Risk Of Late Mortality Research Articles

The effect of pediatric central nervous system tumors on identity in young adult survivors: a project REACH study.

Of all childhood cancers, adult survivors of pediatric central nervous system (CNS) tumors are at the highest risk for late mortality as well as neurocognitive, physical, and psychosocial late effects. Their identity with cancer survivorship, the relationship of their identity to health outcomes, and how their identity differs from other childhood cancer survivors is poorly understood. A total of 127 young adults previously treated for pediatric CNS tumors enrolled in Project REACH, a locally-treated childhood cancer survivor cohort. Participants completed self-report measures on the effects of cancer on identity, someone who had cancer, victim and survivor identity, frequency of thoughts of diagnosis, and health outcomes. The majority of participants identified as a survivor (83%). Survivor identity was linked to diagnosis and treatment but not health outcomes. A minority (9%) endorsed a victim identity, and they were more likely to have poorer mental health (p = 0.03) and depression (p = 0.04) than non-victims. Participants who reported a stronger effect of cancer on their identity also had poorer mental health (p = 0.005). A higher frequency of diagnosis-related thoughts was associated with significantly poorer mental health (p < 0.001), more severe anxiety (p = 0.008), depression (p < 0.001), and neurocognitive impairments (p < 0.01). Those who experienced relapse, radiation, and/or chemotherapy were more likely to identify as someone who had cancer, independent of diagnosis. Our findings suggest the relationships previously reported between identity and sociodemographic, treatment, and health outcomes after adult and pediatric non-CNS cancers cannot be generalized to pediatric CNS tumors. Understanding the unique features of how this population identifies is important for patient-centered care.

More reassuring safety data regarding paclitaxel-eluting technologies in lower extremity revascularization

Paclitaxel-eluting technologies (PET), drug-coated balloons (DCB), and drug-eluting stents may be associated with decreased rates of recurrent stenosis and repeat revascularization.1 A recent study-level meta-analysis of 28 randomized controlled trials (RCTs) comparing PET vs plain-old balloon angioplasty (POBA) in peripheral arterial disease concluded that PET were associated with an increased risk of late mortality.1,2 The analysis suffers from several flaws.

Health-related quality of life in adults treated for paediatric acute lymphoblastic leukaemia: a cross-sectional and longitudinal cohort study

IntroductionAcute lymphoblastic leukaemia (ALL) is the most common form of cancer in children. Although treatment methods have improved and resulted in significant improvement of survival and reduction in late effects...

Pericardial Versus Porcine Valves for Surgical Aortic Valve Replacement.

There still are controversies on which type between bovine pericardial and porcine valves is superior in the setting of aortic valve replacement (AVR). This study aims to compare clinical outcomes of AVR using between pericardial or porcine valves. The study involved consecutive 636 patients underwent isolated AVR using stented bioprosthetic valves between January 2000 and May 2016. Of these, pericardial and porcine valves were implanted in 410 (pericardial group) and 226 patients (porcine group), respectively. Clinical outcomes including survival, structural valve deterioration (SVD) and trans-valvular pressure gradient were compared between the groups. To adjust for potential selection bias, inverse probability treatment weighting (IPTW) was conducted. The mean follow-up duration was 60.1±50.2 months. There were no significant differences in the rates of early mortality (3.1% vs. 3.1%; p=0.81) and SVD (0.3%/patient-year [PY] vs. 0.5%/PY; p=0.33) between groups. After adjustment using IPTW, however, landmark mortality analyses showed a significantly lower late (>8 years) mortality risk in pericardial group over porcine group (hazard ratio [HR], 0.61; 95% confidence interval, [CI] 0.41-0.90; p=0.01) while the risks of SVD were not significantly difference between groups (HR, 0.45; 95% CI, 0.12-1.70; p=0.24). Mean pressure gradient across prosthetic AV was lower in the Pericardial group than the Porcine group at both immediate postoperative point and latest follow-up (p values <0.001). In patients undergoing bioprosthetic surgical AVR, bovine pericardial valves showed superior results in terms of postoperative hemodynamic profiles and late survival rates over porcine valves.

Comparisons between the clinical outcomes of early and late enteral nutrition and mortality risk factors for pediatric burns

Rationale: Burn injuries induce hypermetabolism and consequential increased caloric and protein requirements. This study compared the clinical outcomes of early enteral nutrition (EEN) with those of late enteral nutrition (LEN) for the management of burns.

Risks of late mortality and morbidity among survivors of childhood acute leukemia with Down syndrome: A population-based cohort study.

