Quasi-real-time range monitoring by in-beam PET: a case for 15O.

A fast and reliable range monitoring method is required to take full advantage of the high linear energy transfer provided by therapeutic ion beams like carbon and oxygen while minimizing damage to healthy tissue due to range uncertainties. Quasi-real-time range monitoring using in-beam positron emission tomography (PET) with therapeutic beams of positron-emitters of carbon and oxygen is a promising approach. The number of implanted ions and the time required for an unambiguous range verification are decisive factors for choosing a candidate isotope. An experimental study was performed at the FRS fragment-separator of GSI Helmholtzzentrum für Schwerionenforschung GmbH, Germany, to investigate the evolution of positron annihilation activity profiles during the implantation of [Formula: see text]O and [Formula: see text]O ion beams in a PMMA phantom. The positron activity profile was imaged by a dual-panel version of a Siemens Biograph mCT PET scanner. Results from a similar experiment using ion beams of carbon positron-emitters [Formula: see text]C and [Formula: see text]C performed at the same experimental setup were used for comparison. Owing to their shorter half-lives, the number of implanted ions required for a precise positron annihilation activity peak determination is lower for [Formula: see text]C compared to [Formula: see text]C and likewise for [Formula: see text]O compared to [Formula: see text]O, but their lower production cross-sections make it difficult to produce them at therapeutically relevant intensities. With a similar production cross-section and a 10 times shorter half-life than [Formula: see text]C, [Formula: see text]O provides a faster conclusive positron annihilation activity peak position determination for a lower number of implanted ions compared to [Formula: see text]C. A figure of merit formulation was developed for the quantitative comparison of therapy-relevant positron-emitting beams in the context of quasi-real-time beam monitoring. In conclusion, this study demonstrates that among the positron emitters of carbon and oxygen, [Formula: see text]O is the most feasible candidate for quasi-real-time range monitoring by in-beam PET that can be produced at therapeutically relevant intensities. Additionally, this study demonstrated that the in-flight production and separation method can produce beams of therapeutic quality, in terms of purity, energy, and energy spread.

Production and separation of positron emitters for hadron therapy at FRS-Cave M.

The FRagment Separator FRS at GSI is a versatile spectrometer and separator for experiments with relativistic in-flight separated short-lived exotic beams. One branch of the FRS is connected to the target hall where the bio-medical cave (Cave M) is located. Recently a joint activity between the experimental groups of the FRS and the biophysics at the GSI and Department of physics at LMU was started to perform biomedical experiments relevant for hadron therapy with positron emitting carbon and oxygen beams. This paper presents the new ion-optical mode and commissioning results of the FRS-Cave M branch where positron emitting 15O-ions were provided to the medical cave for the first time. An overall conversion efficiency of 2.9±0.2×10-4 15O fragments per primary 16O ion accelerated in the synchrotron SIS18 was reached.

Precision of the PET activity range during irradiation with10C,11C, and12C beams.

Objective. Beams of stable ions have been a well-established tool for radiotherapy for many decades. In the case of ion beam therapy with stable12C ions, the positron emitters10,11C are produced via projectile and target fragmentation, and their decays enable visualization of the beam via positron emission tomography (PET). However, the PET activity peak matches the Bragg peak only roughly and PET counting statistics is low. These issues can be mitigated by using a short-lived positron emitter as a therapeutic beam.Approach.An experiment studying the precision of the measurement of ranges of positron-emitting carbon isotopes by means of PET has been performed at the FRS fragment-separator facility of GSI Helmholtzzentrum für Schwerionenforschung GmbH, Germany. The PET scanner used in the experiment is a dual-panel version of a Siemens Biograph mCT PET scanner.Main results.High-quality in-beam PET images and activity distributions have been measured from the in-flight produced positron emitting isotopes11C and10C implanted into homogeneous PMMA phantoms. Taking advantage of the high statistics obtained in this experiment, we investigated the time evolution of the uncertainty of the range determined by means of PET during the course of irradiation, and show that the uncertainty improves with the inverse square root of the number of PET counts. The uncertainty is thus fully determined by the PET counting statistics. During the delivery of 1.6 × 107ions in 4 spills for a total duration of 19.2 s, the PET activity range uncertainty for10C,11C and12C is 0.04 mm, 0.7 mm and 1.3 mm, respectively. The gain in precision related to the PET counting statistics is thus much larger when going from11C to10C than when going from12C to11C. The much better precision for10C is due to its much shorter half-life, which, contrary to the case of11C, also enables to include the in-spill data in the image formation.Significance. Our results can be used to estimate the contribution from PET counting statistics to the precision of range determination in a particular carbon therapy situation, taking into account the irradiation scenario, the required dose and the PET scanner characteristics.

