BACKGROUND:Coronary artery embolism (CAE) is an underrecognized cause of myocardial infarction, particularly in patients with limited coronary atherosclerosis. Pulmonary vein thrombosis (PVT) as an embolic source of CAE has rarely been described. CASE SUMMARY:A middle-aged female with known active cocaine use and Factor V Leiden mutation presented following out-of-hospital ventricular fibrillation cardiac arrest. Coronary angiography revealed thrombotic left circumflex artery occlusion without atherosclerosis. Computed tomography identified a nonocclusive left superior pulmonary vein thrombus as a possible embolic source. Drug-eluting stent implantation and apixaban were initiated; ticagrelor was de-escalated to clopidogrel given anticoagulation. Thrombus resolved at 12 weeks. DISCUSSION:Cocaine-provoked PVT causing CAE in inherited thrombophilia is a rare mechanism requiring embolic source evaluation and tailored management. TAKE-HOME MESSAGES:In patients with cryptogenic CAE, cocaine use with inherited thrombophilia should prompt PVT evaluation. When post-percutaneous coronary intervention antiplatelet therapy requires anticoagulation, P2Y12 de-escalation to clopidogrel reduces bleeding risk.
Athletes are generally healthy but might have certain cardiac disorders which might, during athletic participation or training, result in cardiac symptoms including syncope. Vasovagal syncope is probably the most common cause of syncope in athletes, but syncope in the context of these cardiac disorders might be a warning of sudden death.
Rate control is fundamental in the treatment of patients with atrial fibrillation (AF). The independent association of heart rate with outcomes and range of heart rate associated with best outcomes remains uncertain. We assessed the relationship between heart rate and clinical outcomes in patients with persistent or permanent AF enrolled in the randomized, double-blind ARISTOTLE trial. In patients with persistent or permanent AF, a faster heart rate is associated with a modest, but statistically significant increase in death and heart failure hospitalizations.
Atherosclerosis remains a leading cause of cardiovascular diseases. Although the mechanism for atherosclerosis is complex and has not been fully understood, inflammation and oxidative stress play a critical role in the development and progression of atherosclerosis. N-acetylcysteine (NAC) has been used as a mucolytic agent and an antidote for acetaminophen overdose with a well-established safety profile. NAC has antioxidant and anti-inflammatory effects through multiple mechanisms, including an increase in the intracellular glutathione level and an attenuation of the nuclear factor kappa-B mediated production of inflammatory cytokines like tumor necrosis factor-alpha and interleukins. Numerous animal studies have demonstrated that NAC significantly decreases the development and progression of atherosclerosis. However, the data on the outcomes of clinical studies in patients with atherosclerosis have been limited and inconsistent. The purpose of this review is to summarize the data on the effect of NAC on atherosclerosis from both pre-clinical and clinical studies and discuss the potential mechanisms of action of NAC on atherosclerosis, as well as challenges in the field.
HomeCirculationVol. 146, No. 12Duration of Anticoagulation Interruption Before Invasive Procedures and Outcomes in Patients With Atrial Fibrillation: Insights From the ARISTOTLE Trial Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBDuration of Anticoagulation Interruption Before Invasive Procedures and Outcomes in Patients With Atrial Fibrillation: Insights From the ARISTOTLE Trial Sana M. Al-Khatib, Daniel M. Wojdyla, Christopher B. Granger, Lars Wallentin, David A. Garcia, Ziad Hijazi, Claes Held, John H. Alexander, Dragos Vinereanu, Gregory C. Flaker, Elaine M. Hylek and Renato D. Lopes Sana M. Al-KhatibSana M. Al-Khatib Correspondence to: Sana M. Al-Khatib, MD, MHS, Duke Clinical Research Institute, 300 Morgan St, Durham, NC 27701. Email E-mail Address: [email protected] https://orcid.org/0000-0002-3561-0146 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.M.Al-K., D.M.W., C.B.G., J.H.A., R.D.L.). , Daniel M. WojdylaDaniel M. Wojdyla Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.M.Al-K., D.M.W., C.B.G., J.H.A., R.D.L.). , Christopher B. GrangerChristopher B. Granger https://orcid.org/0000-0002-0045-3291 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.M.Al-K., D.M.W., C.B.G., J.H.A., R.D.L.). , Lars