Children with leukemia and Down syndrome (DS) are at higher risk of acute treatment toxicities than those without DS. Whether late toxicity risks are also elevated is unknown. The authors identified all patients diagnosed with leukemia before the age of 18 years in Ontario, Canada between 1987 and 2013 and who survived greater than 5 years since their last pediatric cancer event. Survivors were divided into those with and without DS, matched by birth year, sex, leukemia type, and receipt of radiation. DS survivors were matched to individuals with DS without childhood cancer (DS controls) in a 1:10 ratio. Outcomes were identified through linkage to population-based health services databases. DS survivors (n = 79) experienced inferior overall survival compared to non-DS survivors (n = 231) (20-year overall survival, 81.7% ± 6.8% vs 98.3% ± 1.2%; hazard ratio [HR], 12.8; P < .0001) and to DS controls (n = 790; 96.3% ± 1.2%; HR, 5.4 P < .0001). Pulmonary and infectious deaths were noted among DS survivors. There was no difference in the incidence of congestive heart failure between DS survivors and either control cohort, nor of hearing loss or dementia between DS survivors and DS controls. DS survivors were at substantially higher risk of late mortality than non-DS survivors or DS controls. This excess risk was not attributable to cardiac- or subsequent malignant neoplasm-related late effects, historically main causes of premature death among non-DS survivors. Chronic morbidities associated with DS were not increased compared to DS controls. DS-specific surveillance guidelines may be warranted.

Information needs for Inclusion in a Post-Discharge Guideline Booklet for Mothers with Prematurely born Babies in a Low-Resource Setting in South Africa

Background: Prematurity brings along a high risk of early and late mortality and morbidity that demands specialized care within the NICU. Mothers of premature babies often feel powerless and helpless once the premature baby is discharged from the neonatal intensive care unit (NICU). These experiences might interfere with their transitions into parenthood as they might question their ability to care for their baby. As nurses become greatly concerned regarding the continuity of care at home, the purpose of this study was to explore and describe the information that mothers of prematurely born babies need upon discharge for inclusion in a guideline booklet. Methods: A qualitative explorative design was used to conduct interviews with mothers of prematurely born babies in a NICU of a tertiary hospital in Gauteng Province, South Africa. Purposive sampling was used to select mothers whose prematurely born babies were preparing for discharge from NICU and mothers whose babies were discharged and at home and were brought to the hospital for their six weeks follow-up after discharge. Unstructured individual interviews were conducted. Results: The following seven themes were identified, namely feeding of a prematurely born baby, positioning of the baby, infection control and hygiene, care for a sick baby or baby with special needs, immunisation and clinic visits, normal development and growth, and information guidelines. Conclusion: The findings of this study were used to include essential information in a guideline booklet for mothers with prematurely born babies upon discharge from the NICU.

Two-Year Landmark Survival Analysis after Allogeneic Hematopoietic Cell Transplantation in Acute Lymphoblastic Leukemia: An Analysis from the ALWP of the EBMT

BackgroundLong-term survival and late mortality risk compared to general population for patients (pts) who underwent an allogeneic hematopoietic cell transplant (HCT) is unknown. We analyzed long-term outcomes of 2-year (yr) HCT survivors with acute lymphoblastic leukemia (ALL).MethodsAdult pts with ALL who were alive and relapse-free at 2 yrs after first HCT from 2005-2012 were included. We excluded patients who had a cord blood transplant and ex vivo T cell depletion (TCD). Relative survival analysis was used to estimate HCT-related crude mortality taking into account for background population mortality rates of the general population, matched for age, sex, and country in the year of HCT (www.mortality.org).ResultsA total of 2701 pts were included with a median follow up interval of 99 months and median age of 34 (range 18 - 73.5) yrs. The majority (78.6%) of pts were in 1 st complete remission (CR1) with undetectable MRD (68.3%). There were similar numbers of matched sibling donor (MSD) (43.7%) and unrelated donor transplants (MUD) (53.2%). Most pts received myeloablative conditioning (MAC) (86.5%) and peripheral blood (PB) grafts (75.7%) without in vivo TCD (55.7%).The 10-yr probability for overall survival (OS) and leukemia-free survival (LFS) was 81.3% and 78.2%, respectively. Cumulative incidence of disease relapse and non-relapse mortality (NRM) at 10 years was 9.9% and 11.9%, respectively. The probability of chronic GVHD-relapse-free survival (cGRFS) at 10-yrs was 73.3% (Figure 1). Relapsed ALL and chronic GVHD were common causes of late mortality accounting for 33.9% and 29% of reported deaths, respectively, followed by infection and secondary malignancy. For patients transplanted in countries with available mortality data (92% of patients in our cohort), the probability of dying from another cause is negligible at 1.5% compared to the probability of dying from HCT (16.8%) 10 years after HCT (Figure 1F).ConclusionsIn a large registry-based study, we showed excellent long-term survival of 81.3% at 10-yr among the 2-yr survivors of HCT for ALL. There was no difference in long term outcomes with respect to conditioning intensity, but utilization of BM graft and in vivo TCD resulted in lower NRM, and better OS. Long-term mortality risk among HCT survivors remains significantly higher than expected for the general age-matched population. [Display omitted] DisclosuresLabopin: Jazz Pharmaceuticals: Honoraria. Schroeder: Celgene: Honoraria, Other: Travel support, Research Funding. Bethge: Miltenyi Biotec: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Kite-Gilead: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Celgene: Consultancy, Honoraria, Speakers Bureau. Nicholson: Pfizer: Consultancy; BMS/Celgene: Consultancy; Kite, a Gilead Company: Other: Conference fees, Speakers Bureau; Novartis: Consultancy, Other: Conference fees. Giebel: Janssen: Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Speakers Bureau. Peric: Therakos, Servier, MSD, Astellas, Novartis, Abbvie, Pfizer: Honoraria. Dholaria: Janssen: Research Funding; Pfizer: Research Funding; Takeda: Research Funding; Jazz: Speakers Bureau; MEI: Research Funding; Angiocrine: Research Funding; Poseida: Research Funding; Celgene: Speakers Bureau. Mohty: Sanofi: Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Jazz: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria; Celgene: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria; Astellas: Honoraria; Amgen: Honoraria; Adaptive Biotechnologies: Honoraria.

