Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study.

Background: Antipsychotics are commonly prescribed to treat a range of psychiatric conditions in women of reproductive age and during pregnancy, including schizophrenia, bipolar disorder, anxiety, depression, autism spectrum disorder, and insomnia. This study aimed to evaluate whether children exposed to antipsychotic medication prenatally are at increased risk of specific neurodevelopmental disorders and learning difficulties. Methods: Our population-based cohort study used nationwide register data (1 January 2000-31 December 2020) on pregnant women diagnosed with a psychiatric disorder and their live-born singletons from Denmark, Finland, Iceland, Norway, and Sweden. Cox proportional hazard regression yielded propensity score-weighted hazard ratios (aHRs) and 95% confidence intervals (CIs) for risk of intellectual-, speech or language-, learning-developmental disorders, and a composite outcome of the listed disorders. We defined poor performance as scoring within the lowest quartile on national school tests in mathematics and language arts. We estimated propensity score-weighted risk ratios (aRRs) using Poisson regression. We analysed data from Denmark separately and pooled results using random effects meta-analysis. Findings: Among 213,302 children (median follow-up: 6.7 years), 11 626 (5.5%) were exposed to antipsychotics prenatally. Adjusted risk estimates did not suggest an increased risk of neurodevelopmental disorders: aHR of 1.06 (95% CI 0.94-1.20) for the composite outcome, or for poor academic performance: aRR of 1.04 (95% CI 0.91-1.18) in mathematics, and of 1.00 (95% CI 0.87-1.15) in language arts. Results were generally consistent across individual medications, trimesters of exposure, sibling- and sensitivity analyses. Interpretation: The findings of this large multinational cohort study suggest there is little to no increased risk of child neurodevelopmental disorders or learning difficulties after prenatal exposure to antipsychotics. Our findings can assist clinicians and women managing mental illness during pregnancy. Funding: This study was funded by the NordForsk Nordic Program on Health and Welfare (Nordic Pregnancy Drug Safety Studies, project No. 83539), by the Research Council of Norway (International Pregnancy Drug Safety Studies, project No. 273366) and by the Research Council of Norway through its Centres of Excellence funding scheme (project No. 262700), and UNSW Scientia Programme Awards (PS46019, PS46019-A).

Patterns of attention deficit hyperactivity disorder medicine use in the era of new non-stimulant medicines: A population-based study among Australian children and adults (2013-2020).

BACKGROUND AND AIMS: New therapeutic options such as lisdexamfetamine and guanfacine have recently become available for the treatment of attention deficit hyperactivity disorder. We described contemporary patterns of attention deficit hyperactivity disorder medicine use among children, adolescents and adults in Australia. METHODS: This population-based study used dispensing data for a 10% random sample of Australian residents between July 2012 and December 2020. We estimated the annual prevalence and incidence of attention deficit hyperactivity disorder medicines, second-line guanfacine use and examined concurrent medicine use of both stimulants and non-stimulants. We followed incident users for up to 5 years and analysed treatment persistence using a novel proportion of people covered method. Analyses were stratified by attention deficit hyperactivity disorder medicine, sex and age group; young children (0-5 years), children (6-12 years), adolescents (13-17 years), young adults (18-24 years) and adults (⩾25 years). RESULTS: We observed a twofold increase in the overall prevalence of attention deficit hyperactivity disorder medicine use between 2013 and 2020, from 4.9 to 9.7 per 1000 persons. Incident use also increased across all age groups and both sexes, with the most pronounced increases among adolescent females (from 1.4 to 5.3 per 1000 persons). Stimulant treatment persistence after 5 years was highest among those initiating treatment as young children (64%) and children (69%) and lowest among those initiating treatment in adolescence (19%). Concurrent use of stimulants and non-stimulants was more common among males and younger age groups. Most children (87%) initiating guanfacine had prior dispensings of attention deficit hyperactivity disorder medicines. CONCLUSION: We observed increasing attention deficit hyperactivity disorder medicine use in Australia, especially among young females. Nevertheless, treatment rates remain lower than the estimated prevalence of attention deficit hyperactivity disorder across all subpopulations. Poor long-term treatment persistence in adolescence may warrant improved clinical monitoring of attention deficit hyperactivity disorder in patients transitioning from paediatric to adult care. Reassuringly, use of newly approved guanfacine appeared to be in accordance with guidelines among children.

