Early and Long-Term Outcomes of Endovascular Aortic Repair in Young and Low Surgical Risk Patients in the Global Registry for Endovascular Aortic Treatment

2021 ◽  
pp. 152660282110457
Author(s):  
Michele Piazza ◽  
Francesco Squizzato ◽  
Velipekka Suominen ◽  
Franco Grego ◽  
Santi Trimarchi ◽  
...  
Keyword(s):  
High Risk ◽  
Young Patients ◽  
Low Risk ◽  
Long Term Outcomes ◽  
Surgical Risk ◽  
High Risk Patients ◽  
Risk Patients ◽  
Global Registry ◽  
Related Mortality

Purpose: To investigate early- and long-term outcomes of endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) in young and low surgical risk patients. Methods: The global registry for endovascular aortic treatment (GREAT) was queried for all patients with AAA undergoing standard EVAR; patients were excluded if had previous AAA repair or underwent concomitant procedures. Young patients were defined if age <60; surgical risk was assessed through the validated Medicare perioperative risk score (MPRS) based on age, sex, renal function, heart failure, and peripheral vascular disease. Patients were classified as low (MPRS<3), average (MPRS 3–11), or high (MPRS>11) risk. Young versus older patients and low-risk versus average/high-risk patients were compared. The primary endpoints were early (30 days) major adverse events (MAEs), 5-year freedom from overall mortality, aortic-related mortality, and freedom from device-related reinterventions. Time-to-event endpoints were calculated by Kaplan–Meier curves. Results: Of 3217 included patients, 182 (6%) were <60 years old, 956 (30%) had a low surgical risk, 1561 (49%) an average risk, 700 (22%) a high risk. Young patients had a less angulated proximal neck (27.2±18.4° vs 30.9±21.5°; p=0.05); in low-risk compared to average/high-risk patients, a longer neck length (3±1.8 vs 2.8±1.4 cm; p=0.01) and lower neck angulation (29.7±21.8° vs 33.2±22.2°; p=0.01) were present. Young age alone had no significant impact on early mortality (0% vs 0.6%; p=0.62.) and MAEs (3.9% vs 6.1%; p=0.20), while these were significantly lower in low-risk compared to average/high-risk patients (early mortality: 0.1% vs 0.7%, p=0.04; MAEs: 4.1% vs 6.7%, p=0.005). At 5 years, overall survival was significantly higher in young (88% vs 76%; p<0.001) and lower-risk (77% vs 54%; p<0.001) patients; low-risk patients also had significantly decreased aortic-related mortality (0% vs 2%; p=0.04) and reintervention rates (6% vs 11%; p=0.007). There were no statistically significant differences in mortality (0% vs 2%; p=0.42) and reintervention rate (10% vs 10%; p=1.00) between young and older patients. Conclusion: In this real-world registry, EVAR was more often offered in cases with suitable anatomy in young and low-risk patients. Low operative risk, rather than young age alone, predicted excellent early outcomes and low 5-year mortality, aortic-related mortality, and reintervention rates.

Laparoscopic Sleeve Gastrectomy for High-Risk Patients in a Monocentric Series: Long-Term Outcomes and Predictors of Success

2019 ◽  
Vol 29 (11) ◽  
pp. 3629-3637 ◽  
Author(s):  
Aurora Gil–Rendo ◽  
José Ramón Muñoz-Rodríguez ◽  
Francisco Domper Bardají ◽  
Bruno Menchén Trujillo ◽  
Fernando Martínez-de Paz ◽  
...  
Keyword(s):  
Sleeve Gastrectomy ◽  
High Risk ◽  
Laparoscopic Sleeve Gastrectomy ◽  
Predictors Of Success ◽  
Long Term Outcomes ◽  
High Risk Patients ◽  
Risk Patients

Long-term outcomes of endovascular aneurysm repair for challenging aortic necks using the Talent endograft

Vascular ◽  
2011 ◽  
Vol 19 (3) ◽  
pp. 132-140 ◽  
Author(s):  
Jeffrey Jim ◽  
Brian G Rubin ◽  
Patrick J Geraghty ◽  
Luis A Sanchez
Keyword(s):  
High Risk ◽  
Risk Group ◽  
Endovascular Aneurysm Repair ◽  
High Risk Group ◽  
Low Risk ◽  
Long Term Results ◽  
Long Term Outcomes ◽  
Aneurysm Repair ◽  
Related Mortality

