Cassianni, Claire

Abstract Patients with cancer and venous thromboembolism (VTE) have higher complication rates of anticoagulation. However, studies supporting this data are relatively old reflecting the era of vitamin K inhibitors. To assess VTE recurrence, major bleeding, and clinically relevant non-major bleeding (CRNMB) in patients (March 1, 2013 to April 30, 2023) with cancer-associated VTE and patients without cancer, the prospective Mayo Clinic Thrombophilia Clinic Registry was analyzed. Over the study period, 4,711 patients with acute VTE were enrolled including 2,064 patients with cancer (mean age 62.5 ± 12.4, 46% female) and 2,647 patients without cancer (mean age 59.4 ± 16.0, 45% female). The most common cancers were gastrointestinal (n = 423, 21%), pancreatic (n = 287, 14%), and genitourinary (n = 198, 10%). Direct oral anticoagulants were used in 1,339 (65%) cancer and in 1,952 (74%) non-cancer patients. Among cancer patients, 12-month Kaplan–Meier probability of VTE recurrence was 2.4-fold greater (7.1% vs. 2.9%, p < 0.001) compared with the non-cancer group, including higher recurrent leg deep vein thrombosis (3.0% vs. 1.4%; p = 0.002) and pulmonary embolism (3.5% vs. 1.0%, p < 0.001). Patients with cancer also had 2.1-fold greater risk of major bleeding (6.3% vs. 3.0%; p < 0.001) including bleeding from the gastrointestinal tract (3.0 vs. 1.4, p = 0.01) compared with patients without cancer. Clinically relevant non-major bleeding events were similar between the groups. In this large prospective registry of VTE management, patients with cancer had significantly higher rates of VTE recurrence and major bleeding compared with patients without cancer, yet the rate of complications are substantially smaller relative to historic values of a prior vitamin K antagonist era.

BACKGROUND: Preoperative anemia is common and associated with adverse outcomes in surgical patients. There is limited information to guide the design and implementation of preoperative anemia clinics (PAC), which represents a critical barrier to entry for many practices. METHODS: This is a descriptive observational study highlighting the design and implementation of a multidisciplinary PAC, including key steps in planning, stakeholder engagement, organizational structure, identification of target populations, establishing anemia treatments, information technology and electronic health record integration, provider training, and data infrastructure. Demographic and clinical characteristics, laboratory results, and anemia treatments for individuals evaluated in the PAC from November 4, 2019 through September 15, 2023 are enumerated. Patient-reported outcomes (PROs) assessing changes in anemia symptoms and well-being after surgery are evaluated for 2 subsets of patients (one before PAC implementation [pre-PAC], another after PAC implementation [post-PAC]), without formal statistical comparison given limited sample sizes. RESULTS: The PAC was initiated as a multidisciplinary effort under support from a Mayo Clinic Practice Transformation Award in 2019, including broad representation from anesthesiology, surgery, and medical practices, along with institutional project management support (eg, project manager, information technologists, systems engineers). While initially limited to cardiac surgery patients, the PAC underwent planned incremental expansion to include other surgical services. Over the study period, 1188 PAC consultations across 1159 unique patients met eligibility criteria, with a median age of 66 (57–73) years and 58.1% women. The most common etiology of anemia was iron deficiency (69.1%) followed by anemia related to cancer (17.3%). Anemia-directed therapies were recommended in 1038 (87.4%) encounters, with 730 (70.3%) of those receiving recommended treatment preoperatively. Seven hundred nine (97.1%) treatments included intravenous iron and 146 (20.0%) included erythropoiesis-stimulating agents. Fifteen pre-PAC and 38 post-PAC implementation patients completed PROs. PAC implementation was accompanied by earlier resolution of anemia symptoms and less pronounced declines in postoperative well-being scores. CONCLUSIONS: This report highlights the key steps for successful PAC implementation. Treatment is possible for most patients and may be accompanied by improvements in patient-important outcomes.

