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1.
Swiss Med Wkly ; 150: w20343, 2020 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-33035354

RESUMO

INTRODUCTION: Sudden cardiac death caused by malignant arrhythmia can be prevented by the use of defibrillators. Although the wearable cardioverter defibrillator (WCD) can prevent such an event, its role in clinical practice is ill defined. We investigated the use of the WCD in Switzerland with emphasis on prescription rate, therapy adherence and treatment rate. MATERIALS AND METHODS: The Swiss WCD Registry is a retrospective observational registry including patients using a WCD. Patients were included from the first WCD use in Switzerland until February 2018. Baseline characteristics and data on WCD usage were examined for the total study population, and separately for each hospital. RESULTS: From 1 December 2011 to 18 February 2018, a total of 456 patients (67.1% of all WCDs prescribed in Switzerland and 81.1% of all prescribed in the participating hospitals) were included in the registry. Up to 2017 there was a yearly increase in the number of prescribed WCDs to a maximum of 271 prescriptions per year. The mean age of patients was 57 years (± 14), 81 (17.8%) were female and mean left ventricular ejection fraction (EF) was 32% (± 13). The most common indications for WCD use were new-onset ischaemic cardiomyopathy (ICM) with EF ≤35% (206 patients, 45.2%), new-onset nonischaemic cardiomyopathy (NICM) with EF ≤35% (115 patients, 25.2%), unknown arrhythmic risk (83 patients, 18.2%), bridging to implantable cardioverter-defibrillator implantation or heart transplant (37 patients, 8.1%) and congenital/inherited heart disease (15 patients, 3.3%). Median wear duration was 58 days (interquartile range [IQR] 31–94) with a median average daily wear time of 22.6 hours (IQR 20–23.2). Seventeen appropriate therapies from the WCD were delivered in the whole population (treatment rate: 3.7%) to a total of 12 patients (2.6% of all patients). The most common underlying heart disease in patients with a treatment was ICM (13/17, 76.5%). There were no inappropriate treatments. CONCLUSION: The use of WCDs has increased in Switzerland over the years for a variety of indications. There is high therapy adherence to the WCD, and a treatment rate comparable to previously published registry data.  .

2.
Europace ; 2020 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-33038231

RESUMO

AIMS : The aim of this study is to characterize recurrent syncope, including sex-specific aspects, and its impact on death and major adverse cardiovascular events (MACE). METHODS AND RESULTS: We characterized recurrent syncope in a large international multicentre study, enrolling patients ≥40 years presenting to the emergency department (ED) with a syncopal event within the last 12 h. Syncope aetiology was centrally adjudicated by two independent cardiologists using all information becoming available during syncope work-up and long-term follow-up. Overall, 1790 patients were eligible for this analysis. Incidence of recurrent syncope was 20% [95% confidence interval (CI) 18-22%] within the first 24 months. Patients with an adjudicated final diagnosis of cardiac syncope (hazard ratio (HR) 1.50, 95% CI 1.11-2.01) or syncope with an unknown aetiology even after central adjudication (HR 2.11, 95% CI 1.54-2.89) had an increased risk for syncope recurrence. Least Absolute Shrinkage and Selection Operator regression fit on all patient information available early in the ED identified >3 previous episodes of syncope as the only independent predictor for recurrent syncope (HR 2.13, 95% CI 1.64-2.75). Recurrent syncope carried an increased risk for death (HR 1.87, 95% CI 1.26-2.77) and MACE (HR 2.69, 95% CI 2.02-3.59) over 24 months of follow-up, however, with a time-dependent effect. These findings were confirmed in a sensitivity analysis excluding patients with syncope recurrence or MACE before or during ED evaluation. CONCLUSION : Recurrence rates of syncope are substantial and vary depending on syncope aetiology. Importantly, recurrent syncope carries a time-dependent increased risk for death and MACE. TRIAL REGISTRATION: BAsel Syncope EvaLuation (BASEL IX, ClinicalTrials.gov registry number NCT01548352).

