Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 118
Filtrar
1.
J Am Coll Cardiol ; 2024 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-39217574

RESUMO

BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.

2.
Struct Heart ; 8(5): 100329, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39290678

RESUMO

Background: Tricuspid regurgitation (TR) is a common valvular disorder with limited treatment options. It occurs when tricuspid leaflet closure is prevented by dilation of the right heart or in patients with cardiac implantable rhythm devices when the transvalvular lead impedes proper closure of the valve. The management of these patients can be complicated. The removal of the lead often does not improve the TR, and surgical repair is usually not possible because of comorbidities. A number of percutaneous TR repair and replacement devices have been developed; however, the presence of the right ventricular lead can prevent the delivery of these devices, or the device may displace the pacemaker lead. We report the first implant of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System (Dublin, Ireland) in a patient with massive TR and a right ventricular lead. Methods: The patient was not a fit for surgical treatment and underwent transcatheter treatment following compassionate use approval. The procedure was performed under general anesthetic with echo and X-ray guidance. The device was delivered through the right internal jugular vein. Results: The device was implanted successfully, and the TR was reduced from massive to mild at 90-day follow-up. The patient's quality of life improved significantly with an improvement in 6-minute walk test (382 m at baseline to 467 m at follow-up), the New York Heart Association classification (III at baseline to I at follow-up), and the Kansas City Cardiomyopathy Questionnaire (baseline score 43 increased to 60). The efficacy and clinical improvement have been stable over the past 90 days of follow-up, and the patient has not suffered any adverse events. Conclusions: This is the first implantation of the CroíValve DUO Coaptation Valve System in a patient with a pacemaker lead. In these patients, this device may offer advantages over other current transcatheter approaches.

3.
N Engl J Med ; 2024 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-39216092

RESUMO

BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).

4.
Eur J Heart Fail ; 26(7): 1608-1615, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38847420

RESUMO

AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.


Assuntos
Insuficiência Cardíaca , Insuficiência da Valva Mitral , Índice de Gravidade de Doença , Volume Sistólico , Humanos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/complicações , Feminino , Masculino , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/complicações , Idoso , Estudos Prospectivos , Volume Sistólico/fisiologia , Resultado do Tratamento , Pessoa de Meia-Idade , Fragmentos de Peptídeos/sangue , Valva Mitral/cirurgia , Peptídeo Natriurético Encefálico/sangue , Implante de Prótese de Valva Cardíaca/métodos , Função Ventricular Esquerda/fisiologia
6.
J Clin Med ; 13(6)2024 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-38541846

RESUMO

Introduction: Transthoracic echocardiography (TTE) and cardiovascular magnetic resonance (CMR) are the most important modalities used in clinical practice to assess cardiac chambers. However, different imaging techniques may affect their results and conclusions. The aim of our study was to compare left-ventricle (LV) remodeling assessed using TTE and CMR in the context of various cardiovascular diseases. Methods: A total of 202 consecutive patients sent for an elective cardiovascular diagnosis were scheduled for a 2D TTE and CMR, performed within 2 weeks. The study group was divided and analyzed based on the clinical indications for CMR, including coronary artery disease, heart failure, native aortic valve regurgitation or paravalvular leak after aortic valve replacement, or cardiomyopathies. Results: The mean LV mass index (LVMi) values calculated using TTE were significantly larger (127.1 ± 44.5 g/m²) compared to the LVMi assessed using CMR (77.1 ± 26.2 g/m²; p < 0.001). The LV end-diastolic volumes assessed using TTE were underestimated for all the study patients (78.6 ± 43 mL vs. 100.5 ± 39 mL; p < 0.0001) and subgroups, but a statistical trend was observed in patients with cardiomyopathy. Those differences in single parameters led to differences in LV remodeling and the final treatment decision. CMR and TTE provided similar conclusions on LV systolic dysfunction in 68% of the patients. Conclusions: Our results showed that the greater the degree of LV remodeling and dysfunction, the greater the difference between the modalities. Therefore, CMR should be introduced into routine clinical practice, especially for patients undergoing LV remodeling, which may change clinical decisions in a considerable number of cases.

