Sirolimus-eluting Coronary Stent Research Articles

One-Year Clinical Outcomes of Dialysis Patients After Implantation With Sirolimus-Eluting Coronary Stents

The efficacy of sirolimus-eluting stents (SESs) has not been established in dialysis patients. This study was a non-randomized observational single-center registry in a community hospital: data for 80 consecutive dialysis patients who underwent percutaneous coronary intervention (PCI) with SES were compared with those of a historical group of consecutive 124 dialysis patients treated with bare-metal stents (BMS). After 1 year, the cumulative incidence of major adverse cardiac events (MACE), comprising cardiac death, nonfatal myocardial infarction, stent thrombosis, or target lesion revascularization (TLR), was 25.2% in the SES group and 38.2% in the BMS group (p=0.048). In multivariate analysis, use of SES remained an independent predictor of MACE at 1 year after PCI (risk ratio 0.70, 95% confidence interval 0.52-0.93, p=0.015). Rates of TLR were 21.7% in the SES group and 30.9% in the BMS group and (p=0.15). Subgroup analysis showed that use of SES was effective in patients with small vessels, non-diabetic patients, and patients without highly calcified lesions. In dialysis patients, the implantation of SES was moderately effective in reducing MACE at 1 year after PCI as compared with BMS. However, the TLR rate at 1 year was relatively higher than previously reported.

Abstract 1691: Stages of Chronic Kidney Disease Correlate with Major Adverse Cardiac Events as well as Late Lumen Loss Following the Sirolimus Eluting Coronary Stent

Background: Chronic Kidney Disease (CKD) is considered as a risk factor for development of cardiovascular disease. However, it is unclear whether CKD has association with prognosis following the drug eluting stent implantation. Methods and Results : The Cypher coronary stents were implanted to 302 lesions in 249 patients who underwent elective PCI between January 2005 and April 2006. Average age was 66.3 ± 9.7 and male gender was 80.3%. Diabetes was found in 47% of the patients including 16% of insulin treatment. Stages of CKD are shown in the table 1 and 2 . AHA/ACC lesion type B2/C was 62%. Cypher stents were implanted at maximum pressure at 17.3 ± 3.0 atm. Intravascular ultrasound was used in 92% of the procedure. Clinical follow-up data were available in 89.9 % at 1 year although angiographic follow-up was performed in 73.1% at 8 months. Major adverse cardiac events were frequently observed in association with stages of CKD as shown in the table 1 . Stages of CKD have correlation with late lumen loss at 8 months (Table 2 ). Furthermore, in-stent late lumen loss inversely correlated with glomerular filtration rate (GFR) (R = −0.18, p = 0.0097). Conclusion : Stages of CKD have correlation with major adverse cardiac events as well as late lumen loss following the sirolimus eluting stent implantation. Clinical follow-up at 1 year of study stratified by stages of CKD Angiographic data of study stratified by stages of CKD

Long-Term Clinical Outcomes With Sirolimus-Eluting Coronary Stents: Five-Year Results of the RAVEL Trial

This study examined the clinical outcomes at 5 years in RAVEL (A Randomized Comparison of a Sirolimus-Eluting Stent With a Standard Stent for Coronary Revascularization), the first controlled trial of drug-eluting stents. The 6-month rate of angiographic coronary restenosis has been markedly lowered by sirolimus-eluting stents (SES). The long-term performance of drug-eluting stents, however, is under close scrutiny. The trial included 238 patients (mean age 60.7 +/- 10.4 years, 76% men) with a single, de novo native coronary artery lesion, randomly assigned to treatment with SES versus bare-metal stents (BMS). Rates of major adverse cardiac events (MACE), defined as all-cause mortality, myocardial infarction, and percutaneous or surgical revascularization up to 5 years of follow-up, and rates of stent thrombosis were compared between the 2 treatment groups. Complete datasets were available in 92.5% of patients treated with SES and 89.1% of patients assigned to BMS. The 1-, 3-, and 5-year rates of survival free from target lesion revascularization (TLR) were, respectively, 99.2%, 93.8%, and 89.7% in the SES group versus 75.9%, 75.0%, and 74.0% in the control group (p < 0.001; log-rank). Rates of all MACE at 5 years were 25.8% in patients treated with SES versus 35.2% in patients assigned to BMS (p = 0.03; log-rank). Rates of stent thrombosis, per protocol or by the Academic Research Consortium definitions, were similar in both groups. The 5-year rate of TLR associated with SES was significantly lower than that with BMS. There was no apparent adverse effect associated with the use of SES, although the trial was not powered to examine uncommon complications.

Long-Term Clinical Follow-up of Sirolimus-Eluting (CYPHER™) Coronary Stents in the Treatment of InStent Restenosis in an Unselected Population

Randomised trials in a highly selected patient population have demonstrated a dramatic reduction in the incidence of in-stent restenosis (ISR) following implantation of sirolimus-eluting (S-E) Cypher coronary stents compared with bare metal stents (BMS). The clinical outcome following implantation of S-E stents for treatment of complex, unselected BMS ISR is less well defined. The aim of this study was to assess the safety and efficacy of S-E coronary stents in the treatment of an unselected population of BMS ISR. All patients who received S-E stents for treatment of BMS ISR from May 1 2002-November 30 2003 at a single institution were entered into a prospectively collected database. In-hospital and long-term outcomes were collected. Sixty patients were identified who received S-E stents for the treatment of ISR. Four patients (6%) had undergone previous brachytherapy and 22% were diabetic. The most common target vessel was the left anterior descending coronary artery (40%), and 6% of lesions were in saphenous vein grafts (SVGs). The mean reference diameter was 2.67+/-0.52 (range 1.75-4.0) mm and the mean lesion length was 16.22+/-11.46 (range 3-68) mm. There were no procedural or in-hospital major adverse cardiac events (MACE). Long-term follow-up was available in 59 patients (98%). The 12-month MACE rate (cardiac death, myocardial infarction or target lesion revascularisation) was 12% with a 7% percutaneous coronary intervention rate and a 7% coronary artery bypass graft rate. There were no cardiac deaths and two non-cardiac deaths. Of the seven patients who had clinical restenosis at 12 months, four had previously failed brachytherapy and three involved SVGs. In conclusion, the use of S-E stents appears safe and efficacious in the treatment of an unselected population of BMS ISR with results comparing favourably with historical controls. Further randomised studies are needed to delineate the optimal management of this high risk group of patients.

Isolated left pulmonary artery: Interventional stenting of a persistent fifth aortic arch

A few cases of isolated pulmonary artery have been successfully palliated by stenting the arterial duct using coronary stents. However, progressive luminal narrowing within the stent due to neointimal proliferation and peal formation is a considerable problem. We report the successful interventional palliation in a 7-week-old infant with isolated left pulmonary artery using sirolimus-eluting stents. In this unusual case, the isolated pulmonary artery was supplied by a duct-like remnant of a persistent fifth aortic arch, whereby the distal part of this vessel showed severe constriction. Implantation of two sirolimus-eluting coronary stents re-established good perfusion of the left pulmonary artery. Seven months after the procedure, echocardiography revealed that perfusion of the stented vessel and the left pulmonary artery was still very good. Stents eluting antimitotic agents also help to preserve the patency of small vessels in infants, and may be useful for ductal stenting.

The Sirolimus-eluting coronary stent in daily routine practice in Germany:

Drugeluting coronary stents (DES) are increasingly used during percutaneous coronary interventions (PCI). Due to limited budgets in Germany, no special reimbursement has been given for their use and therefore they were mainly used in selected patients. In order to determine the change in indications in patients treated with a Sirolimus-eluting stent (SES) in daily clinical practice between 2002 and 2005, we analysed data from a prospective multi-centre DES registry, the German Cypher Stent Registry. From April 2002 until September 2005, 11 507 patients at 132 hospitals, who received at least one SES during their PCI, were included. Between 2002 and 2005, the median age of patients increased from 63 years to 66 years (p for trend <0.0001), whereas the prevalence of prior coronary bypass surgery (p<0.0001) and prior PCI (p<0.001) significantly decreased. Initial presentation of patients was stable over time, with a small increase of patients treated for non-ST elevation myocardial infarction (p=0.05). We found a significant increase in the treatment of complex stenoses (p<0.0001) as well as an increase in the proportion of chronic total occlusions (p<0.01). There was a steady increase in the proportion of patients treated for de novo lesions (p<0.0001), which was accompanied by a relative decrease in the proportion of patients treated for in-stent restenosis (p<0.0001). Concerning interventional characteristics a significant increase in the length of SES implanted per lesion, the numbers of SES implanted per lesion as well as an increase of the proportion of patients treated for more than one stenosis during one intervention could be observed (all p<0.0001). There was a significant decrease in the use of glycoprotein II b/IIIa antagonists during the PCI (2002: 26.5 to 14.2% in 2005, p<0.0001). MACE rates until hospital discharge did not change significantly over time. Between 2002 and 2005 there were two trends in the use of SES: a) a significant increase in the use of SES for de novo lesions and b) a significant trend to use SES for longer lesions, smaller arteries, more complex lesions and more SES per lesion. In summary these findings indicate that still SES are mainly used in patients with lesions that are at high risk for restenosis.

