Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 145
Filtrar
1.
Circulation ; 2021 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-34747186

RESUMO

Background: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure (LAAC). Methods: In the investigator-initiated SWISS APERO trial, patients undergoing LAAC were randomized (1:1) open-label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centres. The primary endpoint was the composite of justified crossover to a non-randomized device during LAAC procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary endpoints included procedural complications, device related thrombus (DRT), peridevice leak (PDL) at transesophageal echocardiography (TEE) and clinical outcomes at 45 days. Results: Between June 2018, and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary endpoint was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) Amulet and 70 (70.0%) Watchman patients respectively (risk ratio [RR] 0.97 [95% CI 0.80- 1.16]; P=0.713). A single justified cross-over occurred in an Amulet patient who fulfilled LAA patency criteria at 45-day CCTA. Major procedure related complications occurred more frequently in the Amulet group (9.0% vs. 2.7%; P=0.047), owing to more frequent bleeding (7.2% vs.1.8%). At 45 days, the PDL rate at TEE was higher with Watchman than Amulet (27.5% vs. 13.7%, p=0.020), albeit none was major (i.e. > 5 mm), whereas DRT was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at TEE, respectively. Clinical outcomes at 45 days did not differ between the groups. Conclusions: Amulet was not associated with lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, was however associated with lower PDL rates at TEE, higher procedural complications and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT03399851.

2.
Artigo em Inglês | MEDLINE | ID: mdl-34632490

RESUMO

AIMS: The role of diuretics in patients with intermediate-risk pulmonary embolism (PE) is controversial. In this multicentre, double-blind trial, we randomly assigned normotensive patients with intermediate-risk PE to receive either a single 80 mg bolus of furosemide or a placebo. METHODS AND RESULTS: Eligible patients had at least a simplified PE Severity Index (sPESI) ≥1 with right ventricular dysfunction. The primary efficacy endpoint assessed 24 h after randomization included (i) absence of oligo-anuria and (ii) normalization of all sPESI items. Safety outcomes were worsening renal function and major adverse outcomes at 48 hours defined by death, cardiac arrest, mechanical ventilation, or need of catecholamine. A total of 276 patients underwent randomization; 135 were assigned to receive the diuretic, and 141 to receive the placebo. The primary outcome occurred in 68/132 patients (51.5%) in the diuretic and in 49/132 (37.1%) in the placebo group (relative risk = 1.30, 95% confidence interval 1.04-1.61; P = 0.021). Major adverse outcome at 48 h occurred in 1 (0.8%) patients in the diuretic group and 4 patients (2.9%) in the placebo group (P = 0.19). Increase in serum creatinine level was greater in diuretic than placebo group [+4 µM/L (-2; 14) vs. -1 µM/L (-11; 6), P < 0.001]. CONCLUSION: In normotensive patients with intermediate-risk PE, a single bolus of furosemide improved the primary efficacy outcome at 24 h and maintained stable renal function. In the furosemide group, urine output increased, without a demonstrable improvement in heart rate, systolic blood pressure, or arterial oxygenation.ClinicalTrials.gov identifier NCT02268903.

3.
Thromb Haemost ; 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34560806

RESUMO

Intermediate-high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate-high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.

4.
JACC Cardiovasc Interv ; 14(18): 1965-1974, 2021 09 27.
Artigo em Inglês | MEDLINE | ID: mdl-34556269

RESUMO

OBJECTIVES: This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm). BACKGROUND: PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice. METHODS: Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population. RESULTS: At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021). CONCLUSIONS: Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930).


