P5425Prognostic value of NYHA functional class in heart failure patients undergoing primary prevention implantable cardioverter defibrillator therapy

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Briongos Figuero ◽  
A Estevez ◽  
M L Perez ◽  
J B Martinez-Ferrer ◽  
E Garcia ◽  
...  

Abstract Background NYHA functional class (FC) is used for selection of heart failure (HF) patients who are candidates to primary prevention (PP) implantable cardioverter defibrillator (ICD) therapy. However, FC is subjectively estimated and concerns about its real prognostic value are still present in this setting. Purpose To compare whether mortality and arrhythmic risk are different, in a cohort of HF patients undergoing PP ICD-only implant, according to their FC. Methods All HF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD-only implant were collected from the UMBRELLA nationwide registry (2006–2015). The sample was divided into three groups: no symptoms (NYHA I), mildly symptomatic patients (NYHA II) and severely symptomatic (NYHA III) patients. Outcomes were studied as follow: all-cause death, cardiovascular mortality and arrhythmia free survival (surrogate marker of sudden cardiac death) defined as survival free of first appropriate ICD therapy delivered in ventricular fibrillation (VF) window. Arrhythmic events were collected by remote monitoring and reviewed by a committee of experts. Results Six hundred and twenty one patients were identified (61.1±11.4 years, 87.3% male). Distribution of study groups was as follow: 101 patients in NYHA I; 411 in NYHA II; and 109 in NYHA III. More symptomatic patients were older and had higher prevalence of atrial fibrillation (AF) and chronic kidney disease (CKD). Higher rates of optimal medical treatment were present among study groups (beta-blockers: 92.1%; ACEI or ARB: 86.8%; aldosterone antagonists: 60.2%). After a median follow-up of 4.2 years (IQR, 2.7–5.7 years) 126 patients died (event rate: 20.3%). All-cause mortality was higher in patients with worse FC (13.9% vs. 18.3% vs. 32.9% for NYHA I, II and III respectively; p<0.001, log-rank test). Seventy-eight out of 126 deaths were related to cardiovascular causes (overall event rate: 12.6%). Cardiovascular mortality risk was also higher in more symptomatic patients (6.9% vs. 11% vs. 23.9% for NYHA I, II and III respectively; p<0.001, log-rank test). One hundred and seventeen patients received afirst appropriate ICD therapy (19.4%). Arrhythmia free survival was not different among study groups (20.8% vs. 18.7% vs. 20.8% for NYHA I, II and III, respectively; p=0.495, log-rank test). Cumulative incidence curves for the three outcomes are shown in Figure 1. After multivariate analysis, worse NYHA class independently predicted cardiovascular mortality but not all-cause death. Moreover, diabetes, AF and CKD strongly predicted both all-cause and cardiovascular mortality. Figure 1 Conclusions In HF patients, prophylactic ICD seems to be useful in preventing death due to life threatening arrhythmias, regardless of the baseline FC. Nevertheless, the combination of NYHA class with other comorbidities may be useful to select those ICD candidates who obtain less survival benefit.

