RESUMO
AIMS: TauroPace (Tauropharm, Bavaria Germany), a taurolidine solution for combating cardiac implantable electronic device (CIED) infection, was compared with a historical control of 3% hydrogen peroxide (H2O2) in a prospective observational study. METHODS AND RESULTS: The device pocket was irrigated, and all hardware accessible within (leads, suture sleeves, pulse generator) was wiped with H2O2, TauroPace, or taurolidine in a galenic formulation during any invasive CIED procedure at the study centre. Only CIED procedures covered by TauroPace or H2O2 from 1 January 2017 to 28 February 2022 were included for analysis. Patients who underwent >1 procedure were censored for the last treatment group and reassigned at the next procedure. The primary endpoint was major CIED infection within 3 months. The secondary endpoints were CIED infection beyond 3 months, adverse events potentially related to the antimicrobial solutions, CIED system, procedure, and death, till the end of follow-up. TauroPace covered 654 procedures on 631 patients, and H2O2 covered 551 procedures on 532 patients. The TauroPace group had more patient risk factors for infection than the H2O2 group (P = 0.0058) but similar device and procedure-specific risk factors (P = 0.17). Cardiac implantable electronic device infection occurred in 0/654 (0%) of the TauroPace group and 6/551 (1.1%) of the H2O2 group (P = 0.0075). Death occurred in 23/654 (3.5%) of the TauroPace group and 14/551 (2.5%) of the H2O2 group (P = 0.33). Non-infection related adverse events were rarer in the TauroPace (3.8%) than the H2O2 (6.0%) group (P = 0.0802). CONCLUSION: TauroPace is safe but more effective than H2O2 in reducing CIED infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05576194.
Assuntos
Anti-Infecciosos , Desfibriladores Implantáveis , Cardiopatias , Marca-Passo Artificial , Infecções Relacionadas à Prótese , Humanos , Anti-Infecciosos/efeitos adversos , Desfibriladores Implantáveis/efeitos adversos , Cardiopatias/etiologia , Peróxido de Hidrogênio/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/prevenção & controle , Infecções Relacionadas à Prótese/etiologia , Estudos ProspectivosRESUMO
OBJECTIVES: We investigated the clinical efficacy of a paclitaxel-coated balloon (PCB) with a novel matrix coating and reduced drug concentration in comparison with a widely used PCB with iopromide excipient. METHODS: We prospectively enrolled patients with restenosis in drug-eluting stents. All patients were treated with a novel low-dose PCB with citrate-based excipient (Agent PCB). Angiographic follow-up was scheduled at 6-8 months. Outcomes were compared against those of patients treated with iopromide excipient PCB (SeQuent Please PCB) enrolled in a trial with identical inclusion and exclusion criteria. The primary endpoint was percent diameter stenosis (%DS) at follow-up angiography. The primary hypothesis was that the investigational device would be non-inferior to the control device (ClinicalTrials.gov Identifier: NCT02367495). RESULTS: One hundred twenty-five patients with 151 lesions were enrolled. Mean age was 68.1 ± 10.2 years, 40.8% had diabetes mellitus and 80.1% had focal morphology in-stent restenosis. Follow-up angiography data at 6-8 months was available for 102 (81.6%) patients. The Agent PCB was non-inferior to the SeQuent Please PCB in terms of the primary endpoint (38.9 ± 17.5 vs. 38.1 ± 21.5%; p non-inferiority = 0.0056). Late lumen loss was also comparable between the groups (0.35 ± 0.55 vs. 0.37 ± 0.59; p = 0.71). There was no difference between the groups in the incidence of TLR (27.7% vs. 22.1%; p = 0.31), death or myocardial infarction (4.2% vs. 4.4%; p = 0.92) or target lesion thrombosis (1.0% vs. 0.7%; p = 0.93). CONCLUSION: In patients with DES restenosis, angioplasty with a novel PCB with citrate-based excipient was non-inferior to PCB with iopromide excipient in terms of angiographic outcome.
