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  Figure 7.1 Trends in transplantation: unadjusted rates, wait list, & total & functioning transplants, patients age 20 & older
  Figure 7.2 Patients wait-listed or receiving any transplant within one year of initiation, by age
  Figure 7.3 Wait list counts & multiple listings
  Figure 7.4 Outcomes for wait-listed adult patients within three years of listing, by blood type
  Figure 7.5 Outcomes for first-time wait-listed patients three years after listing in 2007, by age, race, & PRA
  Figure 7.6 Unadjusted. median wait times (years) for adults tx’ed in 2010, by state of tx center
  Figure 7.7 Adjusted. mortality rates (per 100 person yrs of waiting) for wait-listed pts, by state, 2010
  Figure 7.8 Distribution of NHANES participants with diabetes, congestive heart failure, & markers of CKD, with GFR estimated by MDRD & CKD-EPI equations
  Figure 7.9 Three-year cumulative incidence of transfusion in wait-listed pts, by PRA
  Figure 7.10 Donation rates, by age, gender, & race
  Figure 7.11 Deceased donor donations (per 1,000 deaths), by state, 2009–2010
  Figure 7.12 Deceased donor transplants, by age, gender, race, & primary diagnosis
  Figure 7.13 Adjusted transplant rates, by age, gender, race, & primary diagnosis: deceased donors
  Figure 7.14 Living donor transplants, by age, gender, race, & primary diagnosis
  Figure 7.15 Adjusted transplant rates, by age, gender, race, & primary diagnosis: living donors
  Figure 7.16 Adjusted transplant rates (per 100 dialysis patient years) by state of patient residence & donor type, 2010
  Figure 7.17 Outcomes: deceased donor transplants
  Figure 7.18 Outcomes: living donor transplants
  Figure 7.19 Acute rejection within the first year post-transplant
  Figure 7.20 Transplants with delayed graft function (DGF), by donor type
  Figure 7.21 Hospitalization rates in the first & second years post-transplant, 2008
  Figure 7.22 Primary diagnoses of cardiac & infectious hospitalizations in the first & second years post-transplant
  Figure 7.23 Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD)
  Figure 7.24 Cumulative incidence of post-transplant diabetes
  Figure 7.25 Adjusted rates of outcomes after transplant
  Figure 7.26 Causes of death with function, 2006–2010
  Figure 7.27 Immunosuppression use
  Figure 7.28 Follow-up care & screening in the first 12 months post-transplant, by age
  Figure 7.29 Sources of prescription drug coverage in kidney transplant recipients
  Figure 7.30 Sources of prescription drug coverage in kidney transplant recipients, by age & years post-transplant (age 65+)
  Figure 7.31 Transplant recipients enrolled in Part D
  Figure 7.32 Total Part B & Part D medication costs per person per year (PPPY) in kidney transplant recipients
  Figure 7.33 Cardiovascular medication use in the first six months post-transplant, 2008–2010 (Part D data)
  Figure 7.34 Medications for lipid control in the first 6 months post-tx, 2008–2010 (Part D data)
  Figure 7.35 Medications for diabetes control in the first six months post-transplant, 2008–2010 (Part D data)
  Table 7.a Top 15 medications used by Part D-enrolled kidney recipients transplanted in 2007, by days supply
  Table 7.b Top 15 medications used by Part D-enrolled kidney recipients transplanted in 2007, by days supply & cost
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Chapter 7

Transplantation

Introduction

In 2010, the most recent year of available data, 16,843 kidney transplants were performed in patients age 20 and older in the United States — 135 more than in the previous year. There were 85 fewer living donor transplants performed in 2010 compared to 2009, a decrease of 1.4 percent, compared with a 2.0 percent increase in deceased donor transplants. Among patients age 19 and younger, 935 kidney transplants were performed in 2010, 90 fewer than in the previous year.

The number of adult candidates on the waiting list with certified kidney failure continues to increase, growing 6 percent in 2010 to reach 75,807 patients on December 31 (Reference Table E.3); 36 percent of these patients were inactive. Among active listings, 8 percent were listed at more than one transplant center. The rate of new ESRD cases declined 1.1 percent from 2009 to 2010. Twenty-two percent of new ESRD patients in 2009 were added to the waiting list or received a transplant within one year of ESRD certification, a number remaining fairly stable over the past two decades. The percentage of adult candidates who receive a deceased donor transplant within three years of listing varies by candidate blood type, from 20 percent for those with Type O to 47 percent of those with Type AB.

