RESUMO
OBJECTIVES: The aim of this study is to summarize the outcomes of patients undergoing direct stenting (DS) with drug-eluting stents (DES) compared to those who underwent balloon predilatation. BACKGROUND: DS has been associated with improved outcomes in the bare-metal stent era. Although DS with DES implantation has been increasingly adopted in clinical practice, its safety and effectiveness remain controversial. METHODS: The search criteria identified 546 studies in the Medline/PubMed, Cochrane, and EMBASE databases from 2001 to July 2014. From these, seven studies totaling 10,900 patients were selected. Summarized estimates [odds ratio (OR) and 95% confidence intervals] were obtained using a random-effects model. The primary outcomes were a composite of major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and repeat revascularization. The secondary outcomes included a composite of death and MI and the rates of target lesion revascularization (TLR). RESULTS: Overall, 4101 (38%) and 6799 (62%) patients underwent DS with DES and balloon pre-dilatation, respectively. DS with DES reduced the likelihood of MACE (OR: 0.81 [0.71-0.93]). Additionally, DS with DES was associated with reduced rates of death/MI (OR: 0.76 [0.62-0.92]), and TLR (OR: 0.66 [0.44-0.98]). CONCLUSIONS: DS with DES is safe and may be associated with better outcomes in selected patients. © 2016 Wiley Periodicals, Inc.
Assuntos
Angioplastia com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Idoso , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Distribuição de Qui-Quadrado , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Medição de Risco , Fatores de Risco , Resultado do TratamentoRESUMO
OBJECTIVE: Comparison of transradial versus transfemoral access for complex percutaneous coronary intervention (PCI) with regard to both complications and long-term outcomes. BACKGROUND: Radial access has been shown to confer superior results in patients undergoing PCI, especially in patients with acute coronary syndromes. However, radial access has limitations of sheath and device size, which may increase procedure time and result in inferior outcomes. METHODS: Patients undergoing PCI for complex lesions, defined as type C according the ACC/AHA classification system, were included in this study. Propensity matching was performed to adjust for differences in baseline characteristics. Transradial patients were then compared to transfemoral patients in regard to procedural, in-hospital, and 6-month outcomes. RESULTS: Among 2142 patients with 2591 lesions treated, 1876 had femoral access and 267 had radial access. Radial access patients were more likely to be male (75% vs. 66%, P = 0.003) and less likely to present with acute myocardial infarction (27% vs. 42%, P < 0.001). Procedural characteristics demonstrated lower use of heparin in the femoral group (17% vs. 73%, P < 0.001) with similarly low use of glycoprotein inhibitors (5.6% vs. 3.4%, P = 0.14). Patients in the femoral group had higher rates of transfusions (3.7% vs. 0%, P = 0.004) and vascular complications (1.7% vs. 0%, P = 0.03). Following propensity matching, there was no difference in mid-term outcomes between radial and femoral groups. CONCLUSIONS: In patients with complex coronary lesions undergoing PCI, the radial approach demonstrates similar mid-term outcomes as the femoral approach with a potentially lower rate of complications. © 2016 Wiley Periodicals, Inc.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Cateterismo Periférico/métodos , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/epidemiologia , Síndrome Coronariana Aguda/diagnóstico , Idoso , Causas de Morte/tendências , Angiografia Coronária , District of Columbia/epidemiologia , Eletrocardiografia , Feminino , Artéria Femoral , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Artéria Radial , Estudos Retrospectivos , Fatores de TempoRESUMO
