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Mujoomdar M, Russell E, Dionne F, et al. Optimizing Health System Use of Medical Isotopes and Other Imaging Modalities [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2012.
Kidney transplantation is a treatment option for end-stage renal disease (ESRD). It can help to restore patients’ quality of life and reduces morbidity and mortality rates in patients with renal failure.1 However, several complications can occur after transplantation and may result in impaired renal function. These complications can be classified as surgical or medical. Immediate surgical complications include renal artery thrombosis or stenosis, renal vein thrombosis, or urinary leak. Medical complications include organ/tissue rejection, drug toxicity related to anti-rejection treatments (e.g., cyclosporine), acute tubular necrosis (ATN), infection, and transplantation-related malignancies (e.g., post-transplantation lymphoproliferative disorder or lymphoma).2–4 Obstruction in a renal transplant can also occur and result in paranchymal damage due to increased pressure in the collecting system.5
The most common complication of kidney transplantation is allograft dysfunction (dysfunction of the transplanted kidney). This can take place as early as in the operating room (considered “very early” dysfunction), as an early dysfunction (one to 12 weeks post-transplant), or as a late dysfunction (later than three months).6 Symptoms include an acute rise in serum creatinine, decreased urine production, increased blood pressure, pyuria (white blood cells in urine), and proteinuria (protein in the urine). The focus of this report is on acute rejection.
Acute rejection, ATN, and cyclosporine toxicity are the most common causes of early transplant failure.4,7,8 These complications may result in deterioration of renal function as a late permanent event. Therefore, careful monitoring of patients following a kidney transplant is required to detect complications before severe damage occurs.1,9 The common methods of monitoring include the clinical assessment of the patient, ultrasound (U/S) examinations (grey scale and Doppler), isotope-based studies (e.g., renal scintigraphy), needle core biopsy, and fine-needle aspiration biopsy with cytology.1,8,9
Population: Patients who received kidney transplants being evaluated for acute rejection.
Intervention: Renal scintigraphy (also referred to as renal scan) using technetium-99m(99mTc)–labelled radiopharmaceuticals.
Renal scintigraphy has been used to assess the structure, blood flow, and function of kidney transplants.3,5 With nuclear imaging, the radiolabelled isotopes permit the mapping of blood flow through the kidney. This allows the imaging of blood flow, obstructions, or leaks in the newly transplanted kidney.10
During renal scintigraphy, a radiopharmaceutical is administered, and gamma rays emitted from the patient are externally detected with a gamma camera to produce images that reflect the distribution of the radioactive agent.11 Two 99mTc-labelled radiopharmaceuticals that have been used for dynamic renal scintigraphy include 99mTc-diethylenetriamine pentaacetic acid (DTPA) and 99mTc-mercaptoacetyl triglycine (MAG3).12 99mTc-DTPA does not defuse into cells due to its lipid insolubility, and is almost entirely removed from circulation by glomerular filtration. Early images with this agent provide information about renal perfusion, whereas delayed images provide information about glomerular filtration rate (GFR), indicating changes in renal function.12 99mTc-MAG3 is rapidly taken by the kidneys and excreted into the urinary tract.11 Because of the higher extraction efficiency, 99mTc-MAG3 may be preferred over 99mTc-DTPA, especially in patients with decreased renal function.12,13 Using renal scintigraphy, graft function can be assessed both qualitatively and quantitatively.14
The quantitative evaluation of the graft (i.e., transplanted kidney) function is based on the time-activity curves, known as renograms, which reflect three sequential phases of renal function:5,15,16
A renogram of a normal kidney shows rapid increase during the vascular and parenchymal phases, followed by rapid decline during the excretory phase.11
Various quantitative indices have been proposed to evaluate the handling of the tracer by the kidney. The two widely used indices in vascular phase, Hilson's perfusion index and Kirchner's kidney/aorta ratio, reflect the relationship between renal blood flow in the graft and the blood flow in the iliac artery or abdominal aorta. These indices allow the differential diagnosis between ATN and acute rejection. Blood flow of the transplanted kidney is less affected in patients with ATN than in patients with acute rejection.5 To evaluate the function of transplanted kidney, two types of quantitative measures are used: indices of renal function (e.g., tracer uptake capacity, GFR, effective renal plasma flow [ERPF], clearance index) and indices of tracer transit (e.g., mean transit time, excretory index).5 Decreased uptake in the parenchymal phase and prolonged washout in the excretory phase are quantitative scintigraphic features of ATN and acute rejection.11 Accumulation of radiotracer activity in the collecting system is often observed in patients with obstruction.5
Comparators: For this report, the following diagnostic test is considered as an alternative to renal scintigraphy:
Outcomes: Eleven outcomes (referred to as criteria) are considered in this report:
Definitions of the criteria are in Appendix 1.
