A controlled randomized double-blind study of antilymphoblast globulin in cadaver renal transplantation.

Herein are presented the results of a controlled prospective randomized double-blind evaluation of antilymphoblast globulin as an immunosuppressive adjunct to azathioprine and prednisone in cadaver renal transplantation. There were 31 patients and 36 patients randomly assigned to therapeutic and control groups, respectively. ALG-treated patients experienced no major side-effects, a delayed onset of rejection following transplantation (P less than .005), a reduced total number of rejection episodes (P less than .05), fewer days in the hospital (P less than .05), a reduced cost of transplantation (P less than .02), improved graft survival (P less than .05), and patient survival equivalent to that of the control group. These data indicate that ALG is safe, cost-effective, and of immunologic benefit in cadaver renal transplantation.

Long-term results of renal transplantation in recipients with a functioning graft for 2 years.

The late results of renal transplantation are reviewed in 214 recipients with a functioning allograft for 2 years. Graft survival was better (P less than 0.001) in living related recipients (t 1/2 = 17 years) compared with cadaver graft recipients (t 1/2 = 7.7 years). Graft survival was also significantly different (P less than 0.001) in patients with a 2-year serum creatinine level of less than or equal to 2.0 (t 1/2 = 16.4 years), 2.1 to 3.0 (t 1/2 = 6.5 years), or greater than 3.0 mg/dl (t 1/2 = 2.9 years). A greater proportion of patients with a 2-year serum creatinine level of greater than 3 mg/dl had experienced greater than two rejection episodes (P less than 0.0001). Among recipients with a 2-year serum creatinine level of less than or equal to 2.0 mg/dl, living related grafts achieved better graft survival than cadaver grafts (P less than 0.05). Major complications of transplantation were more common in patients with a cadaver graft, 2-year serum creatinine level of greater than 3 mg/dl, or age greater than 45 years. One hundred and forty-two patients are currently alive, 93% of whom have achieved complete rehabilitation.

A prospective analysis of the accuracy and cost-effectiveness of digital subtraction angiography for living-related renal donor evaluation.

From 1982 to 1984, we conducted a prospective study to evaluate the usefulness of i.v. renal digital subtraction angiography (DSA) for living-related donor (LRD) evaluation. Twenty-eight LRDs were evaluated with the traditional approach of intravenous pyelography (IVP) and standard catheter arteriography (SCA) (group 1). During the same period, 33 LRDs underwent renal DSA and IVP from a single i.v. contrast injection (group 2). If renal arterial imaging with DSA was considered satisfactory, no further radiographic studies were done (group 2-A, n = 23). If renal arterial imaging with DSA was not satisfactory, SCA was then obtained (group 2-B, n = 10). DSA alone accurately defined the number and location of renal arteries in 21 of 23 patients from group 2-A, and in 5 of 10 patients from group 2-B. The major limitation of DSA was in patients with multiple renal arteries; accurate imaging was obtained in only 7 of these 13 patients (54%). In group 2 overall, preoperative renal imaging was not accurate in 2 of 33 patients (6%); in both cases, an unsuspected polar artery was found at nephrectomy. The mean cost per patient of all radiographic renal imaging studies was $953.00 for group 2 and $1721.00 for group 1. These data suggest that the approach of preferentially evaluating LRDs with DSA-IVP, and obtaining SCA only if DSA yields poor visualization, is more cost-effective but not as accurate as the traditional policy of obtaining SCA and IVP in all cases.

Pregnancy after donor nephrectomy.