Rates of deceased donation remained flat in 2010, at 21.8 donors per million population, and at 2.4 donations per 1,000 deaths in 2009–2010 combined. With the number of candidates awaiting transplant continuing to increase, transplant rates per 100 dialysis patient years continue to decline, in 2010 reaching 2.4 and 1.3 for deceased and living donor transplants, respectively.

One-year all-cause graft failure continues to reach all-time low levels, at 9 percent for recipients of first-time, deceased donor transplants, and 3 percent for recipients of first-time, living donor transplants in 2009. Five-year all-cause graft failure rates also continue to fall, reaching 29 and 17 percent in deceased and living donor recipients. In 2010, delayed graft function was reported in 23 and 3 percent of deceased and living donor transplants. The rate varies, from 22 percent for standard criteria donors to 28 percent and 41 percent, respectively, for expanded criteria donors and donations after cardiac death.

Attention continues to focus on reducing the incidence of acute rejection and other post-transplant metabolic, cardiovascular, and infectious complications, and on improving long-term outcomes. The incidence of acute rejection episodes during the first year post-transplant, reported in 11 and 10 percent of deceased and living donor recipients in 2009, has declined approximately 50 percent over the past decade. New-onset diabetes following transplant, however, remains common, with over 40 percent of adult, non-diabetic, Medicare-covered recipients having evidence of diabetes by the end of the third year after transplant. Thirty-one percent of non-diabetic transplant recipients with Medicare Part D coverage have claims for insulin during the first six months post-transplant, while 10 percent have claims for sulfonylureas.

Congestive heart failure remains the leading cause of cardiovascular hospitalization during the first two years post-transplant. Among recipients who die with a functioning transplant, cardiovascular disease continues to be the leading cause of death, accounting for 30 percent of deaths, followed by infectious causes and malignancies at 21 and 9 percent. Urinary tract infections are the leading cause of hospitalization due to infection in the first post-transplant year. And in the three years post-transplant, lymphoproliferative disorders are reported in 0.5 and 1.6 percent of adult and pediatric Medicare-covered recipients.

Among all transplant recipients alive with a functioning transplant at the beginning of 2010, 56 percent were enrolled in a Part D prescription drug plan, compared to 44 percent of those receiving a transplant during the year. Reflecting continued attention to the prevention of cardiovascular events, beta blockers are prescribed for 75 and 71 percent of deceased and living donor recipients, respectively, during the first six months post-transplant. ACE inhibitors are prescribed for 23 and 22 percent, dihydropyridine calcium channel blockers for 65 and 58 percent, and loop diuretics for 44 and 27 percent. Approximately 41 percent of transplant recipients with Part D coverage have claims for statins during the first six months post-transplant, and 90 percent of recipients age 35 or older at transplant have a lipid screening performed during the first year. Targeting post-transplant cardiovascular complications will continue to yield improvements in recipient outcomes.

Medicare prescription drug costs, including all Part D costs as well as Part B costs for injectable and immunosuppressive drugs, reached $10,000 per transplant patient per year in 2010. Metoprolol, an antihypertensive agent, was the most common medication prescribed in each of the first three years post-transplant. The highest costs to Medicare during the first year post-transplant were for valganciclovir, recommended by the KDIGO Guidelines for Care of the Kidney Transplant Recipients (Guideline 13.2.1) for chemoprophylaxis of CMV infection during the first three months post-transplant and for six weeks following treatment with a T-cell depleting antibody. Use of valganciclovir during years two and three is reduced, although it remains the top medication by cost during year two and the fourth medication by cost during year three post-transplant. Unadjusted incident & transplant rates: limited to ESRD patients age 20 & older, thus yielding a computed incident rate higher than the overall rate presented elsewhere in the Annual Data Report. Wait list counts: patients age 20 & older listed for a kidney or kidney-pancreas transplant on December 31 of each year. Wait time: patients age 20 & older entering wait list in the given year. Transplant counts: patients age 20 & older as known to the USRDS.

Figure 7.1 Trends in transplantation: unadjusted rates, wait list, & total & functioning transplants, patients age 20 & older

Wait list

Figure 7.2 Patients wait-listed or receiving any transplant within one year of initiation, by age

Sixty percent of pediatric patients age 0–17 starting ESRD therapy in 2009 were wait-listed or received a deceased donor transplant within one year, compared to 28 percent of those age 35–49. Incident ESRD pts younger than 70.

Figure 7.3 Wait list counts & multiple listings

At the end of 2010, there were 55,060 active patients on the wait list for a kidney or kidney-pancreas transplant, and 31,560 inactive patients. Patients age 18 & older listed for a kidney or kidney-pancreas transplant on December 31 of each year (7.3).

