Potentially inappropriate medication use in institutionalized older adults according to the Beers Criteria

The need for specific care, coupled with new family arrangements, has contributed to the increasing institutionalization of elderly members. The purpose of this study was to evaluate drug use by institutionalized older adults according to Beers Criteria. This prospective, longitudinal study was conducted in the three non-profit long-stay geriatric care institutions of Campo Grande, in the Central-West region of Brazil. All subjects aged 60 years and above on November 2011 were included and followed until November 2012. Eighteen subjects were excluded and the final sample consisted of 133 individuals aged 60 to 113 years. Overall, 212 medications were used at geriatric care institution A, 532 at B, and 1329 at C. Thirty-four drugs were inappropriately prescribed 89 times at geriatric care institution A (41.98%), 49 prescribed 177 times at B (33.27%), and 91 prescribed 461 times at C (34.68%). Statistical differences in the inappropriate drug use were found between genders (p=0.007). The most commonly used potentially inappropriate medication were first-generation antihistamines (15.34%). There was a high frequency in the use of potentially inappropriate medications which can initiate marked side effects and may compromise the fragile health of institutionalized elderly. Thus, adopting the Beers Criteria in prescribing medication contributes to minimize adverse reactions and drug interactions

Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: The ALPHEE study

Background—Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death. Methods and Results—Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction 40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation–triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile. Conclusions—Celivarone was not effective for the prevention of ICD interventions or sudden deat

Antiarrhythmic medication for atrial fibrillation (AIM-AF) study: a physician survey of antiarrhythmic drug (AAD) treatment practices and guideline adherence in Europe

Abstract Background The 2020 European Society of Cardiology (ESC) guidelines provide detailed recommendations for the management of patients with atrial fibrillation (AF). In symptomatic patients, AADs are advised for rhythm control. Purpose This study was designed to investigate AAD treatment practices and adherence to guidelines in four European countries. Methods An online survey (n=321) of cardiologists or cardiac electrophysiologists (CDs) and interventional electrophysiologists (EPs) was conducted in Germany (DE; n=83), Italy (IT; n=95), Sweden (SE; n=60) and the UK (n=83). Respondents were actively treating ≥10 patients with AF. Results (1) The majority of physicians considered guidelines to be the most important non-patient factor influencing their AF management practices (pooled: 65%; range: 55–72%), with 96% (range: 89–100%) following ESC guidelines. Although amiodarone use was most frequent in heart failure with reduced left ventricular (LV) ejection fraction (pooled: 91%; range: 88–93%) where it is a recommended first-line option, non-adherent AAD selection was common. Amiodarone was frequently selected as a typical treatment choice for minimal/no structural heart disease (SHD) where it is not recommended for initial therapy; this was particularly common in the UK versus SE (Figure 1). Other deviations included use of class 1C drugs in those with coronary artery disease (CAD) (with the exception of SE; Figure 1) and other SHD, as well as use of sotalol in LV hypertrophy (pooled: 30%) and renal impairment (Figure 1). Furthermore, absence of inpatient initiation of sotalol was generally high, with the exception of SE (Figure 1). (2) Sotalol and dronedarone use in CAD varied between country (pooled: 28% [range: 16–41%] and pooled: 19% [range: 10–54%], respectively). (3) CDs and EPs used rhythm control as initial therapy in most patients with paroxysmal AF (PAF); however, other than SE, this was not the case for persistent AF (Figure 2). (4) AADs were preferred over ablation as initial therapy for individuals with infrequent, mildly symptomatic PAF (pooled: 61%), with the exception of SE (48%). Ablation was favoured for most patients with frequent, symptomatic PAF; however, in SE, AADs were preferred for infrequent, highly symptomatic PAF (53%) and frequent, symptomatic PAF (53%). (5) Rhythm control therapies were selected for asymptomatic or subclinical AF; AADs were used more often (average: 41% [range: 22–60%]; ablation was used less frequently (average: 11% [range: 2–18%]). Conclusion Despite assertion that guidelines are the primary determinant for rhythm control treatment decisions, non-adherence was notable in European practice. While deviation may be reasonable in select individual patients, in general, non-adherence could compromise patient safety. As such, establishing the drivers of non-adherent practices is key, and education directed at clinicians to improve optimal and safe use of AADs is warranted in Europe. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Sanofi </jats:sec

A randomized, double-blind, placebo-controlled trial assessing the efficacy of S66913 in patients with paroxysmal atrial fibrillation

Anti-arrhythmic drugs (AAD) for the treatment of atrial fibrillation (AF) are associated with limited efficacy and adverse effects. Inhibition of the atrial current IKur, absent from the ventricle, is expected to be antiarrhythmic, without adverse cardiac effects, particularly ventricular pro-arrhythmic effects.A randomized clinical trial in symptomatic paroxysmal AF patients being considered for ablation. The primary endpoint was AF burden (AFB) as measured by insertable continuous monitoring (ICM) devices. Screened patients had an ICM implanted and were included if AFB was between 1-70% after 4 weeks of recording. They were randomly allocated to 4-week treatment of a selective IKur inhibitor S66913 (5 mg, 25 mg, or 100 mg orally per day) or placebo. The study was to enroll 160 patients.The study was terminated prematurely, due to non-study related preclinical safety concerns, after 58 patients had been enrolled. The median AFB ranged from 4.3% to 10.3% at baseline in the 4 treatment groups. S66913 had no significant effect on AFB or on AFB plus atrial tachycardia (AT) burden, at any dosage; nor on any secondary endpoints including the number and duration of AT or AF episodes, and symptoms. The drug was well tolerated with no safety concern during the treatment or the extended clinical follow-up.DIAGRAF-IKUR was the first study to show that using ICM to assess the effect of an AAD is feasible. The selective IKur inhibitor S66913 was safe but had no clinically meaningful effect at the time of early termination of the study.A. John Camm, Paul Dorian, Stefan H. Hohnloser, Peter R. Kowey, Benoît Tyl, Yongbin Ni, Victoria Vandzhura, Pierre Maison-Blanche, Mirko de Melis, and Prashanthan Sanders, for the DIAGRAF-IKUR study investigator

