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1.
Clin Res Cardiol ; 108(3): 333-340, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30536045

RESUMO

AIMS: Percutaneous left atrial appendage occlusion (LAAo) is commonly performed under fluoroscopy including the use of contrast dye. In this study, we aimed to assess feasibility and safety of contrast-free, 3D-echo-based LAAo with the use of the AMPLATZER™ Amulet™ device. METHODS AND RESULTS: We analyzed 20 patients (74 ± 10 years, 65% males) at an increased thromboembolic and bleeding risk (CHA2DS2VASC 4.0 ± 1.3; HAS-BLED 3.5 ± 0.9) with chronic renal failure (GFR 41 ± 21 ml/min) undergoing LAAo without the use of contrast dye at our center and compared the results with a propensity-matched cohort (1:1 matching) of conventionally treated patients receiving contrast agent. Contrast-free LAAo was associated with less radiation exposure (13.1 ± 19.2 vs. 32.9 ± 21.2 Gy*cm2, p < 0.01) and fluoroscopy time (5.0 ± 3.4 vs. 11.6 ± 4.9 min, p < 0.01). Procedural success rates were excellent in both groups (100%) without severe periprocedural complications (i.e. procedural death, stroke/systemic embolism, myocardial infarction, cardiac tamponade or major bleeding). CONCLUSIONS: Echocardiographically guided LAAo without the use of contrast dye appears safe and feasible. This approach appears to be associated with reduced radiation exposure and may represent an alternative to traditional LAAo, especially in patients in whom the avoidance of contrast dye is warranted.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana/métodos , Dispositivo para Oclusão Septal , Cirurgia Assistida por Computador/métodos , Idoso , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/diagnóstico , Meios de Contraste , Ecocardiografia Tridimensional , Estudos de Viabilidade , Feminino , Fluoroscopia/métodos , Seguimentos , Humanos , Masculino , Pontuação de Propensão , Estudos Prospectivos , Resultado do Tratamento
2.
Biomed Res Int ; 2017: 1519362, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29085833

RESUMO

INTRODUCTION: Left atrial appendage closure (LAAC) is considered an alternative to oral anticoagulation therapy in patients with atrial fibrillation (AF). The aim of this study was to compare the safety and efficacy of the first- and second-generation AMPLATZER Devices for LAAC, AMPLATZER Cardiac Plug (ACP) versus AMPLATZER Amulet™. METHODS: Procedural data, such as fluoroscopy time, radiation dose, and contrast-dye, as well as VARC criteria and major adverse events (MAEs) were assessed for both devices. The rate of peridevice leaks was analyzed at echocardiographic follow-up. RESULTS: A total of 196 patients with AF underwent LAAC with the ACP (n = 99) or Amulet device (n = 97). The use of Amulet was associated with significantly lower fluoroscopy time (14.8 ± 7.4 min versus 10.6 ± 4.1 min; p < 0.001), lower radiation dose (4833 ± 3360 cGy⁎cm2 versus 3206 ± 2169 cGy⁎cm2; p < 0.001), and reduced amount of contrast-dye (150.2 ± 83.9 ml versus 128.8 ± 46.0 ml; p = 0.03). Furthermore, LAAC with Amulet devices resulted in lower device-resizing rates (3 versus 16 cases; p = 0.001). Peridevice leaks were less frequent in the Amulet group (12 versus 4; p = 0.03). MAE occurred in 6 ACP and 4 Amulet patients (p = 0.58). CONCLUSIONS: The Amulet device is associated with shorter fluoroscopy times and radiation dosages, reduced use of contrast-dye, lower recapture rates, and less peridevice leaks as compared to the ACP.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos/instrumentação , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico por imagem , Procedimentos Cirúrgicos Cardíacos/métodos , Feminino , Fluoroscopia , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Dispositivo para Oclusão Septal
3.
JACC Cardiovasc Interv ; 10(4): 391-399, 2017 02 27.
Artigo em Inglês | MEDLINE | ID: mdl-28231907

RESUMO

OBJECTIVES: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. METHODS: Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. RESULTS: Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients' mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). CONCLUSIONS: Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.


Assuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Falha de Equipamento , Trombose/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Canadá , Cateterismo Cardíaco/efeitos adversos , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Ecocardiografia Doppler em Cores , Ecocardiografia Transesofagiana , Europa (Continente) , Feminino , Humanos , Incidência , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose/diagnóstico por imagem , Fatores de Tempo , Resultado do Tratamento
4.
Arch Cardiovasc Dis ; 108(2): 122-31, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25684570

RESUMO

BACKGROUND: Current guidelines recommend unfractionated heparin (UFH) or low-molecular-weight heparin plus an oral anticoagulant for the prevention of thromboembolism in patients undergoing electric cardioversion of atrial fibrillation (AF). Selective factor Xa inhibitors, such as fondaparinux, which has a favourable benefit-risk profile in the prevention and treatment of venous thromboembolism and the management of acute coronary syndromes, have not been systematically evaluated in this setting. AIM: To evaluate the efficacy and safety of fondaparinux versus standard treatment in patients undergoing echocardiographically-guided cardioversion of AF. METHODS: In this multicentre, randomized, open-label, controlled, two-parallel-group, phase II pilot study, patients with AF undergoing electric cardioversion following transoesophageal echocardiography (TEE) were randomized to fondaparinux or standard therapy (UFH plus vitamin K antagonist [VKA]). Patients showing an atrial thrombus in the first TEE (clot-positive) were randomized to treatment with fondaparinux or standard care for 4 weeks before cardioversion. RESULTS: The primary endpoint (combined rate of cerebral neurological events, systemic thromboembolism, all-cause death and major bleeding events) occurred in 3 of 174 (1.7%) patients on fondaparinux and 2 of 170 (1.2%) patients on UFH+VKA. The rate of thrombus disappearance among clot-positive patients was higher in the fondaparinux arm (11 of 14; 78.6%) than in the UFH+VKA arm (7 of 14; 50.0%). Incidences of adverse events were similar (45.4% with fondaparinux and 46.5% with UFH+VKA). CONCLUSION: In this pilot study in patients with TEE-guided cardioversion, the use of fondaparinux appeared to be well tolerated, with similar efficacy to UFH+VKA. Furthermore, a trend to greater thrombus resolution was observed.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/terapia , Cardioversão Elétrica , Fator X/antagonistas & inibidores , Polissacarídeos/uso terapêutico , Tromboembolia/prevenção & controle , Idoso , Ecocardiografia Transesofagiana , Feminino , Fondaparinux , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Cirurgia Assistida por Computador
5.
Thromb Haemost ; 108(1): 65-73, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22534746

