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1.
Artigo em Inglês | MEDLINE | ID: mdl-32036047

RESUMO

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (AVR) in aortic stenosis (AS). Infective endocarditis (IE) in patients with prosthetic heart valves is associated with significant morbidity and mortality. Data on the incidence, risk factors, and outcomes of IE after TAVI are conflicting. We evaluated these issues in patients with percutaneous TAVI vs. isolated surgical AVR (SAVR) at a nationwide level. METHODS: Based on the administrative hospital-discharge database, the study collected information for all patients with aortic stenosis treated with AVR in France between 2010 and 2018. RESULTS: A total of 47,553 patients undergoing TAVI and 60,253 patients undergoing isolated SAVR were identified. During a mean follow-up of 2.0 years (median [25th to 75th percentile] 1.2 [0.1-3.4] years), the incidence rates of IE were 1.89 (95% confidence interval [CI] 1.78-2.00) and 1.40 (95%CI 1.34-1.46) events per 100 person-years in unmatched TAVI and SAVR patients, respectively. In 32,582 propensity-matched patients (16,291 with TAVI and 16,291 with SAVR), risk of IE was not different in patients treated with TAVI vs SAVR (incidence rates of IE 1.86 [95% CI 1.70-2.04] %/year vs 1.71 [95% CI 1.58-1.85] %/year respectively, relative risk [RR] 1.09, 95% CI 0.96-1.23). In these matched patients, total mortality was higher in TAVI patients with IE (43.0% 95%CI 37.3-49.3) than in SAVR patients with IE (32.8% 95%CI 28.6-37.3; RR 1.32, 95% CI 1.08-1.60). CONCLUSION: In a nationwide cohort of patients with AS, treatment with TAVI was associated with a risk of IE similar to that following SAVR. Mortality was higher for patients with IE following TAVI compared to those with IE following SAVR.

2.
Am J Cardiol ; 2020 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-31932082

RESUMO

An implantable cardioverter defibrillator (ICD) is recommended in primary prevention patients with a coronary artery disease (CAD) and reduced left ventricular ejection fraction. Benefits of ICD in CAD unrelated to coronary thrombosis are unknown. We sought to compare the prognosis of patients with CAD implanted with a prophylactic ICD according to the type of myocardial infarction (MI). Patients from the Very-High-Rate registry implanted with a prophylactic ICD for CAD between 2006 and 2016 were retrospectively included. Cardiac resynchronization therapy patients were excluded. Patients with type 2 MI were matched (1:4) with patients with type 1 MI using propensity score. The following events were collected: death, hospitalization for heart failure, cardiac transplantation, and appropriated therapies on ventricular arrhythmia (≥220 beats/min). Among 571 consecutive ischemic patients, 65 type 2 MI patients were matched to 260 type 1. After a mean follow up of 55 ± 36 months, 63 patients (24%) died in type 1 group, 18 (28%) in type 2 group (p = 0.19). Survival rate from appropriate therapies on high-rate ventricular arrhythmias was significantly lower in type 2 group (p = 0.04). In conclusion, patients implanted with a prophylactic ICD for severe CAD, whether type 1 or type 2 MI, have similar outcomes.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31960345

RESUMO

The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter-defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer-specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life-threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision-making process.

4.
PLoS One ; 15(1): e0225301, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31978044

RESUMO

OBJECTIVE: The objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective. METHODS: A Markov model was developed with a lifetime horizon and cycle length of 3 months. All inputs were drawn from real-world evidence (RWE) studies: data on baseline patient characteristics at model entry were obtained from a French RWE study, clinical event rates as well as persistence rates for the VKA treatment arm were estimated from a variety of RWE studies, and a meta-analysis provided comparative effectiveness for rivaroxaban compared to VKA. Model outcomes included costs (drug costs, clinical event costs, and VKA monitoring costs), quality-adjusted life-years (QALY) and life-years (LY) gained, incremental cost per QALY, and incremental cost per LY. Sensitivity analyses were performed to test the robustness of the model and to better understand the results drivers. RESULTS: In the base-case analysis, the incremental total cost was €714 and the total incremental QALYs and LYs were 0.12 and 0.16, respectively. The resulting incremental cost/QALY and incremental cost/LY were €6,006 and €4,586, respectively. The results were more sensitive to the inclusion of treatment-specific utility decrements and clinical event rates. CONCLUSIONS: Although there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective.