Stent fracture and restenosis after placement of a drug-eluting device in the vertebral artery origin and treatment with the stent-in-stent technique

The authors report two cases of stent fracture and restenosis after placement of a drug-eluting device in the vertebral artery (VA) origin, and describe management of restenosis with the stent-in-stent technique. Two women, one 62 and the other 67 years of age, underwent stent placement in the VA origin to treat symptomatic and angiographically significant stenosis in this vessel. Sirolimus-eluting coronary stents (Cypher) were used in both cases. Four months after placement of the devices, the symptoms recurred. Follow-up angiography performed 5 months after insertion of the devices revealed a transverse stent fracture with separation of the fragments and severe in-stent restenosis in both cases. The restenoses were treated with reinsertion of coronary stents (Cypher and Jostent FlexMaster) by using the stent-in-stent technique. After stent reinsertion, the patients exhibited relief of symptoms. This paper is the first report of fracture in a drug-eluting stent and restenosis after stent placement in the VA origin. Restenosis caused by such a fracture can be managed successfully by performing the stent-in-stent maneuver. The physical properties of metallic devices, stent strut geometry, and anatomical peculiarities of the subclavian artery may be associated with stent fractures. Earlier follow-up angiography studies (within 6 months) are warranted.

Epidural Catheters and Drug-Eluting Stents: A Challenging Relationship

DRUG-ELUTING STENTS (DESs) have revolutionized the practice of invasive cardiology, and they have also significantly altered the management of the patient in the perioperative setting. The issue of thrombosis of DESs in the perioperative period has been previously addressed. 1 Murphy J.T. Fahy B.G. Thrombosis of sirolimus-eluting coronary stent in the postanesthesia care unit. Anesth Analg. 2005; 101: 971-973 Crossref PubMed Scopus (35) Google Scholar , 2 McFadden E.P. Stabile E. Regar E. et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004; 364: 1519-1521 Abstract Full Text Full Text PDF PubMed Scopus (1333) Google Scholar The etiology is hypothesized to be related to the systemic inflammatory response and hypercoagulable state 3 Mendoza C.E. Shah N. Virani S. Percutaneous coronary intervention before noncardiac surgery: More threat than benefit?. J Am Coll Cardiol. 2004; 43: 713 Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar in conjunction with the discontinuation of dual antiplatelet therapy (aspirin and clopidogrel). 4 Spahn D.R. Howell S.J. Delabays A. et al. Coronary stent and perioperative anti-platelet regimen: Dilemma of bleeding and stent thrombosis. Br J Anaesth. 2006; 96: 675-677 Crossref PubMed Scopus (41) Google Scholar Survival from coronary stent thrombosis episodes requires immediate cardiac interventions coupled with the administration of intravenous anticoagulant and antiplatelet agents. The situation becomes more complex if the patient received continuous neuraxial blockade intraoperatively. In this context, the key issue resides in balancing the risk of an epidural hematoma (anticoagulation) against the benefit of immediate coronary revascularization (percutaneous coronary interventions).