The aim of the present paper is to evaluate the long-term outcomes of endovascular aneurysm repair (EVAR) for challenging aortic necks. Subgroup analyses were performed on 156 patients from the prospective multicenter Talent eLPS (enhanced Low Profile Stent Graft System) trial. Patients with high-risk aortic necks (length < 15 mm or diameter ≥28 mm) were compared with the remaining patients. Patients with high-risk ( n = 86) and low-risk necks ( n = 70) had similar age and gender distribution. Despite similar prevalences of co-morbidities, the high-risk group had higher Society for Vascular Surgery scores. The high-risk group also had larger maximum aneurysm diameters (56.6 versus 53.0 mm, P < 0.02). There were lower freedoms from major adverse events (MAEs) for the high-risk group at 30 days (84.9 versus 95.7%; P < 0.04) and 365 days (73.4 versus 89.2%; P = 0.02). Effectiveness endpoints at 12 m showed no significant differences. Freedom from all-cause mortality at 30 days (96.5 versus 100%) and aneurysm-related mortality at 365 days (96.0 versus 100%) were similar. At five years, there were no differences in endoleaks or change in aneurysm diameter. All migrations occurred in the high-risk group. The five-year freedom from aneurysm-related mortality for the high- and low-risk groups was 93.2 and 100%, respectively. In conclusion, despite a higher rate of MAEs within the first year and higher migration rates at five years, EVAR in aneurysms with challenging aortic necks can be treated with acceptable long-term results.

scholarly journals Strong Predictors of Chromosomal Aberrations and Myeloid Neoplasia Following Immunosuppression Therapy for Severe Aplastic Anemia: A Retrospective Cohort Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 601-601
Author(s):  
Emma M. Groarke ◽  
Bhavisha A. Patel ◽  
Ruba Shalhoub ◽  
Fernanda Gutierrez-Rodrigues ◽  
Parth Desai ◽  
...  
Keyword(s):  
High Risk ◽  
Clonal Evolution ◽  
Low Risk ◽  
Competing Risk ◽  
Long Term Outcomes ◽  
Risk Patients ◽  
Risk Evolution ◽  
Pre Treatment ◽  
Myeloid Neoplasia

Abstract Introduction: Immune aplastic anemia (AA) is effectively treated with either immunosuppressive treatment (IST) or allogeneic hematopoietic stem cell transplant (HSCT). Clonal evolution remains the most feared long-term complication after IST. We investigated predictor factors, genetic characteristics, and long-term outcomes of patients who developed either secondary myeloid neoplasia or isolated chromosomal abnormalities without morphologic dysplasia after immunosuppression. Methods: All patients with severe AA treated at the NIH Clinical Center with IST from 1989-2020 who underwent clonal evolution were categorized as "high-risk" (overt myeloid neoplasia, or isolated chromosome 7 abnormality / complex cytogenetics) or "low-risk" (isolated chromosome abnormalities without overt myeloid neoplasia or dysplasia; isolated chromosome 7 abnormality or complex cytogenetics were characterized as high-risk). Univariable analysis was performed using the Fine-Gray competing risk regression model using death as a competing risk to determine predictors of clonal evolution. Classification and regression tree analysis of time to clonal evolution was performed on continuous baseline variables to partition the data based on the best categorical cutoff. Long term outcomes assessed included overall survival (OS) and HSCT. Error corrected next-generation sequencing (ECS) was used to assess for pathogenic somatic variants in known myeloid cancer genes in clonal evolvers both at time of evolution and in serial samples prior when available. Results: Of 659 patients with severe AA included in this study, 95 developed clonal evolution: 59 high-risk and 36 low-risk. Age &gt;48 years at diagnosis and pre-treatment ANC &gt;0.87x10 9/L were strong predictors of high-risk clonal evolution. High-risk clonal evolution was increased in patients aged &gt;48 years, with cumulative incidence (CI) of 13.9% by 5 years compared to patients aged &lt;48 years of 3.8% by 5 years (p&lt;0.001). Baseline ANC &gt;0.87 x10 9/L (independent of age) predicted an even higher risk of evolution; CI for high-risk evolution was 17% by 5 years (p&lt;0.001). Combined high ANC and older age (&gt;48 years) were prognostic of the greatest risk of high-risk evolution, with a hazard ratio (HR) of 5.51; conversely, ANC &lt;0.87 x10 9/L and age &lt;48 years was protective, with HR 0.32. High-risk clonal evolution was not significantly increased by use of eltrombopag with IST versus IST only (p=0.3), but there was an increase when all clonal evolution was considered (p=0.02). Overall survival in high-risk evolution was 35% at 5 years and in low-risk evolution was 84% (p&lt;0.001). Patients with high-risk evolution who underwent HSCT (n=26) had better OS compared to those treated with chemotherapy or supportive care (p=0.005). RUNX1 (13 variants in 8 [35%] patients) and ASXL1 (13 variants in 10 [43%] patients) were the most frequent mutated genes at time of clonal evolution in high-risk patients, and BCOR/L1 (14 variants in 8 [32%] patients) was the most frequently mutated in the low-risk group. Longitudinal data were available in five high-risk and eight low-risk patients. Three of five high-risk patients had acquisition or expansion of RUNX1 clones at evolution. Small RUNX1 variants were present in two patients as early as three years prior to high-risk evolution. Splicing factor genes and RUNX1 somatic variants were detected exclusively in the high-risk group; DNMT3A, BCOR/L1 and ASXL1 gene mutations were present in both groups. Conclusion: Age and pre-treatment ANC strongly predict high-risk clonal evolution in AA patients after IST and may be used determine at-risk patients for long term follow-up. Outcomes in patients with low-risk evolution are favorable but poor in high-risk evolution without HSCT. The clonal landscape differs between high-risk and low-risk evolution; MDS-associated genetic mutations are enriched in high-risk evolution, in particular RUNX1. Further study of the role of RUNX1 in high-risk clonal evolvers may give insight into leukemogenesis in AA. Figure 1: Cumulative incidence (CI) of clonal evolution since immunosuppression with death treated as competing risk. (A) CI for development of all clonal evolution in patients &gt;37 years (B) and high-risk clonal evolution in patients &gt;48 years (C) CI for development of all clonal evolution when baseline ANC &gt;0.87x10 9/L and (D) high-risk clonal evolution when baseline ANC &gt;0.87x10 9/L. Figure 1 Figure 1. Disclosures Young: Novartis: Research Funding.