The literature search was performed by an information specialist using a peer-reviewed search strategy.
Published literature was identified by searching the following bibliographic databases: MEDLINE with In-Process records and daily updates via Ovid; The Cochrane Library (2011, Issue 2) via Wiley; and PubMed. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were radionuclide imaging and kidney transplantation.
Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, and non-randomized studies, including diagnostic accuracy studies. The search was limited to English language documents. No date or human limits were applied for the systematic reviews search. For primary studies, the retrieval was limited to the human population and to documents published between January 1, 1996 and March 14, 2011. Regular alerts were established to update the search until October 2011. Detailed search strategies are located in Appendix 2.
Grey literature (literature that is not commercially published) was identified by searching relevant sections of the CADTH Grey Matters checklist. Google was used to search for additional web-based materials. The searches were supplemented by reviewing the bibliographies of key papers. See Appendix 2 for more information on the grey literature search strategy.
Targeted searches were done as required for the criteria, using the aforementioned databases and Internet search engines. When no literature was identified addressing specific criteria, experts were consulted.
There were five potential clinical articles identified through the meta-analyses/systematic review/health technology assessment (MA/SR/HTA) filtered search, none of which were relevant. A total of 404 potential primary studies were identified with the primary studies search and 47 articles underwent full-text review. No randomized controlled trials (RCTs) reporting on the accuracy of diagnostic tests of interest, patients outcomes, or quality of life were found. Seven observational studies reported on the relative diagnostic accuracy of renal scintigraphy and the alternative tests of interest.17–23
The original search did not capture studies evaluating the diagnostic accuracy of fine-needle aspiration biopsy (FNAB) compared to renal scintigraphy or vice versa. One older study comparing FNAB, renal scintigraphy, and U/S to core needle biopsy was found from the reference lists of the included articles.24 The remaining articles from the database searches, along with other articles found through searching the grey literature, articles from the targeted searches, or articles from the reference lists of the identified potential articles, were used to abstract information relevant to the remaining criteria.
Table 1. Summary of Criterion Evidence (PDF, 141K)
The potential population requiring post-transplant renal scintigraphy or its alternatives includes patients who have received kidney transplants. This includes newly transplanted kidneys (incident cases), as well as the total number of patients living with functioning transplanted kidneys (prevalent cases). According to the Canadian Organ Replacement Register (CORR), a registry of the Canadian Institute for Health Information,25 1,171 Canadians adults and 53 children received kidney transplants in 2009. As of December 31, 2009, the prevalence of people living with a functioning kidney transplant in Canada was 15,434 (4.57 per 10,000).25 Of 10,641 kidney transplant procedures registered with CORR between 2000 and 2009, 1,141 (11%) were retransplants.25 It is assumed that only a proportion of these patients require imaging in a given year.
