Vlazny, Danielle T.

Abstract Guidelines recommend placement of inferior vena cava filters (IVCFs) in patients with acute proximal lower extremity deep vein thrombosis (DVT) and a contraindication to anticoagulation. IVCF placement during pregnancy or immediately postpartum presents technical challenges and is not extensively described in the existing literature. This study aimed to describe the use of IVCFs in the obstetric population along with outcomes related to filter placement. Retrospective chart review of all patients at Mayo Clinic from 2001 to 2020 with an IVCF at the time of conception or who underwent placement during pregnancy/postpartum. About 24 pregnancies in 23 women (mean age 26.3 years, range 18–41) were included: 5 (21%) with IVCF placement prior to pregnancy, 7 (29%) during pregnancy, and 12 (50%) during postpartum. IVCFs placed during pregnancy were frequently in the suprarenal position, in 5 (71%) cases. Meanwhile, 16 (94%) were deployed in an infrarenal position prior to pregnancy and postpartum. Complications included multiple attempts to remove the IVCF (n = 2), severe angulation (n = 4), embedded struts (n = 3), fracture (n = 1), and one case of cardiac tamponade (n = 1). Complications were more common when placement was performed prior to pregnancy or during pregnancy (2, 40% and 4, 57% respectively) versus postpartum (2, 17%). IVCF placement prior or during pregnancy/postpartum is uncommon and is associated with a high incidence of complications, although most did not fundamentally impact clinical outcomes. While IVCFs remain an option for clinicians treating pregnant and postpartum patients, these should be considered a last resource.

Abstract Background: Prophylactic-dose or low-dose apixaban and rivaroxaban have been studied in randomized controlled trials for the extended prevention of venous thromboembolism (VTE) after 6 months of treatment with therapeutic anticoagulation. However, the optimal timing of dose adjustment has not been fully explored, and the rationale for a precise transition at the 6-month mark is lacking. Aim: Evaluate the clinical outcomes and demographic differences between transition to low-dose DOAC before or after the previously studied 6-month timeframe. Methods: Consecutive patients with VTE were identified using the Mayo Clinic VTE Registry from March 1st, 2013 to December 31st, 2021. Patients with recurrent VTE or bleeding during the first 3 months were excluded. Patients were followed prospectively for outcomes of VTE recurrence, major bleeding, and clinically relevant non major bleeding (CRNMB), either in person or by survey. After completion of anticoagulation treatment for 3 months, the cohort of patients continuing anticoagulation with eventual transition to low-dose rivaroxaban or apixaban were evaluated. Results: A total of 466 patients were included with 167 (36%) undergoing transition to low dose prior to 6 months and 299 (64%) after 6 months of treatment. The average time to low-dose transition in the total population was 7.8 months (5.9, 3.0-55.8). The early transition group had less PE (82 versus 191, p=0.017) and significantly fewer patients with concurrent DVT and PE (32 versus 101, p=0.004). There was nearly equal representation of cancer in the two groups (34.7% versus 35.8%). Evaluation of clinical outcomes from transition time forward in the groupings before and after six months revealed no significant differences (VTE recurrence p=0.233, MB p=0.114, CRNMB p=0.745). Conclusions: This real-world patient population demonstrates that anticoagulant prescribers transition to low-dose DOACs ahead of the historically studied 6-month time point. The results of this study do not indicate a significant difference in clinical outcomes of VTE recurrence or bleeding complications based on time of transition to low-dose DOACs either before or after 6 months.

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.

