Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial.

BACKGROUND: Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates. OBJECTIVE: To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD. DESIGN: Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973). SETTING: Fourteen academic and community-based electrophysiology clinics in the United States. PARTICIPANTS: Black adults with heart failure who were eligible for a primary prevention ICD. INTERVENTION: An encounter-based video decision support tool or usual care. MEASUREMENTS: The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians. RESULTS: Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, -0.8 percentage point [95% CI, -13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, -2.6 [CI, -5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, -4.9 minutes [CI, -9.4 to -0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes. LIMITATION: The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study. CONCLUSION: A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute.

Cardiac resynchronization therapy outcomes with left ventricular lead concordant with latest mechanical activation: A meta-analysis.

BACKGROUND: For cardiac resynchronization therapy (CRT), image-guided approaches targeting left ventricular (LV) lead placement at the site of latest mechanical activation had inconsistent outcomes. We examined evidence for improved CRT outcomes when LV lead placement concordant with latest mechanical activation occurred. METHODS: A review of EMBASE and PubMed was performed for randomized controlled trials or prospective observational studies from October 2008 through October 2020 comparing outcomes with concordant versus discordant LV lead placement. Meta-analyses were performed to assess the association between concordance and death, death or heart failure (HF) hospitalization, ≥ 15% reduction in LV end systolic volume (LVESV), and changes in LVESV or ejection fraction (LVEF). RESULTS: From 5897 citations, nine publications (eight studies) with 1355 patients were selected; 975 with a concordant LV lead and 380 with a discordant lead. Mean age was 66-68 years, 82% were male, and 64% had ischemic cardiomyopathy. Meta-analyses demonstrated a statistically significant reduction in death/HF hospitalization at 2 years (OR 0.38; 95% CI 0.16, 0.92) and LVESV at 6 months (mean difference [MD] -13.4%; 95% CI -6.7%, -20.0%), and an increase in LVEF (MD 4.03; 95% CI 0.77, 7.30) with the concordant LV lead. There were trends toward decreased death at 2 years (OR 0.49; 95% CI 0.19, 1.23) and ≥ 15% reduction in LVESV at 6 months (OR 3.81; 95% CI 0.24, 61.24) with concordant LV lead placement. CONCLUSION: A concordant LV lead was associated with better CRT outcomes. Further study of feasible methods to achieve LV lead concordance is needed.

Outcomes of Cardiac Resynchronization Therapy with Image-Guided Left Ventricular Lead Placement at the Site of Latest Mechanical Activation: A Systematic Review and Meta-Analysis.

Aim: To assess evidence for an image-guided approach for cardiac resynchronization therapy (CRT) that targets left ventricular (LV) lead placement at the segment of latest mechanical activation. Methods: A systematic review of EMBASE and PubMed was performed for randomized controlled trials (RCTs) and prospective observational studies from October 2008 through October 2020 that compared an image-guided CRT approach with a non-image-guided approach for LV lead placement. Meta-analyses were performed to assess the association between the image-guided approach and NYHA class improvement or changes in end-systolic volume (LVESV), end-diastolic volume (LVEDV), and ejection fraction (LVEF). Results: From 5897 citations, 5 RCTs including 818 patients (426 image-guided and 392 non-image-guided) were identified. The mean age ranged from 66 to 71 years, 76% were male, and 53% had ischemic cardiomyopathy. Speckle tracking echocardiography was the primary image-guided method in all studies. LV lead placement within the segment of the latest mechanical activation (concordant) was achieved in the image-guided arm in 45% of the evaluable patients. There was a statistically significant improvement in the NYHA class at 6 months (odds ratio 1.66; 95% confidence interval (CI) [1.02, 2.69]) with the image-guided approach, but no statistically significant change in LVESV (MD -7.1%; 95% CI [-16.0, 1.8]), LVEDV (MD -5.2%; 95% CI [-15.8, 5.4]), or LVEF (MD 0.68; 95% CI [-4.36, 5.73]) versus the non-image-guided approach. Conclusion: The image-guided CRT approach was associated with improvement in the NYHA class but not echocardiographic measures, possibly due to the small sample size and a low rate of concordant LV lead placement despite using the image-guided approach. Therefore, our meta-analysis was not able to identify consistent improvement in CRT outcomes with an image-guided approach.