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
ACJ Van Der Lingen ◽  
MT Rijnierse ◽  
AM Hooghiemstra ◽  
S Elshout ◽  
VP Van Halm ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Psychological distress, such as symptoms of anxiety and depression, are frequently present in patients receiving an implantable cardioverter defibrillator (ICD) and they are associated with adverse outcomes. Multiple pathophysiological mechanisms may explain the link between psychological distress and cardiovascular disease, such as autonomic dysfunction, neuro-endocrine alterations and chronic inflammation. Purpose The present study aims to examine the prevalence of psychological distress at time of ICD implantation and evaluates the complex interplay between psychological distress, autonomic function, neuro-endocrine alterations and inflammatory status in ICD patients. Methods We conducted a prospective study that included ICD patients receiving an ICD for primary and secondary prevention of sudden cardiac death. Prior to implantation, patients underwent extensive psychological evaluation, including validated questionnaires for depression, anxiety and personality traits. Cardiac status was evaluated by left ventricular ejection fraction (LVEF) assessment, New York Heart Association (NYHA) functional class evaluation, 6-minute walk test (6MWT), and 24-hour Holter monitoring for heart rate variability (HRV). Thyroid function, catecholamine levels and inflammatory status were also evaluated. Results Of 178 patients included (age 64 ± 12, 79% male, LVEF 35 ± 13%), 35% had symptoms of depression and 32% had symptoms of anxiety. Symptoms of depression and anxiety increased significantly with higher NYHA functional class (P &lt; 0.001). Depressive symptoms were associated with a reduced 6MWT (411 ± 128 m versus 488 ± 89 m, P &lt; 0.001), lower LVEF (29 ± 9% versus 36 ± 13%, P = 0.03), higher heart rate (74 ± 13 bpm versus 70 ± 13 bpm, P = 0.02), higher thyroid stimulating hormone levels (1.8 [1.3-2.8] mU/L versus 1.5 [1.0-2.2] mU/L, P = 0.04) and multiple HRV parameters, indicating reduced HRV. Anxiety symptoms were only associated with a reduced 6MWT (433 ± 112 m versus 477 ± 102, P = 0.02). Symptoms of depression or anxiety were not correlated with c-reactive protein, NT-proBNP or catecholamine levels. Conclusion A substantial part of ICD patients has symptoms of depression and anxiety at time of ICD implantation. Depression was correlated with a higher NYHA class, reduced exercise capacity,  reduced LV-function and alterations in autonomic function, suggesting a biological link between depression and cardiac status. Whether depression and anxiety leads to an increase in ventricular arrhythmias will be determined during further follow-up. Abstract Figure. NYHA class and psychological distress


2017 ◽  
Vol 8 (4) ◽  
pp. 487-494 ◽  
Author(s):  
Sachin Talwar ◽  
Sukhjeet Singh ◽  
Vishnubhatla Sreenivas ◽  
Kulwant Singh Kapoor ◽  
Saurabh Kumar Gupta ◽  
...  

Objectives: Studies on older patients undergoing primary Fontan operation (FO) are limited, with conflicting results. We review our experience with these patients beyond the first decade of life. Patients and Methods: Between January 2000 and December 2014, a total of 105 patients ≥10 years of age (mean 15.6 ± 4.9, range 10-31, median 15 years) underwent primary FO without a prior bidirectional superior cavopulmonary anastomosis (Bidirectional Glenn [BDG]). Mean preoperative New York Heart Association (NYHA) class was 2.2 ± 0.57. Results: Operative procedure was extra-cardiac FO in 62 patients (8 were fenestrated). Forty-three had a lateral tunnel FO (26 were fenestrated). There were 11 (10.5%) early deaths. Fourteen of the 94 early survivors experienced prolonged pleural effusions, 7 had arrhythmias, and 2 had thromboembolic events. Two patients underwent Fontan takedown. On univariate analysis, NYHA functional class III, mean pulmonary artery (PA) pressure ≥15 mm Hg, hematocrit ≥60%, preoperative ventricular dysfunction, and atrioventricular valve regurgitation (AVVR) were associated with early mortality. Median follow-up was 78 (mean 88.9 ± 6.3) months. In 94 survivors, 6 (6.4%) late deaths were encountered. At last follow-up, 81 (86.2%) survivors were in NYHA class I. Actuarial survival was 84.7% ± 3.7% at 5, 10, and 15 years. Conclusion: Carefully selected adolescents and young adults can safely undergo the primary FO. However, persistent pleural effusions, arrhythmias, thromboembolic events, and the need for reoperation mandate regular follow-up in such patients. Preoperative NYHA functional class III, mean PA pressure ≧ 15 mm Hg, hematocrit ≥ 60%, ventricular dysfunction, and AVVR were associated with early mortality, suggesting that primary FO should be avoided in such patients.


2001 ◽  
Vol 19 (2) ◽  
pp. 425-431 ◽  
Author(s):  
Giorgio Pizzocaro ◽  
Luigi Piva ◽  
Maria Colavita ◽  
Sonia Ferri ◽  
Raffaella Artusi ◽  
...  