Computational investigation of the haemodynamics shows criticalities of central venous lines used for chronic haemodialysis in children.

Background: Haemodialysis is a life-saving treatment for children with kidney failure. The majority of children have haemodialysis through central venous lines (CVLs). The use of CVLs in pediatric patients is often associated to complications which can lead to their replacement. The aim of this study is to investigate haemodynamics of pediatric CVLs to highlight the criticalities of different line designs. Methods: Four models of CVLs for pediatric use were included in this study. The selected devices varied in terms of design and sizes (from 6.5 Fr to 14 Fr). Accurate 3D models of CVLs were reconstructed from high-resolution images including venous and arterial lumens, tips and side holes. Computational fluid dynamics (CFD) analyses were carried out to simulate pediatric working conditions of CVLs in ideal and anatomically relevant conditions. Results: The arterial lumens of all tested CVLs showed the most critical conditions with the majority of blood flowing through the side-holes. A zone of low flow was identified at the lines' tip. The highest shear stresses distribution (>10 Pa) was found in the 8 Fr line while the highest platelet lysis index in the 10 Fr model. The analysis on the anatomical geometry showed an increase in wall shear stress measured in the 10 F model compared to the idealised configuration. Similarly, in anatomical models an increased disturbance and velocity of the flow was found inside the vein after line placement. Conclusion: This study provided a numerical characterization of fluid dynamics in pediatric CVLs highlighting performance criticalities (i.e. high shear stresses and areas of stagnation) associated to specific sizes (8 Fr and 10 Fr) and conditions (i.e. anatomical test).

Children's Relative Age and Medicine Treatment for Attention-Deficit/Hyperactivity Disorder Across Australian Jurisdictions with Different School Enrolment Policies.

Background: Children who are relatively young for their school grade are more likely to receive treatment for attention-deficit/hyperactivity disorder (ADHD). It is unclear whether the phenomenon also exists across Australia or is impacted by the school enrolment policy in place. Objective: We evaluated the association between children's relative age and initiation of ADHD medicines across Australian jurisdictions with different school enrolment policies and rates of delayed school entry. Methods: We used Australia-wide dispensing data for a 15% random sample of children 4-9 years of age in 2013-2017 to create a nationwide cohort. Due to high rates of delayed school entry in New South Wales (NSW), we used linked prescribing and education data for a cohort of NSW residents starting school in 2009 and 2012. We estimated incidence rate ratios (IRRs) for ADHD medicine across children's birth month, sex, and jurisdiction. We used asthma medicines as a negative control. Results: For girls, we observed a relative age effect in three out of five jurisdictions, with an IRR ranging from 1.3 to 2.8, comparing the youngest versus oldest birth month thirds. We observed more modest effects among boys, ranging from null to 1.5-fold. In NSW, the relatively youngest boys were less likely to initiate stimulant medicines than the oldest (IRR = 0.5, 95% confidence interval 0.29-0.78). We did not observe a relative age effect for initiation of asthma medicines. Conclusions: In jurisdictions with low rates of delayed entry, relatively young children were more likely to initiate ADHD medicines than their older classmates. We observed the inverse association in NSW where delayed entry was highest, likely reflecting the characteristics and needs of children who delay school entry for 1 year and become the oldest children in the grade. Increased awareness around children's maturity differences and school readiness may enhance appropriate diagnosis and treatment of ADHD.

Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children.

