Renal & Urology News May-June 2017

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V O L U M E 16, I S S U E N U M B E R 3

Sipuleucel-T May Help Blacks More Longer survival compared with whites reported

BY JODY A. CHARNOW BOSTON—Treatment with sipuleucel-T is associated with longer overall survival in blacks versus whites with metastatic castration-resistant prostate cancer (mCRPC), according to data presented at the American Urological Association’s 2017 annual meeting.

In a study led by A. Oliver Sartor, MD, the Laborde Professor of Cancer Research at Tulane University School of Medicine in New Orleans, black patients had an additional median overall survival (OS) benefit of 9.3 months compared with white patients (37.3

IN THIS ISSUE 11

Elevated cholesterol is linked to high-grade prostate cancer

11

New nomogram predicts passage of ureteral stones

12

Water vapor ablation eases BPH-related urinary retention

15

Active surveillance in selected cystic renal mass cases is safe

15

VTE risk continues long after radical cystectomy

Patients who undergo radical cystectomy are at elevated VTE risk for many years after surgery.

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vs. 28.0 months). In addition, among patients who had PSA levels below the median (26.8 ng/mL) at the time of treatment, black men had an OS benefit of almost 2 additional years compared with whites (54.3 vs. 33.4 months).

On multivariate analysis, black race was an independent baseline predictor of improved OS following treatment with sipuleucel-T, the investigators reported.

The findings reported by Dr. Sartor’s team are based on 630 men with mCRPC enrolled in the PROCEED registry. The cohort consisted of 210 blacks and 420 whites matched by baseline PSA level.

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RACIAL DIFFERENCES IN SURVIVAL In a study, sipuleucel-T treatment in patients with metastatic castrationresistant prostate cancer was associated with significantly longer median survival times, in months, among blacks versus whites. n Blacks n Whites

60

40

54.3

37.3

33.4

28.0 20

0

Overall cohort

Patients with PSA levels below the median

Source: Sartor AO, Armstrong A, Ahaghotu C, et al. Overall survival analysis of African American and Caucasian patients receiving sipuleucel-T: Preliminary data from the PROCEED registry. [abstract] J Urol. 2017;197(4S):e456-e457.

Oral presentation at the American Urological Association 2017 annual meeting in Boston on May 13, 2017. PD24-12.

The incidence of prostate cancer and the mortality rate from the disease are substantially higher among black than white men. In an interview with Renal & Urology News, Dr. Sartor said he was surprised by the racial difference in survival. “We’ve kind of gotten accustomed

to African Americans doing worse, and this was a reversal of that theme. I’m thinking that the most likely explanation is African-American immune systems are a little bit different. In this case, they’re different in a favorable way.” continued on page 9

AUA Releases PUL Efficacy for BPH Confirmed Updated Renal BY NATASHA PERSAUD who would have undergone, until now, BOSTON—Prostatic urethral lift TURP or another equivalent therapy.”

Mass Guidelines (PUL), a minimally invasive treatment Of 212 patients referred for transureBY JODY A. CHARNOW BOSTON—Updated guidelines for the evaluation and management of renal masses released by the American Urological Association (AUA) at its 2017 annual meeting provide clinicians with more clearly defined criteria for the use of radical and partial nephrectomy, and active surveillance. The guidelines also now advocate the use of thermal ablation in selected cases, particularly for small tumors.

Steven Campbell, MD, PhD, who chaired the AUA panel that developed the guidelines, said the expectation is that the guidelines will lead to more continued on page 9

for benign prostatic hyperplasia (BPH), demonstrates efficacy over 2 years for most candidates for transurethral resection of the prostate (TURP), researchers reported at the American Urological Association’s 2017 annual meeting.

“PUL is a new and promising surgical technique which may alleviate symptomatic BPH, even in severely obstructed patients,” Karl-Dietrich Sievert, MD, PhD, professor of urology at University Rostock, Germany, told Renal & Urology News. “It is an easy surgical technique and has been efficacious in candidates

thral resection of the prostate (TURP), 86 patients (aged 38 to 85) opted for PUL after receiving information on the less invasive therapy. Unlike select participants from previous studies who had only mild to moderate obstruction, these patients had a range of obstruction and were treated in a real-world clinical setting at 5 German medical centers during 2012 to 2014. No patients were excluded from the study due to high post void residual (PVR), prostate volume (PV), a history of urinary retention,

THE NEW mCRPC DRUGS: WHAT THE FUTURE HOLDS

E. David Crawford, MD, and Tomasz M. Beer, MD, offer their perspectives.

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continued on page 9

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DASH-Style Diet Associated with Lower Gout Risk GOUT RISK IS LOWER among individuals who follow a DASH-style diet and higher among those who consume a Western diet, investigators reported in BMJ 2017;357:j1794.

The DASH (Dietary Approaches to Stop Hypertension) diet emphasizes high intake of fruits, vegetables and

whole grains and low intake of red and processed meats and sweetened beverages. Western diets include high intake of red and processed meats, refined grains, and sweets.

The study, led by Hyon K. Choi, MD, of Harvard Medical School in Boston, included 44,444 men who participated

in the Health Professionals Follow-up Study who had no history of gout at baseline. Using validated food frequency questionnaires, researchers calculated DASH dietary pattern and Western dietary pattern scores. A total of 1731 confirmed gout cases were documented during 26 years of follow-up.

Compared with individuals in the lowest quintile of DASH score, those in the highest quintile had a 32% lower risk of incident gout in multivariable analysis. Compared with individuals in the lowest quintile of Western diet score, those in the highest quintile had a 42% higher risk of gout. n

www.renalandurologynews.com MAY/JUNE 2017

Renal & Urology News 5

Post-Tx Infections, Cancer Do Not Up Mortality OPPORTUNISTIC viral and fungal infections develop in one-third of kidney transplant recipients, but they do not affect patient or graft survival, study findings presented at the 2017 American Transplant Congress in Chicago. suggest.

In a single-center retrospective review, Michelle L. Lubetzky, MD,

and colleagues at Montefiore Medical Center in Bronx, NY, studied 673 kidney transplant recipients. During a median follow-up of 3.8 years, opportunistic infections or malignancy developed in 226 (34%). Of these, 19.8% had BKV, 1.9% had BK nephropathy, 9.6% had cytomegalovirus (CMV), 2.1%

had invasive CMV infection, 2.2% had fungal infections, and 5.8% had malignancies. The investigators found no difference in patient or graft survival between the group that experienced opportunistic viral or fungal infections or malignancies and patients without these complications.

A significantly higher percentage of patients with infections or malignancies received decease-donor kidneys than those who did not have these complications (81% vs. 74%). The infection/ malignancy group were more likely to receive kidneys from older donors (mean age 45.4 vs. 42.6 years) and had longer cold ischemia times (1354 vs.

1159 minutes) than the group without these complications. The groups showed no significant differences in acute rejection episodes (14% vs 9%), development of recurrent or de novo glomerular disease (8.1% vs. 61%), or transplant glomerulopathy (7.6% vs. 8.8%), and de novo donor-specific antibodies (17.3% vs. 14.7%). The most recent serum creatinine measurements were significantly higher in the infection/malignancy group (1.6 vs. 1.5 mg/dL). n

LKD Graft Survival Is Improving SURVIVAL OF renal grafts from living kidney donors (LKD) has improved significantly, researchers reported at the 2017 American Transplant Congress in Chicago.

Using the United Network for Organ Sharing database, Vaughn E. Whittaker, MD, and colleagues at the State University of New York at Syracuse studied 114,620 adults who received kidneys from LKDs from 1987 to 2015.

They divided the study period into 4 eras: 1987–1994, 1995–2001, 2002– 2008, and 2009–2015. For patients who received kidney transplants in these eras, the 5-year graft survival rates increased with each successive era: 76.6%, 79.7%, 83.1%, and 85.4%, respectively. Ten-year graft survival increased from 56.1% in 1987–1994 to 58.6% and 62.6% in 1995–2001 and 2002–2008, respectively. The 15-year graft survival rate rose from 37.7% in 1987–1994 to 39.9% in 1995–2001.

During 1987–1994, 1995–2001, 2002–2008, and 2009–2015, the median age of recipients was 36, 43, 48, and 50 years, respectively, and the median age of donors was 37, 39, 41, and 43 years, respectively. n

Cosmos Communications

6 Renal & Urology News

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FROM THE MEDICAL DIRECTOR EDITORIAL ADVISORY BOARD

What (Not) to Eat After Nephrectomy

I

n the past, nephrectomy, either for kidney donation or cancer, did not appear to be associated with a higher risk of chronic kidney disease (CKD) and end-stage renal disease (ESRD). The more recent literature, however, has been relatively consistent in suggesting that both donor and cancer nephrectomy are associated with a several-fold higher risk. For example, a study by Abimereki D. Muzaale, MD, MPH, of Johns Hopkins University in Baltimore, found that the risk of ESRD at 15 years after donation was 30.8 per 10,000 among kidney donors compared with 3.9 per 10,000 in a group of matched healthy non-donor counterparts.1 And, based on a meta-analysis, Morgan E. Grams, MD, also of Johns Hopkins, and colleagues found that the 15-year observed risks for ESRD were 3.5 to 5.3 times as high as the projected risks in the absence of donation.2 Not infrequently, both urologists and nephrologists provide follow-up and continuity of care to patients after cancer nephrectomy. Patients invariably ask us what to eat to protect the remaining kidney. We deal with the same question from kidney donors. In the past, doctors may have reassured kidney donors that they are not at higher risk of ESRD. Today, it would be naïve for physicians to believe that patients with a solitary kidney after nephrectomy do not have a serious condition and do not need dietary advice or diet and lifestyle modification. In fact, many contemporary patients who undergo donor or cancer nephrectomy demand nutritional advice.

