Incidence of complications following 5-fluorouracil with trabeculectomies

To investigate the incidence of complications reportedly caused by the use of 5-fluorouracil (5-FU) in glaucoma filtering surgery, we performed trabeculectomy with 5-FU on 57 eyes of 56 patients with advanced glaucoma. The mean preoperative intraocular pressure was 34.8 mm Hg. The most frequent complication encountered was superficial punctate keratopathy (26%), followed by shallowing of the anterior chamber (12%), choroidal detachment (9%), and flap retraction (7%). We, however, did not encounter any cases of confluent corneal epithelial defect, subepithelial scarring, or striate melanokeratosis which are usually described with the use of 5-FU. With a mean follow-up of 7.1 months, an intraocular pressure less than 16 mm Hg without hypotensive therapy were achieved in 73.7% of cases, and less than 21 mm Hg without hypotensive therapy in 86%. Considering the low incidence of complications and the high success rate, we recommend the use of 5-FU in routine glaucoma filtering surgery.     

Suprachoroidal hemorrhage. Clinical features and results of secondary surgical management

PURPOSE: The purposes of this study are to identify clinical features in eyes with suprachoroidal hemorrhage which portend a poor visual prognosis and to determine visual outcome in these eyes after secondary surgical management of suprachoroidal hemorrhage. METHODS: This was a retrospective study of 106 patients with suprachoroidal hemorrhages occurring in association with trauma (35), cataract surgery (30), glaucoma surgery (17), penetrating keratoplasty (6), corneal perforation (5), secondary lens implantation (3), pars plana vitrectomy (3), and other causes (7). RESULTS: Five (10%) of 49 eyes with a suprachoroidal hemorrhage and an initial retinal detachment had a visual outcome of 20/200 or better compared with 21 (43%) of 49 eyes without a retinal detachment. The presence or absence or a retinal detachment could not be determined in eight patients and all eight of these patients had a poor visual outcome. Sixteen (20%) of 82 eyes with a 360 degrees suprachoroidal hemorrhage had a visual outcome of 20/200 or better compared with 10 (47%) of 21 for those with suprachoroidal hemorrhage limited to one or two quadrants. The extent of the hemorrhage could not be determined in three eyes. Overall, 34% (14/41) of the patients with suprachoroidal hemorrhage who had a secondary surgical procedure achieved a visual outcome of 20/200 or better. Forty-three percent (6/14) who had a suprachoroidal hemorrhage during or after cataract surgery and who were treated with secondary surgical management achieved a visual outcome of 20/200 or greater. CONCLUSION: Clinical features associated with a poorer visual outcome included initial or indeterminate retinal detachment and 360 degrees suprachoroidal hemorrhage. Limited suprachoroidal hemorrhage without initial retinal detachment usually has a good visual prognosis and does not usually require secondary surgical intervention. However, if the former complication is present, secondary surgical intervention should be considered.     

Survival of patients with carcinoma of the esophagus treated with combined-modality therapy

Since 1985, 229 cases of carcinoma of the esophagus have been considered for entry into a protocol with the use of preoperative chemotherapy and radiation therapy followed by surgical intervention as the primary element of treatment. One hundred sixty-five patients (93 with adenocarcinoma and 72 with squamous cell carcinoma) had esophagogastrectomy. The 5-year survival of the protocol patients who underwent resection was 25% for both groups--squamous cell carcinoma and adenocarcinoma. Of the protocol patients with squamous cell carcinoma who underwent resection, 40% had a sterilized specimen, whereas of those with adenocarcinoma, 20% had a sterilized specimen. If the patient had a sterilized specimen, the 5-year survival was approximately 60% for adenocarcinoma and 40% for squamous cell carcinoma. Those patients with adenocarcinoma and Barrett's esophagus had a 5-year survival of 55%. Of the patients who underwent only esophagectomy and esophagogastrectomy and had not been entered into the protocol, none lived beyond 3 years. The operative mortality rate for those who had esophagogastrectomy was 5%. Sixty-four patients completed the radiation therapy and chemotherapy but did not undergo surgical procedures because of progressive disease or refusal. Of those patients who completed chemotherapy and radiation therapy without surgical intervention, 5-year survival was 18% in patients with squamous cell carcinoma, whereas no patients with adenocarcinoma survived beyond 3 years. The finding of a sterilized specimen after esophagectomy is a favorable prognostic factor in patients with adenocarcinoma or squamous cell carcinoma. The finding that patients with Barrett's esophagus and adenocarcinoma have an improved chance for survival is perhaps related to an earlier diagnosis. It is clear that some patients with squamous cell carcinoma who did not undergo surgical procedures did have a sterilized specimen, because the survival in this group approached 20% at 5 years.     

