A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial.

BACKGROUND: No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions. METHODS: Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. RESULTS: The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. CONCLUSIONS: A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.

SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel.

Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the true risk of radiation exposure from performing cardiac catheterization procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterization personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the fetus of pregnant women in the cardiac catheterization laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterization laboratory. However, radiation exposure among pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.

SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel.

Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the true risk of radiation exposure from performing cardiac catheterisation procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterisation personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the foetus of pregnant women in the cardiac catheterisation laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterisation laboratory. However, radiation exposure amongst pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.

Predictors of primary percutaneous coronary intervention delay in cases of myocardial infarction diagnosed in hospitals without hemodynamic support systems / Predictores de demora en el intervencionismo coronario percutáneo primario en el infarto de miocardio diagnosticado en hospitales sin hemodinámica.

OBJECTIVES: The need for primary percutaneous coronary intervention in hospitals without hemodynamic support capability is associated with delays between first medical contact (FMC) and reperfusion. It is important to identify factors involved in delays, particularly if they are relevant to the organization of emergency services. MATERIAL AND METHODS: Analysis of a registry of patients treated in hospitals without advanced hemodynamic support systems in a catchment area with an established care network for acute ST-segment elevation myocardial infarction (STEMI). The registry included care times. RESULTS: The network served 2542 patients with a mean (SD) age of 63 (13) years. FMC-to-reperfusion time was within 120 minutes in 42% of the cases. Nine of the hospitals had a chest-pain unit in the emergency department, and this factor was an independent predictor of FMC-to-reperfusion times of 120 minutes or less (odds ratio, 0.64; 95% CI, 0.54­0.77; P < .0001); the time was shortened by 11 minutes in such hospitals. FMC-to-reperfusion was delayed beyond 120 minutes in relation to the following factors: shock and need for intubation at start of care, age, gender, FMC at night, left bundle branch block, and Killip class. One-month and 1-year mortality rates increased in hospitals without hemodynamic support systems in proportion to reperfusion delay, by 1.7% and 3.5% if the delay was 106 minutes or less and by 7.3% and 12.4% if the delay was 176 minutes or longer (P < .0001). CONCLUSION: FMC-to-reperfusion time in STEMI exceeds recommendations in 58% of the hospitals without hemodynamic support systems and delay is inversely proportional to the availability of an emergency department chest pain unit. One-month and 1-year mortality is proportional to the degree of delay.

OBJETIVO: La indicación de intervencionismo coronario percutáneo primario (ICPP) en hospitales sin hemodinámica (HSH) se asocia con tiempos primera asistencia-apertura de la arteria (TPA) prolongados. Es pertinente identificar los factores implicados, especialmente aquellos relacionados con la organización de los servicios de urgencias. METODO: Análisis de un registro de pacientes atendidos en HSH en una región sanitaria con una red asistencial para infarto agudo de miocardio con elevación del segmento ST (IAMEST) establecida y de sus tiempos de actuación. RESULTADOS: En 2.542 pacientes, de edad 63 ± 13 años, se alcanzó un TPA 120 minutos en un 42% de casos. En 9 de los 16 HSH analizados existía un box de dolor torácico en el área de urgencias, que se comportó como factor predictor independiente de un TPA 120 minutos [OR 0,64 (IC 95% 0,54-0,77), p 0,001], con una reducción de 11 minutos de este. Se asociaron de forma independiente con un TPA superior a 120 minutos la intubación y shock durante la primera asistencia, edad, sexo, atención en horario nocturno, bloqueo de rama izquierda y la clase Killip. La mortalidad al mes y al año aumentó en los HSH proporcionalmente al TPA (1,7% y 3,5% si TPA 106 minutos y del 7,3% y 12,4% si TPA 176 minutos, p 0,001). CONCLUSIONES: El TPA alcanzado en activaciones procedentes de HSH supera las recomendaciones en el 58% de casos y se relaciona inversamente con la disponibilidad de un box de dolor torácico en urgencias. La mortalidad al mes y al año es proporcional al grado de retraso en la reperfusión.

