To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients.
This retrospective analysis ...followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing.
Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years.
Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.
...many patients exhibit multiple forms of VAs over time. ...clinicians who encounter patients with VAs face important questions regarding which diagnostic tests are needed and which treatments, if ...any, should be offered. ...the specific arrhythmia and the underlying structural heart disease (SHD), if any, may have important prognostic and treatment implications. Wherever appropriate, the reader is referred to other publications regarding the indications for implantable cardioverter-defibrillator (ICD) implantation 1,2, catheter ablation 3, inherited arrhythmia syndromes 4,5, congenital heart disease (CHD) 6, the use of amiodarone 7, and the management of patient with ICD shocks 8, syncope 9, or those nearing end of life 10. The risk of cardiac events is often dictated by an underlying heart disease rather than the arrhythmia. ...optimal treatment of underlying cardiovascular diseases and risk factors is recommended.
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FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, UILJ, UL, UM, UPCLJ, UPUK, VSZLJ, ZAGLJ, ZRSKP
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