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1.
Catheter Cardiovasc Interv ; 92(5): 844-851, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-29451949

RESUMO

BACKGROUND: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.


Assuntos
Arteriopatias Oclusivas/etnologia , Povo Asiático , Cateteres Cardíacos , Cateterismo Periférico/instrumentação , Angiografia Coronária/instrumentação , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Hemorragia/etnologia , Hemostasia , Intervenção Coronária Percutânea/instrumentação , Artéria Radial/fisiopatologia , Grau de Desobstrução Vascular , Idoso , Idoso de 80 Anos ou mais , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/fisiopatologia , Cateterismo Periférico/efeitos adversos , Angiografia Coronária/efeitos adversos , Doença da Artéria Coronariana/etnologia , Doença da Artéria Coronariana/fisiopatologia , Desenho de Equipamento , Feminino , Humanos , Incidência , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Artéria Radial/diagnóstico por imagem , Fatores de Risco , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
2.
Catheter Cardiovasc Interv ; 83(1): E1-7, 2014 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-23441063

RESUMO

OBJECTIVES: To compare clinical outcomes between transradial (TRI) and transfemoral intervention (TFI) in primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI) with or without shock. BACKGROUND: TRI for STEMI has benefits in TRI high volume centers. However, TRI has not been reported for STEMI with shock even in such centers. METHODS: We retrospectively studied 425 STEMI patients who underwent primary PCI. Patients were divided into four groups according to approach site and presence of cardiogenic shock, including TRI without shock (TR group, n = 273), TRI with shock (TRS group, n = 38), TFI without shock (TF group, n = 71), and TFI with shock (TFS group, n = 43). RESULTS: PCI success rates were similar among the four groups. The TR group was superior to the TF group in terms of shorter cath lab to first device activation time, and lower access site complications, and 30-day mortality rates (1.1% vs. 11.3%, P < 0.001). In shock patients, cardiopulmonary arrest was commonly observed in both the TRS and TFS groups (42.1% and 51.2%, respectively). The TRS group showed a trend toward a shorter door to first device activation time compared to the TFS group and lower access site complications; however, 30-day mortality rate was 28.9% in TRS and 25.6% in TFS group (P = 0.7). CONCLUSIONS: In TRI high volume center, TRI for STEMI was safe and feasible as a default approach. TRI could be applied to severe shock patients with similar clinical outcome to TFI.


Assuntos
Cateterismo Cardíaco/métodos , Artéria Femoral , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/métodos , Artéria Radial , Choque Cardiogênico/etiologia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Estudos de Viabilidade , Feminino , Hospitais com Alto Volume de Atendimentos , Humanos , Japão , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Retrospectivos , Fatores de Risco , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/mortalidade , Fatores de Tempo , Tempo para o Tratamento , Resultado do Tratamento
3.
Circ J ; 78(12): 2950-4, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25283791

RESUMO

BACKGROUND: The purpose of the present study was to confirm the diagnostic accuracy of Global Registry of Acute Coronary Events (GRACE) risk score 1.0 (GRACE 1.0) and updated GRACE 1.0 (GRACE 2.0) for in-hospital and 360-day mortality in ST-elevation myocardial infarction (STEMI) in Japanese patients. GRACE 1.0 and GRACE 2.0 are the established predictive models in acute coronary syndrome, but their application to Japanese patients has not been fully verified. METHODS AND RESULTS: The present study retrospectively analyzed 412 consecutive STEMI patients who had undergone primary percutaneous coronary intervention from January 2006 to September 2011. All causes of death during hospitalization were examined to confirm the diagnostic accuracy of GRACE 1.0 on receiver operating characteristic (ROC) analysis. Similarly, all causes of death during the 360 days after hospitalization were analyzed to confirm the diagnostic accuracy of GRACE 2.0. The average GRACE 1.0 score was 175.8±50.9. In-hospital and 360-day mortality were 13.1% and 15.5%, respectively. Area under the ROC curve, which describes the diagnostic accuracy of the GRACE 1.0 predicted in-hospital mortality and the GRACE 2.0 predicted 360-day mortality, was as high as 0.95 and 0.92, respectively. CONCLUSIONS: Both GRACE 1.0 and GRACE 2.0 had a high diagnostic accuracy for prediction of in-hospital and 360-day mortality in Japanese STEMI patients.


