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Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.
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Tomada de Decisão Compartilhada , Técnicas de Apoio para a Decisão , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Desfibriladores Implantáveis , Humanos , Medicare , Projetos Piloto , Estados UnidosRESUMO
Cardiac sarcoidosis (CS) may impart substantial morbidity and mortality, and novel imaging modalities are now available to aid in early diagnosis of this clinically silent disease. A better understanding of the clinical experience with CS is important. Twenty-eight patients were diagnosed with the aid of multimodality imaging techniques and were treated by a multidisciplinary team. Demographics, symptomatology, imaging, and therapeutic interventions were compiled from our referral center. In patients with CS, nuclear and MR techniques were often the first studies performed. Echocardiographic findings differed widely. Immunosuppressive therapy and cardiac devices were frequently used. Importantly, isolated CS was not an infrequent finding.
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Cardiomiopatias , Sarcoidose , Cardiomiopatias/diagnóstico por imagem , Cardiomiopatias/terapia , Ecocardiografia , Humanos , Sarcoidose/diagnóstico , Sarcoidose/terapiaRESUMO
OBJECTIVES: Comparison of outcomes, device deployment time (DT), and total time (TT) using a single tapered Coons dilator versus sequential serial dilation for implantation of the Micra leadless pacemaker. BACKGROUND: Micra leadless pacemaker placement requires a 23 French Micra introducer sheath (MIS) for percutaneous delivery. We sought to evaluate outcomes with use of a single tapered Coons dilator (CD) versus sequential serial dilatation (SD) method to facilitate insertion of the Micra introducer sheath. METHODS: 35 patients were included in the SD arm and 49 in the CD arm. DT and TT were recorded in minutes and cost in dollars. Analysis was performed using independent t-test between two groups and one-way ANOVA to evaluate inter-operator variability in the CD arm. RESULTS: Both DT and TT were significantly lower for the CD arm (15.1 ± 5.1 vs 23.5 ± 9.3, p < 0.0005 and 29.9 ± 14 vs 39.3 ± 13.5 min, p = 0.000374; respectively). The cost was also significantly lower using a CD versus SD. There was no inter-operator variability in the CD arm between 6 operators (p = 0.177 for DT and p = 0.304 for TT). No complications occurred in the SD arm. There were 3 vascular access site complications in the CD arm, all of which occurred early in the operator's experience. CONCLUSION: Coons dilator is an efficient and cost-effective method for vascular dilatation to facilitate Micra leadless pacemaker insertion. Rate of complications is low and expected to improve with greater experience.
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BACKGROUND: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA. OBJECTIVE: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remede System, Respicardia, Inc). METHODS: The remede System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration. RESULTS: In the remede System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty-two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months. CONCLUSION: In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.
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Diafragma/inervação , Terapia por Estimulação Elétrica/instrumentação , Neuroestimuladores Implantáveis , Nervo Frênico/fisiopatologia , Implantação de Prótese , Respiração , Apneia do Sono Tipo Central/terapia , Terapia por Estimulação Elétrica/efeitos adversos , Humanos , Duração da Cirurgia , Desenho de Prótese , Implantação de Prótese/efeitos adversos , Apneia do Sono Tipo Central/diagnóstico , Apneia do Sono Tipo Central/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: We evaluated the prevalence of isolated T-wave inversions (TWI) in American athletes using contemporary ECG criteria. Ethnic and gender disparities including the association of isolated TWI with underlying abnormal cardiac structure are evaluated. METHODS: From 2004 to 2014, 1755 collegiate athletes at a single American university underwent prospective collection of medical history, physical examination, 12-lead ECG, and 2-dimensional echocardiography. ECG analysis was performed to evaluate for isolated TWI as per contemporary ECG criteria. RESULTS: The overall prevalence of isolated TWI is 1.3%. Ethnic and gender disparities are not observed in American athletes (black vs. white: 1.7% vs. 1.1%; p=0.41) (women vs. men: 1.5% vs. 1.1; p=0.52). No association was found with underlying cardiomyopathy. CONCLUSION: A lower prevalence of isolated TWI in American athletes than previously reported. Isolated TWI was not associated with an abnormal echocardiogram. No ethnic or gender disparity is seen in American college athletes.
