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1.
J Am Heart Assoc ; 10(19): e018513, 2021 10 05.
Article in English | MEDLINE | ID: mdl-34581201

ABSTRACT

Background Long QT has been associated with ventricular dysrhythmias, cardiovascular disease (CVD) mortality, and sudden cardiac death. However, no studies to date have investigated the dynamics of within-person QT change over time in relation to risk of incident CVD and all-cause mortality in a real-world setting. Methods and Results A cohort study among members of an integrated health care delivery system in Northern California including 61 455 people (mean age, 62 years; 60% women, 42% non-White) with 3 or more ECGs (baseline in 2005-2009; mean±SD follow-up time, 7.6±2.6 years). In fully adjusted models, tertile 3 versus tertile 1 of average QT corrected (using the Fridericia correction) was associated with cardiac arrest (hazard ratio [HR], 1.66), heart failure (HR, 1.62), ventricular dysrhythmias (HR, 1.56), all CVD (HR, 1.31), ischemic heart disease (HR, 1.28), total stroke (HR, 1.18), and all-cause mortality (HR, 1.24). Tertile 3 versus tertile 2 of the QT corrected linear slope was associated with cardiac arrest (HR, 1.22), ventricular dysrhythmias (HR, 1.12), and all-cause mortality (HR, 1.09). Tertile 3 versus tertile 1 of the QT corrected root mean squared error was associated with ventricular dysrhythmias (HR, 1.34), heart failure (HR, 1.28), all-cause mortality (HR, 1.20), all CVD (HR, 1.14), total stroke (HR, 1.08), and ischemic heart disease (HR, 1.07). Conclusions Our results demonstrate improved predictive ability for CVD outcomes using longitudinal information from serial ECGs. Long-term average QT corrected was more strongly associated with CVD outcomes than the linear slope or the root mean squared error. This new evidence is clinically relevant because ECGs are frequently used, noninvasive, and inexpensive.


Subject(s)
Heart Failure , Long QT Syndrome , Myocardial Ischemia , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/epidemiology , Cohort Studies , Death, Sudden, Cardiac/epidemiology , Delivery of Health Care , Female , Humans , Long QT Syndrome/diagnosis , Long QT Syndrome/epidemiology , Male , Middle Aged
2.
Front Immunol ; 12: 631869, 2021.
Article in English | MEDLINE | ID: mdl-33868251

ABSTRACT

Objectives: Hydroxychloroquine (HCQ) is widely used to treat rheumatic diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and Sjögren's syndrome (SS). Cardiac arrhythmia has been concerned as important safety issue for HCQ. The aim of this study was to investigate whether hydroxychloroquine increases new-onset arrhythmia among patients with RA, SLE or SS. Methods: This was a retrospective cohort study that conducted from the longitudinal health insurance database of Taiwan. Patients with newly diagnosed RA, SLE or SS with age ≥20 years old were selected from 2000 to 2012. Patients who received HCQ and without HCQ treatment groups were matched by propensity score to minimize the effect of selection bias and confounders. The Cox proportional hazard model was used to analyze the risk of arrhythmia between the two groups after controlling for related variables. Results: A total of 15892 patients were selected to participate and finally 3575 patients were enrolled in each group after matching. There was no different risk of all arrhythmia in patients using HCQ than without HCQ (adjusted hazards ratio 0.81, 95% CI 0.61-1.07) and ventricular arrhythmia as well. The incidence of arrhythmia did not increase when HCQ co-administrated with macrolides. The arrhythmia risk was also not different regardless of daily HCQ dose <400mg or ≥400mg or follow-up duration of ≦4 months or >4 months. Conclusion: The administration of HCQ did not increase the risk of all cardiac arrhythmia and ventricular arrhythmia regardless of different duration of treatment (≦4 months or >4 months) or cumulative dose (<400mg or ≥400mg) in patients with common autoimmune diseases such as RA, SLE and SS.


