How can pharmacists better support patients with chronic diseases? The patient perspective.

BACKGROUND: Patients' perceptions of their interaction with pharmacists can affect how they use this resource for chronic disease care. OBJECTIVE: This qualitative study explored pharmacist-patient interactions and patients' perceptions of pharmacists' roles in cardiovascular disease (CVD) and inflammatory bowel disease (IBD). METHODS: Patient volunteers, recruited through Janssen's Patient Engagement Research Council program, completed a 15-minute prework survey before a 90-minute live virtual focus group session to provide feedback on pharmacist-patient interactions, the pharmacist's role in patient care, and recommendations for improvement. RESULTS: In total, 27 patients participated. Among patients with CVD (n=18), 56% were female, 61% aged ≥65 years, and 39%/39% Black/White. Of those with IBD (n=9), 56% were female, 89% aged 25-44 years, and 33%/56% Black/White. In the CVD cohort, patients conversed with their pharmacists at least monthly, on average. Patients were generally happy with their relationship with their pharmacist, viewing pharmacists as a trusted resource for medication information. Polypharmacy was common in the CVD cohort (mean, 10.8 medications). For patients with IBD, pharmacist-patient interactions were less frequent, relationships were generally perceived as transactional, patients took fewer medications (mean, 3.2), and felt uncomfortable discussing their disease in public. All patients (CVD and IBD) were unaware of pharmacists' medical training/knowledge. Recommendations included private spaces for sensitive conversations, phone/text support, in-depth regular check-ins, and proactive communication to highlight that the pharmacist's role is to provide patient-centered holistic care. CONCLUSION: This research demonstrates a lack of understanding of pharmacist training, accessibility and role among patients with chronic disease, and highlights opportunities to amend delivery of care. These insights can be used to inform strategies and approaches tailored to address unique needs of specific patient populations to enhance pharmacist-patient interactions.

Racial or ethnic differences on treatment adherence and persistence among patients with inflammatory bowel diseases initiated with biologic therapies.

BACKGROUND: Inflammatory bowel disease (IBD) is a chronic disease with the potential for significant morbidity in case of suboptimal treatment (e.g. low treatment adherence). In spite of immense research in IBD, literature on association of IBD with race/ethnicity is fragmented. In this study, we aimed to evaluate the association between race/ethnicity and treatment adherence and persistence among patients with Crohn's disease (CD) or ulcerative colitis (UC) initiated with biologic therapies. METHODS: This observational, retrospective study utilized the Optum Clinformatics (Optum) Extended Data Mart Socioeconomic Status (SES) database. Adult patients with ≥ 2 medical claims for CD or UC diagnosis, ≥ 1 medical or pharmacy claim for corresponding FDA-approved biologic therapy, and a ≥ 12-month pre-index (index date: date of the first biologic medical/pharmacy claim) continuous health plan enrollment were included. Treatment adherence was measured as the proportion of days covered of ≥ 80% and treatment persistence by the number of days from the index date to the biologics discontinuation date. Switching among biologics was allowed for both treatment adherence and treatment persistence. Multivariable regression analyses were performed to evaluate the association between race/ethnicity and treatment adherence/persistence. RESULTS: Among patients with CD (N = 1430) and UC (N = 1059) included, majority were White (CD: 80.3%, UC: 78.3%), followed by African Americans (AA; CD: 10.5%, UC: 9.7%). Among patients with CD, AA were significantly less likely to adhere to biologics (adjusted OR [95%CI]: 0.61 [0.38; 0.99]) and more likely to discontinue biologics earlier (adjusted HR [95%CI]: 1.52 [1.16; 2.0]) during the follow-up period compared to Whites, after adjusting for other patient sociodemographic and clinical characteristics. Among patients with UC, no significant differences in the treatment adherence/persistence were observed between different races/ethnicities. CONCLUSIONS: Patients with CD were found to display racial differences in the treatment adherence and persistence of biologics, with significantly lower adherence and earlier discontinuation in AA compared to Whites. Such differences were not observed in patients with UC. Future studies are warranted to understand the possible reasons for racial differences, particularly in patients with CD.

Recurrent hospitalization and healthcare resource use among patients with deep vein thrombosis and pulmonary embolism: findings from a multi-payer analysis.