Association between continuous-flow left ventricular assist device infections requiring long-term antibiotic use and post-heart transplant morbidity and mortality.

There exists controversy regarding the impact of infection in patients with a left ventricular assist device (LVAD) on post-heart transplant outcomes. This study evaluated the association between infections during LVAD support and the risk of early and late post-heart transplant infection, rejection, and mortality in transplant recipients bridged with an LVAD. This is a single-center retrospective observational cohort study of consecutive adults supported with a continuous flow LVAD undergoing heart transplant between 2006 and 2019 at the Toronto General Hospital. The grade of LVAD infection was classified as per International Society of Heart and Lung Transplantation guidelines. Patients were divided into three groups: (1) patients with LVAD-specific infection confirmed with positive cultures requiring long-term antibiotic use until the time of transplant; (2) patients with any type of infection in whom antibiotics were stopped at least 1 month before transplant; (3) patients without any infections between LVAD implant and transplant. Logistic regression and Cox proportional hazard models were used to evaluate early- and late-post transplant outcomes, respectively. We included 75 LVAD recipients: 16 (21%) patients had a chronic LVAD-related infection on suppressive antibiotics, 30 (40%) had a resolved infection, and 29 (39%) had no infections. During a median post-transplant follow-up time of 4 (2 to 7) years, 65 (87%) patients developed infections, 43 (64%) rejections, and 17 (23%) deaths. Both short- and long-term risks of infection, rejection, and mortality did not differ significantly among the groups. LVAD patients with infections did not have a significantly higher risk of infection, rejection, or mortality at any time point after transplant.

Hospital-based delays to revascularization increase risk of postoperative mortality and short bowel syndrome in acute mesenteric ischemia

ObjectiveAcute mesenteric ischemia (AMI) is a surgical emergency for which delays in treatment have been closely associated with high morbidity and mortality. Although the duration of ischemia as a determinant of outcomes for AMI is well known, the objective of this study was to identify hospital-based determinants of delayed revascularization and their effects on postoperative morbidity and mortality in AMI. MethodsAll patients who underwent any surgery for AMI from a multi-center hospital system between 2010 and 2020 were divided into two groups based on timeliness of mesenteric revascularization after presentation. Early revascularization (ER) was defined as having both vascular consultation ≤12 hours of presentation and vascular surgery performed at the patient’s initial operation. Delayed revascularization (DR) was defined as having either delays to vascular consultation or vascular surgery. A retrospective review of demographic and postoperative data was performed. The effect of DR on major postoperative outcomes, including 30-day and 2-year mortality, total length of bowel resection, and development of short bowel syndrome, were analyzed. Effects of delayed vascular consultation alone, delayed vascular surgery alone, no revascularization during admission, and admitting service on outcomes were also examined on subgroup analyses. ResultsA total of 212 patients were analyzed. Ninety-nine patients received ER, whereas the remaining 113 patients experienced a DR after hospital presentation. Among the DR group, 55 patients (25.9%) had delayed vascular consultation, whereas vascular surgery was deferred until after the initial operation in 37 patients (17.4%). Fifty-one patients (24.0%) were never revascularized during admission. DR was a significant predictor of 30-day (odds ratio [OR], 2.09; 95% confidence interval [CI], 1.4-4.9; P = .03) and 2-year mortality (hazard ratio, 1.55, 95% CI, 1.0-2.3; P = .04). DR was also independently associated with increased bowel resection length (OR, 7.47; P < .01) and postoperative short bowel syndrome (OR, 2.4; P = .03) on multivariate analyses. When examined separately on subgroup analysis, both delayed vascular consultation (OR, 3.38; P = .03) and vascular surgery (OR, 4.31; P < .01) independently increased risk of 30-day mortality. Hospital discharge after AMI without mesenteric revascularization was associated with increased risk of short bowel syndrome (OR, 2.94; P < .01) and late mortality (hazard ratio, 1.60; P = .04). ConclusionsDelayed vascular consultation and vascular surgery are both significant hospital-based determinants of postoperative mortality and short bowel syndrome in patients with AMI. Timing-based management protocols that emphasize routine evaluation by a vascular surgeon and early, definitive mesenteric revascularization should be established and widely adopted for all patients with clinically suspected AMI at presentation.