Figure 7.4 Outcomes for wait-listed adult patients within three years of listing, by blood type

The percentage of adult patients receiving a deceased donor transplant within three years of listing has fallen considerably since 1991, and varies by blood type. It continues to be highest for those of blood type AB — at 47 percent for patients listed in 2007 — and lowest for those of type O or B, at 20 percent.­ The percentage receiving a living donor transplant has been rising, and varies little by blood type. Patients age 18 & older listed for a first-time kidney or kidney-pancreas transplant.s

Figure 7.5 Outcomes for first-time wait-listed patients three years after listing in 2007, by age, race, & PRA
(see page 440 for analytical methods)

Of patients listed in 2007, 20 percent of whites and Asians received a living donor transplant within three years, compared to just 8.0 percent of blacks/African Americans. Forty-four and 49 percent of Asians and blacks/African Americans were still waiting after three years, rates considerably higher than the 35 percent among whites. Patients age 18 & older listed for a first-time, kidney-only tx in 2007; transplanted patients may have subsequent outcomes in the three-year follow-up period.

Figure 7.6 Unadjusted. median wait times (years) for adults tx’ed in 2010, by state of tx center

Figure 7.7 Adjusted. mortality rates (per 100 person yrs of waiting) for wait-listed pts, by state, 2010

Median wait times for patients transplanted in 2010 exceeded four years in Alabama, Hawaii, New Jersey, California, and South Dakota; the median was 2.6. Adjusted mortality among wait-listed patients in 2010 was 6.2 deaths per 100 person years of waiting, and reached 9.2 in Louisiana. Patients age 18+ receiving a first-time, deceased-donor, kidney-only tx in 2010 (7.6). Pts age 18+, listed for a kidney or kidney-pancreas tx as of Jan. 1, 2010; see appendix for adjustments (7.7).

Figure 7.8 Likelihood of dying while awaiting transplant
(see page 440 for analytical methods)

Figure 7.9 Three-year cumulative incidence of transfusion in wait-listed pts, by PRA
(see page 440 for analytical methods)

Donation

For first-time transplant candidates, the probability of dying within one or five years while awaiting a transplant continued a downward trend in 2009, falling to 0.02 and 0.20. Transfusions are most common among patients who are highly sensitized at the time of transplant (PRA of 80 percent or higher). Patients age 18 & older, listed for a first-time kidney or kidney-pancreas tx (7.8); pts age 18 & older with Medicare primary coverage & first listed for a kidney tx in the given year (7.9).

Figure 7.10 Donation rates, by age, gender, & race

In 2010, rates of kidney donation from deceased donors reached 26 per million population in recipients age 35–64, and 26.3 and 17.2, respectively, in males and females. Since 2005, rates by race have been highest in blacks/African Americans, reaching 28.1 in 2010, compared to just 7.7 and 8.5 among Native Americans and Asians. Rates of donations from living donors are noticably higher among patients age 35–49, reaching 47 per million population in the middle of the decade, and 42 in 2010. By race, rates in 2010 were 6.5 and 11.5 per million among Native Americans and Asians, and 22–23 among whites and blacks/African Americans. Donors younger than 70 whose organs are eventually transplanted.

Figure 7.11 Deceased donor donations (per 1,000 deaths), by state, 2009–2010

In 2009–2010, the overall rate of donations from deceased donors was 2.4 per 1,000 deaths. Rates by state were greater than 3 per 1,000 deaths in Alaska, Delaware, Kansas, Utah, Maryland, Wisconsin, and Colorado, and less than 1.75 in Montana, New Hampshire, Oregon, Rhode Island, and Vermont. Deaths from July 1, 2009 to July 1, 2010.

Transplant

Figure 7.12 Deceased donor transplants, by age, gender, race, & primary diagnosis

Since 2000, the number of deceased donor transplants among patients age 65 and older has more than doubled, to 2,031, and there has been an increase of 50 percent among patients age 50–64. Among those age 18–34, in contrast, transplants have fallen 23 percent, to 1,187. Among blacks/African Americans and Asians, the number of transplants has grown 53 and 111 percent, respectively. Patients age 18 &older. Includes kidney-alone &kidney-pancreas transplants.

