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AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). CONCLUSIONS: Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.
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Doença da Artéria Coronariana , Diabetes Mellitus , Reserva Fracionada de Fluxo Miocárdico , Placa Aterosclerótica , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Humanos , Placa Aterosclerótica/diagnóstico por imagem , Valor Preditivo dos Testes , Estudos Prospectivos , Tomografia de Coerência ÓpticaRESUMO
A case of a 61-year-old male patient suffered chronic renal failure and dialysed for 23 years with destructive cervical spondylarthropathy is presented. The patient presented with sudden onset of cervical pain radiating into his shoulders without neurological deficits. CT and MRI of the cervical and thoracic spine revealed severe destructive changes and compressive fractures of C6 and C7 vertebrae which caused the narrowing of the nerve root canals at these levels. A 360-degree fixation was performed to treat the unstable fracture and the patient's pain (C6 and C7 corpectomy, autolog bone graft replacement of the two vertebral bodies, anterior plate fixation and posterior instrumentation with screws and rods). Postoperatively the patient had no significant pain, no neurological deficit and he was able to manage independent life himself. During the immediate follow-up CT of the neck showed the satisfactory position of the bone graft and the metal implantations. The 6 months follow-up CT revealed the anterior migration of the two screws from the Th1 vertebral body and 2 mm ventral elevation of the caudal end of the plate from the anterior surface of the Th1 vertebral body. The 1-year follow-up could not be performed because the patient died due to cardio-pulmonary insufficiency. This is the second Hungarian report of a chronic dialysis related severe spondylarthropathy which may cause pathologic fractures of the vertebral bodies. The typical radiological and histological findings are discussed. This disease affect patients' quality of life and the conservative treatment alone seems to be ineffective in most cases. Based on the literature and personal experiences, the authors suggest 360-degree fixation of the spine to provide sufficient stability for the vertebrae of "bad bone quality", and early mobilisation of the patient can be achieved.
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Fraturas da Coluna Vertebral , Fusão Vertebral , Espondiloartropatias , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/lesões , Vértebras Cervicais/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Diálise Renal , Espondiloartropatias/complicações , Espondiloartropatias/diagnóstico por imagemRESUMO
BACKGROUND: The aim of this prospective registry was to determine the feasibility, safety, and outcomes of percutaneous transluminal angioplasty and thrombolysis in the treatment of critical hand ischemia (CHI). METHODS: One-hundred one patients (aged 60.6 ± 15.3 years) were treated for CHI between 2012 and 2016 in three cardiovascular centers. Anatomically, the upper arm was divided into three segments (I-subclavian, II-brachial, and III-forearm). We examined the rates of technical and clinical success, major adverse events (MAEs), and vascular complications at 1 year and at long-term follow-up. RESULTS: Nineteen patients (18.8%) were treated for acute CHI, and 82 (81.2%) for chronic CHI. Median follow-up was 36.9 (19.6-68.3) months. Clinical symptoms were isolated rest pain in 91 patients (90.1%) and digital ulcer or gangrene in 10 patients (9.9%). The technical and clinical success rate of intervention was 96.0% (97/101) and 84.2% (85/101) at 1 year. Angioplasty was performed in Segments I, II, and III in 28 (27.7%), in 29 (28.7%), and 44 (43.5%) patients. Stent implantation was necessary in 47 patients (46.8%). Vascular access site complications were found in 2.1% of the sample. After 1 year, MAEs occurred in 27 patients (26.9%), and the target lesion revascularization rate was 11.9%. In two patients (1.9%), thoracic sympatectomy was necessary, and two patients (1.9%) underwent minor finger amputations. CONCLUSIONS: Angioplasty of hand vessels for CHI is a feasible and safe procedure with acceptable rates of technical success and hand healing. MAEs are frequent because the rate of severe comorbidities is high.
