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Management of high-risk patients with severe aortic stenosis (AS) is a challenging issue. The prognosis of patients with AS presenting with therapy-refractory pulmonary edema (RPE) or cardiogenic shock (CS) remains poor. The purpose of this study was to assess the 30-day mortality of rescue percutaneous balloon aortic valvuloplasty (PBAV) in AS patients presenting with RPE or CS in a community-based hospital without on-site heart surgery. From January 2016 to February 2019, we identified consecutively admitted patients with CS or RPE related to severe AS who underwent emergent PBAV. The primary end point was 30-day mortality. Secondary end points included procedural adverse events according to the Valve Academic Research Consortium (VARC)-2 criteria and predictive factors of the primary end point. We identified 51 patients with either CS (n = 22) or RPE (n = 29). All PBAV procedures were successful with a significant reduction in peak-to-peak gradient (median, [IQR] from 40 [27] mmHg to 15 [20] mmHg, p < 0.001). No procedural deaths occurred, while adverse events included stroke (4%), minor vascular complications (6%), minor (4%) and major bleedings (4%), and no life-threatening bleeding. Overall, 15 deaths (29%) were noted at 30 days after PBAV, while 53% of the surviving patients were successfully bridged to transcatheter aortic valve implantation (TAVI). 30-day mortality was significantly higher in the CS group compared to the RPE (n = 10 (45%) vs n = 5 (7%), p = 0.029), and was significantly associated with the presence of acute kidney injury (OR 9.09, 95% CI 2.13-38.77, p = 0.003) and elevated pulmonary artery systolic pressure (OR 1.06, 95% CI 1.0-1.12, p = 0.047). Rescue PBAV in patients with severe AS presenting with RPE or CS is a feasible and effective therapeutic option, even in a community-based hospital without on-site heart surgery. Rescue PBAV resulted in 30-day survival of more than 70%, with more than half of the surviving patients having been successfully bridged to TAVI.
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Estenose da Valva Aórtica , Valvuloplastia com Balão , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Valvuloplastia com Balão/efeitos adversos , Prognóstico , Choque Cardiogênico , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgiaRESUMO
Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.
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Substituição da Valva Aórtica Transcateter , Catéteres , Humanos , Incidência , Razão de Chances , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
BACKGROUND: Results of randomized controlled trials (RCT) do not provide definite guidance for secondary prevention after ischemic stroke (IS)/transient ischemic attack (TIA) attributed to patent foramen ovale (PFO). No recommendations can be made for patients > 60 years. We aimed to compare interventional and medical PFO-management in cryptogenic IS/TIA patients, including patients > 60 years. METHODS: Prospective case series including consecutive cryptogenic IS/TIA patients with PFO at Tuebingen university stroke unit, Germany. 'PFO-closure' was recommended in patients ≤70 years when featuring high-risk PFO (i.e., with atrial septal aneurysm, spontaneous, or high-grade right-to-left shunt during Valsalva). Primary (recurrent IS/intracranial hemorrhage) and secondary endpoints (e.g., disability) were assessed during ≥1-year follow-up; planned subgroup analyses of patients ≤60/> 60 years. RESULTS: Among 236 patients with median age of 58 (range 18-88) years, 38.6% were females and median presenting National Institutes of Health Stroke Scale score was 1 (IQR 0-4). Mean follow-up was 2.8 ± 1.3 years. No intracranial hemorrhage was observed. Recurrent IS rate after 'PFO-closure' was 2.9% (95%CI 0-6.8%) and 7% (4-16.4) in high-risk PFO patients ≤60 (n = 103) and > 60 years (n = 43), respectively, versus 4% (0-11.5) during 'medical therapy alone' MTA (n = 28). 42 low-risk PFO patients treated with MTA experienced no recurrent IS/TIA. CONCLUSIONS: In our real-world study, IS recurrence rate in 'PFO-closure' high-risk PFO patients ≤60 years was comparable to that observed in recent RCT. High-risk PFO patients > 60 years who underwent PFO-closure had similar IS recurrence rates than those who received MTA. MTA seems the appropriate treatment for low-risk PFO. TRIAL REGISTRATION: ClinicalTrials.gov, registration number: NCT04352790 , registered on: April 20, 2020 - retrospectively registered.
