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1.
Neth Heart J ; 2024 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-38865067

RESUMO

INTRODUCTION: When electrical storm (ES) is amenable to neither antiarrhythmic drugs, nor deep sedation or catheter ablation, autonomic modulation may be considered. We report our experience with percutaneous left stellate ganglion block (PSGB) to temporarily suppress refractory ventricular arrhythmia (VA) in patients with structural heart disease. METHODS: A retrospective analysis was performed at our institution of patients with structural heart disease and an implantable cardioverter defibrillator (ICD) who had undergone PSGB for refractory VA between January 2018 and October 2021. The number of times antitachycardia pacing (ATP) was delivered and the number of ICD shocks/external cardioversions performed in the week before and after PSGB were evaluated. Charts were checked for potential complications. RESULTS: Twelve patients were identified who underwent a combined total of 15 PSGB and 5 surgical left cardiac sympathetic denervation procedures. Mean age was 73 ± 5.8 years and all patients were male. Nine of 12 (75%) had ischaemic cardiomyopathy, with the remainder having non-ischaemic dilated cardiomyopathy. Mean left ventricular ejection fraction was 35% (±â€¯12.2%). Eight of 12 (66.7%) patients were already being treated with both amiodarone and beta-blockers. The reduction in ATP did not reach statistical significance (p = 0.066); however, ICD shocks (p = 0.028) and ATP/shocks combined were significantly reduced (p = 0.04). At our follow-up electrophysiology meetings PSGB was deemed ineffective in 4 of 12 patients (33%). Temporary anisocoria was seen in 2 of 12 (17%) patients, and temporary hypotension and hoarseness were reported in a single patient. DISCUSSION: In this limited series, PSGB showed promise as a method for temporarily stabilising refractory VA and ES in a cohort of male patients with structural heart disease. The side effects observed were mild and temporary.

2.
J Am Heart Assoc ; 13(8): e032033, 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38591264

RESUMO

BACKGROUND: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort. METHODS AND RESULTS: This is a subanalysis of the nationwide Dutch-Outcome in ICD Therapy (DO-IT) registry of primary prevention ICD recipients in The Netherlands between September 2014 and June 2016 (n=1442). We identified patients with chronic ischemic heart disease (n=663) and assessed available coronary angiograms for CTO presence (n=415). Patients with revascularized CTOs were excluded (n=79). The primary end point was the composite of all-cause mortality and appropriate ICD shocks. Clinical follow-up was conducted for at least 2 years. A total of 336 patients were included, with an average age of 67±9 years, and 20.5% was female (n=69). An unrevascularized CTO was identified in 110 patients (32.7%). During a median follow-up period of 27 months (interquartile range, 24-32), the primary end point occurred in 21.1% of patients with CTO (n=23) compared with 11.9% in patients without CTO (n=27; P=0.034). Corrected for baseline characteristics including left ventricular ejection fraction, and the presence of a CTO was an independent predictor for the primary end point (hazard ratio, 1.82 [95% CI, 1.03-3.22]; P=0.038). CONCLUSIONS: Within this nationwide prospective registry of primary prevention ICD recipients, the presence of an unrevascularized CTO was an independent predictor for the composite outcome of all-cause mortality and appropriate ICD shocks.


Assuntos
Oclusão Coronária , Desfibriladores Implantáveis , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Oclusão Coronária/complicações , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/terapia , Arritmias Cardíacas , Desfibriladores Implantáveis/efeitos adversos , Volume Sistólico , Incidência , Função Ventricular Esquerda , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Sistema de Registros , Fatores de Risco
3.
JACC Clin Electrophysiol ; 9(3): 345-355, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36752476