PURPOSE: Because interferon gave promising results in the management of metastatic renal cell carcinoma in the 1980s, a multicentric randomized controlled trial was planned to compare adjuvant recombinant interferon alfa-2b (rIFNα2b) with observation after radical nephrectomy in patients with Robson stages II and III renal cell carcinoma. Overall and event-free survival were to be evaluated together with prognostic factors. PATIENTS AND METHODS: Overall and event-free survival curves for 247 patients (124 controls and 123 treated) were estimated by the Kaplan-Meier method and compared using the log-rank test. Cox’s multiple regression models were adopted to perform a joint analysis of treatment and prognostic factors. RESULTS: The 5-year overall and event-free survival probabilities were 0.665 and 0.671, respectively, for controls and 0.660 and 0.567, respectively, for the treated group; the differences were not statistically significant (2P = .861 for overall and 2P = .107 for event-free survival with the log-rank test). Regarding prognostic factors, only grade, pT, and pN demonstrated a significant prognostic role. First-order interactions of treatment with pT and pN category were investigated; a significant interaction was found between pN and treatment. A harmful effect of rIFNα2b in the 97 treated pN0 patients and a protective effect in the 13 treated pN2/pN3 patients were statistically significant. CONCLUSION: Adjuvant rIFNα2b is not indicated after radical nephrectomy for renal cell carcinoma. The protective effect in the small group of pN2/pN3 patients requires further investigation.


2019 ◽  
Vol 29 (9) ◽  
pp. 1355-1360 ◽  
Author(s):  
Giorgio Bogani ◽  
Daniele Vinti ◽  
Ferdinando Murgia ◽  
Valentina Chiappa ◽  
Umberto Leone Roberti Maggiore ◽  
...  

ObjectiveNodal involvement is one of the most important prognostic factors in cervical cancer patients. We aimed to assess the prognostic role in relation to the burden of nodal disease in stage IIICp cervical cancer.MethodsData on all consecutive patients diagnosed with cervical cancer undergoing primary surgery (radical hysterectomy plus lymphadenectomy) or neoadjuvant chemotherapy followed by radical hysterectomy plus lymphadenectomy, between January 1980 and December 2017, were collected in a dedicated database. Exclusion criteria were: (1) consent withdrawal; (2) synchronous malignancies (within 5 years). Survival outcomes were assessed using Kaplan-Meier and Cox models.ResultsOverall, 177 (14.1%) of 1257 patients with cervical cancer were diagnosed with positive lymph nodes. After a median follow-up of 58 (range 4–175) months, 66 (37.3%) and 37 (20.9%) patients developed recurrent disease and died of disease, respectively. Via multivariate analysis, positive para-aortic nodes (HR 2.62, 95% CI 1.12 to 6.11; p=0.025) and the number of positive nodes (HR 1.06, 95% CI 1.02 to 1.11; p=0.002) correlated with worse disease-free survival. Furthermore, the number of positive nodes (HR 1.06, 95% CI 1.01 to 1.12; p=0.021) correlated with worse overall survival. Number of positive nodes (1, 2 or ≥3) strongly correlated with both disease-free survival (p<0.001, log-rank test) and overall survival (p=0.001, log-rank test). Focusing on patients receiving adjuvant radiation and chemotherapy, the number of positive lymph nodes was associated with response to treatment (p<0.001). Median disease-free survival was 100, 42, and 12 months for patients with one, two, or three or more positive lymph node(s), respectively (p<0.001, log-rank test).ConclusionsIn stage IIICp cervical cancer, adjuvant radiation and chemotherapy provides adequate overall survival in patients diagnosed with only one metastatic node, while survival outcomes are poor in patients with two or more metastatic nodes. This highlights the need for innovative treatments in patients with a high burden of lymphatic disease.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 261-261 ◽  
Author(s):  
Mats Brune ◽  
Sylvie Castaigne ◽  
John Catalano ◽  
Kurt Gehlsen ◽  
Wolf-Karsten Hofmann ◽  
...  