Right ventricular lead location and outcomes among patients with cardiac resynchronization therapy: A meta-analysis.

BACKGROUND: Cardiac resynchronization therapy (CRT) has been demonstrated to improve heart failure (HF) symptoms, reverse LV remodeling, and reduce mortality and HF hospitalization (HFH) in patients with a reduced left ventricular (LV) ejection fraction (LVEF). Prior studies examining outcomes based on right ventricular (RV) lead position among CRT patients have provided mixed results. We performed a systematic review and meta-analysis of randomized controlled trials and prospective observational studies comparing RV apical (RVA) and non-apical (RVNA) lead position in CRT. METHODS: Our meta-analysis was constructed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews and meta-analyses. We searched EMBASE and MEDLINE. Eligible studies reported on at least one of the following outcomes of interest: all-cause mortality, the composite endpoint of death and first HFH hospitalization, change in LVEF, New York Heart Association (NYHA) class improvement, and change in LV end systolic volume (LVESV). We performed meta-analysis summaries using a DerSimonian-Laird random-effects model and conservatively used the Knapp-Hartung approach to adjust the standard errors of the estimated model coefficients. RESULTS: We included nine studies representing a total of 1832 patients. Of those, 1318 (72%) patients had RVA lead placement and 514 (28%) had RVNA lead placement. The mean age of patients was 65.5 ± 4.4 years, and they were predominantly men (69%-97%). There was no statistically significant difference in all-cause mortality by RVA vs. RVNA (OR = 0.77, 95% CI 0.32-1.89; I2 = 16.7%, p = 0.31), or in the combined endpoint of all-cause mortality and first HFH (OR 0.88, 95% CI 0.62-1.25; I2 = 0%, p = 0.84). Also, there was no difference between RVA and RVNA for NYHA class improvement (OR = 1.03, 95% CI 0.9-1.17; I2 = 0%, p = 0.99), change in LVEF (mean difference (MD) = 1.33, 95% CI -1.45 to 4.10; I2 = 47%; p = 0.093), and change in LVESV (MD = -1.11, 95% CI -3.34 to 1.12; I2 = 0%; p = 0.92). CONCLUSION: This meta-analysis shows that in CRT pacing, RV lead position does not appear to be associated with clinical outcomes or LV reverse remodeling. Further studies should focus on the relationship of RV lead vis-à-vis LV lead location, and its clinical importance.

Long-Term Outcomes and Associations With Major Adverse Limb Events After Peripheral Artery Revascularization.

BACKGROUND: Long-term cardiovascular and limb outcomes after revascularization for peripheral artery disease and, in particular, prognosis after post-procedure major adverse limb events (MALE) are not well-studied. OBJECTIVES: This study sought to describe outcomes after peripheral revascularization and assess relationships between post-procedure MALE hospitalization and subsequent events. METHODS: Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2015, in the Premier Healthcare Database were examined for the co-primary outcomes of interest, composite myocardial infarction (MI) or stroke and composite major amputation or peripheral revascularization. Multivariable adjusted Cox proportional hazards models with post-procedure MALE hospitalization included as a time-dependent covariate were developed to estimate hazard ratios for outcomes. RESULTS: Among 393,017 revascularized patients followed for a median of 2.7 years (interquartile range: 1.3 to 4.4 years), the cumulative incidence of MI or stroke was 9.8% and that of major amputation or peripheral revascularization was 41.9%. A total of 50,750 patients (12.9%) had at least 1 post-procedure MALE hospitalization. In time-dependent covariate adjusted models, post-procedure MALE hospitalization was associated with greater risk of subsequent MI or stroke (hazard ratio: 1.34; 95% confidence interval: 1.28 to 1.40) and major amputation or peripheral revascularization (hazard ratio: 8.13; 95% confidence interval: 7.96 to 8.29). After peripheral revascularization with or without post-procedure MALE hospitalization, risk of limb events increased rapidly post-procedure and more slowly after the first year, whereas cardiac risk increased steadily during follow-up. CONCLUSIONS: Revascularized peripheral artery disease patients face earlier limb and later cardiovascular ischemic risk that is heightened among patients with post-procedure MALE hospitalization. Increased provider awareness of these long-term risks may guide efforts to improve post-procedural outcomes.