RESUMO

BACKGROUND: Idiopathic ventricular fibrillation (iVF) is a diagnosis of exclusion. Systematic diagnostic testing is important to exclude alternative causes for VF. The early use of "high yield" testing, including cardiac magnetic resonance (CMR), exercise testing, and sodium channel blocker provocation, has been increasingly recognized. OBJECTIVES: The purpose of this study was to investigate the importance and consistency of systematic diagnostic testing in iVF. METHODS: This study included 423 iVF patients from 11 large secondary and tertiary hospitals in the Netherlands. Clinical characteristics and diagnostic testing data were ascertained. RESULTS: IVF patients experienced the index event at a median age of 40 years (IQR: 28-52 years), and 61% were men. The median follow-up time was 6 years (IQR: 2-12 years). Over the years, "high yield" diagnostic tests were increasingly performed (mean 68% in 2000-2010 vs 75% in 2011-2021; P < 0.001). During follow-up, 38 patients (9%) originally labeled as iVF received an alternative diagnosis. Patients in whom "high-yield" diagnostic tests were consistently performed during the initial work-up received an alternative diagnosis less frequently during follow-up (HR: 0.439; 95% CI: 0.219-0.878; P = 0.020). Patients who received an alternative diagnosis during follow-up had a worse prognosis in terms of cardiac death (P = 0.012) with a trend toward more implantable cardioverter-defibrillator therapy (P = 0.055). CONCLUSIONS: Although adherence to (near) complete diagnostic testing in this population of iVF patients increased over the years, patients with iVF still undergo varying levels of diagnostic evaluation. The latter leads to initial underdiagnosis of alternative conditions and is associated with a worse prognosis. Our results underscore the importance of early systematic diagnostic assessment in patients with apparent iVF.


Assuntos
Eletrocardiografia , Recidiva Local de Neoplasia , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Feminino , Sistema de Registros , Fertilização in vitro
4.
Eur Heart J ; 43(21): 2037-2050, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35090007

RESUMO

AIMS: To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices. METHODS AND RESULTS: Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS. CONCLUSION: In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.


Assuntos
Desfibriladores Implantáveis , Arritmias Cardíacas , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Volume Sistólico , Resultado do Tratamento
5.
Europace ; 23(6): 887-897, 2021 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-33582797

RESUMO

AIMS: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. METHODS AND RESULTS: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. CONCLUSION: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.


Assuntos
Desfibriladores Implantáveis , Antagonistas de Receptores de Angiotensina , Inibidores da Enzima Conversora de Angiotensina , Estudos de Coortes , Morte Súbita Cardíaca/prevenção & controle , Humanos , Prevenção Primária , Fatores de Risco
6.
Pacing Clin Electrophysiol ; 43(10): 1173-1179, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32901950

RESUMO

BACKGROUND: In the 123-study, we prospectively assessed, in a randomized fashion, the minimal cryoballoon application time necessary to achieve pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) with the aim to reduce complications by shortening the application duration. The first results of this study demonstrated that shortened cryoballoon applications (<2 minutes) resulted in less phrenic nerve injury (PNI) without compromising acute isolation efficacy for the right PVs. We now report the 1-year follow-up results regarding safety and efficacy of shorter cryoballoon applications. METHODS: A total of 222 patients with AF were randomized to two applications of 1 min "short," 2 min "medium," or 3 min "long" duration, 74 per group. Recurrence of AF and PV reconduction at 1-year follow-up were assessed. RESULTS: The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium, and long application groups (77%, 74%, and 85% for short, medium, and long application groups, respectively; P = 0.07). In 30 patients, a redo PVI procedure was performed. For all four PVs, there was no significant difference in reconduction between the three groups. Reconduction was most common in the left superior PV (57%). The right superior PV (RSPV) showed significantly less reconduction (17%) compared to the other PVs. CONCLUSIONS: Shortening cryoballoon applications of the RSPV to <2 minutes results in less PNI, while acute success and 1-year freedom from AF are not compromised. Therefore, shorter cryoballoon applications (especially) in the RSPV could be used to reduce PNI.


Assuntos
Fibrilação Atrial/cirurgia , Criocirurgia/métodos , Nervo Frênico/lesões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Fatores de Tempo
7.
Pacing Clin Electrophysiol ; 42(12): 1541-1551, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31677279

RESUMO

BACKGROUND: Use of the subcutaneous implantable defibrillator (S-ICD) has increased because the device received US Food and Drug Administration approval in 2012, but we still know little about whether the quality of life (QoL) of patients with an S-ICD versus a transvenous ICD (TV-ICD) is comparable. We compared S-ICD patients with TV-ICD patients on QoL, depression, and anxiety up to 12 months' follow-up. METHODS: A matched cohort of S-ICD (N = 167) and TV-ICD patients (N = 167) completed measures on QoL, depression, anxiety, and personality at baseline, 3, 6, and 12 months post implant. Data were analyzed using multivariable modeling with repeated measures. RESULTS: In adjusted analyses, we found no statistically significant differences between cohorts on physical and mental QoL and depression (all Ps > .05), while S-ICD patients reported lower anxiety than TV-ICD patients (P = 0.0007). Both cohorts experienced improvements in physical and mental QoL and symptoms of depression and anxiety over time (all Ps < .001), primarily between implant and 3 months. These improvements were similar for both cohorts with respect to physical and mental QoL and anxiety (Ps > .05), while S-ICD patients experienced greater reductions in depressive symptoms (P = .0317). CONCLUSION: The QoL and depression levels were similar in patients with an S-ICD and a TV-ICD up to 12 months' follow-up, while S-ICD patients reported lower anxiety levels and a greater reduction in depression over time as compared to TV-ICD patients. This knowledge may be important for patients and clinicians, if the indication for implantation allows both the S-ICD and the TV-ICD, making a choice possible.


