Validation of 1-year predictive score of long-term response to interferon-ß in everyday clinical practice multiple sclerosis patients.

BACKGROUND AND PURPOSE: The Rio score (RS) and the modified Rio score (MRS) are two scoring systems that can identify the early predictive factors of disability progression in relapsing-remitting multiple sclerosis (RRMS) patients treated with interferon-ß (IFN-ß). The objective of the study was to validate the usefulness of the RS and MRS in a large cohort of multiple sclerosis patients treated with IFN-ß in daily clinical practice. METHODS: The analysis included a cohort of RRMS patients treated with different formulations of IFN-ß for at least 1 year. The RS and MRS were used to classify the patients after 1 year of treatment. Multivariate analysis was performed to identify predictive variables of suboptimal response at 5 years, defined as Expanded Disability Status Scale confirmed progression or switching to a second-line therapy. RESULTS: Sixty-nine of 416 included patients were considered as suboptimal responders at 5-year evaluation. The possible score range was 0-3. A higher risk of suboptimal response was found for RS and MRS in the presence of ≥2 scores (hazard ratio 3.0, P = 0.002, and hazard ratio 5.0, P < 0.0001, respectively). CONCLUSIONS: Our study confirmed, in a daily clinical setting, that MRS had a better specificity and accuracy than RS in identifying the patients who will have a poor response to long-term IFN-ß treatment.

Prospective multicenter quality assessment of endotherapy of biliary stones: does center volume matter?

BACKGROUND AND STUDY AIMS: To study the effectiveness of endoscopic treatment for biliary stones in a large case list of patients treated in units with different experience and different workloads in a region of northern Italy. PATIENTS AND METHODS: We prospectively studied 700 patients undergoing endoscopic retrograde cholangiopancreatography or sphincterotomy, in 14 units (> or < 200 examinations/year), for their first treatment of biliary stones. The difficulty of the examinations, the results in terms of clearance of the stones, and the late outcomes (24 months) were recorded. A questionnaire (GHAA-9modified) was administered 24 hours and 30 days after the procedure to measure patient satisfaction. RESULTS: There were six units with a heavy workload and eight with a light schedule. There were 176 (25.1 %) difficult examinations (Schutz grades 3, 4, and 5). Stones were found in 580 (82.9 %) and were cleared in 504 of these patients (86.9 %). No differences were observed in the clearance of stones for the different groups of difficulty and high- and low-volume centers. Over the 24-month follow-up period, 96 patients (13.7 %) complained of recurrent symptoms and 44 (6.3 %) had proof of stones. In all, 603 questionnaires were evaluable and more than 80 % of patients expressed satisfaction. CONCLUSIONS: Our findings confirm the effectiveness of endoscopic treatment of biliary stones. However, the number of patients with symptoms (13.7) after 24 months, with or without persistence of stones, was not insignificant. It is feasible to record patient satisfaction, and in this series patients stated they were satisfied. Criticism mostly concerned pain control and explanations provided before the examination.

Surgical technique of mammosite RTS implant for accelerated radiation delivery in breast conserving surgery.

Breast conserving surgery followed by radiation therapy has been accepted as an alternative to mastectomy in the management of patients with early-stage breast cancer. Over the past decade there has been increasing interest in a variety of radiation techniques designed to treat only the portion of the breast deemed to be at high risk for local recurrence and to shorten the duration of treatment. This article describes the surgical technique of implant of a new device developed with the goal of making breast conserving therapy more widely adopted. Our preliminary results showed that breast conserving therapy, using high dose-rate brachytherapy delivered with this new device as the sole radiation modality, is both technically feasible and well tolerated by the patients with excellent cosmetic results. This new method seems to be an important step forward in the search for a more conservative treatment for women with breast cancer, and for providing a better quality of life.

Optic neuritis: diagnostic criteria application in clinical practice.

