Medication cost-reducing behaviors in older adults with atrial fibrillation: The SAGE-AF study.

BACKGROUND: As patient prices for many medications have risen steeply in the United States, patients may engage in cost-reducing behaviors (CRBs) such as asking for generic medications or purchasing medication from the Internet. OBJECTIVE: The objective of this study is to describe patterns of CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications among older adults with atrial fibrillation (AF) and examine participant characteristics associated with CRB. METHODS: Data were from a prospective cohort study of older adults at least 65 years with AF and a high stroke risk (CHA2DS2VASc ≥ 2). CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications were evaluated using validated measures. Chi-square and t tests were used to evaluate differences in characteristics across CRB, and statistically significant characteristics (P < 0.05) were entered into a multivariable logistic regression to examine factors associated with CRB. RESULTS: Among participants (N = 1224; mean age 76 years; 49% female), 69% reported engaging in CRB, 4% reported cost-related medication nonadherence, and 6% reported spending less on basic needs. Participants who were cognitively impaired (adjusted odds ratio 0.69 [95% CI 0.52-0.91]) and those who did not identify as non-Hispanic white (0.66 [0.46-0.95]) were less likely to engage in CRB. Participants who were married (1.88 [1.30-2.72]), had a household income of $20,000-$49,999 (1.52 [1.02-2.27]), had Medicare insurance (1.38 [1.04-1.83]), and had 4-6 comorbidities (1.43 [1.01-2.01]) had significantly higher odds of engaging in CRB. CONCLUSION: Although CRBs were common among older adults with AF, few reported cost-related medication nonadherence and spending less on basic needs. Patients with cognitive impairment may benefit from pharmacist intervention to provide support in CRB and patient assistance programs.

Feasibility study for echocardiography-guided lead insertion for permanent cardiac implantable electronic devices.

BACKGROUND: Permanent cardiac implantable electronic devices (CIEDs) are traditionally implanted with the assistance of fluoroscopy. While clinically effective, this technique exposes both patients and providers to radiation which is associated with adverse health effects and represents an occupational hazard. In this study, we investigate the safety and feasibility of permanent CIED placement under the guidance of transthoracic echocardiography (TTE). There is also increasing interest in use of non-fluoroscopic options for noninvasive cardiac electrophysiologic procedures. METHODS: Fifteen patients consecutively consented for initial implant of CIEDs, specifically dual chamber pacemakers (DCPM) and dual chamber implantable cardioverter defibrillators (DCICDs). Patients were excluded if they had previous implants, abandoned leads, or anatomic anomalies including congenital and known persistent left superior vena cava (PLSVC). We used TTE to guide and implant atrial and ventricular leads. RESULTS: Eleven patients received DCPMs and four patients received DCICDs. The procedure duration was 49.3 min for DCICD and 52.3 min for DCPM, p = .807. The average number of right atrial lead attempts was 1.6 for DCPMs and 1.8 for DCICD, p = .860. The average number of right ventricular lead attempts for DCPMs was 2.2 and 1.0 attempt for DCICDs, p = .044. There were no complications at 90-day follow-up. CONCLUSION: We demonstrate the feasibility of TTE-guided DCPM/DCICD implantation without use of fluoroscopy. We present this method as a safe alternative for permanent CIED placement that may reduce risk of radiation exposure and cost while maintaining safety and efficacy. No operators wore lead aprons during the procedure.

Physical, cognitive, and psychosocial conditions in relation to anticoagulation satisfaction among elderly adults with atrial fibrillation: The SAGE-AF study.

