Abstract 14293: Time to Wound Healing and Major Adverse Limb Events in Patients With Critical Limb Ischemia Treated With Endovascular Therapy

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Grant W Reed ◽  
Negar Salehi ◽  
Pejman Raeisi-Giglou ◽  
Umair Malik ◽  
Rami Kafa ◽  
...  

Introduction: There have been few studies evaluating the influence of time to wound healing on outcomes in patients with critical limb ischemia (CLI) after endovascular therapy. Methods: In this prospective study, patients with CLI treated with endovascular therapy were assessed for comorbidities, presence of wounds, wound healing, and major adverse limb events (MALE; major amputation, surgical endartectomy, or bypass) over time. The incidence of MALE was compared across patient and wound characteristics by Kaplan-Meier analysis. Associations between these variables and MALE were determined by Cox proportional hazards analysis. Results: A total of 252 consecutive patients with CLI were treated between November 1, 2011 and April 1, 2015; 179 (71%) had wounds, of which 97 (54%) healed. During median follow-up of 12.7 months (interquartile range 3.9 - 23.9 months), 46 (18%) had MALE. Wounds were associated with a greater risk of MALE (Hazard Ratio [HR] 3.5; 95% Confidence Interval [CI] 1.4-8.9; p=0.008). As a time-dependent covariate, wound healing was associated with less MALE (HR 0.23; 95% CI 0.10-0.53; p<0.001), and MALE was more frequent in patients with unhealed wounds (23% vs 11%; p<0.0001) (Figure - A). There was significantly less MALE in patients whose wounds healed within 4 months (24% vs 10%; p=0.032) (Figure - B), and less major amputation in those with healed wounds within 3 months (16% vs 5%; p=0.033). After multivariate adjustment for age, presence of diabetes, renal function, wound size, and procedural failure, independent predictors of MALE were wound healing as a time-dependent covariate (HR 0.18; 95% CI 0.08 - 0.40; p<0.0001), and creatinine ≥ 2 (HR 2.3; 95% CI 1.3-4.2; p=0.005). Conclusions: A shorter time to wound healing is associated with less MALE in patients with CLI after endovascular therapy. Efforts should be made to achieve wound healing as quickly as possible in this population, especially in those with renal dysfunction.

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Hiroyuki Jinnouchi ◽  
Yoshimitsu Soga ◽  
Yohei Kobayashi ◽  
Yusuke Tomoi

Introduction: Clinical outcome of patients with atrial fibrillation (AF) after endovascular therapy for critical limb ischemia (CLI) is unclear. The aim of this study was to investigate if atrial fibrillation (AF) influences clinical outcomes after femoropopliteal artery intervention in patients with CLI. Methods: A retrospective review of all patients undergoing femoropopliteal artery intervention for CLI was performed. We compared clinical outcome between patients with and without AF. The primary endpoint was amputation free survival (AFS). The secondary endpoints were overall survival, limb salvage, freedom from repeat revascularization, and freedom from surgical conversion were compared between two groups. Kaplan-Meier analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. Results: A total of 398 limbs with 342 patients were performed with femoropopliteal artery intervention in patients with CLI. (male 58.4%, 73.9±10.8 years old, mean follow up 17 months; interquartile range 5-32 months). We identified 58 limbs with AF, 340 without AF. At median follow-up period, AFS and overall survival was significantly lower in patients with AF (51.0 % vs 70.5 % P=0.0004 by log-rank, 53.9 % vs 77.1 % P<0.0001; relatively). Other outcomes were not significantly different between the groups. Risk-adjusted Cox proportional hazards regression showed that AF predicts poor AFS and overall survival (hazard ratio [HR], 1.59; 95% confidential interval [CI] 1.01-2.43; adjusted P=0.044, HR, 1.89; 95%CI, 1.19-2.98; adjusted P=0.008). Conclusion: AF may worse AFS and overall survival rate in patients who underwent femoropopliteal intervention in CLI.


2015 ◽  
Vol 35 (suppl_1) ◽  
Author(s):  
Hendrik Gremmels ◽  
Martin Teraa ◽  
Joost O Fledderus ◽  
Olivier G de Jong ◽  
Yolanda van der Graaf ◽  
...  