Routine psychophysiological screening of 384 men with erectile dysfunction

BACKGROUND AND OBJECTIVE: To determine the efficacy of combined phacoemulsification--trabeculectomy in preventing early postoperative increases in intraocular pressure (IOP). PATIENTS AND METHODS: Eighty patients were enrolled in a prospective cohort study. Thirty-six patients with cataracts and uncontrolled glaucoma underwent combined phacoemulsification--trabeculectomy, and 44 patients with cataracts underwent phacoemulsification alone. The operations were performed in a standardized manner by one surgeon. IOP was measured at 4 hours, 1 day, and 7 days after surgery. The need for intervention (digital massage, medications) and the presence of complications were documented. RESULTS: Four hours after surgery, 5.5% of patients undergoing the combined procedure had IOPs greater than 30 mm Hg, compared with 22.7% of phacoemulsification patients (P < .05). No significant difference in IOP was found between the groups at postoperative day 1 or day 7. CONCLUSION: These results suggest that combined phacoemulsification-trabeculectomy protects against early postoperative elevations in IOP. This finding may influence the surgical management of cataracts in patients with poorly controlled glaucoma and significant compromise of visual field or optic nerve.     

Glaucoma drainage implants in pediatric patients

To assess the use of drainage implants in pediatric patients with glaucoma refractory to conventional medical and surgical therapy, we retrospectively reviewed 20 consecutive eyes in children 10 years of age or younger treated with 16 Molteno (three of which were removed and replaced with second Molteno shunts) and seven Baerveldt implants. The age of the patients ranged from 1 month to 10 years (mean, 3 years). The patients had undergone a mean of two previous failed glaucoma procedures (range, one to six). The mean intraocular pressure (IOP) prior to drainage tube implantation was 37 +/- 4 mm Hg, compared with a mean of 18 +/- 6 mm Hg following surgery, with average postoperative follow up of 25 months (range, 8 to 41 months). The overall success, defined as IOP < or = 21 mm Hg without further surgical therapy, was 80%. Postoperative glaucoma medications were required in 75% of patients. There were 23 complications, one of which resulted in decreased visual acuity. These findings demonstrate that drainage tube implants can be effective in lowering IOP in uncontrolled pediatric glaucomas. Patients often require postoperative glaucoma medications and close monitoring for complications.     

Relation of saphenous vein graft obstruction to serum cholesterol levels

Thirty patients with symptomatic colorectal carcinoma were commenced on treatment with 5-fluorouracil (2.5 g week-1) administered by continuous intravenous infusion and alpha 2b interferon (3 x 10(6) U s.c. three times a week). Six out of 30 patients (20%) achieved a partial response. Three patients (10%) had stable disease and 21 patients (70%) progressed on treatment. Twenty patients (67%) completed ten or more weeks of treatment. In nine patients, treatment was withdrawn after 2-9 weeks because of disease progression or death. One patient's treatment was interrupted by emergency surgery. The median survival for all patients was 210 days (7 months). The principal side-effects were oral mucositis (12/30 patients), nausea (8/30 patients) and transient diarrhoea (4/30 patients), and initial constitutional symptoms due to alpha 2b interferon. The combination of low-dose continuous infusional 5-fluorouracil and low-dose alpha 2b interferon is well tolerated but has no obvious advantage over alternative infusional regimens using 5-fluorouracil as a single agent.     