Subject(s)
Antirheumatic Agents/therapeutic use , Arrhythmias, Cardiac/epidemiology , Hydroxychloroquine/therapeutic use , Rheumatic Diseases/drug therapy , Antirheumatic Agents/adverse effects , Arrhythmias, Cardiac/chemically induced , Cohort Studies , Female , Humans , Hydroxychloroquine/adverse effects , Incidence , Male , Middle Aged , National Health Programs/statistics & numerical data , Propensity Score , Proportional Hazards Models , Retrospective Studies , Rheumatic Diseases/epidemiology , Taiwan
3.
Circ Arrhythm Electrophysiol ; 14(3): e009458, 2021 03.
Article in English | MEDLINE | ID: mdl-33554620
4.
Curr Probl Cardiol ; 46(3): 100718, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33097299

ABSTRACT

Omega-3-fatty-acids are now increasingly being used for potential beneficial anti-inflammatory effect in the treatment and management of cardiovascular disease. Eicosapentaenoic acid and Docosahexaenoic acid are 2 essential omega-3 fatty acids found predominately in fish and fish oil supplements. Despite the increased use of fish oil products for both primary and secondary prevention of cardiovascular morbidity and mortality, the available literature evidence are controversial. We searched through PubMed for studies that have investigated the impact of omega-3 fatty acids on coronary heart disease and mortality. Our systemic review suggests that most studies, which are mostly observational, have found there to be a potential benefit of omega-3 fatty acids on coronary heart disease whereas some other studies have found conflicting results. More randomized controlled studies are warranted with adequate sample size to clearly establish the risk and benefits of omega-3 fatty acids on cardiovascular disease.


Subject(s)
Arrhythmias, Cardiac , Cardiovascular Diseases , Fatty Acids, Omega-3 , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/prevention & control , Cardiovascular Diseases/etiology , Cardiovascular Diseases/prevention & control , Docosahexaenoic Acids/administration & dosage , Docosahexaenoic Acids/adverse effects , Eicosapentaenoic Acid/administration & dosage , Eicosapentaenoic Acid/adverse effects , Fatty Acids, Omega-3/administration & dosage , Fatty Acids, Omega-3/adverse effects , Fish Oils/therapeutic use , Humans , Randomized Controlled Trials as Topic , Secondary Prevention
6.
J Robot Surg ; 15(1): 37-44, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32277400

ABSTRACT

Evaluation of safety is of paramount importance with adoption of novel surgical technology. Although robotic surgery has become widely used in oncologic surgery, analysis of safety is lacking in comparison to traditional techniques. Standardized assessment of robotic surgical outcomes and adverse events following oncologic surgery is necessary for quality improvement with innovative technology. Between 2003 and 2016, 10,013 unique robotic operations were performed in 9,858 patients. Our prospectively maintained database was retrospectively reviewed for hospital readmissions and Clavien-Dindo grade ≥ 2 complications within 30 days. Multivariable logistic regression was used to identify predictors of surgical complications and hospital readmissions. Cases were stratified by discipline: genitourinary (n = 8240), gynecologic (n = 857), thoracic (n = 457), gastrointestinal (n = 322), hepatobiliary (n = 60), ear/nose/throat (n = 44) and general (n = 33). Intraoperative complications occurred in 42 surgeries (0.4%). Postoperative complications occurred in 946 patients [9.4%, highest grade 2 (n = 574), 3 (n = 288), 4 (n = 72), 5 (n = 10)]. Most frequent complications were ileus (154, 16.3%), anemia (91, 9.6%), cardiac arrhythmia (62, 6.6%), deep vein thrombosis/pulmonary embolus (47, 5.0%), wound infection (45, 4.8%) and urinary leak (43, 4.5%). 405 patients (4.0%) required readmission. Most common causes for hospital readmission were ileus (44, 10.9%), urinary leak (23, 5.7%), urinary tract infection (23, 5.7%), intra-abdominal abscess/fluid collection (23, 5.7%), and small bowel obstruction (19, 4.7%). On multivariable analysis, longer operative time and older age predicted complications and readmissions (p ≤ 0.02). Robotic-assisted surgery appears a safe for oncologic surgery with acceptable hospital readmission and complication rates. Older age and longer operative time were associated with complications and readmission.


