027), higher WIfI clinical stage (OR, 3.88; 95% CI, 1.74-10.1; P = .0005), higher IPD (OR, 2.16; 95% CI, 1.16-4.02; P = .012), and non-visualized perfusion to wounds (OR, 5.74: 95% CI, 2.45-14.0; P < .0001) as significant for prolonged wound healing. Multivariate analysis showed higher WIfI stage (OR, 5.04; 95% CI, 1.74-14.6; P = .0029) and non-visualized perfusion to wounds (OR, 4.34; 95% CI, 1.71-11.0; P = .0021) as significant, whereas IPD was not detected as significant. Regarding blood supply to the foot, although graft flow was significantly lower in IPD-P2 than IPD-P0/P1, graft flow was similar regardless of the status of angiographic circulation to wounds, suggesting that distribution of blood supply to the wound would be more important than total amount of blood supply to the foot for wound healing. ConclusionsWIfI clinical stage and pedal circulatory environment were important factors for wound healing after bypass surgery. Pedal anatomical classification system including perfusion status would be important for decision making in CLTI treatment.

Employing magnetic resonance histology for precision chronic limb-threatening ischemia treatment planning

ObjectiveRecent randomized controlled trials have demonstrated a notable prevalence of immediate technical failures in percutaneous vascular interventions (PVIs) for complex arterial lesions associated with chronic limb-threatening ischemia. Current imaging modalities present inherent limitations in identifying these lesions, making it challenging to determine the most suitable candidates for PVI. We present a novel preprocedural magnetic resonance imaging (MRI) histology protocol for identifying lesions that might present a higher rate of immediate and midterm PVI failure. MethodsWe enrolled 22 patients (13 females, average age 65.8 ± 9.72 years) scheduled for PVI were prospectively and underwent 3T MRI using ultrashort echo time and steady-state free precession contrasts to characterize target lesions before PVI. Lesions were scored as hard if >50% of the lumen was occluded by hard components (calcium/dense collagen) on MRI in the hardest cross-section. Two readers evaluated MRI datasets. Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)/Global Limb Anatomic Staging System (GLASS)/Wound, Ischemia and Foot infection scoring was performed based on intraprocedural angiograms and chart review. The relationship between MRI scoring, TASC/GLASS scoring, and procedural outcomes was investigated using univariate analysis. Midterm follow-up (revascularization and amputation rates) was recorded at 3 and 6 months after the intervention. ResultsOur cohort of 22 patients yielded 40 target lesions. Five lesions were excluded (two for nondiagnostic image quality; three PVIs were ultimately diagnostic only). Six lesions (17%) were scored as hard. MRI-scored hard lesions had a higher proportion of immediate technical failure (hard vs soft 83% [5/6] vs 3% [1/29]; P < .001). Hard vs soft MRI scoring was the only factor significantly associated with immediate PVI technical success (P < .001), as opposed to TASC/GLASS scoring. Both at 3 months and 6 months after PVI, the reintervention rate was significantly higher among those lesions which were scored hard on MRI (3 months hard, 80% vs soft, 16% [P =.011]; 6 months hard, 80% vs soft, 27%; P = .047). ConclusionsMRI histology could be a valuable tool for optimizing PVI patient selection and treatment strategies.

Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds.

Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.Methods and Results: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.

Patient-Reported Outcomes 10 Years After Breast-Conserving Surgery for Early-Stage Breast Cancer.

Patient-reported outcomes (PROs) are a critical component of value-based care. Limited data exist describing long-term PROs in patients undergoing breast-conserving surgery (BCS). Patients undergoing surgery for stage 0-III breast cancer at our institution from 2002 to 2012 who agreed to be contacted were invited to participate in a cross-sectional PRO study. Health-related quality of life outcomes using BREAST-Q, EORTC QLQ-C30, and EORTC QLQ-BR45 were collected. Patients reporting chemotherapy within 6 months of receiving the survey were excluded. For this work, we focused on patients who underwent BCS. Multivariable linear regression was performed to identify factors associated with PRO scores, adjusting for age, time since surgery, anatomic stage, molecular subtype, receipt of systemic and/or radiation therapy (RT), locoregional recurrence, or contralateral breast cancer. Among 562 interested and eligible patients, 437 (78%) responded; median time from surgery to survey completion was 10.4 years (interquartile range: 8.0-13.5). Median age at surgery was 53 years (standard deviation 9.8 years), ≥ 90% were white, had upfront surgery for early-stage disease, and completed adjuvant RT. Physical and psychological well-being scores were generally high, with more variation seen for sexual well-being and satisfaction with breasts. This study provides long-term PRO data for patients treated with BCS, demonstrating the ongoing association of breast cancer surgery with quality of life in the survivorship period and highlighting the importance of examining PROs beyond the perioperative period. These data also provide important reference values for the interpretation of PROs among women treated with BCS as we move towards value-based care.

Toward a paradigm shift in prognostication and treatment of early-stage Hodgkin lymphoma.

Twenty years after the conceptual revolution that occurred in the millennium turnaround upon the introduction of PET/CT in lymphoma staging, restaging, and prognostication, a number of new parameters for PET reading have been proposed: (1) the shift from a qualitative to a semi-quantitative reading for PET reporting, (2) an international consensus on these novel interpretation keys, (3) a standardized and agreed procedure to measure the total metabolic tumour volume (TMTV), and (4) the proposition of new indexes to portray the tumour spread: (D-Max and Total Lesion Surface -TLS). These proved to be very powerful prognosticators, able to revolutionize the traditional Ann Arbor four-stage lymphoma staging. During the 17° Lugano meeting on lymphoma, one main question was asked to experts attending a closed workshop dedicated to new metrics for lymphoma diagnosis, staging, restaging, and prognostication: "Should the traditional 4-stage anatomic staging system be simplified to a more clinically relevant 2-stage system (e.g., limited vs. extensive disease)?" Early-stage HL is an example of how these new metrics could fit with this proposal.