Management of ophthalmic complications of homocystinuria

OBJECTIVE: To determine the safety and efficacy of surgical versus medical management in the treatment of ophthalmic complications of homocystinuria, and also to document ocular complications of homocystinuria other than lens dislocation. DESIGN: Retrospective case series. PARTICIPANTS: Forty-five patients with ophthalmic complications of homocystinuria participated. INTERVENTION: Eighty-four surgical procedures were performed on 40 patients. There were 82 procedures done with the patients under general anesthesia and 2 with the patients under local anesthesia. Medical therapy was attempted initially in all patients with lens dislocation and was the sole therapy used for five patients. MAIN OUTCOME MEASURES: Complications resulting from medical or surgical treatment and final visual acuity were studied. RESULTS: All patients had a history of lens subluxation or dislocation. Fourteen (31%) were receiving dietary treatment at the time of presentation and 29 (64%) were mentally retarded. Eighty-two procedures were performed with the patients under general anesthesia with 2 surgical complications and 1 postsurgical complication. Lens dislocation into the anterior chamber was the most frequent indication for surgery (50%) followed by pupillary block glaucoma (12%). Prophylactic peripheral iridectomy was not successful in preventing lens dislocation into the anterior chamber in five patients. Anesthetic precautions such as stockings to prevent deep venous thrombosis, preoperative hydration, or aspirin were given in 85% of cases. Other common ophthalmic complications found include optic atrophy (23%), iris atrophy (21%), anterior staphylomas (13%), lenticular opacities (9%), and corneal opacities (9%). CONCLUSION: Laser iridectomy was unsuccessful in preventing lens dislocation into the anterior chamber. With appropriate anesthetic precautions and modern microsurgical techniques, the risks associated with the surgical management of ocular complications of homocystinuria are reduced. Surgical treatment should be considered, especially for cases of repeated lens dislocation into the anterior chamber or pupillary block glaucoma. If a conservative, nonsurgical approach is undertaken, these patients must be observed carefully for repeat episodes of lens dislocation.     

A long-term assessment of adjuvant chemotherapy on outcome of patients with extracapsular spread of cervical metastases from squamous carcinoma of the head and neck

BACKGROUND: Extracapsular spread (ECS) of cervical lymph node metastases of squamous cell carcinoma from head and neck sites portend poor prognosis. Therefore, a program of combined surgery, postoperative irradiation therapy, and adjuvant methotrexate and 5-fluorouracil (5-FU) was initiated in 1982 for such patients. METHOD: All patients operated on between June 1982 and December 1992 by the full-time faculty of the Department of Otolaryngology at the University of Pittsburgh School of Medicine were eligible and reported in this trial. All patients had negative surgical margins of excision of the primary carcinoma, and histologic evidence of cervical metastases with ECS. Postoperative irradiation included 50-60 cGy for 5 to 6 weeks followed by methotrexate and 5-FU administered on an outpatient basis on days 1 and 8 every 21 days. All patients were followed for 30 or more months for evidence of recurrent disease. RESULT: A total of 371 patients met eligibility criteria. Of this group, 53 (14%) were treated with surgery only, 187 (50%) received surgery and postoperative irradiation, and 131 (35%) received surgery, irradiation therapy, and chemotherapy. The primary site, extent of nodal involvement, and stage of the three patient groups were similar. However, performance status (Karnofsky) was best in the patients who received chemoradiation (average 90) when compared with those who received surgery and irradiation (average 80) or surgery only (average 70). Absolute disease free survival rate (30 months) was 9.5% in patients treated with surgery only, 34% in patients treated with surgery plus irradiation, and 53% in patients treated with surgery, irradiation, and chemotherapy. When adjusted for patients who died of intercurrent disease with less than 30 months follow-up, survival rates became 17%, 40%, and 58%, respectively. These differences are highly significant (P < 0.001). CONCLUSION: Results of this study suggest that postoperative chemoradiation may improve survival in patients with ECS of cervical metastases. Compliance with the chemoradiation was suboptimal and suggests that improved strategy must be developed.     