The objective of this study was to assess deep vein thrombosis and pulmonary embolism (DVT/PE) recurrence rates and resource utilization among patients with an initial DVT or PE event across multiple payer perspectives. Retrospective analyses were performed using a software tool that analyzes health plan claims to evaluate treatment patterns and resource utilization for various cardiovascular conditions. Six databases were analyzed from three payer perspectives (Commercial, Medicare, and Medicaid). Patients were ≥18 years old with a primary diagnosis of DVT or PE associated with an inpatient and/or emergency room claim, had received an antithrombotic within 7 days before or 14 days after index, and had no diagnosis of atrial fibrillation during follow-up. Outcomes were assessed over a 1 year period following index. More PE patients were hospitalized for their index event than DVT patients (42-59 % DVT and 69-86 % PE) and had longer mean length of stay (2.35-2.95 days DVT and 3.26-3.76 days PE). Recurrent event rates among PE patients (12-32 %) were higher than those for DVT patients (6-16 %) across all payers. The highest rate of recurrence was observed among the Medicaid population [23 % overall (VTE); 16 % DVT; 32 % PE]. All-cause hospitalization in the year following their VTE episode occurred in 23-67 % DVT patients and 30-68 % PE patients. Medicaid had the highest proportion of patients with hospitalizations and ER visits. Recurrent VTE events and all-cause hospitalizations are relatively common, especially for patients who had a PE, and among those in the Medicaid payer population.

Nurses' self-reported time estimation of anticoagulation therapy: a survey of warfarin management in long-term care.

BACKGROUND: A nursing shortage in the United States has resulted in increased workloads, potentially affecting the quality of care. This situation is particularly concerning in long-term care (LTC) facilities, where residents are older, frailer, and may be receiving multiple medications for comorbidities, thus requiring a greater commitment of nurse time. We conducted a survey of LTC nurses to determine how much of their time each week is spent managing newly started and stable warfarin-treated residents. METHODS: Forty LTC nurses validated the questionnaire to determine what protocols/procedures are involved in warfarin management. Twenty LTC nurses completed the survey, quantifying the time they spend on procedures related to warfarin management, and how often they performed each procedure for each resident each week. RESULTS: The nurses reported that 26% of their residents were receiving warfarin; the majority (approximately 75%) of these residents began warfarin after admission to the facility. On average, the nurses spent 4.6 hours per week for treatment procedures and monitoring patients initiating warfarin therapy and 2.35 hours per week for each resident who was stable on warfarin therapy on admission. Overall, to care for an average number of newly initiated and stable warfarin patients in a medium-size LTC facility, staff nurses are estimated to spend 68 hours per week. Study limitations include the potential for bias because of the small sample size, representativeness of the sample, and the possibility of inaccuracies in respondents' self-reported time estimation of warfarin-related procedures. CONCLUSIONS: In the context of a well-documented and expanding nursing shortage in the United States, the substantial use of time and resources necessary to initiate, monitor, and manage warfarin treatment in elderly LTC patients is of concern. Until the problem of understaffing is resolved, implementation of therapies that are simpler and require less nursing time-e.g. the use of new oral anticoagulants in the place of warfarin-may be a way to free up nursing time for other essential care tasks.

Anticoagulant use for the prevention of stroke in patients with atrial fibrillation: findings from a multi-payer analysis.