BACKGROUND: Successful anticoagulation is critical for stroke prevention in adults with atrial fibrillation (AF). Anticoagulation satisfaction is a key indicator of treatment success. While physical, cognitive, and psychosocial limitations are common in elderly AF patients, their associations with anticoagulation satisfaction are unknown. OBJECTIVE: Examine whether anticoagulation satisfaction differs among AF patients with and without physical, cognitive, and psychosocial conditions. METHODS: The study comprised AF patients greater than or equal to 65 years old who were prescribed an oral anticoagulant (warfarin 57%; direct oral anticoagulant [DOAC] 43%). Frailty, cognitive function, social support, depressive symptoms, vision, hearing, and anxiety were assessed using validated measures. Anticoagulation satisfaction was measured using the anticlot treatment scale. RESULTS: Participants (n = 1037, 50% female) were on average 76 years old. The following conditions were prevalent: frailty (14%), cognitive impairment (42%), social isolation (13%), vision impairment (35%), hearing impairment (36%), depression (29%), and anxiety (24%). Average anticlot treatment burden scale was 55 out of 60 (lower burden scales indicating higher perceived burden). Patients with high perceived burden were older, more likely to be female, and receive warfarin. After adjusting for confounders, visual impairment (adjusted odds ratio [95% confidence interval]: 1.7 [1.2-2.4]), depressive symptoms (2.4 [1.6-3.7]), and anxiety (1.8 [1.2-2.7]) were significantly associated with high perceived burden. Different conditions were associated with high perceived burden in warfarin vs DOAC users. CONCLUSION: Physical, cognitive, and psychosocial limitations are prevalent and associated with high perceived anticoagulation burden among elderly AF adults. These conditions merit consideration in anticoagulation prescribing.

Cognitive impairment and treatment strategy for atrial fibrillation in older adults: The SAGE-AF study.

BACKGROUND: Cognitive impairment is strongly associated with atrial fibrillation (AF). Rate and rhythm control are the two treatment strategies for AF and the effect of treatment strategy on risk of cognitive decline and frailty is not well established. We sought to determine how treatment strategy affects geriatric-centered outcomes. METHODS: The Systematic Assessment of Geriatric Elements-AF (SAGE-AF) was a prospective, observational, cohort study. Older adults with AF were prospectively enrolled between 2016 and 2018 and followed longitudinally for 2 years. In a non-randomized fashion, participants were grouped by rate or rhythm control treatment strategy based on clinical treatment at enrollment. Baseline characteristics were compared. Longitudinal binary mixed models were used to compare treatment strategy with respect to change in cognitive function and frailty status. Cognitive function and frailty status were assessed with the Montreal Cognitive Assessment Battery and Fried frailty phenotype tools. RESULTS: 972 participants (mean age = 75, SD = 6.8; 49% female, 87% non-Hispanic white) completed baseline examination and 2-year follow-up. 408 (42%) were treated with rate control and 564 (58%) with rhythm control. The patient characteristics of the two groups were different at baseline. Participants in the rate control group were older, more likely to have persistent AF, prior stroke, be treated with warfarin and have baseline cognitive impairment. After adjusting for baseline differences, participants treated with rate control were 1.5 times more likely to be cognitively impaired over 2 years (adjusted OR: 1.47, 95% CI:1.12, 1.98) and had a greater decline in cognitive function (adjusted estimate: -0.59 (0.23), p < 0.01) in comparison to rhythm control. Frailty did not vary between the treatment strategies. CONCLUSIONS: Among those who had 2-year follow-up in non-randomized observational cohort, the decision to rate control AF in older adults was associated with increased odds of decline in cognitive function but not frailty.

Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope.

BACKGROUND: Cardiovascular implantable electronic device (CIED) infection rates are increasing faster than implantation rates. More effective antimicrobial prophylaxis may help reduce CIED infections and improve clinical outcomes. The AIGIS(Rx)(®) antibacterial envelope is a polymer mesh implanted in the generator pocket with the CIED. After implantation it releases two antibiotics, minocycline and rifampin, that have been shown to reduce infections associated with other medical devices. The purpose of this retrospective cohort study is to determine the rate of CIED implantation success and CIED infection in procedures utilizing the antibacterial envelope. METHODS: This study enrolled consecutive CIED procedures utilizing the antibacterial envelope at 10 US academic, community, and Veterans Affairs medical centers. Procedures following an explantation for a prior CIED infection or off-label use of the antibacterial envelope were excluded. RESULTS: The 624 eligible procedures (age 70 ± 13 years, 68.1% men, 27.2% renal insufficiency, 35.4% oral anticoagulant use, 67.8% replacement/revision procedures) utilized pacemakers (35%), implantable cardioverter-defibrillators (ICD)(29%), and cardiac resynchronization therapy with defibrillator devices (CRT-D)(36%). Nearly half of the patients (49%) had at least three predefined risk factors for CIED infection. CIED implantation was successful in 621 procedures (99.5%[95% confidence interval (CI) 98.8-99.9]). There were three major infections (0.48%[95%CI 0.17-1.40]) after 1.9 ± 2.4 months follow-up. The infections followed one ICD revision and two CRT-D replacements. There were seven deaths; none was a result of the antibacterial envelope or the CIED procedure. CONCLUSIONS: CIED procedures that utilized an antibacterial envelope had a high rate of CIED implantation success (>99%). Although the follow-up to date is short, there was also a low rate of infection (<0.50%) in this population at high risk for CIED infection.

