RESUMO
BACKGROUND: Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. METHODS: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. RESULTS: Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. CONCLUSION: Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.
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Anticoagulantes , Estimulação Cardíaca Artificial , Heparina , Marca-Passo Artificial , Humanos , Heparina/administração & dosagem , Heparina/efeitos adversos , Masculino , Idoso , Feminino , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Resultado do Tratamento , Estudos Retrospectivos , Fatores de Tempo , Fatores de Risco , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade , Esquema de Medicação , Implantação de Prótese/instrumentação , Implantação de Prótese/efeitos adversos , Desenho de PróteseRESUMO
INTRODUCTION: Permanent pacing indications are common after cardiac surgery and transcatheter structural valve interventions. Leadless pacemakers (LPs) have emerged as a useful alternative to transvenous pacemakers. However, current commercially available LPs are unable to provide atrial pacing or cardiac resynchronization and relatively little is known about LP outcomes after cardiac surgery and transcatheter valve interventions. METHODS: This retrospective study included patients who received a Micra VR (MicraTM MC1VR01) or Micra AV (MicraTM MC1AVR1) (Medtronic) leadless pacemaker following cardiac surgery or transcatheter structural valve intervention between September 2014 and September 2022. Device performance and clinical outcomes, including ventricular pacing burden, ejection fraction, and need for conversion to transvenous pacing systems, were evaluated during follow-up. RESULTS: A total of 78 patients were included, of whom 40 received a Micra VR LP implant, and 38 received a Micra AV LP implant. The mean age of the cohort was 65.9 ± 17.9 years, and 48.1% were females. The follow-up duration for the entire cohort was 1.3 ± 1.1 years: 1.6 ± 1.3 years for the Micra VR group and 0.8 ± 0.5 years for the Micra AV group. Among the cohort, 50 patients had undergone cardiac surgery and 28 underwent transcatheter structural valve interventions. Device electrical performance was excellent during follow-up, with a small but clinically insignificant increase in ventricular pacing threshold and a slight decrease in pacing impedance. The mean right ventricle pacing (RVP) burden significantly decreased over time in the entire cohort (74.3% ± 37.2% postprocedure vs. 47.7% ± 40.6% at last follow-up, p < .001), and left ventricle ejection fraction (LVEF) showed a modest but significant downward trend during follow-up (55.0% ± 10.6% vs. 51.5% ± 11.2% p < .001). Patients with Micra VR implants had significantly reduced LVEF during follow-up (54.1% ± 11.9% vs. 48.8% ± 11.9%, p = .003), whereas LVEF appeared stable in the Micra AV group during follow-up (56.1% ± 9.0% vs. 54.6% ± 9.7%, p = .06). Six patients (7.7%) required conversion to transvenous pacing systems, four who required cardiac resynchronization for drop in LVEF with high RVP burden and two who required dual-chamber pacemakers for symptomatic sinus node dysfunction. CONCLUSION: Leadless pacemakers provide a useful alternative to transvenous pacemakers in appropriately selected patients after cardiac surgery and transcatheter structural valve interventions. Device performance is excellent over medium-term follow-up. However, a significant minority of patients require conversion to transvenous pacing systems for cardiac resynchronization or atrial pacing support, demonstrating the need for close electrophysiologic follow-up in this cohort.