BACKGROUND: Oral anticoagulation is recommended for stroke prevention in intermediate/high stroke risk atrial fibrillation (AF) patients. The objective of this study was to demonstrate the usefulness of analytic software tools for descriptive analyses of disease management in atrial AF; a secondary objective is to demonstrate patterns of potential anticoagulant undertreatment in AF. METHODS: Retrospective data analyses were performed using the Anticoagulant Quality Improvement Analyzer (AQuIA), a software tool designed to analyze health plan data. Two-year data from five databases were analyzed: IMS LifeLink (IMS), MarketScan Commercial (MarketScanCommercial), MarketScan Medicare Supplemental (MarketScanMedicare), Clinformatics™ DataMart, a product of OptumInsight Life Sciences (Optum), and a Medicaid Database (Medicaid). Included patients were ≥ 18 years old with a new or existing diagnosis of AF. The first observed AF diagnosis constituted the index date, with patient outcomes assessed over a one year period. Key study measures included stroke risk level, anticoagulant use, and frequency of International Normalized Ratio (INR) monitoring. RESULTS: High stroke risk (CHADS2 ≥ 2 points) was estimated in 54% (IMS), 22% (MarketScanCommercial), 64% (MarketscanMedicare), 42% (Optum) and 62% (Medicaid) of the total eligible population. Overall, 35%, 29%, 38%, 39% and 16% of all AF patients received an anticoagulant medication in IMS, MarketScanCommercial, MarketScanMedicare, Optum and Medicaid, respectively. Among patients at high risk for stroke, 19% to 51% received any anticoagulant. CONCLUSIONS: The AQuIA provided a consistent platform for analysis across multiple AF populations with varying baseline characteristics. Analyzer results show that many high-risk AF patients in selected commercial, Medicare-eligible, and Medicaid populations do not receive appropriate thromboprophylaxis, as recommended by treatment guidelines.

Racial and Ethnic Disparities in Health-Related Outcomes in Crohn's Disease: Results From the National Health and Wellness Survey.

Background: Crohn's disease (CD) is a chronic inflammatory condition affecting the entire gastrointestinal tract that is associated with significant humanistic, clinical, and economic burdens. Few studies have assessed the association between CD severity and patient-reported outcomes (PROs), healthcare resource utilization (HCRU), and medical costs; even fewer have examined differences in disease outcomes among patients of various racial/ethnic groups. Methods: In this cross-sectional study, sociodemographic data, PROs, and economic outcomes for participants with self-reported CD were collected from the National Health and Wellness Survey (2018-2020). Multivariable analyses were used to assess the association of CD severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), HCRU, and medical costs. Results: Analyses included 1077 participants with CD (818 non-Hispanic White, 109 non-Hispanic Black, and 150 Hispanic). Participants with self-reported moderate/severe CD reported significantly worse HRQoL and WPAI, greater HCRU, and higher medical costs than those with self-reported mild CD. Non-Hispanic Black participants reported better HRQoL and fewer healthcare provider visits than non-Hispanic White participants. There were no significant differences in PROs between non-Hispanic White and Hispanic groups. Interactions between race/ethnicity and CD severity emerged for some, but not all groups: Specifically, non-Hispanic Black participants with moderate/severe CD reported greater absenteeism and more gastroenterologist visits than non-Hispanic Black participants with mild CD. Conclusions: Participants with moderate/severe CD reported worse PROs, greater HCRU, and higher medical costs than those with mild CD. Additionally, racial/ethnic differences were found across several HCRU and economic outcomes. Further research is needed to better understand factors contributing to burden among patients with varying CD severity across racial/ethnic groups.

Racial and Ethnic Disparities in Treatment Initiation Among Patients with Newly Diagnosed Psoriatic Arthritis: A Retrospective Medicaid Claims Database Study.

INTRODUCTION: In patients with psoriatic arthritis (PsA), potential differences in care by race/ethnicity have not been well studied. METHODS: This retrospective, observational cohort analysis utilized the IBM MarketScan® Multi-State Medicaid database. Patients aged ≥ 18 years with two or more PsA-related claims between January 1, 2010 and December 31, 2019, and ≥ 12 months of continuous enrollment before the first diagnosis of PsA (index date) were included. Outcomes evaluated were the use of disease-modifying antirheumatic drugs (DMARDs) overall and by type (conventional synthetic, biologic, targeted synthetic) within 12 months following initial PsA diagnosis, as well as the time to DMARD initiation after initial PsA diagnosis, stratified by race/ethnicity. Multivariate Cox proportional hazards models were used to assess potential associations between patient baseline characteristics and time to DMARD initiation. RESULTS: Among patients with newly diagnosed PsA (N = 3432), the mean age was 44.4 years, 69.9% were female, 77.4% were White, and 10.1% were Black. Of the 2993 patients with at least 12 months of follow-up, fewer Black patients received any DMARD therapy compared with White patients (68.4 vs. 76.4%, respectively, p = 0.002), and, specifically, a lower percentage of Black patients received biologic DMARDs compared with White patients (33.6 vs. 42.6%, respectively, p = 0.003). After adjusting for baseline characteristics, Black patients had significantly longer time to initiation of any DMARD (HR [95% CI] 0.82 [0.71-0.94]) and biologic DMARD (0.84 [0.71-0.99]) compared with White patients. Other baseline variables such as older age, anxiety, and hepatitis C were also significantly associated with longer time to any DMARD initiation after initial PsA diagnosis. CONCLUSIONS: Time to treatment initiation was significantly longer in Black patients compared with White patients with newly diagnosed PsA. These findings suggest care delivery disparities in patients with PsA and highlight the need for future studies to understand factors that drive the observed differences in drug therapy by race/ethnicity.