Ischemic Stroke in a Patient With Atrial Tachycardia, Methylenetetrahydrofolate Reductase Mutation and New-Onset Atrial Fibrillation: Is Early Initiation of Anticoagulation Therapy Indicated?

Atrial fibrillation is the most common dysrhythmia, affecting about 6 million people in the United States. Atrial fibrillation has been shown to be an independent risk factor for stroke. Atrial tachycardia are common findings on Holter monitoring in the general population and may be associated with the development of atrial remodeling and atrial fibrillation inducibility. Studies have shown that atrial tachycardia is associated with the development of atrial fibrillation and subsequent stroke. The American Heart Association current guidelines recommend the use of oral anticoagulants in patients with atrial fibrillation and an elevated CHA2DS2-VASc ≥2 in men or ≥3 in women. However, anticoagulant therapy is not currently recommended in patients with atrial tachycardia despite increasing evidence of its association with the development of stroke. We report the case of a 68-year-old woman with a past medical history significant for repetitive atrial tachycardia and methylenetetrahydrofolate reductase mutation who presented to an outside emergency department following a fall, weakness and associated aphasia while in atrial fibrillation. Thrombolysis and control of the patient's rhythm resulted in an initial improvement in the patient symptoms and reversal to normal sinus rhythm. She was subsequently referred to a tertiary stroke center for further management.

Successful Radiofrequency Ablation of Recurrent Supraventricular Tachycardia in a Patient with Complex Congenital Heart Disease.

BACKGROUND Radiofrequency ablation (RFA) is the criterion standard treatment for patients with atrioventricular nodal reentrant tachycardia (AVNRT). Knowledge about RFA in patients with dextrocardia and situs inversus is limited due to their rare incidence and complexity. The incidence of dextrocardia is reported to be 1 in 12 000 births, with situs inversus occurring in one-third of the cases. The incidence of congenital heart disease is about 5% in these patients. However, data on rhythm and conduction disorders in this group of patients are currently limited, making management more difficult owing to their individual anatomy. CASE REPORT We report the case of an obese 21-year-old man with complex congenital heart disease (CCHD) (situs inversus dextrocardia, pulmonary atresia, single ventricle, common atrium with single atrioventricular valve), asplenia, and multiple cardiac-corrective surgeries (Fontan repair, bidirectional Glenn anastomosis, and Blalock-Taussig shunt) who underwent successful RFA of recurrent supraventricular tachycardia. CONCLUSIONS Supraventricular arrhythmias are common in the setting of CCHD. Although catheter ablation procedures are technically challenging to perform in patients with CCHD, they remain the best therapeutic option for these arrhythmias. To our knowledge, this case is the first to be described in the literature of successful ablation of AVNRT in a patient with situs inversus dextrocardia, pulmonary atresia, a single ventricle, a common atrium with a single atrioventricular valve, and multiple cardiac-corrective surgeries.

Geriatric Elements and Oral Anticoagulant Prescribing in Older Atrial Fibrillation Patients: SAGE-AF.

