Article Clinical Outcomes After Parathyroidectomy in a Nationwide

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Article Clinical Outcomes After Parathyroidectomy in a Nationwide Article Clinical Outcomes after Parathyroidectomy in a Nationwide Cohort of Patients on Hemodialysis | Areef Ishani,*†‡ Jiannong Liu,* James B. Wetmore,* Kimberly A. Lowe,§ Thy Do,§ Brian D. Bradbury,§ Geoffrey A. Block, and Allan J. Collins* Abstract Background and objectives Patients receiving dialysis undergo parathyroidectomy to improve laboratory parameters in resistant hyperparathyroidism with the assumption that clinical outcomes will also improve. *Chronic Disease fi Research Group, However, no randomized clinical trial data demonstrate the bene ts of parathyroidectomy. This study aimed to Minneapolis Medical evaluate clinical outcomes up to 1 year after parathyroidectomy in a nationwide sample of patients receiving Research Foundation, hemodialysis. Minneapolis, Minnesota; †Minneapolis Veterans Design, setting, participants, & measurements Using data from the US Renal Data System, this study identified $ Affairs Health Care prevalent hemodialysis patients aged 18 years with Medicare as primary payers who underwent parathy- System, Minneapolis, roidectomy from 2007 to 2009. Baseline characteristics and comorbid conditions were assessed in the year Minnesota; ‡ preceding parathyroidectomy; clinical events were identified in the year preceding and the year after Department of parathyroidectomy. After parathyroidectomy, patients were censored at death, loss of Medicare coverage, Medicine, University fi of Minnesota, kidney transplant, change in dialysis modality, or 365 days. This study estimated cause-speci ceventratesfor Minneapolis, both periods and rate ratios comparing event rates in the postparathyroidectomy versus preparathyroidectomy Minnesota; §Center for periods. Observational Research, Amgen Inc, Thousand Oaks, Results Of 4435 patients who underwent parathyroidectomy, 2.0% died during the parathyroidectomy California; and | hospitalization and the 30 days after discharge. During the 30 days after discharge, 23.8% of patients were Denver Nephrology rehospitalized; 29.3% of these patients required intensive care. In the year after parathyroidectomy, hospital- Clinical Research izations were higher by 39%, hospital days by 58%, intensive care unit admissions by 69%, and emergency room/ Division, Denver, observation visits requiring hypocalcemia treatment by 20-fold compared with the preceding year. Cause- Colorado specific hospitalizations were higher for acute myocardial infarction (rate ratio, 1.98; 95% confidence interval, Correspondence: 1.60 to 2.46) and dysrhythmia (rate ratio 1.4; 95% confidence interval1.16 to 1.78); fracture rates did not differ (rate fi Dr. Areef Ishani, ratio 0.82; 95% con dence interval 0.6 to 1.1). Chronic Disease Research Group, Conclusions Parathyroidectomy is associated with significant morbidity in the 30 days after hospital discharge Minneapolis Medical and in the year after the procedure. Awareness of clinical events will assist in developing evidence-based Research Foundation, fi 914 South 8th Street, risk/bene t determinations for the indication for parathyroidectomy. Suite S4.100, Clin J Am Soc Nephrol 10: 90–97, 2015. doi: 10.2215/CJN.03520414 Minneapolis, MN 55404. Email: [email protected] Introduction KDIGO guidelines currently state that patients with Secondary hyperparathyroidism (SHPT) is common CKD stages 3–5D with severe hyperparathyroidism among patients receiving dialysis (1). A major focus who fail to respond to medical therapy should un- of therapy for these patients is directed at control- dergo parathyroidectomy. This recommendation ling parathyroid hormone (PTH) levels, because may have been based on observational, not-randomized large, population-based observational studies have clinical trial evidence describing potentially benefi- suggested an association between severely elevated cial effects on short-term laboratory parameters and/or PTH values and poor patient outcomes (2,3). In re- on longer-term clinical outcomes including fracture and cent years, therapy for the management of SHPT has death (5,6). Some (7–12) but not all (5) reports suggest undergone several changes based on recommenda- that short-term adverse outcomes related to para- tions from the Kidney Disease Outcomes Quality thyroidectomy produce only modest adverse conse- Initiative (4) and the Kidney Disease Improving quences. However, many of these reports are based Global Outcomes (KDIGO) international guideline on single-center experiences, and may represent group (3). Unfortunately, the guideline working highly selected and high-performing surgical units groups have had little randomized clinical trial (7–12). In addition, the comparability of nonpara- data available to inform high-quality recommendations thyroidectomized control groups in these studies is for care. unknown. 