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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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The NCDR Left Atrial Appendage Occlusion Registry Freeman, James V.; Varosy, Paul; Price, Matthew J. ...
Journal of the American College of Cardiology,
04/2020, Volume:
75, Issue:
13
Journal Article
Peer reviewed
Open access
Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.
The purpose of this ...study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.
The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.
A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.
The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
ACC/AHA Task Force Members Glenn N. Levine, MD, FACC, FAHA, Chair Patrick T. O’Gara, MD, MACC, FAHA, Chair-Elect Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair‡‡ Sana M. Al-Khatib, MD, ...MHS, FACC, FAHA Joshua A. Beckman, MD, MS, FAHA Kim K. Birtcher, PharmD, MS, AACC Biykem Bozkurt, MD, PhD, FACC, FAHA‡‡ Ralph G. Brindis, MD, MPH, MACC‡‡ Joaquin E. Cigarroa, MD, FACC Lesley H. Curtis, PhD, FAHA‡‡ Anita Deswal, MD, MPH, FACC, FAHA Lee A. Fleisher, MD, FACC, FAHA Federico Gentile, MD, FACC Samuel Gidding, MD, FAHA‡‡ Zachary D. Goldberger, MD, MSc, FACC, FAHA Mark A. Hlatky, MD, FACC, FAHA John Ikonomidis, MD, PhD, FAHA‡‡ José A. Joglar, MD, FACC, FAHA Laura Mauri, MD, MSc, FAHA‡‡ Mariann R. Piano, RN, PhD, FAHA Susan J. Pressler, PhD, RN, FAHA‡‡ Barbara Riegel, PhD, RN, FAHA‡‡ Duminda N. Wijeysundera, MD, PhD‡‡Former Task Force member; current member during the writing effort.Table of Contents Top 10 Take-Home Messages For the Management of Bradycardia and Cardiac Conduction Delaye53 Preamblee54 Introductione55 1.1.Methodology and Evidence Reviewe55 1.2.Organization of the Writing Committeee55 1.3.Document Review and Approvale55 1.4.Scope of the Guidelinee56 1.5.Class of Recommendation and Level of Evidencee56 1.6.Abbreviationse56 2. General Evaluation of Patients With Documented or Suspected Bradycardia or Conduction Disorderse61 4.1.History and Physical Examination of Patients With Documented or Suspected Bradycardia or Conduction Disorderse61 4.2.Noninvasive Evaluatione66 4.2.1.Resting ECG in Patients With Documented or Suspected Bradycardia or Conduction Disorderse66 4.2.2.Exercise Electrocardiographic Testing in Patients With Documented or Suspected Bradycardia or Conduction Disorderse66 4.2.3.Ambulatory Electrocardiography in Patients With Documented or Suspected Bradycardia or Conduction Disorderse67 4.2.4.Imaging in Patients With Documented or Suspected Bradycardia or Conduction Disorderse69 4.2.5.Laboratory Testing in Patients With Documented or Suspected Bradycardia or Conduction Disorderse70 4.2.6.Genetic Testing in Patients With Documented or Suspected Bradycardia or Conduction Disorderse71 4.2.7.Sleep Apnea Evaluation and Treatment in Patients With Documented or Suspected Bradycardia or Conduction Disorderse72 4.3. In patients with a left ventricular ejection fraction between 36% to 50% and atrioventricular block, who have an indication for permanent pacing and are expected to require ventricular pacing >40% of the time, techniques that provide more physiologic ventricular activation (e.g., cardiac resynchronization therapy, His bundle pacing) are preferred to right ventricular pacing to prevent heart failure. Because conduction system abnormalities are common after transcatheter aortic valve replacement, recommendations on postprocedure surveillance and pacemaker implantation are made in this guideline. Using the principles of shared decision-making and informed consent/refusal, patients with decision-making capacity or his/her legally defined surrogate has the right to refuse or request withdrawal of pacemaker therapy, even if the patient is pacemaker dependent, which should be considered palliative, end-of-life care, and not physician-assisted suicide.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
In patients with a left ventricular ejection fraction between 36% to 50% and atrioventricular block, who have an indication for permanent pacing and are expected to require ventricular pacing >40% of ...the time, techniques that provide more physiologic ventricular activation (e.g., cardiac resynchronization therapy, His bundle pacing) are preferred to right ventricular pacing to prevent heart failure. Because conduction system abnormalities are common after transcatheter aortic valve replacement, recommendations on postprocedure surveillance and pacemaker implantation are made in this guideline. Presidents and Staff American College of Cardiology C. Michael Valentine, MD, FACC, President Timothy W. Attebery, MBA, FACHE, Chief Executive Officer William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publishing MaryAnne Elma, MPH, Senior Director, Science, Education, Quality, and Publishing Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing American College of Cardiology/American Heart Association Katherine A. Sheehan, PhD, Director, Guideline Strategy and Operations Abdul