Figure 7.13 Adjusted transplant rates, by age, gender, race, & primary diagnosis: deceased donors

The adjusted deceased donor transplant rate has increased 54 percent since 2000 for patients age 65 and older, while falling 42 percent for those age 18–34. By race, the rate is down 34 percent among whites, while rising 11 percent for blacks/African Americans and Asians. Patients age 18 & older. Adjusted: age/gender/race/ethnicity/primary diagnosis (rates by one factor adjusted for remaining four).

Figure 7.14 Living donor transplants, by age, gender, race, & primary diagnosis

Among patients younger than 50, the number of living donor transplants has fallen 7–10 percent since 2000. For those age 50–64, in contrast, the number is now 42 percent higher, and for patients age 65 and older it has more than doubled. Living donor transplants among whites and blacks/African Americans have increased 8 and 16 percent, respectively, in this period, and have more than doubled among Asians. Patients age 18 &older. Includes kidney-alone &kidney-pancreas transplants.

Figure 7.15 Adjusted transplant rates, by age, gender, race, & primary diagnosis: living donors

Rates of living donor transplants peaked at the beginning of the decade, and have since fallen for many patient groups. As with deceased donor transplants, rates by race are now greatest in the Asian population, reaching 2.3 per 100 dialysis patient years in 2010 — 41 percent higher than in 2000. Patients age 18 & older. Adj: age/gender/race/ethnicity/primary diagnosis (rates by one factor adjusted for remaining four).

Figure 7.16 Adjusted transplant rates (per 100 dialysis patient years) by state of patient residence & donor type, 2010

Outcomes

In 2010, the national rate of deceased donor transplantation was 2.6 per 100 dialysis patient years. The highest rates were seen among residents of Vermont, Colorado, and Wyoming, with rates of 3.6 to 6.8. The rate of living donor transplantation was 1.5 nationally, and above 3.1 in Minnesota and North Dakota. Patients age 18 & older. Adjusted: age/gender/race/primary diagnosis; reference: prevalent dialysis patients, 2010.

Figure 7.17 Outcomes: deceased donor transplants

Figure 7.18 Outcomes: living donor transplants

Among patients who received a deceased donor kidney transplant in 2009, the probability of all-cause graft failure in the first year following transplant was 0.09, compared to 0.03 in those receiving a transplant from a living donor. The one-year graft and survival advantage experienced by living donor transplant recipients continues at five and ten years post-transplant, with probabilities of 0.17 and 0.39 compared to 0.29 and 0.56 in those receiving a deceased donor transplant. The probability of returning to dialysis or being retransplanted has lessened for both deceased and living donor recipients. For transplants performed between 1992 and 2001, the probability of return to dialysis by ten years post-transplant fell 26 and 23 percent, respectively. In contrast, the probability of death with function at ten years post-transplant has increased approximately 10 percent in both populations. Patients age 18 & older receiving a first-time, kidney-only transplant; unadjusted.

Figure 7.19 Acute rejection within the first year post-transplant

Figure 7.20 Transplants with delayed graft function (DGF), by donor type

The percentage of transplant patients experiencing an acute rejection has declined steadily over the past decacade, and three-fourths of reported acute rejections are biopsy-proven. In 2010, delayed graph function was reported in 2.6 percent of transplants from living donors, compared to 22, 28, and 41 percent of SCDs, ECDs, and donations after cardiac death. Patients age 18 & older with a functioning graph at discharge.

Figure 7.21 Hospitalization rates in the first &second years post-transplant, 2008

In the second year post-transplant, hospitalization rates for adult recipients are 54 percent lower than in the first year, at 67 admissions per 100 patient years. Admissions due to transplant complications fall 69 percent, to 12.1, while admissions due to cardiovascular causes and to infection fall 45 and 46 percent, to 8.2 and 18.1. First-time, kidney-only transplant recipients, age 18 &older, transplanted in 2008; ref: transplant patients, 2005.

Figure 7.22 Primary diagnoses of cardiac &infectious hospitalizations in the first &second years post-transplant

In the first year after transplant, 21 percent of cardiovascular hospitalizations are due to congestive heart failure; this number rises in the second year, to 24 percent. Hospitalizations for coronary atherosclerosis and CVA/TIA also increase, from 5.8 and 5.0 percent, respectively, in year one to 10.5 and 9.7 percent in year two. Urinary tract infection, septicemia, and pneumonia are the most common diagnoses among transplant patients admitted for infection, at 15–16 percent in the second year after transplant. First-time, kidney-only transplant recipients, age 18 & older, with Medicare primary payor coverage, transplanted in 2006–2008.