Use of warfarin in long-term care: a systematic review.

BACKGROUND: The use of warfarin in older patients requires special consideration because of concerns with comorbidities, interacting medications, and the risk of bleeding. Several studies have suggested that warfarin may be underused or inconsistently prescribed in long-term care (LTC); no published systematic review has evaluated warfarin use for stroke prevention in this setting. This review was conducted to summarize the body of published original research regarding the use of warfarin in the LTC population. METHODS: A systematic literature search of the PubMed, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library was conducted from January 1985 to August 2010 to identify studies that reported warfarin use in LTC. Studies were grouped by (1) rates of warfarin use and prescribing patterns, (2) association of resident and institutional characteristics with warfarin prescribing, (3) prescriber attitudes and concerns about warfarin use, (4) warfarin management and monitoring, and (5) warfarin-related adverse events. Summaries of study findings and quality assessments of each study were developed. RESULTS: Twenty-two studies met the inclusion criteria for this review. Atrial fibrillation (AF) was the most common indication for warfarin use in LTC and use of warfarin for stroke survivors was common. Rates of warfarin use in AF were low in 5 studies, ranging from 17% to 57%. These usage rates were low even among residents with high stroke risk and low bleeding risk. Scored bleeding risk had no apparent association with warfarin use in AF. In physician surveys, factors associated with not prescribing warfarin included risk of falls, dementia, short life expectancy, and history of bleeding. International normalized ratio was in the target range approximately half of the time. The combined overall rate of warfarin-related adverse events and potential events was 25.5 per 100 resident months on warfarin therapy. CONCLUSIONS: Among residents with AF, use of warfarin and maintenance of INR levels to prevent stroke appear to be suboptimal. Among prescribers, perceived challenges associated with warfarin therapy often outweigh its benefits. Further research is needed to explicitly consider the appropriate balancing of risks and benefits in this frail patient population.

Impact of non-medical switching of prescription medications on health outcomes: an e-survey of high-volume medicare and medicaid physician providers.

BACKGROUND: Non-medical switching refers to a change in a stable patient's prescribed medication to a clinically distinct, non-generic, alternative for reasons other than poor clinical response, side-effects or non-adherence. OBJECTIVE: To assess the perceptions of high-volume Medicare and/or Medicaid physician providers regarding the impact non-medical switching has on their patients' medication-related outcomes and health-care utilization. METHODS: We performed an e-survey of high-volume Medicare and/or Medicaid physicians (spending >50% of their time caring for Medicare and/or Medicaid patients), practicing for >2 years but <30 years post-residency and/or fellowship; working in a general, internal, family medicine or specialist setting; spending ≥40% of their time providing direct care and having received ≥1 request for a non-medical switch in the past 12 months. Physicians were queried on 15-items to assess perceptions regarding the impact non-medical switching on medication-related outcomes and health-care utilization. RESULTS: Three-hundred and fifty physicians were included. Respondents reported they felt non-medical switching, to some degree, increased side-effects (54.0%), medication errors (56.0%) and medication abandonment (60.3%), and ~50% believed it increased patients' out-of-pocket costs. Few physicians (≤13.4% for each) felt non-medical switching had a positive impact on effectiveness, adherence or patients' or physicians' confidence in the quality-of-care provided. Non-office visit and prescriber-pharmacy contact were most frequently thought to increase due to non-medical switching. One-third of physicians felt office visits were very frequently/frequently increased, and ~ 1-in-5 respondents believed laboratory testing and additional medication use very frequently/frequently increased following a non-medical switch. About 1-in-10 physicians felt non-medical switching very frequently/frequently increased the utilization of emergency department or in-hospital care. CONCLUSION: This study suggests high-volume Medicare and/or Medicaid physician providers perceive multiple negative influences of non-medical switching on medication-related outcomes and health-care utilization.