Assuntos
Infarto do Miocárdio/diagnóstico , Índice de Gravidade de Doença , Idoso , Área Sob a Curva , Comorbidade , Feminino , Mortalidade Hospitalar , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea , Prognóstico , Curva ROC , Estudos Retrospectivos , Medição de Risco , Fatores de Risco
4.
Health Sci Rep ; 6(12): e1739, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38033711

RESUMO

Background and Aims: As the population of aging societies continues to grow, the prevalence of complex coronary artery diseases, including calcification, is expected to increase. Rotational atherectomy (RA) is an essential technique for treating calcified lesions. This study aimed to assess the usefulness of the drilling noise produced during rotablation as a parameter for evaluating the safety and effectiveness of the procedure. Methods: A human body model mimicking calcified stenotic coronary lesions was constructed using plastic resin, and burrs of sizes 1.25 and 1.5 mm were utilized. To identify the noise source during rotablation, we activated the ROTAPRO™ rotablator at a rotational speed of 180,000 rpm, recording the noise near the burr (inside the mock model) and advancer (outside). In addition to regular operation, we simulated two major complications: burr entrapment and guidewire transection. The drilling noise recorded in Waveform Audio File Format files was converted into spectrograms for analysis and an autoencoder analyzed the image data for anomalies. Results: The drilling noise from both inside and outside the mock model was predominantly within the 3000 Hz frequency domain. During standard operation, intermittent noise within this range was observed. However, during simulated complications, there were noticeable changes: a drop to 2000 Hz during burr entrapment and a distinct squealing noise during guidewire transection. The autoencoder effectively reduced the spectrogram data into a two-dimensional representation suitable for anomaly detection in potential clinical applications. Conclusion: By analyzing drilling noise, the evaluation of procedural safety and efficacy during RA can be enhanced.

5.
Catheter Cardiovasc Interv ; 75(7): 1006-12, 2010 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-20517961

RESUMO

OBJECTIVES: The aim of this study was to evaluate the safety and effectiveness of a 0.010-inch guidewire and a balloon catheter for treatment of chronic total occlusion (CTO). BACKGROUND: Pathological studies have shown that 60-70% of CTO lesions have microchannels of sizes equal to or less than 0.010 inch. METHODS: The PIKACHU registry is a prospective, multicenter registry study. A 0.010-inch guidewire had to be used as the first guidewire to attempt to pass the CTO lesion. The primary endpoint was device success using a 0.010 system. RESULTS: A total of 141 patients with 141 lesions were enrolled. The median duration of occlusion was 9 months (range 3-156). Average guiding catheter size was 5.8 +/- 0.7 Fr. and TRI was 76.6 %. CTOs were mostly between 10-20 mm long, observed in 53 occlusions. There were 107 lesions (75.9%) with bending of more than 45 degrees. Calcification was seen in 91 lesions (64.5%). A 0.010-inch guidewire was successfully passed through in 97 of 141 lesions (68.8%). A 0.010-inch guidewire compatible balloon catheter was passed in 87 of the 97 lesions (88.7%) and final PCI success was achieved in all the cases. The overall clinical success rate was 87.9% (124/141). No MACE or bleeding complications were observed. CONCLUSION: The PIKACHU registry data suggest that the 0.010-inch system is safe and practicable for treatment of CTO lesions.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Oclusão Coronária/terapia , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Doença Crônica , Desenho de Equipamento , Feminino , Cardiopatias/etiologia , Hemorragia/etiologia , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Miniaturização , Estudos Prospectivos , Sistema de Registros , Resultado do Tratamento
6.
Circ J ; 74(8): 1609-16, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20534942

