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1.
BMJ Open ; 9(11): e032124, 2019 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-31699742

RESUMO

OBJECTIVE: This study sought to evaluate the diagnostic performance of the 1-hour troponin algorithm for diagnosis of myocardial infarction (MI) without persistent ST-segment elevations (non-ST-segment MI (NSTEMI)) in a cohort with a high prevalence of MI. This algorithm recommend by current guidelines was previously developed in cohorts with a prevalence of MI of less than 20%. DESIGN: Prospective cohort study from November 2015 until December 2016. SETTING: Dedicated chest pain unit of a single referral centre. PARTICIPANTS: Consecutive patients with suspected MI were screened. Patients with subacute symptoms lasting more than 24 hours, new ST-segment elevations at presentation, or an already diagnosed or ruled-out acute MI were excluded. All enrolled patients (n=1317) underwent a full clinical assessment and measurements of high-sensitivity troponin, and were scheduled for an early invasive strategy if clinically indicated. MAIN OUTCOME MEASURES: Final diagnosis of MI according to the Fourth Universal Definition of MI. RESULTS: The prevalence of NSTEMI in the present cohort was 36.9%. The sensitivity for rule-out of MI was 99.8%. The specificity for rule-in of MI was found to be 94.3%. However, in 35.7% of patients neither rule-in nor rule-out was possible. In 51.4% of patients diagnosed with MI, a primary non-coronary reason for MI was found (type 2 MI). Different receiver operating characteristic-curve derived cut-offs for troponin and its dynamics did not provide a sufficient differentiation between type 1 and 2 MI for clinical decision making (negative predictive value for rule-out of type 1 MI <70%). CONCLUSIONS: The 1-hour diagnosis algorithm for patients with suspected NSTEMI can accurately diagnose acute MI in high-risk cohorts. However, discrimination between patients needing an early invasive strategy or not is limited. TRIAL REGISTRATION NUMBER: DRKS00009713.

2.
Artigo em Inglês | MEDLINE | ID: mdl-31721430

RESUMO

OBJECTIVES: We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD. BACKGROUND: Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI. METHODS: Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208. RESULTS: Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p < .001). HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001). HD was also strongly associated with 2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST. Following adjustment for HPR and other covariates, HD was independently associated with overall mortality, MI, ST, and major bleeding at 2 years. The relationship between HD status and 2-year MACE was consistent in patients with and without HPR (Pinteraction = .78). CONCLUSIONS: Nearly two-thirds of patients on HD exhibited HPR on clopidogrel, and both HD and HPR were independently associated with 2-year adverse outcomes after DES implantation. However, the deleterious impact of HD on clinical outcomes was present in both patients with and without HPR.

3.
J. Am. Coll. Cardiol. ; 74(13 supl.): 187-187, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024965

RESUMO

BACKGROUND: Assessment of the safety and clinical performance of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) from the combined analysis of BIOSOLVE- II and -III studies at 36 months. METHODS A total of 184 subjects have been enrolled in the BIOSOLVE-II and -III studies. Clinical follow-ups are scheduled at 1, 6, 12, 24, and 36 months plus 60 months for BIOSOLVE-II. Angiographies are planned at 6 months and voluntarily at 12 and 36 months in BIOSOLVE-II, and 1 angiography is mandatory at 12 months in the BIOSOLVE-III study. Dual antiplatelet therapy is recommended for a minimum of 6 months. The angiographic results are analyzed by an independent core laboratory and all clinical events were adjudicated by an independent clinical events committee. RESULTS A total of 117 men and 67 women with 189 lesions, mean age 65.5 _ 10.8 years, were enrolled at 18 sites in Europe, Brazil, and Singapore. Hypertension was presente in 79.3% of the subjects and 62% had hyperlipidemia. The mean lesion length was 12.6 _ 5.1 mm with a mean reference vessel diameter of 2.70 _ 0.43 mm. At 12 months, 97 patients had available angiographic follow-up. There was no difference in late lumen loss between the 2 studies; in the overall population, it was 0.25 _ 0.31 mm in-segment and 0.39 _ 0.34 mm in-scaffold. The target lesion failure (TLF) rate of the combined population was 3.3%, including 2 cardiac deaths (1.1%), 1 target vessel myocardial infarction (0.6%), and 3 clinically driven target lesion revascularizations (1.7%). The 36-month clinical data of BIOSOLVE- II study are available. Target lesion failure occurred in 8 patients (6.8%) and included 2 cardiac deaths (1.7%), 1 target vessel myocardial infarction (0.9%), and 5 clinically driven target lesion revascularizations (4.3%). No definite or probable scaffold thrombosis was observed. The 36- month clinical visits are ongoing for BIOSOLVE-III patients and data of the combined cohort will be available upon presentation. CONCLUSION The 36-month results of DREAMS 2G, meaning 2 years beyond the completion of resorption, are encouraging on safety and clinical performance standpoints. They will be presented for a larger population of subjects enrolled in the BIOSOLVE-II and -III studies. (AU)