7.
Int J Cardiol ; 401: 131820, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-38307419

RESUMO

BACKGROUND: Post-myocardial infarction ventricular septal rupture (VSR) is a rare and severe complication of myocardial infarction. To find early mortality (<30 days) risk factors of device VSR closure and to evaluate its medium-term outcome. METHODS: Multicenter retrospective analysis on all 46 consecutive patients with percutaneous (n = 43) or hybrid (n = 3) VSR closure in 2000-2020 with various nitinol wire mesh occluders. Medical records, hemodynamic data, procedure results, short- and mid-term follow-up were analyzed (4.8 ± 3.7 years, range: 0.1-15, available in 61.7% of patients). Of the patients, 34.8% underwent VSR closure in acute phase (<21 days after VSR occurrence), 17.4% underwent device closure due to significant residual shunt after previous VSR surgery. RESULTS: Success rate was 78.3%. More than moderate residual shunt, major complications, and early surgical reintervention affected 18.9%, 15.2% (including 2 intra-procedural deaths), and 21.7% of patients, respectively. Early mortality was 26.1% (13.9% in successful vs. 70% in unsuccessful closure; p < 0.001). Older age, need for intra-aortic balloon counterpulsation, severe complications, and procedural failure were identified as risk factors for early mortality. Among patients who survived the early period, the 5-year survival rate was 57.1%. NYHA class improved in 88.2% patients at the latest follow-up. CONCLUSIONS: Procedure of VSR device closure demonstrates an acceptable technical success rate; however, the incidence of severe complications and early mortality is notably high. Older patients in poor hemodynamic condition and those with unsuccessful occluder deployment are particularly at a higher risk of a fatal outcome. The prognosis after early survival is promising.


Assuntos
Infarto do Miocárdio , Ruptura do Septo Ventricular , Humanos , Ruptura do Septo Ventricular/diagnóstico , Ruptura do Septo Ventricular/etiologia , Ruptura do Septo Ventricular/cirurgia , Estudos Retrospectivos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/cirurgia , Infarto do Miocárdio/complicações , Fatores de Risco , Prognóstico , Resultado do Tratamento
8.
Arch Cardiovasc Dis ; 116(12): 580-589, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37951755

RESUMO

BACKGROUND: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. AIMS: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. METHODS: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. RESULTS: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged<18years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. CONCLUSIONS: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.


Assuntos
Forame Oval Patente , Comunicação Interatrial , Dispositivo para Oclusão Septal , Humanos , Forame Oval Patente/diagnóstico por imagem , Forame Oval Patente/terapia , Estudos Prospectivos , Cateterismo Cardíaco , Comunicação Interatrial/diagnóstico por imagem , Comunicação Interatrial/terapia , Resultado do Tratamento
9.
Postepy Kardiol Interwencyjnej ; 19(3): 270-276, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37854960

RESUMO

Introduction: Transcatheter closure of paravalvular leak (PVL) is still a demanding procedure due to the complex anatomy of PVL channels and risk of interference between the implanted occluder and surrounding structures. Efforts are made to improve procedural outcomes in transcatheter structural heart interventions by establishing treatment strategy in advance with the use of 3D-printed physical models based on data obtained from cardiac computed tomography (CT) studies. Aim: In this feasibility study 3D printing of PVL models based on data recorded during transesophageal echocardiography (TEE) examinations was evaluated. Material and methods: 3D-TEE data of patients with significant PVL around mitral valve prostheses were used to prepare 3D models. QLab software was used to export DICOM images in Cartesian DICOM format of each PVL with the surrounding tissue. Image segmentation was performed in Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the Polyjet printer with a transparent, rigid material. We measured dimensions of PVLs both in TEE recordings and printed 3D models. The results were correlated with sizes of occluding devices used to close the defects. Results: In 7 out of 8 patients, there was concordance between procedurally implanted occluders and pre-procedurally matched closing devices based on 3D-printed models. Conclusions: 3D-printing from 3D-TEE is technically feasible. Both shape and location of PVLs are preserved during model preparation and printing. It remains to be tested whether 3D printing would improve outcomes of percutaneous PVL closure.

12.
Anatol J Cardiol ; 27(10): 573-579, 2023 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-37288866

RESUMO

BACKGROUND: Paravalvular leaks can be detected in almost 15% of patients after mitral valve prosthesis implantation. This complication can result in congestive heart failure and hemolysis. Despite advancements in non-invasive imaging, percutaneous closure of paravalvular leaks is not always successful. Therefore, efforts are made to improve treatment outcomes by using 3D-printed models of defects as pre-procedural support for interventional cardiologists. METHODS: Retrospectively, 3D-transesophageal echocardiography recordings of 8 patients with clinically significant mitral paravalvular leaks were analyzed. Qlab Software was used to export DICOM images of each paravalvular leak channel, including surrounding tissue. Image segmentation was performed in 3D Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the poly jet Stratasys Objet 30 printer with a transparent, rigid material. RESULTS: Duration of model preparation and printing, as well as the total cost, was calculated. Mean total time of model preparation was 430.5 ± 196 minutes. CONCLUSION: 3D-printing from 3D-transesophageal echocardiography is technically feasible. Both shape and location of paravalvular leaks are preserved during model preparation and printing. It remains to be tested if 3D-printing would improve outcomes of percutaneous paravalvular leaks closure.