Abstract Background: Histamine dihydrochloride (HDC) potentiates immune-based therapies by protecting pivotal anti-neoplastic lymphocytes from phagocyte-induced suppression. Previous results in AML indicated that post-consolidation treatment with HDC and low-dose interleukin-2 (IL-2) is safe and feasible, and that the combination may prolong leukemia-free survival (LFS). Aims: The primary objective was to determine if post-consolidation treatment with IL-2 and HDC could improve LFS for AML pts in complete remission (CR). Secondary objectives included overall survival (OS), LFS in CR1 and CR>1 subgroups, and safety. Methods: This international, randomized, open-label, phase III study was conducted at 92 centers. From June 1998 to October 2000, 320 AML pts [148 females, 172 males, median age 57 (18–84) yrs] were enrolled in CR after completion of standard consolidation therapy. Pts were stratified by CR1 or CR>1 and randomized to either treatment (n=160) or no treatment (control, n=160) arms. The treatment was self-administered at home and included 10 cycles of low-dose IL-2 (aldesleukin, Chiron Corp) 18 000 U/kg, sc bid plus HDC (Maxim Pharmaceuticals) 0.5 mg sc bid. For cycles 1–3, each cycle comprised 3 wks of treatment and 3 wks of rest, whereas in cycles 4–10 the rest periods were 6 wks. The study arms were well balanced with respect to age, sex, karyotype-based risk, time from CR to inclusion and frequency of secondary leukemia. Pts were followed for relapse and survival using an identical assessment schedule until 3 yrs after last enrollment. All efficacy analyses were intent-to-treat. Results: The median follow-up of living pts was 46 months. For the primary endpoint, treatment with HDC/IL-2 increased LFS in the entire study population (CR1/CR>1, n=320, p=0.026 stratified log-rank test). There was no significant difference in OS (p=0.33). In the analysis of pre-stratified subgroups, one pt was excluded. For CR1 pts (n=262), HDC/IL-2 significantly improved LFS (p=0.011, log-rank test), with 3-year Kaplan-Meier estimates of 26% (control group) and 40% (treatment group). The difference in OS did not reach significance (p=0.16). For CR>1 pts (n=57), outcome was not affected by treatment. Side effects attributable to IL-2 included fever and local inflammatory reactions. HDC treatment induced symptoms of transient vasodilatation. Serious adverse events occurred in approximately 20% of pts in both groups. There were no treatment-related deaths. Conclusions: For AML pts in CR, post-consolidation therapy with HDC and IL-2 was safe and significantly improved LFS compared to standard of care. The benefit observed of HDC/IL-2 treatment appears to be explained by a reduction of relapses in CR1 pts.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5358-5358
Author(s):  
Abrahão Elias Hallack Neto ◽  
Graziela Toledo Costa Mayrink ◽  
Luciano J. Costa ◽  
Kelli Borges dos Santos

Abstract Introduction: The association between classical Hodgkin's Lymphoma (cHL) and tumor Epstein-Barr virus (EBV) status is well established. However, the presence of EBV within Hodgkin/Reed-Sternberg (HRS) cells and its prognosis remains controversial, with conflicting findings from studies of various regions of the world. It is considered essential to deepen the understanding of the pathogenic role of EBV in cHL and its impact in prognosis. Methods: We assessed the correlation between EBV presence in HRS and outcomes in a cohort of Brazilian patients with cHL. EBV positivity was determined by in situ hybridization (ISH) for EBV-encoded RNA (EBER) and immunohistochemistry (IMH) for viral latent membrane protein (LMP-1). All cases were histologically confirmed by an expert hematopathologist who also performed the assays for EBV identification. We examined the prognostic impact of EBV status in 29 patients with cHL. The prognostic factors by IPS (International Prognostic Score) for patients with advanced stage and the risk factors by GHSG (German Hodgkin Study Group) for patients with limited stage were correlated with EBV status tumor cells. For associations between the presence of EBV and other categorical variables, we applied Chi-square or Fisher's exact tests. For describe the effect size (ES) measures for chi-square, we used Cramér's V (V) and odds ratios (OR) with the respective 95% Confidence Intervals (CIs). To evaluate the correlation between all methods of identification of EBV status and among evaluators in histological classification, we applied the Kappa test (K), which measures the degree of agreement these assessments. Differences in OS (overall survival) and EFS (event-free survival) Kaplan-Meier survival curves between EBV-positive and EBV-negative patients were compared statistically using the log-rank test. To evaluate the impact of EBV status on event-free survival controlling for prognostic factors and unfavorable risks, we applied Cox proportional hazards regression to determine hazards ratios (HR) and associated the respective 95% CIs. Multivariate analyses included variables significant at p ≤ 0.15 in univariate models. Results: The mean age at diagnosis was 33 years. Sixty-five percent of the patients had the Nodular Sclerosis histologic subtype and 62,1% had Ann Arbor stage I or II disease at diagnosis. According to GHSG, 88,3% of early-stage patients were classified with unfavorable risk (at least one risk factor) at diagnosis. Compared to advanced-stage patients, 81,9% were considered with favorable IPS (< 4 prognostic factors) at diagnosis. HRS cells were EBV-positive in 37.9% of cases. EBV-positive cHL cases were more frequent in patients ≥ 45 years (71,4% vs. 27,3%, p =0,07). Mixed cellularity (MC) histology subtype was more common in EBV-related tumor cells (p= 0,02) and its effect-size index was medium. The correlation between all methods of identification of EBV status was 96,5% (p< 0,001; K=0.93). The correlation among evaluators in histological classification was 89,6% (p< 0,001; K=0.79). In univariate analysis, age, stage, histologic subtype, nodal involvement, extranodal disease, sex, bulky disease, laboratory data were not associated with adverse EFS (p>0,05). EBV-positive HL seemed to have better EFS than EBV-negative HL (log-rank test, p = 0,07). Cox proportional hazards model confirmed that EBV-positive tumor status and prognosis factors did not impact HL outcome. Conclusions: Despite EBV status in HRS cells not being associated with adverse prognostic factors and not influencing the overall and event-free survivals, the presence of EBV was linked to MC subtype, showing possible implication in histological subtype and worse prognosis. Disclosures Costa: Sanofi: Honoraria, Research Funding.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10574-10574
Author(s):  
Jonathan Riess ◽  
Millie Snigdha Das ◽  
Paul Henry Frankel ◽  
Erich Schwartz ◽  
Robyn Bennis ◽  
...  