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OBJECTIVES: The aim of this study was to compare the 30-day procedural, clinical and echocardiographic outcome of the new balloon-expandable Edwards Sapien 3 (ES3) valve with the Edwards Sapien XT (ESXT). BACKGROUND: Post-implant paravalvular leaks (PVL) after transfemoral aortic valve replacement (TAVR) resulting in residual aortic regurgitation (AR) are a major limitation for long term outcome. New TAVR-devices have to eliminate this problem. METHODS: Transfemoral TAVR was performed in 209 consecutive intermediate-high-risk surgical patients (pts) with symptomatic aortic stenosis (ESXT n = 102, ES3 n = 107). Transthoracic echocardiography (TTE) and 3-dimensional computed tomography were used for valve size selection. Primary endpoint of the study was none/trace AR derived by TTE 30-days after TAVR. RESULTS: All pts underwent successfully TAVR with a combined device success of 100/102 (99%) in ESXT and 107/107 (100%) in ES3 pts. Fluoroscopy time (ESXT 11.8 ± 0.5 min vs. ES3 10.0 ± 0.5 min, P = 0.003) and contrast (ESXT 188.9 ± 5.6 mL vs. ES3 170.4 ± 4.7 mL, P = 0.04) were significantly lower in ES3 patients. 30-day clinical events did not differ. Transvalvular mean pressure gradients were significantly reduced to 7.4 ± 0.8 mmHg after ESXT and to 10.1± 0.4 mmHg after ES3 implantation. After 30 days none/trace AR was found in 34.3% (n = 35) of all ESXT pts in contrast to 89.7% (n = 96) of all ES3 patients. Moderate-to-severe AR was found rarely (ESXT 2.9% vs. ES3 0%, P = 0.073). CONCLUSIONS: Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage. © 2016 Wiley Periodicals, Inc.
Assuntos
Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/terapia , Valva Aórtica , Valvuloplastia com Balão , Cateterismo Cardíaco/instrumentação , Artéria Femoral , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/mortalidade , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/mortalidade , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/métodos , Cateterismo Periférico/mortalidade , Ecocardiografia , Feminino , Artéria Femoral/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Punções , Radiografia Intervencionista , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
Stroke and thromboembolic events after transfemoral aortic valve replacement (TAVR) continue to be a problem. The aim of our study was to compare platelet aggregation (Agg) and platelet activation (PA) observed with two different catheter valves, the ESV-XT and the newer ESV-3 valve in patients (pts) undergoing TAVR on dual antiplatelet therapy (DAPT). A total of 174 patients with severe aortic stenosis and high surgical risk successfully underwent TAVR (60 ESV-XT; 114 ESV-3). Platelet Agg and PA (CD62P expression) were evaluated before and the following three days after TAVR under DAPT. Platelet Agg was inhibited to the same extent in both valve types and there was no significant difference in platelet drop between both valve types between day 0 and day 3 [ESV-XT vs ESV-3: median (25th-75th percentile): platelet count (x1000): 55 (42-74) vs 61(42-93), p=0.280]. However, there was an enhanced CD62P expression directly after TAVR with the ESV-XT compared to the ESV-3 [CD62P (MIF): 7.4 (6.8-8.6) vs 6.6 (6-7.9), p=0.014]. Surface expression of platelet CD62P was associated with the occurrence of residual aortic regurgitation (AR) and was significantly higher in patients with residual AR [CD62P (mild AR) vs CD 62P (no or trace AR): 7.9 (7.3-9.1) vs 7.1 (6.4-8.0), p < 0.001)]. PA was significantly enhanced in patients with the ESV-XT compared to the ESV-3 valve and was associated with the amount of residual AR which was significantly reduced by ESV-3. This may have implications for thromboembolic events following TAVR procedure.