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Early diagnosis and careful management of complications prevents premature loss of the kidney transplant and reduces patient mortality and morbidity.1,4,26,27 Timely diagnosis is particularly important in young children: renal graft outcomes can be less favourable than in older recipients, due to more intense immune-reactivity and higher graft rejection rates in children, as well as inconsistent adherence to medication in this group of transplant recipients.27 Baseline imaging studies should be performed immediately after transplantation, as the diagnosis of complications can be made based on changes in the results of imaging studies over time.4
According to the Saskatchewan hospital guidelines, renal scintigraphy should be performed within the first 24 hours after transplantation in cases of suspected acute rejection (Patrick Au, Acute and Emergency Services Branch, Saskatchewan Ministry of Health: unpublished data, 2011). The suggested renal scintigraphy wait time targets for patients with suspected renal artery stenosis, urinary leak, or obstructive uropathy after transplantation is two to seven days (Patrick Au, Acute and Emergency Services Branch, Saskatchewan Ministry of Health: unpublished data, 2011). The same guidelines indicate that U/S for diagnosis of renal transplant rejection should be conducted within two to seven days after transplantation (Patrick Au, Acute and Emergency Services Branch, Saskatchewan Ministry of Health: unpublished data, 2011). However, the use of U/S is suggested within the first 24 hours in cases with suspected thrombosis of renal artery or vein (Patrick Au, Acute and Emergency Services Branch, Saskatchewan Ministry of Health: unpublished data, 2011).
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Kidney transplant patients are at risk of complications, including loss of transplant function. Timely diagnosis of these complications is important in order to reduce patient mortality and morbidity.4 Some cases of acute rejection and ATN may not present clinical symptoms.1 Failure to perform the appropriate imaging tests may result in increased rates of graft dysfunction (due to delayed or inappropriate treatment) and post-transplant mortality.
Two studies evaluating the relationship between kidney graft function and patient survival were identified through targeted searches.28,29
In 2005, Knoll et al. published a retrospective cohort study on the effects of functional renal transplant loss on patient survival, using the data from the CORR (n = 4,743 primary renal transplant recipients transplanted between 1994 and 1999).28 In five years of follow-up, 411 patients (8.7%) died.28 One-hundred and three deaths were attributed to graft failure.28 The unadjusted death rate was 5.14 per 100 patients with kidney transplant failure.28 After controlling for possible confounding variables (e.g., recipient age, gender, race, cause of ESRD, comorbidity, pretransplant dialysis time, donor source, and donor age), transplant failure was shown to significantly increase the risk of death more than three times, as compared with patients who maintained transplant function (adjusted hazard ratio = 3.39; 95% Confidence Interval [CI], 2.75 to 4.16; P < 0.0001).28 The authors concluded that kidney transplant failure following renal transplantation is a significant predictor of mortality.28
A previous study (1999) by Woo et al. investigated the association between graft and patient survival rates (n = 589 patients who received their first kidney transplants from deceased donors between 1984 and 1993).29 The median follow-up time was seven years.29 Patient survival rates were 95%, 82%, and 65% at one, five, and 10 years after transplantation, respectively.29 One-hundred and sixty-eight patients (28.5%) died during follow-up; 79 (47% of all deaths) were due to transplant failure. In this study, good graft function (serum creatinine levels < 200 µmol/L) at three months was associated with significantly improved long-term graft survival (P < 0.001). Long-term survival was higher for patients with functioning grafts (85% and 70% at five and 10 years, respectively) than for those who had graft failure (75% and 56%, at five and 10 years, respectively; P = 0.004 for log-rank test). The authors concluded that patient survival after kidney transplant is related to graft outcomes, and that patients with early graft rejection, or early graft loss, are at increased risk of mortality.
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One of the main goals of kidney transplantation is to improve patient quality of life.38 Two studies evaluating the relationship between kidney graft function and patient morbidity or quality of life were identified through targeted searches.30,31
In 2006, Ouellette et al.31 performed a qualitative literature review on the psychological impacts of renal graft loss. The following findings of the reviewed studies were discussed in the article:
A 1999 study by Aultman et al.30 followed 179 consecutive renal transplant recipients grouped according to their length of graft success: failure within six months of implantation (n = 18), failure between six months and three years (n = 41), and grafts surviving longer than three years (n = 120). As would be expected, those transplant recipients with grafts surviving longer than three years experienced the greatest benefit.30 Patients with primarily successful renal transplants (grafts surviving longer than six months, but less than three years) experienced a significantly greater number of complications and more serious, life-threatening outcomes (i.e., bacterial sepsis, pneumonia, severe wound infection) when compared with either of the two other groups (see Table 2).30
Morbidity Associated With Graft Rejection.
If a test was not available to monitor the transplanted kidney, patients would risk more severe and permanent complications — such as graft lost, for example. Patients with known graft failure may resume dialysis, or be listed for repeat transplantation.28
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To be scored locally.
