Two-year results of an open-label randomized comparison of everolimus-eluting stents and sirolimus-eluting stents.

BACKGROUND: Second generation drug-eluting stents were developed to improve the safety and efficacy of first generation stents. So far, limited long term randomized data exist comparing the second generation everolimus-eluting stents (EES) with first generation sirolimus-eluting stents (SES). METHODS: A prospective, open-label, randomized, single center trial comparing EES and SES in all-comer patients. The primary endpoint was a composite of cardiac mortality, myocardial infarction and target vessel revascularization. Secondary endpoints included individual components of the composite, along with target lesion revascularization and stent thrombosis. RESULTS: In total, 977 patients were randomized, of which 498 patients to EES and 479 to SES. Average age was 65.2 ± 11.2 years and 71.6% of the population was male. Fifty percent of patients were treated for acute coronary syndrome, more often for ST-elevation myocardial infarctions in EES patients (13.7% vs. 9.2% in SES). In contrast, SES patients more often had prior interventions and showed more calcified lesions. Two-year follow-up was available in 98% of patients. The primary endpoint occurred in 10.7% of EES patients compared to 10.6% of SES patients (HR 1.00, 95% CI 0.68-1.48). Additionally, secondary endpoints were similar between groups. The rate of stent thrombosis was low for both stent types. CONCLUSION: In this all-comer population, there were no differences in endpoints between EES and SES during two-year follow-up. Stent thrombosis rates were low, supporting the safety of drug-eluting stent appliance in clinical practice. TRIAL REGISTRATION: TrialRegister.nl NTR3170.

Spontaneous adrenal haemorrhage in early pregnancy.

A 32-year-old primigravida presented at our emergency room at 6 weeks of gestation with acute severe right upper quadrant abdominal pain, radiating to the right flank. Vital signs were stable. Abdominal ultrasound showed a round inhomogeneous mass of 10 cm diameter behind the right kidney, suspected for adrenal haemorrhage. The patient was admitted for observation. An MRI showed some right-sided pleural effusion and a round mass in the adrenal region with no recognisable adrenal gland, therefore most likely originating from the right adrenal. After 10 days the patient was discharged with no change in size of the haematoma. MRI was carried out every 2 months which showed a decrease in size of the haematoma, with no other abnormalities. Based on stable MRI and the patient's preference, a vaginal delivery mode was chosen. At 37 weeks of gestation labour was induced, followed by an uncomplicated delivery.

Social burden and lifestyle in adults with congenital heart disease.

We aimed to evaluate how the presence and severity of congenital heart disease (CHD) influence social life and lifestyle in adult patients. A random sample (n = 1,496) from the CONgenital CORvitia (n = 11,047), the Dutch national registry of adult patients with CHD, completed a questionnaire on educational attainment, employment and marital statuses, and lifestyle (response 76%). The Utrecht Health Project provided a large reference group (n = 6,810) of unaffected subjects. Logistic regression models were used for subgroup analyses and to adjust for age, gender, and socioeconomic status where appropriate. Of all patients 51.5% were men (median age 39 years, interquartile range 29 to 51) with mild (46%), moderate (44%), and severe (10%) CHD. Young (<40-year-old) patients with CHD were more likely to have achieved a lower education (adjusted odds ratios [ORs] 1.6 for men and 1.9 for women, p <0.05 for the 2 comparisons), significantly more often unemployed (adjusted ORs 5.9 and 2.0 for men and women, respectively), and less likely to be in a relationship compared to the reference group (adjusted ORs 8.5 for men and 4.5 for women). These poorer outcomes were seen in all severity groups. Overall, the CHD population smoked less (adjusted OR 0.5, p <0.05), had more sports participation (adjusted OR 1.2, p <0.05), and had less obesity (adjusted OR 0.7, p <0.05) than the reference group. In conclusion, there was a substantial social disadvantage in adult patients with CHD, which was seen in all severity groups and primarily in young men. In contrast, adults with CHD had healthier lifestyles compared to the reference group.

Interobserver agreement on the radiological criteria of the International Panel on the diagnosis of multiple sclerosis.