Background: Patients with Critical Limb Ischemia (CLI) have a high risk of amputations and mortality. We hypothesize that inflammation is involved in atherosclerotic disease progression. In this study we investigate whether levels of plasma cytokines are associated with disease progression in CLI. Methods: Data were collected from a randomized controlled trial cohort investigating cell therapy for CLI (the JUVENTAS study) from 2006 to 2012. The primary outcome measures were major amputation and mortality at 6 months; secondary outcomes included Ankle/Brachial Index (ABI) and Transcutaneous O2 Pressure. Plasma was collected at inclusion in the study and a panel of cytokines consisting of GROa, HGF, LIF, SCF, SCGFb, SDF1a, TRAIL, IL-6, IL-8, FGFb, GCSF, GMCSF, IP10, MCP1, PDGFbb, RANTES, TNFa and VEGF was measured and evaluated for predictive power. Results: Data on 108 patients was collected with a follow-up of 6 months. Patients who underwent a major outcome had significantly higher levels of IL-6, IL-8 and GROa (p=0.0004, 0.006 and 0.009 resp.). Univariate Kaplan-Meier analysis showed that amputation-free survival was 94.4% in the lowest tertile, 74% in the middle tertile and 64% in the highest tertile of plasma IL-6 levels (p=0.009, Fig A). Adjustment for potential confounders in multivariate Cox proportional hazards models showed that IL-6 remained independent predictor of major outcome. The ROC of a model using Il-6 as single predictor for major outcomes is 0.73 (Fig. B) Conclusion: Plasma levels of inflammatory cytokines, in particular IL-6 are associated with disease progression in CLI and can serve as an independent predictor of amputation-free survival.


2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.


2019 ◽  
Vol 26 (3) ◽  
pp. 305-315 ◽  
Author(s):  
Michel M. P. J. Reijnen ◽  
Iris van Wijck ◽  
Thomas Zeller ◽  
Antonio Micari ◽  
Pierfrancesco Veroux ◽  
...  

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.


2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Si-wei Pan ◽  
Peng-liang Wang ◽  
Han-wei Huang ◽  
Lei Luo ◽  
Xin Wang ◽  
...  

Background. In gastric cancer, various surveillance strategies are suggested in international guidelines. The current study is intended to evaluate the current strategies and provide more personalized proposals for personalized cancer medicine. Materials and Methods. In the aggregate, 9191 patients with gastric cancer after gastrectomy from 1998 to 2009 were selected from the Surveillance, Epidemiology, and End Results database. Disease-specific survival was analyzed by Kaplan-Meier method and the log-rank test. Cox proportional hazards regression analyses were used to confirm the independent prognostic factors. As well, hazard ratio (HR) curves were used to compare the risk of death over time. Conditional survival (CS) was applied to dynamically assess the prognosis after each follow-up. Results. Comparisons from HR curves on different stages showed that earlier stages had distinctly lower HR than advanced stages. The curve of stage IIA was flat and more likely the same as that of stage I while that of stage IIB is like that of stage III with an obvious peak. After estimating CS at intervals of three months, six months, and 12 months in different periods, stages I and IIA had high levels of CS all along, while there were visible differences among CS levels of stages IIB and III. Conclusions. The frequency of follow-up for early stages, like stages I and IIA, could be every six months or longer in the first three years and annually thereafter. And those with unfavorable conditions, such as stages IIB and III, could be followed up much more frequently and sufficiently than usual.


2019 ◽  
Vol 53 (4) ◽  
pp. 310-315 ◽  
Author(s):  
O. Mironov ◽  
R. Zener ◽  
N. Eisenberg ◽  
K.T. Tan ◽  
Graham Roche-Nagle

