Israel Medical Association Journal

Background: Early prenatal ultrasound is an important part of prenatal screening in Israel. No studies have described the rate of trisomy 21 [T21] identification at 14–17 weeks gestation.

Objectives: To describe the rate of T21 identification by transvaginal sonograms (TVS) at 14–17 weeks gestation. 

Methods: We conducted a historical prospective study. Since 1986, early TVS of 72,000 fetuses at 14–17 weeks gestation have been prospectively recorded together with prenatal screening data at a private ultrasound center (AL-KOL, Haifa). We calculated the fraction of T21 cases by dividing the total number of cases with abnormal sonographic findings by the total number of diagnosed T21 cases. We also examined the percentage of verified T21 cases that had completely normal prenatal screening tests prior to the early prenatal TVS, thus revealing the contribution of this examination to the existing prenatal screening. Fisher’s exact test was used to calculate odds ratios for each sonographic marker. 

Results: Of 137 T21 fetuses, 123 had sonographic markers on early TVS, yielding a prediction capability of at least 89.87%. Of all T21 cases, 14% had completely normal nuchal translucency/first-trimester screening prior to the abnormal 14–17 week TVS findings. Isolated abnormal sonographic findings, which were found to increase the risk for T21, were common atrioventricular septal canal (odds ratio 88.88), duodenal atresia (OR 88.23), nuchal edema (OR 39.14), and hydrocephalus (OR 15.78). Fetal hydronephrosis/pyelectasis was non-significant when isolated (OR 1), and cardiac echogenic focus was associated with a decreased risk (OR 0.13).

Conclusions: Early prenatal TVS at 14–17 weeks may identify almost 90% of T21 and adds 14% to the identification rate at the first-trimester screening.

 

Background: Radiotherapy to the prostate bed is used to eradicate residual microscopic disease following radical prostatectomy for prostate cancer. Recommendations are based on historical series. 

Objectives: To determine outcomes and toxicity of contemporary salvage radiation therapy (SRT) to the prostate bed. 

Methods: We reviewed a prospective ethics committee-approved database of 229 patients referred for SRT. Median pre-radiation prostate-specific antigen (PSA) was 0.5 ng/ml and median follow-up was 50.4 months (range 13.7–128). Treatment was planned and delivered using modern three-dimensional radiation techniques. Mean bioequivalent dose was 71 Gy (range 64–83 Gy). Progression was defined as two consecutive increases in PSA level > 0.2 ng/ml, metastases on follow-up imaging, commencement of anti-androgen treatment for any reason, or death from prostate cancer. Kaplan-Meier survival estimates and multivariate analysis was performed using STATA. 

Results: Five year progression-free survival was 68% (95%CI 59.8–74.8%), and stratified by PSA was 87%, 70% and 47% for PSA < 0.3, 0.3–0.7, and > 0.7 ng/ml (P < 0.001). Metastasis-free survival was 92.5%, prostate cancer-specific survival 96.4%, and overall survival 94.9%. Low pre-radiation PSA value was the most important predictor of progression-free survival (HR 2.76, P < 0.001). Daily image guidance was associated with reduced risk of gastrointestinal and genitourinary toxicity (P < 0.005). 

Conclusions: Contemporary SRT is associated with favorable outcomes. Early initiation of SRT at PSA < 0.3 ng/ml improves progression-free survival. Daily image guidance with online correction is associated with a decreased incidence of late toxicity.

 

Background: Anti-BLyS treatment with the human belimumab monoclonal antibody was shown to be a safe and effective therapeutic modality in lupus patients with active disease (i.e., without significant neurological/renal involvement) despite standard treatment.

Objectives: To evaluate the “real-life” safety and efficacy of belimumab added to standard therapy in patents with active lupus in five Israeli medical centers.

Methods: We conducted a retrospective open-labeled study of 36 lupus patients who received belimumab monthly for at least 1 year in addition to standard treatment. Laboratory tests (C3/C4, anti dsDNA autoantibodies, chemistry, urinalysis and complete blood count) were done every 3–4 months. Adverse events were obtained from patients’ medical records. Efficacy assessment by the treating physicians was defined as excellent, good/partial, or no response.

Results: The study group comprised 36 lupus patients (8 males, 28 females) with a mean age of 41.6 } 12.2 years. Belimumab was given for a mean period of 2.3 } 1.7 years (range 1–7). None of the patients discontinued belimumab due to adverse events. Four patients (11.1%) had an infection related to belimumab. Only 5 patients (13.9%) stopped taking belimumab due to lack of efficacy. The response was excellent in 25 patients (69.5%) and good/partial in the other 6 (16.6%). Concomitantly, serological response (reduction of C3/C4 and anti-dsDNA autoantibodies) was also observed. Moreover, following belimumab treatment, there was a significant reduction in the usage of corticosteroids (from 100% to 27.7%) and immunosuppressive agents (from 83.3% to 8.3%).

Conclusions: Belimumab, in addition to standard therapy, is a safe and effective treatment for active lupus patients.