AIMS: We performed a network meta-analysis of randomized controlled trials (RCTs) in patients with primary hypercholesterolaemia to compare the impact of proprotein convertase subtilisin-kexin type 9 serine protease (PCSK9) inhibitors with placebo and ezetimibe on lipid levels and outcomes. METHODS AND RESULTS: MEDLINE/PubMed, Cochrane CENTRAL, and ClinicalTrials.gov were searched for RCTs assessing PCSK9 inhibitors vs. other therapies in patients with primary hypercholesterolaemia. Network meta-analysis with both a frequentist approach and a Bayesian framework was performed to directly and indirectly compare PCSK9 inhibition on lipid levels with ezetimibe and placebo. Odds ratios with 95% confidence intervals (OR [95% CIs]) were generated with random-effects models to compare outcomes. Our meta-analysis included 17 RCTs with 13 083 patients that were randomized to PCSK9 inhibitors (n = 8250), placebo (n = 3957), ezetimibe (n = 846), or PCSK9 inhibitors and ezetimibe (n = 30). The mean age was 59 ± 10, 52% were male, 34% had coronary artery disease, 51% had hypertension, 19% had diabetes mellitus, baseline LDL of 122 ± 36 mg/dL, total cholesterol of 199 ± 39 mg/dL, and HDL of 51 ± 14 mg/dL. inhibitors significantly reduced LDL cholesterol by 57% relative to placebo (P < 0.001) and 36.1% relative to ezetimibe (P < 0.001). Proprotein convertase subtilisin-kexin type 9 serine protease inhibitors reduced the incidence of all-cause mortality [OR 0.43 (95% CI 0.22-0.82), P = 0.01] but was associated with an increased incidence of neurocognitive adverse events [OR 2.34 (95% CI 1.11-4.93), I(2) = 4%, P = 0.02] when compared with placebo. CONCLUSION: Proprotein convertase subtilisin-kexin type 9 serine protease inhibition significantly improved lipid profiles and reduced the incidence of all-cause mortality compared with placebo but had a higher rate of neurocognitive adverse events. Thus, PCSK9 inhibitor therapy may serve as an alternative for patients with statin intolerance and for those who do not respond to other lipid reduction therapy.
Assuntos
Anticolesterolemiantes/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Inibidores de PCSK9 , LDL-Colesterol/efeitos dos fármacos , LDL-Colesterol/metabolismo , Humanos , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the current standard for nonoperable and high-risk surgical patients with aortic stenosis, including those of advanced age. However, the clinical profiles, procedural characteristics, and outcomes of nonagenarians undergoing TAVR have not been thoroughly reported. METHODS: A total of 654 patients (n = 107 >90 years old and n = 547 <90 years) with severe aortic stenosis undergoing TAVR were included in this analysis. Baseline characteristics, procedural variables, and in-hospital outcomes and complications at 30 days and 12 months were analyzed. RESULTS: Overall, of the patients included, 46% were high risk and 53% inoperable. Although nonagenarians had a higher Society of Thoracic Surgeons score of 9.2 ± 4 (12.1 ± 4 vs 8.6 ± 4, P < .001), other factors were considerably lower in this group: diabetes (22% vs 36%, P = .008), hyperlipidemia (65% vs 83%, P < .001), prior coronary artery bypass (13% vs 39%, P < .001), and mean body mass index (24.5 ± 5 vs 28.1 ± 7 kg/m(2), P < .001). The correlates for 1-year mortality in nonagenarians were as follows: ≥moderate aortic insufficiency post-TAVR (hazard ratio [HR] 5.07, 95% CI 1.17-22, P = .03), pacemaker implantation after TAVR (HR 6.87, 95% CI 2.32-20.3, P = .001), and peripheral vascular disease (HR 2.35, 95% CI 1.03-5.38, P = .042). Mortality at 30 days (12.1% vs 7.1%, P = .07) and at 1 year (25% vs 21%, P = .35) was similar between groups. CONCLUSION: Nonagenarians undergoing TAVR had a healthier clinical profile compared with younger patients. Age alone should not be a discriminatory factor when screening elderly patients with aortic stenosis because even the nonagenarians are doing well when compared with the younger elderly population. Transcatheter aortic valve replacement remains a viable option for the treatment of severe symptomatic aortic stenosis for the elderly regardless of their age.