Specialist physician perspectives on non-medical switching of prescription medications.

Introduction: A non-medical switch is a change to a patient's medication regimen for reasons other than lack of clinical response, side-effects or poor adherence. Specialist physicians treat complex patients who may be vulnerable to non-medical switching. Objectives: To evaluate specialist physicians' perceptions regarding the frequency of non-medical switch requests, and the impact on their patients' outcomes and healthcare utilization. Methods: An online survey of randomly sampled physicians spending ≥10% of time providing patient care and having received ≥1 non-medical switch request during the prior 12-months. Results: Among 404 specialist physicians surveyed, non-medical switch requests were reported as very frequent or frequent by 35.0% of oncologists (for injectable cancer agents) and up to 80.3% of endocrinologists (for injectable anti-hyperglycemics). Respondents reported decreased medication effectiveness (25.0% of oncologists to 75.0% of dermatologists) and increased side-effects (32.5% of oncologists to 66.7% of psychiatrists). Most specialists reported very frequent or frequent increases in non-office visits (52.5% of oncologists to 75.3% of endocrinologists) and calls with pharmacies (57.5% of oncologists to 80.5% of rheumatologists) due to non-medical switching. Conclusions: Receipt of non-medical switching requests were common among specialist physicians. Non-medical switching may lead to negative effects on patient care and require increased healthcare utilization.

Physicians' perspectives regarding non-medical switching of prescription medications: Results of an internet e-survey.

BACKGROUND: Physicians are in an ideal position to describe the impact of medication non-medical switching (switching commonly due to formulary changes by insurer for reasons unrelated to patient health) on their practice dynamics and patient care. We sought to examine physicians' openness to requests for non-medical switching and their experiences and opinions regarding the impact of non-medical switching on their practice, staff and patients. METHODS: An online survey of randomly-sampled physicians spending ≥10% of time providing patient care and having received ≥1 non-medical switch request during the prior 12-months. The impact of non-medical switching on clinical decision-making process; professional experience with clinical practice, patient-physician relationship, insurance process; and perceived impact on practice, staff and patients were assessed. Weighted percent responses were calculated. RESULTS: We sampled 1,010 physicians (response rate = 55.5%). Many responded being frequently not amenable (26.0%) or had reservations (41.8%) to non-medical switch requests; with >50% indicating patient stability on current therapy and suboptimal alternatives as factors frequently influencing amenability. Physicians agreed non-medical switching can create ethical concerns (clinical judgement, autonomy, ability to treat per guidelines; 74.8%, 82.3%, 53.5%, respectively), while forcing them to take responsibility for insurers' decisions (81.1%) and diverting their clinical time (84.3%). Most indicated non-medical switching increased practice burden (administrative, non-billable interactions, additional staffing, non-office patient contact, calls to/from the pharmacy; 85.0%, 72.5%, 62.2%, 64.2%, 69.5%, respectively). Physicians felt insurer processes discouraged non-medical switch challenges (76.7%) and required inconvenient lengths-of-time (76.1%) speaking to insurer representatives without proper expertise (62.0%). They believed non-medical switching negatively impacted aspects of care (effectiveness, side-effects, medication adherence and abandonment, out-of-pocket costs, medication errors; 46.5%, 53.2%, 50.6%, 49.4%, 59.6%, 54.5%, respectively). CONCLUSIONS: Physicians were frequently not amenable or had reservations regarding non-medical switching. They noted ethical concerns due to non-medical switching. Most felt non-medical switches burdened their practice and negatively impacted care.

Communication of Medication Nonmedical Switching Policies and Procedures by Insurance Companies: Results of an E-Survey.