Background: Silicone breast augmentation is a common cosmetic surgery. Previous case reports demonstrated lymphadenopathy in the presence of implant ruptures.

Objectives: To investigate the association between enlarged axillary lymph nodes and silicone implant ruptures as seen on breast magnetic resonance imaging (MRI).

Methods: Two groups were derived retrospectively from breast MRI reports in our institution for the period December 2011–May 2014. A search of our hospital records for "silicone" and "lymph node" was performed (group A), and the relationship between the presence of enlarged nodes and ruptures was evaluated. The prevalence of ruptures in the presence of nodes was calculated and the association between MRI imaging features and ruptures evaluated. A search for "silicone" and "implant rupture" was performed (group B) and, as for group A, the relationship between the presence of ruptures and nodes was evaluated and the prevalence of enlarged nodes in the presence of ruptures calculated.

Results: Group A comprised 45 women with enlarged nodes. Intracapsular ruptures were associated with nodes (P = 0.005), while extracapsular ruptures showed a trend of association with nodes (P = 0.08). The prevalence of ruptures in the presence of nodes was 31.4%. Nodes associated with ruptures showed a strong silicone signal (P = 0.008) and absent enhancement (P = 0.005). Group B comprised 73 women with ruptures. Enlarged nodes were associated with both intra- and extracapsular ruptures (P < 0.001 and P = 0.002 respectively). The prevalence of nodes in the presence of ruptures was 22.2%.

Conclusions: Enlarged axillary nodes were associated with ruptures in two groups of patients. This finding can guide clinical decisions when either enlarged nodes or ruptures are encountered in patients with silicone implants. The association between silicone lymphadenopathy and implant rupture raises concerns regarding the role of rupture in silicone-induced systemic disease.

 

Background: Early surgical correction of congenital heart malformations in neonates and small infants may be complicated by acute kidney injury (AKI), which is associated with higher morbidity and mortality rates, especially in patients who require dialysis. Glomerular filtration rate (GFR) is considered the best measurement of renal function which, in neonates and infants, is highly dependent on heart function. 

Objective: To determine whether measurements of creatinine clearance after open heart surgery in neonates and young infants can serve as an early indicator of surgical success or AKI.

Method: We conducted a prospective observational study in 19 neonates and small infants (body weight < 5 kg) scheduled for open heart surgery with cardiopulmonary bypass. Urine collection measurement of creatinine clearance and albumin excretion was performed before and during surgery and four times during 48 hours after surgery.

Results: Mean creatinine clearance was lowest during surgery (25.2 ± 4. ml/min/1.73 m2) and increased significantly in the first 16 hours post-surgery (45.7 ± 6.3 ml/min/1.73 m2). A similar pattern was noted for urine albumin which was highest during surgery (203 ± 31 µg/min) and lowest (93 ± 20 µg/min) 48 hours post-surgery. AKI occurred in four patients, and two patients even required dialysis. All six showed a decline in creatinine clearance and an increase in urine albumin between 8 and 16 hours post-surgery. 

Conclusions: In neonates and small infants undergoing open heart surgery, a significant improvement in creatinine clearance in the first 16 hours postoperatively is indicative of a good surgical outcome. This finding has important implications for the early evaluation and treatment of patients in the intensive care unit on the first day post-surgery.

 

Background: Laparoscopy has gradually become the gold standard for the treatment of non-palpable testicles (NPT), with different success and complication rates. 

Objectives: To evaluate outcomes of the one-stage laparoscopic orchiopexy for NPT in our department.

Methods: We retrospectively evaluated the medical files of patients who underwent laparoscopic orchidopexy with the identical technique. Only patients with at least one year follow-up were included. At follow-up we assessed the age (at surgery), follow-up time, laterality of testes, postoperative complications, testicular size and testicular localization. 

Results: Thirty-six consecutive patients, median age 16 months, underwent one-stage laparoscopic orchiopexy. Sixteen patients (44.4%) had peeping testis type, in 13 patients (36.1%) the testicle was located within 2 cm from the internal ring and in the remaining 7 patients (19.4%) it was detected > 2 cm from the internal ring. In six children (16.7%) dividing the spermatic vessels was performed in one stage with laparoscopic orchiopexy. In the remaining 30 patients (83.7%) a laparoscopic one-stage procedure was performed with preservation of the spermatic vessels. Testicular atrophy was observed in 2 cases (5.6%), and 6 patients (16%) had a relatively small testicle compared to the contralateral normal testicle at follow-up. Two patients (5.6%) presented with testicle positioning at the entrance area into the scrotum. None of the patients demonstrated hernia recurrence at follow-up. There was no difference in surgical outcome in children who had surgery with preservation of the spermatic vessels versus those who underwent orchiopexy with division of the spermatic vessels in one stage. 

Conclusions: Laparoscopic transection of the testicular vessels appeared to be safe in boys with high abdominal testes that did not reach the scrotum after laparoscopic high retroperitoneal dissection.