Apixaban and Rivaroxaban in Patients With Acute Venous Thromboembolism.

OBJECTIVE: To compare the clinical efficacy and safety of apixaban with those of rivaroxaban for the treatment of acute venous thromboembolism (VTE). PATIENTS AND METHODS: Consecutive patients enrolled in the Mayo Thrombophilia Clinic Registry (between March 1, 2013, and January 30, 2018) and treated with apixaban or rivaroxaban for acute VTE were followed forward in time. The primary efficacy outcome was VTE recurrence. The primary safety outcome was major bleeding; the second safety outcome was clinically relevant nonmajor bleeding (CRNMB); and the third was a composite of major bleeding or CRNMB. RESULTS: Within the group of 1696 patients with VTE enrolled, 600 (38%) were treated either with apixaban (n=302, 50%) or rivaroxaban (n=298, 50%) within the first 14 days of VTE diagnosis and who completed at least 3 months of therapy or had a study event. Recurrent VTE was diagnosed in 7 patients (2.3%) treated with apixaban and in 6 (2%) treated with rivaroxaban (adjusted hazard ratio [aHR], 1.4; 95% CI, 0.5-3.8). Major bleeding occurred in 11 patients (3.6%) receiving apixaban and in 9 patients (3.0%) receiving rivaroxaban (aHR, 1.2; 95% CI, 0.5-3.2). Clinically relevant nonmajor bleeding was diagnosed in 7 patients (2.3%) receiving apixaban and in 20 (6.7%) receiving rivaroxaban (aHR, 0.4; 95% CI, 0.2-0.9). The rates of composite major bleeding or CRNMB were similar (aHR, 0.6; 95% CI, 0.3-1.2). Most study events occurred in patients with cancer. CONCLUSION: In the setting of a standardized, guideline-directed, patient-oriented clinical practice, the efficacy and safety of apixaban and rivaroxaban for the treatment of acute VTE were comparable.

Predictors of early mortality and readmissions among dialysis patients undergoing lower extremity amputation.

OBJECTIVE: Patients receiving dialysis are at increased risk for lower extremity amputations (LEAs) and postoperative morbidity. Limited studies have examined differences in 30-day outcomes of mortality and health care use after amputation or the preoperative factors that relate to worsened outcomes in dialysis patients. Our objective was to examine dialysis dependency and other preoperative factors associated with readmission or death after LEA. METHODS: A retrospective cohort study was conducted of dialysis-dependent and nondialysis patients undergoing major LEA in the 2012 to 2013 American College of Surgeons National Surgical Quality Improvement Program. Primary outcomes included death and hospital readmission within 30 days of amputation. RESULTS: Of 6468 patients, 1166 (18%) were dialysis dependent. The dialysis cohort had more blacks (39% vs 23%), diabetes (76% vs 58%), below-knee amputations (62% vs 55%), and in-hospital deaths (8% vs 3%; all P < .001). The 30-day postoperative death rates (15% vs 7%) and readmission rates (35% vs 20% per 30 person-days; both P < .001) were higher in dialysis patients. Among the live discharges, the rate of any readmission or death within 30 days from amputation was highest in those aged ≥50 years (40% per 30 person-days). Multivariable analyses in the dialysis cohort revealed increased age, above-knee amputation, decreased physical status, heart failure, high preoperative white blood cell count, and low platelet count to be associated with death (P < .05; C statistic, 0.75). The only preoperative factor associated with readmission in dialysis patients was race (P = .04; C statistic, 0.58). CONCLUSIONS: Readmission or death after amputation is increased among dialysis patients. Predicting which dialysis patients are at highest risk for death is feasible, whereas predicting which will require readmission is less so. Risk factor identification may improve risk stratification, inform reimbursement policies, and allow targeted interventions to improve outcomes.

Symptomatic Venous Thromboembolism is Associated with Inferior Survival among Patients Undergoing Nephrectomy with Inferior Vena Cava Tumor Thrombectomy for Renal Cell Carcinoma.