Optic neuritis (ON) refers to any inflammatory optic neuropathy. In clinical practice ON is mainly diagnosed by ophthalmologists and less frequently by neurologists. ON diagnostic criteria are included in the Classification of International Headache Society (IHS) and in other classification systems, both in neurological and ophthalmologic fields. The aims of this study were to verify the application of IHS ON diagnostic criteria in clinical practice and the role of the ocular pain qualitative aspects. We performed a partially retrospective (140 cases) and prospective (43 cases) study analysing the clinical characteristics of patients with ON. We observed retro orbital pain in a huge percentage of patients; it was provoked or spontaneous and worsened by eye movements. We found that the new IHS classification criteria (IHS 2004) do not fully satisfy the requirements for ON diagnosis. Further study is necessary to validate the diagnostic criteria of ON in clinical practice.

A prospective, randomized, controlled clinical trial of tissue adhesive (2-octylcyanoacrylate) versus standard wound closure in breast surgery.

BACKGROUND: Recent studies suggest that the use of tissue adhesive for closure of both traumatic lacerations and incisional surgical wounds leads to cosmetic outcome comparable to conventional sutures. To date, no studies have investigated tissue adhesive in breast surgery and costs. Our aim was to compare the tissue adhesive 2-octylcyanoacrylate (OCA) with standard suture in breast surgery. METHODS: A prospective randomized study was conducted in which 151 patients were assessed for eligibility, and 133 were randomly allocated to skin closure with OCA adhesive or monofilament suture. Cosmetic outcome with blinded assessment, wound management by the patients, complication rates, and economic outcome were recorded. RESULTS: There was no difference in cosmetic score in the 2 groups, nor in complications at the early, 6-month, and 1-year follow-up. Patient satisfaction with the wound closed with OCA was rated significantly higher when compared with standard suture (P <.0001). The application of the tissue adhesive was significantly faster than that for standard suture (P <.001). In economic terms total costs were less in the tissue adhesive group, mainly due to lower postoperative costs of physician and assistant services (P <.001). CONCLUSIONS: OCA is effective and reliable in skin closure for breast surgery, yielding similar cosmetic results to standard suture. OCA is faster than standard wound closure and offers several practical advantages over suture repair for patients. Cost analysis has found that OCA adhesive can significantly decrease health care costs.

Surgical approach to the intraabdominal infections.

AIM: The term intraabdominal infectioncomprises a broad of variety of pathological conditions which are characterized by signs of systemic infection as a response to an abdominal source of infection and ranges from a confined problem to a devastating disease regarding all organ systems. Septic abdomen is an interesting challenge in general surgery: to decide when and how to treat septic abdomen lacks of a general consensus and has not been standardized yet. METHODS: A total of 1 110 patients underwent surgical treatment for abdominal infection in a period of 10 years in the Department of Surgery of San Gerardo Hospital, Monza, Italy. We focused our attention on 94 patients who required re-exploration for residual or recurrent intra-abdominal infection. RESULTS: The procedure was associated with a mortality rate of 40%. The median number of re-explorations was 5.1. CONCLUSION: Planned multiple relaparotomies with temporarily abdomen closure are performed only in a selected high mortality risk group of elderly patients with surgical evidence of diffuse peritonitis, presence of primary infectious process of more than 72 hours, and a APACHE II score > 20. Relaparotomy on demand is required instead in those patients who develop a clinical deterioration after a first safe surgical control of the source of infection. Lack of improvement is not considered a condition to reoperate. Early detection of persisting infection, < 24-36 hours, is an important prognostic factor of outcome.

Surgical removal of subfoveal choroidal neovascular membranes in high myopia.