RESUMO

BACKGROUND: Several studies have indicated that the clinical outcomes of sirolimus-eluting stents (SES) are significantly associated with longitudinal positioning of the stent relative to the underlying plaque distribution. METHODS AND RESULTS: Optimal SES landing was determined using unique stepwise intravascular ultrasound (IVUS) criteria, mainly targeting the sites with plaque burden <50% (plaque area/external elastic membrane area x100). To verify the criteria, (1) achievability and (2) actual impact on clinical and angiographic outcomes were assessed. A total of 162 consecutive patients with 180 lesions were enrolled and treated according to the IVUS criteria. Plaque burden at the proximal and distal margins was 41.4+/-13.6% (n=144) and 34.9+/-15.6% (n=170), respectively (within 3 mm of stent ends). The target was achieved in 72.3% of the proximal and 84.1% of the distal margin for the criteria. A strikingly low angiographic margin re-stenosis rate (2.7% of proximal and 1.4% of distal margin) and low target lesion revascularization rate (2.2%) were achieved. Receiver operator characteristic curve indicated that plaque burden was the strongest predictor of margin re-stenosis and its threshold (51.6%) was almost identical to that of the criteria. CONCLUSIONS: The proposed stepwise IVUS criteria mainly targeting plaque burden <50% are feasible and useful in the real-world practice of SES implantation.


Assuntos
Stents Farmacológicos , Implantação de Prótese/métodos , Sirolimo/administração & dosagem , Ultrassonografia de Intervenção , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placa Aterosclerótica
7.
Catheter Cardiovasc Interv ; 73(5): 605-10, 2009 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-19309699

RESUMO

OBJECTIVE: To evaluate the safety and feasibility of a new 0.010-inch guidewire and a specialized balloon catheter for the 0.010-inch guidewire in routine percutaneous coronary intervention (PCI). BACKGROUND: Several reports have shown that a new 0.010-inch system is effective for specific situations where reduction of catheter size may be necessary. However, the safety of this system in routine PCI is unknown. METHODS: The IKATEN registry is a prospective, multicenter, nonrandomized registry study. Patients who underwent elective PCI with a 0.010-inch guidewire and its associated balloon catheter as primary devices were enrolled. The coprimary endpoints were clinical success and device success rates. The secondary endpoints were major adverse cardiac events (MACE) and bleeding complications. RESULTS: A total of 133 patients with 148 lesions were enrolled. The majority were male (75.3%), and mean age was 68 +/- 10 years. Type B2/C lesions comprised 60% of the lesions, prevalence of chronic total occlusion (CTO) was 16.9%, and bifurcation lesions were found in 22.3% of patients. A transradial approach was used in 79.7% of patients, and the average guiding catheter size was 5.1 +/- 0.4 Fr. Clinical success rate was 99.2%, and device success rate was 99.3%. Device failure occurred only in one case of chronic total occlusion because of unsuccessful guidewire passage. No MACE or bleeding complications were reported except for a small hematoma at the puncture site in one patient. Stent delivery success rate on 0.010-inch guidewire was 93.9% because of failure of stent balloon to pass eight lesions. CONCLUSION: The IKATEN registry data suggest that the 0.010-inch system is safe and its use is feasible in routine PCI including bifurcation and CTO lesions.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Oclusão Coronária/terapia , Estenose Coronária/terapia , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Doenças Cardiovasculares/etiologia , Doença Crônica , Desenho de Equipamento , Falha de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Hemorragia Pós-Operatória/etiologia , Estudos Prospectivos , Sistema de Registros , Resultado do Tratamento
8.
Indian Heart J ; 60(1 Suppl A): A22-6, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-19359743