Figure 7.23 Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD)

Figure 7.24 Cumulative incidence of post-transplant diabetes

At 36 months after transplant, the cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) is more than three times greater among pediatric patients than among adults, at 1.63 percent compared to 0.48. Adults, in contrast, have a higher incidence of post-transplant diabetes, reaching 41 percent at 36 months, compared to 13 percent among pediatric patients. Patients receiving a first-time, kidney-only transplant, 2003–2007 combined.

Figure 7.25 Adjusted rates of outcomes after transplant

Figure 7.26 Causes of death with function, 2006–2010

The overall graft failure rate among adult transplant recipients fell to 6.2 per 100 patient years in 2010, while the rate of failure requiring dialysis or retransplantation fell to 3.0. Cardiovascular disease and infection are the main cause of death for 30 and 21 percent of adult patients who die with a functioning graft. Patients age 18+ at transplant; adjusted: age/gender/race (7.25). First-time, kidney-only transplant recipients, age 18+, 2006–2010, who died with functioning graft (7.26).

Figure 7.27 Immunosuppression use

Ninety percent of patients transplanted in 2010 used tacrolimus as their initial calcineurin inhibitor, and mycophenolate has almost completely replaced azathioprine as the anti-metabolite used in new transplant recipients. Use of mTOR inhibitors, both initially and post-transplant, has changed little, while steroid use seems to be stabilizing. Use of T-cell depleating and IL2-RA induction agents showed a negligible increased in 2010. Patients age 18 & older receiving a first-time, kidney-only transplant. CsA: cyclosporine A; CsM: cyclosporine microemulsion.

Follow-up care

Figure 7.28 Follow-up care & screening in the first 12 months post-transplant, by age

In 2009, 23 percent of recipients age 18–34 received an influenza vaccination in the 12 months post-transplant, compared to 37 percent of those age 60–64, and 48 percent of those age 65 and older. Lipid screening rates range from 84 percent in the youngest adults to 92–93 percent in those age 60 and older. Since 2003, nearly all recipients have received a CBC test in the year after transplant. Patients age 18 &older, with Medicare primary payor coverage, receiving a first-time, kidney-only transplant.

Part D medications in kidney transplant recipients

Figure 7.29 Sources of prescription drug coverage in kidney transplant recipients

Figure 7.30 Sources of prescription drug coverage in kidney transplant recipients, by age & years post-transplant (age 65+)

Figure 7.31 Transplant recipients enrolled in Part D

Figure 7.32 Total Part B & Part D medication costs per person per year (PPPY) in kidney transplant recipients

Figure 7.33 Cardiovascular medication use in the first six months post-transplant, 2008–2010 (Part D data)

Figure 7.34 Medications for lipid control in the first 6 months post-tx, 2008–2010 (Part D data)

Figure 7.35 Medications for diabetes control in the first six months post-transplant, 2008–2010 (Part D data)

Table 7.a Top 15 medications used by Part D-enrolled kidney recipients transplanted in 2007, by days supply

Table 7.b Top 15 medications used by Part D-enrolled kidney recipients transplanted in 2007, by days supply & cost

In 2010, 56 percent of kidney transplant patients were enrolled in Medicare Part D: 34 percent with the low income subsidy (LIS), and 22 percent without. Transplant patients age 65 and older are less likely to have the LIS than those age 20–64, at 19 and 40 percent, respectively. Since 2006, the proportion of recipients enrolled in Part D has increased from 38 to 44 percent at the time of transplant, and from 48 to 56 percent among living recipients.

In 2010, total Part B per person per year medication costs for transplant patients were slightly higher than those for Part D, at $5,420 and $4,580, respectively.

Data on cardiovascular medication use in the first six months after transplant show that both living and deceased donor transplant recipients are more likely to receive a beta blocker or dihydropyridine calcium channel blocker than an ACE inhibitor or angiotension receptor blocker; loop diuretics, however, are far more widly used in deceased donor recipients, at 44 versus 26 percent. Recipients are more likely to use statins than other types of lipid lowering medications, and 80 percent of those with diabetes at the time of transplant use insulin compared to 22 and 10.5 percent, respectively, using sufonylureas or TZDs.

Among those transplanted in 2007, metoprolol tartrate was the most frequently used medication in the first three years post-transplant. Valganciclovir hydrochloride was the most costly medicationin the first two years post-transplant, and insulin the most costly in year three. Patients enrolled in Medicare Part D & transplanted in 2007. Costs are estimated Medicare payment, defined as the sum of plan covered payment amount & low income subsidy amount. “Year 1” is the period from transplant to one year later. Years 2 & 3 are similarly defined.