3.
PLoS One ; 15(9): e0239667, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32986751

RESUMO

Life expectancy of contemporary cardiac pacemakers is limited due to the use of an internal primary battery. Repeated device replacement interventions are necessary, which leads to an elevated risk for patients and an increase of health care costs. The aim of our study is to investigate the feasibility of powering an endocardial pacemaker by converting a minimal amount of the heart's kinetic energy into electric energy. The intrinsic cardiac muscle activity makes it an ideal candidate as continuous source of energy for endocardial pacemakers. For this reason, we developed a prototype able to generate enough power to supply a pacing circuit at different heart rates. The prototype consists of a mass imbalance that drives an electromagnetic generator while oscillating. We developed a mathematical model to estimate the amount of energy harvested from the right ventricle. Finally, the implemented prototype was successfully tested during in-vitro and in-vivo experiments.

4.
JACC Cardiovasc Interv ; 13(18): 2124-2133, 2020 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-32972574

RESUMO

OBJECTIVES: The aim of this study was to investigate the impact of valvular and nonvalvular atrial fibrillation (AF) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: AF has been associated with adverse clinical outcomes after TAVR. However, the differential impact of valvular as opposed to nonvalvular AF has not been investigated. METHODS: In a retrospective analysis of a prospective registry, valvular AF was defined as AF in the setting of concomitant mitral stenosis or the presence of a mitral valve prosthesis. The presence of mitral stenosis was determined by pre-procedural echocardiography. The primary endpoint was a composite of cardiovascular death or disabling stroke at 1 year after TAVR. RESULTS: Among 1,472 patients undergoing TAVR between August 2007 and June 2018, AF was recorded in 465 patients (31.6%) and categorized as nonvalvular in 376 (25.5%) and valvular in 89 (6.0%). AF scores including HAS-BLED, CHADS2, and CHA2DS2-VASc were comparable between patients with nonvalvular and valvular AF. The primary endpoint occurred in 9.3% of patients with no AF, in 14.5% of patients with nonvalvular AF (hazard ratio: 1.57; 95% confidence interval: 1.12 to 2.20; p = 0.009), and in 24.2% of patients with valvular AF (hazard ratio: 2.75; 95% confidence interval: 1.71 to 4.41; p < 0.001). Valvular AF conferred an increased risk for cardiovascular death or disabling stroke compared with nonvalvular AF (hazard ratio: 1.77; 95% confidence interval: 1.07 to 2.94; p = 0.027). CONCLUSIONS: The presence of valvular AF in patients undergoing TAVR increased the risk for cardiovascular death or disabling stroke compared with both no AF and nonvalvular AF. (SWISS TAVI Registry; NCT01368250).

5.
Artigo em Inglês | MEDLINE | ID: mdl-32734408

RESUMO

PURPOSE: PR interval prolongation > 200 ms resulting in the diagnosis of first-degree atrioventricular block (AVB1) is caused by a delay in the AV nodal/His conduction and/or the right intra-atrial conduction (RIAC). The aim of the study was to assess the prevalence of AVB1 due to RIAC delay (AVB1 with normal AH and HV) in patients with atrial fibrillation (AF) and atrial flutter (AFlu). METHODS: We included 1067 consecutive patients (33% female, age 63 ± 13 years) referred for catheter ablation of AF (AF-group) (453 patients), AF and AFlu (136 patients), AFlu (292 patients), and AVNRT/AVRT (186 patients). AH-, HV-, PR-interval, and P-wave duration were measured on the 12-lead ECG and the intracardiac electrograms in sinus rhythm. RIAC delay was defined as a prolonged PR interval > 200 ms with normal AH and HV intervals. RESULTS: The prevalence of AVB1 is higher in patients with AFlu (41%) and AF (21%) and patients with both arrhythmias (30%) as compared with a reference group (8%) of patients with AVNRT/AVRT. AVB1 was due to RIAC delay in 42 of 67 patients (63%) in the AF-group, in 37 of 96 patients (39%) in the AFlu-group, and in 17 of 36 patients (47%) in the AF/AFlu group, respectively. AV nodal conduction delay was more common in AFlu patients compared with AF patients. CONCLUSION: RIAC delay is a common underlying cause of AVB1 in patients with AF and AFlu. These findings may impact the prescription of antiarrhythmic and AV-nodal blocking drugs.