BACKGROUND: Medicine prescribing for children is impacted by a lack of paediatric-specific dosing, efficacy and safety data for many medicines. OBJECTIVES: To estimate the prevalence of medicine use among children and the rate of 'off-label' prescribing according to age at dispensing. METHODS: We used population-wide primarily outpatient dispensing claims data for 15% of Australian children (0-17 years), 2013-2017 (n = 840,190). We estimated prescribed medicine use and 'off-label' medicine use according to the child's age (<1 year, 1-5 years, 6-11 years, 12-17 years) defined as medicines without age-appropriate dose recommendations in regulator-approved product information. Within off-label medicines, we also identified medicines with and without age-specific dose recommendations in a national prescribing guide, the Australian Medicines Handbook Children's Dosing Companion (AMH CDC). RESULTS: The overall dispensing rate was 2.0 dispensings per child per year. The medicines with the highest average yearly prevalence were systemic antibiotics (435.3 per 1000 children), greatest in children 1-5 years (546.9 per 1000). Other common medicine classes were systemic corticosteroids (92.7 per 1000), respiratory medicines (91.2 per 1000), acid-suppressing medicines in children <1 year (47.2 per 1000), antidepressants in children 12-17 years (40.3 per 1000) and psychostimulants in children 6-11 years (27.0 per 1000). We identified 12.2% of dispensings as off-label based on age, but 66.3% of these had age-specific dosing recommendations in the AMH CDC. Among children <1 year, off-label dispensings were commonly acid-suppressing medicines (35.5%) and topical hydrocortisone (33.1%); in children 6-11 years, off-label prescribing of clonidine (16.0%) and risperidone (13.1%) was common. Off-label dispensings were more likely to be prescribed by a specialist (21.7%) than on-label dispensings (7.5%). CONCLUSIONS: Prescribed medicine use is common in children, with off-label dispensings for medicines without paediatric-specific dosing guidelines concentrated in classes such as acid-suppressing medicines and psychotropics. Our findings highlight a need for better evidence to support best-practice prescribing.

The impact of tightened prescribing restrictions on proton pump inhibitor use in Australia: An evaluation using interrupted time series analysis.

AIM: In May 2019, Australia's Pharmaceutical Benefits Scheme (PBS) tightened the prescribing restrictions for publicly subsidized high and standard strength proton-pump inhibitors (PPIs). We aimed to determine the impacts on PPI use in Australia. METHODS: Population-based interrupted time series analysis of PBS dispensing claims for a 10% sample of PBS-eligible Australian residents from January 2017 to December 2020 and national prescription and over-the-counter sales to pharmacies from January 2017 to October 2020. We examined trends in monthly PPI dispensings, switches from higher to lower strength formulations, and volume (kg) dispensed and sold. RESULTS: From May 2019, we observed a small, immediate decrease (-7830 [95%CI: -8818 to -6842]) in standard strength PPI dispensings/month, which rebounded to exceed pre-intervention levels by December 2020. High strength dispensings decreased until the end of the study period to less than half their pre-intervention average/month; low strength dispensings/month increased until the end of the study period to more than double their pre-intervention average/month. We observed transient increases in switches to lower strength formulations post-intervention. The kilograms of PPIs sold/month followed a similar pattern to PBS kilograms dispensed/month with the exception of standard strength formulations where PBS dispensings decreased by -74 (95%CI: -93 to -55) but total sales remained unchanged (comprising PBS and private prescriptions, and over-the-counter sales). CONCLUSIONS: Tightened prescribing restrictions had an immediate and sustained impact on PPI use in Australia, with decreased high strength use and increased low strength use. Some patients likely switched to private market prescriptions for standard strength PPI, given the observed patterns in total volume sold/dispensed.

Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia: History, Challenges and a Roadmap for the Future.

Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia's limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.

The changing face of Australian data reforms: impact on pharmacoepidemiology research.

OBJECTIVE: A wealth of data is generated through Australia's universal health care arrangements. However, use of these data has been hampered by different federal and state legislation, privacy concerns and challenges in linking data across jurisdictions. A series of data reforms have been touted to increase population health research capacity in Australia, including pharmacoepidemiology research. Here we catalogued research leveraging Australia's Pharmaceutical Benefits Scheme (PBS) data (2014-2018) and discussed these outputs in the context of previously implemented and new data reforms. METHODS: We conducted a systematic review of population-based studies using PBS dispensing claims. Independent reviewers screened abstracts of 4,996 articles and 310 full-text manuscripts. We characterised publications according to study population, analytical approach, data sources used, aims and medicines focus. RESULTS: We identified 180 studies; 133 used individual-level data, 70 linked PBS dispensing claims with other health data (66 across jurisdictions). Studies using individual-level data focussed on Australians receiving government benefits (87 studies) rather than all PBS-eligible persons. 63 studies examined clinician or patient practices and 33 examined exposure-outcome relationships (27 evaluated medicines safety, 6 evaluated effectiveness). Medicines acting on the nervous and cardiovascular system account for the greatest volume of PBS medicines dispensed and were the most commonly studied (67 and 40 studies, respectively). Antineoplastic and immunomodulating agents account for approximately one third of PBS expenditure but represented only 10% of studies in this review. CONCLUSIONS: The studies in this review represent more than a third of all population-based pharmacoepidemiology research published in the last three decades in Australia. Recent data reforms have contributed to this escalating output. However, studies are concentrated among specific subpopulations and medicines classes, and there remains a limited understanding of population benefits and harms derived from medicines use. The current draft Data Availability and Transparency legislation should further bolster efforts in population health research.