Assuntos
Ansiedade/psicologia , Desfibriladores Implantáveis/psicologia , Depressão/psicologia , Qualidade de Vida/psicologia , Estudos de Casos e Controles , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
9.
J Card Fail ; 25(10): 812-818, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31479745

RESUMO

BACKGROUND: The beneficial effects of a cardiac resynchronization defibrillator (CRT-D) in patients with heart failure, low left ventricular ejection fraction (LVEF), and wide QRS have clearly been established. Nevertheless, mortality remains high in some patients. The aim of this study was to develop and validate a risk score to identify patients at high risk for early mortality who are implanted with a CRT-D. METHODS AND RESULTS: For predictive modelling, 1282 consecutive patients from 5 centers (74% male; median age 66 years; median LVEF 25%; New York Heart Association class III-IV 60%; median QRS-width 160 ms) were randomly divided into a derivation and validation cohort. The primary endpoint is mortality at 3 years. Model development was performed using multivariate logistic regression by checking log likelihood, Akaike information criterion, and Bayesian information criterion. Model performance was validated using C statistics and calibration plots. The risk score included 7 independent mortality predictors, including myocardial infarction, LVEF, QRS duration, chronic obstructive pulmonary disease, chronic kidney disease, hyponatremia, and anemia. Calibration-in-the-large was suboptimal, reflected by a lower observed mortality (44%) than predicted (50%). The validated C statistic was 0.71 indicating modest performance. CONCLUSION: A risk score based on routine, readily available clinical variables can assist in identifying patients at high risk for early mortality within 3 years after CRT-D implantation.


Assuntos
Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Medição de Risco/métodos , Idoso , Bélgica/epidemiologia , Terapia de Ressincronização Cardíaca/métodos , Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Desfibriladores Implantáveis/estatística & dados numéricos , Cardioversão Elétrica/estatística & dados numéricos , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Humanos , Estimativa de Kaplan-Meier , Masculino , Mortalidade , Países Baixos/epidemiologia , Prognóstico , Sistema de Registros/estatística & dados numéricos , Fatores de Risco , Volume Sistólico , Suíça/epidemiologia , Função Ventricular Esquerda
10.
Europace ; 21(9): 1360-1368, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31168604

RESUMO

AIMS: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. CONCLUSION: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.


Assuntos
Assistência Ambulatorial/métodos , Monitorização Ambulatorial da Pressão Arterial , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Eletrocardiografia , Insuficiência Cardíaca/terapia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Tecnologia de Sensoriamento Remoto/métodos , Assistência ao Convalescente , Idoso , Peso Corporal , Cardiologia , Falha de Equipamento , Europa (Continente) , Feminino , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/psicologia , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Prevenção Primária , Prevenção Secundária
11.
Europace ; 21(10): 1519-1526, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31114860

RESUMO

AIMS: Idiopathic ventricular fibrillation (IVF) is a rare cause of sudden cardiac arrest. Implantable cardioverter-defibrillator (ICD) implantation is currently the only treatment option. Limited data are available on the prevalence and complications of ICD therapy in these patients. We sought to investigate ICD therapy and its complications in patients with IVF. METHODS AND RESULTS: Patients were selected from a national registry of IVF patients. Patients in whom no underlying diagnosis was found during follow-up were eligible for inclusion. Recurrence of ventricular arrhythmia (VA) was derived from medical and ICD records, electrogram records of ICD therapies were used to differentiate between appropriate or inappropriate interventions. Independent predictors for appropriate ICD shock were calculated using cox regression. In 217 IVF patients, recurrence of sustained VAs occurred in 66 patients (30%) during a median follow-up period of 6.1 years. Ten patients died (4.6%). Thirty-eight patients (17.5%) experienced inappropriate ICD therapy, and 32 patients (14.7%) had device-related complications. Symptoms before cardiac arrest [hazard ratio (HR): 2.51, 95% confidence interval (CI): 1.48-4.24], signs of conduction disease (HR: 2.27, 95% CI: 1.15-4.47), and carrier of the DPP6 risk haplotype (HR: 3.24, 1.70-6.17) were identified as independent predictors of appropriate shock occurrence. CONCLUSION: Implantable cardioverter-defibrillator therapy is an effective treatment in IVF, treating recurrences of potentially lethal VAs in approximately one-third of patients during long-term follow-up. However, device-related complications and inappropriate shocks were also frequent. We found significant predictors for appropriate ICD therapy. This may imply that these patients require additional management to prevent recurrent events.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Eletrocardiografia , Taquicardia Ventricular/terapia , Adulto , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Taquicardia Ventricular/mortalidade , Taquicardia Ventricular/fisiopatologia , Resultado do Tratamento
12.
Pacing Clin Electrophysiol ; 42(5): 508-514, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30756393