The use of living-related kidney donors has been a routine practice in most major transplant centers in the United States for more than 20 years. Concern has arisen regarding the potential for developing hypertension and progressive renal dysfunction after renal donation. Pregnancy results in hyperfiltration and might be an added risk for the development of hypertension, proteinuria, or renal insufficiency in donors. From 1963 until 1984, the Cleveland Clinic Foundation performed 1031 renal transplants, 355 from living donors. Of these 355 living donors, 191 were female, and of these, 23 successfully conceived after kidney donation. Prenatal and delivery records of all 23 were reviewed. There were 39 pregnancies in 23 women with 32 viable births. Conception ranged from 2 weeks to more than 9 years postnephrectomy. Mean blood pressure at the time of donor evaluation was 120/75 mm Hg (SD: +/- 11/8 mm Hg). Mean blood pressure during pregnancy was 114/68 mm Hg (SD: +/- 7/6 mm Hg). One plus proteinuria was detected in 2 women during the third trimester and trace proteinuria was seen in 7 pregnancies; this proteinuria disappeared after delivery. Thirteen of twenty women who carried to term were reevaluated 2-14 years after donor nephrectomy. All parameters studied were normal. Mean length of follow-up after donor nephrectomy was 7.9 years. These data suggest that, after donor nephrectomy, women can have a normal pregnancy without significant problems related to the kidney donation. Also, hyperfiltration associated with the combination of unilateral nephrectomy and pregnancy does not lead to significant hypertension, proteinuria, change in glomerular filtration rate, or abnormalities of the urinary sediment.

Detrimental effect of cyclosporine on initial function of cadaver renal allografts following extended preservation. Results of a randomized prospective study.

We report herein the results of a randomized prospective trial comparing maintenance cyclosporine (CsA)-prednisone immunosuppression to a regimen of azathioprine-prednisone-antilymphocyte globulin (ALG) in cadaver renal transplant recipients. Fifty-six patients were entered into this study with 31 assigned to the ALG group and 25 to the CsA group. These two groups were well matched for most major determinants of graft outcome and the mean renal preservation time was 37 hr in each group. The incidence of acute tubular necrosis (ATN) was high in both groups (58% ALG, 72% CsA, NS). There were five cases of primary nonfunction in the CsA group and only one in the ALG group (P = .05). Of the kidneys that functioned, the mean serum creatinine nadir (1.5 vs. 2.2 mg/dl, P = .06) and the mean number of days to reach the serum creatinine nadir (24.2 vs. 43.3 days, P = .03) were both less in the ALG group. The actuarial one-year graft survival rate in the ALG and CsA groups is 78% and 48%, respectively (P less than .05). This difference is mainly due to the large number of primary nonfunctioning grafts in the latter group, which we attribute to the effect of CsA's nephrotoxicity superimposed on renal ischemia incurred prior to transplantation. These data emphasize that, in order to realize the full benefit of CsA in cadaver transplantation, renewed emphasis must be placed on minimizing ischemic renal damage.

A critical look at survival of diabetics with end-stage renal disease. Transplantation versus dialysis therapy.

The survival of 100 consecutive patients with diabetic nephropathy after treatment with hemodialysis, peritoneal dialysis, or renal transplantation was reviewed at our institution from 1976 to 1982. Standard actuarial survival analysis revealed an overall survival of 83% and 61% at one and two years, respectively. Coronary angiography was used as a screening procedure for renal transplantation. In the dialysis group, 27 patients were considered acceptable transplant candidates on the basis of the coronary angiography but were not transplanted for other reasons. When the survival analysis was limited to those "transplant candidates" the survival rates were 78%, 51%, and 8% at 1, 2, and 5 years, respectively. In comparison, survival after transplantation was 81%, 67%, and 45%, at 1, 2, and 5 years, respectively. In order to eliminate bias, survival comparisons were subsequently made using the Cox Proportional Hazard Model to take into account the time the transplant patients spent on dialysis prior to renal transplantation. When this analysis was performed, there was no significant difference in survival between transplantation and dialysis for the first two years, but overall survival after five years was significantly better after renal transplantation even when the comparison was limited to acceptable transplant candidates who remained on dialysis (P = .04). Survival for patients with significant coronary disease (greater than 70% stenosis of a coronary vessel or moderate to severe left ventricular dysfunction) was analyzed according to therapeutic modality. Although overall prognosis was poor in this group as a whole (1, 2, and 5 year survivals were 76%, 45%, and 19%, respectively), the cardiac patients had a trend to better survival after renal transplantation than when maintained on dialysis (P = .22). In addition to other factors such as quality of life, rehabilitation, and progression of other diabetic complications, the benefit of renal transplantation on patient survival must be considered when deciding between renal transplantation and maintenance dialysis therapy for diabetic patients with renal failure.

