Venous thromboembolism management in people with cystic fibrosis.

BACKGROUND: Rates of venous thromboembolism (VTE) are increasing in people with cystic fibrosis (PwCF). Providers treating VTE in PwCF have reported low confidence concerning anticoagulant drug selection, dose, duration, and drug-drug interactions. As there are currently no published reports regarding management of VTE in PwCF, our objective was to describe the management of VTE in PwCF. METHODS: PwCF and VTE at the University of Utah Health were identified through electronic medical record searches. Patients were categorized into one of three treatment groups: warfarin, direct oral anticoagulant (DOAC), and low molecular weight heparin (LMWH). The primary outcome was episodes of major bleeding. Secondary outcomes included clinically relevant nonmajor (CRNM) bleeding. RESULTS: Nine PwCF with a total of 12 unique VTE episodes were included in the study, with all but one episode associated with a peripherally inserted central catheter (PICC). Of the 12 VTE cases, 25% were treated with warfarin, 50% with a DOAC, and 25% with LMWH. There were no episodes of major bleeding and only one episode of CRNM bleeding (Hemoptysis) in the LMWH group. All anticoagulant doses and durations generally followed guidelines for persons without CF. DOACs were the most common VTE treatment, at doses and duration consistent with guidelines for persons without CF, with no major or CRNM bleeding. CONCLUSION: VTE treatment in PwCF is generally consistent with guidelines for persons without CF with low rates of bleeding. DOACs are a potential option for treatment of VTE in PwCF, but more research is needed.

Clinical outcomes associated with anti-Xa-monitored enoxaparin for venous thromboembolism prophylaxis.

STUDY OBJECTIVE: The objective of the study was to assess clinical outcomes (composite of any venous thromboembolism [VTE], any bleeding, and mortality) associated with anti-Xa monitoring in the 30 days following enoxaparin initiation for VTE prophylaxis. DESIGN: Retrospective cohort study. SETTING: Hospital within an academic healthcare system. PATIENTS: Propensity score-matched hospitalized adults receiving enoxaparin for VTE prophylaxis. INTERVENTION: Low-molecular-weight heparin anti-Xa monitoring. MEASUREMENTS AND MAIN RESULTS: During the 13-month study period, a total of 6611 patients received enoxaparin for VTE prophylaxis, 301 in the anti-Xa monitored group and 6310 in the unmonitored group (4.6% received monitoring). The mean age was 52.9 years and 52% of patients were male. The mean body mass index was 31 kg/m2 and the mean creatinine clearance was 109 mL/min. Twenty percent of patients had active cancer. The most common indication for enoxaparin prophylaxis was hospitalization for medical illness (52%) followed by nonorthopedic surgery (37%). The adjusted odds ratio for the primary outcome comparing monitored to unmonitored patients was 1.26 (95% confidence interval, 0.75-2.11). None of the between-group differences in the individual components of the composite outcome were statistically significant. CONCLUSIONS: Thirty-day clinical outcomes in patients receiving enoxaparin for VTE prophylaxis were not improved by anti-Xa monitoring. Our results support current evidence-based guideline recommendations against anti-Xa monitoring for patients receiving enoxaparin for VTE prophylaxis.

Pilot Study on Feasibility and Outcome of a Nerve-Preserving Aortoiliac Exposure Technique.

BACKGROUND: Dysfunctional ejaculation is a common complication following open aortoiliac aneurysm surgery. It may occur in 49-63% of patients and is caused by iatrogenic damage to the sympathetic lumbar splanchnic nerves and superior hypogastric plexus. A nerve-preserving operative technique based on a unilateral right-sided approach to the abdominal aorta, was implemented in clinical practice. The aim of this pilot study was to establish the safety and feasibility of the technique, and whether a sympathetic pathway and ejaculatory function was preserved. METHODS: Patients were asked to fill out questionnaires preoperatively, and 6 weeks, 6 months, and 9 months postoperatively. The International Index of Erectile Function, Cleveland Clinic Incontinence Score (CCIS), Patient assessment of constipation symptoms (Pac-Sym), and International Consultation on Incontinence Questionnaire on male lower urinary tract symptoms were used. Surgeons were asked to complete a technical feasibility questionnaire. RESULTS: Twenty-four patients undergoing aortoiliac aneurysm surgery were included. The nerve-sparing phase of the procedure added an average of 5-10 min of operating time and was technically feasible in twenty-two patients. No major complications occurred during nerve-sparing exposure. Fifteen of twenty-four patients were sexually active at some point throughout the study. No postoperative loss of ejaculation was seen in sexually active patients. CCIS, Pac-sym, International Index of Erectile Function, and Incontinence Questionnaire on male lower urinary tract symptoms scores remained similar throughout the study. CONCLUSIONS: Nerve-preserving aortoiliac reconstruction surgery is safe and feasible. Ejaculatory function is preserved. Given the low number of patients in the study, further research is needed to provide robust data.