OBJECTIVES: Oral anticoagulants are the cornerstone of stroke prevention in high-risk patients with atrial fibrillation (AF). Geriatric elements, such as cognitive impairment and frailty, commonly occur in these patients and are often cited as reasons for not prescribing oral anticoagulants. We sought to systematically assess geriatric impairments in patients with AF and determine whether they were associated with oral anticoagulant prescribing. DESIGN: Cross-sectional analysis of baseline data from the ongoing Systematic Assessment of Geriatric Elements in Atrial Fibrillation (SAGE-AF) prospective cohort study. SETTING: Multicenter study with site locations in Massachusetts and Georgia that recruited participants from cardiology, electrophysiology, and primary care clinics from 2016 to 2018. PARTICIPANTS: Participants with AF age 65 years or older, CHA2 DS2 -VASc (congestive heart failure; hypertension; aged ≥75 y [doubled]; diabetes mellitus; prior stroke, transient ischemic attack, or thromboembolism [doubled]; vascular disease; age 65-74; female sex) score of 2 or higher, and no oral anticoagulant contraindications (n = 1244). MEASUREMENTS: A six-component geriatric assessment included validated measures of frailty, cognitive function, social support, depressive symptoms, vision, and hearing. Oral anticoagulant use was abstracted from the medical record. RESULTS: A total of 1244 participants (mean age = 76 y; 49% female; 85% white) were enrolled; 42% were cognitively impaired, 14% frail, 53% pre-frail, 12% socially isolated, and 29% had depressive symptoms. Oral anticoagulants were prescribed to 86% of the cohort. Oral anticoagulant prescribing did not vary according to any of the geriatric elements (adjusted odds ratios [ORs] for oral anticoagulant prescribing and cognitive impairment: OR = .75; 95% confidence interval [CI] = .51-1.09; frail OR = .69; 95% CI = .35-1.36; social isolation OR = .90; 95% CI = .52-1.54; depression OR = .79; 95% CI = .49-1.27; visual impairment OR = .98; 95% CI = .65-1.48; and hearing impairment OR = 1.05; 95% CI = .71-1.54). CONCLUSION: Geriatric impairments, particularly cognitive impairment and frailty, were common in our cohort, but treatment with oral anticoagulants did not differ by impairment status. These geriatric impairments are commonly cited as reasons for not prescribing oral anticoagulants, suggesting that prescribers may either be unaware or deliberately ignoring the presence of these factors in clinical settings. J Am Geriatr Soc 68:147-154, 2019.

Cardiac Pacing Training in Africa: Endorsed by the Africa Heart Rhythm Association (AFHRA): JACC International.

The field of pacing in Africa has evolved in an uncoordinated way across the continent with significant variation in local expertise, cost, and utilization. There are many countries where pacemaker services do not meet one-hundredth of the national demand. Regional, national, and institutional standards for pacemaker qualification and credentials are lacking. This paper reviews the current needs for bradycardia pacing and evaluates what standards should be set to develop pacemaker services in a resource-constrained continent, including the challenges and opportunities of capacity building and training as well as standards for training programs (training prerequisites, case volumes, program content, and evaluation).

Geriatric Conditions and Prescription of Vitamin K Antagonists vs. Direct Oral Anticoagulants Among Older Patients With Atrial Fibrillation: SAGE-AF.

Background: Geriatric conditions are common among patients with atrial fibrillation (AF) and relate to complications of oral anticoagulation (OAC). Objective: To examine the prevalence of geriatric conditions among older patients with AF on OAC and relate type of OAC to geriatric conditions. Methods: Participants had a diagnosis of AF, were aged ≥65 years, CHA2DS2VASC ≥ 2, and had no OAC contraindications. Participants completed a 6-component geriatric assessment that included validated measures of frailty (CHS Frailty Scale), cognitive function (MoCA), social support (MOS), depressive symptoms (PHQ9), vision, and hearing. Type of OAC prescribed was documented in medical records. Results: 86% of participants were prescribed an OAC. These participants were on average aged 75.7 (SD: 7.1) years, 49% were women, two thirds were frail or pre-frail, and 44% received a DOAC. DOAC users were younger, had lower CHA2DS2VASC and HAS-BLED scores, and were less likely to be frail. In Massachusetts, pre-frailty was associated with a significantly lower odds of DOAC vs. VKA use (OR = 0.64, 95%CI 0.45, 0.91). Pre-frailty (OR = 0.33, 95%CI 0.18-0.59) and social isolation (OR = 0.38, 95%CI 0.14-0.99) were associated with lower odds of DOAC receipt in patients aged 75 years or older. Social isolation was associated with higher odds of DOAC use (OR = 2.13, 95%CI 1.05-4.29) in patients aged 65-74 years. Conclusions: Geriatric conditions were common and related to type of OAC prescribed, differentially by age group. Research is needed to evaluate whether a geriatric examination can be used clinically to better inform OAC decision-making in older patients with AF.