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Insuficiência da Valva Aórtica/terapia , Estenose da Valva Aórtica/terapia , Valva Aórtica , Valvuloplastia com Balão , Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Ativação Plaquetária , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/sangue , Insuficiência da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/sangue , Estenose da Valva Aórtica/diagnóstico , Biomarcadores/sangue , Cateterismo Cardíaco/efeitos adversos , Quimioterapia Combinada , Feminino , Alemanha , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Selectina-P/sangue , Ativação Plaquetária/efeitos dos fármacos , Agregação Plaquetária , Inibidores da Agregação Plaquetária/uso terapêutico , Contagem de Plaquetas , Testes de Função Plaquetária , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND AND PURPOSE: Since patients with phenylketonuria (PKU) have to follow a lifelong restriction of natural protein to lower phenylalanine-intake, they never eat fish. This diet may lead to a chronic deficit of omega-3 and omega-6 fatty acids with the risk of early atherosclerotic changes. The aim of the study was to analyse the fatty acid profile of PKU patients and to correlate the results with surrogate markers of early atherosclerotic changes [enhanced carotid intima media thickness (CIMT) and ß-stiffness index] and platelet activation. METHODS: In 43 PKU patients and in 58 healthy controls we prospectively examined the fatty acid profile, CIMT, ß-stiffness index and platelet activation (flow cytometric determination of markers of platelet activation). CIMT was measured bilaterally by ultrasound. CIMTmean was defined as the mean value of the sum of CIMTleft and CIMTright. RESULTS: Despite of lower HDL-cholesterol and higher triglyceride concentrations in the PKU group, there was no significant difference in the omega-6 or omega-3 fatty acid profile, CIMT, ß-stiffness index between both groups. Platelet activation was not enhanced in the PKU group. CONCLUSIONS: Fish-free diet does not induce early atherosclerotic changes or enhanced platelet activation in PKU patients.
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Aterosclerose/etiologia , Dieta com Restrição de Proteínas/efeitos adversos , Peixes , Fenilcetonúrias/dietoterapia , Ativação Plaquetária/fisiologia , Adulto , Animais , Espessura Intima-Media Carotídea , Estudos de Casos e Controles , HDL-Colesterol/sangue , Ácidos Graxos/sangue , Feminino , Citometria de Fluxo , Humanos , Masculino , Fenilcetonúrias/sangue , Fenilcetonúrias/complicações , Fenilcetonúrias/fisiopatologia , Triglicerídeos/sangue , Rigidez Vascular/fisiologiaRESUMO
AIMS: Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented. METHODS AND RESULTS: One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period. CONCLUSIONS: The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Reestenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Stents , Dispositivos de Acesso Vascular , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Reestenose Coronária/diagnóstico , Reestenose Coronária/etiologia , Intervalo Livre de Doença , Feminino , Alemanha , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Metais , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Inibidores da Agregação Plaquetária/uso terapêutico , Desenho de Prótese , Retratamento , Fatores de Tempo , Resultado do TratamentoRESUMO
Background. Benefits of cardiac screening in kidney transplant candidates (KTC) will be dependent on the availability of effective interventions. We retrospectively evaluated characteristics and outcome of percutaneous coronary interventions (PCI) in KTC selected for revascularization by a cardiac screening approach. Methods. In 267 patients evaluated 2003 to 2006, screening tests performed were reviewed and PCI characteristics correlated with major adverse cardiovascular events (MACE) during a follow-up of 55 months. Results. Stress tests in 154 patients showed ischemia in 28 patients (89% high risk). Of 58 patients with coronary angiography, 38 had significant stenoses and 18 cardiac interventions (6.7% of all). 29 coronary lesions in 17/18 patients were treated by PCI. Angiographic success rate was 93.1%, but procedural success rate was only 86.2%. Long lesions (P = 0.029) and diffuse disease (P = 0.043) were associated with MACE. In high risk patients, cardiac screening did not improve outcome as 21.7% of patients with versus 15.5% of patients without properly performed cardiac screening had MACE (P = 0.319). Conclusion. The moderate procedural success of PCI and poor outcome in long and diffuse coronary lesions underscore the need to define appropriate revascularization strategies in KTC, which will be a prerequisite for cardiac screening to improve outcome in these high-risk patients.