Health disparity might be present if disadvantaged social groups systematically experience worse health or more health risks than do more advantaged social groups.39 Disadvantaged groups can be defined based on gender, age, ethnicity, geography, disability, sexual orientation, socioeconomic status, and special health care needs. Our targeted search found disparity concerns in the following disadvantage groups:
Matsuda-Abedini et al.(2009)40 conducted a retrospective, single Canadian centre database review to determine the short- and long-term outcomes of kidney transplantation in Aboriginal children compared to non-Aboriginals in British Colombia. Of the 159 kidney transplant recipients included in this study, 15% were Aboriginal.40 At the end of first year post-transplant, there was no difference between Aboriginal and non-Aboriginal children regarding early transplant outcomes such as delayed graft function, episodes of acute rejection, and estimated glomerular function rate.40 However, Aboriginal kidney recipients had a significantly lower long-term transplant survival than the non-Aboriginal group (delayed rejection rate: 50% versus 26.7%, P = 0.03).40 Assuming uniform access to health care across the province of British Columbia, the authors attributed the difference in outcomes observed in Aboriginal and non-Aboriginal children to a combination of factors:
Kim et al.(2004)41 studied 5,082 Canadian patients who received kidney transplantation between 1988 to 1997, across 20 transplant centres. Patients were followed from the date of transplantation to the time of graft failure, death, or end of study (December 31, 1997).41 Centre-specific, covariate-adjusted hazard ratios were calculated.41 These can be interpreted as the covariate-adjusted rate for a given centre, divided by the covariate-adjusted rate for all remaining centres.41 Graft failure (including patient death) hazard ratios varied from 0.51 (approximately 49% lower graft failure, relative to the remaining centres) to 1.77 (approximately 77% higher graft failure rates, relative to the remaining centres).41 Covariate-adjusted hazard ratios for mortality varied from 0.44 to 1.84.41 Six centres showed significantly elevated rates of graft loss (range: 1.36 to 1.84; i.e., 36% to 84% higher than other centres), whereas five centres showed significantly decreased rates (range: 0.44 to 0.65; i.e., 35% to 66% lower than other centres).41 Patient death and graft loss rates were lower in larger centres (with ≥ 200 transplants over the study period).41 The variation in transplant outcomes persisted after adjustment for known prognostic factors such as recipient age, proportion of deceased- and living-donor transplants performed, and the percentage of patients with diabetes.41 In addition, disparities in centre-specific outcomes increased with increasing time from transplantation (at one, three, and five years).41 The authors concluded that significant centre-specific variation in the success of renal transplantation exists in Canada.41 This disparity could be impacted by a lack of availability to imaging, particularly if smaller centres have more difficulties acquiring 99mTc-based radiopharmaceuticals and accessing alternate imaging modalities.
Liu et al. (2007)42 evaluated the effect of gender on HQoL in 66 female and 72 male kidney transplant recipients in one American transplant centre. HQoL was measured using the SF-36 Health Survey.42 Women reported significantly lower scores on the SF-36 physical functioning (P = 0.049), role-physical (P = 0.014), and bodily pain (P = 0.028) scales.42 The authors concluded that women may experience worse physical functioning and more body pain and face more problems with work and other daily activities than men.42 They suggested that the study findings could be used in developing interventions to optimize HQoL in renal transplant patients.42
Schaeffner et al.(2008)43 investigated the relationship between level of education and transplantation outcomes in 670 American patients who received renal transplants between 1996 and 1997.43 There was no significant association between educational level and graft failure.43 However, the rates of graft loss from causes other than death significantly decreased from lowest to highest level of education, so that patients who had a college degree had 43% lower rates of graft loss than the ones who did not complete high school (relative risk: 0.57, 95% CI, 0.31 to 1.04; P-value for trend = 0.03).43 The authors suggested that the greater risk of graft loss in patients with lower education might be related to comorbidities and poor medication adherence.43
In a single-centre study in the United Kingdom, Stephens et al. (2010) investigated the impact of socioeconomic deprivation on post-transplant outcomes in 621 renal transplant recipients.44 Patients in the most income-deprived group had a significantly higher rate of acute rejection than the ones in the least income-deprived group (36% versus 27%, P = 0.013).44 Income deprivation was significantly associated with five-year graft survival (log-rank test for least deprived versus most deprived, P = 0.018).44 The authors concluded that socioeconomic deprivation might adversely influence outcomes following renal transplantation.44
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Overall, renal scan is reported to be well-tolerated.12 However, patients may have concerns about radiation exposure and the intravenous injection of a radiopharmaceutical agent. Intravenous fluids might be required if the adequacy of hydration is a concern.45 Because a full bladder may slow drainage of the radiopharmaceutical from the upper part of the urinary tract, the bladder should be emptied frequently. Bladder catheterization may be required, especially in pediatric patients. Catheterization may be associated with some discomfort, particularly in children.32
Some discomforts associated with U/S include cold, unspecified pain, and tenderness. This test may be preferred in pediatric patients, as there is no exposure to ionizing radiation, and the test does not require sedation.