Direction of predator approach and the decision to flee to a refuge

PURPOSE: We report the local control and survival of two Phase I dose escalation trials of combined preoperative 5-fluorouracil (5-FU), low-dose leucovorin (LV), and radiation therapy followed by postoperative LV/5-FU for the treatment of patients with locally advanced and unresectable rectal cancer. METHODS AND MATERIALS: A total of 36 patients (30 primary and 6 recurrent) received two monthly cycles of LV/5-FU (bolus daily x 5). Radiation therapy (50.40 Gy) began on day 1 in the 25 patients who received concurrent treatment and on day 8 in the 11 patients who received sequential treatment. Postoperatively, patients received a median of four monthly cycles of LV/5-FU. RESULTS: The resectability rate with negative margins was 97%. The complete response rate was 11% pathologic and 14% clinical for a total of 25%. The 4-year actuarial disease-free survival was 67% and the overall survival was 76%. The crude local failure rate was 14% and the 4-year actuarial local failure rate was 30%. Crude local failure was lower in the four patients who had a pathologic complete response (0%) compared with those who either did not have a pathologic complete response (16%) or who had a clinical complete response (20%). CONCLUSION: Our preliminary data with the low-dose LV regimen reveal encouraging downstaging, local control, and survival rates. Additional follow-up is needed to determine the 5-year results. The benefit of downstaging on local control is greatest in patients who achieve a pathologic complete response.     

Occlusive ligature and standardized fenestration of a Baerveldt tube with and without antimetabolites for early postoperative intraocular pressure control

OBJECTIVE: To determine the effectiveness of a surgical modification for a nonvalved aqueous tube shunt in controlling intraocular pressure (IOP) in the early postoperative period. The effect of antimetabolite use on IOP also was studied. DESIGN: A retrospective study of consecutive patients who underwent modified Baerveldt 350-mm2 implant with varied, nonrandomized, exposure to antimetabolites. PARTICIPANTS: Fifty-one eyes of 46 patients with uncontrolled glaucoma were examined. INTERVENTION: Identical surgical modification of a Baerveldt 350-mm2 tube was performed in all cases and consisted of placement of an occlusive 7-0 polyglactin suture just anterior to the plate followed by a through-and-through penetration of the tube just anterior to the occlusive ligature with a standardized 15 degrees blade. Seventeen eyes were not exposed to antimetabolite, while 2 groups of 17 eyes had 3 minutes' episcleral exposure to either 5-fluorouracil 50 mg/ml or mitomycin C 0.4 mg/ml at the location corresponding to the fenestration. The Tenon's layer and conjunctiva were not exposed because of concerns regarding conjunctival erosion over the device. MAIN OUTCOME MEASURE: Intraocular pressure and number of antiglaucoma medications required were analyzed. RESULTS: For the group, mean IOP before surgery and on postoperative days 1, 4, 10, 21, 42, 63, 84, and 112 was (in millimeters of mercury) 34.6, 20.1, 17.0, 17.2, 22.0, 17.3, 18.7, 17.4, and 15.6, respectively. There was an elevation of IOP at day 21 relative to fibrotic blockage of the fenestration before suture autolysis. This was temporized with antiglaucoma medication until suture autolysis occurred or treated with laser suture lysis (8 eyes). On day 1, hypotony occurred in 3 (6%) eyes whereas IOP greater than 30 mmHg was observed in 13 (26%) eyes. By day 10, the frequency had decreased to one (2.1 %) eye and three (6.4%) eyes, respectively. The use of antimetabolites did not result in lower IOP or less medication needed for any group at any interval (analysis of variance). CONCLUSION: This modification of a nonvalved glaucoma tube shunt device provides adequate IOP control in the early postoperative period with a low rate of hypotony and surgical complications. If elevation of IOP occurs before suture autolysis, it generally is well controlled by antiglaucoma medications or laser suture lysis. Antimetabolite exposure did not influence early postoperative IOP in this study.     