The EXTREME registry: titanium-nitride-oxide coated stents in small coronary arteries.

OBJECTIVES: We sought to explore the immediate results of Titan2 stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow-up. BACKGROUND: The safety of Titan2 stent has been confirmed in several studies in real-life unselected populations. METHODS: We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0-2.75 mm). All lesions were treated with Titan2 stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow-up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, target lesion revascularization (TLR) during follow-up, and stent thrombosis. RESULTS: The mean age was 67.3 +/- 10.9 years (65.9% males). A total of 356 Titan2 stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in-hospital MACE or acute stent thrombosis was reported. Clinical follow-up was completed for an average of 8 +/- 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. CONCLUSIONS: Titan2 stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid-term follow-up.

Gender-based issues in interventional cardiology: a consensus statement from the Women in Innovations (WIN) Initiative.

Cardiovascular disease (CVD) is the leading cause of mortality in women, yet studies have suggested that it is often under-recognized. Of particular concern is the apparent suboptimal treatment of women in comparison to men, with less revascularization and use of evidence-based medications. The Women in Innovations group of cardiologists aims to highlight these issues and change perceptions to optimize the treatment of female patients with CVD, to support future research, and to encourage and guide the training of female interventional cardiologists.

Techniques and material used in the percutaneous treatment of chronic coronary occlusions. Data from the CIBELES study.

INTRODUCTION: In recent years, various specific techniques and materials have been developed for the treatment of coronary chronic total occlusions (CTO). OBJECTIVE: To evaluate the current situation in the treatment of CTO (techniques and material) in our setting. METHODS: We evaluated data on techniques and material used in the CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) trial, a randomized comparison of sirolimus- and everolimus-eluting stents in 207 patients with CTO in 13 centers in Spain and Portugal. RESULTS: A radial approach was used in 23% of patients, and retrograde techniques were used in only 5%. A high number of balloons were used (2.2±0.9 per patient). Microcatheters were used in 33% of patients, and post-dilatation balloons in only 25%. The mean number of stents implanted per patient was 2.1±1.0, with a mean total stent length of 49±24 mm. Other devices and techniques used were: Tornus penetration catheter in 4% of patients, rotational atherectomy in 2%, and cutting balloon in 1%. Intracoronary ultrasound was used in only 6% of patients. In 34% of cases, operators used guidewires that were not specifically for CTO. Considerable variability between centers was detected in the use of different techniques, the highest and lowest variability being observed in the use of intracoronary ultrasound and the use of CTO guidewires, respectively. CONCLUSIONS: In the CIBELES trial, techniques and devices specifically designed for the treatment of CTO were used in a relatively low proportion of patients. Considerable variability between centers was detected.

ACS and STEMI treatment: gender-related issues.

Cardiovascular disease is the leading cause of death amongst women, with acute coronary syndromes (ACS) representing a significant proportion. It has been reported that in women presenting with ACS there is underdiagnosis and consequent undertreatment leading to an increase in hospital and long-term mortality. Several factors have to be taken into account, including lack of awareness both at patient and at physician level. Women are generally not aware of the cardiovascular risk and symptoms, often atypical, and therefore wait longer to seek medical attention. In addition, physicians often underestimate the risk of ACS in women leading to a further delay in accurate diagnosis and timely appropriate treatment, including cardiac catheterisation and primary percutaneous coronary intervention, with consequent delayed revascularisation times. It has been acknowledged by the European Society of Cardiology that gender disparities do exist, with a Class I, Level of Evidence B recommendation that both genders should be treated in the same way when presenting with ACS. However, there is still a lack of awareness and the mission of Women in Innovation, in association with Stent for Life, is to change the perception of women with ACS and to achieve prompt diagnosis and treatment.

The occupational effects of interventional cardiology: results from the WIN for Safety survey.