PURPOSE: We investigated the incidence and survival impact of symptomatic venous thromboembolism after nephrectomy with inferior vena cava tumor thrombectomy. MATERIALS AND METHODS: We retrospectively reviewed the records of 183 patients who underwent nephrectomy with inferior vena cava tumor thrombectomy (level I-IV) for renal cell carcinoma between 2000 and 2010. Postoperative venous thromboembolism was defined as symptomatic bland thrombus or embolism confirmed on imaging. The cumulative incidence of venous thromboembolism was estimated by the Kaplan-Meier method. Associations of clinicopathological features with time to thromboembolism after surgery and all cause mortality were evaluated on multivariable analysis with Cox models. RESULTS: Symptomatic venous thromboembolism developed in 55 patients a median of 23 days (IQR 5-142) postoperatively, including pulmonary thrombosis in 24, deep venous thrombosis in 17, bland inferior vena cava thrombosis in 13 and portal vein thrombosis in 1. The cumulative incidence of thromboembolism 30, 90 and 365 days following surgery was 17%, 22% and 27%, respectively. A history of smoking (HR 2.15, 95% CI 1.09-4.24, p = 0.028), ECOG (Eastern Cooperative Oncology Group) performance status 1 or greater (HR 2.15, 95% CI 1.17-3.93, p = 0.013), hypercoagulability disorder (HR 5.12, 95% CI 1.93-13.59, p = 0.001) and bulky lymphadenopathy at surgery (HR 4.84, 95% CI 1.87-12.51, p = 0.001) was significantly associated with an increased risk of venous thromboembolism on multivariable analysis. Postoperative venous thromboembolism was significantly associated with an increased risk of all cause mortality (HR 1.53, 95% CI 1.04-2.23, p = 0.029). CONCLUSIONS: Venous thromboembolism after nephrectomy and tumor thrombectomy is common within 90 days of surgery. Symptomatic venous thromboembolism in this population is independently associated with a greater risk of mortality.

Direct oral anticoagulant medications in calciphylaxis.

BACKGROUND: Recent studies suggest that calciphylaxis is a thrombotic condition in which arteriolar thrombosis leads to painful skin infarcts and consequent morbidity and mortality. Paradoxically, warfarin is implicated as a risk factor for calciphylaxis. Our objective is to report the use of oral direct thrombin and factor Xa inhibitors (termed direct oral anticoagulants [DOACs]) in patients with calciphylaxis. METHODS: We retrospectively reviewed records of 16 patients with calciphylaxis who received concomitant administration of novel anticoagulants. Patient data, including demographics, comorbidities, other treatments, and adverse events, were abstracted from the health records. RESULTS: Eleven patients (69%) had chronic kidney disease (stage ≥3A), and eight (50%) received dialysis. Apixaban was the most frequently used agent (n = 11 [69%]). Dabigatran (n = 4 [25%]) and rivaroxaban (n = 2 [13%]) were reserved for patients with mild renal impairment (stage ≤2). One clinically relevant but nonmajor bleeding event occurred. There were no major bleeding events. Nine patients (56%) were alive at last follow-up, and five (31%) had complete resolution of their calciphylaxis (mean follow-up, 523 days; range, 26-1884 days). CONCLUSION: DOACs were safe and well tolerated in patients with calciphylaxis, in this initial experience. Several patients had improvement or resolution of calciphylaxis in response to therapy that included DOACs. The degree of renal impairment should guide DOAC choice. Randomized trials are required to determine treatment efficacy.

Applying quality improvement methods in a hyperbaric oxygen program: reducing unnecessary glucose testing.