Impact of type of anticoagulant on clinical outcomes in cancer patients who had atrial fibrillation.

To date, evidence on optimal anticoagulant options in patients with AF who concurrently have active cancer remains elusive. To describe anticoagulant patterns and clinical outcomes among patients with a concomitant diagnosis of AF and cancer. Data were obtained from the University of Utah and Huntsman Cancer Institute (HCI) Hospitals. Patients were included if they had diagnosis of AF and cancer. Outcome was type and pattern of anticoagulant. Clinical outcomes were stroke, bleeding and all-cause mortality. From October 1999 to December 2020, there were 566 AF patients who concurrently had active cancer. Mean age ± standard deviation was 76.2 ± 10.7 and 57.6% were males. Comparing to warfarin, patients who received direct oral anticoagulant (DOACs) were associated with similar risk of stroke (adjusted hazard ratio, aHR 0.8, 95% confidence interval [CI] 0.2-2.7, P = 0.67). On contrary, those who received low-molecular-weight heparin (LMWH) were associated with significantly higher risk of stroke comparing to warfarin (aHR 2.4, 95% CI 1.0-5.6, P = 0.04). Comparing to warfarin, DOACs and LMWH was associated with similar risk of overall bleeding with aHR 1.1 (95% CI 0.7-1.6, P = 0.73) and aHR 1.1 (95% CI 0.6-1.7, P = 0.83), respectively. Patients who received LMWH but not DOACs were associated with increased risk of death as compared to warfarin, aHR 4.5 (95% CI 2.8-7.2, P < 0.001) and 1.2 (95% CI 0.7-2.2, P = 0.47). In patients with active cancer and AF, LMWH, compared to warfarin, was associated with an increased risk of stroke and all-cause mortality. Furthermore, DOACs was associated with similar risk of stroke, bleeding and death as compared to warfarin.

Direct Oral Anticoagulants in Obese Patients with Venous Thromboembolism: Results of an Expert Consensus Panel.

In clinical practice, direct oral anticoagulants (DOACs) are increasingly used for venous thromboembolism treatment and prevention. A substantial proportion of patients with venous thromboembolism are also obese. International guidance published in 2016 stated that DOACs could be used in standard doses in patients with obesity up to a body mass index (BMI) of 40 kg/m2, but should not be used in those with severe obesity (BMI >40 kg/m2) owing to limited supporting data at the time. Although updated guidance in 2021 removed this limitation, some health care providers still avoid DOACs even in patients with lower levels of obesity. Furthermore, there are still evidence gaps regarding treatment of severe obesity, the role of peak and trough DOAC levels in these patients, use of DOACs after bariatric surgery, and appropriateness of DOAC dose reduction in the setting of secondary venous thromboembolism prevention. This document describes proceedings and outcomes of a multidisciplinary panel convened to review these and other key issues regarding DOAC use for treatment or prevention of venous thromboembolism in individuals with obesity.

Development of a Human Immunodeficiency Virus Risk Prediction Model Using Electronic Health Record Data From an Academic Health System in the Southern United States.