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Dual antiplatelet therapy (DAPT) with aspirin (ASA) and clopidogrel (Clp) is the standard treatment to reduce ischaemic coronary events, but in patients with end-stage renal disease (ESRD) the efficacy of Clp remains unclear. Patients with ESRD are at higher risk for coronary artery disease (CAD) and also their post-interventional outcome is worse compared to patients with normal renal function. Little is known about the influence of haemodialysis (HD) on ASA and Clp responsiveness. To assess the effect of HD on ASA- and Clp-responsiveness in patients with documented CAD and ESRD, 31 patients with ESRD (mean age 66.5 ± 1.8 years, 23 male) on DAPT were evaluated for their ASA and Clp responsiveness with the Verify Now System (Accumetrics Inc.) We measured the antiplatelet effect in all ESRD patients at three time points: T1: just before HD; T2: directly after HD; T3: steady state on a HD free day one week after T1. In our study at baseline 10 (32.3%) patients were ASA-low responder (ASA-LR) and 14 (45.2%) patients Clp-low responder (Clp-LR). There was a significant difference in the PRU values before (T1) and immediately after HD (T2) [PRU T1=234 (169; 274) vs PRUT2= 247 (199; 278); pT1,2=0.036; ]. Results were shown as median ARU T1 (25th, 75th percentile) or median PRU T1 (25th, 75th percentile). Hence HD seems to impair responsiveness to Clp, resulting in an increase of 6.5 % Clp-LR. No significant differences in the ARU values at the different time-points were found.
Assuntos
Aspirina/uso terapêutico , Plaquetas/efeitos dos fármacos , Doença da Artéria Coronariana/terapia , Falência Renal Crônica/terapia , Inibidores da Agregação Plaquetária/uso terapêutico , Diálise Renal/efeitos adversos , Ticlopidina/análogos & derivados , Idoso , Clopidogrel , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/complicações , Feminino , Seguimentos , Humanos , Falência Renal Crônica/sangue , Falência Renal Crônica/complicações , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Ativação Plaquetária/efeitos dos fármacos , Testes de Função Plaquetária , Estudos Prospectivos , Receptores Purinérgicos P2Y12/metabolismo , Risco , Ticlopidina/uso terapêuticoRESUMO
AIMS: Percutaneous coronary intervention (PCI)-related risks are increased among patients with left main disease (LMD). The aim was to evaluate the impact of antithrombotic therapy on outcomes after LMD PCI in a predominantly ACS population. METHODS AND RESULTS: One hundred and seventy-seven patients undergoing LMD PCI were identified in a pooled dataset of 14,326 patients from three large randomised trials comparing treatment with heparin plus glycoprotein IIb/IIIa inhibitors (GPI) or bivalirudin alone, including the REPLACE-2, ACUITY and HORIZONS-AMI trials. Overall, net adverse clinical events (NACE) and non-CABG major bleedings at 30 days occurred more frequently in patients undergoing LMD PCI compared to the overall non-LMD PCI population (NACE: 19.8% vs. 10.6%, p≤0.001, major bleeding: 9.6% vs. 4.6%, p≤0.001). In the LMD group, bivalirudin was associated with significantly less non-CABG related major bleeding compared to heparin+GPI (4.5% versus 14.6%, relative risk [RR] 0.27, 95% CI: 0.09-0.83; p=0.013), while the composite ischaemic endpoint (death/MI/TVR) at 30 days was similar in the two groups (11.4% vs. 12.4%, p=0.513) resulting in a benefit on NACE for bivalirudin over heparin+GPI (14.8% vs. 24.7%; RR 0.53; p=0.039). CONCLUSIONS: Among patients undergoing LMD PCI, the use of bivalirudin instead of heparin+GPI resulted in significantly less major bleeding and improved short-term net clinical outcome. Bivalirudin may be the preferred anticoagulation strategy in LMD PCI patients.