RESUMO

Currently the 0.014-inch guidewire is commonly used for coronary intervention and all devices are 0.014 inch-compatible. The size of common guiding catheters is 6-F or 7-F. However, PCI requires oral administration of antiplatelet agents, and punctured-site complications such as hemorrhage and hematoma occur more frequently with use of a 6-F or 7-F guiding catheter compared to a 5-F guiding catheter. Moreover, 6-F or larger guiding catheters may cause radial arterial occlusion, although the transradial approach causes less punctured-site complications compared to the transfemoral approach. Recently, 0.010-inch guidewires applicable for the Kissing Balloon Technique (KBT) using a 5-F guiding catheter and 0.010-inch guidewire-compatible balloons have been developed in Japan, and a 3-F angiography catheter has also been developed. We refer to these devices as the "Slender System", and we have used this system for active treatment of bifurcation lesions and chronic total occlusion (CTO). In this report, we describe angiography using a 3-F catheter, the KBT using a 5-F guiding catheter and 0.010-inch guidewires, and treatment of CTO using a 5-F catheter and 0.010-inch guidewires. For CTO treated using the Slender System at our facility, the transradial arterial approach was used in 96% of cases, treatment using the Slender System alone succeeded in 68%, and the overall success rate was 89%. Therefore, our results show that complex lesions may be treatable using the Slender System, and that not all complex lesions require a 6-F or larger guiding catheters, a femoral arterial approach, or bilateral guiding catheters.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateterismo Cardíaco/instrumentação , Angiografia Coronária/instrumentação , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/terapia , Artéria Radial , Desenho de Equipamento , Humanos
10.
Int J Cardiol Heart Vasc ; 19: 27-33, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29946560

RESUMO

BACKGROUND: Whether an individually determined appropriate level of cardiac rehabilitation (CR) has a favorable effect on the renal function still remains unclarified. The aim of this study was to confirm the effect of CR on the estimated glomerular filtration rate (eGFR) using cystatin C, which is known to be unaffected by physical exercise. METHODS: The study population was comprised of 86 patients (61 males; average age 74 y/o) with a lower-moderate level of chronic kidney disease (CKD) who was admitted to our hospital for treatment of cardiovascular disease (CVD) and who participated in our 3-month CR program. The exercise capacity was assessed by cardiopulmonary exercise testing (CPX) and the eGFR was measured by a formula based on the serum cystatin C concentration (eGFRcys) in each patient both at the beginning and end of the CR. RESULTS: In the CVD patients with CKD, both the peak oxygen uptake (VO2) and peak work rate (WR) improved significantly after CR (15.0 ±â€¯3 to 15.8 ±â€¯3 ml/min/kg, p = 0.002. 65.5 ±â€¯21 to 70.2 ±â€¯25 W, p = 0.001). Regarding the renal function, the eGFRcys improved (45.2 ±â€¯11 to 47.3 ±â€¯13 ml/min/1.73 m2, p = 0.023), however, the eGFR assessed by the serum creatinine (eGFRcr) did not improve after CR (45.1 ±â€¯12 to 44.9 ±â€¯13 ml/min/1.73 m2, p = 0.834). CONCLUSIONS: In CVD patients, a novel CR program significantly improved the exercise capacity. Further, CR was shown to have a favorable effect on the renal function when it was estimated by the eGFRcys.

12.
Int J Cardiol ; 230: 346-352, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-28040288

RESUMO

BACKGROUND: Collateral filling of chronic total occlusion (CTO) segments is considered to affect hemodynamic stability in primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) with CTO, however its value as a prognostic indicator for mortality is uncertain. The present study examined the relationship between collateral filling of CTO segments and short-term mortality in patients with STEMI with a comorbid CTO lesion. METHODS: Among 829 STEMI patients who underwent primary PCI, 74 patients with CTO were identified. Collateral filling of their CTO segment was assessed by Rentrop grade (0; n=10, 1; n=13, 2; n=31, 3; n=20) in their initial angiogram and whether the origin of the feeding collateral donor artery was infarct-related artery (IRA) was evaluated using their final angiogram in primary PCI; IRA (n=26) and non-IRA group (n=48). The relationship between these classifications and 30-day all-cause mortality was examined retrospectively. RESULTS: The 30-day mortalities were 4.5% in single-vessel disease, 18.3% in multi-vessel disease (MVD) without CTO and 25.7% in MVD with CTO. Mortality of MVD with CTO reduced with increasing Rentrop grade from 0 to 3 (80.0%, 30.8%, 19.4%, and 5.0%, respectively). IRA was associated with a significant higher mortality than those of non-IRA (50.0% vs. 12.5%, P=0.0004). Low Rentrop grade 0 or 1 was extracted as an independent predictor of 30-day death (HR 3.28, 95% CI 1.20-9.96, P=0.0203). CONCLUSIONS: Poor collateral filling of the CTO segment assessed by Rentrop grade was an independent angiographic predictor for 30-day death in patients with STEMI combined with CTO.