Dawning of the N=32 Shell Closure Seen through Precision Mass Measurements of Neutron-Rich Titanium Isotopes.

A precision mass investigation of the neutron-rich titanium isotopes ^{51-55}Ti was performed at TRIUMF's Ion Trap for Atomic and Nuclear science (TITAN). The range of the measurements covers the N=32 shell closure, and the overall uncertainties of the ^{52-55}Ti mass values were significantly reduced. Our results conclusively establish the existence of the weak shell effect at N=32, narrowing down the abrupt onset of this shell closure. Our data were compared with state-of-the-art ab initio shell model calculations which, despite very successfully describing where the N=32 shell gap is strong, overpredict its strength and extent in titanium and heavier isotones. These measurements also represent the first scientific results of TITAN using the newly commissioned multiple-reflection time-of-flight mass spectrometer, substantiated by independent measurements from TITAN's Penning trap mass spectrometer.

Measurement of Excitation Spectra in the

Excitation spectra of ^{11}C are measured in the ^{12}C(p,d) reaction near the η^{'} emission threshold. A proton beam extracted from the synchrotron SIS-18 at GSI with an incident energy of 2.5 GeV impinges on a carbon target. The momenta of deuterons emitted at 0° are precisely measured with the fragment separator (FRS) operated as a spectrometer. In contrast to theoretical predictions on the possible existence of deeply bound η^{'}-mesic states in carbon nuclei, no distinct structures are observed associated with the formation of bound states. The spectra are analyzed to set stringent constraints on the formation cross section and on the hitherto barely known η^{'}-nucleus interaction.

Is outdoor recreational activity an independent predictor of cardiovascular disease mortality - NHANES III?

BACKGROUND AND AIMS: To investigate if frequency of outdoor recreational activity (ORA) predicts cardiovascular disease (CVD) mortality, independent of serum 25(OH)D concentration. METHODS AND RESULTS: Baseline data on ORA and serum 25(OH)D, collected from 11,746 participants aged 30-90 years in the Third National Health and Nutrition Examination Survey during 1988-1994, were linked to the National Death Index for assessment of CVD deaths from baseline through December 2006. CVD mortality as a primary cause of death was assessed during a mean follow up of 12.9 (SD, 4.2) years. There were 1519 CVD deaths during follow up. A strong positive association was observed between frequency of ORA in the last month and serum 25(OH)D (p < 0.001). Compared to participants who did no ORA in the last month, the hazard ratio (HR) of CVD mortality was 0.72 (95% confidence interval 0.58-0.90) for those doing ORA 1-4 times, 0.64 (0.47-0.89) for 5-12 times, 0.70 (0.56-0.89) for 13-30 times and 0.63 (0.47-0.84) for ≥30 times (p-trend < 0.001), in a Cox proportional hazards regression model which included 25(OH)D and CVD risk factors. Serum 25(OH)D was inversely associated with CVD mortality (p-trend, 0.01) in this same model. CONCLUSIONS: An inverse association between ORA and CVD mortality was observed independent of 25(OH)D. The underlying mechanism for this association may not involve 25(OH)D hence, further studies are warranted to confirm and investigate the underlying mechanism.

BpiB05, a novel metagenome-derived hydrolase acting on N-acylhomoserine lactones.