RESUMO

BACKGROUND: The second-generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123-study aimed to assess the minimal cryoballoon application duration necessary to achieve PVI (primary endpoint) and the effect of application duration on prevention of phrenic nerve injury (PNI). METHODS: Patients <75 years of age with paroxysmal atrial fibrillation, normal PV anatomy, and left atrial size <40 cc/m² or <50 mm were randomized to two applications of different duration: "short," "medium," or "long." A total of 222 patients were enrolled, 74 per group. RESULTS: Duration per application was 105 (101-108), 164 (160-168), and 224 (219-226) s and isolation was achieved in 79, 89, and 90% (P < 0.001) of the PVs after two applications in groups short, medium, and long, respectively. Only for the left PVs, the success rate of the short group was significantly less compared to the medium- and long-duration groups (P < 0.001). PNI during the procedure occurred in 19 PVs (6.5%) in the medium and in 20 PVs (6.8%) in the long duration groups compared to only five PVs (1.7%) in the short duration group (P < 0.001). CONCLUSIONS: Short cryoballoon ablation application times, less than 2 min, did affect the success for the left PVs but not for the right PVs and resulted in less PNI. A PV tailored approach with shorter application times for the right PVs might be advocated.


Assuntos
Fibrilação Atrial/cirurgia , Criocirurgia/métodos , Nervo Frênico/lesões , Veias Pulmonares/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
13.
Europace ; 20(2): e1-e10, 2018 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-28339818

RESUMO

Aims: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in systolic heart failure patients with ventricular conduction delay. Variability of individual response to CRT warrants improved patient selection. The Markers and Response to CRT (MARC) study was designed to investigate markers related to response to CRT. Methods and results: We prospectively studied the ability of 11 clinical, 11 electrocardiographic, 4 echocardiographic, and 16 blood biomarkers to predict CRT response in 240 patients. Response was measured by the reduction of indexed left ventricular end-systolic volume (LVESVi) at 6 months follow-up. Biomarkers were related to LVESVi change using log-linear regression on continuous scale. Covariates that were significant univariately were included in a multivariable model. The final model was utilized to compose a response score. Age was 67 ± 10 years, 63% were male, 46% had ischaemic aetiology, LV ejection fraction was 26 ± 8%, LVESVi was 75 ± 31 mL/m2, and QRS was 178 ± 23 ms. At 6 months LVESVi was reduced to 58 ± 31 mL/m2 (relative reduction of 22 ± 24%), 130 patients (61%) showed ≥ 15% LVESVi reduction. In univariate analysis 17 parameters were significantly associated with LVESVi change. In the final model age, QRSAREA (using vectorcardiography) and two echocardiographic markers (interventricular mechanical delay and apical rocking) remained significantly associated with the amount of reverse ventricular remodelling. This CAVIAR (CRT-Age-Vectorcardiographic QRSAREA -Interventricular Mechanical delay-Apical Rocking) response score also predicted clinical outcome assessed by heart failure hospitalizations and all-cause mortality. Conclusions: The CAVIAR response score predicts the amount of reverse remodelling after CRT and may be used to improve patient selection. Clinical Trials: NCT01519908.