BACKGROUND: Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is underutilized in the southern United States. Rapid identification of individuals vulnerable to diagnosis of HIV using electronic health record (EHR)-based tools may augment PrEP uptake in the region. METHODS: Using machine learning, we developed EHR-based models to predict incident HIV diagnosis as a surrogate for PrEP candidacy. We included patients from a southern medical system with encounters between October 2014 and August 2016, training the model to predict incident HIV diagnosis between September 2016 and August 2018. We obtained 74 EHR variables as potential predictors. We compared Extreme Gradient Boosting (XGBoost) versus least absolute shrinkage selection operator (LASSO) logistic regression models, and assessed performance, overall and among women, using area under the receiver operating characteristic curve (AUROC) and area under precision recall curve (AUPRC). RESULTS: Of 998 787 eligible patients, 162 had an incident HIV diagnosis, of whom 49 were women. The XGBoost model outperformed the LASSO model for the total cohort, achieving an AUROC of 0.89 and AUPRC of 0.01. The female-only cohort XGBoost model resulted in an AUROC of 0.78 and AUPRC of 0.00025. The most predictive variables for the overall cohort were race, sex, and male partner. The strongest positive predictors for the female-only cohort were history of pelvic inflammatory disease, drug use, and tobacco use. CONCLUSIONS: Our machine-learning models were able to effectively predict incident HIV diagnoses including among women. This study establishes feasibility of using these models to identify persons most suitable for PrEP in the South.

A risk-stratified approach to venous thromboembolism prophylaxis with aspirin or warfarin following total hip and knee arthroplasty: A cohort study.

INTRODUCTION: Venous thromboembolism (VTE) and bleeding events following total knee and hip arthroplasty (TKA/THA) are associated with significant morbidity. Clinical guidelines recommend administration of pharmacologic VTE prophylaxis post-operatively, although controversy exists regarding optimal prophylactic strategies. METHODS: We performed a retrospective cohort study in patients who underwent elective TKA/TKA in an academic medical center. Patients were stratified by surgery type (TKA/THA) and VTE risk determined by a novel risk stratification protocol and compared pre- and post-protocol implementation. Patients received warfarin pre-protocol and either aspirin or warfarin post-protocol for VTE prophylaxis. Natural language processing identified VTE events and ICD codes were used to identify bleeding events, with all events validated manually. RESULTS: A total of 1379 surgeries were included for analysis, 839 TKAs and 540 THAs. Post-protocol implementation, 445 (94.1%) patients following TKA and 294 (97.4%) patients following THA received aspirin for VTE prophylaxis. A significant reduction in bleeding events (hazard ratio [HR] = 0.19, p = 0.048) was observed in low-risk THA patients treated with aspirin (post-protocol) compared patients treated with warfarin (pre-protocol). Bleeding events did not differ significantly between low-risk TKA patients treated with aspirin or warfarin. No significant differences in VTE events were observed following the protocol implementation. CONCLUSIONS: The use of a novel risk stratification system to guide VTE prophylaxis selection between aspirin or warfarin following TKA and THA appears safe and effective. Among low-risk patients, aspirin use was associated with fewer bleeding events following THA, without an observed increase in VTE events.

Anticoagulant therapy management of venous thromboembolism recurrence occurring during anticoagulant therapy: a descriptive study.

Limited evidence exists regarding management of recurrent venous thromboembolism (VTE) that occurs during anticoagulant therapy. We aimed to describe patient characteristics, drug therapy management, and outcomes of patients with VTE recurrence during anticoagulant therapy. We identified 30 relevant episodes of VTE recurrence. Mean age was 48.9 (15.9) years, 56.7% were male, and 93.3% were White. Common VTE risk factors included cancer (46.6%), recent surgery (33.3%), and prolonged immobility (30.0%). At the time of recurrent VTE, 40.0% were receiving enoxaparin, 30.0% warfarin, and 23.3% direct oral anticoagulants. Potential causes for VTE recurrence included indwelling venous catheters (40.0%), cancer (33.3%), subtherapeutic anticoagulation (26.7%), and nonadherence (23.3%). Recurrent VTE management strategies included switching anticoagulants (26.7%), increasing anticoagulant dose (20.0%), temporarily adding enoxaparin or unfractionated heparin to oral anticoagulation therapy (13.3%), or no change in anticoagulation therapy (43.3%). Only four adverse 90-day outcomes occurred among 17 patients who received anticoagulant therapy changes in response to VTE recurrence, whereas eight adverse outcomes occurred in the 13 patients who received no change in anticoagulation therapy in response to a recurrent VTE episode (P value 0.04). Regardless of the potential etiology of recurrent VTE during anticoagulant therapy; switching anticoagulants, temporarily adding injectable anticoagulants, or increasing anticoagulant intensity appears preferable to continuing current anticoagulant therapy unchanged.