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Angioplastia com Balão , Fibrinolíticos/administração & dosagem , Mãos/irrigação sanguínea , Isquemia/terapia , Terapia Trombolítica , Adulto , Idoso , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Comorbidade , Estado Terminal , Estudos de Viabilidade , Feminino , Fibrinolíticos/efeitos adversos , Humanos , Hungria , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recuperação de Função Fisiológica , Fluxo Sanguíneo Regional , Sistema de Registros , Fatores de Risco , Stents , Terapia Trombolítica/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: To explore the predictors of deferred lesion failure (DLF) in patients with diabetes mellitus (DM) and lesions with a fractional flow reserve (FFR) >0.80 and to examine whether a predictive relationship between negative FFR values (>0.80-1.00) and DLF exists. BACKGROUND: DM is associated with rapidly progressive atherosclerosis and predictors of DLF in FFR negative lesions in this high-risk group are unknown. METHODS: All DM patients who underwent FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/7/2015. Patients carrying ≥1 FFR negative lesion(s) were assessed for DLF, and multivariate models used to identify independent factors associated with DLF. RESULTS: A total of 205 patients with 252 FFR >0.80 lesions were identified. At a mean follow-up of 3.1 ± 1.4 years, DLF occurred in 29/205 (14.1%) patients, 31/252 (12.3%) lesions. Using marginal Cox regression multivariate analysis, insulin requiring DM [HR 2.24 (95%CI; 1.01-4.95), P = 0.046] and prior revascularization [HR 2.70 (95%CI 1.21-6.01), P = 0.015] were identified as being associated with a higher incidence of DLF. Absolute FFR values in FFR negative lesions in DM patients are not predictive of DLF (receiver operating characteristics curve analysis: area under the curve: 0.57 ± 0.06, 95%CI 0.46-0.69). CONCLUSIONS: In DM patients with FFR negative lesions, insulin requiring DM and prior revascularization are predictors for DLF. In contrast to non-DM patients, no predictive relationship between absolute negative FFR values (ranging >0.80-1.00) and the risk of DLF exists in DM patients. © 2017 Wiley Periodicals, Inc.
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Doença da Artéria Coronariana/terapia , Diabetes Mellitus , Reserva Fracionada de Fluxo Miocárdico , Revascularização Miocárdica/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Cateterismo Cardíaco , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/tratamento farmacológico , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Curva ROC , Estudos Retrospectivos , Fatores de Risco , Falha de TratamentoRESUMO
BACKGROUND: In-stent restenosis occurs in 10-30% of patients following bare metal stent (BMS) implantation and has various risk factors. Mannose-binding lectin (MBL) is known to have effect on the progression of atherosclerosis. Single nucleotide polymorphisms (SNP) of the MBL2 gene intron 1 (codon 52, 54, 57) are known to modulate the bioavailability of the MBL protein. Our aim was to identify the association of these polymorphisms of the MBL gene in the occurrence of in-stent restenosis after coronary artery bare metal stent implantation. METHODS: In a non-randomized prospective study venous blood samples were collected after recoronarography from 225 patients with prior BMS implantation. Patients were assigned to diffuse restenosis group and control group based on the result of the coronarography. MBL genotypes were determined using quantitative real-time PCR. Proportion of different genotypes was compared and adjusted with traditional risk factors using multivariate logistic regression. RESULTS: Average follow-up time was 1.0 (+ - 1.4) year in the diffuse restenosis group (N = 117) and 2.7 (+ - 2.5) years in the control group (N = 108). The age, gender distribution and risk status was not different between study groups. Proportion of the MBL variant genotype was 26.8% (29 vs. 79 normal homozygous) in the control group and 39.3% (46 vs. 71 normal homozygous) in the restenosis group (p = 0.04). In multivariate analysis the mutant allele was an independent risk factor (OR = 1.96, p = 0.03) of in-stent restenosis. CONCLUSIONS: MBL polymorphisms are associated with higher incidence of development of coronary in-stent restenosis. The attenuated protein function in the mutant allelic genotype may represent the underlying mechanism.
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Doença da Artéria Coronariana/terapia , Reestenose Coronária/genética , Lectina de Ligação a Manose/genética , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Polimorfismo de Nucleotídeo Único , Stents , Idoso , Estudos de Casos e Controles , Distribuição de Qui-Quadrado , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Feminino , Frequência do Gene , Estudos de Associação Genética , Predisposição Genética para Doença , Heterozigoto , Homozigoto , Humanos , Modelos Logísticos , Masculino , Metais , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Fenótipo , Estudos Prospectivos , Desenho de Prótese , Reação em Cadeia da Polimerase em Tempo Real , Medição de Risco , Fatores de Risco , Fatores de TempoRESUMO