14.
J Am Coll Cardiol ; 70(7): 830-841, 2017 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-28797351

RESUMO

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to defibrillate ventricular arrhythmias, avoiding drawbacks of transvenous leads. The global EFFORTLESS S-ICD (Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) registry is collecting outcomes in 985 patients during a 5-year follow-up. OBJECTIVES: The primary goal of the EFFORTLESS registry is to determine the safety of the S-ICD by evaluating complications and inappropriate shock rate. METHODS: This is the first report on the full patient cohort and study endpoints with follow-up ≥1 year. The predefined endpoints are 30- and 360-day complications, and shocks for atrial fibrillation or supraventricular tachycardia. RESULTS: Patients were followed for 3.1 ± 1.5 years and 82 completed the study protocol 5-year visit. Average age was 48 years, 28% were women, ejection fraction was 43 ± 18%, and 65% had a primary prevention indication. The S-ICD system and procedure complication rate was 4.1% at 30 days and 8.4% at 360 days. The 1-year complication rate trended toward improvement from the first to last quartile of enrollment (11.3% [quartile 1]) to 7.8% [quartile 2], 6.6% [quartile 3], and 7.4% [quartile 4]; quartile 1 vs. quartiles 2 to 4; p = 0.06). Few device extractions occurred due to need for antitachycardia (n = 5), or biventricular (n = 4) or bradycardia pacing (n = 1). Inappropriate shocks occurred in 8.1% at 1 year and 11.7% after 3.1 years. At implant, 99.5% of patients had a successful conversion of induced ventricular tachycardia or ventricular fibrillation. The 1- and 5-year rates of appropriate shock were 5.8% and 13.5%, respectively. Conversion success for discrete spontaneous episodes was 97.4% overall. CONCLUSIONS: This registry demonstrates that the S-ICD fulfills predefined endpoints for safety and efficacy. Midterm performance rates on complications, inappropriate shocks, and conversion efficacy were comparable to rates observed in transvenous implantable cardioverter-defibrillator studies. (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD [The EFFORTLESS S-ICD Registry]; NCT01085435).


Assuntos
Desfibriladores Implantáveis , Sistema de Registros , Taquicardia Ventricular/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento
15.
Am J Cardiol ; 118(4): 520-6, 2016 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-27353211

RESUMO

The first clinical results from the Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the subcutaneous implantable cardioverter defibrillator (EFFORTLESS S-ICD) Registry on the entirely S-ICD system are promising, but the impact of the S-ICD system on patients' quality of life (QoL) is not known. We evaluated the QoL of patients with an S-ICD against an unrelated cohort with a transvenous (TV)-ICD system during 6 months of follow-up. Consecutively implanted patients with an S-ICD system were matched with patients with a TV-ICD system on a priori selected variables including baseline QoL. QoL was measured with the Short-Form Health Survey at baseline, 3, and 6 months after implant and compared using multivariable modeling with repeated measures. Patients with an S-ICD (n = 167) versus a TV-ICD system (n = 167) did not differ significantly on physical (p = 0.8157) and mental QoL scores (p = 0.9080) across baseline, 3, and 6 months after implantation in adjusted analyses. The evolution in physical (p = 0.0503) and mental scores (p = 0.3772) during follow-up was similar for both cohorts, as indicated by the nonsignificant interaction effect for ICD system by time. Both patients with an S-ICD system and a TV-ICD system experienced significant improvements in physical and mental QoL between time of implant and 3 months (both p's <0.0001) and between time of implant and 6 months (both p's <0.0001) but not between 3 and 6 months (both p's >0.05). In conclusion, these first results show that the QoL of patients with an S-ICD versus TV-ICD system is similar and that patients with either system experience improvements in QoL on the short term.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Qualidade de Vida , Sistema de Registros , Taquicardia Ventricular/terapia , Fibrilação Ventricular/terapia , Atividades Cotidianas , Adulto , Idoso , Morte Súbita Cardíaca/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Prospectivos , Implantação de Prótese/métodos , Taquicardia Ventricular/complicações , Fibrilação Ventricular/complicações
16.
Europace ; 18(7): 1010-5, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26324840

RESUMO

AIMS: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). METHODS AND RESULTS: In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). CONCLUSION: There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.


Assuntos
Procedimentos Cirúrgicos Cardíacos/educação , Desfibriladores Implantáveis , Cardioversão Elétrica , Curva de Aprendizado , Implantação de Prótese/educação , Adulto , Idoso , Bases de Dados Factuais , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Resultado do Tratamento
17.
J Neurol ; 262(3): 682-8, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25557280

RESUMO

Atrial fibrillation (AF) is a strong risk factor for first-ever stroke and stroke recurrence. The detection rate is low and detection is often costly and time-consuming. We evaluated the diagnostic yield of an external loop recorder (ELR) in patients with acute ischemic stroke or TIA, and assessed factors that are associated with AF detection. We prospectively studied patients admitted to the stroke unit with ischemic stroke or TIA, without a history of AF, and no AF on routine-ECG and 24-h telemetry. Patients received an ELR for another 24-h registration. Rhythm registration with an ELR was performed in 94 patients. AF was identified in 5 patients (5 %). AF was associated with cryptogenic stroke and cortical or subcortical involvement. If ELR was limited to patients with cryptogenic stroke in combination with cortical or subcortical involvement, the detection rate increased to 17 %. Automated recording with ELR was easy to use in the acute setting of ischemic stroke or TIA and seems promising to detect AF or atrial flutter, in particular in patients with cryptogenic stroke in combination with cortical or subcortical symptoms.