The N-acyl-homoserine lactones (N-AHLs) play an important role in bacterial cell-cell signaling. Up to date, however, only a few different experimentally proven classes of N-AHL ring-cleaving enzymes are known. Here we report on the isolation and biochemical characterization of a novel hydrolase derived from the soil metagenome and acting on N-AHLs. The identified protein designated BpiB05 is weakly similar to hypothetical proteins from Bacteroides fragilis, the draft genomes of two Burkholderia species as well as a marine metagenomic ORF but is otherwise not similar to any known protein. BpiB05 was overexpressed in Escherichia coli as a 10× His-tagged fusion protein. The recombinant protein revealed a molecular weight of about 70kDa and was tested for its quorum quenching (QQ) activities using a lacZ-bioassay. Additional HPLC-MS analyses confirmed the lactonolytic activity of the purified protein in the presence of Ca²âº. Further tests suggested that BpiB05 strongly reduces motility in Pseudomonas aeruginosa, pyocyanin synthesis and biofilm formation in this microbe. Because BpiB05 is not distantly related to any of the currently known hydrolases it forms probably a novel group within the growing number of proteins acting on N-AHLs.

Metagenome-derived clones encoding two novel lactonase family proteins involved in biofilm inhibition in Pseudomonas aeruginosa.

Here we report the isolation and characterization of three metagenome-derived clones that interfere with bacterial quorum sensing and degrade N-(3-oxooctanoyl)-l-homoserine lactone (3-oxo-C(8)-HSL). By using a traI-lacZ gene fusion, the metagenome-derived clones were identified from a soil DNA library and analyzed. The open reading frames linked to the 3-oxo-C(8)-HSL-degrading activities were designated bpiB01, bpiB04, and bpiB07. While the BpiB07 protein was similar to a known lactonase, no significant similarities were observed for the BpiB01 and BpiB04 proteins or the deduced amino acid sequences. High-performance liquid chromatography-mass spectrometry analyses confirmed that the identified genes encode novel lactone-hydrolyzing enzymes. The original metagenome-derived clones were expressed in Pseudomonas aeruginosa and employed in motility and biofilm assays. All clones were able to reproducibly inhibit motility in P. aeruginosa. Furthermore, these genes clearly inhibited biofilm formation in P. aeruginosa when expressed in P. aeruginosa PAO1. Thus, this is the first study in which metagenome-derived proteins have been expressed in P. aeruginosa to successfully inhibit biofilm formation.

Assessment of publication bias for the surgeon scientist.

BACKGROUND: Publication bias occurs when statistically non-significant (negative) findings are not published. It can profoundly affect the results of systematic reviews and meta-analyses. METHODS: Qualitative and quantitative methods of detecting publication bias are described, including their advantages and disadvantages. RESULTS AND CONCLUSION: Accepted quality standards for the reporting of meta-analyses recommend assessment of publication bias, but currently there is no uniform standard for reporting. Quantitative methods are being used with increasing frequency. Authors should take steps to minimize publication bias, and use both qualitative and quantitative assessment methods to determine whether it is present.

Meta-analysis: antibiotic prophylaxis to prevent peristomal infection following percutaneous endoscopic gastrostomy.

BACKGROUND: Despite numerous guidelines recommending prophylactic antibiotics prior to percutaneous endoscopic gastrostomy, their use remains controversial. AIM: To conduct a systematic literature review and performed meta-analyses to determine the benefit of antibiotic prophylaxis for percutaneous endoscopic gastrostomy placement. METHODS: We performed a systematic literature review by searching healthcare databases and grey literature for randomized-controlled trials of antibiotic prophylaxis against wound infection after percutaneous endoscopic gastrostomy. Relative risks were calculated for individual trials and data pooled using fixed-effects model. Relative risk reduction, absolute risk reduction and number needed to treat were calculated and are reported with 95% confidence intervals. RESULTS: Ten randomized-controlled trials met the inclusion criteria and 1059 cases were pooled. Overall findings indicated that antibiotic prophylaxis resulted in a relative risk reduction of 64% and an absolute risk reduction of 15%. Number needed to treat to prevent one wound infection was 8. Cephalosporin prophylaxis was associated with a relative risk reduction of 64%, absolute risk reduction of 10% and number needed to treat of 10, whereas penicillin-based prophylaxis was associated with a relative risk reduction of 62%, absolute risk reduction of 13% and number needed to treat of 8. CONCLUSIONS: Antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy is effective in reducing the incidence of percutaneous endoscopic gastrostomy site wound infection. Based on sensitivity analyses, penicillin-based prophylaxis should be the prophylaxis of choice.