AIMS: Interventional cardiologists are amongst the most intensive radiation users within medicine. To assess the implications of this usage, the "Women In Innovation" Group (WIN) created a web-based survey called "WIN for Safety" distributed through the European Association of Percutaneous Coronary Intervention (EAPCI) to all catheterisation laboratory healthcare professionals, enquiring about radiation protection measures, compliance with monitoring, health (orthopaedic issues), radiation-associated problems (cataracts and cancer) and restrictions imposed upon the pregnant female. METHODS AND RESULTS: In total, there were 615 participants: 72.8% were interventional cardiologists. Most (73.5%) of them were male and 63.3% were aged 31-50 years. A radiation collar badge was used by the majority (64.4%) and the most frequently utilised protective measure was the thyroid shield (87.2%). Potential illnesses related to radiation exposure included 19.5% orthopaedic problems (back/neck/hip pain), 5.5% varicose veins, 2.4% blood count problems and 2.0% cataracts. Notably, an association between orthopaedic problems and years of exposure was found (p=0.001). Overall, only 2.2% had ever been diagnosed with a cancer, with a trend for more females to be affected (4.4% vs. 1.8%; p=0.067). Finally, 62.1% have restrictions imposed upon the pregnant female in the working environment. CONCLUSIONS: Awareness of radiation in the field of interventional cardiology is essential. The main risk is orthopaedic problems and measures should be taken for prevention. Cancer has not been demonstrated to be a direct consequence; however, we should remain vigilant and monitor individuals.

[Analysis of reperfusion delay in patients with acute myocardial infarction treated with primary angioplasty based on first medical contact and time of presentation]. / Análisis de los tiempos de atención en pacientes con infarto agudo de miocardio tratados con angioplastia primaria según su procedencia y según el horario de realización del procedimiento.

INTRODUCTION AND OBJECTIVES: In primary angioplasty, the interval between first medical contact (FMC) and reperfusion should be less than 120 minutes. The time to reperfusion varies depending on where FMC is established. Recent studies suggest longer times in patients presenting in off-hours. The objective is to evaluate the time intervals between the onset of symptoms and reperfusion according to where the FMC occurs and time of day of patient presentation. METHODS: Prospective observational study of acute myocardial infarction patients treated with primary angioplasty (February 2007 to May 2009). Depending on the FMC, patients were classified as belonging to the hospital group (hospital with primary angioplasty), the transfer group (hospital without primary angioplasty), or the emergency medical system (EMS) group (out-of-hospital care). For each group, the prehospital delay, diagnostic delay, delay in activation and/or transfer, and procedure delay were recorded. RESULTS: Primary angioplasty was performed in 457 patients: 155 in the hospital group, 228 in the transfer group and 72 in the EMS group. The median [interquartile range] door-to-reperfusion times were 80 [63-107], 148 [118-189] and 81 [66-98] minutes, respectively (P<.0001). The transfer group showed a greater delay in diagnosis (P<.0001) and delayed activation and/or transfer (P<.0001). The EMS group had the shortest total time due to a reduced prehospital delay (P=.001). No difference was found with regard to the time of presentation (P=.42). CONCLUSIONS: Transfer group patients were treated later and EMS group patients much earlier. There were no differences in association with the time of presentation. The identification of inappropriate delays should enable the introduction of measures to improve the efficiency of treatment.

SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel.

Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the true risk of radiation exposure from performing cardiac catheterisation procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterisation personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the fetus of pregnant women in the cardiac catheterisation laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterisation laboratory. However, radiation exposure among pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.

Gender-based issues in interventional cardiology: a consensus statement from the Women in Innovations (WIN) initiative.

Cardiovascular disease is the leading cause of mortality in women yet studies have suggested it is often under-recognized. Of particular concern is the apparent suboptimal treatment of women in comparison to men, with less revascularization and use of evidence-based medications. The Women in Innovations group of cardiologists, aims to highlight these issues and change perceptions to optimize the treatment of female patients with cardiovascular disease, support future research, and encourage and guide the training of female interventional cardiologists.

Gender-based issues in interventional cardiology: a consensus statement from the Women in Innovations (WIN) initiative.