Assuntos
Estenose da Valva Aórtica/mortalidade , Diagnóstico por Imagem/métodos , Medição de Risco , Substituição da Valva Aórtica Transcateter , Fatores Etários , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Angiografia Coronária , District of Columbia/epidemiologia , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: The prevalence of concomitant significant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) ranges from 2% to 33%. The impact of significant MR on post-TAVR outcomes remains controversial. METHODS: The data from a cohort of patients with symptomatic severe AS undergoing TAVR at out institution were retrospectively analyzed. The last transthoracic echocardiogram (TTE) before the index TAVR procedure was selected as the baseline assessment of the degree of MR. The total study cohort (N = 589) was divided into 2 groups: significant ≥moderate MR (n = 68) versus nonsignificant Assuntos
Estenose da Valva Aórtica/cirurgia
, Insuficiência da Valva Mitral/epidemiologia
, Substituição da Valva Aórtica Transcateter
, Idoso
, Idoso de 80 Anos ou mais
, Estenose da Valva Aórtica/diagnóstico por imagem
, Estenose da Valva Aórtica/epidemiologia
, Estudos de Coortes
, Comorbidade
, Bases de Dados Factuais
, Ecocardiografia
, Feminino
, Humanos
, Masculino
, Insuficiência da Valva Mitral/diagnóstico por imagem
, Mortalidade
, Prognóstico
, Modelos de Riscos Proporcionais
, Estudos Retrospectivos
, Índice de Gravidade de Doença
, Análise de Sobrevida
, Resultado do Tratamento
RESUMO
OBJECTIVES: We sought to identify if baseline characteristic differences in patients who receive a 23 mm vs. 26 mm valve impact clinical outcomes. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is currently an approved therapy for patients with severe aortic stenosis who are considered inoperable or are at high risk. METHODS: We retrospectively examined baseline characteristics and outcomes of patients receiving a 23 mm (n = 132) vs. 26 mm valve (n = 81) via the transfemoral approach. RESULTS: Gender (P < 0.01), previous coronary artery bypass surgery (P < 0.01), history of atrial fibrillation (P = 0.04), and mean Society of Thoracic Surgeons (STS) score (P < 0.01) were significantly different between groups. There were no significant differences in the rates of minor/major vascular complications (2.2 vs. 3.7%, P = 0.68 and 13.0 vs. 12.3%, P = 0.89, respectively). Bleeding complications were also comparable (major bleed 2.3 vs. 1%, P >0.99, minor bleed 19.0 vs. 22.0%, P = 0.67 and life threatening bleed 7.0 vs. 5.0%, P = 0.77). In-hospital death (6.0 vs. 5.0%, P >0.99), 30-day all-cause death (7.6 vs. 6.2%, P = 0.69), and all-cause death at 1 year (17.4 vs. 25.9%, P = 0.13) were also similar between groups. Gender, valve size, previous coronary bypass surgery and atrial fibrillation were not independently associated with mortality; however, on multivariate analysis STS score was (HR 1.11; 95% CI 1.02-1.19; P = 0.01). CONCLUSION: Patients undergoing TAVR with 23 and 26 mm valves have similar clinical outcomes despite significant differences in baseline characteristics. © 2015 Wiley Periodicals, Inc.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Desenho de Prótese , Estudos Retrospectivos , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
OBJECTIVE: We evaluate the prevalence of complications and failure rates between the most commonly used "active" anchoring vascular closure device (VCD), AngioSeal™ and the "passive" anchoring VCD, Mynx™, in all-comers undergoing percutaneous coronary intervention (PCI). METHODS: A total of 4,074 patients between 2008 and 2014, representing an era when both devices were available, were included. Thirty-two percent were acute coronary syndromes (37% STEMI). VCD choice was at the operator's discretion and included AngioSeal (n = 2,910) or Mynx (1,164). Cardiogenic shock or patients receiving intra-aortic balloon pumps were excluded. Safety was assessed by vascular complications defined as either vascular injury (perforation, dissection, acute limb ischemia, arteriovenous fistula, pseudoaneurysm with thrombin injection, or surgical repair) or access-site bleed (hemoglobin droP >3 g/dL requiring transfusion, retroperitoneal bleed, or hematoma >5 cm, or the composite of both. Efficacy was evaluated by device failure and defined as inability to achieve immediate hemostasis or use of