INTRODUCTION AND AIM: Surgical tibial bypass for critical limb ischemia is associated with significant morbidity, mortality, and graft failure, whereas percutaneous angioplasty and stenting has promising results. The objective of this study was the investigation of the long term results of below-knee percutaneous angioplasty for restoring straight inline arterial flow in patients with critical limb ischemia. METHOD: The clinical and angiographic data of 281 consecutive patients with critical limb ischemia treated by PTA between 2008 and 2011 was evaluated in a prospective register. The aim of the revascularization was to achieve a straight inline flow to the wound with balloon angioplasty. Stent implantation was done in the case of recoil and flow limiting dissection. Primary end points were clinical success (relief of resting pain, healing of ulceration, limb survival) and major adverse events (death, myocardial infarction, major unplanned amputation, need for surgical revascularization, or major bleeding). Secondary end points were the angiographic result of the intervention, procedural data and consumption of angioplasty equipment. The impact of diabetic leg syndrome and the result of the angioplasty on the limb salvage was also investigated. We have analysed the impact of major amputation on long term mortality. RESULTS: Mean age of patients was 72.5 ± 10.6 years and the follow-up period was 40.8 ± 9.7 months. Technical success was reached in 255 (90.7%) of the patient's: 255 limbs straight inline flow with good angiographic result was restored to at least one tibial vessel. Balloon angioplasty, stent implantation and rotational atherectomy was performed in 278 (98.9%), 74 (26.3%) and 2 patients (0.7%). From clinical end points the rest pain was ceased in 56.6%, the ulcer and the gangrena was healed in 73.5% and 46.5%. The long term limb survival was 73.5%; 65.8% in diabetic and 89.6% in non-diabetic leg syndrome (p = 0.001). The major adverse events at long-term follow-up occured in 122 (43.8%) patients. Death occured in 57 (20.3%) of the patients during the long-term follow-up: 38 (13.5%) vs. 19 (6.8%) in diabetic vs. non-diabetic leg subgroup, respectively (p = 0.932). Long-term limb saving occured in 72.3% vs. 84.6% of the patients dependening the procedure was successful or unsuccessful (p = 0.225). CONCLUSION: Below-knee stent angioplasty for critical limb ischemia results in good clinical outcome, but the major adverse event rate is high. Diabetes mellitus is associated with a high rate of mortality and amputation. Orv. Hetil., 2017, 158(11), 418-425.
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Angioplastia/métodos , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Idoso , Angioplastia com Balão , Feminino , Seguimentos , Humanos , Isquemia/fisiopatologia , Masculino , Pessoa de Meia-Idade , Stents , Resultado do TratamentoRESUMO
BACKGROUND: Successful angioplasty is one of the main factor of limb salvage during critical limb ischemia. In complex femoropopliteal to infrapopliteal occlusions, an anterograde recanalization attempt can fail in up to 20% of the cases. The purpose of this dual center pilot study was to evaluate the acute success and clinical impact of retrograde transpedal access for retrograde below-the-knee and femoropopliteal chronic total occlusions after failed anterograde attempt and to access the late complications at the puncture site. METHODS: The clinical and angiographic data of 51 consecutive patients with CLI treated by retrograde transpedal recanalization between 2010 and 2011 were evaluated in a pilot study. We have examined the 2-month and 1 year major adverse events (MAEs) and clinical success. In all cases after failure of the anterograde recanalization of occluded below-the-knee segments due to unsuccessful penetration or failed re-entry, the anterior tibial or posterior tibial artery was punctured under fluoroscopic guidance and retrograde recanalization was performed. Direct revascularization was tried firstly following the angiographic zones, but in failed cases indirect revascularization was carried out with increasing the collateral flow to the wound. RESULTS: Successful direct retrograde revascularization was achieved successfully in 40 patients (78.4%) and indirect revascularization was done in 10 patients (19.6%). Revascularization was failed in one patient (2%). MAE at 2 and 12 months follow-up was 6 (11.7%) and 11 (24%). Limb salvage at 2 and 12 months was 93% and 82.3%, respectively. Balloon angioplasty was performed in all interventions and provisional stenting was done in 34 patients (66.7%). One major and three minor vascular complications occurred after the procedure. The mean basal and control creatinine level was 120.9 ± 133.4 and 123.8 ± 131.3 µmol/L (P = 0.83) after the procedure. CONCLUSION: Failed antegrade attempts to recanalize CTO-s of femoropopliteal and infrapopliteal vessels can be salvaged using a retrograde transpedal access, with a low acute and late complication rate. This technique could be valuable for patients with critical limb ischemia due to femoropopliteal and infrapopliteal occlusions.
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Angioplastia com Balão/métodos , Artéria Femoral , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Constrição Patológica , Estado Terminal , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Isquemia/diagnóstico , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Punções , Radiografia , Retratamento , Fatores de Risco , Stents , Falha de TratamentoRESUMO
Background: Acute limb ischaemia (ALI) is of great clinical importance due to its consequent serious complications and high comorbidity and mortality rates. The purpose of this study was to compare the acute success and complication rates of CDT performed via transradial, transbrachial, and transfemoral access sites in patients with acute lower limb vascular occlusion and to investigate the 1-year outcomes of CDT and MT for ALI. Methods: Between 2008 and 2019, 84 consecutive patients with ALI were treated with CDT in a large community hospital. Data were collected and retrospectively analysed. The primary ("safety") endpoints encompassed major adverse events (MAEs), major adverse limb events (MALEs), and the occurrence of complications related to the access site. Secondary ("efficacy") endpoints included both technical and clinical achievements, treatment success, fluoroscopy time, radiation dose, procedure time, and the crossover rate to an alternative puncture site. Results: CDT was started with radial (n = 17), brachial (n = 9), or femoral (n = 58) access. CDT was technically successful in 74/84 patients (88%), but additional MT and angioplasty and/or stent implantation was necessary in 17 (20.2%) and 45 cases (53.6%), respectively. Clinical success was achieved in 74/84 cases (88%). The mortality rate at 1 year was 14.3%. The cumulative incidence of MAEs and MALEs at 12 months was 50% and 40.5%, respectively. After conducting multivariate analysis, history of Rutherford stage IIB (hazard ratio [HR], 3.64; 95% confidence interval [CI], 1.58-8.41; p = 0.0025), occlusion of the external iliac artery (HR, 27.52; 95% CI, 2.83-267.33; p = 0.0043), being a case of clinically unsuccessful thrombolysis (HR, 7.72; 95% CI, 2.48-23.10; p = 0.0004), and the presence of diabetes mellitus (HR, 2.18; 95% CI, 1.01-4.71; p = 0.047) were independent predictors of a high MAE mortality rate at 12 months. For MALEs, statistically significant differences were detected with the variables history of Rutherford stage IIB (HR, 4.30; 95% CI, 1.99-9.31; p = 0.0002) and external iliac artery occlusion (HR, 31.27; 95% CI, 3.47-282.23; p = 0.0022). Conclusions: Based on the short-term results of CDT, acute limb ischaemia can be successfully, safely, and effectively treated with catheter-directed thrombolytic therapy with radial, brachial, or femoral access. However, radial access is associated with fewer access site complications. A history of Rutherford stage IIB, occlusion of external iliac artery, unsuccessful thrombolysis, and the presence of diabetes mellitus were independently associated with an increased risk of MAEs. A history of Rutherford stage IIB and external iliac artery occlusion are independent predictors of MALEs.
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AIMS: To evaluate the individual as well as combined impact of OCT-detected vulnerability features (OCT-VFs) in the prediction of major adverse cardiovascular events (MACE) in non-ischemic lesions in patients with diabetes mellitus (DM). METHODS AND RESULTS: The COMBINE OCT-FFR (NCT02989740) was a prospective, double-blind, international, natural history study that included patients with DM having ≥1 lesions with a fractional flow reserve >0.80, undergoing systematic OCT assessment. Pre-specified OCT-VFs included TCFA, r-MLA, h-PB, and CP. The primary endpoint (MACE) was a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or hospitalization for unstable angina up to 5 years, analyzed according to the presence of these OCT-VFs, both individually and in combination. TCFA, r-MLA, h-PB and CP were identified in 98 (25.1%), 159 (40.8%), 56 (14.4%), and 116 (29.8%) patients, respectively. The primary endpoint rate increased progressively from 6.9% to 50.0% (HR=10.10; 95%CI, 3.37 to 30.25, p<0.001) in patients without OCT-VFs compared to those with concomitant h-PB, r-MLA, CP, and TCFA. Importantly, while TCFA, h-PB, r-MLA and CP were individually associated with the primary endpoint, the presence of two or more OCT-VFs significantly increased the likelihood of adverse events at 5 years. CONCLUSIONS: In patients with DM and non-ischemic lesions, TCFA, h-PB, r-MLA and CP were predictors of adverse events. However, the presence of two or more OCT-VFs significantly increased the likelihood of MACE at 5 years. Further studies are warranted to confirm these findings and their potential clinical implications in a randomized fashion.
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Background: Fractional flow reserve (FFR) is an established method to guide decisions on revascularization; however, in patients with diabetes mellitus (DM), FFR-negative lesions carrying an optical coherence tomography-detected thin-cap fibroatheroma (TCFA) remain at high risk for adverse cardiac events. Methods: In this prespecified subanalysis of the COMBINE OCT-FFR trial, DM patients with ≥1 FFR-negative, TCFA-positive medically treated target lesions referred to as vulnerable plaque (VP group), were compared to patients with exclusively FFR-positive target lesions who underwent complete revascularization (CR group). The primary endpoint was first and recurrent event analysis for target lesion failure and the secondary endpoint was a composite of cardiac death, target vessel myocardial infarction, target lesion revascularization, or hospitalization due to unstable angina. Results: Among 550 patients enrolled, 98 belonged to the VP group while 93 to the CR group and were followed up to 5 years. The VP group had a higher occurrence of the primary endpoint (20.4% vs 8.6%; HR, 2.22; 95% CI, 0.98-5.04; P = .06). Recurrent event analysis showed that the VP group had significantly higher rates of the primary and secondary endpoints (9.17 vs 3.76 events per 100 PY; RR, 2.44; 95% CI, 1.16-5.60; P = .01 and 13.45 vs 5.63 events per 100 PY; RR, 2.39; 95% CI, 1.30-4.62; P < .01). Conclusions: In a population with DM, medically treated nonischemic, TCFA-carrying target lesions were associated with higher risk of reoccurring adverse cardiac events compared to target lesions that underwent complete revascularization, opening the discussion about whether a focal preventive revascularization strategy could be contemplated for highly vulnerable lesions.