RESUMO

Patients who receive long-term oral anticoagulant (OAC) therapy often require interruption of OAC for an elective invasive procedure. Current guidelines allow bridging therapy with either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Apart from the risk of embolism, bleeding is an important complication in this setting and the optimal perioperative management of such patients is still under discussion. The aims of this prospective, observational, multicentre registry of patients treated by cardiologists were: 1) to evaluate current practice of perioperative management of OAC in a large outpatient cohort, 2) to document embolic and haemorrhagic events, and 3) to identify risk factors predicting adverse events. In the years 2009 and 2010, 1,000 invasive procedures (cardiac catheterisation n=533, pacemaker implantation n = 128, surgery n = 194, other n = 145) were performed in patients with OAC. Sixty- one (6.1%) of those patients did not receive bridging therapy during interruption of OAC, 937 (93.7%) patients were treated with LMWH, two patients (0.2%) received UFH. In 22 patients (2.2%) LMWHs were given in prophylactic dose, 727 patients (72.7%) were treated with halved therapeutic (i.e. weight-adapted) LMWH doses and 188 (18.8%) received full therapeutic LMWH doses. Four thromboembolic complications were observed during 30 days of follow-up (two retinal embolisms, one stroke, one myocardial infarction; 0.4%). One major bleeding (0.1%) and 35 clinically relevant bleedings (3.5%) occurred. Rehospitalisation after bleedings was necessary in 20 patients. Independent predictors for bleedings were history of mechanical heart valve replacement (MVR) (p=0.0002) and the HAS-BLED score (<0.0001), with a cut off value ≥ 3 being the most predictive variable for haemorrhage (hazard ratio 11.8, 95% confidence interval 5.6-24.9, p<0.0001). A total of 527 patients with atrial fibrillation and a CHADS2 score ≤ 2 received halved therapeutic or full therapeutic dosages of LMWH despite a low embolic risk, whereas 49 of the patients with heart valve replacement (51%) did not receive dosages of bridging therapy as recommended in guidelines. In conclusion, in this registry of patients treated by cardiologists, 94% of patients who required interruption of OAC before invasive procedures received LMWH as a bridging therapy, of whom 73% were treated with halved therapeutic LMWH-dosages. Guideline recommendations were followed in only 31% of cases. Importantly, 69% of patients with AF were over-treated while 51% of patients with heart valve replacement were under-treated with LMWHs. A HASB-BLED score ≥ 3 was highly predictive of bleeding events.


Assuntos
Anticoagulantes/efeitos adversos , Cateterismo Cardíaco , Cardiopatias/cirurgia , Hemorragia/diagnóstico , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina/administração & dosagem , Complicações Intraoperatórias/diagnóstico , Implantação de Prótese , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Cuidados Intraoperatórios , Complicações Intraoperatórias/induzido quimicamente , Complicações Intraoperatórias/prevenção & controle , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Sistema de Registros , Fatores de Risco
6.
Heart ; 96(22): 1831-6, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20889990

RESUMO

BACKGROUND: Calcified aortic valve stenosis (AVS) is a disease found in the elderly which is often complicated by severe co-morbidities. AIMS: To assess the survival of conservatively treated patients >75 years with severe AVS compared to patients with non-severe AVS but who have a similar clinical risk profile; and to identify risk factors affecting prognosis. METHODS AND RESULTS: From 2002 to 2006, 161 patients (mean age 86±7.7 years) were studied: 79 with aortic valve area (AVA) <1 cm(2) (group A), 82 with AVA ≥1 cm(2) (group B). Cumulative mortality rates were 77.5% in group A, and 44.4% in group B. Survival rates at 6, 12, 18 and 24 months in groups A and B were: 70.9% versus 98.8%, 65.8% versus 84.1%, 49.4% versus 69.5% and 41.8% versus 59.8%, respectively. Independent predictors for death in group A were pulmonary artery pressure (PAP), the STS-PROM score, serum creatinine and diabetes. PAP >30 mm Hg identified patients at high mortality risk. In group B the predictive variables were ejection fraction, PAP, serum creatinine, and treatment with ß-blockers or ACE inhibitors. CONCLUSION: Severe aortic valve stenosis is a medical condition with limited short-term survival in patients over the age of 75 years at high surgical risk. Clinical variables rather than symptomatic status were able to predict the patients' outcome. Patients with the highest surgical risk have the worst prognosis if AVS is not treated.