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Atletas/estatística & dados numéricos , Cardiomiopatia Hipertrófica/diagnóstico , Cardiomiopatia Hipertrófica/epidemiologia , Eletrocardiografia/estatística & dados numéricos , Estudantes/estatística & dados numéricos , Adolescente , Negro ou Afro-Americano/estatística & dados numéricos , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Testes Diagnósticos de Rotina/estatística & dados numéricos , Diagnóstico Precoce , Eletrocardiografia/métodos , Feminino , Humanos , Incidência , Kansas/etnologia , Masculino , Testes Obrigatórios/estatística & dados numéricos , Programas de Rastreamento/estatística & dados numéricos , Prevalência , Prognóstico , Reprodutibilidade dos Testes , Medição de Risco/métodos , Fatores de Risco , Sensibilidade e Especificidade , Taxa de Sobrevida , Universidades , População Branca/estatística & dados numéricosRESUMO
BACKGROUND: Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications. METHODS: Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications. RESULTS: Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site. CONCLUSIONS: This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.
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BACKGROUND: Atrial fibrillation (AF) ablation carries the risk of silent cerebral event (SCE) and silent cerebral lesion (SCL). Although "silent," these may have long-term clinical implications and are challenging to study as postprocedural magnetic resonance imaging (MRI) is not standard of care. OBJECTIVE: The neurological assessment subgroup (NAS) of ADVENT compared cerebral effects of pulsed field ablation (PFA) with standard-of-care thermal ablation. METHODS: The NAS included consecutive randomized PFA and thermal ablation patients who received postprocedural brain MRI 12-48 hours after ablation. Patients with apparent SCE or SCL findings underwent a modified Rankin scale assessment. MRI images were subsequently reviewed by a blinded brain imaging core laboratory. RESULTS: In total, 77 patients with paroxysmal AF were enrolled at 6 centers; 71 had analyzable scans (34 PFA; 37 thermal ablation). Through individual center review, 6 PFA and 4 thermal scans were identified as SCE/SCL positive, of which 3 PFA and 0 thermal SCE/SCL findings were confirmed by a blinded core laboratory. MRI findings revealed 1 patient with 2- to 4-mm SCEs, 1 patient with a 3-mm SCE, and 1 patient with 2 SCLs (5.5 mm and 11 mm). All modified Rankin scale and National Institutes of Health Stroke Scale scores were 0 before discharge and at 90-day follow-up. There were only 2 neurological safety events (1 transient ischemic attack [PFA] and 1 stroke [thermal ablation]) in the ADVENT study, neither of which was part of the NAS. CONCLUSION: The ADVENT trial provides the first prospective, randomized data on the cerebral impact of PFA and thermal ablation of AF. Incidence of SCE/SCL after ablation in the NAS was low.
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BACKGROUND: The ADVENT randomized trial revealed no significant difference in 1-year freedom from atrial arrhythmias (AA) between thermal (radiofrequency/cryoballoon) and pulsed field ablation (PFA). However, recent studies indicate that the postablation AA burden is a better predictor of clinical outcomes than the dichotomous endpoint of 30-second AA recurrence. OBJECTIVES: The goal of this study was to determine: 1) the impact of postablation AA burden on outcomes; and 2) the effect of ablation modality on AA burden. METHODS: In ADVENT, symptomatic drug-refractory patients with paroxysmal atrial fibrillation underwent PFA or thermal ablation. Postablation transtelephonic electrocardiogram monitor recordings were collected weekly or for symptoms, and 72-hour Holters were at 6 and 12 months. AA burden was calculated from percentage AA on Holters and transtelephonic electrocardiogram monitors. Quality-of-life assessments were at baseline and 12 months. RESULTS: From 593 randomized patients (299 PFA, 294 thermal), using aggregate PFA/thermal data, an AA burden exceeding 0.1% was associated with a significantly reduced quality of life and an increase in clinical interventions: redo ablation, cardioversion, and hospitalization. There were more patients with residual AA burden <0.1% with PFA than thermal ablation (OR: 1.5; 95% CI: 1.0-2.3; P = 0.04). Evaluation of outcomes by baseline demographics revealed that patients with prior failed class I/III antiarrhythmic drugs had less residual AA burden after PFA compared to thermal ablation (OR: 2.5; 95% CI: 1.4-4.3; P = 0.002); patients receiving only class II/IV antiarrhythmic drugs pre-ablation had no difference in AA burden between ablation groups. CONCLUSIONS: Compared with thermal ablation, PFA more often resulted in an AA burden less than the clinically significant threshold of 0.1% burden. (The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation [ADVENT]; NCT04612244).