Systematic reviews and meta-analysis for the surgeon scientist.

BACKGROUND: Understanding of data-reporting methods is imperative for correct interpretation of the medical literature as well as for proper performance of future clinical research. Recent developments in biostatistics have greatly changed the types of statistical analyses used and the minimum quality standards that must be maintained. METHOD: Different types of review are described, including systematic review with and without meta-analysis. Minimum reporting standards, sources of bias, both quantitative and qualitative, and references are discussed. RESULTS AND CONCLUSION: Meta-analysis has become a clearly defined technique, with reporting standards for both randomized controlled trials and observational studies. It is assuming a wider role in the surgical literature. Although many sources of bias exist, there are clear reporting standards and readers should be aware of these when studying the literature.

Diagnosis and treatment frequency for overweight children and adolescents at well child visits.

Obesity in children is a rapidly growing problem and may be underrecognized by pediatricians. We reviewed 473 consecutive well child visits to assess frequency of correctly identifying overweight children. Of children with a body mass index greater than the 95th percentile for gender and age, only 27 (29%) were diagnosed as overweight by the physician. Our results suggest that the frequency of diagnosing children as overweight at well child visits is critically low.

Predictors of acquiring a nosocomial bloodstream infection on extracorporeal membrane oxygenation.

PURPOSE: The aim of this study was to identify independent predictors of acquiring a nosocomial bloodstream infection (BSI) during extracorporeal membrane oxygenation (ECMO). METHODS: This retrospective cohort consisted of 202 neonates treated with ECMO from 1989 to 1998 at the author' institution. Data collected included patient demographics, primary and secondary diagnoses, white blood cell counts, antibiotic usage, presence of central lines, operative procedures, and outcome. Surveillance blood cultures were drawn daily from the circuit using sterile technique to identify acquired pathogens. Statistical analyses included logistic regression, Cox proportional regression analysis, and discriminate analysis. RESULTS: There were 1,245 blood cultures drawn on 202 patients (6.2 cultures per patient), and a nosocomial BSI was identified in 7 patients (3.4%) during this 10-year span. These were infections that were neither present nor incubating on admission. Pre-ECMO diagnoses of patients who had a nosocomial BSI while on bypass included group B beta-hemolytic streptococcal sepsis (n = 2), herpes simplex viral sepsis (n = 1), congenital diaphragmatic hernia (n = 2), persistent pulmonary hypertension (n = 1), and congenital heart disease (n = 1). The median time on ECMO before obtaining a positive culture was 390 hours. The infectious agents responsible for these BSIs included Staphylococcus epidermidis (n = 5), Staphylococcus aureus (n = 1), and Escherichia coli (n = 1). The major factor associated with acquiring a nosocomial BSI on ECMO was the duration of bypass (391 v 141 hours, P =.002). Additionally, patients in the BSI group were more likely to have had an arterial catheter in place (16 v 7 days, P =.009) and to have received more screening blood cultures (16 v 6 cultures, P < 001). White blood cell counts, absolute neutrophil counts, and immature/total (I/T) ratios were not useful in predicting a nosocomial BSI. Of the 31 patients who required ECMO for more than 10 days, 7 (23%) had a positive blood culture, and 5 of these 7 infants (71%) died (P =.03). CONCLUSIONS: The only predictor of acquiring a nosocomial BSI on ECMO was the duration of support for greater than 10 days. Because classical predictors of infection are unreliable while the patient is on ECMO, the authors suggest that obtaining daily surveillance blood cultures beginning on the tenth day should be performed with prolonged ECMO courses. The authors confirmed previous reports of the association between a prolonged ECMO course and a high mortality rate. However, the authors speculate that, in actuality, the primary diagnosis leads to the prolonged course of support and is the major factor in the infant' demise.

Espátulas rectas paralelas de Velasco: experiencia del servicio con un nuevo instrumento extractor del feto en el período expulsivo detenido / Velasco spatules: experience of the service with a new fetus extraction instrument

Se presentan las espátulas rectas y paralelas de Velasco (ERV), se describe el instrumento, sus características y se da a conocer una experiencia preliminar en un período de 3 años entre 1997 y 2000 y los resultados obtenidos en nuestro servicio de parto con fetos expulsivos detenidos y alteraciones de sus latidos cardíaco

Pulmonary edema develops after recurrent obstructive apneas.

There are anecdotal reports of pulmonary edema after a night of recurrent obstructive apneas (OAs) in humans, but no data on lung water, gas exchange, filling pressure, or cardiac output (Q) exist in these patients. By clamping the endotracheal tube of eight intubated, anesthesized dogs, we created repetitive OAs of 45-s duration at 30-s intervals, for 8 h. Five additional dogs without apneas, but identically instrumented, were studied simultaneously, serving as nonapneic controls. Sa (O(2)) was measured by intraarterial catheter, pulmonary capillary wedge pressure (Pcw), continuous cardiac output (Q), and mixed venous oxygen saturation (Sv(O(2))) were measured by flotation catheter. Basal and hourly hemodynamics and blood gases (arterial and venous) under steady state respiration were measured. Venous admixture (Q S/Q T) was calculated by standard equations. Pa(O(2)) from the beginning to the end of the experiment fell from 89.6 to 82.8 mm Hg in apneic animals and from 92.2 to 85.5 mm Hg in controls. The Q S/Q T increased in both groups but more so in the apnea group (3.3 to 19.4%) than in nonapneic controls (3.1 to 7.9%). Neither Q nor Pcw changed significantly in either group. Lung wet/dry weight was 5.40 +/- 0.93 in apneic animals and 5.00 +/- 0.67 in controls. Light microscopy showed gross alveolar fluid in three apneic dogs, and electron microscopy showed interstitial fluid in two additional apneic dogs. One of the lung edema dogs expired of acute heart failure in the seventh hour of the experiment. Worsening of gas exchange and histology suggest that lung edema can result from recurrent OAs.

The quality of medical evidence in hematology-oncology.

PURPOSE: The purpose of this study was to evaluate the quality of the medical evidence available to the clinician in the practice of hematology/oncology. METHODS: We selected 14 neoplastic hematologic disorders and identified 154 clinically important patient management decision/interventions, ranging from initial treatment decisions to those made for the treatment of recurrent or refractory disease. We also performed a search of the scientific literature for the years 1966 through 1996 to identify all randomized controlled trials in hematology/oncology. RESULTS: We identified 783 randomized controlled trials (level 1 evidence) pertaining to 37 (24%) of the decision/interventions. An additional 32 (21%) of the decision/interventions were supported by evidence from single arm prospective studies (level 2 evidence). However, only retrospective or anecdotal evidence (level 3 evidence) was available to support 55% of the identified decision/interventions. In a retrospective review of the decision/interventions made in the management of 255 consecutive patients, 78% of the initial decision/interventions in the management of newly diagnosed hematologic/oncologic disorders could have been based on level 1 evidence. However, more than half (52%) of all the decision/interventions made in the management of these 255 patients were supported only by level 2 or 3 evidence. CONCLUSIONS: We conclude that level 1 evidence to support the development of practice guidelines is available primarily for initial decision/interventions of newly diagnosed diseases. Level 1 evidence to develop guidelines for the management of relapsed or refractory malignant diseases is currently lacking.

