To test the hypothesis that tolerating some subretinal fluid (SRF) in patients with neovascular agerelated macular degeneration (nAMD) treated with ranibizumab using a treat-and-extend (T&E) regimen can achieve similar visual acuity (VA) outcomes as treatment aimed at resolving all SRF.Design: Multicenter, randomized, 24-month, phase 4, single-masked, noninferiority clinical trial.Participants: Participants with treatment-naïve active subfoveal choroidal neovascularization (CNV). Methods: Participants were randomized to receive ranibizumab 0.5 mg monthly until either complete resolution of SRF and intraretinal fluid (IRF; intensive arm: SRF intolerant) or resolution of all IRF only (relaxed arm: SRF tolerant except for SRF >200 mm at the foveal center) before extending treatment intervals. A 5-letter noninferiority margin was applied to the primary outcome.Main Outcome Measures: Mean change in best-corrected VA (BCVA), and central subfield thickness and number of injections from baseline to month 24.Results: Of the 349 participants randomized (intensive arm, n ¼ 174; relaxed arm, n ¼ 175), 279 (79.9%) completed the month 24. The mean change in BCVA from baseline to month 24 was 3.0 letters (standard deviation, 16.3 letters) in the intensive group and 2.6 letters (standard deviation, 16.3 letters) in the relaxed group, demonstrating noninferiority of the relaxed compared with the intensive treatment (P ¼ 0.99). Similar proportions of both groups achieved 20/40 or better VA (53.5% and 56.6%, respectively; P ¼ 0.92) and 20/200 or worse VA (8.7% and 8.1%, respectively; P ¼ 0.52). Participants in the relaxed group received fewer ranibizumab injections over 24 months (mean, 15.8 [standard deviation, 5.9]) than those in the intensive group (mean, 17 [standard deviation, 6.5]; P ¼ 0.001). Significantly more participants in the intensive group never extended beyond 4-week treatment intervals (13.5%) than in the relaxed group (2.8%; P ¼ 0.003), and significantly more participants in the relaxed group extended to and maintained 12-week treatment intervals (29.6%) than the intensive group (15.0%; P ¼ 0.005).Conclusions: Patients treated with a ranibizumab T&E protocol who tolerated some SRF achieved VA that is comparable, with fewer injections, with that achieved when treatment aimed to resolve all SRF completely.
Objectives: Upon completion of this article, the reader will be able to (1) explain the incidence and potential complications of bullet embolization, and (2) recall the challenge of diagnosing this entity and the therapeutic possibilities available including endovascular retrieval. Accreditation: Tufts University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit: Tufts University School of Medicine designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Case PresentationA 46-year-old man presented to a local level 2 trauma center after sustaining a single gunshot wound to the right upper quadrant of the abdomen. The patient was hemodynamically unstable and was taken emergently to the operating room for exploration of the abdomen. He was found to have a through and through injury to the liver, small intestinal injury at two locations, and a single injury to the infrarenal vena cava. The Keywords ► penetrating trauma ► bullet embolization ► endovascular retrieval ► interventional radiology AbstractBullet embolization after penetrating trauma is an infrequent but important phenomenon. It presents an unexpected sequelae to the otherwise predictable injury pattern of penetrating missile injury mechanism and poses a challenging diagnostic and therapeutic dilemma. Bullets from penetrating wounds can gain access to the vasculature and migrate to nearly every large vascular bed. Patients can be asymptomatic, but the potential complications can be devastating including limb-threatening ischemia, sepsis, endocarditis, cardiac valvular incompetence, pulmonary embolism, stroke, and even death. The exact incidence of bullet embolization is unknown, but it was estimated to be 0.3% during the Vietnam War and 1.1% in the recent conflict in Afghanistan and Iraq. The scarcity of the condition and the lack of concentrated experience at any single institution contribute to the controversies pertaining to the management approach. Traditionally, surgical extraction of embolized bullets may involve difficult and invasive surgical exposures. Recent advancement in endovascular techniques provides an additional option in this treatment algorithm. In this article, we describe a case of venous bullet embolization from the left iliac vein treated by a combined endovascular and surgical approach.
Purpose Malignancies may cause urinary tract obstruction, which is often relieved with placement of a percutaneous nephrostomy tube, an internal double J nephro-ureteric stent (double J), or an internal external nephroureteral stent (NUS). We evaluated the affect of these palliative interventions on quality of life (QoL) using previously validated surveys. Methods Forty-six patients with malignancy related ureteral obstruction received nephrostomy tubes (n = 16), double J stents (n = 15), or NUS (n = 15) as determined by a multidisciplinary team. QoL surveys were administered at 7, 30, and 90 days after the palliative procedure to evaluate symptoms and physical, social, functional, and emotional well-being. Number of related procedures, fluoroscopy time, and complications were documented. Kruskal–Wallis and Friedman’s test were used to compare patients at 7, 30, and 90 days. Spearman’s rank correlation coefficient was used to assess correlations between clinical outcomes/symptoms and QoL. Results Responses to QoL surveys were not significantly different for patients receiving nephrostomies, double J stents, or NUS at 7, 30, or 90 days. At 30 and 90 days there were significantly higher reported urinary symptoms and pain in those receiving double J stents compared with nephrostomies (P = 0.0035 and P = 0.0189, respectively). Significantly greater fluoroscopy time was needed for double J stent–related procedures (P = 0.0054). Nephrostomy tubes were associated with more frequent minor complications requiring additional changes. Conclusion QoL was not significantly different. However, a greater incidence of pain in those receiving double J stents and more frequent tube changes in those with nephrostomy tubes should be considered when choosing palliative approaches.
Pelvic fractures account for ∼3% of all fractures and usually occur in patients with polytrauma. Pelvic fractures usually indicate high energy transfer and a significant mechanism of injury, and they can involve massive hemorrhage. For this reason, mortality from pelvic trauma is high, ranging from 40% to 60% among patients in shock, and up to 90% in patients considered to be in extremis. Multidisciplinary approaches in the treatment of patients with pelvic fractures have resulted in improved outcomes for these complex and challenging injuries. In this article, we describe a case of a pediatric patient who suffered severe pelvic fracture with massive hemorrhage, requiring a multidisciplinary approach for control of hemorrhage and definitive repair of injuries.
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