Assuntos
Estenose da Valva Aórtica/terapia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/patologia , Comorbidade , Contraindicações , Ecocardiografia Doppler , Métodos Epidemiológicos , Feminino , Implante de Prótese de Valva Cardíaca , Humanos , Masculino , Prognóstico , Resultado do Tratamento
7.
Thromb Haemost ; 101(6): 1085-90, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19492151

RESUMO

If surgery or another intervention is planned, current guidelines recommend bridging oral anticoagulation (OAC) with heparins in patients at elevated thromboembolic (TE) risk. While patients with renal impairment have a higher risk of bleeding and dosing of heparins is more difficult, there are no specific recommendations for bridging the latter patients. Hence, we aimed to investigate the efficacy and tolerability of using reduced low-molecular-weight heparin (enoxaparin) dosages for bridging of OAC. Three hundred twenty-two hospitalised and 51 ambulatory adult patients at moderate to high TE risk were enrolled. Patients with renal insufficiency (n=274 with creatinine clearance [CrCl] 30-50 ml/min and n=99 with CrCl 20-29 ml/min) received after discontinuation of OAC therapy enoxaparin 1mg/ kg once daily. Surgery was performed at international normalised ratio (INR) <1.5. Mean time between the last enoxaparin dose and procedure was 26.8 +/- 2.7 hours. Within 30 days of individual follow-up, no case of TE was observed (0 %; 95 % confidence interval [CI] 0- 0.9). A total of 30 bleeding events (8.0 %; CI 5.5-11.3) occurred (3 major [0.8 %; CI 0.2-2.3] and 27 minor [7.2 %; CI 4.8-10.4]). Bleeding events occurred in 6.5% (CI 3.9-10.2) of patients with CrCl 30-50 ml/min and in 12.1% (CI 6.4-20.2) of patients with CrCl 20-29 ml/min (p between groups =0.08). Logistic regression analysis identified the CHADS(2) score as the only independent haemorrhagic risk factor (p= 0.03). No heparin-induced thrombocytopenia (HIT-II) was reported. Bridging therapy could be performed in 51 (13.7%) ambulatory patients. In renally impaired patients undergoing bridging of OAC, the use of a priori reduced dosage of enoxaparin was not compromised by any TE events. It appeared well tolerated as the rate of major bleeds was low.


Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Assistência Perioperatória , Insuficiência Renal/tratamento farmacológico , Tromboembolia/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Creatinina/metabolismo , Cálculos da Dosagem de Medicamento , Enoxaparina/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Guias de Prática Clínica como Assunto , Insuficiência Renal/complicações , Insuficiência Renal/fisiopatologia , Insuficiência Renal/cirurgia , Fatores de Risco , Trombocitopenia/induzido quimicamente , Trombocitopenia/prevenção & controle , Tromboembolia/etiologia , Resultado do Tratamento
8.
Thromb Haemost ; 101(2): 325-32, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19190817

RESUMO

Low-molecular-weight heparins (LMWH) are commonly used as peri-procedural bridging anticoagulants. The usefulness of measurement of anti-factor Xa activity (anti-Xa) to guide bridging therapy with LMWH is unknown. It was the objective of this study to determine levels of anti-Xa during standard bridging therapy with enoxaparin, and to examine predictors for residual anti-Xa. Consecutive patients receiving enoxaparin at a dosage of 1 mg/kg body weight/12 hours for temporary interruption of phenprocoumon were prospectively enrolled to the study. Blood-samples were obtained 14 hours after LMWH-application immediately pre- procedurally. Procedural details, clinical and demographic data were collected and subsequently analyzed. Seventy patients were included (age 75.2 +/- 10.8 years, Cr Cl 55.7 +/- 21.7ml/min, body mass index [BMI] 27.1 +/- 4.9). LMWH- therapy was for a mean of 4.2 +/- 1.6 days; overall anti-Xa was 0.58 +/- 0.32 U/ml. In 37 (52.8%) of patients anti-Xa was > or U/ml, including 10 (14.3%) patients with anti-Xa > 1U/ml. Linear regression analysis of single variables and logistic multivariable regression analysis failed to prove a correlation between anti-Xa and single or combined factors. No major bleeding, no thromboembolism and four (5.7%) minor haemorrhages were observed. When bridging OAC with therapeutic doses of enoxaparin a high percentage of patients undergo interventions with high residual anti-Xa. The levels of anti-Xa vary largely and are independent of single or combined clinical variables. Since the anti-Xa-related outcome of patients receiving bridging therapy with LMWH is not investigated, no firm recommendation on the usefulness of monitoring of anti-Xa can be given at this stage.