Assuntos
Circulação Colateral , Circulação Coronária/fisiologia , Oclusão Coronária/fisiopatologia , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Idoso , Causas de Morte/tendências , Doença Crônica , Oclusão Coronária/complicações , Oclusão Coronária/cirurgia , Feminino , Seguimentos , Humanos , Japão/epidemiologia , Masculino , Prognóstico , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Taxa de Sobrevida/tendências , Fatores de Tempo
13.
Eur Heart J Acute Cardiovasc Care ; 6(7): 623-631, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26880852

RESUMO

BACKGROUND: In ST-elevation myocardial infarction (STEMI) patients with diffuse ectatic coronary artery, extensive thrombi inhibit achievement of final successful revascularization of Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow after primary percutaneous coronary intervention. However, clinical and angiographic outcomes of such patients are uncertain. The present study examined clinical and angiographic outcomes in STEMI incorporating giant coronary artery with diffuse ectasia. METHODS: Seven hundred and forty-four STEMI patients undergoing primary percutaneous coronary intervention were surveyed retrospectively. Culprit lesions in giant coronary artery with diffuse ectasia (Ectatic group, n=39) were investigated. Percutaneous coronary intervention success rate and angiographic or clinical outcomes at 360 days were compared with those of the Non-ectatic group ( n=705). RESULTS: Angiographic percutaneous coronary intervention success rate was significantly lower in the Ectatic group due to lower achievement of final TIMI grade 3 flow (53.8% vs. 92.9%, p<0.0001; 53.8% vs. 93.5%, p<0.0001, respectively). In follow-up angiography, 86% of the Ectatic group showed angiographic improvement from TIMI grade 2 or less immediately after percutaneous coronary intervention to TIMI grade 3 flow at follow-up. In contrast, angiographic improvement was observed in only 25% of cases in the Non-ectatic group. All-cause 360-day mortality was significantly lower in the ectatic group (2.6% vs. 14.5%, p=0.0361, respectively). CONCLUSION: In patients with STEMI in giant coronary artery with diffuse ectasia, achievement of TIMI grade 3 flow was significantly reduced immediately after percutaneous coronary intervention. However, improvement of coronary flow up to TIMI grade 3 was not uncommon at follow-up angiogram. Patients had low mortality despite low TIMI grade 3 achievement immediately after primary percutaneous coronary intervention.


Assuntos
Velocidade do Fluxo Sanguíneo/fisiologia , Aneurisma Coronário/cirurgia , Circulação Coronária/fisiologia , Trombose Coronária/complicações , Vasos Coronários/diagnóstico por imagem , Complicações Pós-Operatórias , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Idoso , Causas de Morte/tendências , Aneurisma Coronário/diagnóstico , Aneurisma Coronário/etiologia , Angiografia Coronária , Trombose Coronária/diagnóstico , Trombose Coronária/cirurgia , Vasos Coronários/fisiopatologia , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Taxa de Sobrevida/tendências
14.
EuroIntervention ; 13(5): e549-e556, 2017 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-28218605

RESUMO

AIMS: The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO. METHODS AND RESULTS: We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm. CONCLUSIONS: In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.


Assuntos
Arteriopatias Oclusivas/cirurgia , Angiografia Coronária/instrumentação , Hemorragia/etiologia , Artéria Radial/cirurgia , Grau de Desobstrução Vascular/fisiologia , Idoso , Cateterismo Cardíaco/métodos , Angiografia Coronária/efeitos adversos , Angiografia Coronária/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos
15.
J Invasive Cardiol ; 29(1): 16-23, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27315578