Subject(s)
Comprehensive Health Care/statistics & numerical data , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Neoplasms/surgery , Oncology Service, Hospital/statistics & numerical data , Patient Readmission/statistics & numerical data , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/statistics & numerical data , Aged , Anemia/epidemiology , Anemia/etiology , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/etiology , Databases as Topic , Female , Humans , Ileus/epidemiology , Ileus/etiology , Male , Pulmonary Embolism/epidemiology , Pulmonary Embolism/etiology , Quality Improvement , Quality of Health Care , Retrospective Studies , Surgical Wound Infection/epidemiology , Surgical Wound Infection/etiology , Treatment Outcome , Venous Thrombosis/epidemiology , Venous Thrombosis/etiology
7.
Clin Pharmacol Ther ; 109(6): 1606-1617, 2021 06.
Article in English | MEDLINE | ID: mdl-33283267

ABSTRACT

Drugs that prolong QT may cause torsade de pointes (TdP). However, translation of nonclinical assessment of QT prolongation or hERG channel, targeted by QT-prolonging drugs, into clinical TdP risk has been insufficient to date. In this blinded study, we confirmed the utility of a Normalized TdP Score System in predicting drug-induced TdP risks among 34 drugs, including 28 with low, intermediate, and high TdP risks under the Comprehensive In Vitro Proarrhythmia Assay (CiPA) initiative plus six compounds with names blinded to the investigators, using the rabbit ventricular wedge assay. Concentration-dependent TdP scores were determined by drug-induced changes in QT, Tp-e , and proarrhythmias. Disclosure of the names and testing concentrations was made after completion of the experiments and report to the sponsors. Drugs' normalized TdP scores were calculated thereafter based on their respective free clinical maximum concentration (Cmax ). Drugs' normalized TdP scores were calculated and ranked for 33 drugs, excluding 1 investigational drug, and the TdP risks of the 28 CiPA drugs were correctly distinguished according to their respective categories of low, intermediate, and high TdP risks under the CiPA initiative. Accordingly, we are able to propose the cutoff values of the normalized TdP scores at 1 × Cmax : ≤ 0, > 0 to < 0.65 and ≥ 0.65, respectively, for low, intermediate, and high risk. This blinded study supports utility of our Normalized TdP Score System in predicting drug-induced TdP risks in 33 drugs, including 28 used for characterization of other assays under the CiPA initiative. However, these results need to be replicated in other laboratories.


Subject(s)
Arrhythmias, Cardiac/chemically induced , Arrhythmias, Cardiac/epidemiology , Torsades de Pointes/chemically induced , Torsades de Pointes/epidemiology , Animals , Drug Evaluation, Preclinical , Electrocardiography , Heart Ventricles/physiopathology , Long QT Syndrome/chemically induced , Rabbits , Risk Assessment
9.
Plast Reconstr Surg ; 146(1): 54e-60e, 2020 07.
Article in English | MEDLINE | ID: mdl-32590653

ABSTRACT

BACKGROUND: The wide-awake local anesthesia no tourniquet (WALANT) technique in hand surgery is gaining popularity. The authors aimed to prospectively analyze the frequency and type of arrhythmias in patients undergoing hand surgery under local anesthesia and to examine whether the addition of adrenaline affects their incidence. METHODS: Adult patients undergoing hand surgery under local anesthesia were randomized into two groups: group 1, local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT). Patients with a history of arrhythmias were excluded. Patients were connected to Holter electrocardiographic monitoring before surgery and up until discharge. The records were blindly compared between the groups regarding types of arrhythmias, and frequency and timing relative to injection and tourniquet inflation. RESULTS: One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group). No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group. Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia) were recorded in 68 patients (66.6 percent), with no statistical difference between the groups. There were three patients with minor arrhythmias during inflation of the tourniquet. Patients in the adrenaline group had 2 percent sinus tachycardia during injection and 4 percent asymptomatic bradyarrhythmias. These findings do not require any further treatment. CONCLUSIONS: The authors' results show that hand operations using WALANT technique in patients with no history of arrhythmia are safe and are not arrhythmogenic; therefore, there is no need for routine perioperative continuous electrocardiographic monitoring. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.