Assuntos
Ecocardiografia Tridimensional , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Valva Mitral/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Ecocardiografia Transesofagiana , Estudos Retrospectivos , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Impressão Tridimensional , Cateterismo Cardíaco/métodos , Falha de Prótese
15.
Circ Cardiovasc Interv ; 15(10): e012193, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36256693

RESUMO

BACKGROUND: Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure. METHODS: Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. RESULTS: We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (P=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (P=0.371); and clinical success rates of 70.3% and 88.0%, respectively (P=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; P=0.002; 3.6 [1.1-11.1]; P=0.036; and 3.7 [1.2-11.9]; P=0.025; respectively). CONCLUSIONS: Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05089136.


Assuntos
Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Sistema de Registros , Insuficiência Cardíaca/etiologia , Cateterismo Cardíaco , Falha de Prótese
16.
J Clin Med ; 11(18)2022 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-36143002

RESUMO

BACKGROUND: Shear forces affecting erythrocytes in PVL channels can be calculated with computational fluid dynamics (CFD). The presence of PVLs is always associated with some degree of hemolysis in a simplified model of the left ventricle (LV); however, data from real-life examples is lacking. METHODS: Blood flow through PVL channels was assessed in two variants. Firstly, a PVL channel, extracted from cardiac computed tomography (CCT), was placed in a simplified model of the LV. Secondly, a real-life model of the LV was created based on CCT data from a subject with a PVL. The following variables were assessed: wall shear stress (τw) shear stress in fluid (τ), volume of PVL channel with wall shear stress above 300 Pa (V300), duration of exposure of erythrocytes to shear stress above 300 Pa (Vt300) and compared with lactate dehydrogenase (LDH) activity levels. RESULTS: τw and τ were higher in the simplified model. V300 and Vt300 were almost identical in both models. CONCLUSIONS: Parameters that describe blood flow through PVL channels can be reliably assessed in a simplified model. LDH levels in subjects with PVLs may be related to V300 and Vt300. Length and location of PVL channels may contribute to a risk of hemolysis in mitral PVLs.

18.
BMJ Open ; 12(9): e063990, 2022 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-36130748

RESUMO

INTRODUCTION: Atrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA2DS2-VASc ≥3) and not suitable for chronic oral anticoagulation, owing to history of major bleeding or other contraindications, left atrial appendage occlusion (LAAO) is indicated for stroke prevention, as it lowers patient's ischaemic burden without augmentation in their anticoagulation profile. METHODS AND ANALYSIS: Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER) will be conducted in 10 heart surgery and cardiology centres across Poland to assess the outcomes of LAAO performed by fully thoracoscopic-epicardial, percutaneous-endocardial or hybrid endo-epicardial approach. The registry will include patients with nonvalvular AF at a high risk of thromboembolic and bleeding complications (CHA2DS2-VASc Score ≥2 for males, ≥3 for females, HASBLED score ≥2) referred for LAAO. The first primary outcome is composite procedure-related complications, all-cause death or major bleeding at 12 months. The second primary outcome is a composite of ischaemic stroke or systemic embolism at 12 months. The third primary outcome is the device-specific success assessed by an independent core laboratory at 3-6 weeks. The quality of life (QoL) will be assessed as well based on the QoL EQ-5D-5L questionnaire. Medication and drug adherence will be assessed as well. ETHICS AND DISSEMINATION: Before enrolment, a detailed explanation is provided by the investigator and patients are given time to make an informed decision. The patient's data will be protected according to the requirements of Polish law, General Data Protection Regulation (GDPR) and hospital Standard Operating Procedures. The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval was granted by the local Bioethics Committee of the Upper-Silesian Medical Centre of the Silesian Medical University in Katowice (decision number KNW/0022/KB/284/19). The results will be published in peer-reviewed journals and presented during national and international conferences. TRIAL REGISTRATION NUMBER: NCT05144958.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Isquemia Encefálica , Acidente Vascular Cerebral , Tromboembolia , Animais , Anticoagulantes/uso terapêutico , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Isquemia Encefálica/complicações , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Estudos Observacionais como Assunto , Qualidade de Vida , Sistema de Registros , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Resultado do Tratamento , Urodelos
19.
Postepy Kardiol Interwencyjnej ; 18(1): 14-26, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35982740

RESUMO

Introduction: Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous. Aim: To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES. Material and methods: Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes. Results: Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months. Conclusions: Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.

20.
J Clin Med ; 11(11)2022 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-35683542

RESUMO

Percutaneous device closure has become a valuable alternative to surgery in the management of paravalvular leaks. Consequently, imaging in these patients is currently not only meant to verify the hemodynamic significance of the lesion but also to assess the feasibility of transcatheter treatment. We present a methodology of comprehensive echocardiography assessment that allows for the selection of patients and plans the intervention. Next, procedure-oriented steps of echocardiography imaging, which are essential for eventual success, are reviewed.

SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA