Practical Requirements for the Development of an Advanced Cardiorenal Unit.

BACKGROUND: Heart failure is frequently associated with kidney disease, and patients with kidney disease are at increased risk of heart failure. The co-occurrence of both entities not only significantly increases morbidity and mortality but also complicates therapy. SUMMARY: Cardiorenal syndrome often requires a broad, comprehensive, and multidisciplinary approach. As a result, a need has arisen to create specialized cardiorenal units that allow for rigorous and personalized management of this condition. Moreover, in some cases, cardiorenal syndrome is more complex, owing to an acute and critical situation that requires the concept of the cardiorenal unit to be extended toward advanced diagnostic and therapeutic positions, thus confirming the need for an advanced cardiorenal unit. The creation of these units constitutes a real challenge, necessitating a specific multilevel action plan, covering governance and management, type of patient, personnel requirements, service portfolio, care process, information systems, and other resources. Specific lines of action must be proposed for each of the relevant points in order to facilitate development of these units, together with continuous evaluation of unit activity through specific indicators, and to detect areas for improvement. KEY MESSAGES: This study addresses the conditions and organizational characteristics that enable the creation, development, and continuous improvement of advanced cardiorenal units.

Consequences of the implementation of K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease in a population of patients on chronic hemodialysis.

BACKGROUND: After application of K/DOQI recommendations, a large proportion of our patients failed to reach the proposed targets. This study examined the causes of these findings. METHODS: Patients (n=163) were compared in 2 periods (8 months before and after application of K/DOQI guidelines). Serum calcium (Ca), phosphorus (P), parathyroid hormone (PTH) and calcium x phosphate product (Ca x P); mean dialysate Ca content; mean doses of vitamin D; and average prescription of Ca-based phosphate binders and sevelamer in both periods were analyzed. RESULTS: Prescription of Ca salts as phosphate-binding agents decreased and prescription of sevelamer increased in an attempt to maintain serum Ca levels between 8.4 and 9.5 mg/dL post-K/DOQI. Increased serum PTH levels were associated with decreased serum Ca levels (relative risk [RR] = 41.1, p<0.001) and increased serum P levels (RR=6.81, p<0.01). Use of dialysis fluids with Ca content of 2.5 mEq/L was associated with an increased risk of having PTH levels >300 pg/mL (RR=11.4, p<0.003). Vitamin D metabolites had to be discontinued in 26 patients (37.1% of those receiving them from study start) due to hyperphosphoremia or hypercalcemia post-K/DOQI; and serum PTH significantly increased (445.8 +/- 238.2 pg/mL vs. 715.2 +/- 549.5 pg/mL; p<0.001). Ninety-three patients (57%) did not receive vitamin D at study start; in 20 of those (21.5%), vitamin D had to be started post-K/DOQI. CONCLUSIONS: Clinical guidelines do not appear to be sufficient to overcome all difficulties arising in daily management of these patients.

Implementation of 'K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease' after the introduction of cinacalcet in a population of patients on chronic haemodialysis.

BACKGROUND: The purpose of the present study was to evaluate the impact of cinacalcet administration on the attainment of Kidney Disease Outcomes Quality Initiative of the National Kidney Foundation (NFK-K/DOQI) targets, in a group of dialysis patients with secondary hyperparathyroidism that were not controlled with vitamin D metabolites due to inadequate elevations in serum calcium and/or phosphorus. METHODS: Twenty-eight patients undergoing haemodialysis that presented secondary hyperparathyroidism (PTH > 300 pg/ml) with difficulty to use vitamin D either because of hypercalcaemia (>10.2 mg/dl) and/or hyperphosphoraemia (>5.5 mg/dl) were included in this study. The follow-up period was 9 months before and after the introduction of cinacalcet. We started by adding 30 mg of cinacalcet orally once daily to their previous vitamin D metabolite treatment. The following variables were calculated and recorded: the mean of all measurements of serum Ca, P and parathyroid hormones (PTH), and Ca x P in each patient; calcium in dialysate (mEq/l); doses of vitamin D administered; doses of cinacalcet used, and the average prescription of calcium-based phosphate binders, sevelamer hydrochloride and aluminum binders, corresponding to two periods according to the introduction of cinacalcet. The proportions of patients with different serum Ca levels as well as serum P levels; serum PTH levels and CaxP at the beginning and at the end of the nine month period of treatment with cinacalcet were calculated. RESULTS: Serum PTH (826.9 +/- 325 vs 248.1 +/- 77.3, P < 0.001), serum calcium (9.9 +/- 0.6 vs 8.6 +/- 0.4, P < 0.001) and the Ca x P product (94.7 +/- 7.3 vs 43.6 +/- 8.5; P < 0.001) diminished significantly whereas serum phosphorus remained unchanged (4.8 +/- 1.5 vs 4.3 +/- 1.1; P = NS). Before cinacalcet, 23 patients had severe hyperparathyroidism (serum PTH > 500) and 15 patients hypercalcaemia (serum calcium >10.2 mg/dl). After 9 months of treatment, all 28 patients showed serum PTH < 500 pg/ml and serum calcium <10.2 mg/dl; 64.7% of the patients achieved Ca, P, Ca x P and PTH objectives simultaneously. While the mean dose of cinacalcet increased along the 9 months of treatment (P < 0.001), there were no significant changes in vitamin D metabolites (P = 0.5), neither in the mean doses of calcium-containing agents, nor in the mean prescribed doses of sevelamer (P < 0.01), and aluminium-containing agents diminished significantly (P < 0.05). CONCLUSIONS: In summary, the combination of cinacalcet and low doses of vitamin D improved significantly the control of PTH and Ca x P in patients with severe secondary hyperparathyroidism on chronic haemodialysis, without adverse effects and with lower doses of phosphate binders.