additional hemostatic mechanisms. Outcomes at 30-days were evaluated. RESULTS: Groups (AngioSeal vs Mynx) were fairly balanced with regards to bleeding risk factors of gender (male, 65% vs 66%), body mass index (30 ± 6 vs 30 ± 7), heart failure class III/IV (5% vs 6%), chronic kidney disease (15% vs 17%), use of glycoprotein IIb/IIIa inhibitor (5% vs 4%), or bivalirudin (86% vs 88%), all P >0.5. The AngioSeal group was slightly younger (64 ± 12 vs 65 ± 12, P < 0.001) with less peripheral arterial disease (11.3% vs 13.9%, P = 0.03), and increased 7F sheath use compared with Mynx (59% vs 22%, P < 0.001). Safety and efficacy outcomes were similar between groups. CONCLUSIONS: AngioSeal and Mynx appear to be equally safe and efficacious VCDs following PCI. The passive anchoring system may prove desirable as no intra-arterial anchor remains upon device removal.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Hemostasia Cirúrgica/instrumentação , Intervenção Coronária Percutânea/efeitos adversos , Hemorragia Pós-Operatória/cirurgia , Dispositivos de Oclusão Vascular , Idoso , Falso Aneurisma/etiologia , Falso Aneurisma/prevenção & controle , Pesquisa Comparativa da Efetividade , Feminino , Hemostasia Cirúrgica/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Fatores de Risco , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversos , Dispositivos de Oclusão Vascular/classificaçãoRESUMO
The prevention of major bleeding during percutaneous coronary intervention is one of the most widely discussed and often controversial topics within interventional cardiology. The choice of arterial access should be considered a mechanism for bleeding avoidance, and various strategies have been proposed to prevent or lower major bleeding and vascular complications with varying levels of strength. Herein, we review the current literature on arterial access as a bleeding avoidance strategy during percutaneous coronary intervention and its impact on outcome and provide a consensus opinion based on the strength of the evidence supporting various techniques.
Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Cateterismo Cardíaco/métodos , Doença da Artéria Coronariana/cirurgia , Artéria Femoral , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/métodos , Hemorragia Pós-Operatória/prevenção & controle , Artéria Radial , Angiografia Coronária/métodos , Humanos , Guias de Prática Clínica como Assunto , Cirurgia Assistida por Computador , Resultado do Tratamento , Dispositivos de Oclusão VascularRESUMO
BACKGROUND: Multiple studies have evaluated the diagnostic and prognostic performance of conventional troponin (cTn) and high-sensitivity troponin (hs-cTn). We performed a collaborative meta-analysis comparing cTn and hs-cTn for diagnosis of acute myocardial infarction (AMI) and assessment of prognosis in patients with chest pain. METHODS: MEDLINE/PubMed, Cochrane CENTRAL, and EMBASE were searched for studies assessing both cTn and hs-cTn in patients with chest pain. Study authors were contacted and many provided previously unpublished data. RESULTS: From 17 included studies, there were 8,644 patients. Compared with baseline cTn, baseline hs-cTn had significantly greater sensitivity (0.884 vs 0.749, P < .001) and negative predictive value (NPV; 0.964 vs 0.935, P < .001), whereas specificity (0.816 vs 0.938, P < .001) and positive predictive value (0.558 vs 0.759, P < .001) were significantly reduced. Based on summary receiver operating characteristic curves, test performance for the diagnosis of AMI was not significantly different between baseline cTn and hs-cTn (0.90 [95% CI 0.85-0.95] vs 0.92 [95% CI 0.90-0.94]). In a subanalysis of 6 studies that alternatively defined AMI based on hs-cTn, cTn had lower sensitivity (0.666, P < .001) and NPV (0.906, P < .001). Elevation of baseline hs-cTn, but negative baseline cTn, was associated with increased risk of death or nonfatal myocardial infarction during follow-up (P < .001) compared with both negative. CONCLUSION: High-sensitivity troponin has significantly greater early sensitivity and NPV for the diagnosis of AMI at the cost of specificity and positive predictive value, which may enable early rule in/out of AMI in patients with chest pain. Baseline hs-cTn elevation in the setting of negative cTn is also associated with increased nonfatal myocardial infarction or death during follow-up.
