RESUMO
BACKGROUND: INSTANT (INhalation of flecainide to convert recent-onset SympTomatic Atrial fibrillatioN to sinus rhyThm) was a multicenter, open-label, single-arm study of flecainide acetate oral inhalation solution (FlecIH) for acute conversion of recent-onset (≤48 hours) symptomatic atrial fibrillation (AF) to sinus rhythm. OBJECTIVES: This study investigated the efficacy and safety in 98 patients receiving a single dose of FlecIH delivered via oral inhalation. METHODS: Patients self-administered FlecIH over 8 minutes in a supervised medical setting using a breath-actuated nebulizer and were continuously monitored for 90 minutes using a 12-lead Holter. RESULTS: Mean age was 60.5 years, mean body mass index was 27.0 kg/m2, and 34.7% of the patients were women. All patients had ≥1 AF-related symptoms at baseline, and 87.8% had AF symptoms for ≤24 hours. The conversion rate was 42.6% (95% CI: 33.0%-52.6%) with a median time to conversion of 14.6 minutes. The conversion rate was 46.9% (95% CI: 36.4%-57.7%) in a subpopulation that excluded predose flecainide exposure for the current AF episode. Median time to discharge among patients who converted was 2.5 hours, and only 2 patients had experienced AF recurrence by day 5. In the conversion-no group, 44 (81.5%) patients underwent electrical cardioversion by day 5. The most common adverse events were related to oral inhalation of flecainide (eg, cough, oropharyngeal irritation/pain), which were mostly of mild intensity and limited duration. CONCLUSIONS: The risk-benefit of orally inhaled FlecIH for acute cardioversion of recent-onset AF appears favorable. FlecIH could provide a safe, effective, and convenient first-line therapeutic option. (INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm [INSTANT]; NCT03539302).
Assuntos
Antiarrítmicos , Fibrilação Atrial , Flecainida , Humanos , Fibrilação Atrial/tratamento farmacológico , Feminino , Masculino , Flecainida/administração & dosagem , Pessoa de Meia-Idade , Idoso , Antiarrítmicos/administração & dosagem , Administração por Inalação , Administração Oral , Resultado do TratamentoRESUMO
Background Takotsubo syndrome (TS) and myocardial infarction (MI) share similar clinical and laboratory characteristics but have important differences in causes, demographics, management, and outcomes. Methods and Results In this observational study, the National Inpatient Sample and National Readmission Database were used to identify patients admitted with TS, type 1 MI, or type 2 MI in the United States between October 1, 2017, and December 31, 2019. We compared patients hospitalized with TS, type 1 MI, and type 2 MI with respect to key features and outcomes. Over the 27-month study period, 2 035 055 patients with type 1 MI, 639 075 patients with type 2 MI, and 43 335 patients with TS were identified. Cardiac arrest, ventricular fibrillation, and ventricular tachycardia were more prevalent in type 1 MI (4.02%, 3.2%, and 7.2%, respectively) compared with both type 2 MI (2.8%, 0.8%, and 5.4% respectively) and TS (2.7%, 1.8%, and 5.3%, respectively). Risk of mortality was lower in TS compared with both type 1 MI (3.3% versus 7.9%; adjusted odds ratio [OR], 0.3; P<0.001) and type 2 MI (3.3% versus 8.2%; adjusted OR, 0.3; P<0.001). Mortality rate (OR, 1.2; P<0.001) and cardiac-cause 30-day readmission rate (adjusted OR, 1.7; P<0.001) were higher in type 1 MI than in type 2 MI. Conclusions Patients with type 1 MI had the highest rates of in-hospital mortality and cardiac-cause 30-day readmission. Risk of all-cause 30-day readmission was highest in patients with type 2 MI. The risk of ventricular arrhythmias in patients with TS is lower than in patients with type 1 MI but higher than in patients with type 2 MI.