WallentinLars Wallentin Uppsala Clinical Research Center and the Department of Medical Sciences, Cardiology, Uppsala University, Sweden (L.W., Z.H., C.H.). , David A. GarciaDavid A. Garcia Hematology Division, University of Washington, Seattle (D.A.G.). , Ziad HijaziZiad Hijazi https://orcid.org/0000-0002-7420-743X Uppsala Clinical Research Center and the Department of Medical Sciences, Cardiology, Uppsala University, Sweden (L.W., Z.H., C.H.). , Claes HeldClaes Held https://orcid.org/0000-0001-9402-7404 Uppsala Clinical Research Center and the Department of Medical Sciences, Cardiology, Uppsala University, Sweden (L.W., Z.H., C.H.). , John H. AlexanderJohn H. Alexander https://orcid.org/0000-0002-1444-2462 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.M.Al-K., D.M.W., C.B.G., J.H.A., R.D.L.). , Dragos VinereanuDragos Vinereanu https://orcid.org/0000-0002-9054-8779 University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.). , Gregory C. FlakerGregory C. Flaker Division of Cardiology, University of Missouri, Columbia, MO (G.C.F.). , Elaine M. HylekElaine M. Hylek Boston University School of Medicine, Boston, MA (E.M.H.). and Renato D. LopesRenato D. Lopes https://orcid.org/0000-0003-2999-4961 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.M.Al-K., D.M.W., C.B.G., J.H.A., R.D.L.). Originally published19 Sep 2022https://doi.org/10.1161/CIRCULATIONAHA.122.059438Circulation. 2022;146:958–960Factor Xa inhibitors are the predominant type of oral anticoagulant for stroke prevention in atrial fibrillation.1 Although recommendations exist on holding these medications before procedures with a low, intermediate, or high bleeding risk, whether and for how long to interrupt these medications around the time of a procedure continue to be debated.2In a previous analysis of the ARISTOTLE trial (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation), the 30-day postprocedure risk of stroke and major bleeding was similarly low in apixaban- and warfarin-treated patients, regardless of whether or not anticoagulation was interrupted at the time of a procedure.3 Despite these results, many clinicians remain concerned about the risk of stroke when anticoagulation is held and the risk of bleeding when anticoagulation is not held before an invasive procedure. We conducted this subanalysis to examine how the duration of anticoagulation interruption before an invasive procedure in patients with atrial fibrillation is associated with 30-day outcomes.This post hoc descriptive analysis included patients in ARISTOTLE who underwent an invasive procedure with a known procedure date (n=10 674).4 Procedures were not included if study medication was intermittently stopped and restarted in the 7 days before a procedure (n=204) or if no doses of study medication were taken for >7 days before a procedure (n=1210), because such interruptions were assumed not to be related to the procedure. We classified each procedure as "no interruption" (no interruption of study drug or if it was interrupted on the day of the procedure) or "interruption" (interruption 1–7 days before the procedure). Outcomes examined in this analysis include 30-day stroke or systemic embolism, myocardial infarction, all-cause death, major bleeding, a composite of major or clinically relevant nonmajor bleeding (per International Society on Thrombosis and Haemostasis criteria), and a net benefit end point of stroke, systemic embolism, or major bleeding. The study was approved by institutional review committees, and all patients provided informed consent.4 The data that support the findings of this study are available from the corresponding author on reasonable request.Of 18 201 patients enrolled in ARISTOTLE, 5439 (29.9%) had a procedure that met the criteria for this analysis, and 9260 procedures (3468 with no interruption and 5792 with interruption) were identified. Of these, 8994 were nonemergency procedures and 266 were emergency procedures. The most prevalent procedures were tooth extraction/oral surgery (14.6%), colonoscopy (9.9%), eye surgery (8.0%), upper gastrointestinal endoscopy (7.6%), and pacemaker implantation (3.5%). In 11.7% of the procedures, bridging with a parenteral anticoagulant was undertaken either before or after the procedure. In patients who interrupted study drug (n=5792), 38.1% were on study drug 1 day after the procedure, 57.8% were on it 2 days after the procedure, and 17.1% did not restart study drug within 