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Procedimentos Cirúrgicos Cardíacos , Marca-Passo Artificial , Feminino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Estudos Retrospectivos , Lipopolissacarídeos , Resultado do Tratamento , Desenho de Equipamento , Estimulação Cardíaca Artificial/efeitos adversosRESUMO
AIMS: Single-connector (DF4) defibrillator leads have become the predominantly implanted transvenous implantable cardioverter-defibrillator lead. However, data on their long-term performance are derived predominantly from manufacturer product performance reports. METHODS AND RESULTS: We reviewed medical records in 5289 patients with DF4 leads between 2011 and 2023 to determine the frequency of lead-related abnormalities. We defined malfunction as any single or combination of electrical abnormalities requiring revision including a sudden increase (≥2×) in stimulation threshold, a discrete jump in high-voltage impedance, or sensing of non-physiologic intervals or noise. We documented time to failure, predictors of failure, and management strategies. Mean follow-up after implant was 4.15 ± 3.6 years (median = 3.63), with 37% of leads followed for >5 years. A total of 80 (1.5%) leads demonstrated electrical abnormalities requiring revision with an average time to failure of 4 ± 2.8 years (median = 3.5). Of the leads that malfunctioned, 62/80 (78%) were extracted and replaced with a new lead and in the other 18 cases, malfunctioned DF4 leads were abandoned, and a new lead implanted. In multivariable models, younger age at implant (OR 1.03 per year; P < 0.001) and the presence of Abbott/St. Jude leads increased the risk of malfunction. CONCLUSION: DF4 defibrillator leads demonstrate excellent longevity with >98.3% of leads followed for at least 5 years still functioning normally. Younger age at implant and lead manufacturer are associated with an increased risk of DF4 lead malfunction. The differences in lead survival between manufacturers require further investigation.
Assuntos
Desfibriladores Implantáveis , Humanos , Desfibriladores Implantáveis/efeitos adversos , Falha de Equipamento , Estudos RetrospectivosRESUMO
BACKGROUND: Data on the management of Micra transcatheter pacing system (TPS) at the time of an upgrade or during battery depletion is limited. OBJECTIVE: We sought to evaluate the management patterns of patients implanted with a Micra TPS during long-term follow-up. METHODS: We retrospectively identified patients who underwent Micra implantation from April 2014 to November 2019. We identified patients who underwent extraction (n = 11) or had an abandoned Micra (n = 12). RESULTS: We identified 302 patients who received a Micra during the period of the study. Mean age was 72.7 ± 15.4 years, 54.6% were men, and left ventricular ejection fraction was 51.9 ± 5.2%. Mean follow-up was 1105.5 ± 529.3 days. Procedural complications included pericardial tamponade (n = 1) treated with pericardiocentesis, significant rise in thresholds (n = 6) treated with reimplantation (n = 4), and major groin complications (n = 2). Indications for extraction included an upgrade to cardiac resynchronization therapy (CRT) device (n = 3), bridging after extraction of an infected transvenous system (n = 3), elevated thresholds (n = 3), and non-Micra-related bacteremia (n = 2). The median time from implantation to extraction was 78 days (interquartile range: 14-113 days), with the longest extraction occurring at 1442 days. All extractions were successful, with no procedural or long-term complications. Indications for abandonment included the need for CRT (n = 6), battery depletion (n = 2), increasing thresholds/failure to capture (n = 3), and pacemaker syndrome (n = 1). All procedures were successful, with no procedural or long-term complications. CONCLUSION: In this large single-center study, 6% of patients implanted with a Micra required a system modification during long-term follow-up, most commonly due to the requirement for CRT pacing. These patients were managed successfully with extraction or abandonment.
Assuntos
Marca-Passo Artificial , Idoso , Idoso de 80 Anos ou mais , Animais , Desenho de Equipamento , Humanos , Estágios do Ciclo de Vida , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Volume Sistólico , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
BACKGROUND: There are limited data on cardiac implantable electronic device implantation (CIED) in patients with persistent left superior vena cava (PLSVC). OBJECTIVE: To describe the outcomes of implanting CIEDs with a focus on cardiac resynchronization therapy (CRT) in patients with PLSVC. METHODS: We identified all patients with a PLSVC that underwent CIED implantation from December 2008 until February 2019 at our institution by querying the electronic medical record (n = 34). We then identified controls in a 3:1 fashion (n = 102) by matching on device type (CRT vs non-CRT). Procedure success, complications, fluoroscopy and procedural time were recorded. Outcomes were compared using a two-way analysis of variance test and conditional regression modeling for continuous and categorical variables, respectively. RESULTS: A total of 34 patients with PLSVC underwent 38 procedures. Four patients underwent dual chamber system implantation followed by a subsequent upgrade to CRT. Thirteen patients underwent CRT implantation: one was implanted via the right subclavian while the rest were implanted via the PLSVC. Left ventricular (P = .06). Procedure and fluoroscopy times were significantly higher in the PLSVC as compared with the control group (97.7 vs 66.1 minute, P < .001 and 18.1 minute vs 8.7 minutes, P = .005, respectively). CONCLUSION: CIED implant in patients with PLSVC is feasible but technically more challenging and appears to be associated with higher risk of right ventricular lead dislodgment.
Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Cardioversão Elétrica/instrumentação , Veia Cava Superior Esquerda Persistente/complicações , Implantação de Prótese/instrumentação , Veia Cava Superior/anormalidades , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia de Ressincronização Cardíaca/efeitos adversos , Bases de Dados Factuais , Desfibriladores Implantáveis , Cardioversão Elétrica/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Veia Cava Superior Esquerda Persistente/diagnóstico por imagem , Implantação de Prótese/efeitos adversos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Veia Cava Superior/diagnóstico por imagemRESUMO
BACKGROUND: Outcomes of catheter ablation for persistent atrial fibrillation (PeAF) are suboptimal. The convergent procedure (CP) may offer improved efficacy by combining endocardial and epicardial ablation. METHODS: We reviewed 113 consecutive patients undergoing the CP at our institution. The cohort was divided into two groups based on the presence (n = 92) or absence (n = 21) of continuous rhythm monitoring (CM) following the CP. Outcomes were reported in two ways. First, using a conventional definition of any atrial fibrillation/atrial tachycardia (AF/AT) recurrence lasting >30 seconds, after a 90 day blanking period. Second, by determining AF/AT burden at relevant time points in the group with CM. RESULTS: Across the entire cohort, 88% had either persistent or long-standing persistent AF, mean duration of AF diagnosis before the CP was 5.1 ± 4.6 years, 45% had undergone at least one prior AF ablation, 31% had impaired left ventricle ejection fraction and 62% met criteria for moderate or severe left atrial enlargement. Mean duration of follow-up after the CP was 501 ± 355 days. In the entire cohort, survival free from any AF/AT episode >30 seconds at 12 months after the blanking period was 53%. However, among those in the CM group who experienced recurrences, mean burden of AF/AT was generally very low (<5%) and remained stable over the duration of follow-up. Ten patients (9%) required elective cardioversion outside the 90 day blanking period, 11 patients (9.7%) underwent repeat ablation at a mean of 229 ± 178 days post-CP and 64% were off AADs at the last follow-up. Procedural complications decreased significantly following the transition from transdiaphragmatic to sub-xiphoid surgical access: 23% versus 3.8% (P = .005) CONCLUSIONS: In a large, consecutive series of patients with predominantly PeAF, the CP was capable of reducing AF burden to very low levels (generally <5%), which appeared durable over time. Complication rates associated with the CP decreased significantly with the transition from transdiaphragmatic to sub-xiphoid surgical access. Future trials will be necessary to determine which patients are most likely to benefit from the convergent approach.
Assuntos
Técnicas de Ablação , Fibrilação Atrial/cirurgia , Eletrocardiografia Ambulatorial , Sistema de Condução Cardíaco/cirurgia , Telemetria , Técnicas de Ablação/efeitos adversos , Potenciais de Ação , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter , Criocirurgia , Intervalo Livre de Doença , Eletrocardiografia Ambulatorial/instrumentação , Feminino , Sistema de Condução Cardíaco/fisiopatologia , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Recidiva , Reoperação , Telemetria/instrumentação , Fatores de TempoRESUMO
BACKGROUND: Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. METHODS: We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion. RESULTS: OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108). CONCLUSION: Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.