Subject(s)
Adrenergic beta-Agonists/adverse effects , Anesthesia, Local/methods , Arrhythmias, Cardiac , Epinephrine/adverse effects , Hand/surgery , Vasoconstrictor Agents/adverse effects , Adult , Aged , Anesthesia, Local/adverse effects , Arrhythmias, Cardiac/chemically induced , Arrhythmias, Cardiac/epidemiology , Female , Humans , Incidence , Male , Middle Aged , Prospective Studies
10.
Cochrane Database Syst Rev ; 3: CD003177, 2020 02 29.
Article in English | MEDLINE | ID: mdl-32114706

ABSTRACT

BACKGROUND: Omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3)), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) may benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this. OBJECTIVES: To assess the effects of increased intake of fish- and plant-based omega-3 fats for all-cause mortality, cardiovascular events, adiposity and lipids. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to February 2019, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to August 2019, with no language restrictions. We handsearched systematic review references and bibliographies and contacted trial authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation or advice to increase LCn3 or ALA intake, or both, versus usual or lower intake. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression. MAIN RESULTS: We included 86 RCTs (162,796 participants) in this review update and found that 28 were at low summary risk of bias. Trials were of 12 to 88 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most trials assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet. LCn3 doses ranged from 0.5 g a day to more than 5 g a day (19 RCTs gave at least 3 g LCn3 daily). Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.93 to 1.01; 143,693 participants; 11,297 deaths in 45 RCTs; high-certainty evidence), cardiovascular mortality (RR 0.92, 95% CI 0.86 to 0.99; 117,837 participants; 5658 deaths in 29 RCTs; moderate-certainty evidence), cardiovascular events (RR 0.96, 95% CI 0.92 to 1.01; 140,482 participants; 17,619 people experienced events in 43 RCTs; high-certainty evidence), stroke (RR 1.02, 95% CI 0.94 to 1.12; 138,888 participants; 2850 strokes in 31 RCTs; moderate-certainty evidence) or arrhythmia (RR 0.99, 95% CI 0.92 to 1.06; 77,990 participants; 4586 people experienced arrhythmia in 30 RCTs; low-certainty evidence). Increasing LCn3 may slightly reduce coronary heart disease mortality (number needed to treat for an additional beneficial outcome (NNTB) 334, RR 0.90, 95% CI 0.81 to 1.00; 127,378 participants; 3598 coronary heart disease deaths in 24 RCTs, low-certainty evidence) and coronary heart disease events (NNTB 167, RR 0.91, 95% CI 0.85 to 0.97; 134,116 participants; 8791 people experienced coronary heart disease events in 32 RCTs, low-certainty evidence). Overall, effects did not differ by trial duration or LCn3 dose in pre-planned subgrouping or meta-regression. There is little evidence of effects of eating fish. Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20; 19,327 participants; 459 deaths in 5 RCTs, moderate-certainty evidence),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25; 18,619 participants; 219 cardiovascular deaths in 4 RCTs; moderate-certainty evidence), coronary heart disease mortality (RR 0.95, 95% CI 0.72 to 1.26; 18,353 participants; 193 coronary heart disease deaths in 3 RCTs; moderate-certainty evidence) and coronary heart disease events (RR 1.00, 95% CI 0.82 to 1.22; 19,061 participants; 397 coronary heart disease events in 4 RCTs; low-certainty evidence). However, increased ALA may slightly reduce risk of cardiovascular disease events (NNTB 500, RR 0.95, 95% CI 0.83 to 1.07; but RR 0.91, 95% CI 0.79 to 1.04 in RCTs at low summary risk of bias; 19,327 participants; 884 cardiovascular disease events in 5 RCTs; low-certainty evidence), and probably slightly reduces risk of arrhythmia (NNTB 91, RR 0.73, 95% CI 0.55 to 0.97; 4912 participants; 173 events in 2 RCTs; moderate-certainty evidence). Effects on stroke are unclear. Increasing LCn3 and ALA had little or no effect on serious adverse events, adiposity, lipids and blood pressure, except increasing LCn3 reduced triglycerides by ˜15% in a dose-dependent way (high-certainty evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and low-certainty evidence suggests that increasing LCn3 slightly reduces risk of coronary heart disease mortality and events, and reduces serum triglycerides (evidence mainly from supplement trials). Increasing ALA slightly reduces risk of cardiovascular events and arrhythmia.