Assuntos
Angioplastia Coronária com Balão , Fármacos Cardiovasculares , Reestenose Coronária , Stents Farmacológicos , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica/induzido quimicamente , Constrição Patológica/complicações , Angiografia Coronária/efeitos adversos , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Humanos , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Estudos Prospectivos , Stents/efeitos adversos , Resultado do TratamentoRESUMO
Renal nerve stimulation (RNS) can result in substantial blood pressure (BP) elevation, and the change was significantly blunted when repeated stimulation after ablation. However, whether RNS could provide a meaningful renal nerve mapping for identification of optimal ablation targets in renal denervation (RDN) is not fully clear. Here, we compared the antihypertensive effects of selective RDN guided by two different BP responses to RNS and explored the nerve innervations at these sites in Kunming dogs. Our data indicated that ablation at strong-response sites showed a more systolic BP-lowering effect than at weak-response sites (P=0.002), as well as lower levels of tyrosine hydroxylase and norepinephrine in kidney and a greater reduction in plasma norepinephrine (P=0.004 for tyrosine hydroxylase, P=0.002 for both renal and plasma norepinephrine). Strong-response sites showed a greater total area and mean number of renal nerves than weak-response sites (P=0.012 for total area and P<0.001 for mean number). Systolic BP-elevation response to RNS before RDN and blunted systolic BP-elevation to RNS after RDN were correlated with systolic BP changes at 4 weeks follow-up (R=0.649; P=0.012 and R=0.643; P=0.013). Changes of plasma norepinephrine and renal norepinephrine levels at 4 weeks were also correlated with systolic BP changes at 4 weeks (R=0.837, P<0.001 and R=0.927, P<0.001). These data suggest that selective RDN at sites with strong BP-elevation response to RNS could lead to a more efficient RDN. RNS is an effective method to identify the nerve-enriched area during RDN procedure and improve the efficacy of RDN.
Assuntos
Ablação por Cateter/métodos , Estimulação Elétrica/métodos , Hipertensão/cirurgia , Nervos Esplâncnicos/cirurgia , Simpatectomia/métodos , Análise de Variância , Animais , Determinação da Pressão Arterial/métodos , Modelos Animais de Doenças , Cães , Feminino , Hipertensão/fisiopatologia , Rim/inervação , Masculino , Norepinefrina/sangue , Distribuição Aleatória , Valores de Referência , Cirurgia Assistida por Computador/métodos , Resultado do TratamentoAssuntos
Aterectomia Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/lesões , Vasos Coronários/cirurgia , Infarto do Miocárdio/cirurgia , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Humanos , Masculino , Infarto do Miocárdio/diagnóstico por imagemRESUMO
According to current guidelines prophylactic implantable cardioverter-defibrillator (ICD) therapy is recommended in patients with significantly impaired left ventricular systolic function. However, the recently published DANISH trial did not find a significantly lower long-term rate of death from any cause compared with usual clinical care in patients with non-ischemic cardiomyopathy. We investigated whether registry data from a multi-center 'real-life' registry on patients with non-ischemic cardiomyopathy are similar to this trial. The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focused on patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction ≤35% who received a prophylactic ICD. Out of 779 patients with symptomatic heart failure and nonischemic cardiomyopathy, 33.1% received a single chamber ICD (VVI), while 11.0% were implanted with a dual-chamber ICD (DDD), and 55.8% received a defibrillator system for cardiac resynchronization therapy. Median follow-up was 16.1 months. 90.7% were alive at follow-up, 9.3% had died during this period. Overall mortality after one year was 5.4%. Overall mortality one year after implantation was significantly increased in patients 68 years and older(7.9%) as compared to younger patients (59-68 years: 2.5%; < 59 years: 3.8%; p < 0.015). Data from the present registry support the recently published results of the DANISH trial. In particular the influence of an increased age as proven in the DANISH trial might also play a role in the present collective. This limits the potential beneficial effect of ICD therapy in particular in the elderly population.
Assuntos
Terapia de Ressincronização Cardíaca/efeitos adversos , Cardiomiopatias/terapia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Idoso , Cardiomiopatias/mortalidade , Causas de Morte , Feminino , Alemanha/epidemiologia , Insuficiência Cardíaca , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Números Necessários para Tratar , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Taxa de SobrevidaRESUMO
Coronary calcifications remain associated to increased rate of complications and worse clinical outcomes, particularly in the setting of in-stent restenosis. We present the first reported case of combined rotational atherectomy and intravascular lithotripsy for the treatment of heavily calcified neoatherosclerosis.
Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana/terapia , Reestenose Coronária/terapia , Stents Farmacológicos , Litotripsia , Intervenção Coronária Percutânea/instrumentação , Placa Aterosclerótica , Calcificação Vascular/terapia , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Índice de Gravidade de Doença , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/etiologiaRESUMO
INTRODUCTION: Stochastic damage of the ionizing radiation to both patients and medical staff is a drawback of fluoroscopic guidance during catheter ablation of cardiac arrhythmias. Therefore, emerging zero-fluoroscopy catheter-guidance techniques are of great interest. METHODS AND RESULTS: We investigated, in a prospective pilot study, the feasibility and safety of the cryothermal (CA) slow-pathway ablation in patients with symptomatic atrioventricular-nodal-re-entry-tachycardia (AVNRT) using solely intracardiac echocardiography (ICE) for endovascular and endocardial catheter visualization. Twenty-five consecutive patients (mean age 55.6 ± 12.0 years, 17 female) with ECG-documentation or symptoms suggesting AVNRT underwent an electrophysiology study (EPS) in our laboratory utilizing ICE for catheter navigation. Supraventricular tachycardia was inducible in 23 (92%) patients; AVNRT was confirmed by appropriate stimulation maneuvers in 20 (80%) patients. All EPS in the AVNRT subgroup could be accomplished without need for fluoroscopy, relying solely on ICE-guidance. CA guided by anatomical location and slow-pathway potentials was successful in all patients, median cryo-mappings = 6 (IQR:3-10), median cryo-ablations = 2 (IQR:1-3). Fluoroscopy was used to facilitate the trans-septal puncture and localization of the ablation substrate in the remaining 3 patients (one focal atrial tachycardia and two atrioventricular-re-entry-tachycardias). Mean EPS duration in the AVNRT subgroup was 99.8 ± 39.6 minutes, ICE guided catheter placement 11.9 ± 5.8 minutes, time needed for diagnostic evaluation 27.1 ± 10.8 minutes, and cryo-application duration 26.3 ± 30.8 minutes. CONCLUSIONS: ICE-guided zero-fluoroscopy CA in AVNRT patients is feasible and safe. Real-time visualization of the true endovascular borders and cardiac structures allow for safe catheter navigation during the ICE-guided EPS and might be an alternative to visualization technologies using geometry reconstructions.
Assuntos
Cateterismo Cardíaco , Criocirurgia , Ecocardiografia Doppler em Cores , Ecocardiografia Doppler de Pulso , Taquicardia por Reentrada no Nó Atrioventricular/cirurgia , Taquicardia Supraventricular/cirurgia , Ultrassonografia de Intervenção/métodos , Potenciais de Ação , Adulto , Idoso , Cateterismo Cardíaco/efeitos adversos , Estimulação Cardíaca Artificial , Criocirurgia/efeitos adversos , Eletrocardiografia , Técnicas Eletrofisiológicas Cardíacas , Estudos de Viabilidade , Feminino , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Projetos Piloto , Valor Preditivo dos Testes , Estudos Prospectivos , Taquicardia por Reentrada no Nó Atrioventricular/diagnóstico por imagem , Taquicardia por Reentrada no Nó Atrioventricular/fisiopatologia , Taquicardia Supraventricular/diagnóstico por imagem , Taquicardia Supraventricular/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR. METHODS: We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6-8month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups. RESULTS: In total, 264 patients were treated with BTHC-PCB (n=127) or iopromide-PCB (n=137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 [SD 8.2]% vs. 18.4 [SD 9.9]%, P=0.001). At 6-8month angiography, diameter stenosis was 40.4 [SD 21.9]% vs. 37.4 [SD 21.4]% in the BTHC-PCB and iopromide-PCB groups, respectively (P=0.16, Padjusted=0.32). At 1year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 [95% CI 0.62-1.70], P=0.91, Padjusted=0.96). CONCLUSIONS: In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1year compared with iopromide-PCB.