Should adult medulloblastoma patients at low risk receive adjuvant chemotherapy? Long-term results of a prospective study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2018-2018
Author(s):  
E. Franceschi ◽  
A. Tosoni ◽  
M. Ermani ◽  
V. Blatt ◽  
P. Amistà ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Survival Rates ◽  
Low Risk ◽  
Long Term Results ◽  
High Risk Patients ◽  
Significant Difference ◽  
Risk Patients

2018 Background: Due to the rarity of medulloblastoma (MB) in adults, the few studies available on this condition are retrospective, and the follow-up tends to be short. Furthermore, the different therapeutic strategies used in these patients makes it difficult to assess survival rates and prognostic factors. Methods: Between January 1989 and February 2001, a prospective phase II trial was performed to evaluate the efficacy of treatment for adults with medulloblastoma. Patients were completely staged with a neuroradiological examination of the brain and neuraxis and by CSF cytology, according to Chang’s staging system. Low risk patients received radiotherapy alone, while high risk patients were given 2 cycles of upfront chemotherapy followed by radiotherapy and adjuvant chemotherapy. The results of the preliminary analysis of this study at a median follow-up of 3.7 years are reported elsewhere. The present papers reports on the long- term results of the same trial. Results: After a median follow up of 7.6 years, among a total of 36 enrolled adults with medulloblastoma, overall progression free survival (PFS) and overall survival (OS) at 5 years were 72% (range 59% to 84%) and 75% (62% to 91%), respectively. No difference was found between low and high risk patients in terms of PFS and OS at 5 years: in low-risk patients the 5-year PFS was 80% (range, 59–100%) and the 5-year OS, 80% (range, 58 - 100%); in high-risk patients the 5-year PFS was 69% (range, 54 -89%) and the 5-year OS, 73% (range, 58 - 92%). Conclusions: A long-term follow-up is essential to evaluate the real impact of treatments in adult patients with MB. Since there is no significant difference between low-risk and high-risk patients for PFS and OS, the use of chemotherapy is also questionable in low-risk patients. No significant financial relationships to disclose.