Assuntos
Reestenose Coronária , Stents Farmacológicos
4.
Europace ; 2019 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-31578544

RESUMO

AIMS: We sought to assess the need for permanent pacemaker implantation (PPI) in patients with QRS <120 ms in electrocardiogram (ECG) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We retrospectively analysed 1139 consecutive patients who underwent transfemoral TAVI between 2008 and 2016, receiving different valve types. All patients were surveyed by continuous ECG monitoring for 48 h, 12-lead ECGs starting immediately after procedure, as well as 24-h Holter recording the day before discharge. Indication for PPI was at the discretion of the attending physician. Among 760 patients with QRS <120 ms prior to the TAVI procedure, 400 patients showed QRS <120 ms immediately after procedure, whereas 360 patients had QRS ≥120 ms. In the group with QRS <120 ms, PPI was performed in 34 patients [8.5%; 95% confidence interval (CI) 5.6-11.2%] during the first week. Eight of the PPIs in the group with QRS <120 ms (2%; CI 0.8-3.5%) fulfilled Class I indications for PPI after TAVI, whereas 26 PPIs had different indications [left bundle branch block, sick sinus, low-grade atrioventricular (AV) block]. Complete AV block developed in three patients of the group of QRS <120 ms (0.75%; CI 0.0-1.7%), which in all cases occurred after the 48 h-surveillance period. During 1-year follow-up, 11 PPIs were performed (2.8%; CI 1.2-4.5%), thereof three PPI for Class I indications including one complete AV block. CONCLUSION: In patients with QRS duration <120 ms immediately after TAVI, the risk for complete AV block was low during the first week after TAVI and 1-year follow-up.

5.
JACC Cardiovasc Interv ; 12(19): 1915-1923, 2019 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-31601387

RESUMO

OBJECTIVES: The aim of this study was to assess the prognostic impact of post-procedural troponin T increase and mortality in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) to define the threshold at which procedure-related myocardial injury drives mortality. BACKGROUND: Coronary CTO recanalization represents the most technically challenging PCI. The complexity harbors a significant increased risk for complications with CTO PCI with compared with non-CTO PCI. However, there are evidenced biomarker cutoff levels that help identify those patients at risk for unfavorable clinical outcomes. METHODS: A total of 3,712 consecutive patients undergoing PCI for at least 1 CTO lesion were enrolled, and comprehensive troponin T measurements were performed 6, 8, and 24 h after the procedure. All-cause mortality was defined as the primary study endpoint. RESULTS: Using spline curve analysis, a more than 18-fold increase of troponin above the upper reference limit was significantly associated with mortality. In a Cox regression analysis, the crude hazard ratio was 2.32 (95% confidence interval: 1.83 to 2.93; p < 0.001) for a ≥18-fold increase compared with patients with post-procedural troponin increase <18-fold of the upper reference limit. Results remained virtually unchanged after bootstrap- or clinical confounder-based adjustment. CONCLUSIONS: This large-scale outcome study demonstrates for the first time the prognostic value of post-procedural troponin T elevation after PCI in patients with CTOs. A threshold was defined for procedure-related myocardial injury in patients with CTOs to differentiate them from those without CTOs that may help guide post-procedural clinical care in this high-risk patient population.

6.
Dtsch Med Wochenschr ; 144(20): 1417-1422, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31594016

RESUMO

This article gives an overview of the novelties of the current ESC-guideline on "myocardial revascularization (2018)". Twenty completely new recommendations were given (seven class I, five class IIa, six class IIb and two class III). Moreover, four recommendations were upgraded and six downgraded. The comprehensive changes relate to preprocedural (diagnosis, choice of revacularisation-strategy), intraprocedural (revascularisation) and postprocedural aspects.

