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2.
JACC Cardiovasc Interv ; 14(19): 2127-2140, 2021 10 11.
Artigo em Inglês | MEDLINE | ID: mdl-34620391

RESUMO

OBJECTIVES: The aim of this retrospective analysis was to categorize patients with severe aortic stenosis (AS) according to clinical presentation by applying unsupervised machine learning. BACKGROUND: Patients with severe AS present with heterogeneous clinical phenotypes, depending on disease progression and comorbidities. METHODS: Unsupervised agglomerative clustering was applied to preprocedural data from echocardiography and right heart catheterization from 366 consecutively enrolled patients undergoing transcatheter aortic valve replacement for severe AS. RESULTS: Cluster analysis revealed 4 distinct phenotypes. Patients in cluster 1 (n = 164 [44.8%]), serving as a reference, presented with regular cardiac function and without pulmonary hypertension (PH). Accordingly, estimated 2-year survival was 90.6% (95% CI: 85.8%-95.6%). Clusters 2 (n = 66 [18.0%]) and 4 (n = 91 [24.9%]) both comprised patients with postcapillary PH. Yet patients in cluster 2 with preserved left and right ventricular structure and function showed a similar survival as those in cluster 1 (2-year survival 85.8%; 95% CI: 76.9%-95.6%), whereas patients in cluster 4 with dilatation of all heart chambers and a high prevalence of mitral and tricuspid regurgitation (12.5% and 14.8%, respectively) died more often (2-year survival 74.9% [95% CI: 65.9%-85.2%]; HR for 2-year mortality: 2.8 [95% CI: 1.4-5.5]). Patients in cluster 3, the smallest (n = 45 [12.3%]), displayed the most extensive disease characteristics (ie, left and right heart dysfunction together with combined pre- and postcapillary PH), and 2-year survival was accordingly reduced (77.3% [95% CI: 65.2%-91.6%]; HR for 2-year mortality: 2.6 [95% CI: 1.1-6.2]). CONCLUSIONS: Unsupervised machine learning aids in capturing complex clinical presentations as observed in patients with severe AS. Importantly, structural alterations in left and right heart morphology, possibly due to genetic predisposition, constitute an equally sensitive indicator of poor prognosis compared with high-grade PH.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Análise por Conglomerados , Ecocardiografia , Hemodinâmica , Humanos , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
5.
Clin Res Cardiol ; 110(12): 1993-2006, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34505192

RESUMO

BACKGROUND: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI). AIMS: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis. METHODS: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated. RESULTS: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm3, TAV 848mm3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different. CONCLUSIONS: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation.

6.
J Am Coll Cardiol ; 78(6): 545-558, 2021 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-34353531

RESUMO

BACKGROUND: Cardiovascular magnetic resonance (CMR) is increasingly used for risk stratification in aortic stenosis (AS). However, the relative prognostic power of CMR markers and their respective thresholds remains undefined. OBJECTIVES: Using machine learning, the study aimed to identify prognostically important CMR markers in AS and their thresholds of mortality. METHODS: Patients with severe AS undergoing AVR (n = 440, derivation; n = 359, validation cohort) were prospectively enrolled across 13 international sites (median 3.8 years' follow-up). CMR was performed shortly before surgical or transcatheter AVR. A random survival forest model was built using 29 variables (13 CMR) with post-AVR death as the outcome. RESULTS: There were 52 deaths in the derivation cohort and 51 deaths in the validation cohort. The 4 most predictive CMR markers were extracellular volume fraction, late gadolinium enhancement, indexed left ventricular end-diastolic volume (LVEDVi), and right ventricular ejection fraction. Across the whole cohort and in asymptomatic patients, risk-adjusted predicted mortality increased strongly once extracellular volume fraction exceeded 27%, while late gadolinium enhancement >2% showed persistent high risk. Increased mortality was also observed with both large (LVEDVi >80 mL/m2) and small (LVEDVi ≤55 mL/m2) ventricles, and with high (>80%) and low (≤50%) right ventricular ejection fraction. The predictability was improved when these 4 markers were added to clinical factors (3-year C-index: 0.778 vs 0.739). The prognostic thresholds and risk stratification by CMR variables were reproduced in the validation cohort. CONCLUSIONS: Machine learning identified myocardial fibrosis and biventricular remodeling markers as the top predictors of survival in AS and highlighted their nonlinear association with mortality. These markers may have potential in optimizing the decision of AVR.

7.
JACC Cardiovasc Interv ; 14(14): 1578-1590, 2021 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-34294400

RESUMO

OBJECTIVES: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR). BACKGROUND: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences. METHODS: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included. RESULTS: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement. CONCLUSIONS: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.


Assuntos
Síndrome Coronariana Aguda , Estenose da Valva Aórtica , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/terapia , Estudos de Viabilidade , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
10.
JACC Cardiovasc Interv ; 14(2): 198-207, 2021 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-33478637

RESUMO

OBJECTIVES: This study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR). BACKGROUND: Coronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated. METHODS: Patients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry. RESULTS: Between July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non-ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p = 0.150). CONCLUSIONS: Unplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indication to PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromes become prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparent differences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501).