No controlled clinical trial, however, has examined whether dietary approaches, such as a low-protein and low-salt diet, are effective in mitigating the higher risk of CKD and ESRD, but there are extensive data suggesting that higher protein intake is associated with glomerular hyperfiltration and higher risk of CKD.3 At my institution, we invariably suggest slightly lowered dietary protein intake of 0.8–1.0 g/kg per day combined with moderately low sodium diet of less than 4 grams per day. This slight dietary modification is pragmatic, as many of our patients do follow these recommendations. We strongly hope that additional studies are inspired and supported based on this and other discussions and publications. A challenge remains with athletes such as bodybuilders and weight lifters with a solitary kidney, who often look at me as the crazy, disconnected, non-athletic doctor when I tell them to lower protein intake.

Kam Kalantar-Zadeh, MD, MPH, PhD Chief, Division of Nephrology & Hypertension Professor of Medicine, Pediatrics and Public Health University of California Irvine School of Medicine 1. Muzaale AD, Massie AB, Wang MC, et al. Risk of end-stage renal disease following live kidney donation. JAMA. 2014;311:579-586.

2. Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.

3. Ko GJ, Obi Y, Tortorici AR, Kalantar-Zadeh K. Dietary protein intake and chronic kidney disease.

Curr Opin Clin Nutr Metab Care. 2017;20:77-85.

Medical Director, Urology

Medical Director, Nephrology

Robert G. Uzzo, MD, FACS G. Willing “Wing” Pepper Chair in Cancer Research Professor and Chairman Department of Surgery Fox Chase Cancer Center Temple University School of Medicine Philadelphia

Kamyar Kalantar-Zadeh, MD, MPH, PhD Professor & Chief Division of Nephrology & Hypertension University of California, Irvine School of Medicine Orange, Calif.

Urologists

Nephrologists

Christopher S. Cooper, MD Director, Pediatric Urology Children’s Hospital of Iowa Iowa City

Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, N.C.

R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto

David S. Goldfarb, MD Professor, Department of Medicine Clinical Chief New York University Langone Medical Center Chief of Nephrology, NY Harbor VA Medical Center

Stanton Honig, MD Department of Urology Yale University School of Medicine New Haven, CT J. Stephen Jones, MD, FACS President, Cleveland Clinic Regional Hospitals & Family Health Centers Professor & Horvitz/Miller Distinguished Chair in Urological Oncology Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology University of California Irvine

Csaba P. Kovesdy, MD Chief of Nephrology Memphis VA Medical Center Fred Hatch Professor of Medicine University of Tennessee Health Science Center, Memphis Edgar V. Lerma, MD, FACP, FASN, FAHA Clinical Associate Professor of Medicine Section of Nephrology Department of Medicine University of Illinois at Chicago College of Medicine, Chicago Allen Nissenson, MD Emeritus Professor of Medicine The David Geffen School of Medicine at UCLA, Chief Medical Officer, DaVita Inc.

James M. McKiernan, MD Assistant Professor of Urology Columbia University College of Physicians and Surgeons New York City

Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto

Kenneth Pace, MD, MSc, FRCSC Assistant Professor Division of Urology St. Michael’s Hospital University of Toronto

Robert Provenzano, MD Chief, Section of Nephrology St. John Hospital and Medical Center Detroit

Ryan F. Paterson, MD, FRCSC Assistant Professor Division of Urologic Sciences University of British Columbia Vancouver, Canada

Robert S. Rigolosi, MD Director, Regional Hemodialysis Center Holy Name Hospital, Teaneck, N.J.

Renal & Urology News Staff Editor Web editor Production editor Group art director, Haymarket Medical Production manager Production director Circulation manager National accounts manager Group Publisher Editorial director

Jody A. Charnow Natasha Persaud Kim Daigneau Jennifer Dvoretz Brian Wask Kathleen Millea Grinder Paul Silver William Canning Chad Holloway Kathleen Walsh Tulley

General manager, medical communications

Jim Burke, RPh

CEO, Haymarket Media Inc.

Lee Maniscalco

Renal & Urology News (ISSN 1550-9478) Volume 16, Number 3. Published bimonthly by Haymarket Media, Inc., 275 7th Avenue, 10th Floor, New York, NY 10001. Periodicals postage paid at New York, NY, and an additional mailing office. The subscription rates for one year are, in the U.S., $75.00; in Canada, $85.00; all other foreign countries, $110.00. Single issues, $20.00. www.renalandurologynews.com. Postmaster: Send address changes to Renal & Urology News, c/o DMD Data Inc., 2340 River Road, Des Plaines, IL 60018. Copyright: All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of Haymarket Media, Inc. Copyright © 2017.

8 Renal & Urology News

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Contents

MAY/ JUNE 2017 ■ VOLUME 16, ISSUE NUMBER 3

Urology 11

ONLINE

14

this month at renalandurologynews.com 15

Clinical Quiz Test your knowledge by taking our latest quiz at renalandurologynews.com/ ClinicalQuiz

20

HIPAA Compliance Our latest article offers tips for the safekeeping of protected health information off-site.

Drug Information

9

VTE Risk Continues Long After RC The 10-year cumulative incidence of venous thromboembolism was about 6.7%, with the complication developing a median of 216 days after surgery.

The New mCRPC Drugs: Clinical Practice Trends E. David Crawford, MD, and Tomasz Beer, MD, offer their perspective on the medications for metastatic castration-resistant prostate cancer that have come along in recent years.

High Uric Acid Levels Up Nephrolithiasis Risk New study found the association only among men, whose likelihood of kidney stone formation rose with increasing uric acid levels.

19

Urate-Lowering Drugs for Gout Underused in US Regardless of chronic kidney disease stage, most gout sufferers do not have the condition under control.

21

Accepting High-Risk Kidneys Is Better Than Waiting This option can maximize the probability of having a function graft for young and old patients, researchers concluded.

25

Diabetes Increases Post-Tx Mortality Diabetic donor-recipient pairs have a 3-fold higher 5-year death risk compared with non-diabetic pairs.

Job Board

News Coverage Visit our website for daily reports on the latest medical developments.

Neoadjuvant Chemo Benefits Some MIBC Patients Researchers report prolonged survival among patients who have neuroendocrine bladder tumors.

Nephrology

Search a comprehensive drug database for prescribing and other information on more than 4000 drugs.

Be sure to check our latest listings for professional openings across the United States.

New Nomogram Predicts Stone Passage It is based on factors found to be associated with stone passage, including size and location, white blood cell count, and history of stone passage.

CV death rates due to causes other than SCD have decreased markedly in dialysis patients over the past 2 decades, but little improvement has occurred for SCD.

See our story on page 19

CALENDAR Canadian Urological Association Annual Meeting Toronto June 24–27 International Continence Society Annual Meeting Florence, Italy September 12–15 American Society for Radiation Oncology Annual Meeting San Diego September 24–27 American Society of Nephrology Kidney Week New Orleans October 31–November 5 Genitourinary Cancers Symposium San Francisco February 8–10, 2018 Annual Dialysis Conference Orlando, FL March 3–6 National Kidney Foundation Spring Clinical Meeting Austin, TX April 10–14

26

Departments 6

From the Medical Director What to eat or not eat after nephrectomy

10

News in Brief Study links prescription NSAIDs to BPH

26

Practice Management Determining a practice's net collection rate

www.renalandurologynews.com MAY/JUNE 2017

Renal mass guidelines continued from page 1

sensible use of these management approaches. “There have been a lot of patients getting a radical nephrectomy who do not need one,” said Dr. Campbell, Professor of Surgery at Cleveland Clinic in Ohio. “We now really have a well-defined role for radical nephrectomy, with the hope that the patients who have increased oncologic risk and really fit the selection criteria will get a radical nephrectomy. If they don’t fit that profile, they should be considered for partial nephrectomy.” Partial nephrectomy has been underutilized, he added.

Radical nephrectomy criteria The guidelines recommend that radical nephrectomy be considered for patients who opt for active treatment and who have a solid or Bosniak 3/4 complex cystic renal mass in which tumor size, renal mass biopsy, and/or imaging characteristics suggest increased oncologic potential. In such patients, radical nephrectomy is preferred if all of the following criteria are met: high tumor complexity and partial nephrectomy would be challenging even in experienced hands; the patient has no preexisting chronic kidney disease (CKD) or proteinuria; and the patient has a normal contralateral kidney and new

PUL efficacy confirmed continued from page 1

or oral therapy for lower urinary tract symptoms (LUTS). The investigators reported that 2 to 7 PUL implants were inserted in each patient during the 35- to 90-minute procedure using general or local anesthesia. A majority (86%) reported a lessening of symptoms within a month of PUL. Over 2 years of follow up, average maximum urinary flow (Qmax) and PVR improved significantly. According to questionnaire responses, patients’ International Prostate Symptom Score (IPSS) and

Sipuleucel-T continued from page 1

Dr. Sartor postulated that blacks either have a more robust immune system or their tumors are more responsive to immunotherapy compared with whites.

Africa, he noted, is rife with infectious diseases and “it very well could be that the American-American immune system is geared to be more active.”

baseline estimated glomerular ­filtration rate (eGFR) will likely be greater than 45 mL/min/1.73 m2.

be consider this modality as an alternative approach in the management of cT1a renal masses smaller than 3 cm.

For patients who opt for this treatment, a percutaneous technique is preferred over a surgical approach when feasible to minimize morbidity.

Renal & Urology News 9

solitary kidney, bilateral tumors, known family history of renal cell carcinoma, and preexisting CKD, or proteinuria.

Partial nephrectomy should also be considered for patients who are young, have multifocal masses, or comorbidities that are likely to impact renal function in the future, such as diabetes, morbid obesity, moderate to severe hypertention, diabetes, and recurrent urolithiasis.

