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4.
Artigo em Inglês | MEDLINE | ID: mdl-30280487

RESUMO

OBJECTIVES: In this retrospective observational study, we investigate outcome of patients treated with or without covered stent (CS) implantation in the management of coronary artery perforation (CAP) during coronary intervention. BACKGROUND: CSs have shown to be effective devices to achieve acute hemostasis in large CAP. However, doubts have been raised regarding their long-term outcome. METHODS: Data of 19 061 PCI procedures during a 10-year period were reviewed. Fifty-five cases of large CAP were withheld (Ellis type 2, 3 or cavity spilling). All medical and procedural records of these cases were retrospectively reviewed. RESULTS: Twenty-four (43.6%) patients were treated with CS implantation (15 polytetrafluoroethylene and 9 pericardium CSs). Twenty-six (47.3%) patients were managed without CS implantation, of whom five had unsuccessful delivery of a CS (stent delivery failure 17.2%). Although significantly more Ellis type-3 perforations were present in the CS group compared to the Non-CS group (75.0% vs 45.2%; P = 0.03), in-hospital mortality was not significantly different (8.3% vs 6.4%; [P = 0.79]). We observed a high rate of CS restenosis (29.2%) but a lower rate of CS thrombosis (4.2%). Despite these observations, 5-year MACE and all-cause mortality were not significantly different between CS and Non-CS group (respectively, 58.8% vs 50.0% (P = 0.26) and 26.7% vs 13.3% (P = 0.36)). CONCLUSION: Although deliverability of CSs was not flawless and a high rate of CS restenosis appeared, short- and long-term outcome were comparable between patients treated with or without CS. Therefore, CSs are justifiable in the treatment of CAP.

5.
J Med Genet ; 2018 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-29967133

RESUMO

BACKGROUND: Missense variants in SMAD2, encoding a key transcriptional regulator of transforming growth factor beta signalling, were recently reported to cause arterial aneurysmal disease. OBJECTIVES: The aims of the study were to identify the genetic disease cause in families with aortic/arterial aneurysmal disease and to further define SMAD2 genotype-phenotype correlations. METHODS AND RESULTS: Using gene panel sequencing, we identified a SMAD2 nonsense variant and four SMAD2 missense variants, all affecting highly conserved amino acids in the MH2 domain. The premature stop codon (c.612dup; p.(Asn205*)) was identified in a marfanoid patient with aortic root dilatation and in his affected father. A p.(Asn318Lys) missense variant was found in a Marfan syndrome (MFS)-like case who presented with aortic root aneurysm and in her affected daughter with marfanoid features and mild aortic dilatation. In a man clinically diagnosed with Loeys-Dietz syndrome (LDS) that presents with aortic root dilatation and marked tortuosity of the neck vessels, another missense variant, p.(Ser397Tyr), was identified. This variant was also found in his affected daughter with hypertelorism and arterial tortuosity, as well as his affected mother. The third missense variant, p.(Asn361Thr), was discovered in a man presenting with coronary artery dissection. Variant genotyping in three unaffected family members confirmed its absence. The last missense variant, p.(Ser467Leu), was identified in a man with significant cardiovascular and connective tissue involvement. CONCLUSION: Taken together, our data suggest that heterozygous loss-of-function SMAD2 variants can cause a wide spectrum of autosomal dominant aortic and arterial aneurysmal disease, combined with connective tissue findings reminiscent of MFS and LDS.

7.
EuroIntervention ; 13(13): 1603-1611, 2018 01 20.
Artigo em Inglês | MEDLINE | ID: mdl-28966159

RESUMO

AIMS: This study aimed to assess the safety and efficacy at midterm follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. METHODS AND RESULTS: Between June 2009 and November 2016, 457 consecutive patients (63% male, 75±12 yrs, CHA2DS2-VASc 4±0.6, HAS-BLED 3.5±0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1.9%), four major bleedings (0.8%) and two device embolisations (0.4%). Among patients successfully implanted having a complete follow-up (672 patient-years, median follow-up 370 days), the actual annual stroke rate was 1.2%, lower than the expected stroke risk of 4% (70% reduction). The observed bleeding rate was 2%, while the calculated risk was 3.7% (46% reduction). Kaplan-Meier analysis showed a similar overall survival (93±2% and 87±3% versus 91±3% and 87±4%; p=0.35) and event-free survival (92±2% and 84±3% versus 88±3% and 80±5%; p=0.17) at one and two years, for the ACP/Amulet versus the WATCHMAN groups of patients, respectively. CONCLUSIONS: The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.