Introduction: Current methods of evaluating adequacy of endovascular procedures are imperfect and do not always predict which patients will do well. The purpose of this study was to evaluate the role of real-time quantitative measurements of perfusion among patients with critical limb ischemia. Materials and Methods: Thirty-four patients with critical limb ischemia undergoing endovascular treatment were recruited. Perfusion Images of the foot were obtained pre and post successful angioplasty using an SPY Elite System (Novadaq Technologies, Ontario, Canada). Patients were followed for 6 months. Subsequently a logistic regression was performed to determine whether intraprocedural perfusion parameters predicted the odds of wound healing. Results: Twenty-nine patients had successful angioplasty. Median age was 69.5% ± 8.3; 75% were men and 64% were diabetic. Rutherford stages were (4%-39%, 5%-57%, 6%-4%), and the average target limb ankle–brachial index (ABI) was 0.58 (SD 2.24). There was no significant correlation between the ABI and perfusion parameters. Inflow perfusion rate correlated significantly with Rutherford stage (Spearman rho 0.398, P = .036). After successful angioplasty 39% had a decrease in inflow rate and 57% had a decreased total inflow. In all, 25 patients completed 6 months of follow-up. Resolution of rest pain and/or healing of the ischemic wound occurred in 10 (40%) patients at 1 month, 4 (16%) at 3 months, and 2 (8%) at 6 months. One patient underwent a major amputation at 2 months. Eight (32%) patients never healed or had persistent rest pain. None of the real-time perfusion variables were significant predictors of wound healing. Conclusion: Many patients experience a paradoxical decrease in perfusion following successful angioplasty suggesting perfusion may not correlate with angiographic outcome, possibly due to microemboli, microvascular disease, or vasospasm. Real-time perfusion imaging following intra-arterial infusion of indocyanine green does not predict the odds of wound healing.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nguyen Van Thai ◽  
Nguyen Tien Thinh ◽  
Thai Doan Ky ◽  
Mai Hong Bang ◽  
Dinh Truong Giang ◽  
...  

Abstract Background This retrospective analysis was undertaken to evaluate the efficiency of SIRT with Y-90 microspheres and determined prognostic factors affecting patients with unresectable HCC. Methods A total of 97 patients diagnosed with unresectable HCC who underwent SIRT with Y-90 microspheres. Patient survival was assessed using the Kaplan–Meier method, and prognostic factors affecting survival were assessed using log-rank tests and Cox proportional hazards regression. Results Among the 97 patients (90 males, mean age 60.4 ± 12.3 years) who underwent SIRT, the median clinical follow-up was 16.4 (1.8–62) months. The median overall survival (OS) was 23.9 ± 2.4 months. Tumor response according to the Modified RECIST in patients followed up beyond 6 months included a complete response (CR) to treatment in 12 patients (18.8%), partial response (PR) in 23 (35.8%), stable disease (SD) in 8 (12.5%), and progressive disease (PD) in 21 (32.8%). Factors associated with longer OS included age > 65 years, BCLC stage B, tumor size < 5 cm, tumor burden < 25%, and tumor response (CR/PR). In multivariate analysis, unilobar disease and objective tumor response (CR/PR) were predictors of longer OS. Conclusion SIRT was an effective treatment for unresectable HCC. Unilobar disease before SIRT and tumor response (CR/PR) were positive prognostic factors.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015101 ◽  
Author(s):  
Hsien-Feng Lin ◽  
Kuan-Fu Liao ◽  
Ching-Mei Chang ◽  
Cheng-Li Lin ◽  
Shih-Wei Lai

ObjectiveThis study aimed to investigate the association between splenectomy and empyema in Taiwan.MethodsA population-based cohort study was conducted using the hospitalisation dataset of the Taiwan National Health Insurance Program. A total of 13 193 subjects aged 20–84 years who were newly diagnosed with splenectomy from 2000 to 2010 were enrolled in the splenectomy group and 52 464 randomly selected subjects without splenectomy were enrolled in the non-splenectomy group. Both groups were matched by sex, age, comorbidities and the index year of undergoing splenectomy. The incidence of empyema at the end of 2011 was calculated. A multivariable Cox proportional hazards regression model was used to estimate the HR with 95% CI of empyema associated with splenectomy and other comorbidities.ResultsThe overall incidence rate of empyema was 2.56-fold higher in the splenectomy group than in the non-splenectomy group (8.85 vs 3.46 per 1000 person-years). The Kaplan-Meier analysis revealed a higher cumulative incidence of empyema in the splenectomy group than in the non-splenectomy group (6.99% vs 3.37% at the end of follow-up). After adjusting for confounding variables, the adjusted HR of empyema was 2.89 for the splenectomy group compared with that for the non-splenectomy group. Further analysis revealed that HR of empyema was 4.52 for subjects with splenectomy alone.ConclusionThe incidence rate ratio between the splenectomy and non-splenectomy groups reduced from 2.87 in the first 5 years of follow-up to 1.73 in the period following the 5 years. Future studies are required to confirm whether a longer follow-up period would further reduce this average ratio. For the splenectomy group, the overall HR of developing empyema was 2.89 after adjusting for age, sex and comorbidities, which was identified from previous literature. The risk of empyema following splenectomy remains high despite the absence of these comorbidities.