10574 Background: Biomarkers predicting efficacy of chemotherapy are highly desirable. Fiber array scanning technology (FAST) is a novel method of detecting circulating tumor cells (CTCs) that does not employ an EpCam enrichment step. The purpose of this study was to use FAST to evaluate ERCC1 expression on CTCs to determine whether ERCC1 expression correlates with progression-free survival (PFS) in patients who received platinum-based chemotherapy for metastatic non-small-cell lung cancer (NSCLC). Methods: Peripheral blood from one hundred enrolled patients with metastatic NSCLC was collected by two institutions (Stanford Cancer Institute and Billings Clinic Cancer Center). FAST was used to identify individual CTCs on immunofluorescence by pancytokeratin antibodies. Nuclear localization of ERCC1 expression by immunofluorescence was quantified on individual CTCs. Total patient ERCC1 levels were determined from the average expression of all the CTCs in each patient sample. Fifty-seven of the one hundred patients enrolled received platinum chemotherapy. Seventeen of those fifty-seven patients (30%) had ≥ 2 evaluable intact CTCs and were analyzed retrospectively. Linear regression (F-test) was used to evaluate the correlation between ERCC1 expression and PFS. Kaplan-Meier survival analysis (log-rank test) was used to compare PFS in patients with CTCs with no detectable ERCC1 expression versus patients with CTCs that expressed any level of ERCC1. Results: PFS decreased with increasing ERCC1 expression (P<0.04 F-test, linear regression). Lack of ERCC1 expression was associated with longer PFS (266 days vs. 172 days, log-rank test P<0.02). The difference in survival was statistically significant with a hazard ratio of 4.20 (95% CI 1.25-14.1, p<0.02, log-rank test). Conclusions: In this small study, using FAST to isolate CTCs, low expression of ERCC1 on evaluable CTCs correlated with increased PFS in patients with metastatic NSCLC who received platinum chemotherapy. A larger, prospective study to validate these retrospective results is warranted.


2021 ◽  
Vol 11 (8) ◽  
pp. 787
Author(s):  
Ronald Wihal Oei ◽  
Yingchen Lyu ◽  
Lulu Ye ◽  
Fangfang Kong ◽  
Chengrun Du ◽  
...  

Background: The Cox proportional hazards (CPH) model is the most commonly used statistical method for nasopharyngeal carcinoma (NPC) prognostication. Recently, machine learning (ML) models are increasingly adopted for this purpose. However, only a few studies have compared the performances between CPH and ML models. This study aimed at comparing CPH with two state-of-the-art ML algorithms, namely, conditional survival forest (CSF) and DeepSurv for disease progression prediction in NPC. Methods: From January 2010 to March 2013, 412 eligible NPC patients were reviewed. The entire dataset was split into training cohort and testing cohort in a ratio of 90%:10%. Ten features from patient-related, disease-related, and treatment-related data were used to train the models for progression-free survival (PFS) prediction. The model performance was compared using the concordance index (c-index), Brier score, and log-rank test based on the risk stratification results. Results: DeepSurv (c-index = 0.68, Brier score = 0.13, log-rank test p = 0.02) achieved the best performance compared to CSF (c-index = 0.63, Brier score = 0.14, log-rank test p = 0.38) and CPH (c-index = 0.57, Brier score = 0.15, log-rank test p = 0.81). Conclusions: Both CSF and DeepSurv outperformed CPH in our relatively small dataset. ML-based survival prediction may guide physicians in choosing the most suitable treatment strategy for NPC patients.