Assuntos
Infarto Miocárdico de Parede Anterior , Infarto do Miocárdio , Cardiomiopatia de Takotsubo , Humanos , Cardiomiopatia de Takotsubo/diagnóstico , Cardiomiopatia de Takotsubo/epidemiologia , Cardiomiopatia de Takotsubo/terapia , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Pacientes Internados , Fibrilação Ventricular/diagnóstico , Fibrilação Ventricular/epidemiologia , Fibrilação Ventricular/terapiaRESUMO
Background Routine addition of an atrial lead during an implantable cardioverter-defibrillator (ICD) implantation for primary prevention of sudden cardiac death, in patients without pacing indications, was not shown beneficial in contemporary studies. We aimed to investigate the use and safety of single- versus dual-chamber ICD implantations in these patients. Methods and Results Using the National Inpatient Sample database, we identified patients with no pacing indications who underwent primary-prevention ICD implantation in the United States between 2015 and 2019. Sociodemographic and clinical characteristics, as well as in-hospital complications, were analyzed. Multivariable logistic regression was used to identify predictors of in-hospital complications. An estimated total of 15 940 patients, underwent ICD implantation for primary prevention of sudden cardiac death during the study period, 8860 (55.6%) received a dual-chamber ICD. The mean age was 64 years, and 66% were men. In-hospital complication rates in the dual-chamber ICD and single-chamber ICD group were 12.8% and 10.7%, respectively (P<0.001), driven by increased rates of pneumothorax/hemothorax (4.6% versus 3.4%; P<0.001) and lead dislodgement (3.6% versus 2.3%; P<0.001) in the dual-chamber ICD group. Multivariable analyses confirmed atrial lead addition as an independent predictor for "any complications" (odds ratio [OR], 1.1 [95% CI, 1.0-1.2]), for pneumo/hemothorax (odds ratio, 1.1 [95% CI, 1.0-1.4]), and for lead dislodgement (odds ratio, 1.3 [95% CI, 1.1-1.6]). Conclusions Despite lack of evidence for clinical benefit, dual-chamber ICDs are implanted for primary prevention of sudden cardiac death in a majority of patients who do not have pacing indication. This practice is associated with increased risk of periprocedural complications. Avoidance of routine implantation of atrial leads will likely improve safety outcomes.
Assuntos
Fibrilação Atrial , Desfibriladores Implantáveis , Masculino , Humanos , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Feminino , Desfibriladores Implantáveis/efeitos adversos , Fibrilação Atrial/etiologia , Hemotórax/etiologia , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Prevenção Primária/métodos , Sistema de RegistrosRESUMO
Background Most published reports describing outcomes of patients with cardiovascular implantable electronic device-related infective endocarditis (CIED-IE) are single-center studies with small patient sample sizes. The goal of this study was to utilize population-based data to assess trends in CIED-IE hospitalization and to compare outcomes between patients hospitalized with CIED-IE, prosthetic valve endocarditis (PVE), and native valve endocarditis (NVE). Methods and Results A query of the National (Nationwide) Inpatient Sample (NIS) database between 2003 and 2017 identified 646 325 patients hospitalized with infective endocarditis in the United States of whom 585 974 (90%) had NVE, 27 257 (4.2%) had CIED-IE, and 26 111 (4%) had PVE. There was a 509% increase in CIED-IE hospitalizations in the United States from 2003 to 2017 (P trend<0.001). In-hospital mortality and length of stay associated with CIED-IE decreased during the study period from 15% and 20 days in 2003 to 9.7% and 19 days in 2017 (P trend=0.032 and 0.018, respectively). The in-hospital mortality rate was lower in patients hospitalized with CIED-IE (9.2%) than in patients with PVE (12%) and NVE (12%). Length of stay was longest in the CIED-IE group (17 compared with 14 days for both NVE and PVE). Hospital costs were highest for the CIED-IE group ($56 000 compared with $37 000 in NVE and $45 000 in PVE). Conclusions Despite the fact that the number of comorbidities per patient with CIED-IE increased during the study period, mortality rate and hospital length of stay decreased. The mortality rate was significantly lower for patients with CIED-IE than for patients with NVE and PVE. Patients with CIED-IE had the longest lengths of stay and highest hospital costs.