8 days after the procedure. The number of patients stopping study drug 5 to 7 days before the procedure was slightly higher in the warfarin (25.1%) than in the apixaban group (19.1%), the remaining rates were similar between the 2 groups. The rates of stroke/systemic embolism, myocardial infarction, death and major bleeding were <0.5% for patients on study drug 1 or 2 days after the procedure. However, for patients who did not start study drug within 8 days from the procedure, the rates of stroke, myocardial infarction, death, and major bleeding were 1%, 0.8%, 1.3%, and 5.1%, respectively. The death rate ranged from 0.26% for a 3-day interruption to 3.94% for a 1-day interruption. The main results are shown in the Figure.Download figureDownload PowerPointFigure. Associations between the duration of apixaban and warfarin interruption before an invasive procedure in patients with atrial fibrillation and 30-day outcomes.The net benefit end point includes stroke/SE or major bleeding. CRNM indicates clinically relevant nonmajor; and SE, systemic embolism.In this analysis, the risk of stroke or systemic embolism was very low (2/2314; 0.086%) when anticoagulation (with apixaban or warfarin) was interrupted for up to 3 days before a procedure, a finding that is consistent with results from the PAUSE study (Perioperative Anticoagulation Use for Surgery Evaluation).5 The risk of stroke or systemic embolism in the present study increased to 0.61% if anticoagulation was interrupted for 5 days. Major bleeding varied from 1.10% for a 3-day interruption to 2.27% for a 1-day interruption. Although the numbers for 6-day and 7-day interruptions were small, the relatively higher rates of major bleeding in those subgroups likely reflect greater morbidity and higher use of bridging. The higher rate of death in the 1-day interruption group likely conveys the need for urgent procedures on acutely ill patients and major periprocedural bleeding.Our study's strengths include a large sample size and prospective and rigorous data. Key limitations are that the day of interruption before a procedure was not randomized, the number of patients in certain subgroups was too small to allow meaningful inferences, and with how data were collected, we could not discern if the study drug was interrupted for ≤2 consecutive doses. Also, decisions regarding interruption of anticoagulation in clinical practice where the type of anticoagulant is known are different from those made in the context of a double-blind, double-dummy clinical trial like ARISTOTLE.In conclusion, in the context of the ARISTOTLE trial, a 2- to 3-day interruption of apixaban appeared to be associated with the most favorable efficacy and safety profiles, including a low risk of stroke or systemic embolism and a low risk of major bleeding. This observation should be examined in future studies for further validation.Article InformationRegistration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00412984.Sources of FundingThe ARISTOTLE study (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation) was funded by Bristol-Myers Squibb and Pfizer, Inc. Dr Al-Khatib has received research grants from the National Institutes of Health. Dr Granger received research grants from the Food and Drug Administration and consulting/speaker fees from the National Institutes of Health. Dr Hijazi received research support from the Swedish Society for Medical Research (S17-0133) and the Swedish Heart-Lung Foundation (20200722). Dr Held received research grants from Swedish Heart and Lung foundation. Dr Alexander received research grants from the Food and Drug Administration and the National Institutes of Health.Disclosures Dr Al-Khatib received research funding from Abbott, Medtronic and Boston Scientific. Dr Granger received research grants and consulting/speaker fees from Boehringer Ingelheim, Bristol-Myers Squibb, Janssen Pharmaceuticals, Pfizer, AstraZeneca, and Novartis; research grants from Daichii-Sankyo, AKROS, Apple, GlaxoSmithKline; and consulting/speaker fees from Bayer Corp, Boston Scientific Corp, Abbvie, Espero BioPharma, Medscape, Merck, NovoNordisk, Roche Diagnostics, Rho Diagnostics, Sirtex, and Verseon. Dr Wallentin received institutional research grants from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline, Roche Diagnostics, Merck & Co; consulting fees from Abbott; holds 2 patents involving GDF-15 licensed to Roche Diagnostics (EP2047275B1 and US8951742B2). Dr Hijazi received research