Mortality among heart transplant candidates on the waiting list is a significant problem. Patients awaiting heart transplantation in the US are prioritized by waiting time within medical urgency status (1A, 1B, 2) and distribution area. The shortage of donor hearts requires more efficient use of donor organs to improve survival benefit from transplantation. As a first step, better understanding of the relative risk (RR) of the predictors of waiting list mortality is needed. SRTR data were used to analyze time-dependent mortality risk for 10,478 adult heart candidates first listed for a heart transplant during 2/1/99–12/31/02.

Background: Several observational studies reported lower mortality risk among hemodialysis patients treated with doses greater than the standard dose. The present study evaluates, with observational data, the secondary randomized Hemodialysis (HEMO) Study finding that greater dialysis dose may benefit women, but not men. Methods: Data from 74,120 US hemodialysis patients starting end-stage renal disease therapy were analyzed. Patients were classified into 1 of 5 categories of hemodialysis dose according to their average urea reduction ratio (URR), and their relative risk (RR) for mortality was evaluated by using Cox proportional hazards models. Similar analyses using equilibrated Kt/V were completed for 10,816 hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 7 countries. Results: For both men and women, RR was substantially lower in the URR 70%-to-75% category compared with the URR 65%-to-70% category. Among women, RR in the URR greater-than-75% category was significantly lower compared with the URR 70%-to-75% group (P < 0.0001); however, no further association with mortality risk was observed for the greater-than-75% category among men (P = 0.22). RR associated with doses greater than the Kidney Disease Outcomes Quality Initiative guidelines (URR ≥ 65%) was significantly different for men compared with women (P < 0.01). Similar differences by sex were observed in DOPPS analyses. Conclusion: The agreement of these observational studies with the HEMO Study supports the existence of a survival benefit from greater dialysis doses for women, but not for men. Responses to greater dialysis dose by sex deserve additional study to explain these differences.

The Thoracic Simulated Allocation Model (TSAM) evaluates thoracic organ allocation policy changes prior to implementation. To evaluate the potential to decrease waitlist deaths, we compared TSAM results for (1) current cardiac allocation policy based on waiting time within medical urgency status (1A, 1B, 2) and distribution area (local OPO, zone A, B, C) (current rules) with (2) a broader initial distribution area that combines local and zone A (<500 miles) for status 1A and then 1B candidates (broader sharing rules). TSAM input data consisted of waitlist arrivals, status changes, and removal information for patients on the heart waiting list in 2000 and evaluated differences in outcomes between the two policies. For patients who did not receive a TSAM transplant by the time of their actual transplant, status change histories and waitlist death dates were imputed to complete waitlist histories according to status at time of transplant, mortality risk, and other factors. TSAM results using current rules were validated against actual outcomes for that year. Post-Tx survival was estimated using Cox models based on significant patient and donor characteristics (mean post-Tx follow-up = 0.46 years). Compared with current rules, broader sharing rules resulted in 417 (26%) more transplants for status 1A and 1B patients and 18% fewer overall waitlist deaths. Status 2 waitlist deaths increased by 3%. Post-Tx fraction dead was similar (12.1% vs. 12.7%). TSAM results suggest that broader sharing rules for allocation to status 1A and 1B patients could substantially reduce overall deaths, particularly on the waiting list, and lead to more transplants for high urgency status patients. ∗ Current Rules Broader Sharing Rules for Status 1A and 1B Waitlist deaths Post-Tx deaths Transplants Waitlist deaths Post-Tx deaths Transplants Status 1A 166 125 892 102 194 1352 Status 1B 92 84 733 78 71 690 Status 2 131 56 562 136 17 178 Overall 594 ∗ includes 205 inactive 265 2187 485 includes 169 inactive. 282 2220 ∗ includes 205 inactive ∗∗ includes 169 inactive. Open table in a new tab