Assuntos
Endocardite Bacteriana , Endocardite , Próteses Valvulares Cardíacas , Infecções Relacionadas à Prótese , Eletrônica , Endocardite/diagnóstico , Endocardite/epidemiologia , Endocardite/terapia , Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/epidemiologia , Endocardite Bacteriana/terapia , Próteses Valvulares Cardíacas/efeitos adversos , Hospitalização , Humanos , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/terapia , Estudos RetrospectivosRESUMO
PURPOSE OF REVIEW: We aimed to describe the epidemiology of sudden cardiac death (SCD) in the obese, elaborating on the potential pathophysiological mechanisms linking obesity, SCD, and the outcomes in SCD survivors, as well as looking into the intriguing "obesity paradox" in these patients. RECENT FINDINGS: Several studies show increased mortality in patients with BMI > 30 kg/m2 admitted to the hospital following SCD. At the same time, other studies have implied that the "obesity paradox," described in various cardiovascular conditions, applies to patients admitted after SCD, showing lower mortality in the obese compared to normal weight and underweight patients. We found a significant body of evidence to support that while obesity increases the risk for SCD, the outcomes of obese patients post SCD are better. These findings should not be interpreted as supporting weight gain, as it is always better to prevent the "disaster" from happening than to improve your chances of surviving it. Obesity is shown to be significantly associated with increased risk for SCD; however, there is a growing body of evidence, supporting the "obesity paradox" in the survival of SCD victims. Prospectively, well-designed studies are needed to confirm these findings.
Assuntos
Morte Súbita Cardíaca , Obesidade , Índice de Massa Corporal , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Hospitalização , Humanos , Obesidade/complicações , Fatores de RiscoRESUMO
Background: Obesity has been associated with increased incidence and severity of various cardiovascular risk factors and increased risk for stroke. However, the evidence of its effect on outcomes in stroke victims have been equivocal. We aimed to investigate the distribution of BMI in a nation-wide cohort of individuals, admitted for a stroke, and the relationship between BMI and in-hospital mortality. Methods: Data from the U.S. National Inpatient Sample (NIS) was collected, to identify hospitalizations for stroke, between October 2015 and December 2016. The patients were sub-divided into six groups based on their BMI: underweight, normal weight, overweight, obese I, obese II and extremely obese groups. Various sociodemographic and clinical parameters were gathered, and incidence of mortality and the length of hospital stay were analyzed. Multivariable analysis was performed to identify independent predictors of in-hospital mortality. Results: A weighted total of 84,185 hospitalizations for stroke were included in the analysis. The approximate mean patients aged was 65.5 ± 31 years, the majority being female (55.3%) and white (63.1%). The overall in-hospital mortality during the study period was 3.6%. A reverse J-shaped relationship between the body mass index and in-hospital mortality was documented, while patients with elevated BMI showed significantly lower in-hospital mortality compared to the underweight and normal weight study participants, 2.8% vs. 7.4%, respectively, p < 0.001. Age and several comorbidities, as well as the Deyo Comorbidity Index, were found to predict mortality in a multivariable analysis. Conclusion: A reverse J-shaped relationship between body mass index and in-hospital mortality was documented in patients admitted for a stroke in the U.S. during the study period. The above findings support the existence of an "obesity paradox" in patients hospitalized following a stroke, similar to that described in other cardiovascular conditions.
RESUMO
BACKGROUND: Catheter ablation (CA) for atrial fibrillation (AF) is increasingly utilized in recent years, with promising results. We aimed to investigate the nationwide trends in utilization and procedural complications of CA for AF in patients with mechanical prosthetic valves (MPVs). METHODS AND RESULTS: We drew data from the US National Inpatient Sample (NIS) database to identify cases of AF ablations in patients with MPVs, between 2003 and 2015. Sociodemographic and clinical data were collected, and incidence of procedural complications, mortality, and length of stay were analyzed. We compared the outcomes to a propensity-matched cohort of patients without MPVs. The study included a weighted total of 1898 CA for AF cases in patients with MPVs. The median age of the study population was 67 (61-75) years and 53% were males. Despite the increasing age and significant uptrend in the prevalence of individual comorbidities and Deyo-Charlson Comorbidity Index (CCI) over the years, the risk of peri-procedural complications and mortality in the study group did not change between the early (2003-2008) and late (2009-2015) study years. The peri-procedural complication rate (8.4% vs. 10.4%, p = .33) and in-hospital mortality (0.2% vs. 0.2%, p = .9) did not differ significantly between patients with MPVs and 1901 matched patients without MPVs. Length of stay was higher among patients with prior MPVs compared to the controls (4.0 ± 0.2 vs. 3.3 ± 0.2 days, p = .011). CONCLUSION: This nationwide analysis shows that AF ablation in patients with mechanical valve prothesis bares a similar risk of periprocedural complications and mortality as in patients without prosthetic valves.