Assuntos
Estenose da Valva Aórtica , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Canadá , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
5.
Lancet Haematol ; 8(9): e627-e636, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34363769

RESUMO

BACKGROUND: Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. This is a particular patient category for whom optimal treatment (anticoagulant treatment, reperfusion strategies, and duration of hospitalisation) is currently unknown. We investigated whether treatment of acute intermediate-risk pulmonary embolism with parenteral anticoagulation for a short period of 72 h, followed by a switch to a direct oral anticoagulant (dabigatran), is effective and safe. METHODS: We did a multinational, multicentre, single-arm, phase 4 trial at 42 hospitals in Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain. Adult patients (aged ≥18 years) with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis, were enrolled. Patients received parenteral low-molecular-weight or unfractionated heparin for 72 h after diagnosis of pulmonary embolism before switching to oral dabigatran 150 mg twice per day following a standard clinical assessment. The primary outcome was recurrent symptomatic venous thromboembolism or pulmonary embolism-related death within 6 months. The primary and safety outcomes were assessed in the intention-to-treat population. The study was terminated early, as advised by the data safety and monitoring board, following sample size adaptation after the predefined interim analysis on Dec 18, 2018. This trial is registered with the EU Clinical Trials Register (EudraCT 2015-001830-12) and ClinicalTrials.gov (NCT02596555). FINDINGS: Between Jan 1, 2016, and July 31, 2019, 1418 patients with pulmonary embolism were screened, of whom 402 were enrolled and were included in the intention-to-treat analysis (median age was 69·5 years [IQR 60·0-78·0); 192 [48%] were women and 210 [52%] were men). Median follow-up was 217 days (IQR 210-224) and 370 (92%) patients adhered to the protocol. The primary outcome occurred in seven (2% [upper bound of right-sided 95% CI 3]; p<0·0001 for rejecting the null hypothesis) patients, with all events occurring in those with intermediate-high-risk pulmonary embolism (seven [3%; upper bound of right-sided 95% CI 5] of 283). At 6 months, 11 (3% [95% CI 1-5]) of 402 patients had at least one major bleeding event and 16 (4% [2-6]) had at least one clinically relevant non-major bleeding event; the only fatal haemorrhage occurred in one (<1%) patient before the switch to dabigatran. INTERPRETATION: A strategy of early switch from heparin to dabigatran following standard clinical assessment was effective and safe in patients with intermediate-risk pulmonary embolism. Our results can help to refine guideline recommendations for the initial treatment of acute intermediate-risk pulmonary embolism, optimising the use of resources and avoiding extended hospitalisation. FUNDING: German Federal Ministry of Education and Research, University Medical Center Mainz, and Boehringer Ingelheim.


Assuntos
Anticoagulantes/uso terapêutico , Dabigatrana/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Dabigatrana/efeitos adversos , Esquema de Medicação , Feminino , Seguimentos , Hemorragia/etiologia , Heparina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/complicações , Fatores de Risco , Resultado do Tratamento , Tromboembolia Venosa/complicações
6.
J Clin Med ; 10(16)2021 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-34441911

RESUMO

We aimed to compare six available bleeding scores, in a real-life cohort, for prediction of major bleeding in the early phase of pulmonary embolism (PE). We recorded in-hospital characteristics of 2754 PE patients in a prospective observational multicenter cohort contributing 18,028 person-days follow-up. The VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), ORBIT (Outcomes Registry for Better Informed Treatment), HEMORR2HAGES (Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol) scores were assessed at baseline. International Society on Thrombosis and Haemostasis (ISTH)-defined bleeding events were independently adjudicated. Accuracy of the overall original 3-level and newly defined optimal 2-level outcome of the scores were evaluated and compared. We observed 82 first early major bleedings (3.0% (95% CI, 2.4-3.7)). The predictive power of bleeding scores was poor (Harrel's C-index from 0.57 to 0.69). The RIETE score had numerically higher model fit and discrimination capacity but without reaching statistical significance versus the ORBIT, HEMORR2HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C-index, integrated discrimination improvement, and net reclassification improvement compared to the others. The rate of observed early major bleeding in score-defined low-risk patients was high, between 15% and 34%. Current available scoring systems have insufficient accuracy to predict early major bleeding in patients with acute PE. The development of acute-PE-specific risk scores is needed to optimally target bleeding prevention strategies.

7.
JACC Cardiovasc Interv ; 14(15): 1704-1713, 2021 08 09.
Artigo em Inglês | MEDLINE | ID: mdl-34274294

RESUMO

OBJECTIVES: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND: The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.