The standardized mortality ratio (SMR) has been used to provide information about adjusted survival outcomes at dialysis facilities. There has been concern that high rates of transplantation could unjustly lead to unfavorable SMR profiles for individual dialysis units because healthier patients would be removed from dialysis therapy, leaving less healthy patients in the dialysis pool. We correlated 1999 overall adjusted SMR and 1999 standardized transplantation ratio (STR) weighted for mortality patient count and count of first transplantations of patients younger than 65 years. A total of 2,362 facilities were included in analyses. We found no correlation between rates of transplantation (by STR) and overall mortality profile (by SMR) based on Pearson's correlation coefficients (r), either unweighted, weighted by number of patients included in the 1999 mortality calculation (SMR), or weighted by number of patients included in the 1999 transplantation calculation (r = -0.016, r = -0.015, and r = -0.015, respectively; P > 0.40 for each). Sensitivity analyses using SMR and STR over 3- and 3.5-year periods (January 1997 to June 2000) also showed no correlation between SMR and STR, respectively. We conclude that reported standardized rates for transplantation do not correlate with those reported for mortality by dialysis facilities.

Hyperphosphatemia is highly prevalent among patients with end-stage renal disease (ESRD) and is associated with increased mortality risk in hemodialysis (HD) patients. The mechanism through which this mortality risk is mediated is unclear. Data from two national random samples of HD patients (n = 12,833) was used to test the hypothesis that elevated serum PO(4) contributes mainly to cardiac causes of death. During a 2-yr follow-up, the cause-specific relative risk (RR) of death for patients was analyzed separately for several categories of cause of death, including coronary artery disease (CAD), sudden death, and other cardiac causes, cerebrovascular and infection. Cox regression models were fit for each of the eight cause of death categories, adjusting for patient demographics and non-cardiovascular comorbid conditions. Time at risk for each cause-specific model was censored at death that resulted from any of the other causes. Higher mortality risk was seen for patients in the high PO(4) group (>6.5mg/dl) compared with the lower PO(4) group (< or =6.5mg/dl) for death resulting from CAD (RR 1.41; P < 0.0005), sudden death (RR 1.20; P < 0.01), infection (RR 1.20; P < 0.05), and unknown causes (RR 1.25; P < 0.05). Patients in the high PO(4) group also had non-significantly increased RR of death from other cardiac and cerebrovascular causes of death. The RR of sudden death was also strongly associated with elevated Ca x PO(4) product (RR 1.07 per 10 mg(2)/dl(2); P < 0.005) and serum parathyroid hormone levels greater than 495 pg/ml (RR 1.25; P < 0.05). This study identifies strong relationships between elevated serum PO(4), Ca x PO(4) product, and parathyroid hormone and cardiac causes of death in HD patients, especially deaths resulting from CAD and sudden death. More vigorous measures to reduce the prevalence of these factors in HD patients may result in improved survival.

Residual renal function (RRF) in end-stage renal disease is clinically important as it contributes to adequacy of dialysis, quality of life, and mortality. This study was conducted to determine the predictors of RRF loss in a national random sample of patients initiating hemodialysis and peritoneal dialysis. The study controlled for baseline variables and included major predictors. The end point was loss of RRF, defined as a urine volume <200 ml/24 h at approximately 1 yr of follow-up. The adjusted odds ratios (AOR) and P values associated with each of the demographic, clinical, laboratory, and treatment parameters were estimated using an “adjusted” univariate analysis. Significant variables ( P < 0.05) were included in a multivariate logistic regression model. Predictors of RRF loss were female gender (AOR = 1.45; P < 0.001), non-white race (AOR = 1.57; P = <0.001), prior history of diabetes (AOR = 1.82; P = 0.006), prior history of congestive heart failure (AOR = 1.32; P = 0.03), and time to follow-up (AOR = 1.06 per month; P = 0.03). Patients treated with peritoneal dialysis had a 65% lower risk of RRF loss than those on hemodialysis (AOR = 0.35; P < 0.001). Higher serum calcium (AOR = 0.81 per mg/dl; P = 0.05), use of an angiotensin-converting enzyme inhibitor (AOR = 0.68; P < 0.001), and use of a calcium channel blocker (AOR = 0.77; P = 0.01) were independently associated with decreased risk of RRF loss. The observations of demographic groups at risk and potentially modifiable factors and therapies have generated testable hypotheses regarding therapies that may preserve RRF among end-stage renal disease patients.