Diagnostic and therapeutic strategy of insulinomas. Apropos of a personal experience of 21 cases

Insulinomas account for about 90% of all pancreatic endocrine tumors and their surgical resection leads to cure in 90% of patients. Although current laboratory tests have simplified the clinical diagnosis of insulinomas, despite recourse to an array of most preoperative diagnostic procedures in 10-15% of patients the exact location of the tumor remains undefined. Tumor localization is difficult because: 80% of insulinomas measure less than 2 cm, about 10-12% of insulinomas are multicentric and 4-6% escape detection because are multiple endocrine neoplasms (MEN). If preoperative imaging fails to detect the site of the lesion, the surgeon could be obliged to perform a "blinded resection" with high risks of failure. The Authors refer their experience in a series of 21 patients operated on for insulinoma over the past 8 years (1987-1995). Arteriography with calcium stimulation (ASVS) and scintigraphy with 111-Indium-labeled octreotide performed in the later 16 and 13 cases respectively, achieved a correct tumor localization (confirmed by surgery) in 100% and 84.7% of patients. Intraoperative ultrasonography, performed in 18 cases, allowed not only to localize the tumor but also to study the tumor's neighbouring anatomic structures (Wirsung duct. splenic artery and vein), thus providing the anatomical and surgical information necessary to plan the right surgical strategy (tumor enucleation or pancreatic resection). Tumor enucleation was performed in 15 patients, distal pancreatic resections in 5 cases and multiple liver biopsies in 1 case: this patient had liver micrometastases from a malignant insulinoma without a palpable tumor. Operative mortality was nil. Postoperative complications occurred only in 5 of the 15 enucleations (1 pseudocyst successfully treated with a ultrasound-guided drainage and 4 pancreatic fistula resolved by medical therapy).     

The expression of HLA, Epstein-Barr virus nuclear antigen and the infiltration of T lymphocyte subsets in nasopharyngeal biopsy tissues

In this study, 79 patients with locally advanced head and neck cancer were treated with induction chemotherapy. Cisplatin, 25 mg/m2, and 5-fluorouracil (5-FU), 1000 mg/m2, were employed, both of them in 24-hour continuous infusion over 96 hours, four cycles. The patients later underwent surgery and/or radiation therapy. The response to chemotherapy was 49%: of the complete responses (CR), 56% were histological; 29% were partial responses (PR). With the administration of the fourth cycle, CR increased from 30% to 49%. Once the complete treatment had been finished, 75% of CR and 5% PR were achieved. With a maximum follow-up period of 44 months, overall survival stands at 50%.     

Salvage mitomycin/5-fluorouracil after platinum-based therapy for women with advanced ovarian cancer and related gynecologic malignancies

PURPOSE: to determine response rates, survival, and toxicity of a regimen of mitomycin-C and 5-fluorouracil in patients previously treated with platinum-based combinations for ovarian cancer and related gynecologic malignancies. PATIENTS AND METHODS: retrospective chart review of all cases of persistent or recurrent ovarian, fallopian tube, and peritoneal carcinoma treated with mitomycin-C 7 mg/m2 followed by continuous infusion of 5-fluorouracil 600 mg/m2/day over 4 days. RESULTS: 26 patients were treated after a median of 2 prior platinum-based regimens, 22 with ovarian cancer, 3 with peritoneal cancer, and one with fallopian tube cancer. Only 2 patients completed 6 or more cycles. 2 patients had partial responses (8%); no complete responses were seen. 24 patients died a median of 3 months after the initiation of therapy, while 2 patients were alive 4 and 8 months after beginning therapy. All deaths were attributable to disease, not complications of treatment. 8 patients required dose modification or treatment delay for toxicity. Nine patients required a total of 11 unscheduled admissions. CONCLUSIONS: toxicity attributable to mitomycin-C/5-fluorouracil therapy of ovarian cancer is acceptable, but responses are few. More effective alternative should be sought.     