Assuntos
Fibrilação Atrial , Substituição da Valva Aórtica Transcateter , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Vitamina K
8.
Chest ; 160(5): 1832-1843, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34217683

RESUMO

BACKGROUND: Improved prediction of the risk of early major bleeding in pulmonary embolism (PE) is needed to optimize acute management. RESEARCH QUESTION: Does a simple scoring system predict early major bleeding in acute PE patients, identifying patients with either high or low probability of early major bleeding? STUDY DESIGN AND METHODS: From a multicenter prospective registry including 2,754 patients, we performed post hoc multivariable logistic regression analysis to build a risk score to predict early (up to hospital discharge) major bleeding events. We validated the endpoint model internally, using bootstrapping in the derivation dataset by sampling with replacement for 500 iterations. Performances of this novel score were compared with that of the VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), and BACS (Bleeding, Age, Cancer, and Syncope) models. RESULTS: Multivariable regression identified three predictors for the occurrence of 82 major bleeds (3.0%; 95% CI, 2.39%-3.72%): Syncope (+1.5); Anemia, defined as hemoglobin <12 g/dL (+2.5); and Renal Dysfunction, defined as glomerular filtration rate <60 mL/min (+1 point) (SARD). The PE-SARD bleeding score was calculated by summing all the components. Overall, 52.2% (95% CI, 50.29%-54.11%) of patients were classified as low bleeding-risk (score, 0 point), 35.2% (95% CI, 33.39%-37.04%) intermediate-risk (score, 1-2.5 points), and 12.6% (95% CI, 9.30%-16.56%) high-risk (score >2.5 points). Observed bleeding rates increased with increasing risk group, from 0.97% (95% CI, 0.53%-1.62%) in the low-risk to 8.93% (95% CI, 6.15%-12.44%) in the high-risk group. C-index was 0.74 (95% CI, 0.73-0.76) and Brier score 0.028 in the derivation cohort. Similar values were calculated from internal bootstrapping. Performance of the PE-SARD score was better than that observed with the VTE-BLEED, RIETE, and BACS scores, leading to a high proportion of bleeding-risk reclassification in patients who bled and those who did not. INTERPRETATION: The PE-SARD bleeding risk score is an original, user-friendly score to estimate risk of early major bleeding in patients with acute PE.

9.
J Am Heart Assoc ; 10(13): e020917, 2021 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-34187182

RESUMO

Background We assessed the impact of preprocedural plasma levels of MRproANP (midregional N-terminal pro-atrial natriuretic peptide) and sST2 (soluble suppression of tumorigenicity 2) on recurrence of atrial fibrillation (AF) at 1 year after catheter ablation of AF. Methods and Results This was a prospective, multicenter, observational study including patients undergoing catheter ablation of AF. MRproANP and sST2 were measured in a peripheral venous blood preprocedure, and MRproANP was assessed in the right and left atrial blood during ablation. The primary end point was recurrent AF between 3 and 12 months postablation, defined as a documented (>30 seconds) episode of AF, flutter, or atrial tachycardia. We included 106 patients from December 2017 to March 2019; 105 had complete follow-up, and the mean age was 63 years with 74.2% males. Overall, 34 patients (32.1%) had recurrent AF. In peripheral venous blood, MRproANP was significantly higher in patients with recurrent AF (median, 192.2; [quartile 1-quartile 3, 155.9-263.9] versus 97.1 [60.9-150.7] pmol/L; P<0.0001), as was sST2 (median, 30.3 [quartile 1-quartile 3, 23.3-39.3] versus 23.4 [95% CI, 17.4-33.0] ng/mL; P=0.0033). In the atria, MRproANP was significantly higher than in peripheral blood and was higher during AF than during sinus rhythm. Receiver operating characteristic curve analysis identified a threshold of MRproANP>107.9 pmol/L to predict AF recurrence at 1 year and a threshold of >26.7 ng/mL for sST2. By multivariate analysis, MRproANP>107.9 pmol/L was the only independent predictor of recurrent AF (OR, 24.27; 95% CI, 4.23-139.18). MRproANP<107.9 pmol/L identified subjects at very low risk of recurrence (negative predictive value >95%). Conclusions Elevated MRproANP level independently predicts recurrent AF, whereas sST2 levels do not appear to have any prognostic value in assessing the risk of recurrence of AF up to 1 year after catheter ablation. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03351816.