Assuntos
Anticoagulantes/administração & dosagem , Monitoramento de Medicamentos/métodos , Enoxaparina/administração & dosagem , Inibidores do Fator Xa , Femprocumona/administração & dosagem , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Tromboembolia/prevenção & controle , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Esquema de Medicação , Enoxaparina/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Coeficiente Internacional Normatizado , Modelos Lineares , Modelos Logísticos , Pessoa de Meia-Idade , Tempo de Tromboplastina Parcial , Femprocumona/efeitos adversos , Projetos Piloto , Valor Preditivo dos Testes , Estudos Prospectivos , Medição de Risco , Tromboembolia/etiologia , Resultado do Tratamento
9.
Med Klin (Munich) ; 102(10): 809-15, 2007 Oct 15.
Artigo em Alemão | MEDLINE | ID: mdl-17928964

RESUMO

BACKGROUND AND PURPOSE: Oral anticoagulant (OAC) therapy should be temporarily interrupted for an elective procedure or surgery, and perioperative prophylaxis with heparins should be initiated in patients who face a high or moderate risk of thrombosis. To date, the optimal heparin dose has not been established. The authors investigated the efficacy and safety of a risk-adapted regimen with the low-molecular-weight heparin enoxaparin in two different, body weight-adapted regimens. PATIENTS AND METHODS: In the own institution, adult patients were consecutively documented in the prospective BRAVE registry, if they required bridging therapy. Patients with moderate thromboembolic risk (35.7%) received, after interruption of OAC and reaching an International Normalized Ratio (INR) of 1.5, enoxaparin 1 mg/kg body weight daily, those with high risk (64.3%) enoxaparin 1 mg/kg body weight twice daily (in case of compromised renal function half this dose, respectively). Events were recorded at 30 days post intervention by on-site examination of the patient or telephone follow-up. RESULTS: Of 779 patients, none had a thromboembolic event. Enoxaparin was well tolerated. A total of four major bleedings in three patients (0.5%, all in the high-risk group), 46 minor bleedings (5.9%), and twelve cases of thrombocytopenia (1.5%, however, no heparin-induced thrombocytopenia [HIT] II) were noted. CONCLUSION: The absence of thromboembolic events confirms the efficacy of enoxaparin in perioperative bridging. The rate of major bleedings was low and, of note, no cases of HIT II were noted. Reducing the dose to half the standard was shown to be effective and well tolerated in patients with moderate risk. Likewise, enoxaparin in a reduced dose can be safely used in patients with renal insufficiency who require bridging.


Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Assistência Perioperatória , Complicações Pós-Operatórias/prevenção & controle , Sistema de Registros , Tromboembolia/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Relação Dose-Resposta a Droga , Esquema de Medicação , Procedimentos Cirúrgicos Eletivos , Enoxaparina/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Injeções Subcutâneas , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Medição de Risco , Trombocitopenia/induzido quimicamente , Resultado do Tratamento
10.
J Heart Valve Dis ; 16(3): 285-92, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17578050