5.
Int J Cardiol ; 301: 114-118, 2020 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-31753583

RESUMO

BACKGROUND: According to guidelines, implantable cardioverter defibrillator (ICD) candidates must have a "reasonable expectation of survival with a good functional status >1 year". Identifying risk for early mortality in ICD candidates could be challenging. We aimed to identify factors associated with a ≤1-year survival among patients implanted with ICDs. METHODS: The DAI-PP program was a multicenter, observational French study that included all patients who received a primary prevention ICD in the 2002-2012 period. Characteristics of patients who survived ≤1 year following the implantation were compared with those who survived >1 year, and predictors of early death determined. RESULTS: Out of the 5539 enrolled patients, survival status at 1 year was known for a total of 5,457, and overall 230 (4.2%) survived ≤1 year. Causes of death were similar in the two groups. Patients with ≤1-year survival had lower rates of appropriate (14 vs. 23%; P = 0.004) and inappropriate ICD therapies (2 vs. 7%; P = 0.009) than patients who lived >1 year after ICD implantation. In multivariate analysis, older age, higher NYHA class (≥III), and atrial fibrillation were significantly associated with ≤1-year survival. Presence of all 3 risk factors was associated with a cumulative 22.63% risk of death within 1 year after implantation. CONCLUSIONS: This is the largest study determining the factors predicting early mortality after ICD implantation. Patients dying within the first year had low ICD therapy rates. A combination of clinical factors could potentially identify patients at risk for early mortality to help improve selection of ICD candidates.

6.
Circulation ; 141(4): 260-268, 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-31736332

RESUMO

BACKGROUND: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. METHODS: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. RESULTS: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P=0.005), cardiovascular death (relative risk, 0.82; corrected P=0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P<0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P<0.0001). CONCLUSIONS: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.

8.
Heart Rhythm ; 17(1): e220-e228, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31103461

RESUMO

The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter-defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer-specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life-threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision-making process.

11.
EuroIntervention ; 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31763981

RESUMO

AIMS: To describe the mid-term outcomes in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients with aortic stenosis (AS), and specifically those treated with TAVI between 2010 and 2018. Cox regression was used for the analysis of predictors of events. We compared patients according to their age. Within the studied period, 71,095 patients older than 90 yo with AS were identified. After matching on baseline characteristics, TAVI was associated with lower rates of a combined outcome of all-cause death, rehospitalization for heart failure and stroke (Relative risk (RR) 0.58, p<0.001) in comparison with matched nonagenarians with AS treated medically. During follow-up (median 161, interquartile range 13-625), the combined outcome occurred more frequently in nonagenarians (RR 1.22, p<0.01) who had a TAVI than in younger patients undergoing this procedure. All cause death was reported in 17.6% vs. 14.5% of nonagenarians, rehospitalization for heart failure in 21.3% vs. 18.2% and stroke in 3.7% vs. 2.9% (p<0.01 for all parameters). We identified Charlson comorbidity index, heart failure, atrial fibrillation, stroke, vascular disease, cognitive impairment and denutrition as independent predictors of adverse outcomes in nonagenarians undergoing TAVI. CONCLUSIONS: Within nonagenarians with AS, patients treated with TAVI had lower risk of cardiovascular events than matched patients treated medically. The patients undergoing a TAVI at this age were often highly selected and the procedure was associated with acceptable long term outcomes.

12.
Circulation ; 140(22): 1834-1850, 2019 11 26.
Artigo em Inglês | MEDLINE | ID: mdl-31765261

RESUMO

Cardiac thromboembolism attributed to atrial fibrillation (AF) is responsible for up to one-third of ischemic strokes. Stroke may be the first manifestation of previously undetected AF. Given the efficacy of oral anticoagulants in preventing AF-related ischemic strokes, strategies of searching for AF after a stroke using ECG monitoring followed by oral anticoagulation (OAC) treatment have been proposed to prevent recurrent cardioembolic strokes. This white paper by experts from the AF-SCREEN International Collaboration summarizes existing evidence and knowledge gaps on searching for AF after a stroke by using ECG monitoring. New AF can be detected by routine plus intensive ECG monitoring in approximately one-quarter of patients with ischemic stroke. It may be causal, a bystander, or neurogenically induced by the stroke. AF after a stroke is a risk factor for thromboembolism and a strong marker for atrial myopathy. After acute ischemic stroke, patients should undergo 72 hours of electrocardiographic monitoring to detect AF. The diagnosis requires an ECG of sufficient quality for confirmation by a health professional with ECG rhythm expertise. AF detection rate is a function of monitoring duration and quality of analysis, AF episode definition, interval from stroke to monitoring commencement, and patient characteristics including old age, certain ECG alterations, and stroke type. Markers of atrial myopathy (eg, imaging, atrial ectopy, natriuretic peptides) may increase AF yield from monitoring and could be used to guide patient selection for more intensive/prolonged poststroke ECG monitoring. Atrial myopathy without detected AF is not currently sufficient to initiate OAC. The concept of embolic stroke of unknown source is not proven to identify patients who have had a stroke benefitting from empiric OAC treatment. However, some embolic stroke of unknown source subgroups (eg, advanced age, atrial enlargement) might benefit more from non-vitamin K-dependent OAC therapy than aspirin. Fulfilling embolic stroke of unknown source criteria is an indication neither for empiric non-vitamin K-dependent OAC treatment nor for withholding prolonged ECG monitoring for AF. Clinically diagnosed AF after a stroke or a transient ischemic attack is associated with significantly increased risk of recurrent stroke or systemic embolism, in particular, with additional stroke risk factors, and requires OAC rather than antiplatelet therapy. The minimum subclinical AF duration required on ECG monitoring poststroke/transient ischemic attack to recommend OAC therapy is debated.