R. Abdullah, MD, Science and Medicine Advisor Thomas S. D. Getchius, Manager, Guideline Science Sam Shahid, MBBS, MPH, Associate Science and Medicine Advisor Zainab Shipchandler, MPH, Associate Guideline Advisor, Clinical Practice Guidelines American Heart Association Ivor J. Benjamin, MD, FAHA, President Nancy Brown, Chief Executive Officer Rose Marie Robertson, MD, FAHA, Chief Science and Medical Officer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations Paul St. Laurent, DNP, APRN, Science and Medicine Advisor Jody Hundley, Production and Operations Manager, Scientific Publications, Office of Science OperationsAppendix 1 Author Relationships With Industry and Other Entities (Relevant)—2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay (July 2018) Appendix 2 Abbreviated Reviewer Relationships With Industry and Other Entities—2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay (August 2018)∗ Title Organization Publication Year (Reference) Guidelines Ventricular arrhythmias and sudden cardiac death ACC/AHA/HRS 2017 (S1.4-3) Syncope ACC/AHA/HRS 2017 (S1.4-4) Stable ischemic heart disease ACC/AHA/AATS/PCNA/SCAI/STS 2014∗ (S1.4-5) 2012 (S1.4-6) Atrial fibrillation AHA/ACC/HRS 2014 (S1.4-7) Perioperative cardiovascular evaluation and management of patients undergoing non-cardiac surgery ACC/AHA 2014 (S1.4-8) Non–ST-elevation acute coronary syndromes AHA/ACC 2014 (S1.4-9) Heart failure ACC/AHA 2013 (S1.4-10) ST-elevation myocardial infarction ACC/AHA 2013 (S1.4-11) Device-based therapy for cardiac rhythm abnormalities ACC/AHA/HRS 2013 (S1.4-2) Coronary artery bypass graft surgery ACC/AHA 2011 (S1.4-12) Hypertrophic cardiomyopathy ACC/AHA 2011 (S1.4-13) Percutaneous coronary intervention ACC/AHA/SCAI 2011 (S1.4-14) Guidelines for cardiopulmonary resuscitation and emergency cardiovascular care—Part 9: post-cardiac arrest care AHA 2010 (S1.4-15) Other related references Expert consensus statement on cardiovascular implantable electronic device lead management and extraction HRS 2017 (S1.4-16) Management of cardiac involvement associated with neuromuscular diseases AHA 2017 (S1.4-17) Expert consensus statement on magnetic resonance imaging HRS 2017 (S1.4-18) Eligibility and disqualification recommendations for competitive athletes with cardiovascular abnormalities: Same QRS morphology criteria as complete RBBB but with a QRS duration between 110 and 119 ms▪LBBB (as defined in adults):▪Complete LBBB:1.QRS duration ≥120 ms in adults2.Broad notched or slurred R wave in leads I, aVL, V5, and V6 and an occasional RS pattern in V5 and V6 attributed to displaced transition of QRS complex3.Absent Q waves in leads I, V5, and V6, but in the lead aVL, a narrow Q wave may be present in the absence of myocardial pathology4.R peak time >60 ms in leads V5 and V6 but normal in leads V1, V2, and V3, when small initial R waves can be discerned in the precordial leads5.ST and T waves usually opposite in direction to QRS▪Incomplete LBBB:1.QRS duration between 110 and 119 ms in adults2.Presence of left ventricular hypertrophy pattern3.R peak time >60 ms in leads V4, V5, and V64.Absence of Q wave in leads I, V5, and V6▪Nonspecific intraventricular conduction delay (as defined in adults): QRS duration >110 ms where morphology criteria for RBBB or LBBB are not present▪Left anterior fascicular block:▪QRS duration <120 ms▪Frontal plane axis between −45° and −90°▪qR (small r, tall R) pattern in lead aVL▪R-peak time in lead aVL of ≥45 ms▪rS pattern (small r, deep S) in leads II, III, and aVF▪Left posterior fascicular block:▪QRS duration <120 ms▪Frontal plane axis between 90° and 180° in adults. Because of the more rightward axis in children up to 16 years of age, this criterion should only be applied to them when a distinct rightward change in axis is documented.▪rS (small r, deep S) pattern in leads I and aVL▪qR (small q, tall R) pattern in leads III and aVF Table 3 Table of Definitions Antihypertensive Antiarrhythmic Psychoactive Other ▪Beta adrenergic receptor blockers (including beta adrenergic blocking eye drops used for glaucoma)▪Clonidine▪Methyldopa▪Non-dihydropyridine calcium channel blockers▪Reserpine ▪Adenosine▪Amiodarone▪Dronedarone▪Flecainide▪Procainamide▪Propafenone▪Quinidine▪Sotalol ▪Donepezil▪Lithium▪Opioid analgesics▪Phenothiazine antiemetics and antipsychotics▪Phenytoin▪Selective serotonin reuptake inhibitors▪Tricyclic antidepressants ▪Anesthetic drugs (propofol)▪Cannabis▪Digoxin▪Ivabradine▪Muscle relaxants (e.g., succinylcholine) Table 4 Medications That Can Induce/Exacerbate Bradycardia or Conduction Disorders Intrinsic Cardiomyopathy (ischemic or nonischemic) Congenital heart disease Degenerative fibrosis Infection/inflammation▪Chagas disease▪Diphtheria▪Infectious endocarditis▪Lyme disease▪Myocarditis▪Sarcoidosis▪Toxoplasmosis Infiltrative disorders▪Amyloidosis▪Hemochromatosis▪Lymphoma Ischemia/infarction Rheumatological conditions▪Rheumatoid arthritis▪Scleroderma▪Systemic lupus erythematosus Surgical or procedural trauma▪Cardiac procedures such as ablation or cardiac catheterization▪Congenital heart disease