Renal transplantation for end-stage polycystic kidney disease.

From 1963 to 1984, 56 renal transplants were performed in 51 patients with end-stage renal failure due to autosomal dominant polycystic kidney disease (ADPKD). There were 49 cadaver and 7 living-related transplants. Overall patient and graft survival was 88 per cent and 66 per cent at one year, 59 per cent and 49 per cent at five years, respectively. There was no significant difference in patient or graft outcome with cadaver versus living-related donor kidneys. One-year graft success with and without pretransplant bilateral nephrectomy (BN) was 78 per cent versus 58 per cent, respectively (n.s.). Patient survival after return to dialysis after graft loss was not compromised by the earlier performance of BN. In patients who did not undergo pretransplant BN, there were no complications from the retained native kidneys after transplantation. In cadaver recipients, the two-year graft success rate with and without preliminary blood transfusions was 54 per cent versus 61 per cent, respectively (n.s.). Cadaver graft survival with and without adjunctive antilymphocyte globulin (ALG), excluding 3 recipients managed with cyclosporine, was 88 per cent versus 50 per cent at one year, and 70 per cent versus 32 per cent at five years, respectively (p less than 0.05). This beneficial effect of ALG was still evident when only transfused cadaver recipients were analyzed and was achieved with no resulting compromise in patient survival. Follow-up computerized tomography (CT) scanning of the transplant kidney in 10 recipients with a long-term (1-9 years) functioning allograft showed no evidence of recurrent ADKPKD.

Comparison of renal transplantation and dialysis in rehabilitation of diabetic end-stage renal disease patients.

We have reviewed the outcome of replacement therapy for end-stage renal disease (ESRD) in 100 diabetic patients with emphasis on late complications, extrarenal diabetic manifestations, and overall patient rehabilitation. Long-term complications, other than myocardial infarction, were not different after renal transplantation compared with chronic dialysis. Overall rehabilitation was better after renal transplantation compared with chronic dialysis (p less than 0.05). Retinopathy and neuropathy were more stable with renal transplantation and peritoneal dialysis compared with hemodialysis (p less than 0.05). These factors should be considered along with expected patient survival when deciding between different treatment modalities for diabetic ESRD.

Developing core competencies for medical/surgical nursing.

The development of competency-based education is a task requiring the skills of educators and expert clinicians. This article provides information on a competency-based core orientation for medical/surgical nursing.

Improving quality through an integrated partnership model.

Improved models for quality management/quality improvement (QM/QI) activities must include a partnership with other disciplines and integration of functions and responsibilities. Current and projected changes in health care dictate the need to change policy, roles, behavior, standards, and patient care delivery systems to be more cost efficient. Nursing leaders must be proactive in this new arena to ensure the continued survival of nursing. The incorporation of the integrated partnership model into QM/QI activities provides methods to review issues at the most appropriate level to ensure speedy resolution.

Pretransplant donor specific blood transfusions for one haplotype stimulatory mixed lymphocyte culture living related donor transplants.

Three donor specific blood transfusions were given at 2-wk intervals pretransplantation, to those donor-recipient pairs who were one haplotype identical, but had stimulatory MLC. Two of 10 recipients who received donor specific blood transfusions developed T cell cytotoxic antibodies against their donor and were not transplanted. Eight recipients were successfully transplanted with no evidence of hyperacute rejection. All eight grafts are functioning from 2 to 15 mo post-transplant. Serum creatinines range from 1.0--3.9 mg%. There have been five patients who developed acute rejection episodes during the first 5 days post-transplant, and there have been a mean of 2.4 rejection episodes per patient. These results compare favorably to historical controls at the same institution who had a 40% incidence of graft success. The long-term graft survival remains to be elucidated.