UNLABELLED:Survival advantage in Asian American end-stage renal disease patients.BACKGROUND:An earlier study documented a lower mortality risk for end-stage renal disease (ESRD) patients in Japan compared with the United States. We compared the mortality of Caucasian (white) and Asian American dialysis patients in the United States to evaluate whether Asian ancestry was associated with lower mortality in the United States.METHODS:The study sample from the U.S. Renal Data System census of ESRD patients treated in the United States included 84,192 white or Asian patients starting dialysis during May 1995 to April 1997, of whom 18,435 died by April 30, 1997. Patient characteristics were described by race. Relative mortality risks (RRs) for Asian Americans relative to whites were analyzed by Cox proportional hazards regression models adjusting for characteristics and comorbidities. Population death rates were derived from vital statistics for the United States and Japan by age and sex.RESULTS:Adjusting for demographics, diabetes, comorbidities, and nutritional factors, the RR for Asian Americans was 0.75 (P = 0.0001). Race-specific background population death rates accounted for over half of the race-related mortality difference. For whites, mortality decreased as the body mass index (BMI) increased. For Asians, the relationship between BMI and survival was u-shaped. The ratio of Asian American/white dialysis death rates and the ratio of Asian American/white general population death rates both varied by age in a similar pattern. The population death rates of Asian American and Japanese were also similar.CONCLUSION:Among dialysis patients, Asian Americans had a markedly lower adjusted RR than whites. The effect of BMI on survival differed by race. Compared with the respective general population, dialysis patients had the same relative increase in death rates for both races. The difference in death rates between the United States and Japan does not appear to be primarily treatment related, but rather is related to background death rates.

Noncompliance with hemodialysis (HD), depending on the definition, occurs in 2% to more than 50% of patients. To better understand predictors and outcomes of noncompliance, we evaluated patient characteristics associated with noncompliance and the impact of noncompliance on survival. Using data from two USRDS special studies, we identified 6,251 patients who were on dialysis for more than 1 year for inclusion in this study. Noncompliance was defined in four ways: skipping one or more HD sessions in a month, shortening by 10 or more minutes one or more HD sessions in a month, an interdialytic weight gain (IWG) of more than 5.7% of dry weight, or a serum phosphate (PO4) of greater than 7.5 mg/dL. Sociodemographic predictors of noncompliance were identified using logistic regression. Survival analysis was done using Cox proportional hazards models with adjustments for sociodemographics, comorbid conditions, and dose of HD. Overall, 8.5% of patients skipped HD, 20% shortened HD (7% three or more times), 10% had more than a 5.7% IWG, and 22% had a PO4 greater than 7.5. There was a significant correlation among the measures of noncompliance. Blacks (adjusted odds ratio [AOR] = 2.10), patients aged 20 to 39 years (AOR = 1.62), and smokers (AOR = 1.34) were significantly more likely to skip HD than whites, patients aged 40 to 59 years, and nonsmokers, respectively (P < 0.01 for each). Similar results were seen for the other measures of noncompliance, except for PO4, in which blacks were significantly less likely to be noncompliant (NC) (AOR = 0.85, P < 0.05). Compared with compliant patients, those who skipped one or more HD sessions in a month had a 25% higher risk of death (P < 0.01). Those who had greater than a 5.7% IWG had a 35% higher risk of death (P < 0.001), whereas those with a PO4 > 7.5 had a 13% higher risk of death (P < 0.05). Overall, patients who shortened HD sessions did not have a higher risk of death, but those who shortened three or more in 1 month had a 20% higher risk of death (P < 0.05). Compliance with a medical regimen is a complex issue. Noncompliance in HD often, but not always, is associated with a higher risk of an adverse outcome. This is a US government work. There are no restrictions on its use. (Am J Kidney Dis 1998 Jul;32(1):139-45)

THIS 1998 Annual Data Report (ADR) of the USRDS is the 10th Anniversary Edition of a series of reports that started in 1989. This ADR provides a comprehensive review of many of the issues that are important to the care of patients with end-stage renal disease (ESRD), including recent trends in the incidence and prevalence of treated ESRD, methods of treatment, and patient outcomes. Examples of outcomes include patient survival, hospitalization, kidney graft survival, and cost. Separate chapters have been devoted to issues unique to cost of ESRD therapy, renal transplantation, characteristics of facilities providing dialysis, and international comparisons of incidence and treatment patterns.