8.
Acta Cardiol ; 73(2): 200-201, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28745134

RESUMO

Coronary artery fistulae are rare cardiac anomalies with a prevalence of 0.2% of all the patients undergoing coronary angiography. The majority of them are congenital and generally origin from the right coronary artery. Occasionally acquired (mostly iatrogenic) fistulae can develop. Although frequently subclinical, symptoms of angina and congestive heart failure may occur. We present an unusual well-illustrated case of a strongly dilated circumflex coronary artery with formation of two giant aneurysms and fistulous communication towards the right atrium.

10.
EuroIntervention ; 13(Z): Z14-Z16, 2017 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-28504223

RESUMO

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world. This is, at least in part, due to a well-developed social security system on which all citizens can rely. Over the last 5-10 years, however, this system has come under increasing pressure. This has resulted in insufficient, incomplete and late reimbursement of all technologies that were introduced over the last ten years in the cathlab: intracoronary imaging techniques are not reimbursed at all, and FFR only to a vastly insufficient degree. For several structural heart interventions, a system of limited and incomplete reimbursement has recently been set up, with a requirement to organise these procedures within the frames of hospital networks. Numbers of PCIs have risen by 15% over the last four years, coinciding with an increase in the number of cathlabs by 50%, aiming at better access to primary PCI for STEMI patients. This has also resulted in a decrease in the average procedure volume per centre. Two thirds of PCIs are performed via the radial access. DES penetration has increased to 74%, approaching 100% in some centres, while the uptake of BRS has been very limited so far.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Bélgica , Coração/fisiopatologia , Hospitais , Humanos , Intervenção Coronária Percutânea/métodos , Fatores de Tempo
11.
JACC Cardiovasc Interv ; 10(2): 133-143, 2017 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-28104206

RESUMO

OBJECTIVES: The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BACKGROUND: The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. METHODS: In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. RESULTS: Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. CONCLUSIONS: This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Oclusão Coronária/terapia , Reestenose Coronária/diagnóstico por imagem , Trombose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Polímeros/química , Sirolimo/administração & dosagem , Idoso , Bélgica , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Método Simples-Cego , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
12.
J Am Coll Cardiol ; 68(7): 715-23, 2016 08 16.
Artigo em Inglês | MEDLINE | ID: mdl-27515331

RESUMO

BACKGROUND: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES: This study aimed to analyze whether BCM, compared with saline control, would result in less LV dilation and fewer adverse clinical events between baseline and 6 months. METHODS: In an international, randomized, double-blind, controlled trial, 303 subjects with large areas of infarction despite successful primary percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) were randomized 2:1 to BCM or saline injected into the infarct-related artery 2 to 5 days after primary PCI. The primary outcome was mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months. Secondary outcomes included change in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk time, and New York Heart Association functional class at 6 months. The primary safety endpoint was a composite of cardiovascular death, recurrent MI, target-vessel revascularization, stent thrombosis, significant arrhythmia requiring therapy, or myocardial rupture through 6 months. RESULTS: In total, 201 subjects were assigned to BCM and 102 to saline control. There was no significant difference in change in LVEDVI from baseline to 6 months between the groups (mean change ± SD: BCM 14.1 ± 28.9 ml/m(2) vs. saline 11.7 ± 26.9 ml/m(2); p = 0.49). There was also no significant difference in the secondary endpoints. The rates of the primary safety outcome were similar between the 2 groups (BCM 11.6% vs. saline 9.1%; p = 0.37). CONCLUSIONS: Intracoronary deployment of BCM 2 to 5 days after successful reperfusion in subjects with large myocardial infarction did not reduce adverse LV remodeling or cardiac clinical events at 6 months. (IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction [PRESERVATION I]; NCT01226563).


Assuntos
Implantes Absorvíveis , Ventrículos do Coração/fisiopatologia , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/prevenção & controle , Stents , Remodelação Ventricular , Idoso , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Método Duplo-Cego , Eletrocardiografia , Feminino , Seguimentos , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/fisiopatologia , Desenho de Prótese , Resultado do Tratamento , Função Ventricular Esquerda/fisiologia
13.
EuroIntervention ; 12(2): e160-6, 2016 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-27290675