Interventions for Preventing Thromboembolic Events in Patients With Atrial Fibrillation: A Systematic Review.

Background: The comparative safety and effectiveness of treatments to prevent thromboembolic complications in atrial fibrillation (AF) remain uncertain. Purpose: To compare the effectiveness of medical and procedural therapies in preventing thromboembolic events and bleeding complications in adults with nonvalvular AF. Data Sources: English-language studies in several databases from 1 January 2000 to 14 February 2018. Study Selection: Two reviewers independently screened citations to identify comparative studies of treatments to prevent stroke in adults with nonvalvular AF who reported thromboembolic or bleeding complications. Data Extraction: Two reviewers independently abstracted data, assessed study quality and applicability, and rated strength of evidence. Data Synthesis: Data from 220 articles were included. Dabigatran and apixaban were superior and rivaroxaban and edoxaban were similar to warfarin in preventing stroke or systemic embolism. Apixaban and edoxaban were superior and rivaroxaban and dabigatran were similar to warfarin in reducing the risk for major bleeding. Treatment effects with dabigatran were similar in patients with renal dysfunction (interaction P > 0.05), and patients younger than 75 years had lower bleeding rates with dabigatran (interaction P < 0.001). The benefit of treatment with apixaban was consistent in many subgroups, including those with renal impairment, diabetes, and prior stroke (interaction P > 0.05 for all). The greatest bleeding risk reduction was observed in patients with a glomerular filtration rate less than 50 mL/min/1.73 m2 (P = 0.003). Similar treatment effects were observed for rivaroxaban and edoxaban in patients with prior stroke, diabetes, or heart failure (interaction P > 0.05 for all). Limitation: Heterogeneous study populations, interventions, and outcomes. Conclusion: The available direct-acting oral anticoagulants (DOACs) are at least as effective and safe as warfarin for patients with nonvalvular AF. The DOACs had similar benefits across several patient subgroups and seemed safe and efficacious for a wide range of patients with nonvalvular AF. Primary Funding Source: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42017069999).

Predicting Thromboembolic and Bleeding Event Risk in Patients with Non-Valvular Atrial Fibrillation: A Systematic Review.

BACKGROUND: Atrial fibrillation (AF) is a common cardiac arrhythmia that increases the risk of stroke. Medical therapy for decreasing stroke risk involves anticoagulation, which may increase bleeding risk for certain patients. In determining the optimal therapy for stroke prevention for patients with AF, clinicians use tools with various clinical, imaging and patient characteristics to weigh stroke risk against therapy-associated bleeding risk. AIM: This article reviews published literature and summarizes available risk stratification tools for stroke and bleeding prediction in patients with AF. METHODS: We searched for English-language studies in PubMed, Embase and the Cochrane Database of Systematic Reviews published between 1 January 2000 and 14 February 2018. Two reviewers screened citations for studies that examined tools for predicting thromboembolic and bleeding risks in patients with AF. Data regarding study design, patient characteristics, interventions, outcomes, quality, and applicability were extracted. RESULTS: Sixty-one studies were relevant to predicting thromboembolic risk and 38 to predicting bleeding risk. Data suggest that CHADS2, CHA2DS2-VASc and the age, biomarkers, and clinical history (ABC) risk scores have the best evidence for predicting thromboembolic risk (moderate strength of evidence for limited prediction ability of each score) and that HAS-BLED has the best evidence for predicting bleeding risk (moderate strength of evidence). LIMITATIONS: Studies were heterogeneous in methodology and populations of interest, setting, interventions and outcomes analysed. CONCLUSION: CHADS2, CHA2DS2-VASc and ABC scores have the best prediction for stroke events, and HAS-BLED provides the best prediction for bleeding risk. Future studies should define the role of imaging tools and biomarkers in enhancing the accuracy of risk prediction tools. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute (PROSPERO #CRD42017069999).