Regarding thermal ablation, the guidelines state that physicians should

Active surveillance Active surveillance should be considered for patients who have suspicious renal masses, especially those smaller than 2 cm. For patients with these masses, “physicians should prioritize active surveillance/expectant management when the anticipated risk of intervention or competing risks of death outweigh the potential oncologic benefits of active treatment,” the guidelines state.

For patients with a solid or Bosniak 3/4 complex cystic renal mass in whom the risk/benefit analysis for treatment is equivocal and who prefer AS, physicians should repeat imaging in 3-6 months to assess for interval growth and may consider renal mass biopsy for additional risk stratification.

The guidelines also include an expanded section on patient counseling. “Physicians should provide counseling that includes current perspectives about tumor biology and a patient-specific risk assessment inclusive of sex, tumor size/complexity, histology (when obtained), and imaging characteristics.”

No index patients In an important departure from the previous guidelines released in 2009, the panel abandoned the use of index patients. The previous guidelines were framed on 4 different index patients (healthy vs. unhealthy and those with T1a vs. T1b disease). “This time around the panel felt very strongly that there was so much variance and heterogeneity in the clinical characteristics of patient health, co-morbidities, functional issues, and oncologic issues, and that there were so many gray zones that the new guidelines do not use index patients,” Dr. Campbell told Renal & Urology News. “Rather, the panel advocates for more individualized patient evaluation and management.”

The new guidelines also have a greater focus on the functional implications of each management strategy “with the recognition that patients with localized kidney cancer typically do not die of cancer and their functional outcomes are a critically important part of their cancer survivorship as they move on with the rest of their lives,” he said. The guidelines provide recommendations about who should be referred to a nephrologist and the use of CKD staging before management. Such patients may include those with an eGFR less than 45 mL/min/1.73 m2, confirmed proteinuria, diabetics with preexisting CKD, or whenever eGFR is expected to be less than 30 mL/ min/1.73 m2 after intervention. n

quality of life improved from baseline to 1, 6, 12, and 24 months after surgery. No patients reported diminishing of sexual function, including ejaculation; some even reported improvement.

Patients with an in-dwelling catheter placed before surgery were able to void post-operatively with an acceptable PVR of less than a third of bladder capacity. At 6 months after surgery, the average Qmax was 12.8 mL per second and the PVR was 43.3 mL, and these improvements remained.

Eleven patients (13%) without severe obstruction required additional treatment due to their high PVR. Of these,

2 had another PUL that proved efficacious. The other 9 patients, with PVR values of 90 to 280 mL, underwent TURP. Four patients did not have further improvement following TURP. “Thirty-eight percent of our more severely obstructed patients would have been denied PUL utilizing previously reported study criteria,” Dr. Sievert noted. “PVR or even a placed transurethral catheter for retention seems not to be a contraindication.”

After 2 years, no patient required more oral drug treatment or surgery within the first year of PUL. Although urologists suggested TURP for 5 patients

with a PVR 50 to 100 mL, patients chose observation with no additional surgery.

“PUL is a treatment option for many patients. Its range of possible indications has not been fully evaluated. According to our findings, the positives are higher than the negatives,” said Dr. Sievert, an adjunct professor at Medical University Vienna in Austria. “Patients who have co-morbidities, risk of bleeding, or difficulty with general anesthesia may be good candidates for PUL. Since it is a minimally invasive approach, it does not exclude further treatment. If necessary, patients can undergo another PUL or opt for classic surgical treatment.” n

Dr. Sartor said he always thought that the place of sipuleucel-T is in relatively early-stage asymptomatic disease, but “now I’m really thinking about it for the African-American population.”

Sipuleucel-T, which is m ­ arketed as Provenge by Dendreon Pharmaceuticals, is an autologous cellular immunotherapy approved by the FDA in April 2010 for the treatment of asymptomatic or ­minimally ­symptomatic mCRPC. The

FDA approved the treatment on the basis of three phase 3 trials involving 737 patients. In one trial, sipuleucelT extended median survival by 4.1 months compared with a control group (25.8 vs. 21.7 months). The therapy reduced the overall death risk by 22.5% compared with controls.

Last year, the Society for Immuno­ therapy of Cancer published a consensus statement in the Journal for

ImmunoTherapy of Cancer (2016;4:92) stating that sipuleucel-T has a role in the management of mCRPC “prior to chemotherapy in the era of abiraterone and enzalutamide.”

“The role of sipuleucel-T may be somewhat limited,” the statement read, “but the optimal patients for this approach should be carefully defined, such that patients with mCRPC have as many options as possible.” n

Partial nephrectomy candidates Partial nephrectomy should be prioritized for the management of cT1a renal masses when intervention is indicated, the guidelines state. In these cases, partial nephrectomy minimizes the risk of CKD or CKD progression and is associated with favorable oncologic outcomes. In addition, nephron-sparing approaches should be prioritized for patients with an anatomic or ­functionally

More individualized patient care is a major emphasis of the new recommendations.

10 Renal & Urology News

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News in Brief

Please visit us at www.renalandurologynews.com for the latest news updates from the fields of urology and nephrology

Short Takes Chronic Prostatitis Has Adverse Effects on Sperm

of 151 ADPKD patients with a median

Chronic prostatitis has a detrimental

follow-up time of 4.38 years, Laura

effect on sperm, according to the find-

Girardat-Rotar, of the University of

ings of a systematic review and meta-

Zurich in Switzerland, and colleagues

analysis published online in the Journal

found that coffee drinkers did not

of Endocrinological Investigation.

have a statistically significant dif-

In a prospective longitudinal study

Chronic bacterial prostatitis was

ference in kidney size or estimated

associated with a reduction in sperm

glomerular filtration rate compared

concentration, sperm vitality, sperm

with those who did not drink coffee.

total and progressive motility, Rosita the University of Catania in Catgania,

BPH Risk Linked to Use of Prescription NSAIDs

Italy, reported. Chronic prostatitis/

Use of prescription non-steroidal

chronic pelvic pain syndrome was

anti-inflammatory drugs (NSAIDs) is

related to reduction in semen volume,

associated with an increased risk of

sperm concentration, sperm pro-

benign prostatic hyperplasia (BPH),

gressive motility, and sperm normal

according to study findings published

mortality.

online in The Prostate.

A. Condorelli, MD, and colleagues at

The population-based study, led by

Coffee Consumption Does Not Worsen ADPKD

Teemu J. Murtola, MD, of the Univer-

Coffee consumption does not worsen

included 74,754 Finnish men without

the course of autosomal dominant

previous BPH at baseline in 1996–

polycystic kidney disease (ADPKD),

1999. Of these, 57,707 (77.2%) used

researchers reported online ahead of

prescription NSAIDs. NSAID users

print in the Journal of Nephrology.

had a 2-fold increased risk of BPH

sity of Tampere, Tampere, Finland,

medication use, 59% increased risk

Prior in vitro studies of human PKD cells identified caffeine as a risk factor

of a recorded BPH diagnosis, and

for promoting cyst enlargement in

61% increased risk for BPH surgery

ADPKD patients.

compared with non-users.

Kidney Stones in Children Do you has have been a disaster?

Mostthink pediatricObamacare patients with renal stones an identifiable underlying metabolic and/or infective etiology, according to a recently published study of 511 children presenting with kidney stones over a 22-year period. Investigators classified the stones as follows:

Idiopathic

Metabolic

44%

34% Infective

22%

Source: Issler N, Dufek S, Kleta R, et al. Epidemiology of paediatric renal stone disease: a 22-year single centre experience in the UK. BMC Nephrol. 2017;18:136.

Cinacalcet May Lower Death Risk In Dialysis Subgroups C

inacalcet treatment is associated with decreased overall and cardiovascular mortality among younger dialysis patients and those with moderate secondary hyperparathyroidism (SHPT) and who do not have diabetes, researchers reported online in the European Journal of International Medicine.

Claudia Friedl, MD, of the Medical University of Graz, Graz, Austria, and colleagues studied 7983 dialysis patients, of whom 1572 (19.7%) were prescribed cinacalcet. A total of 3574 patients (44.8%) died, 1342 (16.8%) from cardiovascular causes, during a median follow-up of 2.7 years. Survival analysis in a propensity-score matched study population showed lower all-cause mortality for cinacalcet-treated versus untreated patients in subsets of patients characterized by younger age, low prevalence of diabetes, intact parathyroid hormone levels of 300 to 599 pg/mL, and concomitant therapy with v­ itamin D and phosphate binders.

Stenting Linked to Better Transplant RAS Outcomes S

tenting of transplant renal artery stenosis (RAS) is associated with less residual stenosis compared with angioplasty alone and may result in lower restenosis rates, Ling-Xin Chen, MD, MS, and colleagues at the UC Davis Medical Center in Sacramento reported at the 2017 American Transplant Congress in Chicago.

The researchers conducted a retrospective single-center cohort study that included 82 kidney transplant recipients who underwent percutaneous angiography (PTA) for transplant RAS. Of these patients, 58 underwent PTA alone and 24 underwent PTA with stenting. The stented patients had significantly less residual stenosis post-intervention compared with the angioplasty group (7.6% vs 15.8%).

Restenosis occurred in a significantly greater proportion of patients in the PTAonly group than the stent group (28% vs 9%).

HIV-Infected Living Kidney Donors Have Low ESRD Risk H

IV-positive individuals with well-controlled disease and no comorbidities have a low risk of end-stage renal disease (ESRD) following living kidney donation, researchers concluded in a paper published online ahead of print in the American Journal of Transplantation.

Abimereki D. Muzaale, MD, MPH, of Johns Hopkins University in Baltimore, and colleagues compared the incidence of ESRD among 41,968 HIV-positive patients followed for a median of 5 years with the incidence of ESRD among comparable HIV-negative individuals followed for a median of 14 years.