Surgical intervention for patients with stage IV-A hepatocellular carcinoma without lymph node metastasis: proposal as a standard therapy

OBJECTIVE: The aim of this study was to evaluate the effects of surgical treatments for patients with stage IV-A hepatocellular carcinoma (HCC) without lymph node metastasis. SUMMARY BACKGROUND DATA: Nonsurgical therapy for highly advanced HCC patients has yielded poor long-term survival. Surgical intervention has been initiated in an effort to improve survival. METHODS: The outcome of 150 patients who underwent hepatic resection was studied. Survival analysis was made by stratifying stage IV-A HCC patients into two groups-those with and those without involvement of a major branch of the portal or hepatic veins. Those with involvement were further divided into subgroups according to major vascular invasions. RESULTS: Patients who had multiple tumors in more than one lobe without vascular invasion had a significantly better 5-year survival rate (20%) than those with vascular invasion (8%) (p < 0.01). The survival rate of patients with hepatic vein tumor thrombi (10%) was better than the rate for those with tumor thrombi in the inferior vena cava (0%), in whom no patients survived more than 2 years, although the survival rate for those with portal vein tumor thrombi in the first branch (11%) was no different from the rate for that in the portal trunk (4%). The operative mortality decreased from 14.3% in the first 6 years to 1.4% in the following 5 years. CONCLUSIONS: Surgical intervention for stage IV-A HCC patients brought longer survival rates for some patients. We recommend surgical intervention as an effective therapeutic modality for patients with advanced HCC.     

Palliative chemotherapy with CMF after the same adjuvant regimen for breast cancer. The Breast Cancer Study Group

BACKGROUND: The results of palliative chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) in patients with advanced breast cancer who received adjuvant therapy with the same regimen were investigated. RESULTS: Of 47 patients, 14 (30%) achieved an objective remission (median duration 9.5, range 5-21 months) and 8 (17%) stabilisation of disease (median duration 6, range 3-17 months). Objective remissions were observed in premenopausal as well as in postmenopausal women, in patients with all categories of dominant localisation of disease and regardless of the oestradiol receptor status of the primary tumour or eventual previous endocrine therapy. One of 4 and 13 of 43 patients who started palliative chemotherapy within or later than 12 months after the last adjuvant course obtained an objective remission. The median survival time from start of therapy of all treated patients was 12 (range 1-40) months. Patients with an objective remission or stable disease and patients with progressive disease had a median survival time of 20 (range 6-40) and 6 (range 1-35) months respectively (p < 0.0001). CONCLUSIONS: Palliative treatment with CMF should not be rejected for patients who have relapsed after adjuvant chemotherapy with the same modality.     

Pharmacokinetics of CDDP by the route of administration in patients with ovarian cancer

Seventy patients with local squamous cell carcinoma of the esophagus were treated between 1981 and 1990 with preoperative chemotherapy, surgical resection, and possible postoperative radiation therapy and/or chemotherapy. Chemotherapy included two cycles of 5-fluorouracil (1000 mg/m2) by continuous intravenous infusion on days 1-4 and cisplatin (100 mg/m2) on day 4. Complete clinical response (CCR) was achieved in 28 (41%) patients, partial clinical response (PCR) in 17 (25%), and no response in 23 (34%). Fifty-five (81%) patients were resected, 6 (9%) were explored, and 7 (10%) were unable to have surgery. Microscopic analysis of 55 resected patients showed 50 (91%) with active tumor, 1 (2%) with necrotic tumor, and 4 (7%) with a pathological complete response to chemotherapy. Twenty-six of the 55 resected patients (47%) had no gross evidence of disease at the time of surgical inspection. Median overall survival was 21.86 months (range 2-107 months) for all patients and 26.71 months (range 2-107 months) for resected patients. Actuarial 5-year survival rate was 31% for all patients and 39% for resected patients. Prolonged survival correlates with complete clinical response to chemotherapy, low pathological stage of disease, and successful resection of the lesion.     