Intro: Venous thromboembolism (VTE) is a common cause of death among cancer patients, second only to cancer progression. Identifying factors predicting worse outcomes among cancer patients with VTE would be useful clinically. For cancer patients with pulmonary emboli (PE), it remains unclear whether concomitant leg deep vein thrombosis (DVT) as a source for further embolization adversely impacts this risk. The aim of this project was to determine the impact of residual DVT on adverse outcomes among cancer patients suffering acute PE. Methods: Consecutive patients with confirmed acute PE (March 1, 2013 - June 30, 2021) underwent ultrasound (US) imaging and were divided into two groups depending on the presence or absence of leg DVT. PE severity was classified based on AHA criteria. Patients were followed prospectively for VTE recurrence, major and clinically relevant non-major bleeding (CRNMB) and all-cause mortality. Results: Over the study interval, 1,035 cancer patients with PE were enrolled (Table 1). Of these, 375 (36.2%) had leg DVT confirmed by US. Patients with leg DVT were older (64.2 vs 61.4 years, p = 0.01), heavier (90.2 vs 85.1 kg, p &lt;0.001), with lower metastatic disease prevalence (49.1% vs 57.1%, p = 0.01) compared to those without leg DVT. Cancer type distribution also differed between groups. PE patients with DVT more often had prostate, genitourinary, and hematologic cancers while those without DVT more often had pancreatic and breast cancers. Patients with DVT more often had symptomatic PE (48.2% vs. 35.9%, p &lt; 0.001), massive (2.9% vs 0.5%, p &lt; 0.001), and submassive (22.0% vs 7.6%, p &lt; 0.001). Patients with DVT more often received unfractionated heparin (39.5% vs 18.7%, p &lt; 0.001) whereas those without DVT were more frequently treated with low molecular weight heparin (57.5% vs. 44.3%, p &lt;0.001), and apixaban (16.4% vs. 11.7%, p &lt; 0.05). Anticoagulant duration, VTE recurrence, major bleeding and CRNMB were similar between groups (Table 2). Conclusion: Among a large cohort of cancer patients with pulmonary emboli, significant clinical and cancer specific differences exist comparing those with and without leg DVT.While theoretically increasing the risk of recurrent embolization, the presence of residual DVT does not appear to adversely impact important outcomes among cancer patients adequately treated with anticoagulation.

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.

Background: Reduced or low-dose direct oral anticoagulants (DOACs) have been studied in randomized control trials for the extended prevention of venous thromboembolism (VTE) after 6 months of treatment at full, therapeutic doses. The real-world effectiveness as well as utilization of this approach in clinical practice compared to continuing at therapeutic doses is unclear. Aims: Examine the effectiveness, safety and utilization of reduced-dose DOACs in cancer patients and overweight patients. Methods: Consecutive patients with VTE were identified using the Mayo Clinic VTE Registry from March 1st, 2013 to December 31st, 2021. Patients were followed prospectively for outcomes of VTE recurrence, death, major bleeding and clinically relevant non major bleeding (CRNMB) either in person or by survey. Patients with recurrent VTE or bleeding during the first 3 months were excluded from further analysis. After completion of anticoagulation treatment for 3 months with either rivaroxaban or apixaban, patients continuing anticoagulation were evaluated in a nested case-control study. Results: A total of 404 patients (283 (70%) on apixaban and 121 (30%) on rivaroxaban) were identified in the low dose DOAC and 3060 in the full dose anticoagulation group. Overall, the mean age was 60.7 years (SD 14.4), mean weight was 89.9 kg (SD 23.8) and 55.1% were males. Within the full cohort, patients with active cancer were less likely to be prescribed low dose DOACs (HR 0.56; 95%CI 0.42-0.73; p&lt;0.001). However, low dose DOAC prescription was more likely in patients with pulmonary embolism alone (HR 1.48; 95%CI 1.21-1.80; p&lt;0.001) or in combination with DVT (HR 1.54; 95%CI 1.25,1.90; p&lt;0.001). Patients transitioned to low dose DOACs had similar age, sex and weight compared to the full dose anticoagulation group, however, fewer patients with weight ≥120 kg had reduced dosing (HR 0.68; 95%CI 0.46,0.99; p=0.046). The mean time to start of a low dose DOAC was 5.1 months overall, 5.4 months in cancer patients, and 3.6-4.9 months in non-cancer patients (Table 1). Non-cancer patients had significantly lower transition numbers in those ≥120kg (HR 0.62; 95%CI 0.40,0.97; p=0.038). In non-cancer patients In comparing weight, ≥120kg to &lt;120kg, in the low dose group, only death was statistically different with higher risk in those ≥120kg (HR 6.44; 95%CI1.27,32.81; p=0.025). Cancer patients transitioned to low dose DOACs around 5 months on average with a median of 3.3 months. Apixaban continued to be the dominant DOAC used (78%) in the low dose group. The cancers with the most patients on low dose DOACs include lymphoma, prostate, melanoma, ovarian, and breast. There was no significant difference in VTE recurrence or death in the cancer group on different DOAC doses. Conclusion: Our results show that anticoagulant prescribers are not always waiting until 6 months to transition to low doses and low doses are being utilized in cancer patients despite lack of cancer-specific studies during the analyzed time period. Although the sample size limits the precision of this analysis, we did not find statistically significant increases in VTE recurrence with low dose DOACs in either cancer patients or with elevated body weight. We did find CRNMB but not MB was observed more frequently in weights above 120kg, possibly from unadjusted confounding in this unadjusted analysis.