For 40-year-old HIV-positive individuals with health characteristics similar to those of age-matched kidney donors, CD4+ count of 500 cells/μL or higher, and viral load less than 400 copies/mL, the 9-year cumulative incidence of ESRD was higher than that of their HIV-negative counterparts, but still low: 3.0 versus 1.3 per 10,000 among white men, 2.5 versus 1.1 per 10,000 among white women, 15.8 versus 4.4 per 10,000 among black men, and 13.2 versus 3.6 per 10,000 among black women, the researchers reported.

www.renalandurologynews.com MAY/JUNE 2017

■ AUA 2017, Boston

Renal & Urology News 11

American Urological Association 2017 Annual Meeting, Boston

Cholesterol Linked to High-Grade PCa Elevated total cholesterol and HDL found to increase the risk of Gleason 7 or higher prostate cancer

BY JODY A. CHARNOW ELEVATED CHOLESTEROL levels are associated with an increased risk of high-grade prostate cancer (PCa), investigators reported.

The study, by Juzar Jamnagerwalla, MD, a chief resident at Cedars-Sinai Medical Center in Los Angeles and colleagues, included 4904 men who participated in the 4-year REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study and were not taking statins. As part of the study protocol, patients were required to undergo study-mandated biopsies. Each 1 mg/ dL increase in total cholesterol was significantly associated with 23% greater odds of high-grade PCa (Gleason score 7 or higher) at the 2-year biopsy. Total cholesterol levels were not associated with overall and low-grade PCa risk.

In addition, elevated high-density lipoprotein (HDL) levels were significantly associated with 34% and 74% greater odds of overall and high-grade

Outpatient IPP Surgery on the Rise PERFORMANCE OF inflatable penile prosthesis (IPP) surgery on an outpatient basis increased significantly from 2005 to 2015, according to newly released data.

In a study of 40,488 IPP surgeries performed during that 10-year period, Richmond Owusu, MD, of the University of California San Diego, the proportion of outpatient IPP

PCa compared with men who had low levels. The investigators found no association between low-density lipoprotein levels and PCa risk.

“Epidemiological studies linking cholesterol to prostate cancer are mixed.

However, results may be biased as cholesterol has been shown to be associated with PSA, thus influencing biopsy rates,” Dr. Jamnagerwalla told Renal & Urology News. “Given this, we tested the association between serum lipids and prostate cancer in the REDUCE study, in which all men received studymandated biopsies, finding that both HDL and total cholesterol were associated with significant increases in the risk of high-grade prostate cancer.”

“There is a lot of interest in how cholesterol relates to prostate cancer risk,” said senior author Stephen J. Freedland, MD, Professor of Surgery at CedarsSinai, where he also serves as Associate Director for Faculty Development in the Samuel Oschin Comprehensive Cancer

Institute. “We found that higher cholesterol was linked selectively with highgrade prostate cancer. This mirrors the data [showing] that statins may have little effect on overall prostate cancer risk, but reduce the risk of aggressive prostate cancer. This study provides further

Finding is based on a study of 4909 men who participated in the REDUCE study. support for research testing whether lowering cholesterol can prevent and/ or treat aggressive prostate cancer as well as to understand the mechanisms through which this occurs.”

The new study adds to mounting evidence of a link between elevated cholesterol and aggressive PCa. For example, a previous study of 55,875 veterans

published in the Journal of the National Cancer Institute (2011;103:885-892) found that each 10 mg/dL increase in baseline total cholesterol increased the risk of high-grade PCa by 6%. The highest quartile of baseline total cholesterol was associated with a 3-fold higher risk of high grade PCa compared with the lowest quartile. Total cholesterol was not associated with low-grade PCa. In another study, which included 5586 men randomized to the placebo arm of the Prostate Cancer Prevention Trial, researchers found that men with low cholesterol (less than 200 mg/dL) had 59% decreased odds of Gleason 8–10 PCa than men with high cholesterol (200 mg/dL or greater). The investigators, who reported their findings in Cancer Epidemiology, Biomarkers & Prevention (2009;18:2807-2813), observed no association between cholesterol and total PCa and Gleason 2–6 or Gleason 7 PCa. n

New Nomogram Predicts Stone Passage RESEARCHERS HAVE developed a nomogram for predicting ureteral stone passage in patients on medical expulsive therapy.

The nomogram is based on factors found to be associated with stone passage, such as stone size and location, a history of stone passage, and serum white blood cell count.

“This tool may be used for patient counseling, shared decision making, and to help identify patients who could benefit from early intervention,” lead author Vishnu Ganesan, MD, of the Cleveland Clinic Lerner College

of Medicine in Ohio, told Renal & Urology News.

In a study of 1146 emergency department visits for ureteral stones confirmed by computed tomography, Dr. Ganesan and his colleagues found that each 1 mm increase in stone size is associated with 50% decreased odds of stone passage.

Compared with patients who had proximal ureteral stones, those with middle and distal stones had 1.6 and 3.1 times increased odds of stone passage. A history of stone passage was associated with 1.7 times increased odds of passage.

Each 1000-cell increase in WBC count

was associated with 10% increased odds of passage.

The nomogram assigns points to each of these variables, and these points are added to come up with a score (on a scale of 1 to 100). Higher scores indicated a greater probability of stone passage.

Age, gender, serum creatinine level, and hydronephrosis had no significant effect on stone passage.

Of the 1146 patients, 48% were lost to follow-up, 31% had spontaneous stone passage, and 20% underwent a procedure to remove the stone. n

surgeries increased from 54.3% in 2005 to 83.2% in 2015.

During the study period, the South­east region performed the highest proportion of outpatient surgeries (46.7%), followed by the Midwest (21.5%), Southwest (12.7%), West (11.9%), and Northeast (7.1%).

Surgery for infection occurred significantly more frequently in the inpatient setting (1.5% vs 0.9%). n

‘Real-World’ Data Support PUL Use for LUTS PROSTATIC URETHRAL lift (PUL) procedures for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia offer symptom relief through at least 12 months of follow-up, according to “real-world data.”

PUL involves placement of small permanent metallic implants into the pros-

tate that lift the lateral lobes away from the urethra and remove obstruction.

Paul Cozzi, MBBS, of the Sydney Urology Research Foundation in New South Wales, Australia, and colleagues analyzed pooled data from 197 commercial PUL cases performed at various centers in Australia and North

America. At 1, 3, and 12 months, patients had a 30%, 42%, and 31% improvement in International Prostate Symptom Score, respectively, and a 51%, 46%, and 61% improvement in quality of life, respectively. Patients experienced mild improvement in peak flow rate during the 12 months. n

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American Urological Association 2017 Annual Meeting, Boston

Water Vapor Ablation Eases Urinary Retention

BY JODY A. CHARNOW BOSTON—A minimally invasive therapy that uses water vapor to ablate prostate tissue can effectively treat recalcitrant urinary retention in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), new findings show.

In a study, convective radiofrequency water vapor energy prostate ablation (Rezum), 43 (81.1%) of 53 BPH sufferers with urinary retention were catheter-free after months of being dependent on a catheter, a team led by Kevin T. McVary, MD, Chair and Professor of Urology at Southern Illinois University (SIU) School of Medicine in Springfield, reported. The men were catheter-free after an average of 28 days post-procedure.

Preoperatively, the cohort, which was selected from an international registry founded at SIU, had a mean age of 77 years, mean prostate size of 64.5 mL, and mean post-void residual (PVR) of 614 mL. After the ablation procedure, the mean PVR dropped to 116 mL. The mean post-procedure International Prostate Symptom Score (IPSS) for the cohort was 9. The primary endpoint of the study was successful trial without catheter (TWOC).

Among the men who had a successful TWOC, the mean PVR decreased from 506 mL before the procedure to 97 mL afterward.

The investigators cited studies showing that the rates of urinary retention in BPH/LUTS patients are as high as 35.9 per 1000 person-years, and 67% of patients with the condition undergo surgery after spontaneous urinary retention within 4 years. They noted that men in urinary retention are typically excluded from all randomized controlled trials for standard surgical procedure trials and pharmaceutical trials, as well as minimally invasive surgical treatments.

“Men in urinary retention are a special understudied group because they tend to be older, frailer, with larger prostates, and difficult to successfully treat,” Dr. McVary told Renal & Urology News. “Understanding them better and finding new minimally invasive ways to safely free them from the rigors, discomfort and complications of a catheter dependent life is an unmet need in urology. This international registry founded at SIU opens the door to

exam a new way to measure the clinical impact of this new technology.”

In a poster presented at the American Urological Association 2016 annual meeting, Dr. McVary and ­colleagues

reported findings from a study of 197 men with BPH/LUTS showing that water vapor ablation provides durable symptom improvement while preserving sexual function. For the study,

the i­nvestigators randomly assigned patients to undergo water vapor ablation or to receive a control procedure consisting of rigid cystoscopy with mimicked active treatment sounds. At

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3 months, LUTS improved by 11 points in the water ablation group compared with 4.3 points in the control arm.

In patients with severe LUTS (IPSS greater than 19), 85% achieved a 30% or greater reduction in symptoms. At 3 months, peak flow rate increased 68% (6.2 mL/sec) in the water ­vaporization

group compared with no change in the control group. These improvements were sustained in 96% of treated subjects who completed their 1 year follow-up.

At study entry, 52% of treatment subjects had a history of erectile dysfunction (ED) and 26% had

decreased-stoppage ejaculation. Dr. McVary’s group included only sexual active men (91 of the 136 water ablation patients) in sexual function analyses. In these men, the International Index of Erectile Function baseline mean score was 17.2 and the Male Sexual Health Questionnaire for

Renal & Urology News 13

Ejaculatory Dysfunction mean score was 7.8. The researchers reported no clinically meaningful negative changes in scores over 12 months.