7.
Clin Res Cardiol ; 2019 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-31555985

RESUMO

AIMS: Identifying factors associated with worse outcome following carotid endarterectomy (CEA) is important to improve prevention of major adverse cardiovascular and cerebrovascular events (MACCE), yet rarely used for registries. We intended to identify predictors of MACCE following CEA as recently analysed for stenting. METHODS AND RESULTS: Patients undergoing CEA at 2 centers over 13 years were entered into a database. Baseline clinical characteristics, procedural factors and a panel of clinical and lesion-related high-risk features (SHR) and exclusion criteria (SE), empirically compiled for stratification in the SAPPHIRE trial, were differentially analysed using Cox regressions. The analysis included 748 operations; 262 (35%) asymptomatic, 208 (28%) with previous strokes, and 278 (37%) with transient ischemic attacks (TIA). The overall 30-day MACCE rate was 6.7%, 5.0% in asymptomatic and 7.6% in symptomatic patients. Previous MI (HR 2.045, p = 0.022), diabetes (HR 2.111, p = 0.011) and symptomatic patients (HR 2.045, p = 0.044) were independently associated with MACCE. SE patients (n = 81) had a MACCE rate of 13.6%; the MACCE rate of the remainder dropped to 5.8% (4.7% in asymptomatic and 6.5% in symptomatic patients). Hazard ratio for SHR patients was 2.069 (CI 1.087-3.941) and 2.389 for SE (CI 1.223-4.666), each compared to all patients with lower risk and adjusted for symptomatic status. Among SHR and SE criteria NYHA 3-4, contralateral occlusions and intraluminal thrombus were significant determinants and MI < 4 weeks before CEA showed a strong trend (p = 0.05). CONCLUSION: Patients identified by SHR and SE criteria, prior MI and diabetes warrant increased attention to prevent MACCE following CEA.

8.
Blood ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31481482

RESUMO

Clinical observations implicate a role of eosinophils in cardiovascular diseases, because markers of eosinophils activation are elevated in atherosclerosis and thrombosis. However, their contribution to atherosclerotic plaque formation and arterial thrombosis remains unclear. In these settings, we investigated how eosinophils are recruited and activated through an interplay with platelets. Here, we provide evidence for a central importance of eosinophil-platelet interactions in atherosclerosis and thrombosis. We show that eosinophils support atherosclerotic plaque formation involving enhanced von Willebrand factor exposure on endothelial cell and augmented platelet adhesion. During arterial thrombosis, eosinophils are quickly recruited in an integrin-dependent manner and engage in interactions with platelets leading to eosinophil activation as we show by intravital calcium imaging. These direct interactions induce the formation of eosinophil extracellular traps (EETs), which are present in human thrombi and constitute a substantial part of extracellular traps in murine thrombi. EETs are decorated with the granule protein major basic protein, which causes platelet activation by eosinophils. Consequently, targeting of EETs diminished thrombus formation in vivo identifying this approach as a novel antithrombotic concept. Finally, in our clinical analysis of coronary artery thrombi we identified female patients with stent thrombosis as the population that might derive the greatest benefit from an eosinophil inhibiting strategy. In summary, eosinophils contribute to atherosclerotic plaque formation and thrombosis through an interplay with platelets, resulting in mutual activation. Therefore, eosinophils are a promising new target in the prevention and therapy of atherosclerosis and thrombosis.

9.
N Engl J Med ; 381(16): 1524-1534, 2019 10 17.
Artigo em Inglês | MEDLINE | ID: mdl-31475799

RESUMO

BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Inibidores da Agregação de Plaquetas/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticagrelor/uso terapêutico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Idoso , Trombose Coronária/epidemiologia , Feminino , Hemorragia/induzido quimicamente , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Stents , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Ticagrelor/efeitos adversos
11.
Am J Cardiol ; 124(9): 1380-1388, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31477234