RESUMO

BACKGROUND AND AIM OF THE STUDY: The study aim was to determine the safety and feasibility of a standardized bridging regimen in patients with mechanical heart valves at high thromboembolic risk, using low-molecular-weight heparin (LMWH). METHODS: Since the year 2000, all patients at the authors' institution, with mechanical heart valves and a need for periprocedural interruption of oral anticoagulation (OAC), were prospectively enrolled in this registry. Patients were treated with enoxaparin following a pre-specified, standardized bridging regimen. The main outcome measures were the incidence of hemorrhagic or thromboembolic events. The follow up period was 30 days after hospital discharge. RESULTS: A total of 116 patients was included (31 with mitral valve replacement, 76 aortic valve replacement, nine double valve replacement). Patients underwent either major surgery (n = 25), minor surgery (n = 36), pacemaker implantation (n = 21), or coronary catheterization (n = 34). Bridging therapy with enoxaparin was administered for a mean of 7.0 +/- 4.6 days. Eighteen patients (15.5%) were treated as outpatients. In 35 patients (34%) with renal impairment (creatinine clearance <50 ml/min), LMWH dosage was halved. No thromboembolic (95% CI 0-3.1%) and only one major bleeding complication occurred (0.86%; 95% CI 0.02-4.7%); minor bleeding occurred in 10 patients (8.6%; 95% CI 4.2-15.3%). The hemorrhages arose after a mean of 5.4 +/- 1.4 days LMWH therapy. CONCLUSION: Bridging therapy following a standardized LMWH-based regimen with enoxaparin was effective and relatively safe in a large cohort of patients with mechanical heart valves. Extended duration of LMWH therapy seems to promote the incidence of hemorrhage. Neither dose reduction in patients with renal impairment nor outpatient treatment affected the safety and efficacy of this bridging regimen. These findings warrant that more extensive studies be conducted to investigate the safety of this approach.


Assuntos
Anticoagulantes/uso terapêutico , Enoxaparina/uso terapêutico , Implante de Prótese de Valva Cardíaca , Assistência Perioperatória , Tromboembolia/prevenção & controle , Idoso , Valva Aórtica/cirurgia , Estudos de Viabilidade , Próteses Valvulares Cardíacas , Hemorragia/etiologia , Humanos , Coeficiente Internacional Normatizado , Valva Mitral/cirurgia , Estudos Prospectivos , Sistema de Registros
11.
Curr Med Res Opin ; 22(6): 1109-22, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16846544

RESUMO

BACKGROUND: In patients receiving chronic oral anticoagulation with vitamin K antagonists (VKAs) it may be necessary to temporarily discontinue VKA therapy to allow surgery or other invasive procedures to be performed, as maintaining treatment may increase the risk of bleeding during the procedure. This, however, creates a clinical dilemma, since discontinuing VKAs may place the patient at risk of thromboembolism. SCOPE: We undertook a systematic narrative review of patients on chronic oral anticoagulation, requiring a periprocedural bridging therapy with heparin during invasive procedures. FINDINGS AND RECOMMENDATIONS: For patients requiring temporary discontinuation of VKA, current guidelines recommend the use of 'bridging' therapy with unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in patients considered to be at intermediate-to-high risk of thromboembolism, such as those with prosthetic heart valves or atrial fibrillation. Recent studies show that LMWHs are associated with low rates of thromboembolism and, when compared with UFH, are as effective and safe as UFH when used as periprocedural bridging therapy in such patients. LMWHs also offer advantages such as ease of administration and predictable anticoagulant effects. Moreover, outpatient-based periprocedural bridging therapy with LMWH has been shown to result in significant cost savings compared with in-hospital UFH. CONCLUSIONS: The decision to provide bridging therapy requires careful consideration of the relative risks of thromboembolism and bleeding in each patient. Based upon the studies reviewed we recommend a therapeutic dose of UFH or LMWH for patients at intermediate-to-high thromboembolic risk requiring interruption of VKA, especially for low bleeding risk procedures. We would like to propose upgrading the American College of Chest Physicians (ACCP) guideline recommendations from 2C to 1C. However, there is still a need for a randomized controlled trial on the efficacy and safety of the available bridging strategies, including heparin and placebo comparators, in preventing thromboembolism for specific patients and procedures.


Assuntos
Anticoagulantes/administração & dosagem , Heparina de Baixo Peso Molecular/administração & dosagem , Tromboembolia , Vitamina K/antagonistas & inibidores , Anticoagulantes/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Tromboembolia/induzido quimicamente , Tromboembolia/etiologia
12.
J Am Coll Cardiol ; 46(1): 9-14, 2005 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-15992628

RESUMO

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.