Sirolimus-eluting coronary stents: a review

The sirolimus-eluting coronary stent received CE Mark approval in Europe in April 2002. In the US, FDA approval followed in April 2003. Since the preliminary results from the First-in-Man feasibility study were presented, several randomized, controlled trials have documented the profound antiproliferative effects of sirolimus, a macrolide antibiotic and potent cytostatic inhibitor of smooth muscle cell proliferation. Subsequently, the body of clinical evidence was increased by the second wave of evidence from trials in more complex lesions (such as in-stent restenosis, small vessels, chronic total occlusions) and "high-risk" patients such as those with diabetes. More recently we have had the opportunity to compare the two commercially available drug-eluting stents following the presentation of data from six head-to-head trials. As a result of numerous single and multi-center, national and international studies in which the safety and efficacy of sirolimus-eluting coronary stents have been subjected to close scrutiny, the global interventional cardiology community now has a wealth of evidence in support of the use of this technology resulting in dramatically improved patient outcomes after percutaneous intervention.

The sirolimus-eluting coronary stent in clinical practice: impact of direct stenting versus stenting with balloon pre-dilatation.

When using bare metal stents (BMS), direct stenting (DS) has become an established method for percutaneous coronary interventions (PCI). If drug-eluting stents are used, DS is currently not recommended. We analysed the data of the German Cypher Stent Registry to evaluate current use and outcome of DS using the sirolimus-eluting stent (SES). 4,437 patients at 122 hospitals who received a single SES for one lesion and completed follow-up, were included. DS was performed in 1,727 (38.9%) of these patients. However, there was a wide range from 0% to 77.8% within the centres. The following factors were independently associated with the use of DS: degree of stenosis (per 10%) (p<0.0001), type C lesion (p<0.0001), three vessel disease (p<0.0001), age (per decade) (p<0.0001), target vessel = LAD (p=0.0029), diabetes mellitus (p=0.0222) and renal insufficiency (p=0.0260). There were no higher event rates for DS compared to predilatation from admission until the end of follow-up: death rates were 1.4% versus 1.9%, p=0.1854, TVR rates 7.9% versus 8.7%, p=0.3388 and TVR or MACCE rates 10.8% versus 12.1%, p=0.2088. This was confirmed after correction for confounding factors. In current clinical practice DS with the SES is performed within a very wide range at the different hospitals. Further predictors for the use of DS with the SES are similar to those known from BMS. DS with the SES in such selected patients seems to be safe and effective.

Revisão do stent coronário com eluição de sirolimus

O stent coronário com eluição de sirolimus foi aprovado pela CE Mark, na Europa, em abril de 2002, e nos Estados Unidos, pelo Food and Drug Administration (FDA), em abril de 2003. Desde os resultados iniciais do estudo de viabilidade First In Man (FIM), alguns trabalhos randomizados, controlados, documentaram o poder antiproliferativo do sirolimus, um antibiótico macrolídeo e potente inibidor citostático da proliferação de células musculares lisas. O benefício clínico aumentou após a segunda fase de estudos envolvendo lesões mais complexas (como reestenose intrastent, vasos pequenos, oclusões crônicas) e pacientes de alto risco, como os diabéticos. Recentemente, foi possível comparar os dois stents com liberação de fármacos comercialmente disponíveis nos Estados Unidos, em cinco estudos do tipo "cabeça a cabeça". Com o resultado de vários estudos multicêntricos e unicêntricos, nacionais e internacionais, em que a segurança e a eficácia do stent coronário com eluição de sirolimus foram avaliadas de forma minuciosa, hoje, a comunidade global de Cardiologia Intervencionista tem evidências para apoiar o uso dessa tecnologia, resultando em significativa melhora dos desfechos nos pacientes submetidos a intervenção coronária percutânea.

Pulmonary Capillary Bleeding in a Patient with Severe Left Ventricular Failure after Acute Myocardial Infarction under Anti-thrombotic Therapy

A 52-year-old man who was admitted for cardiogenic shock after acute myocardial infarction developed severe left ventricular dysfunction despite reperfusion therapy with coronary stents. After the 40th hospital day, he started to have cough and pulmonary infiltrates. Antimicrobial therapies and subsequent prednisolone for bronchiolitis obliterans organizing pneumonia were ineffective. Bronchoscopic examination revealed diffuse pulmonary bleeding and exudation of hemosiderin-containing macrophages in bronchial lavage fluid. Pulmonary capillary bleeding has been reported in the terminal stage of patients with mitral stenosis in the pre-cardiac surgery era. This complication reemerges in patients with severe heart failure receiving intensive anti-coagulation therapy after implanting a sirolimus-eluting coronary stent.