Differences in clinical and functional outcomes of atrial fibrillation in women and men: two-year results from the ORBIT-AF Registry

IMPORTANCE:Despite the frequency of atrial fibrillation (AF) in clinical practice, relatively little is known about sex differences in symptoms and quality of life and how they may affect treatment and outcomes. OBJECTIVE:To determine whether symptoms, quality of life, treatment, and outcomes differ between women and men with AF. DESIGN, SETTING, AND PARTICIPANTS:This observational cohort study included 10 135 patients with AF. The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation is a prospective, nationwide, multicenter outpatient registry of patients with incident and prevalent AF enrolled at 176 sites between June 2010 and August 2011. MAIN OUTCOMES AND MEASURES:Symptoms, quality of life as measured by Atrial Fibrillation Effects on Quality of Life scores, AF treatment, cardiovascular outcomes, stroke or non-central nervous system embolism, and all-cause mortality. RESULTS:Overall, 4293 of the cohort (42%) were female. Compared with men, women were older (77 years; interquartile range [IQR], 69-83, vs 73 years; IQR, 65-80; P < .001) and had higher median CHA2DS2-VASc scores (5; IQR, 4-6, vs 3; IQR, 2-5; P < .001), but less sleep apnea (578 [13.5%] vs 1264 [21.6%]; P < .001). Only 32.1% of women (n = 1378) were asymptomatic (European Heart Rhythm Association class I) compared with 42.5% of men (n = 2483) in unadjusted analyses (P < .001). Women had lower (more severe) unadjusted baseline overall Atrial Fibrillation Effects on Quality of Life scores (n = 2007; 80; IQR, 62-92 vs 83; IQR, 69-94; P < .001). Women had similar rates of anticoagulation and similar time in therapeutic range. In follow-up, women experienced lower risk-adjusted all-cause mortality (adjusted hazard ratio, 0.57; 95% CI, 0.49-0.67) and cardiovascular death (adjusted hazard ratio, 0.56; 95% CI, 0.44-0.72); however, they had a higher risk for stroke or non-central nervous system embolism (adjusted hazard ratio, 1.39; 95% CI, 1.05-1.84; P = .02) compared with men. CONCLUSIONS AND RELEVANCE:Women with AF have more symptoms and worse quality of life. Despite higher risk, women have lower risk-adjusted all-cause and cardiovascular death compared with men, but higher stroke rates. Future studies should focus on how treatment and interventions specifically affect AF-related quality of life and cardiovascular outcomes in women. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01165710.Jonathan P. Piccini, DaJuanicia N. Simon, Benjamin A. Steinberg, Laine Thomas, Larry A. Allen, Gregg C. Fonarow ... et al

Supplementary Material for: Use of the HAVOC Score to Identify Patients at Highest Risk of Developing Atrial Fibrillation

Background: Recent studies using insertable cardiac monitors (ICMs) show a high incidence of atrial fibrillation (AF). Further identifying subsets of patients who could benefit most from ICMs is desirable. We evaluated whether the HAVOC risk score which predicts AF in patients with cryptogenic stroke also predicts AF detection by ICMs in those without recent stroke. Methods: Participants were included from the prospective, industry-sponsored REVEAL AF study assessing AF incidence in patients with CHADS2 scores ≥3 or =2 with 1 or more additional AF risk factors, who had ICM data and were not receiving anti-arrhythmic drugs. Ischemic stroke occurring less than 1 year prior to enrollment or documented AF were exclusion criteria. AF was defined as an adjudicated ICM-detected episode ≥6 min in duration. HAVOC scores were calculated by assigning 4 points for congestive heart failure, 2 points for each of hypertension, age ≥75 years, valvular disease, and coronary artery disease, and 1 point for each of peripheral vascular disease and obesity (body mass index >30). Scores classified risk as low (0–4), intermediate (5–9), or high (10–14); corresponding AF detection rates were compared using the log-rank test. AF incidence rates in patients with and without a history of remote stroke at baseline were also compared. Results: Among 391 participants, the mean age was 71.5 ± 9.8 years and 186 (47.6%) were women. In total, 130 (33.2%) developed AF over 18 months. Stratification by HAVOC risk score was: 95 (24%) low, 241 (62%) intermediate, and 55 (14%) high. At 18 months, AF incidence in patients with low HAVOC scores (19.5%) was lower than in those with intermediate (32.1%) or high (34.2%) scores. AF incidence was similar among those with (n = 78) versus without (n = 313) remote stroke (27.3% vs. 29.8%; median time from stroke to ICM insertion was 4.2 [2.2–8.2] years). Conclusions: The HAVOC risk score identified a subset of individuals at greatest risk of developing AF, while AF incidence rates were similar among those with and without remote stroke. The use of the HAVOC score could help identify those at greatest likelihood of manifesting AF during long-term monitoring