Assuntos
Fibrilação Atrial/complicações , Fibrilação Atrial/terapia , Oclusão com Balão/instrumentação , Isquemia Encefálica/prevenção & controle , Cateterismo Cardíaco/instrumentação , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes , Apêndice Atrial , Isquemia Encefálica/etiologia , Contraindicações , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
13.
Eur J Heart Fail ; 5(5): 615-9, 2003 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-14607200

RESUMO

Patients with chronic coronary heart disease often suffer from congestive heart failure (CHF) despite multiple drug therapies. D-Ribose has been shown in animal models to improve cardiac energy metabolism and function following ischaemia. This was a prospective, double blind, randomized, crossover design study, to assess the effect of oral D-ribose supplementation on cardiac hemodynamics and quality of life in 15 patients with chronic coronary artery disease and CHF. The study consisted of two treatment periods of 3 weeks, during which either oral D-ribose or placebo was administered followed by a 1-week wash out period, and then administration of the other supplement. Assessment of myocardial functional parameters by echocardiography, quality of life using the SF-36 questionnaire and functional capacity using cycle ergometer testing was performed. The administration of D-ribose resulted in an enhancement of atrial contribution to left ventricular filling (40+/-11 vs. 45+/-9%, P=0.02), a smaller left atrial dimension (54+/-20 vs. 47+/-18 ml, P=0.02) and a shortened E wave deceleration (235+/-64 vs. 196+/-42, P=0.002) by echocardiography. Further, D-ribose also demonstrated a significant improvement of the patient's quality of life (417+/-118 vs. 467+/-128, P< or =0.01). In comparison, placebo did not result in any significant echocardiographic changes or in quality of life. This feasibility study in patients with coronary artery disease in CHF revealed the beneficial effects of D-ribose by improving diastolic functional parameters and enhancing quality of life.


Assuntos
Diástole/fisiologia , Insuficiência Cardíaca/tratamento farmacológico , Qualidade de Vida , Ribose/uso terapêutico , Trifosfato de Adenosina/metabolismo , Administração Oral , Estudos Cross-Over , Método Duplo-Cego , Ecocardiografia , Estudos de Viabilidade , Feminino , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ribose/administração & dosagem , Função Ventricular Esquerda/fisiologia
14.
Pacing Clin Electrophysiol ; 26(8): 1691-8, 2003 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12877702

RESUMO

Atrial tachyarrhythmias play an important role in the treatment of patients with malignant ventricular tachyarrhythmias not only with respect to inappropriate discharges but also to left ventricular function and stroke risk. A combined dual chamber defibrillator provides separate therapies for atrial and ventricular tachyarrhythmias. To assess the incidence of atrial tachyarrhythmias in patients with this dual chamber implantable defibrillator, 40 patients with ventricular tachyarrhythmias and concomitant atrial tachyarrhythmias and/or AV conduction disturbances were included in a prospective study. During a mean follow-up of 25 +/- 11 months, 26 of 40 patients had a total of 1,430 recurrences of atrial tachyarrhythmias. The vast majority of the atrial tachyarrhythmias with regular atrial cycles had a mean median atrial cycle length of 235 +/- 37 ms and a mean duration of 34 +/- 144 minutes. Atrial tachyarrhythmias with irregular atrial cycles exhibited a median atrial cycle length of 198 +/- 31 ms and had a mean duration of 246 +/- 1,264 minutes. In addition, 67% of 375 tachyarrhythmias, in which the median ventricular cycle length during the ongoing episode could be documented, had a ventricular rate <100 beats/min. Continuous atrial arrhythmia detection with a dual chamber ICD reveals a high incidence of atrial tachyarrhythmias with a predominantly short duration of paroxysmal recurrences <1 hour in the vast majority of episodes.


Assuntos
Fibrilação Atrial/terapia , Desfibriladores Implantáveis , Algoritmos , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/fisiopatologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva
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