Variations in Long-term Opioid Therapy Definitions: A Systematic Review of Observational Studies Using Routinely Collected Data (2000-2019).

Routinely collected data have been increasingly used to assess long-term opioid therapy (LTOT) patterns, with very little guidance on how to measure LTOT from these data sources. We conducted a systematic review of studies published between January 2000 and July 2019 to catalogue LTOT definitions, the rationale for definitions and LTOT rates in observational research using routinely collected data in nonsurgical settings. We screened 4056 abstracts, 210 full-text manuscripts and included 128 studies, mostly from the United States (81%) and published between 2015 and 2019 (69%). We identified 78 definitions of LTOT, commonly operationalised as 90 days of use within a year (23%). Studies often used multiple criteria to derive definitions (60%), mostly based on measures of duration, such as supply days/days of use (66%), episode length (21%) or prescription fills within specified time periods (12%). Definitions were based on previous publications (63%), clinical judgment (16%) or empirical data (3%); 10% of studies applied more than one definition. LTOT definition was not provided with enough details for replication in 14 studies and 38 studies did not specify the opioids evaluated. Rates of LTOT within study populations ranged from 0.2% to 57% according to study design and definition used. We observed a substantial rise in the last 5 years in studies evaluating LTOT with large variability in the definitions used and poor reporting of the rationale and implementation of definitions. This variation impacts on research reproducibility, comparability of findings and the development of strategies aiming to curb therapy that is not guideline-recommended.

Medicine treatment of glaucoma in Australia 2012-2019: prevalence, incidence and persistence.

OBJECTIVE: Medical therapy can halt or significantly slow the progression of glaucoma if medicines are used in accordance with the guidelines. We used dispensing claims for a 10% sample of all Australians dispensed publicly subsidised glaucoma medicines to determine the prevalence and incidence of glaucoma medicine treatment and to examine treatment persistence between July 2012 and June 2019. METHODS: We estimated incidence and prevalence per 10 000 population for Australian financial years (1 July to 30 June). We defined prevalence as at least one dispensing of any glaucoma medicine and incidence as a dispensing of any glaucoma medicine with no previous dispensing during the preceding 12 months. We estimated duration of treatment for a cohort initiating glaucoma medicines and used Kaplan-Meier methods to estimate the proportion of people persisting on treatment at 6, 12, 18 and 36 months after initiation. We stratified analyses by the number of repeats prescribed at initiation, age, sex and medicine class. RESULTS: Prevalence remained stable over the study period at around 180/10 000 people/year; incidence was also stable around 36/10 000/year. Among 34 900 people initiating glaucoma medicines, 37.0% remained on treatment at 6 months from initiation, 29.8% at 12 months and 19.2% at 36 months. Median duration of treatment was 13.2 months (IQR: 2.5-not reached) for people initiating prostaglandin analogues and less than 3 months for those initiating other medicine classes. CONCLUSION: Prevalence and incidence of glaucoma treatment have not changed in Australia over the past decade. Persistence to treatment increased with age but remained poor throughout the study period.

Long-term use of proton-pump inhibitors: whole-of-population patterns in Australia 2013-2016.

BACKGROUND: Proton-pump inhibitors (PPIs) are among the most prescribed medicines worldwide and concern about their long-term use is growing. We used dispensing claims for every person in Australia dispensed publicly subsidized PPIs between 2013 and 2016 to determine the incidence and prevalence of PPI use and to examine the patterns and durations of PPI treatment among individuals continuing treatment beyond the guideline-recommended maximum 12 weeks. METHODS: We estimated annual prevalence and incidence per 100 people and duration of treatment for every Australian dispensed publicly subsidized PPIs between 2013 and 2016. We examined patterns of PPI treatment in three patient subgroups using PPIs for more than 12 weeks duration; people receiving maintenance, long-term continuous or long-term intermittent treatment. We calculated the proportion in each subgroup stepping down from higher to lower PPI strengths, stepping up from lower to higher PPI strength and discontinuing treatment. RESULTS: PPIs were dispensed to 4,388,586 people; 60% were women; median age at initiation was 52 years [interquartile range (IQR): 36-65]. Standard and high strength PPIs accounted for 95% of dispensings. Annual incidence and prevalence were 3.9/100 and 12.5/100, respectively, in 2016 and highest among individuals over 65 years (prevalence range: 33-43/100). Most people (67%) stopped treatment after one dispensing; while 25%, 6% and 10% continued on maintenance, long-term continuous and long-term intermittent treatment, respectively. Median duration of treatment in people continuing treatment was 501 days (IQR: 180-not reached) for maintenance treated individuals and 'not reached' for long-term treated individuals. We observed 35%, 20% and 47% of people stepping down from higher to lower treatment strengths on maintenance, long-term continuous and long-term intermittent treatment, respectively. CONCLUSIONS: Longer-term treatment with higher strength PPIs is common. Targeted regulation of PPI prescribing may improve the uptake of lower strength formulations and reduce both harms and costs associated with long-term PPI treatment.