RESUMO

Hypertension is associated with vascular and endothelial dysfunction that may result in a greater propensity for reactive platelets to cause thrombosis. We sought to assess whether the risk of major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) in patients with on-clopidogrel residual high platelet reactivity (HPR) varies in patients with versus without hypertension. Assessment of dual antiplatelet therapy with drug eluting stents (ADAPT-DES) was a prospective, multicenter registry of patients successfully treated with coronary drug-eluting stents (DES). HPR was defined as P2Y12 reaction units (PRU) >208, as assessed by the VerifyNow point-of-care assay. Multivariable Cox proportional hazards regression was used to assess whether the adjusted association between HPR and 2-year risk of MACE (cardiac death, myocardial infarction [MI], or stent thrombosis) was different in patients with versus without hypertension. A total of 6833 of 8582 patients (79.6%) had a history of hypertension. Patients with compared with those without hypertension were older, more likely to have other cardiovascular risk factors, and had higher PRU (190.1 ± 97.3 vs 179.5 ± 94.3; p <0.0001). Patients with hypertension had significantly higher 2-year rates of MACE (7.0% vs 4.4%, p <0.001), all-cause death (4.2% vs 2.5%, p = 0.001), and MI (5.2% vs 3.2%, p <0.001), and had nominally higher rates of stent thrombosis (1.0% vs 0.5%, p = 0.059). A significant interaction was present between hypertension and HPR regarding 2-year MACE risk (adjusted hazard ratio for HPR vs no HPR 1.38, 95% confidence interval 1.14 to 1.68 for patients with hypertension vs 0.81, 95% confidence interval 0.50 to 1.33 for patients without hypertension, p = 0.046). In conclusion, following successful PCI with DES, 2-year MACE rates are increased in patients with both hypertension and residual HPR on clopidogrel. HPR had a greater effect on the risk of adverse events among patients with versus without hypertension.

12.
Heart Rhythm ; 2019 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-31494091

RESUMO

BACKGROUND: Radiation is one of the main hazards of electrophysiological device implantation, and insertion of cardiac resynchronization therapy (CRT) devices in particular is associated with high radiation doses. OBJECTIVE: The purpose of this study was to evaluate the impact of a new ultralow-dose radiation protocol on radiation doses, success rate, and safety of electrophysiological device implantations. METHODS: In 2018, we established a new ultralow-dose radiation protocol (reduced pulse width, increased thickness of minimum copper filters, reduced detector entrance dose, reduced pulse rate, optimized image postprocessing settings) for de novo device implantation at our hospital. A total of 1173 patients (11% single-chamber devices, 69% dual-chamber devices, 20% CRT devices) were analyzed. Five hundred twelve patients (44%) in the ultralow-dose group were compared to 661 patients (66%) treated during 2017 with a conventional low-dose protocol. RESULTS: With the ultralow-dose radiation protocol, effective doses could be reduced by 59% (median 0.25 [interquartile range: 0.11-0.63] vs median 0.10 [interquartile range: 0.03-0.28] mSv; P <.0001) per procedure without a significant change in procedure time (P = .5). This dose reduction could be achieved without decreasing procedure success (P = 1) or increasing complication rate (P = .8). Male gender, higher body mass index, increased procedure and fluoroscopy times, and use of the conventional radiation protocol were independent predictors of higher radiation doses in multivariate regression analysis. CONCLUSION: By establishing a new ultralow-dose radiation protocol, we could significantly decrease radiation exposure, reaching the lowest radiation doses for electrophysiological device implantation reported to date.

14.
JACC Cardiovasc Interv ; 12(16): 1521-1537, 2019 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-31202949

RESUMO

Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the standard treatment for patients undergoing percutaneous coronary intervention. The availability of different P2Y12 receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment regimens, which may include escalation or de-escalation of P2Y12-inhibiting therapy. Indeed, individualized and alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early- vs. long-term treatment), and patient risk for ischemic and bleeding complications. A tailored DAPT approach may be potentially guided by platelet function testing (PFT) or genetic testing. Although the routine use of PFT or genetic testing in percutaneous coronary intervention-treated patients is not recommended, recent data have led to an update in guideline recommendations that allow considering selective use of PFT for DAPT de-escalation. However, guidelines do not expand on when to implement the selective use of such assays into decision making for personalized treatment approaches. Therefore, an international expert consensus group of key leaders from North America, Asia, and Europe with expertise in the field of antiplatelet treatment was convened. This document updates 2 prior consensus papers on this topic and summarizes the contemporary updated expert consensus recommendations for the selective use of PFT or genotyping in patients undergoing percutaneous coronary intervention.

15.
Eur Heart J ; 40(24): 1942-1951, 2019 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-31226213

RESUMO

AIMS: The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel. METHODS AND RESULTS: Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups. CONCLUSION: Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel.