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Four observational studies17,18,24,33 on the relative diagnostic accuracy of renal scintigraphy and U/S were included in this report. The studies focus primarily on the diagnostic accuracy of 99mTc-labelled radiotracer scintigraphy compared with renal biopsy. One study directly compared U/S to renal scintigraphy.33 One older study comparing FNAB, renal scintigraphy, and U/S to core needle biopsy was found from the reference lists of the included articles.24 Detailed descriptions of the individual studies can be found in Appendix 4. The methods and results of the included studies are summarized in tabular form in Appendix 5.
| Study (year) | Population (n) | Outcome | Standard of Reference | Renal Scan | U/S | ||
|---|---|---|---|---|---|---|---|
| Sens. (%) | Spec. (%) | Sens. (%) | Spec. (%) | ||||
| Kim et al. (2005)33 | Adults (100) | Evaluation of renal perfusion | Renal scan | N/A | N/A | 85 | 90 |
| Isiklar et al. (1999)18 | Adults (29) | Acute renal transplant rejection | Renal biopsy | 59 | 57 | 81 | 57 |
| Aktas et al. (1998)17 | Patients with biopsy-proven acute rejection (26) | Acute renal transplant rejection | Renal biopsy | 45 to 100 | N/A | 36 to 88 | N/A |
| Delaney et al. 1993)24 | Adults (150); episodes of allograft dysfunction, 128 transplant recipients) | Acute renal transplant rejection | Core needle biopsy | 70 | N/A | 43 | N/A |
ATN = acute tubular necrosis; N/A = not available; Sens. = sensitivity; Spec = specificity; U/S = ultrasound.
One study33 compared the diagnostic accuracy of harmonic U/S (with microtubular contrast agent) to renal scintigraphy in the diagnosis of renal perfusion abnormalities.33 In this study, the sensitivity and specificity of harmonic U/S was reported to be 85% and 90%, respectively.33
Two studies17,18 compared the diagnostic accuracies of renal scintigraphy and U/S, using renal biopsy as the gold standard. Isiklar et al. (1999) found power Doppler U/S to be more sensitive than renal scintigraphy (81% versus 59%) in detecting post-transplant renal perfusion impairments.18 A year earlier, Aktas et al. (1998) reported the overall sensitivity of renal scintigraphy to be higher than that of both gray scale and Doppler U/S.17
Delaney et al.(1993)24 compared renal scintigraphy, Doppler U/S, and FNAB, using biopsy as the gold standard. Scintigraphy was found to be the most sensitive method for detection of acute rejection (70%) during the early post-transplant period, FNAB had a sensitivity of 52%, and U/S a sensitivity of 43%.
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Adverse events from renal scintigraphy are rare but may include reaction to the radiopharmaceutical, rash, fever, or chills.34 There is also a relative contraindication in the administration of captopril in patients with a solitary kidney, as it may precipitate transient acute renal failure if the kidney has physiologically significant renal artery stenosis (MIIMAC expert opinion).
There are no reported risks associated with U/S in the literature that was reviewed.