2018 ◽  
Vol 108 (1) ◽  
pp. 23-29
Author(s):  
J. Rhu ◽  
G. S. Choi ◽  
J. M. Kim ◽  
C. H. D. Kwon ◽  
S. J. Kim ◽  
...  

Background and Aims: This study was designed to analyze the feasibility of laparoscopic right posterior sectionectomy compared to laparoscopic right hemihepatectomy in patients with hepatocellular carcinoma located in the posterior segments. Material and Methods: The study included patients who underwent either laparoscopic right posterior sectionectomy or laparoscopic right hemihepatectomy for hepatocellular carcinoma located in segment 6 or 7 from January 2009 to December 2016 at Samsung Medical Center. After 1:1 propensity score matching, patient baseline characteristics and operative and postoperative outcomes were compared between the two groups. Disease-free survival and overall survival were compared using Kaplan–Meier log-rank test. Results: Among 61 patients with laparoscopic right posterior sectionectomy and 37 patients with laparoscopic right hemihepatectomy, 30 patients from each group were analyzed after propensity score matching. After matching, baseline characteristics of the two groups were similar including tumor size (3.4 ± 1.2 cm in laparoscopic right posterior sectionectomy vs 3.7 ± 2.1 cm in laparoscopic right hemihepatectomy, P = 0.483); differences were significant before matching (3.1 ± 1.3 cm in laparoscopic right posterior sectionectomy vs 4.3 ± 2.7 cm in laparoscopic right hemihepatectomy, P = 0.035). No significant differences were observed in operative and postoperative data except for free margin size (1.04 ± 0.71 cm in laparoscopic right posterior sectionectomy vs 2.95 ± 1.75 cm in laparoscopic right hemihepatectomy, P < 0.001). Disease-free survival (5-year survival: 38.0% in laparoscopic right posterior sectionectomy vs 47.0% in laparoscopic right hemihepatectomy, P = 0.510) and overall survival (5-year survival: 92.7% in laparoscopic right posterior sectionectomy vs 89.6% in laparoscopic right hemihepatectomy, P = 0.593) did not differ between the groups based on Kaplan–Meier log-rank test. Conclusion: For hepatocellular carcinoma in the posterior segments, laparoscopic right posterior sectionectomy was feasible compared to laparoscopic right hemihepatectomy when performed by experienced laparoscopic surgeons.


2021 ◽  
Author(s):  
Denis Skrypnik ◽  
Sultan Butaev ◽  
Artur Arakelyan ◽  
Coral Falco ◽  
Roman Vinogradov ◽  
...  

Abstract Background To investigate the influence of duration of bilateral acute limb ischemia (BALI) due to acute aortic occlusion (AAO) on the amputation-free survival in the early- and mid-term follow-ups (FUs). Methods A retrospective analysis of patients treated due to primary occlusion of the infrarenal aorta and BALI was performed. Univariate analysis was used to determine the risk factors of adverse outcomes and to compare the duration of BALI between amputation-free survival and the non-amputation-free survival group. The log-rank test was used to compare amputation-free survival in the FU. Results The data of 16 patients, with a mean age of 70 ± 11 years, were analyzed. Predominantly females (56.3%, 9/16) were included in the study. The median FU was 32 months (range, 26–108 months). The mean ischemia time was significantly shorter in the amputation-free survival group compared to that in the non-amputation-free survival group (7.4 ± 3.5 hours vs. 22.4 ± 16.3 hours, p = .01). The time frame for successful bilateral lower limb revascularization was at <11h (p= .001, Cramer’s V= .71). Amputation-free survival in the early- and mid-term FUs was improved, if the duration of BALI was < 11 hours (log rank test, p = .006). Conclusions The duration of BALI due to AAO < 11 hours was shown to be associated with improved amputation-free survival in the early- and mid-term FUs. Trial registration: The study was retrospectively registered in TCTR international registry (identification no. TCTR20210609002).


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