6.
Heart Rhythm ; 2020 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-32798776

RESUMO

BACKGROUND: Pacing leads are the Achilles heel of pacemakers. Most manufacturers report a 3-year survival rate of >99% of their leads. We observed several failures of the Beflex/Vega leads (MicroPort, Shanghai, China; formerly Sorin/LivaNova). OBJECTIVE: The purpose of this study was to investigate failure rates of Beflex/Vega leads. METHODS: We analyzed the performance of Beflex/Vega leads implanted at our tertiary referral center. All-cause lead failures (any issues requiring reinterventions such as lead dislocations, cardiac perforations, and electrical abnormalities) were identified during follow-up. The Beflex/Vega lead was compared with a reference lead (CapSureFix Novus 5076, Medtronic, Minneapolis, MN) implanted within the same period and by the same operators. RESULTS: A total of 585 leads were analyzed (382 Beflex/Vega and 203 CapSureFix Novus 5076 leads). Cumulative failure rate estimates were 5.2%, 6.3%, and 12.4% after 1, 2, and 3 years for the Beflex/Vega lead. This was worse compared to the reference lead (1.5%, 1.5%, 3.7% after 1, 2, and 3 years; P = .001). Early failure manifestations up to 3 months occurred at a similar rate (Beflex/Vega vs CapSureFix Novus 5076 lead: 1.3% vs 0.5% for dislocations; 1.3% vs 1.0% for perforations). During follow-up, electrical abnormalities such as noise oversensing (P = .013) and increased pacing thresholds (P = .003) became more frequent in the Beflex/Vega group. Electrical abnormalities were the most common failure manifestation 3 years after implantation in this group (9.4% vs 2.2% for the CapSureFix Novus 5076). CONCLUSION: The failure rate of the Beflex/Vega lead of >10% after 3 years was higher than that of a competitor lead. This gives rise to concern since >135,000 such leads are active worldwide.

8.
ESC Heart Fail ; 7(4): 1817-1829, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32452635

RESUMO

AIMS: The aim of this study was to investigate the diagnostic and prognostic utility of the QRS-T angle, an electrocardiogram (ECG) marker quantifying depolarization-repolarization heterogeneity, in patients with suspected acute decompensated heart failure (ADHF). METHODS AND RESULTS: We prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of ADHF. The QRS-T angle was automatically derived from a standard 12-lead ECG recorded at presentation. The primary diagnostic endpoint was a final adjudicated diagnosis of ADHF. The primary prognostic endpoint was all-cause mortality during 2 years of follow-up. Among the 1915 patients enrolled, those with higher QRS-T angles were older, were more commonly male, and had a higher rate of co-morbidities such as arterial hypertension, coronary artery disease, or chronic kidney disease. ADHF was the final adjudicated diagnosis in 1140 (60%) patients. The QRS-T angle in patients with ADHF was significantly larger than in patients with non-cardiac causes of dyspnoea {median 110° [inter-quartile range (IQR) 46-156°] vs. median 33° [IQR 15-57°], P < 0.001}. The diagnostic accuracy of the QRS-T angle as quantified by the area under the receiver operating characteristic curve (AUC) was 0.75 [95% confidence interval (CI) 0.73-0.77, P < 0.001], which was inferior to N-terminal pro-B-type natriuretic peptide (AUC 0.93, 95% CI 0.92-0.94, P < 0.001), but similar to that of high-sensitivity troponin T (AUC 0.78, 95% CI 0.76-0.80, P = 0.09). The AUC of the QRS-T angle for discrimination between ADHF and non-cardiac dyspnoea remained similarly high in subgroups of patients known to be diagnostically challenging, including patients older than 75 years [0.71 (95% CI 0.67-0.74)], renal failure [0.79 (95% CI 0.71-0.87)], and atrial fibrillation at presentation [0.68 (95% CI 0.60-0.76)]. Mortality rates according to QRS-T angle tertiles were 4%, 6%, and 10% after 30 days (P < 0.001) and 24%, 31%, and 43% after 2 years (P < 0.001). After adjustment for clinical, laboratory, and ECG parameters, the QRS-T angle remained an independent predictor for 2 year mortality with a 4% increase in mortality for every 20° increase in QRS-T angle (P = 0.02). CONCLUSIONS: The QRS-T angle is a readily available and inexpensive marker that can assist in the discrimination between ADHF and non-cardiac causes of acute dyspnoea and may aid in the risk stratification of these patients.