Major Adverse Limb Events and 1-Year Outcomes After Peripheral Artery Revascularization.

BACKGROUND: Revascularization is important for symptom treatment and limb salvage in peripheral artery disease, yet little data exist on the incidence of post-procedure major adverse limb events (MALE) and longer-term outcomes. OBJECTIVES: This study sought to characterize hospitalizations and outpatient endovascular revascularizations after peripheral artery revascularization, assess temporal trends for outcomes, and identify factors associated with subsequent MALE hospitalization. METHODS: Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2014, in the Premier Healthcare Database were examined for the primary outcome of 1-year MALE hospitalization. Secondary outcomes included 1-year outpatient endovascular revascularization and limb-related, cardiovascular, and all-cause inpatient hospitalizations. Multivariable logistic regression was used to identify factors associated with 1-year MALE hospitalization. RESULTS: Among 381,415 revascularized patients, within 1 year post-index revascularization, 10.3% (n = 10,182) had a hospitalization for MALE, 11.0% (n = 42,056) had an outpatient endovascular revascularization, 18.8% (n = 71,663) had a limb-related hospitalization, 12.8% (n = 48,875) had a cardiovascular hospitalization, and 38.9% (n = 148,457) had any inpatient hospitalization. Over the study period, limb-related, cardiovascular, and all-cause hospitalizations decreased, whereas rates of outpatient endovascular revascularizations increased. Male sex, black race, Medicare and Medicaid insurance, diabetes, renal insufficiency, heart failure, smoking, baseline critical or acute limb ischemia, surgical revascularization, and noncardiology operator specialty were significantly associated with increased risk of MALE hospitalization. CONCLUSIONS: In contemporary practice, hospitalization for MALE occurs in 1 in 10 patients within 1 year after peripheral revascularization and is associated with patient and procedural factors. These data may inform efforts to improve post-procedure outcomes and limb-related clinical trial design.

Dofetilide dose reductions and discontinuations in women compared with men.

BACKGROUND: Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide, and higher rates of drug-induced torsades de pointes, but the dofetilide dosing algorithm is the same for men and women. OBJECTIVE: The purpose of this study was to evaluate the tolerability of the 500 µg twice daily dose of dofetilide for men and women. METHODS: Men and women admitted to Duke University Medical Center (January 1, 2006, to October 19, 2012) for the initiation of dofetilide 500 µg twice daily were matched 1:1 on age and estimated creatinine clearance. Electrocardiograms throughout dosing were analyzed, and rates of dofetilide discontinuations and dose reductions were compared in unadjusted and adjusted analyses. RESULTS: For 220 matched men and women, the median age was 62.5 years (interquartile range 55-69 years) and the median eCrCl was 98.1 mL/min (interquartile range 77.6-126.2 mL/min). Women were less likely than men to have hypertension and interventricular conduction delay but were otherwise similar. During dofetilide initiation, women were more likely than men to have their dofetilide dose discontinued or reduced (55% vs 32%; P < .001). In most women (82%) and men (69%), the reason for dose adjustment was significant QTc prolongation. In the adjusted analysis, female sex was associated with higher rates of dofetilide dose discontinuations or reductions (odds ratio 3.01; 95% confidence interval 1.58-5.71; P < .01). CONCLUSION: More than half of women who initiated on 500 µg twice daily of dofetilide required medication discontinuations or dose reductions, mostly because of QTc prolongation. Additional studies are needed to evaluate the optimal dosing algorithm of dofetilide in women.