Assuntos
Fibrilação Atrial/cirurgia , Fator Natriurético Atrial/sangue , Ablação por Cateter , Átrios do Coração/cirurgia , Frequência Cardíaca , Proteína 1 Semelhante a Receptor de Interleucina-1/sangue , Idoso , Fibrilação Atrial/sangue , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Biomarcadores/sangue , Ablação por Cateter/efeitos adversos , Feminino , França , Átrios do Coração/metabolismo , Átrios do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Recidiva , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Regulação para Cima
10.
EuroIntervention ; 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34105514

RESUMO

BACKGROUND: Optical flow ratio (OFR) is a novel method for fast computation of fractional flow reserve (FFR) from optical coherence tomography (OCT) images. AIMS: We aimed to evaluate the accuracy of OFR in predicting post-percutaneous coronary intervention (PCI) FFR and to evaluate the impact of stent expansion on within-stent OFR pressure drop (In-stent OFR). METHODS: Post-PCI OFR was computed in patients with both OCT and FFR interrogation immediately after PCI. Calculation of post-PCI OFR (called simulated residual OFR) from pre-PCI OCT pullbacks after elimination of the stenotic segment by virtual stenting was performed in a subgroup of patients who had pre-PCI OCT images. Stent underexpansion was quantified by the minimum expansion index (MEI) of the stented segment. RESULTS: A total of 125 paired comparisons between post-PCI OFR and FFR were obtained in 119 patients, among which simulated residual OFR was obtained in 64 vessels. Mean post-PCI FFR was 0.92 ± 0.05. Post-PCI OFR showed good correlation (r = 0.74, p<0.001) and agreement (mean difference = -0.01 ± 0.03, p = 0.051) with FFR. The accuracy in predicting post-PCI FFR≤0.90 was 84% for post-PCI OFR. Simulated residual OFR significantly correlated with post-PCI FFR (r = 0.42, p<0.001). MEI showed moderate correlation (r=-0.49, p<0.001) with In-stent OFR. CONCLUSIONS: Post-PCI OFR showed good diagnostic concordance with post-PCI FFR. Simulated residual OFR significantly correlated with post-PCI FFR. Stent underexpansion significantly correlated with in-stent pressure drop.

11.
Pacing Clin Electrophysiol ; 44(6): 1018-1026, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33969505

RESUMO

OBJECTIVE: We aimed to investigate pacemaker dependency after at least 1 year in patients with early (<7 days) implantation, compared to those who received a pacemaker ≥7 days after cardiac surgery. Secondary endpoints were length of hospital stay and in-hospital complications. METHODS: Retrospective analysis of 108 consecutive patients who received a pacemaker after cardiac surgery between 06/2012 and 06/2018. Characteristics and outcomes were compared between patients with early (<7 days) and late (≥7 days) implantation. Patients were followed up with evaluation of pacemaker dependency between April and June 2019. We identified predictors of dependency by logistic regression. RESULTS: In total, 63.9% were men, average age 71.9 ± 11.8 years; 32 (29.6%) had early implantation, and 76 (70.4%) late implantation. After a median 3.2 years [IQR 1.9, 4.5] of follow-up, 30 patients (27.8%) had died, and there was no difference in pacemaker dependency among survivors (66.7% vs. 46.5%, early vs. late respectively, p = .15). Patients in the early group had a shorter length of stay (11.5 [9.0, 14.0] vs. 15.0 [11.5, 20] days, p = .002) and less often had new-onset atrial fibrillation (AF) post-surgery (22.7% vs. 47.8%, p = .05). The only significant predictor of dependency was aortic valve replacement surgery (OR = 4.70, 95% CI [1.36 to 16.24]). CONCLUSION: Early implantation of a permanent pacemaker (<7 days after cardiac surgery) does not impact on the proportion of patients with long-term (>12 months) pacemaker dependency, but is associated with shorter length of stay and less frequent new-onset AF. These findings warrant prospective confirmation in randomized trials.