Cardiovascular disease (CVD) is the leading cause of mortality in women, yet studies have suggested that it is often under-recognized. Of particular concern is the apparent suboptimal treatment of women in comparison to men, with less revascularisation and use of evidence-based medications. The Women in Innovations group of cardiologists aims to highlight these issues and change perceptions to optimize the treatment of female patients with CVD, to support future research, and to encourage and guide training of female interventional cardiologists.

Análisis de los tiempos de atención en pacientes con infarto agudo de miocardio tratados con angioplastia primaria según su procedencia y según el horario de realización del procedimiento / Analysis of reperfusion delay in patients with acute myocardial infarction treated with primary angioplasty based on first medical contact and time of presentation

Introducción y objetivos. En la angioplastia primaria se recomienda un tiempo inferior a 120 min entre el primer contacto médico (PCM) y la reperfusión. El retraso hasta la reperfusión varía según dónde se realice el PCM. Estudios recientes señalan peores tiempos en horario de guardia. El objetivo es el análisis de distintos intervalos de tiempo hasta la reperfusión según dónde se produce el PCM y el horario de presentación. Métodos. Estudio prospectivo observacional de pacientes con infarto tratados con angioplastia primaria (febrero de 2007-mayo de 2009). Según el PCM, se diferenció: grupo Hospital (hospital con angioplastia primaria), grupo Traslado (hospital sin angioplastia primaria) y grupo SEM (sistema de emergencias médicas, atención extrahospitalaria). Para cada grupo se registró: retraso prehospitalario, retraso diagnóstico, retraso en activación y/o traslado y retraso en el procedimiento. Resultados. Se realizó angioplastia primaria a 457 pacientes, 155 en el grupo Hospital, 228 en el grupo Traslado y 72 en el grupo SEM. Las medianas [intervalo intercuartílico] del tiempo PCM-reperfusión fueron 80 [63-107], 148 [118-189] y 81 [66-98] min respectivamente (p<0,0001). El grupo Traslado presentó mayor retraso diagnóstico (p<0,0001) y retraso en activación y/o traslado (p<0,0001). El grupo SEM presentó el tiempo total más corto por tener un retraso prehospitalario menor (p=0,001). No se encontró diferencia según el horario de realización (p=0,42). Conclusiones. A los pacientes del grupo Traslado se los reperfundió más tardíamente y a los del grupo SEM, más precozmente. No hubo diferencias según el horario. La identificación de demoras injustificadas debe permitir adoptar medidas que mejoren la eficiencia del tratamiento (AU)

Introduction and objectives. In primary angioplasty, the interval between first medical contact (FMC) and reperfusion should be less than 120minutes. The time to reperfusion varies depending on where FMC is established. Recent studies suggest longer times in patients presenting in off-hours. The objective is to evaluate the time intervals between the onset of symptoms and reperfusion according to where the FMC occurs and time of day of patient presentation. Methods. Prospective observational study of acute myocardial infarction patients treated with primary angioplasty (February 2007 to May 2009). Depending on the FMC, patients were classified as belonging to the hospital group (hospital with primary angioplasty), the transfer group (hospital without primary angioplasty), or the emergency medical system (EMS) group (out-of-hospital care). For each group, the prehospital delay, diagnostic delay, delay in activation and/or transfer, and procedure delay were recorded. Results. Primary angioplasty was performed in 457 patients: 155 in the hospital group, 228 in the transfer group and 72 in the EMS group. The median [interquartile range] door-to-reperfusion times were 80 [63-107], 148 [118-189] and 81 [66-98] minutes, respectively (P <.0001). The transfer group showed a greater delay in diagnosis (P <.0001) and delayed activation and/or transfer (P <.0001). The EMS group had the shortest total time due to a reduced prehospital delay (P =.001). No difference was found with regard to the time of presentation (P =.42). Conclusions. Transfer group patients were treated later and EMS group patients much earlier. There were no differences in association with the time of presentation. The identification of inappropriate delays should enable the introduction of measures to improve the efficiency of treatment (AU)