Trends in Late Mortality and Life Expectancy After Allogeneic Blood or Marrow Transplantation Over 4 Decades

The past 4 decades have seen substantial changes in allogeneic blood or marrow transplantation (BMT) practice, with the overarching goal of expanding the eligible patient pool while optimizing disease-free survival. To determine trends in life expectancy and cause-specific late mortality after allogeneic BMT performed over a 40-year period. A retrospective cohort study of 4741 individuals who lived 2 or more years after allogeneic BMT performed between January 1, 1974, and December 31, 2014, was conducted at City of Hope, University of Minnesota, or University of Alabama at Birmingham. The end of follow-up was March 23, 2020. Allogeneic BMT performed in 3 eras: 1974-1989, 1990-2004, and 2005-2014. All-cause, recurrence-related, and nonrecurrence-related mortality and projected reduction in life expectancy. Information regarding vital status and cause of death was obtained from the National Death Index Plus and Accurint databases. Of the 4741 individuals included in the study, 2735 (57.7%) were male; median age at BMT was 33 years (range, 0-75 years). The cumulative incidence of recurrence-related mortality plateaued at 10 years, reaching 12.2% (95% CI, 11.0%-13.4%) at 30 years from BMT. In contrast, the incidence of nonrecurrence-related mortality continued to increase and was 22.3% (95% CI, 20.4%-24.3%) at 30 years. Leading causes of nonrecurrence-related mortality included infection (30-year cumulative incidence, 10.7%; standardized mortality ratio [SMR], 52.0), subsequent malignant neoplasms (30-year cumulative incidence, 7.0%; SMR, 4.8), cardiovascular disease (30-year cumulative incidence, 4.6%; SMR, 4.1), and pulmonary disease (30-year cumulative incidence, 2.7%; SMR, 13.9). Compared with the general population, the relative mortality remained higher at 30 or more years after BMT (SMR, 5.4; 95% CI, 4.0-7.1). The cohort experienced a 20.8% reduction in life expectancy (8.7 years of life lost). Compared with 1974-1989 (reference), the adjusted 10-year hazard ratio (HR) of all-cause mortality declined over the 3 eras (1990-2004: HR, 0.67; 95% CI, 0.53-0.85; 2005-2014: HR, 0.52; 95% CI, 0.39-0.69; P < .001 for trend), as did years of life lost (1974-1989: 9.9 years [reference]; 1990-2004: 6.5 years; and 2005-2014: 4.2 years). The reduction in late mortality was most pronounced among individuals who underwent transplantation at ages younger than 18 years (1990-2004: HR, 0.62; 95% CI, 0.40-0.96; 2005-2014: HR, 0.30; 95% CI, 0.16-0.54; reference: 1974-1989; P < .001 for trend) and those who received bone marrow (1990-2004: HR, 0.70; 95% CI, 0.54-0.90; 2005-2014: HR, 0.45; 95% CI, 0.29-0.69; reference: 1974-1989; P < .001 for trend). This cohort study noted that late mortality among recipients of allogeneic BMT has decreased over the past 40 years; however, life expectancy was not restored to expected rates compared with the general US population. Furthermore, the reduction in risk of late mortality appeared to be confined to those who underwent transplantation at a younger age or those who received bone marrow. Further efforts to mitigate disease recurrence, infections, subsequent neoplasms, cardiovascular disease, and pulmonary disease may be useful in this population.

Sex differences in outcomes following coronary artery bypass grafting: a meta-analysis.

Previous reports have found females are a higher risk of morbidity and mortality following isolated coronary artery bypass grafting (CABG). Here, we describe the differences in outcomes following isolated CABG between males and females. Following a systematic literature search, studies reporting sex-related outcomes following isolated CABG were pooled in a meta-analysis performed using the generic inverse variance method. The primary outcome was operative mortality. Secondary outcomes included rates of stroke, repeat revascularization, myocardial infarction, major adverse cardiac events, and late mortality. Subgroup analyses were performed for studies published before and after the year 2000 and for the type of risk adjustment. Eighty-four studies were included with a total of 903 346 patients. Females were at higher risk for operative mortality (odds ratio: 1.77, 95% confidence interval [CI]: 1.64-1.92, P < 0.001). At subgroup analysis, there was no difference in operative or late mortality between studies published prior and after 2000 or between studies using risk adjustment. Females were at a higher risk of late mortality (incidence rate ratio [IRR]: 1.16, 95% CI: 1.06-1.26, P < 0.001), major adverse cardiac events (IRR: 1.40, 95% CI: 1.19-1.66, P < 0.001), myocardial infarction (IRR: 1.28, 95% CI: 1.13-1.45, P < 0.001) and stroke (IRR: 1.31, 95% CI: 1.15-1.51, P > 0.001) but not repeat revascularization (IRR: 0.99, 95% CI: 0.76-1.29, P = 0.95). The use of the off-pump technique or multiple arterial grafts was not associated with the primary outcome. Females undergoing CABG are at higher risk for operative and late mortality as well as postoperative events including major adverse cardiac events, myocardial infarction and stroke. CRD42020187556.