Embarazo abdominal de tercer trimestre con feto vivo complicado con rotura prematura de membranas / Third trimester abdominal pregnancy with a living fetus and complicated with premature membranes rupture

Presentamos el caso clínico de la paciente SPR, portadora de una gestación intraabdominal de tercer trimestre, 34 + 2 semanas, con feto vivo, resuelta en nuestro servicio con éxito. Se extrajo recién nacido sano y se dejó la placenta in situ, como lo indica la experiencia de las escasas pacientes presentados en la cauística mundial. Se revisa la bibliografía nacional y mundial, y se destacan algunas de las conductas más importantes

Changing trends in esophageal cancer: a 15-year experience in a single center.

OBJECTIVE: Esophageal adenocarcinoma is increasing in white men. We sought to identify trends in esophageal cancer in different patient groups in our region. METHODS: We reviewed the records of all patients with esophageal cancer seen at two hospitals in Columbia, SC between 1981 and 1995. Patients were divided into three cohorts (1981-1985, 1986-1990, and 1991-1995). Demographic data, histological type, tumor stage, grade, and survival were recorded. RESULTS: Histology was available in 371 of 386 patients (cohort 1, 113 patients; cohort 2, 144; and cohort 3, 114). Adenocarcinoma accounted for 24%, 27%, and 49% of esophageal cancer in white men in cohorts 1, 2, and 3, respectively (p = 0.03). Corresponding figures for African-Americans were 10%, 7%, and 3% (p = 0.22). Women comprised 8%, 14%, and 22% of patients with squamous carcinoma in the three cohorts (p = 0.03). Median survival for esophageal cancer was 6.0, 6.8, and 10.4 mo in cohorts 1, 2, and 3 (p = 0.0002). CONCLUSION: Adenocarcinoma is increasing in whites. Squamous carcinoma remains the predominant type in this region, seen mainly in African-Americans. Esophageal squamous carcinoma is increasing in women. The mean age at diagnosis of squamous carcinoma has decreased in whites. There is a trend toward improved survival in patients with esophageal cancer.

Ethnicity and decision-makers in a group of frail older people.

OBJECTIVE: To assess the relationship between ethnicity and decision-makers expressing healthcare wishes in a group of frail older persons enrolled in the Program of All-inclusive Care for the Elderly (PACE). DESIGN: A retrospective chart review of 1193 participants in the PACE program. SETTING: Program of All-inclusive Care for the Elderly, a comprehensive managed care demonstration program serving frail older participants at 10 sites across the nation. PARTICIPANTS: A total of 1193 older adults, all of whom met state criteria for nursing home level of care. Three hundred were non-Hispanic whites, 364 were black, 156 were Hispanic, and 288 were Asian. MEASUREMENTS: Demographic characteristics of the patients and the presence or absence of an alternative decision-maker; the characteristics of alternative decision-makers included the relationship to the participant as recorded in the patient's medical record. RESULTS: Ninety-one percent of white patients expressed their own healthcare wishes in contrast to only 85% of Hispanic, 83% of Asian, and 67% of black patients. An alternative decision-maker was identified for about 15% of Asians and Hispanics and for one-third of blacks, but only about 8% of whites had an alternative decision-maker. Black and Hispanic patients were most likely to have a daughter as an alternative decision-maker, Asians were most likely to have a son, and whites patients were most likely to have a spouse as an alternative decision-maker. Blacks, particularly black men, were the most likely to have a relative other than a spouse or child as an alternative decision-maker. CONCLUSIONS: In this population, we found significant ethnic variation in the person identified to be the decision-maker in a group of frail older people. Ethnic variation reflected sociodemographic as well as cultural differences. However, there are important limitations to this study, and caution should be used in extrapolating the results to other populations or in attributing the results to ethnicity alone. An awareness of cross-cultural patterns in identified or de facto decision-makers can be significant for healthcare workers when they approach patients and their families about issues surrounding end of life decisions.

Influence of gender on in-hospital clinical and angiographic outcomes and on one-year follow-up in the New Approaches to Coronary Intervention (NACI) registry.

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients-975 women and 1,880 men-who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p < 0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p < 0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p < 0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.