12.
Arch Cardiovasc Dis ; 114(5): 340-351, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33926830

RESUMO

BACKGROUND: Systems of care have been challenged to control progression of the COVID-19 pandemic. Whether this has been associated with delayed reperfusion and worse outcomes in French patients with ST-segment elevation myocardial infarction (STEMI) is unknown. AIM: To compare the rate of STEMI admissions, treatment delays, and outcomes between the first peak of the COVID-19 pandemic in France and the equivalent period in 2019. METHODS: In this nationwide French survey, data from consecutive STEMI patients from 65 centres referred for urgent revascularization between 1 March and 31 May 2020, and between 1 March and 31 May 2019, were analysed. The primary outcome was a composite of in-hospital death or non-fatal mechanical complications of acute myocardial infarction. RESULTS: A total of 6306 patients were included. During the pandemic peak, a 13.9±6.6% (P=0.003) decrease in STEMI admissions per week was observed. Delays between symptom onset and percutaneous coronary intervention were longer in 2020 versus 2019 (270 [interquartile range 150-705] vs 245 [140-646]min; P=0.013), driven by the increase in time from symptom onset to first medical contact (121 [60-360] vs 150 [62-420]min; P=0.002). During 2020, a greater number of mechanical complications was observed (0.9% vs 1.7%; P=0.029) leading to a significant difference in the primary outcome (112 patients [5.6%] in 2019 vs 129 [7.6%] in 2020; P=0.018). No significant difference was observed in rates of orotracheal intubation, in-hospital cardiac arrest, ventricular arrhythmias and cardiogenic shock. CONCLUSIONS: During the first peak of the COVID-19 pandemic in France, there was a decrease in STEMI admissions, associated with longer ischaemic time, exclusively driven by an increase in patient-related delays and an increase in mechanical complications. These findings suggest the need to encourage the population to seek medical help in case of symptoms.


Assuntos
COVID-19/epidemiologia , Pandemias , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Comorbidade , Diabetes Mellitus/epidemiologia , Feminino , França/epidemiologia , Pesquisas sobre Serviços de Saúde , Ruptura Cardíaca Pós-Infarto/epidemiologia , Mortalidade Hospitalar , Humanos , Hiperlipidemias/epidemiologia , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Admissão do Paciente/estatística & dados numéricos , Intervenção Coronária Percutânea/estatística & dados numéricos , Utilização de Procedimentos e Técnicas , Prognóstico , Fatores de Risco , SARS-CoV-2 , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Fumar/epidemiologia , Stents , Tempo para o Tratamento , Resultado do Tratamento
13.
J Cardiovasc Transl Res ; 14(5): 930-940, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33884564

RESUMO

Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The "Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.

14.
Catheter Cardiovasc Interv ; 98(6): E870-E880, 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-33909348

RESUMO

OBJECTIVES: To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. METHODS: The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dl in men and <12 g/dl in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (Bleeding Academic Research Consortium ≥3b) at 30 days. RESULTS: Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30 days between patients with and without anemia, irrespective of the type of anticoagulant used (pinteraction  = 0.71 for NACE, pinteraction  = 1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42-4.16, p = 0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16-2.59, p = 0.007) compared to non-anemic patients at 30 days. CONCLUSIONS: Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH.