Late morbidity and mortality following revascularization surgery for moyamoya disease in the pediatric population.

There are limited reports on long-term morbidity in pediatric patients who have undergone surgical revascularization for moyamoya disease (MMD). Here, the authors report long-term morbidity and mortality in a population of pediatric patients who underwent pial synangiosis for MMD from 1988 through 2016. A single-center retrospective review of the hospital and personal operative databases of the senior authors was carried out to identify all patients who were treated for MMD at Boston Children's Hospital between 1988 and 2016, and who experienced any episode of late morbidity or mortality, which the authors defined as an event resulting in significant neurological deficit or death occurring more than 1 year after revascularization surgery. Hospital records were reviewed to determine pertinent demographic data, the initial mode of patient presentation, and associated comorbidities. Radiographic studies, when available, were reviewed for documentation of the diagnosis and for confirmation of the late complication, and the literature on this topic was reviewed. In total, 460 patients with MMD underwent surgery between 1988 and 2016 using the pial synangiosis surgical technique; 15 (3.3%) of these patients (9 females and 6 males) experienced documented late death (n = 14) or severe morbidity (n = 1). The median age at revascularization surgery was 8.0 years (range 1-21 years). The causes of these late complications were grouped into three etiologies: intraventricular or intracerebral hemorrhage (n = 8), systemic complications related to associated comorbidities or preoperative disabilities (n = 5), and the development of malignant brain tumors (n = 2). Four patients whose MMD was associated with a history of cranial radiation therapy died. These events occurred from as early as 2 years to as late as 27 years postoperatively. The risk of late morbidities and mortality following pial synangiosis for MMD in the pediatric patient appeared to be low. Nevertheless, the occurrence of catastrophic cerebrovascular events, particularly intracerebral and intraventricular hemorrhage in the otherwise neurologically stable revascularized patient, was concerning. Although there is value in long-term surveillance of patients who have undergone surgery for MMD, from both a neurological and a general medical standpoint, particularly in patients with the risk factor of prior cranial radiation therapy, it is not clear from the data how the late deaths in this population could have been prevented.

Adult onset epilepsy is defined by phenotypic clusters with unique comorbidities and risks of death.

This study was undertaken to identify clusters of adult onset epilepsy with distinct comorbidities and risks of early and late death. This was a retrospective open cohort study that included all adults meeting a case definition for epilepsy after the Acceptable Mortality Recording date in the Health Improvement Network database for the years 2000-2012 inclusive. Unsupervised agglomerative hierarchical clustering was performed to identify unique clusters of patients based on their predicted risk of early (<4years of epilepsy diagnosis) and late (≥4years from diagnosis) mortality and patient-level clinical characteristics. We identified 10 499 presumed incident cases of epilepsy from 11 194 182 patients. Four phenotypic clusters were identified in the early and late risk periods. Early clusters include older adults with cardiovascular disease and a high risk of death (median predicted risk = 20%, interquartile range [IQR] = 9%-31%), a group with moderate risk of death and cancer (median predicted risk = 6%, IQR = 2%-15%), a group with psychiatric disease/substance use and few somatic comorbidities (median predicted risk = 5%, IQR = 2%-9%), and one with a younger age at onset and few comorbidities (median predicted risk = 4%, IQR = 1%-11%). There was minimal movement of individuals between clusters for those surviving the early risk period. Age- and sex-standardized 3-year mortality ratios were more than sixfold higher than the general population for every cluster, even those primarily comprised of healthy younger adults. Adult onset epilepsy is marked by unique clusters of comorbid conditions and elevated risks of death that form discrete populations for targeted therapeutic interventions. These clusters remain relatively stable between the early and late mortality risk periods. Of particular interest are the clusters marked by young and otherwise healthy adults whose standardized mortality ratio is sixfold higher than general population despite few conventional risk factors for premature death.

The CIBMTR Chronic GVHD Risk Group Predicts Major Outcomes In An Independent Validation Cohort