RESUMO

OBJECTIVES: To evaluate the safety and feasibility of virtual 3 Fr (V3), sheathless 5 Fr percutaneous coronary intervention (PCI). BACKGROUND: A small-diameter guiding catheter (GC) makes less-invasive PCI possible. The V3 is an extremely slender PCI system; however, the outcome of using this system has not yet been determined. METHODS: The V3 registry is a prospective, multicenter, non-randomized study that enrolled patients who underwent elective V3-PCI. The primary endpoint was clinical success rate, and the secondary endpoints were PCI success rate in all cases, major adverse cardiac and cerebrovascular event (MACCE) at 30 days, and access-site complications. RESULTS: A total of 260 patients with 321 lesions were enrolled. Of this group, 70% were male and the mean age was 70.8 ± 10.0 years. Type B2/C lesions comprised 50.7% of the total. The clinical success rate was 95.8%, and the PCI success rate was 99.2%. PCI failure was reported in 2 chronic total occlusion cases. No MACCE was reported. Although there was no major bleeding, hematoma occurred at the puncture site in 12.7% of cases. There was a single radial artery occlusion (0.4%) without symptoms. CONCLUSIONS: PCI with the V3 was safe and feasible. Radial artery occlusion and major bleeding complications were extremely low. However, access-site hematoma frequently complicated catheter exchange.


Assuntos
Cateteres Cardíacos , Estenose Coronária/cirurgia , Intervenção Coronária Percutânea/instrumentação , Sistema de Registros , Interface Usuário-Computador , Adulto , Idoso , Idoso de 80 Anos ou mais , Estenose Coronária/diagnóstico , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
17.
Cardiovasc Interv Ther ; 31(1): 38-41, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26141373

RESUMO

The aim of this study was to evaluate the safety and feasibility of the new 5 Fr Glidesheath Slender (GSS). The transradial (TR) approach has become popular because of several advantages, such as a reduced rate of vascular access site complications. However, because the radial artery is narrow, a limitation of TR access is the potential for artery spasm or occlusion. Studies of radial artery size demonstrate that 5 Fr sheaths are too wide for more than 10 % of patients. The GSS (Terumo, Tokyo, Japan) is a new radial sheath with a thinner wall and a hydrophilic coating. It has an inner diameter that is compatible with a 5 Fr guiding catheter, while the outer diameter is similar to that of a 4 Fr sheath. A total of 21 consecutive patients undergoing transradial angiography and/or transradial percutaneous coronary intervention with the 5 Fr GSS were included, and safety and feasibility of the device were assessed. Transradial angiography was performed in 10 patients, and transradial intervention in 11 patients. All procedures were successful, without the need for conversion to the transfemoral approach. The radial artery occlusion rate was 0 %, including a patient who had experienced six previous radial artery punctures. There were no cases of artery spasm, hematoma, major bleeding or functional disorders. One coronary artery perforation caused by a guidewire was reported, but it was unrelated to the sheath introducer. The new 5 Fr GSS was safe and feasible for transradial angiography and transradial intervention.


Assuntos
Catéteres , Angiografia Coronária/instrumentação , Intervenção Coronária Percutânea/instrumentação , Artéria Radial , Materiais Revestidos Biocompatíveis , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados da Assistência ao Paciente , Estudos Prospectivos , Grau de Desobstrução Vascular
18.
Int J Cardiol ; 218: 158-163, 2016 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-27232928

RESUMO

BACKGROUND: Patients with ST-elevation myocardial infarction (STEMI) and multi-vessel disease (MVD) have higher mortality, especially with comorbid chronic total occlusion (CTO). The origin of collateral flow to the CTO segment has not been studied in regard to short-term mortality. This study examined the impact of collateral feeding donor arteries from an infarct-related artery (IRA) or non-IRA to the comorbid CTO segment in regard to STEMI short-term mortality. METHODS: Data from 760 consecutive STEMI patients who underwent primary percutaneous coronary intervention were obtained retrospectively from medical records. The number of vessels involved and origin of the collateral feeding donor artery were evaluated using angiograms from the primary percutaneous coronary intervention. The study population was divided into patients with: single-vessel disease (SVD) (n=483), MVD without CTO (n=208), and MVD with CTO (n=64). All CTO segments had collateral flow from an IRA (n=23) or non-IRA (n=46). All-cause mortality (30-day) was analyzed. RESULTS: Compared to SVD and MVD without CTO, MVD with comorbid CTO had a higher mortality (5.4% vs. 15.9% vs. 24.6%, P<0.0001, respectively). Of patients with CTO, those with collateral flow from the IRA had significantly higher mortality than the non-IRA group (52.2% vs. 10.9%, P<0.0001). Collateral flow from the IRA was extracted as an independent predictor associated with 30-day all-cause mortality using a multivariate Cox proportional hazards model (hazard ratio 4.71, 95% confidence interval 1.60-14.2, P=0.0005). CONCLUSIONS: The origin of the collateral donor artery from the IRA had an impact on short-term mortality in STEMI patients with comorbid CTO lesions.


