There are an estimated 14,000 randomized trials published in chronic
kidney disease. The most frequently reported outcomes are biochemical endpoints,
rather than clinical and patient-reported outcomes including cardiovascular
disease, mortality, and quality of life. While many trials have focused on
optimizing kidney health, the heterogeneity and uncertain relevance of outcomes
reported across trials may limit their policy and practice impact. The
international Standardized Outcomes in Nephrology (SONG) Initiative was formed
to identify core outcomes that are critically important to patients and health
professionals, to be reported consistently across trials. We convened a SONG
Implementation Workshop to discuss the implementation of core outcomes.
Eighty-two patients/caregivers and health professionals participated in plenary
and breakout discussions. In this report, we summarize the findings of the
workshop in two main themes: socializing the concept of core outcomes, and
demonstrating feasibility and usability. We outline implementation strategies
and pathways to be established through partnership with stakeholders, which may
bolster acceptance and reporting of core outcomes in trials, and encourage their
use by end-users such as guideline producers and policymakers to help improve
patient-important outcomes.
The arteriovenous fistula used for vascular access for hemodialysis may contribute to development of congestive heart failure. Theses patients can present with frequent episodes of congestive hear failure. Traditional management of high-inflow, a high-cardiac-output fistula generally involves either closure or banding. Although high-output state can be controlled, the lifeline of the patient is lost. We describe a series of 17 hemodialysis patients (10 men and 7 women) in whom a novel inflow reduction method was employed. All patients had symptoms of heart failure (15 brachiocephalic fistulas and two brachioaxillary bypass grafts) and a fistula inflow rate above 1600 ml/min. The inflow reduction procedure included ligation of the brachial anastomosis and reconstruction of the fistula by using an expanded polytetrafluoroethylene (Gore-Tex Intering) vascular graft in a bypass from the radial artery. The mean (+/- SD) time between fistula creation and the inflow reduction procedure was 30 +/- 17 months. The mean access inflow rate decreased significantly after the inflow reduction procedure, from 3135 +/- 692 to 1025 +/- 551 ml/min (p =0.0001). The mean cardiac output rate decreased from 8 +/- 3.1 to 5.6 +/- 1.7 l/min (p = 0.001) with resolution of symptoms. During the follow-up period thrombosis or stenosis developed in seven patients, three of whom underwent surgical revision. Thirteen of the seventeen accesses (77%) subjected to the inflow reduction procedure remained patent. Access loss was due to failed fistuloplasty or thrombosis. To our knowledge, this is the first report demonstrating that inflow reduction obtained by distalization of the anastomosis of the access fistula is feasible and safe for managing high-inflow, high-cardiac-output fistulas. Longer and larger studies of the inflow reduction procedure and its benefits are needed.
Brachial artery aneurysm (BAA) is a rare condition. We describe a series of cases of BAA with arteriovenous access. Thirteen patients were retrospectively identified between January 2006 and July 2009 using a patient database. All were associated with brachio-cephalic fistulas. Mean age was 51.2 +/- 13.8 years. Twelve males (93.3%) were identified. Characteristics were: diabetes 1, hypertension 8, hypercholesterolemia 2, ischemic heart disease 2, family history of aneurysmal disease 2. Five BAA developed after access ligation, eight while it was working, one after trauma. One was associated with a venous aneurysm. While the average life of the access was 161 +/- 115 months, the average time for BAA formation was 40 +/- 35.8 months. BAA was asymptomatic in three patients, whereas 10 presented with ischemic and neurologic symptoms. None presented with a rupture. All patients underwent surgical repair, seven an aneurysm excision and end-to-end reconstruction of the brachial artery. Venous conduits were utilized: four long saphenous veins, one cephalic, and one basilic vein. All patients had patent brachial arteries with a complete relief of symptoms at 14 months. BAA is a rare but significant complication of vascular access. The surgical approaches presented offer a reasonable outcome.
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