2021 ◽  
pp. 1-14 ◽  
Author(s):  
Olga Mitelman ◽  
Hoda Z. Abdel-Hamid ◽  
Barry J. Byrne ◽  
Anne M. Connolly ◽  
Peter Heydemann ◽  
...  

Background: Studies 4658-201/202 (201/202) evaluated treatment effects of eteplirsen over 4 years in patients with Duchenne muscular dystrophy and confirmed exon-51 amenable genetic mutations. Chart review Study 4658-405 (405) further followed these patients while receiving eteplirsen during usual clinical care. Objective: To compare long-term clinical outcomes of eteplirsen-treated patients from Studies 201/202/405 with those of external controls. Methods: Median total follow-up time was approximately 6 years of eteplirsen treatment. Outcomes included loss of ambulation (LOA) and percent-predicted forced vital capacity (FVC%p). Time to LOA was compared between eteplirsen-treated patients and standard of care (SOC) external controls and was measured from eteplirsen initiation in 201/202 or, in the SOC group, from the first study visit. Comparisons were conducted using univariate Kaplan-Meier analyses and log-rank tests, and multivariate Cox proportional hazards models with regression adjustment for baseline characteristics. Annual change in FVC%p was compared between eteplirsen-treated patients and natural history study patients using linear mixed models with repeated measures. Results: Data were included from all 12 patients in Studies 201/202 and the 10 patients with available data from 405. Median age at LOA was 15.16 years. Eteplirsen-treated patients experienced a statistically significant longer median time to LOA by 2.09 years (5.09 vs. 3.00 years, p < 0.01) and significantly attenuated rates of pulmonary decline vs. natural history patients (FVC%p change: –3.3 vs. –6.0 percentage points annually, p < 0.0001). Conclusions: Study 405 highlights the functional benefits of eteplirsen on ambulatory and pulmonary function outcomes up to 7 years of follow-up in comparison to external controls.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S201-S202
Author(s):  
M Kabir ◽  
K Curtius ◽  
P Kalia ◽  
I Al Bakir ◽  
C H R Choi ◽  
...  

Abstract Background Racial disparities in inflammatory bowel disease (IBD) phenotypic presentations and outcomes are recognised. However, there are conflicting data from Western population-based cohort studies as to whether racial differences in colitis-associated colorectal cancer (CRC) incidence exists. To our knowledge this is the first study to investigate the impact of ethnicity on the natural history of dysplasia in ulcerative colitis (UC). Methods We performed a retrospective multi-centre cohort study of adult patients with UC whose first low-grade dysplasia (LGD) diagnosis within the extent of colitis was made between 1 January 2001 and 30 December 2018. Only patients with at least one follow-up colonoscopy or colectomy by 30 August 2019 were included. The study end point was time to CRC or end of follow-up. Statistical differences between groups were evaluated using Mann-Whitney U tests and Chi-squared tests. Survival analyses were performed using Kaplan-Meier estimation and multivariate Cox proportional hazards models. Results 408 patients met the inclusion criteria (see Figure 1 for patient and clinical demographics). More patients from a Black or Asian (BAME) background progressed to CRC [13.4% vs. 6.4%; p=0.036] compared to their White Caucasian counterparts, despite having surveillance follow-up. Figure 2 displays Kaplan-Meier curves demonstrating the probability of remaining CRC-free after LGD diagnosis and categorised by ethnicity. BAME patients were more likely to have moderate-severe inflammatory activity on colonic biopsy within the 5 preceding years [42.0% vs. 28.9%; p=0.023], but no significant differences in medication use and a longer median time interval from LGD diagnosis to colectomy date [32 months vs. 11 months; p=0.021]. After adjusting for sex, age and UC duration at time of LGD diagnosis and presence of moderate-severe histological inflammation, being Black or Asian was a predictive factor for CRC progression on multivariate Cox proportional hazard analysis [HR 2.97 (95% CI 1.22 – 7.20); p = 0.016]. However, ethnicity was no longer predictive of CRC progression on sub-analysis of the 317 patients who did not have a colectomy during the follow-up period. Conclusion In this UK multi-centre cohort of UC surveillance patients diagnosed with LGD, delays in receiving cancer preventative colectomy may contribute to an increased CRC incidence in certain ethnic groups. Further work is required to elucidate whether these delays are related to institutional factors (e.g. inequity in the content of decision-making support given or access to healthcare) or cultural factors.


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