A Proposed Opioid Tapering Tool.

INTRODUCTION: Previous studies suggest a lack of confidence among primary care providers in managing patients on chronic opioid therapy (COT) for chronic non-cancer related pain (CNCP). The US Department of Health and Human Services (HHS) recently introduced guidelines on opioid tapering. In light of these recommendations, our group developed an opioid tapering software to assist healthcare providers in managing patients on COT. METHODS: The initial iteration of our software utilizes RedCap for the application programming interface (API). This tool is designed to reduce a patient's prescribed chronic opioids by 5-10% every month, or 5 morphine milligram equivalents per day (MME), whichever is the greatest, in line with HHS guidelines. Users can also adjust the rate of taper. DISCUSSION: Our group plans to use this software in an upcoming pilot study to taper patients on COT for CNCP. We are exploring the possibility of transitioning our software into other available APIs with the goal of integrating this software into major electronic health record systems. Our group envisions that our software will provide an additional tool within a patient-centered, multi-modal framework in managing patients on COT for CNCP.

Temporal trends in first-line outpatient anticoagulation treatment for cancer-associated venous thromboembolism.

BACKGROUND: First-line treatment and secondary prevention of venous thromboembolism (VTE) in patients with cancer consisted, historically, of unfractionated heparin or low-molecular weight heparin (LMWH). With recent clinical trials of direct oral anticoagulants (DOAC) showing similar efficacy as LMWH, little is known about anticoagulant prescribing patterns in patients with cancer and a VTE. This study characterized the temporal trends in first-line outpatient anticoagulation therapy for cancer-associated VTE. MATERIALS AND METHODS: This retrospective cohort study of patients who were hospitalized for a cancer-associated venous thromboembolism (VTE) between 01/01/2000 and 10/31/2017 identified patients from the cancer registries at two regions of an integrated healthcare delivery system. The primary outcome was the trend in age- and sex-adjusted rates of first-line anticoagulant therapy during the 30 days post-hospital discharge. Therapies were categorized as 1) injectable LMWH monotherapy, 2) warfarin ± injectable, 3) injectable fondaparinux monotherapy, or 4) DOAC ± injectable. RESULTS: Overall, 9816 patients were included with a mean age of 66 ± 13 years and 54% were female. From 2000 to 2003, warfarin ± injectable was used in ≈90% of cases. After 2003, there was a steady decline in warfarin use (25% in 2017) corresponding with increased LMWH use: 11% in 2003 to 55% in 2017. The DOAC ± injectable use has rapidly increased from <1% in 2014 to 20% in 2017. CONCLUSIONS: From 2000 to 2017, first-line anticoagulant therapy for cancer-associated VTE has experienced a substantial increase in LMWH and DOAC use with a resultant decline in warfarin use.

Survey of current treatment practices for venous thromboembolism in patients with cystic fibrosis.

BACKGROUND: Patients with cystic fibrosis (CF) and venous thromboembolism (VTE) pose therapeutic challenges including potential drug interactions between CF-related therapies and anticoagulants. Despite these challenges, there are no recommendations for VTE management specific to patients with CF. Our objective was to describe VTE treatment practices among Cystic Fibrosis Foundation (CFF)-accredited care centers and affiliate programs in the United States. METHODS: An online survey was distributed to CF center directors. The survey included questions regarding centers' demographics and posed a series of hypothetical clinical scenarios to gather centers' VTE treatment practices including choice of anticoagulant, dosing practices, duration decisions, and monitoring efforts. Descriptive statistics were utilized to summarize the survey results. RESULTS: The survey response rate was 56.3%. Most centers reported treating zero to five VTE episodes per year. The following anticoagulants were used most often for VTE treatment: low-molecular-weight heparin (LMWH) (73.2%), apixaban (36.6%), warfarin (35.2%), rivaroxaban (33.8%), and unfractionated heparin (18.3%). On a scale of 0 to 100, the median confidence level in managing anticoagulant therapy was 50. Many centers expressed a desire for a CF-specific VTE treatment guideline. The most commonly cited challenging clinical situations were managing anticoagulant therapy complications (26.5%) and drug-drug interactions (21.3%). For common VTE scenarios, pediatric patients were most often treated with LMWH and warfarin, whereas adult patients were more often treated with apixaban or rivaroxaban. CONCLUSIONS: Survey results indicated CF care centers find managing VTE in patients with CF challenging and indicated that a CF-specific VTE treatment guideline would be helpful.