We assessed the interobserver agreement on the radiological part of the International Panel (IP) criteria for the diagnosis of multiple sclerosis (MS), comprising the assessment of dissemination in space (DIS) and time (DIT) based exclusively on MRI. Four radiologists trained and four radiologists naive in the application of the IP criteria scored the fulfillment for DIS (i.e., > or =3 periventricular, > or =1 infratentorial, > or =1 juxtacortical, > or = 1 enhancing lesion or a total of > or =9 T2-weighted lesions) and DIT (presence of new or enhancing lesions at follow-up) in baseline and two follow-up scans from 20 patients suspected for having MS. The IP-trained radiologists agreed at least moderately on all assessments (kappa>0.40), whereas the IP-naive radiologists showed fair agreement (kappa<0.40) on five of 16 assessments. In the final conclusion on DIS and DIT, the IP-trained radiologists agreed substantially on both items (kappa=0.62 and kappa=0.60, respectively) compared with a fair agreement on DIS (kappa=0.29) and moderate agreement on DIT (kappa=0.52) among the IP-naive radiologists. Given the poor interobserver agreement among IP-naive observers, the new IP criteria for MS require additional training and should perhaps be simplified.

Uterine artery embolization in the treatment of symptomatic uterine fibroid tumors (EMMY trial): periprocedural results and complications.

PURPOSE: Uterine artery embolization (UAE) is an emerging treatment for symptomatic uterine fibroid tumors. This study was performed to evaluate the periprocedural results of the UAE procedure and identify risk factors for technical failure, fever after UAE, pain, and other complications. MATERIALS AND METHODS: As part of a multicenter, randomized trial to compare UAE versus hysterectomy in patients with symptomatic uterine fibroid tumors, 81 patients underwent UAE. Univariate and multivariate analyses were used to identify predictors for technical failure, postprocedural fever, complications as defined by the Society of Interventional Radiology (SIR), and pain scores. RESULTS: The technical failure rate according to SIR guidelines was 5.3% (95% CI, 2.3%-10.1%). The procedural failure rate was 17.3% (95% CI, 9.8%-27.3%). Bilateral failure occurred in four of 81 patients and unilateral failure occurred in 10 of 81 patients. Technical failure occurred mainly as a result of difficult anatomy (3.7%) or absence of the uterine artery (3.1%). The overall complication rates were 28.4% during the patients' hospital stay and 60.5% for the 6 weeks after discharge. The risk of technical failure was found to increase in the presence of a single fibroid tumor (odds ratio [OR], 6.21; 95% CI, 1.65-23.41; P = .007) and/or a small uterine volume (<500 cm(3); OR, 10.8; 95% CI, 1.25-93.36; P = .03). The amount of embolization material was associated with the onset of fever after UAE (OR, 2.05; 95% CI, 1.09-3.87; P = .027), major complications (OR, 5.68; 95% CI, 2.05-15.75; P = .001), and high pain scores (OR, 1.97; 95% CI, 1.08-3.58; P = .027). CONCLUSIONS: The procedural failure rate for UAE was higher than those reported by others, mainly as a result of difficult anatomy and absence of a uterine artery in some cases. The risk of procedural failure was increased for patients with single fibroid tumors and/or small uterine volumes. A clear dose-effect response was revealed between the amount of embolization material used and the risk for postprocedural fever, major complications, and severe pain.

How to exclude the dilated false lumen in patients after a type B aortic dissection? The cork in the bottleneck.

PURPOSE: To report techniques for excluding the dilated false lumen associated with chronic type B aortic dissection following placement of a stent-graft in the true lumen. CASE REPORTS: Two patients underwent stent-graft implantation for a dilated false lumen after chronic aortic dissection, but the false lumen was not excluded from the circulation by this procedure. The false lumen was obliterated in one case with Greenfield filters and detachable balloons placed above a renal artery orifice that was perfused via the false lumen. This acted like "a cork in the bottleneck" to block retrograde flow into the thoracic portion of the false lumen above the blockade. In the other patient, an occluder device was used as the "cork." In both cases, a good result was obtained. The occluder device is preferred because deployment is more controllable. CONCLUSIONS: An occluder device may be used like a cork in a bottle to exclude the dilated false lumen in the thoracic aorta after a type B dissection.

Fatal sepsis after uterine artery embolization with microspheres.

A case report of fatal sepsis after uterine artery embolization (UAE) with microspheres is presented. At autopsy, microspheres were found not only in arteries in the leiomyomata and myometrium but also in the parametria and the vagina, leading to a necrotic vaginal wall and uterine cervix. At present, polyvinyl alcohol particles are usually used in UAE. Recently, study results of the use of microspheres in embolization procedures have become available. The rationale for the choice of a specific embolization particle and the clinical implications of possible sepsis after UAE are discussed.