Passing the acid test? Evaluating the impact of national education initiatives to reduce proton pump inhibitor use in Australia.

BACKGROUND: Proton pump inhibitor (PPI) use is widespread. There have been increasing concerns about overuse of high-dose PPIs for durations longer than clinically necessary. OBJECTIVE: To evaluate the impact of national education initiatives on reducing PPI use in Australia. DESIGN: Population-based, controlled interrupted time series analysis of PPI dispensing claims data for Australian adults from July 2012 to June 2018; we used statin dispensing as a control. INTERVENTIONS: A year-long educational initiative led by NPS MedicineWise (previously the National Prescribing Service) from April 2015. Simultaneously, Choosing Wisely released recommendations in April 2015 and May 2016. Both promoted review of prolonged PPI use and encouraged stepping down or ceasing treatment, where appropriate. MEASUREMENTS: We examined monthly changes in PPI (and statin) dispensing (stratified by high, standard and low tablet strength), rates of switching from higher to lower strength PPIs and rates of PPI (and statin) discontinuation. RESULTS: We observed 12 040 021 PPI dispensings to 579 594 people. We observed a sustained -1.7% (95% CI: -2.7 to -0.7%) decline in monthly dispensing of standard strength PPIs following the initiatives until the end of the study period. There were no significant changes in high or low strength PPI (or statin) dispensings, switching to lower strength PPIs, or PPI (and statin) treatment discontinuation. CONCLUSION: Our findings suggest that these educational initiatives alone were insufficient in curbing overuse of PPIs on a national level. Concerted efforts with policy levers such as imposing tighter restrictions on subsidised use of PPIs may be more effective. Noting low strength esomeprazole is not publicly subsidised in Australia, availability of these preparations may also facilitate more appropriate practice.

A new integrative approach to increase quality of life by reducing pain and fear of movement in patients undergoing total hip arthroplasty: the IARA model.

Total hip arthroplasty (THA) improve the patients' quality of life, and one of the most important problems after surgery is to optimize postoperative pain management. It has been shown that pain is intimately linked to the fear of movement, the so-called kinesiophobia, which can affect the entire perioperative period and quality of life in people undergoing THA. In this study, we aimed to present a new integrative approach called IARA model specifically focused on educational interventions such as knowledge and awareness of illness, guided imagery, and drawings to help the patient achieve full autonomy and confidence about the perioperative period and surgery. The Hip Injury and Osteoarthritis Outcome Score (HOOS), Tampa Scale Kinesiophobia (TSK) questionnaire, and Numeric Rating Scale 0-10 have been used to test the efficacy of IARA. The main finding in the present study was the effectiveness of IARA model in improving indexes of pain (p < 0.01) and QoL (p < 0.01) and to keep kinesiophobia levels low in patients undergoing THA.

Eficacia y seguridad de la ablación por radiofrecuencia en pacientes con fibrilación auricular / Efficacy and Safety of Radiofrequency Catheter Ablation in Patients with Atrial Fibrillation