support from Uppsala University Hospital, Sweden; lecture and consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Roche Diagnostics. Dr Held: received institutional research grants from Pfizer; consulting fees from AstraZeneca, Boehringer Ingelheim, Bayer, and Coala Life. Dr Alexander received research grants from Bayer, Bristol-Myers Squibb, CryoLife, CSL Behring, Ferring, GlaxoSmithKline, Humacyte, XaTek; and consulting fees from AbbVie, Akros, Atricure, Bristol Myers Squibb, CryoLife, Ferring, Janssen, Pfizer, Portola Pharmaceuticals, VA Cooperative Studies. Dr Vinereanu received research grants and consulting/ speaker fees from Pfizer, Boehringer Ingelheim, Bayer, Novartis, and Amgen. Dr Hylek received research support from Abbott, Anthos Therapeutics, Bristol-Myers Squibb, CryoLife, Janssen, Medtronic; consulting fees from Bayer, Boston Scientific, Medtronic; and speaker fees from Boehringer Ingelheim and Pfizer. Dr Lopes received institutional research grants and consulting fees from Bristol-Myers Squibb, Pfizer, GlaxoSmithKline, Medtronic PLC, and Sanofi; and consulting fees from Amgen, Bayer, and Boehringer Ingelheim. The other authors report no conflicts.FootnotesCirculation is available at www.ahajournals.org/journal/circThis manuscript was sent to Paul Gurbel, Guest Editor, for review by expert referees, editorial decision, and final disposition.For Sources of Funding and Disclosures, see page 960.Correspondence to: Sana M. Al-Khatib, MD, MHS, Duke Clinical Research Institute, 300 Morgan St, Durham, NC 27701. Email [email protected]duke.eduReferences1. Luo N, Xu H, Jneid H, Fonarow GC, Lopes RD, Piccini JP, Curtis AB, Russo AM, Lewis WR, Matsouaka RA, et al. Use of oral anticoagulation in eligible patients discharged with heart failure and atrial fibrillation.Circ Heart Fail. 2018; 11:e005356. doi: 10.1161/CIRCHEARTFAILURE.118.005356LinkGoogle Scholar2. Doherty JU, Gluckman TJ, Hucker WJ, JanuzziOrtel JLTL, Saxonhouse SJ, Spinler SA. 2017 ACC expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation: a report of the American College of Cardiology Clinical Expert Consensus Document Task Force.J Am Coll Cardiol. 2017; 69:871–898. doi: 10.1016/j.jacc.2016.11.024CrossrefMedlineGoogle Scholar3. Garcia D, Alexander JH, Wallentin L, Wojdyla DM, Thomas L, Hanna M, Al-Khatib SM, Dorian P, Ansell J, Commerford P, et al. Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures.Blood. 2014; 124:3692–3698. doi: 10.1182/blood-2014-08-595496CrossrefMedlineGoogle Scholar4. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, et al; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation.N Engl J Med. 2011; 365:981–992. doi: 10.1056/NEJMoa1107039CrossrefMedlineGoogle Scholar5. Douketis JD, Spyropoulos AC, Duncan J, Carrier M, Le Gal G, Tafur AJ, Vanassche T, Verhamme P, Shivakumar S, Gross PL, et al. Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant.JAMA Intern Med. 2019; 179:1469–1478. doi: 10.1001/jamainternmed.2019.2431CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Wang L, Zhang Y, Zhou W, Chen J, Li Y, Tang Q, Chen B, Zhang H, Zellmer L, Chen J, Chen Z, Li W, Liu X and Zhou H (2023) Relationship between left atrial appendage peak flow velocity and nonvalvular atrial fibrillation recurrence after cryoablation, Frontiers in Cardiovascular Medicine, 10.3389/fcvm.2023.1053102, 10 September 20, 2022Vol 146, Issue 12 Advertisement Article InformationMetrics © 2022 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.122.059438PMID: 36121911 Originally publishedSeptember 19, 2022 Keywordsatrial fibrillationembolism, paradoxicalstrokehemorrhageapixabananticoagulantsPDF download Advertisement SubjectsAtrial Fibrillation
Critical limb ischemia (CLI) is a severe complication of diabetes mellitus that occurs without effective therapy. Excessive reactive oxygen species (ROS) production and oxidative stress play critical roles in the development of diabetic cardiovascular complications. N-acetylcysteine (NAC) reduces ischemia-induced ROS production. The present study aimed to investigate the effect of NAC on the recovery of ischemic limb in an experimental model of type-2 diabetes. TALLYHO/JngJ diabetic and SWR/J non-diabetic mice were used for developing a CLI model. For NAC treatment, mice received NAC (1 mg/mL) in their drinking water for 24 h before initiating CLI, and continuously for the duration of the experiment. Blood flow, mechanical function, histology, expression of antioxidant enzymes including superoxide dismutase (SOD)-1, SOD-3, glutathione peroxidase (Gpx)-1, catalase, and phosphorylated insulin receptor substrate (IRS)-1, Akt, and eNOS in ischemic limb were evaluated in vivo or ex vivo. Body weight, blood glucose, plasma advanced glycation end-products (AGEs), plasma insulin, insulin resistance index, and plasma TNF-a were also evaluated during the experiment. NAC treatment effectively attenuated ROS production with preserved expressions of SOD-1, Gpx-1, catalase, phosphorylated Akt, and eNOS, and enhanced the recovery of blood flow and function of the diabetic ischemic limb. NAC treatment also significantly decreased the levels of phosphorylated IRS-1 (Ser307) expression and plasma TNF-α in diabetic mice without significant changes in blood glucose and AGEs levels. In conclusion, NAC treatment enhanced the recovery of blood flow and mechanical function in ischemic limbs in T2D mice in association with improved tissue redox/inflammatory status and insulin resistance.
BACKGROUND AND AIMS:Inflammation and reactive oxygen species (ROS) are important to the pathogenesis of atherosclerosis. The effect of antioxidants on atherosclerosis is inconsistent, and sometimes controversial. We aimed to test the hypothesis that attenuation of atherosclerosis by N-acetylcysteine (NAC) depends on NAC treatment timing and duration.METHODS:Male LDL receptor deficient (LDLR-/-) mice were fed a normal diet (ND) and divided into controls (on ND for 24 months), models 1-2 (at age of 9 months, starting NAC treatment for 3 or 6 months), and model 3 (at age of 18 months, starting NAC treatment for 6 months). To determine if hyperlipidemia compromises NAC treatment outcome, mice were fed a high fat diet (HFD) starting at age of 6 weeks and treated with NAC starting at 9 months of age for 6 months.RESULTS:NAC treatment for 6 months, not for 3 months, significantly attenuated atherosclerosis progression, but did not reverse atherosclerotic lesions, in aging LDLR-/- mice on ND. NAC had no effect on atherosclerotic lesions in mice on HFD. NAC treatment significantly decreased aortic ROS production, and the levels of inflammatory cytokines in serum and aorta of aging LDLR-/- mice with increased CD146 level. Bone marrow transplantation study with GFP-positive bone marrow cells showed that NAC treatment preserved M2 population and M2 polarization in the aorta of LDLR-/- mice.CONCLUSIONS:Early and adequate NAC treatment could effectively attenuate inflammation and atherosclerosis progression with preserved M2 population and increased CD146 level in aging LDLR-/- mice without extreme hyperlipidemia.
Cross stimulation is defined as stimulation of one cardiac chamber when the stimulation of the other chamber is expected. We present a case of an eighty three year old patient with history of dual chamber pacemaker implantation with recent generator change which showed interesting ECG findings.
Background Among patients with nonvalvular atrial fibrillation (AF) and an elevated stroke risk, guidelines recommend direct oral anticoagulants (DOACs) over warfarin for stroke prevention. Changes in DOAC use over the past decade have not been well described. Methods and Results We evaluated trends in use of DOACs and warfarin from 2011 to 2020 among adults with AF and a CHA 2 DS 2 ‐VASc score ≥2 based on electronic health record data from 88 health systems in the United States contributing to Cerner Real World Data. The use of DOACs and warfarin was described over time, by age, sex, race, and ethnicity, and at the health‐system level. We identified 436 864 patients with AF at risk for stroke (median age, 78 years; 52.1% men). From 2011 to 2020, overall anticoagulation rates increased from 56.3% to 64.7%, as DOAC use increased steadily (from 4.7% to 47.9%), while warfarin use declined (from 52.4% to 17.7%). DOAC uptake was similar across age, sex, and race and ethnicity groups but varied by health system. In 2020, the median health‐system‐level proportion of patients with AF on a DOAC was 49% (interquartile range, 40%–54%). Conclusions Over the past decade, anticoagulation rates for patients with AF have increased modestly as DOACs largely replaced warfarin, though significant gaps remain: One in 3 high‐risk patients with AF is not on any anticoagulant. While DOAC adoption was generally consistent across major demographic groups, use between health systems remained highly variable, suggesting that provider and system factors influence DOAC uptake use more than patient‐level factors.