OBJECTIVE: To describe the implementation of a quality improvement (QI) project that aimed at improving and standardizing glucose checks on patients with diabetes undergoing hyperbaric oxygen (HBO2) therapy. METHODS: This is a prospective cohort study. Following the Model for Improvement, nurses and physicians ran several Plan-Do-Study-Act (PDSA) cycles over a four-month period, with multiple iteration and testing changes. They developed and implemented a nurse-led protocol that was tested prospectively. RESULTS: Compared to the pre-protocol baseline (N = 332), glucose checks per session guided by the protocol decreased by 37.7% (2.84 vs. 1.77 per session, P⟨0.001). Compliance with the new protocol was higher than compliance with the existing protocol (97.3% to 84.2%, P⟨0.001). There were no cases of a symptomatic hypoglycemic event after the implementation of the protocol. CONCLUSIONS: A quality improvement project implemented by a multidisciplinary team in a hyperbaric practice was feasible and has improved the management of diabetic patients undergoing HBO2 therapy. Considering how the hyperbaric community values the culture of safety and considering the feasibility of this project, more QI training and projects in hyperbaric programs should be performed.

The incidence of hypoglycemia during HBO2 therapy: A retrospective review.

BACKGROUND: Hypoglycemia is concerning in patients with diabetes undergoing hyperbaric oxygen (HBO2) therapy. We aimed to estimate the incidence, risk factors and a pretreatment glucose threshold of HBO2-associated hypoglycemia. METHODS: We retrospectively evaluated a patient cohort undergoing HBO2 therapy. We calculated the area under the curve (AUC) and odds ratio (OR) with 95% confidence interval (CI) adjusting for patients' age, gender, diabetes type, insulin use, body mass index, hemoglobin A1c and HBO2 treatment time. RESULTS: During 77 months, 3,136 HBO2 sessions were performed on patients with diabetes. In-chamber glucose was higher than pre-HBO2 glucose in 1,708/3,136 sessions (54%). The incidence of hypoglycemia (defined as ≤ 70 mg/dL) during or immediately after HBO2 treatment was 1.5% (0.8-2.1%). Hypoglycemia that was symptomatic or severe was rare. A glucose value pre-HBO2 of 150 mg/dL best predicted the risk of subsequent hypoglycemia (AUC 0.80; 95% CI, 0.75-0.86). Type 1 diabetes was independently associated with increased risk of hypoglycemia (OR 3.69; 95% CI, 1.67, 8.19) whereas insulin use was not. CONCLUSIONS: In patients with diabetes undergoing HBO2, severe hypoglycemia is rare and occurs more frequently in Type 1 diabetes. Pre-HBO2 glucose values may be used to predict subsequent hypoglycemia and reduce the need for routine glucose monitoring during and after HBO2.

Lumbar artery pseudoaneurysm caused by a Gunther Tulip inferior vena cava filter.

Inferior vena cava (IVC) filters are widely used to decrease the risk of pulmonary embolism in patients with contraindications to anticoagulation. Complications include local hematoma, access site deep venous thrombosis (DVT), filter migration and embolization, leg penetration through the IVC wall, IVC occlusion, and filter fracture with embolization. Other rare complications include leg penetration into adjacent organs including duodenum and ureter. Lumbar artery pseudoaneurysms are rare and may be spontaneous, iatrogenic, or traumatic. To date, there have been 3 case reports of lumbar artery pseudoaneurysms caused by IVC filters. We present an additional case of a lumbar artery pseudoaneurysm caused by a Gunther Tulip IVC filter treated successfully with selective embolization.

Pediatric median arcuate ligament syndrome: first report of familial pattern and transperitoneal laparoscopic release.

Median arcuate ligament syndrome (MALS) is a rare disorder resulting from luminal narrowing of the celiac artery by the insertion of the diaphragmatic muscle fibers. Surgical management entails division of the median arcuate ligament with or without celiac artery reconstruction. We are presenting an interesting case of a 16-year-old girl with postprandial abdominal pain and weight loss. Her mother also had MALS treated via open celiotomy with complete median arcuate ligament division and patch angioplasty of the celiac artery owing to persistent stenosis at our institution. After a diagnosis of MALS was confirmed in our patient, a transperitoneal laparoscopic release of the median arcuate ligament with skeletonization of the celiac artery and branch vessels was performed. The postoperative course was uneventful, and she was dismissed on postoperative day 2. She remains asymptomatic at 12-months follow-up. This represents the first report of a transperitoneal laparoscopic approach to MALS in an adolescent and the first report of a familial/generational component to MALS.