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Fibrilação Atrial , Ablação por Cateter , Recidiva , Humanos , Fibrilação Atrial/cirurgia , Fibrilação Atrial/terapia , Fibrilação Atrial/fisiopatologia , Masculino , Feminino , Pessoa de Meia-Idade , Ablação por Cateter/métodos , Idoso , Qualidade de Vida , Resultado do TratamentoRESUMO
Historically, early repolarization (ER) has been considered a marker of good health as it is more prevalent in athletes, younger persons, and at slower heart rates. However, contemporary reports, largely based on data from resuscitated sudden cardiac arrest patients, suggest an association between ER and an increased risk for sudden cardiac death and the development of malignant ventricular arrhythmias. Therefore, after we present a brief-case presentation, we intend to review a challenging topic in recognition of malignant variants and propose a four-step comprehensive approach to simplify ECG discrimination when assessing ER changes.
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Sinais (Psicologia) , Fibrilação Ventricular , Humanos , Arritmias Cardíacas/diagnóstico , Morte Súbita Cardíaca/etiologia , EletrocardiografiaRESUMO
The COVID-19 pandemic accelerated adaption of a telehealth care model. We studied the impact of telehealth on the management of atrial fibrillation (AF) by electrophysiology providers in a large, multisite clinic. Clinical outcomes, quality metrics, and indicators of clinical activity for patients with AF during the 10-week period of March 22, 2020 to May 30, 2020 were compared with those from the 10-week period of March 24, 2019 to June 1, 2019. There were 1946 unique patient visits for AF (1,040 in 2020 and 906 in 2019). During 120 days after each encounter, there was no difference in hospital admissions (11.7% vs 13.5%, p = 0.25) or emergency department visits (10.4% vs 12.5%, p = 0.15) in 2020 compared with 2019. There was a total of 31 deaths within 120 days, with similar rates in 2020 and 2019 (1.8% vs 1.3%, p = 0.38). There was no significant difference in quality metrics. The following clinical activities occurred less frequently in 2020 than in 2019: offering escalation of rhythm control (16.3% vs 23.3%, p <0.001), ambulatory monitoring (29.7% vs 51.7%, p <0.001), and electrocardiogram review for patients on antiarrhythmic drug therapy (22.1% vs 90.2%, p <0.001). Discussions about risk factor modification were more frequent in 2020 compared with 2019 (87.9% vs 74.8%, p <0.001). In conclusion, the use of telehealth in the outpatient management of AF was associated with similar clinical outcomes and quality metrics but differences in clinical activity compared with traditional ambulatory encounters. Longer-term outcomes warrant further investigation.
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Fibrilação Atrial , COVID-19 , Telemedicina , Humanos , Fibrilação Atrial/tratamento farmacológico , Pacientes Ambulatoriais , PandemiasRESUMO
In a series of 35 MRI examinations with non-MRI-conditional devices with a mismatch between the manufacturer of the device generators and leads, there were no adverse events.