90 Copyright © 2015 by the American Society of Nephrology www.cjasn.org Vol 10 January, 2015 Clin J Am Soc Nephrol 10: 90–97, January, 2015 Clinical Outcomes after Parathyroidectomy, Ishani et al. 91 There is a paucity of data describing the clinical clinical outcomes of interest were all-cause mortality outcomes that occur within the year after parathyroid- and hospitalization events including total number of hos- ectomy. Using data from the US Renal Data System pitalizations, specific causes, intensive care unit (ICU) (USRDS), we sought to (1) evaluate morbidity and stays, total number of hospital days, outpatient visits in- mortality after a parathyroidectomy procedure and (2) cluding emergency department visits, hospital obser- compare event rates in the year immediately after para- vation stays, and outpatient physician visits with thyroidectomy with rates in the year immediately preced- hypocalcemia. We also ascertained the total number of ing it, using a nationwide sample of United States dialysis fractures. The process for identifying fractures, which patients who underwent parathyroidectomy between used a combination of ICD-9-CM and Current Procedural 2007 and 2009. Terminology codes and place of service, and a complete listing of the codes themselves are detailed in Supple- mental Appendix 1. For hospitalizations and outpatient Materials and Methods visits, we determined whether hypocalcemia requiring Data Source, Populations, and Case Definition treatment was associated with the event. Treatment for This study used USRDS ESRD data, which include data hypocalcemia was defined by ICD-9-CM diagnosis code from the ESRD Medical Evidence Report (US Centers for 275.41, 275.49, or 275.5 with drug code J0610 or J0620. Medicare and Medicaid Services [CMS] form CMS-2728), Hospitalization with hypocalcemia was defined as any fi the ESRD Death Noti cation (form CMS-2746), the United hospitalization with ICD-9-CM diagnosis code 275.41, Network for Organ Sharing kidney transplant database, 275.49, or 275.5. Cause-specific hospitalizations were de- Medicare Part A institutional claims (inpatient, outpatient, fined using the following primary diagnosis codes: skilled nursing facility, home health, and hospice), and CVA/TIA 430–438; congestive heart failure 398.91; acute Medicare Part B physician claims (inpatient, outpatient, myocardial infarction 402.x1, 422.xx, 425.xx, 428.xx, 404.x1, and supplier). 408.x3, v421, or 410.xx; and dysrhythmia 426–427, v450, The study population included all prevalent patients or v533. aged $18 years receiving hemodialysis who underwent parathyroidectomy between January 1, 2007, and December 31, 2009. Patients were required to have Medicare as the Statistical Analyses The characteristics of hemodialysis patients undergoing primary insurance payer for both Part A and Part B and to parathyroidectomy were evaluated using descriptive have been receiving hemodialysis for at least 1 year before statistics means and standard deviations or medians and undergoing parathyroidectomy. Parathyroidectomy was 25th/75th percentiles for continuous variables, and counts identified from Medicare inpatient claims using Inter- and percentages for categorical variables. The study is a national Classification of Diseases, Ninth Revision, Clini- pre-post comparison of patients who underwent para- cal Modification (ICD-9-CM) procedure codes 06.8x and thyroidectomy, in which events occurring in the 1 year 06.95(13).Thedateoftheparathyroidectomywasconsid- after parathyroidectomy were compared with the same ered the index date, and the hospitalization during which events occurring in the 1 year before parathyroidectomy. parathyroidectomy occurred was considered the index The hospitalization for the parathyroidectomy procedure hospitalization. was not included as an outcome in either the prepara- thyroidectomy or the postparathyroidectomy timeframe, Patient Characteristics and Outcomes but mortality during that hospitalization was included. Patient characteristics were derived from the ESRD Med- Event rates were calculated for each outcome as the ical Evidence Report and Medicare claims. Characteristics number of events divided by follow-up time years. Rate assessed as of the index date included age, race (white, black, ratios (RRs) and 95% confidence intervals (95% CIs) were other), sex, primary ESRD cause (diabetes, hypertension, used to compare the occurrence of clinical events in the glomerulonephritis, other), body mass index, dialysis duration, 1-year periods after versus immediately preceding para- geographic region (18 US Renal Networks), and comorbid thyroidectomy. We present results for the population conditions (congestive heart failure, cerebrovascular accident/ overall and within strata of important baseline character- transient
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