Assuntos
Angioplastia Coronária com Balão/métodos , Materiais Revestidos Biocompatíveis/administração & dosagem , Angiografia Coronária/métodos , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Idoso , Angioplastia Coronária com Balão/normas , Materiais Revestidos Biocompatíveis/normas , Angiografia Coronária/normas , Stents Farmacológicos/normas , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Desenho de Prótese/normas , Resultado do TratamentoRESUMO
The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort of patients with 6 or 12 months DAPT after implantation of predominantly second-generation drug-eluting stents. We analyzed data of patients enrolled in the ISAR-SAFE trial. Patients were classified into low (<2) or high (≥2) DAPT score groups. Primary ischaemic (all-cause death, myocardial infarction, definite stent thrombosis or stroke) and bleeding (TIMI major or minor) outcomes were analyzed in the low and high DAPT score groups. Data of 3976 patients were available for DAPT score calculation. 2407 patients (60.5 %) were classified in the low DAPT score group and 1569 patients (39.5 %) in the high DAPT score group. In the low DAPT score group there were no significant differences between 6 and 12 months DAPT regarding ischaemic (1.0 % vs. 1.4 %, HR=0.74, 95 % CI, 0.35-1.57; p=0.43) or bleeding outcomes (0.3 % vs. 0.8 %, HR=0.44, 95 % CI, 0.13-1.42; p=0.17). In the high DAPT score group there were also no significant differences between 6 and 12 months DAPT regarding ischaemic (1.9 % vs. 1.8 %, HR=1.02, 95 % CI, 0.49-2.14; p=0.96) or bleeding (0.3 % vs. 0.5 %, HR=0.51, 95 % CI, 0.09-2.78; p=0.44) outcomes. In conclusion, the DAPT score failed to show a differential treatment effect in patients receiving 6 or 12 months DAPT after contemporary drug-eluting stent implantation.
Assuntos
Doença das Coronárias/terapia , Técnicas de Apoio para a Decisão , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/administração & dosagem , Ticlopidina/análogos & derivados , Idoso , Aspirina/administração & dosagem , Tomada de Decisão Clínica , Clopidogrel , Doença das Coronárias/diagnóstico , Doença das Coronárias/mortalidade , Trombose Coronária/etiologia , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Masculino , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Desenho de Prótese , Reprodutibilidade dos Testes , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis. BACKGROUND: DCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy. METHODS: In this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year. RESULTS: Follow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year. CONCLUSIONS: In patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371).
Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Reestenose Coronária/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/mortalidade , Trombose Coronária/etiologia , Feminino , Alemanha , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Terapêutica , Fatores de TempoRESUMO
BACKGROUND: Observational studies suggest there are gender based differences in the treatment of coronary artery disease, with women receiving evidence based therapy less frequently than suggested by current guidelines. The aim of our study was to evaluate gender based differences in the use of DES. METHODS: We analysed prospectively collected data from 100704 stent implantations in the PCI registry of the ALKK between 2005 and 2009. RESULTS: The usage of DES increased from 16.0 to 43.9%. Although women had smaller vessel sizes, they received DES less often compared to men (28.2 vs. 31.3%), with an adjusted odds ratio of 0.93 (95% confidence interval 0.89-0.97) at the age of 75, and an adjusted odds ratio of 0.89 (95% confidence interval 0.84-0.94) at the age of 80. CONCLUSION: Despite having smaller vessels than men, women were treated less often with DES. These findings apply to women above the age of 75 years. These findings support previous reports, that elderly women with coronary artery disease are treated differently to men.
Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Disparidades em Assistência à Saúde , Intervenção Coronária Percutânea/instrumentação , Avaliação de Processos em Cuidados de Saúde , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Doença da Artéria Coronariana/diagnóstico por imagem , Feminino , Alemanha , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: There is growing evidence for beneficial prognostic and economic effects of FFR-guided treatment of stable coronary artery disease. We sought to evaluate the real-world use of FFR measurements in patients undergoing elective coronary angiography. METHODS AND RESULTS: We analyzed the data of the prospective ALKK coronary angiography and PCI registry including data of 38 hospitals from January 2010 to December 2013. A total of 100,977 patients undergoing coronary angiography were included. In 3240 patients (3.2 %) intracoronary pressure measurement was performed. There was a wide range of use of FFR measurement in the different analyzed ALKK hospitals from 0.1 to 8.8 % in elective patients with suspected or known coronary artery disease (median 2.7 %, quartiles 0.9 and 5.3 %), with a successive increase of use over time during the study period. Overall, it was performed in 3.2 % of coronary angiographies. Use in patients with three-vessel disease (2.5 %) and recommendation for bypass surgery (1.6 %) was less frequent. In procedures without PCI, dose area product was higher in the FFR group (2641 cGy × cm2 vs. 2368 cGy × cm2, p < 0.001), while it was lower in procedures with ad hoc PCI (4676 cGy × cm2 vs. 5143 cGy × cm2, p < 0.001). The performing center turned out to be the strongest predictor. CONCLUSIONS: The use of FFR measurement was very heterogeneous between different hospitals and in general relatively low, in particular in patients with multivessel disease or recommendation for bypass surgery, but there was a positive trend during the study period. Technically, FFR measurement was not associated with an increased periprocedural complication rate.