Introducción La ablación por radiofrecuencia de la fibrilación auricular es más eficaz que las drogas antiarrítmicas en el control de los síntomas, particularmente cuando la arritmia es paroxística. Consiste en un procedimiento laborioso y complejo no exento de complicaciones. Objetivo Evaluar los resultados de la ablación por radiofrecuencia en una población seleccionada consecutiva con fibrilación auricular recurrente y refractaria a drogas antiarrítmicas. Material y métodos Se evaluaron 111 pacientes, 90 hombres, con fibrilación auricular paroxística (n = 75) o persistente (n = 36), refractaria a 2 (1,5-3) drogas antiarrítmicas que fueron seleccionados para la ablación por radiofrecuencia. Todos los procedimientos se realizaron siguiendo una metodología uniforme. La edad fue de 56 ± 11 años, con un diámetro de la aurícula izquierda de 41,5 (39-45) mm y fracción de eyección del ventrículo izquierdo del 60% (56,5-66,5%). Se realizaron 126 procedimientos de ablación por radiofrecuencia, incluyendo 15 segundos procedimientos. Se aislaron 476/489 (97,3%) venas pulmonares. Veinticinco pacientes (22,5%) presentaron actividad ectópica espontánea de las venas pulmonares. Se presentaron complicaciones no mortales en 7/126 procedimientos (5,5%), que se resolvieron satisfactoriamente. Tres pacientes presentaron complicaciones vasculares y se observó una complicación anestésica, un taponamiento cardíaco subagudo, una pericarditis sin derrame y una estenosis de vena pulmonar. Luego de un seguimiento de 22 (13-35) meses, 83 pacientes (74,8%) se mantuvieron en ritmo sinusal sin drogas antiarrítmicas. Los 28 pacientes restantes (25,2%) presentaron recurrencias. Cuatro de ellos respondieron satisfactoriamente a estas drogas (previamente ineficaces), ocho tuvieron fibrilación auricular a pesar de recibir drogas antiarrítmicas y 1 paciente se encuentra en plan de reablación. A los 15 pacientes restantes se les realizó un segundo procedimiento de ablación. Diez de ellos se mantienen sin recurrencias luego de 12 (9-31) meses. Conclusión En esta serie consecutiva de pacientes con fibrilación auricular refractaria a drogas antiarrítmicas, la ablación por radiofrecuencia mostró una tasa de éxito adecuada y un nivel bajo de complicaciones.(AU)

Introduction Radiofrequency catheter ablation of atrial fibrillation is more effective than antiarrhythmic drugs for symptoms control, particularly in paroxysmal atrial fibrillation. The procedure is laborious and complex and not exempt from complications. Objective The aim of this study was to evaluate the outcomes of radiofrequency catheter ablation in a consecutive and selected population with recurrent atrial fibrillation refractory to antiarrhythmic drugs. Methods One-hundred and eleven patients (90 men) with paroxysmal (n = 75) or persistent (n = 36) atrial fibrillation, refractory to 2 (1.5-3) antiarrhythmic drugs were selected for radiofrequency catheter ablation. All the procedures were performed following a uniform methodology. Mean age was 56 ± 11 years, left atrial diameter was 41.5 (39-45) mm and left ventricular ejection fraction was 60% (56.5-66.5%). A total of 126 radiofrequency catheter ablation procedures were performed, including 15 second procedures, and 476/489 (97.3%) pulmonary veins were isolated. Twenty-five patients (22.5%) presented spontaneous ectopic activity in the pulmonary veins. Nonfatal complications occurred in 7/126 procedures (5.5%) and were satisfactorily resolved. Three patients presented vascular complications; other complications included one related to anesthesia, one subacute cardiac tamponade, one pericarditis without effusion and one pulmonary vein stenosis. After 22-month follow-up (13-35 months), 83 patients (74.8%) remained in sinus rhythm without antiarrhythmic drugs. The remaining 28 patients (25.2%) presented recurrences. Four of these patients had a favorable response to these previously inefficient drugs, 8 had atrial fibrillation in spite of receiving antiarrhythmic drugs and 1 patient will undergo a new ablation. The remaining 15 patients underwent a second ablation procedure; 10 of them are free of recurrences after 12 (9-31) months. Conclusion In this consecutive series of patients with atrial fibrillation refractory to drugs, radiofrequency catheter ablation showed an adequate rate of success and low level of complications.(AU)

Eficacia y seguridad de la ablación por radiofrecuencia en pacientes con fibrilación auricular / Efficacy and Safety of Radiofrequency Catheter Ablation in Patients with Atrial Fibrillation