Use of Antiarrhythmic Medications in Medicare Part D Patients With an Implantable Cardioverter-Defibrillator and Ventricular Tachycardia.

Ventricular tachycardia (VT) is common in cardiomyopathy patients with an implantable cardioverter-defibrillator. This analysis evaluated antiarrhythmic medication use and change in use over time in patients with VT and structural heart disease. Query of Medicare claims identified patients with an implantable cardioverter-defibrillator and VT. Patients with atrial fibrillation or supraventricular tachycardia were excluded. Two cohorts were created of patients enrolled in Medicare Part D for the 12 months before 2007 and 2012. Patients were identified through a search for antiarrhythmic medication fills with a supply covering January 1 of the cohort year. Adjusted logistic regression modeling evaluated the association between patient characteristics and antiarrhythmic medication use. The 2007 (n = 2,334) and 2012 (n = 3,892) Medicare Part D cohorts had similar demographics: median age 76 years, 64%-67% male, and 87%-89% white. Of the 2007 cohort, 1,380 (59%) patients were on a beta blocker, and 484 (20.7%) were on an antiarrhythmic medication (70% amiodarone and 20% sotalol). Between 2007 and 2012, there was a statistically significant higher use of any antiarrhythmic medication (p = 0.014), beta blockers (p <0.0001), mexiletine (p = 0.005), and ranolazine (p <0.0001), while amiodarone use remained unchanged (p = 0.53). After multivariable adjustment, male gender and renal disease were associated with higher antiarrhythmic medication use. In conclusion, although antiarrhythmic medication and beta blocker use in patients with VT increased over time, <1 in 4 patients were on an antiarrhythmic medication and only 65% of the patients were on a beta blocker.

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program.

Single-site, intensive, community-based blood pressure (BP) intervention programs have led to BP improvements. The authors examined the American Heart Association's Check. Change. CONTROL: (CCC) program (4069 patients/18 cities) to determine whether BP interventions can effectively be scaled to multiple communities, using a simplified template and local customization. Effectiveness was evaluated at each site via site percent enrollment goals, participant engagement, and BP change from first to last measurement. High-enrolling sites frequently recruited at senior residential institutions and service organizations held hypertension management classes and utilized established and new community partners. High-engagement sites regularly held hypertension education classes and followed up with participants. Top-performing sites commonly distributed BP cuffs, checked BP at engagement activities, and trained volunteers. CCC demonstrated that simplified community-based hypertension intervention programs may lead to BP improvements, but there was high outcomes variability among programs. Several factors were associated with BP improvement that may guide future program development.

Reporting of Sex Effects by Systematic Reviews on Interventions for Depression, Diabetes, and Chronic Pain.

Systematic reviews (SRs) have the potential to contribute uniquely to the evaluation of sex and gender differences (termed "sex effects"). This article describes the reporting of sex effects by SRs on interventions for depression, type 2 diabetes mellitus, and chronic pain conditions (chronic low back pain, knee osteoarthritis, and fibromyalgia). It includes SRs published since 1 October 2009 that evaluate medications, behavioral interventions, exercise, quality improvement, and some condition-specific treatments. The reporting of sex effects by primary randomized, controlled trials is also examined. Of 313 eligible SRs (86 for depression, 159 for type 2 diabetes mellitus, and 68 for chronic pain), few (n = 29) reported sex effects. Most SRs reporting sex effects used metaregression, whereas 9 SRs used subgroup analysis or individual-patient data meta-analysis. The proportion of SRs reporting the sex distribution of primary studies varied from a low of 31% (n = 8) for low back pain to a high of 68% (n = 23) for fibromyalgia. Primary randomized, controlled trials also infrequently reported sex effects, and most lacked an adequate sample size to examine them. Therefore, all SRs should report the proportion of women enrolled in primary studies and evaluate sex effects using appropriate methods whenever power is adequate.