The Association of Black Cardiologists (ABC) Cardiovascular Implementation Study (CVIS): A Research Registry Integrating Social Determinants to Support Care for Underserved Patients.

African Americans, other minorities and underserved populations are consistently under- represented in clinical trials. Such underrepresentation results in a gap in the evidence base, and health disparities. The ABC Cardiovascular Implementation Study (CVIS) is a comprehensive prospective cohort registry that integrates social determinants of health. ABC CVIS uses real world clinical practice data to address critical gaps in care by facilitating robust participation of African Americans and other minorities in clinical trials. ABC CVIS will include diverse patients from collaborating ABC member private practices, as well as patients from academic health centers and Federally Qualified Health Centers (FQHCs). This paper describes the rationale and design of the ABC CVIS Registry. The registry will: (1) prospectively collect socio-demographic, clinical and biospecimen data from enrolled adults, adolescents and children with prioritized cardiovascular diseases; (2) Evaluate the safety and clinical outcomes of new therapeutic agents, including post marketing surveillance and pharmacovigilance; (3) Support National Institutes of Health (NIH) and industry sponsored research; (4) Support Quality Measures standards from the Center for Medicare and Medicaid Services (CMS) and Commercial Health Plans. The registry will utilize novel data and technology tools to facilitate mobile health technology application programming interface (API) to health system or practice electronic health records (EHR). Long term, CVIS will become the most comprehensive patient registry for underserved diverse patients with cardiovascular disease (CVD) and co morbid conditions, providing real world data to address health disparities. At least 10,000 patients will be enrolled from 50 sites across the United States.

Obstructive Sleep Apnea among Players in the National Football League: A Scoping Review.

OBJECTIVE: Obstructive sleep apnea (OSA) is a common sleep-disordered breathing condition that has emerged as a significant public health problem given its increased prevalence over the past decade. The high prevalence of obesity and large waist circumference among NFL players are two risk factors that might contribute to the high susceptibility of football players to develop OSA. National Football League linemen might be particularly vulnerable since they tend to have a higher body mass index. In this scoping review, we aim to bring attention to the limited research regarding OSA among National Football League players and highlight the negative consequences of OSA in an attempt to increase awareness of the urgent need for further research in this area. METHODS: Search terms associated with obstructive sleep apnea and football were used to examine Google Scholar, EMBASE, CINAHL, PubMed, ProQuest, and Web of Science Plus for relevant studies. All relevant studies were included and documented. RESULTS: Findings included (n=4) studies of interest. All 4 studies revealed a near or slightly above 50% prevalence of OSA in the investigated cohorts (mostly retired NFL linemen). Most participants in the study (active NFL players) showed symptoms associated with a sleep-disorder breathing condition (snoring). CONCLUSION: OSA requires more attention from the research and medical community. As suggested by results in the 4 studies included in this paper, OSA and associated symptoms are prevalent in the NFL population. Further research is required to investigate the extent of OSA and OSA risk in this population. There is an urgent need to conduct OSA risk surveillance in the athletic community.

QRS width and its impact on inducibility of ventricular arrhythmia at the time of electrophysiology study.

The inducibility of sustained ventricular arrhythmia by programmed electrical stimulation is a well-established marker of an increased risk of ventricular tachyarrhythmia. The purpose of this investigation was to determine whether there was a significant difference in the QRS duration or ejection fraction (EF) amongst patients who could be induced and those who could not be induced into ventricular arrhythmia at the time of standard electrophysiology study (EPS). All the patients who were studied for inducibility of ventricular arrhythmias between March 2003 and March 2004 (a total of 137 patients) were included in the study. An EF less than or equal to 30% was used to define decreased EF, and a QRS width greater than 120 ms was used to define widened QRS width. Patients were studied using standard EPS protocol after obtaining informed consent. In the univariate analysis, increasing age, male gender and low EF were predictors of inducibility, while widened QRS width did not have any predictive value. With multivariate analysis, there was a significant increase in the odds of inducibility with decreasing EF and widened QRS width. Interestingly, males had significantly more numbers of positive results.