Background: Diagnosis of heart failure with preserved ejection fraction (HFpEF) is challenging due to non-diagnostic imaging outputs and discordant clinical features. Using only a single videoclip from a standard transthoracic echocardiogram (TTE), we developed an artificial intelligence (AI) model to differentiate patients with HFpEF from those without HFpEF. In a separate test population, we assessed the model’s ability to predict cardiac mortality. Methods: A 3-dimensional convolutional neural network was developed and trained on apical 4-chamber videoclips to classify patients with HFpEF (cases) versus without HFpEF (controls). Overall and cardiac mortality were obtained from the National Death Index. Results: The model was independently tested in 646 cases and 638 controls from 8 centers in 4 states. Sensitivity (87.8%; 84.5-90.9%) and specificity (81.9%; 78.2-85.6%) were high and sustained in various subgroups, including increased left atrial volume index, average E/e’ ≥15, and pulmonary artery systolic pressure >35 mm Hg. During follow-up (median [IQR] 3.4 [1.7-6.5] years), 540 patients died. There were 135 cardiac deaths attributable to heart failure (47%), coronary artery disease (41%), valve disease (4%), arrhythmia (4%), and others (5%). Compared to a negative output, all-cause mortality was higher in patients with a positive (HR 2.9 [2.4-3.5]) or uncertain output (HR 1.8 [1.2-2.5]), and cardiac mortality (Figure) was also higher in patients with a positive (HR 7.7 [4.5-13.3]) or uncertain output (HR 3.4 [1.4-8.1]). Cardiac mortality differences according to AI model prediction remained after age adjustment (positive: HR 5.9 [3.3-10.4], p<0.001; uncertain: HR 2.8 [1.2-6.8], p=0.02). Conclusion: A novel AI model to detect HFpEF based on a single routinely acquired TTE videoclip also identifies those at increased risk of cardiac mortality.

Purpose/Introduction: Patients with cancer and venous thromboembolism (VTE) have higher complication rates including thrombosis recurrence and bleeding. Real world prospective clinical outcome estimates of VTE management comparing cancer and non-cancer patients are limited. To assess VTE recurrence, major bleeding, and clinically relevant non-major bleeding (CRNMB) in patients with cancer and without cancer, the prospective Mayo Clinic Thrombophilia Clinic Registry was analyzed. Methods: Upon recruitment, consecutive patients with confirmed acute VTE (03/01/2013 - 04/30/2023) were treated in a standardized, guideline-sanctioned, protocol driven strategy incorporating shared patient-decision making. Patients were divided into groups based on cancer status. After enrollment, patients were actively followed at 3 month intervals, in person whenever feasible, by mailed questionnaire or scripted phone interview to assess vital status, medication compliance, VTE recurrence, major bleeding and CRNMB. Results: Over the study time-frame, 2,064 patients (53.8% male, 46.2% female) with a cancer and 2,647 patients (54.9% male, 45.1% female) without cancer were enrolled. The most common cancers were gastrointestinal (n=423, 20.5%), pancreatic (n=287, 13.9%), genitourinary (n=198, 9.6%), hematologic (n=171, 8.3%), and lung cancer (n=170, 8.2%). Patients with cancer were older, had lower weight and lower platelet counts compared to non-cancer patients (Table1). Pulmonary embolism (PE, 52.6% vs 43.7%, p&lt;0.001), upper extremity DVT (9.1% vs 6.0%, p&lt;0.001), and splanchnic DVT (11.1% vs 6.9%, p&lt;0.001) were more frequent among cancer patients. In contrast, leg DVT was more frequent among non-cancer patients (65.4% vs.47.2%, p&lt;0.001). While mean duration of anticoagulation was similar between groups, notable differences in 3 month and &gt; 9 month durations were evident as were initial anticoagulant choices (Table 1). Despite a well-organized protocol driven and guideline sanctioned management strategy, patients with active cancer experienced a 2.2-fold higher rate of VTE recurrence (p&lt;0.001) and a 1.8 fold higher rate of major bleeding (p&lt;001) compared to non-cancer patients (Table 2). CRNMB rates did not differ by cancer status. Conclusions: In this large prospective, guideline-driven and patient-centric registry of VTE management, patients with cancer had significantly higher rate of VTE recurrence and major bleeding, compared to non-cancer patients. These data provide important estimates for power calculations for future randomized trials of VTE treatment.