Incorporation of pharmacogenetic testing into medication therapy management.

AIM: To assess feasibility and patient satisfaction with a pharmacist-delivered medication therapy management (MTM) plus pharmacogenetic (PGx) testing service. METHODS: Thirty patients from a cardiology outpatient clinic were enrolled to attend two MTM sessions, undergo PGx testing and complete pre- and post-intervention surveys. Outcome measures included duration of MTM sessions, clinical application of test results, self-reported medication adherence, patient recall of results and perceived value of testing and MTM. RESULTS: Overall, patients were very satisfied with the MTM plus PGx testing service. About half of participants (47%) were able to accurately recall their PGx test results. Comparable to MTM without PGx testing, the first MTM session averaged 40 min and the follow-up MTM session averaged 15 min. CONCLUSION: PGx testing incorporated into a clinical MTM service offered by pharmacists may be a feasible delivery model and is satisfactory to patients.

Comparisons of hospitalization rates among younger atrial fibrillation patients receiving different antiarrhythmic drugs.

BACKGROUND: Antiarrhythmic drugs (AADs) are used to reduce the frequency, severity, and duration of atrial fibrillation (AF) events, which should reduce hospitalizations; however, little is known about the associations between different AADs and hospitalization­particularly among younger AF patients without structural heart disease. METHODS AND RESULTS: Using MarketScan® claims data, we identified AF patients without coronary artery disease or heart failure who received their first AAD prescription (amiodarone, sotalol, dronedarone, or Class Ic) within 14 days post-first AF encounter. The primary outcome was time from first AAD prescription to AF hospitalization, and secondary outcomes included time to cardiovascular and all-cause hospitalizations. We used inverse probability-weighted estimators to adjust for differences in treatment allocation in the Cox proportional hazards model for each outcome. Among 8562 AF patients with a median age of 56 years (interquartile range 49, 61), risk of AF hospitalization was greater with dronedarone than Class Ic (hazard ratio [HR] 1.59; 95% confidence interval 1.13-2.24), amiodarone (HR 2.63; 1.77-3.89), and sotalol (HR 1.72; 1.17-2.54), but lower with amiodarone versus Class Ic (HR 0.68; 0.57-0.80) and sotalol (HR 0.63; 0.53-0.75). Risk of cardiovascular hospitalization was lower with amiodarone than Class Ic (HR 0.80; 0.70-0.92), but not non-AF cardiovascular hospitalization (HR 1.26; 1.01-1.57). There was no difference in all-cause hospitalization between amiodarone, Class Ic, and sotalol. CONCLUSIONS: Differences in hospitalization rates were found between AADs in younger AF patients without structural heart disease. Amiodarone had the lowest risk of AF hospitalization and dronedarone had the greatest risk. Additional research is needed to better understand associations between AADs and hospitalization risk.

Challenges to integrating pharmacogenetic testing into medication therapy management.

Some have proposed the integration of pharmacogenetic (PGx) testing into medication therapy management (MTM) to enable further refinement of treatments to reduce risk of adverse responses and improve efficacy. PGx testing involves the analysis of genetic variants associated with therapeutic or adverse response and may be useful in enhancing the ability to identify ineffective and/or harmful drugs or drug combinations. This "enhanced" MTM might also reduce patient concerns about side effects and increase confidence that the medication is effective, addressing 2 key factors that impact patient adherence: concern and necessity. However, the feasibility and effectiveness of the integration of PGx testing into MTM in clinical practice has not yet been determined. In this commentary, we consider some of the challenges to the integration and delivery of PGx testing in MTM services.

Antiarrhythmic drug use in patients <65 years with atrial fibrillation and without structural heart disease.