Subject(s)
Cardiovascular Diseases/prevention & control , Dietary Supplements , Fatty Acids, Omega-3/therapeutic use , Primary Prevention , Secondary Prevention , Adiposity , Adult , Arrhythmias, Cardiac/epidemiology , Cardiovascular Diseases/diet therapy , Cardiovascular Diseases/mortality , Cause of Death , Coronary Disease/mortality , Docosahexaenoic Acids/therapeutic use , Eicosapentaenoic Acid/therapeutic use , Fatty Acids, Omega-3/adverse effects , Hemorrhage/epidemiology , Humans , Pulmonary Embolism/epidemiology , Randomized Controlled Trials as Topic , Regression Analysis , Stroke/epidemiology , Treatment Outcome , alpha-Linolenic Acid/therapeutic use
13.
J Am Coll Cardiol ; 73(14): 1756-1765, 2019 04 16.
Article in English | MEDLINE | ID: mdl-30975291

ABSTRACT

BACKGROUND: Information on young patients with Brugada syndrome (BrS) and arrhythmic events (AEs) is limited. OBJECTIVES: The purpose of this study was to describe their characteristics and management as well as risk factors for AE recurrence. METHODS: A total of 57 patients (age ≤20 years), all with BrS and AEs, were divided into pediatric (age ≤12 years; n = 26) and adolescents (age 13 to 20 years; n = 31). RESULTS: Patients' median age at time of first AE was 14 years, with a majority of males (74%), Caucasians (70%), and probands (79%) who presented as aborted cardiac arrest (84%). A significant proportion of patients (28%) exhibited fever-related AE. Family history of sudden cardiac death (SCD), prior syncope, spontaneous type 1 Brugada electrocardiogram (ECG), inducible ventricular fibrillation at electrophysiological study, and SCN5A mutations were present in 26%, 49%, 65%, 28%, and 58% of patients, respectively. The pediatric group differed from the adolescents, with a greater proportion of females, Caucasians, fever-related AEs, and spontaneous type-1 ECG. During follow-up, 68% of pediatric and 64% of adolescents had recurrent AE, with median time of 9.9 and 27.0 months, respectively. Approximately one-third of recurrent AEs occurred on quinidine therapy, and among the pediatric group, 60% of recurrent AEs were fever-related. Risk factors for recurrent AE included sinus node dysfunction, atrial arrhythmias, intraventricular conduction delay, or large S-wave on ECG lead I in the pediatric group and the presence of SCN5A mutation among adolescents. CONCLUSIONS: Young BrS patients with AE represent a very arrhythmogenic group. Current management after first arrhythmia episode is associated with high recurrence rate. Alternative therapies, besides defibrillator implantation, should be considered.


Subject(s)
Arrhythmias, Cardiac , Brugada Syndrome , Heart Arrest , Quinidine/therapeutic use , Risk Assessment/methods , Secondary Prevention/methods , Ablation Techniques/methods , Adolescent , Anti-Arrhythmia Agents/therapeutic use , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/genetics , Arrhythmias, Cardiac/prevention & control , Brugada Syndrome/diagnosis , Brugada Syndrome/epidemiology , Brugada Syndrome/physiopathology , Brugada Syndrome/therapy , Child , Defibrillators, Implantable/statistics & numerical data , Electrocardiography/methods , Electrophysiologic Techniques, Cardiac/methods , Female , Heart Arrest/diagnosis , Heart Arrest/prevention & control , Humans , Male , Medical History Taking/statistics & numerical data , Risk Factors , Syncope/diagnosis , Syncope/epidemiology , Syncope/etiology , Young Adult
15.
Heart ; 105(7): 538-544, 2019 04.
Article in English | MEDLINE | ID: mdl-30377259

ABSTRACT

BACKGROUND: Tachyarrhythmias and bradyarrhythmias affect 20%-50% of adult patients with tetralogy of Fallot (TOF) and some of these patients will require cardiac implantable electronic devices (CIED) such as pacemaker and/or internal cardioverter defibrillator. METHODS: The Mayo Adult Congenital Heart Disease database was queried for patients with repaired TOF and history of CIED implantation, 1990-2017. The study objectives were: (1) determine the occurrence of device-related complications defined as lead failure, lead recall, device infection and lead thrombus; and (2) determine the occurrence and risk factors for defibrillator shock. RESULTS: There were 99 patients (age 46±14 years and 66 (66%) men) with CIED, and the CIEDs were 41 (41%) pacemakers and 73 (73%) defibrillators. Indication for defibrillator implantation was for primary prevention in 28 (38%) and secondary prevention in 45 (62%). Device-related complications occurred in 20 (20%) patients (lead failure 17, lead recall 4, device infection 12 and thrombus 3). Twenty-five per cent of all device infections occurred within 30 days from the time of device generator change. Annualised rates of appropriate and inappropriate shocks were 5.7% and 6.2%, respectively. The use of class III antiarrhythmic drug was protective against defibrillator shock. CONCLUSION: The current study provides useful outcome data to aid patient counselling and clinical decision-making. Further studies are required to explore ways to decrease the risk of postprocedural infection after device generator change, and to determine which patients will benefit from empirical antiarrhythmic therapy as a strategy to decrease incidence of inappropriate defibrillator shock.