Background: Morbid obesity (BMI > 35 kg/m2 with comorbid conditions) is present in 25 -35% of acute decompensated heart failure (AHF) patients. Prevalence of HF increases with duration of morbid obesity from 30% at 15 years to over 90% at 30 years. There is a need to develop pragmatic therapies that address the unique physical and mental challenges faced by obese AHF patients. Siddha is 5,000 year old Tamil Medicine using yoga and mind-body methods towards higher consciousness. Hunger gratitude Experience (HUGE) is intuitive Siddha fasting method which may improve in-hospital AHF outcomes independent of weight reduction.Case summary: We present 5 cases of morbidly obese patients with cardiorenal syndrome (CRS) that began intermittent fasting either during their AHF hospitalization or in the outpatient setting for refractory symp-toms despite hospitalization. Initiation of fasting correlated with reduction of respiratory distress and edema as well as improvements in psychological wellbeing and functional capacity.Discussion: Siddha fasting mediates hemodynamic and anti-inflammatory effects through natural ketosis and psychological benefits through empowerment in AHF. Potential role of fasting in reducing myocardial work-load, coronary steal, angina, volume overload, and CRS needs further study in cardiac patients.Published by Elsevier Inc.
Pepper spray is used as a crowd control agent and for self-defense. It has been thought to be safe; however, 27 persons have died in police custody after exposure to pepper spray. We report on a 21-year-old man, with no underlying heart disease and a normal ECG and echocardiogram in the past, who was pepper sprayed and developed ventricular fibrillation. An admission ECG showed marked ST segment elevation but subsequent coronary arteriography was normal. We hypothesize that pepper spray triggered coronary spasm, resulting in ventricular fibrillation. This report adds to a body of information that pepper spray is dangerous.
Introduction: The accuracy of electronic health record (EHR) data to identify prevalent disease status and/or clinical events is a major concern for the use of ‘real world’ data for research. We assessed the accuracy of EHR data for specific CV conditions based on EHR data compared with manual chart review. Methods: Using a cloud-based infrastructure, Cerner’s HealtheIntent EHR data from two health systems were de-identified and aggregated. We created EHR-based computable phenotypes for patients with ASCVD, (based on prior diagnosis and procedure codes, to identify comorbidities and hospitalizations with acute limb ischemia (ALI), bleeding, acute coronary syndrome (ACS), and cerebrovascular events (stroke/transient ischemic attack/intracranial hemorrhage). Chart reviews were performed (n=1,869) to validate the hospitalization final diagnosis and prevalent comorbidities, with the first 100 charts undergoing review by two concurrent chart reviewers. When reviewers noted an absence of a comorbidity, but EHR data indicated it may be present, an automated cue was presented to the reviewer of “Are you Sure?”. Cohen’s kappas (κ) were calculated to indicate agreement inter-review of event types and comorbidities. The PPV of EHR data for hospitalization diagnosis and comorbidities compared with cue-augmented chart review as gold standard were assessed. Results: The inter-rater agreement for the hospitalization diagnosis was very good overall and highest for ACS (0.83), followed by ALI (0.75), , and cerebrovascular events (0.69). The PPV of EHR-based diagnoses for single chart reviewers was 0.93 for cerebrovascular events, 0.81 for bleeding, 0.78 for ACS, and 0.51 for ALI. Similarly, the predictive accuracy of the EHR-based computable phenotypes for comorbidities and events was variable: as high as 0.93 for hypertension, 0.87 for atrial fibrillation, and 0.86 for peripheral arterial disease, to as low as 0.13 for type 1 diabetes, 0.38 for prior transient ischemic attack, and 0.56 for heart failure with reduced ejection fraction. Providing the chart reviewer with automated cue for comorbidities improved PPV. Conclusions: Many, but not all, clinical outcomes and comorbidities can be identified using EHR-based algorithms, with variable performance depending on the condition. Human chart reviews, long considered a gold standard, may be improved using EHR data.