13.
Arch Cardiovasc Dis ; 112(12): 781-791, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31734139

RESUMO

Cardiac arrhythmias that occur in patients referred to intensive care units worsen symptoms and outcomes and need urgent correction, especially in patients admitted for refractory heart failure. Electrical storm is a frequent reason for referral to an intensive care unit. Specific, efficient and rapid management of patients presenting with various arrhythmias is therefore mandatory and procedures should be known by any physician involved in an intensive care unit. This article reviews the current knowledge on the management of supraventricular and ventricular arrhythmias in this setting, from medications and sedation to ablation and more exceptional therapy. It also covers the occasional indications of resynchronization in refractory heart failure and the interest for haemodynamic assistance when specific therapy fails.

14.
Europace ; 2019 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-31725156

RESUMO

The field of observational studies or "real world studies" is in rapid development with many new techniques introduced and increased understanding of traditional methods. For this reason the current paper provides an overview of current methods with focus on new techniques. Some highlights can be emphasized: We provide an overview of sources of data for observational studies. There is an overview of sources of bias and confounding. Next There is an overview of causal inference techniques that are increasingly used. The most commonly used techniques for statistical modelling are reviewed with focus on the important distinction of risk versus prediction. The final section provides examples of common problems with reporting observational data.

15.
Europace ; 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31638652

RESUMO

AIMS: The real-life benefits and risks of the non-vitamin K antagonist oral anticoagulants for stroke prevention in very elderly patients with atrial fibrillation (AF) are still debated. METHODS AND RESULTS: Cohorts of new users of rivaroxaban 15 mg, dabigatran 110 mg, or vitamin K antagonists (VKA) for AF ≥85 years old in 2013 or 2014 were identified in the nationwide French claims database and followed-up for 1 year. Cohorts were compared after 1:1 matching using high-dimensional propensity score. Compared to VKA use and considering 1-year cumulative incidences, risk of stroke, and systemic embolism was not different with rivaroxaban use [hazard ratio 1.14, 95% confidence interval (CI): 0.93-1.40] and lower with dabigatran use (0.77, 95% CI: 0.60-0.99), risk of major bleeding was not different with rivaroxaban use (0.91, 95% CI: 0.74-1.11) and with dabigatran use (0.81, 95% CI: 0.64-1.03), risk of all-cause death was borderline to significance lower with rivaroxaban use (0.91, 95% CI: 0.83-1.00), and lower with dabigatran use (0.87, 95% CI: 0.78-0.97). The risk for a composite of all events above was not different with rivaroxaban use (0.96, 95% CI: 0.88-1.04) and lower with dabigatran use (0.87, 95% CI: 0.79-0.96) as compared with VKA use. The risk for the composite of all events was not different with rivaroxaban use as compared with dabigatran use (1.09, 95% CI: 0.97-1.23). CONCLUSION: This study shows for the first time in more than 25 000 new real-life anticoagulant users for AF aged ≥85 years a neutral overall benefit-risk of rivaroxaban 15 mg vs. VKA and a favourable overall benefit-risk of dabigatran 110 mg vs. VKA on relevant clinical events. STUDY REGISTRATION: European Medicines Agency EUPAS14567 (www.encepp.eu) and Clinicaltrials.gov id NCT02864758.

16.
J Cardiovasc Electrophysiol ; 30(11): 2578-2581, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31512298

RESUMO

INTRODUCTION: We sought to develop an efficient method to upgrade pacing-induced cardiomyopathy (PICM) patients from a leadless pacemaker (LPM) to cardiac resynchronization therapy. METHODS AND RESULTS: Three consecutive patients with chronic atrial fibrillation, implanted with an LPM, with permanent right ventricular pacing, and who developed left ventricular systolic dysfunction due to PICM, were included. A conventional biventricular pacemaker with two different coronary sinus leads, one used for left lateral ventricular pacing, one for early right ventricular sensing, was implanted. It was then synchronized with the LPM working as the right ventricular pacing lead to provide biventricular pacing. The upgrading technique was feasible in all cases, without any perioperative complication. All patients had an improved clinical status during follow-up. CONCLUSION: This new upgrading technique allows efficient cardiac resynchronization therapy in LPM patients while preventing tricuspid valve crossing and providing an increased battery longevity.