Treatment of incomplete analgesia after placement of an epidural catheter and administration of local anesthetic for women in labor

BACKGROUND: Approximately 15% of women still have pain after placement of an epidural catheter and administration of local anesthetic for labor analgesia. Two techniques frequently used to treat this pain were compared: (1) withdrawal of the catheter 1 cm and repeated dosing with additional local anesthetic, and (2) repeated dosing with additional local anesthetic without any catheter manipulation. METHODS: Fifteen minutes after placement of a multiple-orifice epidural catheter 5 cm into the epidural space and administration of 13 ml 0.25% bupivacaine to the parturient in labor, the adequacy of analgesia was assessed. All women who had incomplete analgesia were randomized (first intervention) to receive an additional 5 ml 0.25% bupivacaine (local-anestheticonly group) or to receive 5 ml 0.25% bupivacaine after first withdrawing the epidural catheter 1 cm (catheter-manipulation group). If after 15 min the woman still had pain, then (second intervention) the catheter was withdrawn 1 cm and an additional 5 ml 0.25% bupivacaine was administered to the local-anesthetic-only group, whereas 5 ml 0.25% bupivacaine was given to the catheter-manipulation group without further catheter manipulation. The success rate of the second intervention was assessed 15 min later. RESULTS: Seventy-eight women were enrolled in the study, 39 to each group. In the local-anesthetic-only group, 29 (74%) women were successfully treated with the first intervention and the remaining 10 (100%) were successfully treated with the second intervention. In the catheter-manipulation group, 30 (77%) were successfully treated with the first intervention and 7 (100%; 2 patients were not studied because of investigator error) were successfully treated with the second intervention (P=NS). CONCLUSIONS: Administration of additional local anesthetic without first withdrawing the epidural catheter will effectively treat most women for whom analgesia is incomplete after the placement of an epidural catheter during labor.     

Recurrent bleb infections

AIM: To report the patient characteristics, causative organisms, and clinical outcomes in patients with recurrent bleb related ocular infections. METHODS: The medical records of all patients diagnosed with bleb related ocular infection at the New York Eye and Ear Infirmary over a 10 year period were reviewed. Recurrent bleb infection was defined as at least two episodes of bleb purulence with or without associated intraocular inflammation separated by a quiescent period of at least 3 months. RESULTS: Recurrent bleb infections developed in 12 eyes of 12 patients (10 men, two women) a mean of 16.3 (SD 17.9) months (range 3-51 months) after the initial infection. Two patients developed a third episode 3 and 20 months, respectively, after the second infection, yielding a total of 14 recurrent infection episodes. Recurrent infection developed after trabeculectomy in 11 eyes (adjunctive 5-fluorouracil, nine eyes; mitomycin C, one eye; no antifibrosis agent, one eye) and following cataract extraction with inadvertent bleb formation in one eye. Four (36.4%) of the filtered eyes had undergone trabeculectomy at the inferior limbus. The mean follow up time from filtering surgery to the first bleb related infection was 28 months for the nine patients treated with 5-fluorouracil and 14 months for the single patient treated with mitomycin C. 11 (78.6%) cases had a documented bleb leak in the 4 week period before or at the time of recurrent infection. Topical, prophylactic antibiotics had been used in 7/14 (50%) cases. The same organism was cultured from the initial and recurrent infections in 2/14 (14.3%) cases. CONCLUSION: Eyes that have been successfully treated for bleb related infection remain at risk for recurrent infection. No apparent correlation exists between organisms responsible for the initial and recurrent infections. The increased rate of recurrent bleb related infection in patients receiving adjunctive 5-fluorouracil compared to mitomycin C may have been related to the longer follow up of the 5-fluorouracil eyes.     