surgery▪Septal myomectomy for hypertrophic obstructive cardiomyopathy▪Valve surgery (including percutaneous valve replacement) Extrinsic Autonomic perturbation▪Carotid sinus hypersensitivity▪Neurally-mediated syncope/presyncope▪Physical conditioning▪Situational syncope▪Cough▪Defecation▪Glottic stimulation▪Medical procedures▪Micturition▪Vomiting▪Sleep (with or without sleep apnea) Metabolic▪Acidosis▪Hyperkalemia▪Hypokalemia▪Hypothermia▪Hypothyroidism▪Hypoxia Table 5 Conditions Associated With Bradycardia and Conduction Disorders Types of Monitor Device Description Patient Selection Nonphysician prescribed smartphone-based systems ▪Commercially available smartphone–based systems▪Can record a rhythm strip when the patient has symptoms or continuously depending on the technology Patient access to the technology Holter monitor ▪Continuous recording for 24–72 h; up to 2 wk with newer models▪Symptom rhythm correlation can be achieved through a patient event diary and patient-activated annotations Symptoms frequent enough to be detected within a short period (24–72 h) of monitoring Patient-activated, transtelephonic monitor (event monitor) A recording device that transmits patient-activated data (live or stored) via an analog telephone line to a central remote monitoring station (e.g., physician office) ▪Frequent, spontaneous symptoms likely to recur within 2–6 wk▪Limited use in patients with incapacitating symptoms External loop recorder (patient or auto triggered)∗ ▪A device that continuously records and stores rhythm data over weeks to months▪Patient activated, or auto triggered (e.g., to record asymptomatic arrhythmias) to provide a recording of events antecedent to (3–14 min), during, and after (1–4 min) the triggered event▪Newer models are equipped with a cellular telephone, which transmits triggered data automatically over a wireless network to a remote monitoring system Frequent, spontaneous symptoms potentially related to bradycardia or conduction disorder, likely to recur within 2–6 wk External patch recorders ▪Patch device that continuously records and stores rhythm data, with patient-trigger capability to allow for symptom-rhythm correlation▪No leads or wires, and adhesive to chest wall/sternum▪Various models record from 2–14 d▪Offers accurate means of assessing burden of AF▪Patient activated, or auto triggered (e.g., to record asymptomatic arrhythmias) to provide a recording of events antecedent to, during, and after the triggered event ▪Can be considered as an alternative to external loop recorder▪Given that it is leadless, can be accurately self-applied, and is largely water resistant, it may be more comfortable and less cumbersome than an external loop recorder, potentially improving compliance▪Unlike Holter monitors and other external monitors, it offers only 1-lead recording Mobile cardiac outpatient telemetry ▪Device that records and transmits data (up to 30 d) from preprogrammed arrhythmias or patient activation to a communication hub at the patient’s home▪Significant arrhythmias are detected; the monitor automatically transmits the patient’s electrocardiographic data through a wireless network to the central monitoring station, which is attended by trained technicians 24 h/d ▪Spontaneous symptoms, potentially related to bradycardia or conduction disorder, that are too brief, too subtle, or too infrequent to be readily documented with patient activated monitors▪In high-risk patients whose rhythm requires real-time monitoring Implantable cardiac monitor ▪Subcutaneously implanted device, with a battery lif
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
AV conduction abnormalities are observed in 15–30% of patients with hypertrophic cardiomyopathy but are usually not severe enough to require permanent pacemaker implant. Both septal myectomy and ...alcohol septal ablation are effective options to relieve symptoms due to left ventricular outflow tract gradient in patients with hypertrophic cardiomyopathy but have procedure-specific effects on AV conduction and the His Purkinje system. Septal myectomy is associated with the development of LBBB in 50–100% of patients, while alcohol septal ablation is associated with RBBB in 37–70% of patients. Baseline abnormalities in the contralateral bundles and the presence of conduction disease have an important impact on the likelihood of the development of AV block for both of these therapies. AV block requiring permanent pacing occurs in approximately 2–3% of patients after septal myectomy and 10–15% of patients after alcohol septal ablation. Permanent pacemaker implant after alcohol septal ablation is more common in older patients (> 55 years old 13 vs. < 55 years old 5%;
p
= 0.06). Improved outcomes for septal myectomy and alcohol septal ablation are observed in experienced centers. Septal reduction therapies should be performed at medical centers with a dedicated hypertrophic cardiomyopathy program using a multidisciplinary approach.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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