15.
Eur Heart J Acute Cardiovasc Care ; 10(2): 207-215, 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33675658

RESUMO

AIMS: We estimated the 2020 European Society of Cardiology-Acute Cardio Vascular Care (ESC-ACVC) quality indicators (QI) for the management of acute myocardial infarction, from three existing registries to determine the feasibility of assessment, room for improvement, association with outcomes, and suitability for centre benchmarking. METHODS AND RESULTS: Data were extracted from three French nationwide registries, namely FAST-MI 2005, 2010, and 2015. Feasibility of assessment and room for improvement were estimated by the denominator (patients in whom QI could be measured) and numerator (patients who satisfied the QI, among those eligible). Associations between composite QIs (CQIs) and mortality were assessed by multivariate analysis. Centre benchmarking was based on the centres mean CQI, vs. the national mean. The 2020 QIs were measured in 12 660/13 130 patients from FAST-MI. Measurement feasibility ranged from 15% to 100% with greater potential for implementation with the 2020 QI set. The mean (±SD) value of the opportunity-based CQI was 0.72 ± 0.01 and attainment of the all-or-none CQI 8.5%. Both CQIs were associated with adjusted 1-year mortality. Centre categorization into low, intermediate, and high quality was feasible, and distinguished centres with differing mortality. CONCLUSION: Most of the 2020 QI can be measured from existing registries in all domains but not in the patient's satisfaction domain. This assessment shows potential for implementation. Both CQIs were inversely associated with one-year mortality and centre benchmarking was feasible.

17.
Crit Care ; 25(1): 57, 2021 02 09.
Artigo em Inglês | MEDLINE | ID: mdl-33563311

RESUMO

BACKGROUND: Renal dysfunction influences outcomes after pulmonary embolism (PE). We aimed to determine the incremental value of adding renal dysfunction, defined by estimated glomerular filtration rate (eGFR), on top of the European Society of Cardiology (ESC) prognostic model, for the prediction of 30-day mortality in acute PE patients, which in turn could lead to the optimization of acute PE management. METHODS: We performed a multicenter, non-interventional retrospective post hoc analysis based on a prospectively collected cohort including consecutive confirmed acute PE stratified per ESC guidelines. We first identified which of three eGFR formulae most accurately predicted death. Changes in global model fit, discrimination, calibration and reclassification parameters were evaluated with the addition of eGFR to the prognostic model. RESULTS: Among 1943 patients (mean age 67.3 (17.1), 50.4% women), 107 (5.5%) had died at 30 days. The 4-variable Modification of Diet in Renal Disease (eGFRMDRD4) formula predicted death most accurately. In total, 477 patients (24.5%) had eGFRMDRD4 < 60 ml/min. Observed mortality was higher for intermediate-low-risk and high-risk PE in patients with versus without renal dysfunction. The addition of eGFRMDRD4 information improved model fit, discriminatory capacity, and calibration of the ESC model. Reclassification parameters were significantly increased, yielding 18% reclassification of predicted mortality (p < 0.001). Predicted mortality reclassifications across risk categories were as follows: 63.1% from intermediate-low risk to eGFR-defined intermediate-high risk, 15.8% from intermediate-high risk to eGFR-defined intermediate-low risk, and 21.0% from intermediate-high risk to eGFR-defined high risk. External validation in a cohort of 14,234 eligible patients from the RIETE registry confirmed our findings with a significant improvement of Harrell's C index and reclassification parameters. CONCLUSION: The addition of eGFRMDRD4-derived renal dysfunction on top of the prognostic algorithm led to risk reclassification within the intermediate- and high-risk PE categories. The impact of risk stratification integrating renal dysfunction on therapeutic management for acute PE requires further studies.


Assuntos
Injúria Renal Aguda/diagnóstico , Embolia Pulmonar/classificação , Injúria Renal Aguda/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Taxa de Filtração Glomerular/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Embolia Pulmonar/mortalidade , Embolia Pulmonar/fisiopatologia , Sistema de Registros/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco/métodos
18.
EuroIntervention ; 17(2): e124-e131, 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-33226003

RESUMO

BACKGROUND: Intravascular ultrasound (IVUS)-guided PCI improves the prognosis of left main stem (LMS) PCI and is currently recommended by international guidelines. Although OCT resolution is greater than that of IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data. AIMS: This pilot study aimed to analyse the feasibility, safety and impact of OCT-guided LMS PCI. METHODS: This prospective, multicentre trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria). RESULTS: Seventy patients were included in the final analysis (median age: 72 [64-81] years, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86% of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant strut malapposition in 24% of the cases. OCT guidance modified the operators' strategy in 26% of the patients. The rate of one-year survival free from major adverse clinical events was 98.6% (97.2-100). CONCLUSIONS: This pilot study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Feminino , Humanos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Projetos Piloto , Estudos Prospectivos , Stents , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de Intervenção
19.
EuroIntervention ; 17(2): e132-e139, 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-32392171