Subject(s)
Arrhythmias, Cardiac , Defibrillators, Implantable/adverse effects , Device Removal/adverse effects , Electric Stimulation Therapy , Pacemaker, Artificial/adverse effects , Prosthesis-Related Infections , Tetralogy of Fallot/complications , Adult , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/prevention & control , Arrhythmias, Cardiac/therapy , Defibrillators, Implantable/standards , Device Removal/methods , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/instrumentation , Electric Stimulation Therapy/methods , Electrocardiography/methods , Equipment Failure Analysis , Female , Humans , Incidence , Male , Middle Aged , Needs Assessment , Outcome and Process Assessment, Health Care , Prosthesis-Related Infections/epidemiology , Prosthesis-Related Infections/prevention & control , Retrospective Studies , Tetralogy of Fallot/epidemiology , United States/epidemiology
16.
Clin Pharmacol Ther ; 105(2): 466-475, 2019 02.
Article in English | MEDLINE | ID: mdl-30151907

ABSTRACT

The International Council on Harmonization (ICH) S7B and E14 regulatory guidelines are sensitive but not specific for predicting which drugs are pro-arrhythmic. In response, the Comprehensive In Vitro Proarrhythmia Assay (CiPA) was proposed that integrates multi-ion channel pharmacology data in vitro into a human cardiomyocyte model in silico for proarrhythmia risk assessment. Previously, we reported the model optimization and proarrhythmia metric selection based on CiPA training drugs. In this study, we report the application of the prespecified model and metric to independent CiPA validation drugs. Over two validation datasets, the CiPA model performance meets all pre-specified measures for ranking and classifying validation drugs, and outperforms alternatives, despite some in vitro data differences between the two datasets due to different experimental conditions and quality control procedures. This suggests that the current CiPA model/metric may be fit for regulatory use, and standardization of experimental protocols and quality control criteria could increase the model prediction accuracy even further.


Subject(s)
Arrhythmias, Cardiac/chemically induced , Arrhythmias, Cardiac/epidemiology , Computer Simulation , Databases, Factual , Drug Evaluation, Preclinical/methods , ERG1 Potassium Channel/drug effects , Humans , Ion Channels/drug effects , Myocytes, Cardiac/drug effects , Reproducibility of Results , Risk Assessment , Sensitivity and Specificity
17.
Cochrane Database Syst Rev ; 11: CD003177, 2018 11 30.
Article in English | MEDLINE | ID: mdl-30521670