The beneficial anti-leukemic effect of chronic GVHD (CGVHD) is offset by an increased risk of late treatment-related mortality (TRM). Several clinical risk factors have been identified as predictors of outcomes in patients with CGVHD. We previously identified 10 variables significantly associated with TRM and survival in5343 patients with CGVHD transplanted between 1995 and 2004. We then developed a CGVHD CIBMTR risk score using these variables (Arora, M., et al.: Blood, 2011; 117: 6714-6720). Variables included in the score were age, prior acute GVHD, time from HCT to CGVHD, donor type, disease status at transplant, GVHD prophylaxis, gender match, serum bilirubin and Karnofsky score and platelet count at time of diagnosis of CGVHD. Six risk-groups were identified with powerful discriminative ability to predict TRM and survival. In the current study we sought to validate this risk score in an independent dataset of 1007 patients with CGVHD transplanted between 2005 and 2007 using the same inclusion criteria and risk-score calculations. Patients were divided into 4 risk groups (RGs) according to the sum of the overall risk score: RG1 (0-2), RG2 (3-6), RG3 (7-8) and RG4 (9-10) (Table), and cumulative incidences of TRM and survival were calculated. TRM and survival at 12 and 24 months after CGVHD for each RG are shown in the Table. We found a strong correlation between CGVHD RG with TRM (p<0.0001) and survival (p<0.0001). Also, TRM and survival were significantly different between each RG (Figure and Table). Our study validates the prognostic value of the CIBMTR CGVHD RGs for OS and TRM in a contemporary transplant population. The CIBMTR CGVHD RGs can be used to predict major outcomes and tailor treatment planning. [Display omitted] TableOutcomes by Risk Group, according to CGVHD CIBMTR risk-score (RS)Adjusted Overall Survival, (95% CI) after CGVHDAdjusted Cumulative Incidence, TRM, (95% CI) after CGVHDRisk GroupOverall RSPatients, n (%)12 months24 months12 months24 months10-2213 (21)88 (84-93)80 (75-86)6 (3-10)9 (5-13)23-6684 (68)74 (71-77)64 (60-67)15 (18-33)20 (17-23)37-899 (10)44 (34-54)37 (28 -48)33 (24-42)37 (28-46)49-1011 (1)43 (14-73)43 (14-73)39 (16-63)39 (16-63) Disclosures:No relevant conflicts of interest to declare.

Individualized Treatment Summaries and Survivorship Care Plans (SCPs) for Hematopoietic Cell Transplant (HCT) Survivors Reduces Cancer Treatment Distress in a Randomized, Multicenter Study

Purpose: As HCT recipients are at risk for late effects, SCPs are increasingly being used in clinical practice to facilitate survivor care despite the lack of high-quality data on their implementation or efficacy. We conducted a randomized study to evaluate the impact of SCPs on HCT survivors' confidence in survivorship information (CSI), with secondary analyses evaluating cancer treatment distress (CTXD), knowledge of transplant exposures, health behaviors, health care utilization (HCU) and health general self-efficacy.Methods: Adult (≥18 yrs at HCT) survivors who were 1-5 years post-transplant, proficient in English, and without relapse or second cancers were eligible. To enhance generalizability, recipients with any diagnosis, HCT/donor type, and conditioning regimen could participate. Treatment summaries were generated using patient-specific clinical data submitted by transplant centers to the Center for International Blood and Marrow Transplant Research (CIBMTR). Focus group feedback from patients/caregivers, HCT physicians/nurses/social workers and general hematologist-oncologists informed the design of paper-based SCPs. Individualized SCPs were developed based on patient risk-factors and treatment exposures (e.g., age, sex, HCT type, graft-versus-host disease [GVHD], and use of total body irradiation [TBI] or steroids) and published guidelines for long-term followup of HCT survivors (Majhail et al, BBMT 2012). A baseline phone survey was conducted after enrollment and included standardized patient-reported outcomes (PROs) related to the objectives listed above. Patients were then randomized to SCP or routine care (RC) per their transplant center. A phone survey 2 weeks later assessed health literacy for patients on both arms and asked questions related to use of SCP for patients on the intervention arm. End-of-study phone PRO surveys were then administered at 6 months. The study was powered to detect a standardized effect size of ≥0.3 for the intent-to-treat primary outcome of CSI.Results: A total of 495 patients were enrolled at 17 transplant centers, of whom 458 completed baseline survey and were randomized (SCP=231, RC=227); 201 (87%) SCP and 199 (88%) RC patients completed 6 month assessments. Patient and transplant characteristics (including health literacy scores) were well balanced between the two arms. Median age was 59 yrs in both arms; 96% (SCP) and 92% (RC) patients were White, 49% and 60% were male, 48% and 44% had received allogeneic HCT, 11% and 16% had received a previous HCT, and 21% and 20% had received TBI based conditioning, respectively. Among allogeneic HCT recipients, 63% and 67% had a history of acute GVHD and 60% and 66% had a history of chronic GVHD, respectively. Receiving a SCP was not associated with a change in CSI, but was significantly associated with reduction in CTXD after Bonferroni correction for multiple outcomes (Table). Decrease in CTXD score in the SCP arm was independent of sex, transplant type, GVHD status, diagnosis, and health literacy. Age was significantly associated with CTXD scores (with higher distress among younger patients), although not with the SCP effect size (no significant interaction). No SCP effect was observed on any of the other secondary outcomes.Summary: In this large multicenter randomized study, we demonstrate that SCPs generated automatically using a centralized clinical registry (CIBMTR) to individualize to patient risk-factors, without clinical contact to interpret or personalize the SCP, is feasible and can produce a tool that lowers CTXD scores at 6 months in HCT survivors. Our study supports further development and implementation of individualized SCPs in this population that is at significant risk for late morbidity and mortality from transplantation. [Display omitted] DisclosuresMajhail:Anthem, Inc.: Consultancy; Sanofi: Honoraria.