Assuntos
Dor no Peito/sangue , Infarto do Miocárdio/diagnóstico , Troponina/sangue , Dor no Peito/etiologia , Humanos , Infarto do Miocárdio/mortalidade , Prognóstico , Curva ROC , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To evaluate access site and other bleeding complications associated with radial versus femoral access in patients receiving oral anticoagulation (OAC) with warfarin. BACKGROUND: Patients receiving OAC with warfarin undergoing coronary angiography and percutaneous coronary intervention (PCI) may have OAC continued despite the risk of bleeding. To what extent arterial access site impacts bleeding in such patients is not well studied. METHODS: Over 6 years, we identified 255 consecutive patients in whom warfarin was continued who underwent coronary angiography with an international normalized ratio >1.8. A total of 97 patients also underwent PCI at the same setting (27% femoral vs 73% radial). The primary outcome was Bleeding Academic Research Consortium bleeds; a secondary end point was frequency of access site complications in the 72 hours post-PCI. Complications were evaluated based on the initial access site attempted. RESULTS: Minimal baseline clinical characteristics differences existed between the groups. International normalized ratio was significantly higher in the radial group (2.42 ± 0.67 vs 2.24 ± 0.49, P = .02). Bivalirudin use was greater during radial PCI than femoral (76% vs 42%, P < .05), whereas unfractionated heparin alone was greater during femoral PCI than radial (46% vs 18%, P < .05). No significant difference was seen in the primary end point between femoral (2.8%) and radial (1.6%, P = .54) during coronary angiography alone. However, PCI via the femoral artery had significantly more Bleeding Academic Research Consortium bleeding (19.2% vs 1.4%, P = .005) and transfusions (15% vs 0%, P = .004) than via the radial artery. Patients who underwent PCI using radial access were less likely to have any vascular or bleeding complications (1% vs 23%, P = .001). CONCLUSIONS: Patients who underwent coronary angiography during uninterrupted OAC had similar bleeding rates regardless of access site. However, when PCI was performed, radial access was associated with fewer bleeding and vascular complications than the femoral approach. CONDENSED ABSTRACT: We retrospectively identified 255 consecutive patients on warfarin who underwent coronary angiography, 97 of whom underwent a percutaneous coronary intervention. The data reveal a reduction in Bleeding Academic Research Consortium bleeds (1.6% vs 8.1%, P = .02) with radial versus femoral access. The radial approach was associated with an overall lower rate of any vascular or bleeding complication than the femoral approach during percutaneous coronary intervention (1% vs 23%, P = .001).
Assuntos
Angiografia Coronária/métodos , Isquemia Miocárdica/cirurgia , Intervenção Coronária Percutânea/métodos , Varfarina/administração & dosagem , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Feminino , Artéria Femoral , Seguimentos , Humanos , Masculino , Isquemia Miocárdica/diagnóstico por imagem , Artéria Radial , Estudos Retrospectivos , Resultado do TratamentoAssuntos
Síndrome Coronariana Aguda/prevenção & controle , Aprovação de Drogas , Lactonas/uso terapêutico , Placa Aterosclerótica/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Piridinas/uso terapêutico , Comitês de Monitoramento de Dados de Ensaios Clínicos , Hemorragia/epidemiologia , Humanos , Lactonas/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Piridinas/efeitos adversos , Receptor PAR-1/antagonistas & inibidores , Medição de Risco , Estados UnidosAssuntos
Currículo , Educação de Pós-Graduação em Medicina/normas , Bolsas de Estudo , Pediatria/educação , Intervenção Coronária Percutânea/educação , Intervenção Coronária Percutânea/normas , Garantia da Qualidade dos Cuidados de Saúde , Humanos , Guias de Prática Clínica como Assunto , Radiografia Intervencionista/normas , Sistema de Registros , Sociedades Médicas , Estados UnidosAssuntos
Hospitais , Provedores de Redes de Segurança , Humanos , Estados Unidos/epidemiologia , CoraçãoRESUMO
PURPOSE: Evaluate the safety of MynxGrip® for common femoral vein closure. METHODS AND MATERIALS: This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (nâ¯=â¯104) or manual compression (nâ¯=â¯104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups. RESULTS: There was no difference between the groups for venous thrombosis, (0%, pâ¯=â¯1). Overall, there was no significant change in access site calf (-0.18⯱â¯1.38â¯cm, pâ¯=â¯0.18) or thigh diameter (0.33⯱â¯2.86, pâ¯=â¯0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51⯱â¯1.1 vs. -0.64⯱â¯1.3â¯g/dL, pâ¯=â¯0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12⯱â¯0.89 vs. 7.6⯱â¯5.7â¯min, respectively (pâ¯<â¯0.001). CONCLUSIONS: The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.