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Anticoagulantes/administração & dosagem , Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial , Insuficiência Cardíaca/terapia , Marca-Passo Artificial , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Estimulação Cardíaca Artificial/efeitos adversos , Esquema de Medicação , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
Aims: THERMOCOOL SMARTTOUCH® SF Catheter is a new contact-force (CF)-sensing catheter with 56-hole porous tip designed for improved cooling and reduced fluid delivery compared with a standard 6-hole open-irrigated catheter. The SMART SF study examined the periprocedural safety, acute effectiveness, and procedural efficiency of the catheter for drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) ablation. Methods and results: The prospective, open-label, non-randomized SMART-SF was conducted at 17 US sites. Circumferential pulmonary vein (PV) isolation was performed with confirmation of entrance block in all PVs. Stable ablation sites were identified using CARTO VISITAG™ Module. Primary adverse events (AEs; ≤1 week of index procedure), periprocedural AEs within 30 days of ablation procedure, acute effectiveness (confirmation of entrance block for targeted PVs), CF, and procedural parameters were assessed. Overall, 165 patients were enrolled (mean age, 62.7 years; male, 57.9%; white, 97%; left ventricular ejection fraction, 60.1 ± 7%; left atrium diameter, 38.8 ± 6 mm); 159 underwent radiofrequency ablation and comprised the safety cohort. Primary safety performance criteria were met: primary AE rate was 2.5% (4/159; cardiac tamponade [n = 2], thrombo-embolism [n = 1], transient ischaemic attack [n = 1]). All primary AEs resolved/improved within the 1-month follow-up period. Acute procedural effectiveness was attained in 96.2% (95% confidence interval: 92.0-98.6%) of patients. Procedure time, fluoroscopy time, and fluid delivered were observed in comparison to predecessor catheters. Conclusion: In the SMART-SF trial, the predetermined safety performance goal was met, demonstrating the safety and acute effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter for PAF ablation.
Assuntos
Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Ablação por Cateter/instrumentação , Frequência Cardíaca , Veias Pulmonares/cirurgia , Irrigação Terapêutica/instrumentação , Potenciais de Ação/efeitos dos fármacos , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Resistência a Medicamentos , Desenho de Equipamento , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Porosidade , Estudos Prospectivos , Veias Pulmonares/fisiopatologia , Fatores de Risco , Irrigação Terapêutica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVES: This study compared risks associated with magnetic resonance imaging (MRI) in patients with non-MRI conditional and MRI conditional pacing and defibrillator systems with particular attention to clinically actionable outcomes. BACKGROUND: While recipients of new MRI conditional pacemaker and defibrillator systems may undergo MRI scanning with very low risk, safety and regulatory concerns persist regarding such scanning in recipients of non-MRI conditional systems. METHODS: Patients with any cardiac device who were referred for MRI were prospectively enrolled at a single center and underwent scanning at 1.5 Tesla. Pre- and postscan lead characteristic changes, system integrity, and symptoms were analyzed. A comparison was made between non-MRI conditional and MRI conditional devices. RESULTS: 105 patients were evaluated allowing for comparison of 97 scans with non-MRI conditional devices and 16 scans with MRI conditional devices. The cohort included those with pacemaker dependency, defibrillator, and cardiac resynchronization devices. Small, nonsignificant changes were observed in lead characteristics following scanning, and there was no significant difference when comparing non-MRI and MRI conditional devices. Lead parameter changes did not require lead revision or programming changes. No device reset, failures, or premature scan termination was observed. CONCLUSIONS: 1.5 T MRI scanning in patients with MRI conditional and non-MRI conditional cardiac devices was performed with similar, low clinical risk.