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PURPOSE: This registry compared the safety and efficacy of vascular closure device Perclose (PC) with figure-of-eight stitch (Fo8) and manual compression (MC) following catheter ablation of atrial fibrillation/flutter. METHODS: VAscular Closure for Cardiac Ablation Registry (VACCAR) is a prospective, observational registry that assessed the time to hemostasis (TTH), time to ambulation (TTA), length of stay (LOS), complications, patient-reported outcomes, and pain medication use. RESULTS: A total of 434 patients (mean age 64.0±11.0 years; 38% female; 94.9% white) were enrolled between October 2017 and May 2019: 156 in MC, 203 in Fo8, and 75 in the PC group. Median TTH was significantly reduced in the PC and Fo8 group at 7 and 9 min respectively vs. the MC group at 20 min (p<0.001). Median TTA was significantly reduced in both the PC and Fo8 group at 2.2 h vs. the MC group at 6.5 h (p<0.001 for both). Median LOS for the PC group was significantly reduced at 27.5 h compared to the MC and Fo8 group at 29 h (p<0.01). A higher proportion of same-day discharges were noted in the PC and Fo8 groups at 14 (18.7%) and 25 (12.3%), respectively, compared to 5 (3.2%) in the MC group (p<0.01 for all). There was no significant difference in complications between the three groups. CONCLUSIONS: Both PC and Fo8 are safe with improved TTH, TTA, LOS, and a higher number of same-day discharges compared to MC.
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Fibrilação Atrial , Flutter Atrial , Ablação por Cateter , Idoso , Fibrilação Atrial/cirurgia , Feminino , Técnicas Hemostáticas , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs. METHODS: This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method. RESULTS: We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA's, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions. CONCLUSIONS: Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT03374891.
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Técnicas de Apoio para a Decisão , Desfibriladores Implantáveis , Idoso , Humanos , Tomada de Decisões , Tomada de Decisão Compartilhada , Medicare , Participação do Paciente , Estados UnidosRESUMO
PURPOSE: Compliance with anticoagulation treatment for atrial fibrillation is highly variable. Smartphone electrocardiograms that allow patients to have greater insight into their arrhythmia burden may improve anticoagulant compliance. METHODS: Patients were enrolled if they had atrial fibrillation with a CHA2DS2-VASc score of 2 or more, were eligible for anticoagulation and had a smartphone. Participants were randomly assigned to receive a smartphone electrocardiogram (AliveCor Kardia) to record their electrocardiograms 5 times/week or to the control group. All patients received 6 months of anticoagulant (apixaban) dispensed as 1-month pre-loaded pill boxes. RESULTS: A total of 100 patients were enrolled from July 2017 to August 2019, but 5 patients in the monitor arm and 1 in the control arm withdrew prematurely. The monitor and control groups did not differ in age, gender, CHA2DS2-VASc score, or comorbidities. Median medication compliance was 99.7%, with nonsignificantly greater compliance in the monitor group (100%) than in the control group (99.7%) (p-value = 0.247). There was also no significant difference between missing any dose and use/nonuse of the smartphone monitor (48.9% vs. 55.1%; p-value = 0.692). Mean monitor compliance was 86.8% ± 14.0% with an average of 4.34 recorded electrocardiograms per week. Monitor group patients with perfect medication compliance had significantly higher monitor compliance than those patients who missed doses (median 95.3% vs 86.7%; p-value = 0.02). CONCLUSIONS: In a study population with higher-than-expected medication compliance, the use of smartphone electrocardiogram did not demonstrate an improvement in medication compliance as compared to usual care. Greater monitor compliance was associated with greater medication compliance. CLINICAL TRIAL REGISTRATION: BOAT-OAR ClinicalTrials.gov number, NCT03515083.