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Feminino , Mortalidade Hospitalar , Humanos , Pacientes Internados , Masculino , Resultado do TratamentoRESUMO
BACKGROUND: Oral and intravenous flecainide is recommended for cardioversion of atrial fibrillation. In this open-label, dose-escalation study, the feasibility of delivering flecainide via oral inhalation (flecainide acetate inhalation solution) for acute conversion was evaluated. We hypothesized that flecainide delivered by oral inhalation would quickly reach plasma concentrations sufficient to restore sinus rhythm in patients with recent-onset atrial fibrillation. METHODS: Patients (n=101) with symptomatic atrial fibrillation (for ≤48 hours) self administered flecainide acetate inhalation solution using a nebulizer (30 mg [n=10], 60 mg [n=22], 90 mg [n=21], 120 mg [n=19], and 120 mg in a formulation containing saccharin [n=29]). Electrocardiograms and flecainide plasma concentrations were obtained, cardiac rhythm using 4-hour Holter was monitored, and adverse events were recorded. RESULTS: Conversion rates increased with dose and with the maximum plasma concentrations of flecainide. At the highest dose, 48% of patients converted to sinus rhythm within 90 minutes from the start of inhalation. Among patients who achieved a maximum plasma concentration >200 ng/mL, the conversion rate within 90 minutes was 50%; for those who achieved a maximum plasma concentration <200 ng/mL, it was 24%. Conversion was rapid (median time to conversion of 8.1 minutes from the end of inhalation), and conversion led to symptom resolution in 86% of the responders. Adverse events were typically mild and transient and included: cough, throat pain, throat irritation; at the highest dose with the formulation containing saccharin, these adverse events were reported by 41%, 14%, and 3% of patients, respectively. Cardiac adverse events consistent with those observed with oral and intravenous flecainide were uncommon and included postconversion pauses (n=2), bradycardia (n=1), and atrial flutter with 1:1 atrioventricular conduction (n=1); none required treatment, and all resolved without sequelae. CONCLUSIONS: Administration of flecainide via oral inhalation was shown to be safe and to yield plasma concentrations of flecainide sufficient to restore sinus rhythm in patients with recent-onset atrial fibrillation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03539302.
Assuntos
Fibrilação Atrial , Flutter Atrial , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Cardioversão Elétrica , Flecainida/efeitos adversos , Humanos , Sacarina/uso terapêuticoRESUMO
BACKGROUND: Cardiovascular events in the context of COVID-19 infection increase the risk of negative patient outcomes, but large cohort studies describing this association are limited. The purpose of the current study was to investigate the potential associations between cardiovascular events and mortality in patients hospitalized due to COVID-19. METHODS: A retrospective chart review was performed in 2450 patients hospitalized for confirmed COVID-19 infection within a single hospital network between March 15 and June 15, 2020. Logistic regression analysis was used to identify predictors of mortality. RESULTS: In the study population, 57% of patients had elevated high sensitivity troponin (hs-TnT) levels. Acute heart failure occurred in 23% of patients and arrhythmias were observed in 8% of patients. Of the 1401 patients with elevated hs-TnT levels, a primary cardiac etiology (e.g., myocardial infarction) was identified in 653 (47%) patients. In the remaining 748 (53%) patients, there was evidence of a primary non-cardiac etiology for hs-TnT elevation such as renal failure (n = 304) and critical illness (n = 286). Elevated hs-TnT was associated with increased risk of mortality. A significantly higher mortality rate was observed for hs-TnT elevation associated with a primary cardiac etiology (OR 4.6, 95% CI: 2.7-7.6; P < 0.001) than a primary non-cardiac etiology (OR 2.7, 95% CI: 1.6-4.5; P < 0.001). CONCLUSIONS: Elevated hs-TnT in the context of COVID-19 infection is associated with a significantly increased mortality risk. Hs-TnT elevation in the context of a primary cardiac etiology confers a nearly 2-fold higher mortality risk than hs-TnT elevation due to a primary non-cardiac etiology.