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Desfibriladores Implantáveis/estatística & dados numéricos , Traumatismos por Eletricidade/epidemiologia , Falha de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/estatística & dados numéricos , Imageamento por Ressonância Magnética/instrumentação , Imageamento por Ressonância Magnética/estatística & dados numéricos , Marca-Passo Artificial/estatística & dados numéricos , Idoso , Causalidade , Contraindicações , Desenho de Equipamento , Análise de Falha de Equipamento , Feminino , Georgia/epidemiologia , Humanos , Masculino , Prevalência , Fatores de RiscoRESUMO
INTRODUCTION: This report presents safety data on the use of a new open-irrigation radiofrequency ablation (RFA) catheter with a 56-hole porous tip in 742 patients enrolled in 2 US prospective, multicenter observational registry studies representing real-world use of the catheter. METHODS: This analysis is comprised of patients who underwent RFA of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (AF). Acute adverse events (AEs) were collected and categorized by seriousness, timing, and relatedness, with 7 days of follow-up data in one study and at least 120 days of data from a 1-year follow-up in the other. Acute serious adverse events (SAEs) that were identified as potentially related to the device and/or procedure were adjudicated by an independent safety committee. RESULTS: A total of 30 patients (4.0%) in the combined studies experienced an acute SAE related to the device and/or procedure, which was similar in the subset of patients age 65 and over (4.2%). These SAEs included 1.2% cardiac tamponade/perforation, 0.7% pericarditis, 0.5% pulmonary events, and 0.8% vascular access complications. No myocardial infarction, stroke, transient ischemic attack, or atrioesophageal fistulas within 7 days postprocedure were reported. In the study with extended follow-up, 1 pulmonary vein stenosis and 1 esophageal injury were seen beyond 7 days postprocedure (0.2% each). There were no device or procedure related deaths. CONCLUSION: Results from 2 large observational studies demonstrated that a new porous tip RFA catheter was safe for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF, including treatment of older patients (≥65 years).
Assuntos
Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Ablação por Cateter/instrumentação , Irrigação Terapêutica/instrumentação , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Sistema de Registros , Fatores de Risco , Irrigação Terapêutica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
BACKGROUND: Because of differences in chest wall anatomy, female patients may have higher rates of subcutaneous implantable cardioverter-defibrillator (S-ICD) pocket-related complications. OBJECTIVE: We sought to evaluate sex-based outcomes after S-ICD implantation. METHODS: Patients implanted with an S-ICD at Emory Healthcare between 2010 and 2023 were included in the analysis. Patients' clinical characteristics and post-S-ICD implantation complications were collected. RESULTS: There were 429 male patients (68%) and 199 female patients (32%) observed for a median duration of 2.3 years (0.6-4.4 years). Male and female patients had comparable rates of diabetes (28%), end-stage renal disease (29.5%), ejection fraction (30.2% ± 13.4%), and body mass index (29.1 ± 6.6 kg/m2). There was no statistical difference in the incidence of shocks between men and women (26.3% vs 20.1%; P = .09), including appropriate shocks (14.7% vs 12%; P = .98) and inappropriate shocks (11.7% vs 9.5%; P = .98). Pocket-related complications occurred in 21 patients; these included pocket infection (n = 12), wound dehiscence (n = 7), and hematoma requiring drainage (n = 2). Female patients had a significantly higher pocket-related complication rate compared with male patients (7.2% vs 2.5%; P = .016). In controlling for age, body mass index, diabetes, and end-stage renal disease, female patients had higher odds of pocket-related complications compared with male patients (odds ratio, 3.15; 95% confidence interval, 1.27-7.75). Pocket-related complications decreased after 2018 compared with before 2018 (6% vs 2.6%, P = .052), mainly driven by reduction in complications in women (12.3% vs 3.2%; P = .034) but not in men (2.8% vs 2.4%; P = 1). CONCLUSION: In this cohort of S-ICD patients, women had a higher rate of post-S-ICD pocket-related complications that could be explained by sex-based differences in anatomy.
RESUMO
BACKGROUND: Class IC antiarrhythmic agents are effective for treating atrial tachyarrhythmias, but their use is restricted in patients with coronary artery disease (CAD). Data on the safety of the use of IC agents in patients with CAD in the absence of recent acute coronary syndromes are lacking. OBJECTIVES: This study sought to evaluate the safety and feasibility of treatment with IC agents in patients with varying degrees of CAD in a large serial, real-world cohort. METHODS: We retrospectively identified all patients at our institution from January 2005 to February 2021 on a IC agent (n = 3,445) and those on sotalol or dofetilide (n = 2,216) as controls, excluding those with a prior history of ventricular tachycardia, implantable cardioverter-defibrillator placement, or nonrevascularized myocardial infarction. Baseline clinical characteristics included degree of CAD (categorized as none, nonobstructive, or obstructive), other comorbid illness, and medication use. Clinical outcomes, including survival, were ascertained. We performed Cox regression analysis to evaluate the effect of IC use on event-free survival across varying degrees of CAD. RESULTS: After adjustment for baseline characteristics, there was an independent association between IC use and improved mortality. However, there was an interaction between IC use and degree of CAD (compared to sotalol) demonstrating poorer event-free survival among those with obstructive coronary disease (HR: 3.80; 95% CI: 1.67-8.67; P = 0.002). CONCLUSIONS: Among select patients with nonobstructive CAD and without a history of ventricular tachycardia, IC agents are not associated with increased mortality. Therefore, these agents may be an option for some patients in whom they are frequently restricted. Further prospective studies are warranted.
