Impact of malignancy on outcomes in European patients with atrial fibrillation: a report from the ESC-EHRA EURObservational Research Programme in Atrial Fibrillation General Long-Term Registry

Background Management of patients with atrial fibrillation (AF) and malignancy is a clinical challenge given the paucity of evidence supporting the appropriate clinical management. Purpose To evaluate the outcomes of patients with active or prior malignancy in a large contemporary cohort of European AF patients. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. We stratified the population into three categories (i) No Malignancy (NoM) (ii) Prior Malignancy (PriorM) and (iii) Active Malignancy (ActM). The primary outcome for this analysis was all-cause death among the three groups. The association between anticoagulant treatment, all-cause death and haemorrhagic events was also evaluated. Results Among the original 11 096 AF patients enrolled, 10 383 were included in this analysis (median age 71 years (interquartile range [IQR] 63–77, males 59.7%). Of these, 9 597 (92.4%) were NoM patients, 577 (5.6%) PriorM and 209 (2%) ActM. Patients with malignancy (prior or active) had a higher median age, median CHA2DS2-VASc and HAS-BLED scores, compared to patients without malignancy (p<0.001). Lack of anticoagulation (AC) prescription occurred more commonly in ActM (21.5%) as compared with the other groups (PriorM 10.1% vs NoM 12.8%, p<0.001). In case of AC treatment, patients with ActM were treated more frequently with heparins (ActM 8.1% vs PriorM 2.4% vs NoM 2%, p<0.001). After a median follow-up of 730 days [IQR 692–749], 982 (9.5%) patients died. Among all deaths, the proportion of cardiovascular death was different according to the three groups (40.0% in NoM, 26.0% in PrioM and 22.2% in ActM, p=0.002). For all cause-death, Kaplan-Meier analysis showed a progressively higher cumulative risk in the PriorM and ActM groups compared to NoM patients (Figure 1). On multivariable Cox regression analysis, adjusted for CHA2DS2-VASc score, use of AC, type of AF and chronic kidney disease, ActM group was independently associated with a higher risk for all cause death (hazard ratio [HR] 2.90, 95% confidence interval [CI] 2.23–3.76) while PriorM group was not. Among PriorM and NoM patients, multivariable adjusted Cox regression analysis found that the use of any AC was independently associated with a lower risk for all-cause death (HR 0.36, 95% CI 0.19–0.66; HR 0.66, 95% CI 0.54–0.81). No significant association between AC and all-cause death was found for ActM patients. Conclusions In a large contemporary cohort of European AF patients, active malignancy was found to be independently associated with all-cause death. Use of any AC was associated with a lower risk for all-cause death in patients with no malignancies and with prior malignancies, but with no significant association amongst patients with active malignancies. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): Since the start of EORP, the following companies have supported the programme: Abbott Vascular Int. (2011–2021), Amgen Cardiovascular (2009–2018), AstraZeneca (2014–2021), Bayer (2009–2018), Boehringer Ingelheim (2009–2019), Boston Scientific (2009–2012), The Bristol Myers Squibb and Pfizer Alliance (2011–2016), The Alliance Daiichi Sankyo Europe GmbH and Eli Lilly and Company (2011–2017), Edwards (2016–2019), Gedeon Richter Plc. (2014–2017), Menarini Int. Op. (2009–2012), MSD-Merck & Co. (2011–2014), Novartis Pharma AG (2014–2020), ResMed (2014–2016), Sanofi (2009–2011), SERVIER (2010–2021), and Vifor (2019–2022). Figure 1. Kaplan-Meier for all-cause death

Chorioretinal Biopsy-Proven Ocular Sarcoidosis in a Patient with a History of B-Cell Lymphoma

The purpose of this report is to describe biopsy-proven ocular sarcoidosis (OS) in a 67-year-old patient with a history of sarcoidosis and diffuse large B-cell lymphoma (DLBCL). Nonspecific posterior chorioretinal lesions in a patient with prior malignancy necessitated chorioretinal biopsy to rule out metastatic lymphoma. The association between sarcoidosis and malignancy remains unclear and can complicate management of similar patients with nonspecific posterior segment findings. Chorioretinal biopsy may, therefore, be required to rule out malignancy in patients with a leading history.