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Anticorpos Monoclonais/uso terapêutico , Antitrombinas/uso terapêutico , Doença da Artéria Coronariana/terapia , Fibrinolíticos/uso terapêutico , Heparina/uso terapêutico , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Abciximab , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Eptifibatida , Feminino , Hemorragia/prevenção & controle , Hirudinas , Humanos , Masculino , Pessoa de Meia-Idade , Peptídeos/uso terapêutico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes/uso terapêutico , Resultado do TratamentoRESUMO
Although vascular plugs allow the interventional closure of medium-sized to large abnormal vessels, their application is limited by the need for long sheaths or large guiding catheters. The authors report their experience with the new Amplatzer vascular plug 4 (AVP 4), a self-expanding spindle-shaped occluder made of Nitinol wire mash, which can be placed through 4-Fr catheters with an internal diameter of 0.038 in. or larger. From October 2009 until June 2012, 14 AVP 4 devices were deployed in 12 patients (ages, 0.3-48.8 years). Nine patients had venovenous or arteriovenous collaterals in functional univentricular hearts. One patient had pulmonary atresia with a ventricular septal defect and major aortopulmonary collateral arteries, and one patient had a pulmonary arteriovenous fistula. One child had a large coronary artery fistula to the right atrium. The authors used AVP 4 devices with diameters of 4-8 mm. In all the patients, the AVP 4 was implanted successfully. No occluder dislocations and no complications related to the procedure occurred. Complete vessel occlusion was achieved in seven cases. In seven additional cases, a residual shunt was present at the end of the procedure while the patients were still fully heparinized. In 2 of 14 vessels, the decision was made to place additional devices to abolish residual shunting. According to the authors' experience, the AVP 4 allows safe and effective occlusion of medium-size and large abnormal vessels. It is also well suited for tortuous high-flow vessels such as coronary or pulmonary arteriovenous fistulas. In case of a suboptimal position, it is possible to reposition the occluder with ease. Further studies are needed to determine whether initial residual shunting in heparinized patients disappears during follow-up care. The AVP 4 represents a valuable new device for the interventional treatment of complex congenital vessel malformations.
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Fístula Arteriovenosa/terapia , Cateterismo Cardíaco/métodos , Embolização Terapêutica/instrumentação , Cardiopatias Congênitas/terapia , Artéria Pulmonar/anormalidades , Veias Pulmonares/anormalidades , Dispositivo para Oclusão Septal , Adolescente , Adulto , Angiografia , Fístula Arteriovenosa/diagnóstico por imagem , Criança , Pré-Escolar , Desenho de Equipamento , Feminino , Seguimentos , Cardiopatias Congênitas/diagnóstico por imagem , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Artéria Pulmonar/diagnóstico por imagem , Veias Pulmonares/diagnóstico por imagem , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
It is well accepted that drug-eluting stents (DES) are effective in reducing restenosis, although implantation of DES may result in increased occurrence of stent thrombosis. The study describes the case of a patient with very late stent thrombosis (VLST) despite intravascular ultrasound (IVUS) control after implantation of a paclitaxel-eluting stent, an adequate response to antiplatelet therapy, and the lack of distinct risk factors for VLST. Stent thrombosis remains a serious complication after stent implantation even after prolonged time, and studies are urgently needed to optimize diagnosis and treatment of VLST.