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BACKGROUND: Thin-cap fibroatheroma (TCFA) lesions are associated with a high risk of future major adverse cardiovascular events. However, the impact of other optical coherence tomography-detected vulnerability features (OCT-VFs) and their interplay with TCFA in predicting adverse events remains unknown. AIMS: We aimed to evaluate the individual as well as the combined prognostic impact of OCT-VFs in predicting the incidence of the lesion-oriented composite endpoint (LOCE) in non-ischaemic lesions in patients with diabetes mellitus (DM). METHODS: COMBINE OCT-FFR (ClinicalTrials.gov: NCT02989740) was a prospective, double-blind, international, natural history study that included DM patients with ≥1 non-culprit lesions with a fractional flow reserve>0.80 undergoing systematic OCT assessment. OCT-VFs included the following: TCFA, reduced minimal lumen area (r-MLA), healed plaque (HP), and complicated plaque (CP). The primary endpoint, LOCE - a composite of cardiac mortality, target vessel myocardial infarction, or clinically driven target lesion revascularisation up to 5 years - was analysed according to the presence of these OCT-VFs, both individually and in combination. RESULTS: TCFA, r-MLA, HP and CP were identified in 98 (25.3%), 190 (49.0%), 87 (22.4%), and 116 (29.9%) patients, respectively. The primary endpoint rate increased progressively from 6.3% to 55.6% (hazard ratio 15.2, 95% confidence interval: 4.53-51.0; p<0.001) in patients without OCT-VFs as compared to patients with concomitant HP, r-MLA, CP, and TCFA. The coexistence of TCFA with other OCT-VFs resulted in an increased risk of the LOCE at 5 years. CONCLUSIONS: In DM patients with non-ischaemic lesions, TCFA was the strongest predictor of future LOCE events. However, lesions that present additional OCT-VFs are associated with a higher risk of adverse events than OCT-detected TCFA alone. Further randomised studies are warranted to confirm these findings and their potential clinical implications.
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Doença da Artéria Coronariana , Placa Aterosclerótica , Tomografia de Coerência Óptica , Humanos , Tomografia de Coerência Óptica/métodos , Placa Aterosclerótica/diagnóstico por imagem , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Estudos Prospectivos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/terapia , Diabetes Mellitus/epidemiologia , Método Duplo-Cego , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea/efeitos adversos , Fatores de Risco , Prognóstico , Vasos Coronários/diagnóstico por imagemRESUMO
OBJECTIVES: We aimed to evaluate the long-term safety and efficacy of drug-eluting stent (DES) implantation in the treatment of diffuse bare metal stent (BMS) restenosis as compared to the treatment of de novo coronary lesions in high restenosis risk patient population. BACKGROUND: To date limited long-term data are available about the treatment of BMS restenosis with DES. METHODS: Five hundred and fourteen consecutive patients who underwent DES implantation between January 2003 and October 2006 at our institute were studied: 201 patients received DES for treatment of BMS restenosis and 313 patients received DES for high restenosis risk de novo lesions. Outcomes were calculated using propensity score adjustment. Mean follow-up length was 45.6 ± 21.5 months. RESULTS: The rates of acute coronary syndrome, three-vessel disease, and diabetes were high in both restenosis and de novo groups: 44.8% versus 46.3%, 20.9% versus 28.7%, and 34.3% versus 38.9%, respectively. The incidence of ischemia-driven target lesion revascularization (TLR) yielded similar results in the restenosis group and de novo group at 4 years (10.4% vs 12.4%, P = 0.490). All-cause mortality was lower in the restenosis group at 4 years (7.4% vs 14.7%, P = 0.032); however, the incidence of definite and probable stent thrombosis did not differ (1.9% vs 1.6%, P = 0.708) between the 2 groups. CONCLUSIONS: DESs are safe in the treatment of diffuse BMS restenosis and the rate of additional TLR is acceptable as compared to the use of DES in de novo lesions.