Acceptability of Robotic-Assisted Exercise Coaching Among Diverse Youth: Pilot Study.

BACKGROUND: Almost 80% of adolescents do not achieve 60 minutes or more of physical activity each day as recommended by current US national guidelines. There is a need to develop and promote interventions that increase physical activity among adolescents. With increased interest in digital technologies among adolescents, robotic-assisted platforms are a novel and engaging strategy to deliver physical activity interventions. OBJECTIVE: This study sought to assess the potential acceptability of robotic-assisted exercise coaching among diverse youth and to explore demographic factors associated with acceptance. METHODS: This pilot study used a cross-sectional survey design. We recruited adolescents aged 12-17 years at three community-based sites in Rochester, MN. Written informed consent was obtained from participants' parents or guardians and participants gave consent. Participants watched a brief demonstration of the robotic system-human interface (ie, robotic human trainer). The exercise coaching was delivered in real time via an iPad tablet placed atop a mobile robotic wheel base and controlled remotely by the coach using an iOS device or computer. Following the demonstration, participants completed a 28-item survey that assessed sociodemographic information, smoking and depression history, weight, and exercise habits; the survey also included the eight-item Technology Acceptance Scale (TAS), a validated instrument used to assess perceived usefulness and ease of use of new technologies. RESULTS: A total of 190 adolescents participated in this study. Of the participants, 54.5% were (103/189) male, 42.6% (81/190) were racial minorities, 5.8% (11/190) were Hispanic, and 28.4% (54/190) lived in a lower-income community. Their mean age was 15.0 years (SD 2.0). A total of 24.7% (47/190) of participants met national recommendations for physical activity. Their mean body mass index (BMI) was 21.8 kg/m2 (SD 4.0). Of note, 18.4% (35/190) experienced depression now or in the past. The mean TAS total score was 32.8 (SD 7.8) out of a possible score of 40, indicating high potential receptivity to the technology. No significant associations were detected between TAS score and gender, age, racial minority status, participant neighborhood, BMI, meeting national recommendations for physical activity levels, or depression history (P>.05 for all). Of interest, 67.8% (129/190) of participants agreed that they and their friends were likely to use the robot to help them exercise. CONCLUSIONS: This preliminary study found that among a racially and socioeconomically diverse group of adolescents, robotic-assisted exercise coaching is likely acceptable. The finding that all demographic groups represented had similarly high receptivity to the robotic human exercise trainer is encouraging for ultimate considerations of intervention scalability and reach among diverse adolescent populations. Next steps will be to evaluate consumer preferences for robotic-assisted exercise coaching (eg, location, duration, supervised or structured, choice of exercise, and/or lifestyle activity focus), develop the treatment protocol, and evaluate feasibility and consumer uptake of the intervention among diverse youth.

Patient Satisfaction With Venous Thromboembolism Treatment.

Venous thromboembolism (VTE) represents a major health-care problem. Understanding patient satisfaction with VTE care is an important health-care goal. A national online survey was administered to adults who had experienced a recent VTE event. The survey assessed patient satisfaction by: (1) satisfaction with VTE care provider; (2) likelihood to recommend VTE provider; and (3) satisfaction with communication between VTE care providers. Each question was correlated with patient demographics, patient care harms (ie, misdiagnosis, wrong treatment), patient beliefs concerning outcomes, and type of anticoagulant therapy. Respondents (907) were 52.4 ± 14.4 years, predominantly Caucasian, mostly women, and generally had health insurance. Most respondents were satisfied with VTE care providers, likely to recommend their VTE provider, and satisfied with communication between providers. Dissatisfaction was strongly associated with treatment mistakes, a wrong diagnosis or treatment, or delayed treatment. A national sample of VTE patients were generally satisfied with VTE care experiences. The VTE care dissatisfaction was strongly associated with perceived mistakes in VTE care. Interventions aimed at reducing, acknowledging, and communicating errors could be studied to improve VTE care satisfaction.