LP extractions is a relatively new field with limited operator experience. We compared the Nanostim (NS) vs Micra transcatheter (MT) LP. Pertinent details of retrieval such as indication, days post implantation, complications and post procedure device management was obtained from the database
IMPORTANCE Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain. OBJECTIVE To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF. DESIGN, SETTING, AND PARTICIPANTS An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017. INTERVENTIONS Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096). MAIN OUTCOMES AND MEASURES Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, >= 5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, <=-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, <=-1.3 points). RESULTS Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P <.001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P <.001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P <.001). CONCLUSIONS AND RELEVANCE Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation.
BACKGROUND AND AIMS:Atherosclerosis is an important contributing factor to cardiovascular mortality. The role of Helicobacter pylori (H. pylori) infection in atherosclerosis is inconsistent and sometimes controversial. The present study aimed to determine if H. pylori infection is associated with carotid atherosclerosis. METHODS:17,613 males and females with both carotid ultrasonic examination and 13C-urea breath test for H. pylori infection were screened by a major Chinese university hospital from March 2012 to March 2017 for the study. Baseline demographics, cardiac risk factors, and laboratory studies were obtained. After exclusion for pre-specified conditions, 12,836 individuals were included in the analysis, including 8157 men (63.5%) and 4679 women (36.5%). Analysis was also made for 5-year follow-up data of 1216 subjects (869 males and 347 females) with and without H. pylori infection for development and progression of carotid atherosclerosis. RESULTS:After adjusting for age, sex, body mass index, lipid profile, hypertension, renal function, diabetes mellitus, and smoking, H. pylori infection was found as an independent risk factor for carotid atherosclerosis in males under 50 years, but not in older males or females (odds ratio 1.229, 95% CI 1.054-1.434, p = 0.009). Follow-up data analysis showed that the incidence of carotid atherosclerosis from no atherosclerosis to detectable lesions was significantly higher in young males with persistent H. pylori infection than those without H. pylori infection (p = 0.028) after 3 years. CONCLUSIONS:These data suggest that H. pylori infection might be an important risk factor for carotid atherosclerosis in young Chinese males under 50.
Atrial fibrillation and flutter are well known causes of stroke. Whether other atrial arrhythmias like paroxysmal supraventricular tachycardia (PSVT) is associated with stroke is not clear. We aimed to evaluate the association of PSVT with ischemic and embolic stroke and its impact on short term
We explored associations between INR measures and clinical outcomes in patients with AF using warfarin, and whether INR history predicted future INR measurements. We included patients in ARISTOTLE who were randomized to and received warfarin. Among patients who had events, we included those with ≥ 3 INR values in the 180 days prior to the event, with the most recent ≤ 60 days prior to the event, who were on warfarin at the time of event (n = 545). Non-event patients were included in the control group if they had ≥ 180 days of warfarin exposure with ≥ 3 INR measurements (n = 7259). The median (25th, 75th) number of INR values per patient was 29 (21, 38) over a median follow-up of 1.8 years. A total of 87% had at least one INR value < 1.5; 49% had at least one value > 4.0. The last INRs before events (median 14 [24, 7] days) were < 3.0 for at least 75% of patients with major bleeding and > 2.0 for half of patients with ischemic stroke. Historic time in therapeutic range (TTR) was weakly associated with future TTR (R2 = 0.212). Historic TTR ≥ 80% had limited predictive ability to discriminate future TTR ≥ 80% (C index 0.61). In patients with AF receiving warfarin, most bleeding events may not have been preventable despite careful INR control. Our findings suggest that INRs collected through routine management are not sufficiently predictive to provide reassurance about future time in therapeutic range or to prevent subsequent outcomes, and might be over-interpreted in clinical practice.
Importance Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. Objective To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. Design, Setting, and Participants The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. Interventions The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. Main Outcomes and Measures The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. Results Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P < .001). Conclusions and Relevance Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. Trial Registration ClinicalTrials.gov Identifier: NCT00911508