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Trombose Coronária/diagnóstico por imagem , Stents Farmacológicos/efeitos adversos , Idoso , Angiografia Coronária , Trombose Coronária/etiologia , Feminino , Humanos , Paclitaxel/administração & dosagem , Fatores de Risco , Resultado do Tratamento , UltrassonografiaRESUMO
BACKGROUND: Cardiogoniometry (CGM) is a novel electrocardiac method utilising computer-assisted three-dimensional information on cardiac potentials. OBJECTIVE: To investigate the potential of CGM in discriminating non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and relevant coronary stenosis upon hospital admission by prospectively comparing its sensitivity, specificity and accuracy against those of a single troponin test and a 12-lead ECG performed on admission DESIGN: A multicenter prospective observational trial. SETTING: Eight interventional cardiac centres in Germany. PATIENTS: A cohort of 216 patients (mean age 67 years, 34.7 % female) who presented with acute chest pain or dyspnoea without ST-segment elevation and were scheduled for coronary angiography within 72 h of admission. INTERVENTION: Pre-angiography screening by CGM, troponin test, 12-lead ECG MAIN OUTCOME MEASURES: ECG, troponin and CGM on admission compared with final diagnosis of NSTE-ACS or relevant diameter stenosis ≥70 % verified by an independent review board and an angiographic core laboratory. RESULTS: NSTE-ACS was finally confirmed in 162 cases, whereas the remaining 54 cases without proof of NSTE-ACS served as controls. Diagnostic sensitivity for NSTE-ACS was 28, 50 and 69 % and specificity 78, 96 and 54 % for first ECG, serial troponin and first CGM, respectively. Accuracy was 40, 62 and 65 %. The sensitivity of the tests to detect relevant coronary stenosis (n = 126) was 32, 53 and 74 %, respectively. The sensitivity of CGM to detect NSTE-ACS (65 %) or relevant stenosis (71 %) was high even in patients with normal troponin and ECG. CONCLUSIONS: CGM can detect NSTE-ACS at first medical contact. CGM in conjunction with traditional markers, 12-lead ECG and troponin may effectively aid early decision making in patients presenting with acute chest pain.
Assuntos
Síndrome Coronariana Aguda/diagnóstico , Estenose Coronária/diagnóstico , Eletrocardiografia/métodos , Troponina/metabolismo , Síndrome Coronariana Aguda/fisiopatologia , Idoso , Dor no Peito/etiologia , Angiografia Coronária , Estenose Coronária/fisiopatologia , Dispneia/etiologia , Eletrocardiografia/instrumentação , Feminino , Alemanha , Humanos , Masculino , Estudos Prospectivos , Sensibilidade e EspecificidadeRESUMO
OBJECTIVES: This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial. BACKGROUND: The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented. METHODS: This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 µg/mm(2) balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥ 70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone. RESULTS: During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004). CONCLUSIONS: Treatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period. (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR I]; NCT00106587. Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR II]; NCT00409981).
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Catéteres , Materiais Revestidos Biocompatíveis , Reestenose Coronária/terapia , Paclitaxel/administração & dosagem , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Distribuição de Qui-Quadrado , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/mortalidade , Intervalo Livre de Doença , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Alemanha , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/administração & dosagem , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND AND OBJECTIVES: Paclitaxel-coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in-stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel-eluting Coroflex Please stent in coronary artery lesions. METHODS: One-hundred and twenty-nine patients (66.2 +/- 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post-PTCA restenotic coronary lesions.The mean reference diameter was 2.84 +/- 0.43 mm, the lesion length 12.51 +/- 4.6 mm, and the minimal lumen diameter 0.75 +/- 0.29 mm. Follow-up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. RESULTS: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in-stent late loss and the late-loss index were 0.27 +/- 0.59 mm and 0.17 +/- 0.40 resulting in binary in-stent restenoses in 16/120 (13.3%) subjects and in-segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow-up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. CONCLUSION: The data of the Paclitaxel-eluting Coroflex Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel-eluting stent.