Modest decreases in ejaculatory volume occurred in 6 men (4.4%), anejaculation in 4 men (2.9%). No new ED cases were reported. n

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14 Renal & Urology News

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American Urological Association 2017 Annual Meeting, Boston

Neoadjuvant Chemo Benefits Some MIBC Patients NEOADJUVANT chemotherapy (NAC) before radical cystectomy (RC) may provide a survival advantage for patients with neuroendocrine tumors of the bladder, researchers reported.

Evidence of benefit exists for patients with localized pure urothelial muscleinvasive bladder B:7.25” cancer (MIBC), but it less clear for variant non-pure uroT:7” thelial tumors, including the most S:7”

common types: pure neuroendocrine tumors, squamous cell carcinoma, adenocarcinoma, micropapillary differentiation, and sarcomatoid differentiation.

“Histological bladder cancer variants are systematically excluded from prospective trials and thus, this benefit cannot be translated into generalized recommendations regarding perioperative chemotherapy in MIBC with variant nonpure urothelial histology,” the researchers stated in a poster presentation.

To address the evidence gap, Malte Vetterlein, MD, of Brigham and Women’s Hospital in Boston, and colleagues compared overall survival and pathology between patients receiving RC with (210 patients) and without (1345 patients) NAC for MIBC cT2 and above (without lymph node involvement or metastasis) using the National Cancer Database 2003 to 2011. The investigators defined NAC as multi-agent systemic therapy given within 6 months of RC (single-agent chemotherapy was excluded).

Prolonged survival found among patients with neuroendocrine bladder tumors.

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Among patients with neuroendocrine tumors, the median survival time was 34.1 months for patients who received NAC prior to RC and 18.9 months for those treated with RC alone.

Multivariate analyses revealed a 36% greater overall survival benefit and less upstaging at RC for neuroendocrine tumor patients receiving NAC versus surgery alone.

Patients who had tumors with micropapillary and sarcomatoid differentiation also showed a decrease in pathologic upstaging with NAC, but there were no significant improvements in survival, the investigators reported.

“While neoadjuvant chemotherapy in neuroendocrine tumors seemed to be associated with a survival benefit, this was not in seen in micropapillary and sarcomatoid differentiated tumors, potentially due to the aggressive biology,” Dr. Vetterlein told Renal & Urology News. “However, we observed less upstaging in patients with micropapillary and sarcomatoid variants who received neoadjuvant chemotherapy, which suggests that there might be a benefit in a specific subgroup of patients harboring those variant histologies.” n

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Renal & Urology News 15

VTE Risk Continues Long After RC The cumulative incidence of venous thromboembolism over 10 years was nearly 6.7%, study finds from 2002 to 2014. These RC patients are more susceptible to pulmonary embolism and deep vein thrombosis because cancer, surgery, and immobility are each risk factors. The cohort included 433 patients who had preoperative and 695 who had postoperative chemotherapy.

The 10-year cumulative incidence of VTE was 6.68%, the investigators reported. VTE occurred a median of 216 days and an average of 527 days after surgery. They observed the highest VTE incidence at 20 days post-surgery, however.

“The peak in VTE incidence at 20 days is in keeping with previous data which has shown that a significant burden of VTE events occur following hospital discharge,” Dr. Wallis said.

“Extended, post-discharge prophylaxis is likely warranted.”

Patients treated preoperatively with chemotherapy appeared to have a 32% lower incidence of VTE compared with

AS Safe for Cystic Renal Masses in Selected Patients ACTIVE SURVEILLANCE (AS) with or

A significantly smaller proportion of

without delayed intervention is a suc-

patients with CRMs than SRMs pro-

cessful management approach for well-

ceeded to treatment (23.3% vs 33.9%).

selected patients with localized cystic

Of the patients with CRMs who crossed

renal masses, researchers reported.

over to delayed intervention, 64% did

In a study, Andrew McIntosh, MD, and

so within 2 years.

colleagues at Fox Chase Cancer Center

In the CRM group, younger patients

in Philadelphia found that these patients

were more likely to crossover to delayed

were less likely to proceed to delayed

intervention than older patients (57.2 vs

intervention and had a significantly

64.4 years). The mean change in ETV of

slower mean change in estimated tumor

the cystic masses was 5.8 cm3 per year

volume (ETV) compared with patients on

compared with 11.4 cm3 among patients

AS for solid renal masses.

with SRMs. In the SRM cohort, the mean

The study included 601 patients on AS

linear growth rate of the masses was

for renal masses and who had 5 or more

2.6 mm per year. At 5 years, 95.4% of

years of follow-up. The group included

the CRM patients were alive.

196 patients who had cystic renal

Dr. McIntosh’s team also looked at a

masses (CRMs) and 405 who had solid

subset of 37 CRM patients who had 5 or

renal masses (SRMs). The CRM cohort

more years of follow-up without crossing

had a median follow-up of 59.7 months.

over to delayed intervention. All were alive

Forty-eight CRM patients (24%) crossed

and only 1 patient experienced distant

over to delayed intervention during a

metastases. The mean linear growth rate

median time of 16.7 months.

for this subset was 0.1 mm per year. n

Previous studies may have underestimated venous thromboembolism rates.

those not receiving chemotherapy, but perioperative chemotherapy did not show any significant associations on multivariate analysis. Given the observational design of the study, the investigators could draw no definitive conclusions.

CD Use After Cystectomy Is Declining

BY NATASHA PERSAUD USE OF CONTINENT diversion (CD) with orthotopic neobladder after radical cystectomy has been decreasing in recent years, despite the benefit to bladder cancer patients of an internal reservoir for urine, according to investigators.

Use of CD declined from a peak of about 11% of cases in 2008 to slightly above 8% in 2012, according to the investigators.

“Continent diversions may allow better quality of life and body image perceptions over ileal conduits in selected patients,” lead investigator Robert Weiss, MD, of Rutgers Cancer Institute of New Jersey in New Brunswick, told Renal & Urology News. “The youngest patients may be the best candidates.

We are concerned that urologists may not be adequately discussing the option of continent diversions, especially with younger patients.”

Patients with a previous VTE had 5.1 times higher risk of VTE after RC. Other factors, including age, comorbidity score, diversion type (continent vs ileal conduit), academic treatment center, gender, locale, and treatment year, had no effect on risk.

“A prior history of VTE before bladder cancer diagnosis is the strongest risk factor for subsequent VTE after cystectomy,” Dr. Wallis stated.

“Physicians should consider these patients at high risk and undertake prophylaxis accordingly.”

Previous research found an association between post-RC VTE and a 25%–65% increased risk of mortality at 5 years. “This may represent patients with more aggressive tumors or other adverse factors,” Dr. Wallis commented.

Guidelines for thromboprophylaxis in urologic surgery released recently by the European Association of Urology are a good resource for care, he said. n

Using 2001–2012 data from the National Inpatient Sample, the team calculated and compared urinary diversion rates using ICD-9 codes for CD with orthotopic neobladder versus ileal conduit (IC) in male patients with bladder cancer. During the study period, 69,049 ICs and 6991 CDs were performed.

In a reversal of the rise observed from 2001–2008, CD use declined every year after 2008. Across all age groups, IC was performed more frequently, including in the youngest subgroups of patients (aged 40–59 and 60-69 years).

CD and IC showed similar rates of surgical site complications and in-hospital mortality. Complications overall occurred more frequently among IC than CD patients (52.8% vs. 44.7%).

Factors associated with greater use of CD included male sex, white race, residing in the western United States, and receiving treatment at a large hospital and/or urban teaching center.

“Possible reasons for declining incidence of continent diversions might include physician reimbursement, length of surgical time, higher incidence of robotic surgery, and physician counseling of patients regarding diversion options,” Dr. Weiss stated. n

© BSIP / SCIENCE SOURCE

BY NATASHA PERSAUD THE INCIDENCE OF venous thromboembolism (VTE) peaks at 20 days after radical cystectomy (RC), according to new study findings. Bladder cancer patients, however, continue to be at risk for VTE long after surgery.

Previous studies examining the perioperative period or just 6 months after RC likely underestimated VTE rates, according to the investigators. “The incidence of VTE continues to rise long after the date of surgery. However, the vast majority occur in the first year following surgery,” Christopher J.D. Wallis, MD, PhD, of the University of Toronto in Toronto, Canada, told Renal & Urology News.

Using data from the Ontario Cancer Registry, Ontario Health Insurance Plan, and Canadian Institute for Health Information, Dr. Wallis and his colleagues analyzed VTE occurrence among all 3623 bladder cancer patients in the province undergoing RC

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Renal & Urology News 19

National Kidney Foundation 2017 Spring Clinical Meetings, Orlando, Florida

SCD Rate in HD Population Constant No decline observed despite drop in cardiovascular deaths overall

BY NATASHA PERSAUD FEWER HEMODIALYSIS patients are dying from cardiovascular (CV) causes overall, but progress is needed to reduce the rate of sudden cardiac death (SCD).

“CV death rates due to causes other than SCD have decreased markedly in dialysis patients over the past 2 decades, but little improvement has occurred for SCD,” stated lead study author Charles Herzog, MD, of the University of Minnesota in Minneapolis, on behalf of the Peer Kidney Care Initiative investigators. “Future improvements in the overall CV death rates will require advances in preventing SCD.” During 1996 to 2013, the rate of total CV deaths among hemodialysis (HD) patients fell 42.5% from 12 to 7 per 100 persons per year, according to an analysis of Medicare data. However, after a modest decline from 2004 to 2010, the SCD death rate has remained constant at approximately 5 deaths per 100 patients per year. SCD continued to be a major contributor to CV deaths, accounting for about 61% of such deaths in 2009 and 73% in 2013.