Assuntos
Artérias/cirurgia , Oclusão Coronária/mortalidade , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Oclusão Coronária/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Resultado do Tratamento
19.
J Am Heart Assoc ; 5(12)2016 12 16.
Artigo em Inglês | MEDLINE | ID: mdl-27986755

RESUMO

BACKGROUND: Up to half of patients undergoing percutaneous coronary intervention have multivessel coronary artery disease (MVD) with conflicting data regarding optimal revascularization strategy in such patients. This paper assesses the evidence for complete revascularization (CR) versus incomplete revascularization in patients undergoing percutaneous coronary intervention, and its prognostic impact using meta-analysis. METHODS AND RESULTS: A search of PubMed, EMBASE, MEDLINE, Current Contents Connect, Google Scholar, Cochrane library, Science Direct, and Web of Science was conducted to identify the association of CR in patients with multivessel coronary artery disease undergoing percutaneous coronary intervention with major adverse cardiac events and mortality. Random-effects meta-analysis was used to estimate the odds of adverse outcomes. Meta-regression analysis was conducted to assess the relationship with continuous variables and outcomes. Thirty-eight publications that included 156 240 patients were identified. Odds of death (OR 0.69, 95% CI 0.61-0.78), repeat revascularization (OR 0.60, 95% CI 0.45-0.80), myocardial infarction (OR 0.64, 95% CI 0.50-0.81), and major adverse cardiac events (OR 0.63, 95% CI 0.50-0.79) were significantly lower in the patients who underwent CR. These outcomes were unchanged on subgroup analysis regardless of the definition of CR. Similar findings were recorded when CR was studied in the chronic total occlusion (CTO) subgroup (OR 0.65, 95% CI 0.53-0.80). A meta-regression analysis revealed a negative relationship between the OR for mortality and the percentage of CR. CONCLUSION: CR is associated with reduced risk of mortality and major adverse cardiac events, irrespective of whether an anatomical or a score-based definition of incomplete revascularization is used, and this magnitude of risk relates to degree of CR. These results have important implications for the interventional management of patients with multivessel coronary artery disease.


Assuntos
Doença da Artéria Coronariana/cirurgia , Revascularização Miocárdica/métodos , Intervenção Coronária Percutânea/métodos , Idoso , Doença da Artéria Coronariana/mortalidade , Oclusão Coronária/cirurgia , Feminino , Oclusão de Enxerto Vascular/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/mortalidade , Intervenção Coronária Percutânea/mortalidade , Viés de Publicação , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Regressão , Reoperação , Fatores de Risco , Stents
20.
EuroIntervention ; 10(10): 1178-86, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25244683

RESUMO

AIMS: To create awareness of, to summarise and to classify "Slender TRI": any technique associated with less trauma to the radial artery compared to traditional, established or recommended procedures, predominantly by reduction of French (Fr) size. METHODS AND RESULTS: A literature search was conducted to identify publications on Slender transradial coronary interventions. Based on this search the following techniques will be described: miniaturisation of materials, sheathless coronary intervention, guideless coronary intervention and back-up-improving techniques. The European perspectives will be discussed. CONCLUSIONS: Slender TRI is a new challenge to maximise patient value by improving outcome and reducing costs during TRI. Materials and techniques are continuously being refined and miniaturised to the highest standards. Whether outcome improves while reducing costs remains to be validated.


Assuntos
Desenho de Equipamento , Miniaturização , Intervenção Coronária Percutânea/instrumentação , Artéria Radial/anatomia & histologia , Europa (Continente) , Humanos , Japão , Tamanho do Órgão , Artéria Radial/lesões
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