Assuntos
Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Idoso , Reestenose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , Cardiopatias/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
Takayasu arteritis (TA) is a chronic vasculitis, affecting young women in 80-90% of cases with greatest prevalence in Asians. As exudative pericarditis is an extremely rare, but a possible manifestation of TA, we report on a young women who presented with recurrent febrile pericardial effusion as primary manifestation of TA.
Assuntos
Derrame Pericárdico/diagnóstico , Arterite de Takayasu/diagnóstico , Adulto , Diagnóstico Diferencial , Ecocardiografia Transesofagiana , Feminino , Humanos , Derrame Pericárdico/diagnóstico por imagem , Arterite de Takayasu/diagnóstico por imagemRESUMO
OBJECTIVES: The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt-chromium stent in real-world practice. BACKGROUND: The development of cobalt-chromium bare-metal stents (BMS) with thinner struts has lead to better deliverability and lower target-lesion revascularization rates compared with stainless steel BMS. METHODS: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target-lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in-hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. RESULTS: The registry included 2,315 patients (mean age 64.3 +/- 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B(2)/C-lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6-month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event-free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. CONCLUSIONS: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt-chromium stent platform in real-world practice. In the era of drug-eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Ligas de Cromo , Estenose Coronária/terapia , Isquemia Miocárdica/terapia , Stents , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Ásia/epidemiologia , Estenose Coronária/complicações , Estenose Coronária/mortalidade , Intervalo Livre de Doença , Europa (Continente)/epidemiologia , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Isquemia Miocárdica/etiologia , Isquemia Miocárdica/mortalidade , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care. METHODS AND RESULTS: One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 microg/mm2) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38+/-0.61 mm in the drug-eluting stent group versus 0.17+/-0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15). CONCLUSIONS: Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.
Assuntos
Angioplastia Coronária com Balão , Reestenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Moduladores de Tubulina/administração & dosagem , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/prevenção & controle , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/uso terapêuticoRESUMO
BACKGROUND: The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel. METHODS AND RESULTS: Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 +/- 0.12 years following stent deployment. In the intention-to-treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in-segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 +/- 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (-3.0 +/- 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3-year MACE rate was 22/123 (17.9%). CONCLUSION: The present study describes the paclitaxel-eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Estenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Intervalo Livre de Doença , Feminino , Seguimentos , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Projetos Piloto , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Desenho de Prótese , Medição de Risco , Índice de Gravidade de Doença , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of the study was to evaluate safety, efficacy, and long-term clinical outcome of percutaneous closure of patent foramen ovale (PFO closure) in a low volume center using the Amplatzer PFO occluder without echocardiographic guidance. BACKGROUND: Most centers perform PFO closure either by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance for optimal device selection. As TEE is poorly tolerated by patients in supine position and ICE is a costly alternative that increases vascular access complications, we wanted to assess the safety and efficacy of PFO closure by fluoroscopic guidance only. METHODS: Before PFO closure, all patients had a diagnostic contrast-TEE and morphological classification of PFO. All PFO closures were performed using the 25-mm Amplatzer PFO occluder with fluoroscopic guidance only. Intraprocedural echocardiography was replaced by right atrial opacification using contrast angiography. Contrast TEE was done after 6 weeks, contrast TTE after 3, 6, and 12 months postprocedural. RESULTS: In all 92 patients (52.4 +/- 1.5 years), a 25-mm Amplatzer PFO occluder was implanted in the correct position. Total fluoroscopic time was 8.4 +/- 0.6 minutes and the application of contrast medium was 122.5 +/- 5.8 mL. By contrast-TEE, 12 patients (13 %) showed a small residual shunt (grade 1). During follow-up (2.09 +/- 0.13 years) two patients (2.1%) suffered from a recurrent event (TIA in both cases). CONCLUSIONS: Percutaneous closure of PFO using the 25-mm Amplatzer PFO occluder guided by fluoroscopy only is a safe and efficacious intervention for nearly all patients.