Renal transplantation in the older recipient.

From 1976 to 1983, 13 living related and 54 cadaver renal transplants were done in 62 patients more than 50 years old. Patients with no coronary or myocardial disease upon coronary angiography were selected preferentially for transplantation. Over-all 1-year patient and graft survival rates were 88 and 70 per cent, respectively. Among cadaver recipients graft survival was improved (p less than 0.001) when prophylactic antilymphoblast globulin was used. There were fewer steroid-related complications (p less than 0.001) in recipients managed with a low dose rather than a high dose maintenance prednisone regimen. With careful patient selection and a steroid-sparing immunosuppressive regimen, renal transplantation can be done safely in older recipients with no increased risk of death or graft loss.

Improved results of cadaver renal transplantation with azathioprine, prednisone and antilymphoblast globulin.

From 1980 to 1982, 100 consecutive cadaver renal transplants were performed. All but 2 recipients received preoperative transfusion and all received an initial 2-week course of antilymphoblast globulin. A prospective controlled evaluation of high versus low maintenance prednisone, and antilymphoblast globulin versus intravenous methylprednisolone for first rejection therapy was done. Over-all 1-year graft and patient survivals were 77 and 96 per cent, respectively. Graft survival was equal in the high and low steroid groups. Antilymphoblast globulin was as effective as intravenous methylprednisolone in reversing first rejections. Graft survival was improved with better donor-recipient matched grafts. We conclude that excellent results can be obtained in transfused cadaver renal allograft recipients managed with azathioprine, prednisone and antilymphoblast globulin. The regimen of prophylactic antilymphoblast globulin, low maintenance prednisone and antilymphoblast globulin alone for first rejections is immunologically effective and steroid sparing.

Renal transplantation in end stage renal disease patients with existing urinary diversion.

From 1971 to 1984 renal transplantation was performed in 20 patients with end stage renal disease who presented with an existing form of urinary diversion. These patients were evaluated with a cystometrogram, voiding cystourethrogram and cystoscopy. In some cases bladder function was studied further by cycling through a suprapubically placed catheter. The bladder was considered unstable in 13 patients and undiversion was done at transplantation. The period of prior diversion ranged from 3 to 20 years (mean 12.7 years). There were no surgical complications postoperatively and normal bladder function returned in all patients. Currently, 8 patients have a functioning renal allograft 16 months to 9 years after transplantation (mean 4.2 years). Seven patients were considered to have a nonusable bladder owing to severe neurogenic disease or refractory contracture. In these patients transplantation was done into a pre-fashioned intestinal conduit (5) or cutaneous ureterostomy (2). Currently, 4 patients have a functioning renal allograft 16 months to 6.2 years after transplantation (mean 3.8 years). Transplantation candidates who present with an existing form of urinary diversion should be evaluated carefully, since many will have a usable bladder. Regardless of whether the bladder is usable, transplantation can be performed safely with no increased surgical or immunological risk.

Improved results of cadaver renal transplantation in the diabetic patient.

The results of 54 renal transplants performed on 48 patients with end stage renal disease and insulin-dependent diabetes mellitus are reported. Pre-transplant screening with coronary angiography was done to determine the presence and severity of coronary artery disease and left ventricular dysfunction. There were 12 living related donor (group 1) and 42 cadaver renal transplants. The cadaver transplant recipients were grouped further into those who received additional prophylactic immunosuppression with antilymphoblast globulin (group 2, 18 patients) and those who received standard immunosuppression with azathioprine and prednisone (group 3, 18 patients). The 2-year patient and graft survival rates in groups 1 to 3 were 81 and 67, 88 and 69, and 61 and 32 per cent, respectively. The use of prophylactic antilymphoblast globulin for adjunctive immunosuppression resulted in significantly improved graft survival among cadaver recipients (p less than 0.003). Selection of patients for transplantation on the basis of preliminary screening with coronary angiography was found to have a major impact on patient survival.