Meanwhile, hospital admissions for arrhythmias, a precursor to SCD, remained unchanged from 2004 to

2013, at approximately 4.5 admissions per 100 patients per year.

A number of problems may contribute to SCD in this population, according to Dr. Herzog. Obstructive coronary artery disease, left ventricular hypertrophy, and alterations in myocardial structure and function (e.g., endothelial dysfunction, interstitial fibrosis, decreased perfusion reserve, and diminished

Sudden cardiac death rates remain stable at about 5 deaths per 100 patients/year. ischemia tolerance) are possible contributors. Additional factors specific to HD include rapid electrolyte shifts, lowpotassium dialysate with hyperkalemia, and dialysis vintage.

“Although speculative, I think accurate risk stratification may ultimately rely on a combination of echocardiography, electrocardiography, and cardiac biomarkers, such as high sensitivity cardiac troponins,” Dr. Herzog told Renal & Urology News. “The KDOQI

[Kidney Disease Outcomes Quality Initiative] 2005 cardiovascular practice guidelines still work pretty well. What is still missing is an effective therapy to reduce SCD, which in my opinion is a direct consequence of the ‘cardiomyopathy of CKD,’ the left ventricular hypertrophy and myocardial fibrosis that contribute to arrhythmic death.

“I welcome seeing interventions that actually prevent the development of left ventricular hypertrophy and myocardial fibrosis,” he continued. “It’s potentially a long list that requires testing in randomized clinical trials. I personally think there is a role for ‘device’ therapy in preventing SCD in dialysis patients.”

Lastly, he said he believes physicians need to adequately inform patients about the risks of SCD, particularly at dialysis initiation.

The team encouraged new studies on the timing of cardiovascular events, including whether cardiovascular deaths and arrhythmia-related admissions occur on HD or post-HD days, or before or after a dialysis session. How constituent electrolytes of the dialysis bath affect dialyzability of potentially anti-arrhythmic drugs such as betablockers also needs to be explored. n

Urate-Lowering Drugs for Gout Underused in US MOST INDIVIDUALS in the United States who have been diagnosed with gout are not currently taking adequate medication to lower uric acid levels, new study findings suggest.

In addition, regardless of chronic kidney disease (CKD) stage, the majority of gout sufferers do not have the condition under control.

Jean J. Lim, MA, of Tufts University School of Medicine in Boston, and colleagues analyzed data from 15,868 individuals aged 20 years or older who participated in the National Health and Nutrition Examination Surveys (NHANES) 2007–2012. Of these respondents, 715 had been told by a doctor they had gout. These respondents represented an estimated total of 7.7 million individuals with gout in the United States (prevalence of 3.7%).

Of the estimated gout population, 5.7 million individuals (74%) had normal

to stage 2 CKD, 1.1 million (15%) had stage 3a CKD, and 0.8 million (11%) had stage 3b-5 CKD, Lim and colleagues reported in a poster presentation.

Most of the estimated gout population had uncontrolled gout—defined as the presence of a gout diagnosis and a serum

Most individuals with gout do not have the condition under control. uric acid level of 6 mg/dL or higher— regardless of CKD stage. Results showed that among the estimated gout population with normal to stage 2 CKD, uncontrolled gout was present in 44% of those who were taking a xanthine oxidase inhibitor (XOI) and 68% of those

who were not taking an XOI. In the estimated gout population with stage 3a CKD, uncontrolled gout was present in 36% of those who were taking an XOI and 80% of those not taking an XOI. In the estimated gout population with stage 3b–5 CKD, uncontrolled gout was present in 57% of those taking an XOI and 83% of those not taking an XOI. In the estimated gout population, current use of an XOI (mostly allopurinol) was found in 22% of individuals with normal to stage 2 CKD, 42% of those with stage 3a CKD, and 44% of those with stage 3b–5 CKD. “The majority of non-institutionalized US adults who self-report that they have been diagnosed with gout have uncontrolled gout regardless of CKD stage, with the highest proportion of uncontrolled gout among those patients who have Stage 3b-5 CKD,” the investigators wrote. n

HD Patient Visits to the ED Rising

BY JODY A. CHARNOW RATES OF EMERGENCY department encounters (EDE) and observation stays (OBS) among hemodialysis patients have now exceeded hospital­ ization rates, investigators reported.

David T. Gilbertson, PhD, of the Chronic Disease Research Group, Minneapolis Medical Research Foun­ da­tion, and investigators with the Peer Kidney Care Initiative analyzed the Centers for Medicare & Medicaid Services end-stage renal disease data from 2004 to 2013. They created yearly cohorts during that period comprising patients who were on dialysis and covered by Medicare Part A on January 1 of the year.

The number of prevalent hemodialy­ sis patients increased from 249,439 in 2004 to 374,971 in 2013. From 2004 to 2013, the hospitalization rate decreased from 206 to 164 per 100 patient-years, whereas EDE/OBS rates increased from 166 to 200 per 100 patient-years.

The combined burden of hospital­ izations or EDE/OBS was relatively constant until 2011, and then dipped slightly thereafter, reaching 350 per 100 patient-years in 2013, Dr Gilbertson’s group reported.

“Long-term declines in hospitaliza­ tion rates are seen in the general Medicare population as well as the dialysis population,” Dr. Gilbertson told Renal & Urology News. “Recent declines may be impacted by the Hospital Readmission Reduction Program. In turn, care previously delivered in an inpatient setting may now be delivered in and emergency department or observation-stay setting.”

He continued, “While this rather dramatic change may have occurred in part due to overall declining trends in hospitalization rates as well as hospital lengths of stay, the conse­ quences of this change on patient outcomes is relatively unknown.” n

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n ASK THE EXPERTS

The New mCRPC Drugs: Clinical Practice Trends The medications can prolong survival, but their optimal use remains unclear

BY JODY A. CHARNOW

A number of new drugs for treating metastatic castration-resistant prostate cancer (mCRPC) have come on the market in recent years. For perspective on the use of these drugs in clinical practice, Renal & Urology News spoke with two researchers who have been involved in studies of these agents: E. David Crawford, MD, Professor of Surgery/ Urology/Radiation Oncology and Head of Urologic Oncology at the University of Colorado, Denver, and Tomasz M. Beer, MD, who holds the Grover C. Bagby Endowed Chair for Prostate Cancer Research and is Deputy Director of the Oregon Health & Science University Knight Cancer Institute in Portland.

The new anti-androgens have been on the market in the United States for about 5 or 6 years. How does your experience with these medications in clinical practice compare with clinical trial outcomes?

Dr. Crawford: During the past several years, we have had 5 new drugs, all with different mechanisms of action,

approved for use in advanced prostate cancer. This offers all sorts of opportunities to improve our outcome in men with castration-resistant prostate cancer. These drugs fall into several broad categories, including immunotherapeutics, radiopharmaceuticals, chemotherapy agents, and drugs that interfere with either testosterone production or testosterone action.

Abiraterone is an androgen biosynthesis inhibitor (ABI). Enzalutamide is a third-generation anti-androgen that differs markedly from drugs such as bicalutamide. Both abiraterone and enzalutamide have had remarkable success yet result in modest improvements in survival among men with prostate cancer failing chemotherapy.

Cancer is a collection of genomic changes. The longer it is around, the more that genomic heterogeneity develops and the less responsive it is to therapy. So the natural course of events in the past several years has been to move these drugs into the prechemotherapy space. We are going to see these drugs moved up even earlier

In the future, we may be combining 3 or 4 of these drugs together for a short period of time. ­—E. David Crawford, MD

in the disease process and be used in newly diagnosed metastatic disease in high-risk men with biochemical failure and in men who have high-risk local lesions. These new therapies will be combined with such standard treatments as radical prostatectomy and radiation. I believe the same is true for prostate cancer.

Dr. Beer: In general, my experience mirrors that of the clinical trial results.

However, there are some minor differences.

For example, patients who received different hormonal therapy regimens than were allowed on the clinical trials experience modestly less benefit than the trials reported. We have also gained some more experience with the use of these agents. With enzalutamide, for example, we have seen the benefit of dose reductions for patients with fatigue.

We have also come to appreciate that fatigue with these therapies, and particularly enzalutamide, is a real practical issue we need to pay attention to. But

for the most part, we see in practice what we expect to see based on clinical trial results.

In clinical trials, treatment with the newer agents was associated with a median 4-month improvement in survival compared with placebo. Is there a subgroup of patients who experience substantially better survival? Are there clinical indicators of response?

Dr. Crawford: The fact that survival was only improved on an average of 3 to 5 months postchemotherapy is actually remarkable rather than disappointing. This opened the door to using these drugs earlier. The IMPACT [Immunotherapy for Prostate Adenocarcinoma Treatment] trial showed that sipuleucel-T treatment was associated with significantly prolonged survival among men with lower prostate-specific antigen (PSA) values.

Median survival was 13 months for men with a PSA value in the lowest baseline quartile compared with 2.8 months for those in the highest quartile. There are

I see potential for these agents to be given in combination with leuprolide up front. ­—Tomasz M. Beer, MD

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numerous studies ongoing with all of these drugs earlier in the disease process.

Dr. Beer: I would use caution in describing the survival benefit in terms of the median. That is only 1 point on the survival curve. I also think it leads people to believe that their personal benefit will equal 4 months, which is unlikely to be accurate. Individual patients are likely to benefit more or less. But also, importantly, that benefit was seen with considerable crossover, whether within the trials or through access to standard-of-care drugs. Therefore, the overall survival of the study groups reflects not only the treatment assignment in the trial, but also the effects of all subsequent therapies. This almost certainly results in an underestimation of the benefit. Progression-free survival, which has its own limitations, is a more direct measure of the effects of each drug on the behavior of the disease.