The radiation doses of radiopharmaceuticals used for renal scintigraphy are summarized in Table 4. As the table shows, the effective dose equivalent (weighted organ radiation doses) with 37 megabecquerels (MBq) of 99mTc-MAG3 (0.37 millisieverts [mSv]) or 99mTc-DTPA (0.33 mSv) is less radiation than a plain abdominal X-ray in adults (1.4 mSv).3
Radiation Dose Estimates for the Radiopharmaceuticals Used for Post-Transplant Renal Scintigraphy.
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The personnel required for the performance of imaging tests for post-transplant renal scintigraphy are presented by imaging modality. A summary of the availability of personnel required for the conduct of methods for post-transplant renal scintigraphy, by renal scan or any of the alternative imaging modalities, is provided in Table 5.
Medical Imaging Professionals in Canada.
In Canada, physicians involved in the performance, supervision, and interpretation of renal scans should be nuclear medicine physicians or diagnostic radiologists with training/expertise in nuclear imaging. Physicians should have a Fellowship of Certification in Nuclear Medicine or Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Nuclear medicine technologists are required to conduct renal scans. Technologists must be certified by the Canadian Association of Medical Radiation Technologists or an equivalent licensing body.
In Canada, physicians involved in the performance, supervision, and interpretation of diagnostic computed tomography (CT) scans, MRI, and U/S should be diagnostic radiologists35 and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Foreign-trained radiologists also are qualified if they are certified by a recognized certifying body and hold a valid provincial licence.46
Medical radiation technologists must be certified by the Canadian Association of Medical Radiation Technologists or an equivalent licensing body.
Service engineers are needed for system installation, calibration, and preventive maintenance of the imaging equipment at regularly scheduled intervals. The service engineer's qualification will be ensured by the corporation responsible for service and the manufacturer of the equipment used at the site.
Qualified medical physicists (on site or contracted part-time) should be available for the installation, testing, and ongoing quality control of nuclear medicine equipment.46
Sonographers (or ultrasonographers) should be graduates of an accredited School of Sonography or have obtained certification by the Canadian Association of Registered Diagnostic Ultrasound Professionals. They should be members of their national or provincial professional organization. Sonography specialties include general sonography, vascular sonography, and cardiac sonography.35 In Quebec, sonographers and medical radiation technologists are grouped together; in the rest of Canada, sonographers are considered a distinct professional group.35
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There are notable variations in the availability of medical imaging technologies across Canada. Table 6 provides an overview of the availability of equipment required for post-transplant renal scintigraphy. Data for nuclear medicine cameras (including single-photon emission computed tomography [SPECT]) are current to January 1, 2007. The number of SPECT/CT scanners is current to January 1, 2010. Data were not available for U/S.
Diagnostic Imaging Equipment in Canada.
For renal scans, nuclear medicine facilities with gamma cameras (including SPECT) are required. Three jurisdictions — the Yukon, the Northwest Territories, and Nunavut — do not have any nuclear medicine equipment.35 In 2007, the latest year for which data are available, the average time for renal scintigraphy at McGill University Health Centre hospitals was 13 days. However, the wait times were reported to be less than one day for emergency cases.36
U/S machines are widely available across the country. According to the Fraser Institute, the average wait time for U/S in 2010 was 4.5 weeks.37
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Fee codes from the Ontario Schedule of Benefits were used to estimate the relative costs of renal scintigraphy and its alternatives. Technical fees are intended to cover costs incurred by the hospital (i.e., radiopharmaceutical costs, medical/surgical supplies, and non-physician salaries). Maintenance fees are not billed to OHIP — estimates here were provided by St. Michael’s Hospital in Toronto. Certain procedures (i.e., PET scan, CT scan, MRI scan) are paid for, in part, out of the hospital’s global budget; these estimates were provided by The Ottawa Hospital. It is understood that the relative costs of imaging will vary from one institution to the next.
According to our estimates (Table 7), the cost of renal scintigraphy with 99mTc-based radioisotopes is $241.95. U/S is a minimally less costly alternative.
Cost Estimates Based on the Ontario Schedule of Benefits for Physician Services under the Health Insurance Act (September 2011).
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Table 8. Diagnostic Accuracy of Renal Scintigraphy and Its Alternatives (PDF, 120K)
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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