Assuntos
Estenose da Valva Aórtica , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
11.
Rev Esp Cardiol (Engl Ed) ; 74(7): 584-590, 2021 Jul.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-32819850

RESUMO

INTRODUCTION AND OBJECTIVES: Long-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice. METHODS: Consecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis. RESULTS: A total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation. CONCLUSIONS: In patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Idoso , Doença da Artéria Coronariana/cirurgia , Everolimo , Alemanha , Humanos , Pessoa de Meia-Idade , Desenho de Prótese , Solubilidade , Tecidos Suporte , Resultado do Tratamento
12.
Am J Cardiol ; 138: 92-99, 2021 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-33065085

RESUMO

Bioprosthetic valve thrombosis may complicate transcatheter aortic valve implantation (TAVI). This meta-analysis sought to evaluate the prevalence and clinical impact of subclinical leaflet thrombosis (SLT) and clinical valve thrombosis (CVT) after TAVI. We summarized diagnostic strategies, prevalence of SLT and/or CVT and estimated their impact on the risk of all-cause death and stroke. Twenty studies with 12,128 patients were included. The prevalence of SLT and CVT was 15.1% and 1.2%, respectively. The risk of all-cause death was not significantly different between patients with SLT (relative risk [RR] 0.77; p = 0.22) and CVT (RR 1.29; p = 0.68) compared with patients without. The risk of stroke was higher in patients with CVT (RR 7.51; p <0.001) as compared with patients without, while patients with SLT showed no significant increase in the risk of stroke (RR 1.81; p = 0.17). Reduced left ventricular function was associated with increased prevalence, while oral anticoagulation was associated with reduced prevalence of bioprosthetic valve thrombosis. Bioprosthetic valve thrombosis is frequent after TAVI, but does not increase the risk of death. Clinical valve thrombosis is associated with a significantly increased risk of stroke. Future studies should focus on prevention and treatment of bioprosthetic valve thrombosis.


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/epidemiologia , Trombose/epidemiologia , Substituição da Valva Aórtica Transcateter , Anticoagulantes/uso terapêutico , Doenças Assintomáticas/epidemiologia , Causas de Morte , Humanos , Mortalidade , Complicações Pós-Operatórias/fisiopatologia , Prevalência , Fatores de Proteção , Risco , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Trombose/fisiopatologia , Disfunção Ventricular Esquerda/epidemiologia
13.
Am J Cardiol ; 139: 71-78, 2021 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-33190811

RESUMO

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of "fluoro save," 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm2, p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm2 reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Fluoroscopia/métodos , Lesões por Radiação/prevenção & controle , Cirurgia Assistida por Computador/métodos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Relação Dose-Resposta à Radiação , Feminino , Humanos , Masculino , Prognóstico , Estudos Retrospectivos , Fatores de Risco
14.
EuroIntervention ; 17(6): 481-488, 2021 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-33258774

RESUMO

BACKGROUND: The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. AIMS: We sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon. METHODS: In this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success. RESULTS: OCT data after DES implantation were available for 70 out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon. CONCLUSIONS: In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.


Assuntos
Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Reestenose Coronária , Stents Farmacológicos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Stents , Resultado do Tratamento
15.
ESC Heart Fail ; 8(1): 461-470, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33215870

RESUMO

AIMS: The aim of this study was to assess the prognostic value of the H2 FPEF score in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF). METHODS AND RESULTS: In this multicentre study, a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H2 FPEF score. Patients were dichotomized according to low (0-5 points; n = 570) and high (6-9 points; n = 262) H2 FPEF scores. Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H2 FPEF score. We observed a decrease in stroke volume index (-2.04 mL/m2 /point) and mean transvalvular gradients (-1.14 mmHg/point) with increasing H2 FPEF score translating into a higher prevalence of paradoxical low-flow, low-gradient AS among patients with high H2 FPEF score. One year after TAVI, the rates of all-cause (low vs. high H2 FPEF score: 8.0% vs. 19.4%, P < 0.0001) and cardiovascular (CV) mortality (1.9% vs. 9.0%, P < 0.0001) as well as the rate of CV mortality or rehospitalization for congestive heart failure (6.4% vs. 23.2%, P < 0.0001) were higher in patients with high H2 FPEF score compared with those with low H2 FPEF score. After multivariable analysis, a high H2 FPEF score remained independently predictive of all-cause mortality [hazard ratio 1.59 (1.28-2.35), P = 0.018] and CV mortality or rehospitalization for congestive heart failure [hazard ratio 2.92 (1.65-5.15), P < 0.001]. Among the H2 FPEF score variables, atrial fibrillation, pulmonary hypertension, and elevated left ventricular filling pressure were the strongest outcome predictors. CONCLUSIONS: The H2 FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H2 FPEF score is associated with the presence of paradoxical low-flow, low-gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H2 FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI.