The studies were not designed to robustly identify groups that benefit more, and post-hoc subset analyses suggest that treatment benefits all major subsets of patients. That does not mean that there is not significant variation between patients. Patients who respond, as measured by decline in prostate-specific antigen (PSA) and improvements in radiographically evident disease, would be expected to benefit more than those who do not.

What have you learned about the differences in tolerability of the newer agents, adverse event profiles, and cost?

Dr. Crawford: I have learned that these new agents are remarkably well tolerated. Each has its own nuances but, in general, side effects have been minimal.

Dr. Beer: Tolerability of the agents is quite good, especially compared with chemotherapy. The side effect profiles in practice largely reflect what we saw in the trial reports, and clinical judgment about susceptibility to various side effects drives our selection of the agent for each patient. As an example, patients with diabetes or other contraindications to steroids might do better starting with enzalutamide while patients with pre-existing severe fatigue may do better with abiraterone. These are not evidence-based suggestions, as the 2 drugs have not been compared head to head, but they do represent day-in/ day-out clinical judgment that we exercise in caring for our patients. The cost of these drugs is a significant concern both for patients and for society.

Do you have a preferred sequence of agents? Have you found cancer-specific outcomes to be clinically different based on which agent you start with?

Dr. Crawford: We are beginning to see combinations rather than drug sequencing. Every cancer we cure is a result of drug combinations rather than drug sequencing. With lymphomas, for example, several drugs are used: cyclosphosphamide, hydroxydaunorubicin, vincristine, and prednisone or prednisolone. The same is true for testicular cancer. The curative treatment is 3 drugs, not 1. In the future, we will need to focus on therapeutic layering. Many clinicians will start out with the least toxic agent and move to an agent with more side effects. What this means is that chemotherapy is delayed in the disease process. We are all aware of CHAARTED [Chemohormonal Androgen Ablation Randomized Trial], which evaluated chemotherapy early, but this was in highvolume, newly diagnosed metastatic disease. This group is different from the patients in whom these drugs are being used today. However, it makes sense to move these drugs up early.

Dr. Beer: There is no one-size-fits-all sequence. As mentioned previously, we tend to consider various side effects when selecting which drug we might start with for an individual patient. At our center, when there is no specific factor driving a choice, we tend to start with enzalutamide. This largely reflects our experience in researching the drug and the fact that many of our patients are treated on clinical trials, and we have focused more of our research on enzalutamide.

Do you think the new androgen-receptor targeted drugs have a place as first-line androgen deprivation therapy in place of traditional agents such as leuprolide?

Dr. Crawford: I do not believe there is any question that these drugs will be integrated into first-line therapies. In the future, we may be combining 3 or 4 of these drugs together for a short period of time — for instance 6 months — which is done in many cancers that we control and cure.

Dr. Beer: I see potential for these agents to be given in combination with leuprolide up front. However, this is a question that needs to be answered in clinical trials. It is possible that these agents could also compete head to head with luteinizing hormone-releasing hormone (LHRH) agonists, but I find that to be less likely than the emergence of combination therapy. n

Renal & Urology News 21

Donor-Recipient CMV Matching Promising CYTOMEGALOVIRUS (CMV) matching of deceased kidney donors and kidney transplant recipients optimizes high- and low-risk profiles and has the potential to prevent CMV infections and mortality and decrease costs associated with antiviral prophylaxis and treatment, researchers reported at the 2017 American Transplant Congress in Chicago.

Investigators at the Oregon Health and Science University (OHSU) in Portland and the University of Nebraska in Omaha reported on a pre-transplant CMV matching program that went into effect at their institutions on August 1, 2012 whereby deceased kidney donors and kidney recipients are matched by CMV serostatus. The goal is to reduce the number of highrisk donor positive/recipient negative (D+/R−) transplants and increase the number of low-risk donor negative/ recipient negative (D−/R−) transplants without adversely affecting wait times for a deceased-donor kidney.

Joseph B. Lockridge, MD, of OHSU, and colleagues retrospectively studied 622 deceased-donor kidney transplant recipients: 314 pre-CMV matching and 308 post-CMV matching. The CMV matching strategy decreased the number

of D+/R− transplants from 60 (19.1%) to 9 (2.9%) and increased the number of D−/R− transplants from 42 (13.4%) to 74 (24%), Dr. Lockridge and his colleagues reported.

Before and after intervention, the median number of days on the wait list increased from 651 to 853. The median number of days on the wait list increased from 696 to 862 for CMV negative recipients and from 611 to 843 for CMV positive recipients.

“Not surprisingly, median waiting times for a kidney transplant increased for all patients during this study due to growing waiting list size, but neither CMV negative nor CMV positive patients appeared to be disadvantaged by implementing CMV matching,” the investigators wrote in their study abstract.

In a separate analysis comparing 197 pre-CMV matching and 159 post-CMV matching recipients, the researchers demonstrated that the CMV matching has the potential to significantly improve CMVrelated morbidity and associated costs.

CMV viremia rates decreased from 14.2% to 6.3% after implementing CMV matching. The percentage of patients requiring antiviral treatment for CMV decreased from 11.2% to 5.7%. n

Accepting High-Risk Kidneys Is Better Than Waiting EVEN HIGH-RISK KIDNEYS provide

Due to the low likelihood of a

potential benefit to kidney transplant

transplant, the researchers observed,

candidates compared with declin-

accepting a high KDPI kidney offer can

ing the offer and remaining on the

maximize the probability of having a

kidney transplant wait list, research-

functioning graft among young and old

ers reported at the 2017 American

patients, the researchers reported.

Transplant Congress in Chicago.

Andrew Wey, PhD, of the Scientific

For example, a 35-year-old male transplant candidate who accepts the

Registry of Transplant Recipients in

offer of a high KDPI kidney has a 76%

Minneapolis, and colleagues investigated

probability of having a functioning

the tradeoff between transplanting a

graft 5 years post-offer, according to

high-KDPI [Kidney Donor Profile Index]

the investigators. The probability of

kidney versus the risk of waiting for a

having a functioning graft at 5 years

better kidney. Dr. Wey’s team estimated

post-offer declines to 33% for the

the probability of a functioning kidney

same patient who declines the offer

graft in 1 to 5 years from the time of

and remains on the wait list for 3

offer of a deceased-donor kidney with a

years. For a 65-year-old male candi-

KDPI of 95% and an expected 30 hours

date, the probabilities are 70% and

of cold ischemia time.

20%, respectively. n

24 Renal & Urology News

■ AUA 2017, Boston

MAY/ JUNE 2017 www.renalandurologynews.com

American Urological Association 2017 Annual Meeting, Boston

Nomogram Improves Post-RP Metastasis Predictions BOSTON—Researchers have developed a preoperative nomogram they believe is more suitable than previous nomograms for predicting metastasis after radical prostatectomy (RP)

for localized high-risk prostate cancer (PCa). The nomogram, has greater predictive accuracy for metastasis than the Cancer of the Prostate Risk Assessment (CAPRA) and Memorial Sloan Kettering

Cancer Center (MSKCC) nomograms, Lamont Wilkins, a medical student at the Lerner College of Medicine at the Cleveland Clinic in Ohio, and colleagues reported.

In a collaborative effort, researchers at Cleveland Clinic and Johns Hopkins University in Baltimore developed the nomogram based on findings from a study that included 1241 men who underwent RP from 2005 to 2015 for high-risk or very-high-risk PCa. The investigators divided patients into a training cohort of 620 men and a validation cohort of 621 men.

The area under the curve (AUC) for predicting metastasis was 0.75 for the new nomogram compared with 0.67 and 0.66 for the CAPRA and MKSCC nomograms, which the investigators noted were developed based on cohorts of primarily low- and intermediate-risk men. n

Female UI Linked to Low Testosterone LOW SERUM testosterone in women increases the likelihood of stress and mixed urinary incontinence, according to researchers. The study is the first to demonstrate such an association.

In a study of 2123 women who participated in the 2012 cycle of the National Health and Nutrition Examination Survey and underwent measurements of serum total testosterone, Michelle Kim, MD, PhD, of Massachusetts General Hospital in Boston, and colleagues found that women in the lowest quartile of testosterone level had 48% increased odds of stress incontinence and 65% increased odds of mixed incontinence compared with women not in the lowest quartile.

“The potential mechanism is that testosterone may prevent pelvic floor atrophy, thereby reducing the risk of urinary incontinence,” Dr Kim said in a press conference.

The association between low testosterone and increased risk of stress and mixed incontinence, and the absence of an association with urge incontinence, makes sense because the mechanism of stress incontinence relies more heavily on the integrity of RAYA16AGRX4627_Brief_PI_V2_1_r3_FSU.indd 1

10/18/16 5:17 PM

the pelvic floor, Dr. Kim said. n

www.renalandurologynews.com MAY/JUNE 2017

Renal & Urology News 25

Diabetes Increases Post-Tx Mortality Diabetic donor-recipient pairs have a 3-fold higher 5-year death risk versus non-diabetic pairs

BY NATASHA PERSAUD DIABETES IN A kidney recipient, a deceased donor, or both is associated with worse post-transplant survival, researchers reported at the 2017 American Transplant Congress in Chicago.

Of 706 recipients of deceased-donor kidneys at Houston Methodist Hospital in Texas during 2006–2014, 23 had diabetes and received a diabetic kidney, 26 were free of the disease and received a diabetic kidney, 211 had diabetes and received a non-diabetic kidney, and 446 had no diabetes and received a non-­diabetic kidney. At 5 years posttransplant, the patient mortality rate was 8.5% in the non-diabetic donor and recipient group, compared with 3.8% in the diabetic-donor-only group, 15.6% in the diabetic-recipient-only group, and 21.7% in the diabetic donor and recipient group, Faiza N. Khan, DO, of Houston Methodist Hospital, and colleagues reported in a poster presentation. The diabetic donor-recipient group had a 3.14 times higher risk of death at

5 years compared with donor-recipient pairs free of diabetes. Graft survival at 5 years was 83.4% in the non-diabetic donor-recipient group, 92.3% in the diabetic-donor-only group, 77.1% in the diabetic-recipient-only group, and 66.6% in the diabetic donor-recipient group.