Assuntos
Cateterismo Periférico , Veia Femoral , Hemorragia/prevenção & controle , Técnicas Hemostáticas/instrumentação , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Cateterismo Periférico/efeitos adversos , Desenho de Equipamento , Feminino , Veia Femoral/diagnóstico por imagem , Hemorragia/diagnóstico , Hemorragia/etiologia , Hemostasia , Técnicas Hemostáticas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Pressão , Estudos Prospectivos , Punções , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to determine the risk of scaffold thrombosis (ST) after percutaneous coronary intervention (PCI) with placement of an ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) by conducting a systematic review and meta-analysis. BACKGROUND: PCI with BVS placement holds great potential, but concern has recently been raised regarding the risk of ST. METHODS: MEDLINE/PubMed, Cochrane CENTRAL, and meeting abstracts were searched for all studies that included outcomes data for patients after PCI with BVS placement. For studies comparing BVSs with drug-eluting stents (DES), pooled estimates of outcomes, presented as odds ratios (ORs) with 95% confidence intervals (CIs), were generated with random-effects models. RESULTS: Our analysis included 10,510 patients (8,351 with a BVS and 2,159 with DES) with a follow-up of 6.4 ± 5.1 months and 60 ± 11 years of age; 78% were male, 36% had stable angina, and 59% had acute coronary syndrome (ACS). Among patients with a BVS, cardiovascular death occurred in 0.6%, myocardial infarction (MI) in 2.1%, target lesion revascularization in 2.0%, and definite/probable ST in 1.2% of patients. Of BVS patients, 0.27% had acute ST and 0.57% had subacute ST. Meta-analysis demonstrated that patients who received a BVS were at a higher risk of MI (OR: 2.06, 95% CI: 1.31 to 3.22, p = 0.002) and definite/probable ST (OR: 2.06, 95% CI: 1.07 to 3.98, p = 0.03) compared with patients who received DES, whereas there was a trend toward decreased all-cause mortality with a BVS (OR: 0.40, 95% CI: 0.15 to 1.06, p = 0.06). CONCLUSIONS: Patients undergoing PCI with a BVS had increased definite/probable ST and MI during follow-up compared with DES. Further studies with long-term follow-up are needed to assess the risk of ST with a BVS.
Assuntos
Implantes Absorvíveis , Síndrome Coronariana Aguda/terapia , Angina Estável/terapia , Doença da Artéria Coronariana/terapia , Trombose Coronária/etiologia , Intervenção Coronária Percutânea/instrumentação , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Idoso , Angina Estável/diagnóstico , Angina Estável/mortalidade , Distribuição de Qui-Quadrado , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/diagnóstico , Trombose Coronária/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: To report a case of a thrombosed GORE® VIABAHN® endoprosthesis stent-graft in the femoral artery (SFA) and popliteal artery managed using the pulse-spray technique and complicated by compartment syndrome of the lower leg of the affected limb. CASE REPORT: A 61-year-old woman with three Viabahn stent grafts relining seven bare-metal stents in her right SFA and popliteal artery visited our hospital with complaint of recurrent lifestyle-limiting claudication of right leg. Angiography and intravascular ultrasound showed complete intra-stent obstruction by thrombus from the proximal right SFA to the proximal popliteal artery. Catheter-directed thrombolysis using pulse-spray technique followed by mechanical thrombectomy was performed. Despite successful recanalization, unfortunately, compartment syndrome developed on her right leg on the following day and fasciotomy was performed. CONCLUSION: The larger thrombus burden in Viabahn stent-grafts and its unique physicochemical properties increases the risk for distal embolic complications and potential poor clinical outcomes.