Focal origin of ventricular fibrillation in a patient with ischemic cardiomyopathy.

A 65-year-old patient with history of ischemic cardiomyopathy admitted to the hospital for chest pain and subsequently experienced incessant ventricular fibrillation (VF), requiring repeated defibrillation. Coronary angiogram was unchanged, compared to a study a year before, and acute ischemia was not considered to be the etiology of the VF. A particular premature ventricular contraction morphology was noted on telemetry prior to each episode of VF. The patient subsequently underwent successful radiofrequency ablation of a focus in the left ventricular free wall. Careful examination of initiating foci of VF or polymorphic ventricular tachycardia, with radiofrequency ablation in appropriate cases, could be potentially life-saving.

Ejection fraction and QRS width as predictors of event rates in patients with implantable cardioverter defibrillators.

OBJECTIVES: The Multicenter Automatic Defibrillator Implantation Trial II in 2002 recommended implantable cardioverter defibrillators (ICDs) prophylactically for all patients with a prior myocardial infarction and ejection fraction (EF) of 30% or less. In June of 2003, the Centers for Medicare and Medicaid Services approved reimbursement for ICD placement in patients with an EF of 30% or less who have a QRS interval greater than 120 ms. The purpose of this study was therefore to determine the value of QRS duration in predicting the occurrence of ventricular arrhythmias within the first year after ICD implantation. These ICDs were placed over the past 5 years for various indications. METHODS: EF cut points of 30% or less and 31% or greater and QRS duration of 120 ms or less and 121 ms or greater were used to assess the risk of events. RESULTS: There was a significant increase in events in subjects with EF of 30% or less, compared with patients with EF of 31% or greater (P < 0.05), and there was a trend toward increased likelihood of arrhythmias in patients with widened QRS width. CONCLUSIONS: This study confirms the conclusion of the Multicenter Automatic Defibrillator Implantation Trial II and implies that the Centers for Medicare and Medicaid Services criteria for reimbursement may not be scientifically valid.

Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation.

INTRODUCTION: Prior studies suggest that right ventricular apical (RVA) pacing has deleterious effects. Whether the right ventricular outflow tract (RVOT) is a more optimal site for permanent pacing in patients with congestive heart failure (CHF) has not been established. METHODS AND RESULTS: We conducted a randomized, cross-over trial to determine whether quality of life (QOL) is better after 3 months of RVOT than RVA pacing in 103 pacemaker recipients with CHF, left ventricular (LV) systolic dysfunction (LV ejection fraction < or = 40%), and chronic atrial fibrillation (AF). An additional aim was to compare dual-site (RVOT + RVA, 31-ms delay) with single-site RVA and RVOT pacing. QRS duration was shorter during RVOT (167 +/- 45 ms) and dual-site (149 +/- 19 ms) than RVA pacing (180 +/- 58 ms, P < 0.0001). At 6 months, the RVOT group had higher (P = 0.01) role-emotional QOL subscale scores than the RVA group. At 9 months, there were no significant differences in QOL scores between RVOT and RVA groups. Comparing RVOT to RVA pacing within the same patient, mental health subscale scores were better (P = 0.03) during RVOT pacing. After 9 months of follow-up, LVEF was higher (P = 0.04) in those assigned to RVA rather than RVOT pacing between months 6 and 9. After 3 months of dual-site RV pacing, physical functioning was worse (P = 0.04) than during RVA pacing, mental health was worse (P = 0.02) than during RVOT pacing, and New York Heart Association (NYHA) functional class was slightly better (P = 0.03) than during RVOT pacing. There were no other significant differences between RVA, RVOT and dual-site RV pacing in QOL scores, NYHA class, distance walked in 6 minutes, LV ejection fraction, or mitral regurgitation. CONCLUSION: In patients with CHF, LV dysfunction, and chronic AF, RVOT and dual-site RV pacing shorten QRS duration but after 3 months do not consistently improve QOL or other clinical outcomes compared with RVA pacing.