ABSTRACT

BACKGROUND: Researchers have suggested that omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this. OBJECTIVES: To assess effects of increased intake of fish- and plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events, adiposity and lipids. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to April 2017, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to September 2016, with no language restrictions. We handsearched systematic review references and bibliographies and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation and/or advice to increase LCn3 or ALA intake versus usual or lower intake. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression. MAIN RESULTS: We included 79 RCTs (112,059 participants) in this review update and found that 25 were at low summary risk of bias. Trials were of 12 to 72 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most studies assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet. LCn3 doses ranged from 0.5g/d LCn3 to > 5 g/d (16 RCTs gave at least 3g/d LCn3).Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (RR 0.98, 95% CI 0.90 to 1.03, 92,653 participants; 8189 deaths in 39 trials, high-quality evidence), cardiovascular mortality (RR 0.95, 95% CI 0.87 to 1.03, 67,772 participants; 4544 CVD deaths in 25 RCTs), cardiovascular events (RR 0.99, 95% CI 0.94 to 1.04, 90,378 participants; 14,737 people experienced events in 38 trials, high-quality evidence), coronary heart disease (CHD) mortality (RR 0.93, 95% CI 0.79 to 1.09, 73,491 participants; 1596 CHD deaths in 21 RCTs), stroke (RR 1.06, 95% CI 0.96 to 1.16, 89,358 participants; 1822 strokes in 28 trials) or arrhythmia (RR 0.97, 95% CI 0.90 to 1.05, 53,796 participants; 3788 people experienced arrhythmia in 28 RCTs). There was a suggestion that LCn3 reduced CHD events (RR 0.93, 95% CI 0.88 to 0.97, 84,301 participants; 5469 people experienced CHD events in 28 RCTs); however, this was not maintained in sensitivity analyses - LCn3 probably makes little or no difference to CHD event risk. All evidence was of moderate GRADE quality, except as noted.Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20, 19,327 participants; 459 deaths, 5 RCTs),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25, 18,619 participants; 219 cardiovascular deaths, 4 RCTs), and CHD mortality (1.1% to 1.0%, RR 0.95, 95% CI 0.72 to 1.26, 18,353 participants; 193 CHD deaths, 3 RCTs) and ALA may make little or no difference to CHD events (RR 1.00, 95% CI 0.80 to 1.22, 19,061 participants, 397 CHD events, 4 RCTs, low-quality evidence). However, increased ALA may slightly reduce risk of cardiovascular events (from 4.8% to 4.7%, RR 0.95, 95% CI 0.83 to 1.07, 19,327 participants; 884 CVD events, 5 RCTs, low-quality evidence with greater effects in trials at low summary risk of bias), and probably reduces risk of arrhythmia (3.3% to 2.6%, RR 0.79, 95% CI 0.57 to 1.10, 4,837 participants; 141 events, 1 RCT). Effects on stroke are unclear.Sensitivity analysis retaining only trials at low summary risk of bias moved effect sizes towards the null (RR 1.0) for all LCn3 primary outcomes except arrhythmias, but for most ALA outcomes, effect sizes moved to suggest protection. LCn3 funnel plots suggested that adding in missing studies/results would move effect sizes towards null for most primary outcomes. There were no dose or duration effects in subgrouping or meta-regression.There was no evidence that increasing LCn3 or ALA altered serious adverse events, adiposity or lipids, except LCn3 reduced triglycerides by ˜15% in a dose-dependant way (high-quality evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event and arrhythmia risk.


Subject(s)
Cardiovascular Diseases/prevention & control , Dietary Supplements , Fatty Acids, Omega-3/therapeutic use , Adult , Arrhythmias, Cardiac/epidemiology , Cardiovascular Diseases/diet therapy , Cardiovascular Diseases/mortality , Cause of Death , Coronary Disease/mortality , Docosahexaenoic Acids/therapeutic use , Eicosapentaenoic Acid/therapeutic use , Fatty Acids, Omega-3/adverse effects , Humans , Primary Prevention , Randomized Controlled Trials as Topic , Secondary Prevention , Stroke/epidemiology , Treatment Outcome , alpha-Linolenic Acid/therapeutic use
18.
Rev Esp Cardiol (Engl Ed) ; 71(12): 1047-1058, 2018 Dec.
Article in English, Spanish | MEDLINE | ID: mdl-30420318

ABSTRACT

INTRODUCTION AND OBJECTIVES: The Spanish Automatic Defibrillator Registry has provided activity data since 2002. METHODS: The data in this registry are submitted by implantation centers that voluntarily complete a data collection sheet. RESULTS: During 2017, a total of 6273 implant sheets were received, compared with 6429 reported by Eucomed (European Confederation of Medical Suppliers Associations). Therefore, the registry contains data on 97.6% of the devices implanted in Spain. Compliance ranged from 99.7% for the field "name of the implanting hospital" to 46.1% for the variable "New York Heart Association functional class". A total of 181 hospitals reported data to the registry, representing an increase compared with the number of participating hospitals in 2016 (177) and in previous years (169 in 2015, 162 in 2014, 154 in 2013, and 153 in 2012). CONCLUSIONS: The number of implants per million inhabitants in Spain increased for several years but decreased in 2017. As in previous years, the total number of implants in Spain is still much lower than the European Union average, and the gap continues to widen. There are still substantial differences between autonomous communities.