Prediction of efficacy of octreotide therapy in patients with acromegaly

Octreotide (OCT) administration provides a biochemical cure in most acromegalic patients. This drug, however, causes several side effects and is very expensive. Acute testing has been reported to predict chronic responsiveness to OCT administration. The aim of this retrospective study was to evaluate which test, if any, among acute testing, short-term (1 month) administration, and 111In-pentetreotide (111In-DTPA-Phe-D-OCT) scintigraphy, is best in predicting response to long-term OCT treatment. Sixty-eight patients with active acromegaly were studied. An acute test (100 micrograms sc OCT) was performed as usual: a GH decrease greater than or equal to 50% of baseline was considered a positive response. GH and insulin-like growth factor I (IGF-I) were then assayed after 1 month (300 micrograms daily) and 3 months (150-600 micrograms daily) of OCT administration. GH was considered normalized when decreased less than or equal to 5 micrograms/L. Twenty-six of 68 patients were subjected to 111In-pentetreotide scintigraphy. Linear correlation analysis of the results was performed. Sensitivity, specificity, and positive and negative predictive values of the three tests were also calculated. Thirty-eight of 68 patients (56%) responded to the acute test. Among these 38 patients, 20 experienced normalization of GH and IGF-I levels during long-term therapy, as did 8 patients who did not respond to the acute test. No significant correlation was found between GH percent decrease during acute testing and long-term therapy (r = 0.11). Seven patients who responded to the acute test and 2 who did not respond had adenoma shrinkage during therapy. Conversely, GH and IGF-I decrease after short-term treatment significantly correlated with long-term treatment (r = 0.76 and 0.64, P < 0.01). Of the 26 patients subjected to 111In-pentetreotide scintigraphy, 13 had significant tracer uptake: normalization of GH and IGF-I was obtained in 8 patients. A significant correlation was found between tracer uptake and GH/IGF-I inhibition after 3 months of therapy (r = 0.6; P < 0.05). In the whole population, the positive predictive value of acute testing, short-term OCT administration, and 111In-penetreotide scintigraphy was 53%, 70%, and 73%, respectively, when the GH normalization (< 5 micrograms/L) after 3 months of therapy was considered. Moreover, 111-In-pentetreotide scintigraphy had the highest specificity (100% in patients with baseline GH values below 50 micrograms/L) compared with that of acute testing and short-term OCT administration. The acute test cannot be considered as a valuable index to identify patients' responsiveness to long-term OCT therapy, but it can be useful to test tolerability. By contrast, 1 month of OCT administration or the in vivo imaging of somatostatin receptors by 111-In-pentetreotide might better indicate the patients who might effectively benefit from this treatment.     

Adverse events with transvenous implantable cardioverter-defibrillators: a prospective multicenter study. European 7219 Jewel ICD investigators

BACKGROUND: A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. METHODS AND RESULTS: Adverse events were monitored during prospective clinical evaluation of the Medtronic model 7219 Jewel ICD and were classified according to the definitions of the ISO 14155 standard for device clinical trials into 3 groups: severe and mild device-related and severe non-device-related adverse events. In addition, events were related to the surgical procedure, treatment with the device, or cardiac function. Seven hundred seventy-eight patients were followed up for an average of 4.0 months after ICD implantation. In total, 356 adverse events were observed in 259 patients. At 1, 3, and 12 months after ICD implantation, 99%, 98%, and 97% of the patients, respectively, survived; 95%, 93%, and 92%, respectively, were free of surgical reintervention; and 79%, 68%, and 51%, respectively, were free of any adverse event. Twenty patients died: 6 deaths were related to the surgical procedure, 12 deaths were considered unrelated to ICD treatment, and 2 patients died of an unknown cause. Of 111 nonlethal severe adverse device effects, 47 required surgical intervention, 19 times for correction of a dislodged lead. Inappropriate delivery of therapy was observed 128 times in 111 patients, and the events were typically resolved by reprogramming or drug adjustment. Nine of these required rehospitalization. CONCLUSIONS: Approximately 50% of patients experience an adverse event within the first year after ICD implantation. The observed adverse event rate depends on the definitions and the prospective monitoring. The incidence of inappropriate therapy emphasizes the need for improved detection algorithms and for quality-of-life evaluations, especially when considering ICD treatment in high-risk but arrhythmia-free patients.