“Recipients with diabetes have a significant increase in patient mortality than non-diabetic recipients. This is likely due to diabetes being a known risk factor for micro- and macrovascular disease,” the investigators concluded.

With regard to the study’s potential clinical implications, the investigators noted that diabetic nephropathy is seen in only 30%– 40% of people with diabetes. “The Kidney Donor Profile Index, a calculation that gives a numerical value to each donated kidney, is used by surgeons to decide which kidneys to accept and is heavily influenced by diabetes status of the donor. The bigger clinical implication from this study is exactly this: The KDPI may result in a higher discard rate of kidney organs,” Dr. Khan stated.

Opioid Use Raises Graft Loss Risk

prior to transplantation. Opioid use was more common among female, white, unemployed, and privately insured recipients and those with long pre-transplant dialysis duration, the researchers reported.

In adjusted analyses, the highest-level opioid use was associated with a 45% and 28% higher risk of death and allcause graft loss, respectively, in the first post-transplant year compared with no opioid use. Among recipients with the highest level of pre-transplant opioid use, 60% continued high-level use after transplantation, according to the investigators.

High-level opioid use in the first year after transplantation was also associated with worse outcomes, with an approximately 2-fold higher risk of death and a 68% higher risk of allcause graft loss over the following year, the study found.

In an interview with Renal & Urology News, Dr. Lentine, who is Medical Director for Living Kidney Donation at SLU’s Center for Transplantation, stated, “While associations may in part reflect underlying conditions or behaviors, opioid use history appears relevant in assessing and providing care to kidney transplant candidates and recipients.” n

BY JODY A. CHARNOW OPIOID USE before and after a kidney transplant may increase the risk of graft loss and death, investigators reported at the 2017 American Transplant Congress in Chicago.

In a study of 75,430 kidney transplant recipients, Krista L. Lentine, MD, PhD, Professor of Medicine at Saint Louis University (SLU) in St. Louis, Missouri, and colleagues examined the association between opioid use in the year before and after transplantation and patient and graft survival.

Using a novel database, Dr. Lentine and her colleagues linked national transplant registry identifies for kidney transplant recipients to records from a large US pharmaceutical claims warehouse for the period 2008–2015.

Prescription fills for opioids in the year prior to transplantation were normalized to morphine equivalents. Of the 75,430 patients in the study, 43.1% filled opioid ­prescriptions in the year

Diabetes and Post-Transplant Survival A study examining the effect of diabetes on survival after a kidney transplant found that diabetic recipients of a kidney from a diabetic donor had the highest 5-year post-transplant mortality rate.

Non-diabetic donor and recipient

8.5%

Diabetic recipient only

Diabetic donor and recipient

21.7%

15.6% Diabetic donor only

3.8% Source: Khan F, Suki W, Nguyen D, Graviss E. Outcomes of kidney transplantation using deceased diabetic donors. [abstract] Am J Transplant. 2017;17 (suppl 3). Poster presented at the American Transplant Congress in Chicago, April 29–May 3, 2017. Abstract A103.

A study published earlier this year in Lancet Diabetes & Endocrinology (2017;5:26-33) found that kidney transplant recipients with type 2 diabetes have a 10-year mortality rate more than twice that of non-diabetic recipients (25.3 vs 11.5 deaths per 100 recipients).

Compared with non-diabetic ­recipients,

diabetic recipients had a 1.6 times and 1.5 times greater risk of all-cause mortality and death with a functioning graft, respectively, in adjusted analyses.

The association between diabetes and all-cause mortality and death with a functioning graft was most pronounced among patients younger than 40 years. n

Antibiotics Reduce UTI Rate After Kidney Transplantation FEWER KIDNEY transplant recipients

comes from 2 different treatment eras:

treated with a combination of cephalexin

151 patients treated with cephalexin for

plus sulfamethoxazole-trimethoprim

1 month with or without SMX-TMP during

(SMX-TMP) for prophylaxis against

2014 to 2015 (new era) and 661 patients

Pneumocystis pneumonia (PCP)

treated with or without SMX-TMP alone

experienced post-transplant urinary

during 2005 to 2012 (old era).

tract infection (UTI) than recipients who

In the new era, 12 patients received

received cephalexin alone, new study

another fluoroquinolone, including 8

findings presented at the 2017 American

who also received SMX/TMP.

Transplant Congress in Chicago suggest.

In the new era, the UTI incidence rate

“There was a significant decrease

was significantly lower in cephalexin-

in UTI rates among patients treated

treated patients receiving SMX/TMP

with cephalexin in addition to SMX/

compared with those who did not

TMP PCP prophylaxis compared to

receive SMX/TMP (7.5% vs 25.8%).

patients treated with SMX/TMP alone,”

New era SMX/TMP patients also had a

Patrick M. Klem, PharmD, BCPS, of

significantly lower incidence rate of UTI

the University of Colorado in Aurora,

than SMX/TMP patients in the old era

Colorado, and colleagues concluded

(7.5% vs 16.3%). The first UTI occurred

in their study abstract. “However this

significantly later in the new era at 34

benefit was lost when an alternative

days post-transplant compared with 14

PCP prophylactic was used.”

days in the old era. During both eras,

Dr. Klem and colleagues investigated

the most prevalent bacteria associated

the efficacy of cephalexin, a cephalospo-

with UTIs were Enterococcus species

rin antibiotic, by comparing patient out-

and Escherichia coli. n

26 Renal & Urology News

MAY/JUNE 2017

www.renalandurologynews.com

Practice Management Net collections can be improved by addressing such issues as claim denials and failure to obtain prior authorizations BY TAMMY WORTH

(Payments − Credits) / (Charges − Contractual Agreements) x 100 • Total payments: $500,000 • Refunds/credits: $14,000 • Total charges: $850,000 • Total write-offs: $350,000 • ($500,000 − $14,000) / ($850,00 − $350,000) • $486,000 / $500,000 • 0.972 × 100 • Adjusted collection rate: 97.2% Source: American Academy of Family Physicians

A practice can strive for numbers like a rate of 99%, but Hays said in the real world, somewhere around 95% is optimal. An adjusted collection rate at or below 90% is an indicator the practice has problems in some areas that need to be resolved.

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If the collection rate is in the low 90s, the best way to identify the issues is to break up collections by payer. The same calculations should be performed for each payer to identify outliers. “If only one of your payers is at 90%, it will knock down your total, and you won’t know why it is happening without looking at individual payers,” Hays said.

Denials A few common issues may explain a lower collection rate. The first is denial codes. Many vendors can work with a practice to create reports that track the reasons for denials. By checking these, practices can look for patterns, which can be something as simple as submitting incorrect policy numbers.

Hays used to work at a practice when Cigna came out with new identification numbers that used both zeros and the letter “o.” The staff was inputting them incorrectly. When she began pulling claims, she found that a large number were denied because of incorrect policy numbers.

Prior authorization Another area in which medical offices can trip up is not obtaining prior authorization, Hays said. Practice management systems should have a way to identify which claims prior authorization denials were attached to, what information the practice office should be submitting but is not, and the process for obtaining prior authorization for each scenario. Practices may be able to create a process that flags claims that need prior authorization before the claims are submitted to ensure the appropriate information is attached.

“This is something that isn’t just always up to the front desk, it’s a team effort,” Hays said. “It’s not just billing, but nurses and physicians all need to know that just because they do a procedure, it doesn’t mean they are going to get paid for it.”

© BERNARDASV / GETTY IMAGES

A

host of factors affect a practice’s revenue cycle, but none more important perhaps than the adjusted (or net) collection rate. Barbie Hays, coding and compliance strategist for the American Academy of Family Physicians (AAFP), said knowing this number is crucial to understanding a practice’s income and how the practice can bring in more money.

“The net collection rate is what you need to pay attention to,” she said. “It tells you the health of your practice, and if you are making any money.”

The rate is the percent of total reimbursement collected out of the total a practice could have collected. Tallying this number is a way to find out where and why the practice is losing potential revenue.

To figure the adjusted collection rate, divide charges from payments and multiply by 100 to get the percentage. The following is an example from the AAFP showing how to calculate these numbers.

Tallying the net collection rate of a practice can provide clues to the loss of potential revenue.

Write-offs Hays also recommends a report that checks for high write-offs. Creating this report can inform practices of payers that have write-offs higher than 50%, which Hays said should throw up red flags. In these cases, these payers’ fee schedules can be pulled to see where the discrepancies lie. For instance, if the negotiated rate

into their system, but practices would benefit from doing so, Hays said. For example, if a contract with a payer says it is supposed to pay a practice $140 for a specific code, most electronic medical records (EMR) systems issue an alert and create an exception report if payments are less than the expected amount.

An adjusted collection rate at or below 90% is an indicator the practice has problems in some areas that need to be resolved. is $80 for every $100 charged, and they are using a write-off of $40 for each $100, the payer should be contacted to find a resolution. “Twenty dollars out of $100 is a big chunk of change,” Hays said.

Fee schedules Fee schedules are something that most practices do not take the time to enter

Hays also recommends keeping abreast of the costs of medications and supplies. Prices can fluctuate, and if reimbursement rates do not at least cover these costs, a practice can end up losing money. ■ Tammy Worth is a freelance medical journalist based in Blue Springs, MO.

Want to improve your practice? Look for our tips on how to handle equipment issues, adjust to EHRs, comply with HIPAA, and more at www.renalandurologynews.com/practice.