RESUMO

AIMS: Bioresorbable scaffolds were designed to overcome the limitations of permanent stents. In the BIOSOLVE-I study we aimed to assess the long-term safety and performance of a drug-eluting absorbable metal scaffold (DREAMS) at three years. METHODS AND RESULTS: In this prospective, multicentre first-in-man study, 46 patients with 47 de novo lesions were enrolled. We report the final results at three-year follow-up. Mean age was 65.3±9.7 years, lesions were 2.73±0.48 mm in diameter and 10.99±4.59 mm long. Follow-up at three years was available for 44 patients (one patient died of a non-cardiac cause and one patient withdrew consent). Three target lesion failures (TLF) occurred (6.6%), consisting of two clinically driven target lesion revascularisations at scheduled six-month angiography (4.3%) and one myocardial infarction after drug-eluting balloon treatment in a non-target lesion but target vessel at 12-month angiography (2.2%). No cardiac death or scaffold thrombosis occurred. Seven patients had additional angiographic follow-up at 28±4 months: in-scaffold late lumen loss had improved from 0.51±0.46 mm (median 0.28 mm) at 12 months to 0.32±0.32 mm (median 0.20 mm). CONCLUSIONS: The BIOSOLVE-I study showed excellent long-term outcomes at three years with a low TLF rate and no cardiac death or scaffold thrombosis. No TLF event was observed beyond 377 days.


Assuntos
Implantes Absorvíveis/efeitos adversos , Stents Farmacológicos , Intervenção Coronária Percutânea , Sirolimo/uso terapêutico , Adulto , Idoso , Reestenose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Tecidos Suporte/efeitos adversos
14.
Acta Cardiol ; 71(2): 135-43, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27090034

RESUMO

AIMS: Literature suggests a beneficial effect of percutaneous left atrial appendage occlusion (LAAO) to prevent thrombo-embolic events in patients with non-rheumatic atrial fibrillation (AF). We compared outcome of LAAO versus 'suboptimal standard' treatment in AF patients with high bleeding risk. METHODS AND RESULTS: Patients with sufficient follow-up data (n = 125) who underwent LAAO with the Amplatzer Cardiac Plug (ACP) were selected from the Belgian ACP database. AF patients who survived intracranial haemorrhage were recruited from the Leuven Neurosurgical Registry (LNR, n = 113). After propensity score adjustment, the outcome of both groups was compared for the combined end point (death, stroke, transient ischaemic attack, systemic emboli, and major bleeding event). The LAAO group did not differ from the LNR group for mean age and gender (74 ± 7 versus 75 ± 10 years, P = 0.29; female 39% versus 48%, P = 0.18). However, the CHA2DS2-VASc and HAS-BLED scores were both higher in the LAAO group (4.8 ± 1.7 versus 3.9 ± 1.7, P = 0.0001; 3.5 ± 1.4 versus 3.2 ± 1.4, P = 0.036). After propensity score adjustment, the risk for the primary end point was significantly higher for the LNR group (HR 2.012, 95% CI 1.113-3.638). CONCLUSION: LAAO with ACP seems to improve the combination of survival and the prevention of thrombo-embolic and major bleeding events in patients with atrial fibrillation and increased bleeding risk.


Assuntos
Fibrilação Atrial , Cateterismo Cardíaco , Hemorragia , Implantação de Prótese , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Idoso , Anticoagulantes/administração & dosagem , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/terapia , Bélgica/epidemiologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Masculino , Avaliação de Resultados (Cuidados de Saúde) , Implantação de Prótese/efeitos adversos , Implantação de Prótese/métodos , Sistema de Registros , Estudos Retrospectivos , Risco Ajustado , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
15.
Eur Heart J ; 37(19): 1538-49, 2016 05 14.
Artigo em Inglês | MEDLINE | ID: mdl-26761950

RESUMO

BACKGROUND: Stent thrombosis (ST) is a rare but serious complication following percutaneous coronary intervention. Analysis of thrombus composition from patients undergoing catheter thrombectomy may provide important insights into the pathological processes leading to thrombus formation. We performed a large-scale multicentre study to evaluate thrombus specimens in patients with ST across Europe. METHODS: Patients presenting with ST and undergoing thrombus aspiration were eligible for inclusion. Thrombus collection was performed according to a standardized protocol and specimens were analysed histologically at a core laboratory. Serial tissue cross sections were stained with haematoxylin-eosin (H&E), Carstairs and Luna. Immunohistochemistry was performed to identify leukocyte subsets, prothrombotic neutrophil extracellular traps (NETs), erythrocytes, platelets, and fibrinogen. RESULTS: Overall 253 thrombus specimens were analysed; 79 (31.2%) from patients presenting with early ST, 174 (68.8%) from late ST; 79 (31.2%) were from bare metal stents, 166 (65.6%) from drug-eluting stents, 8 (3.2%) were from stents of unknown type. Thrombus specimens displayed heterogeneous morphology with platelet-rich thrombus and fibrin/fibrinogen fragments most abundant; mean platelet coverage was 57% of thrombus area. Leukocyte infiltrations were hallmarks of both early and late ST (early: 2260 ± 1550 per mm(2) vs. late: 2485 ± 1778 per mm(2); P = 0.44); neutrophils represented the most prominent subset (early: 1364 ± 923 per mm(2) vs. late: 1428 ± 1023 per mm(2); P = 0.81). Leukocyte counts were significantly higher compared with a control group of patients with thrombus aspiration in spontaneous myocardial infarction. Neutrophil extracellular traps were observed in 23% of samples. Eosinophils were present in all stent types, with higher numbers in patients with late ST in sirolimus-and everolimus-eluting stents. CONCLUSION: In a large-scale study of histological thrombus analysis from patients presenting with ST, thrombus specimens displayed heterogeneous morphology. Recruitment of leukocytes, particularly neutrophils, appears to be a hallmark of ST. The presence of NETs supports their pathophysiological relevance. Eosinophil recruitment suggests an allergic component to the process of ST.