Assuntos
COVID-19 , Troponina T , Biomarcadores , Humanos , Prognóstico , Estudos Retrospectivos , SARS-CoV-2RESUMO
While obesity has been shown to be associated with elevated risk for Sudden Cardiac Death (SCD), studies examining its effect on outcomes in SCD victims have shown conflicting results. We aimed to describe the body mass index (BMI) distribution in a nationwide cohort of patients admitted for an out of hospital SCD (OHSCD), and the relationship between BMI and in-hospital mortality. We drew data from the U.S. National Inpatient Sample (NIS), to identify cases of OHSCD. Patients were divided into six groups based on their BMI (underweight, normal weight, overweight, obese I, obese II, extremely obese). Socio-demographic and clinical data were collected, mortality and length of stay were analyzed. Multivariate analysis was performed to identify predictors of mortality. Among a weighted total of 2330 hospitalizations for OHSCD in patients with documented BMI, the mean age was 62.3 ± 29 years, 52.4% were male and 62% were white. The overall rate of in-hospital mortality was 69.3%. A U-shaped relationship between the BMI and mortality was documented, as patients with 25 < BMI < 40 exhibited significantly lower mortality (60.7%) compared to the other BMI groups (75.2%), p < .001. BMI of 25 kg/m2 and below or 40 kg/m2 and above, were independent predictors of in-hospital mortality in a multivariate analysis along with prior history of congestive heart failure and Deyo Comorbidity Index of ≥2. A U-shaped relationship between the BMI and in-hospital mortality was documented in patients hospitalized for an out of hospital sudden cardiac death in the United States in the recent years.
Assuntos
Morte Súbita Cardíaca , Hospitalização , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Lyme carditis, defined as direct infection of cardiac tissue by Borrelia bacteria, affects up to 10% of patients with Lyme disease. The most frequently reported clinical manifestation of Lyme carditis is cardiac conduction system disease. The goal of this study was to identify the incidence and predictors of permanent pacemaker implantation in patients hospitalized with Lyme disease. METHODS: A retrospective cohort analysis of the Nationwide Inpatient sample was performed to identify patients hospitalized with Lyme disease in the US between 2003 and 2014. Patients with Lyme carditis were defined as those hospitalized with Lyme disease who also had cardiac conduction disease, acute myocarditis, or acute pericarditis. Patients who already had pacemaker implants at the time of hospitalization (N = 310) were excluded from the Lyme carditis subgroup. The primary study outcome was permanent pacemaker implantation. Secondary outcomes included temporary cardiac pacing, permanent pacemaker implant, and in-hospital mortality. RESULTS: Of the 96,140 patients hospitalized with Lyme disease during the study period, 10,465 (11%) presented with Lyme carditis. Cardiac conduction system disease was present in 9,729 (93%) of patients with Lyme carditis. Permanent pacemaker implantation was performed in 1,033 patients (1% of all Lyme hospitalizations and 11% of patients with Lyme carditis-associated conduction system disease). Predictors of permanent pacemaker implantation included older age (OR: 1.06 per 1 year; 95% CI:1.05-1.07; P<0.001), complete heart block (OR: 21.5; 95% CI: 12.9-35.7; P<0.001), and sinoatrial node dysfunction (OR: 16.8; 95% CI: 8.7-32.6; P<0.001). In-hospital mortality rate was higher in patients with Lyme carditis (1.5%) than in patients without Lyme carditis (0.5%). CONCLUSIONS: Approximately 11% of patients hospitalized with Lyme disease present with carditis, primarily in the form of cardiac conduction system disease. In this 12-year study, 1% of all hospitalized patients and 11% of those with Lyme-associated cardiac conduction system disease underwent permanent pacemaker implantation.
Assuntos
Doença do Sistema de Condução Cardíaco/epidemiologia , Doença do Sistema de Condução Cardíaco/terapia , Doença de Lyme/complicações , Adulto , Fatores Etários , Idoso , Doença do Sistema de Condução Cardíaco/etiologia , Dispositivos de Terapia de Ressincronização Cardíaca , Feminino , Hospitalização , Humanos , Incidência , Doença de Lyme/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
BACKGROUND: Catheter ablation (CA) for ventricular arrhythmias (VAs) is increasingly utilized in recent years. We aimed to investigate the nationwide trends in utilization and procedural complications of CA for VAs in patients with mechanical valve (MV) prosthesis. METHODS: We drew data from the US National Inpatient Sample database to identify cases of VA ablations, including premature ventricular contraction and ventricular tachycardia, in patients with MVs, between 2003 and 2015. Sociodemographic and clinical data were collected and the incidence of catheter ablation complications, mortality, and length of stay were analyzed. We compared the outcomes to a propensity-matched cohort of patients without prior valve surgery. RESULTS: The study population included a weighted total of 647 CA cases in patients with prior MVs. The annual number of ablations almost doubled, from 34 ablations on average during the "early years" (2003-2008) to 64 on average during the "late years" (2009-2015) of the study (p = .001). Length of stay at the hospital did not differ significantly between patients with MVs and 649 matched patients without prior MVs (5.4 ± 0.4, 4.7 ± 0.3 days, respectively, p = .12). The data revealed a trend toward a higher incidence of complications (12.6% vs. 7.5% respectively, p = .14) and mortality (3.7% vs. 0.7%, respectively, p = .087) among patients with MVs compared to the matched control group, not reaching statistical significance. CONCLUSION: The data show increased utilization of VA ablations in patients with MVs and a trend toward a higher incidence of in-hospital mortality and complications compared to the propensity-matched control group without MVs.
Assuntos
Ablação por Cateter , Taquicardia Ventricular , Complexos Ventriculares Prematuros , Ablação por Cateter/efeitos adversos , Mortalidade Hospitalar , Humanos , Próteses e Implantes , Estudos Retrospectivos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/epidemiologia , Taquicardia Ventricular/cirurgia , Resultado do Tratamento , Complexos Ventriculares Prematuros/complicações , Complexos Ventriculares Prematuros/diagnóstico , Complexos Ventriculares Prematuros/cirurgiaRESUMO
BACKGROUND: Stress and negative emotions contribute to atrial fibrillation (AF). Mind-body practices decrease stress and negative emotions and may reduce AF episodes and improve quality of life for patients with AF. OBJECTIVE: We examined the effects of a multimodal mind-body program, the SMART Program, on AF-related quality of life in patients with paroxysmal AF (PAF). METHODS: In this randomized, waitlist-controlled pilot trial, 18 subjects with PAF participated in an 8-week SMART Program delivered online immediately or 3 months later. Validated measures were completed at baseline and at 3 and 6 months (waitlist group only). RESULTS: Comparing pre- vs post-program scores among all 18 participants, subjects reported improvement in AF-related quality of life (Cohen's d = 0.75, P = .005) and depression (d = 0.50, P = .05) but not anxiety (d = 0.35, P = .16). Subjects also reported improvements in AF symptom severity (P = .026), distress (P = .014), positive affect (P = .003), and ability to cope with stress (P = .001). Compared to waitlist control subjects, those in the immediate group reported improvement in positive affect (d = 1.20, P = .021) and coping with stress (d = 1.36, P = .011) after participating in the program. CONCLUSION: The SMART Program, delivered virtually, may enhance positive emotions and coping with stress as well as decrease negative emotions and AF symptoms. These results warrant a larger trial to better understand the potential benefits of such programs for patients with PAF.
RESUMO
Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.
Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos , Complicações Intraoperatórias/epidemiologia , Derrame Pericárdico/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Implantação de Prótese , Acidente Vascular Cerebral/prevenção & controle , Fibrilação Atrial/complicações , Tamponamento Cardíaco/epidemiologia , Bases de Dados Factuais , Aprovação de Equipamentos , Falha de Equipamento/estatística & dados numéricos , Humanos , Hipotensão/epidemiologia , Mortalidade , Próteses e Implantes , Falha de Prótese , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Trombose/epidemiologia , Fatores de TempoRESUMO
Eliglustat is a first-line oral treatment for adults with Gaucher disease type 1 who have cytochrome P450 (CYP) 2D6 extensive, intermediate, or poor metabolizer phenotypes. Per International Conference on Harmonisation (ICH) E14 guidance, a Phase 1 thorough electrocardiographic (ECG) study was done during drug development to assess eliglustat's effects on cardiac repolarization by measuring ECG intervals in healthy adult subjects. Using data from the thorough ECG study, we performed pharmacokinetic/pharmacodynamic-ECG modeling to establish the relationship between eliglustat concentrations and their effects on ECG intervals. We then used that concentration-response relationship to predict the effects of eliglustat on each ECG interval for each CYP2D6 metabolizer phenotype (the main determinant of eliglustat exposure) and in different drug-drug interaction scenarios. These predictions, together with other exposure-related factors, contributed to the CYP2D6 phenotype-based dosing recommendations for eliglustat, including dose adjustments and contraindications when co-administered with drugs metabolized by the CYP2D6 and CYP3A pathways.