Medical management of carotid stenosis.

Stroke is a leading cause of morbidity and mortality in the developed world. Although the rates of stroke have decreased in North America, there are significant areas of risk stratification and management that can be improved. Hypertension is the most significant and perhaps most modifiable risk factor for stroke. Carotid atherosclerotic disease is associated with 15% of ischemic strokes. Although carotid endarterectomy (CEA) remains a recommendation for significant symptomatic carotid stenosis, controversy continues in the management of asymptomatic and recurrent carotid stenosis. Medical management options and effectiveness has significantly improved since the early CEA trials were published. Optimal medical management now must incorporate aggressive risk factor reduction measures, particularly with antihyperlipidemic therapy. Improved understanding of the natural history of carotid atherosclerosis is necessary to improve the application of management strategies.

Hyperbaric oxygen therapy for chronic refractory osteomyelitis of the sternum.

This report describes a 32-year-old woman with chronic refractory osteomyelitis of the sternum after multiple surgical procedures including a sternotomy with underlying colonic interposition that was successfully managed with hyperbaric oxygen therapy. The clinical course is reviewed, and the complexities of this diagnosis are then discussed, including a brief review of the mechanisms of management with hyperbaric oxygen therapy.

Idiopathic pulmonary artery aneurysm.

A case of idiopathic pulmonary artery aneurysm is presented along with a review of our experience of this rare condition. These entities may have an association with cystic medial degeneration of the arterial wall and are subject to the same complications as aortic aneurysms.

Polycythemia vera--a case report and discussion on pathogenic mechanisms of increased thrombosis.

Polycythemia vera is a myeloproliferative disorder characterized by increased red cell mass and frequently complicated by venous and arterial thrombosis. The mechanism underlying the increased incidence of thrombotic events remains illusive. Presented in this report are a case of a 77-year-old man diagnosed with polycythemia vera and a review of the current literature on the mechanisms underlying the increased incidence of thrombotic events in polycythemia vera.

The role of right ventricular endomyocardial biopsy for idiopathic giant cell myocarditis.

BACKGROUND: Idiopathic giant cell myocarditis (GCM) is an uncommon cause of cardiac failure distinguished clinically from lymphocytic myocarditis by rapidly progressive heart failure, arrhythmias, and heart block. Unlike fulminant lymphocytic myocarditis, patients with fulminant cardiac failure caused by GCM may respond to certain immunosuppressive agents; however, right ventricular endomyocardial biopsy (EMB) is infrequently used to establish the diagnosis partly because the sensitivity of EMB for GCM is unknown. The purpose of this study was to estimate the sensitivity of right ventricular EMB for GCM in a referral population. METHODS AND RESULTS: Twenty subjects (of 63 total) in the Multicenter Giant Cell Myocarditis Registry underwent both right ventricular EMB and heart pathology (HRTP) evaluation from apical wedge, explantation, or autopsy. The false-negative rate of right ventricular EMB was defined as the ratio of negative EMB to positive HRTP results. Ten of the 20 subjects were women. The mean age was 38 years (range, 16-53 years). Twelve (60%) subjects had a positive EMB and positive HRTP confirming GCM. Three (15%) had a negative EMB and positive HRTP for GCM. Five had a positive EMB and negative HRTP evaluation for GCM. The resulting sensitivity of EMB for GCM was 80% (12/15) with a positive predictive value of 71%. Assuming the 5 subjects with a positive EMB and negative HRTP are true positives, the sensitivity improves to 85% (17/20). Predictors of negative HRTP after positive EMB were time from symptom onset to HRTP (P.006) and time from EMB to HRTP (P.03). CONCLUSIONS: The sensitivity of right ventricular EMB is high in patients with GCM who have early disease presentation and a fulminant clinical course. Although these results may not apply to individuals with less aggressive disease, EMB may be used selectively to distinguish fulminant heart failure caused by GCM from other causes in which the prognosis may differ.