Updating national diagnostic reference levels for interventional cardiology and methodological aspects.

The aim of this study is to propose national diagnostic reference levels (DRL) for updating in the field of interventional cardiology and to include technical details to help plan optimization. Medical physics experts and interventional cardiologists from 14 hospitals provided patient dose indicators from coronary angiography and percutaneous coronary interventions. Information about X-ray system dose settings and image quality was also provided. The dose values from 30,024 procedures and 26 interventional laboratories were recorded. The national DRLs proposed for coronary angiography and percutaneous coronary interventions were respectively 39 and 78 Gy·cm2 for air kerma area product (PKA), 530 and 1300 mGy for air kerma at reference point (Ka,r), 6.7 and 15 min of fluoroscopy time and 760 and 1300 cine images. 36% of the KAP meters required correction factors from 10 to 35%. The dose management systems should allow these corrections to be included automatically. The dose per image in cine in reference conditions differed in a factor of 5.5. Including X-ray system dose settings in the methodology provides an insight into the differences between hospitals. The DRLs proposed for Spain in this work were similar to those proposed in the last European survey. The poor correlation between X-ray systems dose settings and patient dose indicators highlights that other factors such as operation protocols and complexity may have more impact in patient dose indicators, which allows a wide margin for optimization. Dose reduction technology together with appropriate training programs will be determinant in the future reduction of patient dose indicators.

Relationship between Urinary Level of Phytate and Valvular Calcification in an Elderly Population: A Cross-Sectional Study.

Pathological calcification generally consists of the formation of solid deposits of hydroxyapatite (calcium phosphate) in soft tissues. Supersaturation is the thermodynamic driving force for crystallization, so it is believed that higher blood levels of calcium and phosphate increase the risk of cardiovascular calcification. However several factors can promote or inhibit the natural process of pathological calcification. This cross-sectional study evaluated the relationship between physiological levels of urinary phytate and heart valve calcification in a population of elderly out subjects. A population of 188 elderly subjects (mean age: 68 years) was studied. Valve calcification was measured by echocardiography. Phytate determination was performed from a urine sample and data on blood chemistry, end-systolic volume, concomitant diseases, cardiovascular risk factors, medication usage and food were obtained. The study population was classified in three tertiles according to level of urinary phytate: low (<0.610 µM), intermediate (0.61-1.21 µM), and high (>1.21 µM). Subjects with higher levels of urinary phytate had less mitral annulus calcification and were less likely to have diabetes and hypercholesterolemia. In the multivariate analysis, age, serum phosphorous, leukocytes total count and urinary phytate excretion appeared as independent factors predictive of presence of mitral annulus calcification. There was an inverse correlation between urinary phytate content and mitral annulus calcification in our population of elderly out subjects. These results suggest that consumption of phytate-rich foods may help to prevent cardiovascular calcification evolution.

Cierre percutáneo de orejuela izquierda para prevención de fenómenos embólicos en fibrilación auricular: experiencia preliminar / Percutaneous closure of left atrial appendage with the amplatzer cardiac plug device in patients with atrial fibrillation: preliminary data

Introducción: Dentro de las complicaciones más importantes de la fibrilación auricular (FA) se encuentra el accidente vascular encefálico embólico (AVE), siendo la terapia anticoagulante oral (TACO) la principal herramienta para su prevención. Cerca de un 20 por ciento de los pacientes con FA presentan condiciones clínicas que impiden su uso. Como la orejuela izquierda (01) ha sido identificada como el principal sitio de formación de trombos en la FA no valvular, se ha postulado que su oclusión podría disminuir la incidencia de eventos embólicos en este tipo de pacientes. Con este objetivo se han desarrollado múltiples técnicas, tanto quirúrgicas como dispositivos percutáneos para el cierre de esta estructura. En esta publicación se presenta la experiencia del cierre percutáneo de la 01 en tres pacientes, con el uso del dispositivo Amplatzer Cardiac Plug (ACP). Métodos: Los tres pacientes tenían alto riesgo embólico y contraindicación para uso de TACO. El procedimiento se realizó en el laboratorio de hemodinamia, bajo guía radioscópica y ecocardiográfica, con anestesia general. Resultados: Se logró la oclusión completa de la 01 en todos los pacientes, realizando además el cierre de un foramen oval permeable (FOP) en uno de ellos. Uno de los pacientes presentó derrame pericárdico el cual requirió pericardiocentesis. Los pacientes no presentaron otras complicaciones. Luego de un seguimiento de 6 meses no se han evidenciado eventos embólicos en ninguno de ellos. Conclusión: En esta experiencia preliminar, hemos comprobado la factibilidad de la oclusión de la 01 con el uso del dispositivo Amplatzer Cardiac Plug, en pacientes con FA con alto riesgo embólico y malos candidatos a TACO.

Embolic Stroke is a major concern in patients with atrial fibrillation. Anticoagulant therapy is the preferred tool to prevent this complication, but some patients have contraindications to anticoagulation. Most of the thrombus originates at the left atrial appendage (LAA), so the closure of LAA could prevent embolization of thrombus. Three patients with high embolic risk and contraindication to anticoagulant therapy were treated at our institution with an occlude device of the LAA (Amplatzer Cardiac Plug). Implantation of the device was successful in all the patients; one had a hem pericardium and underwent pericardiocentesis without further consequences. Patients were discharged without anticoagulants. After 6 months of follow-up, no embolic complications have been reported. In this preliminary experience, we report the feasibility of the closure of LAA with the Amplatzer Cardiac Plug Device.

Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study.

OBJECTIVES: We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown. METHODS: The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points. RESULTS: At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure. CONCLUSIONS: In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.

Long-term results (three to five years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study.

OBJECTIVES: We sought to analyze the very late outcomes of patients treated for in-stent restenosis (ISR) according to treatment allocation and 10 prespecified variables. BACKGROUND: Long-term results (>2 years) of patients with ISR undergoing repeat coronary interventions are not well established. METHODS: The Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study compared these two strategies in 450 patients with ISR. A detailed systematic protocol was used for late clinical follow-up. RESULTS: At one-year follow-up (100% of patients), the event-free survival was similar in the two groups (77% stent implantation [ST] arm, 71% balloon angioplasty [BA] arm, log-rank p = 0.19). Additional long-term clinical follow-up (median 4.3 years, range 3 to 5 years) was obtained in 98.6% of patients. During this time 22 additional patients died (9 ST arm, 13 BA arm), 7 suffered a myocardial infarction (3 ST arm, 4 BA arm), 23 required coronary surgery (11 ST arm, 12 BA arm), and 9 underwent repeat coronary interventions (4 ST arm, 5 BA arm) (nonexclusive events). At four years the event-free survival was 69% in the ST arm and 64% in the BA arm (log-rank p = 0.21). Among the 10 prespecified variables, vessel size > or = 3 mm had a major influence on the clinical outcome at four years, with better results in the ST group (hazard ratio 0.51, 95% confidence interval 0.3 to 0.89, p = 0.016). CONCLUSIONS: Patients with ISR undergoing repeat interventions have a significant event rate at late follow-up. Continued medical surveillance should be continued after one year. Patients with large vessels have a better outcome after repeat stenting.

Early results of direct coronary stenting in consecutive patients when multivessel, complex, long lesions, and small vessels are included.

BACKGROUND: Direct coronary stenting is the dominant technique for coronary stent implantation, but previous randomized studies have strongly selected lesions to treat. To evaluate whether the results can be generalized to routine clinical practice, all consecutive patients with direct stenting in 15 hospitals were entered into a prospective registry. Single vessels and simple lesions, but also multivessel, complex and long lesions, and small vessels size (< or =2.5 mm) were included. Immediately results as well as clinical events within 30 days after the procedure were evaluated. METHODS: Between April and November 2002, direct coronary stenting was performed in 452 consecutive patients (559 lesions) at 15 sites. Stents edge-protected by "sleeves" (SOX technology, NIR Stent, Boston Scientific) or with short transitional edge protection (STEP technology, Multilink Stents, Guidant) were selected to minimize vessel injury outside the stent edges during balloon inflation/deployment. RESULTS: Stents were successfully implanted in 96% of lesions. Lesions were multivessel in 27%, type B2-C in 40%, very angulated in 28%, calcified in 18%, and longer than 20 mm in 10% of patients. Vessels were smaller than < or =2.5 mm in 27% of patients. Direct coronary stenting was unsuccessful in 25 lesions (24 patients) characterized by more unstable angina (p=0.07), more treated lesions (p<0.01), and more distal locations (p=0.001). Dissection occurred in 6% of patients, and one stent embolised. The 30-day follow-up period included 1 death (due to subacute occlusion), 11 (2.4%) acute myocardial infarctions (8 non-Q wave), and one stroke (following carotid surgery). CONCLUSIONS: Direct coronary stenting yielded excellent results at 30 days although some expanded indications will be included.

A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis.

OBJECTIVES: This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR). BACKGROUND: Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high. METHODS: We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events. RESULTS: Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting. CONCLUSIONS: In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.

[Clinical characteristics, prognosis, and variability in the management of non-ST-segment elevation acute coronary syndromes. Data from the PEPA registry]. / Perfil clínico, pronóstico y variabilidad en el tratamiento del síndrome coronario agudo sin elevación del segmento ST. Datos del registro PEPA.

OBJECTIVES: To assess the clinical characteristics and inter-hospital variability in the treatment and prognosis of patients with non-ST-segment elevation acute coronary syndromes. PATIENTS AND METHOD: Data from the PEPA study, a prospective registry that enrolled 4,115 patients in 18 Spanish hospitals, were analyzed. RESULTS: The mean age of the patients enrolled was 65 years, 33% were women, and 26% had diabetes. Large differences were observed in the clinical profile of patients admitted to different centers, especially relative the history of previous disease, prior coronary revascularization, and co-morbidity. Antiplatelet treatment was used in 93% of patients, heparin in 45%, beta-blockers in 42%, nitrates in 67%, and calcium antagonists in 46%. During hospitalization, exercise stress testing was performed in 37% of patients, coronary angiography in 32%, coronary angioplasty in 9%, and coronary surgery in 4%. Inter-hospital variability was minimal for the use of antiplatelet agents, wide for the use of heparin and beta-blockers, and huge for the use of revascularization procedures. Mortality and the incidence of death or myocardial infarction were 2.6% and 4.4% during hospitalization, and 4.6% and 8% at 3 months, with wide inter-hospital variability. These differences were not significant once adjusted for clinical characteristics and the treatment received at admission. CONCLUSIONS: Patients with non-ST-segment elevation acute coronary syndromes represent an heterogeneous group with a high incidence of complications. Pharmacologic and, especially, invasive treatment varies widely in different hospitals. These results underline the importance of correct initial risk stratification and uniform treatment following the recommendations of clinical guidelines.