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Anticoagulantes , Fibrilação Atrial , Humanos , Anticoagulantes/uso terapêutico , Smartphone , Eletrocardiografia , Adesão à MedicaçãoRESUMO
INTRODUCTION: Up to 6% of patients experience complications after radiofrequency catheter ablation (RFA) of atrial fibrillation (AF). The purpose of this study is to determine the prevalence and predictors of periprocedural complications after RFA for AF. METHODS AND RESULTS: The subjects were 1,295 consecutive patients (age = 60 ± 10 years) who underwent RFA (n = 1,642) for paroxysmal (53%) or persistent AF (47%) from January 2007 to January 2010. A complication occurred in 57 patients (3.5%); a vascular access complication in 31 (1.9%); pericardial tamponade in 20 (1.2%); a thromboembolic event in 4 (0.2%); deep venous thrombosis in 1 (<0.01%); and pulmonary vein stenosis in 1 patient (<0.01%). There were no procedure-related deaths. On multivariate analysis, female gender (OR = 2.27; ±95% CI: 1.31-2.57, P < 0.01) and procedures performed in July or August (OR = 2.10; ±95% CI: 1.16-3.80, P = 0.01) were independent predictors of any complication. For vascular complications, treatment with clopidogrel (OR = 4.40; ±95% CI: 1.43-13.53, P = 0.01), female gender (OR = 3.65; ±95% CI: 1.72-7.75, P < 0.01) and performing RFA in July or August (OR = 2.71; ±95% CI: 1.25-5.87, P = 0.01) were independent predictors. The only predictor of cardiac tamponade was prior RFA (OR = 3.32; ±95% CI: 0.95-11.61; P < 0.05). CONCLUSION: Prevalence of perioperative complications for RFA of AF is 3.5% and vascular access complications constitute the majority. The need for clopidogrel therapy should be carefully considered prior to RFA. At teaching institutions close supervision should be exercised during vascular access early in the year. Improvements in ablation technology and elimination of the need for repeat procedures may decrease the risk of pericardial tamponade.
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Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Ablação por Cateter/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Medição de Risco , Fatores de RiscoRESUMO
A 26-year-old woman with recurrent unexplained syncope in the postpartum period was diagnosed with long QT syndrome type 2. Traditional implantation of defibrillator using fluoroscopy became contraindicated after she again became pregnant prior to device implantation. A subcutaneous defibrillator was successfully implanted in the second trimester, after a multidisciplinary evaluation. (Level of Difficulty: Intermediate.).
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This case series demonstrates 2 innovative approaches to successful coronary sinus lead placement in the setting of coronary sinus ostial atresia. Use of venous phase coronary angiography, a computed tomography scan with venous phase, or a left-sided upper extremity venogram may help reveal a variant anatomy and guide tool selection. (Level of Difficulty: Advanced.).
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Atrial fibrillation (AF) is the most common clinically significant arrhythmia, and it increases stroke risk. A preventive approach to AF is needed because virtually all treatments such as cardioversion, antiarrhythmic drugs, ablation, and anticoagulation are associated with high cost and carry significant risk. A systematic review was performed to identify effective lifestyle-based strategies for reducing primary and secondary AF. A PubMed search was performed using articles up to March 1, 2021. Search terms included atrial fibrillation, atrial flutter, exercise, diet, metabolic syndrome, type 2 diabetes mellitus, obesity, hypertension, stress, tobacco smoking, alcohol, Mediterranean diet, sodium, and omega-3 fatty acids. Additional articles were identified from the bibliographies of retrieved articles. The control of hypertension, ideally with a renin-angiotensin-aldosterone system inhibitor, is effective for preventing primary AF and recurrence. Obstructive sleep apnea is a common cause of AF, and treating it effectively reduces AF episodes. Alcohol increases the risk of AF in a dose-dependent manner, and abstinence reduces risk of recurrence. Sedentary behavior and chronic high-intensity endurance exercise are both risk factors for AF; however, moderate physical activity is associated with lower risk of AF. Recently, sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 agonists have been associated with reduced risk of AF. Among overweight/obese patients, weight loss of ≥10% is associated with reduced AF risk. Lifestyle changes and risk factor modification are highly effective for preventing AF.