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Doença da Artéria Coronariana/terapia , Reestenose Coronária/terapia , Stents Farmacológicos , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/mortalidade , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Prospectivos , Stents , Análise de Sobrevida , Resultado do Tratamento , Estados UnidosRESUMO
BACKGROUND: The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled. AIMS: The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population. METHODS: COMBINE OCT-FFR is a prospective, international, double-blind, natural history study. Patients with DM and with ≥1 FFR-negative lesion were classified into 2 groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint (PE) is a composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation during follow-up up to 5 years. RESULTS: Among 390 DM patients (age 67.5±9 years; 37% female) with ≥1 FFR-negative lesion, 292 (74.9%) were TCFA-negative while 98 (25.1%) were TCFA-positive. The PE occurred more frequently in TCFA-positive than in TCFA-negative patients (21.4% vs 8.2%, hazard ratio [HR] 2.89, 95% confidence interval [CI]: 1.61-5.20; p<0.001; 6.42 vs 2.46 events per 100 patient-years, rate ratio [RR] 2.61, 95% CI: 1.38-4.90; p=0.002). Furthermore, when TV-MI, TLR, and UA were treated as recurrent components of the PE, TCFA-positive patients experienced a higher risk of recurrent events (HR 2.89, 95% CI; 1.74-4.80; p<0.001; 13.45 vs 2.87 events per 100 patient-years, RR 4.69, 95% CI: 2.86-7.83; p<0.001). A multivariable analysis identified the presence of TCFA as an independent predictor of the PE (HR 2.76, 95% CI: 1.53-4.97; p<0.001). CONCLUSIONS: OCT-detected TCFA-positive lesions, although not ischaemia-generating, are associated with an increased risk of adverse events during long-term follow-up. CLINICALTRIALS: gov: NCT02989740.
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Doença da Artéria Coronariana , Diabetes Mellitus , Reserva Fracionada de Fluxo Miocárdico , Infarto do Miocárdio , Placa Aterosclerótica , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/patologia , Estudos Prospectivos , Infarto do Miocárdio/terapia , Prognóstico , Angina Instável , Tomografia de Coerência Óptica/métodos , Doença da Artéria Coronariana/terapia , Valor Preditivo dos Testes , Angiografia Coronária/métodosRESUMO
Background: The morphology and functional severity of coronary stenosis show poor correlation. However, in clinical practice, the visual assessment of the invasive coronary angiography is still the most common means for evaluating coronary disease. The fractional flow reserve (FFR), the coronary flow reserve (CFR), and the resting full-cycle ratio (RFR) are established indices to determine the hemodynamic significance of a coronary stenosis. Design/Methods: The READY register (NCT04857762) is a prospective, multicentre register of patients who underwent invasive intracoronary FFR and RFR measurement. The main aim of the registry is to compare the visual estimate of coronary lesions and the functional severity of the stenosis assessed by FFR, as well as the RFR pullback. Characterizations of the coronary vessel for predominantly focal, diffuse, or mixed type disease according to visual vs. RFR pullback determination will be compared. The secondary endpoint of the study is a composite of major adverse cardiac events, including death, myocardial infarction, and repeat coronary revascularization at 1 year. These endpoints will be compared in patients with non-ischemic FFR in the subgroup of cases where the local pressure drop indicates a focal lesion according to the definition of ΔRFR > 0.05 (for <25 mm segment length) and in the subgroup without significant ΔRFR. In case of an FFR value above 0.80, an extended physiological analysis is planned to diagnose or exclude microvascular disease using the CFR/FFR index. This includes novel flow dynamic modeling for CFR calculation (CFRp-3D). Conclusion: The READY register will define the effect of RFR measurement on visual estimation-based clinical decision-making. It can identify a prognostic value of ΔRFR during RFR pullback, and it would also explore the frequency of microvascular disease in the patient population with FFR > 0.80. Clinical Trial Registration: ClinicalTrials.gov (NCT04857762).
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BACKGROUND: Catheter directed thrombolysis (CDT) and thrombectomy represent well established techniques for the treatment of intermediate pulmonary embolism (IPE). The long-term effect of catheter directed thrombolysis of IPE is unknown. METHODS: Clinical, interventional and echocardiographic data from 80 consecutive patients with IPE who were treated with CDT were evaluated. Primary end-points were technical success and major adverse events. Secondary end-points were cardiovascular mortality, all-cause mortality, clinical success, rate of bleeding complications, improvement in pulmonary pressure and echocardiography parameters. CDT completed with alteplase (10 mg bolus and 1 mg/h maintenance dose) through a pig-tail catheter for 24 h. After 24 h, control pulmonary angiography was performed. RESULTS: In total, 80 patients with a mean age of 59.0 ± 16.8 years were treated. CDT was successful after the first post-operative day in 72 (90%) patients, but thrombus aspiration and fragmentation was performed due to failed thrombolysis in 8 (10%) patients. Final technical and clinical success was reached in 79 (98.8%) and 77 (96.3%) patients, respectively. The mean CDT time in IPE was 27.8 ± 9.6 h. Invasive pulmonary pressure dropped from 57.5 ± 16.7 to 38.9 ± 13.5 (p < 0.001). A caval filter was implanted in 4 (5%) patients. The 1-year major adverse events and cardiovascular mortality rate was 4.0% and 1.4%, respectively. Access site complications (6 major and 6 minor) were encountered in 12 (16.2%) patients. CONCLUSIONS: Catheter directed thrombolysis in submassive pulmonary embolism had excellent results. However, additional mechanical thrombectomy was necessary in some patients to achieve good clinical outcomes.