Assuntos
Citocromo P-450 CYP2D6/genética , Citocromo P-450 CYP3A/genética , Doença de Gaucher/tratamento farmacológico , Pirrolidinas/administração & dosagem , Administração Oral , Adulto , Relação Dose-Resposta a Droga , Interações Medicamentosas/genética , Eletrocardiografia , Feminino , Doença de Gaucher/genética , Doença de Gaucher/patologia , Humanos , Inativação Metabólica/genética , Fígado/efeitos dos fármacos , Masculino , Pirrolidinas/farmacocinéticaRESUMO
Background Atrial fibrillation (AF) is common and bears a major clinical impact in patients with hypertrophic cardiomyopathy (HCM). We aimed to investigate the use and real-world safety of catheter ablation for AF in patients with HCM. Methods and Results We drew data from the US National Inpatient Sample to identify cases of AF ablation in HCM patients between 2003 and 2015. Sociodemographic and clinical data were collected, and incidence of catheter ablation complications, mortality, and length of stay were analyzed, including trends between the early (2003-2008) and later (2009-2015) study years. Among a weighted total of 1563 catheter ablation cases in patients with HCM, the median age was 62 (interquartile range, 52-72), 832 (53.2%) were male, and 1150 (73.6%) were white. The average annual volume of AF ablations in patients with HCM doubled between the early and the later study period (79-156). At least 1 complication occurred in 16.1% of cases, and the in-hospital mortality rate was 1%. Cardiac and pericardial complications declined from 8.8% to 2.3% and from 2.8% to 0.9%, respectively, between the early and the later study years (P<0.01). Independent predictors of complications included female sex (odds ratio [OR], 4.81; 95% CI, 2.72-8.51), diabetes mellitus (OR, 6.57; 95% CI, 2.68-16.09) and obesity (OR, 3.82; 95% CI, 1.61-9.06). Conclusions Despite some decline in procedural complications over the years, catheter ablation for AF is still associated with a relatively high periprocedural morbidity and even mortality in patients with HCM. This emphasizes the importance of careful clinical consideration, by an experienced electrophysiologist, in referring patients with HCM for an AF ablation.
Assuntos
Fibrilação Atrial/cirurgia , Cardiomiopatia Hipertrófica/epidemiologia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/tendências , Complicações Pós-Operatórias/etiologia , Padrões de Prática Médica/tendências , Adolescente , Adulto , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Cardiomiopatia Hipertrófica/diagnóstico por imagem , Cardiomiopatia Hipertrófica/mortalidade , Ablação por Cateter/mortalidade , Comorbidade , Bases de Dados Factuais , Feminino , Humanos , Incidência , Pacientes Internados , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
Background Delivery of hydrogels to the heart is a promising strategy for mitigating the detrimental impact of myocardial infarction (MI). Challenges associated with the in vivo delivery of currently available hydrogels have limited clinical translation of this technology. Gelatin methacryloyl (GelMA) bioadhesive hydrogel could address many of the limitations of available hydrogels. The goal of this proof-of-concept study was to evaluate the cardioprotective potential of GelMA in a mouse model of MI. Methods and Results The physical properties of GelMA bioadhesive hydrogel were optimized in vitro. Impact of GelMA bioadhesive hydrogel on post-MI recovery was then assessed in vivo. In 20 mice, GelMA bioadhesive hydrogel was applied to the epicardial surface of the heart at the time of experimental MI. An additional 20 mice underwent MI but received no GelMA bioadhesive hydrogel. Survival rates were compared for GelMA-treated and untreated mice. Left ventricular function was assessed 3 weeks after experimental MI with transthoracic echocardiography. Left ventricular scar burden was measured with postmortem morphometric analysis. Survival rates at 3 weeks post-MI were 89% for GelMA-treated mice and 50% for untreated mice (P=0.011). Left ventricular contractile function was better in GelMA-treated than untreated mice (fractional shortening 37% versus 26%, P<0.001). Average scar burden in GelMA-treated mice was lower than in untreated mice (6% versus 22%, P=0.017). Conclusions Epicardial GelMA bioadhesive application at the time of experimental MI was performed safely and was associated with significantly improved post-MI survival compared with control animals. In addition, GelMA treatment was associated with significantly better preservation of left ventricular function and reduced scar burden.