Little is known in clinical practice about antiarrhythmic drug (AAD) use in patients with atrial fibrillation (AF) (particularly younger ones) who do not have structural heart disease. Using the MarketScan database, we identified patients <65 years without known coronary artery disease or heart failure who had an AAD prescription claim (class Ic drug, amiodarone, sotalol, or dronedarone) after their first AF encounter. A multinomial logistic regression model was created to assess factors associated with using each available AAD compared with using class Ic drugs before and after dronedarone was marketed in the United States. Additionally, we used the Kaplan-Meier method to determine the rates of change in AAD use and discontinuation during the year after AAD initiation. Of 8,562 patients with AF, 35% received class Ic drugs, 34% amiodarone, 24% sotalol, and 7% dronedarone. The median patient age was 56 (interquartile range 49 to 61), and 34% were women. Both before and after dronedarone was marketed, there was a statistically significant lower likelihood of class Ic drug use versus other AAD use with increasing age, inpatient index AF encounter, and previous or concomitant anticoagulation therapy. During the 1 year after AAD initiation, the AAD change rate was 14% for class Ic drugs, 8% for amiodarone, 17% for sotalol, and 18% for dronedarone (p <0.001); the AAD discontinuation rate was 40% for class Ic drugs, 52% for amiodarone, 40% for sotalol, and 69% for dronedarone (p <0.001). In conclusion, we found extensive use of amiodarone that may be inconsistent with guideline recommendations and unexpectedly high rates of AAD discontinuation.

Pilot study: incorporation of pharmacogenetic testing in medication therapy management services.

Aim: To describe the rationale and design of a pilot study evaluating the integration of pharmacogenetic (PGx) testing into pharmacist-delivered medication therapy management (MTM). Study rationale: Clinical delivery approaches of PGx testing involving pharmacists may overcome barriers of limited physician knowledge about and experience with testing. Study design: We will assess the addition of PGx testing to MTM services for cardiology patients taking three or more medications including simvastatin or clopidogrel. We will measure the impact of MTM plus PGx testing on drug/dose adjustment and clinical outcomes. Factors associated with delivery, such as time to prepare and conduct MTM and consult with physicians will be recorded. Additionally, patient interest and satisfaction will be measured. Anticipated results: We anticipate that PGx testing can be practically integrated into standard a MTM service, providing a viable delivery model for testing. Conclusion: Given the lack of evidence of an effective PGx delivery models, this study will provide preliminary evidence regarding a pharmacist-delivered approach.

Check it, change it: a community-based, multifaceted intervention to improve blood pressure control.

BACKGROUND: Although home blood pressure (BP) monitoring interventions have shown potential in selected populations, it is unclear whether such strategies can be generalized. We sought to determine whether a multifaceted BP control program that uses a web-based health portal (Heart360), community health coaches, and physician assistant guidance could improve hypertension control in a diverse community setting. METHODS AND RESULTS: Between September 12, 2010, and November 11, 2011 Check It, Change It, a community-based hypertension quality improvement program, enrolled 1756 patients with hypertension from 8 clinics in Durham County, NC. The Check It, Change It community intervention was evaluated using a prepost study design without a concurrent control. Participants were stratified into 3 tiers according to their initial BP: tier 0 (BP <140/90 mm Hg)=51% of population, tier 1 (BP=140/90-159/99 mm Hg)=30% of total, and tier 2 (BP ≥159/99 mm Hg)=19% of total. Overall, median age was 59 years (interquartile range, 49-69), 67% were female, and 76% black. After 6 months, the mean overall systolic BP declined 4.7 mm Hg. Rates of achieving target BP control (<140/90) increased overall from 51% at baseline to 63% by 6 months, and 69% had either reached their BP target or had reduced their baseline systolic BP by 10 mm Hg or more. CONCLUSIONS: A multicomponent-tiered hypertension program was associated with improved BP control in a diverse community-based population.