Reduction in Late Mortality after Autologous Blood or Marrow Transplantation (autoBMT) in Childhood - a Report from the Blood or Marrow Transplant Survivor Study-2 (BMTSS-2)

Background: AutoBMT is used with a curative intent for several types of childhood cancer. However, there is paucity of information regarding the long-term outcome after autoBMT performed in childhood, and whether mortality rates have changed over the past 4 decades. We address these gaps by examining all-cause, relapse-related [RRM] and non-relapse-related [NRM] mortality in patients undergoing autoBMT between 1980 and 2010 at City of Hope, University of Minnesota or University of Alabama at Birmingham. Methods: To be included in this analysis, patients had to have received a single autoBMT before age 22y, and survived ≥2y after transplantation. Vital status information was ascertained as of December 31, 2016, using medical records, the National Death Index (NDI), and Accurint databases. Information on the cause of death was obtained from the NDI Plus program and medical records. Using Kaplan-Meier techniques, we describe overall survival conditional on surviving 2y and 15y from autoBMT. We describe cumulative incidence of RRM and NRM using competing risk methods. We also describe trends in all-cause mortality over 3 time periods: <1990, 1990-1999 and 2000-2010. Standardized mortality ratio (SMR) was used to compare the mortality of this cohort to the age- sex-, and calendar-specific mortality of the US general population. Proportional subdistribution hazards model (Fine-Gray) for competing risks was used for identifying predictors of late mortality (demographics, primary disease, conditioning agents, and disease status at autoBMT). Results: In this cohort of 364 2+y survivors of autoBMT performed in childhood, the most common primary diagnoses were Hodgkin lymphoma (HL: 26%), neuroblastoma (23%), acute myeloid leukemia (AML: 13%), acute lymphoblastic leukemia (ALL: 12%), and non-Hodgkin lymphoma (NHL: 9%). The distribution of the cohort over the 3 time periods was: <1990 (20%); 1990-1999 (37%); 2000-2010 (43%). After a median follow-up of 14.2y, 104 deaths were observed in this 2+y survivor cohort. The leading causes of death included primary disease (49.5%), subsequent malignant neoplasms (21.0%) and infection (18.2%). The 10y cumulative incidence of RRM (13.6%) exceeded that of NRM (10.2%) (Fig 1). Overall, the cohort was at a 23-fold higher risk of late mortality (SMR 23.6, 95% CI 19.3-28.6), when compared with the general population. The SMR was significantly increased in all groups of primary diagnoses; ALL (SMR 27.0), AML (SMR 7.8), HL (SMR 15.1), NHL (SMR 13.5), and neuroblastoma (SMR 60.7). Conditional on surviving 2y, 5y, 10y and 15y, the overall survival was 81.9%, 91.4%, 95.6% and 99.4%, respectively. Mortality rates continued to remain higher than the general population among those who had survived at least 10y after autoBMT (SMR 12.4, 95% CI 4.9-25.1), but approached those of the general population among the 15+y survivors (SMR 3.0, 95%CI, 0.5-9.4). The all-cause 10y cumulative mortality rate declined over the 3 eras (<1990: 35.1%, 1990-1999: 24.4%; 2000-2010: 20.6%, p=0.02) (Fig 2). Adjusting for demographic and clinical variables, as well as preparative regimens, the hazard ratio (HR) of all-cause mortality declined in the more recent treatment eras (<1990 (referent group): HR=1.0; 1990-1999: HR=0.5, 95%CI, 0.3-0.9, p=0.02; 2000-2010: HR=0.4, 95%CI, 0.2-0.8, p=0.007). Conclusion: Taken together, these findings suggest that the mortality rates of autoBMT recipients are significantly higher than those of the general population. Relapse is the leading cause of death for the first 10y after autoBMT. Importantly, there has been a significant decline in all-cause mortality in children undergoing autoBMT over the past 4 decades. [Display omitted] DisclosuresArora:Takeda Oncology: Consultancy.

Coronary artery bypass grafting versus percutaneous coronary intervention in end-stage kidney disease: A systematic review and meta-analysis of clinical studies.

The most significant complication of end-stage kidney disease (ESKD) is cardiovascular disease, mainly coronary artery disease (CAD). Although the effective treatment of CAD is an important prognostic factor, whether percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) is better for treating CAD in this group of patients is still controversial. We searched Pubmed/Medline, Web of Science, Embase, the Cochrane Central Register of Controlled Trials articles that compared the outcomes of CABG versus PCI in patients with ESKD requiring dialysis. A total of 10 observational studies with 39,666 patients were included. Our analysis showed that when compared to PCI, CABG had lower risk of need for repeat revascularization (relative risk [RR]=2.25, 95% confidence interval [CI] 2.1-2.42, p < 0.00001) and cardiovascular death (RR=1.19, 95% CI 1.14-1.23, p < 0.00001) and higher risk for short-term mortality (RR=0.43, 95% CI 0.38-0.48, p < 0.00001). There was no statistically significant difference between the PCI and CABG groups in the risk for late mortality (RR=1.05, 95% CI 0.97-1.14, p=0.25), myocardial infarction (RR=1.05, 95% CI 0.46-2.36, p=0.91) or stroke (RR=1.02, 95% CI 0.64-1.61, p=0.95). This meta-analysis showed that in ESKD patients requiring dialysis, CABG was superior to PCI in regard to cardiovascular death and need for repeat revascularization and inferior to PCI in regard to short term mortality. However, this meta-analysis has limitations and needs confirmation with large randomized controlled trials.