Subject(s)
Arrhythmias, Cardiac/therapy , Cardiology , Defibrillators, Implantable/statistics & numerical data , Electrophysiologic Techniques, Cardiac/statistics & numerical data , Registries , Societies, Medical , Arrhythmias, Cardiac/epidemiology , Female , Humans , Incidence , Male , Retrospective Studies , Spain/epidemiology
19.
Rev Esp Cardiol (Engl Ed) ; 71(11): 941-951, 2018 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-30268656

ABSTRACT

INTRODUCTION AND OBJECTIVES: This report describes the findings of the 2017 Spanish Catheter Ablation Registry. METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 15 284 ablation procedures were performed by 98 institutions (the highest number of ablations and institutions historically reported in this registry), with a mean of 156±126 and a median of 136 procedures per center. For the first time, the most frequently treated ablation target was atrial fibrillation (n=3457; 22.6%), followed by cavotricuspid isthmus (n=3449; 22.5%) and atrioventricular nodal re-entrant tachycardia (n=3429; 22.4%). The overall success rate was 87%. The rate of major complications was 2.6%, and the mortality rate was 0.09%. The percentage of procedures performed without fluoroscopic support increased to 6% of all ablations, and 2.3% of all ablations were performed in pediatric patients. CONCLUSIONS: The Spanish Ablation Catheter Registry systematically and uninterruptedly collects data on the ablation procedures performed in Spain, revealing that both the number of ablations and the number of centers performing them has progressively increased, while maintaining a high success rate and a low percentage of complications.


Subject(s)
Arrhythmias, Cardiac/surgery , Cardiology , Catheter Ablation/statistics & numerical data , Electrophysiologic Techniques, Cardiac , Registries , Societies, Medical , Arrhythmias, Cardiac/epidemiology , Humans , Morbidity/trends , Retrospective Studies , Spain/epidemiology
20.
BMC Cardiovasc Disord ; 18(1): 129, 2018 06 28.
Article in English | MEDLINE | ID: mdl-29954320

ABSTRACT

BACKGROUND: Atrial and ventricular cardiac arrhythmias are one of the most common early complications after cardiac surgery and these serve as a major cause of mortality and morbidity after cardiac revascularization. We want to evaluate the effect of magnesium sulfate administration on the incidence of cardiac arrhythmias after cardiac revascularization by doing this systematic review and meta-analysis. METHODS: The search performed in several databases (SID, Magiran, IranDoc, IranMedex, MedLib, PubMed, EmBase, Web of Science, Scopus, the Cochrane Library and Google Scholar) for published Randomized controlled trials before December 2017 that have reported the association between Magnesium consumption and the incidence of cardiac arrhythmias. This relationship measured using odds ratios (ORs) with a confidence interval of 95% (CIs). Funnel plots and Egger test used to examine publication bias. STATA (version 11.1) used for all analyses. RESULTS: Twenty-two studies selected as eligible for this research and included in the final analysis. The total rate of ventricular arrhythmia was lower in the group receiving magnesium sulfate than placebo (11.88% versus 24.24%). The same trend obtained for the total incidence of supraventricular arrhythmia (10.36% in the magnesium versus 23.91% in the placebo group). In general the present meta-analysis showed that magnesium could decrease ventricular and supraventricular arrhythmias compared with placebo (OR = 0.32, 95% CI 0.16-0.49; p < 0.001 and OR = 0.42, 95% CI 0.22-0.65; p < 0.001, respectively). Subgroup analysis showed that the effect of magnesium on the incidence of cardiac arrhythmias was not affected by clinical settings and dosage of magnesium. Meta-regression analysis also showed that there was no significant association between the reduction of ventricular arrhythmias and sample size. CONCLUSION: The results of this meta-analysis study suggest that magnesium sulfate can be used safely and effectively and is a cost-effective way in the prevention of many of ventricular and supraventricular arrhythmias.


Subject(s)
Acute Coronary Syndrome/therapy , Anti-Arrhythmia Agents/therapeutic use , Arrhythmias, Cardiac/prevention & control , Magnesium Sulfate/therapeutic use , Percutaneous Coronary Intervention , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/epidemiology , Acute Coronary Syndrome/physiopathology , Adult , Aged , Anti-Arrhythmia Agents/adverse effects , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/physiopathology , Female , Humans , Incidence , Magnesium Sulfate/adverse effects , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Protective Factors , Risk Factors , Treatment Outcome
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