Description of anti-Xa monitoring practices during low molecular weight heparin use.

Certain patient populations (pregnancy, cancer, renal impairment, and obesity) may be at higher risk of adverse events during low molecular weight heparin (LMWH) therapy and may benefit from anti-Xa monitoring. Yet, evidence supporting a standardized approach to anti-Xa monitoring correlated to clinical outcomes is lacking. Patients with at least one documented anti-Xa level and receiving LMWH within a 6-month period were identified. In a 6-month period, 224 adult LMWH patients with 359 anti-Xa levels were identified. Anti-Xa monitoring was most commonly performed in patients with active cancer receiving venous thromboembolism (VTE) treatment doses (57.4%) or obese patients receiving VTE prophylaxis (48.1%). Anti-Xa monitoring during renal impairment and pregnancy were infrequent (0.9% and 1.8%, respectively). Most (71.9%) anti-Xa levels were therapeutic, but only 45% were drawn correctly in relation to LMWH administration time. Compared to those with therapeutic anti-Xa levels, patients with out-of-range levels were four times as likely to receive a LMWH therapy change (odds ratio, 4.16; 95% confidence interval, 2.53-6.84). However, when levels were supratherapeutic or subtherapeutic, the LMWH doses remained unchanged in one-third to one-half of patients, respectively. Anti-Xa monitoring was most commonly performed in patients with cancer or obesity and was more common with VTE prophylaxis dosing. The majority of levels were therapeutic, indicating that anti-Xa monitoring may be unnecessary even in high-risk patient populations. Many out-of-range anti-Xa levels did not prompt a change in LMWH therapy. Further research is still needed to determine if anti-Xa- guided LMWH dosing improves clinical outcomes.

Survey of potential receptivity to robotic-assisted exercise coaching in a diverse sample of smokers and nonsmokers.

A prior project found that an intensive (12 weeks, thrice weekly sessions) in-person, supervised, exercise coaching intervention was effective for smoking cessation among depressed women smokers. However, the sample was 90% White and of high socioeconomic status, and the intensity of the intervention limits its reach. One approach to intervention scalability is to deliver the supervised exercise coaching using a robotic human exercise trainer. This is done in real time via an iPad tablet placed on a mobile robotic wheel base and controlled remotely by an iOS device or computer. As an initial step, this preliminary study surveyed potential receptivity to a robotic-assisted exercise coaching intervention among 100 adults recruited in two community settings, and explored the association of technology acceptance scores with smoking status and other demographics. Participants watched a brief demonstration of the robot-delivered exercise coaching and completed a 19-item survey assessing socio-demographics and technology receptivity measured by the 8-item Technology Acceptance Scale (TAS). Open-ended written feedback was obtained, and content analysis was used to derive themes from these data. Respondents were: 40% female, 56% unemployed, 41% racial minority, 38% current smoker, and 58% depression history. Mean total TAS score was 34.0 (SD = 5.5) of possible 40, indicating overall very good receptivity to the robotic-assisted exercise intervention concept. Racial minorities and unemployed participants reported greater technology acceptance than White (p = 0.015) and employed (p<0.001) respondents. No association was detected between the TAS score and smoking status, depression, gender or age groups. Qualitative feedback indicated the robot was perceived as a novel, motivating, way to increase intervention reach and accessibility, and the wave of the future. Robotic technology has potential applicability for exercise coaching in a broad range of populations, including depressed smokers. Our next step will be to conduct a pilot trial to assess acceptability and potential efficacy of the robotic-assisted exercise coaching intervention for smoking cessation.

Six-Month Outcomes for Collaborative Care Management of Depression Among Smoking and Nonsmoking Patients.