Assuntos
Gelatina/administração & dosagem , Metacrilatos/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Miocárdio/patologia , Adesivos Teciduais/administração & dosagem , Animais , Modelos Animais de Doenças , Composição de Medicamentos , Fibrose , Gelatina/química , Hidrogéis , Metacrilatos/química , Camundongos Endogâmicos C57BL , Infarto do Miocárdio/patologia , Infarto do Miocárdio/fisiopatologia , Estudo de Prova de Conceito , Adesivos Teciduais/química , Função Ventricular EsquerdaRESUMO
Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and impairment of quality of life. Restoration and maintenance of normal sinus rhythm is a desirable goal for many patients with AF; however, this strategy is limited by the relatively small number of antiarrhythmic drugs (AADs) available for AF rhythm control. Although it is recommended in current medical guidelines as first-line therapy for patients without structural heart disease, the use of flecainide has been curtailed since the completion of the Cardiac Arrhythmia Suppression Trial. In clinical trials and real-world use, flecainide has proven to be more effective than other AADs for the acute termination of recent onset AF. Flecainide is also moderately effective and, with the exception of amiodarone, equivalent to other AADs for the chronic suppression of paroxysmal and persistent AF. In patients without structural heart disease, flecainide has been demonstrated to be safe and well tolerated relative to other AADs. Despite this favorable profile, flecainide is underutilized, likely due to a perceived risk of ventricular proarrhythmia, a concern that has not been borne out in patients without underlying structural heart disease. Guidelines for administration and use of flecainide are summarized in this review.
Assuntos
Fibrilação Atrial/tratamento farmacológico , Flecainida/uso terapêutico , Frequência Cardíaca/efeitos dos fármacos , Qualidade de Vida , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/fisiopatologia , HumanosAssuntos
Anticonvulsivantes/efeitos adversos , Eletrocardiografia/efeitos dos fármacos , Estado Epiléptico/tratamento farmacológico , Taquicardia/induzido quimicamente , Anticonvulsivantes/uso terapêutico , Encéfalo/diagnóstico por imagem , Diagnóstico Diferencial , Eletroencefalografia , Epilepsia/etiologia , Evolução Fatal , Feminino , Parada Cardíaca/etiologia , Humanos , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons , Estado Epiléptico/complicações , Taquicardia/etiologiaRESUMO
OBJECTIVES: The aim of this study was to investigate the safety and in-hospital outcomes of transcutaneous lead extraction (TLE) associated with device-related infection (DRI) in the United States from 2003 to 2015. BACKGROUND: DRI remains the most serious complication and the most common indication for lead extraction in patients with cardiac implantable electronic devices. The rates of DRI and associated lead extraction have been growing in line with the increasing number of cardiac implantable electronic device implantations worldwide. METHODS: Data for this study were drawn from the National (Nationwide) Inpatient Sample. The International Classification of Diseases-9th Revision-Clinical Modification coding system was used to identify hospitalizations with TLE for DRI and to investigate the rates of major adverse events. RESULTS: From a total of approximately 100 million unweighted hospitalizations over the 13-year study period, 12,257 unweighted observations were identified. This represents 59,082 (95% confidence interval [CI]: 58,982 to 59,182) patients who underwent TLE for DRI during the study period. A large majority of patients (75%) were older than 60 years. Patients were predominantly male (70%) and Caucasian (76%), and 80% had at least 1 comorbidity. The median length of stay was 8 days (interquartile range 5 to 14 days). At least 1 major adverse event occurred in 10.42% of procedures. The all-cause in-hospital mortality rate was 4.11%. Independent predictors of mortality were weight loss (adjusted odds ratio [aOR]: 4.02; 95% CI: 3.13 to 5.17), congestive heart failure (aOR: 3.28; 95% CI: 2.48 to 4.34), chronic kidney disease (aOR: 2.09; 95% CI: 1.70 to 2.56), pericardial complications (aOR: 2.87; 95% CI: 1.79 to 4.61), and procedure-related pulmonary injury (aOR: 2.06; 95% CI: 1.25 to 3.40). CONCLUSIONS: These results reflect the high rate of complications and mortality for TLE due to DRI in real-world experience, highlighting the importance of comorbidities, especially congestive heart failure and chronic kidney disease, as significant predictors of mortality in these patients.