18.
Arch Cardiovasc Dis ; 112(8-9): 523-531, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31471226

RESUMO

This review summarizes the main findings of the French multicentre DAI-PP pilot programme, and discusses the related clinical and research perspectives. This project included retrospectively (2002-2012 period) more than 5000 subjects with structural heart disease who received an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death, and were followed for a mean period of 3 years. The pilot phase of the DAI-PP programme has provided valuable information on several practical and clinically relevant aspects of primary prevention ICD implantation in the real-world population, which are summarized in this review. This pilot has led to a prospective evaluation that started in May 2018, assessing ICD therapy in primary and secondary prevention in patients with structural and electrical heart diseases, with remote monitoring follow-up using a dedicated platform. This should further enhance our understanding of sudden cardiac death, to eventually optimize the field of preventative actions.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Prevenção Primária/métodos , Morte Súbita Cardíaca/epidemiologia , França/epidemiologia , Humanos , Estudos Multicêntricos como Assunto , Projetos Piloto , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
19.
Stroke ; 50(9): 2469-2476, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31390972

RESUMO

Background and Purpose- We compared the 1-year safety and effectiveness of rivaroxaban 15 mg (R15) or rivaroxaban 20 mg (R20) to vitamin K antagonists (VKAs) in patients with nonvalvular atrial fibrillation. Methods- New user cohort study of patients dispensed R15 or R20 versus VKA in 2013 or 2014 for nonvalvular atrial fibrillation, followed 1 year in the French Système National des Données de Santé (66 million people). R15 and R20 users were matched 1:1 with VKA users on sex, age, date of first drug dispensing, and high-dimensional propensity score. Hazard ratios (95% CIs) for stroke and systemic embolism, major bleeding, and death were computed using Cox proportional hazards or models by Fine and Gray during exposure. Results- In 31 171 matched R20 and VKA, mean age, 71; 62% men; 76% with CHA2DS2-VASc ≥2; 5% HAS-BLED >3 (hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol); incidence rates for stroke and systemic embolism were 1.5% and 1.9% (hazard ratio, 0.79 [0.69-0.90]); major bleeding, 1.5% and 2.2% (0.67 [0.59-0.77]); death, 3.9% and 5.8% (0.67 [0.61-0.73]). In 23 314 matched R15 and VKA patients, mean age, 80; 47% men; 93% with CHA2DS2-VASc ≥2 and 9% with HAS-BLED >3; incidence rates of stroke and systemic embolism were 2.3% and 2.1% (1.05 [0.92-1.21]); major bleeding, 2.4% and 2.9% (0.84 [0.74-0.96]); death, 9.1% and 10.8% (0.85 [0.79-0.90]). Numbers needed to treat to observe one fewer death (NNT) were 46 for R15 and 61 for R20. Conclusions- In real life in France over 2013 to 2015, R15 and R20 were at least as effective and safer than VKA. Clinical Trial Registration- URL: http://www.encepp.eu. Unique identifier: EUPAS14567.

20.
Europace ; 21(10): 1603-1604, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31353412

RESUMO

Despite major therapeutic advances over the last decades, complex supraventricular and ventricular arrhythmias (VAs), particularly in the emergency setting or during revascularization for acute myocardial infarction (AMI), remain an important clinical problem. Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS), mainly due to prompt revascularization and optimal medical therapy, still up to 6% patients with ACS develop ventricular tachycardia and/or ventricular fibrillation within the first hours of ACS symptoms. Despite sustained VAs being perceived predictors of worse in-hospital outcomes, specific associations between the type of VAs, arrhythmia timing, applied treatment strategies and long-term prognosis in AMI are vague. Atrial fibrillation (AF) is the most common supraventricular tachyarrhythmia that may be asymptomatic and/or may be associated with rapid haemodynamic deterioration requiring immediate treatment. It is estimated that over 20% AMI patients may have a history of AF, whereas the new-onset arrhythmia may occur in 5% patients with ST elevation myocardial infarction. Importantly, patients who were treated with primary percutaneous coronary intervention for AMI and developed AF have higher rates of adverse events and mortality compared with subjects free of arrhythmia. The scope of this position document is to cover the clinical implications and pharmacological/non-pharmacological management of arrhythmias in emergency presentations and during revascularization. Current evidence for clinical relevance of specific types of VAs complicating AMI in relation to arrhythmia timing has been discussed.

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