Assuntos
Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Artéria Femoral/cirurgia , Fibrinolíticos/administração & dosagem , Oclusão de Enxerto Vascular/tratamento farmacológico , Doença Arterial Periférica/cirurgia , Artéria Poplítea/cirurgia , Stents , Terapia Trombolítica , Trombose/tratamento farmacológico , Angiografia Digital , Implante de Prótese Vascular/efeitos adversos , Síndromes Compartimentais/etiologia , Síndromes Compartimentais/cirurgia , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Fibrinolíticos/efeitos adversos , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Desenho de Prótese , Terapia Trombolítica/efeitos adversos , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/fisiopatologia , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
AIMS: The objective of this study was to describe and evaluate the adjunctive technique of Angio-Seal (AS) use to augment the dual Perclose ProGlide (PP) in achieving haemostasis in patients undergoing transfemoral percutaneous transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: All patients who underwent TAVR from May 2007 to January 2015 via a planned transfemoral percutaneous approach with a dual PP pre-close strategy were retrospectively analysed. This cohort was divided into two groups: dual PP versus dual PP with adjunctive AS (PP+AS) use based on the specific status of intraprocedural haemostasis. The baseline and procedural characteristics and in-hospital outcomes were prospectively collected and retrospectively compared. Overall, a total of 387 consecutive patients (55% male, mean age 83 years) with dual PP (n=179) vs. dual PP+AS (n=208) were evaluated. There were no statistically significant differences between the dual PP vs. dual PP+AS groups with regard to the in-hospital Valve Academic Research Consortium-2 (VARC-2) primary endpoints of major vascular complications (8.0% vs. 6.6%, p=0.592), minor vascular complications (18.4% vs. 13.7%, p=0.218), life-threatening or disabling bleeding (5.1% vs. 3.0%, p=0.291), major bleeding (1.7% vs. 1.5%, p=1.000), and minor bleeding (14.4% vs. 10.6%, p=0.271). CONCLUSIONS: The adjunctive Angio-Seal technique to augment the dual PP pre-close strategy for patients undergoing percutaneous femoral closure following TAVR is feasible and safe and may be considered as a bail-out or an alternative strategy when the dual PP closure technique fails to obtain complete haemostasis.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Artéria Femoral/cirurgia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/métodos , Feminino , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Técnicas Hemostáticas/efeitos adversos , Humanos , Masculino , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Clinical trial data show overall favorable outcomes of paclitaxel-eluting stents for treatment of femoro-popliteal (FP) occlusive disease. However, external validity of trial results may be restricted to less complex FP lesions, and limited data on outcomes of paclitaxel-eluting stents in real world practice have been published. METHODS: This is a retrospective analysis of data of all patients who received Zilver® PTX® for FP lesion from February 2013 to October 2014 at our center. The primary endpoint was primary patency, defined as peak systolic velocity ratio <2.0 by Doppler ultrasound, or angiographic diameter stenosis <50%, or freedom from clinically driven target lesion revascularization. RESULTS: Seventy-eight patients received Zilver® PTX® for FP lesions in the pre-specified time period. Of them, 63 had follow-up data and were included in this study. Mean patient age was 66.3±9.4years, and 57.1% of the patients were men. Participants had a high prevalence of diabetes (49.2%), hypertension (93.7%), hyperlipidemia (93.7%), previous coronary revascularization (52.4%), or previous peripheral arterial disease (77.8%). Critical limb ischemia was present in 25.4% of the patients, Trans-Atlantic Inter-Society Consensus (TASC) class C or D in 76.2%, in-stent restenosis (ISR) in 36.5%, and total occlusion in 69.8%. Mean lesion length was 218.9±128.3mm, mean number of stents was 2.02±1.0, and total stent length was 189.0±128.5mm. Mean follow-up was 270.4±190.3days. Primary patency rate at 1year was 66.7% by Kaplan-Meier survival curve. When compared with patients with primary patency at follow up, those with an adverse outcome had higher prevalence of TASC II class C or D lesions (100% vs. 68.8%, p=0.013), and were more likely to have ISR (66.7% vs. 27.1%, p=0.012), longer lesion (291.3±138.7 vs. 195.7±117.1, p=0.011), and incomplete coverage of the lesion (full coverage of lesions: 40% vs. 77.1%, p=0.011). CONCLUSION: Post marketing use of Zilver® PTX® for the treatment of FP lesions is associated with lower patency rates compared with clinical trial data. This may be related to the high prevalence of TASC II class C or D lesions and ISR in real world practice. Future studies should be more representative of contemporary clinical practice.