9.
Heart Rhythm ; 17(10): 1664-1671, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32428669

RESUMO

BACKGROUND: Myocardial scarring from infarction or nonischemic fibrosis forms an arrhythmogenic substrate. The Selvester QRS score has been developed to estimate myocardial scar from the 12-lead electrocardiogram. OBJECTIVE: We aimed to assess the value of an automated version of the Selvester QRS score for the prediction of implantable cardioverter-defibrillator (ICD) therapy and death in patients undergoing primary prevention ICD implantation. METHODS: Unselected patients undergoing primary prevention ICD implantation were included in this retrospective, observational, multicenter study. The QRS score was calculated automatically from a digital standard preimplantation 12-lead electrocardiogram and was correlated to the occurrence of death and appropriate and inappropriate shocks during follow-up. Analyses were performed in groups defined by QRS duration < 130 ms vs ≥ 130 ms. RESULTS: Overall, 1047 patients (872 [83%] men; median age 64 years IQR [55-71]) with ischemic (648, 62%) or nonischemic (399, 38%) cardiomyopathy were included. The median QRS duration was 123 ms (interquartile range [IQR] 111-157 ms), and the median QRS score was 5 (IQR 2-8). The QRS duration was <130 ms in 59% and ≥130 ms in 41%. During a median follow-up of 45 months (IQR 24-72 months), a QRS score of ≥5 was independently associated with a significantly higher risk of mortality (hazard ratio [HR] 1.67; 95% confidence interval [CI] 1.05-2.66; P = .031) and appropriate (HR 1.83; 95% CI 1.07-3.14; P = .028) and inappropriate (HR 2.32; 95% CI 1.04-5.17; P = .039) shocks in patients with QRS duration ≥ 130 ms. No association of the QRS score and outcome was observed in patients with QRS duration < 130 ms (P > .05). CONCLUSION: The automatically calculated Selvester QRS score, an indicator of myocardial scar burden, predicts mortality and appropriate and inappropriate shocks in patients undergoing primary prevention ICD implantation with a prolonged QRS duration.

10.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-32451223

RESUMO

INTRODUCTION AND OBJECTIVES: Release kinetics of high-sensitivity cardiac troponin (hs-cTn) T and I in patients with acute myocardial infarction (AMI) are incompletely understood. We aimed to assess whether hs-cTnT/I release in early AMI is near linear. METHODS: In a prospective diagnostic multicenter study the acute release of hs-cTnT and hs-cTnI within 1 and 2hours from presentation to the emergency department was quantified using 3 hs-cTnT/I assays in patients with suspected AMI. The primary endpoint was correlation between hs-cTn changes from presentation to 1 hour vs changes from presentation to 2hours, among all AMI patients and different prespecified subgroups. The final diagnosis was adjudicated by 2 independent cardiologists, based on serial hs-cTnT from the serial study blood samples and additional locally measured hs-cTn values. RESULTS: Among 2437 patients with complete hs-cTnT data, AMI was the adjudicated diagnosis in 376 patients (15%). For hs-cTnT, the correlation coefficient between 0- to 1-hour change and 0- to 2 hour change was 0.931 (95%CI, 0.916-0.944), P <.001. Similar findings were obtained with hs-cTnI (Architect) with correlation coefficients between 0- to 1-hour change and 0- to 2 hour change of 0.969 and hs-cTnI (Centaur) of 0.934 (P <.001 for both). Findings were consistent among type 1 and type 2 AMI and in the subgroup of patients presenting very early after chest pain onset. CONCLUSIONS: Patients presenting with early AMI showed a near linear release of hs-cTnT and hs-cTnI. This near linearity provides the pathophysiological basis for rapid diagnostic algorithms using 0- to 1-hour changes as surrogates for 0- to 2 hour or 0- to 3 hour changes. Registered at ClinicalTrials.gov (Identifier: NCT00470587).