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Doença da Artéria Coronariana , Taquicardia Ventricular , Humanos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/tratamento farmacológico , Flecainida/efeitos adversos , Sotalol/uso terapêutico , Estudos Retrospectivos , Estudos de Viabilidade , Taquicardia Ventricular/tratamento farmacológico , Taquicardia Ventricular/complicaçõesRESUMO
BACKGROUND: Same-day discharge (SDD) after cardiovascular procedures is rapidly gaining ground. OBJECTIVE: We sought to evaluate the safety of SDD after transvenous lead extraction (TLE). METHODS: We performed a retrospective chart review of patients who underwent elective TLE between January 2020 and October 2021 at our institution. The primary outcome was SDD, and major procedural complications and readmissions within 30 days of the procedure were secondary outcomes. RESULTS: In this analysis of 111 patients who underwent elective TLE, 80 patients (72%) were discharged on the same day (SDD group) while 31 patients (28%) stayed overnight (overnight group). Lead malfunction was the most common indication for TLE in both groups. Patients in the overnight group were more likely to have a lead dwell time of ≤10 years than those in the SDD group (38.7% vs 20% of all leads in each group; P = .042), have laser sheaths used for extraction and a higher number of leads extracted. No major complications were reported in both groups. In a multivariate analysis, lower body mass index and the use of laser sheath during TLE were predictors of overnight stay. Patients who underwent a procedure using advanced extraction techniques were 3.5 times more likely to stay overnight (95% confidence interval 1.27-9.78; P = .016). CONCLUSION: In appropriately selected patients undergoing elective lead extraction, SDD is feasible and safe. Higher body mass index, fewer extracted leads, shorter lead dwell times (<10 years), and less frequent use of laser-powered extraction sheaths were associated with an increased likelihood of SDD.
Assuntos
Desfibriladores Implantáveis , Alta do Paciente , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/métodos , Desfibriladores Implantáveis/efeitos adversosRESUMO
PURPOSE: The prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported. METHODS: Ablations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures. RESULTS: Seventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period. CONCLUSIONS: The SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Catéteres , Desenho de Equipamento , Humanos , Masculino , Pessoa de Meia-Idade , Porosidade , Estudos Prospectivos , Veias Pulmonares/cirurgia , Recidiva , Resultado do TratamentoRESUMO
BACKGROUND: Wider availability of continuous rhythm monitoring has made feasible the incorporation of metrics of atrial fibrillation (AF) burden and duration into the decision to initiate anticoagulation. However, the relationship between thresholds of burden and duration and underlying risk factors at which anticoagulation should be considered remains unclear. OBJECTIVE: The purpose of this study was to evaluate the relationships of these metrics with each other and the outcome of stroke/transient ischemic attack (TIA). METHODS: We identified patients with cardiovascular implantable electronic devices (CIEDs) with atrial leads who had at least 1 interrogation in 2016 demonstrating nonpermanent AF and were not receiving oral anticoagulation (OAC). We evaluated the relationship between burden (ie, percentage of time spent in AF), the longest single episode of AF, and risk factors (ie, CHA2DS2-VASc score) in predicting risk of stroke/TIA. RESULTS: The study included 384 patients with mean follow-up of 3.2 ± 0.8 years and incidence of stroke/TIA of 14.8% during follow-up (â¼4.6% per year). The burden of AF and the duration of longest episode demonstrated a significant positive correlation to each other but not CHA2DS2-VASc score. Importantly, although the CHA2DS2-VASc score was predictive of stroke/TIA, neither burden nor duration was associated with stroke/TIA. CONCLUSION: Among patients with CIED-detected AF not receiving OAC, the amount of AF (measured by either burden or duration) does not seem to significantly impact stroke risk, whereas CHA2DS2-VASc score does. These data suggest that among patients with CIED-detected AF, once AF occurs, stroke risk seems to be predominantly driven by underlying risk factors.
Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/diagnóstico , Eletrocardiografia Ambulatorial/instrumentação , Frequência Cardíaca/fisiologia , AVC Isquêmico/etiologia , Medição de Risco/métodos , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Incidência , AVC Isquêmico/epidemiologia , AVC Isquêmico/prevenção & controle , Masculino , Estudos Retrospectivos , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation. METHODS: PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score. RESULTS: A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline. CONCLUSIONS: Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776.
Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Frequência Cardíaca/fisiologia , Qualidade de Vida , Idoso , Fibrilação Atrial/fisiopatologia , Eletrocardiografia , Feminino , Seguimentos , Humanos , Masculino , Período Pós-Operatório , Estudos Prospectivos , Recidiva , Resultado do TratamentoRESUMO
PURPOSE: Sizing of the left atrial appendage (LAA) ostium prior to occlusion (LAAO) is routinely performed with transesophageal echocardiography (TEE). We sought to compare the utility of sizing via fluoroscopy to TEE for percutaneous LAAO. METHODS: We retrospectively evaluated all patients undergoing percutaneous LAAO at our institution from April 2015 through January 2018 (n = 195). We evaluated baseline characteristics, maximum measured ostium size (for both TEE and fluoroscopy), and differences in measured size to device size for both techniques. RESULTS: Of the total cohort, 185 (95%) had both intraoperative TEE and fluoroscopic images available for analysis and were included in the final analysis. The mean age was 74 years and 64% were male. Hypertension was present in 89%, diabetes in 30%, and stroke in 32% of patients. The mean ejection fraction was 51%. The most common LAA morphology was "wind sock" (52%). Measured ostial diameter on fluoroscopy was larger compared with TEE (2.04 ± 3.43 mm larger on fluoroscopy, p < 0.001). Ostium diameter on TEE was more closely correlated to the size of the device implanted compared with fluoroscopy (0.76 vs. 0.61, p = 0.001). CONCLUSIONS: Fluoroscopy results in larger estimated LAA ostium diameter compared with TEE. Despite this, TEE was more strongly correlated to operator choice in device sizing, which may reflect practice patterns. Because compression of the ostium on the device is necessary for long-term procedural success, under-sizing may lead to a higher rate of leaks. Prospective evaluation of the utility of routine fluoroscopic sizing compared with TEE is warranted.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco , Ecocardiografia , Ecocardiografia Transesofagiana , Fluoroscopia , Humanos , Recém-Nascido , Masculino , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to evaluate the safety and effectiveness of catheter ablation of persistent atrial fibrillation (PsAF) using a porous tip contact force-sensing catheter. BACKGROUND: Although the safety and effectiveness of catheter ablation of paroxysmal atrial fibrillation are established, there are limited data on outcomes in patients with PsAF. As such, no ablation catheter is currently approved by the Food and Drug Administration for PsAF ablation. METHODS: The prospective, multicenter, nonrandomized PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF) study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). An individualized treatment approach was used including pulmonary vein isolation with ablation of additional targets permitted at the investigators' discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiography, and Holter monitoring for up to 15 months after ablation. RESULTS: Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event rate was 4.1% (15 events in 14 participants). Kaplan-Meier analyses estimated a primary effectiveness success rate of 61.7% and a clinical success rate of 80.4% at 15 months. CONCLUSIONS: The results demonstrate the clinical safety and effectiveness of PsAF ablation using contact force-sensing technologies. The primary adverse event was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation. (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF; NCT02817776).
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Catéteres , Humanos , Estudos Prospectivos , Veias Pulmonares/cirurgia , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. METHODS: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. RESULTS: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. CONCLUSIONS: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.