Safety of Vitrectomy for Floaters

PurposeTo assess the risks of vitrectomy for the removal of primary and secondary vitreous opacities.DesignRetrospective, nonrandomized, interventional case series.MethodsWe reviewed the results of 116 consecutive cases of vitrectomy for vitreous floaters. Eighty-six cases were primary and 30 cases were secondary floaters. Main outcome measures were the incidence of iatrogenic retinal breaks and postoperative rhegmatogenous retinal detachments.ResultsWe found iatrogenic retinal breaks in 16.4% of operations. There was no statistically significant difference in risk between cases of primary and secondary floaters. Intraoperative posterior vitreous detachment induction was found to increase significantly the risk of breaks. Retinal detachment occurred in 3 cases (2.5%), all after operations for primary floaters. One case of complicated retinal detachment ended with a low visual acuity of hand movements. Cataract occurred in 50% of phakic cases. Transient postoperative hypotony was found after 5.2% of our operations, and transient postoperative high intraocular pressure was encountered in 7.8%. An intraoperative choroidal hemorrhage occurred in 1 case, which resolved spontaneously. The mean visual acuity improved from 0.20 to 0.13 logarithm of the minimal angle of resolution units.ConclusionsThe risk profile of vitrectomy for floaters is comparable with that of vitrectomy for other elective indications. Retinal breaks are a common finding during surgery and treatment of these breaks is crucial for the prevention of postoperative retinal detachment. Patients considering surgery for floaters should be informed specifically about the risks involved

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P < 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Hypotony after 25-gauge vitrectomy

To describe the incidence of hypotony after 25-gauge vitrectomy and to identify preoperative and intraoperative factors that influence the occurrence of hypotony. Retrospective, nonrandomized, interventional case series. We reviewed 122 consecutive cases of 25-gauge vitrectomy for all surgical indications. The primary outcome measure was intraocular pressure (IOP) at postoperative day 1, measured with Goldmann tonometry. Secondary outcome measures were clinical signs of hypotony and other complications. Hypotony, defined as an IOP of 5 mm Hg or less, was found in 13.1% of cases on postoperative day 1. Clinical signs of hypotony were encountered in 7 eyes (5.7%). The risk of hypotony was significantly lower in cases with air or gas tamponade (3.3%) than in cases without tamponade (22.4%). Hypotony was encountered more often in reoperations (29.9%) than in primary operations (9.2%; statistically significant difference). In cases in which intravitreal triamcinolone was used, the risk of hypotony was significantly higher (35.3%) than in cases without triamcinolone (10.3%). Phakic eyes had significantly less chance of hypotony (6.7%) than pseudophakic eyes (15.6%) and eyes undergoing combined phacoemulsification and vitrectomy (25.0%). At postoperative day 7, all cases of hypotony recovered spontaneously. None of our cases developed endophthalmitis. Our results show that a transient hypotony occurs commonly after 25-gauge vitrectomy. Hypotony was significantly influenced by tamponade, reoperation, intraoperative lens status, and use of intravitreal triamcinolone. Although all cases of hypotony recovered spontaneously without permanent damage, the high frequency of hypotony does impose potential risks. Increased vigilance with focus on perioperative antisepsis and low tolerance of sclerotomy leakage are important for the prevention of endophthalmitis. Strategies aimed at lowering the risk of hypotony are needed to improve the safety of this promising techniqu

Early Vitrectomy for Vitreous Hemorrhage Associated With Retinal Tears

PURPOSE: To evaluate outcome of early surgery in vitreous hemorrhage, presumably associated with retinal tears. DESIGN: Retrospective, noncomparative interventional case series. METHODS: We included 40 consecutive cases in 39 patients treated with early vitrectomy for vitreous hemorrhage. Main outcome measures were incidence of tears identified preoperatively and intraoperatively, visual acuity, and complications. RESULTS: Vitrectomy took place after a mean delay of 2.7 days after presentation. A total of 69 tears were found in 40 eyes; 53.7% of tears were identified preoperatively by funduscopy or ultrasound (U/S) and the remaining 46.3% of tears were only identified during vitrectomy. Visual acuity improved significantly from 1/60 to 0.8. The sensitivity of U/S tear detection was 55.9%. A history of predisposing factors was not related to the risk of presence of unsupported tears. In 2 cases a retinal detachment developed between the U/S evaluation and vitrectomy. Postoperative complications were cataract (30%), macular pucker (2.5%), and retinal detachment (5.0%). CONCLUSIONS: Our findings illustrate the potential dangers of a conservative approach to vitreous hemorrhage and show that early vitrectomy has good outcome with acceptable complication rates. Prospective studies on optimal treatment of vitreous hemorrhage associated with tears are needed. (Am J Ophthalmol 2010;150: 529-533. (C) 2010 by Elsevier Inc. All rights reserved.