Assuntos
Trombose Coronária/prevenção & controle , Oclusão de Enxerto Vascular/prevenção & controle , Intervenção Coronária Percutânea/efeitos adversos , Stents , Idoso , Plaquetas , Trombose Coronária/metabolismo , Stents Farmacológicos , Eosinófilos , Feminino , Fibrinogênio/metabolismo , Humanos , Contagem de Leucócitos , Subpopulações de Linfócitos , Masculino , Neutrófilos , Estudos Prospectivos , Falha de Prótese , Trombectomia/métodos
17.
EuroIntervention ; 11(10): 1170-9, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25604089

RESUMO

AIMS: To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). METHODS AND RESULTS: Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. CONCLUSIONS: In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.


Assuntos
Anticoagulantes/uso terapêutico , Apêndice Atrial/cirurgia , Fibrilação Atrial/terapia , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana/métodos , Feminino , Humanos , Masculino , Dispositivo para Oclusão Septal/efeitos adversos , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Resultado do Tratamento
18.
EuroIntervention ; 10(11): 1272-5, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25136884

RESUMO

AIMS: Sirolimus-eluting stents (SES) have been shown to be superior to Endeavor zotarolimus-eluting stents (ZES) and comparable to Resolute ZES at eight-month angiography in patients treated for total coronary occlusions (TCO). This study investigated clinical outcome at three-year follow-up. METHODS AND RESULTS: The PRISON III trial investigated the efficacy and safety of SES against ZES (Endeavor and Resolute) in two study phases. In the first phase, 51 patients were randomised to receive SES and 46 to Endeavor ZES. In the second phase, 103 and 104 patients were randomised to SES or Resolute ZES, respectively. Between one and three years there were only a few additional clinical events in all groups. As a result, the rates of target lesion revascularisation 12.2% vs. 19.6%, p=0.49, target vessel failure 14.3% vs. 19.6%, p=0.68, and definite or probable stent thrombosis 4.1% vs. 2.2% were comparable between SES and Endeavor ZES at three years. In the second study phase, the rates of target lesion revascularisation 10% vs. 5.9%, p=0.42, target vessel failure 10% vs. 7.9%, p=0.79 and definite or probable stent thrombosis 1.0% vs. 0% were similar between SES and Resolute ZES. CONCLUSIONS: The present study demonstrated a low incidence of clinical events between one- and three-year follow-up with either SES compared to Endeavor ZES or SES versus Resolute ZES in patients treated for total coronary occlusions.


Assuntos
Antibióticos Antineoplásicos/uso terapêutico , Oclusão Coronária/cirurgia , Stents Farmacológicos , Sirolimo/análogos & derivados , Sirolimo/uso terapêutico , Idoso , Doenças Cardiovasculares/mortalidade , Oclusão Coronária/tratamento farmacológico , Reestenose Coronária/epidemiologia , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Revascularização Miocárdica/estatística & dados numéricos , Intervenção Coronária Percutânea/instrumentação , Reoperação , Trombose/epidemiologia
19.
Circ Cardiovasc Interv ; 7(6): 806-12, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25351198