PURPOSE: Nonmedical switching is defined as a change in a stable patient's prescribed medication to a clinically distinct, nongeneric alternative for reasons other than lack of clinical response, adverse effects, or poor adherence. Nonmedical switching often results from formulary changes implemented by insurers to lower medication costs. We sought to survey randomly sampled physicians to elicit their opinions regarding insurers' communication about nonmedical switching. METHODS: We performed an online, cross-sectional survey of licensed, practicing physicians who were >2 years but <30 years out of residency and/or fellowship, who practiced in an internal medicine, family medicine, or specialist setting, spent ≥10% of their work time providing direct patient care, and had received at least 1 request for a nonmedical switch for ≥1 patient in the prior 12 months. The survey was fielded from November to December 2018. We report weighted percent responses categorized from 5- or 7-point Likert scale questions. FINDINGS: E-mail invitations were sent to 13,117 randomly sampled physicians, and 1818 opened the e-mail and followed the embedded survey link to participate. Of these, 1010 total physicians (55.5%), 606 primary care and 404 specialists, who treated patients experiencing nonmedical switching in the prior 12 months completed the survey. A few physicians were notified about nonmedical switches by insurers; more frequently physicians learned about them from pharmacies serving their patients. Notification frequently occurred at or after a refill came due. Notification via electronic medical record or insurer letter was less frequent. Few thought that insurers clearly communicated information about alternative medications when a nonmedical switch was required, and most disagreed that insurers provided clear procedures, timelines, and methods to track challenges. Nearly all agreed that insurers should provide supporting documentation or rationale for nonmedical switches and specifics on alternatives. Respondents overwhelmingly agreed that steps to improve communication and physicians' and patients' ability to navigate nonmedical switches or challenge procedures should be implemented. IMPLICATIONS: This survey of primary care and speciality physicians suggests that physicians believe that insurers' current level of communication regarding nonmedical switching is suboptimal. Respondents suggested that insurers did not optimally communicate information about alternative medications when a nonmedical switch was required and did not provide clear procedures, timelines, and methods to track challenges. A preponderance of physicians agreed that steps to improve physician-insurer communication to aid in the navigation of nonmedical switch and to challenge procedures should be implemented. If not addressed, these identified nonmedical switch communication issues may have a negative effect on achieving the quadruple aim of enhancing patient experience, improving population health, reducing costs, and improving the work life of health care practitioners and their staff.

Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: a meta-analysis.

OBJECTIVES: Studies have found that initial treatment of ventilator-associated pneumonia (VAP) and blood stream infections (BSI) with inappropriate antimicrobial therapy is associated with higher rates of mortality, but additional studies have failed to confirm this. METHODS: Databases were searched to identify studies that met the following criteria: observational trials, patients with VAP or BSI receiving appropriate and inappropriate antimicrobial therapy, and mortality data. We conducted random-effects model meta-analyses, both with and without adjustment. RESULTS: Meta-analyses of VAP studies using unadjusted and adjusted data indicated that inappropriate therapy significantly increased patients' odds of mortality (odds ratio [OR], 2.34; 95% confidence interval [CI], 1.51-3.63; P = .0001, I 2 = 28.5% and OR, 3.03; 95% CI, 1.12-8.19; P = .0292, I 2 = 89.2%, respectively). Meta-analyses of BSI studies using unadjusted and adjusted data showed that inappropriate therapy significantly increased patients' odds of mortality (OR, 2.33; 95% CI, 1.96-2.76; P < .0001, I 2 = 48.7% and OR, 2.28; 95% CI, 1.43-3.65; P = .0006, I 2 = 88.2%, respectively). CONCLUSIONS: There appears to be an association between initial inappropriate antimicrobial therapy and increased mortality in patients with VAP and BSI.

The use of protamine after radiofrequency catheter ablation: a pilot study.

OBJECTIVE: Evaluate the effect of administering intravenous protamine immediately post-radiofrequency catheter ablation (RFCA) on thrombotic and bleeding complications in heparinized patients. METHODS: Heparinized patients that had RFCA for atrial or ventricular arrhythmias at our institution between January 2001 and March 2006 and had a complete data set were included in this cohort evaluation. Patients receiving at least one dose of protamine within 15 min of RFCA were deemed the prophylactic group while those not receiving protamine within 15 min were the control group. Thrombotic (cerebrovascular event, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or myocardial infarction) and bleeding events (blood loss requiring transfusion, hematoma requiring intervention, or intracranial hemorrhage) were compared between groups. RESULTS: Overall, 158 patients (74% male, 55 +/- 13.5) met inclusion criteria. Of these, 73.4% received prophylactic protamine (average dose = 39 mg +/- 17). Only one patient (0.9%) in the prophylactic protamine group and zero patients in the control group experienced a thrombotic event (p > 0.99). Only two patients (1.7%) in the protamine group (n = 2 blood transfusions) and zero patients in the control group experienced bleeding events (p = 0.839). CONCLUSIONS: Administering prophylactic intravenous protamine to allow for quicker catheter removal following RFCA in heparinized patients did not markedly impact thrombotic or bleeding complication rates in our population. The perceived benefit in our institution to protamine administration in this population is a reduction in postoperative patient immobilization and discomfort, reduced PACU nursing care, and earlier time to discharge. Given the low rate of thrombotic and bleeding events, a study of several thousand patients would be needed to fully evaluate the impact on these events.

The Use of a Novel Heart Failure Agent in the Treatment of Pregnancy-Associated Cardiomyopathy.

Peripartum cardiomyopathy is an uncommon, pregnancy-related form of dilated cardiomyopathy that is associated with development of new-onset left ventricular dysfunction. Its etiology is presently unknown, but current standard of care involves the use of typical drug therapy for the treatment of heart failure. Pregnancy-associated cardiomyopathy (PACM) is a similar condition that refers to patients who develop such symptoms prior to the last month of pregnancy. We report the case of a nulliparous Caucasian female who develops early, severe PACM during her first pregnancy with postpartum persistence of New York Heart Association class II-III symptoms despite medical therapy. The use of the novel heart failure agent, sacubitril/valsartan (Entresto), is initiated with near-complete resolution of her symptoms.

An Incidentally Detected Right Ventricular Pseudoaneurysm.

Ventricular pseudoaneurysm is an uncommon, potentially fatal complication that has been associated with myocardial infarction, cardiac surgery, chest trauma, and infectious processes. Diagnosis can be challenging, as cases are rare and slowly progressing and typically lack identifiable features on clinical presentation. As a result, advanced imaging techniques have become the hallmark of identification. Ahead, we describe a patient who presents with acute decompensated heart failure and was incidentally discovered to have a large right ventricular pseudoaneurysm that developed following previous traumatic anterior rib fracture.

Stroke risk reduction outweighed bleeding risk increase from vitamin K antagonist treatment among nonvalvular atrial fibrillation patients with high stroke risk and low bleeding risk.

OBJECTIVE: Warfarin is widely used for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). We compared the rates of stroke and major bleeding in NVAF patients with a high stroke risk and low bleeding risk profile during warfarin treated (W+) and warfarin untreated (W-) periods. METHOD: Insurance claims from six commercial, Medicaid or Medicare databases were analyzed from 2000 to 2014. NVAF patients treated with warfarin, with a CHADS2/CHA2DS2-VASc score ≥2, and an ATRIA score ≤3 at baseline were identified. Incidence rate ratios (IRRs) of stroke and major bleeding were calculated for W + versus W- episodes of person-time, as well as for first 30 days versus beyond 30 days of W + episodes. RESULTS: Among 316,145 patients, anticoagulant prophylaxis with warfarin significantly reduced stroke risk, with IRRs ranging from 0.48 (95% CI: 0.46-0.51) to 0.80 (95% CI: 0.70-0.91), and increased major bleeding risk, with IRRs ranging from 1.13 (95% CI: 1.10-1.15) to 1.95 (95% CI: 1.10-3.45). Stroke and major bleeding rates were higher during the first 30 days of W + than beyond. CONCLUSION: In NVAF patients at high risk for stroke and low risk for bleeding, our data confirm the effectiveness of anticoagulation for stroke prevention. The decrease in stroke risk of anticoagulation may outweigh the risk of major bleeding events, particularly among elderly patients. Potential risks of warfarin during initiation warrant attention, especially among patients who stop and start therapy repeatedly.

Developing a Comprehensive Cardio-Oncology Program at a Cancer Institute: The Moffitt Cancer Center Experience.

Cardio-oncology is a multidisciplinary field focusing on the management and prevention of cardiovascular complications in cancer patients and survivors. While the initial focus of this specialty was on heart failure associated with anthracycline use, novel anticancer agents are increasingly utilized and are associated with many other cardiotoxicities including hypertension, arrhythmias and vascular disease. Since its inception, the field has developed at a rapid pace with the establishment of programs at many major academic institutions and community practices. Given the complexities of this patient population, it is important for providers to possess knowledge of not only cardiovascular disease but also cancer subtypes and their specific therapeutics. Developing a cardio-oncology program at a stand-alone cancer center can present unique opportunities and challenges when compared to those affiliated with other institutions including resource allocation, cardiovascular testing availability and provider education. In this review, we present our experiences establishing the cardio-oncology program at Moffitt Cancer Center and provide guidance to those individuals interested in developing a program at a similar independent cancer institution.

Rates and risk of arrhythmias in cancer survivors with chemotherapy-induced cardiomyopathy compared with patients with other cardiomyopathies.

Objectives: There is little information about arrhythmia burden in cancer survivors with chemotherapy-induced cardiomyopathy (CIC). We hypothesise that the rates and risk of arrhythmias will be similar in CIC when compared with other non-ischaemic cardiomyopathy (NICMO) aetiologies. Methods: We retrospectively identified nine patients with CIC and an implantable defibrillator and 18 age and sex-matched control patients (nine patients with NICMO and nine patients with ischaemic cardiomyopathy (ICMO)). Rates and odds of arrhythmias were calculated by type of cardiomyopathy, adjusting for days since implantable cardioverter defibrillator implantation, history of atrial fibrillation and length of follow-up using logistic regression analysis. Results: Compared with patients with NICMO, rates and adjusted odds were similar for patients with CIC for atrial arrhythmias (44.4% vs 33.3%; adjusted OR=1.89; 95% CI0.17 to 21.03; P=0.61), non-sustained ventricular tachycardia (NSVT) (44.4% vs 33.3%; OR=2.10; 95% CI 0.21 to 20.56; P=0.53), and the combined outcome of NSVT, sustained ventricular tachycardia and/or ventricular fibrillation (44.4% vs 44.4%; OR=2.70; 95% CI 0.25 to 29.48; P=0.42). Conversely, compared with patients with NICMO, patients with ICMO demonstrated higher rates and adjusted odds of the combined outcome (88.9% vs 44.4%; OR=28.60; 95% CI 1.26 to 648.2; P=0.04) and NSVT (77.8% vs 33.3%; OR=8.95; 95% CI 0.90 to 88.94; P=0.06). Conclusions: While tentative based on sample size, rates of arrhythmias in patients with CIC appear to be similar to those experienced by patients with other forms of NICMO.

The impact of coenzyme Q10 on systolic function in patients with chronic heart failure.

BACKGROUND: Coenzyme Q10 (CoQ10) is an endogenous cofactor in the mitochondrial energy production. CoQ10 has been touted to improve heart failure, but its effect on systolic function is controversial. Several small, randomized controlled trials evaluating CoQ10 showed variable results and were largely underpowered. We conducted a meta-analysis of these trials to evaluate the impact of CoQ10 therapy on ejection fraction and cardiac output. METHODS AND RESULTS: A systematic literature search was conducted to identify randomized, controlled trials of CoQ10 in heart failure between 1966 and June 2005. Subgroup analysis was conducted to assess clinical heterogeneity between trials. Of the 11 trials identified, 10 evaluated ejection fraction (n = 277) and 2 evaluated cardiac output (n = 42). Doses ranged from 60 to 200 mg/day with treatment periods ranging from 1 to 6 months. There was a 3.7% net improvement in ejection fraction (95% CI 1.59-5.77; P < .00001 for statistical heterogeneity). A more profound effect among patients not receiving angiotensin-converting enzyme inhibitors was observed (6.74% [95% CI 2.63-10.86]). Cardiac output increased an average of 0.28 L/minute (95% CI 0.03-0.53; P = .96 for statistical heterogeneity). CONCLUSION: CoQ10 enhances systolic function in chronic heart failure, but its effectiveness may be reduced with concomitant use of current standard therapies.