11.
Europace ; 22(6): 939-946, 2020 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-32361742

RESUMO

AIMS: Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator's experience on leadless PM implantation quality and procedural efficiency. METHODS AND RESULTS: We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator's experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher [odds ratio 1.09 (95% confidence interval 1.00-1.19), P = 0.05]. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05). CONCLUSION: The operator's learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.

12.
Artigo em Inglês | MEDLINE | ID: mdl-32385774

RESUMO

PURPOSE: Treatment of typical atrial flutter (AFL) with cavo-tricuspid isthmus (CTI) ablation is associated with a high occurrence rate of new onset atrial fibrillation (AF) during follow-up. There are data to support the addition of pulmonary vein isolation (PVI) to CTI ablation in patients with both AF and AFL, but the role of cryoballoon PVI only, with no CTI ablation, in AFL patients with no prior documentation of AF has not been studied. METHODS: CRAFT is an international, prospective, randomised, open with blinded assessment, multicentre superiority study comparing radiofrequency CTI ablation and cryoballoon PVI in patients with typical AFL. Participants with typical AFL are randomised in a 1:1 ratio to either treatment arm, with patients randomised to PVI not receiving CTI ablation. Post-procedural cardiac monitoring is performed using an implantable loop recorder. The primary endpoint is time to first recurrence of sustained symptomatic atrial arrhythmia. Key secondary endpoints include (1) total arrhythmia burden at 12 months, (2) time to first episode of AF lasting ≥ 2 min, (3) time to recurrence of AFL or AT and (4) procedural and fluoroscopy times. The primary safety endpoint is the composite of death, stroke/transient ischaemic attack, cardiac tamponade requiring drainage, atrio-oesophageal fistula, requirement for a permanent pacemaker, serious vascular complications requiring intervention or delaying discharge and persistent phrenic nerve palsy lasting > 24 h. CONCLUSION: This study compares the outcomes of 2 different approaches to typical AFL-the conventional 'substrate'-based strategy of radiofrequency CTI ablation versus a novel 'trigger'-based strategy of cryoballoon PVI. TRIAL REGISTRATION: (ClinicalTrials.gov ID: NCT03401099).

14.
Int J Cardiol ; 309: 78-83, 2020 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-32188583

RESUMO

BACKGROUND: Abnormal 12-lead electrocardiogram (ECG) can predict cardiovascular events, including sudden cardiac death. We tested the hypothesis that ECG provides useful information on guiding implantable cardioverter defibrillator (ICD) therapy into individuals with impaired left ventricular ejection fraction (LVEF). METHODS: Retrospective data of primary prevention ICD implantations from 14 European centers were gathered. The registry included 5111 subjects of whom 1687 patients had an interpretable pre-implantation ECG available (80.0% male, 63.3 ± 11.4 years). Primary outcome was survival without appropriate ICD shocks or heart transplantation. A low-risk ECG was defined as a combination of ECG variables that were associated with the primary outcome. RESULTS: A total of 1224 (72.6%) patients survived the follow-up (2.9 ± 1.7 years) without an ICD shock, 224 (13.3%) received an appropriate shock and 260 (15.4%) died. Low-risk ECG defined as QRS duration <120 ms, QTc interval <450 ms for men and <470 ms for women, and sinus rhythm, were met by 515 patients (30.5%). Multivariable Cox regression showed that the hazard (HR) for death, heart transplantation or appropriate shock were reduced by 42.5% in the low-risk group (HR 0.575; 95% CI 0.45-0.74; p < 0.001), compared to the high-risk group. The HR for the first appropriate shock was 42.1% lower (HR 0.58; 95% CI 0.41-0.82; p = 0.002) and the HR for death was 48.0% lower (HR 0.52; 95% CI 0.386-0.72; p < 0.001) in the low-risk group. CONCLUSION: Sinus rhythm, QRS <120 ms and normal QTc in standard 12-lead ECG provides information about survival without appropriate ICD shocks and might improve patient selection for primary prevention ICD therapy.

15.
J Am Heart Assoc ; 9(5): e014446, 2020 03 03.
Artigo em Inglês | MEDLINE | ID: mdl-32089049

RESUMO

Background Left bundle branch block (LBBB) is common after transcatheter aortic valve implantation (TAVI) and is an indicator of subsequent high-grade atrioventricular block (HAVB). No standardized protocol is available to identify LBBB patients at risk for HAVB. The aim of the current study was to evaluate the safety and efficacy of an electrophysiology study tailored strategy in patients with LBBB after TAVI. Methods and Results We prospectively analyzed consecutive patients with LBBB after TAVI. An electrophysiology study was performed to measure the HV-interval the day following TAVI. In patients with normal His-ventricular (HV)-interval ≤55 ms, a loop recorder was implanted (ILR-group), whereas pacemaker implantation was performed in patients with prolonged HV-interval >55 ms (PM-group). The primary end point was occurrence of HAVB during a follow-up of 12 months. Secondary end points were symptoms, hospitalizations, adverse events because of device implantation or electrophysiology study, and death. Of 373 patients screened after TAVI, 56 patients (82±6 years, 41% male) with LBBB were included. HAVB occurred in 4 of 41 patients (10%) in the ILR-group and in 8 of 15 patients (53%) in the PM-group (P<0.001). We did not identify other predictors for HAVB than the HV interval. The negative predictive value for the cut-off of HV 55 ms to detect HAVB was 90%. No HAVB-related syncope occurred in the 2 groups. Conclusions An electrophysiology study tailored strategy to LBBB after TAVI with a cut-off of HV >55 ms is a feasible and safe approach to stratify patients with regard to developing HAVB during a follow-up of 12 months.

16.
Ann Intern Med ; 172(3): 175-185, 2020 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-31905377

RESUMO

Background: The optimal noninvasive method for surveillance in symptomatic patients with stable coronary artery disease (CAD) is unknown. Objective: To apply a novel approach using very low concentrations of high-sensitivity cardiac troponin I (hs-cTnI) for exclusion of inducible myocardial ischemia in symptomatic patients with CAD. Design: Prospective diagnostic cohort study. (ClinicalTrials.gov: NCT01838148). Setting: University hospital. Patients: 1896 consecutive patients with CAD referred with symptoms possibly related to inducible myocardial ischemia. Measurements: Presence of inducible myocardial ischemia was adjudicated using myocardial perfusion imaging with single-photon emission computed tomography, as well as coronary angiography and fractional flow reserve measurements where available. Staff blinded to adjudication measured circulating hs-cTn concentrations. An hs-cTnI cutoff of 2.5 ng/L, derived previously in mostly asymptomatic patients with CAD, was assessed. Predefined target performance criteria were at least 90% negative predictive value (NPV) and at least 90% sensitivity for exclusion of inducible myocardial ischemia. Sensitivity analyses were based on measurements with an hs-cTnT assay and an alternative hs-cTnI assay with even higher analytic sensitivity (limit of detection, 0.1 ng/L). Results: Overall, 865 patients (46%) had inducible myocardial ischemia. The hs-cTnI cutoff of 2.5 ng/L provided an NPV of 70% (95% CI, 64% to 75%) and a sensitivity of 90% (CI, 88% to 92%) for exclusion of inducible myocardial ischemia. No hs-cTnI cutoff reached both performance characteristics predefined as targets. Similarly, using the alternative assays for hs-cTnI or hs-cTnT, no cutoff achieved the target performance: hs-cTnT concentrations less than 5 ng/L yielded an NPV of 66% (CI, 59% to 72%), and hs-cTnI concentrations less than 2 ng/L yielded an NPV of 68% (CI, 62% to 74%). Limitation: Data were generated in a large single-center diagnostic study using central adjudication. Conclusion: In symptomatic patients with CAD, very low hs-cTn concentrations, including hs-cTnI concentrations less than 2.5 ng/L, do not generally allow users to safely exclude inducible myocardial ischemia. Primary Funding Source: European Union, Swiss National Science Foundation, Kommission für Technologie und Innovation (Innosuisse), Swiss Heart Foundation, Cardiovascular Research Foundation Basel, University of Basel, University Hospital Basel, Roche, Abbott, and Singulex.


Assuntos
Doença da Artéria Coronariana/sangue , Isquemia Miocárdica/sangue , Isquemia Miocárdica/diagnóstico , Troponina I/sangue , Troponina T/sangue , Idoso , Biomarcadores/sangue , Estudos de Coortes , Angiografia Coronária , Feminino , Reserva Fracionada de Fluxo Miocárdico , Humanos , Masculino , Pessoa de Meia-Idade , Imagem de Perfusão do Miocárdio , Valor Preditivo dos Testes , Tomografia Computadorizada de Emissão de Fóton Único
17.
PLoS One ; 15(1): e0227134, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31923225

RESUMO

BACKGROUND: Risk stratification of myocarditis is challenging due to variable clinical presentations. Cardiovascular magnetic resonance (CMR) is the primary non-invasive imaging modality to investigate myocarditis while electrocardiograms (ECG) are routinely included in the clinical work-up. The association of ECG parameters with CMR tissue characterisation and their prognostic value were investigated in patients with clinically suspected myocarditis. METHODS AND RESULTS: Consecutive patients with suspected myocarditis who underwent CMR and ECG were analysed. Major adverse cardiovascular event (MACE) included all-cause death, hospitalisation for heart failure, heart transplantation, documented sustained ventricular arrhythmia, or recurrent myocarditis. A total of 587 patients were followed for a median of 3.9 years. A wide QRS-T angle, low voltage and fragmented QRS were significantly associated with late gadolinium enhancement. Further, a wide QRS-T angle, low voltage and prolonged QTc duration were associated with MACE in the univariable analysis. In a multivariable model, late gadolinium enhancement (HR: 1.90, 95%CI: 1.17-3.10; p = 0.010) and the ECG parameters of a low QRS voltage (HR: 1.86, 95%CI: 1.01-3.42; p = 0.046) and QRS-T-angle (HR: 1.01, 95%CI: 1.00-1.01; p = 0.029) remained independently associated with outcome. The cumulative incidence of MACE was incrementally higher when findings of both CMR and ECG were abnormal (p<0.001). CONCLUSION: In patients with clinically suspected myocarditis, abnormal ECG parameters are associated with abnormal tissue characteristics detected by CMR. Further, ECG and CMR findings have independent prognostic implications for morbidity and mortality. Integrating both exams into clinical decision-making may play a role in risk stratification in this heterogeneous patient population.


Assuntos
Meios de Contraste/química , Eletrocardiografia/métodos , Gadolínio , Imagem por Ressonância Magnética/métodos , Miocardite/diagnóstico por imagem , Medição de Risco/métodos , Adulto , Doenças Cardiovasculares/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Miocardite/complicações , Miocardite/diagnóstico , Miocardite/mortalidade , Prognóstico , Estudos Retrospectivos
18.
Eur Heart J Acute Cardiovasc Care ; : 2048872619853579, 2020 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-31976746

RESUMO

BACKGROUND: Recent advances in digital electrocardiography technology allow evaluating ST-segment deviations in all 12 leads as quantitative variables and calculating summed ST-segment deviation scores. The diagnostic and prognostic utility of summed ST-segment deviation scores is largely unknown. METHODS: We aimed to explore the diagnostic and prognostic utility of the conventional and the modified ST-segment deviation score (Better Analysis of ST-segment Elevations and Depressions in a 12- Lead-ECG-Score (BASEL-Score): sum of elevations in the augmented voltage right - lead (aVR) plus absolute, unsigned ST-segment depressions in the remaining leads) in patients presenting with suspected non-ST-segment elevation myocardial infarction. The diagnostic endpoint was non-ST-segment elevation myocardial infarction, adjudicated by two independent cardiologists. Prognostic endpoint was mortality during two-year follow up. RESULTS: Among 1330 patients, non-ST-segment elevation myocardial infarction was present in 200 (15%) patients. Diagnostic accuracy for non-ST-segment elevation myocardial infarction as quantified by the area under the receiver-operating-characteristics curve was significantly higher for the BASEL-Score (0.73; 95% confidence interval 0.69-0.77) as compared to the conventional ST-segment deviation score (0.53; 95% confidence interval 0.49-0.57, p<0.001). The BASEL-Score provided additional independent diagnostic value to dichotomous electrocardiogram variables (ST-segment depression, T-inversion, both p<0.001) and to high-sensitivity cardiac troponin (p<0.001) as well as clinical judgment at 90 min (p<0.001). Similarly, only the BASEL-Score proved to be an independent predictor of two year mortality. CONCLUSIONS: The modified ST-segment deviation score BASEL-Score focusing on ST-segment elevation in aVR and ST-segment depressions in the remaining leads provides incremental diagnostic and prognostic information.

19.
J Interv Card Electrophysiol ; 57(1): 77-85, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31912448

RESUMO

BACKGROUND: Atrial fibrillation recurrence (AFR) is common after pulmonary vein isolation (PVI), and the rate does not differ between radiofrequency (RF) and cryoballoon (CB) ablation. The aim of this study was to assess the impact of the ablation modality used at the index PVI on the outcome after redo PVI in patients with paroxysmal AF. METHODS: In this prospective, single-center, non-randomized study, consecutive patients with paroxysmal AF who have undergone the index PVI with either RF ablation (RF group) or 2nd-generation CB (CB group) were included. The primary endpoint was freedom from recurrence of atrial arrhythmia lasting > 30 s. RESULTS: A total of 105 patients undergoing redo PVI for paroxysmal AF were included (median age 61 years; 24% female; left ventricular ejection fraction (LVEF) 57 ± 8%; left atrial volume index (LAVI) 34 ± 11 mm). Index PVI was done either with focal RF (n = 81) or with CB (n = 24) and redo PVI only with focal RF. Total procedure time (139 vs. 113 min, p = 0.10) and RF delivery time (1017 vs. 870 s, p = 0.33) of the redo PVI were not significantly different. After a median follow-up of 371 (185-470) days, there were no differences between the RF and CB groups regarding the AFR rate after the second PVI (24 vs. 23%, p = 0.89). The Kaplan-Meier analysis showed no difference between the groups regarding AFR freedom time (p = 0.81). In multivariable logistic regression, only coronary artery disease was identified as an independent long-term predictor of AFR (OR 4.15, 95% CI 1.17-14.71, p = 0.027). CONCLUSIONS: The ablation modality used at the index PVI has no impact on long-term outcome after redo PVI in patients with paroxysmal AF.

20.
IEEE Trans Biomed Eng ; 67(4): 1159-1166, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31380741

RESUMO

OBJECTIVE: Cardiac pacemakers are powered by batteries, which become exhausted after a few years. This is a problem in particular for leadless pacemakers as they are difficult to explant. Thus, autonomous devices powered by energy harvesters are desired. METHODS: We developed an energy harvester for endocardial implantation. The device contains a microgenerator to convert a flexible turbine runner's rotation into electrical energy. The turbine runner is driven by the intracardiac blood flow; a magnetic coupling allows hermetical sealing. The energy harvester has a volume of 0.34 cm3 and a weight of 1.3 g. Computational simulations were performed to assess the hemodynamic impact of the implant. The device was studied on a mock circulation and an in vivo trial was performed in a domestic pig. RESULTS: In this article, we show that an energy harvester with a 2-bladed 14-mm-diameter turbine runner delivers 10.2 ± 4.8 µW under realistic conditions (heart rate 80/min, stroke volume 75 ml) on the bench. An increased output power (>80 µW) and power density (237.1 µW/cm3) can be achieved by higher stroke volumes, increased heart rates, or larger turbine runners. The device was successfully implanted in vivo. CONCLUSION: The device is the first flow-based energy harvester suitable for catheter-based implantation and provides enough energy to power a leadless pacemaker. SIGNIFICANCE: The high power density, the small volume, and the flexible turbine runner blades facilitate the integration of the energy harvester in a pacemaker. This would allow overcoming the need for batteries in leadless pacemakers.

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