RESUMO

BACKGROUND: We aimed to test, for the first time, the feasibility of intracoronary delivery of an innovative, injectable bioabsorbable scaffold (IK-5001), to prevent or reverse adverse left ventricular remodeling and dysfunction in patients after ST-segment-elevation myocardial infarction. METHODS AND RESULTS: Patients (n=27) with moderate-to-large ST-segment-elevation myocardial infarctions, after successful revascularization, were enrolled. Two milliliters of IK-5001, a solution of 1% sodium alginate plus 0.3% calcium gluconate, was administered by selective injection through the infarct-related coronary artery within 7 days after myocardial infarction. IK-5001 is assumed to permeate the infarcted tissue, cross-linking into a hydrogel and forming a bioabsorbable cardiac scaffold. Coronary angiography, 3 minutes after injection, confirmed that the injection did not impair coronary flow and myocardial perfusion. Furthermore, IK-5001 deployment was not associated with additional myocardial injury or re-elevation of cardiac biomarkers. Clinical assessments, echocardiographic studies, 12-lead electrocardiograms, 24-hour Holter monitoring, blood tests, and completion of Minnesota Living with Heart Failure Questionnaires were repeated during follow-up visits at 30, 90, and 180 days after treatment. During a 6-month follow-up, these tests confirmed favorable tolerability of the procedure, without device-related adverse events, serious arrhythmias, blood test abnormalities, or death. Serial echocardiographic studies showed preservation of left ventricular indices and left ventricular ejection fraction. CONCLUSIONS: This first-in-man pilot study shows that intracoronary deployment of an IK-5001 scaffold is feasible and well tolerated. Our results have promoted the initiation of a multicenter, randomized controlled trial to confirm the safety and efficacy of this new approach in high-risk patients after ST-segment-elevation myocardial infarction. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01226563.


Assuntos
Implantes Absorvíveis , Alginatos/administração & dosagem , Gluconato de Cálcio/administração & dosagem , Infarto do Miocárdio/terapia , Medicina Regenerativa/métodos , Engenharia Tecidual/métodos , Tecidos Suporte , Disfunção Ventricular Esquerda/terapia , Função Ventricular Esquerda , Remodelação Ventricular , Implantes Absorvíveis/efeitos adversos , Adulto , Idoso , Alginatos/efeitos adversos , Bélgica , Gluconato de Cálcio/efeitos adversos , Estudos de Viabilidade , Feminino , Alemanha , Ácido Glucurônico/administração & dosagem , Ácido Glucurônico/efeitos adversos , Testes de Função Cardíaca , Ácidos Hexurônicos/administração & dosagem , Ácidos Hexurônicos/efeitos adversos , Humanos , Hidrogéis , Injeções Intra-Arteriais , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/fisiopatologia , Projetos Piloto , Valor Preditivo dos Testes , Inquéritos e Questionários , Fatores de Tempo , Tecidos Suporte/efeitos adversos , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/fisiopatologia
20.
Circ Cardiovasc Interv ; 6(6): 644-53, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24254708

RESUMO

BACKGROUND: The drug-eluting absorbable metal scaffold has demonstrated feasibility, safety, and promising clinical and angiographic outcomes at 12 months in human coronary arteries. This study aimed to evaluate the degradation rate and long-term vascular responses to drug-eluting absorbable metal scaffold. METHODS AND RESULTS: BIOSOLVE-I was a multicenter, single-arm, first-in-man trial assessing the safety and performance of drug-eluting absorbable metal scaffold in 46 patients with coronary artery disease. Patients who underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography, at 6 and 12 months were included in this study. From postimplantation to follow-up, arterial curvature and angulation were significantly increased by the degradation process. The greatest increase was seen from postimplantation to 6 months. The systolic-diastolic changes of the curvature and angulation gradually improved throughout the follow-up period. At the site of implantation, vasoconstriction (-10% mean reduction) was observed during the acetylcholine test at 6 months. The average percent hyperechogenicity of the scaffolded segments showed a continuous decrease over time, with the most pronounced changes within the first 6 months (from 22.1±7.0% to 15.8±3.7%; P<0.001). Struts discernible on optical coherence tomography at 6 and 12 months showed full neointimal coverage, with stabilization of the mean scaffold area from 6 to 12 months. Furthermore, the mean neointimal area (1.55±0.51 versus 1.58±0.34 mm(2); P=0.794) remained unchanged from 6 to 12 months. CONCLUSIONS: This serial analysis of drug-eluting absorbable metal scaffold confirmed the safety and efficacy of this new device, with vasomotion restoration and continued degradation over time demonstrated by multi-invasive imaging modalities. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01168830.


Assuntos
Implantes Absorvíveis , Angioplastia/instrumentação , Doença da Artéria Coronariana/terapia , Magnésio , Sirolimo/análogos & derivados , Tecidos Suporte , Angioplastia/métodos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Everolimo , Seguimentos , Humanos , Incidência , Neointima/diagnóstico por imagem , Neointima/epidemiologia , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de Intervenção
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