First Author: I.Westborg SWEDEN
Co Author(s): S. Albrecht E. Granstam G. Bjärnhall N. Karlsson 0 0 0 0 0 0 0 0 0
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The Swedish Macula Register (SMR), a national quality register for treatment of age-related maculadegeneration (AMD) established in 2003 and web based 2008. Photodynamic therapy was followed initially and since 2007 are 99% of the treatments intravitreal intravitreal injections (IVT). During 2007-2011 98% of all IVT were Ranibizumab. Since September 2011 use of Bevicizumab increased and 2013 when Aflibercept was introduced it was quickly adopted in Sweden. December 2013 39,6% of all IVT for AMD are Ranibizumab, 37% Bevicizumab and 27% Aflibercept 35% . 2013 were 34 eye clinics active in SMR and registered treatments and follow-up visits.
SMR registers age, sex, duration of symptoms, visual acuity (ETDRS, Snellen and nearvision), diagnosis, type of choroid neovascularization (CNV) and treatment. Follow-up visits registers visual acuity, treatment, reasons for no treatment and adverse events. SMR 2013 includes 15 606 patients, 17 877 eyes, 235 508 visits and 108 073 treatments.
SMR analyse results (improvement of vision) related to age, gender, type of lesion, number and type of treatments per clinic/county. Adverse events are reported to the register. Adverse events are registered and a comparison with Medical Products Agency - Sweden (MPA) of severe adverse events has been conducted. 2007- 2012. A survey of operative routines IVT has been sent to all eye clinics/branch receptions in Sweden treating wet AMD November 2013.
Mean age for start of treatment is 79 years and 64% of patients are female. Occult CNV is most frequent. Improvement of visual acuity after 12 months of treatment was ≥5 letters (43%) and ≥15 letters (16%). The number of injections first year of treatment has increased 2007-2013, From 4,46 to 5,08. Registered cases of postoperative endophthalmitis 2007-2012 were 23 cases. This is an incidence of (0,28‰) per IVT and(1,3‰) per patient. MPA has received 12 cases of endophthalmitis 2007-2012. Six cases of endophthalmitis are registered 2013 (incidence 0,22‰ per IVT and 0,65‰ per patient). Suspected systemic adverse events has increased 2010-2012 with 6 reported cases 2010 to 48 2012. This is an incidens 2010 of (1,0‰) and 2012 (5,73‰) per patient. MPA has received115 cases of suspected systemic adverse events. 20 cases have been judged to have connection with IVT 40% cardiovascular and 45% cerebrovascular adverse events. The survey was answered by 100% of clinics. IVT are performed in operation theatre (93%) and sterile room in office (7%). Antibiotics are used on the day of injection in 39 clinics. Only two clinics do not give antibiotics before or after IVT.
The number of patients, treatments and follow–up visits has increased every year. The incidence of endophthalmitis increased 2007 to 2012 during 2013 the rate of endophthalmitis after intravitreal treatment is stable. Intravitreal injections are performed in operation theatre in most eye clinics in Sweden. 95% of eye clinics give antibiotics in conjunction with intravitreal injections. SMR will 2014 start a register for endophthalmitis after intravitreal treatment. Suspected adverse events have increased 2010-2012.Twenty cases have been judged by MPA to have connection with the intravitreal injection 40% cardiovascular and 45% cerebrovascular adverse events.