Assuntos
Cateterismo Cardíaco/tendências , Angiografia Coronária , Estenose Coronária/diagnóstico , Estenose Coronária/terapia , Vasos Coronários/fisiopatologia , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Padrões de Prática Médica/tendências , Idoso , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/estatística & dados numéricos , Cateteres Cardíacos , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/fisiopatologia , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Doses de Radiação , Exposição à Radiação , Sistema de Registros , Transdutores de PressãoRESUMO
Autonomic nervous system plays a crucial role in maintaining and regulating vessel tension. Renal denervation (RDN) may induce renal artery vasodilation by damaging renal sympathetic fibers. We conducted this animal study to evaluate whether renal artery vasodilation could be a direct indicator of successful RDN. Twenty-eight Chinese Kunming dogs were randomly assigned into three groups and underwent RDN utilizing temperature-controlled catheter (group A, n = 11) or saline-irrigated catheter (group B, n = 11) or sham procedure (group C, n = 6). Renal angiography, blood pressure (BP) and renal artery vasodilation measurements were performed at baseline, 30-minute, 1-month, and 3-month after interventions. Plasma norepinephrine concentrations were tested at baseline and 3-month after intervention. Results showed that, in addition to significant BP reduction, RDN induced significant renal artery vasodilation. Correlation analyses showed that the induced renal artery vasodilation positively correlated with SBP reduction and plasma norepinephrine reduction over 3 months after ablation. Post hoc analyses showed that saline-irrigated catheter was superior to TC catheter in renal artery vasodilation, especially for the acute dilatation of renal artery at 30-minute after RDN. In conclusion, renal artery vasodilation, induced by RDN, may be a possible indicator of successful renal nerve damage and a predictor of blood pressure response to RDN.
Assuntos
Denervação/métodos , Artéria Renal/fisiopatologia , Sistema Nervoso Simpático/fisiopatologia , Vasodilatação , Angiografia/métodos , Animais , Pressão Sanguínea , Cães , Rim/irrigação sanguínea , Rim/inervação , Norepinefrina/sangue , Distribuição Aleatória , Artéria Renal/diagnóstico por imagem , Fatores de TempoRESUMO
In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41-1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group; HR 1.00, 95% CI 0.14-7.09, P = >0.99. Major bleeding occurred in 3 patients (0.4%) receiving 6 months clopidogrel and 5 (0.6%) receiving 12 months; HR 0.60, 95% CI 0.15-2.49, P = 0.49. There was no significant difference in net clinical outcomes after DES implantation in ACS patients treated with 6 versus 12 months clopidogrel. Ischaemic and bleeding events were low beyond 6-months.
Assuntos
Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Stents Farmacológicos , Ticlopidina/análogos & derivados , Idoso , Clopidogrel , Seguimentos , Hemorragia/etiologia , Hemorragia/mortalidade , Hemorragia/prevenção & controle , Humanos , Pessoa de Meia-Idade , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Fatores de TempoRESUMO
BACKGROUND: The efficacy of short-term antiarrhythmic drugs (AADs) use compared with no-AADs prescription after catheter ablation of atrial fibrillation (AF) in preventing atrial arrhythmia recurrence is uncertain. METHODS: We searched PubMed, Embase, and the Cochrane Library through December 2015 to identify randomized controlled trials (RCTs) which evaluated the efficacy of short-term AADs use compared with no-AADs prescription after AF ablation in preventing atrial arrhythmia recurrence. The primary outcome was labeled as early atrial arrhythmia recurrence within 3 months after ablation. Secondary outcome was defined as late recurrence after 3 months of ablation. Random-effects model or fixed-effects model was used to estimate relative risks (RRs) with 95% confidence intervals (CIs). RESULTS: Six RCTs with 2,667 patients were included into this meta-analysis. Compared with no-AADs administration after AF ablation, short-term AADs use was associated with significant reduction of early atrial arrhythmia recurrence (RR, 0.68; 95% CI, 0.52-0.87; p = 0.003). Trial sequential analysis (TSA) showed that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, establishing sufficient and conclusive evidence. However, compared with no-AADs prescription, short-term AADs use after AF ablation didn't significantly reduce the risk of late atrial arrhythmia recurrence (RR, 0.92; 95% CI, 0.83-1.03; p = 0.15). TSA supported this result; meanwhile the estimated required information size (1,486 patients) was also met. CONCLUSION: Short-term use of AADs after AF ablation can significantly decrease the risk of early atrial arrhythmia recurrence but not lead to corresponding reduction in risk of late atrial arrhythmia recurrence.