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Fibrinolíticos , Embolia Pulmonar , Catéteres , Fibrinolíticos/uso terapêutico , Humanos , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/terapia , Estudos Retrospectivos , Trombectomia , Terapia Trombolítica , Resultado do TratamentoRESUMO
AIM: To analyze the efficacy of a regionally organized primary percutaneous coronary intervention (PCI) network at the Heart Center, Semmelweis University Budapest, part of the "Budapest model," and the factors that influence it. METHODS: In order to investigate the differences between regular and off-hours patient care in a 24-hour myocardial infarction primary care system, we included 1890 consecutive, unselected patients with ST-segment elevation myocardial infarction and followed them until at least one year. The follow-up was complete for all participants. RESULTS: The difference between regular hours and off-hours mortality was not significant either after 30 days (8.6% vs 8.8%, respectively) or after 1 year (15.3% vs 14.7%, respectively). The rate of patients with re-infarction, frequency of re-intervention, and major adverse cardiac events, including death, re-infarction, re-intervention, and coronary artery bypass graft surgery, were similar in both patient groups. The time delay between the onset of chest pain and arrival to the clinic was 5.9+/-5.8 hours (mean+/- standard deviation) during regular hours and 5.2+/-4.6 hours during off-hours (P=0.235). Direct transport caused significant decrease in the 30-day and 1-year mortality independent of duty time (7.2% vs 9.9%, P=0.027; 12.6% vs 16.7%, P=0.028; respectively). CONCLUSION: Centralized primary PCI network of the "Budapest model" achieved the same level of patient care during both off-hours and regular hours.
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Plantão Médico/organização & administração , Angioplastia Coronária com Balão , Redes Comunitárias , Infarto do Miocárdio/terapia , Atenção Primária à Saúde/organização & administração , Angioplastia Coronária com Balão/efeitos adversos , Feminino , Seguimentos , Humanos , Hungria , Masculino , Pessoa de Meia-Idade , Modelos Organizacionais , Análise de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: To date the early strut coverage with the second-generation durable-polymer ONYX zotarolimus-eluting stent (O-ZES) is unknown. AIM: Optical coherence tomography (OCT) assessed the strut coverage of O-ZES at thirty-day follow-up. MATERIAL AND METHODS: OCT was performed after implantation and at 1-month follow-up in 15 patients treated with O-ZES. RESULTS: Mean patient age was 67 ±7 years (73% males). The clinical presentation consisted of acute coronary syndromes (n = 13) and stable coronary disease (n = 2). Four (26%) patients had diabetes. OCT analysis was performed at baseline and 1-month follow-up in all stents. 378 cross-sections with 3582 struts were assessed at baseline and 3661 at follow-up. At follow-up, 88% struts were covered by tissue with a median thickness 37.91 µm (IQR: 22.32-64.15). Median in-stent area obstruction by neointima was 2.64% (IQR: 1.70-4.84). From the total stent covered area, 92.3% showed complete strut coverage. Homogeneous tissue was observed in 74% of cases. There were no differences in minimal lumen area (5.07 ±1.08 mm2 vs. 4.81 ±0.94 mm2, p = 0.125) or minimal stent area (4.95 ±1.22 mm2 vs. 4.92 ±0.99 mm2) at baseline and at follow-up. There were no differences in the rate of strut malapposition (4.3% vs. 5.7%, p = 0.417). For all stents, malapposition volume was 47.9 mm3 at baseline and 51.7 mm3 at follow-up, giving the late acquired stent malapposition volume of 3.8 mm3. CONCLUSIONS: The second-generation durable polymer O-ZES showed favorable vessel healing at 30-day OCT follow-up.