HIV status and history of prior malignancy in immunotherapy trials.

e14096 Background: Patients with human immunodeficiency virus (HIV) and history of prior malignancy have been historically excluded from clinical trials. In late 2017, ASCO and Friends of Cancer Research proposed to include patients with HIV and history of prior malignancy for which treatment has been completed for at least 2 years. We aimed to determine if these recommendations were followed. Methods: Using clinicaltrials.gov, we performed a systematic review of immunotherapy trials involving pembrolizumab, nivolumab, avelumab, atezolizumab, and durvalumab. We included all solid tumor trials in patients aged 18 years and older performed between January 1, 2016 and December 31, 2019. The following data were recorded for each trial: study period (2016-17 vs. 2018-19), drug type (pembrolizumab vs other), inclusion of HIV positive population (yes or no), and inclusion of prior malignancy per guidelines (yes or no). A Chi-square analysis was performed on the two study periods in relation to HIV status and history of prior malignancy. The same analysis was also performed on HIV status/ history of prior malignancy in relation to the drug type. Significance was set at p-value < 0.05. Results: A total of 305 studies reached final analysis, of which 123 involved pembrolizumab. For all drugs combined, there was no significant change in the two study periods in the inclusion of HIV patients (p = 0.48) or history of prior malignancy (p = 0.68). A subanalysis of the pembrolizumab trials showed a statistically significant inclusion of history of prior malignancy compared to other drugs in the entire study period of 2016-2019 (p = 0.03), but this did not hold true for HIV status (p = 0.69). Conclusions: Our study suggests that recent recommendations by ASCO and Friends of Cancer Research regarding HIV status and history of prior malignancy are not being followed. This could be due to limited awareness surrounding the recommendations or continued fears regarding treatment-related adverse events in this subset of patients. [Table: see text]

Identifying IBD Providers’ Knowledge Gaps Using a Prospective Web-based Survey

Background As treatments, management strategies, and the role of advanced practice providers (APPs) have evolved in recent years, the Crohn’s & Colitis Foundation sought to understand the educational and resource needs of clinicians caring for patients with inflammatory bowel diseases (IBDs). The aim of this study was to describe the self-identified IBD knowledge and resource gaps of clinicians to inform the development of future programming. Methods A survey containing 19 questions created by the foundation’s Professional Education Committee, a subset of its National Scientific Advisory Committee, was conducted from September 7, 2018 to October 15, 2018. Responses were included from providers if they were currently seeing any IBD patients in a clinical setting. The foundation distributed the survey by email and various social media channels to encourage a diverse response. The survey included questions on comfort levels around diagnosis, treatment, and management of patients with IBD, in addition to preferences and utilization of educational resources. The × 2 test was used to evaluate significant differences among respondents in the various domains surveyed. Results There were 197 eligible responses, of which 75% were from MD/Dos, followed by 25% APN/PA/RN/MSN/PhD/other; and 70% of respondents provide care for adult patients. The amount of time in practice was divided evenly among respondents. Fifty-seven percent of respondents practice in an academic/university setting, and approximately 75% indicated that ≥21% of their practice consisted of patients with IBD. Forty-four percent and 46% of respondents reported access to IBD based mental health providers and social workers in their practice, respectively. Seventy-two percent reported access to radiologists, 69% had access to dietitians, and 62% had access to advance practice providers. The areas of greatest educational need were prescribing medical cannabis (if approved locally) for pain management (62%); caring for patients with prior malignancy (35%); caring for pregnant patients and family planning (33%); caring for elderly patients (30%); and therapy decisions, including use of JAK inhibitors (29%), drug holidays (25%), and use of biosimilars (24%). More than 50% of respondents stated they do not participate in shared decision-making, citing time as the most common limiting factor. The majority of providers cited live education as their preferred learning format, and they wish to earn continuing medical education (CME) hours. Conclusion This survey helped identify current IBD educational needs in our professional community. With a rapidly changing treatment landscape and an increase in the diversity of providers delivering care, additional opportunities to keep abreast of practice changes are critical to providing comprehensive, quality care in IBD. Our survey demonstrated that shared decision-making is underutilized in practice due to a need for resources that aid in its efficient integration into practice. Based on our results, a focus on creating live learning opportunities that offer CME are needed in the areas of therapeutic decision-making and treating IBD in special subsets (eg, prior malignancy, pregnancy, elderly).