BACKGROUND: Collaborative care management (CCM) is an evidence-based model that contributes to better outcomes for depression treatment in the primary care setting. Tobacco use increases overall economic costs, morbidity, and mortality and has been shown to impact behavioral health outcomes. Our study aims to observe clinical outcomes for depression treatment for patients with comorbid tobacco use and depression within the CCM model. METHODS: A retrospective chart review study of 2826 adult patients with depression enrolled in CCM was performed to determine the association between regular tobacco use and depression outcomes. Baseline intake data consisting of clinical and demographic variables along with 6-month follow-up of Patient Health Questionnaire-9 (PHQ-9) scores for smokers (n = 727, 25.7%) and nonsmokers (n = 2099, 74.3%) were obtained. Depression remission was defined as a PHQ-9 score <5 and persistent depressive symptoms (PDS) as a PHQ-9 score ≥10 at 6 months. RESULTS: Using an intention-to-treat analysis, the multivariate modeling demonstrated that smokers, at 6 months, had an increased adjusted odds ratio (AOR) for PDS: 1.624 (95% CI: 1.353-1.949). Furthermore, smokers had a lower AOR of depression remission: 0.603 (95% CI: 0.492-0.739). Patient adherence to treatment was also lower in smokers with an AOR of 0.666 (95% CI: 0.553-0.802). CONCLUSIONS: Smokers enrolled in CCM were associated with reduced treatment adherence and worse outcomes for depression treatment at 6 months compared to nonsmokers, even when baseline clinical and demographic variables were controlled. Thus, new tailored practices may be warranted within the CCM model to treat comorbid depression and tobacco use disorders.

Patterns and Appropriateness of Thrombophilia Testing in an Academic Medical Center.

BACKGROUND: Clinical guidelines recommend against routine use of thrombophilia testing in patients with acute thromboembolism. Thrombophilia testing rarely changes acute management of a thrombotic event. OBJECTIVE: To determine appropriateness of thrombophilia testing in a teaching hospital. DESIGN: Retrospective cohort study. SETTING: One academic medical center in Utah. PARTICIPANTS: All patients who received thrombophilia testing between July 1, 2014, and December 31, 2014. MAIN MEASUREMENTS: Proportion of thrombophilia tests occurring in situations associated with minimal clinical utility, defined as tests meeting at least 1 of the following criteria: discharged before results available; test type not recommended; testing in situations associated with decreased accuracy; duplicate testing; and testing following a provoked thrombotic event. RESULTS: Overall, 163 patients received a total of 1451 thrombophilia tests for stroke (50% of tests; 35% of patients), venous thromboembolism (21% of tests; 21% of patients), and pregnancy-related conditions (15% of tests; 25% of patients). Of the 39 different test types performed, the most common were cardiolipin IgG and IgM antibodies (9% each), lupus anticoagulant (9%), and ß2-glycoprotein 1 IgG and IgM antibodies (8% each). In total, 911 tests (63%) were performed in situations associated with minimal clinical utility, with 126 patients (77%) receiving at least one such test. Only 2 patients (1%) had clear documentation of being offered genetic consultation. CONCLUSIONS: Thrombophilia testing in this single-center study was often associated with minimal clinical utility. Strategies to improve testing practices (eg, hematology specialty consult prior to inpatient testing, improved order panels) might help minimize inappropriate testing and promote value-driven care.

Bridge Therapy Outcomes in Patients With Mechanical Heart Valves.

BACKGROUND: Bridge therapy is associated with an increased risk of major bleeding in patients with atrial fibrillation and venous thromboembolism (TE) without a corresponding reduction in TE. The benefits of bridge therapy in patients with mechanical heart valve (MHV) prostheses interrupting warfarin for invasive procedures are not well described. METHODS AND RESULTS: A retrospective cohort study was conducted at an integrated health-care delivery system. Anticoagulated patients with MHV interrupting warfarin for invasive diagnostic or surgical procedures between January 1, 2006, and March 31, 2012, were identified. Patients were categorized according to exposure to bridge therapy during the periprocedural period and TE risk (low, medium, and high). Outcomes validated via manual chart review included clinically relevant bleeding, TE, and all-cause mortality in the 30 days following the procedure. There were 547 procedures in 355 patients meeting inclusion criteria. Mean cohort age was 65.2 years, and 38% were female. Bridge therapy was utilized in 466 (85.2%) procedures (95.2%, 77.3%, and 65.8% of high, medium, and low TE risk category procedures, respectively). The 30-day rate of clinically relevant bleeding was numerically higher in bridged (5.8%; 95% confidence interval [CI], 3.9%-8.3%) versus not bridged procedures (1.2%; 95% CI, <0.1%-6.7%; P = .102). No TEs or deaths were identified. CONCLUSION: The use of bridge therapy is common among patients with MHV and may be associated with increased bleeding risk. Further research is needed to determine whether bridge therapy reduces TE in patients with MHV interrupting warfarin for invasive procedures.