Assuntos
Antiarrítmicos/uso terapêutico , Fibrilação Atrial/terapia , Ablação por Cateter , Antiarrítmicos/efeitos adversos , Fibrilação Atrial/patologia , Fibrilação Atrial/fisiopatologia , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de RiscoRESUMO
The purpose of this study was to investigate whether atrial overexpression of angiotensin-converting enzyme 2 (ACE2) by homogeneous transmural atrial gene transfer can reverse atrial remodeling and its mechanisms in a canine atrial-pacing model. Twenty-eight mongrel dogs were randomly divided into four groups: Sham-operated, AF-control, gene therapy with adenovirus-enhanced green fluorescent protein (Ad-EGFP) and gene therapy with Ad-ACE2 (Ad-ACE2) (n = 7 per subgroup). AF was induced in all dogs except the Sham-operated group by rapid atrial pacing at 450 beats/min for 2 weeks. Ad-EGFP and Ad-ACE2 group then received epicardial gene painting. Three weeks after gene transfer, all animals except the Sham group underwent rapid atrial pacing for another 3 weeks and then invasive electrophysiological, histological and molecular studies. The Ad-ACE2 group showed an increased ACE2 and Angiotensin-(1-7) expression, and decreased Angiotensin II expression in comparison with Ad-EGFP and AF-control group. ACE2 overexpression attenuated rapid atrial pacing-induced increase in activated extracellular signal-regulated kinases and mitogen-activated protein kinases (MAPKs) levels, and decrease in MAPK phosphatase 1(MKP-1) level, resulting in attenuation of atrial fibrosis collagen protein markers and transforming growth factor-ß1. Additionally, ACE2 overexpression also modulated the tachypacing-induced up-regulation of connexin 40, down-regulation of connexin 43 and Kv4.2, and significantly decreased the inducibility and duration of AF. ACE2 overexpression could shift the renin-angiotensin system balance towards the protective axis, attenuate cardiac fibrosis remodeling associated with up-regulation of MKP-1 and reduction of MAPKs activities, modulate tachypacing-induced ion channels and connexin remodeling, and subsequently reduce the inducibility and duration of AF.
Assuntos
Fibrilação Atrial/genética , Remodelamento Atrial , Terapia Genética , Átrios do Coração/metabolismo , Peptidil Dipeptidase A/genética , Adenoviridae/genética , Enzima de Conversão de Angiotensina 2 , Animais , Estimulação Cardíaca Artificial , Cães , Fosfatase 1 de Especificidade Dupla/fisiologia , Feminino , Sistema de Sinalização das MAP Quinases , Masculino , Sistema Renina-Angiotensina/fisiologiaRESUMO
BACKGROUND: The placement of an implantable cardioverter defibrillator (ICD) has become routine practice to protect high risk patients from sudden cardiac death. However, implantation-related myocardial micro-damage and its relation to different implantation strategies are poorly characterized. METHODS: A total of 194 ICD recipients (64±12 years, 83% male, 95% primary prevention of sudden cardiac death, 35% cardiac resynchronization therapy) were randomly assigned to one of three implantation strategies: (1) ICD implantation without any defibrillation threshold (DFT) testing, (2) estimation of the DFT without arrhythmia induction (modified "upper limit of vulnerability (ULV) testing") or (3) traditional safety margin testing including ventricular arrhythmia induction. High-sensitive Troponin T (hsTnT) levels were determined prior to the implantation and 6 hours after. RESULTS: All three groups showed a postoperative increase of hsTnT. The mean delta was 0.031±0.032 ng/ml for patients without DFT testing, 0.080±0.067 ng/ml for the modified ULV-testing and 0.064±0.056 ng/ml for patients with traditional safety margin testing. Delta hsTnT was significantly larger in both of the groups with intraoperative ICD testing compared to the non-testing strategy (p≤0.001 each). There was no statistical difference in delta hsTnT between the two groups with intraoperative ICD testing (p = 0.179). CONCLUSION: High-sensitive Troponin T release during ICD implantation is significantly higher in patients with intraoperative ICD testing using shock applications compared to those without testing. Shock applications, with or without arrhythmia induction, did not result in a significantly different delta hsTnT. Hence, the ICD shock itself and not ventricular fibrillation seems to cause myocardial micro-damage. TRIAL REGISTRATION: ClinicalTrials.gov NCT01230086.