Risk-Adapted, MRD-Refined Therapeutic Approach for the Treatment of Acute Myeloid Leukemia: From a Single Center Experience to the Cooperative Gimema Protocol AML1310

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1422-1422
Author(s):  
Adriano Venditti ◽  
Francesco Buccisano ◽  
Luca Maurillo ◽  
Maria Ilaria Del Principe ◽  
Paola Fazi ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
High Risk ◽  
Myeloid Leukemia ◽  
Young Patients ◽  
High Risk Patients ◽  
Risk Patients ◽  
Related Donor ◽  
Family Donor ◽  
Acute Myeloid

Abstract Abstract 1422 The outcome of young adult (< 60 years) with acute myeloid leukemia (AML) still remains unsatisfactory. In fact, in spite of complete remission (CR) rates ranging from 60 to 80%, only 30–40% of young patients will be long-term survivors. Advances in biologic characterization of AMLs are expected to enhance a more realistic assessment of disease aggressiveness so that therapies will be delivered in the context of a stratified approach. Cytogenetic/genetic profile is the most relevant prognostic factor established at diagnosis. Nevertheless, it is well recognized that it cannot always reliably predict outcome in individual patients. Minimal residual disease (MRD) detection promises to be an efficient tool to establish on an individual basis the leukemia's susceptibility to treatment and guide delivery of risk-tailored therapies. A further element underlying the dismal long-term outcome of young patients with AML pertains the chance to get access to allogeneic stem cell transplantation (ASCT) when carrying high-risk features. The extensive use of ASCT option is precluded by the paucity of full matched family donor (25–30%). These premises are the background to the risk-adapted approach, developed at the Institute of Hematology, University Tor Vergata, based on the following strategies: 1) combination of upfront cytogenetics/genetics and MRD status (< or ≥3.5×10−4 residual leukemic cells as counted by flow cytometry) at the end of consolidation to determine risk assignment; 2) once a given patients was categorized as high-risk (due to the expression of an unfavorable karyotype, FLT3-ITD positivity or post-consolidation positive MRD status) and therefore selected as candidate for ASCT, the transplant procedure was given whatever the source of stem cells. The present analysis includes 30 high-risk patients treated according to this design (prospective cohort = PC) and, for comparative purposes, 55 consecutive high-risk patients treated in an “old fashion” design based on donor availability (retrospective cohort = RC). The PC included 4 patients with favorable-karyotype (FK) and a MRD+ status, 12 with intermediate kayotype (IK) and a MRD+ status, 5 with unfavorable karyotype (UK) and 9 with FLT3-ITD mutation. The RC included 8 FK/MRD+, 34 IK/MRD+, 1 UK and 12 with FLT3-ITD mutation. In the PC, 22 (73%) of 30 patients received ASCT (8 matched family donor, 7 matched unrelated donor, 7 haploidentical related donor), 8 did not due to relapse (6) or because too early (2). In the RC, 12 (22%) received ASCT (11 matched family donor, 1 haploidentical related donor) whereas 24 (44%) autologous SCT (AuSCT); 19 were not transplanted at all due to relapse (13) or mobilization failure (6). Therefore, using the risk-adapted approach, 73% of high-risk patients in the PC received ASCT versus 22% of those in the RC (p <0.001). With a median follow-up of 30 and 50 months for the PC and RC, respectively, DFS is 73% vs 15% (p=0.011), OS 69% vs 20% (p=0.020), CIR 21% vs 76% (p<0.001). Based on these results, the GIMEMA Group has activated a clinical trial (AML1310, ClinicalTrials.gov.Identifier NCT01452646) of “risk-adapted, MRD directed therapy for young adult with AML”. The trial relies on a stringent disease characterization at diagnosis in terms of cytogenetic/genetic definition and identification of “leukemia associated immunophenotype” for MRD assessment at the post-consolidation time-point. The 2 parameters are exploited to qualify the category of risk which the patients belong to: low vs intermediate vs high. All patients will receive induction and consolidation according to the previous GIMEMA LAM99P protocol. After the first consolidation, patients belonging to the low-risk category (CBF+ AML without c-Kit mutations, NPM1+FLT3-ITD- AML) will receive AuSCT and those with high-risk features (UK, FLT3-ITD mutations) ASCT. Patients with FLT3-TKD mutations or c-Kit mutated CBF+ AML and those belonging to the IK category will be stratified according to the post-consolidation MRD status and will receive AuSCT or ASCT. All patients who meet the criteria for high-risk definition will be offered ASCT regardless of the availability of a HLA identical sibling, therefore all the other sources of hematopoietic stem cells will be considered. Applying this strategy, we expect a 10% survival advantage at 24 months as compared to the historical control (LAM99P protocol) where OS at 2 years was 50%. Disclosures: No relevant conflicts of interest to declare.

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