Introducción La ablación por radiofrecuencia de la fibrilación auricular es más eficaz que las drogas antiarrítmicas en el control de los síntomas, particularmente cuando la arritmia es paroxística. Consiste en un procedimiento laborioso y complejo no exento de complicaciones. Objetivo Evaluar los resultados de la ablación por radiofrecuencia en una población seleccionada consecutiva con fibrilación auricular recurrente y refractaria a drogas antiarrítmicas. Material y métodos Se evaluaron 111 pacientes, 90 hombres, con fibrilación auricular paroxística (n = 75) o persistente (n = 36), refractaria a 2 (1,5-3) drogas antiarrítmicas que fueron seleccionados para la ablación por radiofrecuencia. Todos los procedimientos se realizaron siguiendo una metodología uniforme. La edad fue de 56 ± 11 años, con un diámetro de la aurícula izquierda de 41,5 (39-45) mm y fracción de eyección del ventrículo izquierdo del 60% (56,5-66,5%). Se realizaron 126 procedimientos de ablación por radiofrecuencia, incluyendo 15 segundos procedimientos. Se aislaron 476/489 (97,3%) venas pulmonares. Veinticinco pacientes (22,5%) presentaron actividad ectópica espontánea de las venas pulmonares. Se presentaron complicaciones no mortales en 7/126 procedimientos (5,5%), que se resolvieron satisfactoriamente. Tres pacientes presentaron complicaciones vasculares y se observó una complicación anestésica, un taponamiento cardíaco subagudo, una pericarditis sin derrame y una estenosis de vena pulmonar. Luego de un seguimiento de 22 (13-35) meses, 83 pacientes (74,8%) se mantuvieron en ritmo sinusal sin drogas antiarrítmicas. Los 28 pacientes restantes (25,2%) presentaron recurrencias. Cuatro de ellos respondieron satisfactoriamente a estas drogas (previamente ineficaces), ocho tuvieron fibrilación auricular a pesar de recibir drogas antiarrítmicas y 1 paciente se encuentra en plan de reablación. A los 15 pacientes restantes se les realizó un segundo procedimiento de ablación. Diez de ellos se mantienen sin recurrencias luego de 12 (9-31) meses. Conclusión En esta serie consecutiva de pacientes con fibrilación auricular refractaria a drogas antiarrítmicas, la ablación por radiofrecuencia mostró una tasa de éxito adecuada y un nivel bajo de complicaciones.

Introduction Radiofrequency catheter ablation of atrial fibrillation is more effective than antiarrhythmic drugs for symptoms control, particularly in paroxysmal atrial fibrillation. The procedure is laborious and complex and not exempt from complications. Objective The aim of this study was to evaluate the outcomes of radiofrequency catheter ablation in a consecutive and selected population with recurrent atrial fibrillation refractory to antiarrhythmic drugs. Methods One-hundred and eleven patients (90 men) with paroxysmal (n = 75) or persistent (n = 36) atrial fibrillation, refractory to 2 (1.5-3) antiarrhythmic drugs were selected for radiofrequency catheter ablation. All the procedures were performed following a uniform methodology. Mean age was 56 ± 11 years, left atrial diameter was 41.5 (39-45) mm and left ventricular ejection fraction was 60% (56.5-66.5%). A total of 126 radiofrequency catheter ablation procedures were performed, including 15 second procedures, and 476/489 (97.3%) pulmonary veins were isolated. Twenty-five patients (22.5%) presented spontaneous ectopic activity in the pulmonary veins. Nonfatal complications occurred in 7/126 procedures (5.5%) and were satisfactorily resolved. Three patients presented vascular complications; other complications included one related to anesthesia, one subacute cardiac tamponade, one pericarditis without effusion and one pulmonary vein stenosis. After 22-month follow-up (13-35 months), 83 patients (74.8%) remained in sinus rhythm without antiarrhythmic drugs. The remaining 28 patients (25.2%) presented recurrences. Four of these patients had a favorable response to these previously inefficient drugs, 8 had atrial fibrillation in spite of receiving antiarrhythmic drugs and 1 patient will undergo a new ablation. The remaining 15 patients underwent a second ablation procedure; 10 of them are free of recurrences after 12 (9-31) months. Conclusion In this consecutive series of patients with atrial fibrillation refractory to drugs, radiofrequency catheter ablation showed an adequate rate of success and low level of complications.

Informações relevantes da ecocardiografia para o manejo adequado das valvopatias mitrais / Relevant information provided by echocardiography for the correct management of mitral valve disease

A ecocardiografia é, na atualidade, a técnica diagnóstica mais utilizada na cardiologia. Por meio...