Impact of preoperative glycometabolic status on outcomes in cardiac surgery: Systematic review and meta-analysis

BackgroundHistorically, impaired glucose metabolism has been associated with early and late complicated clinical outcomes after cardiac surgery; however, such a condition is not specific to subjects with diabetes mellitus and involves a larger patient population. MethodsDatabases were screened (January 2000 to December 2020) to identify eligible articles; studies that evaluated the association between preoperative metabolic status, as assessed by glycosylated hemoglobin levels and clinical outcomes, were considered. The studies were stratified in thresholds by baseline glycosylated hemoglobin level (lower vs higher). ResultsThirty studies, involving 34,650 patients, were included in the review. In a meta-analysis stratified by glycosylated hemoglobin levels, early mortality was numerically reduced in each threshold comparison and yielded the highest reductions when less than 5.5% versus greater than 5.5% glycosylated hemoglobin levels were compared (risk ratio, 0.39; 95% confidence interval, 0.18-0.84; P = .02). Comparing higher glycosylated hemoglobin threshold values yielded comparable results. Late mortality was reduced with lower levels of glycosylated hemoglobin. Low preoperative glycosylated hemoglobin was associated with the lowest risk of sternal wound infections (risk ratio, 0.50; 95% confidence interval, 0.32-0.80; P = .003 and risk ratio, 0.53; 95% confidence interval, 0.39-0.70; P < .0001) for comparisons of less than 7.5% versus greater than 7.5% and less than 7.0% versus greater than 7.0% glycosylated hemoglobin thresholds, respectively. Additionally, levels of glycosylated hemoglobin lower than 7% were associated with reduced hospital stay, lower risk of stroke/transient ischemic attack (risk ratio 0.53; 95% confidence interval, 0.39-0.70; P < .0001), and acute kidney injury (risk ratio, 0.65; 95% confidence interval, 0.54-0.79; P < .0001). ConclusionsLower levels of glycosylated hemoglobin in patients undergoing cardiac surgery are associated with a lower risk of early and late mortality, as well as in the incidence of postoperative acute kidney injury, neurologic complications, and wound infection, compared with higher levels.

Late morbidity and mortality among survivors of neuroblastoma treated with contemporary therapy: A report from the Childhood Cancer Survivor Study.

10044 Background: Survival rates for neuroblastoma vary widely based on risk group. Therapies have evolved over the past four decades to de-intensify treatment for individuals with low/intermediate risk disease and intensify therapy for those with high risk disease. Risk stratification is predicted to result in differential outcomes in late morbidity and mortality; the magnitude of these differences has not been well studied. Methods: We evaluated late mortality, subsequent malignant neoplasms (SMN) and chronic health conditions (CHC) graded according to CTCAE v4.03 among 491 5-year CCSS survivors of neuroblastoma diagnosed 1987-1999 at ≥1 year of age. Using age, stage at diagnosis, and treatment, survivors were classified into risk groups (low [n=182]; intermediate [n=70]; high [n=239]). Standardized mortality ratios (SMR) and standardized incidence ratios (SIR) of SMN were calculated using rates from NCHS and SEER, respectively. Cox regression models estimated hazard ratios (HR) and 95% confidence intervals (CI) for CHC compared to 1,029 CCSS siblings. Results: Among survivors (48% male; median age 22 years, range 7-42; median follow-up 19 years, range 5-29), 80.4% with low risk disease were treated with surgery alone, while 77.8% with high risk disease received surgery, radiation, chemotherapy ± transplant. The 15-year cumulative incidence of all-cause mortality was 9.2% (CI: 7.1-11.4), with a recurrence-related mortality of 7.3% (CI: 5.3-9.3) and SMN-related mortality of 0.3% (CI: 0-0.7). All-cause mortality was significantly higher in all risk groups: (low, SMR=5.8 [CI: 2.6-13.0]; intermediate, SMR=5.7 [CI: 1.4-23.5]; high, SMR=38.6 [CI: 27.9-53.5]). The risk of SMN was elevated among high risk survivors (SIR=25.1, CI: 16.7-37.6), but did not differ from the US population for survivors of low or intermediate risk disease. Table describes the HR of CHCs (grades 1-5 and 3-5) in survivors, by risk group, as compared with siblings, as well as categories of CHCs for which survivors were at increased risk. Conclusions: Long-term survivors of neuroblastoma have a high risk of late morbidity and mortality; risk is particularly pronounced among survivors of high risk disease. Vigilant lifelong medical surveillance will be required for this relatively young population as they age.[Table: see text]