BACKGROUND: A study was carried out to elucidate the anatomical and functional outcome after surgical excision of subfoveal choroidal neovascular membranes in high myopia. METHODS: Sixty-five patients with high myopia (> or =6 diopters), well-defined subfoveal neovascular membranes on fluorescein angiography and preoperative visual acuity < or =20/100 were selected for surgery. A standardized surgical technique was used in all cases, by a single surgeon. The main outcomes assessed were Snellen visual acuity, surgical retinal pigment epithelium defect and postoperative perfusion of the choriocapillaris. Multifactor analysis of variance and chi-square/Fisher's exact test statistics were used to assess the association between patients' pre- and postoperative characteristics and outcome measures. RESULTS: Follow-up ranged from 6 to 48 months (mean 16 months). Mean postoperative visual acuity (0.18) was significantly better than mean preoperative visual acuity (0.09). Visual acuity improved by at least two lines in 29 eyes (45%) and was unchanged in 24 (37%). Overall, 43 eyes (66%) had visual acuity of 20/200 or better and 15 (23%), 20/60 or better. Predictive factors with a significant effect on final visual acuity were mean visual acuity, preoperative status of retinal pigment epithelium and postoperative perfusion of the choriocapillaris. Postoperative perfusion was detected in 31 (48%) of the total 65 eyes and in 12 (67%) of the 18 eyes with normal retinal pigment epithelium at baseline. The mean postoperative retinal pigment epithelium defect was 4.6 times larger than the original neovascular membrane. In selected patients, SLO macular scotometry showed areas of retained retinal sensitivity within the atrophic scar. CONCLUSION: The natural history of subfoveal neovascularization in high myopia is rarely visually restorative. By contrast, surgical excision of the membranes is feasible and may restore visual acuity in selected patients. This therapeutic approach merits a formal multicenter clinical trial.

Surgical removal of idiopathic, myopic and age-related subfoveal neovascularization.

BACKGROUND: We investigated the functional outcomes of macular surgery for idiopathic, myopic and age-related subfoveal neovascular membranes and looked for preoperative features associated with better final visual acuity (VA). METHODS: We retrospectively studied 61 patients who had undergone macular surgery in our department between October 1992 and September 1994. Follow-up ranged from 5 to 27 months. Of 61 eyes with subfoveal neovascularizations, 6 were idiopathic, 21 had high myopia (-13 D median) and 34 displayed age-related macular degeneration (AMD). Median preoperative VA was 5/200 in AMD, 20/300 in myopia and 20/200 in idiopathic cases. RESULTS: Four of the six eyes with idiopathic subfoveal neovascularization had VA 20/60 or better after a median follow-up of 18 months. Of the 21 eyes with high myopia, 10 (48%) improved and 13 (62%) were 20/200 or greater after a median follow-up of 12 months. Among the 34 eyes with AMD, VA improved in 7 (21%), but only 6 (18%) were 20/200 or better after a median follow-up of 7 months. Overall, complications included five retinal detachments, ten cataracts and an increase in size of the retinal pigment epithelium defect over the neovascular membrane of 2.3 +/- 0.8 times (mean +/- SD) in idiopathic eyes. 5.9 +/- 3.6 times in myopia and 19.5 +/- 12.2 times in AMD. Recurrence rates for idiopathic, myopic and age-related neovascular membranes were 33%, 19% and 18% respectively. Etiology (P = 0.035), initial VA in myopic eyes (P = 0.026) and initial size of the neovascular membranes in AMD (P = 0.025) were preoperative factors with a significant effect on final visual outcome. CONCLUSIONS: Surgical excision of subfoveal neovascular membranes yields different functional results depending on the underlying disease. Severe alteration of the retinal pigment epithelium-Bruch's membrane complex may be responsible for the poor visual outcomes in AMD.

Neoadjuvant chemotherapy in the treatment of recurrent glioblastomas (GBM).

We wondered whether second line chemotherapy in recurrent GBM patients might be useful for debulking the tumor mass and improving patient performance status to prepare the way for second surgical intervention. We have treated 18 recurrent glioma patients with high dose methotrexate (HDMTX) plus 5-fluorouracil (5FU). 5 Patients were responders, 6 had stable disease, and 7 disease progression. 5 patients, 3 PRs and 2 SDs, underwent a second operation after two chemotherapy cycles. Disease progression resumed at 11.5 +/- 7 weeks in the non reoperated patients, and at 32.6 +/- 9.3 weeks in the reoperated group from initiation of neoadjuvant treatment. Survival time in reoperated patients was 82.6 weeks. Although our experience with this policy is still limited, we believe that reoperation in selected recurrent GBM patients can be worthwhile.