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Background. In-stent restenosis (ISR) is the gradual narrowing of the vessel lumen after coronary stent implantation due to the increase in vascular smooth muscle cell proliferation. Vascular endothelial growth factor (VEGF) protein plays an important role in this process. Our aim was to analyze the association of single nucleotide polymorphisms of the VEGF gene (rs2010963 and rs6999447) with the occurrence of ISR after coronary artery bare metal stent (BMS) implantation. Methods. 205 patients with a history of BMS implantation and a repeated coronarography were prospectively enrolled. Patients were assigned to diffuse restenosis group (n = 105) and control group (n = 100) and VEGF genotypes were determined. Results. Diffuse ISR was significantly more frequently observed in patients with homozygous normal genotype of rs2010963 polymorphism, and this polymorphism was independently associated with diffuse ISR. Conclusions. RS2010963 is associated with higher incidence of development of diffuse coronary ISR in patients treated with BMS implantation.
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Reestenose Coronária/genética , Polimorfismo de Nucleotídeo Único , Fator A de Crescimento do Endotélio Vascular/genética , Idoso , Reestenose Coronária/etiologia , Feminino , Homozigoto , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Stents Metálicos Autoexpansíveis/efeitos adversosRESUMO
OBJECTIVES: Although circular ventricular resection techniques are the gold standard of left ventricular (LV) restoration, these techniques can lead to suboptimal results. Postoperative systolic resection can be inadequate, because it must be planned on a heart stopped in diastole. Low cardiac output due to insufficient LV volume results in a potentially unstable condition, and cannot be corrected. Our aim was to find a preoperative method to minimize risk and maximize outcome with ventricular restoration. METHODS: We created a novel method combining surgery with gadolinium-enhanced magnetic resonance to construct a preoperative 3D systolic heart model. The model was utilized to determine resection points that could be intraoperatively used. According to our calculations with the predetermined resection line, the calculated percentage reduction in LV volume was above 30%, and LV volumes were predicted above normal values; thus, performing the operation using these resection points is likely to be safe and effective. We had a mixed, real-life patient group: mitral insufficiency or pulmonary hypertension were not exclusion criteria. RESULTS: Forty-one procedures (12 concomitant mitral valve plasty) were done on consecutive patients in a single-centre experience. The incidence rate of major adverse clinical events was 32% postoperatively (n = 13). Control MRI showed a significant improvement in ejection fraction (18.3 ± 4.3 vs 31.3 ± 3.3; P = 0.04). All patients improved their New York Heart Association (NYHA) class postoperatively (40 patients NYHA III/IV versus 40 NYHA I/II). During long-term follow-up, 1 patient died due to end-stage heart failure. CONCLUSIONS: Using this model, we were able to find the optimal resection line providing an excellent postoperative result, thus minimizing the risk of low cardiac output syndrome.
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Procedimentos Cirúrgicos Cardíacos/métodos , Simulação por Computador , Aneurisma Cardíaco/cirurgia , Ventrículos do Coração , Cirurgia Assistida por Computador/métodos , Interface Usuário-Computador , Idoso , Feminino , Seguimentos , Aneurisma Cardíaco/diagnóstico , Humanos , Imagem Cinética por Ressonância Magnética , Masculino , Estudos RetrospectivosRESUMO
INTRODUCTION: In spite of improving results, the treatment of in-stent restenosis (ISR) of bare-metal stents (BMS), and particularly drug-eluting stents (DES), is a challenging clinical problem. There are promising but limited follow-up data concerning drug-eluting balloons in the treatment of BMS and DES restenosis. The goal of this real-world registry was to assess the long-term safety and efficacy of drug-eluting balloons in the treatment of BMS and DES restenosis. METHODS: In this prospective registry, 82 patients with BMS or DES restenosis treated with paclitaxel-eluting balloons were enrolled. The primary endpoint was ischemia-driven target lesion revascularization (TLR); a secondary endpoint was the rate of major adverse cardiac events (MACE) at 28 months. RESULTS: Thirty-five patients (42.7%) had DES ISR and 16 patients (19.5%) presented with an acute coronary syndrome. The success rate of drug-eluting balloon inflation was 97.6%. The median (interquartile range) duration of follow up was 28.0 (25.0-30.3) months. The rate of TLR was 24.5%, and was not significantly higher in the DES-ISR group than in the BMS-ISR group: 29.0% vs. 21.1%, respectively (p=0.687). There were two cases of definite stent thrombosis in the BMS-ISR group and one probable subacute stent thrombosis in the DES-ISR group. The overall MACE rate was 37.0% and did not differ between the DES-ISR and BMS-ISR group (40.8% vs. 34.7%, respectively; p=0.994). CONCLUSIONS: This real-world registry provided less favorable long-term results for drug-eluting balloons in the treatment of BMS restenosis and in DES restenosis, compared to the promising mid-term results of previous studies. The TLR rate was slightly but not significantly higher after DES restenosis compared to BMS restenosis treatment.