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Fibrilação Atrial/prevenção & controle , Dietoterapia , Exercício Físico , Comportamento de Redução do Risco , Abandono do Hábito de Fumar , Consumo de Bebidas Alcoólicas/epidemiologia , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Cirurgia Bariátrica , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Dieta Mediterrânea , Gorduras Insaturadas na Dieta , Treino Aeróbico , Ácidos Graxos Ômega-3 , Peptídeo 1 Semelhante ao Glucagon/agonistas , Humanos , Síndrome Metabólica/epidemiologia , Síndrome Metabólica/terapia , Obesidade/epidemiologia , Obesidade/terapia , Sobrepeso/epidemiologia , Sobrepeso/terapia , Comportamento Sedentário , Apneia Obstrutiva do Sono/epidemiologia , Apneia Obstrutiva do Sono/terapia , Fumar/epidemiologia , Fumar/terapia , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Redução de PesoRESUMO
BACKGROUND: The remede System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remede System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant. METHODS: Patients remaining in the Pivotal Trial at the time of FDA approval were invited to enroll in the PAS and consented to undergo sleep studies (scored by a central laboratory), complete the Epworth Sleepiness Scale (ESS) questionnaire to assess daytime sleepiness, and safety assessment. All subjects (treatment and former control group) receiving active therapy were pooled; data from both trials were combined for analysis. RESULTS: Fifty-three of the original 151 Pivotal Trial patients consented to participate in the PAS and 52 completed the 5-year visit. Following TPNS therapy, the apnea-hypopnea index (AHI), central-apnea index (CAI), arousal index, oxygen desaturation index, and sleep architecture showed sustained improvements. Comparing 5 years to baseline, AHI and CAI decreased significantly (AHI baseline median 46 events/hour vs 17 at 5 years; CAI baseline median 23 events/hour vs 1 at 5 years), though residual hypopneas were present. In parallel, the arousal index, oxygen desaturation index and sleep architecture improved. The ESS improved by a statistically significant median reduction of 3 points at 5 years. Serious adverse events related to implant procedure, device or delivered therapy were reported by 14% of patients which include 16 (9%) patients who underwent a pulse generator reposition or lead revision (primarily in the first year). None of the events caused long-term harm. No unanticipated adverse device effects or related deaths occurred through 5 years. CONCLUSION: Long-term TPNS safely improves CSA, sleep architecture and daytime sleepiness through 5 years post implant. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01816776.
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OBJECTIVES: This study sought to determine whether the increased use of telehealth was associated with a difference in outcomes for outpatients with heart failure. BACKGROUND: The COVID-19 pandemic led to dramatic changes in the delivery of outpatient care. It is unclear whether increased use of telehealth affected outcomes for outpatients with heart failure. METHODS: In March 2020, a large Midwestern health care system, encompassing 16 cardiology clinics, 16 emergency departments, and 12 hospitals, initiated a telehealth-based model for outpatient care in the setting of the COVID-19 pandemic. A propensity-matched analysis was performed to compare outcomes between outpatients seen in-person in 2018 and 2019 and via telemedicine in 2020. RESULTS: Among 8,263 unique patients with heart failure with 15,421 clinic visits seen from March 15 to June 15, telehealth was employed in 88.5% of 2020 visits but in none in 2018 or 2019. Despite the pandemic, more outpatients were seen in 2020 (n = 5,224) versus 2018 and 2019 (n = 5,099 per year). Using propensity matching, 4,541 telehealth visits in 2020 were compared with 4,541 in-person visits in 2018 and 2019, and groups were well matched. Mortality was similar for telehealth and in-person visits at both 30 days (0.8% vs 0.7%) and 90 days (2.9% vs 2.4%). Likewise, there was no excess in hospital encounters or need for intensive care with telehealth visits. CONCLUSIONS: A telehealth model for outpatients with heart failure allowed for distanced encounters without increases in subsequent acute care or mortality. As the pressures of the COVID-19 pandemic abate, these data suggest that telehealth outpatient visits in patients with heart failure can be safely incorporated into clinical practice.