Assuntos
Ataque Isquêmico Transitório/diagnóstico , Acidente Vascular Cerebral/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/complicações , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/etiologia
18.
Europace ; 17(5): 747-52, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25600767

RESUMO

AIMS: Transcatheter pulmonary vein ablation is the current treatment of choice for symptomatic drug-refractory atrial fibrillation (AF). Video-assisted surgical pulmonary vein isolation (sPVI) is an alternative therapy to percutaneous ablation for the treatment of AF. Long-term results of sPVI are currently unknown. The aim of this study was to report on the long-term efficacy and safety of sPVI in patients with paroxysmal AF. METHODS AND RESULTS: The study design was observational and retrospective. From July 2005 to January 2011, 42 patients with drug-refractory paroxysmal AF underwent video-assisted sPVI in two different centres. Patients were eligible for sPVI when suffering from symptomatic, drug-refractory paroxysmal AF and they agreed to the alternative of sPVI. The median preoperative AF duration was 24 months (range 3-200). Success was defined as the absence of AF on 24 h or 96 h Holter monitoring during follow-up, off antiarrhythmic drugs (AAD). Adverse events and follow-up monitoring were based on the Heart Rhythm Society Consensus Statement 2012 for the catheter and surgical ablation of AF. Mean age was 55 ± 10 years, and 76% were males. After a mean follow-up of 5 years (SD 1.7), 69% of all patients were free from atrial arrhythmias without the use of AAD, and 83% with the use of AAD. Major peri-procedural adverse events occurred in four (9.5%) patients, no strokes or mortalities were registered during long-term follow-up. CONCLUSION: This retrospective study shows that sPVI for the treatment of paroxysmal AF is effective and that the outcomes are maintained at long-term follow-up.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Cirurgia Torácica Vídeoassistida/métodos , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Eletrocardiografia Ambulatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Veias Pulmonares/fisiopatologia , Indução de Remissão , Estudos Retrospectivos , Cirurgia Torácica Vídeoassistida/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
20.
Pacing Clin Electrophysiol ; 37(7): 843-52, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24697703

RESUMO

BACKGROUND: Gender differences in patient-reported outcomes in patients with an implantable cardioverter defibrillator (ICD) have been researched, but findings are inconclusive and mostly based on cross-sectional study designs. To gain a better insight into potential determinants of psychological distress and health-related quality of life (HQOL), we examined the relationship between gender and patient-reported outcomes in patients with an ICD in the first year after ICD implantation. METHODS: Consecutive patients (N = 300) receiving an ICD between September 2007 and February 2010 at Medisch Spectrum Twente hospital, the Netherlands, completed several questionnaires to assess psychological distress and HQOL prior to ICD implantation and at 2 months, 5 months, 8 months, and 12 months postimplantation. RESULTS: Correcting for clinical confounders (e.g., left ventricular ejection fraction, ICD indication, comorbidities, ICD shocks), women reported higher levels of anxiety (P = 0.021) and shock-related anxiety (P = 0.047) than men in the course of a year. On most HQOL subscales, no gender differences were found, except for subscale Physical functioning, where women reported higher levels of improvement compared to men (P = 0.008). Gender was independently associated with poorer device-related acceptance, but only on the Florida Patient Acceptance Scale domain Body image concerns (P = 0.043), with women expressing higher levels of concerns about their body image compared to men. CONCLUSIONS: Women report higher levels of general and shock-related anxiety, and higher levels of body image concerns than men. Women showed more improvement in physical functioning. Screening patients before and after ICD implantation for general and shock anxiety may help determine patients who could benefit from psychological counseling.


Assuntos
Ansiedade/etiologia , Desfibriladores Implantáveis/psicologia , Depressão/etiologia , Qualidade de Vida , Estresse Psicológico/etiologia , Ansiedade/epidemiologia , Depressão/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores Sexuais , Estresse Psicológico/epidemiologia
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