16.
Europace ; 21(6): 871-878, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-31157388

RESUMO

AIMS: Sinus rhythm restoration (SRR) in patients with atrial fibrillation (AF) and heart failure may improve systolic function and impact on consecutive clinical management, but time course and potential predictors of response to SRR are uncertain. METHODS AND RESULTS: We prospectively studied 50 consecutive patients who presented in heart failure with reduced ejection fraction (EF) and concomitant AF. After exclusion of valvular and coronary artery disease patients underwent electrical cardioversion. Serial echocardiography, cardiac magnetic resonance imaging (cMRI), and 24-h electrocardiograms were performed at baseline, and on Days 3 and 40 following SRR. Baseline left ventricular EF of the study population (76% male, age 69 ± 11 years) was 30 ± 7%. Sustained SRR (≥3 days) significantly improved EF (Day 3: 43 ± 7%, n = 46; Day 40: 53 ± 9%, n = 34; P < 0.001) as quantified by echocardiography. Comparable results were obtained using cMRI (baseline: 29 ± 8%; Day 3: 42 ± 9%). Three patients showed no response to SRR (EF improvement <15%). The percentage of patients meeting current criteria for implantable cardioverter-defibrillator (ICD) implantation for primary prevention dropped from 76% (n = 38) to 11% (n = 3) on Day 40 following SRR. No specific clinical or echocardiographic factor predicting improved EF after SRR could be identified. CONCLUSION: The majority of patients presenting with non-ischaemic, non-valvular heart failure with reduced EF and concomitant AF show a significant and rapid improvement in EF following SRR. An attempt at SRR and reassessment of the need for ICD implantation after 40 days may be warranted in all such patients.

17.
Cardiovasc Revasc Med ; 20(5): 392-398, May 2019. ilus, tab
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1006900

RESUMO

Introduction and objective: The edge vascular response (EVR) remains unknown in second generation drugeluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. Results: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not showany significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process a the edges of the RMS. Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imagingmodalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over timein the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.


Assuntos
Humanos , Ultrassonografia de Intervenção , Tomografia de Coerência Óptica
19.
Cardiovasc Revasc Med ; 20(5): 392-398, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31079817

RESUMO

INTRODUCTION AND OBJECTIVE: The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. RESULTS: The segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ±â€¯1.43 mm2 (p = 0.012) and 2.49 ±â€¯1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ±â€¯0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ±â€¯0.48 mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ±â€¯0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ±â€¯0.53 mm2 (p = 0.023) and 0.17 ±â€¯0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ±â€¯1.51 mm2 (p = 0.045) in a distal frame. CONCLUSION: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS. SUMMARY: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

20.
Ultraschall Med ; 2019 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-31141825

RESUMO

PURPOSE: The accuracy of internal carotid artery stenosis (ICAS) quantification depends on the method of stenosis measurement, impacting therapeutic decisions and outcomes. The NASCET method references the stenotic to the distal ICAS lumen, the ECST method to the local outer and the common carotid artery (CC) method to the CC diameter. Direct morphometric stenosis measurement with four-dimensionally guided three-dimensional ultrasonography (4D/3DC-US) demonstrated good validity for the commonly used NASCET method. The NASCET definition has clinically relevant drawbacks. Our purpose was to investigate the validity of the ECST and CC methods. MATERIALS AND METHODS: 4D/3DC-US percent-stenosis measures of 103 stenoses (80 patients) were compared to quantitative catheter angiography and duplex ultrasonography (DUS) in a blinded fashion. RESULTS: The 4D/3DC-US versus angiography intermethod standard deviation of differences (SDD, n = 103) was lower for the CC method (5.7 %) compared to the NASCET (8.1 %, p < 0.001) and ECST methods (9.1 %, p < 0.001). Additionally, it was lower than the NASCET angiography interrater SDD of 52 stenoses (SDD 7.2 %, p = 0.047) and non-inferior for the ECST method (p = 0.065). Interobserver analysis of equivalent grading methods showed no differences for the SDDs between angiography and 4D/3DC-US observers (p > 0.076). Binary comparison to angiography showed equal Kappa values > 0.7 and an accuracy ≥ 85 % for the NASCET and CC methods, higher than for the ECST method. The binary accuracy of ICAS grading did not differ from DUS for all methods. CONCLUSION: The new 4D/3DC-US CC method is an accurate and well reproducible alternative to the NASCET and ECST methods and offers potential for clinical application.

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