Assuntos
Estenose da Valva Aórtica , Insuficiência Cardíaca , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Insuficiência Cardíaca/epidemiologia , Humanos , Prognóstico , Volume Sistólico , Função Ventricular Esquerda
16.
Catheter Cardiovasc Interv ; 98(5): 857-862, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32845090

RESUMO

OBJECTIVES: The present study aims to analyze the angiographic anti-restenotic performance of durable polymer everolimus-eluting stents (EES) for the treatment of in-stent restenosis (ISR) in daily practice. BACKGROUND: Randomized data is available supporting the use of drug-coated balloons and drug-eluting stents for the treatment of ISR; however, additional real-world data including angiographic follow-up is needed. METHODS: Patients who underwent EES-implantation for the treatment of drug-eluting stent ISR and attended for a 6-8 months angiographic surveillance were analyzed. Off-line assessment of the angiograms was conducted at a central quantitative coronary angiographic core laboratory. RESULTS: A total of 426 patients with ISR were treated with EES and had undergone angiographic follow-up. The mean age was 66.8 ± 9.9 years and 27.5% suffered from diabetes. A total of 459 lesions were treated. The diameter stenosis decreased from 64.3 ± 19.1% (preprocedural) to 12.0 ± 6.4% (postprocedural). At 6-8 months angiographic follow-up, the in-segment diameter stenosis was 38.3 ± 21.7% and the in-stent late luminal loss was 0.54 ± 0.74 mm in the treated area analysis. The rate of recurrent binary restenosis was 25.7%. CONCLUSIONS: In the setting of ISR, the angiographic anti-restenotic efficacy of stenting with EES is comparable to that observed in randomized clinical trials and less favorable than its performance in patients undergoing stenting for de novo disease.

17.
J Thorac Dis ; 12(11): 6769-6779, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33282378

RESUMO

Background: This study compares two latest-generation self-expanding transcatheter heart valves (THV), the supra-annular ACURATE neo (Boston Scientific) and the intra-annular Centera THV (Edwards Lifesciences). Methods: In this single center observational cohort trial 317 patients treated with the ACURATE neo and 78 patients treated with the Centera TVH were included. The main endpoints were device success and the early safety endpoint at 30 days. Results: Besides higher incidence of diabetes mellitus and higher body mass index in patients treated with the ACURATE neo THV, there were no baseline differences between the groups. Device success was similar in both groups (neo: 91.8% vs. Centera: 93.6%; P=0.598), with numerically higher rates of moderate to severe paravalvular leakage in the ACURATE neo group (4.7% vs. 1.3%; P=0.214). At 30 days all-cause mortality rates were low in both groups (0.3% vs. 0%; P=0.620) and no difference occurred in the early safety at 30 days (19.3% vs. 16.7%; P=0.599). However, all-cause stroke rates were significantly higher in patients treated with the Centera THV (6.4 vs. 1.6%; P=0.015). Conclusions: The ACURATE neo and the Centera THV show low mortality rates as well as comparable, favorable hemodynamics. The finding of higher stroke rates at 30 days with the repositionable Centera SE-THV needs further assessment.

18.
Clin Res Cardiol ; 2020 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-33367949

RESUMO

AIMS: To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio-RR = 0.83, 95% Confidence intervals-CI (0.57-1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61-2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27-3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke. CONCLUSIONS: In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.

19.
JACC Cardiovasc Interv ; 13(22): 2631-2638, 2020 11 23.
Artigo em Inglês | MEDLINE | ID: mdl-33129822

RESUMO

OBJECTIVES: The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (THVs). BACKGROUND: The latest generation balloon-expandable Ultra THV incorporates new technical features and might improve outcomes following TAVR. METHODS: This registry included all consecutive patients who underwent TAVR with either the Ultra or S3 between January 2014 and January 2020. One-to-one propensity score matching was performed to account for differences in baseline characteristics. In-hospital and 30-day Valve Academic Research Consortium-2-defined outcomes were investigated. RESULTS: A total of 310 patients (n = 155 Ultra, n = 155 S3) were included. There were no significant differences in baseline characteristics after propensity score matching. Procedures were significantly more often performed under conscious sedation with Ultra compared with S3 (97.4% vs. 71.6%; p < 0.001). Pre-dilatation was more frequent with S3 compared with Ultra (85.2% vs. 42.6%; p < 0.001). In-hospital outcomes, including device success (91.6% vs. 95.5%; p = 0.165), major vascular complications (12.3% vs. 11.0%; p = 0.723), and new pacemaker implantation (5.8% vs. 4.5%; p = 0.608), were comparable between S3 and Ultra patients, respectively. Post-procedural mean transprosthetic gradients (13.2 ± 5.7 mm Hg vs. 13.1 ± 4.7 mm Hg; p = 0.829) and rate of moderate or greater paravalvular leakage (PVL) (1.3% vs. 2.7%; p = 0.414) were comparable, whereas mild PVL was more frequent with S3 compared with Ultra (43.0% vs. 18.7%; p < 0.001). CONCLUSIONS: Device success rates were high with both balloon-expandable THVs, with overall low rates of adverse events up to 30 days after TAVR. Despite a lower frequency of pre-dilatation, significant reduction of mild PVL confirms improved annular sealing properties of the novel Ultra THV.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Desenho de Prótese , Resultado do Tratamento
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