RESUMO

BACKGROUND: The best criteria for adequate stent expansion assessment by intracoronary imaging remain debated and their correlation with post-PCI FFR values is unknown. AIMS: This study aimed to analyse the relationship between stent expansion criteria using optical coherence tomography (OCT) analysis and the final PCI functional result. METHODS: This post hoc analysis of the DOCTORS study included non-ST-elevation segment ACS patients undergoing OCT-guided PCI. The procedure functional result was assessed by the measurement of fractional flow reserve (FFR). Stent expansion was assessed on OCT runs according to the DOCTORS criteria and ILUMIEN III criteria. RESULTS: The study included N=116 patients (age: 60.8±11.5 years; male gender: 71%). The final expansion was considered optimal in 10%, acceptable in 9% and unacceptable in 81% of the stents according to ILUMIEN III criteria, although being successful in 70% of the patients according to the DOCTORS criteria. Hypertension and larger proximal reference segment dimension were independent predictors of inadequate device ILUMIEN III expansion. FFR values were, respectively, 0.93 (0.91-0.95) versus 0.95 (0.92-0.97) in patients with optimal+acceptable versus unacceptable ILUMIEN III expansion (p=0.22), 0.94 (0.91-0.97) versus 0.95 (0.93-0.97) in patients with optimal versus non-optimal DOCTORS expansion (p=0.23), and 0.95 (0.92-0.97) versus 0.92 (0.90-0.95) in patients with minimal stent area ≥4.5 mm2 versus <4.5 mm2 (p=0.03). CONCLUSIONS: In this selected population, no relationship was observed between optimal stent expansion according to ILUMIEN III or DOCTORS OCT criteria and final post-PCI FFR values.


Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Stents , Resultado do Tratamento
20.
EuroIntervention ; 17(6): 508-515, 2021 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-33319763

RESUMO

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an increasingly reported but poorly understood condition. Few European data are available. AIMS: The aims of this study were to obtain European data on SCAD, determine the prevalence of fibromuscular dysplasia (FMD) and enable genetic analyses in this population. METHODS: Data from a national French registry of SCAD cases were analysed prospectively and retrospectively. Clinical and angiographic data and management strategy were collected. Major adverse cardiovascular events (MACE) were analysed after one year of follow-up. Subjects were screened for FMD and blood was collected for DNA extraction. RESULTS: From June 2016 to August 2018, 373 SCAD cases were confirmed by the core lab. Mean age was 51.5 years. Patients were mostly women (90.6%) and 54.7% of cases had less than two cardiovascular risk factors. At one year, 295 patients (79.1%) were treated conservatively, the MACE rate was 12.3%, and there were no cases of mortality. The recurrence rate of SCAD was 3.3%. FMD was found at ≥1 arterial site in 45.0% of cases. We also confirmed the genetic association between the PHACTR1 locus and SCAD (odds ratio=1.66, p=7.08×10-8). CONCLUSIONS: Here we describe the DISCO registry, the largest European SCAD cohort where FMD was found in 45% of cases and the genetic association with PHACTR1 was confirmed. This nationwide cohort is a valuable resource for future clinical and genetic investigation to understand SCAD aetiology.


Assuntos
Anomalias dos Vasos Coronários , Displasia Fibromuscular , Doenças Vasculares , Angiografia Coronária , Anomalias dos Vasos Coronários/diagnóstico por imagem , Anomalias dos Vasos Coronários/epidemiologia , Anomalias dos Vasos Coronários/genética , Vasos Coronários , Dissecação , Feminino , Displasia Fibromuscular/epidemiologia , Displasia Fibromuscular/genética , Humanos , Pessoa de Meia-Idade , Prevalência , Sistema de Registros , Estudos Retrospectivos , Doenças Vasculares/diagnóstico por imagem , Doenças Vasculares/epidemiologia , Doenças Vasculares/genética
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...