Cordis Corporation has announced the launch of its third-generation sirolimus-eluting coronary stent, Cypher Select Plus.

Cordis Corporation has announced the launch of its third-generation sirolimus-eluting coronary stent, Cypher Select Plus.

Cordis Corporations's third generation sirolimus-eluting coronary artery stent [Cypher Select Plus] is now available in many markets around the world,

Cordis Corporations's third generation sirolimus-eluting coronary artery stent [Cypher Select Plus] is now available in many markets around the world,

Superior 2-year REALITY-trial* results for the sirolimus-eluting coronary stent,

Superior 2-year REALITY-trial* results for the sirolimus-eluting coronary stent,

Postmarket Surveillance for Drug-Eluting Coronary Stents

The development and introduction of new medical devices have radically changed the practice of medicine. No area of medicine has been affected more than cardiology, with new devices facilitating the effective treatment of coronary artery disease (percutaneous coronary interventions [PCIs]/stents), valvular heart disease (mechanical and bioprosthetic valves), and electrophysiological disorders (pacemakers and automatic implantable cardiodefibrillators). In addition to fueling the growth of the medical device industry, this explosion of technology has driven the development of new medical subspecialties, eg, interventional cardiology and electrophysiology. Other areas of medicine, including orthopedics and general surgery, have witnessed similar transformations. The current regulatory pathway for a significant-risk first-in-class medical device is typically a long, expensive, and risky process, culminating in a pivotal trial designed to demonstrate safety and efficacy. The pivotal trial phase is typically the most time-consuming and costly phase of the process. In the United States, medical devices are regulated by the Center for Devices and Radiological Health at the Food and Drug Administration (FDA), which has been charged by Congress to seek the “least burdensome means” when determining the scope of data required to evaluate the safety and efficacy necessary for device approval.1 Thus, pivotal trials by intention are designed to select patient cohorts most likely to demonstrate procedural benefit while limiting patient/study subject risk within the shortest time frame that can provide meaningful data. The realities of logistics, time, and resources limit the size and duration of most new device trials to 800 to 1500 patients, limiting the power of these trials to detect events with an occurrence rate of <1%. Furthermore, pivotal trials are conducted by the most experienced physician operators at medical centers with sufficient patient volume and research infrastructure to recruit and conduct clinical studies. Some have questioned whether results obtained under these settings from such …

Progress in Percutaneous Heart Procedures Leads to Update in Clinical Guidelines

NOTING RECENT IMPROVEMENTS in devices, techniques, and medications, the cardiology community has updated guidelines for percutaneous coronary intervention (PCI)—just 4 years after publication of previous recommendations. Experts from the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions collaborated on the new guidelines, which were announced November 13 at the American Heart Association’s Scientific Sessions in Dallas (http://www .americanheart.org/presenter.jhtml ?identifier=3035436). PCI is performed about 1 million times annually in the United States. Fueling the 2005 revisions is the rapidly increasing use of drug-eluting stents, said Ted Feldman, MD, a member of the guideline writing committee. Feldman is professor of medicine at Northwestern University Feinberg School of Medicine in Chicago and director of the cardiac catheterization laboratory at Evanston Hospital in Evanston, Ill. He has received research grants and honoraria from drugeluting stent manufacturers. Since the 2001 guidelines were released, the Food and Drug Administration has approved two drug-eluting stents—in 2003, the Cypher sirolimuseluting coronary stent by Cordis Corporation, Miami Lakes, Fla, and in 2004, the Taxus Express paclitaxel-eluting coronary stent system, by Boston Scientific Corporation, Natick, Mass. “Their use in many settings and the data we’ve gathered from clinical trials show their benefit compared with bare-metal stents in a variety of patient subsets,” said Feldman. He added that even though the new devices could achieve superior efficacy and outcomes, the committee could not makeablanket recommendationofdrugeluting over bare-metal stenting for all patients because rigorous studies comparing the two types of stent have yet to be attempted or completed for all conditions. Feldman says that once such research is published, it is likely that drugeluting stents will be recommended for many more patients.

Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease: Meta-analysis of Randomized Trials

CONTEXT: Placement of sirolimus-eluting stents or paclitaxel-eluting stents has emerged as the predominant percutaneous treatment strategy in patients with coronary artery disease (CAD). Whether there are any differences in efficacy and safety between these 2 drug-eluting stents is unclear. OBJECTIVE: To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials. DATA SOURCES: PubMed and the Cochrane Central Register of Controlled Trials, conference proceedings from major cardiology meetings, and Internet-based sources of information on clinical trials in cardiology from January 2003 to April 2005. STUDY SELECTION: Randomized trials comparing the sirolimus-eluting stent with the paclitaxel-eluting stent in patients with CAD reporting the outcomes of interest (target lesion revascularization, angiographic restenosis, stent thrombosis, myocardial infarction [MI], death, and the composite of death or MI) during a follow-up of at least 6 months. DATA EXTRACTION: Two reviewers independently identified studies and abstracted data on sample size, baseline characteristics, and outcomes of interest. DATA SYNTHESIS: Six trials, including 3669 patients, met the selection criteria. No significant heterogeneity was found across trials. Target lesion revascularization, the primary outcome of interest, was less frequently performed in patients who were treated with the sirolimus-eluting stent (5.1%) vs the paclitaxel-eluting stent (7.8%) (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.49-0.84; P = .001). Similarly, angiographic restenosis was less frequently observed among patients assigned to the sirolimus-eluting stent (9.3%) vs the paclitaxel-eluting stent (13.1%) (OR, 0.68; 95% CI, 0.55-0.86; P = .001). Event rates for sirolimus-eluting vs paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (P = .62); 1.4% and 1.6%, respectively, for death (P = .56); and 4.9% and 5.8%, respectively, for the composite of death or MI (P = .23). CONCLUSIONS: Patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Rates of death, death or MI, and stent thrombosis were similar.

Thrombosis of Sirolimus-Eluting Coronary Stent in the Postanesthesia Care Unit

A 44-yr-old woman with a drug-eluting coronary stent placement two weeks before surgery suffered a myocardial infarction in the postanesthesia care unit immediately after hysterectomy. She had missed only one dose of aspirin and clopidogrel preoperatively. Early recognition of subacute stent thrombosis and urgent percutaneous coronary intervention probably prevented her death. In this case report, we highlight perioperative coronary stent issues and discuss their implications.

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents. Three-Year Results of the RAVEL Trial

Debido al rápido crecimiento en las habilidades sociales y emocionales tempranas, variaciones significativas en el desarrollo socioemocional comienzan tempranamente y pueden hacerse más fuertes a través del tiempo. Además, variables individuales y familiares pueden contribuir a incrementar estas diferencias entre niños de una misma edad. Este estudio examina la relación entre la percepción materna del desarrollo socioemocional infantil a los 12 meses de edad con la sensibilidad materna, el sexo y temperamento infantil, y el nivel socioeconómico familiar, y analiza cuál de estas variables predice dicha percepción. Un total de 90 niños y niñas fueron evaluados con sus madres al año de edad, con la Escala Social Emocional (Bayley), el Infant Behavior Questionnaire (IBQ-R-VSF), la Evaluación de Sensibilidad del Adulto (ESA) y un cuestionario sociodemográfico. Los resultados mostraron que el mejor predictor de la percepción materna del desarrollo socioemocional infantil a esta edad era el temperamento del niño, específicamente la dimensión de extraversión.Because of the rapid growth in early social and emotional skills, significant variations in socioemotional development begin early and may become stronger over time. In adittion, individual and family variables may contribute to increase these differences among children of the same age. This study examined the relationship between maternal perception of infants’ social-emotional development at 12 months of age, maternal sensitivity, child's gender and temperament, and family's socioeconomic status, and analyzes which of these variables predict such perception. 90 boys and girls were assessed with their mothers at 1 year old with Bayley Social Emotional Scale, Infant Behavior Questionnaire (IBQ-R-VSF), Adult's Sensitivity Assessment (ESA), and a socio-demographic questionnaire. Results showed that the best predictor of maternal perception of infant socio-emotional development at this age was the child's temperament, specifically the dimension of extraversion.