Bleeding, Recurrent Venous Thromboembolism, and Mortality Risks During Warfarin Interruption for Invasive Procedures.

IMPORTANCE: The risk of bleeding and recurrent venous thromboembolism (VTE) among patients receiving long-term warfarin sodium therapy for secondary VTE prevention who require temporary interruption of anticoagulant therapy for surgery or invasive diagnostic procedures has not been adequately described. OBJECTIVE: To describe the rates of clinically relevant bleeding and recurrent VTE among patients in whom warfarin therapy is interrupted for invasive procedures and compare these rates among patients who did and did not receive bridge therapy. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was conducted at Kaiser Permanente Colorado, an integrated health care delivery system. Patients in whom warfarin therapy was interrupted for invasive diagnostic or surgical procedures between January 1, 2006, and March 31, 2012, were identified via queries of administrative data sets. A total of 1812 procedures in 1178 patients met inclusion criteria. Data on outcomes and exposures were collected between June 1, 2005, and April 30, 2012. EXPOSURES: Use of bridge therapy vs no bridge therapy during warfarin interruption. MAIN OUTCOMES AND MEASURES: Thirty-day clinically relevant bleeding, recurrent VTE, and all-cause mortality. Outcomes were verified via manual review of medical records. RESULTS: Among the 1178 patients, the mean (SD) age was 66.1 (12.7) years, 830 procedures (45.8%) were in men, and the most common indication for warfarin therapy was deep vein thrombosis (56.3%). Most patients were considered to be at low risk for VTE recurrence at the time of warfarin interruption (1431 procedures [79.0%]) according to the consensus guidelines of the American College of Chest Physicians. Clinically relevant bleeding within 30 days after the procedure in the bridge therapy and non-bridge therapy groups occurred in 15 patients (2.7%) and 2 patients (0.2%), respectively (hazard ratio, 17.2; 95% CI, 3.9-75.1). There was no significant difference in the rate of recurrent VTE between the bridge and non-bridge therapy groups (0 vs 3; P = .56). No deaths occurred in either group. CONCLUSIONS AND RELEVANCE: Bridge therapy was associated with an increased risk of bleeding during warfarin therapy interruption for invasive procedures in patients receiving treatment for a history of VTE and is likely unnecessary for most of these patients. Further research is needed to identify patient- and procedure-related characteristics associated with a high risk of perioperative VTE recurrence during warfarin therapy interruption.

Thromboembolic and bleeding outcomes of extended duration low-intensity warfarin following elective total knee arthroplasty.

INTRODUCTION: The purpose of this study was to describe the incidence of symptomatic venous thromboembolism (VTE), clinically-relevant bleeding, and death among a real-world population receiving warfarin prophylaxis targeting an international normalized ratio (INR) of 1.5 to 2.5 for four weeks following total knee arthroplasty (TKA). MATERIALS AND METHODS: This retrospective, observational study included patients receiving warfarin following a TKA between August 1, 2005 and July 31, 2009 identified in the Kaiser Permanente Total Joint Replacement Registry. Patients<18 years, receiving warfarin for another indication, or without continuous KPCO membership during the study period were excluded. RESULTS: There were 1487 patients with TKA included in the analysis. Mean patient age was 67.7 years and 61.7% were female. The median percent of time in therapeutic INR range during follow-up was 55% (interquartile range=35%-75%). Nineteen cases of symptomatic VTE [1.3%; 95% confidence interval (CI) 0.8%-2.0%] including ten pulmonary emboli (PE) (0.7%) were identified within 90 days of surgery. Clinically-relevant bleeding occurred in 1.7% (95% CI 1.1%-2.5%) of patients during warfarin prophylaxis and there were no deaths within 90 days of surgery. CONCLUSIONS: The rates of symptomatic VTE and clinically-relevant bleeding following TKA in patients receiving warfarin prophylaxis with a target INR of 1.5 to 2.5 were low. Additional studies should include low-intensity warfarin to identify the regimen that optimally balances risks of bleeding and symptomatic VTE after major orthopedic surgery.